Electrical stimulation device for human therapy
Patent Information
- Application Number
- CN202521646398.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-08-04
- Publication Date
- 2026-10-30
- Estimated Expiration
- 2035-08-04
AI Technical Summary
尽管大脑由颅骨保护并被脑脊液包围,并且通过血脑屏障与血液循环系统隔离,但大脑的精细构造使其容易受到多种疾病和不同类型脑损伤的影响,这些可能导致大量神经细胞损失
[0059]根据本实用新型的刺激设备可用于治疗由脑部疾病或损伤引起的各种障碍、视网膜病变或其他影响视神经的病理状况。
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Figure CN224911611U_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a device for stimulating a patient using electrical stimulation signals, and more particularly to a device for treating one or more lesions caused by brain injury or brain disease, retinal disease, or other pathological conditions such as those affecting the optic nerve. Specifically, in one example, the device of this invention can be used for the treatment of glaucoma. Background Technology
[0002] The human brain has an extremely complex structure. It contains over 100 billion nerve cells that communicate with each other via axons, which transmit a chain of signal pulses called action potentials. Although the brain is protected by the skull, surrounded by cerebrospinal fluid, and isolated from the circulatory system by the blood-brain barrier, its intricate structure makes it vulnerable to a variety of diseases and different types of brain injury, which can lead to the loss of a large number of nerve cells. These brain diseases can include cognitive impairment. Other potential impairments caused by brain injury or disease include motor disorders, memory impairment, or other functional neurological disorders.
[0003] In addition, any sensory system (such as vision or hearing) can be affected by such brain diseases or injuries. For example, in the visual system, retinal diseases or other pathological conditions that affect the optic nerve (such as glaucoma) can cause visual impairment.
[0004] Glaucoma is an optic nerve disorder that causes abnormally high pressure inside the eyeball, which can damage critical parts of the eye (such as the area at the back of the eyeball).
[0005] In most cases, glaucoma is a progressive disease that gradually worsens over time.
[0006] Glaucoma can cause severe vision loss or even blindness, and is the second leading cause of blindness worldwide.
[0007] International patent application number WO2013107678A1 discloses a neurostimulation device comprising a mask, glasses, or similar eye accessory covering the eye region of a subject, designed to be optically isolated from the surrounding environment, and having a light-emitting surface facing the eyeball, which is connected to (or contains) a visible spectrum light source. The device is secured to the subject's head by a fixation device. A substrate element with an opening on one side is configured to internally house the respective light-emitting surface and light source. Electrode sockets or electrode support surfaces are provided above the substrate element and / or below the area covering the eye region. The electrodes are preferably epidermal electrodes.
[0008] European design patent No. 002341198-0001, owned by the same applicant, shows another example of stimulating glasses. Utility Model Content
[0009] The purpose of this invention is to provide a device for treating a patient suffering from a disease caused by brain or retinal disease / damage, or other pathological conditions affecting the optic nerve.
[0010] In one example, the device can be configured for the treatment of glaucoma.
[0011] The above-mentioned objectives are achieved through the device provided by this utility model.
[0012] This invention provides a device for stimulating a patient.
[0013] The device includes a stimulation unit for applying an electrical stimulation signal having at least one variable stimulation signal parameter, wherein the stimulation signal parameter continuously varies within a range of calculated parameters near a patient’s determined neurophysiological baseline parameter or a preset parameter value.
[0014] Electrical stimulation can be applied by direct current or through magnetic field induction (transcranial magnetic stimulation).
[0015] The device also includes a parameter determination unit for determining at least one neurophysiological basic parameter.
[0016] The parameter determination unit includes a device for detecting electrical signals from the patient's brain or other sensory organs.
[0017] For example, the sensory organ could be the eye.
[0018] The parameter determination unit also includes a device for analyzing the detected electrical signals to determine the patient's basic neurophysiological parameters.
[0019] The neurophysiological baseline parameters determined by the parameter determination unit include the patient's neurophysiological baseline frequencies.
[0020] The parameter determination unit also includes multiple electrodes configured to attach to the patient's skin surface.
[0021] Each electrode is adapted to apply electrical stimulation signals and / or detect electrical signals from the brain and / or another sensory organ.
[0022] For example, one or more of the plurality of electrodes may be configured to apply an electrical stimulation signal, while one or more of the other plurality of electrodes may be configured to detect electrical signals from the brain and / or other sensory organs.
[0023] Alternatively, one or more electrodes may be adapted to both apply electrical stimulation signals and detect electrical signals from the brain and / or another sensory organ (such as the eye).
[0024] In other words, the same electrodes can be used for both the transmission of stimuli and the detection of EEG signals.
[0025] The device also includes a control unit.
[0026] The control unit is configured to operate the device to provide stimulation therapy to the patient when it is determined that the user has entered a one-time code.
[0027] One-time codes are entered by the user through a user interface, which is operatively connected to the control unit.
[0028] Therefore, the device can only be operated at the correct time and by an authorized user with a one-time code (such as a surgeon, assistant, etc.).
[0029] That is, it can greatly prevent accidental operation or other unintended actions on the device.
[0030] This can improve the overall safety of the patient's treatment.
[0031] For example, the user interface may include a touchscreen-type display device. In a possible embodiment of the device according to the present invention, the stimulation unit generates an electrical stimulation signal consisting of multiple periodic electrical stimulation signal sequences, each signal sequence having a corresponding stimulation frequency.
[0032] In one configuration, multiple electrical stimulation signal sequences are separated by signal interruptions for predetermined time periods and have different stimulation frequencies within a calculated frequency range.
[0033] The parameter determination unit may also include a recording device and a transformation device. The recording device is used to record the patient's electroencephalogram (EEG) signal, and the transformation device is used to transform the recorded EEG signal into the patient's neurophysiological baseline frequency.
[0034] For example, the transformation device can be composed of a Fourier frequency transformation device suitable for performing Fourier frequency transformation on the recorded EEG signal.
[0035] Alternatively, the transformation device may be composed of an autoregressive device suitable for performing autoregressive processing on the recorded EEG signal.
[0036] The parameter determination unit can be adapted to detect the flicker-fusion frequency of a patient as the patient's neurophysiological baseline frequency.
[0037] The electrodes can be configured to apply electrical stimulation signals to the patient and / or record the patient's EEG signals.
[0038] In one example, a dual electrode can be used, which can be used both to apply electrical stimulation signals and to acquire measurement signals. The advantage of using such a dual electrode is that it minimizes the number of electrodes attached to the patient and the number of cables connecting the patient to the stimulation device according to this invention.
[0039] The stimulation unit can be configured to stimulate a patient with an electrical stimulation signal having an adjustable stimulation frequency, which is increased to induce a rhythmic flashing light sensation in the patient until the stimulation frequency induces a constant light sensation in the patient.
[0040] In this case, the adjusted stimulation frequency is the flicker fusion frequency that constitutes the patient's neurophysiological baseline frequency.
