WO2016120780A2 - System and method for controlling an electrotherapy device - Google Patents

System and method for controlling an electrotherapy device Download PDF

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Publication number
WO2016120780A2
WO2016120780A2 PCT/IB2016/050369 IB2016050369W WO2016120780A2 WO 2016120780 A2 WO2016120780 A2 WO 2016120780A2 IB 2016050369 W IB2016050369 W IB 2016050369W WO 2016120780 A2 WO2016120780 A2 WO 2016120780A2
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WIPO (PCT)
Prior art keywords
voltage
microprocessor
electrode
command
generator
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PCT/IB2016/050369
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French (fr)
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WO2016120780A3 (en
Inventor
Cesare COVINI
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Whtcare Sa
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Publication of WO2016120780A2 publication Critical patent/WO2016120780A2/en
Publication of WO2016120780A3 publication Critical patent/WO2016120780A3/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator

Definitions

  • TITLE System and method for controlling an electrotherapy device Field of application
  • the present invention relates to the technical sector of systems for controlling electrotherapy devices, and in particular electrotherapy systems comprising a mains power supply and a radiofrequency (RF) voltage generator, a neutral electrode and a capacitive and/or resistive electrode (5) connected to the generator and intended to transfer energy to a patient by means of a neutral electrode and a capacitive or resistive electrode.
  • the invention relates to a control method of the aforementioned type in which the generator generates a radiofrequency (RF) sinusoidal voltage and in which said electrodes are in contact with the patient's body so as to transfer energy to it.
  • RF radiofrequency
  • the present invention also relates to a method for controlling an electrotherapy device of the aforementioned type.
  • an electrotherapy device is an apparatus able to generate voltage or current waveforms at a controllable frequency, within the radiofrequency range, intended to be applied to the human body in order to produce mainly a diathermic effect.
  • The, device is used for therapeutic and non-therapeutic treatments, for example aesthetic treatments, and induces heat in local zones of the human body, at various depths. Transmission of the heat is transcutaneous and substantially helps activate the electric charges present in biological tissue, stimulating the cellular metabolism by means of an increase and reactivation of the microcapillary circulation, and promotes oxygenation of the tissues.
  • Electrotherapy treatments may be used to reactivate the natural reparative and anti-inflammatory processes, without using externally radiated energy or contact heating methods, which act on the surface, but are not very effective for producing heat at a given depth.
  • the electrotherapy device consists typically of an electric generator and two electrodes: an active electrode, arranged manually by an operator in the zone to be treated, and a neutral return electrode, fixed on the patient so as to create an electric circuit.
  • an active electrode arranged manually by an operator in the zone to be treated
  • a neutral return electrode fixed on the patient so as to create an electric circuit.
  • different types of treatment i.e. so-called capacitive or resistive treatments
  • the capacitive treatment exercises its action on the soft tissues which have a high water content, such as the muscles, the venous and lymphatic system and the cartilage.
  • the resistive treatment acts on all those tissues with a low water content, such as the bones, capsules, ligaments, tendons and muscle fibres.
  • the aforementioned electrotherapy devices may also operate with fairly high power and voltage levels, for example 300 W and 600V rm s, and produce electric voltage waveforms at radio frequency with values which lie outside the frequency ranges assigned to radio broadcasting services.
  • the voltage applied to the electrodes should be limited in a varying manner depending on the type of electrode used. It is good practice not to exceed 150 Vrms when using non-insulated active electrodes. When using insulated active electrodes it is advisable not to exceed other predetermined voltage values which depend on the degree of insulation ensured by the dielectric coating layer applied to the electrodes. For example, in the case of a maximum nominal voltage value of 600 Vrms, in order to avoid the risk of triggering electric arcs, it is necessary to use an insulating barrier of suitable size on the electrodes.
  • the device must be able to withstand very short reaction times, for example in the case where the therapist interrupts the therapy or when operational situations recognized as being anomalous by the device control and protection systems arise.
  • the known electrotherapy devices use technical solutions which are not •: ; satisfactory and which do not ensure a high degree of reliability, in safety terms, nor precise adjustment of the electric voltages, and therefore efficient adaptation of the device to the different working load conditions.
  • the technical problem underlying the present invention is therefore to devise a system for controlling an electrotherapy device which is able to overcome all the aforementioned drawbacks, therefore ensuring an apparatus which is entirely reliable, namely is able to detect immediately anomalous currents or electric voltages and interrupt their generation very rapidly, but which also allows the electric voltage to be adjusted and adapted effectively to the varying load conditions, so as to ensure optimum treatment for the patient.
  • the proposed solution forming the basis of the present invention is to control the radiofrequency (RF) electric voltage generated in an electrotherapy device by means of a system comprising a digital software control loop and an analog control loop, thus taking advantage of the speed of the analog loop, in order to reduce the time taken to detect any anomalous electric voltage values, and at the, same time the flexibility and sophistication of the digital software loop, in order to improve the voltage monitoring operations, programming said monitoring operations so as to identify intrinsic malfunctions of the electrotherapy device or malfunctions caused by external factors, such as incorrect setting of the device by the operator or an anomaly in the power supply grid, and employing the two loops in synergy in such a way as to prevent the generation or propagation of .
