An MRI-compatible implantable electrode lead and implantable medical device

Abstract

This utility model relates to the field of medical devices, and more particularly to an MRI-compatible implantable electrode lead and implantable medical device. The implantable electrode lead includes: a conductive core, which may be single-core or multi-core; an insulating layer covering the conductive core; and a shielding layer covering or embedded within the insulating layer. The shielding layer has a mesh structure and is braided from conductive wires with curved sections. This utility model provides a mesh shielding layer made of a biocompatible, electrically conductive material outside the implantable electrode lead. This shielding layer can shield magnetic fields to prevent the internally protected conductive core from overheating, thereby ensuring the safety of the implantable electrode lead during MRI scanning. Furthermore, the shielding layer has a certain degree of elasticity to accommodate the elastic conductor core.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to an MRI-compatible implantable electrode lead and an implantable medical device. Background Technology

[0002] Magnetic Resonance Imaging (MRI) examinations do not pose a direct risk to the human body. However, if a patient has implantable medical devices (IMDs), such as pacemakers, defibrillators, vagus nerve stimulators, spinal cord stimulators, or deep brain stimulators, the implanted metal components will generate heat in the MRI's radiofrequency magnetic field during operation. This is especially true for devices with long, thin conductive structures, such as electrical wires, which, due to their small cross-sectional area and high resistance, are the primary heat-generating components. When these wires cannot avoid direct contact with human tissue, they can cause harm to the patient. Furthermore, most patients require MRI examinations during the device's lifespan. To mitigate this issue, the current mainstream solution is to add a shielding layer to the device's electrical wires. However, because existing electrical wires do not require elasticity, their shielding layers also do not need to be elastic, making them unsuitable for certain applications. Utility Model Content

[0003] To adapt to flexible and stretchable scenarios, this utility model proposes an MRI-compatible implantable electrode lead, comprising: a conductive core, the conductive core including a single core or multiple cores; an insulating layer covering the conductive core; a shielding layer covering the insulating layer, the shielding layer having a mesh structure and being braided from conductive wires with bends; and a silicone layer covering the shielding layer, the silicone layer having tissue compatibility.

[0004] In one or more embodiments, the conductive core has a spring structure.

[0005] In one or more embodiments, the shielding layer has a mesh structure and is woven from conductive warp and weft threads with bends.

[0006] In one or more embodiments, the curved portion includes an S-shape or a zigzag shape.

[0007] In one or more embodiments, the shielding layer has a mesh structure and is woven from conductive warp threads with curved portions, conductive weft threads, a first elastic thread uniformly doped between the conductive warp threads in a certain proportion, and a second elastic thread uniformly doped between the conductive weft threads in a certain proportion.

[0008] In one or more embodiments, the shielding layer further includes a mesh structure or tubular structure formed of conductive rubber, conductive silicone, or conductive plastic.

[0009] In one or more embodiments, when the conductive core is multi-core, each core is covered with an insulating layer and is insulated from each other.

[0010] In a second aspect of this invention, an MRI-compatible implantable medical device is also provided, comprising: a controller and an electrode wire electrically connected to the controller, wherein the electrode wire is an MRI-compatible implantable electrode wire as described in any of the above embodiments.

[0011] In one or more embodiments, the MRI-compatible implantable medical device of the present invention further includes: a stimulation electrode electrically connected to the electrode leads; wherein the controller is configured to generate an electrical stimulation signal and apply it to a designated area via the electrode leads and the stimulation electrode.

[0012] In one or more embodiments, the shielding layer further includes a reinforcing portion disposed at one end of the shielding layer near the stimulating electrode, and the reinforcing portion includes a conductive ring or a conductive sleeve.

[0013] The beneficial effects of this invention include: This invention provides a mesh shielding layer made of a biocompatible electrically conductive material outside the implantable electrode lead. This shielding layer can shield the magnetic field to prevent the conductive core inside from heating up, thereby ensuring the safety of the implantable electrode lead during MRI scanning. In addition, the shielding layer has a certain degree of elasticity to adapt to the elastic core. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other embodiments can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is a schematic diagram of the first structure of an MRI-compatible implantable electrode lead according to the present invention.

[0016] Figure 2 This is a schematic diagram of the second structure of an MRI-compatible implantable electrode lead according to the present invention.

[0017] Figure 3 This is a schematic diagram of the structure of an MRI-compatible implantable medical device according to the present invention.

[0018] Figure 4 This is a schematic diagram of the first connection structure of the shielding layer reinforcement part of this utility model;

[0019] Figure 5 This is a schematic diagram of the second connection structure of the shielding layer reinforcement part of this utility model.

[0020] The meanings of the reference numerals in the above figures are as follows: conductive core 10, insulating layer 20, shielding layer 30, conductive warp 31, conductive weft 32, first elastic thread 33, second elastic thread 34, reinforcing part 35, controller 1, electrode wire 2, stimulation electrode 3. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this utility model clearer, the embodiments of this utility model will be further described in detail below with reference to specific examples and accompanying drawings.

