WO2020119466A1 - Nerve stimulation electrode, implant, silicone packaging method, and silicone packaging device - Google Patents

Nerve stimulation electrode, implant, silicone packaging method, and silicone packaging device Download PDF

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Publication number
WO2020119466A1
WO2020119466A1 PCT/CN2019/121493 CN2019121493W WO2020119466A1 WO 2020119466 A1 WO2020119466 A1 WO 2020119466A1 CN 2019121493 W CN2019121493 W CN 2019121493W WO 2020119466 A1 WO2020119466 A1 WO 2020119466A1
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WIPO (PCT)
Prior art keywords
electrode
stimulation
silicone
mold
groove
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PCT/CN2019/121493
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French (fr)
Chinese (zh)
Inventor
吴天准
赵赛赛
彭勃
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深圳先进技术研究院
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Publication of WO2020119466A1 publication Critical patent/WO2020119466A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0543—Retinal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

  • This application relates to the technical field of medical devices, in particular to a nerve stimulation electrode, an implant, a silicone encapsulation method, and a silicone encapsulation device.
  • Implantable nerve stimulators have a wide range of applications in medicine, such as cochlear implants, artificial retinas, and electrical stimulation systems for the brain. As an important tool for revealing the working mechanism of the nervous system and treating neurological diseases, microelectrodes have received more and more attention from people, and have become an important research direction at present.
  • nerve stimulation electrodes are required to electrically stimulate the corresponding nerve cells.
  • artificial retina products replace the function of photoreceptor cells of retinal damage caused by retinal pigment degeneration and age-related macular degeneration, for example, by using stimulation electrodes to generate stimulation signals to stimulate retinal ganglion cells or bipolar cells .
  • stimulation electrodes to generate stimulation signals to stimulate retinal ganglion cells or bipolar cells
  • other well-preserved visual pathways can also produce a light sensation in the cerebral cortex, which can partially restore the patient's vision.
  • the stimulation signal generated by the stimulation electrode directly determines the intensity of light generated by the patient in the cerebral cortex.
  • the active implanted medical equipment After the active implanted medical equipment is implanted, its electronic devices are particularly sensitive to water vapor and oxygen in body fluids. To ensure the performance and service life of the electronic devices, packaging is required, and the electrode stimulation points need to be exposed during packaging in order to Electrode stimulation points contact nerve cells to generate stimulation signals, but the existing packaging process is complicated and not easy to implant after packaging. In addition, the existing active implanted medical devices have low mechanical strength, which greatly affects the service life.
  • the purpose of the present application is to provide a nerve stimulation electrode, a silicone encapsulation method and a silicone encapsulation device, so as to be able to effectively protect the nerve stimulation electrode without interfering with the stimulation function of the nerve stimulation electrode.
  • a silicone encapsulation method for nerve stimulation electrodes The nerve stimulation electrode includes an electrode tip; the electrode tip is provided with a stimulating portion that can contact a target nerve area; and the silicone encapsulation method includes exposure outside the electrode tip
  • a silicone sleeve is injection-molded by at least part of the stimulation part.
  • the electrode head is provided with a first surface and a second surface facing each other; the stimulation part includes two electrode stimulation regions respectively provided on the first surface and the second surface ; The electrode stimulation area is provided with multiple electrode points;
  • the silicone encapsulation method includes:
  • a silicone sleeve is injection-molded outside the electrode head in such a manner that at least one electrode stimulation area is exposed.
  • the silicone encapsulation method includes:
  • the second mold is covered on the first mold; the second groove on the second mold and the first groove form a cavity for accommodating the electrode head; the first groove and the At least one of the second grooves is provided with a protrusion facing the bottom surface of the protrusion protruding groove; the protrusion covers and shields the electrode stimulation area; the area of the protrusion is not smaller than the electrode The area of the stimulation area;
  • the bottom surface of the groove of the first groove is provided with the protrusion; the bottom surface of the groove of the second groove is not provided with the protrusion;
  • the silicone encapsulation method includes:
  • the electrode stimulation area is aligned with the protrusion; correspondingly, a silicone sleeve is injection-molded outside the electrode head in such a way that one electrode stimulation area is exposed.
