Wearable ultrasound stimulation compatible electrophysiological recording system

Abstract

The present invention relates to a wearable ultrasound stimulation compatible electrophysiological recording system, comprising a wearable collimator module and an ultrasound excitation module and an electrophysiological recording module respectively connected to the wearable collimator module, wherein the wearable collimator module is used to be worn and fixed on a stimulation target; the ultrasound excitation module is used to provide ultrasound stimulation and adjust ultrasound parameters in real time to meet the needs of different target stimulation areas; the electrophysiological recording module is used to collect, record and analyze electrophysiological signals collected by electrophysiological collection electrodes arranged at the stimulation target; the wearable ultrasound stimulation compatible electrophysiological recording system synchronously integrates an in vivo ultrasound adjustable stimulation system and a real-time electrophysiological recording system, which can realize real-time and matching comparison of ultrasound stimulation and electrophysiological regulation effects, and is conducive to providing direct convenience for physical parameter sorting and optimal parameter screening of ultrasound intervention effects.

Description

Technical Field

[0001] The present invention relates to the technical field of ultrasonic nerve regulation, and in particular to a wearable ultrasonic stimulation-compatible electrophysiological recording system. Background Art

[0002] The neuromodulatory effects of low-intensity focused ultrasound (LIFU) have been validated at multiple scales (peripheral tissues, isolated brain slices, and in vivo animals), across multiple species (model organisms, rodents, primates, and humans), and using multiple approaches (molecular biology, electrophysiology, and behavioral techniques). Current research in this field has demonstrated that LIFU is a novel, safe, and effective neuromodulatory technology, promising a new, noninvasive tool for regulating brain nuclei and neuronal function and exploring cognitive function. It plays a crucial role in brain science research and the interventional treatment of brain diseases.

[0003] However, the mechanisms of different neuropsychiatric diseases vary greatly, and the regulation of specific diseased nuclei and neuronal discharges is also different. At present, the parameter differences in the bidirectional regulation of neuronal discharges by ultrasonic radiation force are not clear, especially the study of the intrinsic mechanism of the regulatory effect is an urgent problem that needs to be solved. Classical electrical, magnetic, optical and other neuroregulatory technologies have also been proven to achieve bidirectional regulatory effects on activation or inhibition of neuronal discharges. The differences in regulatory effects obtained by different stimulation parameters often lead to different results in disease treatment. For example, the parameter adjustment of deep brain stimulation technology is very important for the patient's therapeutic effect. Its parameters mainly include stimulation amplitude (mainly voltage), pulse width and stimulation frequency. High-frequency deep brain stimulation (frequencies greater than 100 Hz, usually greater than 130 Hz) is effective for most levodopa-sensitive Parkinson's symptoms, but it is often ineffective for axial symptoms such as abnormal posture and gait, dysphagia, and may even worsen these symptoms. Low-frequency deep brain stimulation (frequencies less than 100 Hz, usually 60 or 80 Hz) stimulating the pedunculopontine nucleus can effectively treat gait abnormalities, which provides a novel solution for the application of deep brain stimulation with changed contact combinations in the treatment of Parkinson's disease. Transcranial magnetic stimulation technology achieves the purpose of exciting or inhibiting local cerebral cortical function by changing the stimulation frequency. High-frequency transcranial magnetic stimulation can produce a sum of excitatory postsynaptic potentials, leading to the excitation of neurons in the stimulation site, while low-frequency stimulation has the opposite effect. Different brain function states of different patients usually require different intensities, stimulation frequencies, stimulation sites, and coil direction adjustments to achieve good therapeutic effects. Similarly, many research reports have shown that the regulatory effect of ultrasound is bidirectional, and brain activity can be activated or reversibly inhibited. Its bidirectional regulatory effect is closely related to the stimulation of different sound field modes of ultrasound.

[0004] However, there is currently a lack of systems that can adjust ultrasound stimulation parameters in real time and in a personalized manner while also taking into account electrophysiological recordings. This makes it impossible to provide equipment support for research on the intrinsic mechanisms of ultrasound regulatory effects, nor is it possible to quickly provide new strategies for clinical disease intervention. Summary of the Invention

[0005] One purpose of the present invention is to provide a wearable ultrasound stimulation-compatible electrophysiological recording system, which has the characteristics of small size and wearability, and can use multiple modules to work together to achieve real-time and personalized adjustment of ultrasound parameters for different target stimulation areas, which is conducive to providing support for the study of the intrinsic mechanism of ultrasound regulation effects, so as to meet the needs of safe, effective, real-time and specific disease treatment.

