Ear electrode cable of ear vagus nerve stimulator and preparation method of ear electrode cable

Abstract

The invention provides an ear vagus nerve stimulator ear electrode cable and a preparation method thereof. The ear electrode cable of the ear vagus nerve stimulator comprises an electrode part, an ear hook part and a wire connecting the electrode part and the ear hook part. The electrode part comprises auditory meatus electrode silica gel, auricular conchae electrode silica gel, an auricular conchae electrode wire, a PCB (Printed Circuit Board), external sealing glue, a circular insert and a sheet-shaped insert; wherein the ear canal electrode silica gel wraps the circular insert, and the auricular concha electrode silica gel wraps the sheet insert; the circular insert is connected with the PCB, the sheet insert is connected with the PCB through the auricular concha electrode wire, and the PCB is connected with the wire; and the external sealing glue is packaged outside the auricular concha electrode lead, the PCB, the circular insert and the sheet-shaped insert. The ear electrode cable of the ear vagus nerve stimulator has the advantages of being reliable in connection, high in strength, high in adaptability and comfortable to wear.

Description

Technical Field

[0001] The present application belongs to the technical field of otology electrodes, and in particular relates to an ear electrode cable for an ear vagus nerve stimulator and a preparation method thereof. Background Art

[0002] The vagus nerve is the longest and most widespread of all cranial nerves. Early studies have shown that vagus nerve treatment has some efficacy in treating hypertension, diabetes, drug-resistant epilepsy, and depression. The US FDA officially approved vagus nerve stimulation (VNS) in 1997 for the treatment of refractory epilepsy and in 2005 as a complementary alternative treatment for refractory depression. This treatment achieves its therapeutic effect by stimulating the left cervical vagus nerve trunk with a stimulator placed in the neck.

[0003] However, the device is relatively expensive and requires surgery, which carries certain risks. It also requires regular adjustments to the device's programming and battery replacement by a professional doctor. Furthermore, the surgical procedure and the implantation of a foreign body can be psychologically taxing for those with depression, potentially exacerbating their condition.

[0004] Modern anatomy believes that the vagus nerve has a branch in the external ear, the auricular branch of the vagus nerve, which is mainly distributed in the external auditory canal and concha area. Figure 1 Points A (the opening of the external auditory canal) and B (the concha area) are the ear acupoints of the vagus nerve. By electrically stimulating points A and B, the stimulation reaches the solitary nucleus of the vagus nerve through the neural pathway, thereby achieving the effect of electrical nerve stimulation treatment.

[0005] There are two ways to wear the ear electrode cables of the prior art ear vagus nerve stimulator: body-worn and behind-the-ear. The body-worn type is relatively large and requires the connection of a very long electrode wire, which is inconvenient to use. The behind-the-ear type is small in size and easy to wear, and the corresponding electrode cable is also shortened. The electrode cable needs to be connected to the behind-the-ear device through the ear hook of the behind-the-ear device. At the same time, the ear hook part must ensure sufficient structural strength, and the wire part of the electrode cable needs to have sufficient tensile strength to prevent it from being pulled out from the ear hook. The electrode part of the electrode cable needs to be provided with two channel electrodes according to the requirements of stimulating acupuncture points A and B. There must be good insulation between the two channel electrodes. At the same time, in order to ensure the output effect of electrical stimulation, the contact between the electrode and the human body must be good, and it must adapt to the individual differences of different human bodies. Therefore, for the ear electrode cable of the behind-the-ear ear vagus nerve stimulator, there is a need for an electrode cable with high connection reliability, high strength, high adaptability, and comfortable wearing. Summary of the Invention

[0006] The present application provides an ear electrode cable for an ear vagus nerve stimulator and a preparation method thereof, which are used to improve the wearing comfort of a behind-the-ear ear vagus nerve stimulator.

[0007] In a first aspect, an embodiment of the present application provides an ear electrode cable for an ear vagus nerve stimulator, comprising: an electrode portion, an ear hook portion, and a wire connecting the electrode portion and the ear hook portion; the electrode portion comprises ear canal electrode silicone, concha electrode silicone, concha electrode wire, a PCB board, an external sealing glue, a circular insert, and a sheet insert; wherein the ear canal electrode silicone covers the circular insert, and the concha electrode silicone covers the sheet insert; the circular insert is connected to the PCB board, the sheet insert is connected to the PCB board through the concha electrode wire, and the PCB board is connected to the wire; the external sealing glue is encapsulated on the outside of the concha electrode wire, the PCB board, the circular insert, and the sheet insert; the core wire of the wire is sheathed with FEP material, the outer sheath of the wire, the outer sheath of the concha electrode wire, and the external sealing glue are made of silicone material; the inner mold of the ear hook is made of polypropylene PP material, and the outer mold of the ear hook is made of TPE material or TPU material; the ear canal electrode silicone and the concha electrode silicone are made of conductive silicone material.

