WO2015042682A1 - Devices and methods for activation of electrodes - Google Patents

Devices and methods for activation of electrodes Download PDF

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Publication number
WO2015042682A1
WO2015042682A1 PCT/CA2013/000819 CA2013000819W WO2015042682A1 WO 2015042682 A1 WO2015042682 A1 WO 2015042682A1 CA 2013000819 W CA2013000819 W CA 2013000819W WO 2015042682 A1 WO2015042682 A1 WO 2015042682A1
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WO
WIPO (PCT)
Prior art keywords
computing device
electronic device
component
pulse
treatment
Prior art date
Application number
PCT/CA2013/000819
Other languages
French (fr)
Inventor
Davor SALAHOVIC
Sasa Marinkovic
Original Assignee
Salahovic Davor
Sasa Marinkovic
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 Salahovic Davor, Sasa Marinkovic filed Critical Salahovic Davor
Priority to PCT/CA2013/000819 priority Critical patent/WO2015042682A1/en
Publication of WO2015042682A1 publication Critical patent/WO2015042682A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0452Specially adapted for transcutaneous muscle stimulation [TMS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0456Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • HELECTRICITY
    • H02GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02JCIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J7/00Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
    • H02J7/0042Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries characterised by the mechanical construction
    • H02J7/0044Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries characterised by the mechanical construction specially adapted for holding portable devices containing batteries
    • HELECTRICITY
    • H02GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02JCIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J7/00Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
    • H02J7/34Parallel operation in networks using both storage and other dc sources, e.g. providing buffering
    • H02J7/342The other DC source being a battery actively interacting with the first one, i.e. battery to battery charging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0492Patch electrodes
    • HELECTRICITY
    • H02GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02JCIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J2310/00The network for supplying or distributing electric power characterised by its spatial reach or by the load
    • H02J2310/10The network having a local or delimited stationary reach
    • H02J2310/20The network being internal to a load
    • H02J2310/23The load being a medical device, a medical implant, or a life supporting device

Definitions

  • the present invention relates generally to a user-administered electrotherapy solution and more particularly to devices for electrotherapy using a personal mobile computing device (e.g. smart phone, tablet computer) to provide user interface, software based control and, optionally, power.
  • a personal mobile computing device e.g. smart phone, tablet computer
  • Electrotherapy Devices Modern research into applications of EDs continues to reveal unique benefits and advantages of different therapeutic methods, often citing minimal side effects, cases of efficacy where other approaches (e.g. pharmaceutical) either failed or were only partially successful, and the like.
  • the third limit to current ED usability is the "therapeutic device" image that a bulky, self-contained unit entails in public view, causing reluctance in the vast majority to use it outside one's home, although many public settings associated with waiting present very practical opportunities for electrotherapy.
  • the current ED offering therefore leaves much to be desired in terms of power economy, true portability and user-friendliness.
  • an electronic device operable to provide, via electrodes, electrical nerve or muscle stimulation, using as the source of power another device's headphone audio output, of industry standard voltage and frequency range.
  • a method for controlling the timing, duration and amplitude of output signal in an electrical nerve or muscle stimulation device by means of executing software on the processor a personal mobile computing device, communicating instructions to the ED via standard headphone audio interface and decoding such instructions using the on-board micro controller and firmware.
  • a method for controlling the timing, duration and amplitude of output signal in an electrical nerve or muscle stimulation device by means of executing software on the processor of a personal mobile computing device, communicating instructions to the ED via a wireless (Bluetooth) interface and decoding such instructions using the on-board micro controller and firmware.
  • an electronic device comprising: at least one power component operable to transform electrical power received from a low voltage power source into a DC voltage supply; a command decoder component, connected to the at least one power component, operable to receive a communication and to extract at least one control command from the communication; at least one micro controller, connected to the command decoder component and the at least one power component, operable to generate at least one pulse-width modulated signal based at least partly on the at least one control command; at least one output buffer, connected to the at least one power component and the at least one micro controller, operable to produce at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and at least one electrode activated by the at least one pulse.
  • a method of activating at least one electrode performed by an electronic device, the electronic device comprising: at least one power component; a command decoder component connected to the at least one power component; at least one micro controller connected to the command decoder component and the at least one power component; at least one output buffer connected to the at least one power component and the at least one micro controller; and at least one electrode; the method comprising: the command decoder component receiving a communication and extracting at least one control command from the communication; the at least one micro controller generating at least one pulse-width modulated signal based at least partly on the at least one control command; the at least one power component transforming electrical power received from a low voltage power source into a DC voltage supply; the at least one output buffer producing at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and activating the at least one electrode by the at least one pulse.
  • a computing device comprising at least one processor coupled to at least one non-transitory computer readable storage medium comprising instructions for processing by the at least one processor to cause the computing device to: receive at least one user input command; in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration; encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal; transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
  • a method of activating at least one electrode performed by a computing device, the method comprising: receiving at least one user input command; in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration; encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal; transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
  • FIG. 1 shows a simplified diagram exemplary of a single channel embodiment of the present invention, reliant on power from a smart phone and controlled via audio interface, in a typical user application scenario;
  • FIG. 2 shows a simplified diagram exemplary of a dual channel embodiment of the present invention, reliant on self-contained power source (battery) and controlled via audio interface, in a typical user application scenario.
  • FIG. 3 shows a simplified diagram exemplary of a dual channel embodiment of the present invention, reliant on self-contained power source (battery) and controlled via wireless (Bluetooth) interface, in a typical user application scenario;
  • FIG. 4 shows a hardware block diagram of an electronic device, exemplary of a single channel embodiment of the present invention
  • FIG. 5 shows a conceptual circuit diagram of an electronic device, exemplary of a single channel embodiment of the present invention
  • FIG. 6 shows a hardware block diagram of an electronic device, exemplary of a dual channel, audio-controlled embodiment of the present invention
  • FIG. 7 shows a conceptual circuit diagram of an electronic device, exemplary of a dual channel, audio-controlled embodiment of the present invention
  • FIG. 8 shows a hardware block diagram of an electronic device, exemplary of a dual channel, wireless-controlled embodiment of the present invention
  • FIG. 9 shows an idealized pulse timing diagram exemplifying a treatment pattern
  • FIG. 10 illustrates a method of decoding commands embedded in an audio stream in accordance with an aspect of the present invention
  • FIG. 1 1 illustrates a method of sharing feedback in accordance with an aspect of the present invention
  • FIG. 12 illustrates a generic computer used to implement aspects of the present invention
  • User-portable devices specifically designed for self-administered electrical nerve stimulation today comprise dedicated power sources, user interfaces and control logic circuitry, all of which contribute to their size, weight and cost, while limiting their portability and visual appeal.
  • This self-contained approach to their design has become redundant in an increasing user base already in possession of consumer electronic devices (mobile phones, personal computing devices, music players etc.) that are capable of lending power, control and user interaction to an electrical stimulation device.
  • power for the electrical nerve stimulation device of the present invention may be obtained from a separate device through an audio output port of that separate device.
  • Many mobile computing devices and personal computing devices include at least one audio output port.
  • Types of audio output ports may have standardized diameters of 3.5 mm, 2.5 mm, 6.35 mm, or any other dimensions, in order to receive a respectively correspondingly-sized connector.
  • Such audio output ports are typically configured to output power having a wattage of about 2.4 mW, although minor variations are possible. In accordance with aspects of the present invention, this output power may be used to satisfy a power demand of high-voltage nerve and muscle stimulation pulses used to activate an electrode for therapeutic electrical stimulation.
  • an audio output port such as a 3.5 mm audio out port (often called a headphone output port) is present on many computing devices, such as mobile phones, tablets, portable gaming devices, personal computers, and other devices
  • the audio output port of the computing device may be used to power a ED device of the present invention.
  • the audio output waveforms outputted at the audio output port may be programmed to carry instructions to the ED device.
  • the ED device of the present invention which may comprise a highly efficient circuit to produce the desired level of stimulation despite a limited and very small available power budget.
  • An instruction coding scheme is also provided by the present invention to embed instructions in an audio stream received from an audio output port of a computing device without compromising the computing device's role as the main power source.
