An endoprosthesis and a method for surface modification thereof

Abstract

The present application provides an implant, comprising: a carbonized coil is arranged on the outer surface of the implant, the coil is arranged around the outer surface of the implant, the coil provides electric stimulation through magnetic induction function, and / or provides heat therapy, and / or charges another device. The beneficial effect of the present application is that the present application adopts a carbonization process to construct a multi-coil system on the surface of the implant, and provides a solution to the problem of decline of system efficiency and reliability caused by electromagnetic interference when the multi-coil is integrated. At the same time, the present technology can realize the spatiotemporal precise control of the stimulation target, thereby providing a reliable, efficient and easy-to-industrialize implementation path for implantable electric stimulation therapy.

Description

Technical Field

[0001] This invention relates to the field of polymer material surface treatment, specifically to an internal plant and its surface modification method. Background Technology

[0002] The human body contains electroactive substances such as free ions, dipoles, and polarized molecules, enabling cells, tissues, and organs to generate and conduct electrical signals. Based on this electrophysiological mechanism, electrostimulation therapy promotes disease treatment by regulating electrical signals and intervening in related electrophysiological processes within the body. For example, electrostimulation can induce the production of reactive oxygen species (ROS), which, as oxygen-derived molecules produced during aerobic metabolism, play important roles in the body, such as clearing pathogens and participating in cell signal transduction.

[0003] However, most medical implants currently used in clinical practice (such as interbody fusion devices, artificial ligaments, artificial joints, bone plates, and skull plates) are made of materials such as ultra-high molecular weight polyethylene, polyetheretherketone, and polylactic acid. Although these materials have excellent mechanical properties and biocompatibility, their electrical activity is generally weak, making it difficult to actively reconstruct the physiological electrical microenvironment at the injury site, thus limiting the tissue healing effect.

[0004] Integrating electrical stimulation or charging functions into implants has become an important trend in rehabilitation engineering, sports medicine, and implantable electronic devices. Currently, the mainstream method involves depositing a piezoelectric material coating on the implant surface; however, this method suffers from problems such as easy coating peeling, complex processes, and difficulty in industrialization. Furthermore, existing technologies mostly rely on physical contact excitation to generate electromotive force, failing to achieve precise non-contact electrical stimulation control.

[0005] To overcome the aforementioned shortcomings, this invention proposes a novel coil integration and electromagnetic control scheme. This design employs a carbonization process to construct a multi-coil system on the implant surface and provides a solution to the problem of decreased system performance and reliability caused by electromagnetic interference during multi-coil integration. Simultaneously, this technology enables precise spatiotemporal control of the stimulation target, thus providing a reliable, efficient, and easily industrialized path for implantable electrical stimulation therapy. Summary of the Invention

[0006] An inner plant, characterized in that it comprises: a carbonized coil disposed on the outer surface of the inner plant, the coil being arranged around the outer surface of the inner plant, the coil being a magnetoelectric induction coupling winding structure, the coil being constructed to form a field effect coupling configuration with an adjacent magnetic field, and / or to form an energy coupling matching configuration with other instruments.

[0007] The aforementioned magnetoelectric induction coupling winding structure refers to a coil that, through a special winding method, can generate a magnetoelectric conversion effect under the action of an external alternating magnetic field, thereby realizing the conversion of magnetic field and electrical energy and the transfer of energy.

[0008] The aforementioned field-effect coupling refers to a form of interaction that utilizes the spatial field effects of electric and magnetic fields to achieve non-contact energy and signal transmission, without the need for direct physical wiring. In this case, magnetic field coupling is the primary method, following Faraday's law of electromagnetic induction. When the magnetic flux of the external magnetic field changes, the coil circuit can generate an electromotive force, thereby completing the non-contact energy conversion and signal interaction.

[0009] The energy coupling matching configuration refers to the ability of the coil to adapt to external devices in terms of parameters such as frequency and impedance, so that the electromagnetic characteristics of both parties can work together to achieve stable energy transmission.

[0010] This invention utilizes the magnetoelectric induction properties of carbonized coils to achieve electrical stimulation, thermotherapy, and wireless charging of other devices.

