Magnetic induction power generation intravascular stent, treatment system and control method of magnetic induction power generation intravascular stent

Abstract

The invention discloses a magnetic induction power generation intravascular stent, a treatment system and a control method thereof, and relates to the technical field of vascular intervention medical instruments. The system comprises a stent serving as an implantation unit and an in-vitro unit, the stent body is of a tubular woven structure, and a closed loop composed of conductive fibers is integrated in the stent body and used for cutting magnetic induction lines for power generation. The in-vitro unit comprises a magnetic field generating device for generating a rotating magnetic field, a driving device and a processing unit. The invention further provides a control method of the system, and the output current of the support is dynamically controlled by adjusting magnetic field parameters. Energy is transmitted through wireless magnetic induction, so that the stent generates controllable electrical stimulation on local blood vessels on the premise that a built-in battery is not needed, the problems that an existing electrified stent is short in power supply service life, uncontrollable in parameter and high in biological safety risk are effectively solved, vascular endothelial repair can be accurately promoted, abnormal proliferation of smooth muscle cells is inhibited, and the vascular endothelial repair rate is increased. The problem of restenosis in the stent is effectively prevented and treated.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of vascular interventional medical devices, and particularly relates to a magnetic induction power generation vascular stent, a treatment system and a control method thereof. BACKGROUND

[0002] Vascular stent implantation is a mature interventional means for treating vascular diseases such as atherosclerotic stenosis. However, in-stent restenosis (ISR) after the operation is still a major clinical challenge affecting the long-term efficacy. The pathological process of ISR involves excessive proliferation and migration of smooth muscle cells after vascular intimal injury and the consequent neointimal hyperplasia. In recent years, bioelectricity research has revealed that microelectric stimulation of specific parameters can effectively promote the repair and proliferation of vascular endothelial cells while inhibiting the abnormal activity of smooth muscle cells, which provides a new direction with great potential for preventing and treating ISR from the physical regulation level.

[0003] At present, in order to achieve local therapeutic electric stimulation of blood vessels, the existing technical solutions all have significant limitations. First, some studies attempt to develop “active” stents with built-in micro-batteries or energy harvesting units, but they face problems such as limited service life, complex structure, high risk of biological safety, and inability to flexibly adjust stimulation parameters after implantation. Second, “passive” stents that use piezoelectric materials to convert blood flow shear force into electrical energy completely rely on unstable physiological blood flow environment for electric stimulation output, which may be insufficient in low blood flow state or diseased blood vessels, and lack active controllability. In addition, the method of applying an external electric field through a body surface electrode is difficult to form an effective and concentrated treatment field strength in the deep target blood vessel area due to severe tissue attenuation, and has poor targeting. SUMMARY

[0004] The purpose of the embodiments of the present application is to provide a magnetic induction power generation vascular stent, a treatment system and a control method thereof. To solve the problems of the “active” electric stent with built-in power supply leading to limited service life, complex structure, high risk of biological safety, and the “passive” piezoelectric stent relying on blood flow and being uncontrollable in parameters, and the external electric field stimulation having poor targeting and being difficult to form an effective treatment field strength.

[0005] To achieve the above purpose, the following technical solutions are adopted in the present application: In a first aspect, a magnetic induction power generation vascular stent is provided, comprising a stent body and a conductive assembly; The stent body is a tubular braided structure made of biocompatible metal material or degradable polymer material; The conductive assembly is integrated in the braided structure of the stent body to form at least one closed conductive loop; The conductive assembly comprises helically woven conductive fibers, both ends of the conductive fibers are respectively electrically connected to two electrodes arranged on the stent body, so that the conductive loop can cut the magnetic lines of the external rotating magnetic field to generate induced current.

[0006] In a possible implementation, the biocompatible metal material of the stent body is selected from at least one of pure titanium, titanium alloy, cobalt-chromium alloy; The degradable polymer material is selected from at least one of polylactic acid, polycaprolactone, and poly-lactic-glycolic acid copolymer.

[0007] In a possible implementation, the conductive fiber is a metal conductive wire or a conductive polymer composite wire.

[0008] In a possible implementation, the braided porosity of the stent body is 40%-60%, the radial expansion rate is ≥200%, and the elongation at break is ≥100%.

[0009] In a possible implementation, the outer surface of the stent body is further coated with a biocompatible coating, and the material of the biocompatible coating is selected from at least one of silk fibroin, gelatin, collagen, and polyethylene glycol.

