WO2017041138A1

WO2017041138A1 - Systems and methods of neuromodulation

Info

Publication number: WO2017041138A1
Application number: PCT/AU2016/050844
Authority: WO
Inventors: Paul S D'URSO; Philip Lewis
Original assignee: D'urso Paul S
Priority date: 2015-09-08
Filing date: 2016-09-08
Publication date: 2017-03-16

Abstract

Systems and methods for providing neuromodulation are disclosed. The systems are based on an implanted receiver and an external device, whereby different neuromodulation patterns may be trialled over extended periods of time.

Description

SYSTEMS AND METHODS OF NEUROMODULATION

FIELD

[001] The present disclosure relates generally to systems and methods for providing neuromodulation. In particular the present disclosure relates to systems and methods for trialling neuromodulation stimulation patterns.

BACKGROUND

[002] Neuromodulation is currently undergoing translational change as both hardware and software technology dramatically improves. Historically, neuromodulation technology used tonic stimulation of neural structures to achieve a neuromodulatory effect. More recently, 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.

[003] In view of this, prior to implantation of a permanent pulse generator in a patient an initial trial procedure is undertaken with a temporary pulse generator. The trial is required to ascertain to what extent the patient will respond to the therapy and, as neuromodulation is somewhat unpredictable, the trial allows for an accurate assessment of the effect of the particular stimulation technology, before determining whether or not a permanent pulse generator should be implanted. As the main contributor to cost of the system is the pulse generator, this cost is preferably deferred until a particular technology has been proven to be of benefit to the patient.

[004] 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.

[005] Therefore, a need exists for neuromodulation systems and methods which address the above problems.

[006] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgement or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

SUMMARY

[007] There is provided 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:

(a) a pulse generator;

(b) a processor; and

(c) a transmitter;

wherein 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.

[008] The pulse generator, processor and transmitter, while comprising the external device, may be contained in the same or different physical units. For example, the pulse generator may be contained in one physical unit and the processor and transmitter in another physical unit.

[009] The receiver may be further configured to transmit signals. The receiver may transmit signals to the transmitter.

[0010] The transmitter may be further configured to receive signals from the receiver.

[0011] 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.

[0012] 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.

[0013] The at least one neuromodulation lead may comprise one or more electrodes. The at least one neuromodulation lead may comprise a plurality of electrodes.

[0014] The system 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. Only selected signal patterns may be available on the transmitter.

[0015] The transmitter and receiver may communicate via handshaking.

[0016] 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.

[0017] 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.

[0018] The receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.

[0019] 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.

[0020] 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.

[0021] 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. [0022] Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.

[0023] With information on electrode impedance, the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] There is also provided 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;

b) placing a device on, or in close proximity to, an exterior surface of the user's body, wherein the device comprises:

i) a pulse generator;

ii) a processor configured to digitally sample stimulus waveform output from the pulse generator; and

iii) a transmitter configured to wirelessly transmit signals to the receiver;

c) digitally sampling, via the processor, stimulus waveform output from the pulse generator;

d) transmitting the resulting digitised stimulus waveform output to the

transmitter; and

e) transmitting one or more signal patterns from the transmitter to the receiver thereby stimulating, via the at least one neuromodulation lead, a target structure of the user's body.

[0030] The receiver may be further configured to transmit signals.

[0031] The transmitter may be further configured to receive signals from the receiver.

[0032] 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.

[0033] 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.

[0034] The at least one neuromodulation lead may comprise one or more electrodes. The at least one neuromodulation lead may comprise a plurality of electrodes. [0035] 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.

Only selected signal patterns may be available on the transmitter.

[0036] The transmitter and receiver may communicate via handshaking.

[0037] 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.

[0038] 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.

[0039] The receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.

[0040] 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. Those skilled in the art will appreciate that other forms of wireless communication may be used to transmit the digitised stimulus waveforms.

[0041] 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.

[0042] 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.

[0043] Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.

[0044] With information on electrode impedance, the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.

