Electrical stimulation method and electrical stimulation device

Abstract

The present application provides an electrical stimulation method. The electrical stimulation method is applicable to an electrical stimulation device. The steps of the electrical stimulation method include: obtaining an electrical stimulation level by the electrical stimulation device, wherein the electrical stimulation level corresponds to a target energy value; and performing electrical stimulation on a target region of a target object by the electrical stimulation device according to the target energy value, wherein all electrodes of the electrical stimulation device are activated when performing the electrical stimulation.

Description

Technical Field

[0001] The embodiments of the present invention mainly relate to an electrical stimulation technique. Background Technology

[0002] In recent years, dozens of therapeutic neurostimulation devices have been developed, and at least tens of thousands of people undergo implantation surgery for these devices each year. Thanks to advancements in precision manufacturing technology, medical devices have been miniaturized and can be implanted inside the human body; for example, implantable neurostimulation devices.

[0003] Traditionally, during electrical stimulation, users often need to decide which electrodes on the leads should be activated (activated or enabled), and which of the activated electrodes are negative and which are positive. Therefore, how to perform electrical stimulation more conveniently is an important issue. Summary of the Invention

[0004] In view of the problems of the prior art described above, embodiments of the present invention provide an electrical stimulation method and an electrical stimulation device.

[0005] An embodiment of the present invention provides an electrical stimulation method. The above-described electrical stimulation method is applicable to an electrical stimulation device. The steps of the above-described electrical stimulation method include: obtaining an electrical stimulation level through the electrical stimulation device, wherein the electrical stimulation level corresponds to a target energy value; and applying electrical stimulation to a target region of a target object according to the target energy value through the electrical stimulation device, wherein all electrodes of the electrical stimulation device are activated during the electrical stimulation.

[0006] An embodiment of the present invention provides an electrical stimulation device. The electrical stimulation device includes a controller and a plurality of electrodes. The controller acquires an effective electrical stimulation level, wherein the acquired electrical stimulation level corresponds to a target energy value. The controller performs electrical stimulation on a target region of a target object according to the target energy value. During electrical stimulation, the plurality of electrodes of the electrical stimulation device are activated.

[0007] Other additional features and advantages of the present invention can be obtained by those skilled in the art through some modifications and refinements based on the electrical stimulation method and electrical stimulation device disclosed in the embodiments of the present invention, without departing from the concept and scope of the present invention. Attached Figure Description

[0008] Figure 1 This is a block diagram showing an electrical stimulation device according to an embodiment of the present invention.

[0009] Figure 2 This is a schematic diagram of an electrical stimulation device according to an embodiment of the present invention.

[0010] Figure 3 This is a waveform diagram of the electrical stimulation signal of an electrical stimulation device according to an embodiment of the present invention.

[0011] Figure 4 This is a detailed schematic diagram of an electrical stimulation device according to an embodiment of the present invention.

[0012] Figure 5A It is a first target energy value group according to an embodiment of the present invention.

[0013] Figure 5B It is a second target energy value group according to an embodiment of the present invention.

[0014] Figure 6 This is a flowchart of an electrical stimulation method according to an embodiment of the present invention.

[0015] Explanation of reference numerals in the attached figures: 100: Electrical stimulation device 110: Power Management Circuit 120: Electrical stimulation signal generation circuit 121: Variable resistor 122: Waveform Generator 123: Differential Amplifier 124: Channel Switching Circuit 125: First resistor 126: Second resistor 130: Measurement Circuit 131: Current Measurement Circuit 132: Voltage Measurement Circuit 140: Control Unit 150: Communication circuit 160: Storage unit 200: External control device 210, L: Conductor 211: One end 212: The other end 221, 222: Electrodes 600: Flowchart S610~S620: Steps T p Pulse cycle time T d Duration T s Electrical stimulation signal cycle time Detailed Implementation

[0016] This section describes preferred embodiments of the invention and is intended to illustrate the concept of the invention rather than to limit the scope of protection of the invention, which shall be determined by the claims.

