Neuromodulation system

Abstract

The present invention provides a neuromodulation system (100), comprising at least one implant unit (10) and at least one tissue interface module (12), wherein the at least one tissue interface module (12) comprises a lead (14) comprising at least one electrode array with at least one electrode (16, 18, 20, 22) and an electrode circuit (24), wherein system (100) comprises a connection module (26) configured and arranged to form a generic tissue interface module (12) - implant unit (10) interface, and wherein the at least one tissue interface module (12), at least in part, is configured and arranged to define the functionality of the system (100).

Description

[0001] Neuromodulation system

[0002] The present invention belongs to the technical field of systems for delivery of neuromodulation therapy.

[0003] The system may be implantable or non-implantable.

[0004] As a non-limiting example, the system may be configured and arranged to deliver cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation, and / or transcutaneous electrical stimulation.

[0005] Systems, e.g., implantable systems, for delivery of neuromodulation therapy are known in the art.

[0006] In the state of the art, implantable neuromodulation systems usually include an implantable pulse generator (IPG) and one or more treatment-specific leads.

[0007] Examples of an IPG and different kinds of treatment-specific leads according to the prior art are shown in Fig. 1.

[0008] Depending on the specific treatment to be delivered, a corresponding suitable lead is chosen.

[0009] In particular, a specific lead is selected in order to deliver electrical energy at the right position (e.g., cortical, sub-cortical, spinal cord, nerve) and, optionally, sense neurological signals (recording).

[0010] The IPG needs to deliver stimulation energy and offer the optional signals sensing system.

[0011] Although, to date, most known IPGs have a specific purpose (e.g., gastric, neuro DBS, neuro pain, or the like), nonetheless their socket header can be generic and potentially accept a series of different electrode types.

[0012] If the IPG software is also conceived in a generic way, the IPG could serve for delivery of a series of therapies rather than just one.

[0013] In particular, this enables a platform-approach comprising a generic IPG and a set of therapyspecific leads. The condition is that said leads must all have a generic connector that matches the generic IPG header socket.

[0014] However, this approach still shows several drawbacks and limitations. For instance, with today’s header technology, the total number of header contacts is limited to about 32, and the number of cable contacts to about 12.

[0015] This means that some high-density electrodes may require more than one cable.

[0016] So far, only cochlear devices may be characterized by a larger number of leads. This is because cochlear devices do not use headers and cable connector to connect the lead to the stimulator, and are thus not constrained by a connector interface.

[0017] Also, today’s header technology does not fully isolate the header contacts from each other (e.g., due to moisture buildup between contacts).

[0018] Contact-to-contact isolation is limited to a couple of 100kQ after long-term implantation.

[0019] Still further, due to anatomical constraints, the IPG is often implanted quite far from the lead electrodes, using long lead cables to make the connection.

[0020] This separation compromises reliability especially of weak neuro-sensing signals.

[0021] Hence, there is room for further improvement.

[0022] In the light of the above, it is an object of the present invention to provide an improved neuromodulation system having enhanced functionality, and which can be easily and reliably adapted for treatment of different kinds of pathologies.

[0023] The problem is solved by the provision of a neuromodulation system according to claim 1.

[0024] According to the invention, a neuromodulation system comprises: at least one implant unit, and at least one tissue interface module, wherein the at least one tissue interface module comprises a lead comprising at least one electrode array with at least one electrode and an electrode circuit, wherein the system comprises a connection module configured and arranged to form a generic tissue interface module - implant unit interface, wherein the at least one tissue interface module, at least in part, is configured and arranged to define the functionality of the system.

[0025] The present invention provides a neuromodulation system. The system comprises at least one implant unit.

[0026] For instance, the system may comprise a single implant unit.

[0027] Alternatively, the system may comprise a plurality of implant units.

[0028] The system further comprises at least one tissue interface module.

[0029] For instance, the system may comprise a single tissue interface module.

[0030] Alternatively, the system may comprise a plurality of tissue interface modules.

[0031] Here, the tissue interface modules can be either of the same kind or different kinds.

[0032] By the provision of tissue interface modules of different kinds, extra system functionalities can be selected and / or added and / or enabled.

[0033] As an example, a deep (sub-cortical) tissue interface module combined with a cortical tissue interface module can be used for adaptive epilepsy therapy.

[0034] The at least one tissue interface module comprises a lead.

[0035] The lead comprises at least one electrode array with at least one electrode.

[0036] The tissue interface module further comprises an electrode circuit.

[0037] The system further comprises a connection module.

[0038] The connection module is configured and arranged to form a generic tissue interface module - implant unit interface.

[0039] The at least one tissue interface module is configured and arranged to at least in part define the functionality of the system.

[0040] Preferably, the electrode circuit is arranged near the one or more electrodes.

[0041] The electrode circuit is configured and adapted to process at least some of the electrode signals, e.g., demultiplexing of stimulation signals, conditioning of sensing signals, or the like.

[0042] The invention is based on the basic idea that, by the provision of a generic tissue interface module - implant unit interface, where said tissue interface module is inter alia provided with an electrode circuit, functionalities of the system can be distributed between the implanted unit and the at least one tissue interface module. In particular, part of the system intelligence can be moved from the implant unit to the tissue interface module, thus forming an improved, integrated system. Also, by relying on a generic (rather than treatment-specific) tissue interface module - implant unit interface, the system can be easily adapted for use in different treatment applications.

[0043] A key advantage of a tissue interface module equipped with active electronics is the limited distance to the actual tissue contact point, i.e. , the electrode. This implies that sensing, signal amplification, and analog-to-digital conversion is done very close to the target tissue, without the presence of long cables, thereby avoiding signal (high-frequency) content loss or interference.

[0044] In addition to analog-to-digital conversion, neural data or other physiology data can be analyzed locally for biomarkers, threshold detection, or the like, which avoids unnecessary communication (e.g., data-rate, bandwidth, integrity, power needs) of big data sets between tissue interface module and implanted unit.

[0045] According to the invention, different treatment applications are handled through a specific combination between the implant unit and one or more tissue interface modules, said combination defining the system functionality.

[0046] That is, by connecting the at least one implant unit with at least one tissue interface module, a specific function can be obtained.

[0047] The at least one implant unit has generic hardware and software configurations.

[0048] That is, no significant hardware and / or software changes need to be carried out to the at least one implant unit for a specific therapeutic application.

[0049] By contrast, only the adaption of stimulation parameters is required.

[0050] Marginal hardware and / or software adjustments may be required for some specific clinical applications. Here, considerations can relate, for example, to deep brain vs. nerve vs. muscles, stimulation frequencies of, e.g., 100Hz for brain vs. >1 kHz for auditory nerves or the like.

[0051] On the other hand, tissue interface module(s) is / are specific to each treatment application.

[0052] Conveniently, the at least one tissue interface module may be or comprise at least one electrode comprising graphene, preferably hydrothermally reduced graphene oxide, for electrical stimulation and / or sensing. Discriminating properties of graphene provide lower impedances and higher charge densities, enabling power reduction and easier chip design, allowing miniaturization of electronics (and, in turn, the entire system).

[0053] However, different solutions are also possible according to the invention.

[0054] The at least one tissue interface module may comprise a transistor comprising graphene and / or engineered graphene for neural Interface.

[0055] Additionally or alternatively, the at least one tissue interface module may comprise an ultrasound stimulator.

