Neuromodulation system

Abstract

The 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 the system (100) comprises a connection module (26) configured and arranged to form a universal tissue interface module (12) - implant unit (10) interface, and wherein the at least one tissue interface module (12) is at least partially configured and arranged to define a functionality of the system (100).

Description

Technical Field

[0001] This invention belongs to the technical field of systems for delivering neuromodulation therapy.

[0002] The system may be implantable or non-implantable.

[0003] As a non-limiting example, the system can be configured and arranged to deliver cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation, and / or transcutaneous electrical stimulation. Background Technology

[0004] Systems for delivering neuromodulation therapies, such as implantable systems, are known in the art.

[0005] In the prior art, implantable neuromodulation systems typically include an implantable pulse generator (IPG) and one or more treatment-specific leads.

[0006] Examples of IPG and different types of treatment-specific leads based on existing technology are shown in Figure 1 middle.

[0007] Select the appropriate lead based on the specific treatment to be delivered.

[0008] Specifically, specific wires are selected to deliver electrical energy at the correct location (e.g., cortex, subcortex, spinal cord, nerve) and optionally to sense neural signals (recording).

[0009] IPGs require the delivery of stimulus energy and the provision of optional signal sensing systems.

[0010] Although most known IPGs to date have specific uses (e.g., stomach, nerve DBS, neuropathic pain, etc.), their socket heads can be universal and may accept a range of different electrode types.

[0011] If IPG software is also conceived in a general way, IPG can be used to deliver a range of therapies, not just one.

[0012] Specifically, this enables a platform approach that includes a universal IPG and a set of therapy-specific leads. The condition is that all of the leads must have universal connectors that mate with the universal IPG head socket.

[0013] However, this method still has some drawbacks and limitations.

[0014] For example, using current head technology, the total number of head contacts is limited to about 32, and the number of cable contacts is limited to about 12.

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

[0016] To date, only cochlear devices can be characterized by a relatively large number of leads. This is because cochlear devices do not use a head and cable connectors to connect the leads to the stimulator, and are therefore not limited by connector interfaces.

[0017] Furthermore, current head technology does not completely isolate the head contacts from each other (for example, due to moisture buildup between the contacts).

[0018] After long-term implantation, the isolation between contacts is limited to several 100 kΩ.

[0019] Furthermore, due to anatomical constraints, IPGs are typically implanted quite far from the lead electrodes, requiring long lead cables for connection.

[0020] This separation compromises reliability, especially the reliability of weak neural sensing signals.

[0021] Therefore, there is still room for further improvement. Summary of the Invention

[0022] In view of the foregoing, the object of the present invention is to provide an improved neuromodulation system that has enhanced functionality and can be easily and reliably adapted to treat various types of pathologies.

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

[0024] According to the present invention, the neural modulation system comprises: At least one implantable unit, and At least one organizational interface module, The at least one tissue interface module comprises a wire, the wire comprising at least one electrode array having at least one electrode and an electrode circuit. The system includes a connection module configured and arranged to form a universal tissue interface module-implantation unit interface. The at least one of the organization interface modules is at least partially configured and arranged to define the functionality of the system.

[0025] This invention provides a neural modulation system.

[0026] The system contains at least one implantable unit.

[0027] For example, the system may contain a single implantable unit.

[0028] Alternatively, the system may comprise multiple implantable units.

[0029] The system further includes at least one organization interface module.

[0030] For example, the system may contain a single organizational interface module.

[0031] Alternatively, the system may include multiple organizational interface modules.

[0032] Here, the organizational interface modules can be of the same type or different types.

[0033] By providing different types of organizational interface modules, additional system functions can be selected and / or added and / or enabled.

[0034] As an example, the combination of deep (subcortical) tissue interface modules and cortical tissue interface modules can be used for adaptive epilepsy therapy.

[0035] At least one organizational interface module contains wires.

[0036] The wire comprises at least one electrode array having at least one electrode.

[0037] The tissue interface module further includes electrode circuitry.

[0038] The system further includes a connection module.

[0039] The connection module is configured and arranged to form a universal tissue interface module-implantation unit interface.

[0040] At least one organizational interface module is configured and arranged to at least partially define the functionality of the system.

[0041] Preferably, the electrode circuit is arranged near one or more electrodes.

[0042] The electrode circuit is configured and adapted to process at least some electrode signals, such as demultiplexing of stimulation signals, modulation of sensing signals, etc.

[0043] This invention is based on the following fundamental idea: by providing a universal tissue interface module-implantation unit interface, wherein the tissue interface module is particularly provided with electrode circuitry, the system's functionality can be distributed between the implantable unit and at least one tissue interface module. Specifically, a portion of the system's intelligence can be transferred from the implantable unit to the tissue interface module, thereby forming an improved integrated system. Furthermore, by relying on a universal (rather than treatment-specific) tissue interface module-implantation unit interface, the system can be easily adapted to different therapeutic applications.

[0044] A key advantage of tissue interface modules equipped with active electronics is the limited distance to the actual tissue contact points (i.e., electrodes). This means that sensing, signal amplification, and analog-to-digital conversion are performed very close to the target tissue, eliminating the need for long cables and thus avoiding signal (high-frequency) content loss or interference.

[0045] In addition to analog-to-digital conversion, neural data or other physiological data can be analyzed locally for biomarkers, threshold detection, etc. This avoids unnecessary communication of large datasets between the tissue interface module and the implanted unit (e.g., data rate, bandwidth, integrity, power requirements).

[0046] According to the present invention, different therapeutic applications are addressed through specific combinations between an implantable unit and one or more tissue interface modules, said combinations defining system functionality.

[0047] In other words, specific functions can be obtained by connecting at least one implantable unit to at least one tissue interface module.

[0048] At least one implantable unit has a common hardware and software configuration.

[0049] In other words, for a specific therapeutic application, no significant hardware and / or software changes are required for at least one implantable unit.

[0050] In contrast, only the stimulation parameters need to be adjusted.

[0051] For certain clinical applications, marginal adjustments to the hardware and / or software may be necessary. Factors to consider here may include, for example, deep brain and nerve / muscle stimulation, such as a stimulation frequency of 100 Hz for the brain versus a stimulation frequency of ≥ 1 kHz for the auditory nerve.

[0052] On the other hand, the tissue interface module is specific to each therapeutic application.

[0053] Conveniently, at least one tissue interface module may be or include at least one electrode for electrical stimulation and / or sensing, said at least one electrode comprising graphene, preferably hydrothermally reduced graphene oxide.

[0054] Graphene's discriminative properties provide lower impedance and higher charge density, thereby reducing power consumption and simplifying chip design, enabling miniaturization of electronic devices (and thus entire systems).

[0055] However, different solutions are also possible according to the present invention.

[0056] At least one tissue interface module may contain a transistor comprising graphene and / or engineered graphene for use in a neural interface.