[0006] To achieve at least one of the above objectives, the present invention provides a wearable ultrasound stimulation-compatible electrophysiological recording system, comprising:

[0007] A wearable collimator module, wherein the wearable collimator module is suitable for being worn and fixed on a stimulation target;

[0008] An ultrasonic excitation module, comprising an ultrasonic transducer mounted on the wearable collimator module, a start-up control unit connected to the ultrasonic transducer, a parameter setting unit connected to the start-up control unit, and an electronic excitation unit connected to the parameter setting unit, wherein the ultrasonic transducer is used to generate and emit an excitation pulse signal to ultrasonically stimulate the stimulation target via the excitation pulse signal; the start-up control unit is used to receive the excitation pulse signal modulated by the electronic excitation unit and the parameter setting unit, thereby stimulating the operation of the ultrasonic transducer and modulating the impedance matching in the circuit operation of the ultrasonic transducer; the parameter setting unit is used to adjust the ultrasonic parameters of the ultrasonic transducer; and the electronic excitation unit is used to electronically control the operation of the oscillator of the ultrasonic transducer; and

[0009] An electrophysiological recording module is connected to the wearable collimator module and is used to collect, record and analyze electrophysiological signals collected by electrophysiological collection electrodes arranged on the stimulation target.

[0010] In one embodiment of the present invention, the electrophysiological recording module includes an electrophysiological recording unit installed on the wearable collimator module, an electrophysiological acquisition system connected to the electrophysiological recording unit, and a data processing unit connected to the electrophysiological acquisition system, wherein the electrophysiological recording unit is used to record the electrophysiological signals transmitted by the electrophysiological acquisition electrodes, the electrophysiological acquisition system acquires the electrophysiological signals of the stimulation target via the electrophysiological acquisition electrodes, and the data processing unit is used to analyze the electrophysiological signals acquired by the electrophysiological acquisition system.

[0011] In one embodiment of the present invention, the electrophysiological recording module further includes a preamplifier unit disposed between the electrophysiological recording unit and the electrophysiological acquisition system, and the preamplifier unit is configured to amplify the electrophysiological signal.

[0012] In one embodiment of the present invention, the wearable collimator module includes an ultrasonic fixing unit, a target fixing unit and an electrophysiological conversion fixing unit. The ultrasonic fixing unit is used to install the ultrasonic transducer. The target fixing unit is used to design the fixed position of the ultrasonic transducer and the effective distance of the ultrasonic stimulation based on the anatomical position information of the target stimulation area through calculation by a positioning system, obtain the fixed coordinates, and fix them on the stimulation target using a fixer; the electrophysiological conversion fixing unit is used to install the electrophysiological recording unit.

[0013] In one embodiment of the present invention, the target fixing unit includes a fixing part and a fixer arranged on the fixing part, the ultrasonic fixing unit includes an ultrasonic transducer adapter hole arranged on the fixing part, the electrophysiological conversion fixing unit includes an electrophysiological converter adapter hole arranged on the fixing part and an electrophysiological conversion end for connecting an electrophysiological acquisition electrode, the electrophysiological recording unit is installed on the electrophysiological converter adapter hole through a plug-in electrophysiological converter, and the electrophysiological conversion end is used to transmit the electrophysiological signal.

[0014] In one embodiment of the present invention, the wearable ultrasound stimulation compatible electrophysiological recording system further includes a power amplifier connected to the ultrasound excitation module, a signal generator connected to the power amplifier and the data processing unit, and a video monitoring system connected to the data processing unit, wherein the video monitoring system is used to monitor the real-time status of the stimulation target when wearing the wearable ultrasound stimulation compatible electrophysiological recording system.

[0015] In one embodiment of the present invention, the electronic excitation unit includes a reference delay determination module for calculating a reference delay when the vibrator of the ultrasonic transducer sends an excitation pulse signal.

[0016] In one embodiment of the present invention, the ultrasonic transducer includes a substrate, a piezoelectric ceramic sheet disposed on the substrate, a cable lead connected to the piezoelectric ceramic sheet, and a housing for encapsulating the piezoelectric ceramic sheet and the cable lead.