[0010] In a second aspect, a magnetic induction electric stimulation blood vessel treatment system is provided, comprising: The implant unit is the magnetic induction power generation blood vessel stent of the first aspect; The extracorporeal unit comprises an extracorporeal magnetic field device, and the extracorporeal magnetic field device comprises: A magnetic field generating unit configured to generate a rotating magnetic field; A driving unit connected to the magnetic field generating unit and configured to drive the rotating of the magnetic field generating unit; A processing unit communicatively connected to the driving unit and configured to control the operating parameters of the driving unit.

[0011] In a possible implementation, the magnetic field generating unit of the extracorporeal magnetic field device comprises a plurality of annularly arranged permanent magnets or electromagnetic coils, and the permanent magnets are selected from at least one of neodymium-iron-boron permanent magnets and samarium-cobalt permanent magnets.

[0012] In a possible implementation, the system is configured to make the current generated by the implant unit be direct current, the current size adjustment range is 10-100 μA, and the application frequency of the electric stimulation is 1-50 Hz.

[0013] In a possible implementation, the extracorporeal unit further comprises a real-time monitoring module, and the real-time monitoring module comprises: A current sensor configured to monitor the current size output by the implant unit; a vascular ultrasound probe configured to monitor a blood vessel lumen diameter of a region where the implant unit is located; The processing unit is in communication connection with the current sensor and the vascular ultrasound probe, and is configured to dynamically adjust parameters of the driving unit based on the monitoring data of the current size and the blood vessel lumen diameter.

[0014] In a third aspect, a control method of a magnetic induction electric stimulation blood vessel treatment system is provided, which is used for controlling the system of the second aspect, and the method comprises: The control step: the processing unit sends a control instruction to the driving unit to drive the magnetic field generating unit to rotate, so as to generate a rotating magnetic field in the region where the implant unit is located; The rotating magnetic field makes the conductive loop of the implant unit cut the magnetic induction lines to generate an induced current, and applies an electric stimulation to the blood vessel wall; The adjustment step: the processing unit changes the control instruction sent to the driving unit to adjust the rotating speed and / or magnetic flux of the magnetic field generating unit, so as to change the size of the induced current.

[0015] Compared with the prior art, the present application has the following beneficial effects: The magnetic induction power generation blood vessel stent provided by the present application integrates the conductive assembly with the stent body and is woven to form a closed conductive loop, so that power generation can be realized by means of an external rotating magnetic field without the need for an internal power supply. The stent structure is simplified, the biological safety risk and life limitation of the internal power supply are avoided, the dependence on the blood flow environment is eliminated, and stable induced current can be generated. At the same time, the tubular woven stent body can provide reliable blood vessel lumen support and meet the basic mechanical requirements of interventional treatment, thereby laying a structural foundation for subsequent electric stimulation prevention and treatment of restenosis.

[0016] In a possible implementation, the specific material and specification of the conductive fiber are specified. The metal conductive wire has high conductivity and good biocompatibility, can stably output induced current, and meets the long-term electric stimulation requirement. The conductive polymer composite wire has conductivity and flexibility, is suitable for deformation in the stent expansion process, and avoids breakage of the conductive circuit. The conductive fibers of different materials can be flexibly selected according to the application scene of the stent, to ensure the reliability and adaptability of the conductive assembly.

[0017] In a possible implementation, by limiting the core mechanics and structure parameters of the stent body, 40%-60% of the woven porosity can ensure the mechanical support strength of the stent, and can also avoid the influence of too small pores on blood perfusion and nutrition exchange of the blood vessel wall, and reduce the risk of thrombosis; the radial expansion rate is greater than or equal to 200%, which ensures that the stent can adapt to blood vessels of different diameters, realizes effective expansion and adhesion to the blood vessel wall; and the elongation at break is greater than or equal to 100%, which improves the anti-deformation ability of the stent during implantation and blood vessel pulsation, avoids structural damage, and ensures the long-term use stability of the stent.

[0018] In a possible implementation, by coating a biocompatible coating on the outer surface of the stent body, the blood compatibility of the stent can be significantly improved, the risk of platelet adhesion and thrombosis can be reduced, and the acute inflammatory reaction after stent implantation can be reduced; meanwhile, the coating material has good biocompatibility and stability, and does not affect the conductivity of the conductive assembly and the mechanical properties of the stent, further optimizing the safety of the stent in clinical use, and creating a stable local vascular microenvironment for electrical stimulation treatment.