[0011] The depth of the coil is 20nm-200μm.

[0012] The coil width is 0.1-0.3mm, and the coil outer diameter is 1-19cm.

[0013] The coil is a single coil.

[0014] This design is suitable for precise stimulation or energy harvesting of local targets, and has the advantages of simple structure and low cost.

[0015] Multiple coils form a topological network, and the arrangement of the multiple coils in the topological network is at least one of the following: matrix array, honeycomb array, staggered array, contour array, gradient density array, and concentric circle array.

[0016] Multiple coils can form a topological network. This networked design improves the coverage of functions.

[0017] Furthermore, the coils constituting the topological network can also have a geometric shape selected from at least one of the following: ring-shaped, zigzag-shaped, teardrop-shaped, spiral-shaped, serpentine, square-shaped, or biomimetic pattern. Different coils in the network can adopt the same or different shapes. The preset arrangement is selected from at least one of the following: matrix array, honeycomb array, staggered array, contoured array, gradient density array, or concentric circle array. For example, matrix arrays are easy to control, honeycomb arrays have the highest space-filling efficiency, contoured arrays can conform to specific physiological contours, and gradient density arrays can achieve a smooth transition in stimulation intensity.

[0018] The coil is a smooth circular ring set on the outer surface of the inner plant, or the coil is a continuous reciprocating zigzag structure set on the outer surface of the inner plant.

[0019] The broken line structure is at least one of the following: wavy, zigzag, teardrop, spiral, snake, meander, or irregular curve.

[0020] Different geometries can adjust the distribution of inductance, the path of current, and the shape of the final induced magnetic field to adapt to different application requirements: among them, spiral coils can generate stronger magnetic field electromotive force and deeper penetration, which is suitable for deep tissue activation; wavy, zigzag, or serpentine coils have large-area contact characteristics, which can achieve uniform stimulation over a larger area; and ring coils have a simple structure and are easier to process.

[0021] More preferably, the coil is covered with a flexible insulating encapsulation layer, and the encapsulation layer has windows at predetermined positions corresponding to the coil to expose the coil, forming electrode points for contact with the surface of a living organism. This design allows electrical energy to be drawn from specific points for precise stimulation, while the encapsulation layer protects the coil body.

[0022] The center-to-center distance between adjacent coils shall not be less than the outer diameter of a single coil.

[0023] The multiple coils in the topology network are arranged in a preset pattern, and the center-to-center distance between any two adjacent coils is not less than the outer diameter of the larger coil. This "distance not less than the outer diameter" layout rule is the core physical design principle for suppressing mutual inductive coupling between adjacent coils and reducing crosstalk.

[0024] The method for suppressing electromagnetic interference in the above-mentioned topological network includes two main strategies: First, by using the aforementioned physical layout rules, i.e., setting the center-to-center distance between adjacent coils to be no less than the outer diameter of the coil, the mutual inductance between coils is reduced spatially; Second, when multiple coils in the network need to operate in the same or similar modes, the multiple coils are controlled to work alternately in a time-sharing manner by a control circuit, or they are tuned to operate at slightly different resonant frequencies, thereby avoiding co-frequency interference in the time or frequency domain.

[0025] The inner plant material is at least one of polyetheretherketone, polylactic acid, ultra-high molecular weight polyethylene, polyglycolic acid, polycaprolactone, polyester, polyimide, carbon fiber polyetheretherketone composite material, polyaryletherketone, polyurethane, collagen, gelatin, and polypropylene.

[0026] A method for modifying the surface of an inner plant, used to prepare the inner plant described in any of the preceding claims; the coil is formed by carbonizing the surface of the inner plant, and the carbonization method is at least one of electron beam surface heat treatment carbonization, laser micro-nano processing carbonization, ion beam irradiation carbonization, plasma surface treatment, corona discharge treatment, chemical vapor deposition, template carbonization, and arc treatment.

[0027] The laser micro / nano fabrication carbonization parameters are: scanning speed 10-300 mm / s, output power 0.15-12 W; the ion implantation parameters are: dose 5 × 10¹ 5 cm², ion implantation energy 400keV; the plasma-enhanced chemical vapor deposition parameters are: carbon source gas 40 sccm CH4, working current 0.2A, working voltage 1200V; the corona discharge parameters are: voltage 8kV; the electron beam surface heat treatment parameters are: voltage 40kV, current 15mA, vacuum degree 10⁻²Pa.

