Ultrasonic stimulation system for targeted enhancement of collateral circulation for treatment of ischemic stroke

Abstract

Disclosed in the present invention is an ultrasonic stimulation system for targeted enhancement of collateral circulation for the treatment of ischemic stroke. The system comprises: an ultrasonic stimulation module for generating non-invasive low-frequency ultrasonic waves to stimulate nerves in a specific region on the brain surface, so as to promote the dilation of pial arteries, thereby enhancing the retrograde blood supply of the collateral circulation; a sensor module for monitoring cerebral blood flow changes in real time and uploading a monitoring result to a control module; and the control module for issuing a corresponding control instruction to the ultrasonic stimulation module according to the monitoring result uploaded by the sensor module, so as to adjust parameters of the low-frequency ultrasonic waves output by the ultrasonic stimulation module. The LIPUS technology can act directly on the scalp surface without anesthesia and surgical operations. The LIPUS technology can act directly on the peripheral terminals of trigeminal ganglion neurons around the pial arteries to dilate the local arteries; the range of action is accurate and limited, and the local blood flow velocity is directly accelerated. The functional near-infrared spectroscopy technology is further combined to monitor the cerebral blood flow changes in real time, thus improving the safety and effects of treatment.

Description

Ultrasound stimulation system for treating ischemic stroke by targeting enhanced collateral circulation TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to an ultrasound stimulation system for treating ischemic stroke by targeting enhanced collateral circulation. BACKGROUND

[0002] Ischemic stroke is one of the leading causes of death and disability worldwide. Current treatment strategies include drug thrombolysis and mechanical thrombectomy, but these methods have limitations such as short treatment time window, limited applicability, and so on, especially for patients with delayed admission or complex underlying diseases. Therefore, developing new non-invasive treatment methods to extend the treatment window and improve prognosis has become an important direction in current medical research.

[0003] Collateral circulation is an important pathway to provide alternative blood flow to damaged brain tissue under ischemic conditions. The blood flow brought by enhancing collateral arteries can slow down the damage process of brain tissue and provide a time buffer for further recanalization therapy.

[0004] In the prior art, the treatment method for expanding cerebral blood vessels by physical stimulation to treat ischemic stroke is mainly pterygopalatine ganglion stimulation. Currently, pterygopalatine ganglion stimulation has shown certain effects in preclinical and preliminary clinical trials. The pterygopalatine ganglion is a postganglionic neuron of the parasympathetic nervous system, and its postganglionic fibers can be distributed to the lacrimal gland, nasal cavity, oral gland, and pial arteries. After the occurrence of ischemic stroke, pterygopalatine ganglion stimulation can expand the pial arteries, thereby relieving ischemia.

[0005] Currently, pterygopalatine ganglion stimulation treatment requires local anesthesia, and a 23mm-long, 2mm-diameter nerve stimulator electrode is implanted in the pterygoid fossa through the upper wall of the oral cavity using a syringe. The electrode stimulates the pterygopalatine ganglion for 4 hours per day, and the stimulation is continuous for 5 days. This treatment requires local anesthesia surgery for implantation, and the operation is complex and poorly tolerated by patients. In addition, the postganglionic fibers of the parasympathetic postganglionic neurons in the pterygopalatine ganglion are distributed to the lacrimal gland, nasal cavity, oral gland, and pial arteries. Pterygopalatine ganglion stimulation is not brain blood vessel targeted, and it will affect the function of multiple glands. The parasympathetic postganglionic fibers emitted by the pterygopalatine ganglion are distributed to the entire cerebral anterior circulation arteries, and cannot focus on ischemic arteries, which may affect the redistribution of cerebral blood flow.

[0006] Therefore, a safer and more efficient method is needed to achieve the dural artery expansion. Research has found that ultrasound can regulate neural excitability through cavitation effect, mechanical force or direct activation of ion channels. Among them, LIPUS (low intensity pulsed ultrasound) as an efficient and safe physical stimulation method has gradually become a new treatment method for nervous system diseases. Because it has many advantages such as non-invasive, reversible and targeted in the field of neural regulation, the efficacy and neural regulation mechanism of LIPUS have been studied in many diseases such as Alzheimer's disease, Parkinson's disease and epilepsy, and some progress has been made.

[0007] We found that transcranial LIPUS, as a non-invasive and potentially safe neural regulation technique, can act on the surface of the dura mater without affecting the activity of cortical neurons. When LIPUS acts on the surface of the dura mater, it can activate the sensory nerve endings on the surface of the brain, dilate the dural arteries, and directly increase the blood flow velocity in the brain blood vessels. Its comprehensive effect is to enhance the reverse blood supply of collateral circulation, relieve ischemic symptoms and reduce cerebral infarction.