[0008] In an implementation of the first aspect, the angle between the ear canal electrode silicone and the concha electrode silicone is 18±2°.

[0009] In an implementation of the first aspect, the circular insert is provided with an annular groove, a circular blind hole, a PCB card slot and a flange; the sheet insert is provided with a protrusion, a U-shaped groove and a circular through hole.

[0010] In an implementation of the first aspect, the external sealant includes a base, an auricle cantilever and a tail tube; wherein, the base is provided with an anti-slip groove and an ear canal glue overflow groove, and the auricle cantilever is C-shaped and is provided with a plurality of staggered grooves and auricle glue overflow grooves.

[0011] In an implementation of the first aspect, the PCB board is provided with an ear canal electrode pad, a concha electrode pad, a winding hole, and a winding groove.

[0012] In an implementation of the first aspect, the ear hook portion is C-shaped as a whole, with a conical cross-section that gradually decreases; the ear hook portion includes an ear hook inner mold, an ear hook outer mold, and a clamp; wherein, the ear hook inner mold is provided with a host connection slot, a plurality of staggered inner mold grooves, and an inner mold boss; the front end of the ear hook outer mold is provided with an outer mold tail pipe.

[0013] In an implementation of the first aspect, the length of the ear hook inner mold is not less than 90% of the length of the ear hook outer mold.

[0014] In an implementation of the first aspect, the clamp is provided on the wire extending into the ear hook portion, wherein one clamp is located at the protruding end of the wire and the remaining clamps are located inside the ear hook inner mold.

[0015] In an implementation of the first aspect, the core wire of the wire is sheathed with FEP material, the outer sheath of the wire, the outer sheath of the concha electrode wire, and the external sealing glue are made of silicone material; the inner mold of the ear hook is made of polypropylene (PP) material, and the outer mold of the ear hook is made of TPE material or TPU material; the ear canal electrode silicone and the concha electrode silicone are made of conductive silicone material; the circular insert and the sheet insert are made of nickel-plated brass.

[0016] In a second aspect, an embodiment of the present application provides a method for preparing an ear electrode cable for an ear vagus nerve stimulator, comprising: fixing one end of a wire, injection molding an ear hook portion, and fixing the wire to the ear hook portion; dividing the other end of the wire into a first wire core and a second wire core, correspondingly welding the first wire core and the circular insert of the electrode portion to a PCB board, welding the sheet insert of the electrode portion to the concha electrode wire, and then correspondingly welding the second wire core and the concha electrode wire to the PCB board, and fixing the wire to the PCB board; passing a fiber bundle in the wire through a winding hole and a winding groove on the PCB board and fixing the PCB board; placing the concha electrode wire, the PCB board, the circular insert, and the sheet insert in a sealing mold, sealing with liquid silicone to form an external sealing glue, and exposing the circular insert and the sheet insert; placing the external sealing glue, the circular insert, and the sheet insert in an electrode mold, coating the circular insert and the sheet insert with solid silicone to form the ear canal electrode silicone and the concha electrode silicone of the electrode portion.

[0017] In an implementation of the second aspect, one end of the fixed wire is injection molded to form an ear hook portion, and fixing the wire to the ear hook portion includes: cutting the wire and stripping both ends of the wire; fixing the ear hook portion of the wire with a clamp; cleaning the rubber-coated portion of the wire with alcohol, drying and plasma-treating it; placing the rubber-coated portion of the wire in an ear hook inner mold for ear hook inner mold injection molding to form an ear hook inner mold; plasma-treating the surface of the injection-molded ear hook inner mold; placing the ear hook inner mold in an ear hook outer mold for ear hook outer mold injection molding to form an ear hook outer mold.

[0018] In an implementation of the second aspect, the core wire of the wire is sheathed with FEP material, the sheath of the wire, the sheath of the concha electrode wire, and the external sealing glue are made of silicone material; the ear hook inner mold is made of polypropylene (PP) material, and the ear hook outer mold is made of TPE material or TPU material; the ear canal electrode silicone and the concha electrode silicone are made of conductive silicone material; the circular insert and the sheet insert are made of nickel-plated brass; the encapsulation process between the ear hook portion, the electrode portion, and the wire includes: wrapping the silicone sheath of the wire with polypropylene (PP) material in combination with a retaining clamp; wrapping the polypropylene (PP) material of the ear hook inner mold with TPE or TPU material to form the ear hook portion; using liquid silicone to wrap the silicone sheath of the concha electrode wire, the silicone sheath of the wire, the PCB board, the circular insert, and the sheet insert to form the external sealing glue, and exposing the circular insert and the sheet insert; and using solid silicone to wrap the exposed parts of the circular insert and the sheet insert to form the ear canal electrode silicone and the concha electrode silicone.

[0019] The ear electrode cable of the ear vagus nerve stimulator provided in the embodiment of the present application has the advantages of reliable connection, high strength, high adaptability and comfortable wearing. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 Diagram showing ear acupuncture points for the auricular vagus nerve.