[0056] Additionally or alternatively, the at least one tissue interface module may comprise optical stimulator

[0057] Further advantageous components of the at least one tissue interface module may comprise one or more among a temperature sensor and / or a blood pressure sensor and / or a heart rate sensor and / or a heart rate variability sensor and / or an oxygenation sensor and / or a ph sensor and / or a hydration sensor and / or an impedance sensor and / or a glucose or metabolite sensor and / or an ECG and / or an EEG and / or EMG and / or motion sensor and / or IMU and / or position sensor.

[0058] Accordingly, an optimized setup for the tissue interface module can be defined according to the needs.

[0059] Conveniently, the system may further comprise at least one communication module.

[0060] The at least one communication module comprises a communication line.

[0061] The communication module is configured and arranged for transferring information, in particular digital signals and / or analog signals and / or synchronization signals.

[0062] Conveniently, the system may further comprise at least one powering module.

[0063] The at least one powering module comprises a power line to provide and / or transfer power and / or synchronization signals from the implant unit to the at least one tissue interface module and / or vice versa.

[0064] Additionally or alternatively, the power line may be configured to provide and / or transfer power and / or synchronization signal or from a first tissue interface module to a second tissue interface module and / or vice versa. For safety reasons, power transfer between different components of the system (e.g., between the implant unit and the tissue interface module(s), or between different tissue interface modules) must be AC and cannot carry DC or have a DC-offset.

[0065] In particular, any DC leakage current may potentially lead to adverse effects in the patient, failure modes in the electronics / cables, such as electromigration or corrosion, and can easily violate regulatory constraints.

[0066] According to ISO14708-1 :214 Implants for surgery - Active implantable medical devices - Clause 16:2, implantable devices of an active implantable medical device shall be electrically neutral when in contact with the body. The direct current density at the surface of any conductive surface or electrode shall be < 0,75pA / mm2.

[0067] Therefore, the at least one powering module may be configured and arranged for AC power transmission.

[0068] An AC signal is defined by several characteristics such as current, voltage, amplitude, shape, and / or frequency.

[0069] Depending on the system and design focus, a trade-off needs to be made around all these characteristics.

[0070] Square waves can be easily and efficiently generated compared to, e.g., sinewaves (electronics design benefit), but have a higher crosstalk to neighboring wires.

[0071] Depending on the amount of energy to be transferred, the signal nature, amplitude, and / or frequency are chosen.

[0072] Higher voltages generated in one central place (e.g., step-up from battery voltage) can be advantageous to power a series of simple tissue interface modules, having step-up electronics in only one place.

[0073] The disadvantage of this approach are the higher losses associated with charging and discharging cable capacitance at every cycle, and with the higher voltage.

[0074] Higher voltages can also trigger electro-corrosion of the non-hermitic parts of the implanted system, exposed to bodily fluids.

[0075] A higher powering frequency allows for smaller capacitors in the rectifying / power supply circuit of the tissue interface modules. The rectifier capacitor is typically large both in value (pF) and physical volume.

[0076] This hampers miniaturization of the tissue interface module electronics. In particular, it can lead to the need for using discrete components instead of a full semiconductor design.

[0077] A variable frequency can be used in case powering needs of the tissue interface modules vary over time.

[0078] For low power demands, the frequency can be low and, as the power demand increases, the system may accordingly increase powering frequency. The voltage ripple on the capacitor can be controlled this way. The lower frequency will reduce the capacitive cable losses, increasing the overall power efficiency during, e.g., idle times.

[0079] This approach can be adopted, for example, in the context of a sensing system where sensing takes place in bursts. During an active burst where, e.g., neuro-signals are being sensed by a tissue interface module, the tissue interface modules power consumption is high (because of active amplifiers, AD converters, or the like), and the powering frequency is increased. Then, upon completion of sensing bursts, the powering frequency drops again, and the tissue interface module returns to an idle state.

[0080] The system may further comprise at least one transfer module.

[0081] The at least one transfer module comprises at least one powering module.

[0082] The at least one transfer module further comprises least one communication module.

[0083] Conveniently, the communication line may be configured and arranged to modulate encoded information.

[0084] Conveniently, modulation may comprise digital modulation, analog modulation, and / or continuous wave modulation.

[0085] All information in electronic communication shall be encoded.

[0086] Depending on the needs, available bandwidth, available power, amount of data to be transferred, reliability, or the like, a preferred / optimal modulation option is selected, e.g., among: pulse modulation (e.g., digital modulation such as pulse code modulation or delta modulation, or analog modulation, such as pulse amplitude modulation, pulse duration / width modulation, and pulse position modulation); continuous wave modulation; amplitude modulation; angle modulation; frequency modulation, and phase modulation.

[0087] The above-mentioned modulation options all describe how to encode information, i.e., bits, into specific signals that are transmitted over a communication channel.

[0088] Modulating data streams take up a certain part of the communication channel bandwidth.

[0089] By using carriers and subcarriers, communication band can be shifted to a specific frequency space available in the communication channel.

[0090] This allows having multiple data streams in parallel on the same channel.

[0091] This requires a modulation and demodulation scheme to be able to have the parallel data streams.

[0092] Multi-channel modulation may also allow for full duplex communication between the implant unit and tissue interface module(s), and also in concurrent communication to a series of tissue interface modules.

[0093] Conveniently the system may comprise multiple tissue interface modules.

[0094] In one configuration, each tissue interface module is individually and / or directly connected via a communication line and / or power line to the implant unit.

[0095] In particular, the multiple tissue interface modules and the implant unit may form a star topology.

[0096] Star topology is commonly used in neuromodulation systems according to the state of the art.

[0097] Here, every tissue interface module connects to the implant unit.

[0098] Even when some adapter cables are used, the electrical topology remains a star configuration. In an alternative configuration, each tissue interface module may be connected via a communication line and / or power line to a central network communication and / or central network powering line.

[0099] Connection points form respective connection nodes.

[0100] The central network communication and / or central network powering line are connected to the implant unit.

[0101] The multiple tissue interface modules and the implant unit form a line or bus topology.

[0102] In another alternative configuration, a first tissue interface module may be individually and / or directly connected via a communication line and / or power line to the implant unit, and a second tissue interface module is connected at a connection node via a communication line and / or power line to the first tissue interface module.

[0103] Here, the multiple tissue interface modules and the implant unit form a line or bus topology.

[0104] According to yet another alternative configuration, at least one tissue interface module among the plurality of tissue interface modules is individually and / or directly connected via a communication line and / or power line to the implant unit.

[0105] Here, at least two tissue interface modules are connected via a communication line and / or power line to a central network communication and / or central network powering line.

[0106] The connection points form connection nodes.

[0107] The central network communication and / or central network powering line is connected to the implant unit.

[0108] Here, the multiple tissue interface modules and the implant unit form a combination of a star topology and a line or bus topology.

[0109] According to a still further alternative configuration, a first tissue module among the plurality of tissue interface modules is individually and / or directly connected via a communication line and / or power line to the implant unit.

[0110] At least a second tissue interface module is connected at a connection node via a communication line and / or power line to the first tissue interface module individually and / or directly connected to the implant unit. Here, the multiple tissue interface modules and the implant unit form a combination of a star topology and a line or bus topology.

[0111] In a bus topology, the power and communication lines are shared across the tissue interface modules, each system module (tissue interface modules and / or implanted unit) has a unique address, and the digital data commands include an address field that identifies its target module.

[0112] The other modules ignore the command.

