Implanted passive closed-loop nerve stimulation system

Abstract

The embodiment of the invention provides an implanted passive closed-loop nerve stimulation system, and relates to the field of medical instruments. The implanted passive closed-loop nerve stimulation system comprises an implantation device used for being implanted into the body of a target object; the energy supply device is used for being attached to the surface of the target object, is in wireless communication connection with the implantation device and is configured to supply power to the implantation device and send stimulation configuration information to the implantation device, so that the implantation device generates a stimulation signal according to the stimulation configuration information and receives a bio-electricity signal sent by the implantation device; and the program control device is used for being in communication connection with the energy providing device and is configured to adjust the stimulation configuration information according to the bio-electricity signal sent by the energy providing device and send the adjusted stimulation configuration information to the energy providing device. According to the passive closed-loop nerve stimulation system provided by the embodiment of the invention, the size of an implanted part is reduced, the operation process is simplified, and the injury to a patient is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular, to an implantable passive closed-loop neural stimulation system. Background Art

[0002] A traditional neurostimulation device includes a control device (e.g., including a pulse generator and a battery, etc.) and an electrode lead implanted in the patient's body. During operation, multiple electrode contacts of the electrode lead deliver the stimulation signal generated by the control device to the patient's body to relieve the patient's pain.

[0003] For example: Dorsal column stimulation, also known as spinal cord stimulation (SCS), is one of the most established forms of neuromodulation for the treatment of neuropathic pain. Neuropathic pain refers to pain that is generated by nerve tissue and is a maladaptive response to nerve damage in the peripheral or central nervous system. Neuropathic pain can exist independently of any form of tissue damage outside of the central nervous system. Examples of conditions that can cause neuropathic pain include disease (e.g., HIV, herpes, diabetes, cancer, autoimmune disorders), acute trauma (surgery, injury, electric shock), and chronic trauma (repetitive motion disorders, chemical toxicity such as alcohol, chemotherapy, or heavy metals).

[0004] However, since the neurostimulation device has a large size, the use of a traditional neurostimulation device may cause greater trauma to the patient. Summary of the invention

[0005] The present application proposes an implantable passive closed-loop neural stimulation system to solve the technical problems of existing neural stimulation devices in the prior art, such as large surgical trauma or complicated surgical procedures.

[0006] In a first aspect, an embodiment of the present application provides an implantable passive closed-loop neural stimulation system, comprising: An implant device, for implantation in a target subject, configured to generate a stimulation signal and transmit it to a target nerve of the target subject, and collect bioelectric signals related to the target nerve, wherein the implant device is implanted at a depth of not less than 2 cm and not more than 4 cm; An energy supply device, which is attached to the surface of the target object and is wirelessly connected to the implant device, and is configured to supply power to the implant device and send stimulation configuration information to the implant device, so that the implant device generates a stimulation signal according to the stimulation configuration information and receives a bioelectric signal sent by the implant device; The program-controlled device is used for communicating with the energy providing device, and is configured to adjust the stimulation configuration information according to the bioelectric signal sent by the energy providing device, and send the adjusted stimulation configuration information to the energy providing device.

[0007] In one possible implementation, the implant device includes at least one stimulation electrode and an electrode control unit; At least one stimulation electrode is arranged at a predetermined position of the target object, each stimulation electrode comprises at least one contact, and each contact is used to output a stimulation signal and / or collect a bioelectric signal; The electrode control unit is configured to control at least one stimulation electrode to output a stimulation signal, acquire a bioelectric signal and send it to the energy providing device.

[0008] In one possible implementation, the energy providing device includes a power supply unit configured to supply power to the implant device.

[0009] In one possible implementation, the implant device includes a first wireless communication unit and a first power receiving unit; The energy providing device includes a second wireless communication unit; The second wireless communication unit is used for wireless communication connection with the first wireless communication unit; The power supply unit includes a transmitting coil, and the first power receiving unit includes a receiving coil. The transmitting coil is used to transmit power to the receiving coil to power the implant device.

[0010] In one possible implementation, the implant device includes a first wireless communication unit, and the energy supply device includes a second wireless communication unit; The first wireless communication unit is configured to wirelessly connect with the second wireless communication unit and receive power delivered from the power supply unit through the second wireless communication unit.

[0011] In a possible implementation, the energy providing device includes: The first processing unit is connected to the electrode control unit for communication, and is configured to send at least one preset stimulation configuration information as stimulation configuration information to the electrode control unit in sequence when it is detected that the program-controlled device is not connected to the energy providing device for communication.

[0012] In a possible implementation, the energy providing device further includes: The signal processing module is communicatively connected to the electrode control unit, and is configured to receive the bioelectric signal output by the electrode control unit, and perform signal preprocessing on the bioelectric signal to obtain a processed bioelectric signal, and send the processed bioelectric signal to the first processing unit so that the first processing unit uses the processed bioelectric signal as a new bioelectric signal; the signal preprocessing includes at least one of the following: filtering, noise reduction, and amplification.

[0013] In one possible implementation, the first processing unit is configured to determine the adjusted stimulation configuration information based on the bioelectric signal when it detects that the programmable device is not in communication connection with the energy providing device, and send the adjusted stimulation configuration information as new stimulation configuration information to the electrode control unit.

[0014] In a possible implementation, the program-controlled device includes a second processing unit and a third communication unit; The program-controlled device is connected to the energy supply device through the third communication unit; The second processing unit is configured to receive the bioelectric signal sent by the first processing unit, determine the adjusted stimulation configuration information based on the bioelectric signal, and send the adjusted stimulation configuration information to the first processing unit, so that the first processing unit sends the adjusted stimulation configuration information as new stimulation configuration information to the electrode control unit.

[0015] In a possible implementation, each contact is connected to a corresponding signal node; Each signal node is configured to send detection information corresponding to the contact point to the electrode control unit when detecting that the corresponding contact point outputs a stimulation signal; The electrode control unit is also configured to determine whether the contact corresponding to each detection information belongs to the target contact. If it is determined that at least one contact corresponding to the detection information does not belong to the target contact, the stimulation signal is re-output through the target contact; the target contact is the contact set to output the stimulation signal.

[0016] In one possible implementation, the implanted passive closed-loop neural stimulation system further includes: a connection piece; Both sides of the connecting piece are provided with adhesive layers; or, one side of the connecting piece is provided with an adhesive layer, the other side is provided with a first magnetic element, and the side of the energy providing device for contacting with the surface of the target object is provided with a second magnetic element.

[0017] In one possible implementation, the implantable passive closed-loop neural stimulation system further includes: a connection belt; The connecting belt is fixedly connected to the energy supply device, and is used for detachably connecting to the target object.

[0018] In a possible implementation, the connecting piece further includes a flexible antenna; the energy supply device is communicatively connected to the implant device via the flexible antenna; The shape of the flexible antenna includes at least one of the following: spiral, ring, and plane; and / or the flexible antenna is made of at least one of the following materials: conductive polymer, metal film, and conductive fabric.

[0019] In one possible implementation, the flexible antenna includes a plurality of flexible coils; The flexible coil includes at least one of the following: The radius of curvature of the flexible coil due to thermal deformation is not less than 5 mm and not more than 20 mm; The difference in the radius of curvature between adjacent flexible coils is no more than 5 mm; The quality factor of the flexible coil is not less than 65 and not more than 70; the quality factor is used to indicate the ratio of energy storage capacity to energy loss.

[0020] In a second aspect, an embodiment of the present application provides an implantable passive closed-loop neural stimulation system, comprising: An implant device, for implantation into a target subject, configured to generate a stimulation signal and transmit the stimulation signal to a target nerve of the target subject, wherein the implantation depth of the implant device is not less than 2 cm and not more than 4 cm; An energy supply device, which is attached to the surface of the target object and is wirelessly connected to the implant device, and is configured to supply power to the implant device and send stimulation configuration information to the implant device, so that the implant device generates a stimulation signal according to the stimulation configuration information; A detection device, arranged on a target object, configured to obtain physiological state information of the target object; the physiological state information is used to represent the activity state and / or posture change of the target object; The program-controlled device is used for communicating with the detection device and the energy supply device, and is configured to adjust the stimulation configuration information according to the physiological state information sent by the detection device, and send the adjusted stimulation configuration information to the energy supply device.

