WO2017041138A1 - Systèmes et procédés de neuromodulation - Google Patents

Systèmes et procédés de neuromodulation Download PDF

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Publication number
WO2017041138A1
WO2017041138A1 PCT/AU2016/050844 AU2016050844W WO2017041138A1 WO 2017041138 A1 WO2017041138 A1 WO 2017041138A1 AU 2016050844 W AU2016050844 W AU 2016050844W WO 2017041138 A1 WO2017041138 A1 WO 2017041138A1
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WO
WIPO (PCT)
Prior art keywords
receiver
transmitter
pulse generator
neuromodulation
processor
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Application number
PCT/AU2016/050844
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English (en)
Inventor
Paul S D'URSO
Philip Lewis
Original Assignee
D'urso Paul S
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Filing date
Publication date
Priority claimed from AU2015903657A external-priority patent/AU2015903657A0/en
Application filed by D'urso Paul S filed Critical D'urso Paul S
Publication of WO2017041138A1 publication Critical patent/WO2017041138A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
    • A61N1/36185—Selection of the electrode configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531—Measuring skin impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36062—Spinal stimulation

Definitions

  • the present disclosure relates generally to systems and methods for providing neuromodulation.
  • the present disclosure relates to systems and methods for trialling neuromodulation stimulation patterns.
  • Neuromodulation is currently undergoing translational change as both hardware and software technology dramatically improves.
  • neuromodulation technology used tonic stimulation of neural structures to achieve a neuromodulatory effect.
  • different patterns of stimulation have been developed. High frequency stimulation, burst stimulation and dorsal root ganglion stimulation have been introduced. It has been found that different types of stimulation achieve different clinical outcomes and the success of a treatment may vary from one patient to another.
  • a traditional trial requires leads to be externalised through an incision in the patient's skin. These leads are connected to a pulse generator which is powered by batteries. The externalisation of the trial leads may allow for infection to enter the incision, cause discomfort to the patient, allow fluid leakage through the open incision and can cause local skin irritation and inflammation. Typically, a trial period will be limited to one to two weeks to prevent more serious complications developing in association with leads exiting through an open wound in the patient's skin.
  • a neuromodulation system comprising:
  • an implantable receiver wherein the receiver is configured to receive signals when implanted in a user's body
  • At least one implantable neuromodulation lead attached to the receiver a device for placing on, or in close proximity to, an exterior surface of the user's body, wherein the device comprises:
  • the processor is configured to digitally sample stimulus waveform output from the pulse generator; wherein the processor is further configured to transmit the resulting digitised stimulus waveform output to the transmitter and wherein the transmitter is configured to wirelessly transmit signals to the receiver.
  • the pulse generator, processor and transmitter, while comprising the external device, may be contained in the same or different physical units.
  • the pulse generator may be contained in one physical unit and the processor and transmitter in another physical unit.
  • the receiver may be further configured to transmit signals.
  • the receiver may transmit signals to the transmitter.
  • the transmitter may be further configured to receive signals from the receiver.
  • the receiver may communicate with the transmitter wirelessly.
  • the receiver may communicate with the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the receiver may communicate with the transmitter by means of radiofrequency waves.
  • the pulse generator, processor and transmitter may communicate with each other wirelessly or by physically connected means.
  • the pulse generator may transmit or receive signals to or from the processor via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the pulse generator may transmit or receive signals to or from the processor via wireless or physically connected means.
  • the processor may transmit or receive signals to or from the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the processor may transmit or receive signals to or from the transmitter via wireless or physically connected means.
  • the processor may digitise signal output from the pulse generator.
  • the digitised signals may be transmitted to the transmitter and in turn transmitted from the transmitter to the receiver.
  • the receiver may reconstruct digitised signals transmitted from the transmitter, into analogue form.
  • the at least one neuromodulation lead may comprise one or more electrodes.
  • the at least one neuromodulation lead may comprise a plurality of electrodes.
  • the system may be secure so that only authorised or paired transmitters and receivers may communicate with each other.
  • this may allow only selected neuromodulation signal patterns to be transmitted to the receiver. Only selected signal patterns may be available on the transmitter.
  • the transmitter and receiver may communicate via handshaking.
  • the transmitter and receiver may be configured with encryption keys thereby facilitating communication between them.