  • FIG. 1 exemplifies an embodiment of the invention in a typical user application, with an electronic device operable to provide electrical nerve stimulation 200 shown being connected to the headphone audio output of a mobile phone device 100 capable of music file playback (henceforth and without loss of generality "smart phone") and a pair of transcutaneous gel- contact electrodes 300 being used to apply electrical signal to the user's body via direct skin contact.
  • the smart phone 100 provides to the electrical stimulation device 200 (which may be referred to as the electronic device 200) all the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrodes 300.
  • Such electrical power need not come from a smart phone, but rather may be provided by any consumer electronic device capable of audio file playback to a pair of industry standard headphones, including, but not limited to, a personal music player, a tablet computing device, laptop computer, desktop computer, or even an embedded audio subsystem, such as that in a massage chair or an airline seat.
  • the electrodes for stimulation need not be limited to those applied to the skin surface, rather, specialized electrodes applied to mucous membranes or penetrating the skin in a needle-like fashion are also possible, depending on the nature of the treatment.
  • FIG. 1 shows only one electrode pair, the invention may be embodied in a device operating multiple electrode pairs simultaneously, as dictated by the needs of the treatment and limited in principle only by the total available power budget.
  • the present invention may be embodied in a device capable of generating such higher values of instantaneous power, taking advantage of the premise that maximum average power available via headphone audio output exceeds average power demand of an electrical stimulation device.
  • the invention may be embodied in a device reliant on a self-contained power source (battery).
  • FIG. 2 exemplifies an embodiment of the invention in another typical user application, with an electronic device 400 operable to provide electrical nerve stimulation 400 shown being connected to the headphone audio output of a smart phone 100 and two pair of transcutaneous gel-contact electrodes 300 and 310, being used to apply electrical signals to the user's body via direct skin contact.
  • the smart phone 100 provides to the electrical stimulation device 400 instructions in the form of digital code words embedded in an audio stream, but the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrode pairs 300 and 310 is supplied by a self-contained on-board power source 410 (i.e. a battery unit).
  • a self-contained on-board power source 410 i.e. a battery unit
  • FIG. 3 exemplifies an embodiment of the invention in yet another typical user application, with an electronic device 500 operable to provide electrical nerve stimulation shown having a wireless communication link with a nearby smart phone 100.
  • the smart phone 100 provides to the electrical stimulation device 500 instructions in the form of digital code words exchanged via a wireless data link stream, but the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrode pairs 300 and 310 is supplied by a self-contained on-board power source 410.
  • the wireless communication link may comprise any type of wireless communication signal, including Bluetooth, near-field communication (NFC), or other communication signals.
  • Wireless communications may be established between a transmitter/receiver component of the smart phone 100 and a transmitter/receiver component of the electronic device 500.
  • FIG. 4 shows a hardware block level diagram of an electronic device 200 exemplary of an embodiment of the invention, shown in FIG. 1 , with headphone audio signal 210 shown as an input and the electrode signal, in this particular case for TENS treatment, shown as the output, 285.
  • the low voltage AC signal arriving from the headphone audio output of an external device is used to generate a DC voltage of magnitude sufficient to power all other internal circuitry.
  • the AC/DC converter block, 220 serves to perform energy-efficient signal rectification to achieve DC value equal to twice the peak AC value, typically in the 3 to 4 V range.
  • rectified electrical power is ultimately used by three other internal hardware blocks: 230, 260 and 270.
  • a high voltage DC/DC converter 230 uses the internally generated DC supply, 225, to generate high-voltage electrical signal, 235, of desired output magnitude.
  • Such voltage is controlled and adjusted to desired level by means of pulse-width modulation signal, 236, driven by the on board programmable micro controller unit, 270, and stored in an on board charge storage block, 240.
  • a person of ordinary skill in the art will readily appreciate that such storage may be capacitive in nature and designed to be of sufficient capacity to cover the energy demand of one output burst, using the time between bursts for replenishment.
  • the output of the high voltage storage block 240 (or capacitive storage component) is a stable power rail, 245, capable of supplying required high voltage and unidirectional or bidirectional currents for the duration of the output power bursts.
  • the purpose of the command demodulator circuit 260 is to extract instructions embedded in the incoming audio signal and send them in the form of a digital data stream, 265, to the MCU, 270, in order to convey and set the user- desired magnitude and timing of the outputs.
  • the design of the command demodulator circuit naturally depends on the type of modulation used, but a person skilled in the art will appreciate that this may include but not be limited to amplitude, phase or frequency. In this embodiment of the invention, amplitude modulation was chosen because it greatly simplifies the decoder circuitry.
  • the MCU, 270 performs three key functions. Firstly, it implements a finite state machine (henceforth FSM) operable to support a predetermined set of possible combinations of timing and signal magnitude at the electrode output (henceforth "user modes"), and uses digitally fed instructions to enter different FSM states, in effect setting the mode the user selected. Secondly, in accord with the digital instructions, it drives the duty cycle of the high voltage DC/DC converter, 230, in effect dictating the absolute magnitude of the high voltage output supply, 245. Thirdly, it provides output control signal, 275, to output buffer, 280, in effect dictating the timing of the output waveform, 285.
  • FSM finite state machine
  • FIG. 5 shows a conceptual circuit diagram of a practical implementation of the embodiment of the present invention shown in FIG. 4.
  • the input transformer, dual diode integrated circuit and capacitors C1 and C2 constitute the AC/DC converter and low voltage storage blocks providing stable DC power to the rest of the device at 3-4 Volts.
  • Q1 , C5, R1 , R3, R5 and Q2 perform the role of the command demodulator, essentially detecting presence or absence of AC input at the audio end and converting it into digital "low” and "high” values, respectively. These logic values are picked up serially by the micro controller unit via the input pin PB4.
  • Large inductor L4, M13, D1 and C3 serve as a simple switched DC-DC converter of the "boost" type, corresponding to blocks 230 and 240 in FIG. 4, generating and storing high DC voltage necessary for device output.
  • this high voltage level can be varied in accord with desired output level.
  • the transistor M15 is used to bleed off excess charge from C3, thus enabling the setting of lower voltage levels, when needed.
  • M11 , M12, R4, R12, D3, R11 , R13, D4, M7, M8, M9 and M10 constitute the output buffer circuit, driving a bi-directional high voltage output to the electrodes in response to control signals PBO and PB1.
  • only one pair of output transistors is turned on at any one time, in this case, M10 and M7 during positive pulse cycle, M8 and M9 during negative.
  • FIG. 6 shows a hardware block level diagram of an electronic device 400 exemplary of an embodiment of the invention, shown in FIG. 2, with headphone audio signal 410 shown as an input and the electrode signals, in this particular case for electrical muscle stimulation, shown as two output channels, 485 and 486.
  • headphone audio signal 410 shown as an input
  • the electrode signals in this particular case for electrical muscle stimulation, shown as two output channels, 485 and 486.
  • EMS is meant to cause muscle contraction
  • TENS is not
  • the voltages used in EMS applications are generally higher than those in TENS.
  • This combined with the dual-channel nature of this second embodiment of the invention, necessitates a greater power budget and therefore the use of a self-contained on board power supply (i.e. a battery), however, the control and user interface functions remain handled by the smart phone.
  • a self-contained on board power supply i.e. a battery
  • the battery, 410 supplies stable, low-voltage power rails, 425, 455 and 456 to the high voltage DC/DC converters 430 (or power component), the MCU, 470, and the command demodulator, 460, respectively.
  • the design of the command demodulator, 460, and the demodulated data stream, 465 are identical to the ones in the previous embodiment, 260 and 265, except in that, due to the greater number of possible user modes on a two-channel device, the supported instruction set may be larger. Similarly, the number of states supported by the FSM in the MCU will be greater, to allow for independent control of timing on the two output channel controls, 475 and 476.
  • the user has the freedom to set different intensity (peak voltage) levels on the two channels, and this is made possible by the control input, 434, to the high voltage DC/DC converter block, 430, which, in fact comprises of two switched boost converters generating independent high-voltage power rails, 435 and 436. These are fed to two separate capacitive charge stores, in the high voltage charge storage block, 440, to provide clean high-voltage lines 445 and 446 to output buffers, 480 and 481 , respectively.
  • the user has the ability to use the first channel only, the second only, or both simultaneously.