[0021] Figure 2 Shown is a schematic diagram of the overall structure of the ear electrode cable of an ear vagus nerve stimulator according to one embodiment of the present application.

[0022] Figure 3 Shown is a schematic diagram of the overall structure of the electrode portion of the ear electrode cable of an ear vagus nerve stimulator according to one embodiment of the present application.

[0023] Figure 4 Shown is a schematic structural diagram of a PCB board in an ear electrode cable of an ear vagus nerve stimulator according to an embodiment of the present application.

[0024] Figure 5 Shown is a schematic diagram of the connection between a circular insert and a PCB board in an ear electrode cable of an ear vagus nerve stimulator according to an embodiment of the present application.

[0025] Figure 6 Shown is a schematic diagram of the connection between the sheet-like insert and the concha electrode wire in the ear electrode cable of an ear vagus nerve stimulator according to one embodiment of the present application.

[0026] Figure 7 Shown is a schematic diagram of the connection between a circular insert, a sheet insert and a PCB board in an ear electrode cable of an ear vagus nerve stimulator according to an embodiment of the present application.

[0027] Figure 8 Shown is a schematic diagram of the overall structure of the ear hook portion of the ear electrode cable of an ear vagus nerve stimulator according to one embodiment of the present application.

[0028] Figure 9 Shown is a schematic structural diagram of the ear hook inner mold in the ear electrode cable of an ear vagus nerve stimulator according to one embodiment of the present application.

[0029] Figure 10 Shown is a schematic diagram of a process for preparing an ear electrode cable for an ear vagus nerve stimulator according to an embodiment of the present application. DETAILED DESCRIPTION

[0030] The following describes the implementation of the present invention through specific embodiments. People skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0031] See also Figures 1 to 10 . It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they have no substantive technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0032] The purpose of this embodiment is to provide an ear electrode cable for an ear vagus nerve stimulator and a method for preparing the same, to improve the wearing comfort of a behind-the-ear ear vagus nerve stimulator. The principles and implementation methods of this embodiment of an ear electrode cable for an ear vagus nerve stimulator and a method for preparing the same will be described in detail below, enabling those skilled in the art to understand the embodiment of this embodiment of an ear electrode cable for an ear vagus nerve stimulator and a method for preparing the same without requiring creative effort.

[0033] The ear electrode cable of the ear vagus nerve stimulator provided in the embodiment of the present application is adapted to be connected to a behind-the-ear ear vagus nerve stimulator. Figure 2 The diagram shows the overall structure of the ear electrode cable of the ear vagus nerve stimulator according to one embodiment of the present application. Figure 2As shown, an embodiment of the present application provides an ear electrode cable for an ear vagus nerve stimulator, wherein the ear electrode cable for the ear vagus nerve stimulator includes: an electrode portion 1, an ear hook portion 2, and a wire 3 (i.e., a main wire) connecting the electrode portion 1 and the ear hook portion 2.

[0034] Among them, in this embodiment, if Figure 3 As shown, the electrode part 1 includes an ear canal electrode silicone 11, a concha electrode silicone 12, a concha electrode wire 13, a PCB board 14, an external sealing glue 15, a circular insert 16 and a sheet insert 17; wherein, the ear canal electrode silicone 11 covers the circular insert 16, and the concha electrode silicone 12 covers the sheet insert 17; the circular insert 16 is connected to the PCB board 14, and the sheet insert 17 is connected to the PCB board 14 through the concha electrode wire 13, and the PCB board 14 is connected to the wire 3; the external sealing glue 15 is encapsulated on the outside of the concha electrode wire 13, the PCB board 14, the circular insert 16 and the sheet insert 17.

[0035] The electrode portion 1 , the ear hook portion 2 , and the wire 3 of this embodiment are described in detail below.

[0036] like Figure 1 When wearing the electrode cable, the ear canal electrode 11 contacts point A (the opening of the external auditory canal), and the concha electrode 12 contacts point B (the concha area). The part of the electrode cable that contacts the human body, that is, the part where the ear canal electrode 11 and the concha electrode 12 contact the human body, are made of conductive silicone.

[0037] In one implementation of this embodiment, the ear canal electrode silicone 11 and the concha electrode silicone 12 are made of conductive silicone. The portion of the electrode cable that contacts the human body, namely the ear canal electrode silicone 11 and the concha electrode silicone 12, is made of conductive silicone. The corresponding external sealing adhesive 15 is also made of silicone. These materials are of the same material, offering good tissue compatibility and high structural strength. The volume resistivity of the ear canal electrode silicone 11 and the concha electrode silicone 12 is preferably 30-40 Ω / cm, with a preferred Shore hardness of 60 HA. This makes them easy to mold, has stable resistance, and is comfortable to wear.

[0038] In one implementation of this embodiment, the angle between the ear canal electrode silicone 11 and the concha electrode silicone 12 is 18±2°.

