A system for stimulating the body according to its physical condition, and how it operates.

Abstract

The present invention relates to a system for body state-dependent stimulation by functional modules, for example an action module (2, D / A module) for stimulating tissues and an acquisition module (3, A / D module) for deriving / measuring biodata or biosignals, characterized in that the two modules communicate via a communication link (5) that meets stringent or at least robust real-time requirements. The communication link (5) preferably comprises a real-time capable bus, in particular an EtherCAT bus, to which the two modules are connected.

Description

Technical Field

[0001] The present invention relates to a system for stimulation according to a body state by real-time communication between an action module and a capture module. In this system, a signal derived from a living body is captured, and at the same time, living tissue is stimulated. The use of this method and assembly is mainly but not exclusively relevant to all medical fields in which biosignals are used for stimulation according to a body state.

Background Art

[0002] As described in WO2017099603(A1), there is a medical treatment method that uses focal neuromodulation technology, which requires determining the correct position on the cerebral cortex suitable for better treating psychological or neurological problems. This treatment can be performed by transcranial magnetic stimulation (TMS) while simultaneously measuring the heart rate. When a systematic change is observed in the form of a decrease in the heart rate (change in heart rate variability), that position is considered to have been found. The heart rate is displayed immediately in response to the repeated pulse sequence of repetitive TMS.

[0003] In order to detect this stimulus-response pattern, an immediate measurement is required that is properly correlated with the response to the stimulus and thus leads to a correct conclusion regarding the medically suitable position of the stimulus location.

[0004] However, the specification does not disclose how to technically implement an immediate response and / or rapid feedback.

[0005] Usually, the modules for action (stimulation by TMS) and capture (measurement of ECG) are connected to each other by a commercially available bus system. However, this cannot guarantee immediate communication, let alone real-time communication.

[0006] From a different perspective, as described in the journal “Elektronikpraxis” no.8, 16 / 04 / 2019, p.19, there are Ethernet transmitters that form a protective device by means of galvanic isolation, for example. [Overview of the project] [Problems that the invention aims to solve]

[0007] Based on known systems for stimulating according to physical condition, the object of the present invention is to provide a system that enables stimulating according to physical condition in a relatively reliable and safe manner.

[0008] This object of the present invention is achieved by the system according to claim 1. Preferred embodiments are described in the dependent claims. [Means for solving the problem]

[0009] Biodata is data generated by measuring biological parameters. Biosignals are also biodata, and in particular, are data streams of various continuous-time or discrete-time measurements that provide valuable information about the state of a tissue or organ. In this regard, such data or signals provide information about the function of organs within a living organism (e.g., ECG, EEG, EMG, EOG, ERG, PPT, respiration, MCG, MEG, BP, SpO2) that supports the measurement of the effects of previous (or quasi-simultaneous) stimuli on the body. Apart from appropriate signal processing, feature extraction, and targeted effects on the human body, the prerequisites for the quality of stimuli according to the state of the body (post-measurement) include artifact-free, interference-free stimuli, which is ensured by the system according to the present invention due to the real-time requirement (immediacy) for communication between the system's acquisition module and action module.

[0010] Depending on the need for treatment, biosignals are derived from a location on the body. This can be done not only from the head (EEG), but also from the body (e.g., EMG, ECG, BP, SpO2).

[0011] During a typical treatment, biosignals are continuously recorded before, during, and / or after the medical intervention by the same type of sensor as well as different types of sensors. The time gap here can range from immediate, i.e., within microseconds, to milliseconds, minutes, or even hours.

[0012] By amplifying the signals and preparing them for digital signal processing, for example, artifact-free signals and information related to therapeutic interventions can be obtained. Parameters here include, for example, the current band characteristics, amplitude, frequency, and / or phase of the electroencephalogram (EEG), individual alpha frequencies of the EEG, continuous systolic time (abbreviated as BP), effective values ​​of the EMG, the pattern of the photoplethysmographic signal, changes in blood oxygen saturation (SpO2), and further parameters that may be combinations thereof.

[0013] Sensors for acquiring / measuring biodata, biosignals, or signals derived from living organisms are preferably located within an acquisition module, also called an acquisition unit. In the advantageous design of the present invention, such a module, also called a functional module herein, is connected to a real-time bus, particularly EtherCAT (Registered trademark) The functional module may be designed to have an interface for connection to a bus. For this purpose, the functional module has an interface section, which includes an interface to an externally connectable device, a device integrated within the functional module, or a downstream part of the equipment. Furthermore, such a functional module has a connection and control section. Preferably, this connection and control section has a microcontroller as the control unit of the functional module and contacts designed to connect to the real-time bus of the device.

[0014] The signal processing or evaluation of biodata or biological signals may be performed already within the acquisition module, or only in the action module, or in a separate evaluation module, also called a signal processing module or master module, that communicates with the action module and acquisition module via a communication link.

[0015] The action module may include, for example, an actuator that can affect tissues and / or organs and / or the body as a whole. The action module may also only provide an interface to such actuators, in which case the actual actuators can be connected to the master module as external components.

[0016] Basically, living organs or tissues can be affected by, for example, electrical actuators, magnetic actuators, electromagnetic actuators, mechanical actuators, pneumatic actuators, and / or hydraulic actuators. Electric currents are introduced and / or applied to locations on the body by electrodes, magnetic fields from coils, mechanical forces from actuators, gases and / or liquids from hoses and / or pipes.

[0017] For stimuli tailored to the body's state, feedback is needed that allows biodata or biosignals to influence the way actuators are controlled, for example. For this purpose, an appropriate controller or control loop (closed loop if necessary) is recommended.

[0018] The following aspects may be considered here: Preferably, the actuator can respond quickly to information about the body's state (biodata or biosignals) for stimulation according to the body's state. Preferably, the actuator outputs only signals that are relevant to and / or desired to affect the human body / organs. Preferably, the stimulus signal levels exist as time-discrete and / or value-discrete digital signals, which, after conversion and amplification (adaptation), are outputs to actuators in the form of mechanical and / or electromagnetic energy. After conversion, the signal level for acquisition will be in the range of nanovolts to millivolts within a frequency band of, for example, zero to several kilohertz. • In the frequency band used (for example, for feature extraction from EEG), large interference signals may be generated by stimuli and the environment. According to the present invention, these interference signals can be taken into account and filtered as needed. For example, the signal source to be tested, which is of electrobiological origin, preferably has high resistance. For example, the physical properties of the stimulating electrode and the intake electrode change over time (e.g., due to changes in electrode transition impedance, electrode voltage, offset potential, contact pressure conditions, or motion artifacts).

[0019] There are known stimulation and signal acquisition systems that partially overcome these problems by carefully selecting methodologies for derivation and the respective techniques for amplification, evaluation, and stimulation. However, high-quality commercially available stimulation and polygraphy systems for simultaneous recording and evaluation of stimuli tailored to physical state and biosignals of different biological origins are very expensive and, in most cases, intended for stationary use only.

[0020] The following describes current methods using actuators and sensors as examples of stimulation tailored to the body's state, based on the acquisition of biological signals.

[0021] Currently, an electrical stimulator for cranial electrotherapy is implemented as a constant current source controlled by a microcontroller. This enables electrical stimulation using any desired form of current. To generate an analog electrical signal, the form of the current is provided in a digital manner by the program of the microcontroller. If there are insufficient scans and the dynamic range is too small, systematic errors may occur in the analog electrical signal for stimulation due to the necessary digital-to-analog conversion, and unwanted frequency lines may appear in the EEG spectrum.

[0022] Measuring EEG during electrical stimulation also poses high requirements for EEG induction technology and EEG derivation. Requirements for EEG measurement include, for example, · Avoiding amplifier saturation with sufficient amplitude resolution, · Avoiding power interference by using a battery-powered capture unit, · Avoiding the influence of capacitance where the outer skin layer interferes with the signal by carefully preparing the skin. These are mentioned.

