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WO2016097731A2 - Appareil de traitement - Google Patents

Appareil de traitement Download PDF

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Publication number
WO2016097731A2
WO2016097731A2 PCT/GB2015/054041 GB2015054041W WO2016097731A2 WO 2016097731 A2 WO2016097731 A2 WO 2016097731A2 GB 2015054041 W GB2015054041 W GB 2015054041W WO 2016097731 A2 WO2016097731 A2 WO 2016097731A2
Authority
WO
WIPO (PCT)
Prior art keywords
pattern
pulses
pulse delivery
unit
period
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2015/054041
Other languages
English (en)
Other versions
WO2016097731A3 (fr
Inventor
Ian Dennis THIRKELL
Russell Graham CANNON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Applied Microcurrent Technology Ltd
Original Assignee
Applied Microcurrent Technology Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Applied Microcurrent Technology Ltd filed Critical Applied Microcurrent Technology Ltd
Publication of WO2016097731A2 publication Critical patent/WO2016097731A2/fr
Publication of WO2016097731A3 publication Critical patent/WO2016097731A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/321—Electromedical belts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/325—Applying electric currents by contact electrodes alternating or intermittent currents for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/326—Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition

Definitions

  • This invention relates to apparatus for treatment by therapy of a human or animal body by passing an electrical current through the body, and in particular a microcurrent.
  • microcurrent therapy on a human or animal body is a well-established method of treatment for a variety of conditions, ranging from wounds and other physical trauma to psychological conditions such as depression.
  • microcurrent pulses of a predetermined pattern are passed through the body via electrodes placed at spaced points on the skin.
  • the microcurrent pulses are typically generated by a device placed in a carrier worn by the human or animal, the carrier having the electrodes and the wiring needed to connect them to the device .
  • the device may include a battery and electronic circuitry operative to generate and deliver the pulses and to control charging of the battery.
  • the device needs to be robust, since it is placed in the carrier worn by the horse, and so will be subject to knocks and vibration. It is therefore necessary that operation of the device should not be interfered with by knocks or other movement.
  • the known device is operated via a remote control unit, which has several buttons and a display screen. This has the advantage that the device itself does not need any controls, but the disadvantage that two pieces of equipment are required, together with means to enable them to communicate. If the remote control unit is lost, the device becomes useless.
  • the known device comprises a casing housing a battery and a printed circuit board having a controller and the other electronic components. It has a port for connection of a charger for the battery, and another port for connection to the electrodes for the delivery of the microcurrent pulses.
  • the disadvantage of this arrangement is that when the device is in use the charger port is open, allowing the ingress of moisture and dirt. A removable cover for the charger port may be provided, but this can easily be lost or damaged, and adds to the cost of the device .
  • a further disadvantage of the two port arrangement is that the casing has two points of weakness.
  • a portable low-frequency electrotherapy apparatus comprising a main body which comprises a universal serial bus (USB) port, a charging part to receive a charging voltage from the power pin of the USB port and a low-frequency signal generator electrically connected to a data pin of the USB port to supply a low-frequency signal through the data pin of the USB port; a low-frequency signal cable which comprises a low-frequency electrode connector at one end of the low-frequency signal cable electrically connected to the data pin of the USB port and an electrode pad at the other end to transmit a low-frequency signal to a human body; and a power cable which comprises a power supply connector at one end of the power cable electrically connected to the power pin of the USB port.
  • USB universal serial bus
  • a disadvantage of this arrangement is that the USB port has separate connections for charging and signal delivery, and so is complex and delicate, and susceptible to damage by knocks and other movement.
  • a treatment unit including a casing, a battery and means for generating and delivering microcurrent pulses, a carrier adapted to be attached to the human or animal body, including a pair of electrodes to contact the body at spaced locations, and means for connecting the electrodes to the treatment unit to receive the microcurrent pulses, in which the treatment unit has : a single port, acting as an input for charging the battery and as an output for the electrode connection means for delivery of the pulses; and means for detecting whether the single port is acting as input or output; and means for controlling the operation of the unit depending on whether the single port is acting as input or output.
  • the arrangement of the invention overcomes the disadvantage of the open charger port in use, since the electrode connection means provides more effective sealing of the port.