[0019] A magnetic induction electrical stimulation blood vessel treatment system, which realizes an external power supply and implantation end power generation mode through the combination of an implanted stent and an external magnetic field device 3, without the need for an internal power supply or an energy collection unit, simplifying the structure of the stent while avoiding the biological safety risk and life limitation of the internal power supply; the processing unit can accurately control the operating parameters of the driving unit to realize controllable adjustment of the rotating magnetic field, thereby ensuring the stability of the induced current, solving the problem of uncontrollable parameters of traditional electrical stimulation stents relying on internal power supply or blood flow, and providing a safe and controllable system solution for local electrical stimulation of blood vessels.

[0020] A control method of a magnetic induction electrical stimulation blood vessel treatment system, which completely discards the internal power supply through the design of driving the implanted stent to generate power by the external magnetic field, simplifies the structure of the stent while eliminating the biological safety hazards such as power leakage and insufficient life; the processing unit of the external unit can actively regulate the magnetic field parameters to realize precise adjustment of 10-100 μA direct current and 1-50 Hz frequency, which is not affected by blood flow speed, solving the problem of unstable stimulation of passive stents; the real-time monitoring module combined with closed-loop regulation can dynamically optimize parameters according to current changes and blood vessel morphology, ensuring that electrical stimulation always adapts to the blood vessel repair process, effectively promoting endothelial cell proliferation and inhibiting smooth muscle cell migration, and reducing the incidence of restenosis in the stent; and the modular design of each unit of the system facilitates clinical operation and maintenance, is suitable for different vascular treatment scenarios, and has high clinical transformation value. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 The overall structure of a magnetic induction power generation stent provided in the present application is shown in the schematic diagram; Figure 2A cross-sectional view of a magnetic induction power generation vascular stent provided for the present application; Figure 3 A comparison chart of current output of different conductive fibers provided for the present application; Figure 4 A table of performance parameters of different stent body materials provided for the present application; Figure 5 A current curve chart of a blood vessel at different repair stages provided for the present application; Figure 6 A use scenario chart of a magnetic induction power generation vascular stent and an external magnetic field device provided for the present application.

[0022] In the drawings, reference numeral: 1, stent body; 2, conductive assembly; 3, external magnetic field device; 4, blood vessel. DETAILED DESCRIPTION

[0023] Hereinafter, only certain exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope. Therefore, the drawings and the description are considered to be exemplary in nature rather than limiting.

[0024] In the description of the present application, it is to be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0025] In addition, the terms "first", "second" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specifically limited.

[0026] In this application, unless specifically defined otherwise, the terms "mounting", "connected", "connection", "fixed", and the like, should be construed broadly and can include fixed connections, detachable connections, or integral connections; mechanical connections, electrical connections, or communication connections; direct connections, or indirect connections through intermediaries; or connections between two elements that are in communication with each other or interact with each other. Those of ordinary skill in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0027] In this application, unless specifically defined otherwise, "on" or "under" of a first feature to a second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, "on", "above", and "over" of a first feature to a second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher in horizontal height than the second feature. "Under", "below", and "underneath" of a first feature to a second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is lower in horizontal height than the second feature.

[0028] The technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor are within the scope of protection of the present application.

[0029] As shown in FIGS. Figure 1 and Figure 2 The magnetic induction power generation vascular stent of the present application can include a stent body 1 and a conductive assembly 2.

[0030] The stent body 1 is a tubular woven structure made of biocompatible metal material or degradable polymer material.

[0031] Specifically, pure titanium wire can be selected to be woven into a tubular stent body 1 with an inner diameter of 3 mm and a length of 15 mm by a weaving machine.

[0032] The conductive assembly 2 is integrated into the woven structure of the stent body 1 to form at least one closed conductive loop. The conductive assembly 2 includes a helically woven conductive fiber, and the two ends of the conductive fiber are respectively electrically connected to two electrodes provided on the stent body 1, so that the conductive loop can cut the magnetic lines of the external rotating magnetic field to generate induced current.

[0033] During the weaving process, platinum wire with a diameter of 100 μm is synchronously embedded as a conductive fiber, and the platinum wire is spirally woven along the circumferential direction of the stent body 1 to form two independent closed conductive loops. The two ends of the platinum wire of each loop are respectively welded on the titanium alloy ring electrodes at the two ends of the stent body 1, and the electrode width is 1 mm. Thus, a magnetic induction power generation vascular stent is prepared.

[0034] After the stent is implanted into the carotid artery of a white mouse, an external magnetic field device 3 containing a neodymium-iron-boron permanent magnet is placed at the corresponding position on the body surface. The device is started to make the permanent magnet rotate at a speed of 500 rpm. The inductive current output by the electrode is 25 μA, which is measured by a current detector.