[0021] In a possible implementation, the detection device includes at least one of the following: an accelerometer, configured to determine first physiological state information based on an activity state and / or a posture change of the target object; a gyroscope, configured to determine second physiological state information based on an activity state and / or a posture change of the target object; A pressure sensor, configured to determine third physiological state information based on pressure distribution of the target object under different activity states; a heart rate sensor, configured to determine fourth physiological state information based on changes in the heart rate of the target object; an electromyography sensor for determining fifth physiological state information based on changes in muscle activity of the target subject; The physiological state information includes at least one of the following: first physiological state information, second physiological state information, third physiological state information, fourth physiological state information, and fifth physiological state information.

[0022] In one possible implementation, the programmable control device is also configured to use a data fusion algorithm and / or a machine learning model to perform data fusion processing on the physiological state information, identify the activity state and / or posture changes of the target object, and determine the stimulation configuration information based on the activity state and / or posture changes of the target object.

[0023] In a possible implementation, the program-controlled device further includes a display screen, which is used to display relevant information of the target object and / or display a parameter setting interface; the relevant information includes at least one of the following: physiological state information, stimulation configuration information, and historical record information, and the parameter setting interface is used to set the stimulation configuration information; and / or, The program-controlled device also includes a voice control module, which is used to respond to the voice command of the target object and execute an operation corresponding to the voice command.

[0024] The beneficial technical effects brought about by the technical solution provided by the embodiment of the present application include: The neurostimulation system of the embodiment of the present application includes an implant device and an energy supply device. The implant device is implanted into the body of the target object, and the energy supply device is attached to the surface of the target object, thereby reducing the volume of the implant part, simplifying the surgical procedure, and reducing patient damage.

[0025] At the same time, the neural stimulation system of the embodiment of the present application is a passive closed-loop neural stimulation system, and the energy supply device can supply power to the implant device and send stimulation configuration information to the implant device, so that the implant device generates a stimulation signal according to the stimulation configuration information. Moreover, the implant device of the embodiment of the present application can collect bioelectric signals related to the target nerve, so that the program-controlled device can adjust the stimulation configuration information according to the bioelectric signals sent by the energy supply device; or, the detection device of the embodiment of the present application can obtain the physiological state information of the target object, so that the program-controlled device can adjust the stimulation configuration information according to the physiological state information sent by the detection device, and send the adjusted stimulation configuration information to the energy supply device. Then, the energy supply device sends the adjusted stimulation configuration information as new stimulation configuration information to the implant device, thereby forming a passive closed-loop neural stimulation system, and delivering the generated stimulation signal to the patient's body to relieve the patient's pain.

[0026] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the following description of the embodiments in conjunction with the accompanying drawings, in which: Figure 1A schematic diagram of the structure of a first implantable passive closed-loop neural stimulation system provided in an embodiment of the present application; Figure 2 A schematic diagram of the structure of an implant device provided in an embodiment of the present application; Figure 3 A schematic diagram of the structure of an energy supply device provided in an embodiment of the present application; Figure 4 A schematic diagram of the structure of a program-controlled device provided in an embodiment of the present application; Figure 5 A schematic diagram of the structure of a second implantable passive closed-loop neural stimulation system provided in an embodiment of the present application; Figure 6 A structural schematic diagram of a third implantable passive closed-loop neural stimulation system is provided for an embodiment of the present application. Reference numerals: 10 - implant device, 110 - stimulation electrode, 120 - electrode control unit, 130 - first wireless communication unit, 140 - first power receiving unit; 20-energy providing device, 210-first processing unit, 220-power supply unit, 230-second wireless communication unit, 240-signal processing module, 250-storage unit; 30-program control device, 310-second processing unit, 320-third communication unit; 40-connecting piece; 50-Detection device. DETAILED DESCRIPTION

[0028] The present application is described in detail below, and examples of embodiments of the present application are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar components or components with the same or similar functions. In addition, if the detailed description of the known technology is unnecessary for the features of the present application shown, it will be omitted. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application, and cannot be interpreted as limiting the present application.

[0029] It will be understood by those skilled in the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as generally understood by those skilled in the art to which this application belongs. It should also be understood that terms such as those defined in common dictionaries should be understood to have meanings consistent with the meanings in the context of the prior art, and will not be interpreted with idealized or overly formal meanings unless specifically defined as here.

[0030] It will be understood by those skilled in the art that, unless expressly stated, the singular forms "one", "said", and "the" used herein may also include plural forms. It should be further understood that the term "comprising" used in the specification of the present application refers to the presence of the features, integers, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. It should be understood that when we refer to an element as being "connected" or "coupled" to another element, it may be directly connected or coupled to the other element, or there may be an intermediate element. In addition, the "connection" or "coupling" used herein may include wireless connection or wireless coupling. The term "and / or" used herein includes all or any unit and all combinations of one or more associated listed items.

[0031] The technical solution of the present application and how the technical solution of the present application solves the above-mentioned technical problems are described in detail below with specific embodiments.

[0032] See also Figure 1 As shown, the present application embodiment provides a schematic diagram of the structure of a first implantable passive closed-loop neural stimulation system. Figure 1 As shown, an embodiment of the present application provides an implantable passive closed-loop neural stimulation system, including: an implant device 10, an energy providing device 20 and a program control device 30.

[0033] The implant device 10 is used to be implanted in the body of a target object. The implant device 10 is configured to generate a stimulation signal and transmit it to the target nerve of the target object, collect bioelectric signals related to the target nerve, and the implantation depth of the implant device is not less than 2 cm and not more than 4 cm.

[0034] The energy supply device 20 is used to be attached to the surface of the target object and is wirelessly connected to the implant device 10. The energy supply device 20 is configured to supply power to the implant device 10 and send stimulation configuration information to the implant device 10, so that the implant device 10 generates a stimulation signal according to the stimulation configuration information and receives the bioelectric signal sent by the implant device 10.

[0035] The programmable control device 30 is used to communicate with the energy providing device 20 . The programmable control device 30 is configured to adjust the stimulation configuration information according to the bioelectric signal sent by the energy providing device 20 , and send the adjusted stimulation configuration information to the energy providing device 20 .

[0036] Optionally, the stimulation configuration information includes pulse parameter information, and the pulse parameter information is used to represent information for generating a stimulation signal, and may include information such as pulse width, frequency, and amplitude of the stimulation signal.

[0037] Optionally, the implant device 10 can be implanted in the spinal cord of the target object to transmit the stimulation signal to the target nerve in the spinal cord. The present application embodiment mainly takes the implant device 10 implanted in the spinal cord as an example for explanation. In practical applications, the present application embodiment can be applied to the implant device 10 heart or abdominal organs, etc.

[0038] The neurostimulation system of the embodiment of the present application includes an implant device 10 and an energy supply device 20. The implant device 10 is implanted into the body of the target object, and the energy supply device 20 is attached to the surface of the target object, thereby reducing the volume of the implant part, simplifying the surgical procedure, and reducing patient damage.

[0039] At the same time, the neural stimulation system of the embodiment of the present application is a passive closed-loop neural stimulation system, and the energy supply device 20 can supply power to the implant device 10 and send stimulation configuration information to the implant device 10, so that the implant device 10 generates a stimulation signal according to the stimulation configuration information. Moreover, the implant device 10 can collect bioelectric signals related to the target nerve, so that the program control device 30 can adjust the stimulation configuration information according to the bioelectric signals sent by the energy supply device 20, and send the adjusted stimulation configuration information to the energy supply device 20, and the energy supply device 20 sends the adjusted stimulation configuration information as new stimulation configuration information to the implant device 10, thereby forming a passive closed-loop neural stimulation system, and delivering the generated stimulation signal to the patient's body to relieve the patient's pain.

[0040] The energy supply device 20 is attached to (positioned on) the patient's surface to transmit the therapeutic energy signal to the implant device 10 and receive the ECAP signal of the patient's target nerve. The implant device 10, the energy supply device 20 and the program control device 30 form a closed-loop treatment.

