Implanted nerve stimulation assembly and system

By dividing the nerve stimulation device into two parts: implantation and energy supply, and using wireless communication and flexible antenna technology, the problem of surgical trauma in the prior art is solved, and simplifying the surgery and improving the treatment effect is achieved.

CN119236300APending Publication Date: 2025-01-03HANGZHOU NUOWEI MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202411447854.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-16
Publication Date
2025-01-03

AI Technical Summary

Technical Problem

The surgical trauma of existing nerve stimulation devices is greater or the surgical process is complicated, resulting in greater trauma to the patient.

Method used

The implanted nerve stimulation component is divided into an implant device and an energy supply device. The implanted device is implanted into the pain area of ​​the target object. The energy supply device is attached to the surface of the target object and wirelessly communicates with the implant device. The target is output through the control electrode. The pulse signal is used to block the pain signal, and the energy supply device sends pulse configuration information to control the electrode output signal.

Benefits of technology

The volume of the implanted part is reduced, the surgical process is simplified, the patient's injury is reduced, and wireless energy transmission efficiency and accuracy is improved through flexible antennas, reducing surgical complexity and trauma.

✦ Generated by Eureka AI based on patent content.

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Abstract

The embodiment of the invention provides an implanted nerve stimulation assembly and system, and relates to the technical field of medical equipment. The implanted nerve stimulation assembly comprises an implantation device which is used for being implanted into a pain area of a target object and comprises at least one first electrode and a first control unit; the at least one first electrode is arranged in a preset distance range of peripheral nerves of a pain area, and the first control unit is configured to control the at least one first electrode to output a target pulse signal to the pain area so as to block or inhibit transmission of a pain signal to central nerves; the energy supply device is attached to the surface of the target object and is in wireless communication connection with the implantation device, and the energy supply device comprises a second control unit; the second control unit is configured to transmit pulse configuration information to the first control unit. According to the embodiment of the invention, the volume of the implanted part is reduced, the operation process is simplified, and the injury to a patient is reduced.
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Description

Technical Field

[0001] The present application relates to the field of medical device technology, and more specifically, to an implantable neural stimulation component and system. Background Art

[0002] Nerve electrical stimulation uses nerve regulation technology to appropriately stimulate the target nerves that cause pain through electrical pulses, feedback adjust the nerve's conductive substances or currents, or produce a numb feeling to cover the painful area, so as to achieve the purpose of relieving pain. It can formulate a relatively personalized treatment plan based on the patient's pain nature, location, duration, psychological and physiological tolerance and other factors.

[0003] Currently, implanting a neurostimulator into a patient requires making a large incision in the patient's body to implant the neurostimulator, which causes great trauma to the patient and the surgical procedure is complicated. Summary of the invention

[0004] The present application proposes an implantable neural stimulation component and system to solve the technical problems in the prior art that the existing neural stimulation devices have large surgical trauma or complicated surgical procedures.

[0005] In a first aspect, an embodiment of the present application provides an implantable neural stimulation assembly, comprising: An implantation device, for implantation into a pain area of ​​a target object, comprising at least one first electrode and a first control unit; the at least one first electrode is arranged within a predetermined distance range of a peripheral nerve in the pain area, the first control unit is configured to control the at least one first electrode to output a target pulse signal to the pain area to block or inhibit the transmission of the pain signal to the central nerve, and the implantation depth of the first electrode is not less than 1 cm and not more than 3 cm; An energy supply device is used to be attached to the surface of a target object and wirelessly connected to an implant device, and includes a second control unit; the second control unit is configured to send pulse configuration information to the first control unit so that the first control unit controls at least one first electrode to output a target pulse signal according to the pulse configuration information.

[0006] In a possible implementation, the energy providing device further includes a power supply unit, and the power supply unit is configured to supply power to the implant device.

[0007] 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.

[0008] 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.

[0009] In one possible implementation, the implanted neural stimulation assembly further includes a 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, 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.

[0010] In one possible implementation, the implanted neural stimulation assembly further includes: a connecting belt; The connecting belt is fixedly connected to the energy supply device, and is used for detachably connecting to the target object.

[0011] 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.

[0012] 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 3 mm and not more than 10 mm; The difference in the radius of curvature between adjacent flexible coils is not greater than 8 mm; The quality factor of the flexible coil is not less than 55 and not more than 60; the quality factor is used to indicate the ratio of energy storage capacity to energy loss.

[0013] In a possible implementation, each first electrode includes at least one contact point, and each contact point is correspondingly connected to a signal node; Each signal node is configured to send detection information corresponding to the contact point to the first control unit when detecting that the corresponding contact point outputs a target pulse signal; The first 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 target pulse signal is re-output through the target contact; the target contact is the contact set to output the target pulse signal.

[0014] In a second aspect, an embodiment of the present application provides an implantable neural stimulation system, comprising: an implantable neural stimulation component of the first aspect; The implant device is implanted into the painful area of ​​the target object, and the energy providing device is attached to the surface of the target object and is wirelessly connected with the implant device.