[0057] Alternatively, at least one tissue interface module may contain an ultrasound stimulator.

[0058] Alternatively, at least one tissue interface module may contain an optical stimulator.

[0059] Additional advantageous components of at least one tissue interface module may include one or more of the following: 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 an EMG and / or a motion sensor and / or an IMU and / or a position sensor.

[0060] Therefore, the optimization settings of the organization interface module can be limited as needed.

[0061] Conveniently, the system may further include at least one communication module.

[0062] At least one communication module contains a communication line.

[0063] The communication module is configured and arranged to transmit information, particularly digital signals and / or analog signals and / or synchronization signals.

[0064] Conveniently, the system may further include at least one power supply module.

[0065] At least one power supply module includes power lines to provide and / or transmit power and / or synchronization signals from the implanted unit to at least one tissue interface module and / or vice versa.

[0066] Alternatively, the power line may be configured to provide and / or transmit power and / or synchronization signals, or to provide and / or transmit power and / or synchronization signals from the first organization interface module to the second organization interface module and / or vice versa.

[0067] For safety reasons, power transfer between different components of the system (e.g., between the implanted unit and the tissue interface module, or between different tissue interface modules) must be AC ​​and cannot carry DC or have DC offset.

[0068] Specifically, any DC leakage current can lead to adverse effects on patients, failure modes of electronic devices / cables such as electromigration or corrosion, and may easily result in regulatory violations.

[0069] According to ISO 14708-1:214 Surgical implants—Active implantable medical devices—Clause 16:2, the implantable device of an active implantable medical device shall be electrically neutral upon contact with the body. The DC current density at any conductive surface or electrode surface shall be ≤ 0.75 µA / mm². 2 .

[0070] Therefore, at least one power supply module can be configured and arranged for AC power transmission.

[0071] AC signals are defined by several characteristics such as current, voltage, amplitude, shape, and / or frequency.

[0072] Depending on the system and design priorities, trade-offs need to be made around all these characteristics.

[0073] Compared to, for example, sine waves, square waves can be generated more easily and efficiently (an advantage of electronic design), but they have higher crosstalk with adjacent wires.

[0074] Choose the signal properties, amplitude, and / or frequency based on the amount of energy to be transmitted.

[0075] A higher voltage generated in a central location (e.g., boosted from battery voltage) may be advantageous for powering a series of simple organizational interface modules with boost electronics in only one location.

[0076] The disadvantage of this method is the higher losses associated with the cable capacitance for each charge and discharge cycle, as well as the higher voltage.

[0077] Higher voltages can also cause electro-corrosion of unsealed parts of implanted systems exposed to bodily fluids.

[0078] A higher power supply frequency allows for smaller capacitors in the rectifier / power supply circuitry of the interface module.

[0079] Rectifier capacitors typically have a large value (µF) and a large physical size.

[0080] This hinders the miniaturization of interface module electronics. Specifically, it may lead to the need to use discrete components instead of a complete semiconductor design.

[0081] Variable frequency can be used when the power requirements of the organization interface module change over time.

[0082] For low power demands, the frequency can be lower, and as power demands increase, the system can increase the supply frequency accordingly. Voltage ripple on the capacitors can be controlled in this way. Lower frequencies will reduce capacitive cable losses, thereby improving overall power efficiency, for example, during idle periods.

[0083] For example, this approach can be employed in the context of a sensing system that senses signals in a burst-like manner. During an active burst, such as when a neural signal is sensed by the tissue interface module, the tissue interface module consumes a lot of power (due to active amplifiers, AD converters, etc.) and the power supply frequency increases. Then, after the sensing burst is complete, the power supply frequency decreases again, and the tissue interface module returns to an idle state.

[0084] The system may further include at least one transmission module.

[0085] At least one transmission module includes at least one power supply module.

[0086] At least one transmission module further includes at least one communication module.

[0087] Conveniently, communication lines can be configured and arranged to modulate encoded information.

[0088] Conveniently, modulation can include digital modulation, analog modulation, and / or continuous wave modulation.

[0089] All information in electronic communications should be encoded.

[0090] Based on requirements, available bandwidth, available power, amount of data to be transmitted, reliability, etc., select the preferred / optimal modulation option from the following, for example: - 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.

[0091] All of the above modulation options describe how to encode information (i.e., bits) into specific signals that are transmitted through a communication channel.

[0092] Modulated data streams occupy a portion of the communication channel bandwidth.

[0093] By using carriers and subcarriers, the communication bandwidth can be shifted to a specific frequency space available in the communication channel.

[0094] This allows multiple data streams to run in parallel on the same channel.

[0095] This requires the modulation and demodulation schemes to have parallel data streams.

[0096] Multichannel modulation also allows full-duplex communication between the implanted unit and the tissue interface module, and also allows simultaneous communication with a range of tissue interface modules.

[0097] Conveniently, the system can include multiple organizational interface modules.

[0098] In one configuration, each tissue interface module is individually and / or directly connected to the implantation unit via communication lines and / or power lines.

[0099] Specifically, multiple tissue interface modules and implantation units can form a star topology.

[0100] According to existing technology, star topology is commonly used in neural modulation systems.

[0101] Here, each tissue interface module is connected to the implantation unit.

[0102] Even when using some adapter cables, the electrical topology remains in a star configuration.

[0103] In an alternative configuration, each organization interface module can be connected to the central network communication and / or central network power supply lines via communication lines and / or power lines.

[0104] The connection points form the corresponding connection nodes.

[0105] The central network communication and / or central network power supply line is connected to the implanted unit.

[0106] Multiple tissue interface modules and implantation units form a linear or bus topology.

[0107] In another alternative configuration, the first tissue interface module can be connected to the implantation unit individually and / or directly via communication lines and / or power lines, and the second tissue interface module can be connected to the first tissue interface module at the connection node via communication lines and / or power lines.

[0108] Here, multiple tissue interface modules and implantation units form a linear or bus topology.

[0109] According to another alternative configuration, at least one of the multiple tissue interface modules is individually and / or directly connected to the implanted unit via communication lines and / or power lines.

[0110] Here, at least two organizational interface modules are connected to the central network communication and / or central network power supply lines via communication lines and / or power lines.

[0111] Connection points form connection nodes.

[0112] The central network communication and / or central network power supply line is connected to the implanted unit.

[0113] Here, multiple tissue interface modules and implantation units form a combination of star topology and linear or bus topology.

[0114] According to alternative configurations, the first tissue module among multiple tissue interface modules is individually and / or directly connected to the implantation unit via communication lines and / or power lines.

[0115] At least the second tissue interface module is connected at the connection node to the first tissue interface module, which is separately and / or directly connected to the implantation unit, via communication lines and / or power lines.

[0116] Here, multiple tissue interface modules and implantation units form a combination of star topology and linear or bus topology.

[0117] In a bus topology, power and communication lines are shared among organization interface modules. Each system module (organization interface module and / or embedded unit) has a unique address, and digital data commands include an address field that identifies its target module.