[0041] The embodiments of the present application use SCS (Spinal Cord Stimulation), which works mainly by enhancing the release of inhibitory neurotransmitters. For example, SCS can widely inhibit the overexcitation of wide-power range neurons in the dorsal horn of the spinal cord, and facilitate the release of inhibitory neurotransmitters such as GABA. In addition, SCS may also reduce pain by activating voltage-gated sodium channels and triggering the release of endogenous neurotransmitters. These mechanisms indicate that SCS has an inhibitory effect, that is, it reduces the transmission of pain signals by regulating neurotransmitters. Compared with PNS (peripheral nerve stimulation), SCS involves more neurotransmitter regulation inside the spinal cord, and the implantation depth of the SCS implant device 10 is deeper than that of PNS.

[0042] Optionally, the bioelectric signal may be an ECAP (Evoked Compound Action Potential) signal. ECAP signals refer to compound action potentials in the brain or nerve tissue induced by external electrical stimulation. When an electrical stimulus is given to the nerve tissue, the nerve fibers will generate action potentials, which are superimposed to form a compound action potential (CAP), namely the ECAP signal. In the field of medical devices and neural stimulation, ECAP signals generally refer to neural response signals induced by electrical stimulation. These signals are used to evaluate neural function, monitor electrode position, and adjust electrical stimulation parameters to optimize the therapeutic effect.

[0043] See also Figure 1 As shown, the implanted passive closed-loop neural stimulation system also includes: a connecting piece 40.

[0044] Both sides of the connecting piece 40 are provided with an adhesive layer; or, one side of the connecting piece 40 is provided with an adhesive layer, the other side is provided with a first magnetic element, and the side of the energy providing device 20 for bonding with the surface of the target object is provided with a second magnetic element.

[0045] In some embodiments, the implantable passive closed-loop neurostimulation system further includes: a connecting belt.

[0046] The connection belt is fixedly connected to the energy supply device 20 , and the connection belt is used for detachably connecting to the target object.

[0047] In practical applications, the energy supply device 20 is attached to the patient's skin surface. The energy supply device 20 controlled in vitro can be attached to the skin surface through a skin patch. Both sides are adhesive layers. When in use, the peeling paper is removed, one side is attached to the skin surface, and the other side is attached to the energy supply device 20. It can also be an adhesive layer on one side and a first magnetic element is set on the other side. The energy supply device 20 is also provided with a corresponding second magnetic element, and the two are magnetically connected. It can also be worn on the patient in the form of a strap. The wearing position is determined according to the implantation position of the implant device 10. In principle, the closer the distance to the implant device 10, the better.

[0048] In the related art, the antenna is usually arranged on the energy providing device 20, but this arrangement has certain limitations. The transmission angle between the antenna and the tissue is often limited, which may affect the transmission efficiency and quality of the signal. In order to solve this problem, the flexible antenna proposed in the embodiment of the present application adopts a special geometric shape and material to optimize the interaction between the antenna and the human tissue.

[0049] In some embodiments, the connecting piece 40 further includes a flexible antenna; the energy providing device 20 is communicatively connected to the implant device 10 via the flexible antenna; The shape of the flexible antenna includes at least one of the following: spiral, ring, and plane; and / or the flexible antenna is made of at least one of the following materials: conductive polymer, metal film, and conductive fabric.

[0050] In the embodiments of the present application, the flexible antenna can adopt a variety of different shapes, such as spiral, ring or plane, to adapt to different application scenarios and user needs. The material of the antenna can be a conductive polymer, a metal film or a conductive fabric, etc., which have good flexibility and biocompatibility.

[0051] Through the above design, the flexible antenna of the embodiment of the present application can form a good coupling with the human body surface, effectively improving the efficiency and accuracy of wireless energy transmission. This not only provides a more reliable energy supply solution for wearable devices, but also provides new possibilities for the development of wireless medical monitoring and treatment equipment.

[0052] The embodiment of the present application adopts an in vitro connecting piece 40 for positioning the energy providing device 20, and the connecting piece 40 is designed with a flexible antenna. The design of the flexible antenna enables it to fit closely to the surface of the human body, so as to transmit and transmit signals more effectively, which not only improves the efficiency of signal transmission, but also enhances the stability and accuracy of the signal.

[0053] In some embodiments, the flexible antenna includes a plurality of flexible coils. The flexible coils include at least one of the following: a curvature radius of the flexible coil bent due to thermal deformation is not less than 5 mm and not more than 20 mm, a difference in curvature radius between adjacent flexible coils is not more than 5 mm, and a quality factor of the flexible coil is not less than 65 and not more than 70. The quality factor is used to indicate the ratio of energy storage capacity to energy loss.

[0054] The special design of the flexible antenna in the embodiment of the present application ensures effective transmission inside and outside the body, and can remove the energy part implanted in the body in the prior art, thereby reducing the volume of the implanted part and making the implantation operation simpler and more convenient. Based on the technology in the embodiment of the present application, the trauma caused by the operation to the patient can be greatly reduced, the complexity of the operation can be reduced, and even the operation completed in the operating room can be turned into an outpatient operation.

[0055] Optionally, the flexible antenna is an external loop antenna, which may include multiple flexible coils, each of which may be made of different materials. Since a certain amount of heat is generated during the transmission and reception of power and data signals, the flexible coils may be deformed by the heat. Each flexible coil may have different thermal deformations, and the deformations of the multiple flexible coils may increase as the distance from the center of the flexible coil increases, so that the bending of the multiple flexible coils due to thermal deformation may occur in the same direction. The deformation of the flexible coil in the outermost circle may be the largest, and the deformation of the flexible coil in the innermost circle may be the smallest.

[0056] Q value (Quality Factor) refers to the quality factor, which is an important parameter to measure the loss of a system (such as an inductor). In electricity, the Q value represents the ratio of the energy stored by a system near the resonant frequency to the energy dissipated per cycle. Simply put, the higher the Q value, the less loss the system has when storing and transmitting energy, and the higher the efficiency.

[0057] For flexible coils, the Q value directly affects their performance in applications such as wireless energy transmission and inductive detection. Specifically, a flexible coil with a high Q value means that it loses less energy when transmitting energy or signals, thereby improving transmission efficiency and stability. In practical applications, a high Q value helps to: (1) improve transmission efficiency: reduce energy loss during transmission; (2) enhance anti-interference ability: in high-frequency applications, a high Q value can help the coil better resist the influence of external noise; (3) improve the signal-to-noise ratio: in applications such as inductive detection, a high Q value helps to improve the quality of the detection signal.

[0058] When the implantation site of the implant device 10 corresponding to the flexible coil is deeper, it means that the flexible coil needs to work in a more complex in vivo environment, and its performance parameters will face new challenges. Therefore, the embodiment of the present application continuously tests the curvature radius of the flexible coil, the difference in curvature radius between adjacent flexible coils, the Q value, the transmission efficiency, and the electromagnetic compatibility (EMC) to obtain the range of the key technical parameters of the flexible coil.

[0059] Because the radius of curvature of deep tissue is usually larger, and it may be necessary to span more tissue layers to ensure that the coil can adapt to position changes at different depths. When the implant site is deeper, a larger range of curvature radii may need to be considered. Compared to PNS, the radius of curvature of the embodiment of the present application extends to 5 mm to 20 mm.

[0060] Since deep implantation may involve more complex curvature changes, the difference in curvature radius between adjacent flexible coils needs to be more strictly controlled to ensure performance stability. Compared with PNS, the difference in curvature radius between adjacent flexible coils in the embodiment of the present application is reduced to no more than 5 mm.

[0061] Because the signal needs to pass through more tissue, deeper implants may result in higher losses, which affects the Q value. In the straight state, the Q value may need to be higher to compensate for the additional losses caused by the deep implant. For example, the target Q value is increased from 60 to 70; in the case of maximum bending, the Q value is increased from 55 to 65.

