Implantable brain stimulation device, wireless brain stimulation system and preparation method

Abstract

The invention relates to an implantable brain stimulation device, a wireless brain stimulation system and a preparation method. The implantable brain stimulation device comprises an expandable supporting structure, an acoustic-electric conversion module, a signal conditioning circuit and an electrode module with a stimulation surface, wherein the acoustic-electric conversion module is integrated on the supporting structure and is used for converting ultrasonic waves received from the outside into electric signals; the signal conditioning circuit is electrically connected with the acoustic-electric conversion module and is used for tuning the electric signal to obtain an electric stimulation signal; and the electrode module is electrically connected with the signal conditioning circuit and is used for applying the electrical stimulation signal. By adopting the device, the deep brain stimulation infection risk and the maintenance difficulty can be reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an implantable brain stimulation device, a wireless brain stimulation system, and a method for its preparation. Background Technology

[0002] Deep brain stimulation (DBS) is an important treatment for neurological diseases such as Parkinson's disease. It involves implanting electrodes to electrically stimulate deep brain nuclei.

[0003] Traditional techniques typically involve craniotomy to implant electrodes and connect subcutaneous leads to an external or chest wall pulse generator to supply and control stimulation signals. However, this method requires long-term reliance on implanted batteries or percutaneous leads, leading to risks such as secondary surgery for power replacement, lead breakage and displacement, and percutaneous infection, which in turn affect the long-term stability of the device and patient safety.

[0004] This shows that traditional techniques still present technical challenges such as high risk of infection and high maintenance difficulty in deep brain stimulation. Summary of the Invention

[0005] Therefore, it is necessary to address the aforementioned technical problems by providing an implantable brain stimulation device, a wireless brain stimulation system, and a preparation method that can reduce the risk of infection and maintenance difficulty associated with deep brain stimulation.

[0006] In a first aspect, this application provides an implantable brain stimulation device, which includes a deployable support structure, a sound-to-electric conversion module, a signal conditioning circuit, and an electrode module with a stimulation surface; wherein:

[0007] The acoustic-to-electric conversion module is integrated into the support structure and is used to convert ultrasonic waves received from the outside into electrical signals.

[0008] The signal conditioning circuit is electrically connected to the acoustic-to-electric conversion module and is used to tune the electrical signal to obtain an electrical stimulation signal.

[0009] The electrode module is electrically connected to the signal conditioning circuit and is used to apply the electrical stimulation signal.

[0010] In one embodiment, the support structure is a tubular support structure applied to the inner wall of a blood vessel.

[0011] In one embodiment, the support structure employs a self-expanding metal bracket.

[0012] In one embodiment, the self-expanding metal support is a nickel-titanium alloy support with a preset mesh structure.

[0013] In one embodiment, the acoustic-electric conversion module includes a piezoelectric material layer or a triboelectric structure.

[0014] In one embodiment, the signal conditioning circuit includes a rectifier unit, a filter unit, and a pulse shaping unit connected in sequence.

[0015] The rectifier unit is used to rectify the electrical signal to obtain a rectified electrical signal;

[0016] The filtering unit is used to filter the rectified electrical signal to obtain a filtered electrical signal.

[0017] The pulse shaping unit is used to shape the filtered electrical signal and adjust the pulse width to obtain the electrical stimulation signal.

[0018] In one embodiment, the rectifier unit includes at least one Schottky diode.

[0019] In one embodiment, the filtering unit employs an RC low-pass filter network.

[0020] In one embodiment, the pulse shaping unit employs a capacitor- and resistor-based charging and discharging circuit.

[0021] In one embodiment, the stimulation surface of the electrode module is a metal oxide nanostructure surface.

[0022] In one embodiment, the surface of the metal oxide nanostructure is an array of copper oxide nanopillars.

[0023] Secondly, this application provides a wireless brain stimulation system, which includes an external energy emission device, a control device, and an implantable brain stimulation device as described above.

[0024] The external energy emission device is used to emit ultrasound waves to the implanted brain stimulation device;

[0025] The control device is communicatively connected to the external energy emitting device and is used to control the emission parameters of the ultrasound waves; the emission parameters include at least one of the following: output frequency, output power, and pulse parameters.

[0026] Thirdly, this application provides a method for preparing an implantable brain stimulation device, the method comprising:

[0027] A deployable support structure is obtained by engraving a pre-set support material using laser engraving technology.

[0028] Electrode material is formed on the support structure, and the electrode material is subjected to thermal oxidation treatment to form an electrode module;

[0029] The acoustic-to-electric conversion module and the signal conditioning circuit are integrated on the support structure so that the signal conditioning circuit is electrically connected to the electrode module.

[0030] The integrated support structure is encapsulated using a biocompatible polymer to obtain an implantable brain stimulation device.

[0031] The aforementioned implantable brain stimulation device, wireless brain stimulation system, and preparation method, through an expandable support structure, enable stable anchoring of the device within brain tissue, reducing reliance on percutaneous leads and external power sources. By integrating an acoustic-to-electric conversion module onto the support structure, externally input ultrasonic energy is wirelessly converted into an initial electrical signal, fundamentally eliminating the infection risks and maintenance challenges associated with traditional batteries or percutaneous power supply. The signal conditioning circuit tunes the received electrical signal, ensuring the generation of a precise electrical stimulation signal that meets the needs of neurostimulation. The electrode module utilizes its stimulation surface to release the electrical stimulation signal, achieving effective stimulation of the target brain region. This significantly reduces the infection risks and the difficulty of secondary surgery caused by long-term use, achieving the technical effect of reducing the infection risks and maintenance difficulties associated with deep brain stimulation. Attached Figure Description

[0032] Figure 1 This is a structural block diagram of an implantable brain stimulation device in one embodiment;

[0033] Figure 2 This is a block diagram of a wireless brain stimulation system in one embodiment;

[0034] Figure 3 This is a flowchart illustrating the preparation method of an implantable brain stimulation device in one embodiment;

[0035] Figure 4 This is a schematic diagram of the structure of an implantable brain stimulation device in one embodiment;

[0036] Figure 5 This is a schematic diagram of the sound-to-electric conversion module in one embodiment;

[0037] Figure 6 This is a schematic diagram of a wireless deep brain stimulator generating biphasic pulses in one embodiment.

[0038] Figure 7 This is a schematic diagram illustrating the generation of biphasic pulses from a simulated input in one embodiment;

[0039] Figure 8 This is a circuit diagram of a signal conditioning circuit in one embodiment;

[0040] Figure 9This is a schematic diagram of a tuned biphasic pulse from a wireless deep brain stimulator in one embodiment.

[0041] Figure 10 This is a schematic diagram of a simulated input tuned biphase pulse in one embodiment;

[0042] Figure 11 This is a schematic diagram of the intravascular implantation path in one embodiment;

[0043] Figure 12 This is a schematic diagram of the process for preparing an implantable brain stimulation device in one embodiment;

[0044] Figure 13 This is a schematic diagram of the behavioral experiment process in one embodiment;

[0045] Figure 14 This is a schematic diagram of the results of an open field test in one embodiment;

[0046] Figure 15 This is a schematic diagram of the quantitative analysis results of a behavioral experiment in one embodiment;

[0047] Figure 16 This is a schematic diagram of the immunohistochemical staining results of tyrosine hydroxylase in one embodiment;

[0048] Figure 17 This is a schematic diagram of the examination results of the brain parenchyma in the subthalamic nucleus region in one embodiment. Detailed Implementation

[0049] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0050] In one embodiment, such as Figure 1 As shown, an implantable brain stimulation device is provided, comprising a deployable support structure 11, a sound-to-electric conversion module 12, a signal conditioning circuit 13, and an electrode module 14 with a stimulation surface; wherein:

[0051] The acoustic-to-electric conversion module 12 is integrated on the support structure 11 and is used to convert ultrasonic waves received from the outside into electrical signals.