[0017] Figure 1 This is a block diagram showing an electrical stimulation device 100 according to an embodiment of the present invention. Figure 1 As shown, the electrical stimulation device 100 may include at least a power management circuit 110, an electrical stimulation signal generation circuit 120, a measurement circuit 130, a control unit 140, a communication circuit 150, and a storage unit 160. Note that in Figure 1 The block diagrams shown are for illustrative purposes only and are not intended to represent embodiments of the present invention. Figure 1 Limited to this. The electrical stimulation device 100 may also include other elements.

[0018] According to one embodiment of the present invention, the electrical stimulation device 100 may be electrically coupled to an external control device 200. The external control device 200 may have an operating interface. Based on the user's operation on the operating interface, the external control device 200 may generate instructions or signals to be transmitted to the electrical stimulation device 100, and transmit the instructions or signals to the electrical stimulation device 100 via a wired communication method (e.g., a transmission line).

[0019] Furthermore, according to another embodiment of the present invention, the external control device 200 may also transmit instructions or signals to the electrical stimulation device 100 via a wireless communication method, such as Bluetooth, Wi-Fi or Near Field Communication (NFC), but the present invention is not limited thereto.

[0020] According to embodiments of the present invention, the electrical stimulation device 100 may be an implantable electrical stimulation device, an external electrical stimulation device with implanted leads, or a transcutaneous electrical-stimulation device (TENS). According to one embodiment of the present invention, when the electrical stimulation device 100 is a non-implantable electrical stimulation device (e.g., an external electrical stimulation device or a transcutaneous electrical stimulation device), the electrical stimulation device 100 may be integrated with an external control device 200 into a single device. According to one embodiment of the present invention, the electrical stimulation device 100 may be a battery-powered electrical stimulation device or an electrical stimulation device that wirelessly transmits power from an external control device 200. According to one embodiment of the present invention, in a trial phase, the electrical stimulation device 100 is an external electrical stimulation device with implanted leads, the leads having electrodes, and the external electrical stimulation device emitting electrical stimulation signals via the electrodes on the leads to the corresponding target area. During the trial phase, after one end of the lead wire with electrodes is implanted into the human body, the other end is connected to the external control device 200. The external electrical stimulation device can then emit electrical stimulation signals to assess the effectiveness of the treatment and confirm whether the lead wire functions normally and whether the implantation position is correct. During the trial phase, the external control device 200 first wirelessly pairs with the external electrical stimulation device (i.e., the non-implantable electrical stimulation device). After the lead wire is implanted in the human body, the external electrical stimulation device (i.e., the non-implantable electrical stimulation device) connects to the lead wire, and the external control device 200 wirelessly controls the external electrical stimulation device (i.e., the non-implantable electrical stimulation device) to provide electrical stimulation to the human body. According to an embodiment of the present invention, if the evaluation during the trial phase is effective, a permanent implantation phase can be performed. In the permanent implantation phase, the electrical stimulation device 100 can be implanted into the human body together with the lead wire. The electrical stimulation device 100 emits electrical stimulation signals that are transmitted to the corresponding target area via the electrodes on the lead wire. When the external control device 200 is to enter the permanent implantation stage, the user or doctor needs to use a phase change card to allow the external control device 200 to sense it. This is done via near-field wireless communication to change the usage status of the external control device 200 from the trial stage to the permanent implantation stage. Furthermore, the external control device 200 can select an upper limit target energy value and a lower limit target energy value from a first target energy value set based on a predetermined electrical stimulation level. Then, the external control device 200 can generate a second target energy value set based on the upper and lower limit target energy values ​​(further explanation will follow).In addition, before or during the permanent implantation procedure, the external control device 200 and the implantable electrical stimulation device will be wirelessly paired, and the external electrical stimulation device (i.e., the non-implantable electrical stimulation device) will be removed, and the connecting wires of the electrical stimulation device 100 (i.e., the implantable electrical stimulation device) will be implanted into the human body.

[0021] According to an embodiment of the present invention, the power management circuit 110 is used to provide power to the components and circuits inside the electrical stimulation device 100. The power provided by the power management circuit 110 may come from a built-in rechargeable battery or an external control device 200, but the invention is not limited thereto. The external control device 200 may provide power to the power management circuit 110 via a wireless power supply technology. The power management circuit 110 may be activated or deactivated according to instructions from the external control device 200. According to one embodiment of the present invention, the power management circuit 110 may include a switching circuit (not shown). The switching circuit may be turned on or off according to instructions from the external control device 200 to activate or deactivate the power management circuit 110.