[0118] Other modules ignore the command.

[0119] Depending on the implantation site of the tissue interface module and the implantation unit, the bus topology can have major advantages.

[0120] Specifically, the bus topology can significantly reduce the amount of cable routing, connectors and connections, as well as the amount of tunnel organization, and can reduce excess cable length.

[0121] Compared to what could be achieved using IPG according to existing technology, the bus topology also allows for more organization of interface modules, with the number of head sockets limited to 4, and in practice limited to 2 (4 would result in a very large head).

[0122] In theory, using a bus topology, the number of interface modules that can be organized can be very large, and is only limited by system power consumption and data bandwidth.

[0123] Conveniently, at least one connection node can contain at least one active element.

[0124] Active components can include amplifiers.

[0125] Alternatively, the active element may include a repeater.

[0126] Alternatively, an active element may include a sensing element.

[0127] When organization interface modules are daisy-chained together, the default approach is to connect the power and communication lines to the organization interface module, move from there to the next organization interface module, and repeat the sequence.

[0128] In this way, a chain begins to be established.

[0129] By linking each node to the bus (communication bundle, power supply, and optional other connections / wires), each node becomes a bus load: it draws power and has a (capacitive) load on the communication channel.

[0130] The concepts of balanced and unbalanced wiring are the same.

[0131] This load will limit the maximum number of nodes.

[0132] At some point, the power supply reaches its maximum value.

[0133] Therefore, supporting a certain number of nodes is a design parameter that can be considered during the design phase.

[0134] For communications, the situation becomes even more complicated.

[0135] Many nodes can listen to messages and information on the communication bus simultaneously, but only one node can broadcast at any given time.

[0136] As the number of nodes increases, the available space on the communication line must be shared and becomes more strained (e.g., allocated time slots).

[0137] Other issues with communication buses include (capacitive) bus loads, crosstalk between bus cables, and noise picked up along the cable path.

[0138] This situation worsens as the number of nodes and cable length increase.

[0139] By adding active components at each node to the communication bus, noise pickup can be limited to the tracks between nodes rather than the entire bus.

[0140] This will significantly reduce noise levels and sensitivity to distortion of communication information (bit) signals.

[0141] The drawback of this solution is that it requires a power-consuming active buffer circuit.

[0142] However, this can be avoided by adding a switch that bypasses the buffer, allowing power consumption of idle or sleeping nodes to be disabled.

[0143] In other words, by closing the switch, the bus will revert to its original passive configuration.

[0144] For example, by having low-speed and high-speed communication modes, low speed can be used to wake up and configure the required nodes and activate their bus buffers (i.e., turn on the bypass switch). The bus speed can then be switched to high-speed mode to, for example, exchange large batches of data, after which the bus speed can be switched back to low-speed mode by closing the bypass switch and turning off the bus buffer.

[0145] Therefore, optimized settings can be obtained.

[0146] Conveniently, at least one implantable unit may contain at least one additional functional module.

[0147] Preferably, the functional module includes a pulse generator.

[0148] Alternatively, the functional module may include a sensor interface module.

[0149] Alternatively, the functional module may include a power interface module.

[0150] Alternatively, the functional module may include a communication interface module.

[0151] Alternatively, the functional module may include a charger power interface module.

[0152] In terms of technology, the number of nodes and their functional distribution can be unlimited, and are only limited by clinical constraints.

[0153] Therefore, a trade-off needs to be struck between the desired function (related to the selected therapy) and its clinical significance, and the options provided by allocating the function.

[0154] Conveniently, at least one communication module can include a Y-shaped connection module.

[0155] The Y-shaped connection module is configured to connect two organizational interface modules to each other.

[0156] Here, an extension cable with a Y-connector at the end is used. The cable is split into two (or more) connectors, allowing multiple wires to be connected.

[0157] Conveniently, at least one organizational interface module can include a socket.

[0158] The outlets are configured and arranged to accommodate common cables.

[0159] Here, the system further includes at least one universal cable and / or at least one universal Y-shaped splitter to connect the implanted unit to at least one tissue interface module.

[0160] The present invention also provides a system comprising a plurality of neuromodulation systems as described above.

[0161] Here, implanted units of multiple neuromodulation systems are operatively interconnected.

[0162] Neuromodulation systems are suitable for neuromodulation, especially neural stimulation, such as cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation and / or transcutaneous electrical stimulation. Attached Figure Description

[0163] Further details and advantages of the invention will now be disclosed in conjunction with the accompanying drawings, in which: Figure 1 Exemplary implantable components for implantable neuromodulation systems according to the prior art are shown. Specifically, implantable pulse generators (IPGs) and various types of implantable leads are demonstrated; Figure 2 This is a diagram illustrating a neuromodulation system according to an embodiment of the present invention. Here, an implantation unit, a first tissue interface module, and a second tissue interface module are exemplarily shown. Figure 3 This illustrates a neural modulation system (such as) according to the present invention. Figure 1 A diagram illustrating an exemplary configuration of a system. Here, the system includes a single implantation unit and four tissue interface modules; Figure 4 It shows the use of Figure 1 A diagram showing details of the implantable unit and tissue interface module in the system, which are operatively connected to each other to form a tissue interface module-implantable unit interface. Figure 5 It is similar to Figure 4 The view shows an exemplary configuration in which the implantation unit and tissue interface module are interconnected via power lines and (digital) data communication lines; Figure 6 It is similar to Figure 5 The view is a view of the view, but a simulated connection is also established between the implanted unit and the tissue interface module; Figure 7 AI is a diagram illustrating additional exemplary power and communication connections between the implanted unit and the tissue interface module; Figure 8 AB is shown Figure 1 A diagram showing the different modulation options for communication information in the system; Figure 9 AC is shown Figure 1 A diagram showing the different topology options for the system. Details are as follows: A. Star topology; B. Bus topology; C. Combined topology; Figure 10 This illustrates a neural modulation system (such as) according to the present invention. Figure 1This is another exemplary configuration diagram of the system. Here, in addition to the implantation unit and tissue interface module, the system includes other interface modules, such as a power interface module and a communication interface module; Figure 11 It shows Figure 1 A diagram of the system's multipoint communication options; Figure 12 AD is shown Figure 1 A diagram showing the different exemplary connectors and body distributions of the system; Figure 13 AD is an indicator for updating / upgrading. Figure 1 A diagram of different methods for the system. Detailed Implementation

[0164] Figure 2-3 A corresponding configuration of the neural stimulation system 100 according to the present invention is shown schematically.

[0165] As a non-limiting example, system 100 can be used to deliver cortical and / or deep brain stimulation, epidural electrical stimulation, subdural electrical stimulation and / or transcutaneous electrical stimulation.

[0166] However, other therapeutic applications are also possible according to the present invention.

[0167] In this embodiment of the invention, system 100 is implantable.

