Electrode lead of implantable nerve stimulator and implantable nerve stimulator system

Abstract

The present disclosure provides an electrode lead of an implantable nerve stimulator, the electrode lead configured to be at least partially implanted in a patient's body, the electrode lead comprising a body in an elongated shape, and a plurality of electrode contacts attached to the body, distributed at intervals in a longitudinal direction of the body, and configured to contact a target tissue in the patient's body, the system includes at least one electrode contact configured to deliver electrical stimulation to the target tissue, and a heater configured to heat the at least one electrode contact to deliver thermal stimulation to the target tissue through the at least one electrode contact. The thermal stimulation can block and interfere the transmission of a pain signal to the brain while reducing the nervous excitability by activating a specific neural pathway, so that the pain is more effectively relieved. The comfort of the patient is improved, and the treatment period is shortened.

Description

[0001] This application is a divisional application. The application number of the original application is 202410667091.8, and the original application date is May 28, 2024. The entire contents of the original application are incorporated into this application by reference. Technical Field

[0002] The present disclosure relates to an implantable neurostimulator and an electrode lead thereof, and in particular, to an electrode lead of an implantable neurostimulator capable of providing electrical stimulation and thermal stimulation simultaneously and an implantable neurostimulator system comprising the electrode lead. Background Art

[0003] In the medical field, implantable neurostimulators are widely used for a variety of therapeutic purposes, such as pain management, neuromodulation, etc. Implantable neurostimulators include elongated electrode leads and a pulse generator. The electrode leads can be at least partially implanted into the patient's body to deliver electrical stimulation to the target tissue through the electrode contacts thereon. However, the therapeutic effect of electrical stimulation alone is weak. Summary of the invention

[0004] In view of this, the present invention improves the electrode leads of an implantable neurostimulator, aiming to solve the problem of weak therapeutic effect of traditional implantable neurostimulators.

[0005] On the one hand, the present disclosure provides an electrode lead for an implantable neurostimulator, the electrode lead being configured to be at least partially implanted in a patient's body. The electrode lead comprises a main body, a plurality of electrode contacts, and a heater. The main body is elongated in shape, a plurality of electrode contacts are attached to the main body, are distributed at intervals along the longitudinal direction of the main body, and are configured to contact a target tissue in the patient's body to deliver electrical stimulation to the target tissue. The heater is configured to heat at least one electrode contact to deliver thermal stimulation to the target tissue through at least one electrode contact.

[0006] In some embodiments, the electrode lead further comprises a sensor configured to sense a temperature of at least one electrode contact.

[0007] In some embodiments, the heater includes at least one heating unit, the sensor includes at least one sensing unit, the at least one heating unit is configured to heat at least one electrode contact respectively, and the at least one sensing unit is configured to sense the temperature of at least one electrode contact respectively.

[0008] In some embodiments, each heating unit is a heating wire in contact with a corresponding electrode contact.

[0009] In some embodiments, each sensing unit is a thermocouple.

[0010] In some embodiments, each thermocouple is in contact with a corresponding heating wire.

[0011] In some embodiments, the body includes a first sleeve and a second sleeve, the first sleeve is located outside the second sleeve and surrounds the second sleeve. At least one electrode contact is at least partially exposed to the inner side of the first sleeve. Each heating wire is located between the first sleeve and the second sleeve, contacts the corresponding electrode contact, and contacts the corresponding thermocouple located between the first sleeve and the second sleeve.

[0012] In some embodiments, the electrode lead also includes at least one heating wire wire, at least one sensing wire and a plurality of contact wires, at least one heating wire wire corresponds to at least one heating wire, at least one sensing wire corresponds to at least one sensing unit, and a plurality of contact wires correspond to a plurality of electrode contacts. The main body also includes a third sleeve and a fourth sleeve, the second sleeve is located outside the third sleeve and surrounds the third sleeve, and the third sleeve is located outside the fourth sleeve and surrounds the fourth sleeve. Each heating wire wire is located between the second sleeve and the third sleeve, wound on the third sleeve, and penetrates the second sleeve at the corresponding heating wire to be electrically connected to the heating wire. Each sensing wire is located between the second sleeve and the third sleeve, wound on the third sleeve, and penetrates the second sleeve at the corresponding sensing unit to be electrically connected to the sensing unit. Each contact wire is located between the third sleeve and the fourth sleeve, wound on the fourth sleeve, and penetrates the third sleeve and the second sleeve in sequence at the corresponding electrode contact to be electrically connected to the electrode contact.

[0013] On the other hand, the present disclosure provides an implantable neurostimulator system, which includes the above-mentioned electrode lead. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and should not be viewed as limiting the scope.

[0015] It should be understood that the same or similar reference numerals are used in the drawings to indicate the same or similar elements.

[0016] It should be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.

[0017] Figure 1 A schematic diagram of the structure of an implantable neurostimulator provided in one embodiment of the present disclosure.

[0018] Figure 2 for Figure 1 Schematic diagram of the wire structure on the inner side of the electrode contact in the electrode lead of the implantable neurostimulator.

[0019] Figure 3 for Figure 2 Schematic diagram of the local enlarged structure in.

[0020] Figure 4 for Figure 3 A schematic diagram of the partially enlarged structure of the part where the wire passes through the casing.

[0021] Figure 5 for Figure 1 Schematic diagram of the electrode contact wire structure of the implantable neurostimulator.

[0022] Figure 6 for Figure 1 A cross-sectional view of the electrode lead structure of an implantable neurostimulator. DETAILED DESCRIPTION

[0023] The following is an exemplary description of the embodiments of the present disclosure in conjunction with the accompanying drawings. It should be understood that the present disclosure can be implemented in a variety of ways and should not be construed as being limited to the embodiments described herein, which are only for a more thorough and clear understanding of the present disclosure.

[0024] In order to improve the therapeutic effect, an implantable neurostimulator with a thermal stimulation function can be provided. For example, the electrode lead 10 of this neurostimulator has independent heating electrodes and stimulation electrodes, so that electrical stimulation and thermal stimulation can be applied to improve the therapeutic effect. However, for this implantable neurostimulator, the independent heating electrodes and stimulation electrodes need to occupy specific areas of the electrode lead 10 respectively, so that the proportion of the total volume of the electrode in the surface area of ​​the lead is significantly increased. This phenomenon not only reduces the utilization efficiency of the internal space of the electrode lead 10, but also may lead to an increase in the size of the overall device, thereby increasing the difficulty and complexity of the implantation operation, prolonging the operation time, and increasing the risk to the patient. As the surface area of ​​the electrode increases, its weight and rigidity increase accordingly, which will directly lead to a decrease in the flexibility of the electrode. During the implantation process and after implantation, as the human body moves, electrodes with poor flexibility are prone to deformation or even breakage, affecting the effective contact between the electrode and the target tissue, resulting in a weakened or uneven stimulation effect. In the long run, the reduction in the mechanical tolerance of the electrode may accelerate the failure of the device, shorten the service life of the device, and increase the risk of patients needing to undergo a secondary operation.

[0025] The present disclosure provides an implantable neurostimulator 1, which can be any type of implantable neurostimulator. In the treatment of chronic pain, the implantable neurostimulator 1 can directly transmit current to the painful area through the electrode lead 10, and relieve pain by stimulating the nerves. For example, for patients with certain types of cancer or other complex regional pain, implanted electrodes can effectively relieve pain and improve the patient's quality of life. Of course, in other examples, the implantable neurostimulator 1 can also be other types of treatment methods.

[0026] For ease of understanding, the structure of the implantable neurostimulator 1 is first illustrated below. It should be understood that the structure of the implantable neurostimulator 1 should not be limited to the following description. For example, one or several elements introduced below can be omitted or replaced, and the layout relationship between them can be replaced.

[0027] refer to Figure 1 The implantable neurostimulator 1 may include a body portion 20 and an electrode lead 10, wherein the electrode lead 10 includes a main body 100, an electrode contact 110, and a heater. Figure 1 Each electrode lead 10 may have four electrode contacts 110, which are the first electrode contact, the second electrode contact, the third electrode contact, and the fourth electrode contact in the longitudinal direction of the electrode lead 10. The number of electrode contacts 110 may also be other numbers. When the doctor uses the implantable neurostimulator 1, the electrode contacts 110 on the implantable neurostimulator 1 act on the tissue nerves to stimulate the nerves with electric pulses. Of course, in other examples, the heater may heat only one nerve contact alone, or may heat multiple nerve contacts together.