[0045] The receiver may sense the tissue/electrode impedance for

one or more electrodes of 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 transmitter. The transmitter then transmits the data to the processor.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] One or more signal patterns may be transmitted to the receiver. Two or more signal patterns may be sequentially transmitted to the receiver.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] There is also provided a method of selecting a neuromodulation signal pattern 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;

i) a pulse generator;

i) a processor configured to digitally sample stimulus waveform output from the pulse generator; and

ii) a transmitter configured to wirelessly transmit signals to the receiver; c) digitally sampling via the processor stimulus waveform output from the pulse generator;

d) transmitting the resulting digitised stimulus waveform output to

the transmitter; and

e) transmitting one or more signal patterns from the transmitter to the receiver thereby stimulating, via the at least one neuromoduiation lead, a target structure of the user's body; and

f) selecting one or more signal patterns based on user feedback.

[0055] 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.

[0056] The implanted pulse generator may be attached to the same

neuromoduiation leads as the receiver.

[0057] The receiver may be further configured to transmit signals.

[0058] The transmitter may be further configured to receive signals from the receiver.

[0059] 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.

[0060] 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.

[0061] The at least one neuromodulation lead may comprise one or more electrodes. The at least one neuromodulation lead may comprise a plurality of electrodes.

[0062] 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. Only selected signal patterns may be available on the transmitter.

[0063] The transmitter and receiver may communicate via handshaking.

[0064] 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.

[0065] 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.

[0066] The receiver may further comprise an encryption device so that only authorised transmitters may transmit signals to the receiver.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] Pulse generators operating in constant-current mode require information on the tissue/electrode impedance of all electrodes on the neuromodulation leads.

[0071] With information on electrode impedance, the pulse generator may deliver a stimulus pulse of known current amplitude by calculating the required voltage to be applied.

[0072] 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).

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0079] 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.

[0080] 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.

[0081] There is also provided 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;

b) placing a device on, or in close proximity to, an exterior surface of the user's

body, wherein the device comprises:

i) a pulse generator;

iii) a transmitter configured to wirelessly transmit signals to the receiver;

c) digitally sampling via the processor stimulus waveform output from the pulse generator;

d) transmitting the resulting digitised stimulus waveform output to the transmitter; and

e) transmitting one or more signal patterns from the transmitter to the receiver thereby stimulating, via the at least one neuromodulation lead, a target structure of the user's body;

f) selecting one or more signal patterns based on user feedback; and g) replacing the implanted receiver with an implanted pulse generator configured to deliver the one or more selected signal patterns.

[0082] The method may deliver a selected signal pattern to the patient.

[0083] The systems and methods of the present disclosure provide substantial improvements in the way that neuromodulation technology is trialled and implemented. 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.

[0084] 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. Instead of the leads being externalised through an incision in the patient's skin to an implanted trial pulse generator, 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.

[0085] The system may use generic "open source" signal pattern technology which is compatible with the leading providers of neuromodulation technology. For example, Medtronic, St Jude Medical, Nevro, and Boston Scientific.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] In any of the herein disclosed aspects or embodiments 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. [0090] The means for sensing may be one or more of chemical, electrical, physical, optical or magnetic.

[0091] The means for stimulating may be one or more of chemical, electrical, physical, optical or magnetic.

[0092] The means for actuating may be one or more of pressure, vacuum or deformation.

[0093] The means for energy generation may be, for example, based on physical movement of the patient or based on other movements.

[0094] In any of the herein disclosed aspects or embodiments the receiver and/or external device may monitor and/or measure patient specific parameters and/or non- patient specific parameters.

[0095] 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.

[0096] Both the external device and receiver may record physical or

environmental information about the patient or user. Examples of such information 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.

[0097] 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.

[0098] 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.

[0099] In any of the herein disclosed aspects or embodiments 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.

[00100] In any of the herein disclosed aspects or embodiments 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.

[00101] The receiver and/or external device may be customized or personalized.

[00102] 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,

[00103] 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.

[00104] 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). Examples of such 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.

[00105] 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.

[00106] Using the anatomical data, 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.

[00107] The external device may, at least in part, be manufactured using additive manufacturing. Advantageously, additive manufacturing provides the ideal method of manufacturing a personalized device based on the anatomical data provided from the one or more imaging devices.

[00108] In any of the herein disclosed aspects of embodiments 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.