[0017] In one embodiment of the present invention, the ultrasonic transducer is prepared by the following steps:

[0018] The piezoelectric ceramic material is bonded to a substrate and cut into shape by grinding, cutting and laser processing to obtain a preformed sample;

[0019] performing laser polarization on the preformed sample;

[0020] Cable leads are connected to the preformed sample after laser polarization to form a positive electrode and a negative electrode; and the preformed sample and the cable leads are packaged with a shell to obtain the ultrasonic transducer.

[0021] In one embodiment of the present invention, the preparation of the ultrasonic transducer further includes the steps of: comprehensively analyzing the structure, sound field and echo of the ultrasonic transducer, and optimizing the size of the ultrasonic transducer based on the bandwidth, signal strength and resolution of the ultrasonic transducer.

[0022] The wearable ultrasound stimulation and electrophysiological recording system of the present invention simultaneously integrates in vivo adjustable ultrasound stimulation with real-time electrophysiological recording, enabling real-time, consistent comparison of ultrasound stimulation and electrophysiological modulation effects. This facilitates the sorting of physical parameters for ultrasound intervention effects and the selection of optimal parameters. It also provides a new strategy for clinical disease intervention, enabling efficient and rapid adjustment of intervention plans to achieve better outcomes.

[0023] Further objects and advantages of the present invention will be fully apparent from an understanding of the following description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a structural block diagram of the wearable ultrasound stimulation-compatible electrophysiological recording system according to a preferred embodiment of the present invention.

[0025] Figure 2 This is a structural diagram of the wearable ultrasound stimulation-compatible electrophysiological recording system according to the preferred embodiment of the present invention, which illustrates the state of use of the system.

[0026] Figure 3 Schematic diagram of the structure of the ultrasonic transducer of the wearable ultrasonic stimulation compatible electrophysiological recording system according to the preferred embodiment of the present invention.

[0027] Figure 4 This is a schematic diagram of the preparation process of the ultrasonic transducer of the wearable ultrasonic stimulation compatible electrophysiological recording system according to the preferred embodiment of the present invention.

[0028] Figure 5 This is a characterization diagram of the acoustic characteristics of the ultrasonic transducer of the wearable ultrasonic stimulation compatible electrophysiological recording system according to the preferred embodiment of the present invention.

[0029] Figure 6 Schematic diagram of the structure of the wearable collimator module of the wearable ultrasound stimulation compatible electrophysiological recording system according to the preferred embodiment of the present invention.

[0030] Explanation of the accompanying drawings: wearable ultrasound stimulation compatible electrophysiological recording system 100; wearable collimator module 10; ultrasound fixing unit 11; ultrasound transducer adapter hole 111; target fixing unit 12; fixing part 121; fixer 122; electrophysiological conversion fixing unit 13; electrophysiological converter adapter hole 131; electrophysiological conversion end 132; ultrasound excitation module 20; ultrasound transducer 21; substrate 211; piezoelectric ceramic piece 212; cable lead 213; housing 214; start control unit 22; parameter setting unit 23; electronic excitation unit 24; reference delay determination module 241; electrophysiological recording module 30; electrophysiological recording unit 31; preamplifier unit 32; electrophysiological acquisition system 33; data processing unit 34; plug-in electrophysiological converter 35; power amplifier 40; signal generator 50; video monitoring system 60. DETAILED DESCRIPTION

[0031] The following description is intended to disclose the present invention and enable those skilled in the art to implement the present invention. The preferred embodiments described below are provided for illustrative purposes only, and those skilled in the art will readily appreciate other obvious variations. The basic principles of the present invention defined in the following description may be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0032] Those skilled in the art should understand that, in the disclosure of the present invention, the terms "vertical", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like to indicate orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0033] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the elements may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0034] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections, electrical connections, or mutual communication; direct connections or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0035] Ultrasonic radiation force can directly excite or inhibit neuronal discharges, regulating animal behavior. The development of novel ultrasound neuromodulation technologies is expected to provide new clinical solutions and powerful intervention tools for the treatment of neuropsychiatric diseases. To better apply novel ultrasound neuromodulation technologies to the basic research and clinical treatment of various neuropsychiatric diseases, and to accurately stimulate and monitor the regulatory effects of ultrasound on neuronal discharge patterns in real time, it is necessary to explore the neuromodulatory effects of different ultrasound sound field modalities, quantify the parameter differences in ultrasound bidirectional regulation of neuronal discharges, and further study its underlying mechanisms to meet the needs of safe, effective, real-time, and specific disease treatment.

