Neurostimulation system

Abstract

The embodiment of the present application relates to the technical field of medical equipment, and discloses a nerve stimulation system. The nerve stimulation system comprises a first sensing assembly arranged outside a body, a data processing assembly arranged outside the body, and a pulse stimulation assembly arranged in the body, and the data processing assembly is in communication connection with the first sensing assembly. The first sensing assembly is used for sensing a first physiological parameter of the human body and sending the first physiological parameter to the data processing assembly. The data processing assembly is used for judging whether the first physiological parameter is abnormal, and generating a first instruction sent to the pulse stimulation assembly when the first physiological parameter is abnormal. The pulse stimulation assembly is used for being in communication connection with the data processing assembly regularly to receive the first instruction, and emitting a stimulation pulse according to the first instruction. The nerve stimulation system provided by the embodiment of the present application can reduce the power consumption of a traditional nerve stimulation system, and can provide better comfort for a patient.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a nerve stimulation system. Background Technology

[0002] Obstructive sleep apnea (OSA) is a clinical syndrome characterized by nocturnal hypoxia, hypoventilation, and apnea. It mainly manifests as hypoxemia, snoring with interrupted breathing during sleep, and sleep disturbances, causing daytime sleepiness, limb weakness, and cognitive impairment. OSA patients also have a higher risk of heart attack or stroke, and are more prone to hypertension and diabetes, which seriously affects their physical health and quality of life.

[0003] There are various traditional treatment options for OSA, including drug therapy such as ephedrine, nasal drops, protriptyline, acetazolamide, and zonisamide; and surgical options such as nasal surgery, palatopharyngeal surgery, glossopharyngeal surgery, jaw advancement surgery, tracheotomy, and weight loss surgery. Among these, uvulopalatopharyngoplasty is a relatively mature procedure.

[0004] With the development of electronic technology, upper airway stimulation therapy has emerged. The principle of upper airway stimulation therapy is to rhythmically stimulate the hypoglossal nerve through an implanted hypoglossal nerve stimulation device, causing contraction of the genioglossus muscle to widen the upper airway. Literature reports that, with patients having the same apnea-hypopnea index, age, and body mass index, patients receiving hypoglossal nerve stimulation implants have significantly better outcomes than those undergoing uvulopalatopharyngoplasty. Therefore, hypoglossal nerve stimulation implants play an important role in the clinical application of surgical treatment for obstructive sleep apnea (OSA).

[0005] However, existing hypoglossal nerve stimulation systems place both the sensor and the pulse stimulation component inside the human body. The pulse stimulation component needs to be turned on frequently to receive and process the human body data sent by the sensor, resulting in high power consumption. Furthermore, the implanted devices are large in size and have poor comfort for the human body. Summary of the Invention

[0006] The purpose of this application is to provide a neurostimulation system that can solve the problem of high power consumption in neurostimulation systems and provide better comfort for patients.

[0007] To address one or more of the aforementioned technical problems, embodiments of this application provide a neural stimulation system, including a first sensing component disposed externally, a data processing component disposed externally, and a pulse stimulation component disposed internally. The data processing component is communicatively connected to the first sensing component. The first sensing component is used to sense a first physiological parameter of the human body and send the first physiological parameter to the data processing component. The data processing component is used to determine whether the first physiological parameter is abnormal and, when the first physiological parameter is abnormal, generate a first instruction to be sent to the pulse stimulation component. The pulse stimulation component is used to periodically communicate with the data processing component to receive the first instruction and to deliver stimulation pulses according to the first instruction.

