WO2026011304A1 - Nerve stimulation apparatus - Google Patents

Abstract

Embodiments of the specification provide a nerve stimulation apparatus, comprising an implantable portion that can be implanted into the human body. The implantable portion comprises a transducer and an electrode. The transducer is configured to receive a vibration signal and convert the vibration signal into an electrical signal, and the electrode is configured to output an electrical stimulation signal on the basis of the electrical signal.

Description

A nerve stimulation device Technical Field

This specification relates to the field of medical device technology, and in particular to a nerve stimulation device.

Background Technology

Deep brain stimulation (DBS) is currently a commonly used surgical treatment for advanced Parkinson's disease (PD) and other movement disorders such as dystonia. DBS works by implanting electrodes in specific areas to continuously deliver high-frequency electrical pulses, stimulating nerve nuclei and nerve tracts, thereby modulating abnormal neural circuits. It is characterized by safety, effectiveness, reversibility, and adjustable parameters. A typical DBS system includes an implanted stimulation probe, a fixation cap, an extension lead, and an implanted pulse generator (IPG). The IPG is implanted subcutaneously, and the stimulation probe is implanted in the target area (e.g., spinal cord region, brain region, heart region), connected by the extension lead, which can easily lead to postoperative infection. Furthermore, the implanted pulse generator has a short battery life and requires frequent replacement; and the wireless charging process generates heat, potentially affecting the patient's health.

Therefore, a nerve stimulation device that is less likely to cause postoperative infection and is easily adjustable is provided.

Summary of the Invention

This specification provides one or more embodiments of a nerve stimulation device, including an implantable part that can be implanted in the human body, the implantable part including: a transducer configured to receive vibration signals and convert the vibration signals into electrical signals; and electrodes configured to output electrical stimulation signals based on the electrical signals.

In some embodiments, the neurostimulation device further includes a non-implantable part comprising an ultrasound generator configured to generate ultrasound waves.

In some embodiments, the non-implantable part further includes an ultrasound control module, which is configured to control at least one of the parameters of the ultrasound wave, such as frequency, amplitude, phase, and power.

In some embodiments, the non-implantable part further includes a signal acquisition component and a processing module, wherein the signal acquisition component is configured to acquire physiological signals of the human body, and the processing module sets the ultrasound control module based on the physiological signals.

In some embodiments, the implantation unit further includes a control circuit configured to adjust the electrical signal output by the transducer into the electrical stimulation signal.

In some embodiments, the implantation unit further includes an energy storage device, which is electrically connected to the transducer and the control circuit respectively. The energy storage device is configured to receive the electrical signal, store it as electrical energy, and supply power to the control circuit.

In some embodiments, the non-implanted portion further includes a wearable support.

In some embodiments, the nerve stimulation device further includes a non-implantable part, the non-implantable part including a magnetic field generator configured to generate a magnetic field, and the implantable part including a vibrating element configured to vibrate under the action of the magnetic field, the vibrating end of the vibrating element abutting against the transducer.

In some embodiments, the non-implantable portion further includes a magnetic field modulation module configured to modulate the magnetic field.

In some embodiments, the non-implantable part further includes a signal acquisition component and a processing module, wherein the signal acquisition component is configured to acquire physiological signals of the human body, and the processing module sets the magnetic field modulation module based on the physiological signals.

In some embodiments, the implantation unit further includes a control circuit configured to adjust the electrical signal output by the transducer into the electrical stimulation signal.

In some embodiments, the implantation unit further includes an energy storage device, which is electrically connected to the transducer and the control circuit respectively. The energy storage device is configured to receive the electrical signal, store it as electrical energy, and supply power to the control circuit.

In some embodiments, the non-implanted portion further includes a wearable support.

In some embodiments, the implantation site further includes an energy storage device and a control circuit, wherein the input terminal of the energy storage device... The device is electrically connected to the transducer, the output terminal of the energy storage device is electrically connected to the input terminal of the control circuit, and the output terminal of the control circuit is electrically connected to the electrode.

In some embodiments, the implantation site further includes a monitoring electrode configured to monitor physiological signals, and the control circuit configured to control the electrode to output an electrical stimulation signal based on the physiological signals.

In some embodiments, the transducer includes a housing, a vibration pickup element, and a transducer element. The vibration pickup element is disposed within and connected to the housing, and the transducer element is disposed on the vibration pickup element. The housing conforms to the human skeleton after being implanted into the human body.

In some embodiments, the neurostimulation device further includes a non-implantable part comprising a vibration source configured to provide vibration to the human body.

In some embodiments, the non-implantable portion further includes a vibration control module configured to control the vibration source.

In some embodiments, the non-implantable part further includes a signal acquisition component configured to acquire physiological signals of the human body, and the vibration control module configured to control the vibration source based on the physiological signals.

In some embodiments, the implantation site further includes an energy storage device and a control circuit. The input terminal of the energy storage device is electrically connected to the transducer, the output terminal of the energy storage device is electrically connected to the input terminal of the control circuit, and the output terminal of the control circuit is electrically connected to the electrode.

In some embodiments, the transducer includes a housing and a transducer element, the transducer element being encapsulated within the housing.

In some embodiments, the maximum surface area of the transducer is no more than 200 square millimeters.

In some embodiments, the maximum surface area of the transducer is no more than 180 square millimeters.

In some embodiments, the maximum surface area of the transducer is no more than 50 square millimeters.

In some embodiments, the thickness of the transducer is no more than 1 mm.

In some embodiments, the implantation part further includes an encapsulation part and a wire, the transducer is disposed in the encapsulation part, the wire connects the encapsulation part and the electrode, and the length of the wire is greater than the distance between the encapsulation part and the electrode after the implantation part is implanted into the human body.

