ELECTRICAL STIMULATION DEVICE AND ELECTRICAL STIMULATION SYSTEM

The present disclosure provides an electrical stimulation device. The electrical stimulation device includes a signal receiving circuit and a signal processing circuit. The signal receiving circuit receives and outputs a frequency signal. The signal processing circuit receives the frequency signal and provides an electrical stimulation signal according to the frequency signal.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority of China Patent Application No. 202111031703.7, filed on Sep. 3, 2021, the entirety of which is incorporated by reference herein.

BACKGROUND

Technology Field

The present disclosure relates to an electrical stimulation device, and, in particular, to an electrical stimulation device and an electrical stimulation system.

Description of the Related Art

In recent years, dozens of therapeutic nerve electrical stimulation devices have been developed, and at least tens of thousands of people undergo electrical stimulation device implantation every year. Due to the development of precision manufacturing technology, the size of medical devices has been miniaturized and may be implanted inside the human body, for example, an implantable electrical stimulation device.

However, some of the current implantable electrical stimulation devices use an implantable electrical stimulator without batteries, instead using an external controller to provide electrical energy to the implantable electrical stimulator so that it can provide electrical stimulation in the manner of wireless power supply. The external controller and the implantable electrical stimulator without battery must be precisely aligned, otherwise the implantable electrical stimulator may not receive electrical energy. In addition, when the implantable electrical stimulator is implanted deep, the efficiency of the implantable electrical stimulator to receive electrical energy may be greatly decreased. Furthermore, the implantable electrical stimulator can easily be induced by mistake. As long as the implantable electrical stimulator is close to unspecified emission source with a similar electromagnetic wave, the implantable electrical stimulator may be immediately induced to perform electrical stimulation, thereby increasing the trouble of the user. Therefore, how to effectively improve the design of the implantable electrical stimulation device to decrease the complexity of circuit design, decrease the size of the electrical stimulation device and increase the convenience of use has become an important issue.

SUMMARY

The present disclosure provides an electrical stimulation device and an electrical stimulation system, thereby decreasing the complexity of circuit design, decreasing the size of the electrical stimulation device, and increasing the convenience of use.

An embodiment of the present disclosure provides an electrical stimulation device, which includes a signal receiving circuit and a signal processing circuit. The signal receiving circuit is configured to receive and output a frequency signal. The signal processing circuit is configured to receive the frequency signal, and generate an electrical stimulation signal according to the frequency signal.

In addition, an embodiment of the present disclosure provides an electrical stimulation system, which includes an external controller and an electrical stimulation device. The external controller includes a signal generating circuit and a signal transmitting circuit. The signal generating circuit is configured to generate a frequency signal. The signal transmitting circuit is configured to receive and transmit the frequency signal. The electrical stimulation device includes a signal receiving circuit and a signal processing circuit. The signal receiving circuit is configured to receive and output the frequency signal. The signal processing circuit, configured to receive the frequency signal, and generate an electrical stimulation signal according to the frequency signal.

According to the electrical stimulation device and the electrical stimulation system disclosed by the present disclosure, the signal receiving circuit receives and outputs the frequency signal, and the signal processing circuit receives the frequency signal, and generates the electrical stimulation signal according to the frequency signal. Therefore, the complexity of circuit design may be effectively decreased, the size of the electrical stimulation device is decreased, and the convenience of use is increased.

DETAILED DESCRIPTION OF THE DISCLOSURE

Technical terms of the present disclosure are based on general definition in the technical field of the present disclosure. If the present disclosure describes or explains one or some terms, definition of the terms is based on the description or explanation of the present disclosure. Each of the disclosed embodiments has one or more technical features. In possible implementation, a person skilled in the art would selectively implement all or some technical features of any embodiment of the present disclosure or selectively combine all or some technical features of the embodiments of the present disclosure.

In each of the following embodiments, the same reference number represents the same or a similar element or component.