[0035] In the embodiment, by integrally weaving the conductive assembly 2 with the stent body 1, a closed conductive loop is formed. The power generation can be realized by means of the external rotating magnetic field without the need for an internal power supply. The stent structure is simplified, the biological safety risk and the life limitation of the internal power supply are avoided, the dependence on the blood flow environment is eliminated, and the inductive current can be stably generated. Meanwhile, the tubular woven stent body 1 can provide reliable lumen support for the blood vessel 4 and meet the basic mechanical requirements of interventional therapy, thereby laying a structural foundation for subsequent electric stimulation for preventing and treating restenosis.

[0036] In a possible embodiment, the biocompatible metal material of the stent body 1 is selected from at least one of pure titanium, titanium alloy, and cobalt-chromium alloy.

[0037] The degradable high polymer material is selected from at least one of polylactic acid, polycaprolactone, and poly-lactic-glycolic acid copolymer.

[0038] Optionally, the stent body 1 is prepared by using two materials respectively. In scheme one, TC4 titanium alloy wire with a wire diameter of 0.15 mm is used for weaving.

[0039] In scheme two, poly-lactic-glycolic acid copolymer (PLGA) with a lactic acid to glycolic acid ratio of 7:3 and a wire diameter of 0.2 mm is used for weaving.

[0040] Both the two stents are integrated with the platinum wire conductive assembly 2. Through mechanical testing, the radial expansion rate of the titanium alloy stent is 220%, and the breaking elongation rate is 110%.

[0041] The radial expansion rate of the PLGA stent is 210%, and the breaking elongation rate is 105%. Both the two materials pass the cytotoxicity test and meet the medical biocompatibility requirements.

[0042] In the embodiment, by specifying the specific material selection of the stent body 1, the biocompatible metal material has excellent mechanical strength and corrosion resistance, and can be used in long-term blood vessel 4 support scenarios; the degradable polymer material can gradually degrade after completing the repair of the blood vessel 4, avoiding foreign body reactions caused by long-term implantation, and adapting to different treatment cycle requirements; at the same time, both types of materials meet the requirements of braiding processing and mechanical properties, ensuring the structural stability and biological safety of the stent during implantation, expansion and use.

[0043] In a possible embodiment, as shown in Figure 3 and Figure 4 The conductive fiber is a metal conductive wire or a conductive polymer composite wire.

[0044] The metal conductive wire is at least one of a platinum wire, a platinum-iridium alloy wire, a gold wire, or a silver-palladium alloy wire.

[0045] The conductive polymer composite wire is a polypyrrole composite wire or a polyaniline composite wire.

[0046] Specifically, the stent structure can be prepared using three types of conductive fibers respectively: Scheme one is a gold wire with a diameter of 80 μm, scheme two is a silver-palladium alloy wire with a diameter of 120 μm, and the silver-palladium ratio is 8:2, and scheme three is a carbon fiber reinforced polypyrrole composite wire with a diameter of 150 μm, and the carbon fiber content is 30%.

[0047] The three stents are placed in the same external magnetic field environment, the magnetic field strength is 0.2 T, and the rotating speed is 400 rpm. The output current of the gold wire is 30 μA, the output current of the silver-palladium alloy wire is 28 μA, and the output current of the carbon fiber reinforced polypyrrole composite wire is 22 μA. After 10 radial expansions, the three types of conductive fibers are not broken, and the conductivity does not decrease significantly.

[0048] In the embodiment, the specific material and specification of the conductive fiber are specified. The metal conductive wire has high conductivity and good biocompatibility, can stably output induced current, and meets the long-term electrical stimulation requirement. The conductive polymer composite wire has conductivity and flexibility, adapts to the deformation during stent expansion, and avoids the breakage of the conductive circuit. Different materials of the conductive fiber can be flexibly selected according to the application scenario of the stent, to ensure the reliability and adaptability of the conductive assembly 2.

[0049] In a possible embodiment, the braiding porosity of the stent body 1 is 40%-60%, the radial expansion rate is ≥200%, and the elongation at break is ≥100%.

[0050] Three groups of the titanium alloy stents are prepared. The braiding porosity of the stent body 1 is controlled by adjusting the braiding density: Group 1: porosity 40%, braiding count 20 meshes / inch; Group 2 porosity 50%, braided mesh 18 mesh / inch; Group 3 porosity 60%, braided mesh 15 mesh / inch.