Attached Figure Description

This specification will be further described by way of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting; in these embodiments, the same reference numerals denote the same structures, wherein:

Figure 1 is a schematic diagram of the application scenario of the nerve stimulation device according to some embodiments of this specification;

Figure 2 is an exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification;

Figure 3 is another exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification;

Figure 4 is yet another exemplary flowchart of a nerve stimulation device according to some embodiments of this specification;

Figure 5 is an exemplary structural schematic diagram of a transducer according to some embodiments of this specification;

Figure 6 is yet another exemplary flowchart of a nerve stimulation device according to some embodiments of this specification;

Figure 7 is another exemplary structural schematic diagram of a transducer according to some embodiments of this specification;

Figure 8 is a schematic diagram of an exemplary structure of the implantation site according to some embodiments of this specification.

Detailed Implementation

To more clearly illustrate the technical solutions of the embodiments in this specification, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are merely some examples or embodiments of this specification. For those skilled in the art, these drawings can be applied to other similar scenarios without creative effort. Unless obvious from the context or otherwise specified, the same reference numerals in the drawings represent the same structures or operations.

It should be understood that the terms "system,""device,""unit," and/or "module" used herein are a method of distinguishing different components, elements, parts, sections, or assemblies at different levels. However, if other terms can achieve the same effect... If the purpose is the same, then other expressions can be used to replace the words.

As indicated in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and/or "the" do not specifically refer to the singular and may also include the plural. Generally speaking, the terms "comprising" and "including" only indicate the inclusion of expressly identified steps and elements, which do not constitute an exclusive list, and the method or apparatus may also include other steps or elements.

Figure 1 is a schematic diagram of the application scenario of the nerve stimulation device according to some embodiments of this specification.

A neurostimulation device is a device used to stimulate nerves in specific parts of the human body. Neurostimulation devices can modulate the activity of the human nervous system through electrical signals, thereby being used to treat chronic pain, neurological disorders (such as Parkinson's disease and epilepsy), depression, and other neurological diseases and symptoms.

In some embodiments, the neurostimulation device can be used in DBS systems, as well as in various implantable or non-implantable neuromodulation medical devices, and active implantable non-neuromodulation medical devices, and has a wide range of applications.

In some embodiments, the neurostimulation device includes an implantable part 100 that can be implanted in the human body.

The implant 100 refers to a component of the neurostimulation device that can be implanted into a target site on the human body. Target sites on the human body may include the brain, heart, or other areas requiring treatment.

In some embodiments, as shown in FIG1, the implantation unit 100 includes a transducer 110 and an electrode 120.

Transducer 110 refers to a component capable of energy conversion. For example, transducer 110 can be a piezoelectric element, etc. In some embodiments, transducer 110 can be positioned close to the body surface after being implanted in the human body. It is understood that the closer the transducer 110 is to the body surface after being implanted in the human body, the lower the loss of energy received from outside the human body during transmission.

In some embodiments, the transducer 110 may be configured to receive vibration signals and convert the vibration signals into electrical signals.

A vibration signal refers to the signal transmitted from a vibration source to a transducer through vibration. The vibration source can include at least one of an ultrasonic generator, a magnetic field generator, or other components capable of generating vibration. The vibration source can transmit the vibration signal to the transducer in various ways, such as contact transmission or non-contact transmission. The vibration source can transfer the mechanical energy generated by the vibration to the transducer, which can then convert the mechanical energy into electrical energy, achieving energy conversion and eliminating the need for an internal battery to power the transducer.

Electrode 120 is a device for emitting electrical stimulation signals. In some embodiments, electrode 120 may be positioned near a target area of the human body.

In some embodiments, the electrode 120 and the transducer 110 can be connected in various ways, such as by making the transducer 110 and the electrode 120 an integral structure, or by connecting the transducer 110 and the electrode 120 with a wire. In some embodiments, the distance between the electrode 120 and the transducer 110 is less than a preset threshold, thereby ensuring the transmission of electrical signals, reducing the loss in the electrical signal transmission process, and reducing the overall structure of the implantation part 100.

In some embodiments, the electrode 120 is configured to output an electrical stimulation signal based on an electrical signal.

An electrical stimulation signal is a signal used to generate electrical stimulation on a target part of the human body. Examples include brain stimulation, peripheral stimulation, and cardiac stimulation. Electrical stimulation signals can be used to achieve therapeutic effects on different target parts of the human body; for example, brain stimulation can be used for analgesia and to suppress epilepsy. In some embodiments, the electrical stimulation signal may include at least one of single-pulse stimulation, continuous-wave stimulation, alternating-wave stimulation, double-pulse stimulation, or other analog signals.

In some embodiments, the electrode 120 can directly output the received electrical signal as an electrical stimulation signal to the nerve tissue.

In some embodiments of this specification, the transducer and electrodes are used as the implantation site of the neurostimulation device, which simplifies the structure of the implantation site. This eliminates the need for a battery, reduces size, and avoids the limitation of battery life on the overall lifespan of the device, thereby extending the lifespan of the neurostimulation device. It also avoids the overheating problems that may arise from battery implantation, improving the reliability of the device. Furthermore, it eliminates the need for complex connection structures and an electrolyte environment to ensure stable electrical performance, resulting in low invasiveness, high biocompatibility, and enhanced biosafety.

Figure 2 is an exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification.

In some embodiments, as shown in FIG2, the neurostimulation device includes an implant 100-1 and a non-implant 201, wherein the implant 100-1 includes a transducer 110 and an electrode 120. For a description of the transducer 110 and the electrode 120, please refer to the relevant description in FIG1.

A non-implantable part refers to a component of a nerve stimulation device that does not require implantation into a target site in the human body. In some embodiments, the non-implantable part can perform functions outside the human body (but this does not preclude the non-implantable part from performing functions that can be implanted in the human body). In some embodiments, the non-implantable part can be used to generate vibration signals.