[0008] In the neurostimulation system of this application embodiment, after the first sensing component senses a first physiological parameter of the human body, it can send the first physiological parameter to a data processing component that is communicatively connected to it. The data processing component is used to determine whether the first physiological parameter is abnormal, and when the first physiological parameter is abnormal, it generates a first instruction to be sent to the pulse stimulation component. The pulse stimulation component can periodically communicate with the data processing component to periodically receive the first instruction, and after receiving the first instruction, it issues stimulation pulses according to the first instruction. For example, in the scenario of hypoglossal nerve stimulation to treat obstructive sleep apnea syndrome, the pulse stimulation component in the neurostimulation system issues stimulation pulses to the hypoglossal nerve of the OSA patient according to the first instruction, so as to expand the patient's airway and improve the airflow into and out of the airway, thereby preventing the OSA patient from experiencing apnea during sleep at night. Furthermore, since the first sensing component and the data processing component are both located outside the body, and only the pulse stimulation component is implanted inside the body, the large size of the implanted device is avoided, which would affect the patient's comfort. In addition, since the first sensing component and the data processing component are outside the body, the power consumption issue does not need to be considered, and the pulse stimulation component is configured to periodically receive the first pulse instruction, which can further reduce power consumption, thereby solving the problem of high power consumption of the neurostimulation system.

[0009] In addition, the pulse stimulation component includes a first control module, a first communication module, and a pulse stimulation module; the data processing component includes a second communication module that is always on; the first control module is used to periodically control the first communication module to turn on, receive the first instruction after the first communication module and the second communication module establish a wireless connection, and issue a pulse delivery instruction to the pulse stimulation module according to the first instruction; the pulse stimulation module is used to deliver stimulation pulses according to the pulse delivery instruction. In this embodiment, the second communication module located outside the body can always be on, so that the first communication module can connect when needed; while the first control module periodically controls the first communication module to turn on so that the pulse stimulation component periodically receives the first instruction, realizing the relevant functions while reducing power consumption.

[0010] In addition, both the first and second communication modules are Bluetooth Low Energy modules or radio frequency modules; wherein, the first communication module is configured to be in broadcast mode after being turned on; and the second communication module is configured to be in scanning mode to further reduce the power consumption of the pulse stimulation component.

[0011] In addition, the pulse stimulation component further includes a second sensing component for sensing a second physiological parameter of the human body; the first control module is also used to control the second sensing component to activate when the first communication module fails to establish a wireless connection with the second communication module within a preset time period, so as to obtain the second physiological parameter of the human body; the first control module is also used to determine whether the second physiological parameter is abnormal, and when the second physiological parameter is abnormal, generate the pulse delivery command, instructing the pulse stimulation module to deliver a stimulation pulse; wherein, the preset time period is longer than the interval for the first communication module to activate. In this embodiment, the pulse stimulation module obtains the physiological parameter of the human body through its own sensing component, so that it can still deliver stimulation pulses when the pulse stimulation component cannot establish a connection with the data processing component, thereby increasing the reliability of the system.

[0012] In addition, the first control module is also used to receive the first instruction sent by the data processing component when it detects that the first communication module and the second communication module have established a wireless connection, and control the second sensing component to turn off, so as to reduce the additional power consumption generated by the second sensing component being turned on for a long time.

[0013] In addition, the pulse stimulation component further includes a second sensing component for sensing a second physiological parameter of the human body. The first control module is also configured to, upon receiving a first instruction from the data processing component, activate the second sensing component to obtain the second physiological parameter of the human body, and if the data processing component determines that the second physiological parameter is also abnormal when it sends the first instruction again, send the pulse delivery instruction to the pulse stimulation module. In this embodiment, after receiving the first instruction, the pulse stimulation component will verify whether an abnormality has occurred in the human body, thereby reducing the possibility that the external first sensing component may malfunction due to itself or the environment, and further increasing the reliability of the nerve stimulation system.

[0014] In addition, the pulse stimulation component further includes a second sensing component for sensing a second physiological parameter of the human body; the first control module is also used to determine whether the second physiological parameter is abnormal, and when the second physiological parameter is abnormal, generate the pulse delivery command, instructing the pulse stimulation module to deliver a stimulation pulse, and notify the data processing component; the data processing component is used to use the value of the first physiological parameter when the second physiological parameter is abnormal as a new threshold to determine whether the first physiological parameter is abnormal. In this embodiment, the threshold of the first physiological parameter is adjusted according to the patient's physiological, psychological, and surrounding environmental factors to improve the treatment effect.

