Adjusting device for carotid sinus nerves

Abstract

The invention discloses an adjusting device for carotid sinus nerves, and the device comprises a biological signal recognition module which is attached to the outer wall of a carotid sinus blood vessel or a blood vessel patch of a carotid artery, and is used for monitoring a biological signal of the blood vessel of the carotid sinus part in real time; the biological signal comprises a blood vessel flow rate and a pulse wave; the processing module is used for processing the biological signal from the biological signal identification module and generating a regulation and control instruction according to the biological signal; the carotid sinus nerve stimulation electrode is implanted into a carotid sinus nerve and is used for generating a nerve stimulation signal and a block stimulation signal which act on the carotid sinus nerve according to the regulation and control instruction sent by the processing module; the nerve stimulation signal and the block stimulation signal are used for simulating the biological function of the carotid sinus where the carotid sinus nerve is located. The method is used for realizing fine adjustment of the carotid sinus nerves and improving the adjustment accuracy and reliability of the carotid sinus nerves.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a regulating device for the carotid sinus nerve. Background Art

[0002] This section aims to provide background or context for the embodiments of the present invention described. The description herein is not admitted to be prior art merely because it is included in this section.

[0003] In recent years, treatment measures for the peripheral nervous system, such as nerve stimulation, block, and ablation techniques, have been explored for the management of various diseases such as hypertension, heart failure, diabetes, and asthma. In particular, the method of inducing baroreflex by electrically stimulating the baroreceptors in the carotid sinus region has attracted wide attention. Research shows that combined electrical stimulation of the carotid body and carotid sinus has little effect on the blood pressure of rats; however, after selectively removing the carotid body, electrical stimulation of the carotid sinus nerve can cause blood pressure to drop; conversely, if only the carotid sinus is removed, this stimulation will cause blood pressure to rise. This indicates that the carotid sinus nerve has dual sensory innervation characteristics, and its different responses in the solitary tract nucleus restrict each other. Specifically, after the activation of baroreceptors, it will cause sympathetic inhibition and reduce blood pressure, while chemoreceptors activate both the sympathetic and parasympathetic systems at the same time.

[0004] At the present stage, there is a scheme of an electrode / stimulator placed on the tissue in the carotid sinus region, which can deliver nerve stimulation to baroreceptors or their innervating nerves to trigger a baroreflex response, and can also deliver block stimulation to the carotid body or its innervating nerves to inhibit the chemoreceptor response. The system it involves relies on external physiological sensors to monitor parameters such as blood pressure, heart rate, and respiration, and adjusts the signal output by the stimulator by processing these data.

[0005] However, the existing technology aims to regulate blood pressure by using the stimulation and block effects of the carotid sinus nerve, but there are the following several main defects:

[0006] 1. It cannot accurately reflect local blood flow changes: The existing technology uses external physiological sensors, which can only provide information such as systemic blood pressure and heart rate, and cannot accurately reflect the actual blood flow condition at the carotid sinus site. Especially in patients with atherosclerosis, there may be significant differences between the distal blood vessels and the central blood vessels in the neck, making the measurement results of external sensors inaccurate.

[0007] 2. The measurement accuracy is insufficient: The current non-invasive physiological monitoring devices are still difficult to meet the requirements of satisfactory real-time performance and accuracy. External sensors may be affected by various factors, resulting in inaccurate measurement results, especially under dynamically changing physiological conditions. Summary of the Invention

[0008] An embodiment of the present invention provides a regulating device for the carotid sinus nerve, which is used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located, realize the fine regulation of the carotid sinus nerve, and improve the accuracy and reliability of the regulation of the carotid sinus nerve. The device includes:

[0009] A biological signal recognition module, which is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and is used to monitor the biological signals of the blood vessels at the carotid sinus site in real time; the biological signals include blood vessel flow velocity and pulse wave;

[0010] A processing module, which is used to process the biological signals from the biological signal recognition module and generate a regulation instruction according to the biological signals;

[0011] A carotid sinus nerve stimulation electrode, which is implanted in the carotid sinus nerve, and is used to generate a nerve stimulation signal and a blocking stimulation signal that act on the carotid sinus nerve according to the regulation instruction issued by the processing module; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located.

[0012] The regulating device for the carotid sinus nerve in the embodiments of the present invention includes: a biological signal recognition module, which is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and is used to monitor the biological signals of the blood vessels at the carotid sinus in real time; the biological signals include blood vessel flow velocity and pulse wave; a processing module, which is used to process the biological signals from the biological signal recognition module and generate a regulation instruction according to the biological signals; a carotid sinus nerve stimulation electrode, which is implanted in the carotid sinus nerve and is used to generate a nerve stimulation signal and a blocking stimulation signal acting on the carotid sinus nerve according to the regulation instruction issued by the processing module; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located. The embodiments of the present invention can regulate the carotid sinus nerve, and realize the regulation of physiological indexes such as blood pressure by monitoring the biological signals at the carotid sinus in real time, so as to treat related diseases. Among them, the biological signal recognition module is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and can directly obtain the key information of the carotid sinus part by monitoring the biological signals of the blood vessels at the carotid sinus in real time, solving the problem of inaccurate monitoring of this part in the prior art; the processing module generates a regulation instruction according to the biological signals monitored by the biological signal recognition module, and the carotid sinus nerve stimulation electrode generates a nerve stimulation signal and a blocking stimulation signal according to the regulation instruction to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located, realizing the fine regulation of the carotid sinus nerve, overcoming the problem of non-fine regulation in the prior art, and can realize higher-resolution and more real-time blood flow parameter monitoring, thereby improving the accuracy and reliability of measurement; in addition, the carotid sinus nerve stimulation electrode can simulate the biological functions of the carotid sinus where the carotid sinus nerve is located, and in this way, it can better realize the regulation of the sinus branch of the carotid sinus nerve, which helps to distinguish the carotid sinus from the carotid body. Brief Description of the Drawings

[0013] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained according to these drawings. In the drawings:

[0014] Figure 1 It is a schematic structural diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention;

[0015] Figure 2 It is a specific example diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention;

[0016] Figure 3 It is a specific example diagram of a biological signal recognizer in an embodiment of the present invention;

[0017] Figure 4 This is a specific example diagram of a carotid sinus nerve stimulator in an embodiment of the present invention;

[0018] Figure 5 This is a specific example diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention;

[0019] Figure 6 This is a specific example diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention;

[0020] Figure 7 This is a specific example diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention. Detailed implementation manners

[0021] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer and more understandable, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Herein, the illustrative embodiments and descriptions of the present invention are used to explain the present invention, but not to limit the present invention.

[0022] The term "and / or" in this article merely describes an association relationship and indicates that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the term "at least one" in this article means any one of multiple or any combination of at least two of multiple. For example, including at least one of A, B, and C can represent including any one or more elements selected from the set composed of A, B, and C.

[0023] In the description of this specification, the terms "include", "comprise", "have", "contain", etc. are all open-ended terms, that is, they are intended to include but not limited to. The descriptions referring to terms such as "an embodiment", "a specific embodiment", "some embodiments", "for example", etc. mean that the specific features, structures or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic descriptions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. The step sequences involved in each embodiment are used to schematically illustrate the implementation of the present application, and the step sequences are not limited and can be adjusted appropriately as needed.

[0024] In the technical solution of this application, the acquisition, storage, use, processing, etc. of data all comply with the relevant provisions of national laws and regulations. The information collected in this application is information and data authorized by users or fully authorized by all parties. Moreover, the processing of relevant data, such as collection, storage, use, processing, transmission, provision, disclosure, and application, all comply with the relevant laws, regulations, and standards of relevant countries and regions. Necessary confidentiality measures are taken, which do not violate public order and good customs, and corresponding operation entrances are provided for users to choose to authorize or refuse. In addition, this application provides corresponding operation entrances for users to choose to agree or refuse the results of automated decision-making. If the user chooses to refuse, they can enter the expert decision-making process.

[0025] It should be noted that in the embodiments of this application, some existing solutions in the industry, such as software, components, models, etc., may be mentioned. For example, some existing software tools, components, algorithm models, or other well-known solutions in other technical fields may be cited. They should be regarded as exemplary. The purpose is only to illustrate the feasibility in the implementation of the technical solution of this application. These mentions should be understood as typical examples, and their core purpose is to elaborate and verify the rationality and feasibility of the technical solution proposed in this application. However, it does not mean that the applicant has already or necessarily used this solution. Such citations do not imply that the applicant has actually adopted these existing solutions, or will necessarily adopt these methods in the process of its technical implementation in the future. In other words, these mentions only serve an illustrative purpose, helping to understand the association and superiority of the innovation point of this application with the existing technology, and do not constitute an endorsement or reliance statement on specific existing technology products.