[0051] Tested, the radial expansion rate of the three groups of stents is 205%, 215%, 225% respectively, and the elongation at break is all ≥100%.

[0052] After implanting the three groups of stents into the carotid arteries of white mice, through the observation of vascular 4 ultrasound, the stents with porosity of 40%-60% all did not appear obvious thrombus adhesion, and did not affect the exchange of nutrients on the wall of the blood vessel 4.

[0053] In this embodiment, by limiting the core mechanics and structure parameters of the stent body 1, the braided porosity of 40%-60% can not only ensure the mechanical support strength of the stent, but also avoid the influence of too small porosity on the blood perfusion and nutrient exchange of the blood vessel 4 wall, and reduce the risk of thrombosis; the radial expansion rate ≥200% ensures that the stent can adapt to different diameter of the lesion blood vessel 4, realizes effective expansion and fits the wall of the blood vessel 4; the elongation at break ≥100% improves the anti-deformation ability of the stent in the implantation and blood vessel 4 pulsation process, avoids structure damage, and guarantees the long-term use stability of the stent.

[0054] In a possible embodiment, the outer surface of the stent body 1 is further coated with a biocompatible coating, and the material of the biocompatible coating is selected from at least one of silk fibroin, gelatin, collagen and polyethylene glycol.

[0055] Specifically, a silk fibroin coating with a thickness of 100 nm can be coated on the outer surface of the titanium alloy stent body 1 by using the dipping method, and a uniform film is formed after the coating is dried.

[0056] The stent with coating and the uncoated stent are respectively implanted into the carotid arteries of white mice, and sampled and observed 7 days after the operation. The number of platelet adhesion on the surface of the uncoated stent is 25±3 per field, and the number of platelet adhesion on the surface of the stent coated with silk fibroin coating is 8±2 per field, and the coating does not fall off, and has no effect on the current output of the electric conduction assembly 2.

[0057] In this embodiment, by coating the biocompatible coating on the outer surface of the stent body 1, the blood compatibility of the stent can be significantly improved, the risk of platelet adhesion and thrombosis can be reduced, and the acute inflammatory reaction after stent implantation can be reduced; at the same time, the coating material has good biocompatibility and stability, and will not affect the electric conduction performance of the electric conduction assembly 2 and the mechanical properties of the stent, further optimizing the clinical use safety of the stent, and creating a stable local microenvironment of the blood vessel 4 for electric stimulation treatment.

[0058] In a possible embodiment, as Figure 6As shown, a magnetic induction electric stimulation blood vessel treatment system is provided, which can include an implant unit and an extracorporeal unit.

[0059] The implant unit is the aforementioned magnetic induction power generation blood vessel stent.

[0060] The extracorporeal unit can include an extracorporeal magnetic field device 3, which includes a magnetic field generating unit, a driving unit, and a processing unit.

[0061] The magnetic field generating unit can be configured to generate a rotating magnetic field.

[0062] Optionally, in the extracorporeal magnetic field device 3 of the extracorporeal unit, the magnetic field generating unit is 8 annularly arranged electromagnetic coils, each with a wire diameter of 0.4mm and 15 turns.

[0063] The driving unit is connected to the magnetic field generating unit and is configured to drive its rotation. The processing unit is communicatively connected to the driving unit and is configured to control the operating parameters of the driving unit.

[0064] Optionally, the driving unit can be a micro stepping motor, and the processing unit can be an STM32F407 single-chip microcomputer, which communicates with the driving unit through a serial port.

[0065] In use, the extracorporeal magnetic field device 3 is fixed on the surface of the patient's stent implant site, the processing unit sends control instructions, and the electromagnetic coil is driven by the motor to rotate at a speed of 300 rpm, generating a 0.15T rotating magnetic field in the stent area, and the stent conductive loop cuts the magnetic induction line to generate a 30μA induced current, which applies an electric stimulus to the wall of the blood vessel 4.

[0066] In this embodiment, the treatment system realizes the mode of extracorporeal power supply and implant end power generation through the combination of the implanted stent and the extracorporeal magnetic field device 3, without the need for built-in power supply or energy harvesting unit, which simplifies the structure of the stent while avoiding the biological safety risk and life limitation of the built-in power supply; the processing unit can accurately control the operating parameters of the driving unit to realize controllable adjustment of the rotating magnetic field, thereby ensuring the stability of the induced current and solving the problem of dependence on built-in power supply or blood flow and uncontrollable parameters of traditional electric stimulation stents, providing a safe and controllable system solution for local electric stimulation of blood vessels 4.