  • electric arcs able to perforate the insulating sheathing of the electrodes, for example in the case where the sheathing has been previously damaged due to wear, or even broken following mechanical stress, therefore avoiding danger for the patient and the operator.
  • the analog and digital loops comprise software and hardware solutions activated by signals sampled via a sensor system and via a system of transducers installed in specific circuit portions of the device which operate in synergy.
  • the microcontrollers used are provided with integrated analog/ digital conversion ports which acquire and interpret information in real time regarding the operating status of the device, increasing significantly the safety of the electrotherapy device and at the same time improving the generation and transfer dynamics of a suitable voltage /current for the diathermic treatment.
  • a system for controlling an electrotherapy device comprising:
  • radiofrequency sinusoidal voltage generator - a neutral electrode and a capacitive electrode and/ or resistive electrode connected to the voltage generator and intended to transfer energy by means of contact to a patient's body, characterized in that it comprises:
  • the hardware detection circuit is connected to the software control module and to a protection block of the power supply, so as to communicate the current and/ or voltage values to the software module and to the hardware protection block, - the software control module and the hardware protection block of the power supply are configured to determine and transmit a respective enabling or disabling command to the voltage generator,
  • the enabling or disabling command of the software control module being determined independently of the enabling or disabling command of the protection block.
  • the protection block and the detection circuit are hardware circuits forming part of the analog control loop.
  • the protection block may disable immediately the voltage generator, when it receives current or voltage values from the detection circuit which lie above predetermined threshold values.
  • the analog control loop has a reaction time greater than that of the digital control loop.
  • the software control module forms part of the digital control loop.
  • the software control module carries out sophisticated checks on the voltage and current values received from the hardware detection circuit and sends to the voltage generator the deactivation command in operating conditions which would not be detectable by the analog loop or by considering other operating parameters of the machine in combination with or separately from the voltage and current values received from the hardware detection circuit.
  • the protection block may generate a command for deactivation of the frequency generator before the software control module or before the software module has been able to determine the respective command for disabling the generator.
  • the software control module may generate a disabling command also in operating conditions where the protection block does not detect actual anomalies.
  • the software control module comprises a first microprocessor ⁇ and a second microprocessor ⁇ 2, a logic AND block which receives at its input control signals of the first microprocessor ⁇ and the second microprocessor ⁇ 2 and generates at its output the command for enabling the voltage generator, if the control signals of the first microprocessor ⁇ 1 and the second microprocessor ⁇ 2 are positive, or generates at its output the command for disabling the voltage generator, if at least one of the control signals of the first microprocessor ⁇ 1 and the second microprocessor ⁇ 2 is negative.
  • the logic AND gate is realized as hardware.
  • the first microprocessor ( ⁇ ) is connected to a command circuit of the electrotherapy device, receives at its input the commands from the command circuit and generates the negative control signal of the first microprocessor in the event of commands not recognized by the command circuit.
  • the first microprocessor ( ⁇ ) if it detects unrecognized commands, generates and sends a signal for deactivation of the second microprocessor ( ⁇ 2) .
  • the first microprocessor ( ⁇ is connected to the second microprocessor ( ⁇ 2) via a two-way communication BUS, and the second microprocessor ( ⁇ 2) receives at its input from the first microprocessor ( ⁇ commands for increasing or reducing the voltage, receives at its input from the hardware detection circuit (7) the real voltage values measured at the outputs of the electrodes and produces at its output the negative control signal of the second microprocessor ( ⁇ ) in the event of a difference between the voltage set with the voltage increasing or , reducing command and the voltage measured at the outputs of the electrodes being higher than a predefined threshold value.
  • the protection block comprises a power supply regulating board connected to the hardware detection circuit and receives at its input a voltage value measured at the output which connects the capacitive electrode and a current value measured on the neutral (or return) electrode and transmits at its output to the voltage generating circuit a shut-down command in the event of voltages at the output of the capacitive electrode higher than a threshold voltage or in the event of a current at the output of the neutral electrode higher than a threshold current.
  • the threshold voltage and current are set in the protection block.
  • the hardware detection circuit forms part of the analog control loop of the electrotherapy device, which comprises also the protection block and the generating circuit.
  • the microprocessors of the software control module form part of the digital control loop which furthermore comprises the detection circuit, the protection block and the generating circuit.
  • the system further comprises a circuit for filtering and resistive adaptation connected to the output of the generator.
  • a capacitive elevator circuit is connected between the output of the filtering and resistive adaptation circuit and the capacitive electrode.
  • a method for controlling an electrotherapy device comprising a power supply, a radiofrequency (RF) sinusoidal voltage generator, a neutral electrode and a capacitive electrode and/ or resistive electrode connected to the generator and intended to transfer energy to a patient's body.
  • RF radiofrequency
  • the figures shows a block diagram of the control system according
  • FIG. 1 shows a block diagram of an electrotherapy device comprising a control system according to the present invention.
  • the electrotherapy device comprises a power supply 1 which can be connected to the electricity power supply grid, a radiofrequency RF sinusoidal voltage generator 2 connected to the power supply 1, and at least one pair of electrodes intended to transfer energy to a patient, in particular by means of contact of the two electrodes with the patient's body.