[0023] In other applications, such as ECG measurement, the same requirements or some of these requirements may similarly apply.

[0024] Generally, these assemblies have at least one of the following drawbacks: · There is no real-time system for stimulation according to the physical state that can perform artifact correction and feature extraction simultaneously, so the processing is slow. · Instability with smaller, especially inconsistent delays for feedback control / regulation coupling applications. · Complexity when significant testing or adaptation is required after changes are made to the setup or operating system.

[0025] In one embodiment, the present invention provides a system for state-of-body stimulation having two functional modules, for example, an action module for stimulating tissue and an intake module for deriving / measuring biodata or biosignals, the two modules communicating via a communication link that satisfies stringent or at least robust real-time requirements.

[0026] The action module and the data acquisition module may have a processor for data processing, such as a central processing unit (CPU). In addition, they may be equipped with electronic data memory for data storage, such as flash memory or a solid-state disk (SSD).

[0027] Both modules can be combined into a single housing to form components of a single device. However, the action module and the intake module may also be intended to be formed separately and / or portable, for example, to facilitate connection to a patient.

[0028] Biodata or biological signals acquired by the acquisition module can be analyzed in more detail by an evaluation assembly. This evaluation assembly can be set up locally with the acquisition module, for example, as a component of the device, or remotely, for example, on a computer desk. The communication link between the acquisition module and the evaluation assembly can be wired via fiber optic cable or copper wire, or directly via a printed circuit of a properly integrated device, but can also be established wirelessly, for example, via one of the GPRS, 3G, 4G (LTE), 5G, or 6G standards, as long as it can meet the necessary time requirements, especially real-time requirements.

[0029] For example, data analysis and output in an integrated display device do not need to be more sophisticated than communication between the master module and the function module, especially when only measurement is required and no stimulus-responsive feedback modulation is needed. Therefore, in one design of the present invention, for example, data transmission with a latency of more than 100ms without real-time functionality is sufficient.

[0030] A suitable protocol for data transmission to an external evaluation unit could be, for example, TCP / IP for use with the Internet or Ethernet. When using the Internet for data transmission, patient-related data is preferably encrypted for transmission.

[0031] For telemedicine applications, the remote evaluation assembly allows, for example, experts in the evaluation of biodata or biosignals to evaluate real-time measurements remotely, i.e., away from the patient, without needing to be on-site during data acquisition from the patient. In this way, the present invention can be used more universally.

[0032] The evaluation assembly may be set up as, for example, a server having a CPU and data memory. Analysis of the measurement data transmitted by the acquisition module can be performed via software. However, the evaluation tool may reside in the cloud as a software-only component. The cloud is a computer network containing many data processor and data memory resources, controlled from a central location and scalable, meaning it can be made available for use as needed. This embodiment has the advantage of being able to collect and compare many different datasets (anonymized if necessary) from different patients.

[0033] The evaluation assembly may include machine learning software, i.e., neural networks and "deep learning" software, to identify patterns from data taken from a patient or a large number of patients (especially in cloud-based solutions). For example, such patterns may be related to characteristic waveforms in the electroencephalogram (EEG) as a result of stimulation by an action module when the EEG is taken up, i.e., currents induced by electrodes on the patient's scalp.

[0034] In other words, the system according to the present invention ensures that the real-time requirement (immediacy) for communication between modules of the system is met. The simultaneous acquisition of biodata and stimulation according to the physical state according to the present invention allows for more frequent and targeted stimulation of the human body. Furthermore, a control module, for example, can emit trigger pulses according to predetermined parameters.

[0035] The acquisition module must be able to rapidly and in real time free EEG signals from artifacts during electrical stimulation. For this purpose, techniques for acquiring signals with a high dynamic range (1 μV to 250 mV) are as important as expertise in the generation and interpretation of artifacts caused by electrical stimulation and how to avoid and / or eliminate them. In addition, information about the operation of the action module must be available, such as whether the action module can operate as expected or whether (indirect) communication from the action module to the acquisition unit exists. Such information flow between modules is also established via a real-time bus, so that some of the information from the action module is uploaded to the master module's data packets, which can then be downloaded to the acquisition module in follow-up packets, typically after 1 millisecond, in the preferred clocking according to the invention of the integrated stimulus and measurement system (MIS).

[0036] In a particularly preferred design of the present invention, data processing, artifact removal, and the like are performed within the master module. In this context, the functional module is used, for example, to take in data and transmit it to the master module, to control actuators according to commands from the master module, or to emit trigger signals to control external devices. In this way, for example, the real-time execution of commands from the master module can be improved because the functional module does not need to perform complex calculation steps.

[0037] Furthermore, a filtering algorithm may be necessary or advantageous for performing EEG measurements concurrently with stimulation (e.g., by tES), which must be used in real time and tolerate little to no delay between the occurrence of an event and the extracted features, as provided by the system according to the present invention. These algorithms must satisfy both the requirements of speed (goal: short delay) and interference suppression (goal: good signal reconstruction). Dynamic regression models are not used here because they require templates and therefore can result in delays of several seconds. Such templates are patterns that describe artifacts in general and are formed by the measurements. Since biological signals are never predictable, it is necessary to estimate the impact of artifacts on biological signals.

[0038] Here, the removal of artifacts from the measurement signal, which are mainly caused by external influences from the environment but can also be caused by stimulus triggers, depends on the modality of neuromodulation therapy, particularly whether TMS measurement or tES measurement is used. Depending on the application, these methods may be recursive methods for filtering, such as FIR filtering, when measurements are performed during neuromodulation therapy.

[0039] In a preferred embodiment of the system according to the present invention, the acquisition module includes a filter device. The filter device may be designed, for example, as a bandpass filter that filters out interfering signals from acquired biodata or biological signals. The interfering signals may have frequencies outside a predetermined frequency interval range, for example. The frequency interval has an upper and lower threshold for amplitude.

[0040] Furthermore, the interference signal may have amplitudes outside of a predetermined amplitude interval, for example. The amplitude interval has upper and lower thresholds for amplitude. The filtered interference signal is ignored in subsequent analysis, thus improving the quality of downstream analysis.

[0041] Artifacts from stimulation by the action module may also be detectable as interference signals and can be filtered. Since the temporal development of artifacts is essentially known based on known stimuli delivered by the action module, they can be filtered in real time in the improvements of the present invention. For example, in transcranial stimulation using electromagnetic pulses, the radiated pulse sequence can also be filtered or calculated from the acquired biosignals or biodata. For example, the effect on the induction electrodes on the patient's head resulting from the use of transcranial stimulation can be determined by direct induction, in this case when the action module and the acquisition module are positioned close to each other on the patient's head.

[0042] Other types of artifacts that can be identified and filtered include, for example, interference resulting from the electrical activity of the heart. These artifacts can also be calculated when an electrocardiogram (ECG) is recorded simultaneously with an EEG.

[0043] An advantageous improvement of the present invention is that, due to high temporal resolution and precise timing of measurement and / or stimulation, artifacts can be immediately taken into account, so the real-time functionality can be optimized, for example, at a data packet rate of 1000 Hz, i.e., 1 data packet / millisecond, so that prediction of the effect of measurement or stimulation is not required.

[0044] Stimulation techniques include TMS (transcranial magnetic stimulation), a non-invasive neuromodulation technique that directly affects brain function. Short magnetic pulses are directed at the patient's head to induce electrical currents in the underlying neurons.

[0045] Similarly, other electrical stimulation techniques such as nTMS (navigated transcranial magnetic stimulation), tDCS (transcranial direct current stimulation), tACS (transcranial alternating current stimulation), tRNS (transcranial random noise stimulation), DBS (deep brain stimulation), FES (functional electrical stimulation), and ultrasound can be used not only on the head but also on surrounding areas (arms, legs, chest, neck, etc.).