In some embodiments, as shown in FIG2, the non-implantable part 201 may include an ultrasound generator 211.

An ultrasound generator 211 is configured to generate ultrasonic waves. For example, the ultrasound generator 211 may be a radio frequency ultrasound generator, etc. In some embodiments, the ultrasonic waves generated by the ultrasound generator 211 can be directly sent as vibration signals to the transducer 110, which can convert the ultrasonic waves into electrical signals. For example, the ultrasound generator 211 can generate ultrasonic oscillations, which, after being focused onto the piezoelectric transducer 110, convert the mechanical energy generated by the mechanical waves of the ultrasonic oscillations into electrical energy. The electrical energy is then rectified through pre-programmed circuitry to form the stimulation signal required for stimulation therapy/neuromodulation.

In some embodiments, the ultrasonic waves generated by the ultrasonic generator 211 are pulsed sound waves. The pulsed sound waves generated by the ultrasonic generator 211 can be directly sent as vibration signals to the transducer 110, and the transducer 110 can convert the pulsed sound waves into electrical signals.

In some embodiments, the non-implantable part 201 further includes an ultrasound control module 221.

The ultrasonic control module 221 is a module that can be used to control the ultrasonic waves generated by the ultrasonic generator 211.

In some embodiments, the ultrasonic control module 221 is configured to control at least one of the parameters such as frequency, amplitude, phase, and power of the ultrasonic wave.

In some embodiments, the ultrasonic control module 221 can send the controlled ultrasonic waves to the transducer 110.

In some embodiments, the ultrasound waves and electrical stimulation signals can be modulated based on the implantation site and the patient's condition. For example, different preset parameters of ultrasound waves can be set for different implantation sites and patient conditions. After the ultrasound modulation module 221 modulates the ultrasound waves based on the different preset parameters, it sends the signals to the transducer 110. In some embodiments, the physician can manually adjust the parameters of the ultrasound waves.

Some embodiments in this specification, by setting up an ultrasound control module, can achieve external control, reduce the number of components in the implanted part, and achieve passive, wireless, and power-free processing in vivo, thereby reducing the burden and risk of implantation in vivo; on the other hand, due to the use of external control, more computing resources are available, enabling high-resolution control.

In some embodiments, the non-implantable part 201 further includes a signal acquisition component 231 and a processing module 241.

The signal acquisition component 231 is configured to acquire physiological signals from the human body. Physiological signals refer to human physiological parameters related to the regulatory target, including electrical and non-electrical signals. Examples of electrical signals include electromyography (EMG), electroencephalography (EEG) (signals generated by the electrical activity of neurons in the brain), and electrocardiogram (ECG). Examples of non-electrical signals include blood oxygenation and pulse signals. In some embodiments, the signal acquisition component 231 can acquire at least one of EMG, EEG, ECG, blood oxygenation, and pulse signals as needed. EEG signals can be used to diagnose diseases such as epilepsy, sleep disorders, and brain injury. Blood oxygenation, ECG, and pulse signals can be used to diagnose diseases such as heart failure.

In some embodiments, the signal acquisition component 231 may be disposed on the surface of human skin or inside the human body. For example, when the physiological signal is an electrical signal, the signal acquisition component 231 may be implanted in the human body, such as implanted in the cerebral cortex to acquire electroencephalogram (EEG) signals. For example, when the physiological signal is a non-electrical signal, the signal acquisition component 231 may be disposed on the surface of human skin, such as in close contact with the human arm to acquire pulse signals.

The processing module 241 is used to process physiological signals. In some embodiments, the processing module 241 can configure the ultrasound control module 221 based on the physiological signals. For example, the processing module 241 can look up the parameters of the ultrasound wave in a first preset table based on the physiological signals and send them to the ultrasound control module 221, which can then control the ultrasound wave based on these parameters. The first preset table includes a mapping relationship between the physiological signals and the parameters of the ultrasound wave, and can be preset based on experience. The parameters of the ultrasound wave include at least one of the following: frequency, amplitude, phase, and power.

In some embodiments, the ultrasound generator 211 can generate ultrasound waves based on physiological signals. For example, for epilepsy... For epilepsy, the ultrasound generator 211 can respond to the physiological signals acquired by the signal acquisition component 231 during the onset of the disease and then generate ultrasound waves for treatment.

In some embodiments, the non-implantable portion 201 further includes a wearable support.

The wearable support is a support device used to fix the non-implanted part 201 near a target part of the human body. In some embodiments, the ultrasound generator 211 can be fixed near the implanted part by the wearable support, so that the ultrasound generator 211 is in close contact with the human body to reduce the attenuation of ultrasound waves in the air.

In some embodiments, the wearable support includes a headband or cap. The non-implantable part 201 can be secured near the implantable part in the human brain by the headband or cap, thereby enabling the neurostimulation device to be used for neurostimulation and modulation of the brain to treat and control brain diseases.

In some embodiments, the wearable support includes a belt, clothing, or pants. The non-implanted part 200 can be secured to the vicinity of the implanted part in the body (such as the heart, waist, limbs, etc.) by a belt, clothing, or pants, thereby enabling the neurostimulation device to be used for neurostimulation and modulation of the body to treat and control body-related diseases.

In some embodiments, as shown in FIG2, the implantation unit 100-1 further includes a control circuit 131. In some embodiments, the nerve stimulation device may include only the control circuit 131, without the aforementioned ultrasound control module 221. In some embodiments, the nerve stimulation device may include both the control circuit 131 and the ultrasound control module 221.

The control circuit 131 is a circuit used to control electrical signals.

In some embodiments, the control circuit 131 is configured to adjust the electrical signal output by the transducer 110 into an electrical stimulation signal. In some embodiments, the control circuit 131 can adjust the electrical signal into different electrical stimulation signals based on the implantation site 100 and the patient's condition. For example, the control circuit 131 can adjust at least one of the frequency, pulse width, intensity, etc. of the electrical stimulation signal.