  • the electrotherapy device is provided with a neutral electrode 3, a resistive electrode 5 and/or a capacitive electrode 4, which are connected to the generator 2 by means of a circuit for filtering and resistive adaptation 10 (resistive electrode 5) and a capacitive step- up circuit 1 1 (capacitive electrode 4) .
  • the capacitive electrode 4 is used together with the neutral electrode 3 for capacitive applications, i.e. those intended to treat soft tissues and the superficial zones of the body, and the resistive electrode is used, again exclusively in combination with the neutral electrode 3, for the treatment of tissues which are deeper-lying or have a greater resistance, such as the bone and cartilage structure.
  • the control system comprises a hardware detection circuit 7 intended to detect the values of the voltage and current output on the neutral, capacitive and resistive electrodes and transmit said values to the software control module 6, for determination of a command for enabling or disabling the voltage generator.
  • the hardware detection circuit 7 is connected to the electrodes 3-5 and to the software control module 6.
  • the hardware detection module 7 is also connected to a protection block 9 of the power supply 1 and transmits the current and voltage values detected on the electrodes 3-5 directly to the protection block 9.
  • the software control module 6 and the hardware circuit 7 are active simultaneously and form, respectively, a digital control loop and an analog control loop, able to monitor simultaneously the electrotherapy device and modify its operating parameters, rapidly interrupting the generator 2 and therefore the supplying of power to the patient, in the event of anomalous electric voltage values, or regulating in real time the generator 2 so as to vary the voltage depending on the conditions detected, for example the load formed by the patient, and therefore producing an electric voltage waveform ideal for treatment of the patient.
  • the software control module 6 comprises a first microprocessor ⁇ and a second microprocessor ⁇ 2, connected to a logic AND block which receives at its input the control signals of the first microprocessor ⁇ 1 and the second microprocessor ⁇ 2 and generates at its output the command for enabling the voltage generator 2, if the control signals of the first microprocessor ⁇ and the second microprocessor ⁇ 2 are positive, or generates at its output the command for disabling the RF voltage generator, if at least one of the control signals of the first microprocessor ⁇ and the second microprocessor ⁇ 2 is negative.
  • the logic AND block since it is intended to prevent any software misalignment in the software module 6, is of the hardware type.
  • the software control module 6 according to the present invention comprises at least one hardware AND block.
  • the first microprocessor ⁇ is connected to a command circuit 8 of the electrotierapy device, which can be regulated manually by the operator of the electrotherapy device, and receives at its input the commands from the command circuit 8 and generates the negative control signal in the event of unrecognized commands.
  • the first microprocessor ⁇ ⁇ is connected directly to the logic AND block and may send directly to the AND block the negative control signal.
  • the first microprocessor is able to interrupt the generator 2 independently of the second microprocessor, for example in the case of identification of operator-defined parameters which are incompatible with the treatment intended to be administered.
  • the second microprocessor ⁇ 2 is connected directly to the logic AND block and may send directly to the AND block the negative control signal, interrupting the generator 2 independently of the first microprocessor.
  • the first microprocessor and the second microprocessor are provided with a memory comprising a set of commands accepted by the command circuit (first microprocessor) and corresponding frequencies of the voltage to be supplied in the respective electrodes (second microprocessor), depending on the treatment selected (capacitive or resistive treatment).
  • the first microprocessor ⁇ in the event of detection of said unrecognized commands, also generates a shut-down signal of the second microprocessor ⁇ 2.
  • the first microprocessor ⁇ 1 and the second microprocessor X2 are connected by means of a two- way communication BUS, and the second microprocessor ⁇ X2 receives at its input from the first microprocessor ⁇ commands for increasing or reducing the voltage of the RF electric signal.
  • the control system also comprises a protocol for identifying the error maximum of 600 V ac .
  • Both the ⁇ voltage value output by the circuit 1 1 and the voltage value output by the circuit 10 as well as the voltage value output by the generator 2 are input to the hardware detection circuit 7 which is connected to the terminal plates (neutral, capacitive and/ or resistive electrodes) which can be applied to thej>atient.
  • control and regulation of the electric voltage of the generator 2 and the voltage output by the resistive adaptation circuit 10 and/ or capacitive circuit 1 1 are redundancy checked by means of the hardware detection circuit 7, which forms part of the analog control loop, and the microprocessors of the software control module 6, which form part of the digital control loop.
  • a further check is provided for checking that the electrotherapy device supplies power only from the output set by means of the command circuit 8, therefore avoiding simultaneous powering, even only for short transient periods, of both the capacitive electrode and the resistive electrode.
  • the firmware of the control module 8 is duly programmed to carry out the check for exclusion of one of the active electrodes 4, 5.
  • a circuit realized as hardware and indicated in the figures by a block ExOR is further provided, said circuit preventing the supplying of current to one of the active electrodes 4,5 in the case where the first microprocessor has already activated the supplying of current to the other active electrode 5, 4.