[0015] In a possible implementation, the implanted neural stimulation system further includes: The collecting device is used to be attached to the surface of the target object and is in communication connection with the energy providing device, and is configured to collect biological state data of the target object and send the biological state data to the second control unit; the biological state data is used to characterize state information related to pain in the pain area.

[0016] In a possible implementation, the implanted neural stimulation system further includes: The programmable control device is used to communicate with the energy providing device, and is configured to adjust the pulse configuration information to obtain the adjusted pulse configuration information, and send the adjusted pulse configuration information to the second control unit, so that the second control unit sends the adjusted pulse configuration information as new pulse configuration information to the first control unit.

[0017] In a possible implementation, the program-controlled device includes a processing unit and a third communication unit; The program-controlled device is connected to the energy supply device through the third communication unit; The processing unit is configured to receive the biological state data sent by the second control unit, and determine the adjusted pulse configuration information according to the biological state data.

[0018] In a possible implementation, the second control unit is configured to send at least one preset pulse configuration information as pulse configuration information to the first control unit in sequence when it is detected that the program-controlled device is not in communication connection with the energy providing device.

[0019] In a possible implementation, the second control unit is configured to determine adjusted pulse configuration information according to the biological state data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit.

[0020] In a possible implementation, at least one first electrode is further used to collect bioelectric signals and send the bioelectric signals to the second control unit; The second control unit is further configured to determine adjusted pulse configuration information according to the bioelectric signal and the biostatus data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit.

[0021] In a possible implementation, the collection device includes: At least one second electrode, used to be attached to the surface of the target object to collect biological status data of the target object; The third control unit is connected to the at least one second electrode, and is used to obtain the biological state data output by the at least one second electrode, and send the biological state data to the second control unit.

[0022] In a possible implementation, the collection device includes: A fourth communication unit, used for communicating with the energy providing device; The second power receiving unit is used to receive the power output by the energy providing device to power the collection device.

[0023] The beneficial technical effects brought about by the technical solution provided by the embodiment of the present application include: The embodiment of the present application divides the implanted nerve stimulation component into an implant device and an energy supply device. The implant device can be implanted in the pain area of ​​the target object, and the energy supply device can be attached to the surface of the target object, thereby reducing the volume of the implanted part, simplifying the surgical process, and reducing patient damage. At the same time, the implant device of the embodiment of the present application controls at least one first electrode to output a target pulse signal to the pain area through a first control unit to block the transmission of the pain signal to the peripheral nerve, and the energy supply device sends pulse configuration information to the first control unit through a second control unit, so that the first control unit controls at least one first electrode to output a target pulse signal according to the pulse configuration information, thereby achieving the effect of alleviating or avoiding pain.

[0024] 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

[0025] 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 1 A schematic diagram of the structure of a first implanted nerve stimulation assembly provided in an embodiment of the present application; Figure 2 A schematic diagram of the structure of a second implanted nerve stimulation assembly provided in an embodiment of the present application; Figure 3 A schematic diagram of the structure of a first implanted neural stimulation system provided in an embodiment of the present application; Figure 4 A schematic diagram of the structure of a second implanted neural stimulation system provided in an embodiment of the present application; Figure 5 A schematic diagram of the structure of a third implanted neural stimulation system provided in an embodiment of the present application; Figure 6 A schematic diagram of the structure of a fourth implanted neural stimulation system provided in an embodiment of the present application; Figure 7 A schematic diagram of the structure of a fifth implanted neural stimulation system provided in an embodiment of the present application; Figure 8 A schematic diagram of the structure of a sixth implanted neural stimulation system provided in an embodiment of the present application; Fig. 9 This is a schematic structural diagram of the seventh implant neural stimulation system provided in an embodiment of the present application. Reference numerals: 10 - implant device, 110 - first electrode, 120 - first control unit, 130 - first wireless communication unit, 140 - first power receiving unit; 20 - energy supply device, 210 - second control unit, 220 - power supply unit, 230 - second wireless communication unit, 240 - storage unit; 30-program control device, 310-processing unit, 320-third communication unit; 40 - collection device, 410 - second electrode, 420 - third control unit, 430 - fourth communication unit, 440 - second power receiving unit; 50-Connecting piece. DETAILED DESCRIPTION

[0026] 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.

[0027] 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.

[0028] 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.

[0029] In related technologies, peripheral nerve stimulation (PNS) is a derivative method developed based on the application of SCS (spinal cord nerve stimulation technology).

[0030] However, since the control device of the existing implanted neural stimulation system has a large volume, it is required to make a large wound on the patient's body to implant the control device into the patient's body. It can be seen that the use of traditional neural stimulation devices will cause great trauma to the patient.

[0031] The implantable neural stimulation component and system provided in this application are intended to solve the above technical problems of the prior art.

[0032] 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.

[0033] See also Figure 1 As shown, the present application embodiment provides a schematic diagram of the structure of a first implanted neural stimulation component. Figure 1 As shown, the implantable nerve stimulation assembly includes: an implant device 10 and an energy supply device 20. The implant device 10 is used to be implanted in the pain area of ​​the target object. 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 pain area is as shown in FIG. Figure 1 Shown by the dashed line.