[0052] The signal conditioning circuit 13 is electrically connected to the acoustic-to-electric conversion module 12 and is used to tune the electrical signal to obtain an electrical stimulation signal.

[0053] Electrode module 14 is electrically connected to signal conditioning circuit 13 and is used to apply discharge stimulation signal.

[0054] Traditional techniques rely on percutaneous lead fixation devices, which are prone to displacement or tissue damage due to traction. In this embodiment, the implantable brain stimulation device can be used to achieve electrical stimulation therapy on deep brain nuclei and can be applied to the intervention of neurological diseases such as Parkinson's disease. In an exemplary embodiment, the implantable brain stimulation device can be applied to cerebral blood vessels, and further, it can be deployed in blood vessels near the target brain region.

[0055] The deployable support structure 11 can transform from a compressed state to an unfolded state through mechanical deformation, thereby adapting to the spatial structure of a specific location within the brain. This allows for unfolding after implantation, achieving stable anchoring of the device within the brain tissue and effectively preventing displacement. In an exemplary embodiment, the support structure 11 can be fixed through stable contact with the blood vessel wall. Exemplary examples of the deployable support structure 11 include, but are not limited to, self-expanding scaffolds, shape memory polymer frames, etc.

[0056] In traditional technologies, implants require batteries for power, necessitating a second surgery for replacement once the power is depleted. In this embodiment, however, an acoustic-to-electric conversion module 12 is used to receive externally applied ultrasound waves and convert the ultrasound energy into an alternating electrical signal, thus serving as the energy source for electrical stimulation. For example, the acoustic-to-electric conversion module 12 may have an input receiving ultrasound waves, an output electrically connected to a signal conditioning circuit 13, and be physically integrated onto a deployable support structure 11. For example, the acoustic-to-electric conversion module 12 may employ conversion modules including, but not limited to, piezoelectric ceramic sheet structures and organic piezoelectric thin film materials.

[0057] The applicant's initial assessment revealed that although the acoustic-to-electrical conversion module 12 could generate basic biphasic pulses, the output signal still exhibited certain high-frequency noise and instability. Therefore, the reliability of the electrical stimulation signal obtained solely from the acoustic-to-electrical conversion module 12 for brain stimulation remained low. Consequently, this embodiment employs a signal conditioning circuit 13 to receive the initial electrical signal output from the acoustic-to-electrical conversion module 12 and process this signal to generate an electrical stimulation signal that meets the requirements of the neural stimulation parameters. For example, signal conditioning may include, but is not limited to, one or more of filtering, rectification, voltage regulation, and pulse shaping circuits.

[0058] Electrode module 14 can receive electrical stimulation signals output by signal conditioning circuit 13 and induce depolarization reactions by utilizing charge exchange between the conductive material surface and nerve tissue. Exemplarily, electrical stimulation signals can be released through the stimulation surface integrated into support structure 11, thereby acting on adjacent target brain region nerve tissue. Further, in some exemplary embodiments, electrode module 14 can employ a platinum-iridium alloy multi-contact ring electrode to release electrical stimulation signals, or it can employ a carbon nanotube-coated flexible microelectrode array, or other micro-electrode materials; this embodiment is not limited to these specific methods.

[0059] In this embodiment, the motor module may employ an electrode material containing a stimulation surface. This stimulation surface may be oriented towards the target brain tissue to achieve effective transmission of electrical stimulation signals to adjacent tissues. It is part of the electrode module 14 and directly participates in the output of the stimulation signal. In an exemplary embodiment, the stimulation surface includes multiple independent contacts arranged in a ring, or it may include a unilateral directional convex structure.

[0060] Taking a scenario where a patient needs to undergo long-term, continuous deep brain stimulation therapy as an example, the implantable brain stimulation device in this embodiment can be stably anchored to the area to be stimulated through an expandable support structure 11. An external ultrasound device periodically emits focused ultrasound waves to penetrate the skull. After receiving the ultrasound waves, the acoustic-to-electric conversion module 12 converts them into an initial electrical signal. This signal is filtered and pulse-shaped by the signal conditioning circuit 13 to generate a standard electrical stimulation signal, which is then released to the surrounding nerve tissue by the stimulation surface of the electrode module 14. This not only eliminates the need for battery and wire power and signal supply, but also effectively avoids the risks of infection and reoperation caused by battery depletion or wire failure.

[0061] This embodiment provides an implantable brain stimulation device that, through an expandable support structure 11, enables stable anchoring of the device within brain tissue, reducing reliance on percutaneous leads and external power sources. An acoustic-to-electric conversion module 12, integrated into the support structure 11, wirelessly converts externally input ultrasonic energy into an initial electrical signal, fundamentally eliminating the infection risks and maintenance challenges associated with traditional batteries or percutaneous power supply. A signal conditioning circuit 13 tunes the received electrical signal, ensuring the generation of a precise electrical stimulation signal that meets the requirements of neurostimulation. An electrode module 14 releases the electrical stimulation signal through its stimulation surface, effectively stimulating the target brain region. This significantly reduces the infection risks and the difficulty of secondary surgery caused by long-term use, achieving the technical effect of reducing the infection risks and maintenance difficulties associated with deep brain stimulation.

[0062] In one embodiment, the support structure is a tubular support structure applied to the inner wall of the blood vessel.

[0063] In this embodiment, the tubular support structure serves as a support carrier applied to the inner wall of the blood vessel. Its structure adapts to the anatomical shape of the blood vessel and provides mechanical support. Deployed along the vascular pathway, it enables stable fixation of the implantable brain stimulation device within the cerebral blood vessel, avoiding direct penetration of brain tissue. In an exemplary embodiment, the tubular support structure can receive mechanical constraint release signals from the blood flow environment within the body, adhere to the inner wall of the blood vessel through a self-expanding mechanism, and achieve long-term anchoring using the radial force between the stent and the blood vessel wall. Exemplarily, the tubular support structure may include, but is not limited to, laser-engravable tubular stent structures or expandable tubular frames made of flexible polymer materials; this embodiment does not impose such limitations.

[0064] This embodiment provides an implantable brain stimulation device. By setting the support structure as a tubular support structure applied to the inner wall of blood vessels, the device can be implanted along the natural path of the blood vessels and stably adhere to the blood vessel wall, avoiding penetration of brain tissue or reliance on percutaneous wires to connect to external devices. This can achieve the technical effect of reducing the infection risk and long-term maintenance difficulty of deep brain stimulation therapy.

[0065] In one embodiment, the support structure employs a self-expanding metal bracket.

[0066] In this embodiment, a self-expanding metal stent is used as the support structure, enabling stable anchoring of the implantable brain stimulation device within the blood vessel. It automatically deploys and conforms to the vessel wall under body temperature or physiological conditions, providing continuous radial support. Wireless stimulation functionality can be achieved through surface-integrated electrode modules and a sound-to-electric conversion module. Furthermore, the self-expanding metal stent can be a metal material with shape memory properties. By receiving body temperature or local thermal stimulation as input signals, it maintains a compressed shape under restricted delivery conditions, releases upon reaching the target location, and automatically recovers its preset deployed shape. For example, recovering the preset deployed shape can be achieved through thermally induced deformation to adapt to the vascular geometry, thereby deploying and conforming to the vessel wall.

[0067] This embodiment provides an implantable brain stimulation device that uses a self-expanding metal stent in its support structure. This stent automatically expands and stably adheres to the inner wall of blood vessels under body temperature or physiological conditions, providing continuous radial support to achieve minimally invasive delivery and long-term mechanical fixation. This reduces the risk of infection, prevents functional failure caused by device displacement, and reduces the need for secondary surgery and maintenance, all without the need for craniotomy, percutaneous leads, or built-in batteries. This achieves the technical effect of reducing the infection risk and long-term maintenance difficulty of deep brain stimulation therapy.