[0041] In one example, before the stimulation unit provides electrical stimulation to the patient, the recording device can continuously record the patient's EEG signals for a predetermined period of time while the patient's eyes are closed.
[0042] The stimulation unit can be configured to continuously or discretely change the stimulation frequency of the electrical stimulation signal.
[0043] The control unit can be configured to control the parameter determination unit to measure the patient's basic neurophysiological parameters and control the stimulation unit to stimulate the patient through electrical stimulation signals.
[0044] In this case, the measurement of basic neurophysiological parameters and stimulation are controlled by the control unit in an alternating manner.
[0045] The various electrical stimulation signal sequences can include different signal forms.
[0046] Preferably, the electrical stimulation signal is a periodic electrical signal.
[0047] Multiple periodic electrical stimulation signal sequences may include pulse signals or have sinusoidal waveforms.
[0048] In this case, the pulse width of the pulse in the electrical stimulation signal sequence can decrease as the stimulation frequency of the electrical stimulation signal sequence increases.
[0049] The electrodes attached to the patient can switch between applying an electrical stimulation signal to the patient in a first operating mode and obtaining a signal to be recorded from the patient in a second operating mode.
[0050] Preferably, the switching of the electrodes is controlled by a control unit.
[0051] The device may also include a memory for storing signals recorded by the attached electrodes in a second operating mode.
[0052] In one configuration, electrodes can be attached to the patient's skin surface via tape, such as one or more areas of the patient's head.
[0053] In another configuration, the device also includes an eye mask or glasses that cover the area around the patient's eyes.
[0054] In this case, at least some of the electrodes are embedded in the eye mask or glasses.
[0055] In another configuration, the device also includes an eye mask or glasses and a hat.
[0056] In this case, one or more electrodes for applying electrical stimulation signals are embedded in the eye mask or glasses.
[0057] In addition, one or more electrodes for detecting electrical signals from the brain and / or other sensory organs are embedded in the cap.
[0058] Preferably, the hat is an EGG hat.
[0059] The stimulation device according to this invention can be used to treat various disorders, retinal diseases, or other pathological conditions affecting the optic nerve caused by brain diseases or injuries.
[0060] In particular, the device according to this invention can be used to treat patients' language disorders, cognitive impairments, motor disorders, memory disorders, hearing or visual impairments, and functional neurological disorders.
[0061] The device can also be used to treat the retina of a patient's eye.
[0062] In addition, the device can also be used to treat glaucoma. It can connect via a network to a database that stores information on multiple patients.
[0063] In addition, the device may include local storage for storing patient data.
[0064] The device according to this utility model can be a mobile device that can be transported or carried.
[0065] Advantageously, the device of this invention can be configured to apply electrical stimulation to a patient and determine their neurophysiological parameters under the control of a computer program executed by a data processing unit (e.g., a microprocessor).
[0066] The computer program can be loaded from a data carrier or from a network server through the device's interface.
[0067] The device of this invention can be used to implement a method for stimulating a patient, wherein an electrical stimulation signal having at least one variable stimulation signal parameter is applied, and the stimulation signal parameter continuously varies within a calculated range around a determined patient neurophysiological baseline parameter or a preset parameter value. Attached Figure Description
[0068] The following description, in conjunction with the accompanying drawings, further illustrates more details and advantages of this utility model, wherein: Figure 1 This invention illustrates one possible implementation of a stimulation device according to the present invention, which is connected to a patient's head via electrodes; Figure 2 It shows Figure 1 A block diagram showing the components of the stimulation device and their operational relationships; Figure 3 Stimulation devices (e.g.) are shown Figure 1 An exemplary structural block diagram of the stimulation device shown; Figure 4 This invention illustrates devices compatible with the present invention (e.g., Figure 1 A schematic diagram of the dual electrodes used in conjunction with the device shown. Figure 5 As shown Figure 4 The dual electrodes shown are related to the device according to this invention (e.g., Figure 1 The connection method between the internal circuits of the device shown.
[0069] Figure 6 A device suitable for use according to this utility model is shown (e.g.) Figure 1 One possible configuration of the dual electrodes in the device shown; Figure 7 The device according to the present invention (e.g.) is shown. Figure 1 The waveform diagram of the stimulation signal and the corresponding EEG signal used in an exemplary embodiment of the device shown; Figure 8 A flowchart of an exemplary method for stimulating a patient is shown, which can be achieved by using a device according to the present invention (e.g., Figure 1 This can be achieved using the device shown. Figure 9 A flowchart of another exemplary method for stimulating a patient is shown, which can also be used by using a device according to this invention (e.g. Figure 1 This can be achieved using the device shown. Figure 10A -C shows an apparatus for illustrating the present invention (e.g., Figure 1 Signal diagram of the neurophysiological basic frequencies used in the device shown; Figure 11 The apparatus according to the present invention (e.g.) is shown. Figure 1 A schematic diagram illustrating the function of the device shown. Figure 12 The device according to this utility model (e.g.) is shown. Figure 1 A waveform diagram of an exemplary EEG signal recorded by the device shown; Figure 13 The device according to this utility model (e.g.) is shown. Figure 1 The device shown is based on Figure 12 The frequency spectrum of the EEG signal shown is calculated. Figure 14 Another exemplary signal diagram is shown to illustrate the stimulation device according to the present invention (e.g., Figure 1 Another possible configuration of the device shown. Detailed Implementation
[0070] Figure 1 A device 1 for stimulating a patient 2 according to an embodiment of the present invention is shown.
[0071] like Figure 1 As shown, in this embodiment, the device 1 for stimulating a patient according to the present invention is attached to the skull or head of the patient 2 via an electrode 3.
[0072] For example, electrode 3 can be attached to the patient's skin with tape, such as the skin of one or more areas of the patient's head.
[0073] The device 1 is configured to treat disorders caused by brain diseases / injuries, retinal diseases, or other pathological conditions affecting the optic nerve.
[0074] In a non-limiting example, the device 1 may be configured for the treatment of glaucoma.
[0075] Device 1 includes a control unit 9, which is configured to operate device 1 to stimulate patient 2 after determining that a user (e.g., surgeon, assistant, etc.) has entered a one-time code.
[0076] The one-time code is entered by the user through a user interface (not shown), which is operatively connected to the control unit 9.
[0077] Therefore, it can greatly prevent misoperation or other unintended operations of the device 1.
[0078] Correspondingly, this can improve the overall treatment safety of patient 2.
[0079] Specifically, the operation of device 1 (and the corresponding stimulation treatment) can only be triggered at the correct time and by an authorized user (such as a surgeon) with the one-time code.
[0080] In one example, the user interface may include a touchscreen-type display device (not shown).
[0081] According to this utility model, other forms of user interface configurations may also be adopted, as long as they are suitable for the intended use.
[0082] The device 1 includes a parameter determination unit 7, which includes multiple electrodes 3.