[0034] See also Figure 2 As shown, the present application embodiment provides a schematic diagram of the structure of a second implanted nerve stimulation component. Figure 2As shown, the implant device 10 includes at least one first electrode 110 and a first control unit 120. At least one first electrode 110 is arranged within a predetermined distance range of the peripheral nerve of the pain area, and the first control unit 120 is configured to control at least one first electrode 110 to output a target pulse signal to the pain area to block or inhibit the transmission of the pain signal to the central nerve, and the implantation depth of the first electrode 110 is not less than 1 cm and not more than 3 cm.

[0035] See also Figure 2 As shown, the energy providing device 20 includes a second control unit 210. The second control unit 210 is configured to send pulse configuration information to the first control unit 120, so that the first control unit 120 controls at least one first electrode 110 to output a target pulse signal according to the pulse configuration information.

[0036] Optionally, the pulse configuration information includes pulse parameter information and electrode information. The pulse parameter information is used to indicate information for generating a target pulse signal, and may include information such as pulse width, frequency, and amplitude. The electrode information is used to indicate relevant information of the electrode that outputs the target pulse signal, and the relevant information may be information of the target contact of each electrode. Therefore, the pulse configuration information is used for the implant device 10 to generate a corresponding target pulse signal and output it through the target contact of the target electrode.

[0037] The embodiment of the present application divides the implantable nerve stimulation component into an implant device 10 and an energy providing device 20. The implant device 10 can be implanted in the pain area of ​​the target object, and the energy providing device 20 can be attached to the surface of the target object, thereby reducing the volume of the implanted part, simplifying the surgical procedure, and reducing patient damage. At the same time, the implant device 10 of the embodiment of the present application controls at least one first electrode 110 to output a target pulse signal to the pain area through the first control unit 120 to block the transmission of the pain signal to the peripheral nerve, and the energy providing device 20 sends pulse configuration information to the first control unit 120 through the second control unit 210, so that the first control unit 120 controls at least one first electrode 110 to output a target pulse signal according to the pulse configuration information, thereby achieving the effect of reducing or avoiding pain.

[0038] The embodiment of the present application is to implant at least one first electrode 110 near the peripheral nerve that controls the pain area, and block the transmission of pain signals through the skin and muscles to suppress pain. It is an effective method for treating intractable pain caused by single neuropathy.

[0039] The embodiment of the present application is based on PNS (peripheral nerve stimulation), which is an effective pain treatment method. Studies have found that PNS may block the transmission of pain signals in the spinal cord by activating inhibitory interneurons. This mode of action also shows that PNS has a "blocking" property to a certain extent. The mechanisms of action of SCS (spinal cord stimulation) and PNS in treating pain are different. Compared with SCS, PNS focuses on blocking the transmission of pain signals by activating inhibitory interneurons.

[0040] See also Figure 1 As shown, the implanted neural stimulation assembly further includes a connecting sheet 50. Both sides of the connecting sheet 50 are provided with an adhesive layer; or, one side of the connecting sheet 50 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 20 for contacting with the surface of the target object is provided with a second magnetic element.

[0041] In some embodiments, the implanted neural stimulation assembly further includes: a connection belt. The connection belt is fixedly connected to the energy supply device 20 and is used for detachable connection with the target object.

[0042] 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.

[0043] 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.

[0044] In some embodiments, the connecting piece 50 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, planar; and / or the flexible antenna is made of at least one of the following materials: conductive polymer, metal film, conductive fabric.

[0045] 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.

[0046] 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.

[0047] The embodiment of the present application adopts an in vitro connecting piece 50 for positioning the energy providing device 20, and the connecting piece 50 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.

[0048] In some embodiments, the flexible antenna includes multiple flexible coils; the flexible coils include at least one of the following: the radius of curvature of the flexible coil due to thermal deformation is not less than 3 mm and not more than 10 mm, the difference in curvature radius between adjacent flexible coils is not more than 8 mm, the quality factor of the flexible coil is not less than 55 and not more than 60, and the quality factor is used to represent the ratio of energy storage capacity to energy loss.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] The two key technical parameters provided by the embodiment of the present application, namely, the curvature radius range and the difference in curvature radius between adjacent coils, can achieve the required Q value. The curvature radius range of the flexible coil in the embodiment of the present application is between 3 mm and 10 mm and the difference in curvature radius between adjacent flexible coils does not exceed 8 mm, mainly to ensure the performance stability and reliability of the flexible coil under different curvature states.

[0054] Specifically, the curvature radius of the flexible coil in the embodiment of the present application ranges from 3 mm to 10 mm, mainly to ensure that the flexible coil can adapt to changes in different curvature radii, thereby maintaining good performance in a variety of application scenarios. Specifically, the following two aspects are considered: (1) Changes in curvature of the human body surface: The curvature of different parts of the human body may vary greatly. For example, the curvature radius of the finger joints is small, while the curvature radius of the arms or legs is large. By setting the curvature radius range, it can be ensured that the coil can adapt to these changes.