  • FIG. 7 shows a conceptual circuit diagram of a practical implementation of the embodiment of the present invention shown in FIG. 6.
  • the low voltage DC power is supplied by the on-board battery pack, V1 , so the input rectifier circuit consisting of R1 , R2, C1 , C2, the transformer and the dual diode integrated circuit serves only the purpose of sending decoded commands to the micro controller unit via PBO, but does not provide any useable power.
  • this embodiment supports two independently controlled high voltage outputs, at voltage levels stored in C3 and C4, which is why it includes two identical high-voltage generator and storage elements, and two sets of output buffers.
  • FIG. 8 shows a hardware block level diagram of an electronic device 500 exemplary of an embodiment of the invention, shown in FIG. 3, using instead of a hard-wired headphone audio interface, a wireless (Bluetooth) link as its interface to user input and control functions on a nearby smart phone.
  • this apparatus uses a wireless (Bluetooth) transmitter/receiver circuit 510 (or transmitter/receiver component) in place of the command demodulator.
  • FIG. 9 shows a simplified timing diagram equally exemplary without loss of generality of all electrotherapeutic applications covered herein. While absolute values of voltage V1 , pulse duration t1 and pulse period t2 vary in accord with the nature and requirements of the treatment, it is generally true that the voltage V1 is many times greater than the peak headphone audio output or any practically usable battery, and that the pulse period t2 is many times longer than the pulse duration t1. In that sense, all embodiments of the invention use special circuitry within the device to generate the pulse train matching the amplitude and timing requirements of the prescribed treatment program, and all rely on personal mobile computing devices for user interface and mode selection.
  • additional programing scenarios are possible, including but not limited to: providing the user the interface and the options to create custom treatment programs by selecting from, combining or sequencing one or more predetermined user modes, resulting in predictable treatment patterns; providing the user with interface and options to delay the start of the treatment to a desired time; set the treatment duration and course in advance; store and re-use previously created and used treatment program; and record history of use, and the like.
  • FIG. 10 exemplifies the method by means of which a desired mode of operation is chosen, activated and used for either therapeutic or muscle toning purposes.
  • the software application executed on the mobile computing device, in this case a smart phone, would acquire the desired mode selection.
  • Such a user choice would then cause the app to encode a digital code word, in this case an 8-bit binary number, into an audio stream sent to the hardware device.
  • the demodulator circuit within the device would decode the audio stream, thus recovering the 8-bit digital number representing the desired mode.
  • the on board micro controller unit would compare the received number to the list of pre-programmed modes, internally stored in memory in the form of a look-up table, and set output timing and intensity parameters accordingly.
  • the output buffers would drive the desired mode to the electrodes until the micro controller receives instructions to do otherwise or an unscheduled interruption occurs (e.g. physical disconnect with the smart phone, incoming phone call, text message, loss of battery power and the like).
  • the app may include the following: (1 ) a menu- based user interface, capable of acquiring user selection of desired modes (timing), from a predetermined set and the desired output intensity level; (2) a communication layer, capable of encoding digital instructions into an audio stream or a wireless bluetooth datastream to be sent to the device; (3) a timer, capable of setting duration of treatment in accord with user's decision (4) an interrupt handler, capable of handling gracefully all possible unscheduled interruptions, namely, incoming phone calls, incoming text messages, physical wire disconnects, loss of wireless connectivity, alarms and alerts, optionally comprising capability to restore the device to "last used" therapeutic or muscle toning session.
  • the app may also comprise the following optional elements: (1) the ability to self-calibrate output intensity by sending and interpreting trial pulses to the user's skin and optimizing output voltages in accord with the electro-resistive properties of the electrode/user contact; (2) the ability to record usage (treatment) history for future reference and use; (3) the ability to acquire user feedback on experience with and perceived effectiveness of the treatments; (4) the ability to share data with others and cloud-based server applications for purposes of future optimization of treatment profiles based on large-scale user experience data and (5) the ability to receive and implement new or modified modes from the cloud, resulting from such improvements.
  • the present invention may be embodied in a device operable to connect to a smart phone via the headphone audio connector, use this connection to draw sufficient electrical power for its operation, furthermore use this connection to receive and decode digital instructions embedded in the audio stream, set any of a number of predetermined end user modes and in accord with those produce electrotherapeutic signals of desired timing and amplitude.
  • software executed on the smart phone serves to provide user interface functionality and specific audio signals that lend power to the device and carry encoded instructions.
  • the present invention may be embodied in a device of example 1 , operable to connect instead to any of a number of consumer electronic devices capable of headphone audio playback and comprising an internal micro processor capable of executing software, including, but not limited to: personal computers (laptops), tablet computers and personal entertainment units, either stand-alone or embedded, such as those in modern airline seats.
  • the present invention may be embodied in a device of example 2, comprising further an autonomous power source (a battery), thus relying on external electronic device for user interaction and control, but not power.
  • a battery an autonomous power source
  • the present invention may be embodied in any of the above exemplified devices, using self-adhesive disposable electrodes to deliver pulses to the end user transcutaneously, for either therapeutic or muscle stimulation purpose.
  • the present invention may be embodied in a device of example 4, using permanent silicone electrodes and conductive gel instead of disposable electrodes.
  • the present invention may be embodied in a device of example 4, using acupuncture needles as electrodes to deliver electrical pulses subcutaneously.
  • the present invention may be embodied in a device of example 4, using abdominal and limb-administered flexible or adjustable belts, comprising skin contacting conductive surfaces instead of stand-alone electrodes.
  • TENS user may use a therapeutic embodiment of the invention to alleviate chronic elbow pain due to a sport related injury.
  • Alice would download a TENS-specific app to her smart phone, connect the device to the phone and apply self- adhesive gel electrodes to the target area.
  • Alice would choose one of the available modes from the user menu, set the number of minutes desired and commence treatment at the lowest intensity level. She would then gradually increase output voltage until a tingling sensation intensifies to the upper threshold her comfort.
  • she would record immediate feedback on her experience. In future sessions, she would have the option to reference previous modes and durations and, over time, optimize her treatment choices for maximum benefits.
  • EMS user may use a muscle toning embodiment of the invention to increase tone in his abdominal and lower back muscles.
  • Bob would download an EMS-specific app to his smart phone, connect the device to the phone and wear the muscle toning belt around his waist.
  • Bob would choose one of the available modes from the user menu, set the number of minutes desired and commence treatment at the lowest intensity level. He would then gradually increase output voltage until a desired level of comfortable muscle contraction is achieved. Following the treatment, he would record immediate feedback on his experience. Additionally, outside treatment sessions, he would record his perception of muscle toning effectiveness using the app. As illustrated in FIG.
  • any module or component exemplified herein that executes instructions may include or otherwise have access to computer readable media such as storage media, computer storage media, or data storage devices (removable and/or non-removable) such as, for example, magnetic disks, optical disks, tape, and other forms of computer readable media.
  • Computer storage media may include volatile and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data.
  • Examples of computer storage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD), blu-ray disks, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by an application, module, or both. Any such computer storage media may be part of the mobile device, tracking module, object tracking application, etc., or accessible or connectable thereto. Any application or module herein described may be implemented using computer readable/executable instructions that may be stored or otherwise held by such computer readable media.
  • FIG. 12 shows a generic computer device 100 that may include a central processing unit (“CPU") 502 connected to a storage unit 504 and to a random access memory 506.
  • the CPU 502 may process an operating system 501 , application program 503, and data 523.
  • the operating system 501 , application program 503, and data 523 may be stored in storage unit 504 and loaded into memory 506, as may be required.
  • Computer device 500 may further include a graphics processing unit (GPU) 522 which is operatively connected to CPU 502 and to memory 506 to offload intensive image processing calculations from CPU 502 and run these calculations in parallel with CPU 502.
  • An operator 507 may interact with the computer device 500 using a video display 508 connected by a video interface 505, and various input/output devices such as a keyboard 510, mouse 512, and disk drive or solid state drive 514 connected by an I/O interface 509.
  • the mouse 512 may be configured to control movement of a cursor in the video display 508, and to operate various graphical user interface (GUI) controls appearing in the video display 508 with a mouse button.