[0026] The carotid sinus nerve is a branch of the glossopharyngeal nerve and conducts afferent nerve impulses from the carotid sinus and carotid body. The carotid sinus is an enlarged part at the origin of the internal carotid artery and is an important baroreceptor in the human body, participating in the baroreceptor reflex of the human body. The baroreceptor converts the stretch stimulus of the blood vessel wall into an electrical signal in the afferent nerve and transmits it to the solitary nucleus of the brainstem. On the one hand, it inhibits sympathetic nerve activity by enhancing the inhibitory effect of the caudal ventrolateral medulla on the rostral ventrolateral medulla. On the other hand, it excites the vagus nerve through the dorsal nucleus of the vagus nerve and the nucleus ambiguus to promote parasympathetic activity. The sympathetic efferent pathway acts on blood vessels and the heart, while the parasympathetic efferent pathway acts on the pacemaker cells in the sinoatrial node of the heart. This reflex pathway of the carotid sinus plays an important role in the short-term and rapid regulation of blood pressure, buffering the rapid changes in blood pressure to maintain the homeostasis of the body.

[0027] Currently, some treatment measures targeting the peripheral nerves and based on techniques such as nerve stimulation, block, and nerve ablation have been attempted for the treatment of diseases such as hypertension, heart failure, diabetes, and asthma. Existing studies have proposed reducing blood pressure by electrically stimulating the baroreceptor area to induce the baroreflex. Further research found that electrical stimulation of the carotid nerve, which combines the carotid body and carotid sinus, did not cause a significant change in the blood pressure of rats. However, after selective denervation of the carotid body, electrical stimulation of the carotid sinus nerve caused a decrease in blood pressure, while after selective denervation of the carotid sinus, electrical stimulation of the carotid sinus nerve caused an increase in blood pressure. This suggests that the dual sensory innervation of the carotid sinus nerve causes opposite responses in the nucleus of the solitary tract and inhibits each other. In other words, baroreceptors cause sympathetic inhibition, reduce blood pressure, and cause bradycardia, while chemoreceptors activate the sympathetic and parasympathetic systems.

[0028] Therefore, in order to more effectively regulate blood pressure, more delicate regulation of the carotid sinus nerve is required, which needs to include but is not limited to: ① selective regulation of the sinus branch of the carotid sinus nerve to distinguish the carotid sinus and carotid body; ② real-time feedback regulation based on blood flow and vascular changes in the carotid sinus area.

[0029] The existing technology has a scheme with an electrode / stimulator placed on the tissue in the carotid sinus area. It can deliver nerve stimulation to the baroreceptor or its innervating nerve to trigger a baroreflex response, and at the same time, it can also deliver block stimulation to the carotid body or its innervating nerve to inhibit the chemoreceptor response. The system places at least one electrode / stimulator on the tissue in the carotid sinus area. The stimulator can deliver nerve stimulation to the baroreceptor area in the carotid sinus area or the nerve innervating the baroreceptor area to trigger a baroreflex response, and deliver block stimulation to the carotid body in the carotid sinus area or the nerve innervating the carotid body to inhibit the chemoreceptor response. Such a stimulator can deliver nerve stimulation and block stimulation. The system monitors indicators such as blood pressure, heart rate, and respiration through multiple external physiological sensors, and the data is processed in an external system (such as a nerve stimulation analyzer), and then the signal delivered by the stimulator in the carotid sinus area is adjusted.

[0030] The existing technology aims to regulate blood pressure by using the stimulation and block effects of the carotid sinus nerve, but there are several main defects as follows:

[0031] 1. The physiological function of the carotid sinus is to provide real-time feedback on the stretch stimulation at the carotid sinus site, thereby achieving fine regulation of blood pressure. The physiological sensors used in this technology are external physiological sensors, which analyze signals such as blood pressure, heart rate, and respiration, and cannot reflect the blood flow and pressure conditions at the carotid sinus site. Especially for the main target population of this product, patients with atherosclerosis, the difference in monitoring values between the peripheral distal blood vessels and the central blood vessels in the neck may be even greater. Currently, the non-invasive physiological monitors cannot achieve satisfactory real-time monitoring effects, the measurement accuracy is insufficient, and the process of wireless signal transmission to the processor may be interfered with and there is a time delay, resulting in a lagged response to physiological fluctuations and potential safety hazards.

[0032] 2. Signal transmission delay and interference:

[0033] During the process of wireless signal transmission from the sensor to the processor, interference may be encountered and there is a certain time delay. This delay may lead to a less timely response to physiological fluctuations, increasing potential safety risks. In addition, the wireless signal transmission may also be affected by environmental factors, further reducing the reliability of the system.

[0034] Specifically, the existing technical solutions mainly aim to trigger a baroreflex response by stimulating the baroreceptor region or its innervating nerves in the carotid sinus area, and to inhibit the chemoreceptor response of the carotid body or its innervating nerves to regulate physiological indicators such as blood pressure. External physiological sensors are used to monitor relevant indicators and process data to adjust the signals delivered by the stimulator to achieve regulation of physiological indicators. However, the existing technology has the following defects: The physiological function of the carotid sinus is to provide real-time feedback on the stretch stimulation at the carotid sinus site, thereby achieving fine regulation of blood pressure. The physiological sensors used in this technology are external physiological sensors, which analyze signals such as blood pressure, heart rate, and respiration, and cannot reflect the blood flow and pressure conditions at the carotid sinus site. Especially for the main target population of this product (patients with atherosclerosis), the difference in monitoring values between the peripheral distal blood vessels and the central blood vessels in the neck may be even greater. Currently, the non-invasive physiological monitors cannot achieve satisfactory real-time monitoring effects, the measurement accuracy is insufficient, and the process of wireless signal transmission to the processor may be interfered with and there is a time delay, resulting in a lagged response to physiological fluctuations and potential safety hazards.

[0035] In summary, the existing technology requires a solution that can more accurately sense the blood flow dynamics in the carotid sinus region and accordingly regulate nerve stimulation in real time. Such a system should be able to overcome the above defects in the existing technology, improve the measurement accuracy and response speed, and thus more effectively regulate blood pressure.

[0036] To solve the above problems, an embodiment of the present invention provides a regulating device for the carotid sinus nerve, which is used to simulate the biological function of the carotid sinus where the carotid sinus nerve is located, realize the fine regulation of the carotid sinus nerve, and improve the accuracy and reliability of the regulation of the carotid sinus nerve. Refer to Figure 1 the structural schematic diagram of the regulating device for the carotid sinus nerve. The device may include:

[0037] A biological signal recognition module 101, attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, is used to monitor the biological signals of the blood vessels at the carotid sinus part in real time; the biological signals include blood vessel flow velocity and pulse wave.

[0038] A processing module 102, which is used to process the biological signals from the biological signal recognition module and generate a regulation instruction according to the biological signals.

[0039] A carotid sinus nerve stimulation electrode 103, implanted in the carotid sinus nerve, is used to generate a nerve stimulation signal and a blocking stimulation signal acting on the carotid sinus nerve according to the regulation instruction issued by the processing module; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological function of the carotid sinus where the carotid sinus nerve is located.

[0040] The embodiment of the present invention can regulate the carotid sinus nerve. By monitoring the biological signals at the carotid sinus part in real time, the regulation of physiological indexes such as blood pressure is realized for the treatment of related diseases. Among them, the biological signal recognition module is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and can monitor the biological signals of the blood vessels at the carotid sinus part in real time, directly obtaining the key information of the carotid sinus part, solving the problem of inaccurate monitoring of this part in the prior art; the processing module generates a regulation instruction according to the biological signals monitored by the biological signal recognition module, and the carotid sinus nerve stimulation electrode generates a nerve stimulation signal and a blocking stimulation signal according to the regulation instruction to simulate the biological function of the carotid sinus where the carotid sinus nerve is located, realizing the fine regulation of the carotid sinus nerve, overcoming the problem of inaccurate regulation in the prior art, and can realize higher-resolution and more real-time blood flow parameter monitoring, thereby improving the accuracy and reliability of measurement; in addition, the carotid sinus nerve stimulation electrode can simulate the biological function of the carotid sinus where the carotid sinus nerve is located. In this way, better regulation of the sinus branch of the carotid sinus nerve can be realized, which helps to distinguish the carotid sinus from the carotid body.

[0041] Specifically in implementation, the biological signal recognition module, attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, is used to monitor the biological signals of the blood vessels at the carotid sinus part in real time; the biological signals include blood vessel flow velocity and pulse wave.

[0042] In the embodiments, the bio-signal recognition module plays a key role in the feedback carotid sinus nerve stimulation system of the present invention. This module is designed to be attached to the outer wall of the carotid sinus blood vessel or in the form of a vascular patch of the carotid artery, aiming to achieve real-time monitoring of the bio-signals of the blood vessels in the carotid sinus area. This attached design enables the bio-signal recognition module to be in close contact with the blood vessels in the carotid sinus area, thereby obtaining more accurate and direct bio-signals.

[0043] The bio-signals cover key information such as blood vessel flow velocity and pulse wave. As an important part of the bio-signals, the blood vessel flow velocity reflects the speed of blood flow in the blood vessels in the carotid sinus area. By real-time monitoring of the blood vessel flow velocity, the dynamic changes of blood flow can be understood, which is of great significance for analyzing the physiological functions of the carotid sinus and subsequent nerve stimulation regulation. The pulse wave is a wave signal generated by the periodic vibration of the blood vessel wall caused by the heartbeat. Monitoring the pulse wave can obtain information about the heartbeat and blood vessel elasticity, etc., further providing a basis for the precise regulation of the carotid sinus nerve by the system.

