Apparatus for stimulating peripheral nerve

Abstract

The present application relates to an apparatus (100) for stimulating a peripheral nerve. The apparatus comprises: an implantable electrode assembly (102), which can be implanted in the body of a patient, and is configured to apply a stimulation signal to a nerve. The implantable electrode assembly (102) comprises: a stimulation electrode (102a), which is fixed to a predetermined position of the body of the patient and is adjacent to a nerve therein, and is configured to operably apply a stimulation signal to the nerve; and an electrode circuit (102b), which is coupled to the stimulation electrode (102a), and is configured to receive stimulation energy in the form of an electromagnetic field, convert the stimulation energy into the stimulation signal and provide the stimulation signal to the stimulation electrode (102a), wherein the stimulation energy is from the outside of the implantable electrode assembly (102). The apparatus further comprises: a stimulation energy generator (104), which can be worn outside the body of the patient, so as to provide stimulation energy to the implantable electrode assembly (102) by means of electromagnetic field coupling. The stimulation energy generator (104) comprises: a generator circuit (658), which is used for generating stimulation energy in the form of an electromagnetic field; and a power source (660), which is coupled to the generator circuit (658), and is configured to supply power to the generator circuit (658).

Description

Devices for stimulating peripheral nerves

[0001] Related applications

[0002] This application claims priority to Chinese patent application number 202310640781.X, filed on May 31, 2023, entitled “Device for stimulating peripheral nerves,” the entire text of which is incorporated herein by reference. Technical Field

[0003] The present application relates to the technical field of medical devices, and in particular to a device for stimulating peripheral nerves. Background Art

[0004] Implantable neurostimulation devices are widely used in the diagnosis, monitoring, and treatment of diseases, such as cardiac pacemakers, brain pacemakers, defibrillators, neurostimulators, and so on. Taking a neurostimulator as an example, a pulse generator set in a closed housing is connected to electrodes through extended wires, thereby transmitting the electrical pulses generated by the pulse generator to electrodes arranged at specific positions to perform electrical stimulation at that position. A typical application scenario of a neurostimulator is deep brain neurostimulation, which treats diseases by electrically stimulating the patient's brain, such as Parkinson's syndrome, drug addiction, etc.

[0005] In addition to the brain, some neurostimulation devices for stimulating peripheral nerves have also appeared, such as for the treatment of neuropathic pain, overactive bladder, or some other diseases. Peripheral nerve stimulation, commonly known as PNS (Peripheral Nerve Stimulation), requires surgery to place a small electrode next to the peripheral nerve, and use it to transmit electrical pulses to the peripheral nerve to achieve the effect of neuroregulation. Traditional peripheral nerve stimulation devices often require the implantation of more components into the human body, including electrodes, pulse generators, extension wires, etc. These components need to be implanted separately through incisions, and the entire operation often requires 3 or more incisions. In addition, these implants are usually large in size, especially the implantation of the pulse generator, which requires a 4 to 5 cm incision in the upper chest. Larger wounds may also cause infection, pain and other adverse reactions in patients.

[0006] Therefore, there is a need for an improved device for stimulating peripheral nerves.

[0007] Summary of the Invention

[0008] According to various embodiments of the present application, a device for stimulating peripheral nerves is provided.

[0009] A device for stimulating peripheral nerves, comprising:

[0010] An implantable electrode assembly capable of being implanted in a patient's body and configured to apply a stimulation signal to the peripheral nerve; wherein the implantable electrode assembly comprises:

[0011] a stimulation electrode fixed to a predetermined location of the patient's body and adjacent to a nerve therein, the stimulation electrode being configured to operably apply a stimulation signal to the nerve; and

[0012] an electrode circuit coupled to the stimulation electrode and configured to receive stimulation energy in the form of an electromagnetic field, convert the stimulation energy into the stimulation signal, and provide the stimulation signal to the stimulation electrode, wherein the stimulation energy comes from outside the implantable electrode assembly;

[0013] A stimulation energy generator capable of being worn outside the patient's body to provide stimulation energy to the implantable electrode assembly through electromagnetic field coupling; wherein the stimulation energy generator comprises:

[0014] a generator circuit for generating stimulation energy in the form of an electromagnetic field; and

[0015] A power supply is coupled to the generator circuit and configured to supply power to the generator circuit.

[0016] In one embodiment, the stimulation electrode comprises:

[0017] an electrode sleeve, which is constructed as a sheath structure having a hollow channel, and the electrode sleeve is provided with openings along its circumference to allow the peripheral nerve to enter the electrode sleeve through the openings and be accommodated in the hollow channel of the electrode sleeve; and

[0018] The electrode contacts are exposed from the inner surface of the electrode sleeve to contact the peripheral nerves.

[0019] In one embodiment, the electrode sleeve has overlapping portions in its circumferential direction to allow the cross-sectional diameter of the electrode sleeve to vary.

[0020] In one embodiment, the stimulation electrode includes a plurality of electrode contacts, and the plurality of electrode contacts are arranged along the length direction of the electrode sleeve.

[0021] In one embodiment, each electrode contact of the stimulation electrode extends along the circumference of the electrode sleeve.

[0022] In one embodiment, the implantable electrode assembly further comprises:

[0023] A lead is configured to connect the electrode sleeve and the electrode circuit to achieve coupling between the stimulation electrode and the electrode circuit.

[0024] In one embodiment, the implantable electrode assembly further comprises:

[0025] The electrode circuit housing defines a cavity for accommodating the electrode circuit.

[0026] In one embodiment, the electrode circuit housing further comprises:

[0027] a housing body having an opening; and

[0028] A feedthrough cover is connected to the housing body at the opening, wherein the feedthrough cover is provided with a through hole to allow the electrode circuit to be led out from the electrode circuit housing.

[0029] In one embodiment, the housing body has an elongated shape, wherein the housing body has a metal ring portion on the opening side.

[0030] In one embodiment, the implantable electrode assembly further comprises:

[0031] An anchoring member is used to fix the electrode circuit housing inside the patient's body, wherein the anchoring member includes a butterfly buckle, which is configured to fix the electrode circuit housing to bones or muscles around a predetermined position of the patient's body.

[0032] In one embodiment, the implantable electrode assembly further comprises:

[0033] An anchoring member is used to fix the electrode circuit housing inside the patient's body. The anchoring member includes a binding wire configured to fix the electrode circuit housing to muscles around a predetermined position of the patient's body.

[0034] In one embodiment, the stimulation electrode comprises a plurality of electrode contacts, and the stimulation energy generator is further configured to provide a stimulation signal in the form of pulses to the plurality of electrode contacts sequentially or simultaneously through the electrode circuit.

[0035] In one embodiment, the maximum voltage amplitude of the pulse-shaped stimulation signal is 3V to 12V, the pulse width is 30us to 240us, and the pulse frequency is 0.1Hz to 50Hz.