[0067] In a possible embodiment, the magnetic field generating unit of the extracorporeal magnetic field device 3 includes a plurality of annularly arranged permanent magnets or electromagnetic coils, the permanent magnets being selected from at least one of neodymium iron boron permanent magnets and samarium cobalt permanent magnets.

[0068] Optionally, the driving unit is a micro motor, and the rotational speed adjustment range of the micro motor is 100rpm-1000rpm.

[0069] Specifically, the in-vitro magnetic field device 3 adopts 6 Nd-Fe-B permanent magnets with a diameter of 5 mm arranged in a ring shape as the magnetic field generating unit, and a micro DC motor is selected as the driving unit. The motor is connected to the magnetic field generating unit through gear transmission, and the motor speed adjustment range is set to 100 rpm-1000 rpm.

[0070] In the experiment of stent implantation in the carotid artery of mice, the motor speed was adjusted to 100 rpm, 500 rpm and 1000 rpm respectively, and the corresponding electrode output current was measured to be 8 μA, 28 μA and 65 μA respectively. The magnetic field rotation was stable, and there was no obvious noise and heating.

[0071] In this embodiment, the core components and parameters of the in-vitro magnetic field device 3 are determined. The ring-shaped arrangement of permanent magnets or electromagnetic coils can form a uniform rotating magnetic field in the stent implantation area, ensuring that the conductive loop fully cuts the magnetic induction lines and improving the power generation efficiency. The speed adjustment range of the micro motor can realize wide-range regulation of the current from low to high, which is suitable for the electrical stimulation needs of different repair stages. At the same time, the device structure is simple and stable in operation, and there is no obvious safety hazard, which provides reliable in-vitro driving protection for stent power generation and parameter regulation.

[0072] In a possible embodiment, the system is configured to make the current generated by the implanted unit direct current, and the current size adjustment range is 10 μA-100 μA, and the application frequency of the electrical stimulation is 1 Hz-50 Hz.

[0073] Optionally, the driving motor speed and electromagnetic coil current are adjusted by the processing unit: When the motor speed is 100 rpm and the coil current is 0.8 A, the stent generates 10 μA direct current; When the speed is 300 rpm and the current is 1.2 A, 50 μA direct current is generated; When the speed is 500 rpm and the current is 1.8 A, 100 μA direct current is generated, realizing a current adjustment range of 10-100 μA.

[0074] The application frequency of the electrical stimulation is 1 Hz-50 Hz, the single electrical stimulation duration is 1 h-4 h, and the daily electrical stimulation frequency is 1-3 times.

[0075] For example, during the patient's treatment process, 1-2 weeks after the operation, the endothelial repair period, 10-30 μA direct current is set for the electrode output, the electrical stimulation frequency is 5 Hz, the device is started at 9 am every day, and the single stimulation duration is 2 h.

[0076] 3-4 weeks after the operation, the proliferation inhibition period, 30-60 μA direct current is output, the frequency is 20 Hz, the stimulation is performed twice a day at 9 am and 5 pm, and the single duration is 3 h.

[0077] After 5-8 weeks, the stable period, output 60-100 μA direct current, frequency 40 Hz, daily stimulation 1 time, single time length 4 h. After 3 months, coronary angiography showed that the stent lumen was unobstructed and there was no significant restenosis.

[0078] In this embodiment, by limiting the system output to 10-100 μA direct current and 1-50 Hz electric stimulation frequency, the optimal electric stimulation parameter range of matching the endothelial cell repair and smooth muscle cell inhibition in blood vessel 4 is matched, avoiding insufficient stimulation or damage to blood vessel 4 caused by too small current, and the frequency is adjusted to adapt to the needs of different treatment stages; The output of direct current can reduce the stimulation of alternating current to the tissue of blood vessel 4, improve the safety of treatment, solve the problem that the parameters of traditional electric stimulation stents have no clear standard and are easy to affect the curative effect due to improper parameters, ensure that the electric stimulation accurately adapts to the treatment needs, and improve the effect of preventing and treating in-stent restenosis.

[0079] In one possible embodiment, the extracorporeal unit further comprises a real-time monitoring module, which comprises a current sensor and a blood vessel 4 ultrasound probe.

[0080] The current sensor is configured to monitor the current output by the implanted unit, and the blood vessel 4 ultrasound probe is configured to monitor the diameter of the blood vessel 4 lumen in the area where the implanted unit is located.

[0081] Optionally, the current sensor can be an ACS712 Hall sensor, which is indirectly coupled with the stent electrode through a flexible lead and collects real-time inductive current data.