[0044] In one embodiment, the bio-signal recognition module includes: a bio-signal recognizer configured as a super-miniature array ultrasound; the bio-signal recognition module is also implanted into the carotid sinus in a percutaneous manner.

[0045] In the embodiments, the super-miniature array ultrasound bio-signal recognizer has high-precision bio-signal detection capabilities. Its super-miniature size design enables it to closely adhere to the outer wall of the carotid sinus blood vessel or the vascular patch of the carotid artery without causing excessive physical interference to the carotid sinus and its surrounding tissues. The configuration of the array ultrasound further enhances its signal acquisition capabilities. Through an array composed of multiple ultrasound sensors, the blood vessels in the carotid sinus area can be scanned from multiple angles and positions, thereby obtaining more comprehensive and detailed bio-signal information.

[0046] This super-miniature array ultrasound bio-signal recognizer has high accuracy and sensitivity in detecting bio-signals such as blood vessel flow velocity and pulse wave. It uses the ultrasound principle to detect the blood flow in the blood vessel and the movement state of the blood vessel wall by transmitting and receiving ultrasound pulses, and then accurately obtains the blood vessel flow velocity and pulse wave signals. Compared with traditional bio-signal detection methods, the super-miniature array ultrasound can provide richer and more accurate bio-signal data, providing a more reliable data basis for the subsequent processing module to precisely regulate the carotid sinus nerve stimulation electrode.

[0047] For percutaneous implantation, the following specific method can be adopted: With the help of special guiding instruments, select a suitable puncture point on the skin surface, and guide the bio-signal recognition module to the area near the carotid sinus through a small incision.

[0048] During the implantation process, image - guiding techniques such as ultrasound imaging or fluoroscopy are utilized to ensure that the percutaneous implantation accurately reaches the target location and does not cause unnecessary damage to the surrounding tissues. The percutaneous implantation method has the advantages of minimal trauma and rapid recovery, reducing the large incisions and long recovery times associated with traditional surgical implantations. Meanwhile, the percutaneous implantation process can be performed under local anesthesia, reducing the patient's discomfort and surgical risks. Once successfully implanted, it can closely adhere to the outer wall of the carotid sinus blood vessel or the carotid artery, real - time monitor biological signals such as blood vessel flow velocity and pulse wave, and transmit these signals to the processing module for further analysis and processing.

[0049] In one embodiment, the biological signals further include blood oxygen saturation and local temperature;

[0050] The biological signal recognition module further includes:

[0051] A multimodal sensor array unit, including: an ultrasonic sensor, a pressure sensor, and an optical sensor; the multimodal sensor array unit is used to obtain biological signals of the blood vessels at the carotid sinus site from multiple dimensions, where the ultrasonic sensor is used to obtain the flow velocity and direction information of the blood flow in the blood vessel, the pressure sensor is used to obtain the pressure change information of the blood vessel wall, and the optical sensor is used to obtain information related to the optical characteristics of the blood vessel wall;

[0052] An adaptive signal processing unit, connected to the multimodal sensor array unit, is used to perform adaptive filtering, amplification, and feature extraction processing on the obtained multimodal biological signals.

[0053] In the above - mentioned embodiment, the multimodal sensor array unit is composed of an ultrasonic sensor, a pressure sensor, and an optical sensor. This combination of multiple sensors can obtain biological signals of the blood vessels at the carotid sinus site from multiple dimensions. The ultrasonic sensor uses ultrasonic technology to obtain the flow velocity and direction information of the blood flow in the blood vessel by emitting and receiving ultrasonic pulses. It can accurately detect the flow dynamics of blood in the blood vessel, providing key data for analyzing the physiological state of the blood vessel. The pressure sensor focuses on obtaining the pressure change information of the blood vessel wall. The pressure change of the blood vessel wall is closely related to factors such as blood flow, heart pulsation, and blood vessel elasticity. By monitoring the pressure change information, the physiological function of the blood vessel can be deeply understood. The optical sensor is used to obtain information related to the optical characteristics of the blood vessel wall. The optical characteristics of the blood vessel wall may be affected by various factors such as blood components, blood vessel wall tissue structure, and physiological state. By monitoring the information related to the optical characteristics, the physiological condition of the blood vessel can be understood from another perspective.

[0054] The adaptive signal processing unit is connected to the multimodal sensor array unit. Its main function is to perform adaptive filtering, amplification, and feature extraction on the acquired multimodal biological signals. During the actual signal acquisition process, due to the complexity of the internal environment of the organism and the existence of various interference factors, the acquired biological signals often contain a large amount of noise and interference components. Adaptive filtering can automatically adjust the filtering parameters according to the characteristics of the signal and the noise, effectively removing the noise and improving the signal-to-noise ratio of the signal. Amplification is to enhance the weak biological signal to an appropriate amplitude for subsequent signal processing and analysis. Feature extraction is to further analyze and process the biological signal after filtering and amplification, extract the characteristic information that is of great significance for analyzing the vascular physiological state and system regulation, and provide the necessary data support for the accurate operation of the entire system.

[0055] During specific implementation, the processing module is used to process the biological signals from the biological signal recognition module and generate a regulation instruction according to the biological signals.

[0056] In the embodiment, the biological signals acquired by the biological signal recognition module contain various information of the blood vessels at the carotid sinus site, such as blood vessel flow velocity, pulse wave, blood oxygen saturation, and local temperature, etc. (in some embodiments, other relevant information may also be included). These biological signals are first transmitted to the processing module.

[0057] The processing module has a complex signal processing mechanism inside. It first analyzes and interprets the received biological signals. For the blood vessel flow velocity information, the processing module will analyze its numerical value, change trend, etc. to understand the state of blood flow. For the pulse wave signal, it will extract key parameters such as its waveform characteristics and frequency to obtain information about heart pulsation and blood vessel elasticity. For signals such as blood oxygen saturation and local temperature, corresponding analysis and processing will also be carried out to master the local oxygen supply situation and temperature state of the blood vessels.

[0058] Based on the comprehensive analysis of the biological signals, the processing module generates a regulation instruction according to the preset algorithms and rules. These regulation instructions are operation instructions for the carotid sinus nerve stimulation electrode, used to guide the electrode to generate appropriate nerve stimulation signals and blocking stimulation signals. For example, if it is found that the blood vessel flow velocity is too fast after analyzing the biological signals, which may mean that the blood pressure is high, the processing module may generate an instruction to require the carotid sinus nerve stimulation electrode to increase the intensity of the blocking stimulation signal to inhibit the sympathetic nerve activity, thereby reducing the blood pressure and restoring the blood vessel flow velocity to the normal range.

[0059] The algorithms and rules of the processing module are set based on in-depth research on the physiological functions of the carotid sinus and the neural regulation mechanism. It needs to take into account the complex relationships between biological signals and physiological indicators such as blood pressure and heart rate, as well as the effects of carotid sinus nerve stimulation on these physiological indicators. By continuously optimizing the algorithms and rules, the processing module can generate more accurate and effective control instructions according to biological signals, achieve fine control of the carotid sinus nerve, and thus achieve the purpose of regulating physiological indicators such as blood pressure.

[0060] In one embodiment, as Figure 5 shown in a specific example diagram of a regulating device for the carotid sinus nerve, the processing module includes:

[0061] A processor 501, configured to determine in real time the output mode of the stimulation electrode for regulating the carotid sinus nerve according to the biological signal transmitted by the biological signal recognition module; generate a control instruction according to the output mode;

[0062] A battery unit 502, configured to supply power to the biological signal recognition module, the processor, and the carotid sinus nerve stimulation electrode.

[0063] In one embodiment, the processing module presents a specific composition form, which includes a processor and a battery unit. By analyzing the dynamic changes of the flow velocity signal, it is possible to understand whether the blood flow state in the blood vessel is stable, and whether there are abnormal accelerations or decelerations.

[0064] For the pulse wave signal, the processor focuses on extracting key parameters such as its waveform characteristics and frequency. The waveform characteristics can reflect the elasticity of the blood vessel and the influence of the heart beat on the blood vessel wall, and the frequency information is closely related to the heart beat frequency. By analyzing these parameters, the interaction relationship between the heart and the blood vessel can be deeply understood.

[0065] For other biological signals such as blood oxygen saturation and local temperature, the processor will also perform detailed analysis and processing. It will judge the oxygenation condition of the blood according to the value of the blood oxygen saturation, and the possible influence of the local temperature on the physiological function of the blood vessel.

[0066] After comprehensively and deeply analyzing the biological signals, the processor determines in real time the output mode of the stimulation electrode for regulating the carotid sinus nerve according to the information obtained. This process needs to consider multiple factors.

[0067] First, the processor will consider the vascular physiological state reflected by the current biological signal. For example, if the blood vessel flow velocity is too fast and the pulse wave frequency is too high, this may imply high blood pressure and too frequent heart beats. At this time, the processor needs to determine a stimulation electrode output mode that can effectively inhibit this abnormal physiological state according to the regulation mechanism of the carotid sinus nerve on blood pressure and heart rate.