  • an electrotherapy device comprising a power supply 1 , a generator 2 of an RF radio frequency electric voltage, a neutral electrode 3 and a capacitive electrode 4 and /or resistive electrode 5 connected to the generator 2 and intended to transfer energy by means of contact with a patient's body can be advantageously controlled by means of a control method, characterized in that it comprises the following steps:
  • the hardware detection circuit (7) detects the radiofrequency voltage and current values on the neutral electrode (3) and on the capacitive electrode (4) and/ or resistive electrode independently and
  • the software control module (6) and the power supply protection block (9) determine, independently of each other, a respective command for enabling or disabling the voltage generator and transmit the enabling or disabling command to the voltage generator (2).
  • the software control steps are redundant to the hardware control steps. These steps form two software and hardware control loops or cycles, respectively, realizing an advanced control method where the flexibility and programming ease of the digital and software components implemented by the first and second microprocessors is provided as a redundancy feature in relation to the reaction speed of the analog and hardware components implemented in the hardware detection and protection circuit.
  • the diathermy or electrotherapy device may be carefully controlled, immediately interrupting any anomalous supplying of electric current, i.e.

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Abstract

The present invention relates to a system and a method for controlling an electrotherapy device comprising a power supply (1), a generator (2) of a radiofrequency (RF) electric voltage, a neutral electrode (3) and a capacitive electrode (4) and/ or resistive electrode (5) connected to the generator (2) and intended to transfer energy to a patient's body by means of contact therewith. The system comprises a software control module (6) connected to the generator (2), a hardware detection circuit (7) designed to detect radiofrequency voltage and current values on the neutral electrode (3), on the capacitive electrode (4) and/or on the resistive electrode (5) independently, the hardware detection circuit (7) being connected to the software control module (6) and to a protection block (9) of the power supply (1), so as to communicate the current and/ or voltage values to the software module and to the protection block. The software control module (6) and the power supply protection block (9) are configured to determine and transmit a respective enabling or disabling command to the radiofrequency voltage generator (2), the enabling or disabling command of the software control module (6) being determined independently of the enabling or disabling command of the power supply protection block (9).

Description

TITLE: System and method for controlling an electrotherapy device Field of application
The present invention relates to the technical sector of systems for controlling electrotherapy devices, and in particular electrotherapy systems comprising a mains power supply and a radiofrequency (RF) voltage generator, a neutral electrode and a capacitive and/or resistive electrode (5) connected to the generator and intended to transfer energy to a patient by means of a neutral electrode and a capacitive or resistive electrode. In particular, the invention relates to a control method of the aforementioned type in which the generator generates a radiofrequency (RF) sinusoidal voltage and in which said electrodes are in contact with the patient's body so as to transfer energy to it.
The present invention also relates to a method for controlling an electrotherapy device of the aforementioned type.
Prior art
As is known, an electrotherapy device is an apparatus able to generate voltage or current waveforms at a controllable frequency, within the radiofrequency range, intended to be applied to the human body in order to produce mainly a diathermic effect.
The, device is used for therapeutic and non-therapeutic treatments, for example aesthetic treatments, and induces heat in local zones of the human body, at various depths. Transmission of the heat is transcutaneous and substantially helps activate the electric charges present in biological tissue, stimulating the cellular metabolism by means of an increase and reactivation of the microcapillary circulation, and promotes oxygenation of the tissues.
Electrotherapy treatments may be used to reactivate the natural reparative and anti-inflammatory processes, without using externally radiated energy or contact heating methods, which act on the surface, but are not very effective for producing heat at a given depth.
The electrotherapy device consists typically of an electric generator and two electrodes: an active electrode, arranged manually by an operator in the zone to be treated, and a neutral return electrode, fixed on the patient so as to create an electric circuit. Depending on the mechanical and electrical characteristics of the active electrodes applied on the patient's body, different types of treatment, i.e. so-called capacitive or resistive treatments, may be obtained. The capacitive treatment exercises its action on the soft tissues which have a high water content, such as the muscles, the venous and lymphatic system and the cartilage. The resistive treatment acts on all those tissues with a low water content, such as the bones, capsules, ligaments, tendons and muscle fibres.
The aforementioned electrotherapy devices may also operate with fairly high power and voltage levels, for example 300 W and 600Vrms, and produce electric voltage waveforms at radio frequency with values which lie outside the frequency ranges assigned to radio broadcasting services.
In view of the power and voltage levels used, operation of the device must be carefully monitored so as to allow the treatment to be carried on the patient in completely safe conditions, without any risk, and preventing a malfunction or unexpected circumstance from causing an electrical discharge in the patient's body. In particular, the use of high power levels results in the need for a safety system which is able to manage critical situations which may be caused both by external factors and by internal factors of the apparatus.
To ensure safety during treatment it is important also that the voltage applied to the electrodes should be limited in a varying manner depending on the type of electrode used. It is good practice not to exceed 150 Vrms when using non-insulated active electrodes. When using insulated active electrodes it is advisable not to exceed other predetermined voltage values which depend on the degree of insulation ensured by the dielectric coating layer applied to the electrodes. For example, in the case of a maximum nominal voltage value of 600 Vrms, in order to avoid the risk of triggering electric arcs, it is necessary to use an insulating barrier of suitable size on the electrodes.