[0113] Depending on the implantation site of the tissue interface modules and implanted unit, a bus topology can have major advantages.

[0114] In particular, it can dramatically save on cable routing, the number of connectors and connections, and the amount of tissue tunneling, and can reduce excess cable length.

[0115] It also allows for more tissue interface modules than would be possible with IPGs according to the state of the art, where the number of header sockets is limited to 4 and, practically, to 2 (4 resulting in a very bulky header).

[0116] Theoretically, using the bus topology, the number of tissue interface modules can be large and is only limited by system power usage and data bandwidth.

[0117] Conveniently, the at least one connection node may comprise at least one active element.

[0118] The active element may comprise an amplifier.

[0119] Additionally or alternatively, the active element may comprise a repeater.

[0120] Additionally or alternatively, the active element may comprise a detection element.

[0121] When tissue interface modules are daisy-chained to each other, the default approach is connecting the power and communication lines to the tissue interface module, and from there moving to the next tissue interface module, and repeating the sequence.

[0122] In this way, a chain starts to build.

[0123] By linking every node to the bus (bundle of communication, power, and optional other connections / wires), each node becomes a bus load: it draws power and has a (capacitive) load on the communication channel.

[0124] The concept is identical for balanced and unbalanced wiring. This load will limit the maximum number of nodes.

[0125] At some point, the power supply reaches its maximum.

[0126] Having to support a certain number of nodes is thus a design parameter and can be considered in the design phase.

[0127] For communication, the situation becomes more complex.

[0128] Many nodes can listen simultaneously to messages and information on the communication bus, but only one node can broadcast at any given time.

[0129] With the increasing number of nodes, the available space on the communication line must be shared and gets tighter (e.g., allocated time slots).

[0130] Other issues with a communication bus are the (capacitive) bus load, cross talk between bus cables, and noise picked up along the cable route.

[0131] This worsens with increasing number of nodes and cable length.

[0132] By adding an active element in the communication bus at every node, noise pickup can be limited to the track between nodes instead of the overall bus.

[0133] This will dramatically reduce noise levels and sensitivity to signal distortion of the communication information (bits).

[0134] The drawback of this solution is that it requires an active buffer circuit that consumes power.

[0135] This may nevertheless be obviated by adding a switch that bypasses the buffer, allowing disabling power drain of idle or asleep node.

[0136] That is, by closing the switch , the bus is reverted to its original passive configuration.

[0137] By having, for example, a low and high-speed communication mode, the low speed can be used to wake up and configure the desired nodes and activate their bus buffers (i.e. , opening the bypass switch). Then, bus speed can be switched to high-speed mode to, e.g., exchange a large amount of bulk data, after which the bus speed can be switched back to the low-speed mode by closing the bypass switches and powering down the bus buffers.

[0138] Accordingly, an optimized setup can be obtained.

[0139] Conveniently, the at least one implant unit may comprise at least one further functional module. Preferably, said functional module comprises a pulse generator.

[0140] Additionally or alternatively, said functional module comprises a sensor interface module.

[0141] Additionally or alternatively, said functional module comprises a power interface module.

[0142] Additionally or alternatively, said functional module comprises a communication interface module.

[0143] Additionally or alternatively, said functional module comprises a charger power interface module.

[0144] Technology wise, the number of nodes and functionality distribution is potentially endless, and are only limited by clinical constraints.

[0145] Therefore, a trade-off needs to be made of what kind of functionality (in connection with the selected therapy) is wanted vs. the clinical implications, vs. the options offered by distributing the functions.

[0146] Conveniently, the at least one communication module may comprise a y-connection module.

[0147] The y-connection module is configured for connecting two tissue interface modules to one another.

[0148] Here, an extension cable is used with a Y-connection at the end. The cable is split into two (or more) connectors, allowing multiple leads to be connected.

[0149] Conveniently, the at least one tissue interface module may comprise a socket.

[0150] The socket is configured and arranged to accept a generic cable.

[0151] Here, the system further comprises at least one generic cable and / or at least one generic Y- splitter to connect the implant unit with the at least one tissue interface module.

[0152] The invention also provides a system, said system comprising a plurality of neuromodulation systems as described in the foregoing.

[0153] Here, implant units of the plurality of neuromodulation systems are operatively interconnected.

[0154] The neuromodulation system is suitable for use for neuromodulation, in particular neurostimulation, e.g., cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation, and / or transcutaneous electrical stimulation. Further details and advantages of the invention will now be disclosed in connection with the drawings, where:

[0155] Fig. 1 shows exemplary implantable components for an implantable neuromodulation system according to the prior art. In particular, an implantable pulse generator (IPG) and different kinds of implantable leads are illustrated;

[0156] Fig. 2 is a diagram showing a neuromodulation system according to an embodiment of the invention. Here, an implant unit, a first tissue interface module, and a second tissue interface module are exemplarily illustrated;

[0157] Fig. 3 is a diagram showing one exemplary configuration for the neuromodulation system according to the invention, such as the system of Fig. 1. Here, the system includes a single implant unit and four tissue interface modules;

[0158] Fig. 4 is a diagram showing a detail of an implant unit and a tissue interface module for use in the system of Fig. 1 , operatively connected to one another to form a tissue interface module - implant unit interface;

[0159] Fig. 5 is a view similar to that of Fig. 4, showing an exemplary configuration where the implant unit and the tissue interface module are interconnected by a power line and a (digital) data communication line;

[0160] Fig. 6 is a view similar to that of Fig. 5, but where an analog connection is further established between the implant unit and the tissue interface module;

[0161] Figs. 7A-I are diagrams showing further exemplary power and communication connections between the implant unit and the tissue interface module;

[0162] Figs. 8A-B are diagrams showing different communication information modulation options for the system of Fig. 1 ;

[0163] Fig. 9A-C are diagrams showing different topology options for the system of Fig. 1. In detail: A. star topology. B. bus topology; C. combined topology;

[0164] Fig. 10 is a diagram showing yet another exemplarily configuration of the neuromodulation system according to the invention, such as the system of Fig. 1. Here, in addition to the implant unit and the tissue interface module, the system comprises further interface modules, such as a power interface module and a communication interface module; Fig. 11 is a diagram showing multi-drop communication options for the system of Fig. 1 ;

[0165] Fig. 12A-D are diagrams showing different exemplary connector and body distributions for the system of Fig. 1 ;

[0166] Fig. 13A-D are diagrams showing different approaches for updating / upgrading the system of Fig. 1.

[0167] Figs. 2-3 schematically show respective configurations for the neurostimulation system 100 according to the invention.

[0168] As a non-limiting example, the system 100 can be used for delivery of cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation, and / or transcutaneous electrical stimulation.

[0169] Nevertheless, other therapeutic applications are also possible according to the invention.

[0170] In the present embodiment, the system 100 is implantable.

[0171] Not shown is that the system 100 may be non-implantable.

[0172] The system 100 includes at least one implant unit 10.

[0173] Said implant unit 10 is abbreviated as “ICU” (implantable control unit) in the drawings for the sake of brevity.

[0174] In the configurations of Figs. 2-3, the system 100 includes a single implant unit 10.

[0175] Nevertheless, the provision of a plurality of implant units 10 is also possible

[0176] The system 100 further comprises at least one tissue interface module 12.

[0177] Said tissue interface module 12 is abbreviated as “TIM” (tissue interface module) in the drawings for the sake of brevity.

[0178] The at least one tissue interface module 12 comprises a lead 14.