  • the single port also means that the casing is inherently stronger.
  • the unit therefore has a simple and robust construction. Controlling the operation the unit depending on whether the single port is acting as input or output prevents damage during charging, and the battery trying to charge itself during delivery of pulses. This allows a simple port, with a single connection, to be used rather than more complex ports having dedicated connections (pins) for charging and for pulse delivery.
  • the treatment unit may be arranged to operate in a first mode, in which the battery is charged through the single port, and in a second mode, in which pulses are delivered through the single port, the means for controlling the operation of the unit being arranged to control the treatment unit to operate in the first mode when the single port is acting as an input, and the second mode when the single port is acting as an output.
  • the detection means may comprise a circuit for detecting the voltage applied across the single port; and the single port is determined to be acting as input or output in dependence on a voltage detected.
  • the treatment unit may be configured to reset to default settings, when the first mode is started.
  • the treatment unit may comprise a charging circuit to deliver charge from the port to the battery to charge the battery, and a separate pulse delivery circuit to deliver pulses to the single port, and the charging circuit and the pulse delivery circuit use a common conduction path through the single port.
  • the means for controlling the operation of the unit is arranged to : enable the charging circuit and disable the pulse delivery circuit when the unit is operating in the first mode; and disable the charging circuit and enable the pulse delivery circuit when the unit is operating in the second mode. This prevents damage to the pulse delivery circuit during charging, and the battery trying to charge itself during pulse delivery.
  • a first type deals with trauma, for example reducing swelling, bruising and pain.
  • a second type deals with imbalances in the body, to promote healing.
  • the first type uses alternate positive and negative polarity for bunches of pulses, and the second type uses only positive polarity pulses in bunches.
  • both types can use alternate positive and negative polarity for bunches of pulses, with the types differentiated by the peak current, the first type having variable peak current and the second type fixed peak current. It has previously been found that it is sufficient for the majority of treatment regimes to have two slightly different waveform patterns of each type, giving four waveform patterns to choose from when selecting treatment regimes.
  • a treatment regime starts with individual treatments of patterns of the first type, and moves on to individual treatments of a combination of patterns of both types, with the 'weighting' of each type changing as the condition being treated is ameliorated.
  • the device of WO2013/171445 provides the possibility of selecting the required combination of the four waveform patterns.
  • An individual treatment is delivered as blocks of eight patterns, each block being chosen as the desired one of the four patterns. It has now been found that four particular combinations of the four patterns is actually sufficient for the majority of treatment regimes, so that each of these combinations can be predetermined by the unit as a treatment programme . This enables the controls to be simpler.
  • the treatment unit also incorporates two control buttons, adapted to be actuated by a user to control operation of the apparatus, rather than these being provided on a separate device . Whilst this may be seen as detracting from the robustness of the unit in that the controls are more prone to inadvertent operation in use, it has been found that it is possible to simplify the controls to be just two buttons, together with LED displays, which can be adequately protected.
  • buttons may be recessed into the casing to prevent inadvertent operation, and sealed to prevent the ingress of dirt and moisture .
  • the treatment unit includes LEDs arranged behind the buttons, and the buttons and/or portions of the casing around the buttons may be transparent or translucent, such that the buttons are illuminated by the LEDs to provide a visual indication of charging state of the battery and operational state of the unit.
  • the treatment unit includes a microcontroller, which generates and delivers the selected programmes of predetermined waveforms.
  • the microcontroller and at least one of the control buttons may be arranged to provide a first response in reaction to a first user actuation, and a second response in reaction to a second user actuation.
  • the control button may be held for more than a threshold time for the first actuation and less than the threshold time for the second actuation.
  • the microcontroller and a first of the control buttons is arranged to turn the treatment unit on or off in response to the first actuation, and serves to select the treatment programme in response to the second actuation.
  • the microcontroller and a second of the control buttons starts and stops the programmes, such that the first actuation starts a first programme and the second actuation starts a second programme.
  • the treatment unit also includes LEDs to provide a visual indication of the programme selection, if desired.
  • Each programme may include a combination of four predetermined patterns.
  • each pattern includes a pulse delivery period in which a plurality of bunches of pulses are delivered, and a second period in which no pulses are delivered.
