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 comprises an electrode part, an ear hook part and a wire for connecting the electrode part and the ear hook part; the ear canal electrode comprises a round electrode and a round electrode holder, and the round electrode comprises ear canal conductive silica gel and a round insert; the auricular concha electrode comprises a flat electrode and a flat electrode holder, and the flat electrode comprises auricular concha conductive silica gel and a sheet-shaped insert; the ear canal conductive silica gel wraps the circular insert, and the auricular concha conductive silica gel wraps the sheet insert; the circular insert is connected with the PCB, the sheet-shaped insert is connected with the PCB through an auricular concha electrode wire, and the PCB is connected with a wire; the circular electrode holder wraps the PCB, the flat electrode holder wraps the joint of the auricular concha electrode wire and the sheet-shaped insert, and the external sealant is packaged outside the auricular concha electrode wire, the circular electrode holder and the flat electrode holder. 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 an ear canal electrode, a concha electrode, a concha electrode wire, a PCB board, and an external sealing glue; wherein, the ear canal electrode comprises a circular electrode and a circular electrode seat, and the circular electrode comprises an ear canal conductive silicone and a circular insert; the concha electrode comprises a flat electrode and a flat electrode seat, and the flat electrode comprises a concha conductive silicone and a sheet insert; the ear canal conductive silicone covers the circular insert, and the concha conductive silicone covers the sheet insert; the circular insert is connected to the PCB board, and the sheet insert is connected to the concha electrode wire through the concha electrode wire. The PCB board is connected, and the PCB board is connected to the wire; the circular electrode seat is covered on the outside of the PCB board, and the flat electrode seat is covered on the connection between the concha electrode wire and the sheet insert, and the external sealing glue is encapsulated on the outside of the concha electrode wire, the circular electrode seat and the flat electrode seat; 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 TPE material or TPU material; the inner mold of the ear hook is PVC material, and the outer mold of the ear hook is TPE material or TPU material; the circular electrode seat and the flat electrode seat are made of PVC material; the ear canal electrode and the concha electrode are made of conductive silicone material.

[0008] In an implementation of the first aspect, the angle between the ear canal conductive silicone and the concha conductive 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 pipe; wherein, the base is provided with an anti-slip groove, and the auricle cantilever is C-shaped and provided with a plurality of staggered 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 TPE material or TPU material; the inner mold of the ear hook is made of PVC material, and the outer mold of the ear hook is made of TPE material or TPU material; the circular electrode seat and the flat electrode seat are made of PVC material; the ear canal electrode and the concha electrode 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; covering the ear canal conductive silicone with a circular insert to form a circular electrode, and covering the concha conductive silicone with a sheet insert to form a flat electrode; dividing the other end of the wire into a first wire core and a second wire core, welding the first wire core and the circular insert to a PCB board respectively, welding the sheet insert to the concha electrode wire, and then welding the second wire core and the concha electrode wire to the PCB board respectively, and fixing the wire to the PCB board; the fiber bundle in the wire passes through the winding hole and winding groove on the PCB board and is fixed to the PCB board; placing the PCB board and the concha electrode wire in an electrode seat mold, injection molding to form a circular electrode seat and a flat electrode seat; placing the concha electrode wire, the circular electrode seat, and the flat electrode seat in a sealing mold, and sealing them with TPU or TPE material to form an external sealing.

[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 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 TPE material or TPU material; the inner mold of the ear hook is PVC material, and the outer mold of the ear hook is TPE material or TPU material; the circular electrode seat and the flat electrode seat are PVC material; the ear canal electrode and the concha electrode are conductive silicone material; the circular insert and the sheet insert are brass nickel-plated material; the encapsulation process between the ear hook part, the electrode part and the wire includes: using PV The TPE or TPU outer sheath of the wire is wrapped with C material in combination with a retaining clamp; the ear hook part is made of the PVC material of the ear hook inner mold using TPE or TPU material; the circular insert and the sheet insert are wrapped with solid conductive silicone to form a circular electrode and a flat electrode; the outer sheath of the concha electrode wire, the PCB board, the circular electrode and the flat electrode are wrapped with PVC material to form a circular electrode seat and a flat electrode seat; the outer sheath of the concha electrode wire, the outer sheath of the wire, the PCB board, the circular electrode seat and the flat electrode seat are wrapped with TPE or TPU material to form an external sealing glue to complete the preparation of the electrode part.