[0015] In addition, the pulse stimulation component also includes a second sensing component in an active state for sensing a second physiological parameter of the human body; the first control module is further configured to acquire the second physiological parameter of the human body, and acquire the first physiological parameter simultaneously with the first instruction, and determine whether to send a pulse delivery instruction to the pulse stimulation module according to the first instruction based on the first physiological parameter and the second physiological parameter. In this embodiment, the stimulation pulse delivered in combination with the first and second physiological parameters has a better and more reliable nerve stimulation effect on the human body.

[0016] In addition, when the second sensing component is in the active state, the first control module acquires the second physiological parameter through the second sensing component, and acquires the abnormal first physiological parameter simultaneously with the first instruction sent by the data processing component. Based on the abnormal first physiological parameter and the second physiological parameter at the time of the abnormal first physiological parameter, the first control module determines whether to send the pulse delivery instruction to the pulse stimulation module according to the first instruction. Alternatively, when the second sensing component is in the inactive state, the first control module activates the second sensing component upon receiving the first instruction and the abnormal first physiological parameter. Upon receiving the first instruction and the abnormal first physiological parameter again, the first control module acquires the second physiological parameter at the time of the abnormal first physiological parameter, and then determines whether to send the pulse delivery instruction to the pulse stimulation module according to the first instruction based on the abnormal first physiological parameter and the second physiological parameter at the time of the abnormal first physiological parameter. This embodiment allows for the determination of the specific method of stimulation pulse delivery based on the configuration of the second sensing component, resulting in greater applicability.

[0017] In addition, the first sensing component and the second sensing component each include one of the following or any combination thereof: blood oxygen saturation sensor, electromyography sensor, pressure sensor, sound acquisition device, electrocardiogram signal sensor, respiratory signal sensing device, and three-dimensional accelerometer, so as to accurately determine the parameters of the emitted stimulation pulse based on the current physiological parameters of the human body.

[0018] In addition, the pulse stimulation component also includes a sensing electrode wire and a stimulation electrode wire. The proximal end of the sensing electrode wire is electrically connected to the first control module, and the distal end is electrically connected to the second sensing component. The proximal end of the stimulation electrode wire is electrically connected to the pulse stimulation module, and the distal end is set at the target position of the human body to be suitable for various sensing components, thereby sensing various physiological parameters.

[0019] In addition, the second sensing component is a blood oxygen saturation sensor, which is disposed on the housing of the pulse stimulation component to reduce the risk of human infection and improve the sensing accuracy of blood oxygen saturation. Attached Figure Description

[0020] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0021] Figure 1 This is a schematic diagram of the structure of a nerve stimulation system according to an embodiment of this application. Figure 1 ;

[0022] Figure 2 This is a schematic diagram of the structure of a nerve stimulation system according to an embodiment of this application. Figure 2 ;

[0023] Figure 3 This is a schematic diagram of a pulse stimulation component provided according to an embodiment of this application. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the various embodiments of this application will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details are presented in the various embodiments of this application to facilitate a better understanding of the application. However, the technical solutions claimed in this application can be implemented even without these technical details and various variations and modifications based on the following embodiments. The division of the various embodiments below is for ease of description and should not constitute any limitation on the specific implementation of this application. The various embodiments can be combined with and referenced by each other without contradiction.

[0025] One embodiment of this application relates to a neurostimulation system, including a first sensing component disposed externally, a data processing component disposed externally, and a pulse stimulation component disposed internally. The data processing component is communicatively connected to the first sensing component. The first sensing component senses a first physiological parameter of the human body and sends the first physiological parameter to the data processing component. The data processing component determines whether the first physiological parameter is abnormal and generates a first instruction to be sent to the pulse stimulation component when the first physiological parameter is abnormal. The pulse stimulation component periodically communicates with the data processing component to receive the first instruction and delivers stimulation pulses according to the first instruction. For example, in a scenario where hypoglossal nerve stimulation is used to treat obstructive sleep apnea syndrome (OSA), the pulse stimulation component in the neurostimulation system delivers stimulation pulses to the hypoglossal nerve of an OSA patient according to the first instruction, thereby expanding the patient's airway, improving airflow in and out of the airway, and thus preventing OSA patients from experiencing sleep apnea at night.

[0026] The following description, using the scenario of treating obstructive sleep apnea syndrome, details the implementation of the neurostimulation system in this embodiment. The following content is provided for ease of understanding and is not essential for implementing this solution.