[0028] The method for modifying the surface of the plant, comprising: (1) Implant pretreatment: The surface of the medical polymer plant substrate is purged with a high-pressure air gun to remove surface impurities; the parameters of the high-pressure air gun are: treatment time 1-3 min, treatment temperature room temperature, pressure 8-12 bar, flow rate 60-100 L / min. (2) Surface carbonization treatment: The pretreated inner plant substrate is carbonized using surface modification technology; (3) Annealing stress relief treatment: Under a protective gas atmosphere, the carbonized inner plant is annealed at a temperature of 80-260℃ and held for 0.5-2h. Then it is cooled in the furnace to eliminate residual stress in the substrate. (4) Insulation encapsulation and electrode point preparation: a medical-grade flexible insulating material is coated on the coil area to form an encapsulation layer. After curing, a window is etched at a preset position at the end of the coil to expose the carbonized coil and form electrode points. The remaining area of ​​the coil is completely covered by the encapsulation layer. (5) Induction performance test: The prepared inner plant was placed in an alternating magnetic field with a frequency of 100kHz, and the open-circuit induced electromotive force at both ends of the coil was tested. (6) Functional Configuration: A micro-control circuit is connected externally or integrated to the coil electrode points to form a reliable electrical compatibility connection structure between the micro-control circuit and the coil electrode points; at the same time, the micro-control circuit is configured to be compatible with the coil circuit form, and the two together constitute a matched circuit architecture with field effect and energy coupling characteristics. Through the configuration of this circuit architecture, the electromagnetic induction characteristics of the coil can be used to realize the functions of electrical stimulation, thermotherapy, and wireless energy supply to other external devices.

[0029] The encapsulation layer is applied using a dispensing or scraping process, with a wet film thickness of 40-50 μm and a curing condition of 60-80℃ for 1-2 hours.

[0030] The electrode point window is circular with a diameter of 2-4 mm, and is formed by laser precision marking.

[0031] The carbonization process is a technique that induces carbonization on the surface of a polymer substrate using a high-energy beam. Based on the photothermal, photochemical, or combined physicochemical effects of high-energy particles, the polymer surface molecular chains undergo bond breaking and cross-linking, causing non-carbon elements to escape and form a carbon layer. Preferably, the carbonization process is at least one of electron beam surface heat treatment carbonization, laser micro / nano processing carbonization, ion beam irradiation carbonization, plasma surface treatment, corona discharge treatment, chemical vapor deposition, template carbonization, and arc treatment. For example, laser micro / nano processing carbonization uses a pulsed or continuous laser at a power of approximately 0.1 W to 12 W and a scanning speed of approximately 10 mm / s to 300 mm / s to scan the polymer surface; the photothermal effect of the laser induces localized pyrolysis carbonization of the polymer (such as polyimide or polyetheretherketone). Ion implantation carbonization accelerates carbon ions to energies of 100 keV to 450 keV, forcibly embedding these high-energy ions into the surface lattice of materials (such as ultra-high molecular weight polyethylene) at a dose of 1×10¹⁵ to 1×10¹⁶ cm². This alters the surface chemical composition and structure through lattice damage and doping effects. Electron beam surface heat treatment utilizes a focused electron beam to bombard the material surface with a voltage of 30 kV to 50 kV and a current of 1 mA to 20 mA. The kinetic energy is instantly converted into heat energy, causing a rapid temperature rise in the material surface and achieving localized carbonization of the polymer.

[0032] The implants are artificial intervertebral discs, intervertebral fusion devices, intracranial fixation plates, joint prostheses, bone plates, rods, femoral stem prostheses, dura mater patches, stents, ligaments, artificial blood vessels, cardiac repair patches, artificial valves, hernia patches, pericardial membranes, or cardiovascular patches.