In some embodiments, the control circuit 131 can send the adjusted electrical stimulation signal to the electrode 120, and the electrode 120 can directly output the adjusted electrical stimulation signal to perform electrical stimulation on the target part of the human body to achieve a therapeutic effect.

In some embodiments, as shown in FIG2, the implantation unit 100-1 further includes an energy storage device 141.

The energy storage device 141 is a device for storing electrical energy. The energy storage device 141 can be a long-term energy storage device, such as a battery. A long-term energy storage device can supply power to devices such as the electrode 120 at any time. The energy storage device 141 can also be a short-term energy storage device, such as a capacitor. A short-term energy storage device can replenish the output of the electrode 120 when the vibration signal is unstable. In some embodiments, the energy storage device 141 is electrically connected to both the transducer 110 and the control circuit 131.

In some embodiments, the energy storage device 141 is configured to receive electrical signals, store them as electrical energy, and supply power to the control circuit 131. The energy storage device 141 can receive electrical signals transmitted by the transducer 110, store them as electrical energy, and supply power to the control circuit 131.

In some embodiments, the nerve stimulation device can generate ultrasonic waves through an ultrasonic generator 211, and obtain target ultrasonic waves by regulating the ultrasonic waves through an ultrasonic control module 221. The transducer 110 can directly convert the target ultrasonic waves into electrical signals, and the control circuit 131 can adjust the electrical signals output by the transducer into target electrical stimulation signals. The electrode 120 performs point stimulation on the target part of the human body based on the target electrical stimulation signals.

In some embodiments of this specification, energy is directly supplied to the transducer via an external ultrasound generator, and energy transmission and conversion can be achieved through wireless ultrasound transmission. This eliminates the need for an antenna as a carrier of energy transmission, thereby reducing the overall size of the nerve stimulation device. Furthermore, electromagnetic radiation interference is not a concern, and ultrasound's strong anti-interference capability ensures effective energy transmission. In addition, ultrasound can achieve a higher maximum permissible energy threshold within the body; compared to radio frequency energy, the maximum permissible energy threshold for ultrasound within the body is 72 times that of radio frequency.

Figure 3 is another exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification.

In some embodiments, as shown in FIG3, the neurostimulation device includes an implant 100-2 and a non-implant 202, wherein the implant 100-2 includes a transducer 110 and an electrode 120. For a description of the transducer 110 and the electrode 120, please refer to the relevant description in FIG1.

In some embodiments, as shown in FIG3, the non-implantable part 202 includes a magnetic field generator 212.

The magnetic field generator 212 is configured to generate a magnetic field. For example, the magnetic field generator 212 can be configured as an electromagnet or the like.

In some embodiments, as shown in FIG3, the implantation part 100-2 includes a vibrating element 150.

The vibrating element 150 is a component used to generate vibration. For example, the vibrating element 150 may be made of a flexible or elastic material.

In some embodiments, the vibrating element 150 is configured to vibrate under the influence of a magnetic field.

In some embodiments, the nerve stimulation device further includes a magnetic field-based encoding-decoding system that works in conjunction with the vibrator 150 so that the vibrator 150 responds only to the magnetic field generated by the magnetic field generator 212, thereby avoiding interference that may be caused by other external magnetic fields.

In some embodiments, as shown in FIG3, the vibrating end of the vibrating element 150 abuts against the transducer 110. For example, the vibrating end of the vibrating element 150 may be fixed to the surface of the transducer 110, or the vibrating element 150 may be integrally formed with the transducer 110.

In some embodiments, the vibrating end of the vibrating element 150 vibrates under the action of a magnetic field, causing the transducer 110, which is in contact with the vibrating end, to vibrate. The transducer 110 can convert the vibration signal into an electrical signal. For example, a changing magnetic field is generated by a magnetic field generator 212. Under the action of this changing field, the vibrating element 150 deforms. The transducer 110, which is closely connected to it, converts the stress generated by the deformation into electrical energy. The electrical energy drives the electrode 120 to output an electrical stimulation signal.

In some embodiments, the vibrating element 150 may be a magnetostrictive material.

Magnetostrictive materials are materials capable of converting between electromagnetic and mechanical energy; for example, they deform when an external magnetic field changes. Magnetostriction refers to the mechanical vibration of an object under the influence of an alternating magnetic field, with the same frequency as the alternating magnetic field. For instance, based on an alternating magnetic field generated by a magnetic field generator 212, a vibrating element 150 made of magnetostrictive material produces mechanical vibration with the same frequency as the alternating magnetic field. The vibration of the vibrating element 150 can drive the transducer 110 to vibrate, and the transducer 110 can convert the vibration signal into an electrical signal.

In some embodiments, as shown in FIG3, the non-implantable part 202 further includes a magnetic field control module 222.

The magnetic field control module 222 is configured to control the magnetic field. For example, the magnetic field control module 222 can control the magnetic field by adjusting the magnetic induction, magnetic field strength, etc. For example, when the magnetic field generator 212 is an electromagnet, the magnetic field control module 222 can control the magnetic field by adjusting the magnitude and direction of the energized current.

In some embodiments, as shown in FIG3, the non-implantable part 202 further includes a signal acquisition component 232 and a processing module 242.

In some embodiments, the signal acquisition component 232 is configured to acquire physiological signals of the human body.

Signal acquisition component 232 is similar to signal acquisition component 231. For more details, please refer to the relevant content in Figure 2.

