Magnetic resonance compatible implantable electrode wire with artifact weakening structure and medical equipment

Abstract

The invention discloses a magnetic resonance compatible implantable electrode wire with an artifact weakening structure and medical equipment, an electrode tip section of the electrode wire is provided with a ring electrode, and one end, far away from a spiral electrode, of an outer wire body is nested on the outer peripheral wall of an outer wire body supporting section of the ring electrode; an inner hole of a contact ring of the ring electrode is fixed with the outer wall of the position, far away from the spiral electrode, of the electrode insulating part, so that an integral insulating structure of the ring electrode and the outer wire body to the internal conductor is formed; the position of the electrode insulator close to the spiral electrode is fixed with the inner hole surface of the rear section of the electrode sleeve; a medicine plug is arranged at the position, close to the spiral electrode, of the electrode sleeve; the ring electrode is provided with a hollow thin wall, and magnetic flux holes distributed in the circumferential direction and / or the axial direction of the ring electrode are formed in the ring electrode. The magnetic flux holes are formed in the ring electrode or other metal parts, the overall artifact area of the metal part is reduced, self heating of the metal part is reduced, and meanwhile the heat dissipation effect of the wire is enhanced through the magnetic flux holes.

Description

Technical Field

[0001] The present invention relates to the technical field of medical electrical wire connectors, and in particular to a magnetic resonance compatible implantable electrode wire and medical equipment with an artifact reduction structure. Background Art

[0002] Magnetic resonance imaging (MRI) is a widely used and increasingly popular medical imaging technique. The demand for MRI examinations among patients with implantable medical devices (IMDs), particularly elderly patients, is also rapidly increasing. Compared to other medical imaging techniques such as CT, MRI offers several advantages, including: 1. It is safer and does not deliver high doses of radiation. 2. Multiple scans are performed without causing radiation damage to the human body. 3. Its soft tissue density resolution is significantly higher than that of CT. 4. It can directly present three-dimensional and cross-sectional images, providing richer and more comprehensive diagnostic information.

[0003] Currently, the electrode leads for medical devices such as pacemakers are mainly divided into active and passive electrode leads. The passive electrode tip has a barbed structure that can be directly hooked onto the myocardial trabeculae. Over time, the electrode tip is wrapped by the myocardium and gradually stabilizes. The active electrode tip, on the other hand, has a spiral structure that telescopes into the myocardium and is fixed in the atrium or ventricle.

[0004] An implantable lead is a medical lead that connects one end to a pacemaker, defibrillator, or other electrical stimulation device and the other end directly to the area of the body that requires electrical stimulation, such as the heart or brain. The primary function of an implantable lead is to transmit tiny electrical pulses from the device to the desired structure and to transmit the body's electrical activity back to the device.

[0005] Magnetic resonance imaging (MRI) technology works through the coordinated cooperation of three magnetic fields, including a high-intensity uniform static magnetic field B0, with common intensities of 1.5T and 3T; a gradient magnetic field G, which can be set to any direction and cooperates with the static magnetic field B0 to encode body spatial information and image specific body parts; and an RF radio frequency field B1 for exciting proton nuclear resonance, which performs high-frequency time-varying switching at the Larmor frequency. In MRI with a static magnetic field B0 of 1.5T and 3T, its frequencies are 64MHz and 128MHz, respectively.

[0006] Implantable products must meet the above-mentioned MRI compatibility requirements. Due to the high-frequency and strong magnetic field working characteristics of MRI, MRI examinations have long been an absolute forbidden area for patients undergoing electrical stimulator implantation surgery (typically pacemakers, defibrillators, deep brain stimulators, etc.). The most important reason is the mutual interference between the MRI integrated field and ferromagnetic materials and / or conductive objects. This leads to a series of adverse consequences, such as displacement and torque caused by mechanical forces on the implanted device in a strong magnetic field; eddy currents and induced currents caused by the high-frequency energy field in the MRI field, and induced heating of the implanted device, especially the electrode wires of the slender conductive structure, leading to thermal damage to the tissue, resulting in increased electrical stimulation thresholds, inducing arrhythmias and perforations, and other serious injuries. At the same time, the wires may emit pulse voltages at unnecessary times and locations, causing stimulation abnormalities; metal and conductive objects in the implant cause distorted and deformed MRI images, affecting the diagnosis of the disease.

[0007] Among them, artifacts generated during MRI scans have a significant impact on disease diagnosis. The metal and conductive objects in the implant have different magnetic susceptibilities than the surrounding tissue. Once the implant enters the MRI magnetic field, the two magnetic fields interfere with each other, disrupting the uniformity of the MRI's B0 magnetic field, thereby affecting the imaging performance of the magnetic resonance scanner and causing local distortion, deformation, or large areas of black shadows in the MRI image. This seriously affects the image quality, rendering the obtained image without diagnostic value and affecting the diagnosis of the disease. The size of the artifacts formed by the implant is not only related to the MRI scanning parameters selected, but also closely related to the size, shape, material, magnetic susceptibility, cross-section, and sharp protrusions of the implant. It is also related to the size of the eddy currents generated by the implant in the high-frequency field.

[0008] Therefore, those skilled in the art are in urgent need of a new magnetic resonance compatible implantable electrode lead with an artifact reduction structure that can effectively alleviate or solve the force and torque applied to the implantable electrode in the strong magnetic field of MRI without increasing the structural complexity of the electrode lead and keeping the overall size small, thereby reducing the impact of the electrode lead on the uniformity of the magnetic field and the intensity of the induced eddy current in the high-frequency field, and thus reducing the artifacts of the electrode lead in MRI imaging. Summary of the Invention

[0009] The main purpose of the present invention is to provide an MRI-compatible implantable electrode lead with an artifact reduction structure, aiming to solve the problem that the implantable electrode is subjected to force and torque in the strong MRI magnetic field, which affects the uniformity of the electrode lead to the magnetic field, and the intensity of the induced eddy current is high under high-frequency fields, resulting in artifacts in the electrode lead in MRI imaging.

[0010] Any magnetic material within an IMD exposed to the static magnetic field B0 of an MRI will be subject to magnetic forces, generating forces and torques that can cause unexpected displacement and twisting of the implanted device, damaging surrounding tissue and threatening the patient's health. The magnitude of the IMD's magnetic force is related to the material's properties and size; paramagnetic and diamagnetic materials are less susceptible to magnetic forces. Furthermore, metal and conductive objects entering the magnetic field shield the magnetic flux lines. This difference in magnetic susceptibility χ0 from human tissue disrupts the uniformity of the MRI magnetic field, affecting the imaging performance of the MRI scanner, distorting and deforming the image, and generating artifacts that can affect disease diagnosis. The magnitude of these artifacts is closely related to the metal component's magnetic susceptibility χ, shape, size, material, and quantity.

[0011] Specifically, the spiral electrode is fixed to the patient's targeted treatment site, and the above-mentioned fixed position depends on the patient's disease, such as the atrium and ventricle muscles of the heart. The ring electrode is usually immersed in human body fluids. Both play the role of transmitting the electrical signals emitted by the implanted medical device (IMD) to the targeted treatment site of the heart waiting for electrical stimulation. In the detection environment of magnetic resonance imaging technology (MRI), the metal materials and conductive objects in the electrode wires will interfere with each other, causing the distortion of the uniform magnetic field of MRI, causing the MRI image to be distorted, and affecting the diagnosis of the disease.