[0179] The lead 14 comprises at least one electrode array with at least one electrode 16, 18, 20, 22.

[0180] The lead 14 further comprises an electrode circuit 24.

[0181] The system may comprise a single tissue interface module 12.

[0182] Preferably, the system 100 comprises a plurality of tissue interface modules 12.

[0183] The plurality of tissue interface modules 12 may be of the same kind.

[0184] Alternatively, said plurality of tissue interface modules 12 may include tissue interface modules 12 of different kinds, as shown in Fig. 3. In particular, in the configuration of Fig. 3, the system 100 includes a single implant unit 10 and four different tissue interface modules 12, each have a specific functionality, adapted to target different areas in the body.

[0185] The implant unit 10 is generic, this meaning that no hardware and / or software changes are required for specific treatment applications. Conversely, only stimulation parameters need to be tuned.

[0186] By the provision of tissue interface modules 12 of different kind (Fig. 3) extra system functionalities can be selected and / or added and / or enabled.

[0187] For example, a deep (sub-cortical) tissue interface module 12 can be combined with a cortical tissue interface module 12 for adaptive epilepsy therapy.

[0188] The system 100 further comprises a connection module 26, configured and arranged to form a generic tissue interface module 12 - implant unit 10 interface.

[0189] The at least one tissue interface module 12 is configured and arranged to at least in part define the functionality of the system 100.

[0190] A key advantage of tissue interface module(s) 12 equipped with active electronics is the limited distance to the actual tissue contact point: the electrode.

[0191] This implies that sensing, signal amplification, and analog-to-digital conversion is done very close to the targeted tissue, without requiring long cables, thus avoiding signal (high- frequency) content loss or interference.

[0192] In addition to analog-to-digital conversion, the neural / other physiology data can be analyzed locally for biomarkers, threshold detection, or the like, thus avoiding unnecessary communication (data-rate, bandwidth, integrity, power needs) of big data sets between tissue interface module(s) 12 and implant unit 10.

[0193] An exemplary tissue interface connection 12- implant unit 10 interface (established though the connection unit 26) is schematically illustrated in Fig. 4.

[0194] Each of the system modules, e.g., the implant unit 10 and the tissue interface module(s) 12, perse has only partial functionality and cannot function independently from the others.

[0195] The connection between modules requires a different interface compared to the solutions according to the state of the art. In particular, power and data need to be exchanged between modules such as the implant unit 10 and the tissue interface module(s) 12.

[0196] In the present embodiment, the system 100 further comprises at least one communication module 28 comprising a communication line COMS. The at least one communication module 28 is configured and arranged for transferring information, in particular digital signals and / or analog signals and / or synchronization signals CLK.

[0197] In the present embodiment, the system 100 further comprises at least one powering module 30.

[0198] The at least one powering module 30 comprises a power line PWR to provide and / or transfer power and / or synchronization signals CLK from the implant unit 10 to the at least one tissue interface module 12 and / or vice versa, or from a first tissue interface module 12 to a second tissue interface module 12 and / or vice versa.

[0199] In the present embodiment, the at least one powering module 30 is configured and arranged for AC power transmission.

[0200] In the present embodiment, the system 100 comprises at least one transfer module, the at least one transfer module comprising at least one powering module 30 and communication module 28.

[0201] The communication line COMS may be configured and arranged to modulate encoded information.

[0202] In particular, modulation may comprise digital modulation, analog modulation, and / or continuous wave modulation.

[0203] Fig. 5 shows an exemplary configuration where the implant unit 10 and a tissue interface module 12 are interconnected by a powering module 30 comprising a power line PWR and a communication line COMS, e.g., a digital data communication line COMS.

[0204] Optionally, an analog connection may be also provided (as illustrated in Fig. 6).

[0205] The examples of Figs. 5-6 show configurations where the implant unit 10 provides power to the tissue interface module(s) 12 (e.g., through a power source).

[0206] However, different configurations are also possible according to the invention, such as:

[0207] - a tissue interface module 12 powering the implant unit 10;

[0208] - the implant unit 10 and tissue interface module(s) 12 each having respective power sources (here, supply of power between implant unit 10 and interface module(s) 12 is not required);

[0209] - a tissue interface module 12 powering other tissue interface module(s) 12;

[0210] - any combinations thereof, and - the provision of an external, non-implantable power source powering the implant unit 10 and tissue interface module(s) 12.

[0211] Advantageously, the at least one tissue interface module 12 may be or comprise at least one electrode comprising graphene, preferably hydrothermally reduced graphene oxide, for electrical stimulation and / or sensing (see electrode 18 in Fig. 3).

[0212] Also, the tissue interface module 12 may comprise a transistor comprising graphene and / or engineered graphene for neural Interface (see element 20 in Fig. 3).

[0213] Not shown is that the tissue interface module 12 may comprise an ultrasound stimulator and / or an optical stimulator.

[0214] Additional components may as well be implemented in the tissue interface module 12, including but not limited to one or more among: a temperature sensor and / or a blood pressure sensor and / or a heart rate sensor and / or a heart rate variability sensor and / or an oxygenation sensor and / or a ph sensor and / or a hydration sensor and / or an impedance sensor and / or a glucose or metabolite sensor and / or an ECG and / or an EEG and / or EMG and / or motion sensor and / or IMU and / or position sensor.

[0215] In the system 100, power and communication data can be transferred using various wiring topologies, as schematically shown in Figs. 7A-I.

[0216] Topologies can be either balanced or unbalanced.

[0217] Unbalanced topologies (see, e.g., Fig. 7A) have the advantage that they use fewer wires, thereby simplifying physical interconnection and mechanics.

[0218] On the other hand, balanced topologies (see, e.g., Fig. 7B) are electrically more reliable (e.g., no ground bounce, less interference from other wires, or the like).

[0219] Depending on the overall system implementation and design choices made, either option can be chosen.

[0220] In the unbalance option shown in Fig. 7A, a ground connection GND is provided, serving as a voltage reference between the implant unit 10 and tissue interface module(s) 12, providing a current return path.

[0221] In the balanced option shown in Fig. 7B, a reference connection can be provided (although not strictly required).

[0222] This may be electrically convenient to link module voltage reference levels.

[0223] This can be done with a single wire (see reference connection in Fig. 7B). Alternatively, although with higher constraints on the electrical design, the reference line can be omitted (Fig. 7E), thus saving a connection between implant unit 10 and tissue interface module(s) 12.

[0224] An in-between option, although still with some constraints, is relying on conductive tissue and / or body fluids to provide the reference connection (Fig. 7F).

[0225] In this case, the implanted components and at least one electrode (e.g., embedded in one or more tissue interface module(s) 12) must be provided, contacting the body tissue or fluids.

[0226] Next to power and communication, analog signals also need to be transmitted.

[0227] For this purpose, an analog connection can be provided between the implant unit 10 and tissue interface module(s) 12, as shown in Figs. 7C-D.

[0228] Analog connection can be established via one or more wires depending on the number of analog signals (a single wire is shown in Figs. 7C-D for simplification).

[0229] As mentioned, power can be transferred from the implant unit 10 to tissue interface module(s) 12 using a powering module 30 including a power line PWR.

[0230] For safety reasons, this power transfer must be AC and cannot carry DC or have a DC-offset.

[0231] In fact, DC leakage current may potentially lead to adverse effects in the patient, failure modes in the electronics / cables (e.g., electromigration or corrosion), and can easily violate regulatory constraints.