  • a first pattern and a second pattern may have a first arrangement of pulse polarity; a third pattern and a fourth pattern may have a second, different, arrangement of pulse polarity; the first pattern and third pattern may have a pulse delivery period of a first duration; and the second pattern and fourth pattern may have a pulse delivery period of a second, different, duration.
  • the ratio between the first duration and the second duration may be 2: 1.
  • the pulse delivery period may comprise alternating periods of positive and negative pulses, the periods of positive and negative pulses having equal duration; and in the third and fourth patterns, the pulse delivery period may comprise alternating periods of positive pulses and no pulses, the period of positive pulses and no pulses having equal duration.
  • the duration of pulse delivery period is 20 seconds; and in the second and fourth patterns, the duration of pulse delivery period is 10 minutes.
  • Each programme may comprise a first period of a predetermined sequence of patterns, a rest period, and a second period of a predetermined sequence of patterns.
  • a first programme comprises: a first pulse delivery period including a repeated sequence of the first pattern repeated twice, followed by the second pattern repeated twice; and a second pulse delivery period identical to the first pulse delivery period.
  • a second programme comprises: a first pulse delivery period including a repeated sequence of the first pattern repeated twice, followed by the third pattern repeated twice; and a second pulse delivery period identical to the first pulse delivery period.
  • a third programme comprises: a first pulse delivery period including a repeated sequence of the first pattern repeated twice, followed by the third pattern repeated twice; and a second pulse delivery period including a repeated sequence of the third pattern repeated twice, followed by the fourth pattern repeated twice.
  • a fourth programme comprises: a first pulse delivery period including a repeated sequence of the first pattern, followed by the second pattern, followed by the third pattern, followed by the fourth pattern; and a second pulse delivery period identical to the first pulse delivery period.
  • the microcontroller responds to actuation of the buttons, the unit may also have means to enable wireless operation, for example by a Bluetooth connection to a suitable device.
  • FIG. 1 is a plan view of a carrier, electrodes and wiring of a treatment apparatus according to the invention
  • Figure 2 is a perspective view of a treatment unit for the apparatus according to the invention.
  • Fi igure 3 is a plan view of the unit of Figure 2;
  • Fi igure 4 is a back view of the unit of Figure 2;
  • Fi igure 5 is a section along the line A-A of Figure 3 ;
  • Fi igure 6 is a schematic diagram of the components of the unit of Figure 2;
  • Fi igure 7A shows one possibility for waveforms for microcurrent pulse patterns delivered by the unit of Figure 2;
  • Figure 7B shows another possibility for waveforms for microcurrent pulse patterns delivered by the unit of Figure 2.
  • the drawings show apparatus for treatment by therapy of a human or animal body by microcurrents.
  • the treatment operates by passing electrical microcurrent pulses through the body tissue between an anode and cathode pair of electrodes.
  • the apparatus as shown in Figure 1 comprises a treatment unit 1 for generating and delivering the microcurrent pulses, a carrier 2 adapted to be attached to the body (not shown) including a pair of electrodes 3 , 4 for contacting the body, and wires 5 , 6 for connecting the respective electrodes 3 , 4 to the treatment unit 1 through a jack plug connector 7.
  • Figure 1 shows the plug connector 7 separated from the treatment unit 1 .
  • the treatment unit 1 is removably accommodated in a pocket 8 in the carrier 2.
  • the carrier 2 is made of a flexible material which may be any suitable cloth or waterproof material, formed in at least two layers . It is substantially H-shaped, with two longitudinal members 9, 10 connected by a transverse portion 1 1 . The transverse portion 1 1 is formed with the pocket 8.
  • the electrodes 3 , 4 are located one on each longitudinal member 9, 10, in line with transverse portion 1 1 .
  • the electrodes 3 , 4 are provided on respective removable pads 12, 13 attached to the carrier 2 by press studs (not shown) . Each press stud portion attached to the carrier 2 is connected to a respective wire 5, 6 accommodated between two layers of the carrier 2.
  • the wires 5, 6 are brought to the outside of the carrier 2 and enclosed in a single sheath 14 before terminating in the connector 7.
  • the longitudinal members 9, 10 of the carrier 2 enable it to form a loop and be wrapped around a limb such as a leg, and fastened.