[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 4A and 4B Shown is a schematic diagram of the structure of a circular electrode in an ear electrode cable of an ear vagus nerve stimulator according to an embodiment of the present application.

[0024] Figure 5A and 5B Shown is a schematic structural diagram of a flat electrode 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 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.

[0026] Figure 7Shown 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.

[0027] Figure 8 Shown is a schematic diagram of the connection between the round electrode seat, the flat electrode seat and the PCB board in the ear electrode cable of the ear vagus nerve stimulator according to one embodiment of the present application.

[0028] Figure 9 Shown is a schematic diagram of the appearance of the electrode portion of an 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 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.

[0030] Figure 11 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.

[0031] Figure 12 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

[0032] 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.

[0033] See also Figures 1 to 12 . 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.

[0034] 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.

[0035] 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 2 As 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.

[0036] Among them, in this embodiment, if Figure 3 As shown, the electrode portion 1 includes an ear canal electrode 11, an ear concha electrode 12, an ear concha electrode wire 13, a PCB board 14 and an external sealing glue 15; wherein, the ear canal electrode 11 includes a circular electrode 111 and a circular electrode seat 112, and the circular electrode 111 includes an ear canal conductive silicone 1111 and a circular insert 1112; the ear concha electrode 12 includes a flat electrode 121 and a flat electrode seat 122, and the flat electrode 121 includes an ear concha conductive silicone 1211 and a sheet insert 1212; the ear canal conductive silicone 1111 covers the circular insert 1112, and the ear concha conductive silicone 1211 covers the sheet insert 12 12; the circular insert 1112 is connected to the PCB board 14 (welding is used to achieve electrical connection), the sheet insert 1212 is connected to the PCB board 14 through the concha electrode wire 13 (welding is used to achieve electrical connection), and the PCB board 14 is connected to the wire to achieve electrical connection; the circular electrode seat 112 is covered on the outside of the PCB board 14, the flat electrode seat 122 is covered on the connection between the concha electrode wire 13 and the sheet insert 1212, and the external sealing glue 15 is encapsulated on the outside of the concha electrode wire 13, the circular electrode seat 112 and the flat electrode seat 122.

[0037] The following combination Figures 2 to 11 The electrode portion 1, the ear hook portion 2, and the wire 3 of this embodiment are described in detail.

[0038] like Figure 1 As shown, when the electrode cable is worn, 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).

[0039] In one implementation of this embodiment, the ear canal conductive silicone rubber 1111 and the concha conductive silicone rubber 1211 are made of conductive silicone. The portion of the electrode cable that contacts the human body, namely, the portion of the ear canal electrode 11 and the concha electrode 12 that contacts the human body, is made of conductive silicone. The volume resistivity of the ear canal conductive silicone rubber 1111 and the concha conductive silicone rubber 1211 is preferably 30-40 Ω / cm, and the Shore hardness is preferably 60HA. This material is easy to mold, has stable resistance, and is comfortable to wear. However, since the molding temperature of silicone rubber is relatively high, generally above 170°C, the outer sheath material of the wire 3 is TPE or TPU, which has a temperature resistance of 100°C to 120°C and cannot withstand the molding temperature of silicone rubber. Therefore, in this embodiment, the ear canal electrode 11 and the concha electrode 12 are first molded using conductive silicone rubber, and the other parts are subsequently encapsulated using materials such as TPE and TPU.

[0040] In one implementation of this embodiment, the angle between the ear canal conductive silicone 1111 and the concha conductive silicone 1211 is 18±2°.

[0041] In this embodiment, the concha electrode lead 13 has one conductive core, consisting of multiple strands (preferably 18 x 0.04 mm silver-plated copper-tin copper alloy wire + one strand of 120D aramid fiber), and is sheathed in TPU or TPE. The strands offer excellent bending resistance and flexibility, while the aramid fiber increases tensile strength. The sheath of the lead 3 is made of the same material as the external sealant 15, providing excellent tissue compatibility and high bonding strength, further enhancing protection for the concha electrode lead 13.

[0042] In one implementation of this embodiment, Figure 4A and Figure 4B As shown, the circular insert 1112 is provided with an annular groove 11121, a circular blind hole 11122, a PCB slot 11123, and a flange 11124. The annular groove 11121 on the circular insert 1112 can improve the bonding strength between the rubber laminating and the circular insert 1112. The flange 11124 can further be knurled to increase the contact area and improve bonding strength.