[0083] Each electrode 3 is adapted to apply electrical stimulation signals and / or detect electrical signals from the brain 5 or other sensory organs.
[0084] In one configuration, one or more of the plurality of electrodes 3 may be used to apply an electrical stimulation signal, while the remaining one or more of the plurality of electrodes 3 may be used to detect electrical signals from the brain and / or other sensory organs of the patient 2.
[0085] In a non-limiting example, the sensory organ may be the eye.
[0086] Alternatively, one or more electrodes 3 may be used both to apply electrical stimulation signals and to detect electrical signals from the brain and / or other sensory organs (such as the eyes).
[0087] Each electrode 3 can be configured to apply electrical stimulation signals to the patient 2 and / or record the patient 2's electroencephalogram (EEG) signals.
[0088] In the illustrated embodiment, the stimulation device 1 is connected to the head of the patient 2 via three electrodes 3-1, 3-2, and 3-3.
[0089] Here, all electrodes 3-i are connected to the stimulation device 1 via cables 4-1, 4-2, and 4-3.
[0090] The number of electrodes 3-i and their corresponding cables 4-i can be varied as needed.
[0091] exist Figure 1 In the illustrated embodiment, two signal electrodes (i.e., electrodes 3-1 and 3-2) are provided, which are used in one operating mode to apply electrical stimulation signals to the head and in another operating mode to acquire electrical measurement signals from the head, including the brain 5.
[0092] exist Figure 1 In the embodiment shown, the third electrode 3-3 is configured as a reference electrode to provide a reference potential for the stimulation device 1.
[0093] exist Figure 1 In the embodiment shown, signal electrodes 3-1 and 3-2 are composed of so-called dual electrodes that can switch between two operating modes.
[0094] In one operating mode of the stimulation device 1, electrical signals (such as EGG signals) from the brain 5 that are derived potentials are measured, while in another operating mode, the electrical stimulation signals generated by the stimulation device 1 are applied to the skin of the patient 2's head.
[0095] exist Figure 1 In the embodiment shown, electrodes 3-1, 3-2, and 3-3 are attached to the skin surface of patient 2.
[0096] In another configuration (not shown), electrode 3-i can be implanted under the skin of patient 2.
[0097] The number of electrodes 3-i can be varied.
[0098] For example, more than three electrodes can be set in different configurations.
[0099] According to this invention, the position of the electrode 3-i, which can be attached to the head of the patient 2, can vary depending on the type of disease or disorder to be treated by the stimulation device 1.
[0100] The stimulation device 1 is configured to apply an electrical stimulation signal having at least one variable stimulation signal parameter (e.g., signal frequency) via electrode 3-i.
[0101] The stimulation device 1 continuously changes the stimulation signal parameters within a calculated range that surrounds the determined patient neurophysiological baseline parameters or preset parameter values.
[0102] The neurophysiological parameters were determined based on electrical signals detected or acquired from the head of patient 2.
[0103] In the measurement operation mode, the detected electrical signal received by the stimulation device 1 through the electrode 3 is analyzed to determine the patient 2's neurophysiological baseline parameters (e.g., specific neurophysiological baseline frequencies).
[0104] The stimulus signal varies within a range of calculated parameters near the determined neurophysiological baseline frequency.
[0105] The electrode 3-i attached to patient 2 can switch between applying an electrical stimulation signal to patient 2's head in a first operating mode and obtaining a signal to be recorded from patient 2's head in a second operating mode. This switching of electrode 3-i is controlled by a control unit integrated in the stimulation device 1.
[0106] In one possible implementation, under the control of the control unit, electrical stimulation in a first operating mode and acquisition of electrical signals to be recorded from patient 2 are performed alternately in a second operating mode.
[0107] In one possible embodiment, the stimulation device 1 first acquires electrical signals (e.g., electroencephalogram (EEG) signals) from the brain 5 of the patient 2 in a signal measurement operation mode, and then calculates individual neurophysiological baseline parameters (e.g., the corresponding individual neurophysiological baseline frequencies of the patient 2).
[0108] Subsequently, the parameter range around the determined neurophysiological baseline parameter is calculated, and the stimulation device 1 is switched to the signal application operation mode.
[0109] After determining the basic neurophysiological parameters and their corresponding parameter ranges, the stimulation device 1 applies an electrical stimulation signal in the signal application operation mode. The parameters of the electrical stimulation signal continuously change within the calculated parameter range near the determined basic neurophysiological parameters.
[0110] Alternatively, the stimulation signal parameters can be continuously varied within a calculated parameter range near preset parameter values input by the operator through the operating interface.
[0111] For spontaneous neural activity in the human brain, it is known that there are multiple frequency ranges, which can be divided into: delta wave band 0.5 Hz - 3 Hz, theta wave band 4 Hz - 7 Hz, alpha wave band 8 Hz - 13 Hz, beta wave band 14 Hz - 30 Hz, and gamma wave band 31 Hz - 60 Hz.
[0112] Different frequency ranges can be used to treat different types of diseases of the brain.
[0113] For example, for treating visual impairments in the visual cortex of the brain, the alpha band between 8 Hz and 13 Hz is used because this band plays an important role in processing visual impressions.
[0114] Brain 5 exhibits a resonance phenomenon.
[0115] When patient 2’s brain 5 is stimulated by a stimulus signal with a predetermined stimulus frequency, it may trigger a spontaneous resonance response in brain 5, wherein the spontaneous resonance response signal has a frequency equal to the stimulus frequency, or a higher frequency (the frequency is the product of the stimulus frequency and an integer multiplication factor, i.e., the applied stimulus frequency multiplied by the integer multiplication factor); or a lower frequency (the frequency is the ratio of the stimulus frequency to the division factor, i.e., the applied stimulus frequency divided by the integer value).
[0116] Brain 5 only exhibits this resonant response when it is stimulated at a frequency relevant to its internal information processing.
[0117] Reference Figure 10A , 10B And 10C describes in more detail an example of the resonance phenomenon exhibited by brain 5.
[0118] According to the present invention, the stimulation device 1 for stimulating a person or patient 2 utilizes the above-mentioned resonance effect to provide targeted treatment for one or more disorders (such as visual impairment) of the brain 5.
[0119] As previously mentioned, the device 1 can be configured to treat diseases affecting the optic nerve, particularly glaucoma.
[0120] In one possible embodiment, an operator (such as a doctor or nurse) inputs the disease to be treated into the stimulation device 1 via a user interface, such as a keyboard or a graphical user interface (GUI).
[0121] The stimulation device 1 selects a relevant frequency band, such as delta wave band, theta wave band, alpha wave band, beta wave band, or gamma wave band, from its internal memory based on the input disease (e.g., glaucoma).
[0122] For example, if the operator inputs a visual impairment to be treated, the stimulation device 1 can select the alpha wave band, that is, the frequency range between 8 Hz and 13 Hz.