  • Each longitudinal member 9, 10 has a short upper leg 15 and a longer lower leg 16.
  • Each lower leg 16 has part of a fastener 17 at its free end. As shown, this is a hook and loop fastener such as Velcro (Registered Trade Mark).
  • the complementary part of each fastener 17 is on the reverse side of the carrier 2, on the respective upper leg 15. It will be appreciated that the fasteners 17 enable the carrier 2 to be adjusted to fit an appropriate limb of the human or animal body.
  • Figures 2 to 5 show the construction of the treatment unit 1. It comprises a casing 20 having upper and lower parts 21 , 22 respectively. A single port 23 for a jack plug is provided at one end.
  • the upper casing part 21 has a pair of apertures 24, 25 to accommodate control buttons 26, 27 and four apertures 28, 29,30, 3 1 each surrounded by an angled internal projection 32, to accommodate an LED light tube (not shown) .
  • Each button 26, 27 is sealingly received in its respective aperture 24, 25 with its upper surface substantially flush with the surface of the casing part 21 , to prevent inadvertent operation.
  • Each button 26, 27 is of translucent polymeric material, so that it can be lit by one or more LEDs behind the button 26, 27 to provide a visual display of the state of operation of the unit 1 .
  • the one or more LEDs may be the same colour, or different colours, or groups of different colours.
  • the visual display is completed by the LED light tubes in the apertures 28 to 3 1 , which can be lit by one or more LEDs.
  • the lower casing part 22 has a ring 33 of small apertures.
  • the casing parts 21 , 22 are configured internally to house a printed circuit board and a battery (not shown), and have four co-operating hollow projections 34, 35 for securing screws (not shown) .
  • the treatment unit 1 can be securely accommodated in the pocket 8 of the carrier 2, with the connector 7 in the port 23 , or removed from the carrier 2 for charging, with a charging lead (not shown) in the port 23.
  • the treatment unit 1 will also normally be prepared for operation before being placed in the pocket 8.
  • Figure 6 shows a schematic diagram of the components of the treatment unit 1.
  • the components are provided on a printed circuit board and comprise a microcontroller 40 and a 3.7V battery 41 , together with circuits for generating and delivering the microcurrent pulses, interface with the user for controlling operation of the unit and displaying the state of operation, and for monitoring and charging the battery 41.
  • the microcontroller 40 may be of any suitable form, for example a PIC microcontroller with embedded software as shown.
  • the battery 41 is a 3.7V Lithium- ion polymer battery, which is of course rechargeable. Charging of the battery 41 will be discussed below.
  • An interface connector 42 comprises the port 23, which as mentioned above can accommodate either the connector 7 or a connector for a charger (not shown).
  • the interface connector 42 includes a single electrical connection over which the pulses may be delivered to the electrodes, or the charge delivered to the battery.
  • a static protection circuit 43 is provided between the port 23 and the rest of the components. This protects the components against the possibility of a static discharge if for any reason there is a potential difference across the electrodes 3, 4 when they are attached to the unit 1. This would not occur when both electrodes 3, 4 are in contact with the skin of the body, as they would then be at approximately the same voltage potential.
  • the static protection circuit 43 includes an avalanche diode .
  • the battery 41 provides power to the unit 1.
  • a battery monitor 44 samples the voltage output from the battery 41 and sends signals accordingly to the microcontroller 40.
  • the battery 41 also supplies a 3.3V regulator 45 to provide a permanent supply to the various circuits.
  • the microcurrent pulses are controlled by the microcontroller 40 (the form of the pulses will be discussed further below but may be of positive or negative polarity) and delivered via an H-bridge 46 operating at 9V.
  • the H-bridge is fed from the battery 41 through a switch 47 controlled by the microcontroller 40 and a step-up regulator 48.
  • the switch 47 enables the voltage supply during treatment, and the regulator converts the 3.7 V supply from the battery to the 9V used for treatment.
  • the pulses are output from the H-bridge 46 to the connector 7 and thence to the electrodes 3, 4.
  • the H-bridge 46 operates with a current shunt 49 to deliver the pulses to the electrodes.
  • the H-bridge 46 controlled by the microcontroller 40, performs the switching to generate pulses of the correct polarity at the correct time, while the current shunt 49, which is also controlled by the microcontroller 40, is a constant current-sink determining the current delivered.