[0043] In one implementation of this embodiment, Figure 5A and Figure 5BAs shown, the sheet insert 1212 is provided with a protrusion 12121, a U-shaped groove 12122, and a circular through-hole 12123. The multiple circular through-holes 12123 on the sheet insert 1212 enhance the bonding strength with the encapsulation material. The protrusions 12121 on both sides of the tail of the sheet insert 1212 enhance the bonding strength between the sheet insert 1212 and the encapsulation material and prevent the sheet insert 1212 from being pulled out. The U-shaped groove 12122 centers the weld point, ensuring a uniform thickness of the encapsulation material on the sheet insert 1212. The weld point is located within the U-shaped groove 12122, reducing the impact of the encapsulation material on the weld point and providing UV protection for the weld point.

[0044] In this embodiment, the circular insert 1112 and the sheet insert 1212 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.

[0045] In this embodiment, the number of core wires in the conductor 3 is 2, and the core wires are sheathed with FEP material, and FEP can withstand temperatures above 200°C. The core wire conductor is twisted from 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). The conductor 3 consists of 2 strands of core wire and 5 strands of 500D aramid fiber, and the conductor 3 has good roundness. Multiple strands of wire have good bending resistance and are soft in state, and the aramid fiber increases the tensile strength. Specifically, the outer sheath of the conductor 3 is made of TPU or TPE, and the outer sheath of the wire is made of the same material as the external sealing glue 15, has good tissue compatibility with the external sealing glue 15 of the electrode part 1, and has high bonding strength. The protection of the concha electrode conductor 13 can be further improved.

[0046] Since silicone is a non-polar material and has poor tissue compatibility with non-silicone materials, the ear canal electrode 11 is structurally connected to the external sealing glue 15 through the circular electrode seat 112, and the concha electrode 12 is structurally connected to the external sealing glue 15 through the flat electrode seat 122. The circular electrode seat 112 and the flat electrode seat 122 are made of PVC material, 25P, Shore hardness 98HA, and the PVC molding mold temperature is below 60°C, which will not have an adverse effect on the outer sheath and core wire outer sheath materials of the wire 3.

[0047] In one implementation of this embodiment, Figure 6 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.

[0048] like Figure 7As shown, the wire 3 is stripped to form core wire 31 and core wire 32. The core wire 31 and the circular insert 1112 are welded to the ear canal electrode pad 141. A PCB slot 11123 is provided at one end of the circular insert 1112 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 1112 on both sides is high. The core wire 32 and the concha electrode wire 13 are welded to the concha electrode pad 142. The solder joints are protected with UV glue. Figure 7 The protrusion 12121, the U-shaped groove 12122, the circular through hole 12123 and the sheet insert 1212 are welded to the concha electrode wire 13. The concha electrode wire 13 is welded in the U-shaped groove 12122 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.

[0049] like Figure 8 As shown, the flat electrode base 122 encases the welds between the sheet insert 1212 and the concha electrode wire 13. To enhance the bonding strength of the subsequent encapsulation, multiple annular grooves 1221 are provided in the encapsulated area of ​​the flat electrode base 122. The circular electrode base 112 encases the circular insert 111211, the concha electrode wire 13, the core wire 31, the core wire 32, the PCB 14, and the fiber bundle 33.

[0050] like Figure 9 As shown, 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 the concha cantilever 152 is C-shaped and has a plurality of staggered concha grooves 1521. The external sealant 15 preferably has a Shore A hardness of 80HA, which is high and can effectively protect internal electrical connections.

[0051] In this embodiment, external sealant 15 can be made of TPE or TPU. PVC can withstand temperatures up to 80°C, so the TPE or TPU molding mold temperature is controlled below 60°C to prevent adverse effects on the PVC. TPU or TPE has good tissue compatibility with PVC and provides high bonding strength. External sealant 15 preferably uses TPU or TPE with a Shore hardness of 80HA. This high hardness effectively protects internal electrical connections.

[0052] In one implementation of this embodiment, Figure 10 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.

[0053] 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 PVC material has high hardness and high connection strength with the ear vagus device host. Figure 11 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.

[0054] 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.