[0033] In terms of functional configuration and implementation, the endophyte is placed in an external alternating magnetic field of a specific frequency and intensity, causing its surface coils (single coils or a network of topologies) to generate an induced electromotive force. In this embodiment, the generated open-circuit induced electromotive force typically ranges from 3mV to 6V. This voltage range is optimized to balance the safety of biological applications with the ability to effectively drive subsequent functional units.

[0034] The coil or network is selectively configured as at least one of the following functional units: (1) Electrical stimulation unit: The electromotive force generated by the induction is directly used for electrical stimulation; (2) Power supply unit: After managing the electrical energy obtained by sensing, it provides power or charges the microelectronic components (such as sensors, processors) or other external devices integrated on the plant; (3) Thermotherapy unit: It provides thermotherapy function by utilizing the Joule heating effect generated by the coil.

[0035] The beneficial effects of this invention are as follows: The endophyte and its surface modification method provided by this invention have the following advantages: Controllable performance and form: The combination of a variety of coil geometries (ring, biomimetic patterns, etc.) and scientific arrangement arrays (matrix, honeycomb, morphology, etc.) allows the electromagnetic performance to be precisely customized according to application requirements.

[0036] Strong anti-interference capability: For multi-coil systems, an innovative hardware and software collaborative anti-interference method combining "spacing rules" and "time-division / frequency-division operation" is proposed to ensure the stability and efficiency of complex network operation.

[0037] Simple preparation process: A carbonization process is used to etch the material inside the inner plant, preserving its original shape and size. The generated electromotive force is within a safe range for the human body and can meet the clinical needs of the medical field. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of the structure of the annular single-coil functional implant of the present invention.

[0039] Figure 2 This is a schematic diagram of the zigzag single-coil functional implant of the present invention.

[0040] Figure 3 This is a schematic diagram of the structure of the serpentine single-coil functional implant of the present invention.

[0041] Figure 4 This is a schematic diagram of the structure of the annular single-coil functional implant of the present invention.

[0042] Figure 5 This is a schematic diagram of the structure of the annular single-coil functional implant of the present invention.

[0043] In the figure: 1-Polyetheretherketone fusion device; 2-Coil; 3-Flexible insulating encapsulation layer; 4-Electrode point window. Detailed Implementation

[0044] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. These embodiments are for illustrative purposes only and are not intended to limit the invention. Any equivalent modifications made by those skilled in the art based on the spirit of the invention fall within the scope of protection of the present invention. Example 1

[0045] Step (1) Implant preparation: The polyetheretherketone fusion device 1 is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0046] Step (2) Carbonization treatment: The pretreated polyetheretherketone (PEEK) fusion device is carbonized using laser micro-nano processing technology. This carbonizes the surface of the PEEK fusion device, forming coil 2 with a depth of 200 μm and a diameter of approximately 25 mm. The shape can be adapted to meet specific requirements, including but not limited to ring, zigzag, serpentine, and contoured shapes (please refer to...). Figure 1 ).

[0047] The parameters for laser micro / nano processing are: scanning speed 80mm / s, output power 1.4w.

[0048] Step (3) Annealing treatment: Under a protective gas atmosphere, the polyether ether ketone fusion vessel is annealed at 260°C and held for 1 hour to remove residual stress, and then cooled with the furnace.

[0049] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using a dispensing or scraping process, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer 3, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows 4 with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two preset points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0050] Step (5) Induced electromotive force test: The prepared polyether ether ketone fusion device sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20µT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 3mV.

[0051] Step (6) Functional Configuration: By connecting an external or integrated micro-control circuit (which can be encapsulated inside the polyetheretherketone fusion device), the induced electromotive force generated in the coil can be modulated to achieve the electrical stimulation function. When the polyetheretherketone fusion device is implanted in the human body, the coil can act as an electrode to provide invasive electrical stimulation to the surrounding tissues to relieve pain or promote tissue repair. Example 2

[0052] Step (1) Implant preparation: The ultra-high molecular weight polyethylene intracranial fixation plate is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0053] Step (2) Carbonization treatment: The surface of the pretreated ultra-high molecular weight polyethylene cranial fixation plate is carbonized by ion implantation technology, so that the surface of the ultra-high molecular weight polyethylene cranial fixation plate is carbonized, and the coil depth is 20μm, the shape is spiral, the outer diameter is 19cm, and the coil width is 0.2mm.