FIG.1is a schematic view of an electrical stimulation system according to an embodiment of the present disclosure. Please refer toFIG.1. The electrical stimulation system100includes an external controller110and an electrical stimulation device120. The external controller110at least includes a signal generating circuit111and a signal transmitting circuit112. The signal generating circuit111is configured to generate a frequency signal. The signal transmitting circuit112is coupled to the signal generating circuit111, and configured to transmit or transmit/receive the frequency signal. In some embodiments, the signal transmitting circuit112may include a coil, an antenna, an ultrasonic circuit, or a combination thereof, but the embodiment of the present disclosure is not limited thereto.

In the embodiment, the electrical stimulation device120is an implanted device and does not have a battery. That is, the electrical stimulation device120may be implanted inside the human body, and the external controller110may be configured outside the human body. Therefore, the electrical stimulation device120of the embodiment does not require any control unit, thereby decreasing the numbers of the circuit components in use and decreasing the complexity of circuit design. In an electrical stimulation device including a control unit, the control unit may be configured to perform frequency conversion of the received energy, control output time parameters (such as pulse width, pulse rate), etc. In addition, the external controller110may be configured at a position where the electrical stimulation device120may receive the frequency signal, and the external controller110does not need to be precisely aligned with the electrical stimulation device120, thereby increasing the convenience of use.

The electrical stimulation device120includes a signal receiving circuit130and signal processing circuit140. The signal receiving circuit130is configured to receive and output the frequency signal. In the embodiment, the signal receiving circuit130may include a coil, an antenna, an ultrasonic circuit, or a combination thereof, but the embodiment of the present disclosure is not limited thereto. For example, the signal receiving circuit130receives the frequency signal transmitted by the signal transmitting circuit112in a wireless manner, and output the received frequency signal. In some embodiments, when the signal transmitting circuit112and the signal receiving circuit130respectively include the coil, the energy transmission manner of the signal transmitting circuit112and the signal receiving circuit130may be an electromagnetic induction or an electromagnetic resonance. In some embodiments, when the signal transmitting circuit112and the signal receiving circuit130respectively include the antenna, the energy transmission manner of the signal transmitting circuit112and the signal receiving circuit130may be in the form of radio wave. In some embodiments, when the signal transmitting circuit112includes an ultrasonic generator and the signal receiving circuit130includes an ultrasonic transducer, the energy transmission manner of the signal transmitting circuit112and the signal receiving circuit130may be in the form of ultrasonic energy transmission.

The signal processing circuit140is coupled to the signal receiving circuit130. The signal processing circuit140is configured to receive the frequency signal, and generate an electrical stimulation signal according to the frequency signal. For example, in some embodiments, the signal processing circuit140may process (for example, filter and/or match) the frequency signal to generate the electrical stimulation signal. Then, the electrical stimulation signal may be output to the lead210, such that the lead210may transmit the electrical stimulation signal a target area to be stimulated corresponding to an electrode221or an electrode222of the lead210, so as to perform an electrical stimulation operation in the target area, as shown inFIG.2. As shown inFIG.3, the signal receiving circuit130and the signal processing circuit140inFIG.1may be configured in an electrical stimulation device310in a packaged manner, and an electrode321and an electrode322may be configured on one side of the electrical stimulation device310. In some embodiment, in some embodiments, the signal processing circuit140may process (for example, filter and/or match) the frequency signal to generate the electrical stimulation signal. The electrical stimulation signal may be transmitted to a target area to be stimulated corresponding to the electrode321or the electrode322, so as to perform an electrical stimulation operation in the target area. In some embodiments, the electrical stimulation device120is a flat rectangular parallelepiped with a length of 3 cm, a width of 1 cm, and a height of 0.5 cm. In addition, the electrical stimulation device310ofFIG.3may be applied to nerves in the shallower layer of human tissue, such as the tibial nerve.