[0055] In one implementation of this embodiment, the length of the ear hook inner mold 21 is not less than 90% of the length of the ear hook outer mold 22. That is, in this embodiment, the length of the ear hook inner mold 21 reaches more than 90% of the length of the ear hook outer mold 22. First, it can strengthen the structural strength of the ear hook, and second, it can effectively improve the positioning, protection and retention strength of the wire 3. A clamp 23 is provided on the wire 3 at the tail end of the ear hook portion 2. When the wire 3 is subjected to tension, the clamp 23 can pull the wire 3, thereby increasing the tensile strength of the outer sheath of the wire 3 and preventing the wire 3 from escaping from the ear hook inner mold 21. Accordingly, the clamp 23 can be added to further enhance the tensile strength. Multiple clamps 23 can be provided at different positions in the ear hook inner mold 21 as needed. The clamp 23 is retained by itself and the outer sheath of the wire 3 through deformation. The ear hook part 2 is used to wear the main body of the ear vagus device, and requires a certain rigidity to provide support. Therefore, it is necessary to select an inner mold material with higher hardness to provide support. At the same time, in order to improve wearing comfort and the ear hook part 2 often encounters slight bending and deformation during use, the ear hook inner mold 21 needs to have a certain toughness and not be easy to break. Through screening, PVC material, 25P, Shore hardness 98HA is preferred to meet the above requirements. The outer sheath of the wire 3 is TPU or TPE material, which has good tissue compatibility with PVC material and strong adhesion. Together with the clamp 23, it can effectively hold the wire 3 and prevent it from moving. The ear hook outer mold 22 is preferably TPU or TPE material, which has good tissue compatibility with the ear hook inner mold PVC material and a Shore hardness of 65 to 75HA. It has a soft touch and is comfortable to wear. It has good biocompatibility and is suitable for long-term contact with the human body environment.

[0056] In addition, the embodiment of the present application provides a method for preparing an ear electrode cable of an ear vagus nerve stimulator. Considering cost control, the ear hook part 2 is prepared first, and then the electrode part 1 is prepared. Specifically, Figure 12 As shown, the method for preparing the ear electrode cable of the 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) The circular insert 1112 covers the conductive silicone rubber 1111 of the ear canal to form a circular electrode 111, and the sheet insert 1212 covers the conductive silicone rubber 1211 of the concha to form a flat electrode 121;

[0059] 3) Splitting the other end of the wire 3 into a first wire core 31 and a second wire core 32, soldering the first wire core 31 and the circular insert 1112 to the PCB 14, soldering the sheet insert 1212 to the concha electrode wire 13, then soldering the second wire core 32 and the concha electrode wire 13 to the PCB 14, and fixing the wire 3 to the PCB 14;

[0060] 4) 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;

[0061] 5) placing the PCB board 14 and the concha electrode wire 13 in an electrode base mold, and injection molding to form a round electrode base 112 and a flat electrode base 122;

[0062] 6) The concha electrode wire 13, the round electrode seat 112 and the flat electrode seat 122 are placed in a sealing mold, and sealed with TPE or TPU material to form an external sealing mold 15.

[0063] In this embodiment, the outer sheath of the core wire of the wire 3 is FEP material, the outer sheath of the wire 3, the outer sheath of the concha electrode wire 13, and the external sealing glue 15 are TPE material or TPU material; the ear hook inner mold 21 is PVC material, and the ear hook outer mold 22 is TPE material or TPU material; the circular electrode seat 112 and the flat electrode seat 122 are PVC material; the ear canal electrode 11 and the concha electrode 12 are conductive silicone material; the circular insert 1112 and the sheet insert 1212 are brass nickel-plated material;

[0064] The encapsulation process between the ear hook portion 2, the electrode portion 1 and the wire 3 includes:

[0065] a. Use PVC material with a retaining clamp to wrap the TPE or TPU outer cover of the three wires;

[0066] b using TPE or TPU material coated ear hook inner mold 21 of PVC material made of ear hook portion 2;

[0067] c. The circular electrode 111 and the flat electrode 121 are formed by coating the circular insert 1112 and the sheet insert 1212 with solid conductive silicone;

[0068] d. The outer part of the concha electrode wire 13 is coated with PVC material, the PCB board 14, the circular electrode 111 and the flat electrode 121 are made into a circular electrode holder 112 and a flat electrode holder 122;

[0069] e. Use TPE or TPU material to wrap the outer sheath of the concha electrode wire 13, the outer sheath of the wire 3, the PCB board 14, the round electrode seat 112 and the flat electrode seat 122 to make an external sealing glue 15 to complete the preparation of the electrode part 1.