[0022] According to an embodiment of the present invention, the electrical stimulation signal generation circuit 120 is used to generate an electrical stimulation signal. The electrical stimulation device 100 can transmit the generated electrical stimulation signal to electrodes on the wire via at least one wire to electrically stimulate a target area of ​​a user (human, animal) or patient's body. The target area may be, for example, the spinal cord, spinal nerve, dorsal root ganglion (DRG), cranial nerve, vagus nerve, trigeminal nerve, lateral recess, or peripheral nerve, but the present invention is not limited thereto. Detailed construction of the electrical stimulation signal generation circuit 120 will be described later. Figure 4 Let me explain.

[0023] Figure 2 This is a schematic diagram of an electrical stimulation device 100 according to an embodiment of the present invention. Figure 2 As shown, an electrical stimulation signal can be output to the wire 210, allowing the signal to be transmitted via one end 211 of the wire 210 to the other end 212 (electrode 221 or electrode 222) for electrical stimulation in the target area. In one embodiment of the invention, the electrical stimulation device 100 and the wire 210 can be electrically connected to each other in a detachable manner, but this is not a limitation of the invention; for example, the electrical stimulation device 100 and the wire 210 can be an integrally formed device.

[0024] According to another embodiment of the present invention, the electrodes can be directly disposed on one side of the electrical stimulation device 100. Electrical stimulation signals can be transmitted to the electrodes to perform electrical stimulation in a target area. That is, in this embodiment, the electrical stimulation device 100 does not need to transmit electrical stimulation signals to the electrodes via wires.

[0025] Figure 3 This is a waveform diagram of the electrical stimulation signal of an electrical stimulation device according to an embodiment of the present invention. Figure 3 As shown, according to one embodiment of the present invention, the aforementioned electrical stimulation signal can be a pulsed radio-frequency (PRF) signal (or simply a pulse signal), a continuous sine wave, or a continuous triangular wave, etc., but the embodiments of the present invention are not limited to these. Furthermore, when the electrical stimulation signal is a pulsed AC signal, the pulse cycle time T... p It includes a pulse signal and at least a rest period, with a pulse cycle time T. p This is the reciprocal of the pulse repetition frequency. The pulse repetition frequency range (also simply called the pulse frequency range) is, for example, between 0 and 1 kHz, preferably between 1 and 100 Hz, while the pulse repetition frequency of the electrical stimulation signal in this embodiment is, for example, 2 Hz. Additionally, the duration T of a pulse within one pulse cycle is... d The pulse width (i.e., the pulse width) is, for example, between 1 and 250 milliseconds, preferably between 10 and 100 ms, while the duration T in this embodiment... d Taking 25ms as an example. In this embodiment, the frequency of the electrical stimulation signal is 500kHz, in other words, the period T of the electrical stimulation signal is... s The duration is approximately 2 microseconds (μs). Furthermore, the frequency of the aforementioned electrical stimulation signal is... Figure 3The intra-pulse frequency of each pulsed AC signal. In some embodiments, the intra-pulse frequency range of the above-mentioned electrical stimulation signal is, for example, from 1 kHz to 1000 kHz. It should be noted that in the various embodiments of the present invention, when only the frequency of the electrical stimulation signal is described, it refers to the intra-pulse frequency of the electrical stimulation signal. Further, the intra-pulse frequency range of the electrical stimulation signal is, for example, from 200 kHz to 800 kHz. Even further, the intra-pulse frequency range of the electrical stimulation signal is, for example, from 480 kHz to 520 kHz. Even further, the intra-pulse frequency of the electrical stimulation signal is, for example, 500 kHz. The voltage range of the above-mentioned electrical stimulation signal can be between -25V and +25V. Further, the voltage of the above-mentioned electrical stimulation signal can also be between -20V and +20V. The current range of the above-mentioned electrical stimulation signal can be between 0 and 60 mA. Further, the current range of the above-mentioned electrical stimulation signal can also be between 0 and 50 mA.