[0028] Since the electrode contacts 110 are all integrated with a heating function, there is no need to set up a special heating electrode. This not only reduces the total number of electrodes, making the layout of the electrode lead 10 more compact, but also improves the uniformity of the spacing between the electrode contacts 110, thereby enhancing the effect of electrical stimulation and thermal stimulation. In addition, reducing the number of electrodes also helps to reduce manufacturing costs and improve the cost performance of the product. At the same time, the increase in the flexibility of the main body 100 is another significant advantage of this electrode lead 10 design. Due to the simplified structure and the reduction in the number of electrodes, the overall weight and volume of the electrode lead 10 are effectively controlled, which makes the bending and twisting of the electrode lead 10 in the body more flexible. The increased flexibility enables the electrode lead 10 to better adapt to the physiological structure in the patient's body, reduces the pressure and damage to the surrounding tissues, and improves the patient's comfort. At the same time, good flexibility also contributes to the close contact between the electrode contacts 110 and the target tissue, thereby ensuring that electrical stimulation and thermal stimulation can be accurately and effectively transmitted to the target tissue.

[0029] The main body 100 of the electrode lead 10 can be made of a material with good biocompatibility, such as a high molecular polymer, to ensure safety and long-term stability when implanted in the body. At the same time, these materials should also have a certain degree of flexibility in order to adapt to the complex tissue structure in the body. The electrode contact 110 can be designed as a small and smooth protrusion to increase the contact area with the target tissue and improve the transmission efficiency of electrical stimulation. The material of the contact should have excellent conductivity and biocompatibility, for example, platinum, iridium or carbon nanotubes. The heater can be integrated inside or outside the main body 100 of the electrode lead 10, and is achieved by resistance heating, microwave heating or laser heating. The heater should be able to accurately control the heating temperature to avoid thermal damage to the surrounding tissue. At the same time, the heater should also have a small size and weight to coordinate with the electrode lead 10 as a whole.

[0030] Exemplarily, in the electrical stimulation mode, the target tissue is electrically stimulated by controlling the electrode contact 110 to release current. In the thermal stimulation mode, the electrode contact 110 is heated by a heater to deliver thermal stimulation to the target tissue. This mode is suitable for a single type of stimulation treatment for a specific tissue. The electrode lead 10 can also be designed to have both electrical stimulation and thermal stimulation functions. By using electrical stimulation and thermal stimulation simultaneously or alternately, the target tissue can be more comprehensively acted on and the treatment effect can be improved. In addition, the parameters and sequence of electrical stimulation and thermal stimulation can be flexibly adjusted according to the patient's specific situation and treatment needs.

[0031] At the same time, the present invention also covers the introduction of intelligent control systems, which monitor the physiological state of the target tissue in real time through sensors, such as temperature, potential, etc., and automatically adjust the parameters of electrical stimulation and thermal stimulation based on this information. This intelligent control mode can improve the accuracy and safety of treatment and reduce errors caused by human operation.

[0032] For example, the electrode lead 10 may also be integrated with a wireless communication module to achieve wireless connection and data transmission with an external device, so that the doctor can remotely monitor the patient's treatment and make remote adjustments as needed.

[0033] When the heater heats the electrode contact 110, the temperature must be strictly controlled to prevent overheating from causing damage to surrounding tissues. Temperature sensors and feedback control algorithms can be used to achieve precise temperature control. When the electrode contact 110 releases current, the safety and stability of the current must be ensured to prevent electric shock to the patient. Technical measures such as isolation circuits and leakage protection can be used to improve safety. Before the electrode lead 10 is implanted in the patient's body, strict biocompatibility testing must be carried out to ensure that the material is harmless to the patient and will not cause allergic reactions or rejection reactions.

[0034] When using the electrode lead 10 for electrical stimulation or thermal stimulation treatment in the clinic, relevant medical standards and operating guidelines must be followed to ensure the safety and effectiveness of the treatment.

[0035] For example, in a spinal cord stimulation system, electrical stimulation and thermal stimulation act on the patient's nerve tissue for the treatment of chronic pain. The electrode contact 110 contacts the spinal cord tissue to provide electrical stimulation to regulate the transmission of pain signals. At the same time, the heater generates thermal stimulation on a specific electrode contact 110 to improve local blood circulation and relieve pain symptoms. Electrical stimulation and thermal stimulation may have a synergistic effect. For example, electrical stimulation promotes nerve regeneration, and thermal stimulation improves local blood circulation and relieves inflammation, thereby accelerating tissue repair and functional recovery. A single device integrates two functions, which is beneficial for reducing trauma, shortening surgical time, and also reducing patient treatment costs. In use, for example, the main body 100 integrates electrical stimulation and thermal stimulation circuits, and the electrode contact 110 is both a contact point for electrical stimulation and a heat source for thermal stimulation. The current size and heating power are adjusted by the control system to achieve independent or synchronous output of electrical stimulation and thermal stimulation. A modular design can also be performed, with the main body 100 internally divided into an electrical stimulation module and a thermal stimulation module, and the two transmit signals through a common or independent electrode contact 110. Electrical stimulation, thermal stimulation, or a combination of the two can be selected and enabled for treatment through software settings.

[0036] The electrode contact 110 is at least partially located on the outer surface of the electrode lead 10. The electrode contact 110 can perform electrical pulse stimulation on the user's nerves. When designing and manufacturing the electrode lead 10, the layout and insulation treatment of the electrode contact 110 are crucial links, which directly affect the functional performance, safety and biocompatibility of the system. Specifically, the arrangement of the electrode contact 110 on the electrode lead 10 includes, but is not limited to, the following two main strategies: circumferential distribution and vector electrode form, and no matter which method is adopted, effective insulation should be ensured between the electrode contacts 110. On the electrode lead 10, the electrode contacts 110 can be evenly or unevenly distributed along its circumference. This layout method is intended to achieve all-round, multi-angle stimulation or monitoring of the target area. For example, the electrode contacts 110 are arranged along the circumferential direction of the electrode lead 10 at a predetermined spacing, such as equiangular intervals. Such a design helps to provide uniform stimulation coverage or data acquisition, and is suitable for application scenarios that require large-area, balanced stimulation or monitoring, such as neural regulation, myocardial electrophysiology research, etc. For example, according to specific medical needs or anatomical characteristics, the electrode contacts 110 can be arranged at a specific angle, spacing or shape. For example, for precise stimulation of a specific nerve bundle or myocardial area, the contacts may be concentrated in the portion of the electrode lead 10 corresponding to the area, forming a local dense layout. This layout method is conducive to improving the pertinence and efficiency of treatment or monitoring. Regardless of how the electrode contacts 110 are distributed circumferentially, it is crucial to ensure the insulation between them. For example, using materials with high insulation properties such as polyimide, silicone rubber, Teflon, etc. to wrap the electrode contacts 110 to form an insulating layer to prevent the current from being directly conducted between the contacts, or setting a physical isolation structure between the electrode contacts 110, such as a raised insulating spacer or groove, to increase the electrical gap between the contacts, further enhance the insulation effect, or strictly control the thickness and uniformity of the insulating layer and the distance between the contacts during the production process to ensure reliable insulation of the electrode in the working state. The vector electrode form refers to the electrode contact 110 as an independent unit, which is separately set and connected to the electrode lead 10. This design provides a higher degree of flexibility and customization, and is suitable for applications that require precise positioning, directional stimulation or monitoring. For example, each electrode contact 110 can be individually implanted at different depths, positions or directions of the target tissue according to actual needs, so as to achieve precise stimulation or recording of specific nerve fibers, muscle bundles or cell groups. For tissue structures with complex three-dimensional morphology or depth changes, such as the spinal cord, vector electrodes can better adapt to these special environments and provide electrical stimulation or monitoring modes that are more in line with actual needs. In some adjustable electrode systems, independent electrode contacts 110 allow for fine-tuning of position or switching of functions after implantation to respond to disease progression, changes in patient response, etc. Similarly, in the form of vector electrodes, good insulation must be ensured between each electrode contact 110 and the electrode lead 10, as well as between the contacts.