  • the bottom surfaces of the grooves of the first groove and the second groove are provided with the protrusions
  • the silicone encapsulation method includes:
  • the electrode stimulation area is aligned with the protrusion; accordingly, a silicone sleeve is injection-molded outside the electrode head in a manner that exposes the two electrode stimulation areas .
  • the boss is provided with a recessed portion that is recessed in a direction opposite to the protrusion direction of the boss; the boss forms a blocking wall on the peripheral side of the recessed portion;
  • the silicone encapsulation method includes:
  • the electrode stimulation area of the electrode head is aligned with the recessed portion; the baffle wall surrounds the electrode stimulation area and conforms to the surface of the electrode head .
  • the first groove is provided with a positioning protrusion;
  • the electrode head is provided with a positioning hole for positioning the nerve stimulation electrode on the eyeball;
  • the silicone encapsulation method includes:
  • the positioning protrusion is inserted into the positioning hole.
  • step of injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve stop glue injection when the glue injection pressure reaches a predetermined pressure.
  • step of injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve stop glue injection when the glue injection hole overflows .
  • the material of the first mold and the second mold is plastic or silicone.
  • the nerve stimulation electrode is applied to one of the following implants: cardiac pacemaker, artificial retina, cochlear implant, defibrillator, vagal nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulation Device, bladder stimulator, gastrointestinal stimulator and deep brain stimulator.
  • a nerve stimulation electrode is applied to the silicone packaging method described in any of the above embodiments.
  • An artificial retinal implant includes the nerve stimulation electrode as described above.
  • a silicone encapsulating device for nerve stimulation electrodes The nerve stimulating electrode includes an electrode tip; the electrode tip is provided with a stimulation part that can contact a target nerve area; the silicone encapsulation device includes: a mold with a cavity. The cavity is used for accommodating the electrode tip of the nerve stimulation electrode; the mold is configured to injection mold a silicone sleeve outside the electrode head in such a manner that at least part of the stimulation portion is exposed.
  • the silicone encapsulation method in this embodiment can improve the mechanical strength of the nerve stimulation electrode by injection molding a silicone sleeve on the electrode tip of the nerve stimulation electrode to prevent mechanical damage during the implantation process.
  • the silicone sleeve It can also play a good role in protecting the nerve stimulation electrode and increase the service life of the nerve stimulation electrode.
  • the silicone sleeve can expose the stimulation part on the electrode head, which is convenient for the stimulation part to electrically stimulate the nerve cells. Affect the normal stimulation function of nerve stimulation electrodes.
  • FIG. 1 is a partial structural schematic diagram of a nerve stimulation electrode provided by an embodiment of the present application.
  • FIG. 2 is a mold for encapsulating FIG. 1;
  • FIG. 3 is a schematic diagram of the second mold of FIG. 2;
  • FIG. 4 is a partial enlarged view of FIG. 3;
  • FIG. 5 is a schematic diagram of the first mold of FIG. 2;
  • FIG. 6 is a partial enlarged view of FIG. 5;
  • FIG. 7 is a schematic diagram of a state of double-sided packaging of an electrode head according to an embodiment of the present application.
  • FIG. 8 is a schematic view of a mold cavity provided by an embodiment of the present application.
  • FIG. 9 is a schematic view of the state of the double-sided packaging of the electrode head of FIG. 8;
  • FIG. 10 is a schematic structural diagram of an artificial retinal implant provided by an embodiment of the present application.
  • the embodiment of the present application provides a method for encapsulating the nerve stimulation electrode 100 in silicone.
  • the nerve stimulation electrode 100 is applied to one of the following implants: cardiac pacemaker, artificial retina, cochlear implant, defibrillator, vagus nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulator, and bladder stimulator , Gastrointestinal stimulator and deep brain stimulator.