At the same time, to ensure an effective electrotherapy treatment, it is necessary to be able to control with a considerable degree of precision the waveform and the amplitude of the electric voltage generated when there is a variation in the impedance of the load.
In particular, in the aforementioned devices used for diathermy with transcutaneous transmission, in the two capacitive and resistive modes, it is required to produce a variable electric voltage with zero mean value and limit the presence of components with frequencies different from the nominal frequency, in order to obtain high performance levels in the various load situations and limit the losses due to heating of the circuitry used, therefore increasing the efficiency of the system and limiting its emissions. In order to provide a safe and reliable device it is necessary to be able to control precisely the variations in the energy supplied , to the patient's body by providing relatively long transients during operating conditions, these being due to variations in load, for example when the electrode is moved on the patient's body, causing a variation in impedance, or following an adjustment made by the therapist.
Vice versa, under other operating conditions, the device must be able to withstand very short reaction times, for example in the case where the therapist interrupts the therapy or when operational situations recognized as being anomalous by the device control and protection systems arise.
The known electrotherapy devices use technical solutions which are not •:; satisfactory and which do not ensure a high degree of reliability, in safety terms, nor precise adjustment of the electric voltages, and therefore efficient adaptation of the device to the different working load conditions.
The technical problem underlying the present invention is therefore to devise a system for controlling an electrotherapy device which is able to overcome all the aforementioned drawbacks, therefore ensuring an apparatus which is entirely reliable, namely is able to detect immediately anomalous currents or electric voltages and interrupt their generation very rapidly, but which also allows the electric voltage to be adjusted and adapted effectively to the varying load conditions, so as to ensure optimum treatment for the patient. Summary of the invention
The proposed solution forming the basis of the present invention is to control the radiofrequency (RF) electric voltage generated in an electrotherapy device by means of a system comprising a digital software control loop and an analog control loop, thus taking advantage of the speed of the analog loop, in order to reduce the time taken to detect any anomalous electric voltage values, and at the, same time the flexibility and sophistication of the digital software loop, in order to improve the voltage monitoring operations, programming said monitoring operations so as to identify intrinsic malfunctions of the electrotherapy device or malfunctions caused by external factors, such as incorrect setting of the device by the operator or an anomaly in the power supply grid, and employing the two loops in synergy in such a way as to prevent the generation or propagation of. electric arcs able to perforate the insulating sheathing of the electrodes, for example in the case where the sheathing has been previously damaged due to wear, or even broken following mechanical stress, therefore avoiding danger for the patient and the operator.
The analog and digital loops comprise software and hardware solutions activated by signals sampled via a sensor system and via a system of transducers installed in specific circuit portions of the device which operate in synergy. The microcontrollers used are provided with integrated analog/ digital conversion ports which acquire and interpret information in real time regarding the operating status of the device, increasing significantly the safety of the electrotherapy device and at the same time improving the generation and transfer dynamics of a suitable voltage /current for the diathermic treatment. On the basis of the proposed solution described above, the technical problem is solved by a system for controlling an electrotherapy device, comprising:
- a power supply,
- a radiofrequency sinusoidal voltage generator, - a neutral electrode and a capacitive electrode and/ or resistive electrode connected to the voltage generator and intended to transfer energy by means of contact to a patient's body, characterized in that it comprises:
- a software control module connected to the voltage generator,
- a hardware detection circuit designed to detect radiofrequency voltage and current values on the neutral electrode and on the capacitive electrode and/ or resistive electrode independently,
- the hardware detection circuit is connected to the software control module and to a protection block of the power supply, so as to communicate the current and/ or voltage values to the software module and to the hardware protection block, - the software control module and the hardware protection block of the power supply are configured to determine and transmit a respective enabling or disabling command to the voltage generator,
- the enabling or disabling command of the software control module being determined independently of the enabling or disabling command of the protection block.
The protection block and the detection circuit are hardware circuits forming part of the analog control loop. Advantageously, the protection block may disable immediately the voltage generator, when it receives current or voltage values from the detection circuit which lie above predetermined threshold values. The analog control loop has a reaction time greater than that of the digital control loop.
The software control module forms part of the digital control loop. The software control module carries out sophisticated checks on the voltage and current values received from the hardware detection circuit and sends to the voltage generator the deactivation command in operating conditions which would not be detectable by the analog loop or by considering other operating parameters of the machine in combination with or separately from the voltage and current values received from the hardware detection circuit.