[0062] Moreover, deep implants may require higher transmission power to overcome tissue absorption losses, thereby affecting transmission efficiency. In order to maintain the same transmission efficiency, the embodiments of the present application may need to increase the transmission power or optimize the antenna design to ensure transmission efficiency. For example, the transmission efficiency is increased from the original 80% to 85%. Deep implants may require higher electromagnetic compatibility to reduce the impact on surrounding tissues and other implanted devices. The embodiments of the present application ensure compatibility with other medical devices through more stringent electromagnetic compatibility test standards.

[0063] As a first example, an embodiment of the present application is a flexible coil for deep implantation (such as the heart or abdominal organs or spinal cord), and it is necessary to ensure its transmission performance at different depths and curvature radii.

[0064] 1. Design goals Curvature radius range: 5 mm to 20 mm.

[0065] Difference in curvature radius between adjacent flexible coils: no more than 5 mm.

[0066] Target Q value: In the straight state, the Q value is 70; in the maximum bending state, the Q value is not less than 65.

[0067] Transmission efficiency: Under maximum bending conditions, the transmission efficiency is not less than 85%.

[0068] 2. Implementation steps (1) Sample manufacturing: A group of flexible coil samples are manufactured. Each sample is designed with different curvature radii at different positions of the coil, but the difference in curvature radii between adjacent flexible coils is controlled within 5 mm.

[0069] (2) Test Q value and transmission efficiency: Use a vector network analyzer (VNA) or other appropriate measuring instruments to measure the Q value of the coil under different curvature radii and test the transmission efficiency.

[0070] (3) Data analysis: Compare the changes in Q value under different curvature radii and analyze its stability; at the same time, evaluate the changes in transmission efficiency.

[0071] Table 1. Experimental results of the first example

[0072] Referring to the experimental results of the first example in Table 1, it can be seen that within the curvature radius range provided in the embodiment of the present application, the variation range of the Q value is still small, basically maintained between 68 and 70, and the transmission efficiency is also above 85%, which meets the design goal.

[0073] Therefore, the embodiment of the present application can ensure that the flexible coil can maintain good transmission performance when deeply implanted by adjusting the design parameters of the flexible coil. This not only helps to improve the performance of the coil in a complex in vivo environment, but also ensures its stability and reliability under different curvature radii.

[0074] At the same time, when the flexible coil is applied to the implantation depth of the implant device 10 of the embodiment of the present application for deep implantation, the difference in curvature radius between adjacent flexible coils needs to be more strictly controlled to ensure the stable performance of the flexible coil in a complex environment. The main reasons for controlling the difference in curvature radius between adjacent flexible coils are: reducing local deformation: deep implantation sites may involve more tissue layers and more complex curvature changes. In order to ensure that the coil can still maintain good performance under these conditions, it is necessary to reduce the impact of local deformation; improve mechanical stability: stricter control of curvature radius difference can reduce the local stress concentration of the coil when it is bent, thereby improving its mechanical stability and extending its service life; optimize electrical performance: smaller curvature radius difference can reduce changes in inductance and Q value, ensuring that the electrical performance of the coil is more stable under different curvature states.

[0075] As a second example, an embodiment of the present application is a flexible coil for deep implantation (such as the heart or abdominal organs), and it is necessary to ensure its transmission performance at different depths and curvature radii.

[0076] 1. Design goals Curvature radius range: 5 mm to 20 mm.

[0077] Difference in curvature radius between adjacent flexible coils: no more than 5 mm.

[0078] Target Q value: In the straight state, the Q value is 70; in the maximum bending state, the Q value is not less than 65.

[0079] Transmission efficiency: Under maximum bending conditions, the transmission efficiency is not less than 85%.

[0080] 2. Implementation steps (1) Sample manufacturing: A group of flexible coil samples are manufactured. Each sample is designed with different curvature radii at different positions of the coil, but the difference in curvature radii between adjacent flexible coils is controlled within 5 mm.

[0081] (2) Test Q value and transmission efficiency: Use a vector network analyzer (VNA) or other appropriate measuring instruments to measure the Q value of the coil under different curvature radii and test the transmission efficiency.

[0082] (3) Data analysis: Compare the changes in Q value under different curvature radii and analyze its stability; at the same time, evaluate the changes in transmission efficiency.

[0083] 3. Experimental results The embodiment of the present application provides two coil samples, one is according to the original design (the difference in curvature radius does not exceed 8 mm), and the other is according to the new design (the difference in curvature radius does not exceed 5 mm).

[0084] Table 2. Experimental data

[0085] From the experimental data in Table 2, it can be seen that: samples A, B, C, D (curvature radius difference ≤ 8 mm): the Q value fluctuates between 62 and 65, and the transmission efficiency is between 79 and 82; samples E, F, G, H (curvature radius difference ≤ 5 mm): the Q value fluctuates between 68 and 70, and the transmission efficiency is between 85 and 87.

[0086] By reducing the difference in curvature radius between adjacent flexible coils to no more than 5 mm, the performance stability of the flexible coil under deep implantation conditions can be significantly improved. Specifically, the Q value is higher: the Q value is increased from 62 to 65 to 68 to 70, indicating that the electrical performance is more stable; the transmission efficiency is better: the transmission efficiency is increased from 79 to 82 to 85 to 87, indicating that the signal transmission is more efficient.

[0087] The design of the flexible coil in the embodiment of the present application not only helps to improve the performance of the flexible coil when deeply implanted, but also ensures its stability and reliability under different curvature states. Through this design, it can better adapt to the complex in vivo environment and improve the reliability and efficiency of the overall system.

[0088] See also Figure 2 As shown, the present application embodiment provides a schematic diagram of the structure of an implant device. Figure 2 As shown, the implant device 10 includes at least one stimulation electrode 110 and an electrode control unit 120 .

[0089] At least one stimulation electrode 110 is arranged at a predetermined position of the target object. Each stimulation electrode 110 includes at least one contact point, and each contact point is used to output a stimulation signal and / or collect a bioelectric signal.

[0090] The electrode control unit 120 is configured to control at least one stimulation electrode 110 to output a stimulation signal, acquire a bioelectric signal, and send the bioelectric signal to the energy providing device 20 .

[0091] Optionally, each stimulation electrode 110 includes at least one contact, and the stimulation configuration information also includes electrode information, which is used to represent relevant information of the stimulation electrode that outputs the stimulation signal, and the relevant information may be information of the target contact of each stimulation electrode. Therefore, the stimulation configuration information is used for the implant device 10 to generate the corresponding stimulation signal and output the target contact.

[0092] Optionally, at least one stimulation electrode 110 is arranged at a predetermined position at the spinal cord of the target subject.

[0093] See also Figure 3 As shown, the present application embodiment provides a schematic diagram of the structure of an energy supply device. Figure 3 As shown, the energy providing device 20 includes a power supply unit 220 , which is configured to supply power to the implant device 10 .

[0094] See also Figure 2 As shown, the implant device 10 includes a first wireless communication unit 130 and a first power receiving unit 140. Figure 3 As shown, the energy providing device 20 includes a second wireless communication unit 230 .

[0095] The second wireless communication unit 230 is used for wireless communication connection with the first wireless communication unit 130; the power supply unit 220 includes a transmitting coil, and the first power receiving unit 140 includes a receiving coil, and the transmitting coil is used to transmit power to the receiving coil to power the implant device 10.

[0096] Optionally, the implant device 10 is powered by the energy supply device 20 to work. The energy supply device 20 also includes an oscillator, a power amplifier, a first data modulation circuit, and a detection circuit. During operation, the carrier signal generated by the oscillator is amplified by the power amplifier and then transmitted through the transmitting coil in the power supply unit 220 to provide energy for the implant device 10.

[0097] In some embodiments, the implant device 10 includes a first wireless communication unit 130 , and the energy providing device 20 includes a second wireless communication unit 230 .

[0098] The first wireless communication unit 130 is configured to wirelessly connect with the second wireless communication unit 230 and receive power transmitted from the power supply unit 220 through the second wireless communication unit 230 .

[0099] Optionally, the first wireless communication unit 130 and the first power receiving unit 140 may be the same unit, for example, using NFC technology, and may share an antenna for communication and charging.

[0100] See also Figure 3 As shown, the energy providing device 20 includes: a first processing unit 210 .