[0012] To achieve the above objectives, the present invention proposes an MRI-compatible implantable electrode lead with an artifact reduction structure. The present invention provides an MRI-compatible implantable electrode lead, which is designed specifically to reduce artifacts. It is not subjected to or is subjected to very small mechanical forces within the strong MRI magnetic field, and does not cause displacement or torque. During MRI scanning, the lead has little impact on the uniformity of the local magnetic field, resulting in less distortion and deformation of MRI images, and a small artifact area, thereby reducing the impact of artifacts on disease diagnosis. The above-mentioned electrode lead includes:

[0013] A conductor main body section has a first end and a second end opposite to each other, the conductor main body section including an outer insulating tube and an outer conductor body, an inner insulating tube and an inner conductor body sequentially arranged in the outer insulating tube;

[0014] an electrode head section, provided at a first end of the lead body section; and a connector section, provided at a second end of the lead body section and connected to a medical device via a connector;

[0015] The electrode head section has a ring electrode, and the end of the outer conductor body close to the spiral electrode is nested in the outer peripheral wall of the outer conductor body support section of the ring electrode; a cavity is provided inside the outer conductor body for the inner insulating tube to pass through, so as to ensure that the inner conductor body and the outer conductor body are insulated from each other;

[0016] The inner hole of the contact ring of the ring electrode is fixed to the outer wall of the electrode insulating member at a position away from the spiral electrode, so as to form an integral insulation structure between the ring electrode and the outer wire body and the internal conductor; the position of the electrode insulating member close to the spiral electrode is fixed to the inner hole surface of the rear section of the electrode sleeve, and the rear section of the electrode sleeve is the position of the electrode sleeve away from the spiral electrode; and a drug plug is provided at the position of the electrode sleeve close to the spiral electrode;

[0017] The ring electrode has a hollow, thin wall and is provided with magnetic flux holes distributed along its circumference and / or axial direction. In an MRI environment, the magnetic flux holes guide magnetic flux lines through, reducing metal usage, reducing local magnetic field distortion, and dispersing MRI artifacts, thereby reducing the overall artifact area of the metal part and reducing the metal part's self-heating. The holes also enhance heat dissipation.

[0018] Optionally, the ring electrode has a contact ring; in use, when the electrode wire is implanted in the human body, the contact ring is immersed in body fluids, forming a loop to transmit pulses and sensing signals;

[0019] The outer insulating tube passes through the outside of the outer conductor and abuts against the outer insulating tube limiting step on the ring electrode. The ring electrode is also provided with a first bonding section bonded to the outer insulating tube by an adhesive.

[0020] The first bonding section is located in the middle of the ring electrode, and the magnetic flux holes are densely arranged in the circumferential and / or axial positions of the first bonding section.

[0021] Optionally, the magnetic flux hole is provided on the metal parts and / or conductive parts on the electrode wire.

[0022] Optionally, the first bonding section is provided with an outer insulating tube limiting step and an outer conductor body welding step at positions close to and far from the spiral electrode respectively;

[0023] The raised height of the outer insulating tube limiting step and the outer conductor welding step ranges from 0.05mm to 0.5mm, and the step has a rounded transition with a radius of 0.05mm to 0.5mm. This design allows for a smooth transition on the surface of the ring electrode, without sharp corners or edges. In an MRI environment, this reduces the sharp changes in magnetic field gradients, MRI artifacts, and self-induced heating. The end of the outer conductor away from the spiral electrode is nested in the outer wall of the outer conductor support section and abuts against the outer conductor welding step, connected by continuous welding or crimping to form a first connection section.

[0024] The outer diameter of one end of the outer conductor body away from the spiral electrode is close to the diameter of the welding step of the outer conductor body.

[0025] Optionally, the inner hole of the contact ring of the ring electrode is bonded and fixed to the electrode insulating member by an adhesive; and / or,

[0026] The front end surface of the electrode insulating member is bonded and fixed to the inner hole surface of the rear section of the electrode sleeve by an adhesive; and / or,

[0027] The drug plug is fixed to the front end of the electrode sleeve by adhesive.

[0028] Optionally, the wall thickness of the ring electrode is 0.1mm to 2mm; the ring electrode is hollow and has a thin wall thickness, which can greatly reduce the amount of metal used while ensuring strength, thereby reducing MRI artifacts and metal self-heating. And / or,

[0029] The ring electrode has a rounded symmetrical structure, a columnar structure, and a cross-section of a circle, a rounded triangle, or a rounded rectangle, or a combination thereof; the symmetrical appearance makes the metal isotropic, reduces mutations, and has a smaller impact on artifacts caused by changes in direction during MRI scanning; the rounded appearance reduces magnetic field distortion and reduces the artifact area. And / or,

[0030] The magnetic flux holes are densely arranged on the first bonding section, and the area of a single magnetic flux hole is 0.05mm 2 to 0.5mm 2 Compared with a few large holes, densely distributed small holes can form a larger hole area while ensuring the same strength of the ring electrode, thereby increasing the area through which the magnetic flux lines pass and reducing the area of artifacts. At the same time, the amount of metal used can be greatly reduced, reducing the heating of parts under high-frequency signals. And / or,

[0031] The magnetic flux hole on the first bonding section is a rounded hole to reduce sharp corners and edges; the magnetic flux hole includes: any one or a combination of circular, elliptical, and rounded rectangular; and / or,

[0032] The magnetic flux holes on the first bonding section are evenly distributed on the first bonding section, and the number of the magnetic flux holes arranged in the circumferential direction and the axial direction of the first bonding section is 2 to 10 rows; and / or,

[0033] The ring electrode has paramagnetism and / or diamagnetic properties, and the ring electrode is also made of a biocompatible imaging material with low magnetic susceptibility, and the material of the ring electrode includes platinum iridium, platinum alloy and tantalum; and / or,

[0034] The adhesive is a biocompatible polymer adhesive, including silicone adhesive and polyurethane adhesive.

[0035] Optionally, the connector segment is used for plugging into a connection interface of an IMD, and transmits an electrical pulse signal emitted by the IMD to the electrode head segment through a signal connection pin and a signal connection ring;

[0036] The signal connection pin is connected to an end of the connector shaft on the connector segment away from the connector segment; the connector insulating member located in the signal connection ring and the inner cavity of the long seal and the short seal passes through the support shaft and is arranged opposite to the signal connection pin through the insulating member limiting step on the connector shaft to limit the axial extension and contraction position of the connector shaft;

[0037] The connector shaft is movably connected to the connector insulating member, and the signal connection needle is rotated to drive the inner wire body to rotate, thereby driving the spiral electrode to rotate and penetrate into the patient's tissue.

[0038] Optionally, the inner conductor welding section on the connector shaft is welded and fixedly connected to the inner conductor, the inner insulating tube passes through the inner conductor and is adhesively and fixedly connected to the inner hole of the connector insulating member; and the inner insulating tube is connected to the connector insulating member at one end away from the spiral electrode;

[0039] The inner wire body is nested in the end position of the connector shaft facing the spiral electrode; and the outer diameter of the inner wire body is close to the diameter of the arc transition section on the connector shaft, thereby reducing the splicing step difference, and the two are fixedly connected by continuous welding.

[0040] Optionally, the signal connection ring is fixedly connected to the outer wall of the connector insulation member; the connection seat welding section on the signal connection ring is fixedly connected to the front welding section on the signal connection seat, and the outer wire body is sleeved on the rear welding section on the signal connection seat and fixedly connected thereto;

[0041] The outer insulating tube passes through the outer conductor body and is bonded and fixed thereto; the long sealing member located on the outside of the outer insulating tube is snap-fitted and positioned with the sealing member limiting protrusion on the signal connecting ring; the long sealing member is fixed to the second bonding section on the signal connecting ring by an adhesive; the short sealing member faces one end of the signal connecting ring, abuts against the short sealing member limiting surface at the end of the signal connecting ring, and is fixedly connected to the outer wall of the connector insulating member.