[0082] The blood vessel 4 ultrasound probe is a 7.5 MHz linear probe, which is fixed beside the extracorporeal magnetic field device 3 and focused on the stent area, and the blood vessel 4 lumen diameter is collected every 30 seconds.

[0083] The processing unit is in communication connection with the current sensor and the blood vessel 4 ultrasound probe, and is configured to dynamically adjust the parameters of the driving unit based on the monitoring data of the current and the diameter of the blood vessel 4 lumen. Optionally, the processing unit can receive sensor data through Bluetooth, and when it is monitored that the current decreases to 8 μA or the diameter of the blood vessel 4 decreases by 5%, the motor speed is automatically increased from 300 rpm to 350 rpm, and the coil current is increased from 1.2 A to 1.5 A, so that the current is restored to 12 μA and the diameter of the blood vessel 4 is stabilized in the normal range.

[0084] In this embodiment, by adding a real-time monitoring module containing a current sensor and an ultrasound probe of blood vessel 4, dynamic monitoring of the electric stimulation current and the morphology of blood vessel 4 is realized. The processing unit adjusts the driving parameters based on the monitoring data in a closed loop, avoiding insufficient current caused by magnetic field attenuation and changes in the patient's body position, or a decrease in stimulation adaptability caused by changes in the lumen of blood vessel 4. The problems of lack of real-time feedback and fixed parameters that cannot adapt to individual differences and treatment progress in traditional treatment systems are solved, ensuring that the electric stimulation is always in the optimal range, improving the accuracy and safety of treatment, and reducing the risk of treatment failure caused by parameter mismatch.

[0085] In one possible embodiment, a control method of a magnetic induction electric stimulation blood vessel treatment system is provided for controlling the aforementioned system. The method comprises: The control step: the processing unit sends control instructions to the driving unit to drive the magnetic field generating unit to rotate, thereby generating a rotating magnetic field in the area where the implanted unit is located.

[0086] The rotating magnetic field causes the conductive loop of the implanted unit to cut the magnetic induction lines to generate an induced current, which applies electric stimulation to the wall of blood vessel 4.

[0087] The adjustment step: the processing unit changes the control instructions sent to the driving unit to adjust the rotational speed and / or magnetic flux of the magnetic field generating unit, so as to change the size of the induced current.

[0088] Optionally, the medical staff can select the "postoperative repair mode" through the touch interface of the processing unit. The processing unit sends control instructions to the driving unit to drive the magnetic field generating unit to rotate at a speed of 250 rpm, generating a rotating magnetic field in the femoral artery area where the implanted unit is located. The conductive loop cuts the magnetic induction lines to generate a direct current of 30 μA, which applies continuous electric stimulation to the wall of blood vessel 4.

[0089] The adjustment step: one week after the operation, the processing unit receives the data of the blood vessel 4 ultrasound probe and finds that there is no significant change in the diameter of the lumen of blood vessel 4. The control instructions are automatically modified to increase the rotational speed of the driving unit to 350 rpm, and the current of the electromagnetic coil is increased from 1.0 A to 1.2 A, so that the induced current is increased to 45 μA, enhancing the effect of electric stimulation.

[0090] If the current sensor detects a sudden increase in current to 80 μA, the processing unit immediately reduces the rotational speed to 300 rpm to avoid damaging the blood vessel 4 due to excessive current.

[0091] Specifically, for the treatment process of another patient, the treatment is regulated in stages according to the repair progress of blood vessel 4: In the initial repair stage, 1-2 weeks after the operation, the rotational speed of the external magnetic field device 3 is adjusted to 200 rpm, and the electrode outputs a current of 20 μA to promote endothelial cell adhesion and initial repair.

[0092] Mid-proliferation stage, 3-5 weeks after operation, the speed is increased to 500 rpm, and the output current is 45 μA, which inhibits the excessive proliferation of smooth muscle cells.

[0093] Late stable stage, 6-8 weeks after operation, the speed is adjusted to 800 rpm, and the output current is 80 μA, which consolidates the repair effect and stabilizes the vascular structure.

[0094] After 4 months of postoperative review, the vascular endothelium is complete, and the patency rate of the lumen is 98%.