[0101] The first processing unit 210 is communicatively connected to the electrode control unit 120. The first processing unit 210 is configured to send at least one preset stimulation configuration information as stimulation configuration information to the electrode control unit 120 in sequence when detecting that the program control device 30 is not communicatively connected to the energy providing device 20.

[0102] In the embodiment of the present application, when the energy supply device 20 is not connected to the programming device 30, the first processing unit 210 of the energy supply device 20 is provided with fixed preset stimulation configuration information, and the implant device 10 is controlled to stimulate with the preset stimulation configuration information of a certain frequency.

[0103] The at least one preset stimulation configuration information may be a fixed stimulation configuration information, or may be a plurality of preset stimulation configuration information arranged in sequence, which are continuously cycled in sequence as stimulation configuration information.

[0104] See also Figure 3 As shown, the energy providing device 20 further includes: a signal processing module 240 .

[0105] The signal processing module 240 is communicatively connected to the electrode control unit 120. The signal processing module 240 is configured to receive the bioelectric signal output by the electrode control unit 120, and perform signal preprocessing on the bioelectric signal to obtain a processed bioelectric signal, and send the processed bioelectric signal to the first processing unit 210 so that the first processing unit 210 uses the processed bioelectric signal as a new bioelectric signal; the signal preprocessing includes at least one of the following: filtering, noise reduction, and amplification.

[0106] The signal processing module 240 is used to collect the bioelectric signal output by at least one stimulation electrode 110 .

[0107] The signal processing module 240 includes at least a front-end block, which is configured to amplify the potential difference of its input signal (V1a, V2a) and filter the stimulation artifact by cutting off the frequency above a predetermined frequency band. The front-end block is also configured with a multi-stage fully differential switched capacitor circuit for discrete-time signal processing. The multi-stage fully differential switched capacitor circuit of the front-end block is capable of performing amplification and filtering operations, and includes a pre-filter stage and a suppression filter stage, wherein the suppression filter stage is located downstream of the pre-filter stage. Each of the pre-filter stage and the suppression filter stage includes a fully differential switched capacitor circuit, and is configured for discrete-time signal processing.

[0108] Optionally, the signal processing module 240 further includes at least one of the following functional modules: a first functional module, a second functional module and a third functional module.

[0109] The first functional module is configured to receive an input synchronization signal from the stimulation electrode 110 during the target pulse signal generated by the stimulation electrode 110, thereby disconnecting or grounding the input of the front-end block. The first functional module is connected upstream of the front-end block.

[0110] The second functional module is configured to remove high frequency components in a signal generated by operation of the first functional module.

[0111] The third functional module is configured to provide high pass filtering to mitigate the offset potential at the at least one stimulation electrode 110 .

[0112] Through the above-mentioned architecture, the embodiments of the present application achieve the accuracy of signal transmission between internal and external devices in wireless situations.

[0113] For example, in actual application scenarios, the precise amplification and filtering of the input signal by the front-end block can effectively remove interference noise, effectively ensuring the accuracy and reliability of the collected bioelectric signals. The coordinated operation of various functional modules, such as the corresponding processing of the first functional module during the stimulation pulse, the effective elimination of high-frequency signals by the second functional module, and the mitigation of the offset potential by the third functional module, further enhance the performance and stability of the entire system, thereby ensuring the accuracy of wireless signal transmission and providing a more effective information transmission channel and means for the wireless treatment of chronic pain.

[0114] In some embodiments, when the first processing unit 210 detects that the programming device 30 is not in communication connection with the energy providing device 20, it is configured to determine the adjusted stimulation configuration information based on the bioelectric signal and send the adjusted stimulation configuration information as new stimulation configuration information to the electrode control unit 120.

[0115] The embodiment of the present application can realize that the energy supply device 20 sends the received bioelectric signal to the programmable device 30. If it is detected that the energy supply device 20 is disconnected from the programmable device 30, the data is automatically saved in the storage unit 250 and sent again when the connection is made.

[0116] The energy supply device 20 of the embodiment of the present application can perform closed-loop algorithm operations on the received bioelectric signals of the patient, timely adjust the stimulation program group plan, and control the stimulation configuration information of the implant device 10 in real time.

[0117] At least one stimulation electrode 110 of the embodiment of the present application can have a collection function, collect bioelectric signals at the same time, and send them to the energy providing device 20. The energy providing device 20 can perform closed-loop algorithm operations based on the bioelectric signals collected by at least one stimulation electrode 110, adjust the stimulation program group plan in time, and make the treatment more accurate by real-time control of the stimulation configuration information of the implant device 10.

[0118] See also Figure 3 As shown, the energy providing device 20 further includes a storage unit 250. The energy providing device 20 can automatically save pre-stored data or acquired data into the storage unit 250.

[0119] See also Figure 4 As shown, the present application embodiment provides a schematic diagram of the structure of a program-controlled device. Figure 4 As shown, the program control device 30 includes a second processing unit 310 and a third communication unit 320 .

[0120] The program control device 30 is connected to the energy providing device 20 through the third communication unit 320. The second processing unit 310 is configured to receive the bioelectric signal sent by the first processing unit 210, determine the adjusted stimulation configuration information according to the bioelectric signal, and send the adjusted stimulation configuration information to the first processing unit 210, so that the first processing unit 210 sends the adjusted stimulation configuration information as new stimulation configuration information to the electrode control unit 120.

[0121] Optionally, in the embodiment of the present application, when the energy supply device 20 is connected to the programming device 30, the second processing unit 310 of the programming device 30 may perform a closed-loop algorithm operation on the received bioelectric signal, timely adjust the stimulation program group plan, and provide stimulation configuration information for real-time control of the implant device 10 through the energy supply device 20.

[0122] Optionally, the program control device 30 can be divided into a doctor side and a patient side. The program control device 30 on the patient side can be a watch, a controller, a mobile phone, etc. without limitation, and the program control device 30 on the doctor side can be a doctor PC side.

[0123] The program control device 30 is connected to the energy supply device 20 in a wired communication manner.

[0124] In some embodiments, each contact is connected to a corresponding signal node.

[0125] Each signal node is configured to send detection information corresponding to the contact point to the electrode control unit 120 when detecting that the corresponding contact point outputs a stimulation signal; The electrode control unit 120 is also configured to determine whether the contact corresponding to each detection information belongs to the target contact. If it is determined that at least one contact corresponding to the detection information does not belong to the target contact, the stimulation signal is re-output through the target contact; the target contact is the contact set to output the stimulation signal.

[0126] Optionally, the detection information is used to indicate that the contact outputs a target pulse signal, and the detection information may include a contact identifier. Each contact has a corresponding contact identifier, and by matching the contact identifier of the detection information with the contact identifier of the target contact, it can be determined whether the contact corresponding to each detection information belongs to the target contact.

[0127] When the signal node detects an error in the signal transmission path, the implant device 10 will automatically trigger a correction mechanism to redirect the signal to the target contact.

[0128] In an actual treatment scenario, when the energy providing device 20 issues a specific stimulation instruction, intending to act on a specific contact of the in-vivo implanted stimulation electrode 110, but due to various factors, the signal transmission deviates from expectations and is erroneously transmitted to other non-target contacts, the signal node connected to the contact will immediately perform detection and judgment, so that the implant device 10 can keenly identify such transmission errors and quickly activate the error correction mechanism to redirect the erroneously transmitted signal to the originally set target contact, thereby ensuring the accuracy and effectiveness of the stimulation.

[0129] The implanted passive closed-loop neural stimulation system of the embodiment of the present application can ensure accurate signal transmission, reduce poor treatment effects or side effects caused by signal transmission errors, and improve the safety and effectiveness of treatment.

[0130] See also Figure 5 As shown, the present application embodiment provides a schematic diagram of the structure of a second implanted passive closed-loop neural stimulation system. Figure 5 As shown, the implant device 10 includes a stimulation electrode 110, an electrode control unit 120, a first wireless communication unit 130 and a first power receiving unit 140. The energy supply device 20 includes a first processing unit 210, a power supply unit 220, a second wireless communication unit 230, a signal processing module 240 and a storage unit 250. The program control device 30 includes a second processing unit 310 and a third communication unit 320.