[0036] This paper proposes a compact, wearable ultrasound stimulation technology and system compatible with electrophysiological recording. This system utilizes multiple modules working together to provide a novel neurostimulation method combining in vivo stimulation with real-time electrophysiological monitoring and assessment. It can be applied to different brain regions with real-time, adjustable stimulation. Furthermore, the system facilitates the sorting of physical parameters for ultrasound intervention effects and the selection of optimal parameters. This allows for real-time, personalized stimulation adjustments tailored to the patient's needs.

[0037] like Figures 1 to 6 As shown, the specific structure of the wearable ultrasound stimulation compatible electrophysiological recording system 100 according to a preferred embodiment of the present invention is explained.

[0038] like Figure 1 and Figure 2As shown, the wearable ultrasound stimulation compatible electrophysiological recording system 100 includes a wearable collimator module 10, an ultrasound excitation module 20 connected to the wearable collimator module 10, and an electrophysiological recording module 30 connected to the wearable collimator module 10. The wearable collimator module 10 is used to be worn and fixed on the stimulation target; the ultrasound excitation module 20 is used to provide ultrasound stimulation and adjust ultrasound parameters in real time to meet the needs of different target stimulation areas; the electrophysiological recording module 30 is used to perform electrophysiological recording and analysis, specifically for collecting, recording and analyzing electrophysiological signals collected by electrophysiological collection electrodes arranged at the stimulation target; the present invention provides a system that synchronously integrates in-vivo ultrasound adjustable stimulation and real-time electrophysiological recording, which can realize real-time and matching comparison of ultrasound stimulation and electrophysiological regulation effects, which is conducive to providing direct convenience for physical parameter sorting and optimal parameter screening of ultrasound intervention effects.

[0039] Furthermore, the ultrasonic excitation module 20 includes an ultrasonic transducer 21 installed on the wearable collimator module 10, a start-up control unit 22 connected to the ultrasonic transducer 21, a parameter setting unit 23 connected to the start-up control unit 22, and an electronic excitation unit 24 connected to the parameter setting unit 23, wherein the ultrasonic transducer 21 is used to generate and emit an excitation pulse signal to ultrasonically stimulate the stimulation target via the excitation pulse signal; the start-up control unit 22 is used to receive the excitation pulse signal modulated by the electronic excitation unit 24 and the parameter setting unit 23, thereby stimulating the ultrasonic transducer 21 to work, and for modulating the impedance matching in the circuit work of the ultrasonic transducer 21; the parameter setting unit 23 is used to adjust the ultrasonic parameters of the ultrasonic transducer 21; the electronic excitation unit 24 is used to electronically control the operation of the vibrator of the ultrasonic transducer 21.

[0040] It is worth mentioning that the electronic excitation unit 24 is a trigger or switch device that generates an excitation pulse signal for the vibrator of the ultrasonic transducer 21. That is, the electronic excitation unit 24 is used to control whether the vibrator of the ultrasonic transducer 21 generates an excitation pulse signal. In addition, the electronic excitation unit 24 also includes a reference delay determination module 241 for calculating the reference delay of the excitation pulse signal emitted by the vibrator of the ultrasonic transducer 21.

[0041] In particular, in actual applications, the parameter setting unit 23 can use different ultrasonic parameters including basic frequency, pulse amplitude, pulse repetition frequency, pulse length, etc. to perform independent ultrasonic stimulation of multiple targets according to the type of disease, severity of the disease, stimulation target selection and stimulation effect, and can adjust the ultrasonic stimulation parameters of the ultrasonic transducer 21 in real time according to feedback.

[0042] Furthermore, the startup control unit 22 is directly connected to the ultrasonic transducer 21 and is configured to receive an excitation pulse signal modulated and coupled by the electronic excitation unit 24 and the parameter setting unit 23, thereby stimulating the operation of the ultrasonic transducer 21. Simultaneously, the startup control unit 22 also has the function of modulating the impedance matching of the circuit operation of the ultrasonic transducer 21.