[0008] SUMMARY

[0009] The technical purpose of the present application is to provide an ultrasound stimulation system for targeting and enhancing collateral circulation to treat ischemic stroke, so as to solve the problems of low implementation efficiency and poor patient tolerance in the prior art.

[0010] To solve the above problems, the technical scheme of the present application is:

[0011] An ultrasound stimulation system for targeting and enhancing collateral circulation to treat ischemic stroke, comprising:

[0012] An ultrasound stimulation module, a sensor module and a control module;

[0013] The ultrasound stimulation module is configured to generate non-invasive low-frequency ultrasound waves to stimulate the nerves in a specific area of the brain surface to promote the dilation of the dural arteries and thus enhance the reverse blood supply of collateral circulation;

[0014] The sensor module is configured to monitor the changes in brain blood flow in real time and upload the monitoring results to the control module;

[0015] The control module is signal connected with the ultrasound stimulation module and the sensor module, and is configured to issue corresponding control instructions to the ultrasound stimulation module according to the monitoring results uploaded by the sensor module, so as to adjust the parameters of the low-frequency ultrasound waves output by the ultrasound stimulation module, including the frequency and intensity of the ultrasound waves.

[0016] Specifically, the ultrasound stimulation module comprises an ultrasound transducer, a driving circuit and a stimulation parameter adjustment unit; the ultrasound transducer is electrically connected with the driving circuit and is configured to receive a driving electrical signal from the driving circuit and convert the driving electrical signal into low-frequency ultrasound waves to stimulate the nerves in a specific region on the brain surface, wherein the frequency range of the low-frequency ultrasound waves is 0.4-1 MHz, and the intensity of the low-frequency ultrasound waves is less than 1 W / cm 2 ;

[0017] The driving circuit is also electrically connected with the control module and is configured to output an electrical signal of a specific frequency to the ultrasound transducer according to the control instruction issued by the control module, and the frequency and intensity of the electrical signal should be accurately matched with the requirements of the ultrasound transducer;

[0018] The stimulation parameter adjustment unit is electrically connected with the driving circuit and the control module respectively and is configured to adjust the electrical signal output by the driving circuit under the control of the control module, thereby indirectly adjusting the parameters of the low-frequency ultrasound waves output by the ultrasound transducer, including the frequency and intensity of the ultrasound waves.

[0019] Specifically, the driving circuit comprises a signal generator and a power amplifier;

[0020] The signal generator is electrically connected with the control module and is configured to output an electrical signal of a specific frequency according to the control instruction issued by the control module;

[0021] The power amplifier is electrically connected with the signal generator and is configured to receive the electrical signal of a specific frequency and amplify the electrical signal to the level required by the ultrasound transducer, and then output to the ultrasound transducer.

[0022] Specifically, the stimulation parameter adjustment unit comprises a frequency adjustment unit and an intensity control unit;

[0023] The frequency adjustment unit is configured to adjust the frequency of the electrical signal output by the driving circuit under the control of the control module, thereby adjusting the frequency of the low-frequency ultrasound waves, wherein the adjustment is based on the real-time changes of the brain blood flow collected by the sensor module;

[0024] The intensity control unit is configured to adjust the voltage and current of the electrical signal output by the driving circuit under the control of the control module, thereby adjusting the intensity of the low-frequency ultrasound waves.

[0025] Specifically, the sensor module comprises a temperature monitoring unit and a blood flow monitoring unit;

[0026] The temperature monitoring unit is arranged in the ultrasound transducer and is electrically connected with the control module and is configured to monitor the temperature of the output end of the ultrasound transducer in real time, and if it is monitored that the temperature exceeds a preset safety threshold, the control module is caused to stop the low-frequency ultrasound waves generated by the ultrasound stimulation module;

[0027] The blood flow monitoring unit is electrically connected with the control module and is configured to monitor the change of the cerebral blood flow, and if the cerebral blood flow is monitored to decrease, the control module adjusts the parameters of the ultrasonic stimulation module to increase the frequency and intensity of the low-frequency ultrasonic waves, and vice versa.

[0028] The blood flow monitoring unit and the control module cooperate with each other to realize feedforward control and feedback control, wherein the feedforward control is that the blood flow monitoring unit provides the baseline data of the cerebral blood flow to the control module to assist the control module to determine the initial parameters of the low-frequency ultrasonic waves; the feedback control is that the blood flow monitoring unit feeds back the change of the cerebral blood flow to the control module in real time, so that the control module adjusts the parameters of the low-frequency ultrasonic waves according to the change of the cerebral blood flow.

