FR3124068A1 - Radio frequency equipment - Google Patents

Abstract

Radiofrequency equipment (1) configured for the heat treatment of vulvo-vaginal tissues comprising: - a radiofrequency generation module comprising a variable frequency oscillator (RFO), configured to generate an integer number N of determined frequencies F1 to FN, the number N being greater than or equal to 2, as well as a radio frequency power amplifier (AMP) configured to amplify the radio frequency signal generated by the variable frequency oscillator,- a radio frequency transmission system receiving the radio frequency signal, amplified by said amplifier (AMP) comprising:-- a vulvovaginal probe (RF-PB), monopolar comprising one or more radio frequency transmitters said vulvovaginal probe configured to be inserted statically in the vagina, Figure of the abstract: Figure 2

Description

Radio frequency equipment

The present disclosure relates to radio frequency equipment configured for the heat treatment of vulvovaginal tissues and which comprises a vulvovaginal probe, intra orifice, with one or more radio frequency emitters (electrodes).

The present disclosure falls within the field of non-surgical equipment, radio frequency finding particular application for treating vaginal relaxation.

Vaginal relaxation can appear, especially after natural childbirth, or even after menopause, and which can result in urinary incontinence and/or loss of sensations during sexual intercourse.

The principle of treatment is based on equipment comprising a thermo-regulated probe which includes at least one emitter of electromagnetic waves which stimulate the natural production of collagen and elastic fibers of the dermis of the vaginal wall.

The state of the art knows of the ThermiVA probe, such a device with a single-use probe, provided with a radio frequency transmitter at its end. According to the findings of the inventor, such a device needs to be moved during the treatment, to scan the length of the area to be treated, and thus obtain a homogeneous treatment over the length of the vaginal wall.

The state of the art still knows, for example from documents EP3195898, US9.713.565, WO2020/101175A1, WO2020/084645, WO2018/0303542, EP3346937, US2018/0303542, US2020/0046969 radio frequency equipment whose intra-orifice probe has several radio frequency transmitters distributed over the length of the probe, and which make it possible to treat the zone, without requiring the probe to be moved over the length of the zone to be treated, which can then remain static during the treatment.

According to the findings of the inventor, the state of the art thus describes intra-orifice probes, with monopolar emitter(s) which provide in-depth treatment of the tissues typically at a fixed excitation frequency, or even bipolar probes which include pairs of electrodes, such as for example taught by US2020/0046969. For bipolar probes, radio frequency energy can be applied sequentially to different pairs of electrodes so that the RF energy sweeps the length of the vagina wall, the probe then static, and as described for example in document US2020/0046969.

According to the findings of the inventor, probes of the bipolar type make it possible to ensure homogeneous treatment of the wall along its length, but do not make it possible to ensure in-depth treatment of the tissues.

According to the findings of the inventor, there is a need for radio frequency equipment comprising a vulvo-vaginal probe providing deep tissue treatment, and homogeneously over the thickness of the wall, namely from the surface to the depth , or even preferably also over the length of the vaginal wall to be treated, and preferably without requiring the vulvo-vaginal probe to be moved during the radiofrequency treatment.

Summary

This disclosure improves the situation.

In general, the present disclosure proposes, at least according to one embodiment, such thermoregulated equipment, the design of which is optimized, with increased safety with respect to potential risks of burns.

A radiofrequency equipment configured for the heat treatment of vulvo-vaginal tissues is proposed, comprising:
- a radio frequency generation module comprising a variable frequency oscillator, configured to generate an integer number N of determined frequencies, the number N being greater than or equal to 2, as well as a radio frequency power amplifier configured to amplify the radio frequency signal generated by the variable frequency oscillator,
- a radio frequency transmission system receiving the radio frequency signal, amplified by said amplifier comprising:
-- a monopolar vulvovaginal probe comprising one or more radio frequency transmitters, said vulvovaginal probe configured to be inserted statically into the vagina,
-- a return antenna, external to the patient's body,
- a first radiofrequency connection cable connecting the radiofrequency transmitter, or the radiofrequency transmitters of the vulvo-vaginal probe to the output of the amplifier, and a second radiofrequency connection cable connecting the return antenna to the output of the amplifier,
- a temperature measurement system arranged to measure the temperature at the level of a wall of the vulvo-vaginal probe configured to emit a temperature signal,
- a control module comprising a microcontroller, receiving the temperature signal as input, a variable frequency oscillator control signal as output, and a memory in which are recorded a setpoint temperature and instructions configured to set implements a cyclical RF transmission method, the cyclical transmission method comprising, at each radiofrequency transmission cycle, a radiofrequency transmission sequence comprising a succession of radiofrequency transmissions at the different determined frequencies F1 to FN, respectively on periods T1 to TN, and the implementation of temperature regulation at said setpoint Tco by reading by the microcontroller of the temperature signal measured in real time, preferably at each transmission cycle.