[0022] It should be noted that all uses of "first" and "second" in the embodiments of this utility model are for the purpose of distinguishing two entities or parameters with the same name but different names. It is clear that "first" and "second" are only for the convenience of expression and should not be construed as limiting the embodiments of this utility model. Subsequent embodiments will not explain this in detail.

[0023] To adapt to scenarios requiring elasticity and stretching, this invention proposes an MRI-compatible implantable electrode lead, such as... Figure 1 As shown, the device includes: a conductive core 10, which may be single-core or multi-core; an insulating layer 20 covering the conductive core; a shielding layer 30 covering the insulating layer 20, the shielding layer 30 having a mesh structure and being braided from conductive wires with bends; and a silicone layer 40 covering the shielding layer, the silicone layer 40 being biocompatible. In this embodiment, the shielding layer covers the outside of the insulating layer, and the mesh structure woven from conductive wires with bends allows the shielding layer to undergo elastic deformation.

[0024] In an optional embodiment, the shielding layer 30 may be embedded within the insulating layer 40 to protect the shielding layer 30, and the insulating layer 40 is made of biocompatible silicone.

[0025] In one embodiment, the conductive core 10 has a spring structure. Specifically, in order to make the conductor core elastic, this embodiment designs the conductive core as a spiral structure similar to a spring.

[0026] In one embodiment, the shielding layer has a mesh structure and is woven from bent conductive warp threads 31 and conductive weft threads 32. This embodiment uses conductive warp threads 31 and conductive weft threads 32 with bent portions to weave the shielding layer, giving it a certain degree of elasticity and stretching in both the radial and axial directions, and making the electrode wires more flexible overall.

[0027] In an optional embodiment, the curved portions of the conductive warp 31 and conductive weft 32 are S-shaped or zigzag-shaped. The S-shape can effectively reduce stress concentration at the bending point of the curved portion and reduce the risk of metal fatigue during elastic deformation.

[0028] In one embodiment, see Figure 2 The shielding layer has a mesh structure and is woven from curved conductive warp threads 31, conductive weft threads 32, first elastic threads 33 uniformly doped between the conductive warp threads in a certain proportion, and second elastic threads 34 uniformly doped between the conductive weft threads in a certain proportion. Specifically, in this embodiment, the addition of the first elastic thread 33 and the second elastic thread 34 can improve the resilience of the shielding layer after stretching.

[0029] In one implementation, please continue to see Figure 2 The natural length of the first elastic cord 33 is less than the stretched length of the bent conductive warp 31, and the natural length of the second elastic cord 34 is less than the stretched length of the bent conductive weft 32. The purpose of this embodiment is to utilize the length of the elastic cords after contraction to ensure the restoration of the bent portions on the conductive warp and conductor weft.

[0030] In an optional embodiment, the first and second elastic threads are made of silicone, and the conductive warp 31 and conductive weft 32 are made of platinum-iridium or nickel-titanium alloy.

[0031] In one embodiment, the diameter of the first elastic line 33 is larger than the diameter of the second elastic line 34. Specifically, since the first elastic line 33 is part of the warp, and the warp provides axial elasticity and requires greater elasticity, the diameter of the first elastic line 33 is thicker.

[0032] In one embodiment, the doping ratio of the first elastic wire 33 is less than the doping ratio of the second elastic wire. Specifically, when the diameter of the first elastic wire 33 is thicker, the required doping ratio of the first elastic wire 33 will be less than that of the second elastic wire 34.

[0033] In one embodiment, the shielding layer further includes a mesh or tubular structure formed of conductive rubber, conductive silicone, or conductive plastic. Specifically, since conductive rubber, conductive silicone, or conductive plastic inherently possess a certain degree of elasticity, they can be woven into a mesh or formed into a tubular structure to directly cover the insulation layer of the wire core. In this embodiment, when a mesh structure is used, the braided wire formed of conductive rubber, conductive silicone, or conductive plastic may not have bending portions and does not require the addition of elastic wires.

[0034] More specifically, taking conductive silicone as an example, its preparation method is as follows: it is made by mixing a dispersed conductive medium with silicone. The conductive medium can be graphene powder, carbon nanotubes, nanowires, etc. The conductive material is mixed into uncured liquid silicone, the amount added is controlled and stirred evenly, so that the conductive material forms a conductive mesh structure in the silicone, thereby achieving an electromagnetic shielding effect. Because the conductive components are not a monolithic entity, and their size is on the nanometer to micrometer scale, the eddy currents generated under an external changing magnetic field are small, and heat generation is not easily achieved. At the same time, because the dispersed conductive materials are not rigidly connected, the shielding layer can maintain its continuity when stretched, compressed, bent, or torn, ensuring the shielding effect.