  • GUI graphical user interface
  • the disk drive or solid state drive 514 may be configured to accept computer readable media 516.
  • the computer device 500 may form part of a network via a network interface 51 1 , allowing the computer device 500 to communicate with other suitably configured data processing systems (not shown).
  • the disclosure provides systems, devices, methods, and computer programming products, including non-transient machine-readable instruction sets, for use in implementing such methods and enabling the functionality described previously.

Abstract

Transcutaneous Electrical Nerve Stimulation (TENS), a method of stimulating nerves using electrical current applied through the skin for therapeutic purposes, has been in use since the late 1970's, as have electronic units for self-administration of TENS therapy. With the recent increase in popularity of mobile devices with processing capabilities (smart phones, portable computing devices, MP3 players etc.), most TENS users already carry consumer electronic equipment capable of providing instruction to another device via its audio port or a wireless link. A TENS unit designed to: (a) be coupled with a personal mobile computing device, (b) rely on it for user interaction and, optionally, (c) make use of its power, provides a smaller, less expensive and more convenient portable treatment solution. This approach can be extended to other electrotherapy forms utilizing similar power budgets: Microcurrent Electrical Nerve Stimulation (MENS), Percutaneous Tibial Nerve Stimulation (PTNS), Electrical Muscle Stimulation/Neuromuscular Electrical Stimulation (EMS/NMES).

Description

DEVICES AND METHODS FOR ACTIVATION OF ELECTRODES
FIELD OF THE INVENTION
[0001] The present invention relates generally to a user-administered electrotherapy solution and more particularly to devices for electrotherapy using a personal mobile computing device (e.g. smart phone, tablet computer) to provide user interface, software based control and, optionally, power.
BACKGROUND OF THE INVENTION
[0002] It has long been recognized that electrical nerve stimulation can have therapeutic effects, in particular in management of chronic pain. This recognition lead to scientific research and clinical trials, which, over the last four decades accumulated a body of evidence sufficient to indicate Transcutaneous Electrical Nerve Stimulation (TENS), as it is now formally known, in medical treatment and management of a number of conditions, related primarily, but not exclusively, to chronic pain. As medical research in the field of electrotherapy broadened, other specific electrotherapeutic methods were developed and standardized, today including but not being limited to: Microcurrent Electrical Nerve Stimulation (MENS), used in muscle and tendon repair and recovery, Percutaneous Tibial Nerve Stimulation (PTNS), indicated in the treatment of overactive bladder syndrome, and Electrical Muscle Stimulation, also known as Neuromuscular Electrical Stimulation (EMS/NMES), used in muscle toning, training, mobility and even cosmetic treatments. For brevity, TENS, MENS, PTNS and EMS/NMES will henceforth be referred to as Electrotherapy Devices (EDs). Modern research into applications of EDs continues to reveal unique benefits and advantages of different therapeutic methods, often citing minimal side effects, cases of efficacy where other approaches (e.g. pharmaceutical) either failed or were only partially successful, and the like.
[0003] Concurrent with these scientific advancements was the development of electronic equipment necessary to produce and administer electrical pulses for electrotherapy. There is now a broad variety of EDs on the market, ranging from sophisticated and highly programmable equipment intended for clinical sessions to considerably less expensive, user-owned devices that a patient can set up, self-administer and use regularly and without help. The latter, often labeled and marketed as "portable", in fact have shortcomings which limit their true portability and popularity that would be expected, given the benefits. [0004] Portable EDs on the market today rely on re-chargeable or disposable batteries. Because they are self-contained devices, often incorporating complex internal logic and user interfaces such as color Liquid Crystal Display (LCD) screens, their battery packs need to supply substantial power beyond that needed for the electrical pulses applied to the electrodes, and as such are invariably either large and heavy, or have short lives and hence require frequent replacement or recharging. Furthermore, the presence of an on-board user interface, most often a digital display, limits how small, truly portable and elegant today's EDs really are. This inherent bulkiness is the primary obstacle to ED use outside the home. The second obstacle to wider and more popular use of ED is the cost of batteries - financial in the case of disposable units or, equally problematic, the burden of inconvenience associated with recharging in the case of reusable ones. Finally, the third limit to current ED usability is the "therapeutic device" image that a bulky, self-contained unit entails in public view, causing reluctance in the vast majority to use it outside one's home, although many public settings associated with waiting present very practical opportunities for electrotherapy. The current ED offering therefore leaves much to be desired in terms of power economy, true portability and user-friendliness.
[0005] Therefore, an improvement in ED portability is desired.
SUMMARY OF THE INVENTION
[0006] In accordance with an aspect of the present invention, there is provided an electronic device operable to provide, via electrodes, electrical nerve or muscle stimulation, using as the source of power another device's headphone audio output, of industry standard voltage and frequency range.
[0007] In accordance with another aspect of the present invention, there is provided a method for controlling the timing, duration and amplitude of output signal in an electrical nerve or muscle stimulation device, by means of executing software on the processor a personal mobile computing device, communicating instructions to the ED via standard headphone audio interface and decoding such instructions using the on-board micro controller and firmware.
[0008] In accordance with yet another aspect of the present invention, there is provided a method for controlling the timing, duration and amplitude of output signal in an electrical nerve or muscle stimulation device, by means of executing software on the processor of a personal mobile computing device, communicating instructions to the ED via a wireless (Bluetooth) interface and decoding such instructions using the on-board micro controller and firmware. [0009] In accordance with an aspect of the present invention there is provided an electronic device comprising: at least one power component operable to transform electrical power received from a low voltage power source into a DC voltage supply; a command decoder component, connected to the at least one power component, operable to receive a communication and to extract at least one control command from the communication; at least one micro controller, connected to the command decoder component and the at least one power component, operable to generate at least one pulse-width modulated signal based at least partly on the at least one control command; at least one output buffer, connected to the at least one power component and the at least one micro controller, operable to produce at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and at least one electrode activated by the at least one pulse.
[0010] In accordance with an aspect of the present invention there is provided a method of activating at least one electrode, performed by an electronic device, the electronic device comprising: at least one power component; a command decoder component connected to the at least one power component; at least one micro controller connected to the command decoder component and the at least one power component; at least one output buffer connected to the at least one power component and the at least one micro controller; and at least one electrode; the method comprising: the command decoder component receiving a communication and extracting at least one control command from the communication; the at least one micro controller generating at least one pulse-width modulated signal based at least partly on the at least one control command; the at least one power component transforming electrical power received from a low voltage power source into a DC voltage supply; the at least one output buffer producing at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and activating the at least one electrode by the at least one pulse.
[001 1] In accordance with an aspect of the present invention there is provided a computing device comprising at least one processor coupled to at least one non-transitory computer readable storage medium comprising instructions for processing by the at least one processor to cause the computing device to: receive at least one user input command; in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration; encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal; transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
[0012] In accordance with an aspect of the present invention there is provided a method of activating at least one electrode, performed by a computing device, the method comprising: receiving at least one user input command; in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration; encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal; transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
[0013] Other aspects and features of the present invention will become apparent to those of ordinary skill in the art upon review of the following description of specific embodiments of the invention with the accompanying figures.
[0014] In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Embodiments will now be described, by way of example only, with reference to the attached figures, wherein:
[0016] FIG. 1 shows a simplified diagram exemplary of a single channel embodiment of the present invention, reliant on power from a smart phone and controlled via audio interface, in a typical user application scenario;
[0017] FIG. 2 shows a simplified diagram exemplary of a dual channel embodiment of the present invention, reliant on self-contained power source (battery) and controlled via audio interface, in a typical user application scenario. [0018] FIG. 3 shows a simplified diagram exemplary of a dual channel embodiment of the present invention, reliant on self-contained power source (battery) and controlled via wireless (Bluetooth) interface, in a typical user application scenario;
[0019] FIG. 4 shows a hardware block diagram of an electronic device, exemplary of a single channel embodiment of the present invention;
[0020] FIG. 5 shows a conceptual circuit diagram of an electronic device, exemplary of a single channel embodiment of the present invention;
[0021] FIG. 6 shows a hardware block diagram of an electronic device, exemplary of a dual channel, audio-controlled embodiment of the present invention;
[0022] FIG. 7 shows a conceptual circuit diagram of an electronic device, exemplary of a dual channel, audio-controlled embodiment of the present invention;
[0023] FIG. 8 shows a hardware block diagram of an electronic device, exemplary of a dual channel, wireless-controlled embodiment of the present invention;
[0024] FIG. 9 shows an idealized pulse timing diagram exemplifying a treatment pattern;
[0025] FIG. 10 illustrates a method of decoding commands embedded in an audio stream in accordance with an aspect of the present invention;
[0026] FIG. 1 1 illustrates a method of sharing feedback in accordance with an aspect of the present invention; and
[0027] FIG. 12 illustrates a generic computer used to implement aspects of the present invention;
[0028] In the drawings, embodiments of the invention are illustrated by way of example. It is to be expressly understood that the description and drawings are only for the purpose of illustration and as an aid to understanding, and are not intended as a definition of the limits of the invention.