[0046] Future applications of individual patient-specific adaptations of brain / neural stimulation using electrical current (tES) to brain activity patterns (EEG) may include preferred embodiments of the present invention described later.

[0047] In a preferred embodiment of the system according to the present invention, the acquisition module is designed to derive and / or measure EEG. This is advantageous because EEG allows for the measurement of brain activity, which can then be used, for example, to perform neural stimulation. This is commonly referred to as neurofeedback.

[0048] EEG measurements can be performed using an electrode assembly for capturing electroencephalograms. For this purpose, the electrode assembly includes multiple, preferably more than 10, electrodes, which are similarly connected to an analog-to-digital converter. For example, the electrodes may be mounted in a hood so that a wide number of different areas of the brain can be monitored for electrical activity. Each electrode may have an actuator for pressing them against the patient's head. The actuators may be electromechanically controlled. Preferably, each actuator is connected to a compressor by a fluid-sealed hose. The compressor can create overpressure in a fluid, such as a gas like air, so that the actuator extends and presses the electrode against the head. For this purpose, each actuator may have a pneumatic cylinder or plastic cushion that can be filled with air.

[0049] The advantage of using pressurized air to perform a pneumatic press is that a particularly uniform press is achieved for each individual electrode of the hood.

[0050] In a preferred embodiment of the system according to the present invention, the action module is designed for transcranial stimulation of tissue. In this context, the term “transcranial” refers to acting on tissue through the skull. The tissue affected may be, for example, the patient’s brain.

[0051] In a preferred improvement of the above-described embodiment, the action module is designed to imprint brain rhythms externally via transcranial interaction stimulation (tACS).

[0052] In another preferred improvement of the embodiments described above, the action module is designed to trigger phase-related transcranial magnetic stimulation for targeted inhibition or excitation of the corticospinal tract.

[0053] In another preferred embodiment of the system according to the present invention, the acquisition module is designed to measure individual EEG alpha peak frequencies (iAPFs). The measured iAPFs enable repeated control of an action module for scientific research, for example, on the treatment of patients with depression. In this regard, the action module can be stimulated by transcranial magnetic stimulation.

[0054] Furthermore, it can be used for other purposes: • Incorporation of EEG and phase-related TMS for scientific research on the treatment of patients with depression. • Development, implementation, and evaluation of accurate and / or rapid techniques for correcting artifacts (tES) in derived biosignals (EEG). Development and implementation of a self-calibrating, low-noise, real-time controllable power supply for tES. • Implementation and evaluation of techniques for accurate detection of events based on phase in EEG. • Development and implementation of a general platform for an integrated stimulation and measurement system (MIS) for combining EEG measurements and multi-channel AC stimulation.

[0055] A central aspect of the present invention relates to communication between an acquisition module and an action module via a communication link (wired or wireless) that satisfies stringent or at least firm real-time requirements. Because biological procedures include transient components, stimuli can only be effectively performed in an adaptive manner when the data on which adaptations are based is provided in a timely manner (firm real-time requirement). For this purpose, measurements must be taken within a specific time limit after stimulation, and furthermore, the measurement results must be evaluated and supplied to the action module for follow-up of the stimulation within another time limit.

[0056] Strict real-time requirements are defined as follows: Failure to meet the response time limit is considered a failure. Calculations must follow the theory of real-time systems after a precise time determination for the application has been made. The real-time system always provides the correct result within a given time limit. When using a strict real-time system, the user can trust this quality. On the other hand, firm real-time requirements are defined as follows: In firm real-time requirements, immediate damage is not expected. However, once the time requirement has elapsed, the results of the calculations may become useless and be discarded.

[0057] A strict real-time requirement can be used throughout the measurement process, in which case individual measurements that do not meet the stringent real-time requirement will be discarded and / or not considered for outputting the analysis.

[0058] In this case, the measurements to be discarded are only relevant to the evaluation of the data. The samples are retained, and the closed-loop method is not interrupted.

[0059] Real-time measurement is intended to enable immediate evaluation and / or observation of the signal. In one embodiment of EEG measurement, the component is designed for frequencies up to 600 Hz. To enable detection of such frequencies, the requirements for scanning by Shannon must be ensured.

[0060] In particular, with bus links, that is, when there are more than two participants, it can be difficult to meet strict real-time requirements on the communication link, for example, because collisions can occur during transmissions by participants. In such cases, time-slice methods or polling are usually recommended.

[0061] The most widely used, and therefore proven, low-cost bus system is Ethernet, which assumes collisions and time delays due to its CSMA / CD architecture and is not inherently real-time.

[0062] There are extensions to the Ethernet standard, such as standards from the field of Time-Sensitive Networking (TSN), which provides real-time functionality. Here, the TSN portion operates at a higher layer of the protocol (ISO / OSI model), allowing the use of widely available standard hardware.

[0063] Alternatively, specialized systems optimized for higher speeds and real-time operation are commercially available, such as Infiniband, which is used in supercomputers and enables extremely low latency, superior to TSN.

[0064] According to the present invention, the use of an EtherCAT bus system as a communication link for the capture module and the action module is proposed.

[0065] The EtherCAT bus system, an international IEC standard, is considered an "Ethernet fieldbus" because it combines the simplicity of traditional fieldbus systems, which avoid the complexity of IT technology, with the advantages of Ethernet.

[0066] EtherCAT overcomes the shortcomings of Ethernet, particularly through its high-performance operating principle, and generally requires only one frame to update output information for all participants and read input information for control within the same frame. Telegrams sent by the EtherCAT master pass through all participants. Each EtherCAT slave reads the transmitted output data and populates the incoming frame with input data. The telegram is delayed only by the hardware processing time. The last participant in a segment (or branch) identifies an open port and sends the telegram back to the master, where the full-duplex characteristics of the Ethernet architecture are utilized. Advantageously, all connected modules (slaves) are physically directly connected to the master via a real-time bus (MAC-to-MAC communication). This allows for direct communication between the functional module and the master without the need to search for ports or other delays caused by communication protocols.

[0067] As a result, Telegram's maximum payload rate exceeds 90%, and the theoretical effective data transfer rate, leveraging full-duplex characteristics, exceeds even 100 Mbit / s (twice 100 Mbit / s, or >90%). The EtherCAT master is the only participant in the segment that can actively transmit EtherCAT frames, while all other participants are simply forwarding frames. This prevents unpredictable delays and ensures real-time functionality. However, it should be noted that this does not mean "forwarding" in the ordinary sense. According to this invention, there is no signal interruption in any functional module. Instead, this setup allows data packets to simply pass through individual modules, as described above, with modules downloading data from frames and uploading data to frames at this point.

[0068] The master uses a standard Ethernet Media Access Controller (MAC) without an additional communications processor. In this way, the master can be installed on any hardware platform that provides an Ethernet port. The real-time operating system or application software used is irrelevant in this case. EtherCAT slaves use an EtherCAT Slave Controller (ESC) for on-the-spot processing. This means that processing is entirely done in hardware, making network performance predictable and independent of individual slave implementations.

[0069] The master generates data packets according to the network architecture. In this way, in at least one preferred embodiment of the present invention, the module configuration can be specified only once on the bus and stored in the master. After this installation, data packets are generated and can be appropriately processed according to the actual physical arrangement in the bus system. This means that the modules can download and process commands specifically directed to each module and upload data to the data packets passing through accordingly.

[0070] This allows generated frames to reach all modules almost simultaneously, constrained only by the physical transit time of data packets through the line. Frames, i.e., such data packets, can reach all functional modules in the real-time bus in less than 100 ns, preferably less than 50 ns, and especially less than 20 ns, for example, within 15 ns.