  • the transmitter and receiver may be configured with the same encryption key.
  • the transmitter and receiver may be paired so as to ensure subsequent secure communication of signals (data). This may be achieved, for example, by the transmitter storing an encryption key for encrypting the signals transmitted to the receiver.
  • the receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.
  • the processor may be configured to convert the digitised stimulus
  • waveforms to a format that may be transmitted by the transmitter over one or more wireless interfaces, which may comprise one or more of electromagnetic, magnetic, optical or ultrasonic interfaces.
  • wireless interfaces which may comprise one or more of electromagnetic, magnetic, optical or ultrasonic interfaces.
  • Those skilled in the art will appreciate that other forms of wireless communication may be used to transmit the digitised stimulus waveforms.
  • the receiver may be configured to convert digitised stimulus waveforms to analogue signals, which may then be delivered to the electrodes of the one or more neuromodulation leads.
  • the at least one neuromodulation lead may be detachable from the receiver and may be configured for attachment to a pulse generator.
  • the pulse generator may be an implantable pulse generator.
  • the at least one lead may be configured for attachment to a range of different pulse generators. That is, the at least one lead may be generic.
  • Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.
  • the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.
  • the receiver may be configured to sense the tissue/electrode impedance for one or more electrodes of the at least one neuromodulation lead.
  • the receiver may be configured to sense tissue/electrode impedance for all electrodes connected to the receiver.
  • the receiver may be configured to transmit this electrode impedance data wirelessly to the transmitter.
  • the transmitter may be configured to transmit the data to the processor.
  • the processor may be configured to then dynamically adjust the impedance of its input terminals, thereby presenting to the external pulse generator, a set of "virtual tissue/electrode impedances" with which the pulse generator may dynamically adjust its output to provide stimuli of the required strength.
  • the receiver may be configured to transmit information on tissue/electrode impedance for one or more electrodes on the at least one neuromodulation lead to the transmitter. This information may be sensed by the pulse generator, via the processor.
  • the receiver may be configured to transmit information on tissue/electrode impedance for all of the electrodes on the at least one neuromodulation lead to the transmitter and then the processor. This information may be sensed by the pulse generator, via the processor.
  • the system may be configured to permit the continuous monitoring of tissue/electrode and electrode/electrode impedance for all combinations of tissue/electrode pairs and electrode/electrode pairs of the one or more neuromodulation leads.
  • This continuously monitored impedance information may be combined with physical or physiological information to inform the user, clinician or other healthcare workers on the influence of the physical and physiological factors on tissue/electrode or electrode/electrode impedance, which may provide for improved control of the neuromodulation signals.
  • a method of Mailing neuromodulation comprising: a) implanting in a user's body a receiver and at least one neuromodulation lead attached to the receiver, wherein the receiver is configured to wirelessly receive signals;
  • a device on, or in close proximity to, an exterior surface of the user's body, wherein the device comprises:
  • a processor configured to digitally sample stimulus waveform output from the pulse generator
  • a transmitter configured to wirelessly transmit signals to the receiver
  • the receiver may be further configured to transmit signals.
  • the transmitter may be further configured to receive signals from the receiver.
  • the receiver may communicate with the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the receiver may communicate with the transmitter wirelessly, for example, by means of radiofrequency waves.
  • the pulse generator, processor and transmitter may communicate with each other wirelessly or by physically connected means.
  • the pulse generator may transmit or receive signals to or from the processor via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the pulse generator may transmit or receive signals to or from the processor via wireless or physically connected means.
  • the processor may transmit or receive signals to or from the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the processor may transmit or receive signals to or from the transmitter via wireless or physically connected means.
  • the processor may digitise signal output from the pulse generator.
  • the digitised signals may be transmitted to the transmitter and in turn transmitted from the transmitter to the receiver.
  • the receiver may reconstruct digitised signals transmitted from the transmitter, into analogue form.
  • the at least one neuromodulation lead may comprise one or more electrodes.
  • the at least one neuromodulation lead may comprise a plurality of electrodes.
  • the trialling method may be secure so that only authorised or paired transmitters and receivers may communicate with each other. Advantageously this may allow only selected neuromodulation signal patterns to be transmitted to the receiver.
  • the transmitter and receiver may communicate via handshaking.