[0037] In conventional technology, the electrode contacts 110 on the electrode lead 10 should have different polarities, and have, for example, at least one positive electrode, or at least one negative electrode, so that a circuit can be formed with the user's tissue nerves. It is also possible that all electrode contacts 110 on the electrode lead 10 have the same polarity, for example, all are cathodes, and the surface of the electrode lead 10 is coated with a conductive layer to act as an anode to form a circuit with the user's nerves. In other words, at least two electrodes with different polarities or at least one electrode with the same polarity that are insulated from each other on the electrode lead 10 are configured to perform electrical pulse stimulation on the user's nerves, wherein the electrodes with the same polarity are configured to form a circuit with the conductive parts that may exist on the outer surface of the electrode lead and the user's nerves, and the two electrodes with different polarities include a cathode electrode and an anode electrode that are configured to form a circuit with the user's nerves; this design can further increase the toughness of the electrode lead 10 and reduce the surface area occupied by the electrodes on the lead. The conductive layer must meet the following conditions: safe and harmless to the human body, good biocompatibility, able to adapt to the complex three-dimensional morphological changes on the surface or inside of the human body, and maintain stable conductivity under long-term use or physiological conditions. The conductive layer can be made of biocompatible conductive polymers, such as poly(3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT:PSS), poly(ethylenedioxythiophene):poly(acrylate) (PEDOT:PAA), polyaniline, etc. These polymer materials have good biocompatibility after proper treatment and can be directly prepared on the surface of biological tissues or medical devices by solution coating, spin coating, printing, etc. to form a conductive layer. When the conductive layer contacts the organism, it has low toxicity, no immune response, and can still maintain conductivity in a wet environment.

[0038] The heater includes at least one heating unit configured to heat at least one electrode contact 110 , respectively.

[0039] The heater can heat at least one electrode contact 110 separately. Since the electrode contacts 110 can be heated relatively independently, this design increases the flexibility of treatment. The doctor can adjust the heating strategy in real time according to the patient's specific situation and treatment effect, including selecting the number of heated electrode contacts 110, the heating sequence, and the heating intensity. The heater can achieve precise temperature control of the electrode contacts 110, which is crucial for electrodes of implantable neurostimulators, etc. Accurate temperature management helps avoid damage caused by overheating of tissues, while ensuring appropriate thermal contact between the electrode and surrounding tissues, which is beneficial to improving the efficiency of electrophysiological signal transmission at the electrode-tissue interface.

[0040] Independent heating units can achieve independent heating control of each contact. This design makes treatment more precise because specific electrode contacts 110 can be selectively heated according to treatment needs. The electrode contacts 110 can be designed with a multi-layer structure. For example, one layer is a thermal conductive material for quickly and evenly transferring heat to the electrode contacts 110; the other layer is an insulating material to ensure safety during the heating process and the stability of the electrode contacts 110. According to the needs of the disease, a single or multiple electrode contacts 110 can be selected for heating, or electrical stimulation and thermal stimulation can be performed simultaneously or alternately, which greatly enhances the flexibility and pertinence of the treatment plan.

[0041] Each heating unit is equipped with an independent control system, and the temperature and time of each heating unit can be adjusted individually according to the treatment needs. This embodiment provides higher treatment flexibility and the possibility of personalized treatment plans. When a certain electrode contact 110 does not need to be heated, its corresponding heating unit can enter low power consumption or sleep mode to save energy and extend the service life of the device. Each electrode contact 110 is internally integrated with a distributed heating element, such as a resistance wire, a PTC thermistor, etc., and the heating current or voltage of each contact is independently adjusted by the control system to achieve precise temperature control. The electrode contact 110 can also be heated in a centralized manner, and the heating unit is located inside or at the proximal end of the main body 100. The heat is transferred to the designated electrode contact 110 through a heat-conducting medium, such as a heat pipe, a phase change material, etc. The control system adjusts the heating unit power and / or the heat-conducting medium flow to control the temperature of each contact. The electrode contact 110 can also be heated in a hybrid manner, where some electrode contacts 110 have built-in heating elements, that is, distributed, and other contacts provide heat through the heating unit and the heat-conducting medium inside the main body 100, that is, centralized. According to the treatment needs, the heating mode can be flexibly selected. This design can individually control the heating state and temperature of each contact to achieve precise thermal stimulation of the target tissue and adapt to complex pathological needs and individual differences. Energy is only provided to the electrode contacts 110 that need to be heated, avoiding unnecessary heat loss and system energy consumption, while reducing heat exposure to non-target areas and improving the safety of treatment. For example, in a spinal cord stimulation system, the electrode contacts 110 contact the spinal cord tissue to provide electrical stimulation to regulate pain signal transmission. For pain-sensitive areas, the corresponding electrode contacts 110 are individually enabled for heating to increase the treatment effect or alleviate drug tolerance.

[0042] Furthermore, the electrode contacts are provided with bioactive substances, which are configured to be released to the target tissue by heating. Bioactive substances, such as drugs, growth factors, antimicrobial agents, etc., can directly act on the target tissue after being released by precisely controlled heating, and produce a synergistic effect with electrical stimulation to enhance the therapeutic effect. For example, in pain management, bioactive substances may be analgesics, which can more effectively relieve chronic pain with electrical stimulation; in nerve regeneration therapy, bioactive substances may be growth factors that promote nerve growth or repair, which can accelerate the nerve regeneration process with electrical stimulation. For example, the electrode surface can be coated with a biocompatible coating to activate or promote bioactive substances, and heating can accelerate the release of these substances, which helps to reduce foreign body reactions and inflammation in patients and enhance the long-term stability of the electrode. In addition, in some cases, heating may be used to activate specific biological reactions, such as promoting cell proliferation and further consolidating the connection between the electrode and the tissue. This design allows the electrode to release the contained bioactive substances through the heating process while delivering electrical stimulation. These substances may be drugs, growth factors, cell adhesion molecules, gene carriers, etc., depending on the purpose of treatment. They are encapsulated or incorporated into the electrode material in a stable state, remaining inert or of low activity when not heated.

[0043] The electrode contacts at least partially contain bioactive substances, such as drugs, growth factors, enzymes or other bioactive molecules, which can be activated or released by the heating process. This design allows the precise release of these substances at the desired time and place, enhancing their bioactivity, reducing non-target side effects, and potentially improving treatment efficiency.

[0044] Bioactive substances, such as analgesics, anti-inflammatory drugs, nerve regeneration promoters, etc., can be triggered by heating to increase local drug concentration, enhance efficacy, and reduce systemic drug dosage and its side effects. Growth factors: For example, neurotrophic factors, vascular endothelial growth factors, etc., help promote nerve regeneration, angiogenesis or tissue repair. Heating can accelerate their release from electrode contacts and promote the absorption and utilization of growth factors by surrounding tissues. Gene therapy vectors: For example, heat-sensitive liposomes, DNA or RNA encapsulated by nanoparticles can rupture when heated, releasing the carried gene fragments to achieve site-specific gene transfection for the treatment of genetic diseases or regulation of specific gene expression. Antimicrobial agents: In cases where the risk of infection is high, the electrode contacts can be loaded with thermosensitive antibiotics or antimicrobial peptides, which are released by heating to prevent or treat infection at the implant site.

[0045] For example, the electrode lead is applied to spinal nerves, and the target tissue is spinal nerve tissue. The electrode contacts are designed to precisely dock with the appropriate position on the surface or deep of the spinal cord to achieve effective electrical stimulation delivery. The bioactive substances may include nerve growth factors, anti-inflammatory drugs or gene vectors, which are intended to promote the reduction of inflammatory responses or regulate the expression of related genes.

[0046] Depending on the patient's condition and treatment plan, electrical stimulation parameters such as frequency, pulse width, intensity and thermal stimulation parameters such as target temperature and heating duration are preset. For example, electrical stimulation may be used to simulate normal nerve impulse patterns to restore motor or sensory function, while thermal stimulation may be used to improve the suitability of the nerve regeneration environment or trigger the release of bioactive substances.

[0047] The electrode body can be made of metals with good biocompatibility and conductivity, such as platinum, titanium alloy, or conductive polymers such as polypyrrole and polythiophene, to ensure charge transfer efficiency and long-term stability. The appropriate shape is designed according to the characteristics of the treatment site and target tissue, and may have a tip structure to improve the electric field concentration. The drug is encapsulated in a specific area near the electrode in the form of microcapsules, nanoparticles, gel networks, etc., which can be a coating on the electrode surface, a microporous structure embedded in the electrode, or a drug carrier material integrated with the electrode. Select drugs suitable for electrothermal release, such as heat-stable proteins, peptides, small molecule drugs, etc., or design thermosensitive drug precursors. The drug encapsulation layer is such as a thermosensitive coating, and a layer of thermosensitive polymer containing drugs is coated on the electrode surface, such as poly N-isopropylacrylamide (PNIPAM), which undergoes a phase change at a specific temperature to release the drug. Or orderly arranged drug microcapsules are embedded on the surface or inside of the electrode, and the capsule shell is made of thermosensitive or soluble materials. The shell breaks under the action of electric heat to release the drug. Alternatively, drug-loaded nanoparticles such as gold and silicon are distributed inside or on the surface of the electrode, and the drug molecules on the surface of the particles are induced to detach by electrothermal means.