[0027] The structure of the nerve stimulation system in this embodiment can be as follows: Figure 1 As shown, it includes: a first sensing component 1, a data processing component 2, and a pulse stimulation component 3, wherein the data processing component 2 can be communicatively connected to the first sensing component 1 and the pulse stimulation component 3, respectively.

[0028] In a specific implementation, the first sensing component 1 can be placed outside the patient's body, such as at the head of the patient's bed or on the body surface. The first sensing component 1 senses a first physiological parameter of the human body and sends the sensed first physiological parameter to a data processing component 2 connected to it. The data processing component 2 is also placed outside the patient's body, but its location is more flexible, as long as it can communicate with the first sensing component 1. The data processing component 2 determines whether the first physiological parameter is abnormal and generates a first instruction to be sent to the pulse stimulation component 3 when the first physiological parameter is abnormal. The pulse stimulation component 3 is placed inside the patient's body and periodically communicates with the data processing component 2 to receive the first instruction and deliver stimulation pulses to the body according to the first instruction. The specific location of the pulse stimulation component 3 is determined based on the patient's condition. In this embodiment, the pulse stimulation component 3 is placed below the patient's clavicle.

[0029] In this embodiment, since both the first sensing component and the data processing component are located outside the body, and only the pulse stimulation component is implanted inside the body, the large size of the implanted device is avoided from affecting human comfort. Furthermore, since the first sensing component and the data processing component are located outside the body, the sensing of the first physiological parameter and the judgment of whether it is abnormal are completed by the external first sensing component and the data processing component, respectively, so there is no need to consider the power consumption issue. Moreover, the pulse stimulation component periodically communicates with the data processing component to receive the first pulse command, which can further reduce power consumption, thereby solving the problem of high power consumption of the nerve stimulation system.

[0030] Exemplarily, the working principle of the neurostimulation system in this embodiment is as follows: The first sensing component 1 is a blood oxygen saturation sensor, and the first physiological parameter is the patient's blood oxygen saturation. If the data processing component 2 detects that the patient's blood oxygen saturation has decreased by 2-3% compared to the baseline, it determines that the patient's first physiological parameter is abnormal. At this time, the data processing component 2 will issue a first instruction to the pulse stimulation component 3, so that the pulse stimulation component 3 will deliver stimulation pulses to the patient's hypoglossal nerve to treat obstructive sleep apnea syndrome (OSA). It is understood that the baseline of blood oxygen saturation mentioned at this time is the baseline of the patient's blood oxygen saturation, and the baseline of blood oxygen saturation may be different for different patients.

[0031] In this embodiment, the first sensing component 1, the data processing component 2, and the pulse stimulation component 3 are all connected via wireless communication. This embodiment does not have any particular limitation on the wireless communication method; the communication method can be Bluetooth, infrared, RF, Wi-Fi, cellular, or ZigBee communication, etc. Since the first sensing component 1 and the data processing component 2 are located externally, power consumption is not a concern, and therefore they can remain connected and communicate continuously, meaning the data processing component 2 can acquire the first physiological parameter in real time. The pulse stimulation component 3 periodically communicates with the data processing component 2 to receive the first instructions from the data processing component 2, reducing the power consumption of the pulse stimulation component 3. Preferably, the periodic communication period between the pulse stimulation component 3 and the data processing component 2 can be 1-2 seconds. In other embodiments, the data processing component 2 can communicate with the first sensing component 1 via a wired connection, for example, based on USB, RS-232 serial port, TCP / IP, Thunderbolt, or IEEE 1394 protocols. In some other embodiments, the data processing component 2 may also be installed in the same device as the first sensing component 1 and connected via a bus.

[0032] This embodiment does not impose any particular limitation on the type of the first sensing component 1. For example, the first sensing component 1 may include one or any combination of the following: a blood oxygen saturation sensor, an electromyography sensor, a pressure sensor, a sound acquisition device, an electrocardiogram signal sensor, a respiratory signal sensing device, or a three-dimensional accelerometer. Therefore, the first sensing component 1 may be of one type or may be a collection of multiple types of sensors mentioned above. Correspondingly, the first physiological parameter may be one physiological parameter or a combination of multiple physiological parameters. Furthermore, the specific form of the first sensing component may be a wearable device, such as a watch, bracelet, armband, or ankle bracelet, which is easy to carry and does not cause the patient to experience a foreign body sensation.