  • the transmitter and receiver may be configured with encryption keys thereby facilitating communication between them.
  • the transmitter and receiver may be configured with the same encryption key.
  • the transmitter and receiver may be paired so as to ensure subsequent secure communication of signals (data). This may be achieved, for example, by the transmitter storing an encryption key for encrypting the signals transmitted to the receiver.
  • the receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.
  • the processor may be configured to convert the digitised stimulus
  • waveforms to a format that may be transmitted over one or more wireless interfaces, which may comprise one or more of electromagnetic, magnetic, optical or ultrasonic interfaces.
  • wireless interfaces which may comprise one or more of electromagnetic, magnetic, optical or ultrasonic interfaces.
  • Those skilled in the art will appreciate that other forms of wireless communication may be used to transmit the digitised stimulus waveforms.
  • the receiver may be configured to convert digitised stimulus waveforms to analogue signals, which may then be delivered to the electrodes of the one or more neuromodulation leads.
  • the at least one neuromodulation lead may be detachable from the receiver and may be configured for attachment to a pulse generator.
  • the pulse generator may be an implantable pulse generator.
  • the at least one lead may be configured for attachment to a range of pulse generators. That is, the at least one lead may be generic.
  • Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.
  • the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.
  • the receiver may sense the tissue/electrode impedance for
  • the receiver may sense tissue/electrode impedance for all electrodes connected to the receiver. The receiver may transmit this electrode impedance data wirelessly to the transmitter. The transmitter then transmits the data to the processor.
  • the processor may then dynamically adjust the impedance of its input terminals, thereby presenting to the external pulse generator a set of "virtual tissue/electrode impedances" with which the pulse generator may dynamically adjust its output to provide stimuli of the required strength.
  • the receiver may transmit information on tissue/electrode impedance for one or more electrodes on the at least one neuromodulation lead to the transmitter.
  • the transmitter may then transmit this information to the processor. This information may be sensed by the pulse generator.
  • the receiver may transmit information on tissue/electrode impedance for all of the electrodes on the at least one neuromodulation lead to the transmitter.
  • the transmitter may then transmit this information to the processor This information may be sensed by the pulse generator.
  • the method may permit the continuous monitoring of tissue/electrode and electrode/electrode impedance for all combinations of tissue/electrode pairs and electrode/electrode pairs of the one or more neuromodulation leads.
  • This continuously monitored impedance information may be combined with physical or physiological information to inform the user, clinician or other healthcare workers on the influence of the physical and physiological factors on tissue/electrode or electrode/electrode impedance, which may provide for improved control of the neuromodulation signals.
  • One or more signal patterns may be transmitted to the receiver. Two or more signal patterns may be sequentially transmitted to the receiver.
  • Each of the one or more signal patterns may be transmitted, or may be available for transmission, for one or more days, or for two or more days, or for three or more days, or for five or more days, or for seven or more days, or for 10 or more days, or for 15 or more days, or for 21 or more days.
  • Each of the one or more signal patterns may be transmitted for up to 10 days, or up to 20 days, or up to 30 days or longer.
  • the signal patterns may comprise tonic stimulation, burst stimulation, high frequency stimulation or other forms of stimulation.
  • High frequency stimulation may be greater than 1200 Hz.
  • a device on, or in close proximity to, an exterior surface of the user's body, wherein the device comprises:
  • a processor configured to digitally sample stimulus waveform output from the pulse generator
  • a transmitter configured to wirelessly transmit signals to the receiver; c) digitally sampling via the processor stimulus waveform output from the pulse generator;
  • the method may further comprise the step of replacing the implanted receiver with an implanted pulse generator configured to deliver the one or more selected signal patterns.
  • the implanted pulse generator may be attached to the same
  • neuromoduiation leads as the receiver.
  • the receiver may be further configured to transmit signals.
  • the transmitter may be further configured to receive signals from the receiver.
  • the receiver may communicate with the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the receiver may communicate with the transmitter wirelessly, for example, by means of radiofrequency waves.
  • the pulse generator, processor and transmitter may communicate with each other wirelessly or by physically connected means.
  • the pulse generator may transmit or receive signals to or from the processor via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the pulse generator may transmit or receive signals to or from the processor via wireless or physically connected means.