[0055] (2) Stability of coil performance: Under different curvature states, the electrical properties of the coil (such as inductance, Q value) will change. By setting a reasonable curvature radius range, it can be ensured that the performance changes of the coil under different curvature states are within an acceptable range.

[0056] Specifically, the difference in curvature radius between adjacent flexible coils in the embodiment of the present application does not exceed 8 mm, in order to control the local change of the coil when it is bent, thereby avoiding unstable performance caused by excessive local curvature change. Specifically, the following three aspects are considered: (1) Reduce local stress concentration: If the difference in curvature radius between adjacent coils is too large, it may cause local stress concentration, thus affecting the mechanical strength and durability of the coil.

[0057] (2) Maintaining consistent electrical performance: By controlling the difference in curvature radius between adjacent coils within a certain range, the degree of inductance change can be reduced, thereby maintaining the consistency of the coil's Q value and other electrical properties.

[0058] (3) Ensure overall performance: By controlling the difference in curvature radius between adjacent coils, the performance of the coil in the overall bending state can be ensured to be more stable, reducing performance fluctuations caused by local curvature changes.

[0059] In practical applications, the curvature radius of a flexible coil and the difference in curvature radius between adjacent flexible coils are interrelated, including: Overall adaptability: By setting the curvature radius range (3 mm to 10 mm), the flexible coil can adapt to the curvature changes of different parts of the human body.

[0060] Local stability: By controlling the difference in curvature radius between adjacent flexible coils (no more than 8 mm), it can be ensured that the performance of the coil will not fluctuate drastically when the local curvature changes.

[0061] The curvature radius of the flexible coil used in the embodiment of the present application ranges from 3 mm to 10 mm, and the difference in curvature radius between adjacent flexible coils does not exceed 8 mm. This is determined through relevant experimental research and comprehensive consideration of various factors. The following is an analysis of two key technical parameters.

[0062] The curvature radius of the embodiment of the present application ranges from 3 mm to 10 mm, mainly to meet the performance requirements of the flexible coil in practical applications. Specifically, the selection of this range takes into account the following factors: 1. Changes in the curvature of the human body surface In medical or biomedical applications, flexible coils often need to be attached to the surface of the human body, and the curvature of the human body surface can range from very flat (such as the outer thigh) to very curved (such as the wrist or ankle). Therefore, choosing a reasonable curvature radius range can ensure that the coil can fit well in different parts.

[0063] Minimum radius of curvature (3 mm): represents the most curved part of the human body surface, such as the finger joints.

[0064] Maximum radius of curvature (10 mm): represents the relatively flat part of the human body surface, but still has a certain curvature.

[0065] 2. Stability of flexible coil performance Selecting an appropriate curvature radius range helps ensure the stable performance of the coil at different curvatures. Too small a curvature radius may cause significant changes in the inductance and Q value of the coil, thus affecting its transmission efficiency and signal quality. Too large a curvature radius may prevent the coil from fitting well to the human body surface, thus affecting its use effect.

[0066] 3. Limitations of material properties Different materials behave differently when bent. Flexible coils are usually made of materials with high flexibility, such as polyimide film. However, even the most flexible materials have their physical limits. If the radius of curvature is too small, it may cause irreversible deformation or fracture of the material. Therefore, it is necessary to select a reasonable range of curvature radius within the physical limits of the material.

[0067] 4. Process feasibility When manufacturing flexible coils, the feasibility of the production process needs to be considered. Too small a curvature radius may be difficult to achieve with existing manufacturing processes, while too large a curvature radius may make the coil difficult to control during the manufacturing process. Therefore, choosing a reasonable curvature radius range is also to ensure the feasibility and economy of the production process.

[0068] As a first example, the embodiment of the present application provides a flexible coil for health monitoring, which needs to be attached to the wrist and needs to maintain good transmission performance in different bending states, and the specific contents include: 1. Design goals Curvature radius range: 3 mm to 10 mm.

[0069] Target Q value: In the straight state, the Q value is 60; in the maximum bending state, the Q value is not less than 55.

[0070] 2. Experimental verification In order to verify whether this design is reasonable, experiments can be conducted to test the performance at different curvature radii.

[0071] Experimental steps: (1) Sample manufacturing: A group of flexible coil samples are manufactured, and each sample is designed with a different curvature radius at different positions of the coil.

[0072] (2) Test Q value: Use a vector network analyzer (VNA) or other appropriate measuring instruments to measure the Q value of the coil under different curvature radii.

[0073] (3) Data analysis: Compare the changes in Q values ​​under different curvature radii and analyze their stability.

[0074] Table 1: Data of the first example

[0075] From the data of the first example in Table 1, it can be seen that within the curvature radius range of 3 mm to 10 mm, the Q value does not change much and basically remains between 58 and 60. This shows that within this curvature radius range, the performance of the flexible coil is stable.

[0076] Therefore, the curvature radius of the flexible coil is determined to be between 3 mm and 10 mm in the embodiment of the present application, which can ensure that the flexible coil can maintain good performance under different human body surface curvatures, thereby meeting the needs of practical applications. This design not only takes into account the curvature changes of the human body surface, but also takes into account the material properties and process feasibility, ensuring the stability and reliability of the flexible coil in a variety of usage scenarios.