[0054] The parameters for ion implantation are: dose 5 × 10⁻⁶ 15 cm 2 Ion implantation energy 400keV.

[0055] Step (3) Annealing treatment: Under a protective gas atmosphere, the ultra-high molecular weight polyethylene intracranial fixation plate is annealed at 120°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0056] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0057] Step (5) Induced electromotive force test: The prepared ultra-high molecular weight polyethylene intracranial fixation plate sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 1mT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 6V.

[0058] Step (6) Functional Configuration: By connecting an external or integrated micro-control circuit (which can be encapsulated inside the ultra-high molecular weight polyethylene skull plate), the induced electromotive force generated in the coil can be modulated to achieve the electrical stimulation function: the control circuit modulates the induced electromotive force into pulses that meet biosafety standards (e.g., frequency 0-100 Hz). When the ultra-high molecular weight polyethylene skull plate is implanted in the human body, the coil can act as an electrode to provide invasive electrical stimulation to the surrounding tissues to relieve pain or promote tissue repair. Example 3

[0059] Step (1) Implant preparation: The L-type polylactic acid ligament is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0060] Step (2) Carbonization treatment: The pretreated L-type polylactic acid ligament is carbonized by ion beam irradiation, which carbonizes the surface of the L-type polylactic acid ligament to form a topological network of three spiral coils connected in series. The three coils in the topological network are arranged in a matrix array with a depth of 25 μm. The coil width is 0.2 mm and the outer diameter is 1 cm.

[0061] The parameters for ion beam irradiation are: current density 0.05 μA / cm². 2 .

[0062] Step (3) Annealing treatment: Under a protective gas atmosphere, the left-hand polylactic acid ligament is annealed at 90°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0063] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0064] Step (5) Induced electromotive force test: The prepared polylactic acid ligament sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20µT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 100mV. Example 4

[0065] Step (1) Implant preparation: The polyester dura mater patch is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0066] Step (2) Carbonization treatment: The pretreated polyester dura mater patch is carbonized by plasma-enhanced chemical vapor deposition to form a topological network of two spiral coils connected in series. The two coils are arranged in a concentric circle array with a depth of 20 nm and a coil width of 0.2 mm. The inner diameter of the inner spiral coil is 2 cm and the outer diameter is 3 cm, while the inner diameter of the outer spiral coil is 4 cm and the outer diameter is 5 cm.

[0067] The parameters for plasma-enhanced chemical vapor deposition are: carbon source gas 40 sccm CH4, operating current 0.2 A, and operating voltage 1200 V.

[0068] Step (3) Annealing treatment: Under a protective gas atmosphere, the polyester dura mater patch is annealed at 80°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0069] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0070] Step (5) Induced electromotive force test: The prepared polyester dura mater patch sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20μT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 90mV. Example 5

[0071] Step (1) Implant preparation: The polyimide ligament is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0072] Step (2) Carbonization treatment: The pretreated polyimide ligament is carbonized using laser micro-nano processing technology to form a topological network of two parallel helical coils. The two coils are arranged in a matrix array with a depth of 60 μm. The inner diameter of the coil is 2 cm and the outer diameter is 4 cm.

[0073] The parameters for laser micro / nano processing are: scanning speed 300 mm / s, output power 12 W.

[0074] Step (3) Annealing: Under a protective gas atmosphere, the polyimide ligament is annealed at 240°C for 1 hour to relieve residual stress, and then cooled in the furnace.

[0075] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0076] Step (5) Induced electromotive force test: The prepared polyimide ligament sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20μT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 120mV.

[0077] Step (6) Functional Configuration: Through an external or integrated micro-control circuit (which can be encapsulated inside a polyimide ligament), the coil acts as an energy receiver (receiving coil), generating induced electrical energy in an alternating magnetic field of a specific frequency. After the control circuit rectifies and stabilizes the electrical energy, it can charge the battery of a connected low-power medical device (such as a neurostimulator). Example 6

[0078] Step (1) Implant preparation: Use a high-pressure air gun to pre-treat the ultra-high molecular weight polyethylene joint prosthesis to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0079] Step (2) Carbonization treatment: The pretreated ultra-high molecular weight polyethylene joint prosthesis is carbonized on the surface using corona discharge treatment technology, so that the surface of the ultra-high molecular weight polyethylene joint prosthesis is carbonized to form a ring-shaped coil with a depth of 150nm and a diameter of 6cm.