  • the processor may transmit or receive signals to or from the transmitter via one or more of electromagnetic, magnetic, optical or ultrasonic means.
  • the processor may transmit or receive signals to or from the transmitter via wireless or physically connected means.
  • the processor may digitise signal output from the pulse generator.
  • the digitised signals may be transmitted to the transmitter and in turn transmitted from the transmitter to the receiver.
  • the receiver may reconstruct digitised signals transmitted from the transmitter, into analogue form.
  • the at least one neuromodulation lead may comprise one or more electrodes.
  • the at least one neuromodulation lead may comprise a plurality of electrodes.
  • the trialling method may be secure so that only authorised or paired transmitters and receivers may communicate with each other.
  • this may allow only selected neuromodulation signal patterns to be transmitted to the receiver. Only selected signal patterns may be available on the transmitter.
  • the transmitter and receiver may communicate via handshaking.
  • the transmitter and receiver may be configured with encryption keys thereby facilitating communication between them.
  • the transmitter and receiver may be configured with the same encryption key.
  • the transmitter and receiver may be paired so as to ensure subsequent secure communication of signals (data). This may be achieved, for example, by the transmitter storing an encryption key for encrypting the signals transmitted to the receiver.
  • the receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.
  • the processor may be configured to convert the digitised stimulus waveforms to a format that may be transmitted by the transmitter over one or more wireless interfaces, which may comprise one or more of electromagnetic, magnetic, optical or ultrasonic interfaces. Those skilled in the art will appreciate that other forms of wireless communication may be used to transmit the digitised stimulus waveforms.
  • the receiver may be configured to convert digitised stimulus waveforms to analogue signals, which may then be delivered to the electrodes of the one or more neuromodulation leads.
  • the at least one neuromodulation lead may be detachable from the receiver and may be configured for attachment to a pulse generator.
  • the pulse generator may be an implantable pulse generator.
  • the at least one lead may be configured for attachment to a range of pulse generators. That is, the at least one lead may be generic.
  • Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.
  • the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.
  • the receiver may sense the tissue/electrode impedance for one or more electrodes on the at least one neuromodulation lead.
  • the receiver may sense tissue/electrode impedance for all electrodes connected to the receiver.
  • the receiver may transmit this electrode impedance data wirelessly to the external device (e.g. the transmitter and subsequently, the processor).
  • the processor may then dynamically adjust the impedance of its input terminals, thereby presenting to the external pulse generator a set of "virtual tissue/electrode impedances" with which the pulse generator may dynamically adjust its output to provide stimuli of the required strength.
  • the receiver may transmit information on tissue/electrode impedance for one or more electrodes on the at least one neuromodulation lead to the transmitter.
  • the transmitter may transmit this information to the processor. This information may be sensed by the pulse generator.
  • the receiver may transmit information on tissue/electrode impedance for all of the electrodes on the at least one neuromodulation lead to the transmitter.
  • the transmitter may transmit this information to the processor. This information may be sensed by the pulse generator.
  • the method may permit the continuous monitoring of tissue/electrode and electrode/electrode impedance for all combinations of tissue/electrode pairs and electrode/electrode pairs in the one or more neuromodulation leads.
  • This continuously monitored impedance information may be combined with information on the aforementioned physical or physiological information to inform the user, clinician or other healthcare workers on the influence of the physical and physiological factors on tissue/electrode or electrode/electrode impedance, which may provide for improved control of the neuromodulation signals.
  • One or more signal patterns may be transmitted to the receiver. Two or more signal patterns may be sequentially transmitted to the receiver. [0078] Each of the one or more signal patterns may be transmitted, or may be available for transmission, for one or more days, or for two or more days, or for three or more days, or for five or more days, or for seven or more days, or for 10 or more days, or for 15 or more days, or for 21 or more days.
  • Each of the one or more signal patterns may be transmitted for up to 10 days, or up to 20 days, or up to 30 days or longer.
  • the signal patterns may comprise tonic stimulation, burst stimulation, high frequency stimulation or other forms of stimulation.
  • the frequency of stimulation may be greater than 1200 Hz.
  • a method of providing neuromodulation comprising: a) implanting in a user's body a receiver and at least one neuromodulation lead attached to the receiver, wherein the receiver is configured to wirelessly receive signals;
  • the device comprises:
  • a processor configured to digitally sample stimulus waveform output from the pulse generator
  • a transmitter configured to wirelessly transmit signals to the receiver
  • the method may deliver a selected signal pattern to the patient.