[0071] Therefore, the EtherCAT bus system may have the capabilities necessary for the aforementioned applications, particularly for the applications of the system according to the present invention: The update time for 1,000 distributed input / output data points, including terminal transit time, is only 30 μs. A single Ethernet frame can exchange 1,486 bytes of process data, which is equivalent to nearly 12,000 digital inputs / outputs. The time it takes to transmit this amount of data is only 300 μs. Performance figures are 256 digital I / Os in 12μs, 1,000 digital I / Os in 30μs, 200 analog I / Os (16-bit) in 50μs (equivalent to a 20kHz sampling rate), 100 servo axes per 100μs, and 12,000 digital I / Os in 350μs.

[0072] In a preferred embodiment of the system according to the present invention, wired data communication using optical fiber cables or copper wires is used for the communication link between the action module and the capture module. This has the advantage of relatively reliable, secure, and high-speed data transmission.

[0073] An advantageous improvement to the system according to the present invention is the use of wireless-enabled data communication compliant with 5G or 6G standards for the communication link between the action module and the capture module and / or master module. This has the advantage of enabling real-time data transmission despite the use of a wireless connection.

[0074] An advantageous improvement of the present invention provides, in addition to an action module for operating an actuator to stimulate tissue and an acquisition module for deriving / measuring biodata or biosignals, a control module for controlling the digital input / output (DIO) of the actuator of an external device, the actuator being designed to stimulate tissue, and a master module for processing module signals / data is also connected to a real-time bus, in particular an EtherCAT bus, also known as ECAT. Furthermore, the modules are designed to exchange information with each other on the real-time bus during the same calculation step with clock pulses provided by the master module, in response to the data processing of the master module, and data / signals measured by the acquisition module, preferably an A / D converter, are sent to the master module, where they are processed, and the master module sends data / commands to the action module to activate tissue stimulation via the actuator.

[0075] According to the present invention, at least one functional module is designed to be compatible with an EtherCAT interface. In this way, the real-time requirements of the system, in particular, the stringent or robust real-time requirements of the device can be met in an improved manner. Advantageously, multiple functional modules related to stimulation, measurement, and / or evaluation, all of which include such a real-time compatible EtherCAT interface. Here, the functional module is connected to the master bus, in this case the EtherCAT bus, as a "slave" in a "master / slave configuration".

[0076] Within a while loop based on the EtherCAT bus, this system allows modules to be adapted to provide information to each other on the bus simultaneously and / or during a single computation step for signal measurement / acquisition, including the acquisition of biosignals such as EEG, ECG, and EXG; control of digital inputs / outputs of external peripheral devices; and generation of analog signals for actuators controlled by action modules. Typically, this is repeated every 1ms based on the bus clock pulse and the data processing performed by the master module.

[0077] An advantageous embodiment of the module of the system according to the present invention provides the following: - The acquisition module (3, A / D module) is equipped with an A / D converter for converting analog biodata / biological signals acquired by this module into digital signals to be processed by the master module, and / or - The action module includes a D / A converter for converting digital control signals provided by the master module into analog signals supplied to actuators for stimulating tissue, and / or - For digital input / output control, the control module controls the signal flow of digital control signals provided by the D / A converters of the action module and the master module, using trigger signals generated by the master module and the control module itself.

[0078] Based on known methods for stimulating according to physical condition, a further object of the present invention may be to provide a method that enables stimulating according to physical condition in a relatively reliable and safe manner.

[0079] This object of the present invention is achieved by the method described in claim 11. Preferred embodiments are described in the dependent claims. The same advantages described in the introduction apply to the method and system according to the present invention.

[0080] A favorable method for physical condition-dependent stimulation based on the system described in any one of the claims of the system provides the following: - The modules communicate with each other in a closed loop; data from an action module influences the operation / function of an ingestion module, and vice versa. - The stimulation consists of excitation / inhibition in neuromodulation therapy. - The action module controls magnetic actuators, electromagnetic actuators, mechanical actuators, pneumatic actuators, and / or hydraulic actuators to directly affect biological tissue or organs. - The action module performs multi-channel stimulation of biological tissue based on features from biodata acquisition of various source biological signals by the acquisition module, in the frequency range of 0 to several kilohertz, particularly up to 100, 200, or 300 kHz. - The acquisition module is designed to acquire EEG, ECG, EXG, EMG, EOG, ERG, PPT, respiration, MCG, MEG, BP, and SpO2 signals.

[0081] The present invention further relates to a device comprising a control module and / or a master module, a real-time master bus, a plurality of module slots, preferably at least two, but at least one module slot, and at least one functional module, wherein at least one module slot is connected to the master module 4 via a real-time-enabled data connection, and at least one functional module is designed to have a real-time-enabled interface and is connected to the real-time-enabled master bus. Herein, real-time functionality can be provided so that stringent or firm real-time conditions are met. Furthermore, at least the functional module is designed to transmit data to be processed, preferably by hardware or software, to downstream internal and / or external components such as data acquisition devices, measurement units, and output devices, under the same real-time conditions.

[0082] According to the present invention, a system for state-of-body stimulation, having a feedback loop for reading out biological signals or biodata in, for example, EEG measurements, for time-accurate stimulation of biological tissue and / or for acquiring signals modulated by feedback, includes at least an AD module and a DA module connected to a master module.

[0083] To emit a trigger at a predetermined time without further stimulation, at least a master module connected to an AD module (acquisition module) and a DIO module (control module) is required.

[0084] For more advanced applications, such as real-time measurement of biodata intended to release a trigger in response to a stimulus, further modules may be provided one by one according to the present invention.

[0085] Feedback and evaluation of specific features from biosignals enable modulation changes depending on the signal or state. Specific parameters depend on the actual application. Examples include the analysis of individual alpha frequencies in an EEG and the emission of a trigger signal for a TMS device at a 90° phase difference in the EEG, or the analysis of heart rate in an ECG and the emission of a current pulse during systole. This allows for analysis of, for example, amplitude, frequency, and phase in the EEG. In the ECG, amplitude, R-wave duration, and time gaps between R-waves can be analyzed.

[0086] The following attached diagrams will be used to describe and explain in more detail advantageous developments and further exemplary embodiments. [Brief explanation of the drawing]

[0087] [Figure 1] This diagram shows an integrated stimulation and measurement system (MIS). [Figure 2] This diagram shows an overview of the first module among the various modules of MIS. [Figure 3]This diagram shows an overview of the second module among the various modules of MIS. [Figure 4] This figure shows an example of a closed-loop sequence in one embodiment of an integrated stimulation and measurement system. [Figure 5] This figure shows the detection of the amplitude peak of a synthesized sine wave signal. [Figure 6] This figure shows the detection of the amplitude peak of the EEG signal. [Figure 7] This figure shows an example of a device according to the present invention having an integrated stimulation and measurement system. [Modes for carrying out the invention]

[0088] Figure 1 shows a schematic diagram of an integrated stimulus and measurement system (MIS) 1 according to the present invention. MIS 1 may be designed as a device having a housing shown in the dashed box in Figure 1. MIS 1 includes a signal processing module 4. The signal processing module 4 has a real-time bus master and a computing unit. The computing unit may be a computer chip with an operating system installed. Advantageously, the signal processing module 4 has an embedded Linux core with an operating system (OS embedded). The signal processing module 4, also called the master module, may include an embedded board having, for example, an 800 MHz to 1 GHz clocking. It is understood that other clockings are also intended, insofar as they meet the stringent or firm real-time requirements applicable to the relevant intended requirements.

[0089] In Figure 1, the Real-Time Bus Master, also called the RT Bus Master, is connected to multiple module slots 9 via the Real-Time Bus 5. Each module slot 9 is designed and provided to accept a functional module 10. In this context, a functional module 10 is any module designed to enable or extend the functionality of the MIS.