Furthermore, the signal processing circuit140is, for example, a passive filter. For example, the signal processing circuit140may include an impedance unit Z1, an impedance unit Z2and an impedance unit Z3. The impedance unit Z1includes a first terminal and a second terminal. The first terminal of the impedance unit Z1is coupled to the signal receiving circuit130and receives the frequency signal. The impedance unit Z2includes a first terminal and a second terminal. The first terminal of the impedance unit Z2is coupled to the second terminal of the impedance unit Z1. The second terminal of the impedance unit Z2is coupled to a ground terminal. The impedance unit Z3includes a first terminal and a second terminal. The first terminal of the impedance unit Z3is coupled to the second terminal of the impedance unit Z1. The second terminal of the impedance unit Z3generates the electrical stimulation signal.

Furthermore, the impedance unit Z1may include an inductor L1and a capacitor C1. The inductor L1includes a first terminal and a second terminal. The first terminal of the inductor L1serves as the first terminal of the impedance unit Z1, is coupled to the signal receiving circuit130and receives the frequency signal. The capacitor C1includes a first terminal and a second terminal. The first terminal of the capacitor C1is coupled to the second terminal of the inductor L1. The second terminal of the capacitor C1serves as the second terminal of the impedance unit Z1.

The impedance unit Z2may include an inductor L2and a capacitor C2. The inductor L2includes a first terminal and a second terminal. The first terminal of the inductor L2serves as the first terminal of the impedance unit Z2, and is coupled to the second terminal of the capacitor C1. The second terminal of the inductor L2serves as the second terminal of the impedance unit Z2, and is coupled to the ground. The capacitor C2includes a first terminal and a second terminal. The first terminal of the capacitor C2is coupled to the first terminal of the inductor L2. The second terminal of the capacitor C2is coupled to the second terminal of the inductor L2. The impedance unit Z3may include a capacitor C3and an inductor L3. The capacitor C3includes a first terminal and a second terminal. The first terminal of the capacitor C3serves as the first terminal of the impedance unit Z3, and is coupled to the second terminal of the capacitor C1. The inductor L3includes a first terminal and a second terminal. The first terminal of the inductor L3is coupled to the second terminal of the capacitor C3. The second terminal of the inductor L3serves as the second terminal of the impedance unit Z3, and generates the electrical stimulation signal.

In some embodiments, the frequency range of the above electrical stimulation signal is, for example, 100 KHz to 2000 KHz. In some embodiments, the frequency range of the electrical stimulation signal is, for example, 200 KHz to 800 KHz. In some embodiments, the frequency range of the electrical stimulation signal is, for example, 480 KHz to 520 KHz. In some embodiments, the frequency of the electrical stimulation signal is, for example, 500 KHz. In addition, the above electrical stimulation signal is, for example, a sine wave signal. Furthermore, in the embodiment, the frequency of the electrical stimulation signal and the frequency of the frequency signal may be the same. Moreover, in addition to frequencies and waveforms of the frequency signal (i.e., the energy transmission signal) and the electrical stimulation signal being the same, the amplitudes, pulse bandwidths and pulse repetition frequencies of the frequency signal and the electrical stimulation signal may also be the same, but the embodiment of the present disclosure is not limited thereto.

In some embodiments, as shown inFIG.4, the above electrical stimulation signal may be a pulsed radio-frequency (PRF) signal (or referred to as a pulse signal), a continuous sine wave, a continuous triangular wave, etc., but the embodiment of the present disclosure is not limited thereto. In addition, when the electrical stimulation signal is a pulse alternating signal, one pulse cycle time Tpincludes a plurality of pulse signals and at least one rest period of time, and the pulse cycle time Tpis the reciprocal of the pulse repetition frequency. The pulse repetition frequency range (also referred to as the pulse frequency range) is, for example, between 0 and 1 KHz, preferably between 1 and 100 Hz. In the embodiment, the pulse repetition frequency of the electrical stimulation signal is, for example, 2 Hz. In addition, the duration time Tdof the plurality of pulses in one pulse cycle time is, for example, between 1 and 250 milliseconds (ms), preferably between 10 and 100 ms. In the embodiment, the duration time Tdis, for example, 25 ms. In the embodiment, the frequency of the electrical stimulation signal is 500 KHz, in other words, the cycle time Tsof the electrical stimulation signal is about 2 microseconds (μs). Furthermore, the frequency of the above electrical stimulation signal is the intra-pulse frequency in each pulse alternating signal ofFIG.4. Moreover, the voltage range of the above electrical stimulation signal may be between −25V and 25V. Furthermore, the voltage range of the above electrical stimulation signal may further be between −20V and 20V. The current range of the above electrical stimulation signal may be between 0 and 60 mA. Furthermore, the current range of the above electrical stimulation signal may further be between 0 and 50 mA.