[0068] Secondly, the processor also refers to preset adjustment strategies. These adjustment strategies are formulated based on in-depth research on the neurophysiological characteristics of the carotid sinus nerve and its mechanism of action in the cardiovascular system. For example, for different degrees of blood pressure abnormalities, corresponding adjustment rules for the output mode of the stimulating electrode are set. Finally, the processor needs to consider the physiological characteristics of the carotid sinus nerve itself. Since the carotid sinus nerve produces different responses to different types and intensities of stimuli, the processor needs to ensure that the determined output mode can effectively regulate nerve activity without damaging nerve function, thereby achieving the regulation of physiological indicators such as blood pressure and heart rate.

[0069] According to the determined output mode, the processor then generates control instructions. These control instructions will be sent to the carotid sinus nerve stimulating electrode to guide the electrode to generate nerve stimulation signals and blocking stimulation signals in a predetermined manner.

[0070] The battery unit needs to have a stable power supply capacity to ensure that the biosignal recognition module can continuously and accurately monitor biosignals, the processor can normally perform signal processing and instruction generation operations, and the carotid sinus nerve stimulating electrode can stably generate nerve stimulation signals and blocking stimulation signals.

[0071] In one embodiment, the processor is further configured to:

[0072] Output the biosignal and the control instructions in real time through Bluetooth and / or NFC transmission methods.

[0073] In the above embodiment, through Bluetooth and / or NFC transmission methods, the processor can achieve efficient communication with external devices. For biosignals, outputting them in real time to external devices helps to more comprehensively monitor and analyze the physiological state of blood vessels in the carotid sinus area. External devices can be professional medical monitoring instruments, which can receive and further process these biosignals, such as performing more complex data mining and analysis, providing more data support for medical research and clinical diagnosis.

[0074] At the same time, it is also of great significance to output the control instructions in real time. External devices can monitor and provide feedback on the operating state of the carotid sinus nerve stimulation system according to the received control instructions.

[0075] For example, medical staff can learn about the current stimulation method and intensity of the carotid sinus nerve by the system and the impact of these stimulations on biosignals through external devices, so as to better evaluate the treatment effect and adjust the treatment plan when necessary.

[0076] In one embodiment, the processor stores physiological data samples of the carotid sinus blood vessels and corresponding regulation strategy data;

[0077] The processor is specifically configured to: compare and analyze the real-time acquired biological signal with the stored data samples to determine the current neuromodulation strategy; and determine the output mode of the stimulation electrode for regulating the carotid sinus nerve according to the current neuromodulation strategy.

[0078] For example, the processing module further includes:

[0079] A big data analysis unit that stores a large number of physiological data samples of the carotid sinus blood vessels and corresponding regulation strategy data, and is used to compare and analyze the real-time acquired biological signal with the stored data samples to determine the most suitable regulation strategy;

[0080] A neural network algorithm unit, based on a deep learning algorithm, is used to further optimize the generation of regulation instructions according to the analysis results of the big data analysis unit, taking into account the dynamic changes in the vascular physiological state and individual differences to achieve more precise regulation;

[0081] A feedback regulation unit is used to adjust and optimize the regulation instructions in real time according to the stimulation effect information fed back by the carotid sinus nerve stimulation electrode.

[0082] Among them, the specific working process of the feedback regulation unit is as follows:

[0083] A signal receiving unit: is used to receive the stimulation effect information fed back by the carotid sinus nerve stimulation electrode, and the stimulation effect information includes but is not limited to the electrophysiological response data of the nerve (such as the frequency and amplitude of nerve impulses), and the subsequent physiological change data of the blood vessels at the carotid sinus site (such as blood pressure changes, blood flow velocity changes, blood vessel wall tension changes, etc.).

[0084] An effect evaluation unit: is connected to the signal receiving unit and evaluates the received stimulation effect information. This unit is built-in with preset evaluation criteria and algorithms, and can compare and analyze the actual stimulation effect with the expected effect to determine whether the stimulation reaches the expected goal and the degree of deviation.

[0085] For example, if the preset blood pressure regulation target is to reduce the blood pressure to a specific range within a certain time, the effect evaluation unit determines whether the target is reached and the deviation situation according to the fed-back blood pressure change data.

[0086] An instruction adjustment unit: adjusts and optimizes the regulation instructions in real time according to the evaluation results of the effect evaluation unit. If the evaluation results show that the stimulation effect does not reach the expectation, the instruction adjustment unit will modify the relevant parameters in the regulation instructions according to the deviation situation and the preset adjustment rules.

[0087] For example, if the intensity of the nerve stimulation signal is insufficient and the nerve response is not obvious, the instruction adjustment unit may increase the intensity parameter of the nerve stimulation signal; if the stimulation frequency is inappropriate and the vascular physiological changes are abnormal, the instruction adjustment unit may adjust the stimulation frequency parameter. The adjusted regulation instruction will be sent to the carotid sinus nerve stimulation electrode again to achieve the dynamic optimization of carotid sinus nerve stimulation, ensure that the device can continuously and effectively simulate the biological function of the carotid sinus, and achieve the precise regulation of physiological indicators such as blood pressure.

[0088] In the above embodiment, the carotid sinus vascular physiological data samples cover the relevant parameters of the carotid sinus blood vessels in various normal and abnormal physiological states, including blood vessel flow velocity, pulse wave characteristics, blood oxygen saturation, and local temperature at different blood pressure levels. The corresponding regulation strategy data is summarized based on a large number of experimental studies and clinical experiences, and details the nerve regulation strategies to be adopted for different physiological data samples.

[0089] Specifically, the processor is used to compare and analyze the biologically-signals obtained in real time with the stored data samples to determine the current nerve regulation strategy. When receiving the biologically-signals from the biological signal recognition module, the processor first extracts and organizes each parameter. For the blood vessel flow velocity signal, its current value and change trend are obtained; for the pulse wave signal, its key waveform characteristics and frequency are extracted; and corresponding processing is also performed on signals such as blood oxygen saturation and local temperature.

[0090] Then, the processor compares these real-time biological signal parameters one by one with the corresponding parameters in the stored carotid sinus vascular physiological data samples. For example, the current blood vessel flow velocity is compared with the sample flow velocities at different blood pressure levels to determine whether it is within the normal range; the waveform characteristics and frequency of the pulse wave are compared with the corresponding samples to analyze whether there are abnormalities.

[0091] Through this comparison and analysis, the processor can determine the current nerve regulation strategy. If the real-time biological signal is closest to a specific physiological data sample, the corresponding regulation strategy may be determined as the currently applicable strategy. For example, if the real-time blood vessel flow velocity and pulse wave characteristics are similar to the sample data in the hypertensive state, the regulation strategy for hypertension may be determined.

[0092] According to the current neuromodulation strategy, the processor further determines the output mode of the stimulating electrode for regulating the carotid sinus nerve. Different modulation strategies correspond to different output modes of the stimulating electrode. For example, if the determined modulation strategy is to lower blood pressure, then it may be necessary to increase the intensity of the blocking stimulation or change the stimulation frequency of the stimulating electrode, etc., to inhibit sympathetic nerve activity, thereby achieving blood pressure regulation. This process of determining the modulation strategy based on data comparison and analysis and further determining the output mode of the stimulating electrode enables the processor to more precisely regulate the carotid sinus nerve to adapt to different physiological states.

[0093] During specific implementation, the carotid sinus nerve stimulating electrode is implanted in the carotid sinus nerve and is used to generate nerve stimulation signals and blocking stimulation signals that act on the carotid sinus nerve according to the regulation instructions issued by the processing module; the nerve stimulation signals and blocking stimulation signals are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located.

[0094] In an embodiment, after the processing module generates regulation instructions based on the biological signals monitored by the biological signal recognition module, the carotid sinus nerve stimulating electrode will receive these instructions. The regulation instructions contain the relevant parameter requirements for the nerve stimulation signals and blocking stimulation signals, such as the intensity, frequency, pulse width, etc. of the signals. The electrode will strictly generate corresponding signals according to the requirements of the regulation instructions. For example, if the regulation instructions require increasing the intensity of the nerve stimulation signal, the electrode will correspondingly adjust its internal circuit parameters to increase the intensity of the stimulation signal, thereby exerting a stronger stimulation effect on the carotid sinus nerve.

[0095] The generated nerve stimulation signals and blocking stimulation signals are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located. The carotid sinus, as an important baroreceptor in the human body, its biological functions are mainly reflected in the regulation of blood pressure. By applying stimulation signals and blocking stimulation signals to the carotid sinus nerve, the activities of the sympathetic nerve and the parasympathetic nerve can be affected, thereby regulating blood pressure.

[0096] When the generated stimulation signals and blocking stimulation signals act on the carotid sinus nerve, a series of neurophysiological reactions will be triggered. For example, appropriate stimulation signals may inhibit sympathetic nerve activity, resulting in a decrease in blood pressure; while the blocking stimulation signals may regulate nerve conduction, affecting the heart beat frequency and the vasoconstriction state of blood vessels, thereby achieving fine regulation of blood pressure and simulating the normal biological functions of the carotid sinus.