[0039] In this embodiment, the concha electrode lead 13 comprises one conductive core wire, consisting of multiple strands (preferably 18 x 0.04 mm silver-plated copper-tin alloy wire + one strand of 120D aramid fiber), with a silicone sheath. The strands offer excellent bending resistance and flexibility, while the aramid fiber increases tensile strength. In this embodiment, both the silicone sheath and the external sealant 15 are made of silicone rubber, which offers excellent tissue compatibility and high bonding strength, further enhancing protection for the concha electrode lead 13.

[0040] In one implementation of this embodiment, the circular insert 16 is provided with an annular groove 161, a circular blind hole 162, a PCB slot 163, and a flange 164. The annular groove 161 on the circular insert 16 can improve the bonding strength between the rubber overmolding and the circular insert 16. Furthermore, the flange 164 can be knurled to increase the contact area and enhance bonding strength.

[0041] In one implementation of this embodiment, the sheet insert 17 is provided with a protrusion 171, a U-shaped groove 172, and a circular through-hole 173. The multiple circular through-holes 173 on the sheet insert 17 enhance the bonding strength with the encapsulating material. The protrusions 171 on either side of the rear end of the sheet insert 17 enhance the bonding strength between the sheet insert 17 and the encapsulating material and prevent the sheet insert 17 from being pulled out. The U-shaped groove 172 centers the weld point, ensuring a uniform thickness of the encapsulation on the sheet insert 17. The weld point is located within the U-shaped groove 172, reducing the impact of the encapsulating material on the weld point during encapsulation and providing UV protection for the weld point.

[0042] In this embodiment, the circular insert 16 and the sheet insert 17 are made of nickel-plated brass, preferably lead brass, with a nickel plating thickness of more than 10 microns. Lead brass has excellent machinability, and nickel plating can effectively prevent rust.

[0043] Because silicone has a high molding temperature, typically above 170°C, conventional wire sheaths like TPE and TPU, with a temperature resistance of 100°C to 120°C, cannot withstand silicone's molding temperature. Therefore, the sheath of wire 3 is made of the same silicone material as the external sealant 15 for easier molding, better compatibility, and higher structural strength. The core sheath of wire 3 is made of FEP, which can withstand temperatures exceeding 200°C and can therefore withstand the molding temperature of the external sealant 15.

[0044] In this embodiment, the conductor 3 has two core wires, each sheathed in FEP, which can withstand temperatures exceeding 200°C. The core conductor is composed of multiple strands of silver-plated copper-tin alloy wire and aramid fiber (preferably 18*0.04mm silver-plated copper-tin alloy wire + 1 strand of 120D aramid fiber). Conductor 3 consists of two core wires and five strands of 500D aramid fiber, and exhibits good roundness. The outer sheath of conductor 3 is made of silicone material, which provides good tissue compatibility with the external sealant 15 of electrode portion 1 and high bonding strength.

[0045] In one implementation of this embodiment, the external sealant 15 includes a base 151, a concha cantilever 152, and a sealant tail tube 153. The base 151 is provided with an anti-slip groove 1511 and an ear canal sealant overflow groove 1512. The concha cantilever 152 is C-shaped and has a plurality of staggered concha grooves 1521 and concha sealant overflow grooves 1522. The external sealant 15 preferably has a Shore A hardness of 80HA, which is high in hardness and can effectively protect internal electrical connections.

[0046] In one implementation of this embodiment, Figure 4 As shown, the PCB board 14 is provided with an ear canal electrode pad 141, an ear concha electrode pad 142, a winding hole 143, and a winding groove 144. There are two ear canal electrode pads 141, symmetrically distributed on both sides of the PCB; there are two ear concha electrode pads 142, symmetrically distributed on both sides of the PCB.

[0047] like Figure 5 As shown, the wire 3 is stripped to form core wire 31 and core wire 32. The core wire 31, the circular insert 16 and the ear canal electrode pad 141 are welded. A slot 163 is provided at one end of the circular insert 16 to be embedded in the PCB board 14. The positioning is accurate, and the welding strength of the ear canal electrode pad 141 and the circular insert 16 on both sides is high. The core wire 32, the concha electrode wire 13 and the concha electrode pad 142 are welded. The solder joints are protected with UV glue. Figure 6 The protrusion 171, the U-shaped groove 172, the circular through hole 173 and the sheet insert 17 are welded to the concha electrode wire 13. The concha electrode wire 13 is welded in the U-shaped groove 172 and protected with UV glue. Figure 7 As shown, the five strands of aramid fibers filled in the conductor 3 are combined to form a fiber bundle 33, which passes through the winding hole 143 and the winding groove 144 and is fixed with UV glue.

[0048] In one implementation of this embodiment, Figure 8 As shown, the ear hook portion 2 is C-shaped as a whole, and its cross-section is conical and gradually decreasing; the ear hook portion 2 includes an ear hook inner mold 21, an ear hook outer mold 22 and a clamp 23; the ear hook inner mold 21 is the same as the ear hook outer mold 22, and the size of the ear hook portion 2 from the tail to the front end of the ear hook portion 2 gradually becomes smaller and is conical.