[0042] Optionally, the support shaft is densely arranged with the magnetic flux holes distributed along its circumferential direction and / or axial direction; and / or,

[0043] The second bonding section on the limiting protrusion of the sealing member is densely arranged with the magnetic holes in the circumferential direction and / or the axial direction.

[0044] Optionally, the signal connection ring is welded to the front welding section of the signal connection seat; and the diameters of the splicing sections of the signal connection ring and the signal connection seat are similar to reduce the diameter difference of the splicing sections; and / or,

[0045] The outer wire body is welded to one end away from the spiral electrode and fixed to the rear welding section of the signal connection seat; and the outer diameter of the outer wire body is close to the diameter of the annular welding step on the rear welding section to reduce the diameter difference of the splicing section.

[0046] Optionally, the spiral electrode further comprises: a spiral electrode tip; during the implantation process, the spiral electrode tip is rotated and inserted into human tissue at the targeted treatment location;

[0047] One end of the inner wire body close to the tip of the spiral electrode is sleeved on the outer wall of the inner wire body support section of the electrode core shaft and fixed to the rear developing ring; the rear developing ring is connected to a position close to the front end of the inner wire body support section, and a front developing ring is further provided at a proximal end of the electrode core shaft close to the tip of the spiral electrode, and the front developing ring is connected to the spiral electrode; the front developing ring is connected to the spiral electrode;

[0048] The spiral electrode and the inner conductor are arranged in the inner insulating tube and are driven to rotate in the inner insulating tube to drive the spiral electrode accommodated in the electrode sleeve to move in a driven manner.

[0049] Optionally, the end of the inner conductor body close to the tip of the spiral electrode has a diameter close to that of the rear developing ring when inserted into the inner conductor body support section, so as to reduce the splicing section difference; and the inner conductor body and the rear developing ring are connected by continuous welding or crimping to form a second connecting section; and / or,

[0050] In order to meet the MRI compatibility requirements, the electrode core shaft also has paramagnetism and / or diamagnetic properties, and the electrode core shaft also needs to have low magnetic susceptibility performance, which includes: one or more combinations of titanium, titanium alloy, platinum alloy, non-magnetic nickel-cobalt-chromium alloy, and conductive polymer materials.

[0051] Optionally, a transmission protrusion is provided in the electrode sleeve; the transmission protrusion is transmission-connected to the spiral electrode to convert the rotational motion of the spiral electrode into a telescopic motion along the axial direction of the spiral electrode; and / or,

[0052] The electrode core shaft passes through the inner contact hole of the conductive limiter and is in contact and electrically connected with the conductive limiter; and an insulating seal is also provided between any two of the conductive limiters, and the insulating seal fits tightly with the conductive limiter to squeeze the insulating seal and fit with the inner cavity wall of the electrode sleeve to form a sealing structure.

[0053] Optionally, the inner cavity of the electrode sleeve has a fixed step, and the fixed step and the end of the electrode insulating member facing the spiral electrode tip form a fixed space, and the fixed space is used to accommodate and position the conductive limiting member;

[0054] The conductive limiting parts respectively cooperate with the front developing ring and the rear developing ring on the electrode core shaft, and the front developing ring and the rear developing ring respectively abut against different conductive limiting parts located on both sides of the insulating seal to limit the telescopic distance between the electrode core shaft and the spiral electrode; and the position of the spiral electrode is positioned according to the developing distance between the conductive limiting parts and the developing ring.

[0055] Optionally, the spiral electrode comprises: the spiral electrode tip and a spiral structure; the spiral electrode tip is a tip structure, adopting a central parabolic tip structure or a smooth transition tip centered at an arbitrary position;

[0056] In an MRI scanning environment, the smoothly transitioned tip can reduce edge effects and smoothly transition magnetic field changes, thereby reducing tip artifacts; at the same time, it can reduce the induced electric field concentration of the electrode wire and reduce tip heating.

[0057] Optionally, there is a connection section difference between the insulating member limiting step and the inner conductor body welding section on the connector shaft, and the connection section difference is transitioned by a circular arc transition section to avoid generating a right-angle step; the inner conductor body welding section is further provided with a tapered transition section toward one end of the inner conductor body, so that the connector shaft and the inner conductor body cavity are nested and connected; the circular arc transition section and the inner conductor body welding section are connected by continuous welding to form a third connection section; and / or,

[0058] The signal connection ring has the front welding section and the rear welding section; the signal connection seat is connected to the front welding section, and the outer wire body is sleeved and connected to the rear welding section to form a step difference between the front welding section and the rear welding section, and the step difference is connected by a welding transition section, and the welding transition section is an arc structure.

[0059] Optionally, the continuous welding method adopted by the first connecting segment and / or the second connecting segment and / or the third connecting segment includes: laser welding, resistance welding or brazing;

[0060] The welding section is smooth around the periphery without sharp corners or edges. In the high-frequency environment of MRI, the reduction of sharp corners and edges reduces magnetic field distortion and effectively reduces the artifact area; at the same time, it reduces the generation and accumulation of induced current, reduces the self-heating of the electrode, and ensures the connection strength.

[0061] The spiral electrode, conductive limiter, front developing ring and rear developing ring can be made of any conductive material. In order to meet the requirements of MRI compatibility and development effect under X-ray irradiation, it is preferred to use a biocompatible development material with paramagnetic and / or diamagnetic properties and low magnetic susceptibility properties, preferably including platinum iridium, platinum alloy, tantalum, etc.

[0062] The inner contact hole has a hole diameter smaller than the outer diameter of the developing ring and is close to the axial diameter of the electrode core shaft, thereby ensuring effective positioning of the developing ring and stable electrical contact with the electrode core shaft.

[0063] The electrode sleeve and electrode insulating member are preferably made of biocompatible insulating materials, such as polyurethane, PEEK, polyimide, PTFE, etc.

[0064] The inner insulating tube is preferably made of a biocompatible insulating material, such as silicone, polyurethane, polyimide, PTFE, etc.

[0065] A medical device, comprising:

[0066] A machine body having a connection interface; and

[0067] The electrode wire is an electrode wire, and the connector of the electrode wire is inserted into the connection interface.

[0068] During MRI scanning, the internal and external morphology of the implanted component also has a significant impact on the size of MRI artifacts. Due to the existence of edge effects, the magnetic field lines will become denser at the boundaries or edges of the metal components, and the uniformity of the magnetic field will also change. The above-mentioned rounded shape structure has a smaller edge effect, and the magnetic field lines are more likely to be smoothly distributed along the edge of the hole, thereby reducing magnetic field distortion. The raised structure will enhance the edge effect, and the density of the magnetic field lines at these tips will increase, destroying the uniformity of the magnetic field. At the same time, there is a corner effect on the metal component in a uniform magnetic field, that is, if there are objects with sharp protrusions on the component, such as objects with angular, needle-shaped protrusions and / or right-angled steps, bosses, etc., local aggregation of magnetic field lines will occur near the protrusions, and this aggregation will cause the magnetic field intensity to increase in these areas, thereby destroying the uniformity of the magnetic field. Therefore, in the present invention, the internal and external morphology of the implanted component is set to a rounded structure.