  • the nerve stimulation electrode 100 includes an electrode head 102.
  • the electrode head 102 is provided with a stimulation part that can contact the target nerve area.
  • the stimulation part can contact the eyeball.
  • the silicone encapsulation method includes: injection molding a silicone sleeve 103 outside the electrode head 102 so as to expose at least part of the stimulation portion.
  • the silicone packaging method in this embodiment can improve the mechanical strength of the nerve stimulation electrode 100 by injection molding a silicone sleeve 103 on the electrode head 102 of the nerve stimulation electrode 100, and prevent mechanical damage during the implantation process.
  • the silicone sleeve 103 can also play a good role in protecting the nerve stimulation electrode 100 and prolong the service life of the nerve stimulation electrode 100; at the same time, the silicone sleeve 103 can expose the stimulation part on the electrode head 102 to facilitate the stimulation part Electrical stimulation of nerve cells does not affect the normal stimulation function of nerve stimulation electrode 100.
  • the silicone encapsulation method in this embodiment uses a silicone sleeve 103 to encapsulate the electrode head 102 to avoid contact between the electrode plate of the nerve stimulation electrode 100 and body fluids, and to isolate the electrode plate from the body fluid phase to protect the normal operation of the nerve stimulation electrode 100 and extend its use. life.
  • the silicone sleeve 103 is made of silicone with biocompatibility.
  • the injection-molded nerve stimulation electrode 100 is biocompatible and can be implanted for a long time. The test results are shown in Table 1 below:
  • the nerve stimulation electrode 100 includes an electrode plate.
  • a plurality of electrode spots are formed on one end of the electrode plate to form an electrode tip 102.
  • the free end of the electrode plate forms the electrode tip 102.
  • the width of the transmission section 101 of the electrode head 102 connected to the electrode plate may be smaller than the width of the electrode head 102 (the length in the left-right direction when the reader faces FIG. 1 is the width).
  • the transmission section 101 may also be encapsulated with a silicone sleeve, which is not particularly limited in this application.
  • the electrode head 102 may have an arc-shaped structure. Specifically, the arc radius of the electrode tip 102 is 13mm-15mm. In this way, the electrode head 102 is tightly sealed to the eyeball, so that the electrode point located in the groove of the silicone sleeve 103 is sealed between the silicone sleeve 103 and the eyeball and directly contacts the retina, prolonging the service life.
  • the electrode head 102 is provided with a first surface and a second surface facing each other.
  • the stimulation part includes two electrode stimulation regions 104 respectively provided on the first surface and the second surface.
  • the electrode stimulation area 104 is provided with multiple electrode points.
  • the electrode stimulation area 104 is substantially flat with the first surface or the second surface, forming a substantially planar structure.
  • the silicone encapsulation method includes: injection molding a silicone sleeve 103 outside the electrode head 102 so as to expose at least one electrode stimulation area 104.
  • the electrode points of the electrode stimulation area 104 may be arranged in an array.
  • the silicone sleeve 103 formed by the silicone encapsulation method has a groove area, and the electrode stimulation area 104 is located in the groove area, which is exposed to facilitate stimulation with the target nerve.
  • a mold 400 is provided in the embodiments of the present application.
  • the mold 400 has a cavity 401.
  • the cavity 401 is used to accommodate the electrode head 102 of the nerve stimulation electrode 100.
  • the mold is configured to injection mold a silicone sleeve 103 outside the electrode head 102 so as to expose at least part of the stimulation portion.
  • the mold 400 includes a first mold 300 and a second mold 200.
  • the first mold 300 and the second mold 200 abut against each other to form a cavity 401 that houses the electrode head 102.
  • the butt surface of the first mold 300 is provided with a first groove 301
  • the butt surface of the second mold 200 is provided with a second groove 201.
  • the first groove 301 and the second groove 201 are aligned facing each other to form a cavity 401.