[0048] Possible embodiment: Chitosan-PEG gel encapsulates the electrode coating of the neurotrophic drug neurotrophin-3 (NT-3), and heating the electrode to about 40 degrees can trigger drug release. Neurotrophin-3 (NT-3) is selected as the encapsulated drug. Neurotrophin-3 (NT-3) is an important neurotrophic factor that supports the proliferation, differentiation and survival of various nerve cells and has important value in nerve damage repair and the treatment of neurodegenerative diseases. Chitosan (Chitosan) and polyethylene glycol (PEG) are selected as a gel matrix. Chitosan (Chitosan) has good biocompatibility, biodegradability and antibacterial properties, while polyethylene glycol (PEG) can improve the water solubility of chitosan (Chitosan), reduce crystallinity and regulate drug release. The two are blended to form a thermosensitive gel that can trigger drug release in response to body temperature of about 40°C. Chitosan and PEG were weighed separately, dissolved in acetate buffer (pH 5.0), heated to 60°C and stirred until completely dissolved to form a uniform transparent solution. Purified NT-3 was dissolved in sterile saline to prepare a solution of a certain concentration. The NT-3 solution was slowly added to the chitosan-PEG solution, and magnetic stirring or ultrasonic treatment was used to ensure that the drug was evenly dispersed in the gel precursor. No additional gelation was required, because chitosan and polyethylene glycol (PEG) would naturally form a gel network after cooling. The solution temperature was kept at room temperature or slightly above room temperature to maintain the fluidity of the solution for easy coating. A platinum (Pt) electrode with good biocompatibility was selected, and an ultrasonic cleaner was used to remove surface grease and impurities to ensure a clean surface. The chitosan-PEG-NT-3 solution was evenly applied to the electrode surface and dried naturally to form a gel coating. To ensure uniform distribution of the drug, a multi-layer coating technique can be used. Each layer is briefly dried before the next layer is applied. The coated electrode is naturally dried at room temperature to form a stable chitosan-polyethylene glycol (Chitosan-PEG) gel coating. No additional curing step is required. A biodegradable protective layer such as polylactic acid can be sprayed on the surface of the coating to slow down the initial release rate of the drug, prolong the drug release cycle, and improve the mechanical stability of the coating.

[0049] 3) The electrodes of gel coating are subjected to drug content determination, coating thickness measurement, drug release curve analysis including release characteristics at 40°C, electrochemical stability test, biocompatibility assessment, etc. It is ensured that the coating contains the expected dose of neurotrophin-3 (NT-3), and can release the drug quickly at around 40°C, the electrode performance is not affected, and the biosafety is good.

[0050] Furthermore, the main body 100 includes a first sleeve 201 and a second sleeve 202, the first sleeve 201 is located outside the second sleeve 202 and surrounds the second sleeve 202, at least one electrode contact 110 is at least partially exposed to the inner side of the first sleeve 201, and each heating unit is constructed as a heating wire 301; the heating wire 301 is located between the first sleeve 201 and the second sleeve 202, spirally wound on the second sleeve 202, and in contact with a corresponding electrode contact 110.

[0051] The double-layer sleeve structure also provides a thermal isolation effect to a certain extent, reduces the possibility of heat diffusion to the surrounding tissue, and reduces the potential risk of thermal damage to the surrounding tissue. At the same time, due to the direct contact between the heating wire 301 and the electrode contact 110, the heating range and temperature can be more accurately controlled, further enhancing the safety of the treatment. Therefore, even at a lower heating power, effective thermal stimulation can be achieved, reducing energy consumption and reducing the discomfort to the patient. The spirally wound heating wire 301 design is not only convenient for installation and fixing during the manufacturing process, but also makes it easier to operate when the heating unit needs to be repaired or replaced. This design reduces manufacturing costs and maintenance difficulties, and improves the reliability and service life of the electrode lead 10. Through the sleeve structure design of the first sleeve 201 and the second sleeve 202, the key components such as the electrode contact 110 and the heating wire 301 are compactly packaged together, saving the implant volume and reducing surgical trauma. The heating wire 301 is spirally wound on the second sleeve 202, directly contacting the electrode contact 110, and improving the efficiency of heat energy transfer. At the same time, the first sleeve 201 acts as a heat insulation layer to limit the diffusion of heat to the surrounding tissues, ensuring the safety of treatment. The spirally wound heating wire 301 has a certain mechanical strength and is easy to be mass-produced on the second sleeve 202. If replacement or maintenance is required, only the first sleeve 201 needs to be disassembled to operate the internal components.

[0052] For example, a spinal cord stimulation system is used to treat chronic pain, and the electrode contacts 110 contact the spinal cord tissue to provide electrical stimulation to regulate pain signal transmission. The heating wire 301 heats the electrode contacts 110 in the pain-sensitive area to enhance the analgesic effect.

[0053] The heating wire 301 is made of a metal with suitable resistivity and good biocompatibility, and the diameter is optimized according to the heating requirements and the inner diameter of the second sleeve 202. An automated winding device is used to accurately control the winding form of the heating wire 301 on the second sleeve 202 according to the set parameters such as the helix angle and pitch to ensure good contact with the electrode contact 110. In terms of design, the first sleeve 201 is made of a biocompatible material with good thermal insulation performance, such as silicone, to ensure the safety and long-term stability of the implant, and to ensure that it is well sealed with the second sleeve 202 to prevent heat leakage and liquid intrusion. The gap between the first sleeve 201 and the second sleeve 202 can be adjusted to accommodate heating wires 301 of different diameters, while ensuring sufficient insulation performance to prevent current leakage.

[0054] The electrode contact 110 can achieve reliable contact with the heating wire 301 by welding, conductive glue or other means to ensure that the current and heat can be smoothly transferred. At the same time, the contact part can be designed with insulation protection to prevent the current from flowing directly to the surrounding tissue. The heating wire 301 is spirally wound on the second sleeve 202. This design can increase the contact area between the heating wire 301 and the second sleeve 202 and improve the heat conduction efficiency. The heating wire 301 can be arranged below or on the side of the electrode contact 110 as needed to achieve precise heating. At the same time, an overcurrent protection circuit is set at the contact part between the heating wire 301 and the electrode contact 110 to prevent damage to the equipment or harm to the patient due to excessive current. The overall structure of the electrode lead 10 is strictly tested for biocompatibility and safety assessment to ensure that it will not cause adverse reactions after being implanted in the body. For example, the introduction of wireless communication technology enables doctors to remotely control the switch and power adjustment of the heating wire 301, which is convenient for real-time adjustment and optimization of treatment.

[0055] Furthermore, the electrode lead 10 also has at least one heating wire conductor 112, and the at least one heating wire conductor 112 corresponds to at least one heating wire 301; each heating wire conductor 112 extends in the second sleeve 202 and passes through the second sleeve 202 at the corresponding heating wire 301 to be electrically connected to the heating wire 301.

[0056] like Figure 4 , which is a schematic diagram of the structure where the heating wire 112 and the sensor wire 302 pass through the sleeve.

[0057] The heating wire conductor 112 can be freely arranged inside the second sleeve 202. For example, a ring structure is added inside the second sleeve 202, and the heating wire conductor 112 is fixed through the ring structure, which avoids the complexity of connecting the heating wire conductor 112 outside the second sleeve 202, and also reduces the potential mechanical interference and damage risk of the heating wire conductor 112, and reduces the chance of the heating wire conductor 112 and the heating wire 301, reducing the risk of wire melting. This flexibility makes the electrode lead 10 more convenient and reliable during implantation and use. When the heating wire 301 or the heating wire conductor 112 fails, the design that the heating wire conductor 112 can be inside the second sleeve 202 makes the maintenance or replacement process easier. The heating wire conductor 112 and the heating wire 301 are routed inside the second sleeve 202, which realizes the physical isolation of the electric heating function, reduces the risk of short circuit, and improves the safety of treatment. For example, the heating wire conductor 112 is directly connected to the heating wire 301, reducing the intermediate joint or adapter, reducing the failure point, and improving the reliability of the electrode lead 10. The corresponding connection mode of the heating wire conductor 112 and the heating wire 301 is conducive to accurate wiring of automated production equipment and improves production efficiency. During maintenance, only the internal wiring of the second sleeve 202 needs to be processed without disassembling the entire electrode lead 10.