[0035] In one embodiment, when the conductive core is multi-core, each core is covered with an insulating layer and is insulated from each other. Optionally, the insulating layer may be a dielectric coating, and the coating material may be ETFE, PTFE, PFA, etc., which have a high dielectric constant. This arrangement can increase the isolation between the pathways within a limited size.

[0036] In a second aspect, an MRI-compatible implantable medical device is provided, such as... Figure 3 As shown, it includes: a controller 1 and an electrode lead 2 electrically connected to the controller 1. The electrode lead 2 adopts the MRI-compatible implantable electrode lead of any of the above embodiments. Specifically, the implantable medical device proposed in this embodiment greatly improves the MRI compatibility of the implantable medical device by adopting the MRI-compatible implantable electrode lead of any of the above embodiments. It should be noted that... Figure 3 The number of electrode wires 2 shown is not intended to limit this application. Those skilled in the art can set up multiple electrode wires 2 to connect to the controller 1 as needed.

[0037] In one implementation, the MRI-compatible implantable medical device further includes a stimulation electrode 3 electrically connected to the electrode lead 2; wherein the controller 1 is configured to generate an electrical stimulation signal and apply it to a designated area via the electrode lead 2 and the stimulation electrode 3.

[0038] In one or more implementations, please refer to Figure 4 and Figure 5The shielding layer 30 also includes a reinforcing portion 35 disposed at one end of the shielding layer 30 near the stimulating electrode 3, and the reinforcing portion 35 includes a conductive ring or a conductive sleeve. When a conductive ring is used, the mesh structure of the shielding layer 30 can be fixedly connected to the conductive ring by a winding method. In this case, the conductive ring is preferably made of the same material as the shielding layer 30 to form an equipotential body with the shielding layer 30. When a conductive sleeve is used, the sleeve is fitted over the shielding layer 30 and fixedly connected to the stimulating electrode by a clamping method. Similarly, to facilitate the formation of an equipotential body with the shielding layer, the material of the conductive sleeve should preferably be the same as the material of the shielding layer 30.

[0039] The above are exemplary embodiments disclosed in this utility model. However, it should be noted that various changes and modifications can be made without departing from the scope of the embodiments of this utility model as defined by the claims. The functions, steps, and / or actions of the methods according to the disclosed embodiments described herein do not need to be performed in any particular order.

[0040] Those skilled in the art should understand that the discussion of any of the above embodiments is merely exemplary and is not intended to imply that the scope of the present invention (including the claims) is limited to these examples. Within the framework of the present invention, technical features of the above embodiments or different embodiments can also be combined, and many other variations of different aspects of the present invention exist, which are not provided in the details for the sake of brevity. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An MRI-compatible implantable electrode lead, characterized in that, include: A conductive wire core, wherein the conductive wire core may be a single core or multiple cores; An insulating layer covering the conductive wire core; A shielding layer covering the insulating layer, the shielding layer having a mesh structure and being woven from conductive wires with bent portions; as well as A silicone layer covering the shielding layer, the silicone layer being biocompatible.

2. The MRI-compatible implantable electrode lead according to claim 1, characterized in that, The conductive core has a spring structure.

3. The MRI-compatible implantable electrode lead according to claim 1, characterized in that, The shielding layer has a mesh structure and is woven from conductive warp and weft threads with curved sections.

4. The MRI-compatible implantable electrode lead according to claim 1 or 3, characterized in that, The curved portion includes an S-shape or a zigzag shape.

5. The MRI-compatible implantable electrode lead according to claim 3, characterized in that, The shielding layer has a mesh structure and is woven from conductive warp threads with curved sections, conductive weft threads, a first elastic thread uniformly mixed between the conductive warp threads in a certain proportion, and a second elastic thread uniformly mixed between the conductive weft threads in a certain proportion.

6. The MRI-compatible implantable electrode lead according to claim 1, characterized in that, The shielding layer further includes: A mesh or tubular structure formed of conductive rubber, conductive silicone or conductive plastic.

7. The MRI-compatible implantable electrode lead according to claim 1, characterized in that, When the conductive core is multi-core, each core is covered with an insulating layer and is insulated from each other.

8. An MRI-compatible implantable medical device, characterized in that, include: A controller and an electrode wire electrically connected to the controller, the electrode wire being an MRI-compatible implantable electrode wire as described in any one of claims 1-7.

9. The MRI-compatible implantable medical device according to claim 8, characterized in that, Also includes: The stimulation electrode is electrically connected to the electrode wire; The controller is configured to generate an electrical stimulation signal and apply it to a designated area via the electrode wires and the stimulation electrodes.

10. The MRI-compatible implantable medical device according to claim 9, characterized in that, The shielding layer further includes a reinforcing portion disposed at one end of the shielding layer near the stimulating electrode, and the reinforcing portion includes a conductive ring or a conductive sleeve.

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