[0026] According to one embodiment of the present invention, the user may operate the electrical stimulation device 100 to perform electrical stimulation only when they feel it is necessary (e.g., when symptoms worsen or do not improve). After the electrical stimulation device 100 performs one electrical stimulation on the target area, the device must wait for a limited time before performing another electrical stimulation on the target area. For example, after the electrical stimulation device 100 performs one electrical stimulation, it must wait 30 minutes (i.e., the limited time) before performing another electrical stimulation on the target area. However, the present invention is not limited to this, and the limited time may also be any time interval of 45 minutes, 1 hour, 4 hours, or 24 hours.

[0027] According to an embodiment of the present invention, the measuring circuit 130 can measure the voltage and current values ​​of the electrical stimulation signal generated by the electrical stimulation signal generation circuit 120. Furthermore, the measuring circuit 130 can measure the voltage and current values ​​on tissues in a target area of ​​the user's or patient's body. According to one embodiment of the present invention, the measuring circuit 130 can adjust the current and voltage of the electrical stimulation signal according to the instructions of the control unit 140. Detailed construction of the measuring circuit 130 will be described below. Figure 4 Let me explain.

[0028] According to embodiments of the present invention, the control unit 140 may be a controller, a microcontroller, or a processor, but the invention is not limited thereto. The control unit 140 can be used to control the electrical stimulation signal generation circuit 120 and the measurement circuit 130. The operation of the control unit 140 will be described below. Figure 4 Let me explain.

[0029] According to an embodiment of the present invention, the communication circuit 150 can be used to communicate with an external control device 200. The communication circuit 150 can transmit instructions or signals received from the external control device 200 to the control unit 140, and transmit data measured by the electrical stimulation device 100 to the external control device 200. According to an embodiment of the present invention, the communication circuit 150 can communicate with the external control device 200 via a wireless or wired communication method.

[0030] According to one embodiment of the present invention, when electrical stimulation is performed, all electrodes of the electrical stimulation device 100 are activated (or enabled). Therefore, the user does not need to select which electrodes on the leads need to be activated, or which activated electrode is negative or positive. For example, if the electrical stimulation device 100 is configured with eight electrodes, these eight electrodes may be arranged with four positive and four negative electrodes alternately.

[0031] Compared to traditional electrical stimulation, which uses low-frequency (e.g., 10kHz) pulse signals and is prone to causing pain or paresthesia and discomfort to the user, in one embodiment of the present invention, the electrical stimulation signal is a high-frequency (e.g., 500kHz) pulse signal, so it will not cause paresthesia to the user, or will only cause very slight paresthesia.

[0032] According to embodiments of the present invention, the storage unit 160 may be a volatile memory (e.g., random access memory, RAM), or a non-volatile memory (e.g., flash memory, read-only memory, ROM), a hard disk, or a combination of the above. The storage unit 160 may be used to store files and data required for electrical stimulation. According to one embodiment of the present invention, the storage unit 160 may be used to store information related to a lookup table provided by an external control device 200.

[0033] Figure 4 This is a schematic diagram of an electrical stimulation device 100 according to an embodiment of the present invention. Figure 4 As shown, the electrical stimulation signal generation circuit 120 may include a variable resistor 121, a waveform generator 122, a differential amplifier 123, a channel switching circuit 124, a first resistor 125, and a second resistor 126. The measurement circuit 130 may include a current measurement circuit 131 and a voltage measurement circuit 132. Note that in Figure 4 The schematic diagrams shown are for illustrative purposes only and are not intended to represent embodiments of the present invention. Figure 4The electrical stimulation device 100 may also include other components or other equivalent circuitry.