[0168] The system 100 shown may be non-implantable.

[0169] The system 100 includes at least one implantable unit 10.

[0170] For the sake of brevity, the implantable unit 10 is abbreviated as "ICU" (Implantable Control Unit) in the accompanying drawings.

[0171] exist Figure 2-3 In the configuration, system 100 includes a single implantation unit 10.

[0172] However, it is also possible to provide multiple implantation units 10.

[0173] System 100 further includes at least one organization interface module 12.

[0174] For the sake of brevity, the organization interface module 12 is abbreviated as "TIM" (Organization Interface Module) in the accompanying drawings.

[0175] At least one organizational interface module 12 includes wires 14.

[0176] The conductor 14 includes at least one electrode array having at least one electrode 16, 18, 20, 22.

[0177] The wire 14 further includes electrode circuit 24.

[0178] The system may contain a single organization interface module 12.

[0179] Preferably, the system 100 includes multiple organizational interface modules 12.

[0180] Multiple organizational interface modules 12 can be of the same type.

[0181] Alternatively, the plurality of organizational interface modules 12 may include different types of organizational interface modules 12, such as Figure 3 As shown.

[0182] Specifically, in Figure 3 In the configuration, the system 100 includes a single implantable unit 10 and four different tissue interface modules 12, each tissue interface module 12 having a specific function suitable for different areas in the body.

[0183] The implant unit 10 is universal, meaning that no hardware and / or software changes are required for specific therapeutic applications. Instead, only the stimulation parameters need to be adjusted.

[0184] By providing different types of organizational interface modules 12 ( Figure 3 You can choose to add and / or enable additional system functions.

[0185] For example, the deep (subcortical) tissue interface module 12 can be combined with the cortical tissue interface module 12 for adaptive epilepsy therapy.

[0186] System 100 further includes a connection module 26, which is configured and arranged to form a universal tissue interface module 12-implantation unit 10 interface.

[0187] At least one organizational interface module 12 is configured and arranged to at least partially define the functionality of system 100.

[0188] A key advantage of the tissue interface module 12 equipped with active electronics is the limited distance to the actual tissue contact point: the electrodes.

[0189] This means that sensing, signal amplification, and analog-to-digital conversion are performed very close to the target tissue, eliminating the need for long cables and thus avoiding loss or interference of signal (high-frequency) content.

[0190] In addition to analog-to-digital conversion, it can also analyze neural / other physiological data locally for biomarker, threshold detection, etc., thereby avoiding unnecessary communication of large datasets (data rate, bandwidth, integrity, power requirements) between the tissue interface module 12 and the implantation unit 10.

[0191] Figure 4 An exemplary tissue interface connection 12-implantation unit 10 interface (established via connection unit 26) is illustrated.

[0192] Each system module in the system module, such as implantation unit 10 and tissue interface module 12, has only partial functionality and cannot function independently of other modules.

[0193] Compared to existing technology solutions, the connections between modules require different interfaces. Specifically, power and data need to be exchanged between modules such as the implantation unit 10 and the tissue interface module 12.

[0194] In this embodiment of the invention, the system 100 further includes at least one communication module 28, the communication module 28 including a communication line CMOS.

[0195] At least one communication module 28 is configured and arranged for transmitting information, particularly digital signals and / or analog signals and / or synchronization signals CLK.

[0196] In this embodiment of the invention, the system 100 further includes at least one power supply module 30.

[0197] At least one power supply module 30 includes a power line PWR to provide and / or transmit power and / or synchronization signal CLK and / or vice versa from the implantation unit 10 to at least one tissue interface module 12, or to provide and / or transmit power and / or synchronization signal CLK and / or vice versa from the first tissue interface module 12 to the second tissue interface module 12.

[0198] In this embodiment of the invention, at least one power supply module 30 is configured and arranged for AC power transmission.

[0199] In this embodiment of the invention, system 100 includes at least one transmission module, which includes at least one power supply module 30 and a communication module 28.

[0200] Communication lines (CMOS) can be configured and arranged to modulate encoded information.

[0201] Specifically, modulation can include digital modulation, analog modulation, and / or continuous wave modulation.

[0202] Figure 5 An exemplary configuration is shown, in which the implantation unit 10 and the tissue interface module 12 are interconnected via a power supply module 30, which includes a power line PWR and a communication line CMOS, such as a digital data communication line CMOS.

[0203] Optionally, a simulated connection (such as) can also be provided. Figure 6 (As shown).

[0204] Figure 5-6 The example illustrates a configuration in which the implanted unit 10 provides power (e.g., via a power source) to the tissue interface module 12.

[0205] However, according to the present invention, different configurations are also possible, such as: - Tissue interface module 12 that powers the implantation unit 10; - The implantation unit 10 and the tissue interface module 12 each have their own power supply (here, no power supply is required between the implantation unit 10 and the interface module 12). - Organization interface module 12 that supplies power to other organization interface modules 12; - any combination thereof; and - Provide an external, non-implantable power source to power the implantation unit 10 and the tissue interface module 12.

[0206] Advantageously, at least one tissue interface module 12 may be or include at least one electrode for electrical stimulation and / or sensing, said at least one electrode comprising graphene, preferably hydrothermally reduced graphene oxide (see Figure 3 Electrode 18 in the middle).

[0207] Furthermore, the tissue interface module 12 may include a transistor containing graphene and / or engineered graphene for use in a neural interface (see [link]). Figure 3 Component 20 in the middle).

[0208] The tissue interface module 12, which is not shown, may include an ultrasound stimulator and / or an optical stimulator.

[0209] Additional components may also be implemented in the tissue interface module 12, including but not limited to one or more of the following: temperature sensor and / or blood pressure sensor and / or heart rate sensor and / or heart rate variability sensor and / or oxygenation sensor and / or pH sensor and / or hydration sensor and / or impedance sensor and / or glucose or metabolite sensor and / or ECG and / or EEG and / or EMG and / or motion sensor and / or IMU and / or position sensor.

[0210] In System 100, various wiring topologies can be used to transmit power and communication data, such as Figure 7 As shown by AI.

[0211] The topology can be balanced or unbalanced.

[0212] Unbalanced topology (see example) Figure 7 A) has the advantage of using fewer wires, which simplifies the physical interconnection and mechanical components.

[0213] On the other hand, balanced topology (see example) Figure 7 B) It is more electrically reliable (e.g., no ground bounce, less interference from other wires, etc.).

[0214] Depending on the overall system implementation plan and the design choices made, any option can be selected.

[0215] exist Figure 7 In the unbalanced option shown in A, a ground connection GND is provided as a voltage reference between the implantation unit 10 and the tissue interface module 12, providing a current return path.

[0216] exist Figure 7 In the unbalanced option shown in B, a reference connection can be provided (although it is not strictly required).

[0217] This allows for convenient electrical connection of the module voltage reference level.