[0077] The difference in curvature radius between adjacent flexible coils in the embodiment of the present application does not exceed 8 mm, mainly to ensure that the flexible coil can still maintain relatively stable performance under different curvature radii. The selection of this value needs to be based on a comprehensive consideration of multiple factors, including the design objectives, material properties, and application environment of the flexible coil.

[0078] The embodiment of the present application provides a method for determining the difference in curvature radius between adjacent flexible coils, and the specific contents include: 1. Design goals The design goal of the embodiment of the present application is to ensure that the quality factor (Q value) of the flexible coil does not change much when the flexible coil is bent, so as to ensure the stability and accuracy of the transmission performance.

[0079] 2. Material properties The elastic modulus and elongation at break of the material also affect how the coil behaves when bent. For example, polyimide (PI) film has good flexibility but may produce permanent deformation when bent too much.

[0080] 3. Application environment In applications on the human body surface, the curvature radius of the skin usually varies from a few millimeters to more than ten millimeters. Therefore, the flexible coil needs to maintain good performance within this range.

[0081] As a second example, the embodiment of the present application provides an example description of the difference in curvature radius between adjacent flexible coils.

[0082] 1. Parameter setting Curvature radius range: 3 mm to 10 mm.

[0083] Difference in curvature radius between adjacent flexible coils: no more than 8 mm.

[0084] Target Q value: In the straight state, the Q value is 60; in the maximum bending state, the Q value is not less than 55.

[0085] 2. Design Example The embodiment of the present application designs a flexible coil whose curvature radius is 10 mm in a straight state. The embodiment of the present application first bends the flexible coil to a state with a curvature radius of 3 mm.

[0086] Initial state: The coil is completely straight with a radius of curvature of 10 mm.

[0087] Bending state: The coil is bent into a section with a curvature radius of 3 mm.

[0088] In the embodiment of the present application, the flexible coil is divided into several sections, and the difference in curvature radius between each section does not exceed 8 mm. For example: First segment: The radius of curvature changes from 10 mm to 10 mm (unchanged).

[0089] Second section: The radius of curvature gradually decreases from 10 mm to 2 mm.

[0090] The third section: The radius of curvature gradually decreases from 2 mm to 3 mm.

[0091] In the second section, the radius of curvature decreases from 10 mm to 2 mm, which means that the maximum difference in the radius of curvature in this section is 8 mm (10 mm - 2 mm = 8 mm). This ensures that when the coil is bent, the difference in the radius of curvature of each section will not exceed 8 mm.

[0092] 3. Experimental verification Step 1: Make a Sample A group of flexible coil samples were manufactured, each of which was designed with different curvature radii at different positions of the coil, but the difference in curvature radii in adjacent areas was controlled within 8 mm.

[0093] Step 2: Test Q value Use a vector network analyzer (VNA) or other appropriate measuring instrument to measure the Q value of the coil at different curvature radii.

[0094] Q value in straight state: Test the Q value of the coil in straight state and record it as the reference value.

[0095] Q value in bending state: Test the Q value when the curvature radius is 3 mm, 5 mm, 7 mm, 9 mm and 10 mm, and record the data.

[0096] Table 2. Second example data

[0097] From the second example data in Table 2, it can be seen that under different curvature radii, the decrease in the Q value is very small, basically remaining between 58 and 60, which meets the design goal.

[0098] Therefore, the embodiment of the present application can effectively reduce the change of Q value by controlling the difference of curvature radius between adjacent coils within 8 mm, thereby improving the transmission performance of the flexible coil under different bending conditions. This design ensures that the coil can still maintain a high quality factor under various bending conditions, thereby ensuring the accuracy and stability of transmission.

[0099] See also Figure 2 As shown, the energy providing device 20 further includes a power supply unit 220 , which is configured to supply power to the implant device 10 .

[0100] In some embodiments, the implant device 10 includes a first wireless communication unit 130 and a first power receiving unit 140 ; ​​the energy providing device 20 includes a second wireless communication unit 230 ; and the second wireless communication unit 230 is used for wireless communication connection with the first wireless communication unit 130 .

[0101] The power supply unit 220 includes a transmitting coil, and the first power receiving unit 140 includes a receiving coil. The transmitting coil is used to transmit power to the receiving coil to supply power to the implant device 10.

[0102] The energy providing device 20 is wirelessly connected to the first wireless communication unit 130 via the second wireless communication unit 230 , and sends pulse configuration information to the implant device 10 .

[0103] The implant device 10 is powered by the energy supply device 20. 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.

[0104] 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 .

[0105] 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 .

[0106] Specifically, 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.

[0107] See also Figure 2 As shown, the energy providing device 20 further includes a storage unit 240. The energy providing device 20 can automatically save pre-stored data or acquired data into the storage unit 240.

[0108] In some embodiments, each first electrode 110 includes at least one contact, and each contact is connected to a corresponding signal node; each signal node is configured to send detection information corresponding to the contact to the first control unit 120 when it is detected that the corresponding contact outputs a target pulse signal.