[0034] like Figure 4 As shown, according to an embodiment of the present invention, the variable resistor 121 can be coupled to a Serial Peripheral Interface (SPI) (not shown) of the control unit 140. The control unit 140 can transmit commands to the variable resistor 121 via the SPI to adjust the resistance value of the variable resistor 121, thereby adjusting the magnitude of the desired output electrical stimulation signal. The waveform generator 122 can be coupled to a Pulse Width Modulation (PWM) signal generator (not shown) of the control unit 140. The PWM signal generator can generate a square wave signal and transmit the square wave signal to the waveform generator 122. After receiving the square wave signal generated by the PWM signal generator, the waveform generator 122 converts the square wave signal into a sine wave signal and transmits the sine wave signal to the differential amplifier 123. The differential amplifier 123 can convert the sine wave signal into a differential signal (i.e., the output electrical stimulation signal) and transmit the differential signal to the channel switching circuit 124 via the first resistor 125 and the second resistor 126. The channel switching circuit 124 can transmit differential signals (i.e., output electrical stimulation signals) sequentially to the electrodes corresponding to each channel via wires L according to the instructions of the control unit 140.

[0035] like Figure 4 As shown, according to an embodiment of the present invention, the current measurement circuit 131 and the voltage measurement circuit 132 can be coupled to the differential amplifier 123 to obtain the current and voltage values ​​of the differential signal (i.e., the output electrical stimulation signal). Furthermore, the current measurement circuit 131 and the voltage measurement circuit 132 can be used to measure the voltage and current values ​​on tissues in a target area of ​​the user's or patient's body. Additionally, the current measurement circuit 131 and the voltage measurement circuit 132 can be coupled to the input / output (I / O) interface (not shown) of the control unit 140 to receive instructions from the control unit 140. According to the instructions from the control unit 140, the current measurement circuit 131 and the voltage measurement circuit 132 can adjust the current and voltage of the electrical stimulation signal to current and voltage values ​​suitable for processing by the control unit 140. For example, if the voltage value measured by the voltage measuring circuit 132 is ±10V, and the voltage value that the control unit 140 is suitable for processing is 0~3V, the voltage measuring circuit 132 can, according to the instruction of the control unit 140, first reduce the voltage value to ±1.5V, and then raise the voltage value to 0~3V.

[0036] After adjusting the current and voltage values, the current measurement circuit 131 and voltage measurement circuit 132 transmit the adjusted electrical stimulation signal to the analog-to-digital converter (ADC) of the control unit 140 (not shown in the figure). The ADC samples the electrical stimulation signal to provide the control unit 140 with data for subsequent calculations and analysis.

[0037] According to one embodiment of the present invention, when electrical stimulation is to be applied to a target area on a patient's body, the user (which may be a medical professional or the patient) can select an electrical stimulation level from multiple electrical stimulation levels on the operating interface of the external control device 200. In embodiments of the present invention, different electrical stimulation levels may correspond to different target energy values. The target energy values ​​may be a set of preset energy values. When the user selects an electrical stimulation level, the electrical stimulation device 100 can determine how many millijoules of energy to provide to the target area for electrical stimulation based on the target energy value corresponding to the electrical stimulation level selected by the physician or user. According to an embodiment of the present invention, during the trial phase, the multiple target energy values ​​corresponding to the multiple electrical stimulation levels may be considered as a first set of preset target energy values. According to an embodiment of the present invention, the first set of preset target energy values ​​(i.e., multiple target energy values) may be a linear sequence, an arithmetic sequence, or a geometric sequence, but the present invention is not limited thereto.

[0038] According to one embodiment of the present invention, during the trial phase, the external control device 200 may have a first look-up table. In this embodiment, the first look-up table may record each electrical stimulation level and its corresponding target energy value. Therefore, based on the electrical stimulation level selected by the user, the external control device 200 can query the first look-up table to obtain the target energy value corresponding to the electrical stimulation level selected by the user from the first target energy value group. After obtaining the target energy value corresponding to the electrical stimulation level selected by the user, the external control device 200 will transmit the target energy value to the electrical stimulation device 100. The electrical stimulation device 100 can then perform electrical stimulation on the target area according to the target energy value.