In some embodiments, the processing module 242 can configure the magnetic field control module 222 based on physiological signals. For example, the processing module 242 can determine the parameters of the magnetic field by looking up a second preset table based on the physiological signals and send them to the magnetic field control module 222. The magnetic field control module 222 can then regulate the magnetic field based on these parameters. The second preset table includes a mapping relationship between physiological signals and magnetic field parameters, and can be preset based on experience. The parameters of the magnetic field include at least one of magnetic flux, magnetic field strength, and magnetic field direction.

In some embodiments, as shown in FIG3, the implantation unit 100-2 further includes a control circuit 132. In some embodiments, the control circuit 132 is configured to adjust the electrical signal output by the transducer 110 into an electrical stimulation signal. In some embodiments, the nerve stimulation device may include only the control circuit 132, without the aforementioned magnetic field control module 222. In some embodiments, the nerve stimulation device may include both the control circuit 132 and the magnetic field control module 222. The control circuit 132 is similar to the control circuit 131; further details can be found in the relevant content of FIG2.

In some embodiments, as shown in FIG3, the implantation unit 100-2 further includes an energy storage device 142. In some embodiments, the energy storage device 142 is electrically connected to the transducer 110 and the control circuit 132, respectively. In some embodiments, the energy storage device 142 is configured to receive electrical signals, store them as electrical energy, and supply power to the control circuit 132. The energy storage device 142 is similar to the energy storage device 141; further details can be found in the relevant content of FIG2.

In some embodiments, the non-implantable portion 202 further includes a wearable support. Further details regarding the wearable support can be found in Figure 2.

In some embodiments, the wearable support can fix the non-implanted part 202 near the implanted part 100-2, so that the distance between the magnetic field generator 212 and the vibrator 150 and transducer 110 is less than a preset distance threshold. The preset distance threshold can be preset based on experience, such as 100cm. The wearable support can ensure that the magnetic field energy generated by the magnetic field generator 212 is not easily dissipated in space when the nerve stimulation device is used, thereby improving energy utilization.

Some embodiments in this specification utilize the magnetoelectric coupling effect. A magnetic field is generated externally by a magnetic field generator, which in turn causes a vibrating component to vibrate, thereby driving the transducer to vibrate and generate an electrical signal. Energy propagation and conversion can be achieved by controlling the magnetic field, enriching the transducer's control methods. The structure is simple and small in size. Since no antenna is required, it can be applied to long-wave communication. Using a magnetoelectric antenna as the core component, it achieves a size one ten-thousandth that of traditional antennas (1/10 of the wavelength). Furthermore, through the vibration of the transducer in the magnetic field, and with mature coding methods, magnetoelectric coupling avoids responses to unexpected changes in the magnetic field, exhibiting strong anti-interference capabilities and ensuring effective energy transmission.

Figure 4 is yet another exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification.

In some embodiments, as shown in FIG4, the neurostimulation device includes an implantation portion 100-3, which includes a transducer 110 and an electrode 120. The transducer 110 and electrode 120 are described in the relevant description in FIG1.

In some embodiments, as shown in FIG4, the implantation unit 100 further includes an energy storage device 143 and a control circuit 133.

In some embodiments, the input terminal of the energy storage device 143 is electrically connected to the transducer 110, and the output terminal of the energy storage device 143 is electrically connected to the input terminal of the control circuit 133. In some embodiments, the output terminal of the control circuit 133 is electrically connected to the electrode 120. The electrical connection can include various methods, such as a wire connection.

In some embodiments, the transducer 110 can convert the vibrations received by the human body during daily activities into electrical signals and send them to the energy storage device 143. The energy storage device 143 stores the electrical signals as electrical energy and supplies power to the control circuit 133. The control circuit 133 can adjust the electrical signals into target electrical stimulation signals and send them to the electrode 120. The electrode 120 can perform electrical stimulation on the target part of the human body based on the target electrical stimulation signals.

The energy storage device 143 is similar to the energy storage device 141, and the control circuit 133 is similar to the control circuit 131. For more information about the energy storage device 143 and the control circuit 133, please refer to the relevant content in Figure 2.

In some embodiments described herein, an electrical signal is generated by a transducer based on normal human body vibrations and stored in an energy storage device in the form of electrical energy; the energy storage device supplies power to a control circuit, which can provide an electrical stimulation signal to the electrodes when needed, thereby enabling the function of a nerve stimulation device without the cooperation of a non-implantable part.

In some embodiments, the implantation unit 100-3 further includes a monitoring electrode 160.

The monitoring electrode 160 is configured to monitor physiological signals. See Figure 2 for a description of these physiological signals. In some embodiments, the monitoring electrode 160 can be used to monitor electromyographic signals, electroencephalographic signals, electrocardiographic signals, etc.

In some embodiments, the control circuit 133 is configured to control the output of an electrical stimulation signal from the electrode 120 based on physiological signals.

In some embodiments, the monitoring electrode 160 can send the monitored physiological signals to the control circuit 133, and the control circuit 133 can control the electrode 120 to output an electrical stimulation signal based on the physiological signals meeting preset trigger conditions. The preset trigger conditions can be preset based on experience, and different preset trigger conditions can be set according to different parts of the human body and different treatment effects.

Figure 5 is an exemplary structural schematic diagram of a transducer according to some embodiments of this specification.

In some embodiments, as shown in FIG5, the transducer 110 includes a housing 111, a vibration pickup element 112, and a transducer element 113.

Housing 111 is the outer shell structure of transducer 110. Housing 111 is used to enclose the internal components of transducer 110.

Vibration pickup element 112 is a component used to receive and transmit vibrations. Vibration pickup element 112 has high sensitivity to vibration signals and good mechanical strength. Vibration pickup element 112 can be made of rigid materials, such as crystalline materials or metallic materials.

In some embodiments, the vibration pickup 112 can be a beam structure that connects the housing 111 and the transducer 113.

The transducer 113 is an energy conversion structure used to convert mechanical vibrations into electrical signals. For example, the transducer 113 can be a piezoelectric element, etc.