[0090] Figure 1 illustrates three module slots, but the number of modules provided in the MIS may be more or less. In this regard, for example, at least two functional modules 10 may be provided for using the MIS according to the present invention. The functional modules 10 are then connected to integrated or external components 14. These components 14 may include actuators, acquisition devices, display devices, electrodes, etc. For example, a component 14 may enable or implement the following functions: EEG measurement, trigger signal setting and / or trigger signal reading, power supply to the MIS and / or one or more of the components 14, data acquisition, data processing and / or data transfer, display of data, function menus, or other information, maintenance and / or control functions for the MIS and / or one of the connected components 14 and / or multiple control functions, in particular touch-sensitive control of the integrated display device.

[0091] The solid double-headed arrows shown in Figure 1 preferably represent communication links that meet real-time conditions. Therefore, the communication link between module slot 9 and functional module 10 is required to meet stringent or firm real-time requirements in order to enable real-time operation of the MIS according to the present invention. The dashed double-headed arrows shown in Figure 1 represent further data connection interfaces that do not typically meet real-time requirements, specifically the USB interface and the LAN interface in the figure. Furthermore, a 12V power supply is shown in Figure 1.

[0092] As shown in the embodiment in Figure 1, the integrated stimulus and measurement system (MIS) 1 is implemented in the form of a functional module 10, which can be enhanced as needed on both the acquisition side (acquisition module 3) and the output side (action module 2) without compromising the ability for accurate and proper data processing between them (see Figures 2 and 3). The modules communicate via a shared communication link 5, which is a real-time bus. The functional module 10 can be used for controlling electrical stimulation, electrical actuators, mechanical actuators, and / or pneumatic actuators, triggering events, acquiring data, and outputting and displaying data. The functional module can also be designed for graphics processing, for example, as a power supply module or as a 3D acceleration module.

[0093] Therefore, MIS1 is a general-purpose platform that can also enable testing in other areas of medical technology by expanding the parameter range for capturing biosignals and developing other forms of output. This can be achieved, for example, by integrating further functional modules designed to capture predetermined parameters. Furthermore, the functional range of the current functional modules is intended to be modified or expanded by adapting their control and / or programming.

[0094] In an advantageous improvement of the present invention, the MIS1 according to the present invention may be designed for one or more of the following applications: • Imprinting of external brain rhythms via transcranial exchange stimulation (tACS) and real-time triggering of phase-related TMS for targeted inhibition or excitation of the corticospinal tract. • Measurement of individual EEG alpha peak frequencies (iAPF) and real-time, repetitive control of TMS devices at this frequency for scientific research on the treatment of depressed patients. • EEG uptake and phase-related events for scientific research on the treatment of depressed patients, e.g., real-time triggering of TMS pulses. • EEG uptake for rehabilitation and phase-related electrical peripheral stimulation (FES) • Blood pressure (BP) uptake and phase-related electrical peripheral stimulation for pain treatment. • Respiration or respiratory signaling, and corresponding stimulation of the upper abdomen.

[0095] Based on MIS, feedback coupling modulation (stimulation) of brain function based on the individual physiological function of the patient observed in real time can be achieved. The implementation proposed herein not only enables faster use in a closed-loop setup according to the present invention, i.e., a closed-loop with EEG acquisition and processing and event triggering speeds of <1-3 ms, but studies have shown that it also enables higher temporal accuracy during acquisition and repeated stimulation without the need for future prediction, which is common in current systems. The phase deviation from the desired trigger time based on the acquired measurement data that can be achieved with MIS according to the present invention may be + / -5° at a frequency of 4 Hz and + / -12° at a frequency of 40 Hz, depending on the frequency in the EEG measurement. In ECG detection of systolic time, the deviation may be, for example, + / -3 ms.

[0096] In particular, the substantial advantages and beneficial improvements of this configuration compared to conventional solutions may be as follows: • The entire signal processing chain (data acquisition - transfer - processing - transfer - action) is integrated into the real-time bus and can be synchronized by the real-time bus. • The real-time bus allows all modules to simultaneously supply new data to the four stages (with a delay equal to the signal transmission time on the bus). The packet interval (bus clock pulse) causes the greatest delay between data acquisition and action based on the packet interval on the bus. Since the interface to the bus may be the same for all modules, acquisition (using acquisition module 3) may be adaptable to all possible biological signals. • Controlling actuators to stimulate biological tissue (using Action Module 2) does not require prediction, as these can also be coupled to the bus via an interface. • Modular setup, and any desired combination of acquisition module 3 and action module 2. Only the processing software needs to be adapted to each task. Data processing and real-time bus control can be performed directly by the embedded Linux OS within the device (e.g., Toradex-SOM).

[0097] Figures 2 and 3 show examples of (functional) modules that can be connected to the Real-Time Bus (RT Bus).

[0098] As a first example of the functional module 10, Figure 2 shows an acquisition module 3, which is designed herein as an EEG module for data acquisition (e.g., ADS1299) and connection to the bus. This acquisition module 3 and the rest of the functional modules 10 include an interface unit or functional unit having an interface for an external device 14, as well as a connection and control unit (RT bus interface) 12. In at least one preferred embodiment, the connection and control unit 12 includes a microcontroller (μC) (e.g., Infineon XMC48xx).

[0099] In the illustrated embodiment, the interface unit includes four interfaces, each having eight channels, and therefore provides up to 32 channels for, for example, EEG measurements. Each channel operates with a 24-bit resolution. In alternative embodiments, the channels may also operate with other resolutions. Here, the EEG module 3 is an analog-to-digital converter (ADC) and is hereafter referred to as the A / D module. The acquisition module 3 is intended to have a sample rate of 1000 samples / second, and therefore allows 1 ms for each sample or data packet. The interface of the functional unit to external components may be wired, but in a favorable improvement, this may also be wireless based on a sufficiently high-speed communication standard such as 5G or 6G, or it may be optical. This applies in a similar manner to the other functional modules.

[0100] The RT bus interface is designed to be located within and integrated into the module slot of the MIS. In this way, the connection to the MIS's real-time bus is established, and the functional module is integrated into the MIS.

[0101] For this purpose, the RT bus interface 12 of the acquisition module 3 has a configuration specifically developed for the acquisition module 3. Here, a microcontroller is used to control data connectivity and data processing for real-time operation with the functional module 10.

[0102] The remaining (functional) modules integrated into the MIS also include the analog setup, i.e., the functional section and the connection and control section.

[0103] As a further example of a functional module 10, Figure 2 shows a control module 7, also called an IO module or DIO module. The control module 7 is used to connect to the bus via a microcontroller (e.g., Infineon XMC48xx). The control module 7 shown here may be designed in particular to emit or receive one or more trigger signals and / or set the level of each of the trigger signals. In the illustrated design, the control module 7 includes four data inputs 7a and four data outputs 7b. Preferably, transistor-transistor logic (TTL) may be provided here. The inputs 7a and outputs 7b are then isolated from the bus by galvanic isolation 6 using a digital isolator (e.g., ISOW78xx Infineon). Here, as with other modules and galvanic isolation, the galvanic isolation may be, for example, a 6kV barrier.

[0104] The galvanic isolation provided here and in the functional module in an advantageous manner allows for electrical isolation of the patient to the measuring device and / or isolation of the individual components of the measuring device from one another. This reduces interference signals and erroneous measurements.

[0105] Figure 2 further shows Action Module 2, referred to herein as the electrical module or current module. The current module is used as an actuator to stimulate by delivering an electric current. The current module is shown here with two channels (Channel A and Channel B). The proposed setup uses isolated power supplies, and therefore has independent power supplies. In this way, lower interference from the power supplies can be achieved. These power supplies are self-calibrating, lower noise, and may be controllable in real time, for example, within 1 ms using new parameters. Therefore, data buffering can be omitted. Also, the RT bus interface is galvanically isolated from the interface section. Depending on the embodiment specifically desired for a given application, durations longer or shorter than 1 ms may also be selected as real-time intervals.