[0049] Because silicone is a non-polar material and has poor tissue compatibility with non-silicone materials, the ear hook portion 2 requires specialized structures and processes to achieve high structural connection strength, such as the use of a clamp 23 and surface plasma treatment. The ear hook inner mold 21 is made of modified PP material capable of withstanding temperatures exceeding 150°C. The ear hook outer mold 22 can be constructed of TPE or TPU, with the mold temperature kept below 60°C to minimize any adverse effects on the inner mold PP material. The PP molding mold temperature is kept below 80°C to minimize any adverse effects on the outer and core sheaths of the wire 3.

[0050] The ear hook inner mold 21 is provided with a host connection slot 211, a plurality of staggered inner mold grooves 212 and an inner mold boss 213. The ear hook inner mold 21 is provided with a host connection slot 211 at the tail of the ear hook. The inner mold PP material has high hardness and high connection strength with the ear vagus device host. Figure 9 As shown, the earhook inner mold 21 is provided with a plurality of staggered inner mold grooves 212 and inner mold protrusions 213. The inner mold grooves 212 are semicircular, and the inner mold protrusions 213 are raised above the surface of the earhook inner mold 21. The inner mold grooves 212 firstly limit the position of the wire 3 during the inner mold injection molding to prevent it from shifting. Secondly, they improve the contact surface between the earhook inner mold 21 and the earhook outer mold 22, combining the concave and convex surfaces to enhance the bonding strength between the earhook inner mold 21 and the earhook outer mold 22. Thirdly, they enhance the toughness of the earhook inner mold 21. The inner mold protrusions 213 and the earhook outer mold 22 form a concave and convex structure, enhancing the bonding strength between the earhook inner mold 21 and the earhook outer mold 22.

[0051] In one implementation of this embodiment, the front end of the ear hook outer mold 22 is provided with an outer mold tail tube 223, which is provided with staggered tail tube grooves. The SR outer mold tail tube 223 provided at the front end of the ear hook outer mold 22 can position the wire 3 and improve the bending resistance of the wire 3 at the ear hook end.

[0052] In one implementation of this embodiment, the length of the earhook inner mold 21 is no less than 90% of the length of the earhook outer mold 22. That is, in this embodiment, the length of the earhook inner mold 21 reaches at least 90% of the length of the earhook outer mold 22. This not only strengthens the structural strength of the earhook, but also effectively improves the positioning, protection, and retention of the wire 3.

[0053] In this embodiment, the outer sheath of the wire 3 is made of silicone. Silicone is a non-polar surface material and has poor adhesion to other materials such as PP, TPU, TPE, etc. The ear hook portion 2 is used to wear the main body of the ear vagus device and requires a certain degree of rigidity to provide support. Therefore, it is necessary to select an inner mold material with a higher hardness to provide support. At the same time, in order to improve wearing comfort and to prevent the ear hook portion 2 from being slightly bent and deformed during use, the ear hook inner mold 21 needs to have a certain toughness and not be easily broken. Through screening, in one implementation of this embodiment, the ear hook inner mold 21 is made of polypropylene PP material, and the Rockwell hardness is preferably 110-120HR. The high hardness can provide good structural support for the wire 3. The optional material of the ear hook outer mold 22 is TPE or TPU material, and the Shore hardness is preferably 65-75HA. It has a soft touch, is comfortable to wear, has good biocompatibility, and is suitable for long-term contact with the human body environment.

[0054] In one implementation of this embodiment, the clamp 23 is made of metal, such as aluminum alloy or copper alloy. The clamp 23 is mounted on the wire 3 extending into the ear hook 2 , with one clamp 23 located at the protruding end of the wire 3 and the remaining clamps 23 located within the ear hook inner mold 21 .

[0055] Since the silicone sheath of the wire 3 is a non-polar material and lacks adhesion to PP, at least one metal clamp 23 is installed on the wire 3 to improve its tensile strength and prevent it from falling out of the earhook inner mold 21. This clamp 23 holds the wire 3 in place through deformation of itself and the sheath. One clamp 23 is located at the wire 3 lead-out end of the earhook, as shown. Other clamps 23 can be installed at various locations within the earhook inner mold 21 as needed. When tension is applied to the wire 3, the clamp 23 holds it in place.