[0123] In this scenario, it is expected that the neurophysiological baseline frequency of Patient 2 will fall within the pre-selected alpha wave band, specifically between 8 Hz and 13 Hz.
[0124] Patient 2, who is to be treated, has his / her individualized neurophysiological baseline frequency, which may also change or drift slightly over time.
[0125] Therefore, before administering stimulation, the patient's actual neurophysiological baseline parameters at the current moment should be determined, i.e., the patient's neurophysiological baseline frequency at this moment.
[0126] In one possible embodiment, the stimulation device 1 generates an electrical stimulation signal consisting of multiple periodic electrical stimulation signal sequences, each sequence having a corresponding stimulation frequency. These electrical stimulation signal sequences are separated by interruptions of predetermined time periods and have different stimulation frequencies within a calculated frequency range (e.g., the alpha band from 8 Hz to 13 Hz).
[0127] The brain consists of multiple distinct areas that must be properly synchronized with each other to accomplish complex tasks.
[0128] In a healthy brain, this synchronization is formed automatically by the brain.
[0129] In contrast, in damaged or functionally impaired brain regions, the synchronization mechanisms between different brain regions cannot function properly.
[0130] The electrical stimulation signal applied by the stimulation device 1 around the neurophysiological baseline frequency of the patient 2 promotes synchronization between the damaged brain regions.
[0131] By continuously varying the parameters of the stimulus signal (e.g., frequency), it is possible to prevent patient 2's brain 5 from adapting (habituating) to the external synchronization frequency, which could jeopardize the effectiveness of brain resynchronization.
[0132] Figure 2 An embodiment of the stimulation device 1 according to the present invention is shown.
[0133] exist Figure 2 In the embodiment shown, the stimulation device 1 for treating patient 2 includes a stimulation unit 6 and a parameter determination unit 7.
[0134] Both the stimulation unit 6 and the parameter determination unit 7 are connected to the switching unit 8.
[0135] like Figure 2 As shown, the stimulation unit 6, parameter determination unit 7, and switching unit 8 are all controlled by the control unit 9 integrated in the stimulation device 1 through control circuits.
[0136] The stimulation unit 6 is used to generate an electrical stimulation signal. In one possible embodiment, the electrical stimulation signal may consist of multiple periodic electrical stimulation signal sequences, each sequence having a corresponding stimulation frequency.
[0137] like Figure 2 The parameter determination unit 7 shown is used to determine at least one neurophysiological basic parameter.
[0138] This neurophysiological baseline parameter can be the patient 2's neurophysiological baseline frequency, which can be obtained through EEG (electroencephalography) or MEG (magnetoencephalography).
[0139] The electrode 3-i attached to the head of patient 2 can be switched between a first operating mode (applying an electrical stimulation signal generated by stimulation unit 6 to patient 2) and a second operating mode (acquiring a signal to be recorded from the head of patient 2 and evaluating it by parameter determination unit 7) via switching unit 8.
[0140] like Figure 2 As shown, the switching operation of electrode 3-i via switch unit 8 is controlled by control unit 9.
[0141] In one possible embodiment, the parameter determination unit 7 may include a recording device and a transformation device, wherein the recording device is used to record EEG signals from the head of the patient 2, and the transformation device is used to transform the recorded EEG signals into the patient's individualized neurophysiological baseline frequency at the current moment.
[0142] In one possible embodiment, the transformation device in the parameter determination unit 7 is composed of a Fourier frequency transformation device configured to perform Fourier frequency transformation on the recorded EEG signal.
[0143] In another alternative embodiment, the transformation device is composed of an autoregressive device configured to perform autoregressive processing on the recorded EEG signal.
[0144] In one example, before the patient 2 is electrically stimulated by the electrical stimulation signal generated by the stimulation unit 6, the recording device in the parameter determination unit 7 records the patient's EEG signal for a preset recording period while the patient's eyes are closed.
[0145] In one embodiment, the stimulation unit 6 continuously changes the stimulation frequency of the electrical stimulation signal.
[0146] In another alternative embodiment, the stimulation unit 6 discretely changes the stimulation frequency of the electrical stimulation signal applied to the patient 2.
[0147] The control unit 9 can be configured to control the parameter determination unit 7 to measure the neurophysiological basic parameters of the corresponding patient 2 and control the electrical stimulation of the patient 2 by the electrical stimulation signal generated by the stimulation unit 6.
[0148] In one possible embodiment, the determination of basic neurophysiological parameters (e.g., the basic neurophysiological frequency of patient 2) and the treatment of patient 2 by stimulation signals are controlled by control unit 9 to be performed alternately.
[0149] In one possible embodiment, the device 1 includes at least one memory for storing signals recorded by the electrode 3-i attached to the patient 2.
[0150] The memory can be located in parameter determination unit 7.
[0151] In one possible embodiment, the control unit 9 is composed of a microprocessor that runs a computer program that controls at least the stimulation unit 6 and the parameter determination unit 7.
[0152] In another embodiment of device 1, parameter determination unit 7 is configured to detect the scintillation fusion frequency as the neurophysiological basis frequency of patient 2.
[0153] In this embodiment, the stimulation unit 6 stimulates the patient 2 with an electrical stimulation signal having an adjustable stimulation frequency, which is increased to induce a rhythmic flashing light sensation in the patient until the stimulation frequency gives the patient a constant light sensation.
[0154] The adjusted stimulation frequency constitutes the flicker fusion frequency of patient 2, which constitutes the neurophysiological basis frequency of patient 2.
[0155] In this embodiment, the frequency of the stimulation signal can be slowly increased from a relatively low frequency value (e.g., 4 Hz) to a relatively high frequency (e.g., 40 Hz).
[0156] Typically, patient 2 experiences optical images that flash rhythmically at the frequency of electrical stimulation, known as "phosphenes".
[0157] When the flickering light disappears and patient 2 identifies the light as constant illumination, the frequency of the stimulus signal is increased to a certain threshold frequency.
[0158] This is the so-called scintillation fusion frequency, which typically ranges from 16 Hz to 40 Hz, with the specific value varying from individual patient to individual.
[0159] From a neurological perspective, this frequency poses a significant limitation on the speed at which the brain responds to visual impressions or perceptions.
[0160] Figure 3 An exemplary structural configuration of the stimulation device 1 is shown.
[0161] Here, the switching unit 8 consists of three switches 8-1, 8-2, and 8-3, each of which is controlled by the control unit 9 to switch between two positions.
[0162] In such Figure 3 In the block diagram shown, electrodes 3-1, 3-2, and 3-3 are switched to stimulation unit 6 and receive electrical stimulation signals generated by stimulation unit 6.
[0163] When switches 8-1, 8-2, and 8-3 are in another position, electrodes 3-1, 3-2, and 3-3 are switched to parameter determination unit 7 for evaluating the detected electrical signals in order to determine at least one neurophysiological baseline parameter of each patient 2.