According to one embodiment, each radiofrequency emission cycle comprises the radiofrequency emission sequence comprising the succession of radiofrequency emissions at the different determined frequencies F1 to FN, respectively over periods T1 to TN, followed by a period Tp without emission radiofrequency, and in which the reading of the temperature signal S _T by the microcontroller for temperature regulation is implemented during the period Tp devoid of radiofrequency emission.

According to one embodiment, the system for measuring the temperature of the probe comprises a thermocouple comprising an open loop formed by two wires of different metals, including a first wire and a second wire welded at their end by a hot weld, as well a control card configured to measure a potential difference between the two son of different metals, and generating the temperature signal, digital and in which the hot solder is made on the radiofrequency transmitter or one of the radiofrequency transmitters. In particular, the first radio frequency link cable being connected to the transmitter or said radio frequency transmitters by welding, the hot weld of the thermocouple can advantageously simultaneously constitute a weld ensuring the connection between the first radio frequency link cable and the said radio frequency transmitter carrying the weld hot.

According to one embodiment, the whole number N is equal to 3 and in which for example:
- the frequency F1 is between 300 kHz and 600 kHz,
- the frequency F2 is between 600 kHz and 1000 kHz,
- the frequency F3 is between 1000 kHz and 2000 kHz.

According to another embodiment, the integer N is equal to 2 and in which for example:
- the frequency F1 is between 300 kHz and 600 kHz,
- the frequency F2 is between 600 kHz and 1500 kHz.

According to one embodiment, the transmission periods T1 to TN at the different frequencies F1 to FN are respectively less than 1 second, in particular less than 0.5 seconds, for example between 0.1 second and 0.4 seconds.

According to one embodiment, the period Th of the emission sequence of the emission cycle, which corresponds to the period Tc of the radiofrequency emission cycle from which the period Tp without radiofrequency emission is subtracted, can be less than 3 seconds, preferably less than 1 second.

According to one embodiment, the control module is configured to implement regulation by comparing the temperature signal Ts with an upper threshold value Tco+δ, higher than the setpoint value Tco, and a lower threshold value Tco- +δ and to stop the radiofrequency emission when the temperature signal Ts reaches or crosses the upper threshold value Tco+δ and to retransmit when the temperature signal Ts drops to the lower threshold value Tco-δ.

According to one embodiment, the vulvo-vaginal probe may comprise several radiofrequency transmitters distributed over the length of the probe, for example, in the form of rings: the radiofrequency transmitter or transmitters may be made of stainless steel. For example, the emitting length defined between the first ring and the last ring, along the axis of the probe can be between 2 cm and 7 cm, for example 3 cm, or even 5 cm.

According to one embodiment, the single radiofrequency transmitter or even the plurality of radiofrequency transmitters extends over a useful length of the probe comprised between 2 cm and 7 cm, for example 3 cm, or even 5 cm.

According to one embodiment, a user interface is configured for setting the setpoint temperature Tco.

Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the appended drawings, in which:

Fig. 1

is an overall schematic view of radiofrequency equipment according to the present disclosure comprising the vulvo-vaginal probe, the return antenna, a command and control box, an actuating pedal and connecting cables.

Fig. 2

is a schematic view of the various electrical/electronic systems of radio frequency equipment.

Fig. 3

is a graph representing on the ordinate the emission frequency of the radiofrequency energy and on the abscissa the time, illustrating a series of emission cycles, with notably for each cycle an emission sequence employing several frequencies F1 to F3 , followed by a period Tp without emission for the radio frequency emission cycles.

Fig. 4

is a graph showing the evolution of the temperature signal as a function of time, with a rising phase when the measured temperature signal is below an upper threshold value Tco+δ and a stabilization phase after reaching the threshold value upper, for which the temperature is maintained between this upper threshold value Tco+δ and a lower threshold value Tco-δ.

Fig. 5

is a view of the probe, comprising a substantially cylindrical body, typically plastic, and three radiofrequency emitters (three monopolar electrodes), in the form of three rings, spaced from each other along the length of the probe, for example made of steel STAINLESS STEEL.

Fig. 6

shows the electrical connection between the first connection cable and the three transmitters in the form of rings.

Fig. 7

is a schematic view, illustrating a solder, made on the internal surface of a radio frequency transmitter, which is used not only to connect the first connecting cable, but also as a hot solder connecting a first wire and a second wire, made of different metals belonging to a thermocouple, and configured to measure the temperature on the transmitter at the same connection point as that of the first connection cable.

The radiofrequency equipment according to the present disclosure finds a particular application for the treatment of vaginal relaxation by radiofrequency, notably allowing a homogeneous treatment of the tissues, whether according to the depth of the tissues, preferably at 360° around the axis of the vulvo-vaginal probe RF-PB, but still on the length of the vulvovaginal probe, which is preferably static during treatment.

The radiofrequency equipment according to this disclosure makes it possible to achieve this objective, with a high level of safety, in particular with respect to the risk of burns.