DETAILED DESCRIPTION
[0029] User-portable devices specifically designed for self-administered electrical nerve stimulation today comprise dedicated power sources, user interfaces and control logic circuitry, all of which contribute to their size, weight and cost, while limiting their portability and visual appeal. This self-contained approach to their design has become redundant in an increasing user base already in possession of consumer electronic devices (mobile phones, personal computing devices, music players etc.) that are capable of lending power, control and user interaction to an electrical stimulation device. In accordance with an aspect of the present invention, it may be possible to rely on such devices to provide power and control functionality to an electrical nerve stimulation device, rather than having dedicated power and logic modules contained at the electrical nerve stimulation device. In particular, in accordance with the present invention, power for the electrical nerve stimulation device of the present invention may be obtained from a separate device through an audio output port of that separate device.
[0030] Many mobile computing devices and personal computing devices include at least one audio output port. Types of audio output ports may have standardized diameters of 3.5 mm, 2.5 mm, 6.35 mm, or any other dimensions, in order to receive a respectively correspondingly-sized connector. Such audio output ports are typically configured to output power having a wattage of about 2.4 mW, although minor variations are possible. In accordance with aspects of the present invention, this output power may be used to satisfy a power demand of high-voltage nerve and muscle stimulation pulses used to activate an electrode for therapeutic electrical stimulation. As an audio output port, such as a 3.5 mm audio out port (often called a headphone output port) is present on many computing devices, such as mobile phones, tablets, portable gaming devices, personal computers, and other devices, the audio output port of the computing device may be used to power a ED device of the present invention. Furthermore, in accordance with an aspect of the present invention, the audio output waveforms outputted at the audio output port may be programmed to carry instructions to the ED device.
[0031 ] In order to realize this functionality, the ED device of the present invention is provided which may comprise a highly efficient circuit to produce the desired level of stimulation despite a limited and very small available power budget. An instruction coding scheme is also provided by the present invention to embed instructions in an audio stream received from an audio output port of a computing device without compromising the computing device's role as the main power source.
[0032] FIG. 1 exemplifies an embodiment of the invention in a typical user application, with an electronic device operable to provide electrical nerve stimulation 200 shown being connected to the headphone audio output of a mobile phone device 100 capable of music file playback (henceforth and without loss of generality "smart phone") and a pair of transcutaneous gel- contact electrodes 300 being used to apply electrical signal to the user's body via direct skin contact. In this embodiment of the invention, the smart phone 100 provides to the electrical stimulation device 200 (which may be referred to as the electronic device 200) all the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrodes 300. A person of ordinary skill will readily appreciate that such electrical power need not come from a smart phone, but rather may be provided by any consumer electronic device capable of audio file playback to a pair of industry standard headphones, including, but not limited to, a personal music player, a tablet computing device, laptop computer, desktop computer, or even an embedded audio subsystem, such as that in a massage chair or an airline seat. A person of ordinary skill will furthermore readily appreciate that the electrodes for stimulation need not be limited to those applied to the skin surface, rather, specialized electrodes applied to mucous membranes or penetrating the skin in a needle-like fashion are also possible, depending on the nature of the treatment. Furthermore, while the embodiment in FIG. 1 shows only one electrode pair, the invention may be embodied in a device operating multiple electrode pairs simultaneously, as dictated by the needs of the treatment and limited in principle only by the total available power budget.
[0033] Electrical nerve stimulation treatments require voltages, currents and slew rates above the operating capability of industry standard headphone audio outputs. For further clarity, values that exemplify signals in the embodiment depicted in FIG. 1 may include:
[0034] 2 Vp-p continuous sine wave of 1 kHz frequency for the audio signal; and
[0035] +/- 40 V square pulses of 50 microsecond duration, 200 millisecond period, for the electrodes 300.
[0036] The present invention, therefore, may be embodied in a device capable of generating such higher values of instantaneous power, taking advantage of the premise that maximum average power available via headphone audio output exceeds average power demand of an electrical stimulation device. Alternatively, the invention may be embodied in a device reliant on a self-contained power source (battery).
[0037] FIG. 2 exemplifies an embodiment of the invention in another typical user application, with an electronic device 400 operable to provide electrical nerve stimulation 400 shown being connected to the headphone audio output of a smart phone 100 and two pair of transcutaneous gel-contact electrodes 300 and 310, being used to apply electrical signals to the user's body via direct skin contact. In this embodiment of the invention, the smart phone 100 provides to the electrical stimulation device 400 instructions in the form of digital code words embedded in an audio stream, but the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrode pairs 300 and 310 is supplied by a self-contained on-board power source 410 (i.e. a battery unit).
[0038] FIG. 3 exemplifies an embodiment of the invention in yet another typical user application, with an electronic device 500 operable to provide electrical nerve stimulation shown having a wireless communication link with a nearby smart phone 100. In this embodiment of the invention, the smart phone 100 provides to the electrical stimulation device 500 instructions in the form of digital code words exchanged via a wireless data link stream, but the electrical power necessary for internal operation of its circuits and the power necessary to generate output signals to the electrode pairs 300 and 310 is supplied by a self-contained on-board power source 410. The wireless communication link may comprise any type of wireless communication signal, including Bluetooth, near-field communication (NFC), or other communication signals. Wireless communications may be established between a transmitter/receiver component of the smart phone 100 and a transmitter/receiver component of the electronic device 500.
[0039] FIG. 4 shows a hardware block level diagram of an electronic device 200 exemplary of an embodiment of the invention, shown in FIG. 1 , with headphone audio signal 210 shown as an input and the electrode signal, in this particular case for TENS treatment, shown as the output, 285. In this embodiment, the low voltage AC signal arriving from the headphone audio output of an external device is used to generate a DC voltage of magnitude sufficient to power all other internal circuitry. The AC/DC converter block, 220, serves to perform energy-efficient signal rectification to achieve DC value equal to twice the peak AC value, typically in the 3 to 4 V range. As will become apparent, thus rectified electrical power is ultimately used by three other internal hardware blocks: 230, 260 and 270.
[0040] In order to enable short electrical bursts of power far in excess of that provided by the continuous audio signal supply, a high voltage DC/DC converter 230 (or power component) uses the internally generated DC supply, 225, to generate high-voltage electrical signal, 235, of desired output magnitude. Such voltage is controlled and adjusted to desired level by means of pulse-width modulation signal, 236, driven by the on board programmable micro controller unit, 270, and stored in an on board charge storage block, 240. A person of ordinary skill in the art will readily appreciate that such storage may be capacitive in nature and designed to be of sufficient capacity to cover the energy demand of one output burst, using the time between bursts for replenishment. The output of the high voltage storage block 240 (or capacitive storage component) is a stable power rail, 245, capable of supplying required high voltage and unidirectional or bidirectional currents for the duration of the output power bursts.
[0041 ] The low-voltage DC power line, 226, coming from the AC/DC converter circuit, 220, feeds capacitive low voltage charge storage, 250, to create stable and clean power rails 255 and 256, powering the command demodulator circuit, 260, and the on board micro controller unit (henceforth MCU), 270, respectively.
[0042] The purpose of the command demodulator circuit 260 (or command decoder component), is to extract instructions embedded in the incoming audio signal and send them in the form of a digital data stream, 265, to the MCU, 270, in order to convey and set the user- desired magnitude and timing of the outputs. The design of the command demodulator circuit naturally depends on the type of modulation used, but a person skilled in the art will appreciate that this may include but not be limited to amplitude, phase or frequency. In this embodiment of the invention, amplitude modulation was chosen because it greatly simplifies the decoder circuitry.