[0218] This can be done with a single wire (see...) Figure 7 This can be accomplished using reference links in B.

[0219] Alternatively, although this imposes higher constraints on electrical design, the reference circuit can be omitted. Figure 7 E), thereby saving the connection between the implantation unit 10 and the tissue interface module 12.

[0220] Although some constraints remain, the intermediate option is to rely on conductive tissues and / or body fluids to provide a reference connection. Figure 7 F).

[0221] In this case, an implantable component and at least one electrode (e.g., embedded in one or more tissue interface modules 12) must be provided to contact body tissue or fluids.

[0222] In addition to electricity and communication, analog signals also need to be transmitted.

[0223] For this purpose, a simulated connection can be provided between the implantation unit 10 and the tissue interface module 12, such as Figure 7 CD shown.

[0224] Depending on the number of analog signals, an analog connection can be established using one or more wires (for simplicity, a single wire is shown in...). Figure 7 CD).

[0225] As described, a power supply module 30 including a power line PWR can be used to transmit power from the implantation unit 10 to the tissue interface module 12.

[0226] For safety reasons, this power transmission must be AC ​​and cannot carry DC or have DC offset.

[0227] In fact, DC leakage current can have adverse effects on patients, cause failure modes of electronic devices / cables (e.g., electromigration or corrosion), and may easily lead to violations of regulatory constraints.

[0228] The AC frequency can also be used to provide a clock signal to the organization interface module 12.

[0229] Figure 7 AF indicates the power combined with the clock signal CLK.

[0230] The clock signal CLK can be used for internal processing (synchronization) in the organization interface module 12.

[0231] It is also used as a synchronization mechanism for communication lines (CMOS, digital data stream) and analog signals (e.g., stimulus pulses, data sensing, multiplexer switching, etc.).

[0232] Alternatively, clock and communication signals can be combined, such as Figure 7 As shown in G, for example, Manchester encoding is used to embed clock-timed communication data into the data stream.

[0233] In this case, the communication signaling includes its own clock, independent of the AC power signal.

[0234] Ultimately, power, clock, and communication signals can be combined on a single electrical channel. Figure 7 H), thereby minimizing the number of wires / connections.

[0235] This method creates an interdependence between the amount of information and the electrical force being transmitted, and also produces a unidirectional default communication direction, i.e., from the implanted unit 10 to the tissue interface module 12, because this is related to the direction of the delivered power.

[0236] However, there are several possible ways to send return information on the same electrical channel, such as: A brief interruption of power transmission is used to create a 'time gap' during which the tissue interface module 12 can drive the circuitry and return information to the implanted unit 10. The amount of information is limited to the period during which 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 even when no power is supplied; - Using backscattering. By modulating the power load through the tissue interface module 12, the implanted unit 10 can export data from the power line PWR and read the response. Although the amount of data that can be sent back is still quite limited, the current option still offers more opportunities compared to the previous one; - Multi-band frequency modulation.

[0237] exist Figure 7 In section I, two communication channels (represented as COMS-1 and COMS-2 in the diagram) are used to generate the interconnection.

[0238] First Channel and Figure 7 The channel shown in H is the same.

[0239] Electricity is transmitted, and information is also transmitted through a suitable pulse modulation scheme (e.g., by using Manchester encoding).

[0240] The second channel can only be used for communication and can be used in both directions.

[0241] This allows large amounts of data to be sent in both directions.

[0242] If the tissue interface module 12 is a sensor, such as including electrodes with sensing mechanisms for electrophysiological signals, this second channel can be used. Figure 7 The COMS-2'' in I sends information to the implanted unit 10 for processing.

[0243] When multiple organizational interface modules 12 are combined in a system 100 characterized by different communication requirements, they can be combined. Figure 7 The options shown in HI.

[0244] For organization interface module 12 with limited communication needs (e.g., configuration only), it can be used Figure 7 The option shown in H disables or disconnects the second communication line CMOS.

[0245] On the other hand, a tissue interface module 12, which provides a large amount of information to the implantation unit 10, such as a sensor or tissue interface module 12 implemented with an analog-to-digital converter, is used to connect to a second dedicated communication channel to send dense information to the implantation unit 10.

[0246] In principle, among these options, the definition of the optimal configuration largely depends on the requirements of the entire system.

[0247] Offering a greater number of wires and / or interconnects provides greater design flexibility and more freedom in communication protocols / speeds.

[0248] On the other hand, fewer wires mean less mechanical hardware and fewer system constraints (e.g., feedthroughs, connectors, and / or cable thickness / flexibility).

[0249] In other words, a trade-off needs to be established based on system requirements.

[0250] AC signals are defined by several characteristics such as current, voltage, amplitude, shape, and frequency.

[0251] Depending on the system and design priorities, trade-offs need to be defined around all these characteristics.

[0252] Compared to, for example, sine waves, square waves can be generated more easily and efficiently (an advantage of electronic design), but they have higher crosstalk with adjacent wires.

[0253] Choose the signal properties, amplitude, and frequency based on the amount of energy to be transmitted.

[0254] A higher voltage generated at a central location (e.g., boosted from battery voltage) could be advantageous for powering a series of simple organizational interface modules 12 with boost electronics in only one location.

[0255] The disadvantage of this method is the higher losses associated with the cable capacitance for each charge and discharge cycle, as well as the higher voltage.

[0256] Higher voltages can also cause electro-corrosion of unsealed parts of implantable systems 100 that are exposed to bodily fluids.

[0257] The higher power supply frequency allows for smaller capacitors in the rectifier / power supply circuit of the interface module 12.

[0258] Rectifier capacitors typically have a large value (µF) and a large physical size.

[0259] This hinders the miniaturization of the electronic components in the organization interface module 12 and necessitates reliance on discrete components rather than a complete semiconductor design.

[0260] A variable frequency can be used when the power supply requirements of the organization interface module 12 change over time.

[0261] For low power requirements, the frequency can be lower, and as power requirements increase, the system 100 can increase the supply frequency. Voltage ripple on the capacitors can be controlled in this way. Lower frequencies will reduce capacitive cable losses, thereby improving overall power efficiency, for example, during idle periods.

[0262] For example, this method can be implemented in a sensing system where sensing occurs in a burst manner. During an active burst, such as when a neural signal is sensed by the tissue interface module 12, the tissue interface module 12 consumes high power (e.g., due to active amplifiers, AD converters, etc.) and the power supply frequency increases. Then, after the sensing burst is complete, the power supply frequency decreases again, and the tissue interface module 12 returns to an idle state.

[0263] In System 100, all information in electronic communications should be encoded.

[0264] Conveniently, the information can be modulated on the CMOS of the communication line.

[0265] Depending on requirements, available bandwidth, available power, amount of data to be transmitted, reliability, etc., the preferred / optimal modulation option can be selected from the following, for example: - 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.

[0266] These modulation schemes all describe how information (i.e., bits) is encoded into specific signals that are transmitted through a communication channel.