  • the shapes of the first groove 301 and the second groove 201 may match the shape of the electrode head 102, and accordingly, the contours of the first groove 301 and the second groove 201 match the contour of the electrode head 102.
  • FIG. 9 when the electrode head 102 is located in the cavity 401, there is a filling space 410 between the electrode head 102 and the inner wall of the cavity 401 to be filled with glue to form a silicone sleeve 103.
  • the second mold 200 is provided with a glue injection hole 202.
  • the glue injection hole 202 penetrates the second mold 200.
  • a glue inlet 302 is provided on the mating surface of the first mold 300. The glue inlet 302 does not penetrate the second mold 200.
  • An infusion tank 303 is provided between the first mold 300 and the first groove 301. When the second mold 200 is closed on the first mold 300, the infusion tank 303 is closed to form an infusion channel. When the second mold 200 and the second mold 200 are pressed together, the glue injection hole 202 is aligned with the glue inlet 302. The glue solution injected into the glue injection hole 202 enters into the glue tank 302, and then enters the cavity 401 through the infusion channel (infusion tank 303).
  • the material of the first mold 300 and the second mold 200 is plastic or silicone.
  • the first mold 300 and the second mold 200 have a rectangular parallelepiped structure, and both of them may be made of hard plastic material or soft silicone material.
  • the first mold 300 and the second mold 200 may be connected by bolts, and the degree of pressing between the first mold 300 and the second mold 200 is controlled by the tightening degree of the bolts.
  • the first mold 300 and the second mold 200 are provided with corresponding bolt holes 203 and 305 at corners to insert bolts for connection.
  • the butt surfaces of the first mold 300 and the second mold 200 have Curved area.
  • the arc area 304 of the first mold 300 has a concave structure
  • the arc area of the second mold 200 has a convex structure.
  • the first groove 301 is located in the arc area 304 of the concave structure
  • the second groove 201 is located in the arc area of the convex structure.
  • the first groove 301 matches the shape of the electrode head 102.
  • the second groove 201 and the first groove 301 on the second mold 200 form a cavity 401 for accommodating the electrode head 102.
  • At least one of the first groove 301 and the second groove 201 is provided with a protrusion 420 facing the stimulation portion and protruding from the bottom surface of the groove.
  • the boss 420 can be attached to the surface of the electrode head 102.
  • the protrusion 420 can cover and block at least part of the stimulation portion.
  • the area of the protrusion 420 is not smaller than the area of the electrode stimulation area 104.
  • a filling space 410 is formed outside the boss 420.
  • the side wall 421 of the boss 420 blocks the glue, so that the glue cannot form a silicone layer on the electrode stimulation area 104, thereby exposing the electrode stimulation area 104.
  • the silicone sleeve 103 forms a groove corresponding to the electrode stimulation area 104.
  • the shape of the boss 420 matches the shape of the electrode stimulation area 104.
  • the electrode stimulation area 104 has a rectangular shape, and a plurality of electrode points arranged in an array are distributed.
  • the boss 420 is also rectangular, and the area of the boss 420 is slightly larger than the area of the electrode stimulation area 104.
  • the protrusion 420 is pressed against the electrode tip 102, and the filling space 410 outside the protrusion 420 enters the glue solution to form a silicone sleeve 103 wrapped on the electrode tip 102.
  • the protrusion 420 covers the electrode stimulation area 104, and the edge of the protrusion 420 may be in contact with the surface of the electrode head 102 on the periphery of the electrode stimulation area 104 To form a seal to avoid the entry of glue.
  • a groove is formed in the electrode stimulation area 104, and the electrode point is exposed in the groove.
  • the silicone encapsulation method includes the following steps:
  • the first groove 301 is provided with positioning protrusions 306.
  • the electrode head 102 is provided with a positioning hole 105 for positioning the nerve stimulation electrode 100 on the eyeball.
  • the positioning protrusion 306 may be a cylindrical structure, and may be inserted into the positioning hole 105 of the electrode head 102.