[0036] In one embodiment, the stimulation energy generator further comprises:

[0037] The stimulation energy generator is further configured to indicate alignment of the stimulation energy generator with the implantable electrode assembly when the stimulation energy generator is aligned with the implantable electrode assembly.

[0038] In one embodiment, the apparatus further comprises:

[0039] The sensing element is configured to sense an abnormal state of the patient's body and generate a corresponding indication signal.

[0040] In one embodiment, the electrode circuit includes an electrode antenna.

[0041] In one embodiment, the apparatus further comprises:

[0042] An external controller is configured to adjust stimulation energy and provide the adjusted stimulation energy to the implantable electrode assembly through electromagnetic field coupling.

[0043] In one embodiment, the stimulation energy generator further comprises:

[0044] a generator housing configured to house at least a portion of the generator circuit and the power source; and

[0045] A patch is removably coupled to the generator housing.

[0046] In one embodiment, the generator circuit comprises a generator antenna, which is arranged in the patch.

[0047] In one embodiment, the patch comprises:

[0048] A connecting member is configured to removably couple to the generator housing.

[0049] In one embodiment, the generator housing comprises:

[0050] A generator housing upper portion and a generator housing lower portion together define a cavity for housing at least a portion of the generator circuit and the power supply.

[0051] In one embodiment, the generator circuit comprises:

[0052] A generator antenna is disposed in the generator housing.

[0053] In one embodiment, the generator circuit comprises:

[0054] Multiple generator antennas, at least one of the multiple generator antennas is arranged in the generator housing, and another generator antenna is arranged in the patch, and the generator antenna in the patch is used to relay the electromagnetic field coupling between the at least one generator antenna in the generator housing and the electrode antenna in the implantable electrode assembly.

[0055] In one embodiment, the implantable electrode assembly further comprises:

[0056] a housing body defining a cavity for accommodating the electrode circuit; and

[0057] The stimulation electrode comprises:

[0058] an electrode sleeve attached to the housing body and configured as a sheath structure having a hollow channel, wherein the electrode sleeve has openings along its circumference to allow the nerve to enter the electrode sleeve through the openings and be accommodated in the hollow channel of the electrode sleeve, and

[0059] The electrode contacts are exposed from the inner surface of the electrode sleeve to contact the peripheral nerves. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the following briefly introduces the drawings required for use in the embodiments or the conventional technology descriptions. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the disclosed drawings without any creative work.

[0061] FIG. 1 a and FIG. 1 b are schematic diagrams showing an application of a device 100 for stimulating peripheral nerves according to an embodiment of the present application.

[0062] FIG. 2 a shows a perspective view of an implantable electrode assembly according to an embodiment of the present application.

[0063] FIG2 b shows a cross-sectional view of a stimulation electrode of an implantable electrode assembly according to an embodiment of the present application.

[0064] FIG. 2 c shows an exploded view of an electrode circuit and its housing according to an embodiment of the present application.

[0065] FIG. 3 a shows a perspective view of an implantable electrode assembly 310 according to one embodiment of the present application.

[0066] FIG3 b shows a cross-sectional view of the implantable electrode assembly 310 according to one embodiment of the present application.

[0067] FIG4 shows a schematic structural diagram of an implantable electrode assembly according to another embodiment of the present application.

[0068] 5a and 5b are schematic structural diagrams showing an implantable electrode assembly according to another embodiment of the present application.

[0069] FIG6 a and FIG6 b show schematic structural diagrams of a stimulation energy generator according to an embodiment of the present application.

[0070] 7a to 7g illustrate various exemplary configurations of stimulation energy generators according to some embodiments of the present application. DETAILED DESCRIPTION

[0071] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0072] Figures 1a and 1b show a device 100 for stimulating peripheral nerves according to an embodiment of the present application. In the embodiment shown in Figure 1a, a portion of the components of the device 100 are arranged on the patient's head 10, for example, on the patient's mandible 12, which can be used to stimulate the hypoglossal nerve to treat obstructive sleep apnea (OSA). When in use, the device 100 can stimulate the patient's tongue 14 by stimulating one or more nerves in the hypoglossal nerve and cause it to produce a single-dimensional forward or lifting movement, thereby increasing the ventilation volume of the patient's breathing, thereby avoiding or reducing apnea (temporary cessation of breathing) and / or hypopnea (slow or shallow breathing) during the patient's sleep.

[0073] Those skilled in the art will appreciate that the device for stimulating peripheral nerves of the present application is not limited to the aforementioned application of hypoglossal nerve stimulation, and can also be used for various suitable diseases or indications. For example, the device can be used to stimulate the occipital nerve to treat neuropathic pain or migraine; can be used to stimulate the tibial nerve to treat overactive bladder; can be used to stimulate the vagus nerve to treat or improve epilepsy or depression; can be used to stimulate the phrenic nerve to treat respiratory insufficiency caused by phrenic nerve control disorders; and can also be used to stimulate the sacral nerve to treat urinary incontinence and various other neurogenic bladder diseases.

[0074] Taking sacral nerve stimulation as an example, sacral nerve stimulation can affect the action of the bladder detrusor muscle and the external urethral sphincter, so that a suitable stimulation signal can be applied by a nerve stimulation device to inhibit the hyperreflexia of the bladder detrusor muscle and achieve the purpose of alleviating urinary incontinence; optionally, the stimulation signal can adopt a specific stimulation pulse sequence, which can stimulate the coordinated action of the bladder detrusor muscle and the external urethral sphincter to achieve controlled urination. When in use, the implantable electrode assembly of the sacral nerve stimulation device can be implanted in the patient's calf and adjacent to the sacral nerve, while the external stimulation energy generator can be worn on the outside of the calf, which can send and apply pulse stimulation signals to the sacral nerve through the implantable electrode assembly, regulate the bladder and intestinal nerve reflexes related to urination and defecation, and restore the abnormal nerve reflexes to balance. Optionally, the patient can control the switch and program settings of the stimulation energy generator through an external controller similar to a remote control, thereby starting or adjusting the nerve stimulation function as needed.

[0075] Unlike the central nervous system, the aforementioned peripheral nerves are generally located outside the brain or spinal cord, with a thinner diameter and a wider and denser distribution of their ends. Adapting to these peripheral nerves, the neurostimulation device according to the embodiment of the present application can adopt a smaller-sized and specially structured in-vivo stimulation electrode assembly, so that the stimulation electrode has a better fit with the peripheral nerves; in addition, the stimulation electrode generally adopts a sleeve structure, which allows the contacts of the stimulation electrode to be distributed circumferentially around the peripheral nerves, thereby more accurately transmitting the electrical stimulation signal to the designated nerve bundle and achieving refined regulation; the small-sized electrode structure allows it to be implanted and anchored near the peripheral nerves, so that a streamlined lead design can be adopted; in addition, the implantation near the peripheral nerves is usually close to the body surface (for example, less than 10 cm), so an external wireless power supply method can be used to apply stimulation energy to the implanted electrode. In the following, the neurostimulation device of the present application will be further explained by taking hypoglossal nerve stimulation as an example. However, those skilled in the art will understand that the neurostimulation device of the present application can be set in other parts of the patient's body in the same or similar manner, and stimulate the peripheral nerves in these parts to treat corresponding diseases.