[0109] The first 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 target pulse signal is re-output through the target contact; the target contact is the contact set to output the target pulse signal.

[0110] 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.

[0111] 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.

[0112] 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 first electrode 110 implanted in the body, 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 start 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.

[0113] The implanted neural stimulation component 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.

[0114] An embodiment of the present application provides an implantable neural stimulation system, including: an implantable neural stimulation component of an embodiment of the present application.

[0115] The implant device 10 is implanted into the painful area of ​​the target object, and the energy providing device 20 is attached to the surface of the target object and is wirelessly connected with the implant device 10 .

[0116] See also Figure 3As shown, the present application embodiment provides a schematic diagram of the structure of a first implanted neural stimulation system. Figure 3 As shown, the implanted neural stimulation system also includes: a collection device 40.

[0117] The acquisition device 40 is used to be attached to the surface of the target object and is communicatively connected to the energy providing device 20. The acquisition device 40 is configured to collect biological state data of the target object and send the biological state data to the second control unit 210; the biological state data is used to characterize state information related to pain in the pain area.

[0118] Optionally, the collection device 40 may be connected to the energy providing device 20 in a wired or wireless communication manner. The collection device 40 may collect biological state data through collection electrodes. The collection device 40 is attached to the patient's skin surface, collects biological state data of the patient's state related to the patient's chronic pain condition and sends it to the energy supply device 20 through wireless communication or wired communication. The biological state data can be physiological data including the patient's autonomous voice tone, heart rate, respiratory rate or blood pressure. The collection device 40 does not have to be set near the energy supply device 20, and can also be a monitoring watch.

[0119] See also Figure 4 As shown, the present application embodiment provides a schematic diagram of the structure of a second implanted neural stimulation system. Figure 4 As shown, the implanted neural stimulation system also includes: a programmable device 30, which is used to communicate with the energy providing device 20, and the programmable device 30 is configured to adjust the pulse configuration information to obtain adjusted pulse configuration information, and send the adjusted pulse configuration information to the second control unit 210, so that the second control unit 210 sends the adjusted pulse configuration information as new pulse configuration information to the first control unit 120.

[0120] 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.

[0121] See also Figure 4 As shown, the collection device 40 is connected to the energy providing device 20 in a wired communication manner.

[0122] The implantable neural stimulation system of the embodiment of the present application is used to treat chronic pain. The implant device 10 is implanted in the patient's painful area and can transmit stimulation signals to the target lesion; the energy supply device 20 can be applied to the patient's surface, not only to transmit stimulation instructions, but also to receive electrode feedback signals; the programmable device 30 can control the pulse configuration information transmitted by the energy supply device 20, and automatically adjust the pulse configuration information according to the received electrical signal of the target nerve and send it to the energy supply device 20.

[0123] See also Figure 5 As shown, the embodiment of the present application provides a schematic structural diagram of a third implanted neural stimulation system. Figure 5 The embodiment shown is Figure 4 The difference between the illustrated embodiments is that the collection device 40 and the energy supply device 20 are connected to each other in a wireless communication manner.

[0124] See also Figure 6 As shown, the present application embodiment provides a schematic diagram of the structure of a fourth implanted neural stimulation system. Figure 6 As shown, the collection device 40 is in communication connection with the energy providing device 20. The second control unit 210 is configured to send at least one preset pulse configuration information as pulse configuration information to the first control unit 120 in sequence when detecting that the program control device 30 is not in communication connection with the energy providing device 20.

[0125] In the embodiment of the present application, when the energy supply device 20 is not connected to the programming device 30, the second control unit 210 of the energy supply device 20 is provided with fixed preset pulse configuration information, and the implant device 10 is controlled to be stimulated with the preset pulse configuration information of a certain frequency.

[0126] The at least one preset pulse configuration information may be a fixed pulse configuration information, or may be a plurality of preset pulse configuration information arranged in sequence, which are continuously cycled in sequence as the pulse configuration information.

[0127] In some embodiments, the second control unit 210 is configured to determine adjusted pulse configuration information according to the biological state data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit 120 .

[0128] The embodiment of the present application can realize that the energy supply device 20 sends the received biological status data 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 240 and sent again when the connection is made.

[0129] The energy supply device 20 of the embodiment of the present application can perform closed-loop algorithm operations on the received biological state data of the patient, timely adjust the stimulation program group plan, and control the pulse configuration information of the implant device 10 in real time.

[0130] In some embodiments, at least one first electrode 110 is also used to collect bioelectric signals and send the bioelectric signals to the second control unit 210 .

[0131] The second control unit 210 is further configured to determine adjusted pulse configuration information according to the bioelectric signal and the bio-state data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit 120 .

[0132] At least one first 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 the at least one first electrode 110 and the biological state data of the patient collected by the collection device 40, adjust the stimulation program group plan in time, and can control the pulse configuration information of the implant device 10 in real time.