[0033] like Figure 2 As shown, in this embodiment, the pulse stimulation component 3 includes: a first control module 31, a first communication module 32, and a pulse stimulation module 33; the data processing component 2 includes a second control module 21, a second communication module 22, and a fourth communication module 23; and the first sensing component 1 includes a sensor module 11 and a third communication module 12.

[0034] Specifically, the sensor module 11 of the first sensing component 1 is used to acquire the first physiological parameter. Since the third communication module 12 of the first sensing component 1 and the fourth communication module 23 of the data processing component 2 are always connected, a communication connection is established between the first sensing component 1 and the data processing component 2, enabling the data processing component 2 to acquire the first physiological parameter sensed by the first sensing component in real time. The second control module 21 of the data processing component 2 determines whether the first physiological parameter is abnormal based on a first threshold and the acquired first physiological parameter. If abnormal, it sends a first instruction to the pulse stimulation component 3. In one example, the first instruction issued by the data processing component 2 to the pulse stimulation component 3 includes abnormal human information to trigger the pulse stimulation component 3 to deliver a pulse to the human body. The first control module 31 sends a pulse delivery instruction with pulse stimulation parameters, such as pulse duration, pulse frequency, and pulse amplitude, to the pulse stimulation module 33. The pulse stimulation module 33 delivers a suitable stimulation pulse to the human body according to this pulse delivery instruction. In this embodiment, the externally located second communication module 22 can always be in an on state, allowing the first communication module 32 to connect whenever needed. In this embodiment, the second communication module 22 and the fourth communication module 23 are two independently configured communication modules to accommodate the point-to-point communication requirements of some communication modules; while in other embodiments, the communication modules can be one-to-many, in which case the fourth communication module 23 can be omitted. In this embodiment, the first threshold can be the factory initial value, or it can be set during doctor follow-up, or it can be an adaptive value of the data processing component 2 within a given range.

[0035] The first control module 31 of the pulse stimulation component 3 is used to periodically control the first communication module 32 to turn on. After the first communication module 32 of the pulse stimulation component 3 establishes a wireless communication connection with the second communication module 22 of the data processing component 2, the first control module 31 receives a first instruction sent by the data processing component 2 and issues a pulse delivery instruction to the pulse stimulation module 33 according to the first instruction. The pulse stimulation module 33 then delivers stimulation pulses according to the pulse delivery instruction. It can be understood that after the communication between the first communication module 32 and the second communication module 22 is completed, that is, after the data processing component 2 sends the first instruction to the pulse stimulation component 3, the first control module 31 controls the first communication module 32 to disconnect from the second communication module 22 and turn it off to reduce the power consumption of the pulse stimulation component 3.

[0036] Preferably, the first communication module 32 is configured to be in a broadcast state after being turned on, so that the first communication module 32 is in a connectable state; the second communication module 22 is configured to be in a scanning state, thereby realizing a low-power periodic connection between the pulse stimulation component 3 and the data processing component 2.

[0037] Preferably, both the first communication module 32 and the second communication module 22 are Bluetooth Low Energy modules or radio frequency modules, in order to further reduce the power consumption of the system.

[0038] In this embodiment, the first physiological parameter is acquired in real time through a long-term connection between the third communication module of the first sensing component and the fourth communication module of the data processing component, and the first instruction is received periodically through a periodic connection between the second communication module of the data processing component and the first communication module of the pulse stimulation component. The different connection strategies ensure the high reliability of the system while also having low power consumption.

[0039] like Figure 3 As shown, in this embodiment, the pulse stimulation component 3 may further include a second sensing component 34, which is used to acquire a second physiological parameter of the human body. Similar to the first sensing component 3, the second sensing component 34 includes one or any combination of the following: a blood oxygen saturation sensor, an electromyography sensor, a pressure sensor, a sound acquisition device, an electrocardiogram signal sensor, a respiratory signal sensing device, and a three-dimensional accelerometer. Therefore, the second sensing component 34 and the first sensing component 3 may be of the same or different types, and correspondingly, the second physiological parameter may be the same as or different from the first physiological parameter. Furthermore, there may be multiple second sensing components 34, and correspondingly, the second physiological parameter may be a combination of various physiological parameters.