[0106] Figure 3 shows a functional module designed as a display device, specifically as a TFT module 11. The TFT module 11 is used to connect the display device to a bus. As previously mentioned, the connection is made via a microcontroller (e.g., Infineon XMC48xx) with galvanic isolation of the display device by a digital isolator from the ADUM1xx series (Analog Devices). In the illustrated design, the TFT module 11 includes control for the TFT screen via an FT813. The display device here has a resolution of 800 x 400 pixels and has touch detection.

[0107] In at least one advanced development of the present invention, the display device is tightly integrated with the MIS. It is understood that other display devices may be similarly incorporated, tightly integrated, or provided as external devices. These display devices may have various features, such as being designed with or without touch detection, having various resolutions, and being monochrome or color. Furthermore, multiple display devices may also be provided.

[0108] Figure 3 further illustrates a functional module designed as a COM module (communication module) 15. The COM module 15 is used to connect to other interfaces, even if they are not real-time responsive, such as one or more USB or RS232 interfaces. Further interfaces are also envisioned, such as one or more CAN bus interfaces, and especially wireless connectivity interfaces for connecting to external devices.

[0109] A further example of a module connected to MIS1 is the LAN module (network module) 13, as shown in Figure 3. The LAN module 13 is used to connect to a conventional local network (Ethernet). For this purpose, the LAN module 13 includes a LAN interface and a port for data cables. The current interface is for a 100 Mbit LAN. It is understood that the interface may also be designed for other transmission speeds.

[0110] Further functional modules 10 could be, for example, a power module for connecting the MIS to a power source. It is also intended that one of the modules be designed as an acquisition module having an interface to an accelerometer. The accelerometer could be used, for example, to acquire one or more frequencies of tremors commonly seen in Parkinson's disease. Further interfaces and functional modules for integration into real-time environments, provided according to the present invention, are also intended.

[0111] All data processing within MIS1 is performed digitally. By using various amplification levels and scan speeds, it is possible to simultaneously acquire stimuli tailored to the body's condition and biosignals from various sources. The modular concept of functional modules via a shared digital interface through a real-time bus allows for any desired cascading connections.

[0112] The data is not acquired in a time-division manner as in conventional systems, but instead can be acquired simultaneously, although the modular structure allows for scanning completely independently of each other. In this way, according to the present invention, it may be possible to trigger a stimulus pulse, for example, a pain stimulus, in a patient within a very strict tolerance range at a predetermined phase of the measured signal while the signal is being acquired.

[0113] To perform tissue stimulation along with measurement under real-time conditions, for example, at least a master module 4 and two additional functional modules 10, specifically an acquisition module 3 for acquiring measurement values ​​and an action module 3 for stimulating tissue, are required.

[0114] To emit a trigger signal along with measurement under real-time conditions, for example, at least a master module 4 and two further functional modules 10, in particular an acquisition module 3 for acquiring measurement values ​​and a control module 7 for emitting a trigger signal, are required.

[0115] The digital interface between functional modules allows for highly efficient galvanic isolation of the measurement assembly from the output and evaluation equipment, without compromising safety for the patient being measured and eliminating the need for sophisticated analog isolation amplifiers to ensure technical safety during medical use. This ensures compliance with the standard EN60601-1 regarding general requirements for basic safety and essential performance.

[0116] Compared to conventional technologies, the proposed solution has the advantages of a smaller design size and lower power consumption. The main reason for this is that only a single central computing unit, i.e., the master module 4, is required instead of several separate computers connected to one another. According to the present invention, all the modules required for measurement and stimulation can be combined into a single device within a housing not shown here.

[0117] Figure 4 shows an example of a closed-loop sequence in one embodiment of an integrated stimulation and measurement system including a real-time bus. Preferably, the real-time bus is an EtherCAT bus, also referred to as ECAT in this figure.

[0118] In Figure 4, the Action Module 2 of the Real-Time Bus in Figure 1, called the D / A module, controls actuators for stimulating tissue, and the Acquisition Module 3 of the Real-Time Bus in Figure 1, called the A / D module, derives / measures biodata or biological signals. In addition, the Control Module 7, referred to in Figure 4 as the DIO module for digital input / output control of the actuators for stimulating tissue, and the Master Module 4, also called the Master in Figure 4, are connected to the EtherCAT bus ECAT to process module signals / data.

[0119] The modules of the EthernetCAT bus (ECAT) are adapted to exchange information with each other on the Real-Time Bus (ECAT) during the same calculation step using clock pulses provided by the master module 4 (master), in response to the data processing of the master module 4 (master).

[0120] The data / signals measured by the acquisition module 3 (A / D module) are sent to the master module 4 (master), where they are processed, and the master module 4 then sends data / commands to the action module 2 (D / A module) to activate tissue stimulation via actuators connected to the action module 2 (D / A module).

[0121] The acquisition module 3 (A / D module) is equipped with an A / D converter for converting the analog biodata / biological signals acquired by this module 3 into digital signals that are processed by the master module 4 (master).

[0122] The action module D / A module includes a D / A converter that converts digital control signals provided by the master module (master) into analog signals supplied to actuators for stimulating tissue.

[0123] The control module 7 (DIO module) performs digital input / output control of the signal flow of digital control signals provided by the D / A converters of the action module 2 (D / A module) and the master module 4 (master), based on trigger signals generated by the master module 4 (master) and the control module 7 (DIO module).

[0124] Within a while loop based on an EtherCAT bus, the system shown in Figure 4 allows modules to be adapted to provide information to each other and / or for each other on the bus simultaneously and / or during a single computation step for signal measurement / acquisition, including the acquisition of biosignals such as EEG, ECG, and EXG; for controlling digital inputs / outputs of external peripheral devices; and for generating analog signals for actuators controlled by action modules. Typically, this is repeated every 1ms based on the bus clock pulse and the data processing performed by the master module.

[0125] Figure 4 shows an exemplary data loop of a related measurement device. Here, the elapsed time is shown vertically from top to bottom. The time shown here in such a data loop is 1 ms, which corresponds to a frequency of 1000 Hz.

[0126] Of course, in other embodiments of the present invention, other frequencies are intended without departing from the idea of ​​the present invention to satisfy real-time conditions. In Figure 4, events placed at the same height horizontally are occurring simultaneously or at least approximately simultaneously.

[0127] As described above, the master module 4 generates data packets to send to the function modules 10, in this case the ingestion module 3, the control module 7, and the action module 2, via a real-time bus, specifically the EtherCAT bus. Here, the real-time bus is designed, figuratively speaking, for data packets to pass through the function modules. During this passage, data is read from and written to the data packets by the function modules. This means that the function modules do not temporarily store the data packets but then forward them. In this way, quasi-simultaneous reception of data packets can be achieved at all function modules.

[0128] Each module is adapted to exchange information with each other on the Real-Time Bus (ECAT) via a Real-Time Communication Link 5, in response to data processing by the master module 4, using clock pulses provided by the master module 4 during the same calculation step. In this configuration, the master module 4 is the only module capable of generating frames, i.e., data packets, and the downstream functional modules 10 can only read these frames and add their own data.

[0129] Therefore, in the closed-loop configuration shown in Figure 4, data packets are generated by the master module and sent to the first functional module, in this case the acquisition module 3. The data packets may contain, for example, a command for the acquisition module 3 to start data acquisition. The acquisition module then begins acquiring data that exists in the form of patient biosignals.

[0130] During this process, the data frame has already moved from the acquisition module 3 to the subsequent function module 10, which is the control module 7 in Figure 4, also known as the DIO module. The control module 7 can, for example, control the digital inputs / outputs to the device's actuators. In doing so, the control module 7 can generate triggers and send them to an external device, and / or read the triggers while the data packets have already moved to the action module 2, shown downstream here.