[0058] At the connection between the heating wire conductor 112 and the heating wire 301, high temperature resistant and insulating fixings such as ceramic pins, heat shrink tubes, etc. are used to ensure stable electrical connection. The heating wire conductor 112 passes through the second sleeve 202 for sealing treatment, such as potting, coating, etc. An automated winding device is used to accurately control the wiring form of the heating wire conductor 112 in the second sleeve 202 according to the set wiring path, fixed point and other parameters to ensure good connection with the heating wire 301. The heating wire conductor 112 can be made of a highly conductive material to reduce resistance and improve the current transfer efficiency. The heating wire conductor 112 is insulated inside the electrode lead 10 to prevent current leakage or short circuit, and ensure the safety of electrical stimulation and thermal stimulation. The heating wire conductor 112 extends in the second sleeve 202 and is electrically connected to the heating wire 301 by passing through the second sleeve 202. To ensure the stability and reliability of the connection, the contact part between the wire and the heating wire 301 can be welded, crimped or other reliable connection methods.

[0059] In the embodiment, each heating wire 301 is equipped with an independent heating wire conductor 112 to ensure that the current can be directly and accurately transmitted to the corresponding heating wire 301, avoiding the problem of uneven current distribution or interference. The heating wire conductor 112 can be connected to an external power supply and a control unit, and the power supply and heating behavior of the heating wire 301 can be accurately controlled by an external device. At the same time, the heating wire 301 can also be combined with a temperature sensor to monitor the temperature of the heating wire 301 in real time, and feed back the temperature information to the control unit. The control unit adjusts the current size of the heating wire conductor 112 according to the temperature feedback to achieve accurate temperature control. By controlling the on-off and current size of the heating wire conductor 112, according to the treatment needs, electrical stimulation can be used alone, thermal stimulation can be used alone, or both can be used at the same time. A fault detection mechanism can also be designed to monitor the connection status of the heating wire conductor 112 and the working status of the heating wire 301 in real time. Once an abnormal situation is detected, such as a wire break, a short circuit of the heating wire 301, etc., an alarm signal is issued in time to remind the doctor to handle it.

[0060] Furthermore, a third sleeve 203 structure is included, the third sleeve 203 is located in the second sleeve 202 structure, each heating wire 112 is located between the second sleeve 202 and the third sleeve 203, and is spirally wound on the third sleeve 203. In this case, the wire connected to the contact electrode is preferably placed in the third sleeve 203.

[0061] The heating wire conductor 112 is placed between the second sleeve 202 and the third sleeve 203, and is spirally wound on the third sleeve 203, so that the arrangement of the wire is more compact and orderly. This design not only reduces the space occupied by the wire in the body, but also avoids mutual interference or entanglement between the wires. Due to the close contact between the heating wire conductor 112 and the third sleeve 203, the design of the spirally wound heating wire conductor 112 makes the manufacturing process simpler and more efficient. At the same time, this design also makes it easier to operate when the wire needs to be repaired or replaced. Maintenance personnel can easily disassemble and reinstall the wire, reducing maintenance costs and time. Compact structure and high space utilization. By adding the third sleeve 203 and spirally winding the heating wire conductor 112 thereon, the space inside the electrode lead 10 is effectively utilized, making the entire device more compact and reducing the volume, which is conducive to reducing surgical wounds, reducing postoperative pain in patients, and accelerating the recovery process. At the same time, this layout method avoids the random scattering of the wire inside the lead, enhances the orderliness of the overall structure, and is convenient for production and later maintenance.

[0062] The spirally wound heating wire conductor 112 forms a stable contact and fixation with the third sleeve 203, which can effectively resist external stress, such as pulling and twisting caused by patient activities, reduce the risk of wire breakage or short circuit, and improve the mechanical stability and durability of the electrode lead 10 during long-term use. This not only ensures the continued stability of the treatment effect, but also reduces the probability of secondary surgery due to equipment failure, which is safer and more reliable for patients. In addition, the spirally wound heating wire conductor 112 is easy to locate and track, which is convenient for precise wiring in the production stage, as well as for quick identification and repair of potential problems during later maintenance. The clear hierarchical structure is also conducive to simplifying the troubleshooting process, shortening maintenance time, and improving the efficiency of medical services.

[0063] By adding the third sleeve 203, the heating wire conductor 112 is further physically isolated from the electrode contact wire 111, which significantly reduces the risk of electrical short circuit and improves the safety of the device. The introduction of the third sleeve 203 allows the heating wire conductor 112 and the electrode contact wire 111 to each have an independent winding space, avoiding mutual interference between the wires, which is conducive to neat and orderly internal wiring, and improves the reliability and maintenance convenience of the device.

[0064] In the spinal cord stimulation system for treating chronic pain, the electrode contact 110 contacts the spinal cord tissue to provide electrical stimulation to regulate the transmission of pain signals. The heating wire 301 is powered by the heating wire conductor 112 in the third sleeve 203, and the electrode contact 110 in the pain-sensitive area is heated to enhance the analgesic effect. The material of the third sleeve 203 should be selected from materials with good mechanical strength to make the third sleeve 203 to ensure the biosafety of electric heat isolation and heat dissipation. At the same time, the opening of the third sleeve 203 is sealed. Welding, crimping or other reliable connection methods can be used to ensure the quality of the electrical connection between the wire and the electrode contact 110. At the key parts of the wire, for example, at the connection with the heating wire 301, additional protective structures, such as insulating sleeves or reinforcement rings, can be set to improve the durability and reliability of the wire. According to actual needs, the length and path of the heating wire conductor 112 are reasonably designed to ensure that the wire can smoothly pass through the second sleeve 202 and achieve reliable connection with the heating wire 301. By optimizing the layout of the wire, the bending and twisting of the wire in the tube are reduced, and the risk of wire damage is reduced. For example, different parts of the electrode lead 10 are modularly designed, for example, the heater part, the electrode contact 110 part and the wire part are made into detachable modules. This modular design facilitates subsequent maintenance and replacement, and improves the service life and maintainability of the electrode lead 10.

[0065] The third sleeve 203 is located inside the second sleeve 202 and maintains a certain gap with the second sleeve 202 to provide additional protection and support for the heating wire 112. Each heating wire 112 is located between the second sleeve 202 and the third sleeve 203, and is spirally wound on the third sleeve 203. This arrangement not only ensures the stability of the wire, but also reduces the movement and friction of the wire in the tube. By optimizing the spiral pitch and the number of winding layers, a close fit between the wire and the third sleeve 203 can be achieved. Inside the third sleeve 203, it is preferred to arrange the wire connecting the contact electrode to ensure that the connection between the wire and the electrode contact 110 is stable and reliable.

[0066] Furthermore, the multiple contact wires 111 correspond to the multiple electrode contacts 110 respectively; each contact wire 111 extends in the third sleeve 203 and passes through the third sleeve 203 and the second sleeve 202 in sequence at the corresponding electrode contact 110 to be electrically connected to the electrode contact 110.

[0067] Each contact wire 111 directly corresponds to a specific electrode contact 110, ensuring that each electrode contact 110 can independently receive electrical signals from an external control device, such as a neurostimulator. This independent connection method enables doctors or therapists to accurately control the electrical stimulation parameters of each electrode contact 110, such as voltage, frequency, pulse width, etc., to achieve differentiated stimulation of the target tissue and adapt to the treatment needs of different parts and different pathological conditions. The contact wire 111 extends in the third sleeve 203, and then directly reaches the corresponding electrode contact 110 through the preset channels of the second sleeve 202 and the third sleeve 203, achieving a high degree of integration of the internal structure of the electrode lead 10. This design not only helps to reduce the impact of external interference on signal transmission, ensure the accuracy and stability of electrical stimulation, but also provides physical protection for the contact wire 111 to prevent it from being damaged during the implantation process or during the patient's daily activities, thereby extending the service life of the electrode lead 10. Since the connection path between the contact wire 111 and the electrode contact 110 is clear and fixed, the doctor can quickly and accurately connect the electrode contact 110 with the corresponding contact wire 111 during the implantation operation, which simplifies the operation steps, shortens the operation time, and reduces the operation risk. Similarly, during the later maintenance or replacement, it is also convenient to locate and handle the relevant components.