Furthermore, in the embodiment, the external controller110may be configured outside the human body, and the electrical stimulation device120may be implanted inside the human body. When the electrical stimulation device120is implanted inside the human body, the electrical stimulation device120may be placed under the skin of the human body, and one terminal211of the lead210is connected to the electrical stimulation device120, and the other terminal212of the lead210is placed close to a target area to be stimulated. The electrical stimulation system100as a spinal cord electrical stimulation system is taken as an example, the other terminal212of at least part of the lead210is disposed in the epidural space to electrically stimulate the spinal cord, the spinal nerve or the dorsal root ganglia (DRG). The signal processing circuit140of the electrical stimulation device120transmits the electrical stimulation signal to an output electrode. That is, the signal processing circuit140may transmit the electrical stimulation signal to the output electrode (such as the electrode221or the electrode222) of the other terminal212of the lead210through the terminal211of the lead210, so as to electrically stimulate the target area. The current transmitted by the electrical stimulation device120may flow out from one output electrode (such as the electrode221or the electrode222) of the lead210, and then conducts through the human tissue, and then flow back to the lead210from the other electrode (such as the electrode222or the electrode221). In the embodiment, the electrode221and the electrode222may be a pair of electrodes. In some embodiments, the electrode221may be a positive electrode, and the electrode222may be a negative electrode. In some embodiments, the electrode221may be the negative electrode, and the electrode222may be the positive electrode.

In addition, the target nerve area of electrical stimulation may also be in the brain for electrical stimulation of brain cortex or deep brain stimulation (DBS) or abdominal and peripheral nerves. In some embodiments, the electrical stimulation system100may also be used to relieve or treat diseases, such as pain, overactive bladder (OAB), renal hypertension, spasm, premature ejaculation or carpal tunnel syndrome (CTS), etc. In some embodiments, the target nerve area of electrical stimulation may also be a lateral recess or a peripheral nervous system (PNS). Furthermore, the target area of the electrical stimulation may also receive less energy per unit time to ensure the subthreshold stimulation, so that the patient implanted with the electrical-stimulation system may reduce the chance of feeling paresthesia to perform the paresthesia-free treatment.

FIG.5is a schematic view of an electrical stimulation system according to another embodiment of the present disclosure. Please refer toFIG.5. The electrical stimulation system500includes an external controller110and an electrical stimulation device510. In the embodiment, the external controller110inFIG.5is the same as or similar to external controller110inFIG.1. Accordingly, the external controller110inFIG.5may refer to the description of the embodiment ofFIG.1, and the description thereof is not repeated herein.

The electrical stimulation device510includes a signal receiving circuit130, a signal processing circuit and a protection circuit520. In the embodiment, the signal receiving circuit130and the signal processing circuit140inFIG.5are the same as or similar to the signal receiving circuit130and the signal processing circuit140inFIG.1. Accordingly, the signal receiving circuit130and the signal processing circuit140inFIG.5may refer to the embodiment ofFIG.1, and the description thereof is not repeated herein.

The protection circuit520is coupled to the signal processing circuit140(such as the second terminal of the impedance unit Z3), and the protection circuit520is configured to determine whether to output the electrical stimulation signal generated by the signal processing circuit140(such as the second terminal of the impedance unit Z3). In some embodiments, the protection circuit520is, for example, a Hall switch or a magnetic reed switch, but the embodiment of the present disclosure is not limited thereto. For example, when the external controller110is configured with a triggering component (such as a magnet), the protection circuit520(such as the Hall switch or the magnetic reed switch) may sense the magnetic field generated by the triggering component (such as the magnet) and be turned on, so as to output the electrical stimulation signal. In addition, when the external controller110is not configured with a triggering component (such as a magnet), the protection circuit520(such as the Hall switch or the magnetic reed switch) may not sense the triggering component and not be turned on, and the protection circuit520does not output the electrical stimulation signal. Therefore, the situation that the electrical stimulation device510senses or receives the frequency signal generated by the other devices or emission sources to generate the error operation (for example, directly perform the electrical stimulation operation) may be effectively avoided, so as to increase the safety of the electrical stimulation device510and decrease the trouble of the user.