  • the systems and methods of the present disclosure provide substantial improvements in the way that neuromodulation technology is trialled and implemented.
  • radio receivers Prior to the introduction of implantable pulse generators, radio receivers were used to avoid the necessity for frequent battery changes associated with the short lifespan of the battery technology.
  • a radiofrequency receiver attached to neuromodulation leads allowed a transcutaneous interface to occur and stimulation to be provided by an external generator without the necessity of a pulse generating battery being implanted into the patient.
  • the implantable device of the present disclosure placed subcutaneously, and attached to the neuromodulation leads may employ wireless technology to provide an advantageous method of trialling neuromodulation technology.
  • the receiver of the present disclosure may be implanted subcutaneously at the time of lead insertion.
  • the patient's wound may be closed and made watertight. With the receiver implanted, a trial can occur over an unlimited time frame. This allows full healing of the wounds and no limitation on trial time.
  • the system may use generic "open source” signal pattern technology which is compatible with the leading providers of neuromodulation technology.
  • generic "open source” signal pattern technology for example, Medtronic, St Jude Medical, Nevro, and Boston Scientific.
  • Third party neuromodulation companies may use the presently disclosed system's open source compatibility to trial proprietary stimulation pattern technology, for example, via the external pulse generator.
  • the system and methods may have leads compatible with currently available pulse generators.
  • the present system and methods may therefore allow the patient to trial a variety of stimulation pattern technologies over an indefinite time, using the same implanted device, to determine which of the stimulation technologies or stimulation patterns is optimal.
  • a pulse generator delivering the selected technology or signal pattern may then permanently implanted.
  • the stimulation patterns may be controlled by a patient utilising an external controller.
  • the choice of stimulation pattern may be controlled by a patient.
  • the duration of stimulation may be controlled by a patient.
  • the receiver and/or external device may provide means for one or more of sensing, stimulating, communicating, actuating, delivering or receiving information, delivering or receiving energy, or generating energy.
  • the means for sensing may be one or more of chemical, electrical, physical, optical or magnetic.
  • the means for stimulating may be one or more of chemical, electrical, physical, optical or magnetic.
  • the means for actuating may be one or more of pressure, vacuum or deformation.
  • the means for energy generation may be, for example, based on physical movement of the patient or based on other movements.
  • the receiver and/or external device may monitor and/or measure patient specific parameters and/or non-patient specific parameters.
  • Patient specific parameters include, but are not limited to, temperature, pressure, or the concentration and/or nature of one or more chemical species.
  • Non-patient specific parameters include, but are not limited to, temperature, pressure, light intensity, electromagnetic radiation, sound, or the concentration and/or nature of one or more chemical species.
  • Both the external device and receiver may record physical or
  • environmental information about the patient or user may include, but are not limited to, bodily movement, postural changes, elevation or altitude, atmospheric pressure, atmospheric temperature, acceleration and deceleration, GPS coordinates and so forth.
  • Both the external device and receiver may record physiological information about the patient or user. Examples of such information may include, but are not limited to, heart rate, skin impedance, blood oxygen saturation, the concentration of various chemical or biochemical species, neural activity and so forth.
  • the transmitter may be configured to transmit data on the
  • neuromodulation signals physical information or physiological information, or any further information derived therefrom, to a further remote device.
  • the transmitter may be configured to receive input from the user on system performance or effectiveness.
  • Such input may be in the form of a physical user interface (e.g. buttons or a dial), verbal input (e.g. via sound recording), or other user techniques for interfacing with devices known to those skilled in the art.
  • This information may be stored alongside physical and physiological data to inform the clinician about the effectiveness of a given neuromodulation signal pattern.
  • the receiver and/or transmitter may provide stimulation to the patient, for example, via communication to a further implanted device.
  • the receiver and/or transmitter may deliver electrical power to, for example, a further implanted device.
  • the receiver and/or external device may be customized or personalized.
  • the external device may be customized in one or more surface regions, said customization being based on patient specific computer imaging data, so that said one or more surface regions match one or more contours of a patient's external surface anatomy,
  • the receiver may customized in one or more surface regions, said customization being based on patient specific computer imaging data, so that said one or more surface regions match one or more contours of said patient's internal anatomy.