[0043] In the present embodiment of the invention, the MCU, 270, performs three key functions. Firstly, it implements a finite state machine (henceforth FSM) operable to support a predetermined set of possible combinations of timing and signal magnitude at the electrode output (henceforth "user modes"), and uses digitally fed instructions to enter different FSM states, in effect setting the mode the user selected. Secondly, in accord with the digital instructions, it drives the duty cycle of the high voltage DC/DC converter, 230, in effect dictating the absolute magnitude of the high voltage output supply, 245. Thirdly, it provides output control signal, 275, to output buffer, 280, in effect dictating the timing of the output waveform, 285.
[0044] FIG. 5 shows a conceptual circuit diagram of a practical implementation of the embodiment of the present invention shown in FIG. 4. Corresponding to blocks 220 and 250 in FIG. 4, the input transformer, dual diode integrated circuit and capacitors C1 and C2 constitute the AC/DC converter and low voltage storage blocks providing stable DC power to the rest of the device at 3-4 Volts. Corresponding to block 260, Q1 , C5, R1 , R3, R5 and Q2, perform the role of the command demodulator, essentially detecting presence or absence of AC input at the audio end and converting it into digital "low" and "high" values, respectively. These logic values are picked up serially by the micro controller unit via the input pin PB4. Large inductor L4, M13, D1 and C3 serve as a simple switched DC-DC converter of the "boost" type, corresponding to blocks 230 and 240 in FIG. 4, generating and storing high DC voltage necessary for device output. Driven by a pulse-width modulated signal from the micro controller unit, PB3, this high voltage level can be varied in accord with desired output level. The transistor M15 is used to bleed off excess charge from C3, thus enabling the setting of lower voltage levels, when needed. Finally, M11 , M12, R4, R12, D3, R11 , R13, D4, M7, M8, M9 and M10 constitute the output buffer circuit, driving a bi-directional high voltage output to the electrodes in response to control signals PBO and PB1. During normal operation, only one pair of output transistors is turned on at any one time, in this case, M10 and M7 during positive pulse cycle, M8 and M9 during negative.
[0045] FIG. 6 shows a hardware block level diagram of an electronic device 400 exemplary of an embodiment of the invention, shown in FIG. 2, with headphone audio signal 410 shown as an input and the electrode signals, in this particular case for electrical muscle stimulation, shown as two output channels, 485 and 486. Because EMS is meant to cause muscle contraction, while TENS is not, the voltages used in EMS applications are generally higher than those in TENS. This, combined with the dual-channel nature of this second embodiment of the invention, necessitates a greater power budget and therefore the use of a self-contained on board power supply (i.e. a battery), however, the control and user interface functions remain handled by the smart phone.
[0046] In this embodiment, the battery, 410, supplies stable, low-voltage power rails, 425, 455 and 456 to the high voltage DC/DC converters 430 (or power component), the MCU, 470, and the command demodulator, 460, respectively. The design of the command demodulator, 460, and the demodulated data stream, 465, are identical to the ones in the previous embodiment, 260 and 265, except in that, due to the greater number of possible user modes on a two-channel device, the supported instruction set may be larger. Similarly, the number of states supported by the FSM in the MCU will be greater, to allow for independent control of timing on the two output channel controls, 475 and 476. Furthermore, in this embodiment, the user has the freedom to set different intensity (peak voltage) levels on the two channels, and this is made possible by the control input, 434, to the high voltage DC/DC converter block, 430, which, in fact comprises of two switched boost converters generating independent high-voltage power rails, 435 and 436. These are fed to two separate capacitive charge stores, in the high voltage charge storage block, 440, to provide clean high-voltage lines 445 and 446 to output buffers, 480 and 481 , respectively. A person skilled in the art will readily appreciate that by means of ability to set either of these high-voltage levels to zero, the user has the ability to use the first channel only, the second only, or both simultaneously. [0047] FIG. 7 shows a conceptual circuit diagram of a practical implementation of the embodiment of the present invention shown in FIG. 6. In this embodiment, the low voltage DC power is supplied by the on-board battery pack, V1 , so the input rectifier circuit consisting of R1 , R2, C1 , C2, the transformer and the dual diode integrated circuit serves only the purpose of sending decoded commands to the micro controller unit via PBO, but does not provide any useable power. Additionally, this embodiment supports two independently controlled high voltage outputs, at voltage levels stored in C3 and C4, which is why it includes two identical high-voltage generator and storage elements, and two sets of output buffers.
[0048] FIG. 8 shows a hardware block level diagram of an electronic device 500 exemplary of an embodiment of the invention, shown in FIG. 3, using instead of a hard-wired headphone audio interface, a wireless (Bluetooth) link as its interface to user input and control functions on a nearby smart phone. Otherwise analogous to the preceding embodiment, this apparatus uses a wireless (Bluetooth) transmitter/receiver circuit 510 (or transmitter/receiver component) in place of the command demodulator.
[0049] FIG. 9 shows a simplified timing diagram equally exemplary without loss of generality of all electrotherapeutic applications covered herein. While absolute values of voltage V1 , pulse duration t1 and pulse period t2 vary in accord with the nature and requirements of the treatment, it is generally true that the voltage V1 is many times greater than the peak headphone audio output or any practically usable battery, and that the pulse period t2 is many times longer than the pulse duration t1. In that sense, all embodiments of the invention use special circuitry within the device to generate the pulse train matching the amplitude and timing requirements of the prescribed treatment program, and all rely on personal mobile computing devices for user interface and mode selection. Furthermore, where the smart phone or other electronic device used for ED control has a processor capable of executing such software instructions, additional programing scenarios are possible, including but not limited to: providing the user the interface and the options to create custom treatment programs by selecting from, combining or sequencing one or more predetermined user modes, resulting in predictable treatment patterns; providing the user with interface and options to delay the start of the treatment to a desired time; set the treatment duration and course in advance; store and re-use previously created and used treatment program; and record history of use, and the like.
[0050] FIG. 10 exemplifies the method by means of which a desired mode of operation is chosen, activated and used for either therapeutic or muscle toning purposes. Through a user interface, the software application (henceforth "app") executed on the mobile computing device, in this case a smart phone, would acquire the desired mode selection. Such a user choice would then cause the app to encode a digital code word, in this case an 8-bit binary number, into an audio stream sent to the hardware device. The demodulator circuit within the device would decode the audio stream, thus recovering the 8-bit digital number representing the desired mode. The on board micro controller unit would compare the received number to the list of pre-programmed modes, internally stored in memory in the form of a look-up table, and set output timing and intensity parameters accordingly. The output buffers would drive the desired mode to the electrodes until the micro controller receives instructions to do otherwise or an unscheduled interruption occurs (e.g. physical disconnect with the smart phone, incoming phone call, text message, loss of battery power and the like).
[0051 ] To support the above functionality, the app may include the following: (1 ) a menu- based user interface, capable of acquiring user selection of desired modes (timing), from a predetermined set and the desired output intensity level; (2) a communication layer, capable of encoding digital instructions into an audio stream or a wireless bluetooth datastream to be sent to the device; (3) a timer, capable of setting duration of treatment in accord with user's decision (4) an interrupt handler, capable of handling gracefully all possible unscheduled interruptions, namely, incoming phone calls, incoming text messages, physical wire disconnects, loss of wireless connectivity, alarms and alerts, optionally comprising capability to restore the device to "last used" therapeutic or muscle toning session.
[0052] Furthermore, the app may also comprise the following optional elements: (1) the ability to self-calibrate output intensity by sending and interpreting trial pulses to the user's skin and optimizing output voltages in accord with the electro-resistive properties of the electrode/user contact; (2) the ability to record usage (treatment) history for future reference and use; (3) the ability to acquire user feedback on experience with and perceived effectiveness of the treatments; (4) the ability to share data with others and cloud-based server applications for purposes of future optimization of treatment profiles based on large-scale user experience data and (5) the ability to receive and implement new or modified modes from the cloud, resulting from such improvements.