[0164] Figure 3 The switch 8-i shown can be a mechanical switch (such as a reed relay) or a semiconductor switch (such as a MOSFET or bipolar transistor).
[0165] exist Figure 3In the configuration shown, the stimulation unit 6 includes controllable current sources 10-2 and 10-3, which are connected to the control unit 9 via a digital data bus 11.
[0166] The stimulation unit 6 includes a corresponding adjustable current source 10-i for each signal electrode 3-2, 3-3.
[0167] For reference electrode 3-1, there is no need to set up a controllable current source.
[0168] The controllable current sources 10-2 and 10-3 are controlled by the control unit 9 via the internal data bus 11 and receive instructions for generating stimulation current pulses.
[0169] exist Figure 3 In the configuration shown, the parameter determination unit 7 includes corresponding analog signal preamplifiers 12-2 and 12-3 for each signal electrode 3-2 and 3-3, which can be composed of operational amplifiers.
[0170] In the second operating mode, preamplifiers 12-2 and 12-3 amplify the signal between the corresponding signal electrode and the reference electrode to evaluate the acquired electrical signal.
[0171] The outputs of each analog preamplifier 12-2 and 12-3 are connected to analog filters 13-2 and 13-3.
[0172] The analog filter 13-i can be in the form of a bandpass filter.
[0173] The goal is to remove potential artifacts from the detected signals, such as the movement of patient 2's eyes or head.
[0174] In addition, high-frequency noise (e.g., noise above 100 Hz) was also removed.
[0175] like Figure 3 As shown, the output of analog filter 13-i is connected to the corresponding analog-to-digital converters 14-1 and 14-2.
[0176] like Figure 3 As shown, the converted digital signal can be transmitted to the control unit 9 via the digital bus 11.
[0177] In the illustrated configuration, the control unit 9 processes the converted electrical signals obtained from the brain 5 of the patient 2 and evaluates the signals to determine the patient 2's neurophysiological baseline parameters.
[0178] Therefore, in this configuration, the control unit 9 performs some of the functions of the parameter determination unit 7.
[0179] In an alternative configuration, the parameter determination unit 7 includes not only an analog preamplifier 12-i, a filter 13-i, and an analog-to-digital converter 14-i, but also a recording device for recording technical electrical signals and a transformation device for transforming the recorded electrical signals to determine the neurophysiological fundamental frequency.
[0180] In this alternative configuration, the parameter determination unit 7 itself includes at least one processor.
[0181] In one possible configuration, an independent signal processor can be set for each signal electrode 3-2, 3-3 to calculate the neurophysiological baseline frequency of patient 2. Then, the average value of all calculated baseline frequencies is acquired and sent to control unit 9 for controlling stimulation unit 6.
[0182] The transformation device in unit 7 can perform Fourier frequency transformation on the recorded signal.
[0183] Alternatively, the transformation device in parameter determination unit 7 can also perform autoregressive processing on the recorded signal.
[0184] Figure 12 An example of a recorded EEG signal within the alpha wave band is shown.
[0185] The transformation device in parameter determination unit 7 performs Fourier frequency transformation or autoregression processing to calculate the neurophysiological baseline frequency of patient 2.
[0186] In the given example, such as Figure 12 The EEG signal shown is processed by the conversion device in parameter determination unit 7, for example, by calculating... Figure 13 The fundamental frequency (e.g., 10 Hz) is shown in the frequency spectrum diagram.
[0187] like Figure 13 As shown, the calculated spectrum has a peak at 10 Hz, which constitutes the neurophysiological baseline frequency of individual patient 2 at the reference time.
[0188] The determined baseline neurophysiological frequencies are individualized, meaning that two different patients have two different baseline neurophysiological frequencies.
[0189] In addition, the neurophysiological baseline frequency of Patient 2 is not constant, but may change over time when it is remeasured after each stimulus sequence is applied.
[0190] The universal digital data bus 11 in the stimulation device 1 can be configured to connect the current source 10-1, the output of the analog-to-digital converter 14-i, and the control unit 9.
[0191] In addition, an interface 15 can be provided for connecting the stimulation device 1 to an external computer.
[0192] The interface 15 could be, for example, a USB interface.
[0193] Figure 4 A schematic diagram of the structure of electrode 3-i, which can be used in the stimulation device 1 of this invention, is shown.
[0194] Specifically, Figure 4 The electrode 3-i shown is a dual electrode that can be attached to the skin 16 of the patient 2 to be treated (especially to the head portion of the patient 12).
[0195] The dual electrode 3-i includes an attachment to the skin 16 of the patient 2 (see...). Figure 4 The passive electrode sheet 17-i.
[0196] The passive electrode 17 is made of a suitable material, such as silver chloride Ag / Cl.
[0197] An electronic switch 18-i is provided inside the dual electrode 3-i, which can be controlled by the control unit 9 (e.g., remote control unit 9) via the control line 20-i in the cable 4-i.
[0198] The dual electrode 3-i includes its own analog signal amplifier 19-i, which is powered by the stimulation device 1 via power lines 21-i, 22-i arranged in the cable 4-i.
[0199] like Figure 3 As shown, in the detection and signal evaluation mode, the output of the first signal amplifier 19-i in the dual electrode 3-i is connected to the input of the second analog signal amplifier 12-i in the stimulation device 1 via the signal line 24-i in the cable 4-i.
[0200] exist Figure 4 In the configuration shown, the cable 4-i connecting the dual electrodes 3-i and the stimulation device 1 includes at least five lines, each of which can be electrically shielded using a suitable material (such as metal).
[0201] In addition, a coating can be applied to prevent cable contact, wherein the coating may be made of an electrically insulating material.
[0202] In the configuration shown, cable 4-i includes: two power lines (+UB, -UB) 21-i and 22-i, for powering the preamplifier 12-i and integrated within the dual electrode 3-i; a signal line 24-i for transmitting the preamplified recording signal (such as an EEG signal) to the parameter determination unit 7 within the stimulation device 1; a control line 20-i for switching between two operating modes using an integrated electronic switch 18-i; and a stimulation signal line 25-i for applying the generated stimulation signal to the passive electrode pad 17-i of the dual electrode 3-i via the switch 18-i.
[0203] Figure 5 The different components within the stimulation device 1 are shown, as well as... Figure 4 The connection method between the active dual electrodes 3-i is shown.
[0204] Control line 20-i is connected to control unit 9 of stimulation device 1.
[0205] Power cords 21-i and 22-i are connected to power unit 23 inside stimulation device 1.
[0206] like Figure 4 The signal line 24-i used to transmit detection signals (such as EEG signals) is connected to the preamplifier 12-i in the stimulation device 1 via the switch 8-i.
[0207] exist Figure 4 and Figure 5 In the illustrated embodiment, each dual electrode 3-i is connected to the stimulation device 1 via a corresponding cable 4-i, and each cable 4-i includes five signal lines. In an alternative embodiment, all dual electrodes 3-i can be connected to the stimulation device 1 via a shared single cable.