  • the current shunt 49 sends a sense signal to the microcontroller 40, which detects when the correct current is not being achieved, and adjusts the shunt 49 accordingly through control signals. There is a limit to the amount of adjustment the current shunt can make. When the limit is reached this may indicate that at least one of the electrodes 3, 4 is not making proper contact.
  • the current shunt 49 then sends a signal to the microcontroller 40 which triggers an LED to indicate the poor-contact status, as will be discussed below.
  • a user interface 50 is also connected to the microcontroller 40, to provide input from the control buttons 26, 27, and to control operation of the LEDs which provide the visual display of the state of operation of the unit 1 , and a sounder (not shown) which provides an audible indication of operation.
  • the sound leaves the unit 1 through the ring 3 1 of apertures in the casing part 22.
  • the sounder may be turned off by the user if it is not required.
  • the unit 1 may also have a Bluetooth module 5 1 , with which the microcontroller 40 is in communication. The unit 1 may then be operated wirelessly if required from a remote device, to which information about the state of operation may also be transmitted.
  • the charging of the battery 41 from a 12V mains-supplied charger is achieved through a charging circuit comprising a step-down regulator 52 and a Lithium-ion polymer charger 53.
  • the regulator 52 converts the 12V mains supply to the 5V supply required by the charger 52.
  • the charger 53 operates to manage the battery charging process, and sends information about the battery charge status to the microcontroller 40.
  • the microcontroller 40 uses this information to control operation of an LED display on the button 26 to indicate the battery charge status.
  • a red LED indicates that the battery is charging, an amber LED that it is nearly charged, and a green LED that it is fully charged.
  • the same conduction path through the static protection circuit 43 and the interface connector 42 is used for both charging the battery 41 and pulse delivery. However, different conduction paths are used between the battery 41 and the input of the static protection circuit 43 in these situations.
  • the unit 1 also includes a charge switch circuit 54, so that the unit 1 operates either in charging mode or pulse delivery mode . It will be appreciated that the charging circuit should not be operational while pulses are being delivered, since the battery 41 would then be charging itself, and that the H-bridge 46 should not be operational while charging is taking place, because of the possibility of damage due to the higher charging voltage.
  • the charge switch circuit 54 therefore operates to detect the voltage applied to the interface connector 42. As discussed above, the battery 41 is charged from the mains- supplied charger at 12V, and the pulses are delivered at a lower voltage (9V). If the charge switch circuit 54 detects the higher charging voltage, it enables the charging circuit to allow charging. If charge switch circuit 54detects a lower voltage, such as zero or the voltage used in pulse delivery, it disables the charging circuit.
  • the charge switch circuit 54 may include any suitable means for detecting the voltage, and any suitable means for enabling and disabling the charging circuit.
  • the means for enabling and disabling the charging circuit may be a switch or other means. The switch can be operated through the microcontroller, or internally within the charge switch circuit 54.
  • the means for enabling and disabling the charging circuit may automatically disable/enable the charging circuit in response to the voltage passing through it or detected (for example a transistor switch or diode).
  • the switch 47 or other means (not shown) may be used for enabling and disabling the pulse supply from the battery 41 to the interface connector 42.
  • Figures 7 A and 7B show two typical patterns of waveforms for the pulses.
  • the upper pattern 60 is of a first type which uses alternative positive and negative polarity for bunches of pulses 63, while the lower pattern 61 is of a second type which uses only positive polarity bunches of pulses 63.
  • the first type of pulse waveform deals with trauma such as swelling, bruising and pain, while the second type deals with imbalances in the body, to promote healing.
  • the microcontroller 40 is programmed with two patterns ( 1A and IB) of the first type 60, which differ only in the time for which they are applied. Similarly, the microcontroller 40 is programmed with two patterns (2A and 2B) of the second type 61 , which differ only in the time for which they are applied. In each case, a first predetermined period of pulse delivery is followed by a second predetermined period when no pulses are delivered, the ratio between the first and second periods (on:off) being 2 to 1. For the each type of pattern, the first pattern ( 1A or 2A) may be on for 20 seconds, and off for 10 seconds. The second pattern ( IB or 2B) may be on for 10 minutes and off for 5 minutes.