[0068] In one embodiment, the self-expanding metal support is a nickel-titanium alloy support with a pre-defined mesh structure.

[0069] In this embodiment, a nickel-titanium alloy bracket is used as a self-expanding metal bracket.

[0070] Among them, nickel-titanium alloy, as the main material of nickel-titanium alloy scaffold, can provide shape memory effect and superelasticity, can trigger phase change under body temperature conditions to achieve automatic deployment, provide continuous and uniform radial support force, and have excellent fatigue resistance and corrosion resistance, making it suitable for long-term use in the body.

[0071] In one exemplary embodiment, the nickel-titanium alloy stent can receive a compression deformation input signal and, based on the shape memory effect and superelasticity of nickel-titanium alloy, recover a preset mesh shape upon body temperature triggering, thereby achieving self-expansion to conform to the blood vessel wall. Exemplarily, the nickel-titanium alloy stent can be formed into a continuous mesh structure by laser cutting of a monolithic tube, or it can be constructed into a flexible mesh frame using braided metal wires; this embodiment does not limit the specific method used.

[0072] The pre-designed mesh structure endows the stent with a specific geometric topology, enabling it to form a uniformly distributed pore structure after deployment. This ensures sufficient radial support strength while reducing local stress concentration on the vessel wall. For example, the pre-designed mesh structure may include, but is not limited to, a periodic rhomboid opening array structure, or a spirally symmetrically distributed internet lattice.

[0073] This embodiment provides an implantable brain stimulation device that uses a nickel-titanium alloy scaffold with a pre-defined mesh structure as a self-expanding metal scaffold. The shape memory effect and superelasticity of the nickel-titanium alloy enable automatic expansion and adhesion to the blood vessel wall triggered by body temperature. The pre-defined mesh structure provides uniform radial support and functional module layout space, thereby achieving the technical effect of reducing the infection risk and long-term maintenance difficulty of deep brain stimulation therapy.

[0074] In one embodiment, the acoustic-to-electric conversion module includes a piezoelectric material layer or a triboelectric structure.

[0075] Among them, the piezoelectric material layer can be used to undergo periodic mechanical deformation under ultrasonic excitation. Through the charge separation generated by the crystal or polarized polymer material under stress, a voltage output is formed, and an alternating current signal synchronized with the ultrasonic excitation is obtained, thereby realizing the conversion of acoustic energy into electrical energy. The generated alternating current signal is processed by the signal conditioning circuit and can be output as a biphasic pulse that meets the requirements of nerve stimulation.

[0076] Triboelectric structures can be used to generate electrostatic induction charges through the relative motion of two different material interfaces under ultrasonic excitation, outputting usable electrical signals to achieve non-piezoelectric acoustic-electric conversion. The generated initial electrical signal, after processing by a signal conditioning module, can be output as a biphasic pulse that meets the requirements of nerve stimulation. For example, the triboelectric structure can employ a metal-polymer double-layer contact structure, or a porous elastic medium to enhance the dynamic response of the friction interface, or other media to achieve triboelectric generation; this embodiment is not limited to these methods.

[0077] This embodiment provides an implantable brain stimulation device that uses an acoustic-electric conversion module, including a piezoelectric material layer or a triboelectric structure. The piezoelectric material layer undergoes periodic deformation and outputs a corresponding voltage under ultrasonic excitation, achieving stable energy conversion. The triboelectric structure generates electrostatic induction charges through relative motion between interfaces, forming usable electrical signals. This effectively converts externally applied ultrasonic energy into electrical signals, eliminating the need for built-in batteries or percutaneous leads for power supply. It also overcomes the problem of low energy transmission efficiency caused by the attenuation of electric field strength in the skull, thus reducing the risk of infection and the difficulty of long-term maintenance in deep brain stimulation therapy.

[0078] In one embodiment, the signal conditioning circuit includes a rectifier unit, a filter unit, and a pulse shaping unit that are connected in sequence.

[0079] The rectifier unit is used to rectify electrical signals to obtain rectified electrical signals;

[0080] The filtering unit is used to filter the rectified electrical signal to obtain a filtered electrical signal;

[0081] The pulse shaping unit is used to shape the filtered electrical signal and adjust the pulse width to obtain an electrical stimulation signal.

[0082] The rectifier unit converts the AC signal output from the acoustic-to-electric conversion module into a unidirectional pulsating DC signal, thereby achieving unidirectional energy conduction and initial stabilization. In an exemplary embodiment, the rectifier unit can utilize one or more of diodes, bridge rectifier structures, etc., to directionally control the alternating input signal, allowing only unidirectional current flow, thus obtaining a rectified signal. Exemplarily, the rectifier unit can employ a bridge rectifier circuit including miniaturized diodes, an integrated low-threshold Schottky diode rectifier structure, or other rectifier circuit structures; this embodiment does not limit this to any particular type.

[0083] The filtering unit is used to remove high-frequency ripple and noise components from the rectified signal to output a stable DC voltage signal, which helps improve the stability of subsequent signal processing. For example, the filtering unit can receive the rectified signal output from the rectifier unit, and through capacitor energy storage combined with inductors and / or resistors, smooth the voltage fluctuations of the rectified signal, attenuate high-frequency interference components, and obtain a filtered signal. For example, the filtering unit can employ, but is not limited to, LC filter circuits containing chip ceramic capacitors and miniature inductors, RC passive filters, etc., and this embodiment is not limited thereto.

[0084] The pulse shaping unit can be used to reconstruct the waveform and adjust the pulse parameters of the filtered DC signal to generate an electrical stimulation pulse signal with specific width and amplitude characteristics. In an exemplary embodiment, the pulse shaping unit can receive the filtered electrical signal output by the filtering unit, and control the discharge timing and pulse width through a combination of passive timing elements and switching devices to form a controllable pulse sequence to obtain the electrical stimulation signal.

[0085] This embodiment provides an implantable brain stimulation device including a signal conditioning circuit comprising a rectifier unit, a filter unit, and a pulse shaping unit connected in sequence. The rectifier unit converts the AC characteristic electrical signal output from the acoustic-to-electric conversion module into a unidirectional rectified electrical signal, enabling unidirectional energy conduction. The filter unit removes high-frequency ripple and noise generated during rectification to output a stable filtered electrical signal, thereby improving signal purity. The pulse shaping unit shapes the waveform and adjusts the pulse width of the filtered signal, thereby generating a precise and controllable electrical stimulation signal that meets the physiological requirements of neurostimulation. It can complete the complete conversion from ultrasound-driven signal to usable stimulation signal without the need for a built-in power supply, avoiding reliance on traditional batteries and percutaneous wire connections. This enables the deep brain stimulation device to operate safely and stably for a long time under wireless power supply conditions, achieving the technical effect of reducing infection risk and maintenance difficulty.

[0086] In one embodiment, the rectifier unit includes at least one Schottky diode.

[0087] Understandably, traditional rectifiers such as ordinary silicon diodes have high forward voltages, leading to significant energy loss under weak signal conditions, making it difficult to meet the efficiency requirements of passive wireless power supply systems. In this embodiment, Schottky diodes can utilize their low forward voltage drop and fast response characteristics to efficiently rectify the weak AC signal output from the acoustic-to-electric conversion module, reducing energy loss and improving rectification efficiency under low input power conditions. Furthermore, the Schottky diode can receive the AC signal output from the acoustic-to-electric conversion module and, through the barrier effect based on the metal-semiconductor junction, allow current to flow rapidly under forward bias and cut off in reverse, thereby achieving efficient unidirectional conduction of high-frequency signals and obtaining a pulsating DC signal after unidirectional conduction processing, i.e., the rectified signal. For example, the rectifier unit can be a half-wave rectifier structure composed of a single Schottky diode, or a full-bridge rectifier circuit composed of multiple Schottky diodes.