[0097] In one embodiment, the carotid sinus nerve stimulating electrode includes a needle electrode; the barb at the tip of the needle electrode is selectively implanted and fixed on the sinus branch of the carotid sinus nerve and moves with the movement of the carotid sinus nerve.

[0098] In the above embodiment, the needle electrode has unique design features. Its overall shape is slender and needle-like, which helps it to be smoothly implanted into the tissue near the carotid sinus nerve. The tip of the needle electrode is provided with a barb structure, and this barb structure has important functions.

[0099] The barbs at the tip of the needle electrode can be selectively implanted into the sinus branch of the carotid sinus nerve. During the implantation process, it is necessary to rely on the doctor's professional skills and precise understanding of the anatomical structure of the carotid sinus nerve. The doctor will perform surgical operations to carefully guide the tip of the needle electrode to the position of the sinus branch of the carotid sinus nerve, and then use the barb structure to enable it to be stably embedded in the nerve tissue. This selective implantation method ensures that the electrode can accurately act on the key part (sinus branch) of the carotid sinus nerve, thereby achieving more precise stimulation and regulation of the carotid sinus nerve.

[0100] Once implanted successfully, the needle electrode can move with the movement of the carotid sinus nerve. Since the carotid sinus nerve may undergo minor positional movements during the physiological activities of the human body, such as with the rotation of the head or the pulsation of blood vessels, this follow-up characteristic is particularly important. The needle electrode is closely connected to the carotid sinus nerve. When the nerve moves, the electrode will also move accordingly, so as to always maintain effective contact with the nerve, ensuring that the stimulation signal can be continuously and stably transmitted to the carotid sinus nerve, and avoiding problems such as the interruption or failure of stimulation caused by the electrode detaching from the nerve.

[0101] In one embodiment, as Figure 6 shown in a specific example diagram of a regulating device for the carotid sinus nerve, the carotid sinus nerve stimulation electrode includes:

[0102] An electrode positioning unit 601 that ensures the electrode is implanted at a preset position of the carotid sinus nerve through ultrasound guidance or electromagnetic navigation technology;

[0103] A stimulation mode selection unit 602 that can switch between multiple preset stimulation modes according to a regulation command; each stimulation mode corresponds to a stimulation signal with different frequencies, intensities, pulse widths, and durations.

[0104] In one embodiment, the carotid sinus nerve stimulation electrode has a more complex structure and function, including an electrode positioning unit and a stimulation mode selection unit.

[0105] The electrode positioning unit plays a key role in ensuring the accurate implantation of the electrode at the preset position of the carotid sinus nerve. It adopts advanced ultrasound guidance or electromagnetic navigation technology.

[0106] When using ultrasound guidance technology, during the electrode implantation process, the ultrasound device emits high-frequency ultrasound signals, which propagate and reflect back in the tissue. By receiving and analyzing the reflected signals, the anatomical structure of the carotid sinus nerve and its surrounding tissues can be clearly observed.

[0107] The electrode positioning unit will precisely guide the electrode to move towards the target position of the carotid sinus nerve according to the information provided by the ultrasound image. The doctor can observe the ultrasound image and adjust the position and direction of the electrode in real time to ensure that the tip of the electrode can accurately reach the preset position of the carotid sinus nerve, such as the sinus branch site.

[0108] For electromagnetic navigation technology, first, an electromagnetic sensor array needs to be set up around the patient's body, and at the same time, an electromagnetic marker is installed on the electrode. When the electromagnetic sensor array emits electromagnetic signals, the electromagnetic marker on the electrode will generate corresponding electromagnetic responses.

[0109] By detecting and analyzing the electromagnetic response signals, the position and direction of the electrode in space can be determined. The electrode positioning unit will control the movement path of the electrode precisely according to this information, so that it can be accurately implanted into the preset position of the carotid sinus nerve, ensuring effective contact between the electrode and the nerve, and laying the foundation for subsequent stimulation operations.

[0110] The stimulation mode selection unit can switch between multiple preset stimulation modes according to the regulation instructions, and each stimulation mode corresponds to stimulation signals with different frequencies, intensities, pulse widths, and durations.

[0111] The stimulation mode selection unit first receives the regulation instructions from the processing module. The regulation instructions contain relevant information about the stimulation mode selection and the parameters of the stimulation signals. The stimulation mode selection unit will parse the regulation instructions and extract the key content about the stimulation mode and signal parameters to determine the stimulation mode to be switched to and the corresponding stimulation signal parameters.

[0112] According to the parsing results, the stimulation mode selection unit can switch between multiple preset stimulation modes. For example, if the regulation instructions require a stimulation mode with a higher frequency and a lower intensity, the stimulation mode selection unit will quickly switch to the corresponding stimulation mode.

[0113] After switching to a specific stimulation mode, the stimulation mode selection unit will generate corresponding stimulation signals according to the parameters such as frequency, intensity, pulse width, and duration corresponding to this mode. These stimulation signals will be transmitted to the carotid sinus nerve through the electrode to achieve precise stimulation and regulation of the carotid sinus nerve, simulate the biological functions of the carotid sinus where the carotid sinus nerve is located, and then adjust physiological indicators such as blood pressure.

[0114] In one embodiment, the carotid sinus nerve stimulation electrode further comprises:

[0115] The anatomical structure sensing unit is used to obtain the anatomical structure information of the carotid sinus nerve according to a preset micro sensor; the anatomical structure information includes the physical properties of the tissue surrounding the carotid sinus nerve; the anatomical structure information is analyzed and processed to generate a three-dimensional structure model of the carotid sinus nerve; the three-dimensional structure model includes the direction of the nerve, branching conditions and relationship with surrounding tissues; based on the three-dimensional structure model of the carotid sinus nerve, determine the preset position of the electrode implanted in the carotid sinus nerve.

[0116] In the above embodiment, the anatomical structure sensing unit obtains the anatomical structure information of the carotid sinus nerve based on the pre-set micro sensors. These micro sensors have highly sensitive detection capabilities and can sense various physical properties of the tissues surrounding the carotid sinus nerve. For example, the sensors can detect parameters such as hardness, density, and elasticity of the tissue. By detecting these physical properties, detailed information about the carotid sinus nerve and its surrounding environment can be collected.

[0117] One of the core functions of the anatomical structure perception unit is to analyze and process the acquired anatomical structure information. Through complex algorithms and data processing techniques, the collected information about the physical properties of the tissue is converted into a three-dimensional structural model of the carotid sinus nerve. This three-dimensional structural model comprehensively presents the direction of the nerve, its branches, and its relationship with surrounding tissues. For example, the model can clearly show the path of the carotid sinus nerve from the starting point to each branch, as well as its spatial position relationship with surrounding blood vessels, muscles and other tissues.

[0118] Based on the generated three-dimensional structural model of the carotid sinus nerve, the anatomical structure perception unit can determine the preset position of the electrode implanted in the carotid sinus nerve. When determining the position, the anatomical structure characteristics of the nerve and the function requirements of the electrode are fully considered. For example, if the model shows that the nerve branches in a certain area are dense and the relationship with the surrounding tissue is complex, then when selecting the electrode implantation location, these complex areas may be avoided, and the nerves are relatively straight and relatively independent from the surrounding tissues. To ensure that the electrode can be stably implanted and effectively stimulate the carotid sinus nerve, while avoiding unnecessary damage to the surrounding tissues.

[0119] In one example, the carotid sinus nerve stimulation electrode further comprises:

[0120] An adjustable stimulation parameter unit is used to dynamically adjust the intensity, frequency, pulse width and other parameters of the nerve stimulation signal and the blocking stimulation signal according to the control instructions to achieve fine control of the carotid sinus nerve;

[0121] An electrode positioning and fixation unit, which has an adaptive positioning and fixation function, can automatically adjust the position and fixation method of the electrode according to the anatomical structure and physiological state of the carotid sinus nerve, ensuring effective contact between the electrode and the nerve and stable stimulation.

[0122] Among them, the adjustable stimulation parameter unit may include:

[0123] A parameter receiving module: used to receive a regulation instruction from the processing module, and the regulation instruction contains set values of parameters such as the intensity, frequency, and pulse width of the nerve stimulation signal and the block stimulation signal.

[0124] An intensity adjustment unit: connected to the parameter receiving module, according to the received intensity set value, changes the intensity of the stimulation signal and the block stimulation signal applied to the carotid sinus nerve by adjusting the current source or voltage source. For example, when the regulation instruction requires an increase in stimulation intensity, the intensity adjustment unit will correspondingly increase the current or voltage output to achieve a stronger stimulation or blocking effect on the nerve.

[0125] A frequency adjustment unit: also connected to the parameter receiving module, based on the received frequency set value, adjusts the frequency of the stimulation signal and the block stimulation signal by controlling the internal clock circuit or signal generator. This can precisely control the period of nerve stimulation to adapt to different physiological needs and regulation targets.