[0053] The above described embodiments are intended to be illustrative, and not limiting to any particular aspect of the any particular embodiment. The described embodiments of carrying out the invention are susceptible to many modifications of form, arrangement of parts, details and order of operation. The invention, rather, is intended to encompass all such modification within its scope, as defined by the claims. Applications
[0054] The following embodiments serve to exemplify possible practical applications of the invention:
[0055] 1. In a practical application, the present invention may be embodied in a device operable to connect to a smart phone via the headphone audio connector, use this connection to draw sufficient electrical power for its operation, furthermore use this connection to receive and decode digital instructions embedded in the audio stream, set any of a number of predetermined end user modes and in accord with those produce electrotherapeutic signals of desired timing and amplitude. In this application, software executed on the smart phone serves to provide user interface functionality and specific audio signals that lend power to the device and carry encoded instructions.
[0056] 2. In another practical application, the present invention may be embodied in a device of example 1 , operable to connect instead to any of a number of consumer electronic devices capable of headphone audio playback and comprising an internal micro processor capable of executing software, including, but not limited to: personal computers (laptops), tablet computers and personal entertainment units, either stand-alone or embedded, such as those in modern airline seats.
[0057] 3. In yet another practical application, the present invention may be embodied in a device of example 2, comprising further an autonomous power source (a battery), thus relying on external electronic device for user interaction and control, but not power.
[0058] 4. In yet another practical application, the present invention may be embodied in any of the above exemplified devices, using self-adhesive disposable electrodes to deliver pulses to the end user transcutaneously, for either therapeutic or muscle stimulation purpose.
[0059] 5. In yet another practical application, the present invention may be embodied in a device of example 4, using permanent silicone electrodes and conductive gel instead of disposable electrodes.
[0060] 6. In yet another practical application, the present invention may be embodied in a device of example 4, using acupuncture needles as electrodes to deliver electrical pulses subcutaneously. [0061 ] 7. In yet another practical application, the present invention may be embodied in a device of example 4, using abdominal and limb-administered flexible or adjustable belts, comprising skin contacting conductive surfaces instead of stand-alone electrodes.
[0038] Furthermore, the following examples illustrate two possible end user scenarios:
[0062] 1 . TENS user, "Alice", may use a therapeutic embodiment of the invention to alleviate chronic elbow pain due to a sport related injury. In this scenario, Alice would download a TENS-specific app to her smart phone, connect the device to the phone and apply self- adhesive gel electrodes to the target area. Following initialization, Alice would choose one of the available modes from the user menu, set the number of minutes desired and commence treatment at the lowest intensity level. She would then gradually increase output voltage until a tingling sensation intensifies to the upper threshold her comfort. Following the treatment, she would record immediate feedback on her experience. In future sessions, she would have the option to reference previous modes and durations and, over time, optimize her treatment choices for maximum benefits.
[0063] 2. EMS user, "Bob", may use a muscle toning embodiment of the invention to increase tone in his abdominal and lower back muscles. In this scenario, Bob would download an EMS-specific app to his smart phone, connect the device to the phone and wear the muscle toning belt around his waist. Following initialization, Bob would choose one of the available modes from the user menu, set the number of minutes desired and commence treatment at the lowest intensity level. He would then gradually increase output voltage until a desired level of comfortable muscle contraction is achieved. Following the treatment, he would record immediate feedback on his experience. Additionally, outside treatment sessions, he would record his perception of muscle toning effectiveness using the app. As illustrated in FIG. 1 1 , using internet connectivity to a cloud server, he would upload and share his experiences with friends and other members of the user community. His results could also be made available to cloud-based software and, along with feedback from other users, serve to evolve treatment options in the direction of greatest perceived benefit. In future sessions, he would have the option to reference this data to optimize his sessions for maximum benefits, as well as download additional modes shown effective in larger-scale studies.
[0064] It will be appreciated that any module or component exemplified herein that executes instructions may include or otherwise have access to computer readable media such as storage media, computer storage media, or data storage devices (removable and/or non-removable) such as, for example, magnetic disks, optical disks, tape, and other forms of computer readable media. Computer storage media may include volatile and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer storage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD), blu-ray disks, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by an application, module, or both. Any such computer storage media may be part of the mobile device, tracking module, object tracking application, etc., or accessible or connectable thereto. Any application or module herein described may be implemented using computer readable/executable instructions that may be stored or otherwise held by such computer readable media.
[0065] Thus, alterations, modifications and variations can be effected to the particular embodiments by those of skill in the art without departing from the scope of this disclosure, which is defined solely by the claims appended hereto.
[0066] The present system and method may be practiced in various embodiments. A suitably configured computer device, and associated communications networks, devices, software and firmware may provide a platform for enabling one or more embodiments as described above. By way of example, FIG. 12 shows a generic computer device 100 that may include a central processing unit ("CPU") 502 connected to a storage unit 504 and to a random access memory 506. The CPU 502 may process an operating system 501 , application program 503, and data 523. The operating system 501 , application program 503, and data 523 may be stored in storage unit 504 and loaded into memory 506, as may be required. Computer device 500 may further include a graphics processing unit (GPU) 522 which is operatively connected to CPU 502 and to memory 506 to offload intensive image processing calculations from CPU 502 and run these calculations in parallel with CPU 502. An operator 507 may interact with the computer device 500 using a video display 508 connected by a video interface 505, and various input/output devices such as a keyboard 510, mouse 512, and disk drive or solid state drive 514 connected by an I/O interface 509. In known manner, the mouse 512 may be configured to control movement of a cursor in the video display 508, and to operate various graphical user interface (GUI) controls appearing in the video display 508 with a mouse button. The disk drive or solid state drive 514 may be configured to accept computer readable media 516. The computer device 500 may form part of a network via a network interface 51 1 , allowing the computer device 500 to communicate with other suitably configured data processing systems (not shown).
[0067] In further aspects, the disclosure provides systems, devices, methods, and computer programming products, including non-transient machine-readable instruction sets, for use in implementing such methods and enabling the functionality described previously.
[0068] Although the disclosure has been described and illustrated in exemplary forms with a certain degree of particularity, it is noted that the description and illustrations have been made by way of example only. Numerous changes in the details of construction and combination and arrangement of parts and steps may be made. Accordingly, such changes are intended to be included in the invention, the scope of which is defined by the claims.
[0069] Except to the extent explicitly stated or inherent within the processes described, including any optional steps or components thereof, no required order, sequence, or combination is intended or implied. As will be will be understood by those skilled in the relevant arts, with respect to both processes and any systems, devices, etc., described herein, a wide range of variations is possible, and even advantageous, in various circumstances, without departing from the scope of the invention, which is to be limited only by the claims.

Claims

What is claimed is:
Any and all features of novelty disclosed or suggested herein, including without limitation the following: 1. An electronic device comprising: at least one power component operable to transform electrical power received from a low voltage power source into a DC voltage supply; a command decoder component, connected to the at least one power component, operable to receive a communication and to extract at least one control command from the communication; at least one micro controller, connected to the command decoder component and the at least one power component, operable to generate at least one pulse-width modulated signal based at least partly on the at least one control command; at least one output buffer, connected to the at least one power component and the at least one micro controller, operable to produce at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and at least one electrode activated by the at least one pulse.
2. The electronic device of claim 1 wherein the at least one power component is operable to receive the electrical power from an audio output port of a computing device.
3. The electronic device of claim 2 wherein the computing device is a mobile computing device. 4. The electronic device of claim 3 wherein the electrical power received is a low voltage AC signal comprising an audible frequency range, and the DC voltage supply is of a DC voltage supply magnitude sufficient to power at least the command decoder component, the at least one micro controller, and the at least one output buffer.
The electronic device of claim 1 wherein the command decoder component is operable to be connectable to an audio output port of a computing device, the communication comprises an audio stream receivable from the audio output port, and the command decoder component is operable to extract the at least one control command embedded in the audio stream.
The electronic device of claim 5 wherein the computing device is a mobile computing device.
The electronic device of claim 1 comprising at least one capacitive storage component, connected to the at least one power component and the at least one output buffer, operable to store a charge of the DC voltage supply for use by the at least one output buffer to produce the at least one pulse.