[0076] Still referring to FIG. 1a , the neurostimulation device 100 includes an implantable electrode assembly implanted in a patient's body, generally located at a predetermined location in the patient's body (e.g., under the tongue), and configured to apply a stimulation signal to the nerve at the predetermined location. In the embodiment shown in FIG. 1a , the implantable electrode assembly has a split structure and may include a stimulation electrode 102a and an electrode circuit 102b, which may be interconnected via a lead. In some embodiments, the stimulation electrode 102a is constructed as a sleeve electrode that can be wrapped around the outside of a peripheral nerve segment, thereby operatively applying a stimulation signal (e.g., a stimulating electrical pulse) to the peripheral nerve from one or more stimulation contacts on the outside of the peripheral nerve segment; while the electrode circuit 102b is used to receive stimulation energy in the form of an electromagnetic field outside the patient's body, convert the stimulation energy into a stimulation signal, and provide it to the stimulation electrode 102a. Accordingly, the neurostimulation device 100 also includes a stimulation energy generator 104 that can be worn outside the patient's body (e.g., on the skin surface outside the mandible 12) to provide stimulation energy to the implantable electrode assembly via electromagnetic field coupling. It should be noted that although FIG1a only shows that the implantable electrode assembly includes one stimulation electrode 102a, in some other embodiments, the implantable electrode assembly may also include another number of stimulation electrodes, such as two, three, or more, which are respectively disposed at different segments of a substantially adjacent peripheral nerve and are coupled to each other via separate leads, or coupled to the electrode circuit 102b via separate leads. In this way, the electrode circuit 102b can provide corresponding stimulation signals to these stimulation electrodes 102a, such as applying stimulation signals simultaneously or applying stimulation signals in a time-sharing manner, and the applied stimulation signals can be the same or different.

[0077] Figure 1b shows a module schematic diagram of a neurostimulation device 100 according to an embodiment of the present application. As shown in Figure 1b, in addition to the implantable electrode assembly 102 and the stimulation energy generator 104, the neurostimulation device 100 may also include some other components to achieve the configuration and in vitro control of the neurostimulation device 100. Optionally, the neurostimulation device 100 may include a charger 106, which is used to charge the stimulation energy generator 104, especially when a rechargeable power supply is used in the stimulation energy generator 104. For example, when the patient does not need neurostimulation treatment (for example, when the patient is not in a sleeping state), the stimulation energy generator 104 can be removed from the patient's body and connected to the charger 106 for charging.

[0078] In some embodiments, the neurostimulation device 100 may further include a patient controller 108 that can wirelessly communicate with the stimulation energy generator 104 to monitor the operating status of the stimulation energy generator 104, such as monitoring the power level of the power supply, or allow the patient to configure certain parameters of the operation of the stimulation energy generator 104, such as configuring the maximum voltage amplitude, pulse width, pulse frequency, device operating time, etc. of the stimulation signal. It will be understood that in some cases, particularly when the stimulation energy generator 104 fails or is in an abnormal state, the patient controller 108 may also receive a corresponding alarm signal from the stimulation energy generator 104 and notify the patient of the failure or abnormal state. In some embodiments, the patient controller 108 may be a dedicated hardware device. In other embodiments, the patient controller 108 may also be implemented as software or an application that can run on a smartphone, tablet computer, or other similar general-purpose hardware device, and utilize the software and hardware processing capabilities of these general-purpose hardware devices to implement the functions of the patient controller. For example, the stimulation energy generator 104 can be integrated with a Bluetooth module or a communication module that complies with a similar wireless communication protocol, or integrated with a communication module that complies with a USB, Type-C protocol or a similar wired communication protocol, so that it can communicate with the patient controller 108 or similar devices through these communication modules.

[0079] In some embodiments, the neurostimulation device 100 may further include a medical stimulator 110 and a medical regulator 112, which, for example, can be operated by a physician to configure or control the operation of the implantable electrode assembly 102 and the stimulation energy generator 104. In particular, during surgery to place the implantable electrode assembly 102 in the patient's body, the medical stimulator 110 can temporarily replace the stimulation energy generator 104 to electromagnetically couple with the implantable electrode assembly 102 and provide stimulation energy thereto. In this way, the physician can understand the placement of the implantable electrode assembly 102 and whether the contact between the electrode and the peripheral nerve is effective during surgery, and can adjust the position of the implantable electrode assembly 102 in the body in a timely manner to achieve the optimal implantation effect. The medical regulator 112 can communicate with the medical stimulator 110 in a wireless or wired manner to control the medical stimulator 110, such as configuring the maximum voltage amplitude, pulse width, pulse frequency, etc. of the stimulation signal applied during surgery or during regular patient follow-up. In some embodiments, the medical regulator 112 and the medical stimulator 110 can be used for regular follow-up visits of patients, typically 1 week, 2 weeks, 4 weeks, etc. after the implantation surgery. This process is also referred to as "titration". During the follow-up process, the doctor can perform titration again once or multiple times. During each titration process, the medical regulator 112 can automatically analyze the patient's relevant historical data, establish a lookup table of the linear relationship between the neural interface impedance, the stimulation threshold voltage, and the stimulation parameters, and after calculating the new neural interface impedance, the parameters of the stimulation signal to be adjusted can be obtained by querying the lookup table. The medical regulator 112 can be configured in the stimulation energy generator 104 for daily treatment of the patient. It will be understood that the medical regulator 112 can be used in conjunction with the medical stimulator 110 (which is typically a desktop device rather than a wearable device), but it can also be used in conjunction with the stimulation energy generator 104, for example, in a manner similar to that of the patient controller 108.

[0080] In some embodiments, an external controller used outside the patient's body, such as the patient controller 108 or the medical regulator 112, can not only adjust the stimulation energy, but also receive the patient's physiological signals and adjust the stimulation energy to be applied to the patient's body according to changes in the patient's physiological signals. For example, the patient's physiological signals can be changes in the impedance of a portion of the patient's body tissue (e.g., body tissue adjacent to the peripheral nerve to be stimulated) sensed and collected by the implantable electrode assembly. To adapt to certain impedance changes, for example, when the impedance decreases, the voltage amplitude of the stimulation signal applied to the peripheral nerve can be reduced to avoid excessive current damaging the patient's body tissue; for example, when the impedance increases, the voltage amplitude of the stimulation signal applied to the peripheral nerve can be increased to meet the minimum threshold requirement for nerve stimulation, avoiding the nerve from being effectively stimulated and failing to achieve a therapeutic effect. In some other examples, the patient's physiological signals can also be detected by additional sensing elements disposed inside or outside the patient's body. These additional sensing elements can be communicatively coupled to the stimulation energy generator 104 to provide it with the detected patient's physiological signals. For example, the sensor element can be used to detect the patient's breathing rhythm or the movement of the patient's external urinary sphincter. These physiological signals can be used to adjust the stimulation duration. Generally speaking, when muscle control is required, the stimulation duration can be minimized to better protect the patient's tissue from damage caused by prolonged stimulation.