[0040] Furthermore, to conserve power, the second sensing component 34 is configured to be in a turned-off state. After the first control module 31 controls the first communication module 32 to turn on and puts the first communication module 32 into a broadcast state, under normal circumstances, the first communication module 32 will establish a wireless communication connection with the second communication module 22, which is always in a scanning state. However, if the first communication module 32 fails to establish a wireless communication connection with the second communication module 22 within a preset time, that is, the second communication module 22 may have lost contact, for example, the data processing component 2 is far from the human body, or the data processing component 2 is damaged or powered off, the first control module 31 cannot receive the first instruction sent by the data processing component 2. At this time, the first control module 31 will control the second sensing component 34 to turn on to obtain the second physiological parameter of the human body. The first control module 31 further compares the obtained second physiological parameter with the second threshold to determine whether the second physiological parameter is abnormal, and if the second physiological parameter is abnormal, generates a pulse emission instruction, instructing the pulse stimulation module 33 to emit a stimulation pulse. If the first control module 31 detects that the first communication module 32 can establish a wireless communication connection with the second communication module 22 again, it will re-receive the first instruction sent by the data processing component 2 and control the second sensing component 34 to turn off to reduce power consumption. In this embodiment, the second threshold can be the factory initial value, the value set by the surgeon when the pulse stimulation component 3 is implanted, the value set by the doctor during follow-up, or the adaptive value of the pulse stimulation component 3 within a given range.

[0041] As can be seen, the pulse stimulation component in this embodiment may also include a sensing component to sense the second physiological parameter, so that when the pulse stimulation component cannot establish a connection with the data processing component, the pulse stimulation module can still deliver stimulation pulses when the body is abnormal, thus ensuring the reliability of the nerve stimulation system.

[0042] In other embodiments, the second sensing component 34 is normally closed. The first control module 31 controls the second sensing component 34 to turn on to acquire the second physiological parameter of the human body. When the first control module 31 receives the first instruction sent by the data processing component, it does not immediately send the pulse delivery instruction to the pulse stimulation module 33, but instead re-verifies whether a pulse needs to be delivered. Specifically, when the first control module 31 receives the first instruction sent by the data processing component 2, it turns on the second sensing component 34 and acquires the second physiological parameter of the human body. When the first control module 31 receives the first instruction sent by the data processing component 2 again, it checks whether the second physiological parameter is also judged to be abnormal. If so, it considers that the human body has an abnormality and needs to send the pulse delivery instruction to the pulse stimulation module 33. Obviously, there can be a reasonable time interval between receiving the first instruction sent by the data processing component 2 again and judging the abnormal second physiological parameter. If the types of the first and second physiological parameters are the same, the interval may be shorter; if the types of the first and second physiological parameters are different, the interval may be longer. For example, the first physiological parameter is lung sounds, and the second physiological parameter is blood oxygen saturation. The acquisition of blood oxygen saturation lags behind the acquisition of lung sounds by 2-3 seconds. After determining that an abnormality has occurred in the human body, the first control module 31 can control the second sensing component 34 to turn off. That is, when the first control module 31 receives the first instruction sent by the data processing component 2 again, it will no longer verify it in order to reduce power consumption.

[0043] As can be seen, after receiving the first instruction, the pulse stimulation component in this embodiment will check whether the human body has any abnormalities, so as to reduce the possibility that the first sensing component outside the body may be abnormal due to itself or the environment, and further increase the reliability of the nerve stimulation system.