[0068] Possible implementations include: pre-setting through holes matching the number of electrode contacts 110 on the second sleeve 202 and the third sleeve 203, and each through hole corresponds to one electrode contact 110. The contact wire 111 extends from the third sleeve 203 through these through holes and is connected to the corresponding electrode contact 110. The through hole position should be precisely designed to ensure that the contact wire 111 and the electrode contact 110 are tightly and stably connected. In order to prevent short circuits between the contact wires 111 or short circuits between the contact wires 111 and other parts of the main body 100, insulating materials can be used to seal or wrap the contact parts of the contact wire 111 and the second sleeve 202 and the third sleeve 203, such as silicone, Teflon coating, etc. At the same time, the connection parts of the contact wire 111 and the electrode contact 110 should also be reliably insulated. The connection method between the electrode contact 110 and the contact wire 111 can be designed to be detachable, for example, using plug-in connectors, welding, crimping, etc., so that replacement or repair can be carried out when necessary. This design needs to ensure that the electrical performance of the connection is good, and at the same time, it has a certain mechanical strength to resist the stress caused by normal physiological activities. To facilitate identification and operation by the operator, color coding, digital labels, bar codes and other labels can be set on the contact wire 111 or its proximal end, corresponding to the position or serial number of the electrode contact 110, to ensure that there is no confusion during implantation and regulation.

[0069] The contact wire 111 is made of a flexible material with good electrical conductivity, such as copper alloy, to ensure that a stable electrical connection can be maintained after implantation in the body. Each contact wire 111 corresponds to the corresponding electrode contact 110 one by one to ensure the accurate transmission of the electrical signal. The contact wire 111 extends in the third sleeve 203, maintaining a certain spacing to prevent mutual interference or crossing. According to the overall structure and implantation position of the electrode lead 10, the length and curvature of the contact wire 111 are reasonably designed to ensure that the wire can smoothly pass through the sleeve and connect with the electrode contact 110. Taking into account the softness and space limitations of human tissue, the flexibility of the wire can be appropriately increased to better adapt to the bending and torsion in the body. For electrode contacts 110 that need to be frequently replaced or repaired, a detachable connector structure can be designed to facilitate subsequent operations. When designing the contact wire 111, it is necessary to consider the electromagnetic compatibility between it and the external control unit to avoid the influence of electromagnetic interference on the transmission of electrical signals. Measures such as shielding structures or filters can be used to improve the electromagnetic compatibility of the electrode lead 10.

[0070] Furthermore, the main body 100 further includes a fourth sleeve 204 , the third sleeve 203 is located outside the fourth sleeve 204 and surrounds the fourth sleeve 204 , and each contact wire 111 is located between the third sleeve 203 and the fourth sleeve 204 and is spirally wound on the fourth sleeve 204 .

[0071] The presence of the fourth sleeve 204 provides additional support and protection for the contact wire 111, while maintaining the compactness of the entire electrode lead 10. Each contact wire 111 is located between the third sleeve 203 and the fourth sleeve 204, forming a new wire layer. The addition of the fourth sleeve 204 and the spiral winding of the contact wire 111 provide a deeper level of protection and fixation for the signal transmission path of the electrode contact 110, thereby enhancing the overall mechanical strength and tensile and twisting resistance of the lead. In particular, under the action of patient activity or external pressure, this structure helps to reduce the risk of displacement, wear or breakage of the contact wire 111, ensure the stable transmission of the electrical stimulation signal, and thus ensure the treatment effect. Placing the contact wire 111 and the heating wire wire 112 at different sleeve levels, such as between the third sleeve 203 and the fourth sleeve 204, effectively isolates the electrical stimulation signal channel from the thermal stimulation control channel, and reduces the electromagnetic interference between the two. This helps to improve the purity of the electrical stimulation signal, ensuring accurate and efficient electrophysiological treatment, and also helps to avoid interference with the thermal stimulation control signal, ensuring accurate control of thermal stimulation. The layout of the spirally wound contact wire 111 on the fourth sleeve 204 allows the wires to maintain clear spacing and order, facilitating accurate wiring during the production process, as well as subsequent fault detection and maintenance work. This structural design is conducive to quickly locating the fault location, simplifying the maintenance process, and reducing medical costs.

[0072] The sleeve should be made of materials with good biocompatibility, moderate mechanical strength and certain insulation properties, such as medical-grade polyurethane, PEEK, etc. The tubular structure is made by precision extrusion or injection molding to ensure its dimensional accuracy and surface quality to meet the needs of spirally wound contact wire 111. For example, suitable fixings or adhesives are set between each sleeve to ensure that the contact wire 111 is firmly fixed after spiral winding to prevent it from loosening during use. At the same time, the sealing treatment between the sleeve layers is done well to prevent body fluids from infiltrating and affecting the performance of the wire or causing infection. Reliable welding, crimping or special connectors are used for electrical connection at the connection between the contact wire 111 and the electrode contact 110 and at the connection with the external controller. After production and assembly are completed, strict electrical performance tests are carried out, including conductivity inspection, insulation resistance measurement, voltage resistance test, etc., to ensure the functional integrity and safety of the electrode lead 10.

[0073] Furthermore, a plurality of contact wires 111 are wound on the fourth sleeve 204 in the form of equidistant spirals.

[0074] The multiple contact wires 111 are wound in an equidistant spiral, so that the stress on each wire is evenly distributed, avoiding stress concentration and significantly improving the fatigue resistance of the electrode lead 10. During patient activities or long-term use, this design can effectively prevent individual wires from failing prematurely due to excessive stress, thereby extending the service life of the device. The equidistant spiral layout allows each contact wire 111 to evenly occupy space on the fourth sleeve 204, making maximum use of the limited internal volume and making the electrode lead 10 more compact. The equidistant spiral layout has regularity and consistency, which facilitates the use of automated equipment for precise wiring during the production process, reduces manual operation errors, and improves production efficiency. At the same time, this standardized design is also conducive to strict quality inspection and control to ensure the electrical performance, mechanical strength, and connection reliability of each contact wire 111 with other components. An insulating material can be coated on the inner wall of the sleeve, or an insulating layer can be added to the outer layer of the wire to provide additional electrical isolation.

[0075] The contact wire 111 is spirally wound in the sleeve. This layout not only optimizes space utilization, but also improves the stability of the wire. This layout not only arranges the wires in an orderly manner, but also effectively avoids mutual interference and crossing between the wires. In implementation, a precision winding machine or other automated equipment is used to wind the contact wire 111 on the fourth sleeve 204 in an equidistant spiral according to the design parameters. During the winding process, key indicators such as coil tightness and wire diameter consistency are monitored in real time to ensure product quality. Subsequently, reliable electrical connections are made between each wire and the electrode contact 110 and the external controller, and sealing and fixing are performed. After the electrode lead 10 is assembled, strict electrical performance tests, mechanical strength tests, such as stretching, bending, torsion, etc., and long-term stability evaluations, such as thermal aging, salt spray tests, etc., are carried out to ensure that the product meets the design requirements and clinical use standards. If necessary, the actual working performance of the electrode lead 10 can be verified in an animal model or clinical trial. During the manufacturing process, laser cutting, winding, welding and other processes can be used to accurately control the size and position of each sleeve, as well as the layout and connection of the contact wire 111. In order to reduce electromagnetic interference, an electromagnetic shielding layer, such as a conductive foil or a metal mesh, can be set inside the sleeve. For the insulation design of the contact wire 111, in addition to the outer insulating layer, an insulating material can be filled between the wire and the sleeve to improve the insulation performance. The different parts of the electrode lead 10 can be designed into a modular structure, such as a heating part, a contact part and a wire part, which is convenient for assembly and maintenance. This modular design can also reduce production costs and improve production efficiency. Insulating material is coated on the outer surface of the contact wire 111 to ensure that the wire will not short-circuit or leak with other parts during the winding and implantation process. Inside the third sleeve 203, an additional support structure or isolation layer can be set to prevent the contact wire 111 from being squeezed or damaged during the winding process. During the winding process, appropriate fixing measures can be adopted, such as using an adhesive or setting a fixing groove to ensure that the position of the contact wire 111 in the fourth sleeve 204 is stable to prevent it from moving or falling off. The contact wire 111 is made of high-strength and high-flexibility materials to ensure that it can withstand certain mechanical stress during winding and implantation. Precision processing techniques, such as CNC winding, laser cutting, etc., are used to ensure that the contact wire 111 is wound in the fourth sleeve 204 in a precise equidistant spiral.

[0076] Furthermore, each contact wire 111 has a diameter D, and a distance W between any two adjacent contact wires 111 is greater than the diameter D.