[0088] This embodiment provides an implantable brain stimulation device. The rectifier unit includes at least one Schottky diode. The Schottky diode utilizes its low forward conduction voltage and fast switching characteristics to efficiently rectify the weak AC signal output from the acoustic-to-electric conversion module, reducing energy loss and improving rectification efficiency. Combined with its adaptability in single or bridge structures, it ensures effective conversion of the ultrasonic driving signal. This allows for effective rectification of the ultrasonic driving signal without an external power supply, ensuring energy supply and signal integrity for subsequent signal conditioning processes, thereby reducing the risk of infection and maintenance difficulty.

[0089] In one embodiment, the filtering unit employs an RC low-pass filter network.

[0090] The RC low-pass filter network in this embodiment can be used to filter out high-frequency ripple and noise interference in the rectified electrical signal, allowing only low-frequency stable components to pass through, thus providing a clean input signal for the pulse shaping unit. In an exemplary embodiment, the RC low-pass filter network can receive the rectified electrical signal output from the rectifier unit, and use a passive network composed of resistors and capacitors to attenuate the high-frequency signal, utilizing the charging and discharging characteristics of the capacitor to smooth voltage fluctuations, thereby obtaining a filtered electrical signal.

[0091] This embodiment provides an implantable brain stimulation device that uses an RC low-pass filter network in its filtering unit to receive the rectified electrical signal output from the rectifier unit. A passive structure composed of resistors and capacitors attenuates high-frequency components, and the charging and discharging characteristics of the capacitors smooth voltage fluctuations. A stable filtered electrical signal is output to the pulse shaping unit, effectively filtering out high-frequency noise and ripple interference while retaining stable low-frequency components suitable for pulse shaping. This ensures that the electrical signal converted from ultrasound-driven energy has sufficient signal-to-noise ratio and time-domain stability, thereby further reducing the risk of infection and maintenance difficulty.

[0092] Understandably, traditional pulse shaping units rely on active integrated circuits and external power supplies, resulting in high power consumption, large size, and the need for regular maintenance. In one embodiment, the pulse shaping unit employs a capacitor- and resistor-based charging and discharging circuit.

[0093] The capacitor- and resistor-based charging and discharging circuit can utilize the RC time constant characteristics to control the discharge timing, perform pulse shaping and width adjustment on the filtered electrical signal, thereby generating a biphasic pulse that meets the requirements of nerve stimulation, i.e., an electrical stimulation signal with stable timing characteristics. Furthermore, the capacitor- and resistor-based charging and discharging circuit can receive the filtered electrical signal output from the filtering unit. Driven by the filtered electrical signal, the capacitor is charged to a threshold through a resistor and then discharged. By setting RC parameters to control the pulse rise edge, duration, and fall edge, passive pulse shaping is achieved, thereby obtaining a pulsed electrical stimulation signal for nerve stimulation.

[0094] This embodiment provides an implantable brain stimulation device that uses a capacitor- and resistor-based charging and discharging circuit in its pulse shaping unit. By utilizing the time constant characteristics of the RC circuit, it achieves timing control of the filtered electrical signal. Through precise adjustment of the capacitor's charging and discharging process, it completes the shaping and pulse width modulation of the pulse signal, generating an electrical stimulation signal with stable amplitude and controllable duration. Thus, it can operate without active devices or external power supplies, eliminating dependence on built-in batteries or complex integrated circuits, reducing system power consumption and thermal effects. At the same time, the passive RC structure has high reliability and long-term stability, which can further reduce the risk of infection and maintenance difficulty.

[0095] In one embodiment, the stimulation surface of the electrode module is a metal oxide nanostructure surface.

[0096] In this embodiment, a metal oxide nanostructure surface is used as the stimulation surface of the electrode module. The nanoscale structural morphology increases the effective contact area with brain tissue, thereby improving charge injection capability and signal transmission efficiency. Simultaneously, the nanostructure surface possesses good biocompatibility and antibacterial properties, thus inhibiting microbial adhesion and colonization at the implantation interface and reducing the risk of infection. In an exemplary embodiment, the metal oxide nanostructure surface can receive the electrostimulation signal. The high electrochemical activity of the metal oxide material and the increased specific surface area brought by the nanostructure enhance ion exchange capacity, resulting in a highly efficient charge transfer response. Exemplarily, the metal oxide can be titanium dioxide, iridium oxide, etc., and this embodiment is not limited to these methods.

[0097] This embodiment provides an implantable brain stimulation device. The stimulation surface of the electrode module is a metal oxide nanostructure surface. The nanoscale morphology of this surface increases the effective contact area with brain tissue, improves charge injection capacity and signal transmission efficiency, enhances ion exchange capacity by leveraging the high electrochemical activity and increased specific surface area of ​​the material, and inhibits bacterial adhesion through surface energy regulation and microscopic topology. This can significantly reduce the risk of infection after deep brain stimulation, maintain long-term stimulation stability, extend the device's lifespan, and reduce the need for secondary surgery and maintenance.

[0098] In one embodiment, the surface of the metal oxide nanostructure is an array of copper oxide nanopillars.

[0099] In this embodiment, the surface of the metal oxide nanostructure employs a copper oxide nanopillar array. In an exemplary embodiment, the copper oxide nanopillar array can receive electrical stimulation signals transmitted through the bottom electrode, increase the effective specific surface area of ​​the electrode through the nanoscale columnar structure to promote ion exchange, and utilize the copper oxide material itself to release trace amounts of copper ions to interfere with microbial metabolism, thereby achieving local antibacterial effects and improving biocompatibility. This results in the release of charges on the tissue side and the generation of a nerve stimulation effect, while maintaining low interfacial impedance and high charge injection capacity.

[0100] This embodiment provides an implantable brain stimulation device that, by setting the surface of a metal oxide nanostructure as an array of copper oxide nanopillars, increases the specific surface area of ​​the electrodes through this nanostructure to improve charge transfer efficiency and releases trace amounts of copper ions to inhibit microbial adhesion and biofilm formation. This can reduce the risk of infection at the implantation site from the material level, improve the energy utilization efficiency of electrical stimulation, and reduce the maintenance frequency caused by electrode performance degradation or energy loss, thereby achieving the technical effect of enhancing the long-term safety and operational stability of the device.

[0101] The modules in the aforementioned implantable brain stimulation device can be implemented entirely or partially through software, hardware, or a combination thereof. These modules can be embedded in or independent of the processor in a computer device, or stored in the memory of a computer device as software, so that the processor can call and execute the operations corresponding to each module.

[0102] In one embodiment, such as Figure 2 As shown, a wireless brain stimulation system is provided, which includes an external energy emission device 2, a control device 3, and an implantable brain stimulation device 1 as described in any of the above embodiments.

[0103] The external energy emission device 2 is used to emit ultrasound waves to the implantable brain stimulation device 1;

[0104] The control device 3 is communicatively connected to the external energy emitting device 2 and is used to control the emission parameters of the ultrasound waves; the emission parameters include at least one of the following: output frequency, output power, and pulse parameters.

[0105] The wireless brain stimulation system, through the coordinated operation of the external energy emission device 2 and the implantable brain stimulation device 1, can achieve non-invasive electrical stimulation of deep brain nuclei. Furthermore, depending on the usage method, the wireless brain stimulation system can be a portable wearable device or a combination of fixed external devices.