[0267] Modulated data streams occupy a portion of the communication channel bandwidth.

[0268] By using carriers and subcarriers, the communication bandwidth can be shifted to a specific frequency space available in the communication channel.

[0269] This allows multiple data streams to run in parallel on the same channel.

[0270] This requires modulation and demodulation schemes to enable parallel streaming.

[0271] Multichannel modulation also allows, for example, full-duplex communication between implantation unit 10 and tissue interface module 12, and also allows simultaneous communication with a series of tissue interface modules 12.

[0272] Figure 8 A shows a single communication flow in the channel.

[0273] For example, this could be simple communication using a single coded pulse stream (half-duplex).

[0274] On the other hand, in such Figure 8 In the case shown in B, where there are multiple carrier frequencies, multiple channels can be assigned to each organization interface module 12, for example: ch1 is assigned to the first organization interface module (TIM1), ch2 is assigned to the first organization interface module (TIM1), ch3 is assigned to the second organization interface module (TIM2), ch4 is assigned to the second organization interface module (TIM2), etc.

[0275] In this embodiment of the invention, system 100 includes multiple organizational interface modules 12, such as... Figure 2-3 As shown.

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

[0277] In this configuration, multiple tissue interface modules 12 and implantation units 10 form a star topology ( Figure 9 A).

[0278] According to existing technology, star topology is commonly used in neural modulation systems.

[0279] Here, each tissue interface module 12 is connected to the implantation unit 10, such as Figure 9 As shown in Figure A.

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

[0281] In another configuration, each organization interface module 12 is connected to the central network communication and / or central network power supply lines via communication lines COMS and / or power lines PWR, with the connection points forming connection nodes.

[0282] The central network communication and / or central network power supply line is connected to the implant unit 10.

[0283] Here, multiple tissue interface modules 12 and implantation units 10 form a linear or bus topology.

[0284] In yet another configuration, the first tissue interface module 12 is connected to the implantation unit 10 individually and / or directly via communication line COMS and / or power line PWR, and the second tissue interface module 12 is connected to the first tissue interface module 12 at the connection node via communication line COMS and / or power line PWR.

[0285] Here, multiple tissue interface modules 12 and implantation units 10 form a linear or bus topology. Figure 9 B).

[0286] In another configuration, at least one tissue interface module 12 is individually and / or directly connected to the implantation unit 10 via a communication line COMS and / or a power line PWR, and at least two tissue interface modules 12 are connected to the central network communication and / or the central network power supply line via a communication line COMS and / or a power line PWR, with the connection points forming a connection node.

[0287] The central network communication and / or central network power supply line is connected to the implant unit 10.

[0288] Here, multiple tissue interface modules 12 and implantation units 10 form a combination of star topology and linear or bus topology.

[0289] In yet another configuration, the first tissue module 12 is connected to the implantation unit 10 individually and / or directly via a communication line COMS and / or a power line PWR, and at least the second tissue interface module 12 is connected at a connection node to the first tissue interface module 12, which is individually and / or directly connected to the implantation unit 10.

[0290] Here, multiple tissue interface modules 12 and implantation units 10 form a combination of star topology and linear or bus topology ( Figure 9 C).

[0291] In the bus topology, power and communication lines (CMOS) are shared among the organization interface modules 12. Each system module (organization interface module 12 and / or implanted unit 10) has a unique address, and digital data commands include an address field that identifies its target module.

[0292] Other modules ignore the command.

[0293] Depending on the implantation site of the tissue interface module 12 and the implantation unit 10, the bus topology may have major advantages.

[0294] Specifically, the bus topology can significantly reduce the amount of cable routing, connectors and connections, as well as the amount of tunnel organization, and it can reduce excess cable length.

[0295] Compared to what could be achieved using a neuromodulation system according to the prior art, the bus topology also allows for more tissue interface modules 12, where the number of head sockets is limited to four, and in practice limited to two (four would result in a very large head).

[0296] In theory, using a bus topology, the number of interface modules 12 can be large and is limited only by system power consumption and data bandwidth.

[0297] Conveniently, in embodiments of the present invention, at least one connection node may include at least one active element.

[0298] Preferably, the active element comprises one or more of an amplifier, a buffer, a repeater, and / or a detection element.

[0299] In an embodiment of the present invention, at least one implantation unit 10 ( Figure 2-3 The configuration shown indicates that a single implantable unit 10 may contain at least one additional functional module.

[0300] Preferably, the functional module may include one or more of the following: a pulse generator, a sensor interface module, a power interface module, a communication interface module, and a charger power interface module.

[0301] A non-restrictive configuration including such functional modules is shown in Figure 10 middle.

[0302] Here, a power interface module and a communication interface module are provided that are directly or indirectly connected to the implantation unit 10.

[0303] However, according to the present invention, different configurations including functional modules are also possible.

[0304] In terms of technology, the number of nodes and their functional distribution may be unlimited, limited only by clinical constraints.

[0305] Therefore, a trade-off needs to be struck between the desired function (related to the selected therapy) and its clinical significance, and the options provided by allocating the function.

[0306] When the organization interface modules 12 are daisy-chained together, the default method is to connect the power line PWR and the communication line CMOS to one organization interface module 12, and then move from there to the next organization interface module 12, repeating the sequence.

[0307] In this way, a chain begins to be established (see example). Figure 9 B, bus topology).

[0308] By linking each node to the bus (communication bundle, power supply, and optional other connections / wires), each node becomes a bus load: it draws power and has a (capacitive) load on the communication channel (see...). Figure 11 A and 11C).

[0309] The concepts of balanced and unbalanced wiring are the same.

[0310] This load limit restricts the maximum number of nodes.

[0311] At some point, the power supply reaches its maximum value.

[0312] Therefore, supporting a certain number of nodes is a design parameter that can be considered during the design phase.

[0313] For communications, the situation becomes even more complicated.

[0314] Many nodes can listen to messages and information on the communication bus simultaneously, but only one node can broadcast at any given time.

[0315] As the number of nodes increases, the available space on the communication line must be shared and becomes more strained (e.g., allocated time slots).

[0316] Other issues with communication buses include (capacitive) bus loads, crosstalk between bus cables, and noise picked up along the cable path.

[0317] This situation worsens as the number of nodes and cable length increase.

[0318] By adding active components (e.g., amplifiers, buffers, repeaters, detection elements, etc., see below) to the communication bus at each node. Figure 11 (B) Noise pickup can be limited to tracks between nodes rather than the entire bus.

[0319] This will significantly reduce noise levels and sensitivity to distortion of communication information (bit) signals.

[0320] The drawback of this solution is that it requires a power-consuming active buffer circuit.

[0321] Add a switch to bypass the buffer (see) Figure 11 D) Allow disabling the power consumption of such idle or hibernating nodes.

[0322] Close the switch to switch the bus back to its original passive configuration.