  • the peak current 62 varies from 50 to 700 ⁇
  • the number of pulses in a bunch 63 varies from 2 to 1 1
  • the spacing of the bunches 64 varies from 1 to 10 milliseconds.
  • the pulse width 65 remains constant at 1 10 microseconds
  • the pulse spacing 66 in a bunch 63 remains constant at 860 microseconds.
  • the upper pattern 60 ( Figure 7A) shows a cycle time 67 of 5 seconds, alternating between a 2.5 second period of positive pulses 67a and a 2.5 second period of negative pulses 67b. As the cycle is repeated the peak current 62, number of pulses in a bunch 63 and bunch spacing 64 varies.
  • the lower pattern 61 ( Figure 7B) shows a cycle time 68 of 5 seconds, but here the cycle is made of a 2.5 second period of positive pulses 68a, and a 2.5 second period of no pulses 68b. Again, as the cycle is repeated the peak current 62, number of pulses in a bunch 63 and the bunch spacing varies 64.
  • the microcontroller 40 is programmed with four combinations of the four patterns, giving four possible selections of programme for treatment. Each programme lasts for 6 hours, divided into two parts of 3 hours each, which may be separated by 1 hour of no pulses.
  • a first programme consists of the pattern sequence 1A, 1A, IB, IB, for 3 hours, this sequence then being repeated for the second 3 hours.
  • a second programme consists of the pattern sequence 1A, 1A, 2 A, 2 A, for 3 hours, and repeated for the second 3 hours.
  • a third programme consists of the pattern sequence 1A, 1A, 2 A, 2 A for 3 hours, followed by 2A, 2A, 2B, 2B for the second 3 hours. These three patterns deal with trauma and then promote healing.
  • a fourth programme consists of the pattern sequence 1A, IB, 2A, 2B for the first 3 hours, and repeated for the second 3 hours and is designed for maintenance of a healthy condition.
  • the operation of the apparatus is controlled by the user actuating the control buttons 26. 27.
  • the microcontroller 40 and control buttons 26, 27 are arranged so that each button 26, 27 may be actuated in a variety of different manners, each different actuation having a different effect on the operation of the apparatus .
  • the apparatus may differentiate between a short press (less than 2 seconds) and a long press (more than 2 seconds).
  • the treatment unit 1 is charged by connecting the mains-supplied charger to the port 23.
  • the unit 1 automatically switches on, as indicated by a sound.
  • the left hand control button 26, as seen in the drawings, will be illuminated red by the appropriate LED(s) to indicate that the battery 41 is charging.
  • a system reset pulse is generated in response to the first rising edge of the charger voltage after the unit 1 has been plugged in. In one example, this may be generated by the charge switch circuit 54, and causes the microcontroller 40 to reset the unit 1 to a default state. This means that any errors or other problems are cleared, and the unit 1 starts delivery of each program from a known state .
  • the left hand control button 26 is illuminated green by the appropriate LED(s) to indicate that the battery 41 is fully charged, and the unit 1 is on.
  • the charger is disconnected, and the unit 1 may be programmed.
  • the illumination of the left hand control button 26 may change through to amber and then green during charging, to indicate the charging status.
  • the unit 1 automatically switches off, and the control buttons 26, 27 are not illuminated. Once the charger is disconnected, the unit 1 can be manually switched on and programmed. The unit 1 is manually switched on by a long press on the left hand control button 26. The unit 1 switches on, as indicated by a sound. When the unit 1 is first switched on, one of the four LED light tube 28-3 1 is illuminated, corresponding to the previous programme delivered
  • the left hand control button 26 is constantly lit to show the battery status indicated by the charger 53 to the microcontroller 40.
  • the left hand control button is lit green if the battery 41 includes sufficient charge to deliver a full program, and red if there is insufficient charge. After 30 seconds the light will start to flash every two seconds. If there is no action taken in a further 90 seconds, the unit 1 will switch back off, indicated by a sound, and the light going out.
  • the unit 1 can be programmed in the period after the unit 1 is turned on (or in the period immediately after the battery 41 is charged). This is achieved by selecting one of the four programmes described above. Pressing the control button 26 with a short press will cycle through the programmes, with the indication of which one is selected being displayed by lighting one of the LEDs for the light tubes of the apertures 28 to 3 1. The number of the programme selected may also be indicated audibly. If the light on the left hand control button 26 is flashing, the short press will also return the illumination of the button 26 to a constant light. The short press also restarts the period after which the light starts to flash and after which the unit 1 is automatically switched off.