[0029] The blood flow monitoring unit adopts functional near-infrared spectroscopy technology, includes a plurality of groups of light sources and detectors arranged correspondingly, is configured to emit near-infrared light to the brain, the near-infrared light scatters and reflects in the brain tissue after penetrating the skull, and receives the reflected light, measures the light absorption difference of the reflected light according to the different light absorption characteristics of oxyhemoglobin and deoxyhemoglobin, and then estimates the oxygenation state and blood flow change of the brain.

[0030] If the oxyhemoglobin is monitored to increase, it indicates that the local cerebral blood flow increases, indicating that the collateral circulation is effectively opened.

[0031] If the deoxyhemoglobin is monitored to decrease, it indicates that the local oxygen consumption decreases or the perfusion is improved, and the ischemic area is better supplied with blood.

[0032] Specifically, the control module includes a signal processor, a storage unit and a communication unit.

[0033] The signal processor is configured to receive the data collected by the sensor module and perform real-time processing, analyze the change of the intracerebral blood flow, feed back the parameters of the ultrasonic stimulation module, and realize closed-loop feedback control.

[0034] The storage unit is configured to store preset ultrasonic parameters, patient historical data, system operation logs, control algorithms and system software, and provide data support for treatment report generation.

[0035] The communication unit is configured to support data interaction with external devices, and support remote monitoring and control through a wireless manner.

[0036] Further preferably, the signal processor also realizes safety control according to the control algorithm in the storage unit, and the safety control includes ultrasonic wave power limitation, temperature monitoring and cooling system linkage, and fault diagnosis and alarm.

[0037] The ultrasonic power limit is used to control the output power of the low-frequency ultrasonic wave, so as to ensure that the output power is always within a preset safety threshold; the temperature monitoring and cooling system is linked, configured to monitor the temperature of the ultrasonic stimulation module in real time through the sensor module, and automatically start the cooling system when the temperature exceeds the preset safety threshold, to prevent overheating; the fault diagnosis and alarm is used for self-diagnosis of the fault of the ultrasonic stimulation system.

[0038] Further preferably, a user interface module electrically connected with the control module is further provided, and the user interface module comprises an interactive display screen, and the interactive display screen is divided into a home screen, a menu bar, a parameter adjustment area and an information prompt box;

[0039] The home screen is configured to display the overall state information of the ultrasonic stimulation system, including the current parameters and temperature of the ultrasonic stimulation module, the monitoring data of the sensor module and the treatment progress;

[0040] The menu bar is configured to provide quick access to the ultrasonic stimulation system settings, data records, alarm logs and help information;

[0041] The parameter adjustment area is configured to provide a parameter manual input area of the ultrasonic stimulation module and selection of ultrasonic preset parameters;

[0042] The information prompt box is configured to pop up the corresponding information prompt box when the ultrasonic stimulation system detects an abnormal condition, to remind the user to pay attention and provide specific operation suggestions.

[0043] Compared with the prior art, the present application has the following advantages and positive effects:

[0044] The present application adopts LIPUS technology, which can directly act on the scalp surface without the need for anesthesia and surgical operation. LIPUS can directly act on the trigeminal ganglion endings around the pial artery, expand the local artery, and the action range is accurate and limited. LIPUS can also directly accelerate the local blood flow rate. The present application also combines functional near-infrared spectroscopy technology to monitor brain blood flow changes in real time, significantly improving the safety and effectiveness of treatment. BRIEF DESCRIPTION OF DRAWINGS

[0045] Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are merely for illustrative purposes and are not considered limiting of the present application.

[0046] Fig. 1 is a structural connection schematic diagram of an ultrasonic stimulation system for targeted enhancement of collateral circulation to treat ischemic cerebral stroke according to the present application;

[0047] Fig. 2 is a schematic diagram of the use of an ultrasound stimulation system for treating ischemic stroke by targeting and enhancing collateral circulation according to the present application;

[0048] Fig. 3 is a schematic diagram of the oxygenated hemoglobin signal of near-infrared brain function monitoring before and after the use of an ultrasound stimulation system for treating ischemic stroke by targeting and enhancing collateral circulation according to the present application. DETAILED DESCRIPTION

[0049] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, specific implementations of the present application will be described below with reference to the drawings. Obviously, the drawings in the following description only represent some embodiments of the present application, and for those skilled in the art, other drawings can be obtained from these drawings without creative labor, and other embodiments can also be obtained.

[0050] In order to make the drawing simple, only the parts related to the present application are shown in each drawing, which do not represent the actual structure of the product. In addition, in order to make the drawing simple and easy to understand, in some drawings, only one of the components with the same structure or function is shown or only one of them is marked. In this article, "one" not only means "only one", but also means "more than one".

[0051] The ultrasound stimulation system for treating ischemic stroke by targeting and enhancing collateral circulation according to the present application will be described in further detail below in combination with the drawings and specific embodiments. The advantages and features of the present application will be clearer according to the following description and claims.