[0039] According to another embodiment of the present invention, the electrical stimulation device 100 may have a built-in first lookup table (e.g., a first lookup table stored in the storage unit 160). In this embodiment, the first lookup table may record each electrical stimulation level and its corresponding target energy value. When the user selects an electrical stimulation level from the external control device 200, the external control device 200 will send an instruction to the control unit 140 of the electrical stimulation device 100 to inform the user of the selected electrical stimulation level. Then, the control unit 140 can automatically select the target energy value corresponding to the electrical stimulation level selected by the user from the first target energy value group according to the built-in first lookup table. After obtaining the target energy value, the electrical stimulation device 100 can perform electrical stimulation on the target area according to the selected target energy value until the corresponding first target energy value has been transmitted to the target area, and then stop the electrical stimulation, thus completing one course of electrical stimulation.

[0040] According to another embodiment of the present invention, the communication circuit 150 can first obtain the electrical stimulation level selected by the user and a first lookup table from the external control device 200. In this embodiment, the first lookup table can record the electrical stimulation level and its corresponding target energy value. Then, the control unit 140 selects the target energy value corresponding to the electrical stimulation level selected by the user from the first target energy value group according to the electrical stimulation level selected by the user and the first lookup table obtained from the external control device 200. After obtaining the target energy value, the electrical stimulation device 100 can perform electrical stimulation on the target area according to the selected target energy value.

[0041] According to an embodiment of the present invention, the user can start by selecting the lowest electrical stimulation level (corresponding to the smallest target energy value in the first target energy value group), and after completing the electrical stimulation and ending the restriction time, select the next target energy value in the first target energy value group. This process continues until the user finds a target energy value that they find more pleasing or therapeutic during electrical stimulation. This target energy value can then be considered a predetermined target energy value, and the electrical stimulation level corresponding to the predetermined target energy value can be considered a predetermined electrical stimulation level.

[0042] According to one embodiment of the present invention, during the permanent implantation stage, an external control device 200 (e.g., a controller of the external control device 200) can select an upper limit target energy value and a lower limit target energy value from a first target energy value set according to a predetermined electrical stimulation level. Then, the external control device 200 (e.g., a controller of the external control device 200) can generate a second target energy value set based on the upper limit and lower limit target energy values. In this embodiment, the external control device 200 (e.g., a controller of the external control device 200) generates a second lookup table based on the electrical stimulation level corresponding to each target energy value in the second target energy value set. The external control device 200 transmits the second lookup table or its associated parameter information to the electrical stimulation device 100. When the user operates the external control device 200, the electrical stimulation device 100 can perform electrical stimulation according to the second lookup table or its associated parameter information. According to one embodiment of the present invention, during the trial phase, an external electrical stimulation device (i.e., a non-implantable electrical stimulation device) provides electrical stimulation to the human body based on a first target energy value set selected by the user from a first lookup table; during the permanent implantation phase, an electrical stimulation device 100 (i.e., an implantable electrical stimulation device) provides electrical stimulation to the human body based on a second target energy value set selected by the user from a second lookup table. In one embodiment of the present invention, the electrical stimulation device 100 provides electrical stimulation to the target area until the corresponding second target energy value has been transmitted to the target area, at which point the electrical stimulation is stopped, thus completing one course of electrical stimulation.

[0043] According to another embodiment of the present invention, during the permanent implantation stage, the electrical stimulation device 100 can select an upper limit target energy value and a lower limit target energy value from a first target energy value group based on a predetermined electrical stimulation level. Then, the electrical stimulation device 100 can generate a second target energy value group based on the upper limit and lower limit target energy values. In this embodiment, the electrical stimulation device 100 generates a second lookup table based on the electrical stimulation level corresponding to each target energy value in the second target energy value group. The electrical stimulation device 100 transmits the second lookup table or its related parameter information to the external control device 200. When the user operates the external control device 200, the electrical stimulation device 100 can perform electrical stimulation operations based on the second lookup table or its related parameter information.

[0044] According to embodiments of the present invention, the second target energy value group may be a linear sequence, an arithmetic sequence, or a geometric sequence, but the present invention is not limited thereto. According to one embodiment of the present invention, the number of target energy values ​​included in the first target energy value group may be the same as the number of target energy values ​​included in the second target energy value group. According to another embodiment of the present invention, the number of target energy values ​​included in the first target energy value group may be different from the number of target energy values ​​included in the second target energy value group.