[0232] AC frequency can also be used to provide a clock signal to tissue interface module(s) 12.

[0233] Figs. 7A-F show the power combined with the clock signal CLK.

[0234] Clock signal CLK can be used for internal processing (synchronization) in the tissue interface module(s) 12.

[0235] It also serves as a synchronization mechanism for the communication line COMS (digital data stream) and for the analog signals (e.g., stimulation pulses, data sensing, mux switching, or the like).

[0236] Alternatively, clock and communication signals can be combined, as shown in Fig. 7G, e.g., by Manchester encoding of the communication data embedding clock timing in the data stream.

[0237] In this case, communication signaling includes its own clock, independent from the AC power signal.

[0238] Ultimately, power, clock, and communication signals can be combined on one electrical channel (Fig. 7H), thus minimizing the number of wires / connections. This approach creates an interdependency between the amount of information and the amount of power that is being transferred, and also leads to a default communication direction which is one-way, i.e. , from the implant unit 10 to the tissue interface module 12, as this is linked to the direction of the power being delivered.

[0239] However, there are several possible ways to send return information on the same electrical channel, such as: briefly interrupting power transfer to create a ‘time gap’ in which the tissue interface module 12 can drive the line and return information to the implant unit 10. The amount of information is limited to the period the tissue interface module 12 can power itself (e.g., ACK or NAK). In any case, the tissue interface module 12 must be able to bridge the gap and remain functional despite not being powered; using a form of back-scattering. By modulating power loading by the tissue interface module 12, the implant unit 10 can derive data from the power line PWR and read the response. Although the amount of data which can be sent back remains quite limited, the present option still provides more opportunities compared to the previous one; multiple band frequency modulation.

[0240] In Fig. 7I, an interconnection is generated using two communication channels (indicated as COMS-1 and COMS-2 in the figure).

[0241] The first channel is identical to the one shown in Fig. 7H.

[0242] Power is transferred and, with an appropriate pulse modulation scheme, information is transferred as well (e.g., by using Manchester encoding).

[0243] The second channel can be used for communication only and can be used in two directions.

[0244] This allows sending high amounts of data in both directions.

[0245] If the tissue interface module 12 is a sensor, e.g., including electrodes with sensing mechanisms for electrophysiological signals, information can be sent to the implant unit 10 for processing using this second channel (COMS-2” in Fig. 7I).

[0246] In case multiple tissue interface modules 12 are combined in a system 100 characterized by different communication needs, the options shown in Figs. 7H-I can be combined.

[0247] For a tissue interface module 12 with limited communication needs, e.g., configuration only, the options shown in Fig. 7H can be used, leaving the second communication line COMS unused or disconnected. On the other hand, with a tissue interface module 12 which supplies large amounts of information for the implant unit 10, e.g., sensors or tissue interface modules 12 implemented with an Analog-to-Digital converter, it connects to the second, dedicated communication channel to send dense information to the implant unit 10.

[0248] In principle, among the several options, the definition of an optimal configuration largely depends on the overall system requirements.

[0249] The provision of a larger number of wires and / or interconnections offers higher design flexibility and more freedom in communication protocols / speeds.

[0250] On the other hand, fewer wires mean less mechanical hardware and fewer system constraints (e.g., feed through, connectors, and / or cable thickness / flexibility).

[0251] That is, a trade-off needs to be established depending on the system requirements.

[0252] An AC signal is defined by several characteristics, e.g., current, voltage, amplitude, shape, and frequency.

[0253] Depending on the system and design focus, a trade-off needs to be defined around all these characteristics.

[0254] Square waves can be easily and efficiently generated compared to, e.g., sinewaves (electronics design benefit) but have a higher crosstalk to neighboring wires.

[0255] Depending on the amount of energy to be transferred, the signal nature, amplitude and frequency are chosen.

[0256] Higher voltages generated in one central place (e.g., step-up from battery voltage) can be advantageous to power a series of simple tissue interface modules 12 having step-up electronics in only one place.

[0257] The disadvantage of this approach are the higher losses associated with charging and discharging cable capacitance at every cycle and with the higher voltage.

[0258] Higher voltages can also trigger electro-corrosion of non-hermitic parts of the implanted system 100, exposed to bodily fluids.

[0259] A higher powering frequency allows for smaller capacitors in rectify ing / power supply circuit of the tissue interface module(s) 12.

[0260] The rectifier capacitor is typically large, both in value (pF) and physical volume.

[0261] This hampers miniaturization of the tissue interface module 12 electronics, and needs to rely on discrete components instead of a full semiconductor design. A variable frequency can be used in case the tissue interface module 12 powering needs vary over time.

[0262] For low power demands, the frequency can be low and, as the power demand increases, the system 100 may increase powering frequency. The voltage ripple on the capacitor can be controlled this way. The lower frequency will reduce the capacitive cable losses, increasing the overall power efficiency during, for example, idle times.

[0263] This approach can be implemented, for example, in a sensing system where sensing takes place in bursts. During an active burst where, e.g., neuro-signals are being sensed by a tissue interface module 12, the tissue interface module 12 power consumption is high (e.g., because of active amplifiers, AD converters, or the like) and the powering frequency is increased. Then, upon completion of sensing bursts, the powering frequency drops again, and the tissue interface module 12 returns to an idle state.

[0264] In the system 100, all information in electronic communication shall be encoded.

[0265] Conveniently, information can be modulated on the communication line COMS.

[0266] Depending on the needs, available bandwidth, available power, amount of data to be transferred, reliability, or the like, a preferred / optimal modulation option can be selected, e.g., among: pulse modulation (e.g., digital modulation such as pulse code modulation or delta modulation, or analog modulation, such as pulse amplitude modulation, pulse duration / width modulation, and pulse position modulation); continuous wave modulation; amplitude modulation; angle modulation; frequency modulation, and phase modulation.

[0267] These modulation forms all describe how to encode information, i.e. , bits, into specific signals that are transmitted over the communication channel.

[0268] Modulating data streams take up a certain part of the communication channel bandwidth.

[0269] By using carriers and subcarriers, the communication band can be shifted to a specific frequency space available in the communication channel.

[0270] This allows having multiple data streams in parallel on the same channel. This requires a modulation and demodulation scheme to be able to have the parallel streams.

[0271] Multi-channel modulation also allows, e.g., for full duplex communication between implant unit 10 and tissue interface module(s) 12, and also in concurrent communication to a series of tissue interface modules 12.

[0272] Fig. 8A shows a single communication stream in the channel.

[0273] For example, this can be a simple communication using a single stream of coded pulses (half duplex).

[0274] On the other hand, in a situation with multiple carrier frequencies as shown in Fig. 8B, multiple channels can be allocated to various tissue interface modules 12, e.g.: ch1 to a first tissue interface module (TIM1), Ch2 from the first tissue interface module (TIM1), Ch3 to a second tissue interface module (TIM2), Ch4 from the second tissue interface module (TIM2), etc.

[0275] In the present embodiment, the system 100 comprises multiple tissue interface modules 12 as shown, e.g., in Fig. 2-3.

[0276] In one configuration, each tissue interface module 12 is individually and / or directly connected via a communication line COMS and / or power line PWR to the implant unit 10.

[0277] In this configuration, the multiple tissue interface modules 12 and the implant unit 10 form a star topology (Fig. 9A).

[0278] Star topology is commonly used in neuromodulation systems according to the state of the art.