[0052] EMBODIMENT

[0053] Referring to Figs. 1 to 3, the present embodiment provides an ultrasound stimulation system for treating ischemic stroke by targeting and enhancing collateral circulation, which is designed for ischemic stroke, stimulates and enhances the reverse blood flow supply of collateral circulation to ischemic area through non-invasive low-intensity pulsed ultrasound, relieves ischemic symptoms, reduces cerebral infarction, and thus improves the effect of intravascular treatment. It mainly has three modules: an ultrasound stimulation module, a sensor module and a control module.

[0054] The ultrasound stimulation module is used to generate non-invasive low-frequency ultrasound waves to stimulate the nerves of a specific area on the brain surface to promote the expansion of the pia mater arteries, and thus enhance the reverse blood flow supply of collateral circulation. The sensor module is used to monitor the changes in brain blood flow in real time and upload the monitoring results to the control module. The control module is signal-connected with the ultrasound stimulation module and the sensor module, and is used to issue corresponding control instructions to the ultrasound stimulation module according to the monitoring results uploaded by the sensor module, so as to adjust the parameters of the low-frequency ultrasound waves output by the ultrasound stimulation module, including the frequency and intensity of the ultrasound waves.

[0055] Specifically, the ultrasonic stimulation module of the present embodiment is described as follows:

[0056] The ultrasonic stimulation module is the core component of the present embodiment, which is specially designed for transcranial use. It mainly generates low-frequency ultrasonic waves to stimulate the nerves in the specific area of the brain surface, especially the trigeminal nerve, to enhance collateral circulation. The module specifically includes an ultrasonic transducer, a driving circuit, and a stimulation parameter adjustment unit.

[0057] The ultrasonic transducer is electrically connected to the driving circuit. Its main function is to receive the driving electrical signal from the driving circuit and convert it into mechanical ultrasonic waves (i.e., low-frequency ultrasonic waves). The generated low-frequency ultrasonic waves can penetrate the skull and act on the nerves in the specific area of the brain surface. The principle of the ultrasonic transducer is based on the piezoelectric effect of piezoelectric materials (such as PZT piezoelectric ceramic), which generates ultrasonic waves by changing the electric field to induce mechanical vibration. Preferably, the frequency range of the low-frequency ultrasonic waves generated by the ultrasonic transducer of the present embodiment should be 0.4-1 MHz. Within this frequency range, it is suitable for penetrating the skull, especially for adjusting blood vessels and nerves in the brain. When implementing the ultrasonic transducer, a biocompatible coating should be applied to its surface to ensure that it does not cause discomfort or irritation when it is close to the skin for a long time. The shape and size of the ultrasonic transducer are specially optimized, combined with an adjustable fixing assembly of the same physical level, to ensure that its output end is tightly attached to the patient's head and accurately targets the target area.

[0058] The driving circuit is also electrically connected to the control module. According to the control instructions issued by the control module, it outputs electrical signals of a specific frequency to the ultrasonic transducer, i.e., it provides stable current and voltage for the ultrasonic transducer. The frequency and intensity of the electrical signal output by the driving circuit should be accurately matched with the requirements of the ultrasonic transducer. Specifically, the driving circuit includes a signal generator and a power amplifier. The signal generator is electrically connected to the control module and outputs electrical signals of a specific frequency according to the control instructions issued by the control module. This frequency can be adjusted according to the patient's needs and treatment plan to achieve different treatment effects. The power amplifier is electrically connected to the signal generator and amplifies the received electrical signals of a specific frequency to the required level of the ultrasonic transducer, and then outputs them to the ultrasonic transducer, ensuring that the ultrasonic transducer can generate ultrasonic waves with sufficient energy.

[0059] The stimulation parameter adjustment unit is electrically connected to the driving circuit and the control module, respectively. It is controlled by the control module to adjust the electrical signal output by the driving circuit, thereby indirectly adjusting the parameters of the low-frequency ultrasonic waves output by the ultrasonic transducer. The two most important adjustment units are the frequency adjustment unit and the intensity control unit.

[0060] Frequency adjustment unit: the frequency of ultrasound is one of the important parameters to adjust the cerebral hemodynamics. The frequency adjustment unit is controlled by the control module, and dynamically adjusts the frequency of ultrasound according to the specific situation of the patient or the treatment plan. The frequency adjustment unit is linked with the real-time monitoring data of the sensor module through the control module, and automatically optimizes the frequency according to the real-time blood flow changes, so as to enhance the blood flow supply of collateral circulation. The adjustment mode is to change the frequency of the output electric signal of the driving circuit, and then adjust the frequency of the low-frequency ultrasound.