[0081] As mentioned above, in some embodiments, the neurostimulation device 100 may further include a sensing element, which may be integrated on the implantable electrode assembly or on the stimulation energy generator, or may be constructed as a separate component (which may be placed on the patient's body). For applications of hypoglossal nerve stimulation, the sensing element may sense abnormal conditions of the patient's tongue (e.g., abnormal conditions of the tongue muscles or nerve tissue) and generate corresponding indication signals. In some embodiments, the sensing element may be an accelerometer that detects abnormal conditions such as apnea or hypopnea that occur during the patient's sleep by detecting the movement of the patient's head. Accordingly, based on the physiological signal reflecting the abnormal condition generated by the sensing element (e.g., when the patient is breathing abnormally), the stimulation energy generator may be allowed to apply stimulation energy to the patient; whereas in other cases (e.g., when the patient is breathing normally), no stimulation signal may be applied.

[0082] It will be appreciated that FIG1b merely illustrates some components of the neurostimulation device 100 according to some embodiments of the present application. Aside from the implantable electrode assembly 102 and the stimulation energy generator 104, the other components are not essential. A physician, patient, or other personnel may select one or more of these components based on practical circumstances.

[0083] Figures 2a to 2c illustrate an example of the implantable electrode assembly shown in Figure 1a, wherein Figure 2a is a perspective view of the implantable electrode assembly, Figure 2b is a cross-sectional view of the stimulation electrode of the implantable electrode assembly, and Figure 2c is an exploded view of the electrode circuit and its housing.

[0084] As shown in Figure 2a, the implantable electrode assembly includes a stimulation electrode 102a and an electrode circuit 102b, which are coupled to each other via a lead 102c. In some embodiments, the lead 102c can be made of a flexible material (e.g., silicone) and encapsulate the conductive wire. This allows the spacing between the stimulation electrode 102a and the electrode circuit 102b to be adjusted to a certain extent to accommodate different positioning requirements.

[0085] 2a and 2b , the stimulation electrode 102a includes an electrode sheath 202, which is constructed as a sheath structure having a hollow channel. The electrode sheath 202 has an opening 204 along its circumference, allowing nerves to enter the electrode sheath 202 through the opening 204 and be contained within the hollow channel of the electrode sheath 202. In some embodiments, the electrode sheath 202 can be made of a flexible material, or optionally a biocompatible flexible material, such as silicone or polyurethane, which can provide electrode fixation while avoiding damage to the patient's nerves or other adjacent tissues. In some embodiments, the electrode sheath 202 has a size comparable to that of the peripheral nerve to be stimulated. For example, in a relaxed state, the diameter of the electrode sheath 202 is approximately 50% to 98%, and optionally 80% to 95%, of the diameter of the peripheral nerve. Thus, when implanted in a patient and wrapped around a peripheral nerve, the electrode sheath 202 can slightly expand outward and generate pressure toward the peripheral nerve, which allows the electrode sheath 202 to be more securely fixed to the peripheral nerve and prevent it from sliding on the peripheral nerve due to patient body movements. In some embodiments, the electrode sheath 202 has overlapping portions in its circumferential direction to allow for variations in the cross-sectional diameter of the electrode sheath. Thus, even if the electrode sheath 202 slightly expands outward to accommodate the peripheral nerve, the electrode sheath 202 can still substantially completely enclose the nerve without forming a significant circumferential gap, thereby ensuring sufficient contact between the electrode sheath 202 and the peripheral nerve.

[0086] The stimulation electrode 102a also includes an electrode contact 206 that is exposed from the inner surface of the electrode sheath 202 to contact the nerve. In some embodiments, the electrode sheath 202 can have a certain length so that when it is attached to the peripheral nerve, the electrode contact 206 can extend a certain length along the length of the peripheral nerve. The stimulation electrode 102a can also include multiple electrode contacts 206, such as the three electrode contacts 206 shown in Figure 2b, which are arranged along the length of the electrode sheath 202. Multiple electrode contacts 206 can not only apply stimulation signals alternately to provide more possible treatment options, but also increase the contact between the stimulation electrode 102a and the peripheral nerve, further improving the stability and reliability of the use of the neurostimulation device. Alternatively, each electrode contact in the stimulation electrode can also extend along the circumferential direction of the electrode sheath 202, or extend in a spiral manner in the electrode sheath 202. It will be understood that the distribution and configuration of the electrode contacts 206 can be configured according to the sensitive section of the peripheral nerve to be stimulated.

[0087] In some embodiments, the stimulation electrode includes a plurality of electrode contacts, and the stimulation energy generator can sequentially provide stimulation energy in the form of pulses to the plurality of electrode contacts through an electrode circuit, wherein the electrode circuit can convert the stimulation energy into stimulation signals in the form of pulses in sequence. In other embodiments, the stimulation energy generator can also simultaneously provide stimulation energy in the form of pulses to the plurality of electrode contacts, wherein the electrode circuit can convert the stimulation energy into stimulation signals in the form of pulses. Optionally, the maximum voltage amplitude of the stimulation signal in the form of pulses is 3V to 12V, the pulse width is 30us to 240us, and the frequency of the stimulation pulses is 0.1Hz to 50Hz.

[0088] Still referring to Figure 2a, the electrode circuit 102b is housed in an electrode circuit housing. The electrode circuit housing can be sealed to encapsulate the electrode circuit 102b and prevent liquids from penetrating the housing and affecting or disrupting the normal operation of the electrode circuit 102b. The structure of the electrode circuit 102b and its housing will be further described below. With the aid of the electrode circuit housing, the electrode circuit 102b can be implanted in the patient's body, adjacent to the stimulation electrode 102a. In some embodiments, the electrode circuit housing can be secured to the patient's body using rivets to enhance the stability and securement of the electrode circuit 102b within the body. In some embodiments, the anchoring member can include a butterfly clasp configured to secure the electrode circuit housing to bone or muscle around a predetermined location in the patient's body. The butterfly clasp has through-holes on both sides for screws to pass through and drill into the bone, thereby securing the electrode circuit housing to the bone. Optionally, the through-holes in the butterfly clasp can also serve as anchor holes for surgical sutures. After passing through the through-holes, the sutures are secured to the muscle tissue at both ends, thereby securing the implant to the muscle. In other embodiments, the anchoring member includes a binding wire, which is configured to fix the electrode circuit housing to the muscle around a predetermined position on the patient's body. A groove may be provided on the outer surface of the electrode circuit housing, and the binding wire can be fixed in the groove by winding, and the two ends of the binding wire can be sutured into the muscle tissue to fix the electrode circuit housing to the muscle. It can be understood that various suitable anchoring members can be used to fix the electrode circuit and its housing. In some embodiments, the anchoring member can be composed of a biodegradable material. The anchoring structure can be a metal material or a polymer material; the metal material can be a titanium alloy; the polymer material can be an absorbable material such as polycaprolactone (PCL), polylactic-co-glycolic acid (PLGA), racemic polylactic acid (PDLLA), poly-L-lactic acid (PLLA), polydioxanone (PDO), etc., which can be absorbed by human tissue during the healing process, further reducing damage to the tissue and improving the patient's recovery.