  • the positioning holes 105 of the electrode head 102 are located in other areas of the electrode stimulation area 104 in the first surface or the second surface.
  • the second groove 201 is also provided with a docking protrusion 204. When the first mold 300 and the second mold 200 are butted, the positioning protrusion 306 and the butt protrusion 204 are butted to form corresponding through holes in the silicone sleeve 103.
  • step S100 when the electrode head 102 is placed in the first groove 301 of the first mold 300, the positioning protrusion 306 is inserted into the positioning hole 105. Specifically, when the electrode head 102 is placed, the positioning protrusion 306 is aligned with the positioning hole 105, and the positioning protrusion 306 is forced to pass through the positioning hole 105 to achieve the initial positioning of the electrode head 102, and then the second mold 200 is closed On the first mold 300.
  • step S300 in order to avoid damage to the nerve stimulation electrode 100, the glue injection is stopped when the glue injection pressure reaches a predetermined pressure.
  • the predetermined pressure may be determined according to the withstand pressure of the electrode head 102, which is not specifically limited in this application. In other embodiments, the glue injection may be stopped when the glue injection hole 202 overflows with glue.
  • the bottom surface of the groove of the first groove 301 is provided with the protrusion 420.
  • the protrusion 420 is not provided on the bottom surface of the second groove 201.
  • the side wall 421 of the boss 420 can block the glue.
  • a silicone sleeve 103 is injection-molded outside the electrode head 102 in such a way that one electrode stimulation area 104 is exposed.
  • the electrode stimulation area 104 on the other side of the electrode head 102 is covered with a silicone sleeve 103, and only the electrode stimulation area 104 on one side is exposed to stimulate the target nerve.
  • the boss 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protrusion direction of the boss 420.
  • the boss 420 forms a blocking wall 426 on the peripheral side of the recessed portion 425.
  • the silicone encapsulation method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 of the electrode head 102 is aligned with the concave portion 425.
  • the blocking wall 426 surrounds the electrode stimulation area 104 and is in contact with the surface of the electrode head 102 and the surface of the electrode head 102.
  • the electrode stimulation area 104 is located in the depression 425, and the blocking wall 426 surrounds the electrode stimulation area 104.
  • the side wall 421 of the boss 420 can form a barrier to the glue to prevent the glue from covering the electrode stimulation area 104.
  • the protrusions 420 are provided on the bottom surfaces of the first groove 301 and the second groove 201.
  • the silicone encapsulation method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 is aligned with the protrusion 420; correspondingly, outside the electrode head 102 A silicone sleeve 103 is injection molded by exposing the two electrode stimulation areas 104.
  • the electrode stimulation areas 104 on both sides of the electrode head 102 are exposed to stimulate the target nerve. In this way, more electrode points can be exposed to form a wider range of electrode stimuli.
  • the boss 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protrusion direction of the boss 420.
  • the boss 420 forms a blocking wall 426 on the peripheral side of the recessed portion 425.
  • the silicone packaging method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 of the electrode head 102 is aligned with the recessed portion 425; the blocking wall 426 surrounds the electrode The stimulation area 104 surrounds and contacts the surface of the electrode head 102.
  • the electrode stimulation area 104 is located in the depression 425, and the blocking wall 426 surrounds the electrode stimulation area 104.
  • the side wall 421 of the boss 420 can form a barrier to the glue to prevent the glue from covering the electrode stimulation area 104.
  • the embodiment of the present application further provides a nerve stimulation electrode, which is applied to any of the above-mentioned silicone packaging methods.
  • the nerve stimulation electrode can be applied to an artificial retinal implant as shown in FIG.