[0061] Intensity control unit: the intensity of ultrasound has a direct impact on the mechanical effect of tissue. The intensity control unit is controlled by the control module to adjust the voltage and current of the output electric signal of the driving circuit, and then accurately adjusts the output intensity of low-frequency ultrasound, so as to ensure effective stimulation without damaging tissue. In order to avoid thermal effect and mechanical damage, in this embodiment, it is designed as a low-intensity ultrasound mode (less than 1 W / cm 2 ), which can be safely used for transcranial stimulation. Of course, the intensity control unit also allows medical staff to manually adjust the ultrasound intensity through the control module, or automatically adjust the output according to real-time feedback, to ensure personalized treatment. Preferably, this embodiment can also adjust other parameters such as intervention time, duty cycle, sound pulse group repetition frequency and stimulation interval time, etc., which will not be described here.

[0062] Referring to FIG. 1, in this embodiment, the sensor module includes a temperature monitoring unit and a blood flow monitoring unit. In order to avoid local overheating caused by long-time ultrasound stimulation, the temperature monitoring unit is arranged in the ultrasonic transducer and electrically connected with the control module, which can monitor the temperature of the output end of the ultrasonic transducer in real time. If the monitored temperature exceeds the preset safety threshold, the control module stops the work of the ultrasonic stimulation module and sends an alarm to remind the operator, so as to ensure that this embodiment always works at a safe temperature.

[0063] Further, the blood flow monitoring unit is electrically connected with the control module, which adopts functional near-infrared spectroscopy (fNIRS) to monitor the changes of brain blood flow, so as to ensure the safety and effectiveness of the treatment. fNIRS is a non-invasive, portable and high-resolution optical imaging technology, which can evaluate the hemodynamic state of the brain by monitoring the changes of hemoglobin concentration in the brain tissue. The blood flow monitoring unit includes a plurality of sets of corresponding light sources and detectors arranged on the scalp of the patient. The light sources emit near-infrared light (700-900 nm wavelength) to the brain, which is scattered and reflected in the brain tissue after penetrating the skull. Since oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) have different light absorption characteristics in this wavelength band, fNIRS samples the light absorption characteristics of different regions and measures the light absorption difference, so as to estimate the oxygenation state and blood flow changes of the brain region. Specifically, if the oxyhemoglobin is monitored to increase, it indicates that the local cerebral blood flow increases, indicating that the collateral circulation is effectively opened. If the deoxyhemoglobin is monitored to decrease, it indicates that the local oxygen consumption decreases or the perfusion improves, and the ischemic area is better supplied with blood.

[0064] The blood flow monitoring unit can achieve real-time monitoring function. By providing real-time spatial and temporal information of cerebral blood flow, the doctor can evaluate the effect of ultrasound stimulation on a specific brain region, and use the monitoring data as a basis for adjusting the intensity and frequency of ultrasound. The blood flow monitoring unit can detect significant changes in local cerebral blood flow, prevent excessive local blood flow increase or deficiency caused by ultrasound stimulation, and ensure that the treatment is carried out within a safe range. The blood flow monitoring unit can also analyze the position of ultrasound stimulation according to the specific cerebral blood flow state of each patient, and dynamically adjust the parameters of ultrasound stimulation to provide personalized treatment plan to maximize the blood supply of collateral circulation.

[0065] Preferably, the blood flow monitoring unit and the control module cooperate with each other to realize feedforward control and feedback control through data synchronization. Specifically, the feedforward control is to provide the baseline data of cerebral blood flow to the control module by the blood flow monitoring unit before the treatment is implemented, so as to assist the control module to determine the initial parameters of low-frequency ultrasound. The feedback control is to feed back the changes of cerebral blood flow to the control module in real time by the blood flow monitoring unit during the treatment, so that the control module adjusts the parameters of low-frequency ultrasound according to the changes of cerebral blood flow.

[0066] Referring to FIG. 1, in the present embodiment, the control module is responsible for managing and coordinating other modules, which processes the data of the sensor module in real time through built-in algorithms, adjusts the ultrasonic output to ensure safety and effectiveness during treatment. Specifically, the control module includes a signal processor, a storage unit and a communication unit. The signal processor is used to receive and process the data collected from the sensor module in real time, analyze the changes in cerebral blood flow, and feedback adjust the parameters of the ultrasonic stimulation module to achieve closed-loop feedback control. The storage unit stores preset ultrasonic parameters, patient historical data, system operation logs, control algorithms and system software, and provides data support for treatment report generation. The communication unit supports data interaction with external devices (such as hospital information systems), and supports remote monitoring and control through wireless means.