[0133] The first electrode 110 of the embodiment of the present application may include at least one contact. According to the position of each contact, the electrode information can be determined, that is, the target contact that outputs the target pulse signal can be determined. The other contacts can synchronously collect bioelectric signals. At the same time, the detection information returned by the signal nodes connected to each contact can be used to detect whether the contact that outputs the target pulse signal is the target contact, and whether each target contact outputs the target pulse signal. Combined with the biological status data, the pulse configuration information of the implant device 10 can be controlled in real time, so that data information of different parameters at different positions can be integrated to make the treatment more accurate.

[0134] See also Figure 7 As shown, the present application embodiment provides a schematic diagram of the structure of a fifth implanted neural stimulation system. Figure 7 As shown, the program control device 30 includes a processing unit 310 and a third communication unit 320 .

[0135] The program control device 30 is communicatively connected to the energy supply device 20 via the third communication unit 320 .

[0136] The processing unit 310 is configured to receive the biological state data sent by the second control unit 210, and determine the adjusted pulse configuration information according to the biological state data.

[0137] Optionally, the program control device 30 is connected to the energy providing device 20 via a third communication unit 320 via wired or wireless communication.

[0138] Optionally, in the embodiment of the present application, when the energy supply device 20 is connected to the programming device 30, the processing unit 310 of the programming device 30 performs a closed-loop algorithm operation on the received biological state data, timely adjusts the stimulation program group plan, and provides pulse configuration information for real-time control of the implant device 10 through the energy supply device 20.

[0139] See also Figure 8 As shown, the present application embodiment provides a schematic diagram of the structure of a sixth implanted neural stimulation system. Figure 8 As shown, the collection device 40 includes: at least one second electrode 410 and a third control unit 420. The at least one second electrode 410 is used to be attached to the surface of the target object to collect biological state data of the target object.

[0140] The third control unit 420 is connected to at least one second electrode, and is used to obtain biological state data output by at least one second electrode 410 , and send the biological state data to the second control unit 210 .

[0141] See also Figure 8 As shown, the collection device 40 includes: a fourth communication unit 430 and a second power receiving unit 440. The fourth communication unit 430 is used to communicate with the energy providing device 20. The second power receiving unit 440 is used to receive the power output by the energy providing device 20 to power the collection device 40.

[0142] See also Fig. 9 As shown, the present application embodiment provides a schematic diagram of the structure of a seventh implanted neural stimulation system. Fig. 9 As shown, the acquisition device 40 and the program control device 30 are both connected to the energy supply device 20 for communication, and the energy supply device 20 is connected to the implant device 10 for wireless communication. The implant device 10 includes a first electrode 110, a first control unit 120, a first wireless communication unit 130 and a first power receiving unit 140.

[0143] The energy supply device 20 includes a second control unit 210, a power supply unit 220, a second wireless communication unit 230 and a storage unit 240. The program control device 30 includes a processing unit 310 and a third communication unit 320. The collection device 40 includes a second electrode 410, a third control unit 420, a fourth communication unit 430 and a second power receiving unit 440.

[0144] Optionally, at least one of the first control unit 120, the second control unit 210, the third control unit 420 and the processing unit 310 may 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 may implement or execute various exemplary logic blocks, modules and circuits described in conjunction with the disclosure of this application. The processor 2001 may 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.

[0145] The storage unit 240 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.

[0146] Optionally, at least one of the program control device 30, the energy supply device 20 and the collection device 40 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.

[0147] 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.

[0148] By applying the embodiments of the present application, at least the following beneficial effects can be achieved: (1) The embodiment of the present application divides the implantable nerve stimulation component into an implant device 10 and an energy supply device 20. The implant device 10 can be implanted in the pain area of ​​the target object, and the energy supply device 20 can be attached to the surface of the target object, thereby reducing the volume of the implanted part, simplifying the surgical process, and reducing patient damage. At the same time, the implant device 10 of the embodiment of the present application controls at least one first electrode 110 to output a target pulse signal to the pain area through the first control unit 120 to block the transmission of the pain signal to the peripheral nerve, and the energy supply device 20 sends pulse configuration information to the first control unit 120 through the second control unit 210, so that the first control unit 120 controls at least one first electrode 110 to output a target pulse signal according to the pulse configuration information, thereby achieving the effect of alleviating or avoiding pain.

[0149] (2) In the embodiment of the present application, the collection device 40 and the energy providing device 20 are separately arranged. The collection device 40 is applied to the patient's skin surface to collect biological state data of the patient's state related to the patient's chronic pain condition and send it to the energy providing device 20 via wireless communication or wired communication, so as to facilitate timely adjustment of pulse configuration information and improve treatment effect.

[0150] (3) In the embodiment of the present application, when the energy supply device 20 is not connected to the program control device 30, the second control unit 210 of the energy supply device 20 is provided with fixed preset pulse configuration information, and the implant device 10 is controlled to be stimulated with the preset pulse configuration information of a certain frequency.

[0151] (4) The energy supply device 20 of the embodiment of the present application can perform closed-loop algorithm calculations on the received biological status data of the patient, timely adjust the stimulation program group plan, and control the pulse configuration information of the implant device 10 in real time.