[0106] The external energy emission device 2 is used to generate and emit ultrasound waves to wirelessly transmit energy to an implanted brain stimulation device, thereby driving the intravascular deep brain stimulation system. In this embodiment, the external energy emission device 2 can receive control signals and drive power from the control device 3, convert electrical signals into mechanical vibrations through a piezoelectric transducer, generate a directional focused ultrasound beam, and obtain ultrasound waves with specific frequency, output power, and pulse characteristics. These parameters are adjusted by the control unit to match the requirements of different target areas. Furthermore, the external energy emission device 2 can employ a multi-element phased array ultrasound transmitter head, or a single-element focusing ultrasound transducer, etc.

[0107] The control device 3 is used to set and adjust the operating parameters of the external energy emission device 2, thereby enabling precise control of the ultrasonic emission process. In one specific embodiment, the control device 3 may receive user operation commands or external monitoring data as the basis for parameter adjustment, generate parameter adjustment signals based on preset or real-time feedback stimulation requirements, and have the control unit execute the parameter setting to obtain control signals for adjusting the ultrasonic emission parameters.

[0108] Transmission parameters define key physical characteristics of the ultrasonic wave transmission process, and include at least one of the following: output frequency, output power, and pulse parameters. For example, the output frequency can be the number of ultrasonic vibrations per second, the output power can be the ultrasonic energy intensity, and the pulse parameters can be the time-domain characteristics of the ultrasonic wave transmission, including pulse width, repetition period, etc.

[0109] This embodiment provides a wireless brain stimulation system that transmits ultrasound waves to an implantable brain stimulation device 1 via an external energy transmitter 2 connected to a control device 3. The control device 3 is communicatively connected to the external energy transmitter 2 to adjust the transmission parameters, which include at least one of output frequency, output power, and pulse parameters. Wireless energy transmission is achieved by generating and transmitting ultrasound waves through the external energy transmitter 2. The control device 3 sets the transmission parameters to achieve precise control of the stimulation process. The implantable brain stimulation device 1 receives the ultrasound waves and converts them into electrical stimulation signals that act on brain tissue. The ultrasound waves, as an energy carrier, penetrate the skull and complete the acoustic-electric conversion within the body. The adjustable transmission parameters can adapt to different treatment needs, enabling non-invasive electrical stimulation treatment of deep brain nuclei. This completely eliminates the infection risks and secondary surgery requirements associated with percutaneous leads or built-in batteries, effectively simplifying the implantable device structure and thus achieving the technical effect of reducing the infection risk and long-term maintenance difficulty of deep brain stimulation treatment.

[0110] Based on the same inventive concept, this application also provides a method for preparing the aforementioned implantable brain stimulation device. The solution provided by this device is similar to the solution described in the above method; therefore, the specific limitations in the embodiments of one or more implantable brain stimulation device preparation methods provided below can be found in the limitations of the implantable brain stimulation device described above, and will not be repeated here.

[0111] In one embodiment, such as Figure 3 As shown, a method for preparing an implantable brain stimulation device is provided, the method comprising:

[0112] Step S100: The preset support material is engraved using laser engraving technology to obtain an expandable support structure.

[0113] Laser engraving can be a process that uses a high-energy focused laser beam to selectively remove or modify material surfaces, ensuring that the support structure exhibits controllable unfolding behavior and mechanical stability. In an exemplary embodiment, laser engraving can be used to etch predetermined hollow or cut patterns onto a pre-set support material by controlling the laser power, scanning path, and dwell time. Furthermore, laser engraving can employ techniques including, but not limited to, pulsed laser ablation, continuous wave laser cutting, and femtosecond laser three-dimensional direct writing.

[0114] The pre-designed support material can be a base material used to construct the deployable support structure. It possesses good mechanical ductility and biocompatibility, and can be laser-engraved into a scaffold structure with elastic recovery capabilities, thus providing a structural foundation for the entire device. For example, the pre-designed support material can be a metal alloy, such as nickel-titanium shape memory alloy foil or medical-grade ultrathin stainless steel sheet, or a polymer sheet, such as a biodegradable polylactic acid polymer film.

[0115] The deployable support structure can be a mesh or spiral structure formed from a pre-etched support material. It automatically unfolds at the target location and conforms to the local anatomical shape, which can be used to achieve stable positioning and mechanical anchoring of the device in the deep brain region, avoiding displacement caused by blood flow impact or tissue movement. In an exemplary embodiment, the deployable support structure can be formed by laser engraving a specific topological pattern on the raw material, enabling it to transform from a low radial dimension transport state to a high radial dimension working state.

[0116] In step S200, electrode material is formed on the support structure, and the electrode material is subjected to thermal oxidation treatment to form an electrode module.

[0117] The electrode material can be a functional conductive layer deposited on the surface of the support structure, used to conduct electrical stimulation signals and serve as a charge exchange medium for the neural interface. It can also be used as a precursor material for the electrode module, providing a conductive interface with low impedance and high charge injection capability. For example, the electrode material can be formed on the support structure by using methods such as physical vapor deposition, electroplating, or spraying to form a conductive coating in a designated area of ​​the support structure.

[0118] Thermal oxidation is a process in which a formed electrode material is placed in a high-temperature, oxygen-containing environment to undergo a surface chemical reaction, thereby altering its surface composition and microstructure. This can improve the electrochemical activity, corrosion resistance, and long-term stability of the electrode material, and reduce polarization effects during stimulation. For example, thermal oxidation involves inducing an oxidation reaction on the surface of the electrode material under controlled temperature and atmosphere conditions, generating a metal oxide layer with a higher specific surface area and greater stability.

[0119] Step S300: Integrate the acoustic-to-electric conversion module and the signal conditioning circuit onto the support structure so that the signal conditioning circuit is electrically connected to the electrode module.

[0120] Integrating the acoustic-to-electric conversion module and signal conditioning circuit onto the support structure allows for electrical connection between the signal conditioning circuit and the electrode module. This can be achieved using micro-assembly, thin-film deposition, or other technologies. The acoustic-to-electric conversion module and signal conditioning circuit are fixed to the surface of the support structure and electrically interconnected via wires or conductive vias. This enables full integration of energy reception, signal processing, and stimulation output, eliminating dependence on external power sources and wires.

[0121] In step S400, the integrated support structure is encapsulated using a biocompatible polymer to obtain an implantable brain stimulation device.

[0122] The biocompatible polymer can be an organic material used to encapsulate electronic components, isolating internal electronic parts from the biological environment, reducing the risk of tissue rejection, and maintaining the long-term functional integrity of the device. It exhibits low immunogenicity, anti-inflammatory properties, and long-term in vivo stability, preventing erosion by bodily fluids while allowing ultrasound penetration. In an exemplary embodiment, the biocompatible polymer can be coated onto the surface of the integrated structure using methods such as solution casting, spin coating, or injection molding to form a dense protective layer. Furthermore, the biocompatible polymer can be one or more of, but not limited to, parylene, polydimethylsiloxane, medical-grade silicone elastomers, and polyurethane copolymer films.

[0123] By encapsulating the integrated support structure with a biocompatible polymer, an implantable brain stimulation device can be obtained. This can be achieved by covering all other areas with the biocompatible polymer while leaving the stimulation surface of the electrode module exposed. For example, a chemical vapor deposition method can be used to grow a parylene film to achieve nanoscale uniform encapsulation. Alternatively, an injection molding process can be used to encapsulate the main structure with medical-grade silicone, exposing only the front electrode area. This provides long-term reliable electrical insulation and a biological barrier, preventing short circuits or corrosion caused by the infiltration of body fluids.