  • the electrode pads 12, 13 are attached to the carrier 2, and the carrier 2 is then attached to an appropriate limb of the human or animal to be treated, and adjusted so it is secure, and the pads 12, 13 are in contact with the skin.
  • the unit 1 can then be connected to the electrodes 3, 4 by the connector 7, and the treatment started by pressing the right hand control button 27, as seen in the drawings.
  • a long press starts the selected seven hour programs, while a short press starts delivery of a three hour treatment program.
  • the three hour treatment programme may be the first three hours of the selected seven hour program, or the second three hours. A sound accompanies the button press to indicate the start of the program.
  • the illuminate of the left hand control button 26 is switched off.
  • the right hand control button 27 When the electrodes 3, 4 are connected to the treatment unit 1 , the right hand control button 27 will be illuminated by an LCD to indicate connectivity. If the electrodes 3 , 4 are connected properly and a complete circuit is formed, the right hand control button is illuminated green. If one or both of the electrodes 3, 4 is not connected properly, the right hand button is illuminated red.
  • a light tube 28-3 1 corresponding to the selected program will start to flash green every two seconds. This indicates which program is being delivered, and continues throughout the delivery of the program.
  • the unit 1 can then be secured in the carrier pocket 8 for the duration of the selected treatment. Any interruption of the delivery will be indicated by a change in the illumination status from flashing green to constant red.
  • the unit 1 After delivery of a full programme, the unit 1 is automatically switched off. This is accompanied by an audible sound, and all illumination switches off, to indicate that the unit 1 is off.
  • the unit 1 can be switched off by a long press of the left hand control button 26. Again, this is accompanied by an audible sound, and all illumination switches off, to indicate that the unit 1 is off.
  • the treatment unit 1 is robust and simple to use.
  • the provision of a single port 23 for charging and output of pulses, together with the charge switch circuit 54 for automatically detecting which is required and switching the charging circuit accordingly, means that ingress of dust and moisture in use is minimised.
  • the pulses and programmes may be altered. Only the upper pattern 60 of pulses is used, with the alternate positive and negative polarity for bunches of pulses, although there is still a difference between the two types of waveforms. In the first type the peak current is variable, while in the second type it is fixed.
  • the microcontroller 40 is programmed with two patterns ( 1A and IB) of the first type, which differ only in the time for which they are applied. Similarly, the microcontroller 40 is programmed with two patterns (2A and 2B) of the second type, which differ only in the time for which they are applied. In each case, a first predetermined period of pulse delivery is followed by a second predetermined period when no pulses are delivered, the ratio between the first and second periods (on:off) being 2 to 1. For each type of pattern, the first pattern ( 1A or 2A) may be on for 5 minutes, and off for 2.5 minutes. The second pattern ( IB or 2B) may be on for 10 minutes and off for 5 minutes.
  • the peak current varies from 50 to 400 ⁇ , the number of pulses in a bunch varies from 2 to 1 1 , and the spacing of the bunches varies from 1 to 10 milliseconds.
  • the pulse width remains constant at 1 10 microseconds, and the space between pulses in a bunch remains constant at 860 microseconds.
  • the peak current is fixed at 140 ⁇ , the number of pulses in a bunch varies from 2 to 1 1 , and the spacing of the bunches varies from 1 to 10 milliseconds.
  • the pulse width remains constant at 1 10 microseconds, and the space between pulses in a bunch remains constant at 860 microseconds.
  • the cycle time of 5 seconds of the upper pattern 60 is used, alternating between equal times of positive and negative pulses. As the cycle is repeated for patterns 1A and IB, the peak current, number of pulses in a bunch and bunch spacing varies. For patterns 2A and 2B the cycle time of 5 seconds of the upper pattern 60 is used, and as the cycle is repeated the number of pulses in a bunch and the bunch spacing varies while the peak current remains fixed.
  • the microcontroller is programmed with four combinations of the four patterns, giving four possible selections of programme for treatment.