[0279] Here, every tissue interface module 12 connects to the implant unit 10, as shown in Fig. 9A

[0280] Even when some adapter cables (not shown) are used, the electrical topology remains a star configuration.

[0281] In another configuration, each tissue interface module 12 is connected via a communication line COMS and / or power line PWR to a central network communication and / or central network powering line, the connection points forming connection nodes.

[0282] The central network communication and / or central network powering line are connected to the implant unit 10.

[0283] Here, the multiple tissue interface modules 12 and the implant unit 10 form a line or bus topology.

[0284] In yet another configuration, a first tissue interface module 12 is individually and / or directly connected via a communication line COMS and / or power line PWR to the implant unit 10, and a second tissue interface module 12 is connected at a connection node via a communication line COMS and / or power line PWR to the first tissue interface module 12. Here, the multiple tissue interface modules 12 and the implant unit 10 form a line or bus topology (Fig. 9B).

[0285] In a still further configuration, at least one tissue interface module 12 is individually and / or directly connected via a communication line COMS and / or power line PWR to the implant unit 10, and at least two tissue interface modules 12 are connected via a communication line COMS and / or power line PWR to a central network communication and / or central network powering line, the connection points forming connection nodes.

[0286] The central network communication and / or central network powering line are connected to the implant unit 10.

[0287] Here, the multiple tissue interface modules 12 and the implant unit 10 form a combination of a star topology and a line or bus topology.

[0288] In yet another configuration, a first tissue module 12 is individually and / or directly connected via a communication line COMS and / or power line PWR to the implant unit 10, and at least a second tissue interface module 12 is connected at a connection node via a communication line COMS and / or power line PWR to the first tissue interface module 12 individually and / or directly connected to the implant unit 10.

[0289] Here, the multiple tissue interface modules 12 and the implant unit 10 form a combination of a star topology and a line or bus topology (Fig. 9C).

[0290] In a bus topology, the power and communication lines COMS are shared across the tissue interface modules 12, each system module (tissue interface modules 12 and / or implant unit 10) has a unique address, and the digital data commands include an address field that identifies its target module.

[0291] The other modules ignore the command.

[0292] Depending on the implantation site of the tissue interface modules 12 and the implant unit 10, a bus topology may potentially have major advantages.

[0293] In particular, it can dramatically save on cable routing, the number of connectors and connections, and the amount of tissue tunneling, and it can reduce excess cable length.

[0294] It also allows for the provision of more tissue interface modules 12 than would be possible with the neuromodulation systems according to the state of the art, where the number of header sockets is limited to four and practically to two (four resulting in a very bulky header).

[0295] Theoretically, using the bus topology, the number of tissue interface modules 12 can be large and is only limited by system power usage and data bandwidth. Conveniently, in the present embodiment, the at least one connection node may comprise at least one active element.

[0296] Preferably, said active element comprises one or more among an amplifier, a buffer, a repeater, and / or a detection element.

[0297] In the present embodiment, the at least one implant unit 10 (a single implant unit 10 being shown in the configurations of Figs. 2-3) may comprise at least one further functional module.

[0298] Preferably, said functional module may comprise one or more among a pulse generator, a sensor interface module, a power interface module, a communication interface module, and a charger power interface module.

[0299] A non-limiting configuration including functional modules of this kind is shown in Fig. 10.

[0300] Here, a power interface module and a communication interface module are provided, directly or indirectly connected to the implant unit 10.

[0301] Nevertheless, different configurations including functional modules are also possible according to the invention.

[0302] Technology wise, the number of nodes and functionality distribution is potentially endless, only limited by clinical constraints.

[0303] Therefore, a trade-off needs to be made of what kind of functionality (in connection with the selected therapy) is wanted vs. the clinical implications, vs. options offered by distributing the functions.

[0304] When tissue interface modules 12 are daisy-chained to each other, the default approach is connection of the power line PWR and communication lines COMS to one tissue interface module 12, and from there moving to the next tissue interface module 12, and repeating the sequence.

[0305] In this way, a chain starts to build (see, e.g., Fig 9B, bus topology).

[0306] By linking every node to the bus (bundle of communication, power, and optional other connections / wires), each node becomes a bus load: it draws power and has a (capacitive) load on the communication channel (see Figs. 11A and 11C).

[0307] The concept is identical for balanced and unbalanced wiring.

[0308] This load limits the maximum number of nodes.

[0309] At some point, the power supply reaches its maximum.

[0310] Having to support a certain number of nodes is thus a design parameter and can be considered in the design phase. For communication, the situation becomes more complex.

[0311] Many nodes can listen simultaneously to messages and information on the communication bus, but only one node can broadcast at any given time.

[0312] With the increasing number of nodes, the available space on the communication line must be shared and gets tighter (e.g., allocated time slots).

[0313] Other issues with a communication bus are the (capacitive) bus load, the cross talk between bus cables, and noise picked up along the cable route.

[0314] This worsens with increasing number of nodes and cable length.

[0315] By adding an active element in the communication bus at every node (e.g., an amplifier, buffer, repeater, detection element, or the like, see Fig. 11 B), the noise pickup can be limited to the track between nodes instead of the overall bus.

[0316] This will dramatically reduce noise levels and sensitivity to signal distortion of the communication information (bits).

[0317] The drawback of this solution is that it requires an active buffer circuit that consumes power.

[0318] Adding a switch (see Fig. 11 D) that bypasses the buffer allows disabling this power drain of idle or asleep node.

[0319] Closing the switch thus turns the bus into the original passive configuration.

[0320] By having, for example, a low and high-speed communication mode, the low speed can be used to wake up and configure the desired nodes and activate their bus buffers (i.e. , opening the bypass switch).

[0321] Then, the bus speed can be switched to high-speed mode to, e.g., exchange a large amount of bulk data, after which the bus speed can be switched back to the low-speed mode by closing the bypass switches and powering down the bus buffers.

[0322] This way, an optimized solution can be obtained.

[0323] The at least one communication module 28 may comprise a Y-connection module, configured for connecting two tissue interface modules 12 to one another.

[0324] Also, in the present embodiment, the at least one tissue interface module 12 may comprise a socket configured and arranged to accept a generic cable.

[0325] Here, the system 100 further comprises at least one generic cable and / or at least one generic Y-splitter to connect the implant unit 10 with the at least one tissue interface module 12.

[0326] In the state of the art, IPGs typically have an integrated header with sockets that accept the leads. That is, the IPG consists of a header and a body.

[0327] The body holds the electronics, and optionally a battery and / or a charging / communication coil.

[0328] The lead sockets are placed in the header, often using a so-called Ball Seal connector stack.

[0329] This header requires a quite significant amount of space, making the overall IPG bulky (a common distribution is approximately 30% vs. 70%).

[0330] This interconnection option is illustrated in Fig. 12A (“option 1”).

[0331] By making a split between the body and the header, an improved arrangement can be obtained, allowing for placement of the implant unit 10 in places where it wouldn’t otherwise fit and / or would cause adverse effects such as skin corrosion.

[0332] This can be implemented in different ways.

[0333] Fig. 12B (“option 2”) shows a configuration where 3 connectors are connected to the implant unit body using cables that connect to the implant unit electronics.

[0334] Fig. 12C (“option 3”) shows another configuration where a single Y-cable is used, departing from the implant unit body.

[0335] This can have both clinical and manufacturing benefits.

[0336] By conceptually separating the header from the implant unit body, the header becomes a socket box (Fig. 12D, “option 4”).