[0056] In addition, the present invention provides a method for preparing an ear electrode cable for an ear vagus nerve stimulator. Considering cost control, the ear hook portion 2 is prepared first, and then the electrode portion 1 is prepared. Specifically, the method for preparing an ear electrode cable for an ear vagus nerve stimulator includes:

[0057] 1) Fixing one end of the wire 3, forming the ear hook portion 2 by injection molding, and fixing the wire 3 to the ear hook portion 2;

[0058] 2) Splitting the other end of the wire 3 into a first wire core and a second wire core, soldering the first wire core and the circular insert 16 of the electrode portion 1 to the PCB 14, soldering the sheet insert 17 of the electrode portion 1 to the concha electrode wire 13, then soldering the second wire core and the concha electrode wire 13 to the PCB 14, and fixing the wire 3 to the PCB 14;

[0059] 3) The five strands of aramid fiber filled in the conductor 3 are combined to form a fiber bundle 33. The fiber bundle 33 in the conductor 3 passes through the winding hole 143 and the winding groove 144 on the PCB board 14 and is fixed to the PCB board 14;

[0060] 4) placing the concha electrode wire 13, the PCB board 14, the circular insert 16, and the sheet insert 17 in a sealing mold, and sealing them with liquid silicone to form an external sealing mold 15, with the circular insert 16 and the sheet insert 17 exposed;

[0061] 5) The external sealing glue 15, the circular insert 16 and the sheet insert 17 are placed in an electrode mold, and the circular insert 16 and the sheet insert 17 are covered with solid silicone to form the ear canal electrode silicone 11 and the concha electrode silicone 12 of the electrode part 1.

[0062] In this embodiment, the core wire of the wire 3 is sheathed with FEP material, the sheath of the wire 3, the sheath of the concha electrode wire 13, and the external sealing glue 15 are made of silicone material; the ear hook inner mold 21 is made of polypropylene PP material, and the ear hook outer mold 22 is made of TPE material or TPU material; the ear canal electrode silicone 11 and the concha electrode silicone 12 are made of conductive silicone material; the circular insert 16 and the sheet insert 17 are made of nickel-plated brass.

[0063] The encapsulation process between the ear hook portion 2, the electrode portion 1 and the wire 3 includes:

[0064] a. The polypropylene PP material is combined with a retaining clamp to coat the wire 3 with a silicone sheath;

[0065] b. The ear hook portion 2 is made of a TPE or TPU material coated with a polypropylene PP material within the ear hook mold 21;

[0066] c. Using liquid silicone to coat the silicone outer sheath of the concha electrode wire 14, the silicone outer sheath of the wire 3, the PCB board 14, the circular insert 16, and the sheet insert 17 to form the external sealant 15, and leaving the circular insert 16 and the sheet insert 17 exposed;

[0067] d. Use solid silicone to coat the circular insert 16 and the exposed portion of the sheet insert 17 to form the ear canal electrode silicone 11 and the concha electrode silicone 12.

[0068] In this embodiment, the ear hook portion 2 is processed as follows: alcohol cleaning and plasma treatment of the encapsulated area can improve the bonding strength between different materials in the encapsulated area:

[0069] Cut the wire 3 → strip both ends → fix the wire 3 with the clamp 23 at the ear hook part 2 → clean and dry the rubberized part with alcohol → plasma treat the rubberized part → injection mold the ear hook inner mold 21 → plasma treat the surface → injection mold the ear hook outer mold 22.

[0070] Specifically, in this embodiment, one end of the fixed wire is injection molded to form an ear hook portion, and the wire is fixed to the ear hook portion, which includes:

[0071] 11) Cutting the wire 3 and stripping both ends;

[0072] 12) Fix the ear hook portion of the wire 3 with the clamp 23;

[0073] 13) Cleaning the coated portion of the wire 3 with alcohol, drying it, and plasma treating it;

[0074] 14) placing the coated portion of the wire 3 in an ear hook inner mold for ear hook inner mold injection molding to form an ear hook inner mold 21;

[0075] 15) Plasma treatment is performed on the surface of the ear hook inner mold 21 formed by injection molding;

[0076] 16) The ear hook inner mold 21 is placed in an ear hook outer mold for ear hook outer mold injection molding to form an ear hook outer mold 22.

[0077] After the ear hook portion 2 at one end of the wire 3 is prepared, the electrode portion 1 is prepared. The steps for preparing the electrode portion 1 are as follows:

[0078] Wire 3 is stripped at both ends → the sheet insert 17 is welded to the concha electrode wire 13 → the concha electrode wire 13 is welded to the PCB board 14 → the circular insert 16 is welded to the PCB board 14 → the wire 3 is stripped and welded to the PCB board 14 → the fiber bundle 33 is passed through the winding hole 143 and the winding groove 144 → the fiber bundle and solder joints are protected with UV glue → cleaned → encapsulated with liquid silicone to make the external sealing glue 15 → encapsulated with solid silicone to make the ear canal electrode silicone 11 and the concha electrode silicone 12.

[0079] Specifically, if Figure 5 As shown, the wire 3 is stripped to form core wire 31 and core wire 32. Core wire 31 and circular insert 16 are welded to ear canal electrode pad 141. A circular blind hole 162 is provided inside circular insert 16 for easy positioning. A slot 163 is provided at one end to allow for accurate positioning, and the ear canal electrode pad 141 and circular insert 16 on both sides are welded with high strength. An annular groove 161 is provided on the circular insert 16 to improve the bonding strength between the rubber coating and the insert. Furthermore, knurling can be performed on the flange 164 to increase the contact area and enhance bonding strength. Core wire 32 and concha electrode wire 13 are welded to concha electrode pad 142. The solder joints are protected with UV glue.