  • Each programme lasts for 6 hours, divided into two parts of 3 hours each, which may be separated by 1 hour of no pulses.
  • a first programme consists of the pattern sequence 1A, 1A, IB, IB, for 3 hours, this sequence then being repeated for the second 3 hours.
  • a second programme consists of the pattern sequence 1A, IB, 2A, 2B, for 3 hours, and repeated for the second 3 hours.
  • a third programme consists of the pattern sequence 1A, 2A, 2A, 2B for 3 hours, repeated for the second 3 hours. These three patterns deal with trauma and then promote healing.
  • a fourth programme consists of the pattern sequence 1A, 2A, IB, 2B for the first 3 hours, and repeated for the second 3 hours and is designed for maintenance of a healthy condition.
  • the microcontroller 40 may be any suitable controller or group of controllers operating in parallel, including processors and memory, and other means for controlling the operation of the treatment unit 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un appareil de traitement par thérapie d'un corps humain ou animal qui comprend une unité de traitement (1) comprenant un boîtier (20), une batterie (41) et un moyen permettant de générer et de délivrer des impulsions à micro-courant (40, 46, 47, 48, 49), un support (2) conçu pour être fixé au corps humain ou animal, comprenant une paire d'électrodes (3, 4) de manière à entrer en contact avec le corps au niveau d'emplacements espacés, et un moyen (7) permettant de connecter les électrodes (3, 4) à l'unité de traitement (1) afin de recevoir les impulsions à micro-courant, laquelle unité de traitement (1) a un port unique (23), agissant en tant qu'entrée pour charger la batterie (41) et en tant que sortie pour le moyen de connexion d'électrode (7) pour la fourniture des impulsions.
PCT/GB2015/054041 2014-12-16 2015-12-16 Appareil de traitement Ceased WO2016097731A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB201422391 2014-12-16
GB1422391.1 2014-12-16

Publications (2)

Publication Number Publication Date
WO2016097731A2 true WO2016097731A2 (fr) 2016-06-23
WO2016097731A3 WO2016097731A3 (fr) 2016-08-04

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Application Number Title Priority Date Filing Date
PCT/GB2015/054041 Ceased WO2016097731A2 (fr) 2014-12-16 2015-12-16 Appareil de traitement

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WO (1) WO2016097731A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017139784A1 (fr) * 2016-02-12 2017-08-17 Axonics Modulation Technologies, Inc. Dispositif générateur d'impulsions externes et procédés associés pour une stimulation nerveuse d'essai
WO2018165481A1 (fr) * 2017-03-08 2018-09-13 Halo Neuro, Inc. Système pour stimulation électrique

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE435679B (sv) * 1980-09-17 1984-10-15 Landskrona Finans Ab Stimulatorsystem, innefattande en av ett uppladdningsbart batteri driven pulsgenerator
US6865423B2 (en) * 1996-06-13 2005-03-08 The Victoria University Of Manchester Stimulation of muscles
CN102309815A (zh) * 2010-06-29 2012-01-11 医博生株式会社 便携式低频电疗设备
GB2502133B (en) * 2012-05-17 2018-06-27 Applied Microcurrent Tech Limited Treatment or therapeutic apparatus

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017139784A1 (fr) * 2016-02-12 2017-08-17 Axonics Modulation Technologies, Inc. Dispositif générateur d'impulsions externes et procédés associés pour une stimulation nerveuse d'essai
US10376704B2 (en) 2016-02-12 2019-08-13 Axonics Modulation Technologies, Inc. External pulse generator device and associated methods for trial nerve stimulation
US11260236B2 (en) 2016-02-12 2022-03-01 Axonics, Inc. External pulse generator device and affixation device for trial nerve stimulation and methods of use
US12226643B2 (en) 2016-02-12 2025-02-18 Axonics, Inc. External pulse generator device and affixation device for trial nerve stimulation and methods of use
WO2018165481A1 (fr) * 2017-03-08 2018-09-13 Halo Neuro, Inc. Système pour stimulation électrique

Also Published As

Publication number Publication date
GB2534681B (en) 2017-08-02
GB201522225D0 (en) 2016-01-27
GB2534681A (en) 2016-08-03
WO2016097731A3 (fr) 2016-08-04

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