[0067] Further, the working principle of the control module is described as follows: the control module receives operation instructions from the user interface (to be described later), real-time data from the sensor module and feedback signals from the ultrasonic stimulation module, and dynamically adjusts the ultrasonic output and the overall working state through the preset control algorithm based on the above information. Specifically, the control module uses the blood flow and oxygenation data obtained by the fNIRS sensor in real time, and performs rapid analysis through the signal processor. According to the analysis results, the control module dynamically adjusts the frequency, intensity and duration of the ultrasound waves to ensure the best treatment effect. In addition, during the implementation process, it can also be switched to an automatic control mode. In this mode, the control module automatically adjusts the ultrasonic stimulation parameters based on the preset treatment plan or intelligent algorithm to ensure the individualization and accuracy of the treatment process; through closed-loop feedback control, the ultrasonic output is adjusted in real time according to the sensor feedback data to avoid excessive stimulation or insufficient stimulation. Of course, the control module also allows users to input individualized data of patients (such as age, gender, severity of illness), and automatically optimizes the treatment parameters based on these data to achieve personalized treatment.

[0068] Further, the signal processor also implements safety control according to the control algorithm in the storage unit, which includes ultrasonic power limitation, temperature monitoring and cooling system linkage, and fault diagnosis and alarm. Among them, the ultrasonic power limitation is to control the output power of the low-frequency ultrasonic wave, to ensure that its output power is always within the preset safety threshold, to avoid tissue damage due to excessive stimulation. The temperature monitoring and cooling system linkage is configured to monitor the temperature of the ultrasonic stimulation module in real time through the sensor module, and automatically start the cooling system when the temperature exceeds the preset safety threshold to prevent overheating. Fault diagnosis and alarm can self-diagnose the faults of the ultrasonic stimulation system and issue an alarm through the user interface.

[0069] Preferably, referring to FIG. 1, a user interface module is also provided in the present embodiment and is electrically connected to the control module. The user interface module is designed to provide an intuitive and simple operation platform, allowing medical personnel to easily control the ultrasound stimulation system and monitor the treatment progress. The user interface module is provided with an interactive display screen, touch screen display and operation buttons, making it more convenient and efficient to adjust system parameters, monitor the state and record treatment data. The design of the user interface module is based on ease of use, intuitiveness and flexibility, ensuring that medical personnel can quickly understand the system status and make necessary adjustments during treatment. Therefore, the user interface module should meet the requirements of intuitiveness, simplicity and support real-time feedback. Intuitiveness means that the display screen can graphically display ultrasound stimulation parameters such as frequency, intensity, duration and real-time blood flow data; different colors and graphics are used to represent treatment status, progress and warning information. Simplicity means that the design conforms to the principles of ergonomics, the interface layout is simple and clear, and the operation steps are simplified, so that non-professionals can quickly get started. Support real-time feedback means that the interface displays real-time ultrasound output and blood flow dynamic data detected by fNIRS, ensuring that medical personnel can immediately understand the treatment effect and adjust the treatment parameters if necessary.

[0070] Specifically, the layout on the interactive display screen is divided into a main screen, a menu bar, a parameter adjustment area and an information prompt box.

[0071] The main screen displays the overall working status information of the ultrasound stimulation system, including the current parameters and temperature of the ultrasound stimulation module, the monitoring data of the sensor module and the treatment progress and other key information. Among them, the blood flow data and brain oxygen concentration level monitored by the sensor module in real time, the main screen displays the blood flow trend in the treatment process through dynamic charts.

[0072] The menu bar provides quick access to the ultrasound stimulation system settings, data recording, alarm logs and help information. Among them, since the present embodiment can automatically record detailed data of each treatment, including ultrasound frequency, intensity, duration and blood flow data before and after treatment, all of which are saved in the storage unit, users can retrieve and view historical treatment data through the menu bar, and generate detailed treatment reports. In addition, data can also be exported to external storage devices or uploaded to the hospital information management system through the communication unit, facilitating long-term tracking of patient treatment effects.

[0073] The parameter adjustment area provides parameter modification of the ultrasound stimulation module. Users can directly set the frequency, intensity, stimulation time and other parameters of ultrasound waves through the touch screen. It is also possible to select the recommended preset parameters provided by the system and allow users to customize adjustments according to the specific circumstances of the patient. Through the slider or numerical input method, users can accurately adjust various treatment parameters, and the adjusted values are displayed in real time on the main screen.

[0074] When the ultrasonic stimulation system detects abnormal conditions, an information prompt box pops up corresponding information prompt box, reminding the user to pay attention and provide specific operation suggestions. For example, when the blood flow monitoring data shows abnormal or the ultrasonic output parameter exceeds the safe range, an audible and visual alarm will be issued, and the specific parameters that need to be adjusted will be prompted; or temperature abnormalities, sensor failure and other equipment failures will also prompt the user to check or maintain through the interface in real time.