[0095] In this embodiment, by designing the implanted stent to generate electricity driven by an external magnetic field, the internal power supply is completely abandoned, the stent structure is simplified, and the biological safety hazards such as power leakage and insufficient life are eliminated; the processing unit of the external unit can actively control the magnetic field parameters to realize precise adjustment of 10-100 μA direct current and 1-50 Hz frequency, which is not affected by blood flow speed and solves the problem of unstable stimulation of passive stents; the real-time monitoring module combined with closed-loop control can dynamically optimize parameters according to current changes and vascular morphology, ensuring that the electrical stimulation always adapts to the vascular repair process, effectively promoting endothelial cell proliferation, inhibiting smooth muscle cell migration, and reducing the incidence of in-stent restenosis; and the modular design of each unit of the system facilitates clinical operation and maintenance, is suitable for different vascular treatment scenarios, and has high clinical conversion value.

[0096] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: modifying the technical solutions recorded in the foregoing embodiments, or making equivalent replacement to part or all of the technical features, does not make the essence of the corresponding technical solution deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A magnetic induction-generated vascular stent, characterized in that, It includes a support body (1) and a conductive component (2); The scaffold body (1) is a tubular braided structure, made of biocompatible metal material or biodegradable polymer material; The conductive component (2) is integrated into the braided structure of the support body (1) to form at least one closed conductive circuit; The conductive component (2) includes a spirally woven conductive fiber, the two ends of which are electrically connected to two electrodes disposed on the support body (1) so that the formed conductive circuit can cut the magnetic field lines of the external rotating magnetic field to generate an induced current.

2. The magnetic induction power generation vascular stent according to claim 1, characterized in that, The biocompatible metallic material of the scaffold body (1) is selected from at least one of pure titanium, titanium alloy, and cobalt-chromium alloy; The biodegradable polymer material is selected from at least one of polylactic acid, polycaprolactone, and polylactic acid-glycolic acid copolymer.

3. The magnetic induction power generation vascular stent according to claim 1, characterized in that, The conductive fiber is a metal conductive wire or a conductive polymer composite material wire.

4. The magnetic induction power generation vascular stent according to claim 1, characterized in that, The braided porosity of the support body (1) is 40%-60%, the radial expansion rate is ≥200%, and the elongation at break is ≥100%.

5. The magnetic induction power generation vascular stent according to claim 1, characterized in that, The outer surface of the scaffold body (1) is also covered with a biocompatible coating, the material of which is selected from at least one of silk fibroin, gelatin, collagen and polyethylene glycol.

6. A magnetic induction electrical stimulation vascular therapy system, characterized in that, include: The implantation unit is the magnetic induction power generation vascular stent as described in any one of claims 1-5; An external unit includes an external magnetic field device (3), the external magnetic field device (3) comprising: The magnetic field generating unit is configured to generate a rotating magnetic field; A driving unit, connected to the magnetic field generating unit, is configured to drive its rotation; The processing unit is communicatively connected to the drive unit and is configured to control the operating parameters of the drive unit.

7. The magnetic induction electrostimulation vascular therapy system according to claim 6, characterized in that, The magnetic field generating unit of the external magnetic field device (3) includes several ring-arranged permanent magnets or electromagnetic coils, wherein the permanent magnets are selected from at least one of neodymium iron boron permanent magnets and samarium cobalt permanent magnets.

8. The magnetic induction electrostimulation vascular therapy system according to claim 6, characterized in that, The system is configured to generate a direct current from the implanted unit, with the current magnitude adjustable from 10μA to 100μA, and the frequency of electrical stimulation applied from 1Hz to 50Hz.

9. The magnetic induction electrostimulation vascular therapy system according to claim 6, characterized in that, The in vitro unit further includes a real-time monitoring module, which includes: A current sensor is configured to monitor the magnitude of the current output by the implanted unit; A vascular ultrasound probe is configured to monitor the diameter of the lumen of the blood vessel (4) in the area where the implanted unit is located; The processing unit is communicatively connected to the current sensor and the vascular ultrasound probe, and is configured to dynamically adjust the parameters of the driving unit based on the monitoring data of the current magnitude and the diameter of the blood vessel (4).

10. A control method for a magnetic induction electrostimulation vascular therapy system, used to control the system according to any one of claims 6-9, characterized in that, The method includes: Control steps: The processing unit sends a control command to the driving unit to drive the magnetic field generating unit to rotate, thereby generating a rotating magnetic field in the area where the implanted unit is located; The rotating magnetic field causes the conductive circuit of the implanted unit to cut magnetic field lines, generating an induced current that applies electrical stimulation to the blood vessel wall. Adjustment steps: The processing unit changes the control command sent to the drive unit to adjust the rotation speed and / or magnetic flux of the magnetic field generating unit, thereby changing the magnitude of the induced current.

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