[0208] Figure 6 A further schematic diagram of a possible configuration of the dual electrodes 3-i used in the stimulation device 1 of this invention is shown.
[0209] In this configuration, the electronic circuitry of the dual electrodes 3 (i.e., the semiconductor switch 18-i and the preamplifier 19-i) is integrated within a housing 26 consisting of a shielding layer 26A and an electrical isolation layer 26B.
[0210] The passive electrode material of the passive electrode sheet 17-i can be gold or Ag / Cl.
[0211] Figure 7 Sections 7A and 7B show schematic diagrams illustrating possible operating modes of the stimulation device 1.
[0212] For example, Figure 7 Section 7A shows that the stimulation unit 6 of the device 1 can generate an electrical stimulation signal.
[0213] For example, the applied signal current intensity can be in the range of 200 µA, and the pulse width in the pulse sequence can be in the range of 5 milliseconds to 10 milliseconds.
[0214] Each individual pulse may be followed by an interruption of up to one second.
[0215] exist Figure 7 The signal diagram in section 7B shows a typical measured EEG signal.
[0216] Typical signal amplitude is in the range of + / - 50 µV.
[0217] Figure 7 Each individual pulse of the stimulus signal shown in section 7A elicits a response in the patient’s brain 5, which varies depending on the amplitude, duration, and form of the applied stimulus signal.
[0218] exist Figure 7 In the schematic diagram shown in section 7A, at points A and C, the stimulation unit 6 is switched to electrode 3, while the parameter determination unit 7 is disconnected.
[0219] Then, at B and D4, stimulation unit 6 is turned off, and electrode 3 is connected to parameter determination unit 7.
[0220] like Figure 7 As shown in section 7A, each pulse can consist of a positive signal peak followed by a negative signal peak, thus making the integral value zero.
[0221] like Figure 7 As shown in section 7B, due to the cognitive processes in brain 5 triggered by the stimulus signal pulses, the signal response of brain 5 is generated with a certain time delay, for example, 100 to 200 milliseconds.
[0222] like Figure 7 As shown in section 7B, the signal response obtained from brain 5 can be a positive response pulse or a negative response pulse.
[0223] In a preferred configuration, the amplitude of the stimulus signal is significantly higher than the amplitude of the obtained response or EEG signal.
[0224] Not shown, in one embodiment, device 1 also includes an eye mask or glasses that cover the eye area of patient 2.
[0225] Here, at least some of the electrodes 3 are embedded in the eye mask or glasses.
[0226] Not shown, in another embodiment, the device 1 further includes an eye mask or glasses and a hat.
[0227] Here, one or more electrodes 3 configured to apply electrical stimulation signals are embedded in the eye mask or glasses.
[0228] Furthermore, one or more electrodes 3 configured to detect electrical signals from the brain 5 and / or other sensory organs (such as the eyes) are embedded in the cap.
[0229] In a preferred configuration, the hat is an EEG hat.
[0230] Figure 8 A device 1 that can be used with this invention is shown (e.g. Figure 1 The device 1) is an example method of stimulating the patient with electrical stimulation signals.
[0231] This example method will be described in more detail below.
[0232] Based on the determination that a user (such as a surgeon, assistant, etc.) has entered a one-time code, the control unit 9 operates the device 1.
[0233] The user enters a one-time code through a user interface (such as a display device of the type of touch screen), which is operatively connected to the control unit 9.
[0234] In order to treat patient 2 with stimulation signals, EEG signals are first recorded in step S1 to assess patient 2’s current neurological state.
[0235] The acquisition and recording of EEG signals can be performed continuously for a preset time period while the patient's eyes are closed.
[0236] In one example, the recorded time period may last from 1 to 2 minutes.
[0237] After the EEG signal is recorded in step S1, the basic neurophysiological frequency is determined in step S2 by the parameter determination unit 7 in the stimulation device 1.
[0238] For example, such as Figure 13 As shown, through as Figure 12 The EEG signal shown indicates that the patient's basic physiological frequency is 10 Hz.
[0239] In one example, the fundamental neurophysiological frequency is determined by performing a Fourier frequency transform or an autoregressive AR transform device.
[0240] In one example, the neurophysiological baseline frequency is determined after removing signal artifacts, such as those caused by the movement of the patient 2's eyeballs or head, from the signal.
[0241] In a further step S3, the frequency range around the determined neurophysiological baseline parameter (e.g., baseline frequency) is calculated.
[0242] For example, this can be achieved by multiplying the detected neurophysiological baseline frequency by an upper limit weighting factor and a lower limit weighting factor, respectively, which represent a percentage value.
[0243] The upper limit weighting or restriction factor can be 140%, or 1.4, while the lower limit weighting factor can be 80%, or 0.8.
[0244] If the neurophysiological baseline frequency determined in step S2 is, for example, 10 Hz, then the upper limit frequency is 14 Hz and the lower limit frequency is 8 Hz.
[0245] Accordingly, the calculated parameter range is, for example, a frequency range of 8 Hz–14 Hz.
[0246] In a further step S4, the desired signal modulation method for the stimulus signal can be selected.
[0247] In one example, the stimulation frequency or parameters of the stimulus signal vary discretely.
[0248] At this point, the frequency range between the upper and lower frequency limits can be divided into at most n intervals of the same size.
[0249] For example, when n = 5, the following frequencies can be calculated: 8 Hz, 9.5 Hz, 11 Hz, 12.5 Hz, and 14 Hz.
[0250] Starting from the lowest frequency of 8 Hz, the entire calculated frequency range is swept across with a distance step length.
[0251] Once the highest frequency of 14 Hz is reached, the entire calculated frequency range is swept in reverse order.
[0252] Therefore, a frequency-varying stimulus signal is applied to the patient 2 to be treated, that is, the stimulus signal has a varying frequency: 8 Hz, 9.5 Hz, 11 Hz, 12.5 Hz, 14 Hz, 12.5 Hz, 11 Hz, 9.5 Hz, 8 Hz, 9.5 Hz, ... etc.
[0253] Alternatively, the calculated frequency range can be swept continuously, for example, the stimulation unit 6 in stimulation device 1 can continuously change the stimulation frequency between two frequency limits.
[0254] In another example, stimulation unit 6 in stimulation device 1 randomly applies a signal with a frequency that varies within a calculated frequency range.
[0255] In a further example, the frequency range between the upper and lower limit frequency ranges is divided into up to four equally sized intervals with a series of discrete frequency steps such as 8 Hz and 9.5 Hz, and the frequency steps are randomly selected by a random generator.
[0256] All of these examples share a common characteristic: because the stimulation frequency is varied by sweeping across a predetermined frequency range or by randomly selecting frequencies within a calculated frequency range, the patient 2's brain 5 does not adapt to a specific stimulation frequency.
[0257] In a further step S5, a stimulation signal is applied to the scalp of the patient 2 to be treated via the stimulation unit 6.