[0075] The specific implementation process of the present embodiment will be briefly described as follows:

[0076] First, the sensor module is firmly worn on the patient's head, ensuring that the light source and the probe of the detector are tightly attached to the patient's scalp. Start the near-infrared light source probe, emit near-infrared light into the brain tissue, and stimulate the brain's hemoglobin absorption and reflection response to light. At the same time, the near-infrared detector probe receives the reflected near-infrared light in real time, generating brain function imaging data. This imaging data is used to monitor the changes in brain blood flow, especially the blood flow state in the collateral circulation area, to determine the appropriate position for ultrasonic stimulation. This process will be dynamically adjusted according to the blood flow monitoring data, and the selected stimulation site will ensure the most ideal treatment effect.

[0077] After confirming the ultrasonic stimulation position, the ultrasonic transducer is adjusted to the stimulation position through the fixing assembly. The fixing assembly of the ultrasonic transducer is designed as an adjustable structure, which can accurately aim at the monitored optimal stimulation point, ensuring that the transducer maintains appropriate contact pressure and angle with the patient's scalp. The operator can view the feedback information of imaging and position calibration in real time through the user interface module to ensure that the transducer accurately aims at the target area. In order to avoid patient discomfort and errors, the structure of the fixing assembly is ergonomically designed so that it does not cause compression to the patient during wearing.

[0078] After confirming the transducer position, start the ultrasonic stimulation system. Through the ultrasonic transducer, ultrasonic waves of a predetermined frequency and intensity are emitted to the determined stimulation position. The ultrasonic waves penetrate the skull and act on the target nerve ganglion or blood vessel area, adjusting the blood supply in the collateral circulation. During the ultrasonic stimulation process, the system monitors key parameters in real time to ensure safety and effectiveness (the specific control logic has been described in detail in the foregoing, so it will not be repeated here). During the entire treatment process, the operator can adjust the ultrasonic frequency, intensity and treatment time in real time through the user interface to ensure personalized, controllable and effective optimization of the blood supply in the collateral circulation.

[0079] The embodiments of the present application are described in detail above in combination with the drawings, but the present application is not limited to the above-described embodiments. Even if various changes are made to the present application, as long as these changes fall within the scope of the claims of the present application and their equivalent technologies, they still fall within the protection scope of the present application.

Claims

1. An ultrasound stimulation system for targeting enhanced collateral circulation for treatment of ischemic stroke, comprising: The application relates to a brain blood flow stimulation device, which comprises an ultrasonic stimulation module, a sensor module and a control module. The ultrasonic stimulation module is configured to generate non-invasive low-frequency ultrasonic waves to stimulate nerves in specific regions of the brain surface, so as to promote the expansion of the pia mater artery and enhance the reverse blood flow supply of the collateral circulation. The sensor module is configured to monitor the changes in the brain blood flow in real time and upload the monitoring results to the control module. The control module is in signal connection with the ultrasonic stimulation module and the sensor module respectively and is configured to issue corresponding control instructions to the ultrasonic stimulation module according to the monitoring results uploaded by the sensor module, so as to adjust the parameters of the low-frequency ultrasonic waves output by the ultrasonic stimulation module, including the ultrasonic wave frequency and the ultrasonic wave intensity. The ultrasonic stimulation module comprises an ultrasonic transducer, a driving circuit and a stimulation parameter adjustment unit.

2. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 1, wherein, The driving circuit is in electrical connection with the control module and is configured to output an electric signal of a specific frequency to the ultrasonic transducer according to the control instructions issued by the control module, and the frequency and intensity of the electric signal should be accurately matched with the requirements of the ultrasonic transducer. The ultrasonic transducer is electrically connected with the driving circuit, configured to receive a driving electrical signal from the driving circuit and convert the driving electrical signal into low-frequency ultrasonic waves to stimulate nerves in a specific region of the brain surface, wherein the low-frequency ultrasonic waves have a frequency range of 0.4-1 MHz, and the intensity of the low-frequency ultrasonic waves is less than 1 W / cm 2 ; The stimulation parameter adjustment unit is in electrical connection with the driving circuit and the control module respectively and is configured to be controlled by the control module to adjust the electric signal output by the driving circuit, so as to indirectly adjust the parameters of the low-frequency ultrasonic waves output by the ultrasonic transducer, including the ultrasonic wave frequency and the ultrasonic wave intensity. The driving circuit comprises a signal generator and a power amplifier.

3. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 2, wherein, The signal generator is in electrical connection with the control module and is configured to output an electric signal of a specific frequency according to the control instructions issued by the control module. The power amplifier is in electrical connection with the signal generator and is configured to receive the electric signal of a specific frequency and amplify the electric signal to the level required by the ultrasonic transducer, and then output the electric signal to the ultrasonic transducer. The stimulation parameter adjustment unit comprises a frequency adjustment unit and an intensity control unit.

4. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 2, wherein, The frequency adjustment unit is configured to be controlled by the control module to adjust the frequency of the electric signal output by the driving circuit, so as to adjust the frequency of the low-frequency ultrasonic waves, wherein the adjustment is based on the real-time changes in the brain blood flow collected by the sensor module. The intensity control unit is configured to be controlled by the control module to adjust the voltage and current of the electric signal output by the driving circuit, so as to adjust the intensity of the low-frequency ultrasonic waves. The sensor module comprises a temperature monitoring unit and a blood flow monitoring unit.

5. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 1, wherein, The temperature monitoring unit is arranged in the ultrasonic transducer and is in electrical connection with the control module and is configured to monitor the temperature of the output end of the ultrasonic transducer in real time, and if the temperature exceeds the preset safety threshold, the control module is caused to stop the low-frequency ultrasonic waves generated by the ultrasonic stimulation module. The blood flow monitoring unit is in electrical connection with the control module and is configured to monitor the changes in the brain blood flow, and if the brain blood flow is reduced, the control module is caused to adjust the parameters of the ultrasonic stimulation module, so as to enhance the frequency and intensity of the low-frequency ultrasonic waves, and vice versa. ​ 6. The ultrasound stimulation system for treating ischemic stroke by targeting enhanced collateral circulation according to claim 5, characterized in that, the blood flow monitoring unit and the control module cooperate to realize feedforward control and feedback control, wherein the feedforward control is that the blood flow monitoring unit provides baseline data of cerebral blood flow to the control module to assist the control module in determining the initial parameters of the low-frequency ultrasound waves; the feedback control is that the blood flow monitoring unit feeds back the changes of cerebral blood flow to the control module in real time, so that the control module adjusts the parameters of the low-frequency ultrasound waves according to the changes of cerebral blood flow; wherein the blood flow monitoring unit adopts functional near-infrared spectroscopy technology, including a plurality of groups of corresponding light sources and detectors, which are configured to emit near-infrared light to the brain, the near-infrared light scatters and reflects in the brain tissue after penetrating the skull, and the reflected light is received, and the oxygenation state and blood flow changes of the brain are estimated according to the different light absorption characteristics of oxyhemoglobin and deoxyhemoglobin; wherein if oxyhemoglobin is monitored to increase, it indicates that the local cerebral blood flow increases, indicating that the collateral circulation is effectively opened; if deoxyhemoglobin is monitored to decrease, it indicates that the local oxygen consumption decreases or perfusion improves, and the ischemic area is better supplied with blood. the control module comprises a signal processor, a storage unit and a communication unit; 7. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 1, wherein, the signal processor is configured to receive and process in real time the data collected by the sensor module, analyze the changes of cerebral blood flow, and feed back to adjust the parameters of the ultrasound stimulation module to realize closed-loop feedback control; the storage unit is configured to store preset ultrasound parameters, patient historical data, system operation logs, control algorithms and system software, and provide data support for treatment report generation; the communication unit is configured to support data interaction with external devices, and support remote monitoring and control through wireless means. the signal processor also realizes safety control according to the control algorithm in the storage unit, which includes ultrasound power limitation, temperature monitoring and cooling system linkage, and fault diagnosis and alarm; 8. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 7, wherein, wherein the ultrasound power limitation controls the output power of the low-frequency ultrasound waves to ensure that the output power is always within the preset safety threshold; the temperature monitoring and cooling system linkage is configured to monitor the temperature of the ultrasound stimulation module in real time through the sensor module, and automatically start the cooling system when the temperature exceeds the preset safety threshold to prevent overheating; the fault diagnosis and alarm is to realize self-diagnosis of the faults of the ultrasound stimulation system. a user interface module electrically connected to the control module is further provided, the user interface module includes an interactive display screen, and the interactive display screen is divided into a home screen, a menu bar, a parameter adjustment area and an information prompt box; 9. The ultrasound stimulation system targeting enhanced collateral circulation treatment of ischemic stroke of claim 1, wherein, the home screen is configured to display the overall state information of the ultrasound stimulation system, including the current parameters and temperature of the ultrasound stimulation module, the monitoring data of the sensor module and the treatment progress; ​ The menu bar is configured to provide quick access to the ultrasonic stimulation system settings, data recording, alarm log, and help information; The parameter adjustment area is configured to provide a parameter manual input area of the ultrasonic stimulation module, and selection of ultrasonic preset parameters; The information prompt box is configured to pop up a corresponding information prompt box when the ultrasonic stimulation system self-checks out an abnormal condition, reminding the user to pay attention and providing specific operation suggestions.

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