[0077] like Figure 5As shown, the spacing W between adjacent contact wires 111 is set to be greater than the diameter D, ensuring that there is enough electrical clearance between the wires, effectively preventing short circuits caused by direct contact between wires due to factors such as vibration and deformation, and ensuring the safe transmission of electrical stimulation signals. At the same time, a larger spacing also helps to reduce electromagnetic interference and improve the signal-to-noise ratio of electrophysiological signals. Increasing the wire spacing is conducive to improving the heat exchange conditions between the wires, improving the heat dissipation efficiency, and reducing local temperature rise, especially when electrical stimulation and thermal stimulation are carried out simultaneously, which can effectively prevent overheating from damaging the insulation performance of the wires and the patient's tissue. In addition, a larger spacing also helps to reduce the temperature gradient caused by heat conduction between adjacent wires, ensuring the consistency of the working temperature of each wire. At the same time, a larger wire spacing allows detergents, disinfectants, etc. to more fully contact each contact wire 111, improving the cleaning and disinfection effect, and further reducing the risk of infection. At the same time, it is also convenient for operators to use tools for deep cleaning, which meets the hygiene requirements of medical equipment.

[0078] The stability and consistency of the contact wire 111 during the winding process are ensured by strictly controlling the dimensional accuracy of the wire diameter D and the spacing W. During the assembly process of the electrode lead 10, a dedicated fixture and assembly process are used to ensure that the contact wire 111 can be accurately wound on the fourth sleeve 204 according to the design requirements. The assembled electrode lead 10 is subjected to strict mechanical property tests, such as bending tests, tensile tests, etc., to ensure that it has good mechanical properties and reliability in actual use.

[0079] Furthermore, it also includes a sensor 303, the sensor 303 includes at least one sensing unit, and the at least one sensing unit is configured to respectively sense the temperature of at least one electrode contact 110; the electrode lead 10 also includes at least one sensing wire 302, and the at least one sensing wire 302 corresponds to at least one sensing unit respectively; each sensing wire 302 is located between the second sleeve 202 and the third sleeve 203, spirally wound on the third sleeve 203, and passes through the second sleeve 202 at the corresponding sensing unit to be electrically connected to the sensing unit.

[0080] like Figure 2 As shown, the sensor wire 302 and the heating wire 301 are arranged together in a spiral shape around the sleeve, and the sensor 303 contacts the heating wire 301 to measure the temperature of the heating wire 301.

[0081] The newly added sensor 303 can monitor the temperature of the electrode contact 110 in real time to ensure that the thermal stimulation is within a safe range and prevent thermal damage to the patient's tissue due to excessive heating. This instant feedback mechanism helps doctors to accurately control the thermal stimulation parameters and improve the treatment effect. When the temperature of the electrode contact 110 exceeds the preset threshold, the sensor 303 can trigger an alarm or automatically adjust the heater output to prevent thermal damage events. This adaptive function enhances the safety of the electrode lead 10 and adapts to individual differences in patients and dynamic changes in tissues. The sensing wire 302 and the heating wire 112 are located in the second sleeve 202 and are spirally wound, realizing the integrated design of the thermal stimulation and temperature monitoring system, effectively utilizing the limited internal space, and maintaining the compact structure of the electrode lead 10.

[0082] In the spinal cord stimulation system for treating chronic pain, the sensor 303 includes multiple sensing units, each corresponding to a plurality of electrode contacts 110. When the system is running, the sensing unit continuously monitors the temperature of each electrode contact 110. Once it exceeds a safety threshold, for example, 43°C, it immediately feeds back to the external control system to automatically adjust the heater output to prevent thermal damage to the spinal cord tissue. This design ensures the safety, accuracy and personalization of spinal cord stimulation treatment.

[0083] The sensor 303 can be integrated inside the main body 100 of the electrode lead 10 so as to be close to the electrode contact 110, so as to accurately sense the contact temperature. Each sensing unit can be designed as a miniature temperature sensor, such as a thermistor or a thermocouple, which can sensitively respond to temperature changes and convert temperature signals into electrical signals. The sensing wire 302 is located between the second sleeve 202 and the third sleeve 203, and is at the same level as the heating wire 112, so as to maintain the compactness and orderliness of the structure. The sensing wire 302 is spirally wound on the third sleeve 203, which not only saves space but also helps to reduce interference between wires.

[0084] Where necessary, the sensing wire 302 passes through the second sleeve 202 and is electrically connected to the corresponding sensing unit to ensure that the temperature signal can be accurately transmitted. The temperature signal is transmitted to an external control unit or processor through the sensing wire 302 for further analysis and processing. The control unit can adjust the parameters of electrical stimulation and thermal stimulation according to the received temperature signal to achieve precise control of the treatment process.

[0085] As part of the implantable neurostimulator, the electrode lead 10 can communicate wirelessly with an external control device. During the treatment process, the sensor 303 senses the temperature of the electrode contact 110 in real time and sends the temperature data to the control device. The control device adjusts the parameters of electrical stimulation and thermal stimulation according to the received temperature data, and displays the current treatment status and parameter settings to the user through the feedback system. In order to ensure the safety of the treatment process, a temperature threshold can be set. When the sensor 303 detects that the temperature of a certain electrode contact 110 exceeds the set threshold, the control device will automatically stop or adjust the output of thermal stimulation to prevent tissue damage. According to the treatment needs and physical reactions of different patients, the control device can adjust the treatment parameters according to the sensed temperature data and formulate a personalized treatment plan.

[0086] Furthermore, the sensing contact of each sensing unit is located in the middle of the corresponding electrode contact 110 in the longitudinal direction.

[0087] like Figure 3 As shown, the sensor 303 is located in the middle of the electric heating wire 301, the length of the electrode contact 110 is L1, the distance from one end of the electrode contact 110 to the sensing contact is L2, and the value range of L2 / L1 can be 0.4-0.6. The sensing contact of the sensor 303 is specially designed and positioned in the middle of the electrode contact 110, which means that the sensing contact of the sensor 303 is roughly aligned with the center position of the electrode contact 110. This layout can ensure that the sensing contact of the sensor 303 can more accurately capture the temperature of the central area of ​​the electrode contact 110, thereby providing more accurate temperature data. In order to ensure that the sensing contact of the sensor 303 can accurately reflect the temperature of the electrode contact 110, there should be good thermal coupling between the sensing unit and the electrode contact 110. This can be achieved by using a material with good thermal conductivity, or by designing a specific thermal contact structure to ensure the thermal conduction efficiency between the sensing contact of the sensor 303 and the electrode contact 110. When the electrode contact 110 is heated, the temperature may be unevenly distributed along its longitudinal direction, and there is a temperature gradient. Placing the sensing contact of the sensor 303 in the middle of the electrode contact 110 can reduce the impact of this temperature gradient on the sensing result, because the middle area usually has a relatively uniform temperature distribution. Since the sensing contact of the sensor 303 is aligned with the center of the electrode contact 110, the design of the electrode lead 10 can more effectively adjust the heater output based on the sensing data, so that the heat energy is more evenly distributed around the electrode contact 110, thereby improving the treatment effect.

[0088] By accurately monitoring the temperature in the middle of the electrode contact 110, the doctor or the control system can more accurately determine the actual effect of electrical stimulation and thermal stimulation on the patient's target tissue. When the temperature exceeds the safety threshold, the system can automatically adjust the stimulation parameters or stop the stimulation to avoid potential harm to the patient. Different patients may react differently to electrical stimulation and thermal stimulation, so it is necessary to adjust the treatment strategy according to individual differences. By real-time monitoring the temperature in the middle of the electrode contact 110, the doctor can formulate a more personalized treatment plan for the patient to improve the treatment effect and reduce side effects. The design of the sensing contact of the sensor 303 being located in the middle of the electrode contact 110 not only improves the accuracy of temperature monitoring, but also helps to optimize the overall structure of the electrode lead 10. By rationally arranging the sensing unit and the electrode contact 110, the volume and weight of the electrode lead 10 can be reduced, making it easier to implant in the patient's body. The sensing contact of the sensor 303 is located in the middle of the electrode contact 110, which can more accurately reflect the temperature of the core area where the electrode contact 110 actually works, avoid temperature measurement deviations caused by edge effects, and ensure accurate control of thermal stimulation. The sensing contacts of the sensor 303 correspond to the positions of the electrode contacts 110, which simplifies the equipment installation, calibration and maintenance process. The doctor does not need to consider the positional relationship between the sensing points and the electrode points, reducing the complexity of the operation. In the spinal cord stimulation system for treating chronic pain, the sensing contacts of the sensor 303 of the sensing unit are precisely aligned with the middle of the electrode contact 110. When the system is running, the sensing contacts of the sensor 303 monitor the center temperature of the electrode contact 110 in real time, and the data is fed back to the external controller to automatically adjust the heater output to ensure that the thermal stimulation temperature of the spinal cord tissue is constant within a safe range. This design improves the accuracy and safety of spinal cord stimulation treatment.

[0089] Furthermore, at least one heating wire 112 and at least one sensing wire 302 are wound on the third sleeve 203 in the form of equidistant spirals.