[0131] Optionally, at least one of the electrode control unit 120, the first processing unit 210, and the second processing unit 310 can be a CPU (Central Processing Unit), a general processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array) or other programmable logic devices, transistor logic devices, hardware components or any combination thereof. It can implement or execute various exemplary logic blocks, modules and circuits described in conjunction with the disclosure of this application. The processor 2001 can also be a combination that implements a computing function, such as a combination of one or more microprocessors, a combination of a DSP and a microprocessor, etc.

[0132] The storage unit 250 may be a ROM (Read-Only Memory) or other types of static storage devices that can store static information and instructions, a RAM (random access memory) or other types of dynamic storage devices that can store information and instructions, or an EEPROM (Electrically Erasable Programmable Read Only Memory), a CD-ROM (Compact Disc Read-Only Memory) or other optical disk storage, optical disk storage (including compressed optical disk, laser disk, optical disk, digital versatile disk, Blu-ray disk, etc.), a magnetic disk storage medium or other magnetic storage device, or any other medium that can be used to carry or store the desired program code in the form of instructions or data structures and can be accessed by a computer, but is not limited thereto.

[0133] Optionally, the program control device 30 and / or the energy supply device 20 may further include an input unit. The input unit may be used to receive input digital, character, image and / or sound information, or generate key signal input related to user settings and function control. The input unit may include, but is not limited to, one or more of a touch screen, a physical keyboard, a function key (such as a switch key, etc.), a trackball, a mouse, a joystick, a camera, a microphone, etc.

[0134] Optionally, at least one of the program-controlled device 30 and the energy providing device 20 may further include an output unit. The output unit may be used to output or display information processed by the processor. The output unit may include but is not limited to one or more of a display device, a speaker, a vibration device, etc.

[0135] See also Figure 6 As shown, the present embodiment provides a schematic diagram of the structure of a third implantable passive closed-loop neural stimulation system. The implantable passive closed-loop neural stimulation system comprises: an implant device 10, an energy supply device 20, a detection device 50 and a program control device 30.

[0136] The implant device 10 is used to be implanted in the body of a target object. The implant device 10 is configured to generate a stimulation signal and transmit it to a target nerve of the target object. The implantation depth of the implant device 10 is not less than 2 cm and not more than 4 cm.

[0137] The energy supply device 20 is used to be attached to the surface of the target object and is wirelessly connected to the implant device 10. The energy supply device 20 is configured to supply power to the implant device 10 and send stimulation configuration information to the implant device 10 so that the implant device 10 generates a stimulation signal according to the stimulation configuration information.

[0138] The detection device 50 is used to be arranged on the target object, and the detection device 50 is configured to obtain physiological state information of the target object; the physiological state information is used to represent the activity state and / or posture change information of the target object.

[0139] The program-controlled device 30 is used to communicate with both the detection device 50 and the energy providing device 20 . The program-controlled device 30 is configured to adjust the stimulation configuration information according to the physiological state information sent by the detection device 50 , and send the adjusted stimulation configuration information to the energy providing device 20 .

[0140] The neurostimulation system of the embodiment of the present application includes an implant device 10 and an energy supply device 20. The implant device 10 is implanted into the body of the target object, and the energy supply device 20 is attached to the surface of the target object, thereby reducing the volume of the implant part, simplifying the surgical procedure, and reducing patient damage.

[0141] At the same time, the neurostimulation system of the embodiment of the present application is a passive closed-loop neurostimulation system, and the energy supply device 20 can supply power to the implant device 10 and send stimulation configuration information to the implant device 10, so that the implant device 10 generates a stimulation signal according to the stimulation configuration information. Moreover, the detection device 50 can obtain the physiological state information of the target object, so that the program control device 30 can adjust the stimulation configuration information according to the physiological state information sent by the detection device 50, and send the adjusted stimulation configuration information to the energy supply device 20, and the energy supply device 20 sends the adjusted stimulation configuration information as new stimulation configuration information to the implant device 10, thereby forming a passive closed-loop neurostimulation system, and delivering the generated stimulation signal to the patient's spinal cord tissue to relieve the patient's pain.

[0142] In some embodiments, the detection device 50 includes at least one of the following: an accelerometer, configured to determine first physiological state information based on an activity state and / or a posture change of the target object; a gyroscope, configured to determine second physiological state information based on an activity state and / or a posture change of the target object; A pressure sensor, configured to determine third physiological state information based on pressure distribution of the target object under different activity states; a heart rate sensor, configured to determine fourth physiological state information based on changes in the heart rate of the target object; an electromyography sensor for determining fifth physiological state information based on changes in muscle activity of the target subject; The physiological state information includes at least one of the following: first physiological state information, second physiological state information, third physiological state information, fourth physiological state information, and fifth physiological state information.

[0143] In the embodiment of the present application, multiple sensors may be provided to determine the activity state and / or posture change of the target object based on the physiological state information transmitted back by the multiple sensors.

[0144] In some embodiments, the programmable control device 30 is also configured to use a data fusion algorithm and / or a machine learning model to perform data fusion processing on the physiological state information, identify the activity state and / or posture changes of the target object, and determine the stimulation configuration information based on the activity state and / or posture changes of the target object.

[0145] The embodiment of the present application fuses the physiological status information from different sensors through a data fusion algorithm and / or a machine learning model, so as to obtain the physical status information of the target object more accurately.

[0146] In some embodiments, the programmable device 30 also includes a display screen, which is used to display relevant information of the target object and / or display a parameter setting interface; the relevant information includes at least one of the following: physiological state information, stimulation configuration information, historical record information, and the parameter setting interface is used to set the stimulation configuration information; and / or, the programmable device 30 also includes a voice control module, which is used to respond to the voice command of the target object and perform operations corresponding to the voice command.

[0147] Optionally, the display screen has a display interface, which can display the activity status, stimulation parameters and historical records of the target object. The display screen can be a touch screen, and the user can manually adjust the stimulation parameters on the display screen.

[0148] The specific structure and function of the implant device 10, energy supply device 20 and program control device 30 of the third implant passive closed-loop neural stimulation system in the embodiment of the present application can be found in the contents of the aforementioned embodiments and will not be repeated here.

[0149] Based on the above embodiments, in spinal cord stimulation therapy, in order to ensure that patients can obtain appropriate stimulation when their postures and body functions change, and to maintain the stability of the treatment effect, a series of technologies and methods are required to perform automatic and real-time spinal cord activation measurement and parameter adjustment. The embodiments of this application use the following key technical means and methods to ensure the treatment effect.

[0150] 1. Sensor Integration In order to monitor the patient's physical state and posture changes in real time, various types of sensors can be integrated: (1) Accelerometer and gyroscope: used to detect the patient's movement status and posture changes.

[0151] (2) Pressure sensor: used to detect the pressure distribution of patients during different activities, such as standing, walking or sitting.

[0152] (4) Heart rate sensor: used to monitor the patient's heart rate changes and indirectly reflect the intensity of physical activity.

[0153] (4) Electromyography (EMG) sensor: used to detect changes in muscle activity and help identify the patient's specific activity status.

[0154] 2. Data fusion and processing Fuse data from different sensors to obtain more accurate information about the patient's physical state. Specific data fusion processing methods include: (1) Data fusion algorithm: Use Kalman filtering, complementary filtering or other data fusion algorithms to integrate information from different sensors; (2) Machine learning model: Train machine learning models (such as support vector machines, random forests or neural networks) to identify different activity states of patients.

[0155] 3. Real-time monitoring and feedback The embodiment of the present application establishes a real-time monitoring system that can dynamically adjust the stimulation configuration information: Optionally, the embodiment of the present application adopts an embedded control system to develop an embedded system that integrates sensor data processing, activity state recognition and stimulation parameter adjustment functions. The embodiment of the present application adopts wireless communication to send sensor data to an external device (such as a smart phone or a dedicated terminal) through wireless communication technology (such as Bluetooth, Wi-Fi), and remotely adjust when necessary.