In some embodiments, the vibration pickup element 112 may be disposed within and connected to the housing 111, and the transducer element 113 is set on the vibration pickup element 112.

In some embodiments, the housing 111 is fitted to the human skeleton after implantation, thereby better receiving external vibrations. For example, in scenarios requiring brain stimulation, the housing 111 can fit against the skull. As another example, in scenarios requiring spinal cord stimulation, the housing 111 can fit against the spine.

In some embodiments, after external vibration is transmitted to the housing 111, it causes the vibration pickup element 112 connected to the housing 111 to vibrate. The vibration pickup element 112 can transmit the vibration to the transducer element 113, and the transducer element 113 can convert the vibration into an electrical signal. The transducer element 113 can be fitted to the vibration pickup element 112 to better transmit the vibration.

Figure 6 is another exemplary schematic diagram of a nerve stimulation device according to some embodiments of this specification.

In some embodiments, as shown in FIG6, the neurostimulation device includes an implant 100-4 and a non-implant 203, wherein the implant 100-4 includes a transducer 110 and an electrode 120. For more information on the transducer 110 and the electrode 120, please refer to the related description in FIG1.

In some embodiments, as shown in FIG6, the non-implantable portion 203 includes a vibration source 213. The vibration source 213 is a device for generating vibration. In some embodiments, the vibration source 213 is configured to provide vibration to a transducer 110, which converts the vibration into an electrical signal, and the electrode 120 outputs an electrical stimulation signal based on the electrical signal. In some embodiments, the vibration source 213 may be in direct contact with the human body and positioned close to the transducer 110 to reduce vibration energy loss.

In some embodiments, vibration source 213 may include a head-mounted vibration source and a belt-type vibration source. A head-mounted vibration source is a device that can be worn near the head and emits vibrations, such as a bone conduction vibration source, capable of emitting mechanical vibrations. An example bone conduction vibration source is a bone conduction headset. A belt-type vibration source is a device that can be worn near the waist and emits mechanical vibrations.

In brain stimulation scenarios, a head-mounted vibration source can be fixed near the skull, transmitting vibrations to the skull via bone conduction, thereby causing the transducers within the skull to vibrate. In spinal cord stimulation scenarios, a waist-mounted vibration source can be fixed near the spine in the lumbar region, transmitting vibrations to the spine via bone conduction, thereby causing the transducers within the spine to vibrate.

In some embodiments, as shown in FIG6, the non-implantable part 203 further includes a vibration control module 223.

The vibration control module 223 is used to adjust vibration parameters. Vibration parameters may include vibration time, vibration amplitude, etc.

In some embodiments, the vibration control module 223 is configured to control the vibration source 213.

In some embodiments, as shown in FIG6, the non-implantable part 203 further includes a signal acquisition component 233. The signal acquisition component 233 is configured to acquire physiological signals of the human body. The signal acquisition component 233 is similar to the signal acquisition component 231, as can be seen in the relevant description in FIG2.

In some embodiments, the vibration control module 223 can be configured to control the vibration source based on physiological signals.

By setting a vibration control module and signal acquisition components outside the body, the vibration of the transducer can be directly controlled. The implanted part does not need to be equipped with control circuits or other control structures, which simplifies the structure of the implanted part inside the body.

Some embodiments in this specification transmit mechanical vibration signals to the transducer through direct contact between the vibration source and the human body, which can improve signal transmission efficiency. Simultaneously, the vibration can be controlled via a vibration control module, thereby regulating the electrical signal output by the transducer and enriching the transducer's control methods.

In some embodiments, as shown in FIG6, the implantation unit 100-4 further includes an energy storage device 144 and a control circuit 134. The input terminal of the energy storage device 144 is electrically connected to the transducer 110, the output terminal of the energy storage device 144 is electrically connected to the input terminal of the control circuit 134, and the output terminal of the control circuit 134 is electrically connected to the electrode 120.

In some embodiments, the transducer 110 can convert the vibration of the vibration source 213 into an electrical signal and send it to the energy storage device 144. The energy storage device 144 stores the electrical signal as electrical energy and supplies power to the control circuit 134. The control circuit 134 can adjust the electrical signal into a target electrical stimulation signal and send it to the electrode 120. The electrode 120 can perform electrical stimulation on the target part of the human body based on the target electrical stimulation signal.

The energy storage device 144 is similar to the energy storage device 141, and the control circuit 134 is similar to the control circuit 131. For more information about the energy storage device 144 and the control circuit 134, please refer to the relevant content in Figure 2.

By incorporating energy storage devices, the vibration energy supplied by the vibration source can be stored, and the energy can be replenished when needed through a control circuit. When needed, the electrical signal is adjusted to an electrical stimulation signal, thereby electrically stimulating the target part of the human body through electrodes, thus broadening the application scenarios of nerve stimulation devices.

Figure 7 is another exemplary structural schematic diagram of a transducer according to some embodiments of this specification.

In some embodiments, as shown in FIG7, the transducer 110 includes a housing 111 and a transducer element 112.

The housing 111 refers to the external structural component of the transducer. The housing 111 can be made of a rigid or flexible material. The housing 111 can have good biocompatibility. When the non-implantable part includes a magnetic field generator, the material of the housing 111 should avoid using magnetic shielding materials. When the non-implantable part includes an ultrasound generator, the material of the housing 111 should be able to conduct ultrasound well. Exemplary housing 111 materials include at least one of titanium alloys, titanium ceramics, etc.

The transducer 112 is a structural component used to convert vibration into electrical energy, such as a piezoelectric sheet.

In some embodiments, the transducer 112 is encapsulated within a housing 111. The encapsulated transducer 110 can be implanted into different target sites on the human body.