[0323] For example, by having low-speed and high-speed communication modes, low speed can be used to wake up and configure the required nodes and activate their bus buffers (i.e., turn on the bypass switch).

[0324] Then, the bus speed can be switched to high-speed mode to, for example, exchange large batches of data, and then the bus speed can be switched back to low-speed mode by closing the bypass switch and turning off the bus buffer.

[0325] In this way, an optimized solution can be obtained.

[0326] At least one communication module 28 may include a Y-shaped connection module configured to connect two organization interface modules 12 to each other.

[0327] Furthermore, in this embodiment of the invention, at least one organization interface module 12 may include a socket configured and arranged to accommodate a universal cable.

[0328] Here, system 100 further includes at least one universal cable and / or at least one universal Y-switch to connect implantation unit 10 to at least one tissue interface module 12.

[0329] In the prior art, IPGs typically have an integrated head with a socket for storing wires.

[0330] In other words, the IPG consists of a header and a body.

[0331] The main body houses the electronic components and optionally houses the battery and / or charging / communication coil.

[0332] The wire socket is placed in the head, typically using a stack of so-called ball-sealed connectors.

[0333] This head requires a considerable amount of space, making the entire IPG huge (commonly distributed at approximately 30% to 70%).

[0334] This interconnection option is shown in Figure 12 Option A ("Option 1").

[0335] By separating the main body from the head, an improved arrangement can be achieved, allowing the implanted unit 10 to be placed in locations that would otherwise be unsuitable and / or cause adverse effects such as skin corrosion.

[0336] This can be implemented in different ways.

[0337] Figure 12 Option B (“Option 2”) shows a configuration in which three connectors are connected to the implant unit body using cables that connect to the implant unit electronics.

[0338] Figure 12 Option C (“Option 3”) shows an alternative configuration in which a single Y-shaped cable is used, away from the implantation unit body.

[0339] This can have clinical and manufacturing benefits.

[0340] By conceptually separating the head from the implanted unit body, the head becomes a socket box. Figure 12 D, "Option 4").

[0341] The main body is then placed in one location, and the socket box is placed in another location, with the two connected electrically via a cable.

[0342] It is possible that at some point, another organizational interface module 12 should be added to system 100.

[0343] As an example Figure 13 A illustrates a configuration in which system 100 includes an implantation unit 10 having a 3-socket head box and 3 tissue interface modules 12.

[0344] If at some point it is desired to add another tissue interface module 12, this will require replacing implant unit 10 with another implant unit having four outputs in the head box, thus including additional sockets for the new tissue interface module 12 to be incorporated.

[0345] However, this solution is suboptimal, especially due to the risks associated with the removal of the implanted unit 10, which requires invasive surgical intervention for the patient.

[0346] Therefore, it may be preferable to add an additional tissue interface module 12 while keeping the implanted unit 10 in place (i.e., without requiring removal).

[0347] Figure 13 B shows an example where one of the organization interface modules 12 (represented as "TIM3" in the figure) is disconnected from the corresponding connection (represented as "Con3" in the figure).

[0348] Insert the extended Y-shaped cable into the previously used connection (Con3).

[0349] The existing interface module (TIM3) now inserts a new connection (represented as "Con4" in the diagram).

[0350] Additional connectivity (represented as "Con5" in the diagram) is provided for connecting to another organization interface module (represented as "TIM4" in the diagram).

[0351] Based on the software / firmware of the implantation unit 10, the new tissue interface module (TIM4) can be directly identified (bus query), initialized, and integrated into the system 100.

[0352] The functionality of the new tissue interface module can be configured using programming tools, such as the clinician programmer (not shown) provided in System 100.

[0353] If the existing software / firmware of implantation unit 10 does not support the new tissue interface module (TIM4, in the illustrated example), implantation unit 10 can be upgraded via software / firmware update.

[0354] After the update / upgrade, the new / upgraded features become available and usable.

[0355] Thus, the clinical impact is greatly reduced compared to a solution that requires replacing implant unit 10.

[0356] Furthermore, incorporating the new organizational interface module 12 into the (existing) system 100 becomes relatively simple.

[0357] pass Figure 13 The alternative solution shown in c can achieve further simplification.

[0358] Here, the interface module 12 is equipped with a socket for storing universal cables. Figure 13 C) And no fixed cable was attached.

[0359] A set of universal cables and Y-splitters are used to establish all connections between the implantation unit 10 and the tissue interface module 12.

[0360] Another advantage is that cables of different lengths can be used, depending on the patient's physique and the implantation location.

[0361] In this context, when an upgrade is planned, disconnection no longer needs to be done near the head box (e.g., Figure 13 (as shown in B), but can be done in the existing interface module (TIM3, in Figure 13 (in the example shown in D) near.

[0362] This means that the new organization interface module 12 can be connected to the disconnected position of system 100.

[0363] System size is typically determined by the battery, wire connectors, and mechanical and material constraints that are determined by reliability.

[0364] This is due to the energy required for the therapeutic application, the number of wires in the wiring, and the volume occupied by the electronic components.

[0365] By using a higher level of circuit integration (ASIC technology), requiring less stimulation and sensing, and distributing functions across system units / modules, mechanical, material, size, and battery constraints can be relaxed.

[0366] The solution according to the present invention enhances the flexibility of the entire system.

[0367] Therefore, new system designs can be developed, including features that cannot be incorporated into system configurations based on existing technologies.

[0368] Constructing such a device can still utilize many STOA design methodologies and techniques. Aside from the use of graphene, no feasibility issues are anticipated. The fabrication and use of graphene have already been addressed in other INBRAIN patents and are no different for this ID.

[0369] A foreseeable obstacle is, for example, the lifespan of a chronically implanted device, but this is irrelevant to this ID (out of scope).

[0370] The present invention further provides a system 200.

[0371] System 200 contains multiple neuromodulation systems 100.

[0372] Here, implanted units of multiple neuromodulation systems 100 are operatively interconnected.

[0373] Based on the above disclosures, the following aspects have been clearly disclosed: Aspect 1: A neuromodulation system, particularly for cortical and / or deep brain stimulation and / or modulation in patients, said neuromodulation system comprising At least one implantable unit, the at least one implantable unit comprising: - A stimulation unit configured and arranged to provide therapeutic neuromodulation signals to the patient; - At least one signal transmitting unit, the at least one signal transmitting unit being configured and arranged to provide an informational signal, preferably a non-therapeutic signal, to the patient; and / or - At least one first recording system and / or sensing system, said at least one first recording system and / or sensing system being configured and arranged to collect and / or integrate signals from said patient.

[0374] Aspect 2: The neuromodulation system according to aspect 1, wherein the stimulation unit and the signal transmission unit are embodied in one unit, and wherein the therapeutic signal and the informational signal have the same or similar signal types.