[0080] The parameters for corona discharge treatment technology are: voltage 8kV.

[0081] Step (3) Annealing treatment: Under a protective gas atmosphere, the ultra-high molecular weight polyethylene joint prosthesis is annealed at 120°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0082] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0083] Step (5) Induced electromotive force test: The prepared ultra-high molecular weight polyethylene joint prosthesis sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20μT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 50mV. Example 7

[0084] Step (1) Implant preparation: The polypropylene hernia patch is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0085] Step (2) Carbonization treatment: The pretreated polypropylene hernia patch is carbonized using laser micro-nano processing technology to form a U-shaped coil with a depth of 30μm. The coil width is 0.2mm, the outer side length is 7cm, and the number of turns is 9.

[0086] The parameters for laser micro / nano fabrication carbonization are: scanning speed 10 mm / s and output power 150 mW.

[0087] Step (3) Annealing treatment: Under a protective gas atmosphere, the polypropylene hernia patch is annealed at 120°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0088] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0089] Step (5) Induced electromotive force test: The prepared polypropylene hernia patch sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 5mT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 4.5V.

[0090] Step (6) Functional Configuration: By connecting an external or integrated micro-control circuit (which can be encapsulated on the outside of the polypropylene hernia patch), the induced electrical energy is directly used to drive the coil's own resistance heating. By adjusting the strength or frequency of the input magnetic field, the coil temperature can be precisely controlled between 38°C and 40°C, thereby performing low-temperature hyperthermia on adjacent tissues and promoting blood circulation. Example 8

[0091] Step (1) Implant preparation: The polyetheretherketone (PEEK) rod is pretreated with a high-pressure air gun to remove dust and other surface impurities. High-pressure air gun parameters: treatment time: 2 min, treatment temperature: room temperature, pressure: 10 bar, flow rate: 80 L / min.

[0092] Step (2) Carbonization: The pretreated polyetheretherketone (PEEK) rod is carbonized using electron beam surface heat treatment technology. This carbonizes the surface of the PEEK rod, forming a topological network of five spatial spiral coils connected in series. The five coils are arranged in a gradually decreasing density array from bottom to top, with a coil depth of 25 μm. The spiral coils are 0.2 mm wide and have 5 turns.

[0093] The parameters for electron beam surface heat treatment technology are: scanning voltage 40KV, current 15mA, and vacuum degree 10. -2 Pa.

[0094] Step (3) Annealing treatment: Under a protective gas atmosphere, the polyether ether ketone rod is annealed at 240°C and held for 1 hour to remove residual stress, and then cooled in the furnace.

[0095] Step (4) Insulation Encapsulation and Electrode Point Fabrication: Using dispensing or scraping processes, a layer of medical-grade silicone rubber is coated onto the coil area as a flexible insulating encapsulation layer, with a wet film thickness of approximately 45 μm. This layer is then cured at 70°C for 1.5 hours to form an ultra-flexible encapsulation layer. Subsequently, using a laser precision marking machine, two circular windows with a diameter of approximately 3 mm are precisely etched onto the encapsulation layer corresponding to two pre-set points at the ends of the coil, fully exposing the underlying conductive coil and forming a pair of clearly defined electrode points. The remaining portion of the coil is well covered and protected by the silicone layer. The silicone encapsulation provides excellent skin affinity and mechanical cushioning.

[0096] Step (5) Induced electromotive force test: The prepared polyether ether ketone rod sample was placed in an alternating magnetic field environment with a frequency of 100kHz and a magnetic induction intensity of 20μT. The open-circuit induced electromotive force at both ends of the coil (measured through the electrode point) was measured to be 5mV.

[0097] Explanation of topology networks and other implementation schemes Implementation of topology networks: For example, multiple coils can be printed on a substrate to form a network. After the entire substrate is coated with an encapsulation layer, windows can be selectively opened at the location where each coil needs to be used as an independent stimulation unit to form an electrode point.