[0258] For example, patient 2 is subjected to electrical stimulation for a predetermined period of time (e.g., for 1 to 20 seconds) at a stimulation frequency.
[0259] Here, stimulation unit 6 generates an electrical stimulation signal consisting of multiple periodic electrical stimulation signal sequences, each sequence having a corresponding stimulation frequency.
[0260] These electrical stimulation signal sequences can be separated by signal interruptions over predetermined time periods and have different stimulation frequencies within a calculated frequency range.
[0261] In one example, the electrical stimulation signal sequence has the same signal form.
[0262] In another alternative example, the electrical stimulation signal sequence can also have different signal forms.
[0263] Periodic electrical stimulation signal sequences can include pulses or a single sinusoidal signal waveform.
[0264] In one example, as the stimulation frequency of the electrical stimulation signal sequence increases, the pulse width of the pulses within the electrical stimulation signal sequence decreases.
[0265] Therefore, the pulse width can be adjusted proportionally according to the frequency change.
[0266] Frequency is the product of the multiplication factor and the fundamental frequency.
[0267] The adjusted pulse width is the value obtained by dividing the initially set pulse width by the multiplication factor.
[0268] In one example, the multiplication factor is, for example, 1.2, and the primary or fundamental frequency of patient 2 is 10 Hz.
[0269] The initial pulse width is set to, for example, 9 milliseconds.
[0270] Based on this set frequency, the adjusted pulse width can be calculated as follows: Stimulation frequency = 1.2 × 10 Hz = 12 Hz; and Pulse width = 9 ms : 1.2 = 7.5 ms For example, the detected fundamental frequency (as determined in step S2) is 10 Hz, and the multiplication factor is set to 0.8 to 1.4, corresponding to the calculated frequency range of 8 Hz to 14 Hz. In one possible implementation, the modulation frequency varies between 8 Hz, 9.5 Hz, 11 Hz, 12.5 Hz and 14 Hz in specific equidistant steps.
[0271] In one example, the patient was first stimulated with a sinusoidal signal at a frequency of 8 Hz for 10 seconds, followed by a 1-minute signal interruption period.
[0272] Next, stimulation unit 6 applies a 9.5 Hz sinusoidal stimulation signal for 10 seconds, followed by a 1-minute signal interruption period.
[0273] Then, stimulation unit 6 applies the next frequency (i.e., 11 Hz) within the frequency range for 10 seconds, followed by a 1-minute signal interruption period, and so on.
[0274] Once the highest frequency of 14 Hz is reached, the frequency of the stimulus signal is gradually reduced according to the calculated frequency steps.
[0275] In one example, frequencies can be randomly selected from the calculated 8 Hz–14 Hz frequency range, such as 8 Hz, 8.3 Hz, 9.7 Hz, 13.1 Hz, 9.2 Hz, etc.
[0276] In another alternative example, such as Figure 14 As shown, adaptive pulse width can be used for electrical stimulation.
[0277] For example, a stimulation signal with a frequency of 10 Hz and a pulse width of 9 ms is followed by a stimulation signal with a frequency of 12 Hz and a pulse width reduced to 7.5 ms, then a stimulation signal with a frequency of 14 Hz and a pulse width further reduced to 6.42 ms, and so on.
[0278] exist Figure 8 In the example shown, electrical stimulation is performed under a feedback mechanism.
[0279] During this process, EEG signals are recorded and evaluated after stimulation at predetermined times to detect possible changes in the neurophysiological baseline frequency of brain 5.
[0280] exist Figure 8 In the example, step S6 determines whether the treatment or process has ended.
[0281] If the total treatment time has been reached, then stimulation should be stopped.
[0282] Otherwise, the method returns to step S1.
[0283] Figure 9 A flowchart is shown as another example of a method for stimulating patient 2 using electrical stimulation signals, which can be implemented by the device of this invention.
[0284] This example method will be described in detail below.
[0285] When it is determined that a user (such as a surgeon, assistant, etc.) has entered a one-time code, the control unit 9 operates the device 1.
[0286] The user enters the one-time code through a user interface (e.g., a user interface of a touchscreen type display device), which is operatively connected to the control unit 9.
[0287] In this example, stimulation device 1 first determines the so-called scintillation fusion frequency in step S7.
[0288] Stimulation unit 6 stimulates the patient with an electrical stimulation signal having an adjustable stimulation frequency. The stimulation frequency is increased to induce rhythmic flashing light sensation in the patient until the stimulation frequency induces a constant light sensation in the patient.
[0289] The stimulation frequency adjusted in response to perceived changes constitutes the flicker fusion frequency, which is the neurophysiological baseline frequency of the corresponding patient 2. Based on the determined scintillation fusion frequency, the frequency range is calculated in step S8, which is related to... Figure 8 Step S3 is the same as in the example shown.
[0290] In the further step S9, corresponding to Figure 8 In step S4, select the modulation method of the stimulus signal.
[0291] Then corresponding to Figure 8 In step S5, a stimulation signal is applied in step S10.
[0292] from Figure 9 As can be seen from the flowchart shown, there is no feedback mechanism in this example.
[0293] exist Figure 9 In the example shown without a feedback mechanism, electrical stimulation therapy is performed on patient 2 within a calculated frequency range.
[0294] Figure 10A , 10B Figure 10C shows a schematic diagram illustrating the frequency resonance phenomenon signal in the brain 5 of patient 2.
[0295] In the given example, patient 2's brain 5 was stimulated at different frequencies, for example... Figure 10A The frequency of 79 Hz shown Figure 10B The frequency of 80 Hz shown and Figure 10C The frequency shown is 81 Hz.
[0296] When a stimulus signal with a frequency of 80 Hz is applied, such as Figure 10B As shown in the signal diagram, the brain 5 generates a neurophysiological basic response frequency of 80Hz.
[0297] Figure 11 This is another schematic diagram illustrating the resonant frequency phenomenon exhibited by patient 2.
[0298] In this example, the stimulation frequency can vary between 1 Hz and 100 Hz.
[0299] Figure 11 The vertical y-axis of the graph shown represents the stimulation frequency, which varies from 1 Hz to 100 Hz.
[0300] Figure 11 The horizontal x-axis of the graph shown represents the measured response frequency.
[0301] from Figure 11 It can be seen that Brain 5 exhibits a resonance effect at certain frequencies (such as the stimulation frequency of 39 Hz) and multiple resonance response frequencies appear: 13 Hz, 26 Hz, 39 Hz, 52 Hz, 59 Hz and 81 Hz.
[0302] The stimulation device 1 according to this utility model can be used to treat various functional disorders caused by brain injury or brain disease in patient 2.
[0303] In particular, the stimulation device 1 according to this invention can be used to treat patients' language disorders, cognitive disorders, motor disorders, memory disorders, and hearing and visual disorders.
[0304] In addition, the stimulation device 1 of this invention can also be used to treat functional neurological disorders in patient 2.