[0069] In general, the present invention utilizes paramagnetic and / or diamagnetic conductive materials with low magnetic susceptibility, expands the scope and proportion of polymer non-conductive materials, optimizes the design of component morphology, such as providing magnetic flux holes and a smooth transitional appearance, reduces step differences at connections, avoids the generation of right-angled steps, sharp points, and edges, and reduces metal usage. It also prioritizes connection methods such as continuous welding and bonding, thereby overall reducing the mechanical forces exerted on the wires in the MRI environment and reducing the area of MRI artifacts caused by magnetic field distortion caused by the electrodes. Furthermore, the electrode wires of the present invention minimize structures such as sharp corners, protrusions, and edges, reducing the accumulation of induced electric fields at sharp corners and other structures. This, to a certain extent, can reduce the hot spots of the electrodes under high-frequency energy fields and improve electrode heating conditions. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0071] Figure 1 A cross-sectional view showing the internal structure of the electrode head section of the electrode wire provided by the present invention;

[0072] Figure 2 A cross-sectional view showing the internal structure of the connector section of the electrode wire provided by the present invention;

[0073] Figure 3 A schematic diagram of the overall structure of the MRI-compatible electrode wire provided by the present invention;

[0074] Figure 4a A schematic diagram of the three-dimensional structure of the ring electrode in Example 1 provided by the present invention;

[0075] Figure 4b A schematic diagram of the three-dimensional structure of the ring electrode in Example 2 provided by the present invention;

[0076] Figure 5a Schematic diagram of magnetic flux line distribution of a magnetic shield without magnetic through holes in a uniform magnetic field in the prior art;

[0077] Figure 5b Schematic diagram of the magnetic flux line distribution of the ring electrode with magnetic flux holes in a uniform magnetic field in the present invention;

[0078] Figure 6 A schematic diagram of the three-dimensional structure of the spiral electrode provided by the present invention;

[0079] Figure 7 A schematic diagram of the three-dimensional structure of the signal connection ring provided by the present invention;

[0080] Figure 8 A schematic diagram of the three-dimensional structure of the signal connection socket provided by the present invention;

[0081] Figure 9 A schematic diagram of the three-dimensional structure of the connector shaft provided by the present invention;

[0082] Figure 10 A schematic diagram of the welding connection between the electrode core shaft and the inner conductor provided by the present invention;

[0083] Figure 11 This is a schematic diagram of the three-dimensional structure of the inner conductor support section provided by the present invention.

[0084] Description of Figure Numbers:

[0085] 1-Spiral electrode; 1a-Spiral electrode tip; 1b-Spiral structure; 2-Ring electrode; 21-Contact ring; 22-First bonding section; 23-External insulating tube limiting step; 24-External conductor welding step; 25-External conductor support section; 3-Drug plug; 30-Inner conductor; 40-Outer conductor; 50-Front developing ring; 51-Rear developing ring; 55-Insulating seal; 60-Conductive limiting member; 70-Electrode core shaft; 70a-Inner conductor support section; 80-Electrode sleeve; 85-Electrode insulation; 90-Inner insulating tube; 91-Outer insulating tube; 100-Electrode tip section; 110-Short seal; 111-Long seal ;130-connector insulator;140-connector shaft;142-arc transition section;143-inner conductor welding section;144-support shaft;145-insulator limiting step;150-signal connection ring;151-seal limiting protrusion;152-second bonding section;154-connector seat welding section;155-short seal limiting surface;160-signal connection seat;161-front welding section;162-welding transition section;163-rear welding section;170-signal connection pin;200-connector section;300-electrode wire;1000-first connection section;1100-second connection section;1200-third connection section.

[0086] The implementation, functional features and advantages of the present invention will be further described with reference to the accompanying drawings in conjunction with embodiments. DETAILED DESCRIPTION

[0087] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0088] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0089] In addition, the descriptions of "first", "second", etc. in the present invention are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the meaning of "and / or" appearing in the full text is to include three parallel solutions. Taking "A and / or B" as an example, it includes solution A, or solution B, or a solution in which both A and B are satisfied. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0090] Example 1

[0091] An implantable lead is a medically implanted electrical wire that connects to a pacemaker, defibrillator, or other electrical stimulation device at one end and directly to the heart, brain, or other part of the body that requires electrical stimulation. The primary function of an implantable lead is to transmit tiny electrical pulses from the device to the desired body structure and to transmit the body's electrical activity back to the device.

[0092] See Figure 1 、 Figure 2 and Figure 3 , Figure 1 A cross-sectional view of the internal structure of the electrode head section of the electrode wire in an embodiment of the present invention is shown. Figure 2 A cross-sectional view of the internal structure of the connector section in the electrode wire in an embodiment of the present invention is shown. Figure 2 The 3D schematic diagram of the overall structure of the MRI-compatible electrode lead in an embodiment of the present invention is shown. The MRI-compatible implantable electrode lead with an artifact-reducing structure includes:

[0093] The conductor body section 400 has a first end and a second end opposite to each other. The conductor body section 400 includes an outer insulating tube 91 and an outer conductor body 40, an inner insulating tube 90, and an inner conductor body 30 sequentially disposed within the outer insulating tube 91.

[0094] The electrode tip section 100 is provided at the first end of the lead body section 400; and the connector section 200 is provided at the second end of the lead body section 400 and connected to the medical device via a connector;

[0095] The electrode head section 100 has a ring electrode 2, and the end of the outer conductor body 40 close to the spiral electrode 1 is nested on the outer peripheral wall of the outer conductor body support section 25 of the ring electrode 2; a cavity is provided inside the outer conductor body 40 for the inner insulating tube 90 to pass through, so as to ensure that the inner conductor body 30 and the outer conductor body 40 are insulated from each other;

[0096] The inner hole of the contact ring 21 of the ring electrode 2 is fixed to the outer wall of the electrode insulating member 85 at a position away from the spiral electrode 1, so as to form an integral insulation structure between the ring electrode 2 and the outer wire body 40 for the internal conductor; the position of the electrode insulating member 85 near the spiral electrode 1 is fixed to the inner hole surface of the rear section of the electrode sleeve 80, and the rear section of the electrode sleeve 80 is the position of the electrode sleeve 80 away from the spiral electrode 1; and the position of the electrode sleeve 80 near the spiral electrode 1 is provided with a drug plug 3;

[0097] The ring electrode 2 has a hollow, thin wall and is provided with magnetic flux holes distributed circumferentially and axially. Furthermore, the metal and conductive parts of the electrode lead 300 in this embodiment are also provided with these magnetic flux holes. Specifically, the support shaft 144 is densely packed with these magnetic flux holes distributed circumferentially and axially; the second bonding section 152 on the seal retaining protrusion 151 is also densely packed with these magnetic flux holes circumferentially and axially.

[0098] See Figure 4a , showing that the ring electrode 2 in the embodiment of the present invention has a contact ring 21; in the use state, when the electrode wire 300 is implanted in the human body, the contact ring 21 is immersed in the body fluid environment, forming a loop to transmit pulses and sensing signals;

[0099] The outer insulating tube 91 passes through the outside of the outer wire body 40 and abuts against the outer insulating tube limiting step 23 on the ring electrode 2. The ring electrode 2 is also provided with a first bonding section 22 that is bonded to the outer insulating tube 91 by an adhesive; the first bonding section 22 is located in the middle of the ring electrode 2, and the magnetic flux holes are densely arranged in the circumferential and axial positions of the first bonding section 22.