[0098] Other encapsulation materials: Besides silicone, parylene or silicon nitride films can also be used as insulating encapsulation layer materials. Silicone is the preferred material for human contact applications due to its excellent biocompatibility and wearability.

[0099] Implementation of other shapes and materials: Other coil shapes and combinations of inner plant materials listed in the claims can be achieved through the same core process as the embodiments.

[0100] The embodiments of the present invention have been described in detail above, but the content described is only a preferred embodiment of the present invention and should not be considered as limiting the scope of the present invention. All equivalent changes and improvements made within the scope of the present invention should still fall within the patent coverage of the present invention.

Claims

1. An endophyte, characterized in that, include: The outer surface of the inner plant is provided with a carbonized coil, which is arranged around the outer surface of the inner plant. The coil adopts a magnetoelectric induction coupling winding structure. The coil is constructed to form a field effect coupling configuration with the adjacent magnetic field and / or an energy coupling matching configuration with other instruments.

2. The endophyte according to claim 1, characterized in that, The depth of the coil is 20nm-200μm.

3. The endophyte according to claim 2, characterized in that, The coil is a single coil.

4. The endophyte according to claim 2, characterized in that, Multiple coils form a topological network, and the arrangement of the multiple coils in the topological network is at least one of the following: matrix array, honeycomb array, staggered array, contour array, gradient density array, and concentric circle array.

5. The endophyte according to claim 3 or 4, characterized in that, The coil is a smooth circular ring set on the outer surface of the inner plant, or the coil is a continuous reciprocating zigzag structure set on the outer surface of the inner plant.

6. The endophyte according to claim 5, characterized in that, The broken line structure is at least one of the following: wavy, zigzag, teardrop, spiral, snake, meander, or irregular curve.

7. The endophyte according to claim 6, characterized in that, The center-to-center distance between adjacent coils shall not be less than the outer diameter of a single coil.

8. The endophyte according to any one of claims 1-7, characterized in that, The inner plant material is at least one of polyetheretherketone, polylactic acid, ultra-high molecular weight polyethylene, polyglycolic acid, polycaprolactone, polyester, polyimide, carbon fiber polyetheretherketone composite material, polyaryletherketone, polyurethane, collagen, gelatin, and polypropylene.

9. A method for modifying the surface of an inner plant, characterized in that, Used to prepare the inner plant as described in any one of claims 1-8; the coil is formed by carbonization of the inner plant surface, wherein the carbonization method is at least one of electron beam surface heat treatment carbonization, laser micro-nano processing carbonization, ion beam irradiation carbonization, plasma surface treatment, corona discharge treatment, chemical vapor deposition, template carbonization, and arc treatment.

10. The method for modifying the surface of inner plants according to claim 9, characterized in that, include: (1) Implant pretreatment: The surface of the medical polymer plant substrate is purged with a high-pressure air gun to remove surface impurities; the parameters of the high-pressure air gun are: treatment time 1-3 min, treatment temperature room temperature, pressure 8-12 bar, flow rate 60-100 L / min. (2) Surface carbonization treatment: The pretreated inner plant substrate is carbonized using surface modification technology; (3) Annealing stress relief treatment: Under a protective gas atmosphere, the carbonized inner plant is annealed at a temperature of 80-260℃ and held for 0.5-2h. Then it is cooled in the furnace to eliminate residual stress in the substrate. (4) Insulation encapsulation and electrode point preparation: a medical-grade flexible insulating material is coated on the coil area to form an encapsulation layer. After curing, a window is etched at a preset position at the end of the coil to expose the carbonized coil and form electrode points. The remaining area of ​​the coil is completely covered by the encapsulation layer. (5) Induction performance test: The prepared inner plant was placed in an alternating magnetic field with a frequency of 100kHz, and the open-circuit induced electromotive force at both ends of the coil was tested. (6) Functional configuration: A micro control circuit is connected or integrated to the coil electrode point, so that the micro control circuit and the coil electrode point form an electrically compatible connection structure, and the micro control circuit and the coil form a matching circuit architecture of field effect and energy coupling.

Images