[0156] 4. Adaptive Algorithm The embodiment of the present application adopts an adaptive algorithm to automatically adjust the stimulation configuration information according to the specific activity status of the patient, which may specifically include the following three methods: (1) Closed-loop control: Design a closed-loop control system to automatically adjust stimulation parameters based on real-time monitored physiological signals (such as electromyography, heart rate, etc.).

[0157] (2) Fuzzy logic control: Use a fuzzy logic controller to dynamically adjust stimulation parameters based on the patient's activity status and physiological responses.

[0158] (3) Reinforcement learning: Using reinforcement learning algorithms, the stimulation parameters are continuously optimized through a reward mechanism to achieve the best therapeutic effect.

[0159] 5. User Interface and Interaction The embodiments of the present application design a user interface that enables patients to easily interact with the passive closed-loop neural stimulation system. The interaction methods include: (1) mobile application: developing a mobile application that allows patients to view their activity status, stimulation parameters and history, and to manually adjust settings; (2) voice control: integrating voice recognition technology to allow patients to control the system through voice commands.

[0160] As a third example, the present application embodiment provides a passive closed-loop neural stimulation system that integrates accelerometers, gyroscopes, and EMG sensors, and uses an embedded system for real-time data processing and control. The system includes: (1) sensor data collection: accelerometers and gyroscopes monitor the patient's motion state, and EMG sensors detect muscle activity; (2) data fusion and state recognition: through data fusion algorithms and machine learning models, the patient's current activity state (such as standing, walking, sitting, etc.) is recognized in real time; (3) stimulation parameter adjustment: the stimulation parameters of SCS, such as frequency, pulse width, voltage, etc., are automatically adjusted according to the activity state to ensure the best stimulation effect in different postures and activities; (4) user interaction: patients can view the current state and history through a smartphone application and manually adjust the settings as needed.

[0161] Based on the above, the embodiment of the present application integrates multiple sensors, advanced data processing technology, adaptive algorithms and a friendly user interface to achieve automatic and real-time adjustment of the passive closed-loop neural stimulation system when different postures and body functions change, thereby ensuring that patients receive appropriate stimulation in daily activities and maintain a stable treatment effect. The system of the embodiment of the present application not only improves the treatment effect, but also enhances the comfort and satisfaction of patients.

[0162] Furthermore, in order to verify the effect of the present application, the following experiments were conducted in the present embodiment: Experimental subjects: 10 patients with chronic back pain, aged between 40 and 60 years old, were selected.

[0163] Experimental equipment: A passive closed-loop neural stimulation system designed using the hardware and software described above.

[0164] Experimental process: Data from the accelerometer, gyroscope, and EMG sensors are recorded while the patient performs daily activities such as standing, walking, sitting, etc.

[0165] The patient's activity state is identified using a SVM model, and the stimulation configuration information is adjusted through a fuzzy logic controller.

[0166] The patients' pain scores (using visual analogue scale VAS) were recorded before and after adjustment.

[0167] Table 3. Experimental results of the third example

[0168] From the experimental results of the third example in Table 3, it can be seen that through the passive closed-loop neural stimulation system of the embodiment of the present application, the pain score was reduced by an average of 4 points (out of 10 points) when the patient performed different activities, indicating that the system can effectively improve the treatment effect and maintain the consistency and stability of the treatment.

[0169] Therefore, the embodiment of the present application can automatically and in real time adjust to the different postures and body function changes of the target object by integrating multiple sensors and adaptive algorithms. The experimental results prove the effectiveness and practicality of the present application, which can significantly improve the treatment effect of patients in daily activities and enhance the stability and comfort of treatment.

[0170] By applying the embodiments of the present application, at least the following beneficial effects can be achieved: (1) The neurostimulation system of the embodiment of the present application includes an implant device 10 and an energy supply device 20. The implant device 10 is implanted into the body of the target object, and the energy supply device 20 is attached to the surface of the target object, thereby reducing the volume of the implanted part, simplifying the surgical procedure, and reducing patient damage.

[0171] (2) The neurostimulation system of the embodiment of the present application is a passive closed-loop neurostimulation system. The energy supply device 20 can supply power to the implant device 10 and send stimulation configuration information to the implant device 10, so that the implant device 10 generates a stimulation signal according to the stimulation configuration information. At the same time, the implant device 10 can collect bioelectric signals related to the target nerve, or obtain physiological state information of the target object through the detection device 50, so that the program control device 30 can adjust the stimulation configuration information and send the adjusted stimulation configuration information to the energy supply device 20. The energy supply device 20 sends the adjusted stimulation configuration information as new stimulation configuration information to the implant device 10, thereby forming a passive closed-loop neurostimulation system, and delivering the generated stimulation signal to the patient's spinal cord tissue to relieve the patient's pain.

[0172] (3) In the embodiment of the present application, when the energy supply device 20 is not connected to the program control device 30, the first processing unit 210 of the energy supply device 20 is provided with fixed preset stimulation configuration information, and the implant device 10 is controlled to perform stimulation with the preset stimulation configuration information of a certain frequency.

[0173] (4) The energy supply device 20 of the embodiment of the present application can perform closed-loop algorithm calculations on the bioelectric signals received from the patient, timely adjust the stimulation program group plan, and control the stimulation configuration information of the implant device 10 in real time.

[0174] (5) In the application embodiment, when the energy supply device 20 is connected to the programmable control device 30, the second processing unit 310 of the programmable control device 30 performs a closed-loop algorithm operation on the received bioelectric signal, timely adjusts the stimulation program group plan, and provides stimulation configuration information for real-time control of the implant device 10 through the energy supply device 20.

[0175] (6) At least one stimulation electrode 110 of the embodiment of the present application can have a collection function to collect bioelectric signals at the same time and send them to the energy providing device 20. The energy providing device 20 can perform closed-loop algorithm operations based on the bioelectric signals collected by at least one stimulation electrode 110, adjust the stimulation program group plan in time, and make the treatment more accurate by real-time controlling the stimulation configuration information of the implant device 10.

[0176] (7) Each contact in the embodiment of the present application is connected to a corresponding signal node, which can ensure accurate signal transmission, reduce poor treatment effects or side effects caused by signal transmission errors, and improve the safety and effectiveness of treatment.

[0177] (8) The design of the flexible coil in the embodiment of the present application not only helps to improve the performance of the flexible coil when deeply implanted, but also ensures its stability and reliability under different curvature states. The design of the flexible coil in the embodiment of the present application can better adapt to the complex in vivo environment and improve the reliability and efficiency of the overall system.

[0178] (9) The embodiments of the present application integrate multiple sensors, advanced data processing technologies, adaptive algorithms, and a friendly user interface, which can realize automatic and real-time adjustment of the passive closed-loop neural stimulation system when different postures and body functions change, thereby ensuring that patients receive appropriate stimulation in daily activities and maintain a stable treatment effect.

[0179] Those skilled in the art will appreciate that the various operations, methods, steps, measures, and schemes in the processes discussed in this application may be alternated, altered, combined, or deleted. Further, other steps, measures, and schemes in the various operations, methods, and processes discussed in this application may also be alternated, altered, rearranged, decomposed, combined, or deleted. Further, the steps, measures, and schemes in the prior art that are similar to those disclosed in this application may also be alternated, altered, rearranged, decomposed, combined, or deleted.

[0180] In the description of the present application, it should be understood that the terms "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0181] The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, "plurality" means two or more.

[0182] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0183] In the description of this specification, specific features, structures, materials or characteristics may be combined in an appropriate manner in any one or more embodiments or examples.

[0184] It should be understood that, although the steps in the flowchart of the accompanying drawings are displayed in sequence as indicated by the arrows, these steps are not necessarily executed in sequence in the order indicated by the arrows. Unless otherwise specified herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least a part of the steps in the flowchart of the accompanying drawings may include multiple sub-steps or multiple stages, and these sub-steps or stages are not necessarily executed at the same time, but can be executed at different times, and their execution order is not necessarily sequential, but can be executed in turn or alternately with other steps or at least a part of the sub-steps or stages of other steps.