[0044] In other embodiments, the second sensing component 34 is normally closed. The first control module 31 controls the second sensing component 34 to turn on to acquire a second physiological parameter of the human body. The first control module 31 further compares the acquired second physiological parameter with a second threshold to determine whether the second physiological parameter is abnormal, and generates a pulse delivery command when the second physiological parameter is abnormal, instructing the pulse stimulation module 33 to deliver a stimulation pulse. At the same time, the first control module 31 notifies the data processing component 2 of the information that the second physiological parameter is abnormal. The data processing component 2 uses the value of the first physiological parameter when the second physiological parameter is abnormal as a new threshold, as a new basis for determining whether the first physiological parameter is abnormal. Here, the second sensing component 34 can be turned on periodically by the first control module 31, or it can be implemented by the doctor sending a command to the first control module 31 to turn on the second sensing component 34 through the data processing component 2 during implantation or follow-up. In this embodiment, after the second sensing component 34 is turned on, the first command received by the first control module 31 to indicate that the first physiological parameter is abnormal can be suspended.

[0045] It can be seen that the threshold of the first physiological parameter can change due to factors such as the patient's physiology, psychology and surrounding environment. Therefore, in order to improve the treatment effect, it is necessary to adjust the threshold of the first physiological parameter regularly or irregularly.

[0046] In other embodiments, after receiving the first instruction from the data processing component 2, the first control module 31 does not immediately send a pulse delivery instruction to the pulse stimulation module 33. Instead, it acquires an abnormal first physiological parameter while receiving the first instruction from the data processing component 2, and combines this with a second physiological parameter to confirm whether an abnormality has occurred in the body and whether to send a pulse delivery instruction to the pulse stimulation module 33 according to the first instruction. Specifically, the second sensing component 34 is always in the on state. The first control module 31 can acquire the second physiological parameter of the human body through the second sensing component 34, and acquire an abnormal first physiological parameter while receiving the first instruction from the data processing component 2. Based on the abnormal first physiological parameter and the second physiological parameter when the first physiological parameter is abnormal, it determines whether to send a pulse delivery instruction to the pulse stimulation module 33 according to the first instruction. Alternatively, the second sensing component 34 may be in the off state. When the first control module 31 receives the first instruction and the abnormal first physiological parameter, it activates the second sensing component 34. Upon receiving the first instruction again and the abnormal first physiological parameter, the first control module 31 acquires the second physiological parameter when the first physiological parameter is abnormal, and determines whether to send a pulse delivery instruction to the pulse stimulation module 33 according to the first instruction based on the abnormal first physiological parameter and the second physiological parameter when the first physiological parameter is abnormal.

[0047] This embodiment does not impose any particular limitations on the specific method for determining whether to follow the first instruction based on the abnormal first physiological parameter and the second physiological parameter when the first physiological parameter is abnormal. As mentioned above, the types of the first and second physiological parameters can be the same or different. When the types of the first and second physiological parameters are the same, a weighted average method can be used to obtain the evaluation value, where the weights can be determined based on the factors affecting the first and second physiological parameters. For example, the second physiological parameter obtained in vivo has a higher weight, while the first physiological parameter obtained in vitro has a lower weight. Then, the evaluation value is compared with a third threshold to determine whether the human body is abnormal. In addition to the weighted average method, other methods can also be used, such as the simple average method, geometric mean, and root mean square mean. When the types of the first and second physiological parameters are different, the first and second physiological parameters can be normalized or otherwise dimensionless to obtain the evaluation value. Then, the evaluation value is compared with a fourth threshold to determine whether the human body is abnormal. In this embodiment, the third and fourth thresholds can be factory initial values, values ​​set by doctors during follow-up, or adaptive values ​​of the first control module 31 within a given range.

[0048] In this embodiment, the pulse stimulation component 3 further includes sensing electrode wires and stimulation electrode wires ( Figure 3 (Not shown in the diagram). The proximal end of the sensing electrode wire is electrically connected to the first control module 31, and the distal end is electrically connected to the second sensing component 34. The proximal end of the stimulation electrode wire is electrically connected to the pulse stimulation module 33, and the distal end is positioned at a target location on the human body to accommodate various types of sensing components, thereby sensing the second physiological parameter. For example, the second sensing component 34 is a pressure sensor used to measure the pressure in the extrapleural space (i.e., the second physiological parameter). If the pressure in the extrapleural space is less than a preset threshold, the second physiological parameter is determined to be abnormal. In this case, a stimulation pulse is sent to the hypoglossal nerve during exhalation. Other sensing components are similar and will not be described further here.