[0100] The first bonding section 22 is respectively provided with an outer insulating tube limiting step 23 and an outer conductor welding step 24 at positions close to and far from the spiral electrode 1;

[0101] The raised height of the outer insulating tube limiting step 23 and the outer conductor welding step 24 ranges from 0.05mm to 0.5mm, and the steps are rounded with a radius of 0.05mm to 0.5mm. The outer conductor 40, located near one end of the spiral electrode 1, is nested within the outer wall of the outer conductor support section 25 and abuts against the outer conductor welding step 24, connected by continuous welding or crimping to form a first connecting section 1000. The outer diameter of the outer conductor 40, located near one end of the spiral electrode 1, is approximately the same as the diameter of the outer conductor welding step 24. In this embodiment, the inner hole of the contact ring 21 of the ring electrode 2 is bonded to the electrode insulation 85 via adhesive. The front end surface of the electrode insulation 85 is bonded to the inner surface of the rear end of the electrode sleeve 80 via adhesive. The drug plug 3 is bonded to the front end of the electrode sleeve 80 via adhesive.

[0102] In this embodiment, in order to reduce the area of MRI artifacts caused by magnetic field distortion caused by the electrode, the wall thickness of the ring electrode 2 is 0.1mm to 2mm; the ring electrode 2 is a rounded symmetrical structure, the ring electrode 2 is a columnar structure, and the cross section of the ring electrode 2 is any one of a circle, a rounded triangle, and a rounded rectangle or a combination thereof. The magnetic flux holes are densely arranged on the first bonding section 22, and the area of a single magnetic flux hole is 0.05mm. 2 to 0.5mm 2 . The magnetic flux holes on the first bonding section 22 are rounded holes to reduce sharp corners and edges of the holes; the magnetic flux holes include: any one or a combination of circular, elliptical, and rounded rectangular. The magnetic flux holes on the first bonding section 22 are evenly distributed on the first bonding section 22, and the number of circumferential and axial arrangements of the first bonding section 22 is 2 to 10 rows. The ring electrode 2 has paramagnetism and / or diamagnetic properties, and the ring electrode 2 is also a biocompatible developing material with low magnetic susceptibility properties. The material of the ring electrode 2 includes platinum iridium, platinum alloy and tantalum. The adhesive is a biocompatible polymer adhesive, including: silicone adhesive, polyurethane adhesive.

[0103] like Figure 2 and Figure 3 As shown, the connector segment 200 is used for connecting to the connection interface of the IMD, and transmits the electrical pulse signal emitted by the IMD to the electrode head segment 100 through the signal connection pin 170 and the signal connection ring 150;

[0104] The signal connection needle 170 is connected to the end of the connector shaft 140 on the connector segment 200 away from the connector segment 200; the connector insulating member 130 located in the inner cavity of the signal connection ring 150 and the long seal 111 and the short seal 110 passes through the support shaft 144 and is arranged opposite to the signal connection needle 170 through the insulating member limiting step 145 on the connector shaft 140 to limit the axial extension and contraction position of the connector shaft 140; Figure 1 and Figure 6 As shown, the connector shaft 140 is movably connected to the connector insulating member 130 , and the signal connection needle 170 is rotated to drive the inner wire body 30 to rotate, thereby driving the spiral electrode 1 to rotate and penetrate into the patient's tissue.

[0105] A connection step is defined between the insulating member limiting step 145 and the inner conductor welding section 143 on the connector shaft 140. The connection step is transitioned through a circular arc transition section 142 to avoid a right-angle step. The inner conductor welding section 143 is further provided with a tapered transition section at one end facing the inner conductor 30, so that the connector shaft 140 is nested and connected to the inner cavity of the inner conductor 30. The circular arc transition section 142 and the inner conductor welding section 143 are connected by continuous welding to form a third connection section 1200.

[0106] See Figure 7 and Figure 8 , Figure 7 This is a schematic diagram of the three-dimensional structure of the signal connection ring provided by the present invention. Figure 8 Schematic diagram of the three-dimensional structure of the signal connection socket provided by the present invention. Figure 9 The fixing method shown is as follows: the inner conductor welding section 143 on the connector shaft 140 is welded and fixedly connected to the inner conductor 30, the inner insulating tube 90 passes through the inner conductor 30 and is adhesively fixedly connected to the inner hole of the connector insulating member 130; and the inner insulating tube 90 is connected to the connector insulating member 130 at the end away from the spiral electrode 1;

[0107] The inner wire body 30 is nested in the end position of the connector shaft 140 facing the spiral electrode 1; and the outer diameter of the inner wire body 30 is close to the diameter of the arc transition section 142 on the connector shaft 140, thereby reducing the splicing step difference, and the two are fixedly connected by continuous welding.

[0108] The signal connection ring 150 is fixedly connected to the outer wall of the connector insulating member 130; the connection seat welding section 154 on the signal connection ring 150 is fixedly connected to the front welding section 161 on the signal connection seat 160, and the outer conductor 40 is sleeved on the rear welding section 163 on the signal connection seat 160 and fixedly connected thereto;

[0109] The outer insulating tube 91 passes through the outer wire body 40 and is bonded and fixed thereto; the long sealing member 111 located on the outside of the outer insulating tube 91 is snap-connected and positioned with the sealing member limiting protrusion 151 on the signal connecting ring 150; the long sealing member 111 is fixed to the second bonding section 152 on the signal connecting ring 150 by an adhesive; the short sealing member 110 faces one end of the signal connecting ring 150, abuts against the short sealing member limiting surface 155 at the end of the signal connecting ring 150, and is fixedly connected to the outer wall of the connector insulating member 130.

[0110] In this embodiment, if Figure 7 and Figure 8 As shown, the signal connection ring 150 is welded to the front welding section 161 of the signal connection base 160; the diameters of the spliced sections of the signal connection ring 150 and the signal connection base 160 are similar to minimize the diameter difference of the spliced sections. The end of the outer conductor 40, which is away from the spiral electrode 1, is nested and welded to the rear welding section 163 of the signal connection base 160; the outer diameter of the outer conductor 40 is similar to the diameter of the annular welding step on the rear welding section 163 to minimize the diameter difference of the spliced sections.

[0111] The signal connection ring 150 has the front welding section 161 and the rear welding section 163; the signal connection seat 160 is connected to the front welding section 161, and the outer wire body 40 is connected to the rear welding section 163 to form a step difference between the front welding section 161 and the rear welding section 163, and the step difference is connected by the welding transition section 162, and the welding transition section 162 is an arc structure.

[0112] In this embodiment, if Figure 1 The spiral electrode 1 shown further includes: a spiral electrode tip 1a; during the implantation process, the spiral electrode tip 1a is rotated and inserted into the human tissue at the targeted treatment location;

[0113] The inner conductor 30 is positioned toward one end of the spiral electrode tip 1a and is sleeved onto the outer wall of the inner conductor support section 70a of the electrode core shaft 70 and secured to the rear developing ring 51. The rear developing ring 51 is connected to the inner conductor support section 70a near the front end. A front developing ring 50 is also provided at the proximal end of the electrode core shaft 70 near the spiral electrode tip 1a, and the front developing ring 50 is connected to the spiral electrode 1. The front developing ring 50 is connected to the spiral electrode 1. The electrode core shaft 70 passes through the inner contact hole of the conductive stopper 60 and is in electrical contact with the conductive stopper 60. An insulating seal 55 is also provided between any two conductive stoppers 60. The insulating seal 55 is tightly fitted with the conductive stopper 60 to squeeze the insulating seal 55 against the inner cavity wall of the electrode sleeve 80 to form a sealed structure. The electrode core shaft 70 has paramagnetic, diamagnetic and low magnetic susceptibility properties to meet MRI compatibility requirements, and includes one or more combinations of titanium, titanium alloy, platinum alloy, non-magnetic nickel-cobalt-chromium alloy and conductive polymer materials.

[0114] The spiral electrode 1 and the inner conductor 30 are disposed within the inner insulating tube 90 and are driven to rotate within the inner insulating tube 90, thereby driving the spiral electrode 1 housed within the electrode sleeve 80 to extend and retract. A transmission protrusion is disposed within the electrode sleeve 80; the transmission protrusion is in driving connection with the spiral electrode 1, converting the spiral electrode 1's rotational motion into telescopic motion along its axial direction.