[0089] Refer to Figure 2c, which shows a schematic diagram of an electrode circuit and its housing. In some embodiments, the electrode circuit may include a circuit substrate 212, on which various electronic components 214 (e.g., passive components such as capacitors, resistors, and switches, or active components such as amplifiers and transistors) constituting the electrode circuit may be mounted and interconnected. Furthermore, the electrode circuit may include an electrode antenna 216, electrically coupled to the electronic components 214 and optionally mounted on the circuit substrate 212, to receive stimulation energy in the form of an external electromagnetic field and generate induced electric potential energy. This induced electric potential energy can be converted into a stimulation signal by the electrode circuit formed by the electronic components 214 and provided to an output terminal of the electrode circuit. The output terminal can be coupled to an electrode contact via a conductive wire, so that the stimulation signal can be applied to the patient's peripheral nerves via the electrode contact. Those skilled in the art will appreciate that the electrode circuit is a circuit for receiving radio-magnetic field energy and converting it into a pulse signal of a predetermined form. Any suitable circuit design may be used to implement the electrode circuit, and this application does not describe this in detail. In some embodiments, the electrode antenna 216 may employ a helical antenna design. Helical antennas have a compact structure, making them suitable for reducing the volume of the electrode circuit and its housing.

[0090] The electrode circuit housing may include a housing body 220 having an opening at one end to allow components such as the circuit substrate 212 and the electrode antenna 216 to be placed inside the housing body 220. The electrode circuit housing also includes a feedthrough cover 218, which is connected to the housing body 220 at the opening of the housing body 220. The feedthrough cover 218 is provided with a through hole to allow the electrode circuit (e.g., the output terminal of the electrode circuit) to be led out of the electrode circuit housing. In some embodiments, the housing body 220 has an electrode antenna, such as the shape of a hollow cylinder shown in FIG2c, and the housing body 220 has a metal ring portion on the opening side, which serves as a buffer and connection area between the housing body 220 and the feedthrough cover 218. In some embodiments, in addition to the metal ring portion, the housing body 220 and the feedthrough cover 218 can be formed of dielectric materials such as ceramics and polymers, which can provide sufficient electrical isolation performance while maintaining airtightness and do not affect the electrode antenna 216 therein from receiving external electromagnetic field energy.

[0091] As previously mentioned, for the implantable electrode assembly shown in FIG2a , the stimulation electrode 102a and the electrode circuit 102b can be coupled using the lead 102c. This allows the induction of the electromagnetic field and the application of the stimulation signal to be at different locations, thereby increasing the flexibility of the configuration of the implantable electrode assembly. However, in some alternative embodiments, the implantable electrode assembly may also use an integrated stimulation electrode and electrode circuit, that is, the stimulation electrode and the electrode circuit are encapsulated in the same housing without being connected to each other via leads. This helps to simplify the structure of the implantable electrode assembly and reduce the complexity of surgical placement of the implantable electrode assembly in the patient's body.

[0092] Figures 3a and 3b illustrate an implantable electrode assembly 310 according to one embodiment of the present application, which employs an integrated structure. Figure 3a is a perspective view of the implantable electrode assembly 310, while Figure 3b is a cross-sectional view of the implantable electrode assembly 310. In some examples, the implantable electrode assembly 310 can be placed near a patient's peripheral nerves and close to the body surface, thereby receiving electromagnetic field energy from an external source and applying corresponding stimulation energy to the peripheral nerves.

[0093] As shown in Figures 3a and 3b, the implantable electrode assembly 310 includes a housing body 312 for housing an electrode circuit (not shown) and an electrode antenna 320. The housing body 312 can have an elongated shape, such as a truncated cylinder or a prism. Optionally, the housing body 312 can include multiple cavities, such as the circuit cavity 313 and antenna cavity 314 shown in Figure 3b, wherein the electronic components and substrate in the electrode circuit can be placed in the circuit cavity 313, and the electrode antenna 320 can be placed in the antenna cavity 314. The electrode antenna 320 can be coupled to the electrode circuit via a conductive wire (not shown). Optionally, the circuit cavity 313 can be partially composed of metal or a similar material, such as having a layer of metal material covering its inner wall, which can improve the shielding performance of the circuit cavity 313 against external electromagnetic waves; while the antenna cavity 314 does not have such electromagnetic shielding material, thereby allowing the electrode antenna 320 to receive electromagnetic field energy from the outside. In some alternative embodiments, the housing body 312 may define only one cavity for accommodating the electronic components, substrate, and electrode antenna 320. The housing body 312 may be made of various suitable materials, such as biocompatible metals (e.g., titanium alloys), polymer materials (e.g., polyimide, polyester resin, etc.), ceramic materials (e.g., zirconium oxide or aluminum oxide ceramic materials, etc.), or other suitable materials. It will be appreciated that in some embodiments, the multiple cavities in the housing body 312 may be separately machined and then connected together (e.g., by welding, bonding, riveting, or other connection methods), or may be integrally formed.

[0094] The implantable electrode assembly 310 also includes an electrode sleeve 316, which is configured in a generally hollow cylindrical shape and extends along the length of the housing body 312. The electrode sleeve 316 may have an opening that divides the electrode sleeve 316 into two sections, each of which is secured to the housing body 312 at one end and extends away from the housing body 312 to the opening, thereby allowing a peripheral nerve to pass through the opening and be received in the electrode sleeve 316. In the embodiment shown in Figures 3a and 3b, the two sections of the electrode sleeve 316 each have a comb-like edge 318 adjacent to the opening, which can engage with each other to securely secure the electrode sleeve 316 to the peripheral nerve and allow the diameter of the electrode sleeve 316 to vary slightly to accommodate peripheral nerves of varying diameters. The number of engaging teeth on each comb-like edge 318 can be equal or unequal. In some embodiments, the length of the electrode sleeve 316 is shorter than the length of the housing body 312, thereby allowing the antenna cavity 314 of the housing body 312 to extend beyond the electrode sleeve 316. In this way, the electrode antenna 320 housed in the antenna cavity 314 will not be blocked by the electrode sleeve 316, and can therefore better receive external electromagnetic field energy. In some embodiments, the electrode sleeve 316 can be a flexible material, or a flexible material with biocompatibility, such as silicone, polyurethane material, etc.; for example, the electrode sleeve 316 can be connected to the shell body 312 by injection molding, bonding or melting. In some optional embodiments, the electrode sleeve 316 can extend beyond the shell body 312, for example, extending beyond the shell body 312 from one end away from the antenna cavity 314. In this way, the length of the electrode sleeve 316 is not limited to the length of the shell body 312, and it can be extended to a sufficient length according to the length of a section of the peripheral nerve to be stimulated to ensure sufficient and effective contact with the peripheral nerve.