[00109] The receiver and/or external device may sense and quantify environmental parameters, for example, light, sound, electromagnetic radiation, thermal radiation or gravitational forces.

[00110] The receiver and/or external device may house GPS and satellite communication systems.

[00111] 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.

[00112] 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.

[00113] 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.

[00114] 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.

[00115] In one embodiment, based on ambient data measurements, the

transmitter may instruct the receiver to release therapeutic materials, such as drugs, via electrical stimulation.

[00 16] 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. For example, data may be transmitted via Bluetooth, WiFi, or radio frequency signals. Thus in one embodiment, 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.

[00117] Throughout this specification, use of the terms "comprises" or "comprising" or grammatical variations thereon shall be taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof not specifically mentioned.

BRIEF DESCRIPTION OF THE DRAWINGS

[00118] Figure 1 illustrates a system according to an embodiment of the present disclosure.

[00119] Figure 2 illustrates a system according to another embodiment of the present disclosure

[00120] Figure 3 illustrates a system according to another embodiment of the present disclosure.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

[00121] Before the present systems, devices and methods are disclosed and described, it is to be understood that unless otherwise indicated this disclosure is not limited to specific systems, devices, components, designs, methods, or the like, as such may vary, unless otherwise specified. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[00122] It must also be noted that, as used in the specification and the appended claims, the singular forms 'a', 'an' and 'the' include plural referents unless otherwise specified. Thus, for example, reference to 'a lead' or 'a device' may include more than one leads or more than one devices, and the like.

[00123] Disclosed herein are systems and methods for providing and trialling neuromodulation.

[00124] Referring to Figure 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.

[00125] Referring to Figure 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.

[00126] Referring to Figure 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.

[00127] It will be appreciated that the presently disclosed systems and methods provide substantial advantages relative to the state of the art.

[00128] As the wound is closed after implanting the receiver the risk of infection is minimised. The patient's comfort during the trial period is far superior compared to existing neuromodulation trial systems. Leads do not exit through the skin via an incision which may allow tissue fluid to leak and causing inflammation and irritation of the skin. This reduces the requirement for dressing changes and improves hygienic wound care.

[00129] A trial can be conducted over a prolonged period rather than being limited to one to two weeks.

[00130] A variety of neuromodulation technologies by leading brands and based on different signal patterns may be trialed before the final pulse generator is selected and implanted.

[00131] The cost to insurers and government health departments is substantially reduced due to the reduction of complications, required dressings, and failure rates associated with trialling single brand technology which require multiple surgeries to implant each of the pulse generators being tested.

[00132] Currently, 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.

[00133] By allowing a patient to select from a variety of different neuromodulation technologies, there will be a higher likelihood of success and better outcomes for patients.

[00134] 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).

[00135] Despite the fact that tonic stimulation is effective in a relatively high percentage of patients, effective coverage at the painful site or region may require alternate stimulation options or settings.

[00136] 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.

[00137] In connection with the present disclosure neuromodulation or

neurostimulation may be:

_* Dorsal root ganglion (DRG) stimulation

_* Occipital nerve stimulation (ONS)

_* Peripheral nerve stimulation (PNS)

Sacral nerve stimulation (SNS) _* Spinal cord stimulation (SCS)

• Transcutaneous electrical nerve stimulation (TENS)

• Deep brain stimulation

_* Cortical brain stimulation

[00138] Low frequency stimulation may be in the range of 30-60Hz.

[00139] High frequency stimulation may be greater than 1200 Hz, for example up to 10,000 Hz.

[00140] While the foregoing description has focused on certain forms of

stimulation, it is contemplated that the systems and methods described herein may find use in a wide range of medical applications.

[00141] It is to be understood that while the present disclosure has been described in conjunction with the specific embodiments thereof, the foregoing description is intended to illustrate and not limit the scope of the disclosure. Other aspects, advantages and modifications will be apparent to those skilled in the art to which the disclosure pertains. Therefore, the above examples are put forth so as to provide those skilled in the art with a complete disclosure and description of how to make and use the disclosed devices, and are not intended to limit the scope of the disclosure.

[00142] For the sake of brevity, only certain ranges are explicitly disclosed herein. However, 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.