[0375] Aspect 3: The neuromodulation system according to aspect 2, wherein the therapeutic signal and the informational signal are both electrical signals, and wherein the therapeutic signal and the informational signal differ, for example, in terms of stimulation rate, amplitude, voltage, current, frequency, slope, and duration.

[0376] Aspect 4: The neuromodulation system according to aspect 1, wherein the informative signal is a non-therapeutic signal and has a signal type different from that of the therapeutic signal.

[0377] Aspect 5: A neuromodulation system according to any of the preceding aspects, wherein the informative signals include information such as battery status, warning messages, feedback on delivered therapy, feedback on tuning status, and bringing the patient's consciousness into a closed loop.

[0378] Aspect 6: The neuromodulation system according to any of the preceding aspects, wherein the first recording system and / or sensing system is or includes at least one sensor, such as an accelerometer, a pressure sensor, a microphone, a voice recognition device, an EEG sensor or an EEG-like signal sensor, etc.

[0379] Aspect 7: A neuromodulation system according to any of the preceding aspects, wherein the system further includes a patient control module, wherein the patient control module is configured and arranged to provide information provided by the patient or user equipped with the system to the first recording system and / or sensing system.

[0380] Aspect 8: The neuromodulation system according to any one of the preceding aspects, wherein the patient control module is or includes a smartwatch, mobile phone, PC, tablet computer, etc.

[0381] Aspect 9: A neural modulation system according to any one of the foregoing aspects, wherein the system further comprises: -At least one first antenna; - At least one wire, the at least one wire having at least one electrode array, the at least one electrode array having at least one electrode; and - At least one wearable device, the at least one wearable device comprising at least one second antenna, wherein the at least one wearable device is configured to wirelessly control the at least one implanted unit and wirelessly communicate with the at least one implanted unit, wherein the at least one electrode is made of reduced graphene oxide, preferably hydrothermally reduced graphene oxide.

[0382] Aspect 10: The neuromodulation system according to one of the preceding aspects, wherein the implanted unit further comprises a pulse generator.

[0383] Aspect 11: A neuromodulation system according to one of the preceding aspects, wherein the implanted unit further comprises a second recording system and / or a sensing system to acquire signals, particularly neurophysiological signals.

[0384] Aspect 12: The neuromodulation system according to any one of the preceding aspects, wherein the wearable device is rechargeable.

[0385] Aspect 13: A neuromodulation system according to one of the foregoing aspects, wherein the wearable device is configured to wirelessly charge or power the at least one implanted unit.

[0386] Aspect 14: A neuromodulation system according to one of the preceding aspects, wherein the wearable device conforms to the shape of a human ear.

[0387] Aspect 15: A neuromodulation system according to any of the preceding aspects, wherein the wearable device has a personalized and / or customized shape to fit a particular human ear.

[0388] Aspect 16: A neuromodulation system according to any one of the preceding aspects, wherein the wearable device includes device software.

[0389] Aspect 17: A neuromodulation system according to one of the preceding 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.

[0390] Aspect 18: A neuromodulation system according to any of the preceding aspects, wherein the mobile device includes a software application configured to process data received from the wearable device and / or establish a network data link to the data base station.

[0391] Aspect 19: The neuromodulation system according to any one of the preceding aspects, wherein the implanted unit is wirelessly rechargeable.

[0392] Aspect 20: A neuromodulation system according to one of the preceding aspects, wherein the implantation unit is anatomically adapted to the implantation site and configured for skull implantation.

[0393] Aspect 21: Use of a neural modulation system according to any one of aspects 1 to 20.

[0394] Figure Labels 100 Neural Modulation System 200 system 10 implantation units 12 Organization Interface Modules 14 conductors 16 electrodes 18 electrodes 20 electrodes 22 electrodes 24-electrode circuit 26 connection modules 28 communication modules 30 power supply module 32 power interface module 34 Communication Interface Module COMS communication lines CLK signal PWR power lines GND ground connection

Claims

1. A neural modulation system (100) comprising: At least one implantable unit (10), and At least one organizational interface module (12). The at least one tissue interface module (12) therein includes a wire (14) which includes at least one electrode array having at least one electrode (16, 18, 20, 22) and an electrode circuit (24). The system (100) includes a connection module (26) configured and arranged to form a universal tissue interface module (12) - implantation unit (10) interface, and The at least one organization interface module (12) is at least partially 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 includes at least one electrode (18) for electrical stimulation and / or sensing, the at least one electrode (18) comprising graphene, preferably hydrothermally reduced graphene oxide.

3. The system (100) according to claim 1, characterized in that... The at least one tissue interface module (12) includes a transistor (20) containing graphene and / or engineered graphene for a 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 an EMG and / or a motion sensor and / or an IMU and / or a position sensor.

4. The system (100) according to any one of claims 1 to 3, characterized in that... The system (100) further includes at least one communication module (28), which includes a communication line (COMS), wherein the at least one communication module (28) is configured and arranged for transmitting information, particularly digital signals and / or analog signals and / or synchronization signals (CLK).

5. The system (100) according to any one of claims 1 to 4, characterized in that... The system (100) further includes at least one power supply module (30), wherein the at least one power supply module (30) includes a power supply line (PWR) to provide and / or transmit power and / or synchronization signal (CLK) and / or vice versa from the implanted unit (10) to the at least one tissue interface module (12), or to provide and / or transmit power and / or synchronization signal (CLK) and / or vice versa from the first tissue interface module (12) to the second tissue interface module (12).

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

7. The system (100) according to any one of claims 4 to 6, characterized in that... The system includes at least one transmission module, wherein the at least one transmission module includes at least one power supply module (30) and a 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 includes digital modulation, analog modulation, and / or continuous wave modulation.

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

10. The system (100) according to any one of claims 4 to 8, characterized in that... The system (100) includes multiple tissue interface modules (12), each of which is connected to a central network communication and / or central network power supply line via a communication line (COMS) and / or a power line (PWR), the connection points forming a connection node, the central network communication and / or central network power supply line being connected to the implantation unit (10), wherein the multiple tissue interface modules (12) and the implantation unit (10) form a linear or bus topology.

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

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

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

14. The system (100) according to claim 10 or claim 11, characterized in that... At least one connection node contains at least one active element. Preferably, the active element comprises one or more of an amplifier, a buffer, a repeater, and / or a detection element.

15. The system (100) according to any one of the preceding claims, characterized in that... At least one implantable unit (10) includes at least one additional functional module. Preferably, the additional functional module includes one or more of the following: 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 any one of claims 4 to 13, characterized in that... The at least one communication module (28) includes a Y-shaped connection module configured to connect two organization interface modules (12) to each other.

17. The system (100) according to any one of the preceding claims, characterized in that... The at least one tissue interface module (12) includes a receptacle configured and arranged to receive a universal cable, wherein the system (100) includes at least one universal cable and / or at least one universal Y-shaped splitter to connect the implanted unit (10) to the at least one tissue interface module (12).

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

Images