[0126] A pulse width adjustment unit: according to the pulse width set value received by the parameter receiving module, uses pulse width modulation technology to change the pulse width of the stimulation signal and the block stimulation signal. Different pulse widths can affect the response mode and degree of the nerve to the stimulation, thereby achieving more refined regulation.

[0127] The electrode positioning and fixation unit may include:

[0128] An anatomical structure perception module: This module contains a micro sensor and an image processing algorithm for obtaining the anatomical structure information of the carotid sinus nerve. The micro sensor can detect the physical properties (such as hardness, density, etc.) of the tissue around the nerve, and the image processing algorithm analyzes and processes the data obtained by the sensor to generate a three-dimensional structure model of the nerve to understand the nerve's direction, branching situation, and relationship with the surrounding tissues.

[0129] A physiological state monitoring module: works in cooperation with the anatomical structure perception module to monitor the physiological state of the carotid sinus nerve. It can detect physiological indicators such as the nerve's electrical activity, temperature, and metabolites, and judge the nerve's functional state and activity level through the analysis of these indicators, providing a basis for electrode positioning and fixation.

[0130] Position adjustment unit: Automatically adjusts the position of the electrode according to the information provided by the anatomical structure perception module and the physiological state monitoring module. The position adjustment unit includes a micro driver and a precise positioning mechanism, which can move the electrode in three-dimensional space to accurately align it with the target site of the carotid sinus nerve, such as a specific area of the sinus branch.

[0131] Fixing method selection unit: Selects the most suitable electrode fixing method based on the anatomical structure and physiological state of the nerve. If the tissue around the nerve is relatively loose, the fixing method selection unit may choose to use a biodegradable adhesive to fix the electrode; if the tissue is relatively tight, mechanical fixing methods such as micro clamps or hooks may be used to ensure the stable fixation of the electrode on the nerve and prevent displacement during use, thereby ensuring the effectiveness and stability of the stimulation.

[0132] In specific implementation, an adjustment device for the carotid sinus nerve provided by an embodiment of the present invention, as Figure 7 shown in the specific example diagram of an adjustment device for the carotid sinus nerve, further includes: a feedback adjustment module, including:

[0133] Signal receiving unit 701, configured to receive the stimulation effect information fed back by the carotid sinus nerve stimulation electrode; the stimulation effect information includes the electrophysiological response data of the nerve and the subsequent physiological change data of the blood vessels at the carotid sinus site; the subsequent physiological change data includes: blood pressure change data, blood flow velocity change data, and blood vessel wall tension change data;

[0134] Effect evaluation unit 702, connected to the signal receiving unit, configured to compare and analyze the stimulation effect information with the expected effect, and generate an evaluation result for characterizing whether the stimulation reaches the expected target and the degree of deviation;

[0135] Instruction adjustment unit 703, configured to regenerate the nerve stimulation signal and the block stimulation signal according to the evaluation result when the evaluation result shows that the stimulation effect does not reach the expectation.

[0136] For example, the feedback adjustment module specifically includes the following units:

[0137] The signal receiving unit is configured to receive the stimulation effect information fed back by the carotid sinus nerve stimulation electrode. These stimulation effect information cover multiple aspects, which are crucial for comprehensively understanding the stimulation effect of the device on the carotid sinus nerve and subsequent adjustments.

[0138] The electrophysiological response data of the nerve is an important part of the stimulation effect information. When the carotid sinus nerve is subjected to the stimulation signal and blocking stimulation signal emitted by the stimulation electrode, the nerve will produce corresponding electrophysiological responses. These responses include changes in parameters such as the frequency and amplitude of nerve impulses. The signal receiving unit can accurately receive these electrophysiological response data, providing a basis for subsequent effect evaluation.

[0139] In addition to the electrophysiological response data of the nerve, the signal receiving unit also receives the subsequent physiological change data of the blood vessels at the carotid sinus site. These data include blood pressure change data, blood flow velocity change data, and blood vessel wall tension change data. The blood pressure change data can reflect the effect of the device on blood pressure regulation. By monitoring the change in blood pressure, it can be judged whether the stimulation signal and blocking stimulation signal emitted by the stimulation electrode have the expected effect on blood pressure. The blood flow velocity change data is related to the flow state of the blood in the blood vessel. The stimulation of the carotid sinus nerve by the device may change the contraction and relaxation state of the blood vessel, thereby affecting the blood flow velocity. The blood flow velocity change data can help understand the degree and effect of this influence. The blood vessel wall tension change data is also an important physiological change index. The change in blood vessel wall tension is related to factors such as the elasticity of the blood vessel and the pressure of blood flow. By monitoring the blood vessel wall tension change data, the influence of the device on the physiological state of the blood vessel can be further understood.

[0140] The effect evaluation unit is connected to the signal receiving unit. Its main function is to compare and analyze the stimulation effect information with the expected effect, generating an evaluation result for characterizing whether the stimulation reaches the expected goal and the degree of deviation. The effect evaluation unit first obtains the stimulation effect information received by the signal receiving unit, including the electrophysiological response data of the nerve and the subsequent physiological change data of the blood vessels at the carotid sinus site.

[0141] Then, the effect evaluation unit will compare this actual stimulation effect information with the pre-set expected effect. The expected effect is set based on the regulation mechanism of the carotid sinus nerve and the design goal of the device. For example, for blood pressure regulation, if the design goal of the device is to reduce the blood pressure to a specific range within a certain time, then the expected effect is that the blood pressure reaches the target range within that time.

[0142] During the comparison process, the effect evaluation unit will compare each parameter one by one. For the electrophysiological response data of the nerve, it will compare whether parameters such as the frequency and amplitude of nerve impulses meet the expectations; for the subsequent physiological change data of the blood vessels at the carotid sinus site, it will compare whether parameters such as blood pressure, blood flow velocity, and blood vessel wall tension reach the expected goal.

[0143] Through this comparative analysis, the effect evaluation unit can generate an evaluation result. The evaluation result can characterize whether the stimulus reaches the expected goal and the degree of deviation. If the actual stimulus effect is exactly the same as the expected effect, then the evaluation result will indicate that the stimulus has reached the expected goal and the degree of deviation is zero. If there is a difference between the actual stimulus effect and the expected effect, then the evaluation result will point out the direction and magnitude of the deviation. For example, if the actual change in blood pressure does not reach the expected degree of reduction, the evaluation result will indicate that blood pressure regulation has not reached the expected goal, and the degree of deviation is the difference between the actual blood pressure and the expected blood pressure.

[0144] The instruction adjustment unit is used to regenerate the nerve stimulation signal and the block stimulation signal according to the evaluation result when the evaluation result shows that the stimulus effect does not reach the expectation. The instruction adjustment unit continuously monitors the evaluation result generated by the effect evaluation unit. When the evaluation result shows that the stimulus effect does not reach the expectation, the instruction adjustment unit will initiate the operation of regenerating the nerve stimulation signal and the block stimulation signal.

[0145] The instruction adjustment unit regenerates the nerve stimulation signal and the block stimulation signal according to the evaluation result. If the evaluation result indicates that blood pressure regulation has not reached the expected goal, for example, the blood pressure drop is insufficient, the instruction adjustment unit may increase the intensity of the block stimulation signal according to the degree of deviation, or adjust parameters such as the frequency and pulse width of the stimulation signal to improve the stimulation effect on the carotid sinus nerve, so that the blood pressure can better reach the expected goal.

[0146] For the nerve electrophysiological response data, if the evaluation result shows that the frequency or amplitude of the nerve impulse does not meet the expectation, the instruction adjustment unit may adjust the intensity or frequency of the stimulation signal to change the electrophysiological response of the nerve to make it meet the expected effect. Through this dynamic adjustment, the instruction adjustment unit can ensure that the stimulation effect of the device on the carotid sinus nerve is continuously optimized, enabling the device to better simulate the biological function of the carotid sinus where the carotid sinus nerve is located and achieve effective regulation of physiological indicators such as blood pressure.

[0147] A specific embodiment is given below to illustrate the specific application of the device of the present invention.

[0148] The carotid sinus area is a common site affected by atherosclerosis, and the carotid sinus is part of the body's important baroreflex system. By reflexively affecting the autonomic nervous system, it participates in regulating the body's blood pressure, heart rate, etc. This embodiment uses a biosignal identifier located in the carotid sinus area, which can analyze the blood flow signal of the blood vessels in the carotid sinus area, so that it can replace the damaged carotid sinus function and help the body restore the response to hemodynamic changes.

[0149] This embodiment relates to a feedback carotid sinus nerve stimulation system, including a bio-signal identifier, a processor / transducer, and a carotid sinus nerve stimulation electrode. The bio-signal identifier can be configured as a super-miniature array ultrasound, which can be attached to the outer wall of the carotid sinus blood vessel or the vascular patch of the carotid artery, and can measure the blood vessel flow velocity and pulse wave 2 in real time. The processor / transducer includes a battery and a processor, powers the system, and adjusts and controls the carotid sinus nerve stimulation electrode in real time according to the bio-signals monitored by the bio-signal identifier, and can export the stored operation data through Bluetooth, NFC, etc. The carotid sinus nerve stimulation electrode is selectively implanted into the sinus branch of the carotid sinus nerve and can stimulate / block the carotid sinus nerve. The feedback carotid sinus nerve stimulation system of the present invention is a biological substitute for the function of the carotid sinus and can replace the damaged carotid sinus to restore its functions in blood pressure and heart rate regulation.