[00143] All documents cited are herein fully incorporated by reference for all jurisdictions in which such incorporation is permitted and to the extent such disclosure is consistent with the description of the present disclosure.

Claims

CLAIMS What is claimed is:

1. A neuromodulation system comprising:

(a) a pulse generator;

(b) a processor; and

(c) a transmitter;

2. A method of trialling neuromodulation comprising:

i) a pulse generator;

iii) a transmitter configured to wirelessly transmit signals to the receiver;

3. A method of selecting a neuromodulation signal pattern 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;

i) a pulse generator;

iii) a transmitter configured to wirelessly transmit signals to the receiver; c) digitally sampling via the processor stimulus waveform output from the pulse generator;

e) transmitting one or more signal patterns from the transmitter to the receiver thereby stimulating, via the at least one neuromodulation lead, a target structure of the user's body; and

f) selecting one or more signal patterns based on user feedback.

4. A method of providing neuromodulation comprising:

i) a pulse generator;

iii) a transmitter configured to wirelessly transmit signals to the receiver;

d) transmitting the resulting digitised stimulus waveform output to the transmitter; and e) transmitting one or more signal patterns from the transmitter to the receiver thereby stimulating, via the at least one neuromodulation lead, a target structure of the user's body;

5. The method according to claim 3 further comprising the step of replacing the implanted receiver with an implanted pulse generator configured to deliver the one or more selected signal patterns.

6. A system according to claim 1 or a method according to any one of claims 2 to 5, wherein the receiver is further configured to transmit signals to the transmitter.

7. A system, according to claim 1 or claim 6 or a method according to any one of claims 2 to 6, wherein the transmitter is further configured to receive signals from the receiver.

8. A system according to any one of claims 1 , 6 or 7, wherein the at least one neuromodulation lead is detachable from the receiver.

9. A system according to any one of claims 1 or 6 to 8, wherein the at least one neuromodulation lead is configured for attachment to an implantable pulse generator.

0. A method according to any one of claims 2 to 7, wherein the signal pattern comprises tonic stimulation, burst stimulation or high frequency stimulation.

1 1 . A method according to claim 4, wherein the implanted pulse generator is attached to the same implanted at least one lead, as the receiver.

12. A system according to claim 6, wherein the receiver is configured to

sense the tissue/electrode impedance for one or more electrodes of the at least one neuromodulation lead.

13. A system according to claim 12, wherein the receiver is configured to transmit information on tissue/electrode impedance for one or more electrodes of the at least one neuromodulation lead to the transmitter.

14. A system according to claim 13, wherein the processor is configured to dynamically adjust the impedance of its input terminals, thereby presenting to the pulse generator a set of virtual tissue/electrode impedances, the pulse generator being configured to dynamically adjust its output based on the virtual impedances, to provide stimuli of required strength.

15. A system according to any one of claims 1 , 6 to 9, or 12 to 14 or a method according to any one of claims 2 to 5, 10 or 1 1 , wherein the neuromodulation lead comprises a plurality of electrodes.

16. A method according to claim 6, wherein the receiver senses the

tissue/electrode impedance for one or more electrodes of the at least one neuromodulation lead.

17. A method according to claim 16, wherein the receiver transmits

information on tissue/electrode impedance for one or more electrodes of the at least one neuromodulation lead to the transmitter.

18. A method according to claim 17, wherein the processor dynamically adjusts the impedance of its input terminals, thereby presenting to the pulse generator a set of virtual tissue/electrode impedances, so that the pulse generator dynamically adjusts its output based on the virtual impedances, to provide stimuli of required strength.

19. A system according to any one of claims 1 , 6 to 9, or 12 to 15 or a method according to any one of claims 2 to 5, 10, 11 , or 16 to 18 wherein the neuromodulation lead comprises a plurality of electrodes.

20. A system according to any one of claims 1 , 6 to 9, 12 to 15 or 19, wherein the receiver and/or external device comprises means for one or more of sensing, stimulating, communicating, actuating, delivering or receiving information, delivering or receiving energy, or generating energy.

21 . A system according to any one of claims 1 , 6 to 9, 12 to 15 or 19, wherein the receiver and/or external device comprises means to monitor and/or measure patient specific parameters and/or non-patient specific parameters.