In particular, the protection block may generate a command for deactivation of the frequency generator before the software control module or before the software module has been able to determine the respective command for disabling the generator. However, the software control module may generate a disabling command also in operating conditions where the protection block does not detect actual anomalies. The software control module comprises a first microprocessor μι and a second microprocessor μ2, a logic AND block which receives at its input control signals of the first microprocessor μι and the second microprocessor μ2 and generates at its output the command for enabling the voltage generator, if the control signals of the first microprocessor μ1 and the second microprocessor μ2 are positive, or generates at its output the command for disabling the voltage generator, if at least one of the control signals of the first microprocessor μ1 and the second microprocessor μ2 is negative. The logic AND gate is realized as hardware. The first microprocessor (μ^ is connected to a command circuit of the electrotherapy device, receives at its input the commands from the command circuit and generates the negative control signal of the first microprocessor in the event of commands not recognized by the command circuit. The first microprocessor (μι), if it detects unrecognized commands, generates and sends a signal for deactivation of the second microprocessor (μ2) . The first microprocessor (μ^ is connected to the second microprocessor (μ2) via a two-way communication BUS, and the second microprocessor (μ2) receives at its input from the first microprocessor (μ^ commands for increasing or reducing the voltage, receives at its input from the hardware detection circuit (7) the real voltage values measured at the outputs of the electrodes and produces at its output the negative control signal of the second microprocessor (μ ) in the event of a difference between the voltage set with the voltage increasing or , reducing command and the voltage measured at the outputs of the electrodes being higher than a predefined threshold value.
The protection block comprises a power supply regulating board connected to the hardware detection circuit and receives at its input a voltage value measured at the output which connects the capacitive electrode and a current value measured on the neutral (or return) electrode and transmits at its output to the voltage generating circuit a shut-down command in the event of voltages at the output of the capacitive electrode higher than a threshold voltage or in the event of a current at the output of the neutral electrode higher than a threshold current. Preferably, the threshold voltage and current are set in the protection block.
The hardware detection circuit forms part of the analog control loop of the electrotherapy device, which comprises also the protection block and the generating circuit. The microprocessors of the software control module form part of the digital control loop which furthermore comprises the detection circuit, the protection block and the generating circuit.
The system further comprises a circuit for filtering and resistive adaptation connected to the output of the generator. A capacitive elevator circuit is connected between the output of the filtering and resistive adaptation circuit and the capacitive electrode.
The technical problem described above is also solved by a method for controlling an electrotherapy device comprising a power supply, a radiofrequency (RF) sinusoidal voltage generator, a neutral electrode and a capacitive electrode and/ or resistive electrode connected to the generator and intended to transfer energy to a patient's body.
The method is characterized by the following steps:
- controlling the voltage generator by means of a software -control module and by means of a hardware detection circuit connected to the voltage generator;
- detecting by means of the hardware detection circuit the radiofrequency voltage and current values on the neutral electrode and on the capacitive electrode and/ or resistive electrode independently and communicating the current and/ or voltage values to the software module and to a protection block of the power supply;
- determining in the software control module and in the power supply protection block, independently of each other, a respective command for enabling or disabling the voltage generator, and transmitting the enabling or disabling command to the voltage generator. Further characteristic features and advantages of the system and the method according to the present invention will become clear from the description hereinbelow with reference to the accompanying drawings provided purely by way of a non-limiting example of the protective scope of the invention. Brief description of the drawings
The figures shows a block diagram of the control system according
/ the present invention. Detailed description
With reference to Figure 1 this shows a block diagram of an electrotherapy device comprising a control system according to the present invention.
The electrotherapy device comprises a power supply 1 which can be connected to the electricity power supply grid, a radiofrequency RF sinusoidal voltage generator 2 connected to the power supply 1, and at least one pair of electrodes intended to transfer energy to a patient, in particular by means of contact of the two electrodes with the patient's body. In particular, the electrotherapy device is provided with a neutral electrode 3, a resistive electrode 5 and/or a capacitive electrode 4, which are connected to the generator 2 by means of a circuit for filtering and resistive adaptation 10 (resistive electrode 5) and a capacitive step- up circuit 1 1 (capacitive electrode 4) . The capacitive electrode 4 is used together with the neutral electrode 3 for capacitive applications, i.e. those intended to treat soft tissues and the superficial zones of the body, and the resistive electrode is used, again exclusively in combination with the neutral electrode 3, for the treatment of tissues which are deeper-lying or have a greater resistance, such as the bone and cartilage structure.
According to the present invention, the control system comprises a hardware detection circuit 7 intended to detect the values of the voltage and current output on the neutral, capacitive and resistive electrodes and transmit said values to the software control module 6, for determination of a command for enabling or disabling the voltage generator. The hardware detection circuit 7 is connected to the electrodes 3-5 and to the software control module 6. The hardware detection module 7 is also connected to a protection block 9 of the power supply 1 and transmits the current and voltage values detected on the electrodes 3-5 directly to the protection block 9.
The software control module 6 and the hardware circuit 7 are active simultaneously and form, respectively, a digital control loop and an analog control loop, able to monitor simultaneously the electrotherapy device and modify its operating parameters, rapidly interrupting the generator 2 and therefore the supplying of power to the patient, in the event of anomalous electric voltage values, or regulating in real time the generator 2 so as to vary the voltage depending on the conditions detected, for example the load formed by the patient, and therefore producing an electric voltage waveform ideal for treatment of the patient.
In particular, the software control module 6 comprises a first microprocessor μι and a second microprocessor \\2, connected to a logic AND block which receives at its input the control signals of the first microprocessor μ1 and the second microprocessor μ2 and generates at its output the command for enabling the voltage generator 2, if the control signals of the first microprocessor μι and the second microprocessor \2 are positive, or generates at its output the command for disabling the RF voltage generator, if at least one of the control signals of the first microprocessor μι and the second microprocessor μ2 is negative.