[0043] In particular, the specific structure of the ultrasonic transducer 21 is as follows: Figure 3 As shown, the ultrasonic transducer 21 includes a substrate 211 , a piezoelectric ceramic piece 212 disposed on the substrate 211 , a cable lead 213 connected to the piezoelectric ceramic piece 212 , and a housing 214 for encapsulating the piezoelectric ceramic piece 212 and the cable lead 213 .

[0044] To achieve wearability, the transducer needs to be sufficiently small and lightweight, while also meeting certain sound intensity requirements. The present invention optimizes the size of the ultrasonic transducer 21 while ensuring performance such as transducer bandwidth, signal strength, and resolution through a comprehensive analysis of the structure, sound field, and echo of the ultrasonic transducer 21. This design results in an ultrasonic transducer 21 that meets wearable size requirements. Furthermore, precision machining processes such as precision grinding, precision cutting, and laser machining are used to produce the ultrasonic transducer 21 with excellent performance.

[0045] Specifically, if Figure 4 As shown, the ultrasonic transducer 21 is prepared by the following steps:

[0046] The piezoelectric ceramic material is bonded to a substrate 211 and cut and shaped using grinding, cutting and laser processing techniques to obtain a preformed sample; the substrate 211 can be a sapphire substrate 211.

[0047] performing laser polarization on the preformed sample;

[0048] The preformed sample after laser polarization is connected with a cable lead 213 to form a positive electrode and a negative electrode; and the preformed sample and the cable lead 213 are packaged with a housing 214 to obtain the ultrasonic transducer 21.

[0049] Figure 5 is a characterization diagram of the acoustic characteristics of the ultrasonic transducer 21, measured by an acoustic impedance analyzer. Figure 5 It shows that the working performance of the ultrasonic transducer 21 is normal and can meet the design requirements of the present invention.

[0050] Continue as Figure 1 and Figure 2As shown, the electrophysiological recording module 30 includes an electrophysiological recording unit 31 installed on the wearable collimator module 10, an electrophysiological acquisition system 33 connected to the electrophysiological recording unit 31, and a data processing unit 34 connected to the electrophysiological acquisition system 33, wherein the electrophysiological recording unit 31 is used to record the electrophysiological signals transmitted by the electrophysiological acquisition electrodes, the electrophysiological acquisition system 33 acquires the electrophysiological signals of the stimulation target via the electrophysiological acquisition electrodes, and the data processing unit 34 is used to analyze the electrophysiological signals acquired by the electrophysiological acquisition system 33.

[0051] It is worth mentioning that the electrophysiological recording module 30 further includes a preamplifier unit 32 disposed between the electrophysiological recording unit 31 and the electrophysiological acquisition system 33 , and the preamplifier unit 32 is used to amplify the electrophysiological signal.

[0052] Furthermore, if Figure 1 As shown, the wearable collimator module 10 includes an ultrasonic fixing unit 11, a target fixing unit 12 and an electrophysiological conversion fixing unit 13. The ultrasonic fixing unit 11 is used to install the ultrasonic transducer 21. The target fixing unit 12 is used to calculate the effective distance between the fixed position of the ultrasonic transducer 21 and the ultrasonic stimulation according to the anatomical position information of the target stimulation area through the positioning system, obtain the fixed coordinates, and fix them on the stimulation target using the fixer 122; the electrophysiological conversion fixing unit 13 is used to install the electrophysiological recording unit 31.

[0053] like Figure 6 As shown, the target fixing unit 12 includes a fixing portion 121 and a fixer 122 arranged on the fixing portion 121, the ultrasonic fixing unit 11 includes an ultrasonic transducer adapter hole arranged on the fixing portion 121, the electrophysiological conversion fixing unit 13 includes an electrophysiological converter adapter hole 131 arranged on the fixing portion 121 and an electrophysiological conversion end 132 for connecting an electrophysiological acquisition electrode, the electrophysiological recording unit 31 is installed on the electrophysiological converter adapter hole 131 through a plug-in electrophysiological converter 35, and the electrophysiological conversion end 132 is used to transmit the electrophysiological signal.

[0054] It can be understood that the electrophysiological recording unit 31 is connected to the wearable collimator module 10 through a plug-in electrophysiological converter, and is connected to the electrophysiological acquisition electrode provided on the stimulation target through the conversion end of the electrophysiological converter, thereby realizing the transmission of electrophysiological signals related to scalp EEG, deep EEG, in-body multi-channel recording electrodes, etc.