Encapsulating the transducer with a housing can reduce adverse reactions to the human body caused by transducer implantation and make the transducer adaptable to the space requirements of the implantation site, thereby increasing the applicable scenarios of the transducer.

In some embodiments, the maximum surface area of the transducer 110 is no more than 200 square millimeters, thereby making the structure of the transducer 110 as small as possible, reducing the volume of the implant 100, and reducing the infection and complications that may be caused after the implant 100 is implanted into the human body.

In some embodiments, the maximum surface area of transducer 110 is no greater than 180 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 170 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 160 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 150 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 140 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 130 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 120 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 110 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 100 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 90 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 80 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 70 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 60 square millimeters. When the non-implantable part includes an ultrasound generator, controlling the area of the transducer 110 can reduce the volume of the implantable part 100 while ensuring the reception of ultrasound signals.

In some embodiments, the maximum surface area of transducer 110 is no greater than 50 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 40 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 30 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 20 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 10 square millimeters. In some embodiments, the maximum surface area of transducer 110 is no greater than 5 square millimeters. When the non-implantable part includes a magnetic field generator, since the vibration is generated by the magnetostrictive material and directly transmitted to the transducer, there is no need to increase the area to ensure the signal reception strength. Therefore, transducer 110 can be provided with a smaller area, thereby further reducing the volume of implantable part 100.

In some embodiments, the thickness of transducer 110 is no greater than 1 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.9 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.8 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.7 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.6 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.5 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.4 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.3 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.2 mm. In some embodiments, the thickness of transducer 110 is no greater than 0.1 mm. By controlling the area and thickness of the transducer, the volume of transducer 110 can be minimized, thereby reducing the volume of implantation part 100 and making the implanted part in the human body as small as possible, thus reducing infection and complications.

Figure 8 is a schematic diagram of an exemplary structure of the implantation site according to some embodiments of this specification.

In some embodiments, as shown in FIG8, the implantation portion 100 further includes an encapsulation portion 170 and a wire 101.

The encapsulation portion 170 is a component used to encapsulate the transducer. In some embodiments, the encapsulation portion 170 may... It is a flexible material.

In some embodiments, the transducer 110 is disposed within the encapsulation portion 170.

In some embodiments, as shown in FIG8, a wire connects the package 170 and the electrode 120. The wire can conduct electricity between the transducer 110 and the electrode 120, and the transducer 110 can transmit electrical signals to the electrode 120 based on the wire.

In some embodiments, the length of the lead wire 101 (length y in FIG. 8) is greater than the distance between the encapsulation portion 170 and the electrode 120 after the implantation is placed in the human body (distance x in FIG. 1). It is understood that after the neurostimulation device is implanted in the human body, the lead wire 101 will be in a bent state between the encapsulation portion 170 and the electrode 120. As the human body moves, the distance between the encapsulation portion 170 and the electrode 120 may increase, and the lead wire 101 will gradually straighten during this process. By reserving length for the lead wire 101, stress on the lead wire 101 can be avoided during the use of the neurostimulation device.

In some embodiments, the non-implantable portion includes a power storage device and a control circuit, both of which may be disposed within the encapsulation portion 170. In some embodiments, the power storage device and the control circuit may be connected by wires; the control circuit and the electrode may also be connected by wires.

The basic concepts have been described above. Obviously, for those skilled in the art, the detailed disclosure above is merely illustrative and does not constitute a limitation of this specification. Although not explicitly stated herein, those skilled in the art may make various modifications, improvements, and corrections to this specification. Such modifications, improvements, and corrections are suggested in this specification and therefore remain within the spirit and scope of the exemplary embodiments described herein.

Furthermore, this specification uses specific terms to describe embodiments thereof. For example, "an embodiment," "one embodiment," and/or "some embodiments" refer to a particular feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "an embodiment," "one embodiment," or "an alternative embodiment" in different locations throughout this specification do not necessarily refer to the same embodiment. Moreover, certain features, structures, or characteristics in one or more embodiments of this specification can be appropriately combined.

Furthermore, unless expressly stated in the claims, the order of processing elements and sequences, the use of numbers and letters, or other names described in this specification are not intended to limit the order of the processes and methods described herein. Although various examples have been discussed in the foregoing disclosure of some embodiments of the invention that are currently considered useful, it should be understood that such details are for illustrative purposes only, and the appended claims are not limited to the disclosed embodiments; rather, the claims are intended to cover all modifications and equivalent combinations that conform to the spirit and scope of the embodiments described herein. For example, while the system components described above can be implemented using hardware devices, they can also be implemented solely using software solutions, such as installing the described system on existing servers or mobile devices.

Similarly, it should be noted that, in order to simplify the description disclosed herein and thus aid in the understanding of one or more embodiments of the invention, the foregoing description of embodiments in this specification may sometimes combine multiple features into a single embodiment, drawing, or description thereof. However, this method of disclosure does not imply that the subject matter of this specification requires more features than those mentioned in the claims. In fact, the embodiments contain fewer features than all the features of a single embodiment disclosed above.

In some embodiments, numbers describing the quantity of components and attributes are used. It should be understood that such numbers used in the description of embodiments are modified in some examples with the terms "approximately," "approximately," or "generally." Unless otherwise stated, "approximately," "approximately," or "generally" indicates that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may be changed depending on the characteristics required by individual embodiments. In some embodiments, numerical parameters should take into account specified significant digits and employ a general method of digit reservation. Although the numerical ranges and parameters used to confirm their breadth of range in some embodiments of this specification are approximate values, in specific embodiments, such values are set as precisely as feasible.

For each patent, patent application, patent application publication, and other material, such as articles, books, specifications, publications, and documents, referenced in this specification, the entire contents of which are incorporated herein by reference. This excludes historical application documents that are inconsistent with or conflict with the content of this specification, as well as documents that limit the broadest scope of the claims in this specification (currently or subsequently appended to this specification). It should be noted that in the event of any inconsistency or conflict between the descriptions, definitions, and/or terminology used in the supplementary materials to this specification and the content of this specification, the descriptions, definitions, and/or terminology used in this specification shall prevail.