The logic AND block, since it is intended to prevent any software misalignment in the software module 6, is of the hardware type. In other words, the software control module 6 according to the present invention comprises at least one hardware AND block.
The first microprocessor μι is connected to a command circuit 8 of the electrotierapy device, which can be regulated manually by the operator of the electrotherapy device, and receives at its input the commands from the command circuit 8 and generates the negative control signal in the event of unrecognized commands. The first microprocessor μ ι is connected directly to the logic AND block and may send directly to the AND block the negative control signal. In other words, the first microprocessor is able to interrupt the generator 2 independently of the second microprocessor, for example in the case of identification of operator-defined parameters which are incompatible with the treatment intended to be administered.
The second microprocessor μ2 is connected directly to the logic AND block and may send directly to the AND block the negative control signal, interrupting the generator 2 independently of the first microprocessor. The first microprocessor and the second microprocessor are provided with a memory comprising a set of commands accepted by the command circuit (first microprocessor) and corresponding frequencies of the voltage to be supplied in the respective electrodes (second microprocessor), depending on the treatment selected (capacitive or resistive treatment).
The first microprocessor μι, in the event of detection of said unrecognized commands, also generates a shut-down signal of the second microprocessor \2. In this connection, the first microprocessor μ1 and the second microprocessor X2 are connected by means of a two- way communication BUS, and the second microprocessor \X2 receives at its input from the first microprocessor μι commands for increasing or reducing the voltage of the RF electric signal.
The control system also comprises a protocol for identifying the error maximum of 600 Vac. Both the^ voltage value output by the circuit 1 1 and the voltage value output by the circuit 10 as well as the voltage value output by the generator 2 are input to the hardware detection circuit 7 which is connected to the terminal plates (neutral, capacitive and/ or resistive electrodes) which can be applied to thej>atient.
Essentially, according to the present invention, control and regulation of the electric voltage of the generator 2 and the voltage output by the resistive adaptation circuit 10 and/ or capacitive circuit 1 1 are redundancy checked by means of the hardware detection circuit 7, which forms part of the analog control loop, and the microprocessors of the software control module 6, which form part of the digital control loop.
A further check is provided for checking that the electrotherapy device supplies power only from the output set by means of the command circuit 8, therefore avoiding simultaneous powering, even only for short transient periods, of both the capacitive electrode and the resistive electrode. The firmware of the control module 8 is duly programmed to carry out the check for exclusion of one of the active electrodes 4, 5. However, as a redundancy safety check, a circuit realized as hardware and indicated in the figures by a block ExOR is further provided, said circuit preventing the supplying of current to one of the active electrodes 4,5 in the case where the first microprocessor has already activated the supplying of current to the other active electrode 5, 4.
Advantageously, all the voltage values are measured by the hardware analog circuit 7 which has a high reaction speed and can then be regulated in the digital software control module 6 which offers a significant degree of programming flexibility. The digital software control module is preferably realized as firmware. According to the present invention, an electrotherapy device comprising a power supply 1 , a generator 2 of an RF radio frequency electric voltage, a neutral electrode 3 and a capacitive electrode 4 and /or resistive electrode 5 connected to the generator 2 and intended to transfer energy by means of contact with a patient's body can be advantageously controlled by means of a control method, characterized in that it comprises the following steps:
- controlling the voltage and the current on the electrodes by means of a hardware detection circuit 7 and transmitting the current and voltage values to a protection block 9 and to a software control module 6.
- controlling the voltage generator 2 by means of a software control module; 6 connected to it and transmitting a command for enabling or disabling the voltage generator 2 from the software control module 6 to the generator 2, and the hardware detection circuit (7) detects the radiofrequency voltage and current values on the neutral electrode (3) and on the capacitive electrode (4) and/ or resistive electrode independently and
I
communicates the current and/ or voltage values to the software module
!
(6) and to a power supply protection block (9), the software control module (6) and the power supply protection block (9) determine, independently of each other, a respective command for enabling or disabling the voltage generator and transmit the enabling or disabling command to the voltage generator (2).
The software control steps are redundant to the hardware control steps. These steps form two software and hardware control loops or cycles, respectively, realizing an advanced control method where the flexibility and programming ease of the digital and software components implemented by the first and second microprocessors is provided as a redundancy feature in relation to the reaction speed of the analog and hardware components implemented in the hardware detection and protection circuit. Advantageously, by means of the control system thus provided, the diathermy or electrotherapy device may be carefully controlled, immediately interrupting any anomalous supplying of electric current, i.e. before said current is supplied to the patient or before it may damage the insulating sheathing of the electrodes, and also precisely regulating the waveform of the voltage, irrespective of the patient undergoing treatment and therefore the load which in each case is applied to the electrotherapy apparatus, thereby improving the beneficial effects of the treatment.