  • An embodiment of the present application further provides a silicone-encapsulated artificial retinal implant, which includes: a coil base 1, which includes a transmission coil and a silicone sleeve 11 matching the shape of the eyeball, the transmission coil being encapsulated in the silicone In the sheet sleeve 11, both ends of the silicone sheet sleeve 11 are connected by a bandage 4, and the silicone sheet sleeve 11 can be fixed to the eyeball through the bandage 4; the integrated package 2 is fixed to the coil base 1 Above, the integrated package 2 includes a silicone sleeve 21 and a titanium sleeve encapsulated in the silicone sleeve 21, the titanium sleeve is provided with a substrate, the transmission coil is electrically connected to the substrate; the nerve electrode 3 , Which includes a silicone arc sleeve 31 and an electrode plate 32, the electrode plate 32 is provided in the silicone arc sleeve 31, one end of the silicone arc sleeve 31 is connected to the side wall
  • the nerve stimulation electrode 100 As the nerve electrode 3, the nerve stimulation electrode 100 disclosed in any of the above embodiments or examples may be used, and details are not described herein again.
  • the artificial retinal implant can refer to the patent application “2017113637331” titled “silicone encapsulated artificial retinal implant”, the contents of which are incorporated herein by reference, and will not be repeated here.
  • Embodiments of the present application also provide a silicone encapsulation device for nerve stimulation electrodes, where the nerve stimulation electrodes include electrode tips.
  • the electrode head is provided with a stimulation part that can contact the target nerve area.
  • the silicone encapsulation device includes a mold having a cavity for accommodating the electrode tip of the nerve stimulation electrode. The mold is configured to injection mold a silicone sleeve outside the electrode head in such a manner that at least part of the stimulation portion is exposed.

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Abstract

Disclosed are a nerve stimulation electrode, an implant, a silicone packaging method, and a silicone packaging device. The nerve stimulation electrode comprises an electrode head. The electrode head is provided with a stimulation part in contact with a target nerve region. The silicone packaging method comprises injection-molding a silicone sleeve outside the electrode head to expose at least part of the stimulation part. According to the nerve stimulation electrode, the implant, the silicone packaging method, and the silicone packaging device provided in the present application, the nerve stimulation electrode can be effectively protected without interfering with the stimulation function of the nerve stimulation electrode.

Description

神经刺激电极、植入体、硅胶封装方法以及硅胶封装设备Nerve stimulation electrode, implant, silica gel packaging method and silica gel packaging equipment 技术领域Technical field
本申请涉及医疗器械技术领域，尤其涉及一种神经刺激电极、植入体、硅胶封装方法以及硅胶封装设备。This application relates to the technical field of medical devices, in particular to a nerve stimulation electrode, an implant, a silicone encapsulation method, and a silicone encapsulation device.
背景技术Background technique
植入式神经刺激器在医学上有着广泛的应用，如人工耳蜗、人工视网膜、神脑部电刺激***等。微电极作为揭示神经***工作机理、治疗神经疾病等的重要工具，越来越受到人们广泛的关注，已成为当前重要的研究方向。Implantable nerve stimulators have a wide range of applications in medicine, such as cochlear implants, artificial retinas, and electrical stimulation systems for the brain. As an important tool for revealing the working mechanism of the nervous system and treating neurological diseases, microelectrodes have received more and more attention from people, and have become an important research direction at present.
有源植入医疗设备在植入的过程中，都需要神经刺激电极对相应的神经细胞进行电刺激。以人造视网膜为例，人造视网膜产品通过替代因视网膜色素变性和老年黄斑变性所造成的视网膜损伤的感光细胞的功能，例如通过利用刺激电极产生刺激信号来对视网膜神经节细胞或者双极细胞进行刺激，并且利用其他保留完好的视觉通路，也能够在大脑皮层产生光感，从而能够部分恢复病人的视觉。刺激电极产生的刺激信号就直接决定了病人在大脑皮层产生的光感强弱。During the implantation of active implantable medical devices, nerve stimulation electrodes are required to electrically stimulate the corresponding nerve cells. Taking artificial retina as an example, artificial retina products replace the function of photoreceptor cells of retinal damage caused by retinal pigment degeneration and age-related macular degeneration, for example, by using stimulation electrodes to generate stimulation signals to stimulate retinal ganglion cells or bipolar cells , And the use of other well-preserved visual pathways can also produce a light sensation in the cerebral cortex, which can partially restore the patient's vision. The stimulation signal generated by the stimulation electrode directly determines the intensity of light generated by the patient in the cerebral cortex.