[0124] This embodiment provides a method for fabricating an implantable brain stimulation device. It achieves stable anchoring after minimally invasive implantation by precisely processing the support structure, optimizes electrode surface characteristics to improve electrochemical performance and long-term stability, achieves wireless energy reception and precise signal output through miniaturization integration, and encapsulates the integrated support structure using a biocompatible polymer to obtain the implantable brain stimulation device. This ensures stable anchoring of the device within brain tissue after minimally invasive implantation, improves the surface stability and electrochemical performance of the electrode module, enhances the reliability of long-term stimulation, and allows the device to be wirelessly powered by external ultrasound to generate precise electrical stimulation signals. It completely eliminates dependence on implanted batteries and percutaneous leads. The biocompatible polymer ensures the long-term stability of internal electronic components and reduces immune rejection and tissue inflammation. This fundamentally avoids the risk of secondary surgery and infection due to battery depletion or lead breakage, achieving the technical effect of reducing the infection risk and long-term maintenance difficulty of deep brain stimulation therapy.

[0125] It should be understood that although the steps in the flowcharts of the embodiments described above are shown sequentially according to the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless explicitly stated herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some steps in the flowcharts of the embodiments described above may include multiple steps or multiple stages. These steps or stages are not necessarily completed at the same time, but can be executed at different times. The execution order of these steps or stages is not necessarily sequential, but can be performed alternately or in turn with other steps or at least some of the steps or stages of other steps.

[0126] To more clearly illustrate the technical solution of this application, a detailed embodiment is also provided.

[0127] Deep brain stimulation (DBS) is an effective treatment for movement disorders such as Parkinson's disease. Traditional DBS systems require craniotomy to implant electrodes into deep brain nuclei and connect them to a pulse generator (including a battery) implanted in the chest wall via subcutaneous leads. This approach has the following significant problems: (1) It does not achieve true wireless and full implantation, and there are risks of infection and failure: Although the implantation part is minimally invasive, it still relies on physical leads that penetrate the blood vessel walls and skin tissue to connect to the external device. This results in a long-term risk of percutaneous infection, the lead may form thrombi in the blood vessel, and the lead itself has the potential for mechanical failure such as breakage and displacement. These risks limit the long-term safety and stability of the device. (2) The stimulation function is limited and the energy transmission efficiency is low: Existing intravascular electrode systems focus more on high impedance recording, and their design is not optimized for efficient and safe charge injection (stimulation). When used for stimulation, they often face problems such as low charge injection capacity, easy tissue damage or electrode corrosion. At the same time, the energy transmission efficiency of high-frequency stimulation through long leads is low, and it is difficult to achieve precise real-time parameter control. (3) Inability to break free from dependence on implantable batteries or the constraints of external wired devices: If wired intravascular nerve recording / stimulation electrode systems are used for long-term stimulation, they face the same "battery dilemma" as traditional DBS: either a battery-powered pulse generator is implanted in the body (increasing volume, weight, and the need for replacement surgery), or patients still need to wear external devices with connecting leads for a long time, seriously affecting quality of life, freedom of movement, and patient compliance. This partially contradicts the original intention of minimally invasive implantation. (4) High system complexity and difficulty in clinical translation: A system integrating intravascular stents, electrode arrays, long flexible leads, and percutaneous connectors has an extremely complex process for manufacturing, packaging, testing, and surgical implantation. Each interface is a potential failure point, and the overall reliability of the system faces severe challenges, raising the barriers to clinical translation and large-scale application.

[0128] Therefore, while existing deep brain stimulation (DBS) technologies offer the possibility of minimally invasive procedures through intravascular implantation, they are limited by "wired connection" and "power supply method," failing to translate the advantages of minimal invasiveness into a safe, long-lasting, wireless, and patient-friendly complete treatment solution. The system has a break in the "implantation-connection-power supply-control" chain.

[0129] In one embodiment, a wireless, fully implantable, intravascular integrated deep brain stimulation system, also known as a wireless intravascular deep brain stimulator (WE-DBS), is provided. This system deeply integrates ultrasonic wireless power transmission technology with intravascular stent electrodes and incorporates miniaturized on-chip signal conditioning circuitry. It can be wirelessly powered via extracranial ultrasound, completely eliminating wires and batteries to achieve wireless power. By employing high specific surface area nanostructure electrodes, charge injection capability is optimized to achieve high stimulation efficiency. All functional modules (energy harvesting, rectification, filtering, pulse generation) are miniaturized and packaged within the stent body, forming a robust and stable single implant, achieving system integration. Transmission parameters (intensity, frequency, pulse width) are externalized through non-invasive control via external ultrasound. This wireless intravascular deep brain stimulation system includes:

[0130] like Figure 4 As shown, the intravascular implanted portion (i.e., the implantable brain stimulation device) includes... Figure 4 The self-expanding metal support a, the electrode layer b, the ultrasonic-to-electrical energy conversion module, and the signal conditioning circuit are integrated on the surface of the support;

[0131] The external energy emitting part (i.e., the external energy emitting device) includes an ultrasonic emitting probe and a control unit, which is used to wirelessly transmit energy to the implanted part;

[0132] The signal modulation and monitoring system (i.e., the control device) is used to adjust stimulation parameters and monitor the treatment response.

[0133] The electrode module employs an electrode layer, which is a nanostructured electrode with a high specific surface area to improve charge injection capability and biocompatibility. Furthermore, the nanostructured electrode is a metal oxide nanostructured electrode. Further, such as... Figure 4 As shown in c and d, the metal oxide nanostructure electrode is an array of copper oxide nanopillars.

[0134] like Figure 5 As shown, the acoustic-to-electric conversion module uses the ultrasonic-to-electrical conversion module. Through piezoelectric materials or triboelectric structures, the direction of electron transmission can be controlled according to compressive and tensile stresses. External ultrasonic waves are converted into alternating electrical signals. After rectification, filtering, and pulse shaping by the signal conditioning circuit, the output is a biphasic or monophasic pulse that meets the requirements of nerve stimulation.

[0135] like Figure 6 As shown, after a preliminary evaluation of the system's output performance, the applicant found that WE-DBS could generate basic biphasic pulses. However, the output signal exhibited high-frequency noise and instability, and similar waveform defects appeared in the corresponding analog inputs, such as... Figure 7As shown, the raw output does not meet the standardization requirements of deep brain stimulation (DBS) waveforms. To address these issues, such as... Figure 8 As shown, the applicant designed a flexible circuit, namely a signal conditioning circuit, around the stent structure, including a rectifier diode, an RC low-pass filter, and a pulse shaping circuit. The rectifier diode uses a Schottky diode for rectification. The signal passes through an RC low-pass filter network to suppress high-frequency oscillations. Finally, a capacitor- and resistor-based charge-discharge circuit is introduced as the pulse shaping circuit to generate an exponentially decaying signal with adjustable pulse width, thereby achieving effective calibration of the output circuit. The designed circuit exhibits excellent mechanical flexibility and is well-suited for integration onto the peripheral surface of vascular stents. Figure 9 As shown, after tuning, the stability of the output waveform is significantly improved, and noise interference is effectively suppressed. Figure 10 As shown, the simulation results further confirm that the tuning process enables the output signal to possess extremely high stability while minimizing noise levels. These optimized parameters not only ensure the high efficiency of neuromodulation but also provide reliable operational safety for long-term implantation studies.

[0136] The external ultrasonic energy emitting part can be composed of an external ultrasonic transducer placed above the skull, which can realize transcranial energy transmission and thus power the device through ultrasound. Its output frequency, power and pulse parameters can be adjusted.

[0137] like Figure 11 As shown, the intravascular implantation pathway can be guided via a microcatheter through the internal jugular vein to a blood vessel near the target brain region (e.g., a blood vessel near the subthalamic nucleus). It anchors to the blood vessel wall through a self-expanding mechanism, thus avoiding craniotomy. Wireless ultrasound power supply achieves complete battery-free operation, avoiding secondary surgery. The self-expanding stent ensures stable contact with the blood vessel wall, and the electrode faces the brain tissue directly, achieving efficient electrical stimulation and realizing the integration of stent and electrode. Through integrated signal conditioning circuitry, signal shaping can be directly completed at the implantation site, outputting stable and adjustable neural stimulation pulses.