[0055] It can also be understood that the transmission path of the electrophysiological signal of the wearable ultrasound stimulation compatible electrophysiological recording system 100 is: the electrophysiological signal is transmitted in sequence through the electrophysiological recording unit 31, the preamplifier unit 32 and the electrophysiological acquisition system 33 to the data processing unit 34 for analysis and processing.

[0056] It is worth mentioning that the data processing unit 34 is a computer.

[0057] Furthermore, the wearable ultrasound stimulation compatible electrophysiological recording system 100 further includes a power amplifier 40 connected to the ultrasound excitation module 20, a signal generator 50 connected to the power amplifier 40 and the data processing unit 34, and a video monitoring system 60 connected to the data processing unit 34. The video monitoring system 60 is used to monitor the real-time status of the stimulation target when wearing the wearable ultrasound stimulation compatible electrophysiological recording system 100, such as Figure 2 shown.

[0058] It is worth mentioning that the stimulation target can be rodents or large animals, such as non-human primates and humans. It is suitable for direct wear on the body to achieve transcranial stimulation, and is also suitable for ex vivo, external peripheral ultrasound stimulation and regulation.

[0059] In addition, the electrophysiological recording unit 31 of the wearable ultrasound stimulation compatible electrophysiological recording system 100 of the present invention can be expanded to an in vivo neurotransmitter monitoring system, in vivo calcium imaging recording and other multifunctional monitoring systems compatible with in vivo ultrasound stimulation, and the present invention does not limit this.

[0060] The wearable ultrasound stimulation-compatible electrophysiological recording system 100 of the present invention uses a small-sized, wearable wearable collimator module 10 to realize the installation of the ultrasonic transducer 21 and the plug-in electrophysiological converter, and enables the electrophysiological recording unit 31 to adapt to the electrophysiological acquisition system 33 through the plug-in electrophysiological converter. The electrophysiological conversion end 132 is designed for connecting to the in-body electrophysiological acquisition electrode for the transmission of electrophysiological signals, which is conducive to the realization of in-body stimulation and real-time electrophysiological effect evaluation.

[0061] The wearable ultrasound stimulation-compatible electrophysiological recording system 100 of the present invention has the characteristics of small size and wearability. It can use multiple modules to work together to achieve real-time and personalized adjustment of ultrasound parameters for different target stimulation areas, which is conducive to providing support for the study of the intrinsic mechanism of ultrasound regulation effects to meet the needs of safe, effective, real-time and specific disease treatment.

[0062] In general, the present invention relates to a small-sized, wearable ultrasound stimulation compatible electrophysiological recording system, which realizes the functions of in-vivo stimulation and real-time electrophysiological effect evaluation through the collaborative work of multiple modules. Compared with the traditional single-element ultrasonic nerve regulation technology, the present invention conducts a comprehensive analysis of the structure, sound field and echo of the transducer, and independently develops and designs a smaller-sized, wearable focused ultrasound transducer on the basis of ensuring the performance of the transducer bandwidth, signal strength, resolution, etc., while meeting the requirements of in-vivo transcranial stimulation with sufficient depth and energy. It is also compatible with in-vivo electrophysiological real-time evaluation, and can realize real-time and matching comparison of ultrasound stimulation and electrophysiological regulation effects, which provides direct convenience for the physical parameter sorting of ultrasound intervention effects and the screening of better parameters. At the same time, it also provides a new strategy for clinical disease intervention, which can effectively and quickly adjust the intervention plan, thereby better improving the disease.

[0063] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, 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.