Finally, it should be understood that the embodiments described in this specification are merely illustrative of the principles of the embodiments described herein. Other variations may also fall within the scope of this specification. Therefore, alternative configurations of the embodiments described herein are intended to be illustrative rather than limiting, and should be considered consistent with the teachings of this specification. Accordingly, the embodiments described herein are not limited to those explicitly introduced and described herein.

Claims (26)

A nerve stimulation device, characterized in that it includes an implantable part that can be implanted in the human body, said implantable part comprising: A transducer is configured to receive vibration signals and convert the vibration signals into electrical signals; The electrodes are configured to output an electrical stimulation signal based on the electrical signal. The nerve stimulation device according to claim 1 is characterized in that the nerve stimulation device further includes a non-implantable part, the non-implantable part including an ultrasound generator configured to generate ultrasound waves. The nerve stimulation device according to claim 2 is characterized in that the non-implanted part further includes an ultrasound control module, the ultrasound control module being configured to control at least one of the parameters such as frequency, amplitude, phase, and power of the ultrasound wave. The nerve stimulation device according to claim 3 is characterized in that the non-implantable part further includes a signal acquisition component and a processing module, the signal acquisition component is configured to acquire physiological signals of the human body, and the processing module sets the ultrasound control module based on the physiological signals. The nerve stimulation device according to claim 2, wherein the implanted part further includes a control circuit configured to adjust the electrical signal output by the transducer into the electrical stimulation signal. According to claim 5, the nerve stimulation device is characterized in that the implantation part further includes an energy storage device, the energy storage device being electrically connected to the transducer and the control circuit respectively, the energy storage device being configured to receive the electrical signal, store it as electrical energy, and supply power to the control circuit. The neurostimulation device according to claim 2 is characterized in that the non-implanted part further includes a wearable support. The nerve stimulation device according to claim 1 is characterized in that the nerve stimulation device further includes a non-implantable part, the non-implantable part including a magnetic field generator configured to generate a magnetic field, the implantable part including a vibrating element configured to generate vibration under the action of the magnetic field, and the vibrating end of the vibrating element abutting against the transducer. The nerve stimulation device according to claim 8 is characterized in that the non-implantable part further includes a magnetic field modulation module, the magnetic field modulation module being configured to modulate the magnetic field. The nerve stimulation device according to claim 9 is characterized in that the non-implantable part further includes a signal acquisition component and a processing module, the signal acquisition component being configured to acquire physiological signals of the human body, and the processing module configuring the magnetic field modulation module based on the physiological signals. The nerve stimulation device according to claim 8, wherein the implanted part further includes a control circuit configured to adjust the electrical signal output by the transducer into the electrical stimulation signal. The nerve stimulation device according to claim 11 is characterized in that the implantation part further includes an energy storage device, the energy storage device being electrically connected to the transducer and the control circuit respectively, the energy storage device being configured to receive the electrical signal, store it as electrical energy, and supply power to the control circuit. The neurostimulation device according to claim 8 is characterized in that the non-implanted part further includes a wearable support. The nerve stimulation device according to claim 1 is characterized in that the implantation part further includes an energy storage device and a control circuit, the input end of the energy storage device is electrically connected to the transducer, the output end of the energy storage device is electrically connected to the input end of the control circuit, and the output end of the control circuit is electrically connected to the electrode. The neurostimulation device according to claim 14 is characterized in that the implantation part further includes a monitoring electrode, the monitoring electrode is configured to monitor physiological signals, and the control circuit is configured to control the electrode to output an electrical stimulation signal based on the physiological signals. According to claim 1, the nerve stimulation device is characterized in that the transducer includes a housing, a vibration pickup element, and a transducer element, the vibration pickup element is disposed inside the housing and connected to the housing, the transducer element is disposed on the vibration pickup element, and the housing conforms to the human skeleton after being implanted into the human body. The neurostimulation device according to claim 16 is characterized in that the neurostimulation device further includes a non-implantable part, the non-implantable part including a vibration source configured to provide vibration to the human body. The nerve stimulation device according to claim 17 is characterized in that the non-implanted part further includes a vibration control module, the vibration control module being configured to control the vibration source. The nerve stimulation device according to claim 18 is characterized in that the non-implantable part further includes a signal acquisition component, the signal acquisition component being configured to acquire physiological signals of the human body, and the vibration control module being configured to control the vibration source based on the physiological signals. The nerve stimulation device according to claim 17 is characterized in that the implantation part further includes an energy storage device and a control circuit, the input terminal of the energy storage device is electrically connected to the transducer, the output terminal of the energy storage device is electrically connected to the input terminal of the control circuit, and the output terminal of the control circuit is electrically connected to the electrode. The nerve stimulation device according to claim 1 is characterized in that the transducer includes a housing and a transducer element, wherein the transducer element is encapsulated within the housing. The nerve stimulation device according to claim 1 is characterized in that the maximum surface area of the transducer is not greater than 200 square millimeters. The nerve stimulation device according to claim 22 is characterized in that the maximum surface area of the transducer is not greater than 180 square millimeters. The nerve stimulation device according to claim 22 is characterized in that the maximum surface area of the transducer is not greater than 50 square millimeters. The nerve stimulation device according to claim 22 is characterized in that the thickness of the transducer is not greater than 1 mm. According to claim 1, the nerve stimulation device is characterized in that the implantation part further includes an encapsulation part and a wire, the transducer is disposed in the encapsulation part, the wire connects the encapsulation part and the electrode, and the length of the wire is greater than the distance between the encapsulation part and the electrode after the implantation part is implanted into the human body.