[0138] In one embodiment, this application also provides a method for preparing an implantable brain stimulation device, comprising: as follows Figure 12 As shown, a nickel-titanium alloy self-expanding scaffold was prepared by laser engraving, and copper oxide nanostructures were grown on a copper substrate by thermal oxidation as electrodes. A piezoelectric conversion layer and flexible circuit were integrated, and finally encapsulated with medical-grade PDMS.

[0139] In one specific embodiment, the implantable brain stimulation device consists of three main components integrated into a single intravascular device. Its core structure is a self-expanding nickel-titanium alloy scaffold with an adjustable diameter between 1.5 mm and 4 mm, providing both mechanical support and ensuring stable positioning within the target vessel. The electrode employs a high-density copper oxide nanostructure designed to enhance charge transport and ensure long-term recording stability. The entire device is coated with a biocompatible medical-grade PDMS (polydimethylsiloxane) coating, offering both electrical insulation and excellent biocompatibility while maintaining the flexibility required to adapt to vascular curvature. The structural substrate of the intravascular deep brain stimulation device is a self-expanding tubular scaffold fabricated from medical-grade nickel-titanium alloy using a laser engraving process. The stent manufacturing process utilized a high-precision fiber laser engraving system (UltraPulse Pro 355 system), with optimization of the following key parameters to ensure high-precision pattern transfer and minimize thermal damage: medical-grade nickel-titanium alloy tubing was used; the laser scanning speed was 800 mm / s; and the focal length was 0.5 mm. Throughout the engraving process, continuous cooling was maintained to further control the heat-affected zone, ensuring smooth cut edges and structural integrity. The copper oxide (CuO) nanostructure functional layer was prepared using an in-situ thermal oxidation method on a high-purity copper substrate. The specific steps were as follows: First, the copper foil was ultrasonically treated sequentially in acetone, ethanol, and deionized water for 10 minutes each to remove surface organic contaminants and impurities; subsequently, the cleaned copper foil was dried under a nitrogen atmosphere. Afterward, the pretreated copper foil was placed in a quartz boat and placed in a tube furnace for thermal oxidation treatment in an ambient air atmosphere. The specific procedure for the oxidation process is as follows: the furnace is heated from room temperature to 500°C at a rate of 10°C per minute, held at 500°C for 4 hours, and then the sample in the furnace is allowed to cool naturally to room temperature.

[0140] To longitudinally evaluate the therapeutic effect of WE-DBS on a Parkinson's disease model, the applicant designed the following behavioral experiment. For example... Figure 13 As shown, WE-DBS treatment was initiated after a 7-day MPTP induction period. Changes in motor function were systematically monitored using open behavioral tests on days 1, 3, 7, and 14, and barbell tests on days 7 and 14.

[0141] like Figure 14 As shown, open field test studies revealed that the control group exhibited normal exploratory behavior, with long and continuous paths and frequent entry into the central area, reflecting lower anxiety levels. In contrast, the MPTP-treated model group showed limited activity, confined to the periphery of the arena, accompanied by significant immobility and bradykinesia, suggesting motor dysfunction and anxiety-like behaviors.

[0142] The WE-DBS group exhibited a recovery pattern with longer trajectories and more frequent entries into the central region, indicating reduced anxiety and improved exploratory behavior. Although not yet fully recovered to the control group levels, the data still show that WE-DBS achieved effective neuromodulation. Figure 15 As shown, quantitative analysis confirmed that the mean speed in the PD model group significantly decreased from 8.39 ± 0.51 cm / s in the control group to 2.56 ± 0.23 cm / s in the PD model group (p < 0.001); after WE-DBS treatment, this speed increased to 5.25 ± 0.41 cm / s (p < 0.01 compared with the PD model group). Furthermore, vertical movement also increased from 3.3 ± 0.8 in the PD model group to 20.5 ± 2.4 in the WE-DBS group (p < 0.01), indicating improved motor function.

[0143] The total movement distance recovered from 90.14 ± 9.87 cm (PD model) to 182.67 ± 15.29 cm (WE-DBS, p < 0.01); the center exploration rate, an indicator of anxiety, increased from 0.188 ± 0.031 (PD model) to 0.391 ± 0.039 (WE-DBS, p < 0.05). In the bar test, mice treated with WE-DBS showed better motor coordination and a significantly shortened bar latency. Bar latency decreased from 12.34 ± 1.45 seconds (PD model) to 6.51 ± 0.89 seconds (WE-DBS, p < 0.05).

[0144] As can be seen, the wireless intravascular deep brain stimulation system WE-DBS in this embodiment can significantly improve motor function in PD models and reduce anxiety-like behaviors.

[0145] To investigate whether the significant behavioral recovery stemmed from structural protection of the nigrostriatal pathway, the applicant performed immunohistochemical staining for tyrosine hydroxylase (TH) in the substantia nigra pars compacta (SNpc) of a Parkinson's disease (PD) model. TH is a marker of dopaminergic neurons. Figure 16As shown, the two left-hand images of the SNpc in the PD group exhibit significant and widespread loss of TH-positive neurons, accompanied by marked degeneration of the substantia nigra structure—a typical characteristic of PD toxicity—and surviving neurons typically show atrophy and significantly reduced staining intensity. In contrast, the two right-hand images of the WE-DBS group show a denser and more complete network of strongly positive TH-positive neurons, indicating that the neurons received clear neurotoxic protection. Quantitative analysis of these neurons further confirmed the qualitative observations: the number of TH-positive neurons in the PD group was significantly reduced to 101±8.5, while WE-DBS treatment significantly alleviated this loss, preserving 162±10.2 TH-positive neurons (p<0.05 compared to the PD group). This finding is significant because it goes beyond simple symptomatic treatment, demonstrating that the WE-DBS system can actively protect vulnerable dopaminergic neurons from degeneration.

[0146] To assess the biocompatibility of the WE-DBS system, the applicant also performed a histological evaluation of the brain tissue surrounding the intended stimulation site using hematoxylin and eosin (H&E) staining. Figure 17 The images show the examination results of the subthalamic nucleus (STN) region of the brain parenchyma. From left to right, the individual experimental groups show HE staining of brain sections, magnified sections, and scalp tissue. The results showed no significant difference between the control group (MPTP) and the WE-DBS group; no signs of microbleeds, neuronal necrosis, glial scarring, or abnormal inflammatory cell infiltration were observed, and the tissue structure remained intact, indicating that the presence of the device and the implementation of wireless stimulation did not induce acute or subacute tissue damage. Furthermore, analysis of the scalp tissue at the percutaneous implantation site showed that the epidermis, dermis, and subcutaneous layer were intact; importantly, no signs of chronic inflammation (such as large-scale accumulation of lymphocytes or macrophages), infection, or foreign body giant cell reaction caused by the implanted device were found. These findings confirm that the device is well-tolerated during both the implantation procedure and long-term placement, highlighting its excellent safety and biocompatibility prospects.

[0147] The wireless intravascular deep brain stimulation system provided in this embodiment can achieve the following technical effects:

[0148] (1) Achieving truly minimally invasive implantation and completely avoiding craniotomy and its risks: Utilizing the vascular system as a natural channel, the device is delivered to blood vessels near the target brain region through interventional surgery. This completely avoids traditional craniotomy, brain tissue puncture, and dura mater incision, minimizing surgical trauma. It directly solves the fundamental problems of traditional DBS surgery, such as large trauma, high risk of bleeding and infection, and long recovery period.