In addition, the signal receiving circuit130, the signal processing circuit140and the protection circuit520may also be configured in the electrical stimulation device310ofFIG.3. The electrical stimulation signal generated by the signal processing circuit140may be transmitted to a target area to be stimulated corresponding to the electrode321or the electrode322through the protection circuit520, so as to perform an electrical stimulation operation in the target area.

FIG.6is a schematic view of an electrical stimulation system according to another embodiment of the present disclosure. Please refer toFIG.6. The electrical stimulation system600includes an external controller110and an electrical stimulation device610. In the embodiment, the external controller110inFIG.6is the same as or similar to external controller110inFIG.1. Accordingly, the external controller110inFIG.6may refer to the description of the embodiment ofFIG.1, and the description thereof is not repeated herein.

The electrical stimulation device610includes a signal receiving circuit130, a rectifying circuit620and a signal processing circuit630. In the embodiment, the signal receiving circuit130inFIG.6is the same as or similar to the signal receiving circuit130inFIG.1. Accordingly, the signal receiving circuit130inFIG.6may refer to the embodiment ofFIG.1, and the description thereof is not repeated herein.

The rectifying circuit620is coupled to the signal receiving circuit130, and configured to receive the frequency signal and rectify the frequency signal to generate a rectified frequency signal. In the embodiment, the rectifying circuit620may be a bridge rectifier, such as a half-bridge rectifier or a full-bridge rectifier, but the embodiment of the present disclosure is not limited thereto. In addition, the above rectified frequency signal is, for example, a square wave signal. The rectified frequency signal with the square wave signal may be processed through the signal processing circuit630to generate an electrical stimulation signal with a sine wave signal. In the above embodiment, the electrical stimulation signal is the square wave signal as an example, but the embodiment of the present disclosure is not limited thereto. In some embodiments, the electrical stimulation signal may also be a triangular wave, a pulse wave, etc.

The signal processing circuit630is coupled to the rectifying circuit620. That is, the rectifying circuit620is coupled between the signal receiving circuit130and the signal processing circuit630. The signal processing circuit630receives the frequency signal (such as the rectified frequency signal) and generates the electrical stimulation signal according to the frequency signal. For example, in some embodiments, the signal processing circuit630is similar to the signal processing circuit140. The signal processing circuit630may process (for example, filter and/or match) the frequency signal to generate the electrical stimulation signal. Then, the electrical stimulation signal may be output to the lead210, such that the lead210may transmit the electrical stimulation signal a target area to be stimulated corresponding to the electrode221or the electrode222of the lead210, so as to perform an electrical stimulation operation in the target area, as shown inFIG.2. In some embodiments, as shown inFIG.3, the signal receiving circuit130, the rectifying circuit620, the signal processing circuit630and the protection circuit650inFIG.6may be configured in the electrical stimulation device310in a packaged manner. The signal processing circuit630may process (for example, filter and/or match) the frequency signal to generate the electrical stimulation signal. The electrical stimulation signal may be transmitted to a target area to be stimulated corresponding to the electrode321or the electrode322through the protection circuit650, so as to perform an electrical stimulation operation in the target area.

Furthermore, the signal processing circuit630may be an active filter. For example, the signal processing circuit630may include a resistor R1, a resistor R2, a capacitor C4, a capacitor C5, a resistor R3and an amplifier640.

The resistor R1includes a first terminal and a second terminal. The first terminal of the resistor R1is coupled to the rectifying circuit620, and receives the rectified frequency signal. The resistor R2includes a first terminal and a second terminal. The first terminal of the resistor R2is coupled to the second terminal of the resistor R1. The second terminal of the resistor R2is coupled to the ground terminal.