[0115] The inner cavity of the electrode sleeve 80 has a fixed step, and the fixed step and the end of the electrode insulating member 85 facing the spiral electrode tip 1a form a fixed space, and the fixed space is used to accommodate and position the conductive limiting member 60;

[0116] The conductive limiting member 60 is respectively matched with the front developing ring 50 and the rear developing ring 51 on the electrode core shaft 70, and the front developing ring 50 and the rear developing ring 51 are respectively abutted against different conductive limiting members 60 located on both sides of the insulating seal 55 to limit the telescopic distance between the electrode core shaft 70 and the spiral electrode 1; and the position of the spiral electrode 1 is positioned according to the developing distance between the conductive limiting member 60 and the developing ring.

[0117] like Figure 11 As shown, in order to reduce artifacts, the end of the inner wire body 30 close to the spiral electrode tip 1a has a diameter close to that of the rear developing ring 51 when inserted into the inner wire body support section 70a, so as to reduce the splicing step difference; and, as shown Figure 10 As shown, the inner conductor body 30 and the rear developing ring 51 are connected by continuous welding or crimping to form a second connecting section 1100 .

[0118] Among them, in this embodiment, Figure 6 As shown, the spiral electrode 1 includes: the spiral electrode tip 1a and the spiral structure 1b; the spiral electrode tip 1a is a tip structure, which adopts a central parabolic tip structure or a smooth transition tip centered at an arbitrary position;

[0119] In an MRI scanning environment, the smoothly transitioned tip can reduce edge effects and smoothly transition magnetic field changes, thereby reducing tip artifacts; at the same time, it can reduce the induced electric field concentration of the electrode wire 300 and reduce tip heating.

[0120] See Figure 5a and Figure 5b , Figure 5a Schematic diagram of magnetic flux line distribution of a magnetic shield without magnetic through holes in a uniform magnetic field in the prior art; Figure 5b Schematic diagram of the magnetic flux line distribution of the ring electrode with magnetic flux holes in a uniform magnetic field in the present invention.

[0121] When the component does not have a magnetic flux hole as a magnetic shield, the magnetic flux line distribution diagram is as follows Figure 5a As shown, for comparison, the magnetic flux line distribution diagram of the component with magnetic flux hole in a uniform magnetic field is shown as follows Figure 5b As shown. According to the principle of magnetic flux continuity, magnetic field lines always tend to flow along paths with high magnetic permeability. The magnetic permeability of metal parts is greater than that of surrounding tissues, thereby guiding the magnetic field lines to gather in the metal layer and pass through, causing strong distortion of the surrounding magnetic field. During MRI scanning, it relies on a uniform magnetic field to encode spatial information. The magnetic field distortion caused by the implanted electrode parts is manifested as shadows on the MRI image, and the image is distorted, affecting the judgment of the disease. In contrast, when there is a magnetic flux hole on the implanted electrode part, the magnetic flux hole has the function of guiding the magnetic flux lines through the metal. The magnetic field lines can pass through the implanted wire part with less deformation and more uniformly, reducing the sharp changes in the uniform magnetic field and reducing the generation of MRI artifacts. At the same time, the magnetic flux hole reduces the metal content of the component, and the higher magnetic permeability χ of the metal is the main factor causing the change in the magnetic field. Reducing the amount of metal also reduces the distortion of the local magnetic field to a large extent, thereby reducing the overall artifact area of the metal part.

[0122] Of course, this embodiment does not specifically limit the distribution of the magnetic flux holes provided on the ring electrode 2. In other embodiments, the ring electrode 2 has a hollow thin wall and is provided with magnetic flux holes distributed along its circumference. Alternatively, the ring electrode 2 is provided with magnetic flux holes distributed along its axial direction. Furthermore, the magnetic flux holes provided on the ring electrode 2 can be randomly arranged, without requiring a fixed arrangement.

[0123] Of course, this embodiment does not specifically limit the connection method between the ring electrode 2 and the electrode insulator 85, the electrode insulator 85 and the electrode sleeve 80, and the drug plug 3 and the electrode sleeve 80. In other embodiments, the inner hole of the contact ring 21 of the ring electrode 2 is fixed to the electrode insulator 85 by means of clamping or welding. The front end surface of the electrode insulator 85 is fixed to the inner surface of the rear end of the electrode sleeve 80 by means of clamping or welding. The drug plug 3 is fixed to the front end of the electrode sleeve 80 by means of clamping or welding.

[0124] Of course, this embodiment does not specifically limit the arrangement of the magnetic flux holes provided on the support shaft 144 and the seal limiting protrusion 151. In other embodiments, the support shaft 144 is provided with strip-shaped magnetic flux holes distributed along its circumference. The second bonding section 152 on the seal limiting protrusion 151 is also provided with strip-shaped magnetic flux holes distributed along its circumference.

[0125] Of course, this embodiment does not specifically limit the continuous welding method of the first connecting segment 1000, the second connecting segment 1100 and the third connecting segment 1200. In other embodiments, the continuous welding method used by the first connecting segment 1000, the second connecting segment 1100 and the third connecting segment 1200 includes: laser welding, resistance welding or brazing;

[0126] The welding section is smooth around the periphery without sharp corners or edges. In the high-frequency environment of MRI, the reduction of sharp corners and edges reduces magnetic field distortion and effectively reduces the artifact area; at the same time, it reduces the generation and accumulation of induced current, reduces the self-heating of the electrode, and ensures the connection strength.

[0127] Example 2

[0128] An implantable lead is a medically implanted electrical wire that connects to a pacemaker, defibrillator, or other electrical stimulation device at one end and directly to the heart, brain, or other part of the body that requires electrical stimulation. The primary function of an implantable lead is to transmit tiny electrical pulses from the device to the desired body structure and to transmit the body's electrical activity back to the device.

[0129] See Figure 1 、 Figure 2 and Figure 3 , Figure 1 A cross-sectional view of the internal structure of the electrode head section of the electrode wire in an embodiment of the present invention is shown. Figure 2 A cross-sectional view of the internal structure of the connector section in the electrode wire in an embodiment of the present invention is shown. Figure 2 The 3D schematic diagram of the overall structure of the MRI-compatible electrode lead in an embodiment of the present invention is shown. The MRI-compatible implantable electrode lead with an artifact-reducing structure includes:

[0130] The conductor body section 400 has a first end and a second end opposite to each other. The conductor body section 400 includes an outer insulating tube 91 and an outer conductor body 40, an inner insulating tube 90, and an inner conductor body 30 sequentially disposed within the outer insulating tube 91.

[0131] The electrode tip section 100 is provided at the first end of the lead body section 400; and the connector section 200 is provided at the second end of the lead body section 400 and connected to the medical device via a connector;

[0132] The electrode head section 100 has a ring electrode 2, and the end of the outer conductor body 40 close to the spiral electrode 1 is nested on the outer peripheral wall of the outer conductor body support section 25 of the ring electrode 2; a cavity is provided inside the outer conductor body 40 for the inner insulating tube 90 to pass through, so as to ensure that the inner conductor body 30 and the outer conductor body 40 are insulated from each other;

[0133] The inner hole of the contact ring 21 of the ring electrode 2 is fixed to the outer wall of the electrode insulating member 85 at a position away from the spiral electrode 1, so as to form an integral insulation structure between the ring electrode 2 and the outer wire body 40 for the internal conductor; the position of the electrode insulating member 85 near the spiral electrode 1 is fixed to the inner hole surface of the rear section of the electrode sleeve 80, and the rear section of the electrode sleeve 80 is the position of the electrode sleeve 80 away from the spiral electrode 1; and the position of the electrode sleeve 80 near the spiral electrode 1 is provided with a drug plug 3;

[0134] The ring electrode 2 has a hollow thin wall and is provided with magnetic flux holes distributed along its circumference and axial direction. In addition, the metal parts and conductive parts on the electrode wire 300 in this embodiment are also provided with the above-mentioned magnetic flux holes.