[0064] The above embodiments merely represent preferred embodiments of the present invention. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. Wearable ultrasound stimulation compatible electrophysiological recording system, characterized in that, include: A wearable collimator module, wherein the wearable collimator module is suitable for being worn and fixed on a stimulation target; An ultrasonic excitation module, comprising an ultrasonic transducer mounted on the wearable collimator module, a start-up control unit connected to the ultrasonic transducer, a parameter setting unit connected to the start-up control unit, and an electronic excitation unit connected to the parameter setting unit, wherein the ultrasonic transducer is used to generate and emit an excitation pulse signal to ultrasonically stimulate the stimulation target via the excitation pulse signal; the start-up control unit is used to receive the excitation pulse signal modulated by the electronic excitation unit and the parameter setting unit, thereby stimulating the operation of the ultrasonic transducer and modulating the impedance matching in the circuit operation of the ultrasonic transducer; the parameter setting unit is used to adjust the ultrasonic parameters of the ultrasonic transducer; and the electronic excitation unit is used to electronically control the operation of the oscillator of the ultrasonic transducer; as well as An electrophysiological recording module, connected to the wearable collimator module, for collecting, recording and analyzing electrophysiological signals collected by electrophysiological collection electrodes provided on the stimulation target; The electronic excitation unit includes a reference delay determination module for calculating the reference delay when the ultrasonic transducer vibrator emits an excitation pulse signal; The electrophysiological recording module includes an electrophysiological recording unit installed on the wearable collimator module. The wearable collimator module includes an ultrasonic fixing unit, a target fixing unit and an electrophysiological conversion fixing unit. The ultrasonic fixing unit is used to install the ultrasonic transducer. The target fixing unit is used to calculate the effective distance between the fixed position of the ultrasonic transducer and the ultrasonic stimulation based on the anatomical position information of the target stimulation area through a positioning system, obtain fixed coordinates, and fix them on the stimulation target using a fixer; the electrophysiological conversion fixing unit is used to install the electrophysiological recording unit.

2. The wearable ultrasound stimulation compatible electrophysiological recording system according to claim 1, characterized in that: The electrophysiological recording module also includes an electrophysiological acquisition system connected to the electrophysiological recording unit and a data processing unit connected to the electrophysiological acquisition system, wherein the electrophysiological recording unit is used to record the electrophysiological signals transmitted by the electrophysiological acquisition electrodes, the electrophysiological acquisition system acquires the electrophysiological signals of the stimulation target via the electrophysiological acquisition electrodes, and the data processing unit is used to analyze the electrophysiological signals acquired by the electrophysiological acquisition system.

3. The wearable ultrasound stimulation compatible electrophysiological recording system according to claim 2, characterized in that: The electrophysiological recording module further includes a preamplifier unit disposed between the electrophysiological recording unit and the electrophysiological acquisition system, and the preamplifier unit is configured to amplify the electrophysiological signal.

4. The wearable ultrasound stimulation compatible electrophysiological recording system according to claim 1, characterized in that: The target fixing unit includes a fixing part and a fixer arranged on the fixing part, the ultrasonic fixing unit includes an ultrasonic transducer adapter hole arranged on the fixing part, the electrophysiological conversion fixing unit includes an electrophysiological converter adapter hole arranged on the fixing part and an electrophysiological conversion end for connecting an electrophysiological acquisition electrode, the electrophysiological recording unit is installed on the electrophysiological converter adapter hole through a plug-in electrophysiological converter, and the electrophysiological conversion end is used to transmit the electrophysiological signal.

5. The wearable ultrasound stimulation compatible electrophysiological recording system according to claim 1, characterized in that: The wearable ultrasound stimulation-compatible electrophysiological recording system also includes a power amplifier connected to the ultrasound excitation module, a signal generator connected to the power amplifier and a data processing unit, and a video monitoring system connected to the data processing unit. The video monitoring system is used to monitor the real-time status of the stimulation target when wearing the wearable ultrasound stimulation-compatible electrophysiological recording system.

6. The wearable ultrasound stimulation compatible electrophysiological recording system according to any one of claims 1 to 5, characterized in that: The ultrasonic transducer includes a substrate, a piezoelectric ceramic sheet arranged on the substrate, a cable lead connected to the piezoelectric ceramic sheet, and a housing for encapsulating the piezoelectric ceramic sheet and the cable lead.

7. The wearable ultrasound stimulation compatible electrophysiological recording system according to any one of claims 1 to 5, characterized in that: The ultrasonic transducer is prepared by the following steps: The piezoelectric ceramic material is bonded to a substrate and cut into shape by grinding, cutting and laser processing to obtain a preformed sample; performing laser polarization on the preformed sample; Connecting cable leads to the preformed sample after laser polarization to form a positive electrode and a negative electrode; and The preformed sample and the cable leads are packaged in a housing to obtain the ultrasonic transducer.

8. The wearable ultrasound stimulation compatible electrophysiological recording system according to claim 7, characterized in that: The preparation of the ultrasonic transducer also includes the steps of: comprehensively analyzing the structure, sound field and echo of the ultrasonic transducer, and optimizing the size of the ultrasonic transducer based on the bandwidth, signal strength and resolution of the ultrasonic transducer.

Images