The capacitor C4includes a first terminal and a second terminal. The first terminal of the capacitor C4is coupled to the second terminal of the resistor R1. The capacitor C5includes a first terminal and a second terminal. The first terminal of the capacitor C5is coupled to the first terminal of the capacitor C4. The resistor R3includes a first terminal and a second terminal. The first terminal of the resistor R3is coupled to the second terminal of the capacitor C4. The second terminal of the resistor R3is coupled to the second terminal of the capacitor C5.

The amplifier640includes a first input terminal, a second input terminal and an output terminal. The first input terminal (such as a positive input terminal) of the amplifier640is coupled to the ground terminal. The second input terminal (such as a negative input terminal of the amplifier640is coupled to the second terminal of the resistor R3. The output terminal of the amplifier640is coupled to the first terminal of the resistor R3, and outputs the electrical stimulation signal.

In some embodiment, the frequency range of the above electrical stimulation signal is, for example, 100 KHz to 2000 KHz. In some embodiments, the frequency range of the electrical stimulation signal is, for example, 200 KHz to 800 KHz. In some embodiments, the frequency range of the electrical stimulation signal is, for example, 480 KHz to 520 KHz. In addition, the above electrical stimulation signal is, for example, a sine wave signal. Furthermore, in the embodiment, the frequency of the electrical stimulation signal and the frequency of the frequency signal may be the same. In some embodiments, the frequency of the electrical stimulation signal and the frequency of the frequency signal must be the same. Moreover, in addition to the frequencies and waveforms of the frequency signal (i.e., the energy transmission signal) and the electrical stimulation signal being the same, the amplitudes, pulse bandwidths and pulse repetition frequencies of the frequency signal and the electrical stimulation signal may also be the same, but the embodiment of the present disclosure is not limited thereto.

In the embodiment, the electrical stimulation device610further includes a protection circuit650. The protection circuit650is coupled to the signal processing circuit630(such as the output terminal of the amplifier640), and the protection circuit650is configured to determine whether to output the electrical stimulation signal generated by the signal processing circuit630(such as the output terminal of the amplifier640). In some embodiments, the protection circuit650is, for example, the Hall switch or the magnetic reed switch, but the embodiment of the present disclosure is not limited thereto. For example, when the external controller110is configured with a triggering component (such as a magnet), the protection circuit650(such as the Hall switch or the magnetic reed switch) may sense the magnetic field generated by the triggering component (such as the magnet) and be turned on, so as to output the electrical stimulation signal. In addition, when the external controller110is not configured with a triggering component (such as a magnet), the protection circuit650(such as the Hall switch or the magnetic reed switch) may not sense the triggering component and not be turned on, and the protection circuit650does not output the electrical stimulation signal. Therefore, the situation that the electrical stimulation device610senses or receives the frequency signal generated by the other devices or emission sources to generate the error operation (for example, directly perform the electrical stimulation operation) may be effectively avoided, so as to increase the safety of the electrical stimulation device610and decrease the trouble of the user.

In summary, according to the electrical stimulation device and the electrical stimulation system disclosed by the present disclosure, the signal receiving circuit receives and outputs the frequency signal, and the signal processing circuit receives the frequency signal, and generates the electrical stimulation signal according to the frequency signal. Therefore, the complexity of circuit design may be effectively decreased, the size of the electrical stimulation device is decreased, and the convenience of use is increased.

In addition, the electrical stimulation device of the embodiment of the present disclosure further includes the protection circuit. The protection circuit may be coupled to the signal processing circuit, and is configured to determine whether to output the electrical stimulation signal generated by the signal processing circuit, wherein the electrical stimulation signal is a sine wave signal. Therefore, the situation that the electrical stimulation device senses or receives the frequency signal generated by the other devices or emission sources to generate the error operation (for example, directly perform the electrical stimulation operation) may be effectively avoided, so as to increase the safety of the electrical stimulation device and decrease the trouble of the user.