  • the computer imaging data may be obtained from one or more imaging devices, that is, any device or devices either singly or in combination that can capture and represent, in digital form, the external and/or internal anatomy of the human body (the anatomical data).
  • imaging devices include, but are not limited to, Computed Tomography, Magnetic Resonance Imaging, Ultrasound, one or more lasers, one or more digital cameras, and medical ultrasound.
  • the external device may be positioned on any part of the patient's external anatomy. In one embodiment the external device may be designed to be positioned on the patient's torso.
  • the external device may be designed to fit the intended user by either a person skilled in the use of three dimensional design software, or by using a set of processes automated in software.
  • the external device may, at least in part, be manufactured using additive manufacturing.
  • additive manufacturing provides the ideal method of manufacturing a personalized device based on the anatomical data provided from the one or more imaging devices.
  • the receiver and/or external device may comprise one or more sensors, actuators, energy delivery or transmission devices, energy harvesting devices, energy storage or generation devices and transducers.
  • the receiver and/or external device may sense and quantify environmental parameters, for example, light, sound, electromagnetic radiation, thermal radiation or gravitational forces.
  • the receiver and/or external device may house GPS and satellite communication systems.
  • the receiver may incorporate monitoring means.
  • Such means may perform one or numerous monitoring functions including, but not limited to, the measurement of pressure, temperature, electrophysiological activity, blood gas saturation, dissolved gas concentration, pH, biochemical species concentration, tissue mechanical properties, tissue optical properties, blood flow, blood velocity, blood rheology, vascular reactivity to pressure, vascular reactivity to biochemical species, vascular endothelial integrity, tissue water content and cellular morphology and microdialysis for biochemical monitoring.
  • This may be performed by wireless powering and/or recharging, using techniques such as electromagnetic induction, radio-wave energy harvesting, piezoelectric conversion of ultrasound, or the photoelectric conversion of light.
  • the receiver may also comprise, hydrocephalus shunts, recording or stimulating electrodes, optical sensors and/or stimulation devices, pressure monitoring devices, temperature monitoring devices, biochemical sensors and so on.
  • the external device may capture ambient data, such as pressure, temperature, chemical data, sound, light and so forth and, based on one or more of such data, instruct the receiver to, for example, stimulate, measure, adjust, modify, or feedback.
  • ambient data such as pressure, temperature, chemical data, sound, light and so forth
  • transmitter may instruct the receiver to release therapeutic materials, such as drugs, via electrical stimulation.
  • the transmission of data obtained from one or more sensors contained within the receiver, and one or more sensors contained within the transmitter may be achieved by one or more of wireless or wired interfaces.
  • data may be transmitted via Bluetooth, WiFi, or radio frequency signals.
  • the receiver transmits data to the transmitter via one or more interfaces as previously described.
  • the transmitter may transmit the data, or a reprocessed form of the data, to a further device remote from the patient. This data may then be used for healthcare delivery.
  • Figure 1 illustrates a system according to an embodiment of the present disclosure.
  • Figure 2 illustrates a system according to another embodiment of the present disclosure
  • Figure 3 illustrates a system according to another embodiment of the present disclosure.
  • FIG. 1 a system (1 ) according to an embodiment of the present disclosure is illustrated.
  • the system comprises neuromodulation lead (2) with associated electrode (3).
  • the lead is connected to implanted receiver (4).
  • Device (5) comprises a pulse generator, a processor and a transmitter located outside the user's body the transmitter being configured to wirelessly transmit signals to the receiver.
  • FIG. 2 a system (6) according to another embodiment of the present disclosure is illustrated.
  • the system comprises neuromodulation lead (7) with associated electrode (8).
  • the lead is connected to implanted receiver (9).
  • Pulse generator (10) is located outside the user's body.
  • the pulse generator (10) is configured to transmit signals to the processor (11 ) which in turn transmits processed signals to the transmitter (12).
  • the transmitter transmits signals wirelessly to the receiver (9)
  • Dashed line (13) indicates the internal/external boundary of the user's body.
  • FIG. 3 a system (14) according to another embodiment of the present disclosure is illustrated.
  • the system comprises neuromodulation lead (15) with associated electrode (16).