[0135] See Figure 4b , showing that the ring electrode 2 in the embodiment of the present invention has a contact ring 21; in the use state, when the electrode wire 300 is implanted in the human body, the contact ring 21 is immersed in the body fluid environment, forming a loop to transmit pulses and sensing signals;

[0136] The outer insulating tube 91 passes through the outside of the outer wire body 40 and abuts against the outer insulating tube limiting step 23 on the ring electrode 2. The ring electrode 2 is also provided with a first bonding section 22 that is bonded to the outer insulating tube 91 by an adhesive; the first bonding section 22 is located in the middle of the ring electrode 2, and the magnetic flux hole is a strip hole arranged in a circumferential position of the first bonding section 22.

[0137] Example 3

[0138] A medical device, comprising:

[0139] A machine body having a connection interface; and

[0140] The electrode wire is the electrode wire described in Example 1 or Example 2, and the connector of the electrode wire is inserted into the connection interface.

[0141] The above descriptions are merely optional embodiments of the present invention and do not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present description and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included in the patent protection scope of the present invention.

Claims

1. A magnetic resonance compatible implantable electrode lead with an artifact reduction structure, the electrode lead (300) comprising: A wire main body section (400) has a first end and a second end opposite to each other, the wire main body section (400) comprising an outer insulating tube (91) and an outer wire body (40), an inner insulating tube (90) and an inner wire body (30) sequentially arranged in the outer insulating tube (91); The electrode head section (100) is provided at the first end of the wire main section (400); and the connector section (200) is provided at the second end of the wire main section (400) and is connected to the medical device via a connector; characterized in that: The electrode head section (100) is provided with a ring electrode (2), and one end of the outer conductor (40) close to the spiral electrode (1) is nested on the outer peripheral wall of the outer conductor support section (25) of the ring electrode (2); a cavity for the inner insulating tube (90) to pass through is provided inside the outer conductor (40), so as to ensure that the inner conductor (30) and the outer conductor (40) are insulated from each other; The inner hole of the contact ring (21) of the ring electrode (2) is fixed to the outer wall of the electrode insulating member (85) at a position away from the spiral electrode (1) to form an integral insulation structure of the ring electrode (2) and the outer wire body (40) to the internal conductor; the position of the electrode insulating member (85) close to the spiral electrode (1) is fixed to the inner hole surface of the rear section of the electrode sleeve (80), and the rear section of the electrode sleeve (80) is the position of the electrode sleeve (80) away from the spiral electrode (1); and a drug plug (3) is provided at the position of the electrode sleeve (80) close to the spiral electrode (1); The ring electrode (2) has a hollow thin wall, and is provided with magnetic flux holes distributed along its circumference and / or axial direction.

2. The electrode lead according to claim 1, wherein: The ring electrode (2) has a contact ring (21); in a use state, when the electrode wire (300) is implanted in a human body, the contact ring (21) is immersed in a body fluid environment, forming a loop to transmit pulses and sensing signals; The outer insulating tube (91) passes through the outside of the outer conductor (40) and abuts against the outer insulating tube limiting step (23) on the ring electrode (2); the ring electrode (2) is further provided with a first bonding section (22) bonded to the outer insulating tube (91) by an adhesive; The first bonding section (22) is located in the middle of the ring electrode (2), and the magnetic flux holes are densely arranged in the circumferential and / or axial positions of the first bonding section (22).

3. The electrode lead according to claim 1, wherein: The magnetic flux hole is provided on the metal parts and / or conductive parts on the electrode wire (300).

4. The electrode lead according to claim 2, characterized in that The first bonding section (22) is provided with an outer insulating tube limiting step (23) and an outer conductor welding step (24) at positions close to and far from the spiral electrode (1). The step protrusion height of the outer insulating tube limiting step (23) and the outer conductor body welding step (24) ranges from 0.05 mm to 0.5 mm, and the steps are rounded transitions with a radius of 0.05 mm to 0.5 mm; the outer conductor body (40) is nested in the outer wall of the outer conductor body support section (25) at one end away from the spiral electrode (1), and is in contact with the outer conductor body welding step (24) and connected by continuous welding or crimping to form a first connection section (1000); The outer diameter of the outer conductor body (40) is close to the diameter of the outer conductor body welding step (24) at one end away from the spiral electrode (1).

5. The electrode lead according to claim 1, characterized in that The inner hole of the contact ring (21) of the ring electrode (2) is bonded and fixed to the electrode insulating member (85) by an adhesive; and / or, The front end surface of the electrode insulating member (85) is bonded and fixed to the inner hole surface of the rear section of the electrode sleeve (80) by an adhesive; and / or, The drug plug (3) is fixed to the front end of the electrode sleeve (80) by bonding with an adhesive.

6. The electrode lead according to claim 2, characterized in that: The wall thickness of the ring electrode (2) is 0.1 mm to 2 mm; and / or, The ring electrode (2) is a rounded symmetrical structure, the ring electrode (2) is a columnar structure, and the cross section of the ring electrode (2) is any one of a circle, a rounded triangle, and a rounded rectangle, or a combination thereof; and / or, The magnetic flux holes are densely arranged on the first bonding section (22), and the area of a single magnetic flux hole is 0.05 mm 2 to 0.5mm 2 and / or, The magnetic flux hole on the first bonding section (22) is a rounded hole to reduce sharp corners and edges of the hole; the magnetic flux hole includes: any one of a circle, an ellipse, and a rounded rectangle, or a combination of multiple shapes; and / or, The magnetic flux holes on the first bonding section (22) are evenly distributed on the first bonding section (22), and the number of circumferential and axial arrangement of the first bonding section (22) is 2 to 10 rows; and / or, The ring electrode (2) has paramagnetism and / or diamagnetic properties, and the ring electrode (2) is also a biocompatible imaging material with low magnetic susceptibility properties, and the material of the ring electrode (2) includes platinum iridium, platinum alloy and tantalum; and / or, The adhesive is a biocompatible polymer adhesive, including silicone adhesive and polyurethane adhesive.

7. The electrode lead according to claim 4, characterized in that The connector section (200) is used for plugging into the connection interface of the IMD, and transmits the electric pulse signal emitted by the IMD through the signal connection pin (170) and the signal connection ring (150), and transmits the electric pulse signal to the electrode head section (100); The signal connection needle (170) is connected to an end of the connector shaft (140) on the connector section (200) away from the connector section (200); the connector insulating member (130) located in the inner cavity of the signal connection ring (150) and the long sealing member (111) and the short sealing member (110) passes through the support shaft (144) and is arranged opposite to the signal connection needle (170) through the insulating member limiting step (145) on the connector shaft (140) to limit the axial extension and contraction position of the connector shaft (140); The connector shaft (140) is movably connected to the connector insulating member (130), and the signal connection needle (170) is rotated to drive the inner wire body (30) to rotate, thereby driving the spiral electrode (1) to rotate and penetrate into the patient's tissue.