[0149] (2) Achieving complete wireless and battery-free operation, eliminating percutaneous infection and lead-related complications: Powered wirelessly by external ultrasound, the implanted portion requires no batteries or physical leads. This fundamentally eliminates the long-term infection risk, lead displacement / breakage, and subcutaneous pulse generator pocket infection or erosion caused by percutaneous lead interfaces. It overcomes the core pain points of existing intravascular electrodes still requiring lead connections and traditional DBS relying on implanted batteries requiring a second surgery for replacement.

[0150] (3) Providing effective neuromodulation and neuroprotection: In an animal model of Parkinson's disease, the stable electrical stimulation generated by the system effectively modulates neural circuits. According to behavioral tests, the movement speed of mice in the treatment group significantly increased from 2.56±0.23 cm / s in the model group to 5.25±0.41 cm / s (p<0.01), and the number of vertical movements increased from 3.3±0.8 to 20.5±2.4 (p<0.01). Histological examination confirmed that the system can protect dopaminergic neurons in the substantia nigra, and the number of neurons is significantly greater than that in the model group. This proves that the stimulation efficacy of this novel minimally invasive mode is no less than or even better than that of traditional invasive methods, realizing a potential improvement from "symptom control" to "symptom control and neuroprotection."

[0151] (4) Achieving stable, precise, and externally adjustable stimulation parameters: The miniaturized conditioning circuit (rectification, filtering, pulse shaping) integrated into the implant can convert the original ultrasound sensing signal into a stable, low-noise, and precisely parameterized treatment pulse (e.g., 200 µs pulse width, 1.3 V amplitude). All treatment parameters (intensity, frequency, timing) can be remotely and in real-time controlled by non-invasively adjusting the external ultrasound transmitter. This overcomes the problems of unstable and noisy original wireless energy conversion signals and provides a flexible, individualized dose control capability that is difficult to achieve with traditional implantable stimulators without the need for reoperation.

[0152] (5) Achieving long-term stability and biocompatibility at the intravascular interface: The self-expanding stent ensures a tight fit and firm anchoring of the device to the vessel wall, preventing displacement. Medical-grade PDMS encapsulation provides excellent biocompatibility and flexibility, adapting to vascular pulsation. High specific surface area nanostructured electrodes (such as CuO) increase charge injection capacity while reducing current density, thus improving electrochemical safety. Histopathological (H&E staining) analysis showed no inflammatory cell infiltration, necrosis, hemorrhage, or glial scarring in the implanted brain tissue and scalp, confirming excellent biocompatibility and long-term safety, ensuring the long-term operational stability, safety, and functional reliability of the device in the harsh intravascular environment.

[0153] (6) Significantly improves patients' quality of life and treatment adherence: Patients have only a tiny intravascular implant in their body, and only need to wear a lightweight ultrasound-emitting patch or headband intermittently. This frees patients from the constraints of surface electrodes, visible lumps, and connecting wires, and bathing, social activities, and sleep are not affected. The psychological burden is significantly reduced, and treatment adherence is expected to improve dramatically. It fundamentally improves the appearance problems, inconveniences, and psychological stress caused by traditional DBS or intravascular systems with leads.

[0154] (7) Laying the hardware foundation for future intelligent and adaptive neuromodulation: This wireless platform can be combined with a closed-loop modulation system. In the future, it can be integrated with micro sensors to monitor local biomarkers or neural electrical activity in real time, and dynamically adjust ultrasound stimulation parameters after analysis by external devices to achieve integrated adaptive therapy of "sensing-analysis-modulation". This provides a feasible implantable hardware carrier for moving beyond the current open-loop, fixed-parameter DBS therapy and towards the next generation of precise and intelligent neuromodulation.

[0155] In summary, this application integrates three core technologies—"endovascular interventional pathway," "wireless ultrasound power supply," and "highly integrated on-chip system"—to achieve synergistic technological effects such as "revolutionary improvement in minimally invasive treatment and safety," "definite efficacy with neuroprotection," "fundamental improvement in patient experience and compliance," and "providing a platform for future intelligent therapies."

[0156] Those skilled in the art will understand that all or part of the processes in the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium. When executed, the computer program can include the processes of the embodiments described above. Any references to memory, databases, or other media used in the embodiments provided in this application can include at least one of non-volatile and volatile memory. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetic random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), graphene memory, etc. Volatile memory can include random access memory (RAM) or external cache memory, etc. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM). The databases involved in the embodiments provided in this application may include at least one type of relational database and non-relational database. Non-relational databases may include, but are not limited to, blockchain-based distributed databases. The processors involved in the embodiments provided in this application may be general-purpose processors, central processing units, graphics processing units, digital signal processors, programmable logic devices, quantum computing-based data processing logic devices, etc., and are not limited to these.

[0157] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0158] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. An implantable brain stimulation device, characterized in that, The implantable brain stimulation device includes a deployable support structure, a sound-to-electric conversion module, a signal conditioning circuit, and an electrode module with a stimulation surface; wherein: The acoustic-to-electric conversion module is integrated into the support structure and is used to convert ultrasonic waves received from the outside into electrical signals. The signal conditioning circuit is electrically connected to the acoustic-to-electric conversion module and is used to tune the electrical signal to obtain an electrical stimulation signal. The electrode module is electrically connected to the signal conditioning circuit and is used to apply the electrical stimulation signal.

2. The implantable brain stimulation device according to claim 1, characterized in that, The support structure is a tubular support structure applied to the inner wall of blood vessels.

3. The implantable brain stimulation device according to claim 1 or claim 2, characterized in that, The supporting structure uses a self-expanding metal bracket.

4. The implantable brain stimulation device according to claim 3, characterized in that, The self-expanding metal support is a nickel-titanium alloy support with a pre-defined mesh structure.

5. The implantable brain stimulation device according to claim 1, characterized in that, The acoustic-electric conversion module includes a piezoelectric material layer or a triboelectric structure.

6. The implantable brain stimulation device according to claim 1, characterized in that, The signal conditioning circuit includes a rectifier unit, a filter unit, and a pulse shaping unit that are connected in sequence. The rectifier unit is used to rectify the electrical signal to obtain a rectified electrical signal; The filtering unit is used to filter the rectified electrical signal to obtain a filtered electrical signal. The pulse shaping unit is used to shape the filtered electrical signal and adjust the pulse width to obtain the electrical stimulation signal.

7. The implantable brain stimulation device according to claim 6, characterized in that, The rectifier unit includes at least one Schottky diode.

8. The implantable brain stimulation device according to claim 6, characterized in that, The filtering unit employs an RC low-pass filter network.

9. The implantable brain stimulation device according to claim 6, characterized in that, The pulse shaping unit employs a charging and discharging circuit based on capacitors and resistors.

10. The implantable brain stimulation device according to claim 1, characterized in that, The stimulation surface of the electrode module is a metal oxide nanostructure surface.

11. The implantable brain stimulation device according to claim 10, characterized in that, The surface of the metal oxide nanostructure is an array of copper oxide nanopillars.

12. A wireless brain stimulation system, characterized in that, The wireless brain stimulation system includes an external energy emission device, a control device, and an implantable brain stimulation device as described in any one of claims 1 to 11. The external energy emission device is used to emit ultrasound waves to the implanted brain stimulation device; The control device is communicatively connected to the external energy emitting device and is used to control the emission parameters of the ultrasound waves; the emission parameters include at least one of the following: output frequency, output power, and pulse parameters.

13. A method for preparing an implantable brain stimulation device, characterized in that, The method for preparing the implantable brain stimulation device includes: A deployable support structure is obtained by engraving a pre-set support material using laser engraving technology. Electrode material is formed on the support structure, and the electrode material is subjected to thermal oxidation treatment to form an electrode module; The acoustic-to-electric conversion module and the signal conditioning circuit are integrated on the support structure so that the signal conditioning circuit is electrically connected to the electrode module. The integrated support structure is encapsulated using a biocompatible polymer to obtain an implantable brain stimulation device.

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