[0337] The body is then located at one position and the socket box at another one, both electrically connected by a cable.

[0338] It may be the case that, at some point in time, an additional tissue interface module 12 shall be added into the system 100.

[0339] As an example, Fig. 13A shows a configuration where the system 100 comprises an implant unit 10 with a 3-socket header box and 3 tissue interface modules 12.

[0340] If, at some point, a wish arises to add another tissue interface module 12, this would require replacement of the implant unit 10 with another one having 4 outputs in the header box, thus including an additional socket for the new tissue interface module 12 to be incorporated.

[0341] This solution is nevertheless suboptimal, in particular because of the risks connected with explantation of the of the implant unit 10, which requires an invasive surgical intervention on the patient.

[0342] Therefore, adding a further tissue interface module 12 while maintaining the implant unit 10 in place (i.e. , without explantation operations being required) could be preferable. Fig. 13B shows an example where one of the tissue interface modules 12 (indicated as “TIM3” in the figure) is disconnected from a respective connection (indicated as “Con3” in the figure).

[0343] An extension Y-cable is inserted into the previously used connection (Con3).

[0344] The existing interface module (TIM3) is now plugged into a new connection (indicated as “Con4” in the figure).

[0345] An extra connection (indicated as “Con5” in the figure) is provided to connect to the additional tissue interface module (indicated as “TIM4” in the figure).

[0346] Depending on the software / firmware of the implant unit 10, the new tissue interface module (TIM4) can be directly recognized (bus query), initialized, and integrated in the system 100.

[0347] Functionality of the new tissue interface module can be configured using a programming tool, such as a clinician programmer (not shown) provided in the system 100.

[0348] In case the new tissue interface module (TIM4, in the shown example) is not supported by existing software / firmware of the implant unit 10, the implant unit 10 can be upgraded through a software / firmware update.

[0349] After the update / upgrade, the new / upgraded functionality becomes available and ready for use.

[0350] This way, the clinical impact is dramatically reduced compared to a solution requiring replacement of the implant unit 10.

[0351] Also, the incorporation of the new tissue interface module 12 into the (existing) system 100 becomes relatively straightforward.

[0352] A further simplification can be achieved through the alternative solution shown in Fig. 13c.

[0353] Here, the tissue interface modules 12 are equipped with a socket that accepts a generic cable (Fig. 13C) and do not have fixed cables attached.

[0354] A generic set of cables and Y-splitters is used to make all connections between the implant unit 10 and the tissue interface modules 12.

[0355] An additional advantage is that cables of various lengths can be used, depending on the patient physiognomy and implant positions.

[0356] In this context, when an upgrade is planned, disconnection does no longer need to be near the header box (as shown in Fig. 13B), but can be near the existing interface module (TIM3, in the example shown in Fig. 13D).

[0357] This implies that the disconnection place can be chosen where the new tissue interface module 12 connects to the system 100. System dimensions are typically set by the battery, lead connectors, and mechanical and material constraints dictated by reliability.

[0358] This is due to the energy needed for the treatment application, the number of wires in the lead, and the volume taken up by the electronic components.

[0359] The mechanical, material, size and battery constraints can be relaxed by using higher level of circuit integration (ASIC technology), less demanding stimulation and sensing requirements, and functionality distributed across unit / modules of the system.

[0360] The solution according to the invention enhances the overall system flexibility.

[0361] Accordingly, a new system design can be developed, including features that could not have been incorporated in the system configurations according to the prior art.

[0362] Building such devices can still leverage much STOA design methodologies and technology. No feasibility issues are foreseen except for the use of Graphene. The manufacturing and use of Graphene is already addressed in other IN BRAIN patents and is not different for this ID.

[0363] Roadblocks which can be expected are for example the longevity in chronic implantation, but this is independent of this IDs (out of scope).

[0364] The present invention further provides a system 200.

[0365] The system 200 comprises a plurality of neuromodulation systems 100.

[0366] Here, implant units of the plurality of neuromodulation systems 100 are operatively interconnected.

[0367] In connection with the above disclosure, the following aspects are explicitly disclosed:

[0368] Aspect 1 : A neuromodulation system, in particular for Cortical and / or Deep Brain Stimulation and / or Modulation of a patient, comprising at least one implant unit comprising: a stimulation unit configured and arranged for providing a therapeutic neuromodulation signal to the patient; at least one signaling unit configured and arranged for providing an informative signal to the patient, preferably a non-therapeutic signal; and / or at least one first recording system and / or sensing system, configured and arranged to gather and / or integrate a signal from the patient. Aspect 2: The neuromodulation system according to Aspect 1 , wherein the stimulation unit and the signaling unit are embodied in one unit and wherein the therapeutic signal and the informative signal are of the same or similar signal type.

[0369] Aspect 3: The neuromodulation system according to Aspect 2, wherein the therapeutic signal and the informative signal are both electrical signals, wherein the therapeutic signal and the informative signal differ, e.g., in stimulation rate, amplitude, voltage, current, frequency, ramping, duration.

[0370] Aspect 4: The neuromodulation system according to Aspect 1 , wherein the in-formative signal is a non-therapeutic signal and of a different signal type than the therapeutic signal.

[0371] Aspect 5: neuromodulation system according to one of the previous Aspects, wherein the informative signal comprises information such as the battery status, warning in-formation, feedback on the therapy delivered, feedback on the tuning status, bringing the patient consciousness in the closed loop, etc.

[0372] Aspect 6: The neuromodulation system according to one of the previous Aspects, wherein the first recording system and / or sensing system is or comprises at least one sensor, such as an accelerometer, a pressure sensor, a microphone, a speech recognition device, an EEG sensor or EEG like signal sensor, etc.

[0373] Aspect 7: The neuromodulation system according to one of the previous Aspects, wherein the system further comprises a patient control module, wherein the patient control module is configured and arranged for providing information provided by the patient equipped with the system or a user to the first recording system and / or sensing system.

[0374] Aspect 8: The neuromodulation system according to one of the previous Aspects, wherein the patient control module is or comprises a smart watch, a mobile phone, a PC, a tablet computer, etc.

[0375] Aspect 9: The neuromodulation system according to one of the previous Aspects, wherein the system further comprises:

[0376] - at least one first antenna,

[0377] - at least one lead having at least one electrode array with at least one electrode; and

[0378] - at least one wearable device comprising at least one second antenna, wherein the at least one wearable device is configured to wirelessly control and wirelessly communicate with the at least one implant unit, in particular wherein the at least one electrode is made of reduced graphene oxide, preferably hydrothermally reduced graphene oxide.

[0379] Aspect 10: The neuromodulation system according to one of the previous Aspects, wherein the implant unit further comprises a pulse generator.

[0380] Aspect 11 : The neuromodulation system according to one of the previous Aspects, wherein the implant unit further comprises a second recording system and / or sensing system to acquire signals, especially neurophysiological signals.

[0381] Aspect 12: The neuromodulation system according to one of the previous Aspects, wherein the wearable device is rechargeable.

[0382] Aspect 13: The neuromodulation system according to one of the previous Aspects, wherein the wearable device is configured to wirelessly charge or power the at least one implant unit.

[0383] Aspect 14: The neuromodulation system according to one of the previous Aspects, wherein the wearable device is form-fitted to a human ear.

[0384] Aspect 15: The neuromodulation system according to one of the previous Aspects, wherein the wearable device has a personalized and / or customized form-fit to specific ear of a human.