[0045] Figure 5A It is a first target energy value group according to an embodiment of the present invention. Figure 5B This is a second target energy value set according to an embodiment of the present invention. Note that... Figure 5A and Figure 5B This is merely an embodiment of the invention for illustrative purposes, and the invention is not intended to be construed as such. Figure 5A and Figure 5B The first and second target energy value groups shown are limited.

[0046] like Figure 5A As shown, the first lookup table stores the correspondence between each electrical stimulation level and each first target energy. The first target energy value group can include target energy values ​​X1 to X10. Electrical stimulation levels Level 1 (L1) to Level 10 (L10) correspond to target energy values ​​X1 to X10, respectively, and the target energy value is an energy value in millijoules (milli-joules). In addition to corresponding target energy values, electrical stimulation levels L1 to L10 can also correspond to different current or voltage values. In this embodiment, during the trial phase, when the user selects a predetermined electrical stimulation level of L6 (i.e., the corresponding predetermined target energy value is X6), the preset upper limit target energy value is X8 and the lower limit target energy value is X5. There is a target energy value interval between the upper limit target energy value X8 and the predetermined target energy value X6, and there is no target energy value interval between the lower limit target energy value X5 and the predetermined target energy value X6.

[0047] During the permanent implantation phase, after obtaining the upper limit target energy value X8 and the lower limit target energy value X5, the electrical stimulation device 100 or the external control device 200 can generate a second set of target energy values ​​based on these values. For example... Figure 5B As shown, the second target energy value group may include target energy values ​​Y1 to Y8, and the target energy values ​​Y1 to Y8 respectively correspond to the electrical stimulation levels L1 to L8 of the external control device 200. Furthermore, in this embodiment, the minimum target energy value Y1 of the second target energy value group corresponds to the lower limit target energy value X5, and the maximum target energy value Y8 corresponds to the upper limit target energy value X8. During the permanent implantation stage, the electrical stimulation device 100 and the external control device 200 can perform electrical stimulation operations according to the second target energy value group.

[0048] According to an embodiment of the present invention, when corresponding to a predetermined electrical stimulation level during the trial phase, the first target energy value includes an upper limit target energy value and a lower limit target energy value. The upper limit target energy value and the lower limit target energy value are carried over to the permanent implantation phase. The upper limit target energy value is the largest target energy value in the second target energy value group, and the lower limit target energy value is the smallest target energy value in the second target energy value group (e.g., ...). Figure 5B (As shown). This ensures that the user can receive electrical stimulation at an energy level near the selected predetermined electrical stimulation level during the permanent implantation phase, thus making it safer.

[0049] According to one embodiment of the present invention, the upper limit target energy value and the predetermined target energy value are separated by a first number of target energy values, and the lower limit target energy value and the predetermined target energy value are separated by a second number of target energy values. According to one embodiment of the present invention, the first number (e.g., 2) is greater than the second number (e.g., 1). Figure 5A (As shown). According to another embodiment of the present invention, the first quantity may be the same as the second quantity.

[0050] According to one embodiment of the present invention, the predetermined target energy value will not be included in the second target energy value group (e.g., Figure 5B (As shown). According to another embodiment of the present invention, the predetermined target energy value may be included in the second target energy value group.

[0051] According to an embodiment of the present invention, the trial stage and the permanent implantation stage can each be further divided into a non-electrical stimulation stage and an electrical stimulation stage. That is, the trial stage includes a non-electrical stimulation stage and an electrical stimulation stage, and the permanent implantation stage also includes a non-electrical stimulation stage and an electrical stimulation stage. The non-electrical stimulation stage refers to the synchronization process when the electrical stimulation device 100 and the external control device 200 are first connected after being turned on, or when the user has not yet started electrical stimulation after the electrical stimulation device 100 and the external control device 200 are connected. The electrical stimulation stage refers to the treatment course in which the electrical stimulation device 100 has started to provide electrical stimulation.

[0052] Figure 6 This is a flowchart 600 of an electrical stimulation method according to an embodiment of the present invention. The flowchart 600 is applicable to the electrical stimulation device 100 and the external control device 200. Figure 6 As shown, in step S610, the electrical stimulation device 100 obtains an electrical stimulation level, wherein the electrical stimulation level obtained by the electrical stimulation device 100 corresponds to a target energy value.