  • the lead is connected to implanted receiver (17).
  • Pulse generator (18) is located outside the patient's body.
  • the pulse generator (18) is configured to transmit or receive signals to or from the processor (19).
  • the processor (19) is configured to receive or transmit signals from or to the transmitter (20).
  • the transmitter is configured to wirelessly transmit or receive signals to or from the receiver (17).
  • Dashed line (21 ) indicates the internal/external boundary of the user's body.
  • a trial can be conducted over a prolonged period rather than being limited to one to two weeks.
  • trial leads are placed and then removed after two weeks and before the risk of infection becomes too high. With the present system and methods trial leads are not necessary. Permanent leads may be placed during the initial surgery and may then be used for the final surgery of pulse generator placement. This eliminates the need for trial leads, again reducing expense for insurers and government health departments.
  • Traditional neuromodulation may be delivered via tonic stimulation, a mode of stimulation that refers to the frequency of the electrical energy that is delivered to interrupt the transmission of pain signals to the brain.
  • Patients utilizing traditional tonic stimulation may feel mild pulses of energy as a tingling sensation (paraesthesia).
  • Burst stimulation is a form of neuromodulation therapy that delivers closely-spaced pulses of electrical energy to a patient's spinal cord to manage chronic pain. Burst stimulation may be an option for patients whose pain is not adequately controlled, or for those who lose therapeutic benefit over time with tonic stimulation. Burst stimulation may be able to deliver therapy with little-to-no paraesthesia and may be more effective than tonic stimulation, especially in managing complex back pain.
  • neurostimulation may be:
  • SNS Sacral nerve stimulation
  • SCS Spinal cord stimulation
  • Low frequency stimulation may be in the range of 30-60Hz.
  • High frequency stimulation may be greater than 1200 Hz, for example up to 10,000 Hz.
  • ranges from any lower limit may be combined with any upper limit to recite a range not explicitly recited, as well as, ranges from any lower limit may be combined with any other lower limit to recite a range not explicitly recited, in the same way, ranges from any upper limit may be combined with any other upper limit to recite a range not explicitly recited.

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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne des systèmes et des procédés de neuromodulation. Les systèmes sont basés sur un récepteur implanté et un dispositif externe, de sorte que différents motifs de neuromodulation puissent être testés sur des périodes de temps prolongées.
PCT/AU2016/050844 2015-09-08 2016-09-08 Systèmes et procédés de neuromodulation WO2017041138A1 (fr)

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AU2015903657A AU2015903657A0 (en) 2015-09-08 System and method of neuromodulation
AU2015903657 2015-09-08

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11065461B2 (en) 2019-07-08 2021-07-20 Bioness Inc. Implantable power adapter

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3796221A (en) * 1971-07-07 1974-03-12 N Hagfors Apparatus for delivering electrical stimulation energy to body-implanted apparatus with signal-receiving means
US20050283202A1 (en) * 2004-06-22 2005-12-22 Gellman Barry N Neuromodulation system
US7076307B2 (en) * 2002-05-09 2006-07-11 Boveja Birinder R Method and system for modulating the vagus nerve (10th cranial nerve) with electrical pulses using implanted and external components, to provide therapy neurological and neuropsychiatric disorders
WO2006074402A1 (fr) * 2005-01-07 2006-07-13 Cystomedix, Inc. Systeme de neuromodulation implantable et methode

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3796221A (en) * 1971-07-07 1974-03-12 N Hagfors Apparatus for delivering electrical stimulation energy to body-implanted apparatus with signal-receiving means
US7076307B2 (en) * 2002-05-09 2006-07-11 Boveja Birinder R Method and system for modulating the vagus nerve (10th cranial nerve) with electrical pulses using implanted and external components, to provide therapy neurological and neuropsychiatric disorders
US20050283202A1 (en) * 2004-06-22 2005-12-22 Gellman Barry N Neuromodulation system
WO2006074402A1 (fr) * 2005-01-07 2006-07-13 Cystomedix, Inc. Systeme de neuromodulation implantable et methode

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11065461B2 (en) 2019-07-08 2021-07-20 Bioness Inc. Implantable power adapter
US11890485B2 (en) 2019-07-08 2024-02-06 Bioness Inc. Implantable power adapter

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