Claims (15)

Radiofrequency equipment (1) configured for the heat treatment of vulvo-vaginal tissues comprising:
- a radio frequency generation module comprising a variable frequency oscillator (RFO), configured to generate an integer number N of determined frequencies F1 to FN, the number N being greater than or equal to 2, as well as a radio frequency power amplifier ( AMP) configured to amplify the radio frequency signal generated by the variable frequency oscillator,
- a radio frequency transmission system receiving the radio frequency signal, amplified by said amplifier (AMP) comprising:
-- a monopolar vulvo-vaginal probe (RF-PB), comprising one or more radio frequency transmitters (2), said vulvo-vaginal probe configured to be inserted statically into the vagina,
-- a return antenna (PR), external to the patient's body,
- a first radiofrequency link cable (3) connecting the radiofrequency transmitter, or the radiofrequency transmitters (2) of the vulvo-vaginal probe (RF-PB) to the output of the amplifier (AMP), and a second link (4) radio frequency connecting the return antenna (RF-PB) to the output of the amplifier (AMP)
- a temperature measurement system arranged to measure the temperature at the level of a wall of the vulvo-vaginal probe ((RF-PB ) configured to emit a temperature signal (S _T ),
- a control module (UC) comprising a microcontroller, receiving the temperature signal (S _T ) as input, a variable frequency oscillator (RFO) control signal as output, and a memory in which are recorded a setpoint temperature (Tco) and instructions configured to implement a cyclic RF transmission process, preferably until the setpoint temperature (Tco) is obtained by the temperature measurement signal (S _T ), the cyclic transmission method comprising, at each radiofrequency transmission cycle, a radiofrequency transmission sequence comprising a succession of radiofrequency transmissions at the different determined frequencies F1 to FN, respectively over periods T1 to TN, and the implementation of a temperature regulation at said setpoint Tco the regulation comprising a reading by the microcontroller of the temperature signal measured in real time, preferably at each transmission cycle. Radiofrequency equipment according to claim 1, in which each radiofrequency emission cycle comprises the radiofrequency emission sequence comprising the succession of radiofrequency emissions at the different determined frequencies F1 to FN, respectively over periods T1 to TN, followed by a period Tp devoid of radiofrequency emission, and in which the reading of the temperature signal (S _T ) by the microcontroller for temperature regulation is implemented during the period Tp devoid of radiofrequency emission. Radiofrequency equipment according to claim 2, in which the probe temperature measurement system comprises a thermocouple comprising an open loop formed by two wires of different metals, including a first wire (5) and a second wire (6) welded at their end by a hot solder (7), as well as a control card (T-CO) configured to measure a potential difference between the two wires of different metals, and generating the temperature signal (S _T ), digital and wherein the hot junction (7) is made on the radio frequency transmitter (2) or one of the radio frequency transmitters (2). Equipment according to claim 3, in which the first radio frequency link cable (3) is connected to the transmitter (2) or to said radio frequency transmitters by soldering, and in which the hot solder (7) of the thermocouple simultaneously constitutes the solder ensuring the connection between the first radiofrequency connecting cable (3) and said radiofrequency transmitter (2) carrying the hot solder (7). Radiofrequency equipment according to one of Claims 1 to 4, in which the integer number N is equal to 3. Radio frequency equipment according to claim 5, in which:
- the frequency F1 is between 300 kHz and 600 kHz,
- the frequency F2 is between 600 kHz and 1000 kHz,
- the frequency F3 is between 1000 kHz and 2000 kHz. Radiofrequency equipment according to one of Claims 1 to 4, in which the integer N is equal to 2. Radio frequency equipment according to claim 7 in which:
- the frequency F1 is between 300 kHz and 600 kHz,
- the frequency F2 is between 600 kHz and 1500 kHz. Radiofrequency equipment according to one of Claims 1 to 8, in which the transmission periods T1 to TN at the various frequencies F1 to FN are respectively less than 1 second, in particular less than 0.5 seconds, for example comprised between 0, 1 second and 0.4 seconds. Radiofrequency equipment according to one of Claims 1 to 9, in which the period Th of the emission sequence of the emission cycle, which corresponds to the period Tc of the radiofrequency emission cycle from which the period Tp without emission is subtracted radio frequency is less than 3 seconds, preferably less than 1 second. Equipment according to one of Claims 1 to 10, in which the control module is configured to implement the regulation by comparing the temperature signal Ts with an upper threshold value Tco+δ, higher than the setpoint value Tco, and a lower threshold value Tco-+δ and in stopping the radiofrequency emission when the temperature signal Ts reaches or crosses the upper threshold value Tco+δ and in re-emitting when the temperature signal Ts drops to the lower threshold value Tco-δ . Equipment according to one of Claims 1 to 11, in which the probe comprises several radiofrequency transmitters distributed over the length of the probe, for example, in the form of rings. Equipment according to one of Claims 1 to 12, in which the radio frequency transmitter or transmitters are made of stainless steel. Equipment according to one of claims 1 to 9 comprising the single radio frequency transmitter or the plurality of radio frequency transmitters, extends over a useful length (L) of the probe at least equal to 2 cm to 7 cm. Equipment according to one of Claims 1 to 14 comprising a user interface configured for setting the setpoint temperature Tco.
.