Claims

1. System for controlling an electrotherapy device, comprising a power supply ( 1) , a radiofrequency (RF) sinusoidal voltage generator (2) , a neutral electrode (3) and a capacitive electrode (4) and/ or resistive electrode (5) connected to the voltage generator and intended to transfer energy by means of contact with a patient's body, characterized in that it comprises: a software control module (6) connected to the generator (2), a hardware detection circuit (7) designed to detect radiofrequency voltage and current values on the neutral electrode (3) and on the capacitive electrode (4) and/ or resistive electrode (5) independently, the hardware detection circuit (7) being connected to the software control module (6) and to a protection block (9) of the power supply ( 1) , so as to communicate the current and/ or voltage values to the software module and to the hardware protection, said software control module (6) and said power supply protection block (9) being configured to determine and transmit a respective enabling or disabling command to the voltage generator (2), the enabling or disabling command of the software control module (6) being determined independently of the enabling or disabling command of the protection block (9) .
2. System according to Claim 1 , characterized in that the software control module (6) comprises a first microprocessor (μ ι) and a second microprocessor (μ2) , a logic AND block which receives at its input control signals of the first microprocessor (μ^ and the second microprocessor (μ2) and generates ' at . its output the command for enabling the voltage generator (2), if the control signals of the first microprocessor (μι) and the second microprocessor (μ2) are positive, or generates at its output the command for disabling the voltage generator (2), if at least one of the control signals of the first microprocessor {μ and the second microprocessor (μ2) is negative.
3. System according to claim 2, characterized in that said logic AND block is realized as hardware.
4. System according to claim 2, characterized in that the first microprocessor (μι) is connected to a command circuit (8) of the electrotherapy device, receives at its input the commands from the command circuit (8) and generates the negative control signal of the first microprocessor (μι) in the event of commands not recognized by the command circuit (8) .
5. System according to claim 4, characterized in that the first microprocessor (μι) , in the event of detection of said unrecognized commands, generates and sends a shut-off signal to the radiofrequency voltage generator (2) and an alarm signal to the second microprocessor (μ2) .
6. System according to claim 5, characterized in that the first microprocessor (μ^ is connected to the second microprocessor (μ2) via a two-way communication BUS, said second microprocessor (μ2) receives at its input from the first microprocessor (μι) commands for increasing or reducing the voltage, receives at is input from the hardware detection circuit (7) the real voltage values measured at the outputs of the electrodes and produces at its output the negative control signal of the second microprocessor (μ2) in the event of a difference between the voltage set with the voltage increasing or reducing command and the voltage measured at the outputs of the electrodes being higher than a predefined threshold value.
7. System according to claim 6, characterized in that said protection block (9) comprises a power supply regulating board connected to the hardware detection circuit (7) and receiving at its input a voltage value measured at the output which connects the capacitive electrode and a current value measured on the return electrode and transmits at its output to the voltage generating circuit (2) a shut-down command in the event of voltages at the output of the capacitive electrode higher than a threshold voltage or a limiting command in the event of a current at the output of the neutral electrode higher than a threshold current, said threshold voltage and current being set in the protection block (9).
8. System according to claim 1 , characterized in that the hardware detection circuit (7) is part of an analog control loop of the electrotherapy device and is interfaced with the two microprocessors of the software control module forming a second digital control loop; the analog control loop is connected to the second microprocessor of the digital control loop and is designed to interact with the digital control loop.
9. System according to claim 1 , characterized in that it comprises a circuit for filtering and resistive adaptation (10) connected to the output of the generator (2) .
10. System according to claim 9, characterized in that it comprises a capacitive step-up circuit (1 1) connected between the output of the filtering and resistive adaptation circuit and the capacitive electrode.
11. Method for controlling an electrotherapy device comprising a power supply (1), a generator (2) of a radiofrequency (RF) sinusoidal electric voltage, a neutral electrode (3) and a capacitive electrode (4) and/ or resistive electrode (5) which are connected to the generator (2) and intended to transfer energy to a patient's body, characterized by: - controlling the voltage generator (2) by means of a software control module (6) and a power supply protection block (9), which are connected to the voltage generator (2);
- detecting, by means of a hardware detection circuit (7), the radiofrequency voltage and current values on the neutral electrode (3) and on the capacitive electrode (4) and/ or resistive electrode (5) independently and communicating the current and/ or voltage values to the software module (6) and to the power supply protection block (9),
- said step of controlling the generator comprising the steps of determining a command for enabling or disabling the radiofrequency voltage generator (2) independently in the software control module (6) and in the power supply protection block (9), and transmitting the enabling and disabling command to the voltage generator (2).
PCT/IB2016/050369 2015-01-26 2016-01-26 System and method for controlling an electrotherapy device WO2016120780A2 (en)

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CN108478277A (en) * 2018-04-08 2018-09-04 河南优德医疗设备股份有限公司 A kind of physiotherapy and rehabilitation equipment based on high frequency heat penetration technology

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CN107241092A (en) * 2017-06-22 2017-10-10 安徽四创电子股份有限公司 A kind of frequency electromagnetic waves physiotherapy equipment
CN107241092B (en) * 2017-06-22 2023-10-27 安徽四创电子股份有限公司 High-frequency electromagnetic wave physiotherapy instrument
CN108478277A (en) * 2018-04-08 2018-09-04 河南优德医疗设备股份有限公司 A kind of physiotherapy and rehabilitation equipment based on high frequency heat penetration technology

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