[0053] In step S620, the electrical stimulation device 100 will perform electrical stimulation on a target area of ​​a target object according to the target energy value corresponding to the obtained electrical stimulation level. When the electrical stimulation device 100 performs electrical stimulation on the target area, all electrodes of the electrical stimulation device 100 will be activated.

[0054] According to the electrostimulation method proposed in this invention, all electrodes of the electrostimulation device 100 are activated during electrostimulation. Therefore, the user does not need to select which electrodes of the leads need to be activated, nor does the user need to select which activated electrode is negative or positive.

[0055] The serial numbers in this specification and the claims, such as "first," "second," etc., are for ease of explanation only and do not have any sequential relationship with each other.

[0056] The steps of the methods and algorithms disclosed in this specification can be directly applied to hardware and software modules or a combination of both by executing a processor. A software module (including execution instructions and related data) and other data can be stored in a data storage device, such as random access memory (RAM), flash memory, read-only memory (ROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), registers, hard disks, portable optical discs, optical disc read-only memory (CD-ROM), DVDs, or any other computer-readable storage media format in the art. A storage media can be coupled to a machine device, for example, a computer / processor (referred to as processor in this specification for convenience), through which the processor can read information (such as program code) and write information to the storage media. A storage media can integrate a processor. An application-specific integrated circuit (ASIC) includes a processor and a storage media. A user equipment includes an application-specific integrated circuit. In other words, the processor and storage media are included in the user equipment in a manner that is not directly connected to the user equipment. Furthermore, in some embodiments, any product suitable for computer programs includes a readable storage medium, wherein the readable storage medium includes program code associated with one or more of the disclosed embodiments. In some embodiments, the product of computer programs may include packaging material.

[0057] The above paragraphs use multiple levels of description. The inspirations in this document can be implemented in many ways, and any particular architecture or functionality disclosed in the examples is merely a representative case. Based on the inspirations in this document, those skilled in the art should understand that the various levels disclosed herein can be implemented independently or that two or more levels can be implemented in combination.

[0058] Although this disclosure has been presented above with reference to embodiments, it is not intended to limit this disclosure. Any person skilled in the art may make some changes and modifications without departing from the concept and scope of this disclosure. Therefore, the scope of protection of the invention shall be determined by the claims.

Claims

1. An electrical stimulation device, comprising: A controller acquires an effective electrical stimulation level, wherein the electrical stimulation level corresponds to a first target energy value group; as well as Multiple electrodes are coupled to the controller described above; The controller is further configured to generate a target energy upper limit and a target energy lower limit based on the first target energy value set, and to select a second target energy value set from the range of the target energy upper limit and the target energy lower limit. The controller, based on the second target energy value set, electrically stimulates a target area of ​​a target object, and during the electrical stimulation, the multiple electrodes are activated.

2. The electrical stimulation device as claimed in claim 1, wherein the electrical stimulation signal output by the plurality of electrodes is a pulsed radio frequency signal, the pulse frequency range being between 0 and 1 kHz, and the pulsed radio frequency signal having a square wave waveform, a sine wave waveform, or a triangular wave waveform.

3. The electrical stimulation device of claim 1, wherein the intrapulse frequency range of an electrical stimulation signal output by the electrodes is in the range of 100 kHz to 1000 kHz.

4. The electrical stimulation device as claimed in claim 1, wherein the intrapulse frequency range of an electrical stimulation signal output by the electrodes is between 480 kHz and 520 kHz.

5. The electrical stimulation device as claimed in claim 1, wherein the electrical stimulation device is an implantable electrical stimulation device or a transcutaneous electrical stimulation device.

6. The electrical stimulation device as claimed in claim 1, wherein the electrical stimulation device is a non-implantable electrical stimulation device, and wherein the electrical stimulation device can be integrated with an external control device into a single device.

7. The electrical stimulation device as claimed in claim 1, wherein after the target area is electrically stimulated once, the controller applies electrical stimulation to the target area again after at least a limited time interval.

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