[0095] On the inner surface of the electrode sheath 316 near the housing body 312, a plurality of electrode contacts 322 are exposed, enabling contact with a segment of the peripheral nerve encapsulated by the electrode sheath 316. The electrode contacts 322 are generally distributed along the extension direction of the electrode sheath 316 and the housing body 312 to increase the contact length between the peripheral nerve and the implantable electrode assembly 310. These electrode contacts 322 can be coupled to the electrode circuit in the circuit cavity 313 of the housing body 312 via conductive wires to receive stimulation signals therefrom. Although in FIG3 b , the electrode contacts 322 only occupy a small portion of the circumferential length of the electrode sheath 316, in some other embodiments, the electrode contacts 322 may extend along a longer length of the circumference of the electrode sheath 316, for example, occupying approximately 20%, 40%, 60%, 80%, 90%, or more of the circumference of the electrode sheath 316.

[0096] Figure 4 shows an implantable electrode assembly 410 according to another embodiment of the present application, which adopts an integrated structure similar to the implantable electrode assembly 310 in Figures 3a and 3b, except that the opening of the electrode sleeve 416 does not adopt a comb-like edge, but instead adopts a structure with overlapping edges similar to the electrode sleeve 202 in Figure 2a.

[0097] Figures 5a and 5b show an implantable electrode assembly 510 according to another embodiment of the present application, which also adopts an integrated structural structure. Figure 5a is a perspective view of the implantable electrode assembly 510, and Figure 5b is a cross-sectional view of the implantable electrode assembly 510. Different from the single-sided electrode antenna of the implantable electrode assembly 310 in Figures 3a and 3b, the implantable electrode assembly 510 shown in Figures 5a and 5b adopts a double-sided electrode antenna, that is, at both ends in the extension direction of the electrode shell 512, two electrode antennas 520a and 520b are respectively accommodated in corresponding antenna cavities 514a and 514b, and these two antennas 520a and 520b do not basically overlap with the electrode sleeve 516. The use of two electrode antennas can improve the ability of the implantable electrode assembly 510 to receive external electromagnetic field energy. In the embodiment shown in Figure 5b, the winding directions of the two electrode antennas 520a and 520b are substantially the same; in some alternative embodiments, the winding directions of the two electrode antennas 520a and 520b may also be different, for example, perpendicular to each other or at other angles, which can reduce the placement requirements of the implantable electrode assembly 510 in the patient's body, especially the orientation requirements relative to the external energy generator.

[0098] Returning to Figure 1a, in conjunction with the implantable electrode assembly, the stimulation energy generator 104 is worn outside the patient's body to provide stimulation energy to the implantable electrode assembly in the patient's body through electromagnetic field coupling. Since it needs to be worn outside the patient's body, for example, in the form of a patch, the stimulation energy generator 104 can adopt a split structure, that is, it includes a patch for wearing and usually disposable, and a generator housing for accommodating the electronic components of the stimulation energy generator and usually reusable. In this way, at least a portion of the components of the stimulation energy generator 104 can be reused, thereby saving usage costs. In some embodiments, the stimulation energy generator 104 may include a generator circuit for generating stimulation energy in the form of an electromagnetic field, and a power supply coupled to the generator circuit and configured to supply power to the generator circuit. At least a portion of the generator circuit and the power supply can be accommodated in the generator housing.

[0099] 6a and 6b show an example of a stimulation energy generator 650 according to an embodiment of the present application. The stimulation energy generator 650 adopts a split structure.

[0100] Optionally, as shown in FIG6a , the stimulation energy generator 650 includes a patch 652 that can be affixed to the patient's body surface to secure the stimulation energy generator 650 outside the patient's body, typically in a location near the implantable electrode assembly. The stimulation energy generator 650 also includes a generator circuit housing. In FIG6a , the generator circuit housing is composed of a generator circuit housing lower portion 654 and a generator circuit housing upper portion 656 , which together define a cavity for accommodating at least a portion of a generator circuit 658 and a power supply 660 . The generator circuit 658 is the primary controller of the stimulation energy generator 650 and is primarily used to generate the stimulation energy required for peripheral nerve stimulation. Optionally, the generator circuit 658 may also have other functions, such as switching the stimulation energy generator 650 and displaying its status, and a display module (e.g., an LCD or LED display device) may be mounted thereon. During use, the patient can observe the display module on the generator circuit 658 through a light-transmissive window on the generator circuit housing upper portion 656 to understand the operating status of the stimulation energy generator 650.

[0101] To transmit an electromagnetic field to the implanted electrode assembly in the body, the stimulation energy generator also includes a generator antenna 664. In the example shown in Figures 6a and 6b, the generator antenna 664 is disposed on the patch 652, for example, attached to or sandwiched between a patch layer 666 (only one patch layer 666 is shown in the figure, but two or more patch layers may be used). The patch layer 666 may be made of, for example, a hydrogel, a fabric material, or the like. Accordingly, the generator circuit 658 located within the generator circuit housing does not include the generator antenna 664, but is coupled to the generator antenna 664 via a conductive line. Alternatively, the generator circuit 658 may be coupled to the generator antenna 664 via an electrical interface located in the lower portion 654 of the generator circuit housing and a connecting member 662 located on the patch 652. The connecting member 662 can be connected to the lower portion 654 of the generator circuit housing, for example, in a snap-fit ​​manner, thereby allowing the patch 652 to be removably coupled to the generator circuit housing and establishing an electrical connection between the generator circuit 658 and the generator antenna 664. In this way, stimulation energy from the generator circuit 658 can be radiated into the space surrounding the generator antenna 664 in the form of an electromagnetic field, so that it can be coupled and received by the implantable electrode assembly. In some embodiments, the power supply 660 can be a disposable battery that can be replaced when the battery is low. In alternative embodiments, the power supply 660 can also be a rechargeable battery, and the generator circuit 658 can be integrated with a charging control module and functionality to control the charging of the power supply 660, or it can be charged by an external charger. Optionally, the generator antenna 664 can also be compatible with existing wireless charging technology, so that the power supply 660 can be charged by receiving external energy through the generator antenna 664.

[0102] In the patch 652 shown in FIG6 b , the generator antenna 664 uses a planar antenna coil, and the generator antenna 664 is not set at other positions of the stimulation energy generator 650 ; however, it can be understood that in some other embodiments, the stimulation energy generator 650 may also use other antenna coil settings.