[0305] The device 1 of this invention can also be used to treat retinal diseases in patients 2.
[0306] In addition, the device can also be used to treat patients' epilepsy and depressive disorders.
[0307] In addition, amblyopia can also be treated with this device.
[0308] In addition, the device 1 of this invention can also be used to treat pathological conditions affecting the optic nerve.
[0309] For example, the device 1 can be used to treat glaucoma.
[0310] Other configurations of the stimulation device 1 are also possible.
[0311] For example, stimulation device 1 can also use conventional electrodes instead of dual electrodes.
[0312] In this configuration, the stimulation signal is applied through a first set of signal electrodes, while the recorded signal is acquired through a second set of signal electrodes.
[0313] In addition to electrical stimulation via electrode 3, patient 2 can also be stimulated by visual or auditory stimulation signals, which can have the same frequency as the electrical stimulation signal.
[0314] For example, the patient 2 to be treated can receive an electrical stimulation signal with a stimulation frequency varying within a frequency range calculated around a determined neurophysiological frequency, and simultaneously watch a display providing a video signal with the same frequency and phase as the electrical stimulation signal.
[0315] Figure Labels 1 device 2 patients 3 electrodes 4 cables 5 Brains 6 stimulation units 7. Determine the unit 8 switch units 9 control units 10 Current Sources 11 Internal Data Bus 12 Preamplifier 13 Analog Filters 14 Analog-to-Digital Converters 15 interfaces 16 skins 17 passive electrode plates 18 electronic switches 19 First Signal Amplifier 20 control lines 21 power cord 22 power cord 23 power supply units 24 signal lines 25 stimulation signal lines 26 shell 26A Shielding Layer (Shell) 26B Electrical Isolation Layer (Enclosure)
Claims
1. A device (1) for stimulating a patient (2), comprising: Stimulation unit (6), the stimulation unit (6) is used to apply an electrical stimulation signal; and parameter determination unit (7), wherein the parameter determination unit (7) is used to determine at least one neurophysiological basic parameter; Its features are: The electrical stimulation signal has at least one variable stimulation signal parameter that continuously varies within a range of calculated parameters surrounding the determined neurophysiological baseline parameters of the patient (2). The parameter determination unit (7) includes: a device for detecting electrical signals from the brain (5) and / or other sensory organs of the patient (2), and a device for analyzing the detected electrical signals to determine the neurophysiological basic parameters of the patient (2); The determined neurophysiological baseline parameters include the neurophysiological baseline frequencies of the patient (2); The parameter determination unit (7) includes a plurality of electrodes (3) configured to attach to the patient's skin surface, each electrode (3) being adapted to apply the electrical stimulation signal and / or detect electrical signals from the brain (5) and / or other sensory organs; and The device (1) further includes a control unit (9) configured to operate the device (1) to stimulate the patient (2) when it is determined that a user has entered a one-time code through a user interface operably connected to the control unit (9).
2. The device (1) according to claim 1, characterized in that, The stimulation unit (6) generates an electrical stimulation signal consisting of multiple periodic electrical stimulation signal sequences, each of which has a corresponding stimulation frequency; The multiple periodic electrical stimulation signal sequences are separated by signal interruption periods of predetermined time periods and have different stimulation frequencies within a calculated frequency range.
3. The device (1) according to claim 1 or 2, characterized in that, The parameter determination unit (7) includes: A recording device for recording the electroencephalogram (EEG) signals of the patient (2); and A conversion device for converting the recorded EEG signal into the neurophysiological baseline frequency of the patient (2).
4. The device (1) according to claim 3, characterized in that, The transformation device is composed of a Fourier frequency transformation device suitable for performing Fourier frequency transformation on the recorded EGG signal, or an autoregressive device suitable for performing autoregressive processing on the recorded EEG signal.
5. The device (1) according to claim 1, characterized in that, The parameter determination unit (7) is adapted to detect the scintillation fusion frequency as the neurophysiological basis frequency of the patient (2).
6. The device (1) according to claim 3, characterized in that, Each electrode (3) is adapted to apply an electrical stimulation signal to the patient (2) and / or record the patient's (2) EEG signal.
7. The device (1) according to claim 5, characterized in that, The stimulation unit (6) is configured to stimulate the patient (2) with an electrical stimulation signal having an adjustable stimulation frequency, the stimulation frequency being increased to cause the patient (2) to produce a rhythmic flashing light sensation until the stimulation frequency induces a constant light sensation in the patient (2). The adjusted stimulation frequency is the flicker fusion frequency that constitutes the neurophysiological basis frequency of the patient (2).
8. The device (1) according to claim 1 or 2, characterized in that, The stimulation unit (6) is configured to continuously or discretely change the stimulation frequency of the electrical stimulation signal.
9. The device (1) according to claim 1 or 2, characterized in that, The control unit (9) is configured to control the parameter determination unit (7) to measure the neurophysiological basic parameters of the patient (2), and to control the stimulation unit (6) to stimulate the patient (2) through an electrical stimulation signal; The determination of the neurophysiological parameters and the stimulation are controlled by the control unit (9) in an alternating manner.
10. The device (1) according to claim 3, characterized in that, The multiple periodic electrical stimulation signal sequences of the electrical stimulation signal include different signal forms.
11. The device (1) according to claim 10, characterized in that, The multiple periodic electrical stimulation signal sequences include pulses or have sinusoidal signal waveforms.
12. The device (1) according to claim 11, characterized in that, The pulse width of the pulses within the electrical stimulation signal sequence decreases as the stimulation frequency of the electrical stimulation signal sequence increases.
13. The device (1) according to claim 1 or 2, characterized in that, The electrode (3) attached to the patient (2) is capable of switching between applying an electrical stimulation signal to the patient (2) in a first operating mode and acquiring a signal to be recorded from the patient (2) in a second operating mode. The switching of the electrode (3) is controlled by the control unit (9).
14. The device (1) according to claim 13, characterized in that, A memory is configured to store signals recorded by the attached electrode (3) in the second operating mode.
15. The device (1) according to claim 1, characterized in that, The electrode (3) is attached to the skin surface of the patient (2) by tape.
16. The device (1) according to claim 1, characterized in that, The device (1) further includes an eye mask or glasses for covering the eye area of the patient (2); At least some of the electrodes (3) are embedded in the eye mask or glasses.
17. The device (1) according to claim 1, characterized in that, The device (1) further includes an eye mask or glasses and a hat; One or more electrodes (3) configured to apply the electrical stimulation signal are embedded in the eye mask or glasses; One or more electrodes (3) configured to detect electrical signals from the brain (5) and / or other sensory organs are embedded in the cap.
18. The device (1) according to claim 1, characterized in that, The device (1) is configured for the treatment of glaucoma.
19. The device (1) according to claim 1, characterized in that, The sensory organ in question is the eye.
Citation Information
Patent Citations
Device for neurostimulation
WO2013107678A1