[0080] like Figure 6 The sheet insert 17 is welded to the concha electrode wire 13 through a protrusion 171, a U-shaped groove 172, and a circular through hole 173. The sheet insert 17 is provided with a plurality of circular through holes 173 to improve the bonding strength with the rubber coating material. The sheet insert 17 has protrusions 171 on both sides of the tail, which can improve the bonding strength between the insert and the rubber coating and prevent the insert from being pulled out. A U-shaped groove 172 is provided at the tail of the sheet insert 17, and the concha electrode wire 13 is welded in the U-shaped groove 172 and protected with UV glue. The U-shaped groove 172 can center the weld point, ensuring that the thickness of the rubber coating of the sheet insert 17 is uniform. The weld point is located in the U-shaped groove 172, which can reduce the impact of the rubber material on the weld point during the rubber coating, and the weld point is protected with UV glue.

[0081] like Figure 7As shown, the five strands of aramid fibers filled in the conductor 3 are combined to form a fiber bundle 33, which passes through the winding hole 143 and the winding groove 144 and is fixed with UV glue.

[0082] The surface of the electrode part 1 welded together is cleaned to remove the soldering agent, UV adhesive, etc. to improve the adhesion between the part and the silicone. Then it is placed in a mold and sealed with liquid silicone to form an external sealant 15. Figure 10 The sheet-shaped insert 17 and the circular insert 16 are exposed. The external sealant 15 is composed of three parts: a base 151, a concha cantilever 152, and a tail tube 153. The concha cantilever 152 is provided with several staggered concha grooves 1521 and a concha glue overflow groove 1522. The concha grooves 1521 not only position the internal concha electrode wires 13 but also enhance the bending performance of the concha cantilever 152. The concha glue overflow groove 1522 prevents the adhesive from overflowing during the subsequent conductive silicone encapsulation, which could affect the appearance. The base 151 is provided with anti-slip grooves 1511 and an ear canal glue overflow groove 1512. The anti-slip grooves 1511 facilitate electrode insertion, while the ear canal glue overflow groove 1512 prevents the adhesive from overflowing during the subsequent conductive silicone encapsulation, which could affect the appearance. The tail tube 153 can limit the position of the wires 3 and improve the bending strength of the junction between the two, thereby increasing the service life of the cable. Preferably, the tail tube 153 is provided with staggered grooves.

[0083] like Figure 2 As shown, the aforementioned components—base 151, circular insert 16, and sheet insert 17—are placed in a mold. Solid silicone is then applied to the circular insert 16 and sheet insert 17 to form the ear canal electrode silicone 11 and the concha electrode silicone 12. The angle between the ear canal electrode silicone 11 and the concha electrode silicone 12 is also 18±2°. The concha cantilever 152 is C-shaped. When the electrode is worn, the concha electrode 12 is displaced backward by force. The C-shaped structure of the concha cantilever 152 provides good force feedback through its own deformation, ensuring the proper fit of the concha electrode 12 against the concha. Ergonomics confirms that an angle of 18±2° between the ear canal electrode silicone 11 and the concha electrode silicone 12 provides optimal wearing comfort and electrode fit. The concha electrode silicone 11 is conical in shape and hollow inside, facilitating deformation to accommodate ear canals of varying sizes. The contact surface between the concha electrode silicone 12 and the concha is an arc surface, preferably 15±2mm in length and 7.5±1mm in width, which has a large contact area with the concha and improves the electrode fit. Figure 3 The minimum distance between the sheet insert 17 and the outer surface of the conductive silicone is 1 mm, and the electrode surface is soft, ensuring wearing comfort.

[0084] In summary, the ear electrode cable for the vagus nerve stimulator provided in the embodiments of the present application has the advantages of reliable connection, high strength, high adaptability, and comfortable wearing. Therefore, the present application effectively overcomes the various shortcomings of the prior art and has high industrial application value.

[0085] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. An ear electrode cable for an ear vagus nerve stimulator, characterized in that: include: An electrode portion, an ear hook portion, and a wire connecting the electrode portion and the ear hook portion; The electrode portion includes an ear canal electrode silicone, a concha electrode silicone, a concha electrode wire, a PCB board, an external sealing glue, a circular insert, and a sheet insert; wherein the ear canal electrode silicone covers the circular insert, and the concha electrode silicone covers the sheet insert; the circular insert is connected to the PCB board, the sheet insert is connected to the PCB board via the concha electrode wire, and the PCB board is connected to the wire; the external sealing glue is encapsulated on the outside of the concha electrode wire, the PCB board, the circular insert, and the sheet insert; The core wire of the wire is sheathed with FEP material, the outer sheath of the wire, the outer sheath of the concha electrode wire, and the external sealing glue are made of silicone material; the inner mold of the ear hook is made of polypropylene PP material, and the outer mold of the ear hook is made of TPE material or TPU material; the ear canal electrode silicone and the concha electrode silicone are made of conductive silicone material.