[0070] 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:

[0071] 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 → treat the ear hook inner mold 21 for injection molding → plasma treat the surface → inject molding the ear hook outer mold 22.

[0072] 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:

[0073] 11) Cutting the wire 3 and stripping both ends;

[0074] 12) Fix the ear hook portion of the wire 3 with the clamp 23;

[0075] 13) Cleaning the coated portion of the wire 3 with alcohol, drying it, and plasma treating it;

[0076] 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;

[0077] 15) Plasma treatment is performed on the surface of the ear hook inner mold 21 formed by injection molding;

[0078] 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.

[0079] After the ear hook portion 2 at one end of the wire 3 is prepared, the electrode portion 1 is prepared. The following describes the process of preparing the electrode portion 1.

[0080] like Figure 4A and 4B As shown, a circular insert 111211 is first coated with conductive silicone rubber 1111 to form a circular electrode 111. Circular insert 111211 is provided with an annular groove 11121 to improve the bonding strength between the rubber coating and the insert. Furthermore, a knurling pattern can be applied to the flange 11124 to increase the contact area and enhance bonding strength. Circular blind holes 11122 are provided within circular insert 1112 to facilitate positioning of the electrode sealant. A PCB slot 11123 is provided at the rear of circular insert 1112 for soldering and positioning with PCB 14.

[0081] like Figure 5A and 5B As shown, the sheet insert 1212 is coated with conductive silicone rubber 1211 to form a flat electrode 121. There are protrusions 12121 on both sides of the tail of the sheet insert 1212, 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 12122 is provided at the tail of the sheet insert 1212. The U-shaped groove 12122 can center the solder joint, ensure the uniform thickness of the rubber coating of the sheet insert 1212, and reduce the impact of the rubber on the solder joint during the rubber coating. A plurality of circular through holes 12123 are provided on the sheet insert 1212, through which the conductive silicone rubber 1211 can pass through the sheet insert 1212, thereby improving the bonding strength between the conductive silicone rubber and the sheet insert 1212.

[0082] Specifically, if Figure 7 As shown, the wire 3 is stripped to form the core wire 31 and the core wire 32. The circular insert 111211 of the circular electrode 111 and the core wire 31 are then welded to the ear canal electrode pad 141. The circular insert 111211 is provided with a PCB slot 11123 that can be embedded in the PCB, and the positioning is accurate. The welding strength between the ear canal electrode 11 pad and the circular insert 1112 on both sides of the PCB 14 is high. The sheet insert 1212 of the flat electrode 121 is welded to the concha electrode wire 13, and the core wire 32 and the concha electrode wire 13 are welded to the concha electrode pad 142. The concha electrode wire 13 is welded in the U-shaped groove 12122 and protected with UV glue. The five strands of 250D aramid fiber filled in the wire 3 are combined into a fiber bundle 33, passed through the winding hole 143 and the winding groove 144, and fixed with UV glue. All welding points are protected with UV glue.

[0083] like Figure 10As shown, the surfaces of the electrode components welded together are cleaned to remove solder additives, UV adhesives, etc., to improve the bonding strength between the components and the external sealant 15. They are then placed in a mold and injection molded with PVC material into a circular electrode holder 112 and a flat electrode holder 122. The flat electrode holder 122 wraps around the welds between the sheet insert 1212 and the concha electrode wire 13. To improve the bonding strength of the subsequent encapsulation, a plurality of annular grooves 1221 are provided on the flat electrode holder 122 where the encapsulation will occur. The circular electrode holder 112 wraps around the circular insert 111211, the concha electrode wire 13, the core wire 31, the core wire 32, the PCB 14, and the fiber bundle 33. To improve the bonding strength of the subsequent encapsulation, a plurality of annular grooves 1121 are provided on the surface of the circular electrode holder 112.