[0152] (5) In the application embodiment, when the energy supply device 20 is connected to the programmable control device 30, the processing unit 310 of the programmable control device 30 performs a closed-loop algorithm operation on the received biological state data, timely adjusts the stimulation program group plan, and provides pulse configuration information for real-time control of the implant device 10 through the energy supply device 20.

[0153] (6) At least one first 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 the at least one first electrode 110 and the biological state data of the patient collected by the collection device 40, adjust the stimulation program group plan in time, and through real-time control of the pulse configuration information of the implant device 10, integrate the data information of different parameters at different positions to make the treatment more accurate.

[0154] (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.

[0155] (8) The special design of the flexible antenna in the embodiment of the present application ensures effective transmission inside and outside the body, and can move the energy part implanted in the body out of 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.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] 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 neural stimulation assembly, characterized in that: include: An implantation device for implantation into a pain area of ​​a target subject, comprising at least one first electrode and a first control unit; At least one of the first electrodes is arranged within a predetermined distance range of a peripheral nerve in the pain area, the first control unit is configured to control at least one of the first electrodes to output a target pulse signal to the pain area to block or inhibit the transmission of the pain signal to the central nerve, and the implantation depth of the first electrode is not less than 1 cm and not more than 3 cm; An energy providing device, which is used to be attached to the surface of the target object and wirelessly connected to the implant device, includes a second control unit; the second control unit is configured to send pulse configuration information to the first control unit, so that the first control unit controls at least one of the first electrodes to output the target pulse signal according to the pulse configuration information.

2. The implantable neural stimulation assembly according to claim 1, characterized in that The energy providing device further comprises a power supply unit configured to supply power to the implant device.

3. The implantable neural stimulation assembly according to claim 2, 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.

4. The implantable neural stimulation assembly according to claim 2, characterized in that: The implant device comprises a first wireless communication unit, and the energy supply device comprises 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.

5. The implantable neural stimulation assembly according to claim 1, characterized in that: Also includes a 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.

6. The implantable neural stimulation assembly 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.

7. The implantable neural stimulation assembly according to claim 5, 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.

8. The implantable neural stimulation assembly according to claim 7, 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 3 mm and not more than 10 mm; The difference in curvature radius between adjacent flexible coils is no more than 8 mm; The quality factor of the flexible coil is not less than 55 and not more than 60; the quality factor is used to indicate the ratio of energy storage capacity to energy loss.

9. The implantable neural stimulation assembly according to claim 1, characterized in that: Each of the first electrodes comprises at least one contact point, and each of the contact points 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 first control unit when detecting that the corresponding contact point outputs a target pulse signal; The first 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 target pulse signal is output again through the target contact; The target contact is a contact set to output a target pulse signal.

10. An implantable neural stimulation system, characterized in that: include: An implantable neural stimulation assembly as claimed in any one of claims 1 to 9; The implant device is implanted into the pain area of ​​the target object, and the energy supply device is attached to the surface of the target object and is wirelessly connected with the implant device.

11. The implantable neural stimulation system according to claim 10, characterized in that: Also includes: A collection device is used to be attached to the surface of the target object and is in communication with the energy providing device, and is configured to collect biological state data of the target object and send the biological state data to the second control unit; the biological state data is used to characterize state information related to pain in the pain area.

12. The implantable neural stimulation system according to claim 11, characterized in that: Also includes: A programmable control device is used to communicate with the energy providing device, and is configured to adjust the pulse configuration information to obtain adjusted pulse configuration information, and send the adjusted pulse configuration information to the second control unit, so that the second control unit sends the adjusted pulse configuration information as the new pulse configuration information to the first control unit.

13. The implantable neural stimulation system according to claim 12, characterized in that: The program-controlled device includes a processing unit and a third communication unit; The program-controlled device is connected to the energy supply device through the third communication unit; The processing unit is configured to receive the biological state data sent by the second control unit, and determine the adjusted pulse configuration information according to the biological state data.

14. The implantable neural stimulation system according to claim 12, characterized in that: The second control unit is configured to send at least one preset pulse configuration information as the pulse configuration information to the first control unit in sequence when it is detected that the program-controlled device is not in communication connection with the energy providing device.

15. The implantable neural stimulation system according to claim 11, characterized in that: The second control unit is configured to determine adjusted pulse configuration information according to the biological state data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit.

16. The implantable neural stimulation system according to claim 11, characterized in that: At least one of the first electrodes is further used to collect bioelectric signals and send the bioelectric signals to the second control unit; The second control unit is further configured to determine adjusted pulse configuration information according to the bioelectric signal and the biological state data, and send the adjusted pulse configuration information as new pulse configuration information to the first control unit.

17. The implantable neural stimulation system according to claim 11, characterized in that: The collection device comprises: at least one second electrode, used to be attached to the surface of the target object to collect biological state data of the target object; The third control unit is connected to at least one of the second electrodes, and is used to obtain biological state data output by at least one of the second electrodes, and send the biological state data to the second control unit.

18. The implantable neural stimulation system according to claim 11 or 17, characterized in that: The collection device comprises: A fourth communication unit, used for communicating with the energy providing device; The second power receiving unit is used to receive the power output by the energy providing device to power the collection device.

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