[0185] The above description is only a partial implementation method of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. An implantable passive closed-loop neural stimulation system, characterized in that: include: An implant device, for implantation in a target subject, configured to generate a stimulation signal and transmit it to a target nerve of the target subject, and collect a bioelectric signal related to the target nerve, wherein the implant device is implanted to a depth of not less than 2 cm and not more than 4 cm; An energy supply device, which is attached to the surface of the target object and is wirelessly connected to the implant device, and is configured to supply power to the implant device and send stimulation configuration information to the implant device, so that the implant device generates the stimulation signal according to the stimulation configuration information and receives the bioelectric signal sent by the implant device; The program-controlled device is used for communicating with the energy providing device, and is configured to adjust the stimulation configuration information according to the bioelectric signal sent by the energy providing device, and send the adjusted stimulation configuration information to the energy providing device.

2. The implantable passive closed-loop neural stimulation system according to claim 1, characterized in that: The implant device comprises at least one stimulation electrode and an electrode control unit; At least one of the stimulation electrodes is arranged at a predetermined position of the target object, each of the stimulation electrodes comprises at least one contact, and each of the contact is used to output a stimulation signal and / or collect the bioelectric signal; The electrode control unit is configured to control at least one of the stimulation electrodes to output a stimulation signal, acquire the bioelectric signal and send it to the energy providing device.

3. The implantable passive closed-loop neural stimulation system according to claim 1, characterized in that: The energy providing device comprises a power supply unit configured to supply power to the implant device.

4. The implantable passive closed-loop neural stimulation system according to claim 3, characterized in that: The implant device includes a first wireless communication unit and a first power receiving unit; The energy providing device includes a second wireless communication unit; The second wireless communication unit is used for wireless communication connection with the first wireless communication unit; The power supply unit includes a transmitting coil, and the first power receiving unit includes a receiving coil. The transmitting coil is used to transmit power to the receiving coil to power the implant device.

5. The implantable passive closed-loop neural stimulation system according to claim 3, characterized in that: The implant device includes a first wireless communication unit, and the energy supply device includes a second wireless communication unit; The first wireless communication unit is configured to wirelessly connect with the second wireless communication unit and receive power delivered from the power supply unit through the second wireless communication unit.

6. The implantable passive closed-loop neural stimulation system according to claim 2, characterized in that: The energy supply device comprises: The first processing unit is connected to the electrode control unit for communication, and is configured to send at least one preset stimulation configuration information as the stimulation configuration information to the electrode control unit in sequence when it is detected that the program-controlled device is not connected to the energy providing device for communication.

7. The implantable passive closed-loop neural stimulation system according to claim 6, characterized in that: The energy supply device also includes: A signal processing module is communicatively connected to the electrode control unit, configured to receive the bioelectric signal output by the electrode control unit, perform signal preprocessing on the bioelectric signal to obtain a processed bioelectric signal, and send the processed bioelectric signal to the first processing unit so that the first processing unit uses the processed bioelectric signal as the new bioelectric signal; the signal preprocessing includes at least one of the following: filtering, noise reduction, and amplification.

8. The implantable passive closed-loop neural stimulation system according to claim 7, characterized in that: The first processing unit is configured to determine the adjusted stimulation configuration information according to the bioelectric signal when it is detected that the program-controlled device is not in communication connection with the energy providing device, and send the adjusted stimulation configuration information as the new stimulation configuration information to the electrode control unit.

9. The implantable passive closed-loop neural stimulation system according to claim 7, characterized in that: The program-controlled device includes a second processing unit and a third communication unit; The program-controlled device is connected to the energy supply device through the third communication unit; The second processing unit is configured to receive the bioelectric signal sent by the first processing unit, determine the adjusted stimulation configuration information based on the bioelectric signal, and send the adjusted stimulation configuration information to the first processing unit, so that the first processing unit sends the adjusted stimulation configuration information as the new stimulation configuration information to the electrode control unit.

10. The implantable passive closed-loop neural stimulation system according to claim 2, characterized in that: Each of the contacts is correspondingly connected to a signal node; Each of the signal nodes is configured to send detection information corresponding to the contact point to the electrode control unit when detecting that the corresponding contact point outputs a stimulation signal; The electrode control unit is further configured to determine whether the contact corresponding to each of the detection information belongs to the target contact, and if it is determined that at least one contact corresponding to the detection information does not belong to the target contact, the stimulation signal is output again through the target contact; The target contact is a contact set to output a stimulation signal.

11. The implantable passive closed-loop neural stimulation system according to claim 1, characterized in that: Also includes: Connecting piece; Both sides of the connecting piece are provided with adhesive layers; or, one side of the connecting piece is provided with an adhesive layer, and the other side is provided with a first magnetic element, and the side of the energy providing device used to adhere to the surface of the target object is provided with a second magnetic element.

12. The implantable passive closed-loop neural stimulation system according to claim 1, characterized in that: Also includes: Connecting belt; The connecting belt is fixedly connected to the energy providing device, and the connecting belt is used for detachably connecting to the target object.

13. The implantable passive closed-loop neural stimulation system according to claim 11, characterized in that: The connecting piece further comprises a flexible antenna; the energy supply device is communicatively connected with the implant device via the flexible antenna; The shape of the flexible antenna includes at least one of the following: spiral, ring, and plane; and / or the flexible antenna is made of at least one of the following materials: conductive polymer, metal film, and conductive fabric.

14. The implantable passive closed-loop neural stimulation system according to claim 13, characterized in that: The flexible antenna includes a plurality of flexible coils; The flexible coil includes at least one of the following: The curvature radius of the flexible coil due to thermal deformation is not less than 5 mm and not more than 20 mm; The difference in curvature radius between adjacent flexible coils is no more than 5 mm; The quality factor of the flexible coil is not less than 65 and not more than 70; the quality factor is used to indicate the ratio of energy storage capacity to energy loss.

15. An implantable passive closed-loop neural stimulation system, characterized in that: include: An implant device, for implantation into a target subject, configured to generate a stimulation signal and transmit the stimulation signal to a target nerve of the target subject, wherein the implantation depth of the implant device is not less than 2 cm and not more than 4 cm; an energy supply device, which is attached to the surface of the target object and is wirelessly connected to the implant device, and is configured to supply power to the implant device and send stimulation configuration information to the implant device, so that the implant device generates the stimulation signal according to the stimulation configuration information; A detection device, used to be arranged on the target object and configured to obtain physiological state information of the target object; The physiological state information is used to represent the activity state and / or posture change of the target object; The program-controlled device is used to communicate with the detection device and the energy providing device, and is configured to adjust the stimulation configuration information according to the physiological state information sent by the detection device, and send the adjusted stimulation configuration information to the energy providing device.

16. The implantable passive closed-loop neural stimulation system according to claim 15, characterized in that: The detection device comprises at least one of the following: an accelerometer, configured to determine first physiological state information based on an activity state and / or a posture change of the target object; a gyroscope, configured to determine second physiological state information based on an activity state and / or a posture change of the target object; A pressure sensor, configured to determine third physiological state information based on pressure distribution of the target object under different activity states; a heart rate sensor, configured to determine fourth physiological state information based on changes in the heart rate of the target object; an electromyography sensor, configured to determine fifth physiological state information based on changes in muscle activity of the target object; The physiological state information includes at least one of the following: first physiological state information, second physiological state information, third physiological state information, fourth physiological state information, and fifth physiological state information.

17. The implantable passive closed-loop neural stimulation system according to claim 16, characterized in that: The program-controlled device is also configured to use a data fusion algorithm and / or a machine learning model to perform data fusion processing on the physiological state information, identify the activity state and / or posture changes of the target object, and determine the stimulation configuration information based on the activity state and / or posture changes of the target object.

18. The implantable passive closed-loop neural stimulation system according to claim 15, characterized in that: The program-controlled device further comprises a display screen, which is used to display relevant information of the target object and / or display a parameter setting interface; the relevant information comprises at least one of the following: physiological state information, stimulation configuration information, and historical record information, and the parameter setting interface is used to set the stimulation configuration information; and / or, The program-controlled device further comprises a voice control module, and the voice control module is used to respond to the voice instruction of the target object and execute an operation corresponding to the voice instruction.

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