[0103] To ensure efficient coupling between the generator antenna 664 and the electrode antenna in the implantable electrode assembly, the distance between the two antennas can be 0.5 cm to 5 cm. In some embodiments, to measure and determine the coupling efficiency between the external and internal antennas, the stimulation energy generator can further include an indicator member capable of indicating alignment of the two when the stimulation energy generator is aligned with the implantable electrode assembly. For example, the stimulation energy generator can include a circuit module that detects electromagnetic coupling. When a change in the position between the two antennas causes a change in the degree of electromagnetic coupling, the circuit module can generate a corresponding coupling detection signal. Thus, when the coupling detection signal indicates that the electromagnetic coupling between the antennas meets predetermined requirements, the indicator member can generate a corresponding alignment prompt signal, such as in the form of vibration, sound, or light. This makes it more convenient for the patient to wear the external stimulation energy generator and avoids the impact of poor antenna alignment on the delivery of stimulation energy. It is understood that in some cases, particularly when the electromagnetic coupling between the antennas does not meet predetermined requirements, the indicator member can continuously generate a corresponding alignment prompt signal, such as by continuous vibration. This can alert the patient to poor antenna alignment and the need to adjust their posture or the position of the stimulation energy generator to meet the required antenna alignment. For example, when a patient is sleeping, if excessive rotation of the patient's head causes mismatch between the stimulation energy generator and the antenna of the implantable electrode assembly, the indicator member may vibrate continuously to prompt the patient to adjust his sleeping posture.

[0104] 7a to 7g illustrate various exemplary configurations of a stimulation energy generator according to some embodiments of the present application, which employ configurations different from those shown in FIG. 6a and FIG. 6b .

[0105] As shown in Figure 7a, the stimulation energy generator 710 adopts a split structure, which includes a patch 711 and a generator housing 712 coupled to the patch 711. The generator antenna 713 and the generator circuit 714 are both arranged inside the generator housing 712 and are coupled to each other by a conductive wire 715. In this way, the patch 711 mainly acts as a fixing mechanism and may not include electronic components, thereby further increasing the number of reusable components and reducing the cost of use. Optionally, the generator antenna 713 can adopt the structure of a planar antenna coil. In this case, the generator antenna 713 can be set as close to the bottom of the generator housing 712 as possible to reduce its distance from the electrode antenna in the body.

[0106] As shown in FIG7 b , the stimulation energy generator 720 adopts a split structure, which includes a patch 721 and a generator housing 722 coupled to the patch 721. The stimulation energy generator 720 also includes a generator circuit 724, and a proximal generator antenna 723 and a distal generator antenna 726 coupled to the generator circuit 724. The two generator antennas 723 and 726 are located on both sides of the generator circuit 724 and are coupled to the generator circuit 724 via respective conductive wires 725. The generator antennas 723 and 726 and the generator circuit 724 are all disposed within the generator housing 722. The use of two antennas can improve the electromagnetic coupling between the stimulation energy generator 720 and the implantable electrode assembly in the body, thereby saving power consumption of the stimulation energy generator 720 or increasing the amplitude of the stimulation signal. In some embodiments, at least one of the generator antennas 723 and 726 can be constructed as a three-dimensional antenna coil, which helps adjust the strength and uniformity of the electromagnetic field to achieve maximum magnetic field strength and uniform magnetic field distribution. In this way, even if a certain longitudinal offset occurs between the stimulation energy generator 720 and the implantable electrode assembly, this can be compensated through electromagnetic field adjustment, thereby providing excellent anti-drift capability.

[0107] As shown in Figure 7c, the stimulation energy generator 730 employs a split-body structure, comprising a patch 731 and a generator housing 732 coupled to the patch 731. A generator antenna 733 and a generator circuit 734 are disposed within the patch 731 and the generator housing 732, respectively, and are coupled to each other via conductive wires 735. In some embodiments, the generator antenna 733 may be constructed as a three-dimensional antenna coil.

[0108] As shown in Figure 7d, the stimulation energy generator 740 employs a split-body structure, comprising a patch 741 and a generator housing 742 coupled to the patch 741. A proximal generator antenna 743 is disposed within the patch 741 and optionally employs a planar antenna coil configuration. Furthermore, the stimulation energy generator 740 includes a distal generator antenna 746, which is disposed within the generator housing 742 along with the generator circuit 744 and is coupled to each other via a conductive wire 745. In some embodiments, both the proximal generator antenna 743 and the distal generator antenna 746 can employ a three-dimensional antenna coil configuration. In some optional embodiments, the proximal generator antenna 743, located closer to the patient's body, can serve as a relay antenna, receiving stimulation energy in the form of an electromagnetic field emitted by the distal generator antenna 746 and forwarding it to the patient's implanted electrode assembly. This antenna relay configuration further enhances the flexibility of the internal structure and circuit design of the stimulation energy generator 740. In addition, when the proximal generator antenna 743 is used as a relay antenna, the patch 741 may not be electrically connected to the generator circuit 744, avoiding electrical losses in the interface, thereby achieving low-cost manufacturing and compensating for the lateral offset between the distal generator antenna 746 and the electrode antenna of the implantable electrode assembly.

[0109] As shown in FIG7e , the stimulation energy generator 750 employs a split-body structure, comprising a patch 751 and a generator housing 752 coupled to the patch 751. A proximal generator antenna 753 is disposed within the patch 751 and may optionally employ a planar antenna coil configuration. Furthermore, the stimulation energy generator 750 includes two distal generator antennas 756 and 757, which are disposed within the generator housing 752 along with the generator circuit 754 and are positioned on either side of the generator circuit 754. Generator antennas 756 and 757 are coupled to the generator circuit 754 via respective conductive lines 755, while generator antenna 753 may or may not be coupled to the generator circuit 754. In some embodiments, the two distal generator antennas 756 and 757 within the generator housing 752 may each employ a three-dimensional antenna coil configuration, while the proximal generator antenna 753, located within the patch 751, may employ a planar antenna coil configuration. In some optional embodiments, the proximal generator antenna 753, which is closer to the patient's body, can serve as a relay antenna, in which case it may not be coupled to the generator circuit 754 via a conductive wire.

[0110] As shown in FIG7f , stimulation energy generator 760 employs a split-body structure, comprising a patch 761 and a generator housing 762 coupled to patch 761. Similar to stimulation energy generator 750 shown in FIG7e , two generator antennas are disposed within generator housing 762 on either side of the generator circuit, which can employ a three-dimensional antenna coil structure. However, unlike stimulation energy generator 750 shown in FIG7e , patch 761 of stimulation energy generator 760 can be bent to a certain degree, for example, to accommodate certain parts of the patient's body (e.g., the neck, legs, or other similarly curved body parts), and generator antenna 763 within patch 761 can also remain in a bent state. In this manner, when stimulation energy generator 760 is worn on the patient's body, generator antenna 763 can assume a three-dimensional antenna coil structure, thereby enabling better alignment with the implantable electrode assembly within the patient's body.