[0049] In other embodiments, the pulse stimulation component 3 further includes stimulation electrode leads, and the second sensing component 34 is a blood oxygen saturation sensor for acquiring the blood oxygen saturation in blood vessels near the pulse stimulation component 3. The blood oxygen saturation sensor can be disposed on the housing of the pulse stimulation component 3, omitting the sensing electrode leads. This reduces the risk of infection to the human body, and the blood oxygen saturation detection is less susceptible to interference from the stimulation pulse, thus improving the sensing accuracy of blood oxygen saturation.

[0050] It should be noted that the examples described above in this embodiment are merely illustrative for ease of understanding and do not constitute a limitation on the technical solution of the present invention.

[0051] Those skilled in the art will understand that the above embodiments are specific examples of implementing this application, and in practical applications, various changes in form and detail may be made without departing from the spirit and scope of the above embodiments. Any person skilled in the art can make their own modifications and alterations without departing from the spirit and scope of the embodiments of this application; therefore, the scope of protection of the embodiments of this application should be determined by the scope defined in the claims.

Claims

1. A neural stimulation system, characterized by, The method comprises the following steps: a first sensing component arranged outside the body, a data processing component arranged outside the body, and a pulse stimulation component arranged inside the body, the data processing component being in communication connection with the first sensing component; the first sensing component is used for sensing a first physiological parameter of the human body and sending the first physiological parameter to the data processing component; the data processing component is used for judging whether the first physiological parameter is abnormal, and generating a first instruction sent to the pulse stimulation component when the first physiological parameter is abnormal; the pulse stimulation component is used for periodically communicating with the data processing component to receive the first instruction, and delivering a stimulation pulse according to the first instruction; wherein the pulse stimulation component comprises a first control module, a first communication module and a pulse stimulation module; the data processing component comprises a second communication module which is always in an open state; the pulse stimulation component further comprises a second sensing component for sensing a second physiological parameter of the human body; the first control module is used for controlling the second sensing component to be turned on to obtain the second physiological parameter of the human body when the first communication module fails to establish a wireless connection with the second communication module within a preset time length; the first control module is used for periodically controlling the first communication module to be turned on, receiving the first instruction after the first communication module establishes a wireless connection with the second communication module, and issuing a pulse delivery instruction to the pulse stimulation module according to the first instruction; the pulse stimulation module is used for delivering a stimulation pulse according to the pulse delivery instruction; the first control module is used for judging whether the second physiological parameter is abnormal, and generating the pulse delivery instruction to instruct the pulse stimulation module to deliver a stimulation pulse when the second physiological parameter is abnormal; wherein the preset time length is greater than an interval time length during which the first communication module is turned on.

2. The neural stimulation system of claim 1, wherein, The first communication module and the second communication module are both low-power Bluetooth modules or radio frequency modules; wherein the first communication module is configured to be in a broadcast state after being turned on; and the second communication module is configured to be in a scanning state.

3. The neural stimulation system of claim 1, wherein, The first control module is further used for receiving the first instruction sent by the data processing component when it is detected that the first communication module establishes a wireless connection with the second communication module, and controlling the second sensing component to be turned off.

4. The neural stimulation system of any one of claims 1 to 3, wherein, The first sensing component and the second sensing component respectively comprise one or any combination of the following: an oxygen saturation sensor, an electromyography sensor, a pressure sensor, a sound acquisition device, an electrocardiogram signal sensor, a respiration signal sensing device, and a three-dimensional accelerometer.

5. The neural stimulation system of any one of claims 1 to 3, wherein, The pulse stimulation component further comprises a sensing electrode lead and a stimulating electrode lead, a proximal end of the sensing electrode lead being electrically connected with the first control module, and a distal end thereof being electrically connected with the second sensing component; a proximal end of the stimulating electrode lead being electrically connected with the pulse stimulation module, and a distal end thereof being arranged at a target position of the human body.

6. The neural stimulation system of any one of claims 1 to 3, wherein, The second sensing component is an oxygen saturation sensor, and the oxygen saturation sensor is arranged on a shell of the pulse stimulation component.

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