[0090] The heating wire conductor 112 and the sensing wire 302 are both wound on the third sleeve 203 in an equidistant spiral manner, realizing an integrated layout of the two functional wires, further optimizing the internal space utilization of the electrode lead 10, and maintaining the compact structure of the device. The equidistant spiral wiring method makes the stress on the heating wire conductor 112 and the sensing wire 302 evenly distributed, avoiding stress concentration, and improving the overall mechanical stability of the electrode lead 10, especially when the patient is active or used for a long time, effectively preventing the wire from breaking or being damaged. The unified spiral wiring rules simplify the wiring operations in the production process and reduce the manufacturing difficulty and cost. At the same time, it is convenient to quickly locate and replace the faulty wire during later maintenance, thereby improving the maintenance efficiency of the equipment.

[0091] In the spinal cord stimulation system for treating chronic pain, the heating wire 112 and the sensing wire 302 are both wound in an equidistant spiral on the third sleeve 203. This design makes the internal wiring of the electrode lead 10 neat and orderly, improves the accuracy and safety of thermal energy control during spinal cord stimulation, and simplifies equipment maintenance.

[0092] like Figure 6 As shown, this figure is a cross-sectional view of the third electrode contact 110 along the longitudinal direction of the lead wire. This figure has two sets of sensors 303 (not shown in the figure). For example, the sensors 303 in this figure are thermocouples and their wires, heating wires 301 and their wires, and electrode contact wires 111. One set of the two sets of wires is for the third electrode contact 110, and the other set is for the fourth electrode contact 110. As can be seen in the figure, there are three wires between the first sleeve 201 and the second sleeve 202. From left to right in the figure, there are two thermocouple connecting wires and the heating wire 301, which are for the third electrode contact. There are five wires between the second sleeve 202 and the third sleeve 203, which are the positive pole of the heating wire 112 for the fourth electrode contact 110, two sensors such as thermocouple wires 302 for the fourth electrode contact 110, the negative pole of the heating wire 112 for the fourth electrode contact 110, and the heating wire 112 connected to the heating wire 301 between the first sleeve 201 and the second sleeve 202, so as to form a loop. There are two wires between the third sleeve 203 and the fourth sleeve 204 from left to right, which are the electrode contact wire 111 for providing electric pulses for the third electrode contact 110, and the electrode contact wire 111 for providing electric pulses for the fourth electrode contact 110. The electrode contact wire 111 for providing electric pulses for the third electrode contact 110 passes through the sleeve and is connected to the third electrode contact 110, so it only surrounds the sleeve once in this cross-sectional view.

[0093] During the manufacturing process, special winding equipment, such as a precision CNC winding machine, is used to automatically wind according to pre-set spiral parameters, such as pitch, starting position, rotation direction, etc. The equipment should have sufficient accuracy to ensure that the heating wire conductor 112 and the sensing wire 302 are accurately wound on the third sleeve 203 according to the law of equidistant spirals, while avoiding problems such as crossing and knotting between wires. During the winding process, key indicators such as coil tightness and wire diameter consistency can be monitored in real time to ensure product quality. For example, a customized third sleeve 203 mold is designed and manufactured, and its inner wall has a spiral groove structure that matches the equidistant spiral parameters. During the winding process, the heating wire conductor 112 and the sensing wire 302 are naturally arranged along the spiral groove of the inner wall of the mold to form a predetermined equidistant spiral layout. The mold should have good wear resistance and dimensional stability to ensure consistent wire winding effects during mass production. For example, a preformed wire assembly is used, that is, the heating wire 112 and the sensing wire 302 are pre-fixed on a flexible substrate in the form of an equidistant spiral line, and then the substrate and the third sleeve 203 are bonded or hot-melted. This method simplifies the on-site winding process and improves production efficiency, but it is necessary to ensure that the substrate material and the third sleeve 203 have good bonding strength and electrical insulation performance. For example, a guide structure is provided on the third sleeve 203, such as an embedded slide rail or a positioning hole, to guide the heating wire 112 and the sensing wire 302 to be manually or semi-automatically wound along an equidistant spiral line trajectory. This method requires high skills from the operator, but has low equipment investment and is suitable for small batch or customized production.

[0094] In the present disclosure, the directional terms "axial", "radial" and "circumferential" are relative, not absolute. The axial direction of a component may refer to the extending direction of its rotation axis, the radial direction may refer to the direction on a radial plane orthogonal to the rotation axis and intersecting the rotation axis, and the circumferential direction may refer to the circumferential direction around the rotation axis.

[0095] It should be understood that although the terms "first" or "second" etc. may be used in the present disclosure to describe various elements, for example, a first electrode contact, a second electrode contact, these elements are not defined by these terms, and these terms are only used to distinguish one element from another.

[0096] The basic principles of the present disclosure are described above in conjunction with specific embodiments. However, it should be noted that the advantages, strengths, effects, etc. mentioned in the present disclosure are only examples and not limitations, and it cannot be considered that these advantages, strengths, effects, etc. are required by each embodiment of the present disclosure. In addition, the specific details disclosed above are only for the purpose of illustration and ease of understanding, and are not limitations. The above details do not limit the present disclosure to the necessity of adopting the above specific details to be implemented.

[0097] The above description has been given for the purpose of illustration and description. In addition, this description is not intended to limit the embodiments of the present disclosure to the forms disclosed herein. Although multiple example aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, changes, additions and sub-combinations thereof.

[0098] The components and devices involved in this disclosure are only illustrative examples and are not intended to require or imply that they must be connected, arranged, or configured in the manner shown in the drawings. For example, those skilled in the art will recognize that these components and devices can be connected, arranged, or configured in any manner.

[0099] The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

1. An electrode lead of an implantable neurostimulator, the electrode lead being configured to be at least partially implanted in a patient's body, characterized in that: The electrode lead comprises: The main body is elongated in shape; a plurality of electrode contacts attached to the body, spaced apart longitudinally along the body, and configured to contact a target tissue in a patient's body to deliver electrical stimulation to the target tissue; and A heater is configured to heat at least one electrode contact to deliver thermal stimulation to the target tissue through the at least one electrode contact.

2. The electrode lead according to claim 1, characterized in that: The electrode contacts are provided with a bioactive substance, and the bioactive substance is configured to be heated by the heater so as to be released to a target tissue.

3. The electrode lead according to claim 2, characterized in that: Also included is a sensor configured to sense a temperature of the at least one electrode contact.

4. The electrode lead according to claim 3, characterized in that: The heater includes at least one heating unit, and the sensor includes at least one sensing unit. The at least one heating unit is configured to heat the at least one electrode contact, respectively, and the at least one sensing unit is configured to sense a temperature of the at least one electrode contact, respectively.

5. The electrode lead according to claim 4, characterized in that: Each heating unit is a heating wire in contact with a corresponding electrode contact.

6. The electrode lead according to claim 5, characterized in that: Each sensing unit is a thermocouple.

7. The electrode lead according to claim 6, characterized in that: Each thermocouple is in contact with a corresponding heating wire.

8. The electrode lead according to claim 7, characterized in that: The main body includes a first sleeve and a second sleeve, the first sleeve is located outside the second sleeve and surrounds the second sleeve, the at least one electrode contact is at least partially exposed to the inner side of the first sleeve, and each heating wire is located between the first sleeve and the second sleeve, in contact with the corresponding electrode contact, and in contact with the corresponding thermocouple located between the first sleeve and the second sleeve.

9. The electrode lead according to claim 8, characterized in that: The main body also includes at least one heating wire, at least one sensing wire and a plurality of contact wires, wherein the at least one heating wire corresponds to the at least one heating wire, the at least one sensing wire corresponds to the at least one sensing unit, and the plurality of contact wires correspond to the plurality of electrode contacts. The main body also includes a third sleeve and a fourth sleeve, wherein the second sleeve is located outside the third sleeve and surrounds the third sleeve, and the third sleeve is located outside the fourth sleeve and surrounds the fourth sleeve. Each heating wire is located between the second sleeve and the third sleeve, wound on the third sleeve, and passes through the second sleeve at the corresponding heating wire to be electrically connected to the heating wire. Each sensing wire is located between the second sleeve and the third sleeve, wound on the third sleeve, and passes through the second sleeve at the corresponding sensing unit to be electrically connected to the sensing unit. Each contact wire is located between the third sleeve and the fourth sleeve, wound on the fourth sleeve, and passes through the third sleeve and the second sleeve in sequence at the corresponding electrode contact to be electrically connected to the electrode contact.

10. An implantable neural stimulator system, characterized in that: Comprising the electrode lead according to any one of claims 1 to 9.

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