[0385] Aspect 16: The neuromodulation system according to one of the previous Aspects, wherein the wearable device comprises a device software.

[0386] Aspect 17: The neuromodulation system according to one of the previous Aspects, wherein the wearable device is configured to wirelessly exchange data with a mobile device, preferably a smartphone and / or another personal electronic device, and / or a data base station.

[0387] Aspect 18: The neuromodulation system according to one of the previous Aspects, wherein the mobile device comprises a software application configured to process data received from the wearable device and / or establish a network data link to the data base station.

[0388] Aspect 19: The neuromodulation system according to one of the previous Aspects, wherein the implant unit is wirelessly rechargeable.

[0389] Aspect 20: The neuromodulation system according to one of the previous Aspects, wherein the implant unit is anatomically fitted to an implant site and configured to be implanted cranially.

[0390] Aspect 21 : Use of a neurostimulation system according to one of aspects 1-20. References

[0391] 100 Neuromodulation system 00 System

[0392] 10 Implant unit

[0393] 12 Tissue interface module

[0394] 14 Lead

[0395] 16 Electrode

[0396] 18 Electrode

[0397] 20 Electrode

[0398] 22 Electrode

[0399] 24 Electrode circuit

[0400] 26 Connection module

[0401] 28 Communication module

[0402] 30 Powering module

[0403] 32 Power interface module

[0404] 34 Communication interface module

[0405] COMS Communication line

[0406] CLK Signal(s)

[0407] PWR Power line

[0408] GND Ground connection

Claims

Claims1. A neuromodulation system (100), comprising: at least one implant unit (10), and at least one tissue interface module (12), wherein the at least one tissue interface module (12) comprises a lead (14) comprising at least one electrode array with at least one electrode (16, 18, 20, 22) and an electrode circuit (24), wherein the system (100) comprises a connection module (26) configured and arranged to form a generic tissue interface module (12) - implant unit (10) interface, and wherein the at least one tissue interface module (12), at least in part, is configured and arranged to define the functionality of the system (100).

2. The system (100) according to claim 1, characterized in that the at least one tissue interface module (12) is or comprises at least one electrode (18) comprising graphene, preferably hydrothermally reduced graphene oxide, for electrical stimulation and / or sensing.

3. The system (100) according to claim 1, characterized in that the at least one tissue interface module (12) comprises a transistor (20) comprising graphene and / or engineered graphene for neural Interface and / or an ultrasound stimulator and / or an optical stimulator and / or a temperature sensor and / or a blood pressure sensor and / or a heart rate sensor and / or a heart rate variability sensor and / or an oxygenation sensor and / or a ph sensor and / or a hydration sensor and / or an impedance sensor and / or a glucose or metabolite sensor and / or an ECG and / or an EEG and / or EMG and / or motion sensor and / or IMU and / or position sensor.

4. The system (100) according to one of claims 1-3, characterized in that the system (100) further comprises at least one communication module (28) comprising a communication line (COMS), wherein the at least one communication module (28) is configured and arrangedfor transferring information, in particular digital signals and / or analog signals and / or synchronization signals (CLK).

5. The system (100) according to one of claims 1-4, characterized in that the system (100) further comprises at least one powering module (30), wherein the at least one powering module (30) comprises a powering line (PWR) to provide and / or transfer power and / or synchronization signals (CLK) from the implant unit (10) to the at least one tissue interface module (12) and / or vice versa, or from a first tissue interface module (12) to a second tissue interface module (12) and / or vice versa.

6. The system (100) according to claim 5, characterized in that the at least one powering module (30) is configured and arranged for AC power transmission.

7. The system (100) according to one of claims 4-6, characterized in that the system comprises at least one transfer module, wherein the at least one transfer module comprises at least one powering module (30) and communication module (28).

8. The system (100) according to claim 4 or claim 7, characterized in that the communication line (COMS) is configured and arranged to modulate encoded information, wherein the modulation comprises digital modulation, analog modulation and / or continuous wave modulation.

9. The system (100) according to one of claims 4-8, characterized in that the system (100) comprises multiple tissue interface modules (12), wherein each tissue interface module (12) is individually and / or directly connected via a communication line (COMS) and / or power line (PWR) to the implant unit (10), in particular wherein the multiple tissue interface modules (12) and the implant unit (10) form a star topology.

10. The system (100) according to one of claims 4-8, characterized in that the system (100) comprises multiple tissue interface modules (12), wherein each tissue interface module (12) is connected via a communication line (COMS) and / or power line (PWR) to a central network communication and / or central network powering line, the connection points forming connection nodes, the central network communication and / or central network powering line being connected to the implant unit (10), in particular wherein the multiple tissue interface modules (12) and the implant unit (10) form a line or bus topology.

11. The system (100) according to one of claims 4-8, characterized in that the system (100) comprises multiple tissue interface modules (12), wherein a first tissue interface module (12) is individually and / or directly connected via a communication line (COMS) and / or power line (PWR) to the implant unit (10), wherein a second tissue interface module (12) is connected at a connection node via a communication line (COMS) and / or power line (PWR) to the first tissue interface module (12), in particular wherein the multiple tissue interface modules (12) and the implant unit (10) form a line or bus topology.

12. The system (100) according to one of claims 1-8, characterized in that the system (100) comprises multiple tissue interface modules (12), wherein at least one tissue interface module (12) is individually and / or directly connected via a communication line (COMS) and / or power line (PWR) to the implant unit (10), further wherein at least two tissue interface modules (12) are connected via a communication line (COMS) and / or power line (PWR) to a central network communication and / or central network powering line, the connection points forming connection nodes, the central network communication and / or central network powering line being connected to the implant unit (10), in particular wherein the multiple tissue interface modules (12) and the implant unit (10) form a combination of a star topology and a line or bus topology.

13. The system (100) according to one of claims 1-8, characterized in that the system (100) comprises multiple tissue interface modules (12), wherein a first tissue module (12) is individually and / or directly connected via a communication line (COMS) and / or power line (PWR) to the implant unit (10), further wherein at least a second tissue interface module (12) is connected at a connection node via a communication line (COMS) and / or power line (PWR) to the first tissue interface module (12) individually and / or directly connected to the implant unit(10), in particular wherein the multiple tissue interface modules (12) and the implant unit (10) form a combination of a star topology and a line or bus topology.

14. The system (100) according to claim 10 or claim 11 , characterized in that at least one connection node comprises at least one active element, preferably wherein said active element comprises one or more among an amplifier, a buffer, a repeater, and / or a detection element.

15. The system (100) according to any of the preceding claims, characterized in that at least one implant unit (10) comprises at least one further functional module, preferably wherein said further functional module comprises one or more among a pulse generator, a sensor interface module, a power interface module, a communication interface module, and a charger power interface module.

16. The system (100) according to one of claims 4-13, characterized in that the at least one communication module (28) comprises a y-connection module, configured for connecting two tissue interface modules (12) to one another.

17. The system (100) according to one of the preceding claims, characterized in that the at least one tissue interface module (12) comprises a socket configured and arranged to accept a generic cable, wherein the system (100) comprises at least one generic cable and / or at least one generic y-splitter to connect the implant unit (10) with the at least one tissue interface module (12).

18. A system (200) comprising a plurality of neuromodulation systems (100) according to any of the preceding claims, wherein implant units (10) of the plurality of neuromodulation systems (100) are operatively interconnected.

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