The electronic device of claim 1 wherein the at least one electrode is for application to human skin, and activation of the at least one electrode by the at least one pulse is of an activation magnitude suitable for therapeutic electrical nerve or muscle stimulation at the human skin.
The electronic device of claim 1 wherein the at least one electrode is for application to human mucous membrane, and activation of the at least one electrode by the at least one pulse is of an activation magnitude suitable for therapeutic stimulation at the human mucous membrane.
The electronic device of claim 1 wherein the communication comprises a digital data stream, and the at least one control command governs a timing and intensity of the activation of the at least one electrode.
The electronic device of claim 10 wherein the at least one pulse-width modulated signal comprises at least one signal duration and at least one signal frequency each governed by the timing and intensity specified by the at least one control command. The electronic device of claim 1 1 wherein the at least one pulse comprises at least one pulse duration governed by the at least one signal duration and the at least one signal frequency.
The electronic device of claim 1 wherein the low voltage power source comprises a battery.
The electronic device of claim 1 comprising a wireless transmitter/receiver component, connected to the command decoder component, and operable to receive the
communication over a wireless communication channel established with a computing device.
The electronic device of claim 1 , wherein the at least one electrode comprises a plurality of electrodes, and each of the at least one micro controller, the at least one power component, and the at least one output buffer is operable so as to activate at least one of the plurality of electrodes independently with respect to the other respective ones of the plurality of electrodes.
A method of activating at least one electrode, performed by an electronic device, the electronic device comprising:
at least one power component;
a command decoder component connected to the at least one power component; at least one micro controller connected to the command decoder component and the at least one power component;
at least one output buffer connected to the at least one power component and the at least one micro controller; and
at least one electrode;
the method comprising:
the command decoder component receiving a communication and extracting at least one control command from the communication;
the at least one micro controller generating at least one pulse-width modulated signal based at least partly on the at least one control command; the at least one power component transforming electrical power received from a low voltage power source into a DC voltage supply;
the at least one output buffer producing at least one pulse of an absolute voltage magnitude corresponding to the DC voltage supply and of timing based at least partly on the at least one pulse-width modulated signal; and
activating the at least one electrode by the at least one pulse.
The method of claim 16 wherein the at least one power component receives the electrical power from an audio output port of a computing device.
The method of claim 17 wherein the computing device is a mobile computing device.
The method of claim 18 wherein the electrical power received is a low voltage AC signal comprising an audible frequency range, and the DC voltage supply is of a DC voltage supply magnitude sufficient to power at least the command decoder component, the at least one micro controller, and the at least one output buffer.
20. The method of claim 16 wherein the command decoder component is connectable to an audio output port of a computing device, the communication comprises an audio stream receivable from the audio output port, and the method comprises the command decoder extracting the at least one control command embedded in the audio stream.
21. The method of claim 20 wherein the computing device is a mobile computing device. 22. The method of claim 16 wherein the electronic device comprises at least one capacitive storage component, connected to the at least one power component and the at least one output buffer, and the method comprises the at least one capacitive storage component storing a charge of the DC voltage supply for use by the at least one output buffer to produce the at least one pulse.
A computing device comprising at least one processor coupled to at least one non- transitory computer readable storage medium comprising instructions for processing by the at least one processor to cause the computing device to:
receive at least one user input command; in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration; encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal; transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
The computing device of claim 23 comprising an audio output port, wherein the encoding comprises encoding the at least one treatment pulse pattern and the at least one treatment duration into a low voltage AC signal comprising an audible frequency range, and the instructions processed by the at least one processor cause the computing device to output the low voltage AC signal at the audio output port.
The computing device of claim 23 wherein the computing device is a mobile computing device.
The computing device of claim 23 comprising a wireless transmitter/receiver component connected to the at least one processor, and the transmitting comprises:
establishing a wireless communication channel with the electronic device using the wireless transmitter/receiver component; and
transmitting the at least one communication signal to the electronic device over the wireless communication channel.
The computing device of claim 23 wherein the instructions processed by the at least one processor cause the computing device to, in accordance with the at least one user input command, delay the transmitting.
The computing device of claim 23 wherein the instructions processed by the at least one processor cause the computing device to, in accordance with the at least one user input command, perform the transmitting at a time specified by the at least one user input command.
29. The computing device of claim 23 wherein the selecting the at least one treatment pulse pattern comprises a selection of treatment pulse amplitude.
30. The computing device of claim 23 wherein the instructions processed by the at least one processor cause the computing device to, in accordance with the at least one user input command, program a new treatment pulse pattern for selection.
31. The computing device of claim 23 wherein the instructions processed by the at least one processor cause the computing device to, in accordance with the at least one user input command, program at least one treatment course comprising at least one sequence of at least one treatment pulse pattern and at least one treatment duration.
32. The computing device of claim 23 wherein the selecting comprises selecting one of the at least one treatment course.
33. The computing device of claim 23 wherein the instructions processed by the at least one processor cause the computing device to, maintain a treatment history corresponding to the transmitting.
34. A method of activating at least one electrode, performed by a computing device, the method comprising:
receiving at least one user input command;
in accordance with the at least one user input command, selecting at least one treatment pulse pattern and at least one treatment duration;
encoding the at least one treatment pulse pattern and the at least one treatment duration into at least one communication signal;
transmitting the at least one communication signal to an electronic device comprising at least one electrode for activation of the at least one electrode in accordance with the at least one treatment pulse pattern and the at least one treatment duration.
35. The method of claim 34 wherein the computing device comprises an audio output port, the encoding comprises encoding the at least one treatment pulse pattern and the at least one treatment duration into a low voltage AC signal comprising an audible frequency range, and the method comprises outputting the low voltage AC signal at the audio output port.
36. The method of claim 34 wherein the computing device is a mobile computing device.
37. The method of claim 34 wherein the computing device comprising a wireless
transmitter/receiver component, and the transmitting comprises:
establishing a wireless communication channel with the electronic device using the wireless transmitter/receiver component; and
transmitting the at least one communication signal to the electronic device over the wireless communication channel.
PCT/CA2013/000819 2013-09-25 2013-09-25 Devices and methods for activation of electrodes WO2015042682A1 (en)

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CN105457161A (en) * 2015-12-05 2016-04-06 浙江大学 Acupuncture point electrical stimulation device based on mobile terminal
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CN106512212A (en) * 2016-12-19 2017-03-22 怡动(北京)科技有限责任公司 Analgesic chip
CN109589494A (en) * 2017-09-30 2019-04-09 苏季阳 Propagated sensation along channel electrotherapy of acupuncture point device
CN112891743A (en) * 2021-01-18 2021-06-04 惠州Tcl移动通信有限公司 Pulse massage method based on audio signal, intelligent terminal and storage medium
WO2022074254A1 (en) * 2020-10-10 2022-04-14 NMES Group AB Neuromuscular electrical stimulation device with automated switchable regulation technologies
TWI784607B (en) * 2021-06-30 2022-11-21 喀藝科技有限公司 Control current variable voltage dual frequency transcutaneous nerve stimulator device

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Publication number Priority date Publication date Assignee Title
CN105457161A (en) * 2015-12-05 2016-04-06 浙江大学 Acupuncture point electrical stimulation device based on mobile terminal
CN105457160A (en) * 2015-12-05 2016-04-06 浙江大学 Electric acupuncture apparatus based on mobile terminal
CN106512212A (en) * 2016-12-19 2017-03-22 怡动(北京)科技有限责任公司 Analgesic chip
CN109589494A (en) * 2017-09-30 2019-04-09 苏季阳 Propagated sensation along channel electrotherapy of acupuncture point device
WO2022074254A1 (en) * 2020-10-10 2022-04-14 NMES Group AB Neuromuscular electrical stimulation device with automated switchable regulation technologies
CN112891743A (en) * 2021-01-18 2021-06-04 惠州Tcl移动通信有限公司 Pulse massage method based on audio signal, intelligent terminal and storage medium
CN112891743B (en) * 2021-01-18 2023-11-14 惠州Tcl移动通信有限公司 Pulse massage method based on audio signal, intelligent terminal and storage medium
TWI784607B (en) * 2021-06-30 2022-11-21 喀藝科技有限公司 Control current variable voltage dual frequency transcutaneous nerve stimulator device

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