[0131] Action Module 2 receives data packets, identifies the digital control commands of Master Module 4 related to Action Module 2 within the frame, converts them into analog signals for actuators connected to Action Module 2, generates signals, initiates patient stimulation, and / or sends a dataset containing stimulation data to an external device that may be connected to the patient for stimulation. As seen in Figure 4, the data packets are returned to Master Module 4 even before stimulation is performed.

[0132] Master module 4 transmits frames or data packets at a given rate, e.g., 1 packet / ms, and these are transmitted continuously in real time through a closed loop.

[0133] In this way, the data captured by the capture module 3 can be attached to a data packet and transferred to the master module for processing. The master module can then use this data to output new control commands for the control module and action module in one of the following frames, if necessary.

[0134] In the illustrated design, the acquisition module 3 includes an A / D converter to convert the acquired analog data, in this case the patient's biological signals, into digital signals for further processing.

[0135] Here, data processing by the master module 4 may include calculations of current phase, amplitude, trigger time, or digital / analog datasets. In this way, the master module 4 can define, modify, or adapt the trigger time based on the received data. For example, it is intended to generate trigger cascades adapted to biodata in this manner. Furthermore, the real-time system and / or device according to the present invention enables combinations of trigger signals, acquisition data, and stimulus data on timescales that were previously impossible. This may also improve the analysis of biological, biophysical, and / or biochemical phenomena.

[0136] The master module 4 is connected to an operator and can receive control commands from it. The operator may be, for example, a person performing measurements or a control device such as a digital instrument. Advantageously, this enables semi-automatic or fully automatic measurements. The master module 4 delivers system responses to the operator based on data processing.

[0137] Figures 5 and 6 illustrate the measurement of the composite signal (Figure 5) and EEG signal (Figure 6) during the detection of the peak amplitude of a sinusoidal oscillation (phase: 90°).

[0138] Figure 5 shows the detection of the amplitude peak 21 of the synthesized sinusoidal signal 20 and the emission of the event trigger 26. Here, the X axis represents time in ms and the Y axis represents the signal amplitude in mV. The sinusoidal signal 20 is the signal measured by the assembly. With a phase of 90°, this signal 20 has a peak 21. For analysis and trigger emission, the sinusoidal signal 20 is first converted to a filtered signal 22. The filtered signal 22 is delayed by 1-2 ms relative to the original signal 20, which is due to the processing time within the measuring device and the conversion from the original signal 20 to the filtered signal 22. Thus, the filtered signal 22 has a peak 23 that occurs with the same amount of time delay as the actual peak 21 of the measured signal 20, 1-2 ms. At the shown frequency of approximately 10 Hz, this time delay corresponds to a phase of approximately 5°. When the peak 23 thus determined is reached, the trigger signal 26 is emitted at this point 27. In Figure 5, the trigger signal 26 is 100mV. It is understood that in actual tissue measurements, the voltage value can be adjusted accordingly and adapted, for example, to measure and / or stimulate the tissue. Graph 24 shown in Figure 5 represents the phase of this signal.

[0139] Figure 6 shows the detection of the amplitude peak 33 of the actual EEG signal 30, which is referred to as the online rereference Pz in the legend of the figure and has a sufficient signal-to-noise ratio. Graph 32 represents the sinusoidal signal calculated based on the offline signal filtering process, i.e., one that may not satisfy the real-time condition. To satisfy the real-time condition, a phase signal 34 is generated by online processing of the measurement signal 30, for example, based on the Goertzel algorithm. Here, the phase signal 34, also referred to as the online Goertzel phase in the legend, always transitions linearly from 0° to 360° in phase. This transition allows for a 90° phase, and a trigger pulse is emitted at this point 37, as can be seen in the trigger signal 36 in Figure 6. According to the present invention, the emission of the event trigger can occur within 1-3 ms after the actual peak of the measurement signal 30 is reached.

[0140] Due to its application in a real-time environment, measurement results can be measured and evaluated so quickly that future predictions by algorithms are not required for stimuli. A simple Goertzel algorithm, for example, can split spectral components within the a-EEG band (8-12 Hz), calculate the phase in just two cycles, and detect events (here, peak amplitude, phase 90°).

[0141] Because the packet spacing jitter is very low, the filter pass-through time can be taken into account in calculations, resulting in an even smaller and more consistent deviation.

[0142] The exemplary graphs shown herein were created without using conventional methods for predicting signal waveforms. Signal prediction is a common means in the prior art for emitting trigger pulses in the correct phase. The real-time method according to the present invention allows for higher accuracy than is possible using prediction. However, it is also intended to continue using prediction in the method provided according to the present invention.

[0143] Figure 7 shows an example of a device having an integrated stimulation and measurement system. This device has a housing 17 that includes a master module 4 and a number of functional modules 10, namely, an acquisition module 3, a control module 7, and an action module 2, as well as a display module 10, which in a given example is a TFT module. The functional modules are connected by a bus structure not shown herein. A display device 18 is formed on the front of the housing 17. This display device 18 is connected to the display module 11. In this regard, the display device 18 may have the various functions described above.

[0144] Furthermore, a series of ports 16 are provided on the front in the illustrated embodiment. Some of these ports are data input sections 7a and / or data output sections 7b of the control module 7. Other ports 16 are for other functional modules used or for other functions of the device.

[0145] Further aspects of the present invention are listed below:

[0146] Embodiment 1: A method for stimulating a physical state, comprising an action module 2 for stimulating tissue, an intake module 3 for deriving (measuring) biodata or biological signals, and a signal processing module 4 connecting the action module 2 and the intake module 3, characterized in that the modules communicate via a protocol that satisfies stringent or at least robust real-time requirements.

[0147] Embodiment 2: The method for stimulating a physical state according to Embodiment 1, characterized in that the protocol is encapsulated within an Ethernet frame.

[0148] Embodiment 3: The method for stimulating a physical state according to Embodiment 2, characterized in that at least one of modules 2, 3 has already evaluated or edited data from a received Ethernet frame before the entire Ethernet frame is received by the module.

[0149] Embodiment 4: The method for stimulating a physical state according to Embodiment 3, characterized in that, before the entire Ethernet frame is received by the module, the module begins transmitting response data based on the evaluated or edited data.

[0150] Embodiment 5: A method for stimulating a physical state according to any one of the embodiments, characterized in that the modules communicate with each other in a closed loop, and the data of the action module affects the operation / function of the acquisition module, and vice versa.

[0151] Embodiment 6: A method for stimulating according to a physical condition according to any one of the embodiments, characterized in that the stimulation consists of excitation or inhibition of neuromodulation therapy.

[0152] Embodiment 7: A system 1 for stimulation according to a physical condition, comprising an action module 2 for stimulating tissue and an intake module 3 for deriving (measuring) biodata or biological signals, wherein the two modules communicate via a communication link 5 that satisfies stringent or at least robust real-time requirements.

[0153] Embodiment 8: The system 1 for physical state-dependent stimulation according to Embodiment 7, characterized in that at least a portion of the processing of the protocol stack of the communication link 5 is performed in hardware, for example, by an ASIC or FPGA.

[0154] Embodiment 9: A system 1 for physical condition-dependent stimulation according to any one of Embodiments 7 and 8, characterized in that a bus protocol, protocol stack, or hardware from the EtherCAT bus system is used.

[0155] Embodiment 10: A system 1 for physical condition-dependent stimulation according to any one of Embodiments 7 to 9, characterized in that galvanic isolation 6 is provided between at least one module and a communication link 5.

[0156] Embodiment 11: A system 1 for physical condition-dependent stimulation according to any one of Embodiments 7 to 10, characterized in that biodata or biological signals are transmitted to an action module 2, and the action module 2 controls an electrical actuator, magnetic actuator, electromagnetic actuator, mechanical actuator, pneumatic actuator, and / or hydraulic actuator to directly affect a biological tissue or organ, taking the biodata into consideration.