[0084] like Figure 11 As shown, the above components are placed in a mold, and TPU or TPE material is injection-molded to form an external sealant 15, forming three parts: a base 151, a concha cantilever 152, and a tail tube 153. The concha cantilever 152 is provided with several staggered grooves 1521, one for positioning the internal concha electrode wire 13, and the other for increasing the bending performance of the concha cantilever. The base 151 is close to the ear canal electrode 11 and is provided with several anti-slip grooves 1511 to facilitate wearing the electrode. The tail tube 153 can limit the wire 3, while improving the bending strength of the junction between the two and increasing the service life of the cable. Preferably, the tail tube 153 is provided with staggered grooves.

[0085] like Figure 11 As shown, 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 can provide good force feedback through its own deformation to ensure that the concha electrode 12 fits the position of the concha. It has been confirmed through ergonomics that the angle of 18±2° between the ear canal conductive silicone 1111 and the concha conductive silicone 1211 is the best for wearing comfort and electrode fit. Among them, the ear canal conductive silicone 1111 is conical in shape and hollow inside, which is conducive to deformation to adapt to ear canals of different sizes. The contact surface between the concha conductive silicone 1211 and the concha is an arc surface, preferably with a length of 15±2mm and a width of 7.5±1mm, which has a large contact area with the concha and improves the electrode fit. As Figure 3 The minimum distance between the sheet insert 1212 and the outer surface of the conductive silicone is 1 mm, and the electrode surface is soft, ensuring wearing comfort.

[0086] 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.

[0087] 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, a concha electrode, an ear concha electrode wire, a PCB board, and an external sealing glue; wherein the ear canal electrode includes a round electrode and a round electrode holder, and the round electrode includes an ear canal conductive silicone and a round insert; the concha electrode includes a flat electrode and a flat electrode holder, and the flat electrode includes a concha conductive silicone and a sheet insert; The conductive silicone in the ear canal covers the circular insert, and the conductive silicone in the concha 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 circular electrode seat is covered on the outside of the PCB board, and the flat electrode seat is covered on the connection between the concha electrode wire and the sheet insert, and the external sealing glue is encapsulated on the outside of the concha electrode wire, the circular electrode seat and the flat electrode seat; the core wire of the wire is sheathed with FEP material, and the outer sheath of the wire, the outer sheath of the concha electrode wire, and the external sealing glue are made of TPE material or TPU material; the inner mold of the ear hook is made of PVC material, and the outer mold of the ear hook is made of TPE material or TPU material; the circular electrode seat and the flat electrode seat are made of PVC material; the ear canal electrode and the concha electrode 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 included angle between the ear canal conductive silicone and the concha conductive 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 for the ear vagus nerve stimulator according to claim 1, wherein: The external sealant includes a base, an ear concha cantilever and a tail pipe; wherein, the base is provided with an anti-slip groove, and the ear concha cantilever is C-shaped and provided with a plurality of staggered 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; The circular insert is covered with the conductive silicone rubber of the ear canal to make a round electrode, and the sheet insert is covered with the conductive silicone rubber of the concha to make a flat electrode; Splitting the other end of the wire into a first wire core and a second wire core, soldering the first wire core and the circular insert to the PCB, soldering the sheet insert to the concha electrode wire, then soldering the second wire core and the concha electrode wire to the PCB, and fixing the wires 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 PCB board and the concha electrode wire into an electrode base mold, and injection molding to form a round electrode base and a flat electrode base; The concha electrode wire, the round electrode seat and the flat electrode seat are placed in a sealing mold, and sealed with TPE or TPU material to form an external sealing mold.

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 core wire of the wire is coated 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 TPE material or TPU material; the inner mold of the ear hook is made of PVC material, and the outer mold of the ear hook is made of TPE material or TPU material; the round electrode seat and the flat electrode seat are made of PVC material; the ear canal electrode and the concha electrode 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 TPE or TPU outer sheath of the wire is coated with PVC material in combination with a retaining clamp; The ear hook part is made of PVC material with TPE or TPU material covering the inner mold of the ear hook; The circular insert and the sheet insert are coated with solid conductive silica gel to form a circular electrode and a flat electrode; The outer sheath of the concha electrode wire, the PCB board, the round electrode and the flat electrode are wrapped with PVC material to form a round electrode base and a flat electrode base; The outer sheath of the concha electrode wire, the outer sheath of the wire, the PCB board, the round electrode seat and the flat electrode seat are coated with TPE or TPU material to form an external sealing glue to complete the preparation of the electrode part.

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