[0150] The present invention will be further described below in conjunction with specific implementation embodiments and corresponding drawings.

[0151] Figure 2 It is a specific example diagram of a regulating device for a carotid sinus nerve in an embodiment of the present invention, which includes: a bio-signal identifier, a processor / transducer, and a carotid sinus nerve stimulation electrode, which can be used as a substitute for this special receptor of the carotid sinus. As Figure 2 shown, the feedback carotid sinus nerve stimulation system according to the embodiment of the present invention includes three parts: a bio-signal identifier, a processor / transducer, and a carotid sinus nerve stimulation electrode.

[0152] Figure 3 It is a specific example diagram of a bio-signal identifier in an embodiment of the present invention. Figure 3 In it, a is the array ultrasound patch. Figure 3 In it, b is the vascular patch. Figure 3 In it, c is the signal transmission line. Figure 3 In it, d is the carotid blood vessel. As Figure 3 shown, for the bio-signal identifier, the array ultrasound patch is fixed on the outer wall of the carotid sinus blood vessel or outside the vascular patch of the carotid artery, and can measure the blood vessel flow velocity and pulse wave in real time. The bio-signal is transmitted to the processor / transducer through the data transmission line and receives power supply.

[0153] The processor / transducer is used to power the system, adjust and control the carotid sinus nerve stimulation electrode in real time according to the bio-signals monitored by the bio-signal identifier, and can export the stored operation data through wifi, Bluetooth, NFC, etc.

[0154] Figure 4 It is a specific example diagram of a carotid sinus nerve stimulator in an embodiment of the present invention. Figure 4 In it, a is the stimulation electrode. Figure 4wherein b is the sinus branch of the carotid sinus nerve. As Figure 4 shown in the carotid sinus nerve stimulation electrode, the barb at its tip can fix it within the nerve, and it is selectively implanted into the sinus branch of the carotid sinus nerve for selectively stimulating / blocking the carotid sinus nerve.

[0155] The object of the present invention is to provide a feedback type carotid sinus nerve stimulation system, which can monitor the blood flow signal at the carotid sinus site in real time and dynamically adjust the stimulation signal of the carotid sinus nerve according to the monitoring result. Functionally, it simulates the function of the human carotid sinus, can replace the carotid sinus damaged due to atherosclerotic lesions or neck vascular surgery, and restore its blood pressure regulation function. Through the feedback type regulation system, it helps to achieve fine regulation of blood pressure in hypertensive patients.

[0156] The object of the present invention is achieved by the following technical solutions:

[0157] A feedback type carotid sinus nerve stimulation system includes a biological signal identifier, a processor / transducer, and a carotid sinus nerve stimulation electrode.

[0158] Preferably, the biological signal identifier is a super-miniature array ultrasound, which can be attached to the outer wall of the carotid sinus blood vessel or the vascular patch of the carotid artery, and can measure the blood vessel flow velocity and pulse wave in real time.

[0159] Preferably, the processor / transducer includes a battery and a processor, powers the system, and adjusts the carotid sinus nerve stimulation electrode in real time according to the biological signal monitored by the biological signal identifier.

[0160] Preferably, the processor / transducer can export the stored operation data through Bluetooth, NFC, etc.

[0161] Preferably, the carotid sinus nerve stimulation electrode is a needle electrode, which can be inserted into the carotid sinus nerve and fixed by the barb at the tip, and can move with the movement of the carotid sinus nerve.

[0162] Preferably, the carotid sinus nerve stimulation electrode is selectively implanted into the sinus branch of the carotid sinus nerve and can stimulate / block the carotid sinus nerve.

[0163] In addition, the pressure reflex receptors of the human body include not only the carotid sinus but also the aortic arch. This site can also be used as a target, but the difficulty and risk of surgery at this site are significantly higher than those at the carotid sinus site.

[0164] In the baroreflex mechanism of the human body, in addition to the carotid sinus, the aortic arch also plays an important role as a receptor. However, the difficulty and risk of surgical operations at the aortic arch site are significantly higher than those at the carotid sinus site. The aortic arch is located in a relatively deep position in the human body, with complex surrounding anatomical structures, involving many important blood vessels and nerve tissues. When performing surgical interventions, higher technical precision and more complex surgical path planning are required. At the same time, there is also a greater risk of bleeding and the possibility of damaging surrounding important organs and tissues.

[0165] In addition, the neural reflex circuits involving the chemoreceptors of the carotid body and aortic body also play a role in regulating the autonomic nervous system. Accordingly, the configuration of chemoreceptor substitution can achieve similar effects, but it is very difficult to perform real-time analysis of the chemical components in the blood.

[0166] In the present invention, the stimulator electrode is configured on the afferent nerve. The stimulator electrodes configured on the central or efferent nerves may also achieve the same effect, but the signals in the central nervous system are more complex and it is difficult to reach surgically, while the efferent nerve may be affected by the regulatory signals of other systems at the same time.

[0167] In the present invention, the stimulator electrode is configured on the afferent nerve, and this method has unique advantages. The stimulator electrodes configured on the central or efferent nerves may also achieve the same effect, but there are some limitations. For the stimulator electrode configured on the central nervous system, due to the more complex signals in the central nervous system, it is difficult to understand and regulate these signals. At the same time, it is extremely difficult to reach the central part surgically, and numerous anatomical and physiological obstacles need to be overcome, and the requirements for surgical techniques and equipment are very demanding. For the stimulator electrode configured on the efferent nerve, although it may regulate the autonomic nervous system to a certain extent, the efferent nerve may be affected by the regulatory signals of other systems at the same time, which will increase signal interference and uncertainty and affect the precise regulation effect of the stimulator electrode. In contrast, configuring the stimulator electrode on the afferent nerve in the present invention can act more directly on the carotid sinus nerve and achieve precise regulation of physiological indicators such as blood pressure.

[0168] Of course, it can be understood that there may be other variation examples for the above detailed process, and the relevant variation examples should all fall within the protection scope of the present invention.

[0169] The regulating device for the carotid sinus nerve in the embodiments of the present invention includes: a bio-signal recognition module, which is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and is used to monitor the bio-signals of the blood vessels at the carotid sinus part in real time; the bio-signals include blood vessel flow velocity and pulse wave; a processing module, which is used to process the bio-signals from the bio-signal recognition module and generate a regulation instruction according to the bio-signals; a carotid sinus nerve stimulation electrode, which is implanted in the carotid sinus nerve and is used to generate a nerve stimulation signal and a blocking stimulation signal acting on the carotid sinus nerve according to the regulation instruction issued by the processing module; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located. The embodiments of the present invention can regulate the carotid sinus nerve. By monitoring the bio-signals of the carotid sinus part in real time, the regulation of physiological indexes such as blood pressure can be realized for the treatment of related diseases. Among them, the bio-signal recognition module is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery, and can monitor the bio-signals of the blood vessels at the carotid sinus part in real time, directly obtaining the key information of the carotid sinus part, solving the problem of inaccurate monitoring of this part in the prior art; the processing module generates a regulation instruction according to the bio-signals monitored by the bio-signal recognition module, and the carotid sinus nerve stimulation electrode generates a nerve stimulation signal and a blocking stimulation signal according to the regulation instruction to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located, realizing the fine regulation of the carotid sinus nerve, overcoming the problem of non-precise regulation in the prior art, and can realize higher-resolution and more real-time blood flow parameter monitoring, thereby improving the accuracy and reliability of measurement; in addition, the carotid sinus nerve stimulation electrode can simulate the biological functions of the carotid sinus where the carotid sinus nerve is located. In this way, the regulation of the sinus branch of the carotid sinus nerve can be better realized, which helps to distinguish the carotid sinus from the carotid body.

[0170] As described above, the feedback-type carotid sinus nerve stimulation system of the present invention can monitor the blood flow signal in real time, and the pressure acting on the blood vessel wall, which is closer to the blood flow parameters sensed by the carotid sinus as a baroreceptor. The processor / transducer of the present invention adjusts and controls the carotid sinus nerve stimulation electrode in real time according to the bio-signals monitored by the bio-signal recognizer, and generates a stimulation / blocking signal through the stimulation electrode to more precisely regulate the carotid sinus nerve.

[0171] The embodiments of the present invention also provide a method for regulating the carotid sinus nerve. The method is executed by a computer device and realizes information processing according to the following steps:

[0172] Obtain the bio-signals of the blood vessels at the carotid sinus part monitored in real time; the bio-signals include blood vessel flow velocity and pulse wave; the bio-signal recognition module is attached to the outer wall of the carotid sinus blood vessel or a vascular patch of the carotid artery;

[0173] Process the biological signal and generate a regulation instruction according to the biological signal; the regulation instruction is used to generate a nerve stimulation signal and a blocking stimulation signal that act on the carotid sinus nerve; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located.