2. The ear electrode cable of the ear vagus nerve stimulator according to claim 1, characterized in that: The angle between the ear canal electrode silicone and the concha electrode silicone is 18±2°.

3. The ear electrode cable of the ear vagus nerve stimulator according to claim 1, characterized in that: The circular insert is provided with an annular groove, a circular blind hole, a PCB card slot and a flange; the sheet insert is provided with a protrusion, a U-shaped groove and a circular through hole.

4. The ear electrode cable of the ear vagus nerve stimulator according to claim 1, characterized in that: The external sealant includes a base, an auricle cantilever and a tail tube; wherein, the base is provided with an anti-slip groove and an ear canal glue overflow groove, and the auricle cantilever is C-shaped and provided with a plurality of staggered grooves and auricle glue overflow grooves.

5. The ear electrode cable of the ear vagus nerve stimulator according to claim 1, characterized in that: The PCB board is provided with an ear canal electrode pad, a concha electrode pad, a winding hole and a winding groove.

6. The ear electrode cable for the ear vagus nerve stimulator according to claim 1, characterized in that: The ear hook portion is C-shaped as a whole, with a conical cross-section that gradually decreases; the ear hook portion includes an ear hook inner mold, an ear hook outer mold and a clamp; wherein, the ear hook inner mold is provided with a host connection slot, a plurality of staggered inner mold grooves and an inner mold boss; the front end of the ear hook outer mold is provided with an outer mold tail pipe.

7. The ear electrode cable for the ear vagus nerve stimulator according to claim 6, characterized in that: The length of the ear hook inner mold is not less than 90% of the length of the ear hook outer mold.

8. The ear electrode cable for the ear vagus nerve stimulator according to claim 6, characterized in that: The clamp is arranged on the wire extending into the ear hook part, wherein one clamp is located at the protruding end of the wire and the other clamps are located inside the inner mold of the ear hook.

9. A method for preparing an ear electrode cable for an ear vagus nerve stimulator, characterized in that: include: Fix one end of the wire, form an ear hook portion by injection molding, and fix the wire to the ear hook portion; Split the other end of the wire into a first wire core and a second wire core, solder the first wire core and the circular insert of the electrode portion to the PCB, solder the sheet-shaped insert of the electrode portion to the concha electrode wire, then solder the second wire core and the concha electrode wire to the PCB, and secure the wire to the PCB. The fiber bundle in the conductor passes through the winding hole and winding groove on the PCB board and is fixed to the PCB board; Placing the concha electrode wire, the PCB board, the circular insert, and the sheet insert in a sealing mold, and sealing with liquid silicone to form an external sealant, with the circular insert and the sheet insert exposed; The external sealing glue, the circular insert and the sheet insert are placed in an electrode mold, and the circular insert and the sheet insert are covered with solid silicone to form the ear canal electrode silicone and the concha electrode silicone of the electrode part.

10. The method for preparing the ear electrode cable of the ear vagus nerve stimulator according to claim 9, characterized in that: One end of the fixed wire is injection molded to form an ear hook portion, and the wire is fixed to the ear hook portion, which includes: Cut the wire and strip both ends of the wire; Fixing the ear hook portion of the wire with a clamp; Cleaning, drying and plasma treating the coated portion of the wire with alcohol; Placing the coated portion of the wire in an ear hook inner mold for ear hook inner mold injection molding to form an ear hook inner mold; Plasma treatment is performed on the surface of the ear hook inner mold formed by injection molding; The ear hook inner mold is placed in an ear hook outer mold and the ear hook outer mold is injection-molded to form the ear hook outer mold.

11. The method for preparing the ear electrode cable of the ear vagus nerve stimulator according to claim 9 or 10, characterized in that: The outer sheath of the core wire of the wire is FEP material, the outer sheath of the wire, the outer sheath of the concha electrode wire, and the external sealing glue are made of silicone material; the inner mold of the ear hook is polypropylene (PP) material, and the outer mold of the ear hook is TPE material or TPU material; the ear canal electrode silicone and the concha electrode silicone are made of conductive silicone material; The circular insert and the sheet insert are made of nickel-plated brass; The encapsulation process between the ear hook portion, the electrode portion, and the wire includes: The polypropylene (PP) material is combined with a retaining clamp to wrap the silicone outer sheath of the wire; The ear hook part is made of polypropylene (PP) material coated with TPE or TPU material on the inner mold of the ear hook; The external sealant is formed by coating the silicone outer sheath of the concha electrode wire, the silicone outer sheath of the wire, the PCB board, the circular insert, and the sheet insert with liquid silicone, and the circular insert and the sheet insert are exposed. Solid silica gel is used to coat the circular insert and the exposed portion of the sheet insert to produce ear canal electrode silica gel and concha electrode silica gel.

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