[0157] Embodiment 12: The system 1 for stimulation according to a physical condition, as described in any one of Embodiments 7 to 11, characterized in that the action module 2 performs multi-channel stimulation of biological tissue based on characteristics from biodata acquisition of various source biological signals by the acquisition module 3 in a frequency range of 0 to several kilohertz, particularly up to 100, 200, or 300 kHz.

[0158] Embodiment 13: The system 1 for physical condition-dependent stimulation according to any one of Embodiments 7 to 12, characterized in that the action module 2 comprises a current pulse converter, and the acquisition module 3 includes an EEG or ECG measurement unit, and both modules are connected to a bus.

[0159] Embodiment 14: A system 1 for physical state-dependent stimulation according to any one of Embodiments 7 to 13, characterized in that, apart from the action module 2 and the acquisition module 3, there exists a signal processing module 4, a shared bus provides a communication link 5 between all modules, data measured by the acquisition module 3 is transmitted to the signal processing module 4, processed, prepared and further processed by the signal processing module 4, and the signal processing module 4 transmits data or commands to the action module 2 to activate a stimulus.

[0160] Embodiment 15: System 1 for physical condition-dependent stimulation according to any one of Embodiments 6 to 14, characterized in that a processor-controlled module is a bus component, monitors System 1, and includes a communication interface to other computers connected via the Internet.

[0161] Embodiment 16: The system 1 according to either Embodiment 14 or Embodiment 15, characterized in that the signal processing module 3 is integrated within the action module 2 or the acquisition module 3.

[0162] Abbreviation ECG: Electrocardiogram EEG: Electroencephalogram EMG: Electromyography EOG: Electroocular Geometry ERG: Electroretinogram PPT: Photoplethysmography MCG: Magnetocardiogram MEG: Magnetoencephalography BP: Blood pressure SpO2: Oxygen saturation RT Bus: Real-time Bus USB: Universal Serial Bus LAN: Local Area Network FES: Functional Electrical Stimulation OS: Operating System MIS: Integrated Stimulation and Measurement System TMS: Transcranial Magnetic Stimulation tES: Transcranial electrical stimulation nTMS: Navigated transcranial magnetic stimulation tDCS: Transcranial direct current stimulation tACS: Transcranial alternating current stimulation tRNS: Transcranial Random Noise Stimulation DBS: Deep Brain Stimulation Therapy iAPF: EEG Alpha Peak Frequency FES: Phase-related electrical peripheral stimulation [Explanation of symbols]

[0163] 1: A system for stimulating the body according to its physical condition 2: Action Module / Current Module 3: Intake Module / EEG Module 4: Signal Processing Module / Master Module 5: Communication Link 6: Galvanic insulation 7: Control Module 7a: Data input section 7b: Data output section 9: Module slots 10: Functional Modules 11: Display module, TFT module 12: Control unit, RT bus interface 13: Network module, LAN module 14: Components, external devices 15: Communication module, COM module 16: Port 17: Housing 18: Display 20: Measurement signal 21: Peak of the measured signal 22: Filtered signal 23: Peak of the filtered signal 24: Phase signal 26: Trigger signal 27: Trigger time 30: Measurement signal 31: Peak of the measured signal 32: Filtered signal 33: Peak of the filtered signal 34: Phase signal 36: Trigger signal 37: Trigger time

Claims

1. A master module (4, Master) for processing module signals / data, A system for stimulating a physical state, comprising at least two functional modules, including an action module (2, D / A module) for stimulating tissue and an intake module (3, A / D module) for extracting / measuring biodata or biological signals, The communication between the modules is conducted via a communication link (5) that satisfies stringent or at least robust real-time requirements. At least one of the functional modules comprises an interface section for an external device (14) and a connection and control section, A system characterized in that the acquisition module (3, A / D module) is configured for electroencephalogram (EEG) derivation / measurement, the action module (2, D / A module) is designed for transcranial tissue stimulation, and the acquisition module includes a filter device designed to filter or remove artifacts induced by transcranial stimulation in real time.

2. The system for stimulating a physical state according to claim 1, characterized in that the communication link (5) includes a real-time response bus (ECAT) to which the at least two functional modules are connected.

3. A system for stimulating a physical state according to claim 2, characterized in that an action module (2, D / A module) for operating actuators for stimulating tissue, an acquisition module (3, A / D module) for extracting / measuring biodata or biological signals, and a control module (7, DIO module) for digital input / output control of the actuators for stimulating tissue of an external device are connected to a real-time bus (ECAT).

4. The system for stimulating a physical state according to claim 2 or 3, characterized in that the modules (2, 3, 4, 7) are adapted to exchange information with each other on a real-time compatible bus (ECAT) during the same calculation step using clock pulses provided by the master module (4, master) in response to data processing by the master module (4, master).

5. A system for stimulating a physical state according to any one of claims 1 to 4, characterized in that an acquisition module (3, A / D module) is designed to transmit measurement data / signals to a master module (4, master) via a communication link (5), the master module (4, master) is designed to process the received data, and the master module (4, master) is further designed to transmit data / commands to an action module (2, D / A module) via an actuator to activate tissue stimulation.

6. The system for stimulating a physical condition according to any one of claims 1 to 5 is characterized in that the acquisition module (3, A / D module) is equipped with an A / D converter for converting analog biodata / biological signals acquired by this module into digital signals processed by the master module (4, master).

7. The system for stimulating a physical state according to any one of claims 1 to 6, characterized in that the action module (2, D / A module) comprises a D / A converter for converting a digital control signal provided by the master module (4, master) into an analog signal supplied to an actuator for stimulating tissue.

8. A system for stimulating a physical state according to any one of claims 1 to 7, characterized in that the control module (7, DIO module) performs digital input / output control of the signal flow of digital control signals provided by the D / A converters of the action module (2, D / A module) and the master module (4, master) by trigger signals (26, 36) generated by the master module (4, master) and the control module (DIO module).

9. A system for physical condition-dependent stimulation according to any one of claims 2 to 8, characterized in that galvanic isolation (6) is provided between at least one module (4, 7) and a real-time response bus (ECAT).

10. The system for stimulating a physical state according to any one of claims 2 to 9, characterized in that the Real-Time Response Bus (ECAT) is a bus adapted to update the output information of all participants in one frame and to read the input information for control in the same frame.

11. A method for operating a system for physical state-dependent stimulation based on the system according to any one of claims 1 to 10, wherein the modules communicate with each other in a closed loop, data from an action module (2, D / A module) affects the operation and / or function of an acquisition module (3, A / D module), and vice versa, and a master module (4, master) generates data packets at a predetermined clocking, the data packets are transmitted to a function module via a communication link (5), pass through the function module, and are returned to the master module.

12. A method for operating a system for physical state-dependent stimulation according to claim 11, wherein an action module (2, D / A module) is provided to receive and execute control commands for excitation / inhibition of stimulation in the form of neuromodulation therapy.

13. A method for operating a system for stimulating a physical condition according to claim 11 or 12, wherein the action module (2, D / A module) controls a magnetic actuator, electromagnetic actuator, mechanical actuator, pneumatic actuator, and / or hydraulic actuator for directly affecting biological tissue or organs.

14. A method for operating a system for stimulation according to a physical state, according to claim 11, claim 12, or claim 13, wherein the action module (2, D / A module) operates an actuator for multi-channel stimulation of biological tissue based on the characteristics of biodata acquired from various sources of biological signals by the acquisition module (3, A / D module) in a frequency range of 0 to 300 kHz.

15. A method for operating a system for physical condition-dependent stimulation according to any one of claims 11 to 14, comprising an acquisition module (3, A / D module) designed to acquire EEG, ECG, EXG, EMG, EOG, ERG, PPT, respiration, MCG, MEG, BP, and SpO2 signals.

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