[0174] In one embodiment, processing the biological signal and generating a regulation instruction according to the biological signal includes:

[0175] Based on the biological signal transmitted by the biological signal recognition module, determine the output mode of the stimulation electrode for regulating the carotid sinus nerve in real time; generate a regulation instruction according to the output mode.

[0176] In one embodiment, processing the biological signal includes:

[0177] Compare and analyze the real-time acquired biological signal with the stored data samples to determine the current nerve regulation strategy; according to the current nerve regulation strategy, determine the output mode of the stimulation electrode for regulating the carotid sinus nerve.

[0178] In one embodiment, acquiring the biological signal of the blood vessel at the carotid sinus part under real-time monitoring includes:

[0179] Acquire the biological signal of the blood vessel at the carotid sinus part from multiple dimensions, including: acquiring the flow velocity and direction information of the blood flow in the blood vessel from an ultrasonic sensor, acquiring the pressure change information of the blood vessel wall from a pressure sensor, and acquiring the information related to the optical characteristics of the blood vessel wall from an optical sensor;

[0180] Perform adaptive filtering, amplification, and feature extraction processing on the acquired biological signal.

[0181] In one embodiment, it further includes:

[0182] Acquire the anatomical structure information of the carotid sinus nerve according to a preset micro sensor; the anatomical structure information includes the physical characteristics of the tissues around the carotid sinus nerve;

[0183] Analyze and process the anatomical structure information to generate a three-dimensional structure model of the carotid sinus nerve; the three-dimensional structure model includes the nerve's orientation, branching situation, and relationship with the surrounding tissues;

[0184] According to the three-dimensional structure model of the carotid sinus nerve, determine the preset position for implanting the electrode into the carotid sinus nerve.

[0185] In one embodiment, it further includes:

[0186] Receive the stimulation effect information fed back by the carotid sinus nerve stimulation electrode; the stimulation effect information includes the electrophysiological response data of the nerve and the subsequent physiological change data of the blood vessels at the carotid sinus site; the subsequent physiological change data includes: blood pressure change data, blood flow velocity change data, and blood vessel wall tension change data;

[0187] Compare and analyze the stimulation effect information with the expected effect to generate an evaluation result for characterizing whether the stimulation reaches the expected goal and the degree of deviation;

[0188] When the evaluation result shows that the stimulation effect does not reach the expectation, regenerate the nerve stimulation signal and the blocking stimulation signal according to the evaluation result.

[0189] Those skilled in the art should understand that the embodiments of the present invention can be provided as a method, a system, or a computer program product. Therefore, the present invention can take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware aspects. Moreover, the present invention can take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk memory, CD-ROM, optical memory, etc.) containing computer-usable program code.

[0190] The present invention is described with reference to the flowcharts and / or block diagrams of methods, apparatuses (systems), and computer program products according to the embodiments of the present invention. It should be understood that each process and / or block in the flowcharts and / or block diagrams, and the combination of processes and / or blocks in the flowcharts and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to the processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing devices to generate a machine, so that the instructions executed by the processor of the computer or other programmable data processing devices generate means for realizing the functions specified in Figure 1 one process or multiple processes and / or blocks Figure 1 one block or multiple blocks.

[0191] These computer program instructions can also be stored in a computer-readable memory that can direct a computer or other programmable data processing device to work in a specific manner, so that the instructions stored in the computer-readable memory generate a manufactured article including instruction means, and the instruction means realizes the functions specified in Figure 1 one process or multiple processes and / or blocks Figure 1 one block or multiple blocks.

[0192] These computer program instructions can also be loaded onto a computer or other programmable data processing apparatus, so that a series of operation steps are performed on the computer or other programmable apparatus to generate a computer-implemented process, thereby the instructions executed on the computer or other programmable apparatus provide steps for implementing the functions specified in one process or a plurality of processes and / or blocks Figure 1 one process or a plurality of processes and / or blocks Figure 1 steps for implementing the functions specified in one block or a plurality of blocks.

[0193] The specific embodiments described above have further elaborated on the objectives, technical solutions and beneficial effects of the present invention. It should be understood that the above are only specific embodiments of the present invention and are not intended to limit the protection scope of the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A regulating device for the carotid sinus nerve, characterized in that Comprising: A bio-signal recognition module, attached to the outer wall of the carotid sinus blood vessel or a blood vessel patch of the carotid artery, for real-time monitoring of the bio-signals of the blood vessels at the carotid sinus site; the bio-signals include blood vessel flow velocity and pulse wave; A processing module, for processing the bio-signals from the bio-signal recognition module and generating a regulation instruction according to the bio-signals; A carotid sinus nerve stimulation electrode, implanted in the carotid sinus nerve, for generating a nerve stimulation signal and a blocking stimulation signal acting on the carotid sinus nerve according to the regulation instruction issued by the processing module; the nerve stimulation signal and the blocking stimulation signal are used to simulate the biological functions of the carotid sinus where the carotid sinus nerve is located.

2. The adjusting device according to claim 1, characterized in that The bio-signal recognition module includes: a bio-signal recognizer configured as an ultra-miniature array ultrasound; the bio-signal recognition module is also implanted in the carotid sinus by a percutaneous method.

3. The adjusting device according to claim 1, characterized in that The processing module includes: A processor, for determining in real time the output mode of the stimulation electrode for regulating the carotid sinus nerve according to the bio-signals transmitted by the bio-signal recognition module; generating a regulation instruction according to the output mode; A battery unit, for supplying power to the bio-signal recognition module, the processor and the carotid sinus nerve stimulation electrode.

4. The adjusting device according to claim 3, wherein, The processor is further used for: Real-time outputting the bio-signals and the regulation instructions through a transmission method of Bluetooth and / or NFC.

5. The adjusting device according to claim 3, characterized in that, The processor stores physiological data samples of the carotid sinus blood vessels and corresponding regulation strategy data; Specifically, the processor is used for: comparing and analyzing the bio-signals obtained in real time with the stored data samples to determine the current nerve regulation strategy; determining the output mode of the stimulation electrode for regulating the carotid sinus nerve according to the current nerve regulation strategy.

6. The adjusting device according to claim 1, characterized in that, The carotid sinus nerve stimulation electrode includes a needle electrode; the barb at the tip of the needle electrode is selectively implanted and fixed on the sinus branch of the carotid sinus nerve and moves with the movement of the carotid sinus nerve.

7. The adjusting device according to claim 1, characterized in that, The bio-signals further include blood oxygen saturation and local temperature; The bio-signal recognition module further includes: A multi-modal sensor array unit, including: an ultrasonic sensor, a pressure sensor and an optical sensor; the multi-modal sensor array unit is used to obtain bio-signals of the blood vessels at the carotid sinus site from multiple dimensions, wherein the ultrasonic sensor is used to obtain the flow velocity and direction information of the blood flow in the blood vessel, the pressure sensor is used to obtain the pressure change information of the blood vessel wall, and the optical sensor is used to obtain information related to the optical characteristics of the blood vessel wall; An adaptive signal processing unit, connected to the multi-modal sensor array unit, for performing adaptive filtering, amplification and feature extraction processing on the obtained multi-modal bio-signals.

8. The adjusting device according to claim 1, characterized in that, The carotid sinus nerve stimulation electrode includes: An electrode positioning unit, for ensuring that the electrode is implanted at a preset position of the carotid sinus nerve through ultrasonic guidance or electromagnetic navigation technology; A stimulation mode selection unit, for switching between multiple preset stimulation modes according to the regulation instruction; each stimulation mode corresponds to stimulation signals with different frequencies, intensities, pulse widths and durations.

9. The adjusting device according to claim 8, characterized in that, The carotid sinus nerve stimulation electrode further includes: An anatomical structure perception unit is configured to obtain the anatomical structure information of the carotid sinus nerve according to preset micro sensors; the anatomical structure information includes the physical characteristics of the tissues surrounding the carotid sinus nerve; analyze and process the anatomical structure information to generate a three-dimensional structure model of the carotid sinus nerve; the three-dimensional structure model includes the nerve's orientation, branching situation, and relationship with the surrounding tissues; determine the preset position for implanting the electrode into the carotid sinus nerve according to the three-dimensional structure model of the carotid sinus nerve.

10. The adjusting device according to claim 1, characterized in that, It further includes a feedback regulation module, which includes: A signal receiving unit is configured to receive the stimulation effect information fed back by the carotid sinus nerve stimulation electrode; the stimulation effect information includes the electrophysiological response data of the nerve and the subsequent physiological change data of the blood vessels at the carotid sinus site; the subsequent physiological change data includes: blood pressure change data, blood flow velocity change data, and blood vessel wall tension change data; An effect evaluation unit is connected to the signal receiving unit and is configured to compare and analyze the stimulation effect information with the expected effect to generate an evaluation result for characterizing whether the stimulation reaches the expected goal and the degree of deviation; An instruction adjustment unit is configured to regenerate the nerve stimulation signal and the blocking stimulation signal according to the evaluation result when the evaluation result shows that the stimulation effect does not reach the expectation.

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