[0111] As shown in FIG7g , stimulation energy generator 770 employs a split-body structure, comprising a patch 771 and a generator housing 772 coupled to patch 771. Similar to stimulation energy generator 760 shown in FIG7f , patch 771 of stimulation energy generator 770 can be bent to a certain degree, for example, to conform to certain parts of a patient's body, and generator antenna 773 within patch 771 can also be maintained in a bent state. Within generator housing 772, a generator antenna 774 employing a planar antenna coil is disposed on one side of the generator circuit and coupled to the generator circuit.

[0112] Those skilled in the art will understand that for the generator antennas used in the stimulation energy generators 710 to 770 shown in Figures 7a to 7g, whether they are planar antenna coils or three-dimensional antenna coils, a uniform distribution of the electromagnetic field formed by the antenna can be achieved by designing and controlling the spacing between the turns of each antenna coil in each axial direction.

[0113] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0114] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A device for stimulating peripheral nerves, characterized in that include: An implantable electrode assembly, which can be implanted in a patient's body and is configured to apply a stimulation signal to a nerve; wherein the implantable electrode assembly comprises: a stimulation electrode fixed to a predetermined location of the patient's body and adjacent to a nerve therein, the stimulation electrode being configured to operably apply a stimulation signal to the nerve; and an electrode circuit, coupled to the stimulation electrode, configured to receive stimulation energy in the form of an electromagnetic field, convert the stimulation energy into the stimulation signal and provide the stimulation signal to the stimulation electrode, wherein the stimulation energy comes from outside the implantable electrode assembly; A stimulation energy generator, which can be worn outside the patient's body to provide stimulation energy to the implantable electrode assembly by electromagnetic field coupling; wherein the stimulation energy generator comprises: a generator circuit for generating stimulation energy in the form of an electromagnetic field; and A power source is coupled to the generator circuit and is configured to supply power to the generator circuit.

2. The device according to claim 1, characterized in that The stimulation electrode comprises: An electrode sleeve, which is constructed as a sheath structure having a hollow channel, and the electrode sleeve is provided with an opening along its circumference to allow the nerve to enter the electrode sleeve through the opening and be accommodated in the hollow channel of the electrode sleeve; and An electrode contact is exposed from the inner surface of the electrode sleeve to contact the nerve.

3. The device according to claim 2, characterized in that The electrode sleeve has overlapping portions in a circumferential direction thereof to allow a cross-sectional diameter of the electrode sleeve to vary.

4. The device according to claim 2, characterized in that The stimulation electrode includes a plurality of electrode contacts, and the plurality of electrode contacts are arranged along the length direction of the electrode sleeve.

5. The device according to claim 4, characterized in that Each electrode contact in the stimulation electrode extends along the circumference of the electrode sleeve.

6. The device according to claim 2, characterized in that The implantable electrode assembly further comprises: A lead is configured to connect the electrode sleeve and the electrode circuit to achieve coupling between the stimulation electrode and the electrode circuit.

7. The device according to claim 1, characterized in that The implantable electrode assembly further comprises: The electrode circuit housing defines a cavity for accommodating the electrode circuit.

8. The device according to claim 7, characterized in that The electrode circuit housing further comprises: A housing body having an opening; and A feedthrough cover is connected to the shell body at the opening, wherein the feedthrough cover is provided with a through hole to allow the electrode circuit to be led out from the electrode circuit shell.

9. The device according to claim 8, characterized in that The housing body has an elongated shape, wherein the housing body has a metal ring portion at the opening side.

10. The device according to claim 7, characterized in that The implantable electrode assembly further comprises: An anchoring member is used to fix the electrode circuit housing inside the patient's body, wherein the anchoring member includes a butterfly buckle, which is configured to fix the electrode circuit housing to bones or muscles around a predetermined position of the patient's body.

11. The device according to claim 7, characterized in that The implantable electrode assembly further comprises: The anchoring member is used to fix the electrode circuit housing inside the patient's body. The anchoring member includes a binding wire configured to fix the electrode circuit housing to the muscles around a predetermined position of the patient's body.

12. The device according to claim 1, characterized in that The stimulation electrode includes a plurality of electrode contacts, and the stimulation energy generator is further configured to provide stimulation signals in the form of pulses to the plurality of electrode contacts sequentially or simultaneously through the electrode circuit.

13. The device according to claim 12, characterized in that The maximum voltage amplitude of the pulse-shaped stimulation signal is 3V to 12V, the pulse width is 30us to 240us, and the pulse frequency is 0.1Hz to 50Hz.

14. The device according to claim 1, characterized in that The stimulation energy generator also includes: The stimulation energy generator is further configured to indicate when the stimulation energy generator is aligned with the implantable electrode assembly. The alignment of the two.

15. The device according to claim 1, characterized in that The device also includes: The sensing element is configured to sense the abnormal state of the patient's body and generate a corresponding indication signal.

16. The device according to claim 1, characterized in that The electrode circuit includes an electrode antenna.

17. The device according to claim 1, characterized in that The device also includes: An external controller is configured to adjust stimulation energy and provide the adjusted stimulation energy to the implantable electrode assembly by electromagnetic field coupling.

18. The device according to claim 1, characterized in that The stimulation energy generator also includes: a generator housing configured to house at least a portion of the generator circuit and the power source; and A patch is removably coupled to the generator housing.

19. The device according to claim 18, characterized in that The generator circuit includes a generator antenna, which is disposed in the patch.

20. The device according to claim 18, characterized in that The patch comprises: A connecting member is configured to removably couple to the generator housing.

21. The device according to claim 20, characterized in that The generator housing comprises: A generator housing upper portion and a generator housing lower portion together define a cavity for accommodating at least a portion of the generator circuit and the power supply.

22. The device according to claim 18, characterized in that The generator circuit comprises: A generator antenna is disposed in the generator housing.

23. The device according to claim 18, characterized in that The generator circuit comprises: A plurality of generator antennas, at least one of the plurality of generator antennas is disposed in the generator housing, and another generator antenna is disposed in the patch, the generator antenna in the patch being used to relay electromagnetic field coupling between at least one generator antenna in the generator housing and an electrode antenna in the implantable electrode assembly.

24. The device according to claim 1, characterized in that The implantable electrode assembly further comprises: a housing body defining a cavity for accommodating the electrode circuit; and The stimulation electrode comprises: an electrode sleeve attached to the housing body and configured as a sheath structure having a hollow channel, the electrode sleeve being provided with an opening along its circumference to allow the nerve to enter the electrode sleeve through the opening and be accommodated in the hollow channel of the electrode sleeve, and An electrode contact is exposed from the inner surface of the electrode sleeve to contact the nerve.

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