8. The electrode lead according to claim 7, characterized in that: The inner conductor welding section (143) on the connector shaft (140) is welded and fixedly connected to the inner conductor (30); the inner insulating tube (90) passes through the inner conductor (30) and is adhesively and fixedly connected to the inner hole of the connector insulating member (130); and the inner insulating tube (90) is connected to the connector insulating member (130) at one end away from the spiral electrode (1); The inner conductor body (30) is nested in the end portion of the connector shaft (140) facing the spiral electrode (1); and the outer diameter of the inner conductor body (30) is close to the diameter of the arc transition section (142) on the connector shaft (140), thereby reducing the splicing step difference, and the two are fixedly connected by continuous welding.

9. The electrode lead according to claim 7, characterized in that: The signal connection ring (150) is fixedly connected to the outer wall of the connector insulating member (130); the connection seat welding section (154) on the signal connection ring (150) is fixedly connected to the front welding section (161) on the signal connection seat (160); the outer conductor (40) is sleeved on the rear welding section (163) on the signal connection seat (160) and fixedly connected thereto; The outer insulating tube (91) passes through the outer conductor (40) and is bonded and fixed thereto; the long sealing member (111) located outside the outer insulating tube (91) is snap-fitted and positioned with the sealing member limiting protrusion (151) on the signal connecting ring (150); the long sealing member (111) is fixed to the second bonding section (152) on the signal connecting ring (150) by an adhesive; the short sealing member (110) faces one end of the signal connecting ring (150), abuts against the short sealing member limiting surface (155) at the end of the signal connecting ring (150), and is fixedly connected to the outer wall of the connector insulating member (130).

10. The electrode lead according to claim 9, characterized in that: The support shaft (144) is densely arranged with the magnetic flux holes distributed along its circumferential direction and / or axial direction; and / or, The second bonding section (152) on the sealing member limiting protrusion (151) is densely arranged with the magnetic flux holes in the circumferential direction and / or the axial direction.

11. The electrode lead according to claim 9, characterized in that The signal connection ring (150) is welded to the front welding section (161) of the signal connection seat (160); and the diameters of the splicing sections of the signal connection ring (150) and the signal connection seat (160) are similar to reduce the diameter difference of the splicing sections; and / or, One end of the outer conductor (40) away from the spiral electrode (1) is nested and welded to the rear welding section (163) of the signal connection seat (160); and the outer diameter of the outer conductor (40) is similar to the diameter of the annular welding step on the rear welding section (163) to reduce the diameter difference of the spliced section.

12. The electrode lead according to claim 1, characterized in that The spiral electrode (1) further comprises: a spiral electrode tip (1a); during the implantation process, the spiral electrode tip (1a) is rotated and inserted into human tissue at a targeted treatment location; One end of the inner wire body (30) close to the spiral electrode tip (1a) is sleeved on the outer wall of the inner wire body support section (70a) of the electrode core shaft (70) and fixed to the rear developing ring (51); the rear developing ring (51) is connected to a position close to the front end of the inner wire body support section (70a); a front developing ring (50) is further provided at a proximal position of the electrode core shaft (70) close to the spiral electrode tip (1a), and the front developing ring (50) is connected to the spiral electrode (1); the front developing ring (50) is connected to the spiral electrode (1); The spiral electrode (1) and the inner conductor (30) are arranged in the inner insulating tube (90) and are driven to rotate in the inner insulating tube (90) to drive the spiral electrode (1) accommodated in the electrode sleeve (80) to move in a driven telescopic manner.

13. The electrode lead according to claim 12, characterized in that: One end of the inner conductor (30) close to the spiral electrode tip (1a) has a diameter similar to that of the rear developing ring (51) when inserted into the inner conductor support section (70a) to reduce the difference in splicing sections; and the inner conductor (30) and the rear developing ring (51) are connected by continuous welding or crimping to form a second connecting section (1100); and / or, In order to meet the MRI compatibility requirements, the electrode core shaft (70) also has paramagnetism and / or diamagnetic properties, and the electrode core shaft (70) also needs to have low magnetic susceptibility performance, which includes: one or more combinations of titanium, titanium alloy, platinum alloy, non-magnetic nickel-cobalt-chromium alloy, and conductive polymer materials.

14. The electrode lead according to claim 12, characterized in that: A transmission protrusion is provided in the electrode sleeve (80); the transmission protrusion is transmission-connected to the spiral electrode (1) to convert the rotational motion of the spiral electrode (1) into a telescopic motion along the axial direction of the spiral electrode (1); and / or, The electrode core shaft (70) passes through the inner contact hole of the conductive limiter (60) and is in electrical contact with the conductive limiter (60); and an insulating seal (55) is provided between any two of the conductive limiters (60), and the insulating seal (55) is tightly fitted with the conductive limiter (60) to squeeze the insulating seal (55) and fit the inner cavity wall of the electrode sleeve (80) to form a sealing structure.

15. The electrode lead according to claim 14, characterized in that The inner cavity of the electrode sleeve (80) has a fixed step, and the fixed step and the end of the electrode insulating member (85) facing the spiral electrode tip (1a) form a fixed space, and the fixed space is used to accommodate and position the conductive limiting member (60); The conductive limiting member (60) is respectively matched with the front developing ring (50) and the rear developing ring (51) on the electrode core shaft (70), and the front developing ring (50) and the rear developing ring (51) are respectively abutted against different conductive limiting members (60) located on both sides of the insulating seal (55) to limit the telescopic distance between the electrode core shaft (70) and the spiral electrode (1); and the position of the spiral electrode (1) is positioned according to the developing distance between the conductive limiting member (60) and the developing ring.

16. The electrode lead according to claim 14, characterized in that The spiral electrode (1) comprises: the spiral electrode tip (1a) and a spiral structure (1b); the spiral electrode tip (1a) is a tip structure, and adopts a central parabolic tip structure or a smooth transition tip centered at an arbitrary position; In an MRI scanning environment, the smoothly transitioned tip can reduce edge effects and smoothly transition magnetic field changes, thereby reducing tip artifacts; at the same time, it reduces the induced electric field concentration of the electrode wire (300) and reduces tip heating.

17. The electrode lead according to claim 9, characterized in that There is a connection section difference between the insulating member limiting step (145) and the inner conductor body welding section (143) on the connector shaft (140), and the connection section difference is transitioned through a circular arc transition section (142) to avoid generating a right-angle step; the inner conductor body welding section (143) is further provided with a tapered transition section at one end facing the inner conductor body (30) so that the connector shaft (140) and the inner conductor body (30) are nested and connected; the circular arc transition section (142) and the inner conductor body welding section (143) are connected in a continuous welding manner to form a third connection section (1200); and / or, The signal connection ring (150) is provided with the front welding section (161) and the rear welding section (163); the signal connection seat (160) is connected to the front welding section (161), and the outer conductor body (40) is sleeved and connected to the rear welding section (163), so as to form a step difference between the front welding section (161) and the rear welding section (163); the step difference is connected via a welding transition section (162), and the welding transition section (162) is an arc structure.

18. The electrode lead according to claim 17, characterized in that The continuous welding method adopted by the first connecting section (1000) and / or the second connecting section (1100) and / or the third connecting section (1200) includes: laser welding, resistance welding or brazing; The welding section is smooth around the periphery without sharp corners or edges. In the high-frequency environment of MRI, the reduction of sharp corners and edges reduces magnetic field distortion and effectively reduces the artifact area; at the same time, it reduces the generation and accumulation of induced current, reduces the self-heating of the electrode, and ensures the connection strength.

19. A medical device, characterized in that The medical equipment includes: A machine body having a connection interface; and An electrode wire, wherein the electrode wire is the electrode wire according to any one of claims 1 to 18, and a connector of the electrode wire is inserted into the connection interface.

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