在有源植入医疗设备在植入后，其电子器件对体液的水汽和氧气特别敏感，为保证电子器件的性能和使用寿命，需要进行封装，而封装时需要将电极刺激点暴露出来，以便电极刺激点接触神经细胞，产生刺激信号，但是现有的封装工艺复杂，封装后不易于植入。另外，现有的有源植入医疗设备机械强度低，十分影响使用寿命。After the active implanted medical equipment is implanted, its electronic devices are particularly sensitive to water vapor and oxygen in body fluids. To ensure the performance and service life of the electronic devices, packaging is required, and the electrode stimulation points need to be exposed during packaging in order to Electrode stimulation points contact nerve cells to generate stimulation signals, but the existing packaging process is complicated and not easy to implant after packaging. In addition, the existing active implanted medical devices have low mechanical strength, which greatly affects the service life.
发明内容Summary of the invention
本申请的目的是提供一种神经刺激电极、硅胶封装方法以及硅胶封装设备，以能够对神经刺激电极形成有效保护，且并不干扰神经刺激电极的刺激功能。The purpose of the present application is to provide a nerve stimulation electrode, a silicone encapsulation method and a silicone encapsulation device, so as to be able to effectively protect the nerve stimulation electrode without interfering with the stimulation function of the nerve stimulation electrode.
本申请的技术方案如下：The technical scheme of this application is as follows:
一种神经刺激电极的硅胶封装方法，所述神经刺激电极包括电极头；所述电极头设有能与目标神经区域相接触的刺激部；所述硅胶封装方法包括在所述电极头外以露出至少部分所述刺激部的方式注塑成型一硅胶套。A silicone encapsulation method for nerve stimulation electrodes. The nerve stimulation electrode includes an electrode tip; the electrode tip is provided with a stimulating portion that can contact a target nerve area; and the silicone encapsulation method includes exposure outside the electrode tip A silicone sleeve is injection-molded by at least part of the stimulation part.
作为一种优选的实施方式，所述电极头设有相背对的第一表面和第二表面；所述刺激部包括分别设置于所述第一表面和第二表面上的两个电极刺激区域；所述电极刺激区域设有多个电极点；As a preferred embodiment, the electrode head is provided with a first surface and a second surface facing each other; the stimulation part includes two electrode stimulation regions respectively provided on the first surface and the second surface ; The electrode stimulation area is provided with multiple electrode points;
相应的，所述硅胶封装方法包括：Correspondingly, the silicone encapsulation method includes:
在所述电极头外以露出至少一个所述电极刺激区域的方式注塑成型一硅胶套。A silicone sleeve is injection-molded outside the electrode head in such a manner that at least one electrode stimulation area is exposed.
作为一种优选的实施方式，所述硅胶封装方法包括：As a preferred embodiment, the silicone encapsulation method includes:
将所述电极头放置于第一模具的第一凹槽中；其中，所述第一凹槽与所述电极头形状相匹配；Placing the electrode head in the first groove of the first mold; wherein the first groove matches the shape of the electrode head;
将第二模具盖合在所述第一模具上；所述第二模具上的第二凹槽与所述第一凹槽形成容纳所述电极头的型腔；所述第一凹槽和所述第二凹槽中的至少一个设有面对所述刺 激部凸出凹槽底面的突台；所述突台将所述电极刺激区域覆盖遮挡；所述突台的面积不小于所述电极刺激区域的面积；The second mold is covered on the first mold; the second groove on the second mold and the first groove form a cavity for accommodating the electrode head; the first groove and the At least one of the second grooves is provided with a protrusion facing the bottom surface of the protrusion protruding groove; the protrusion covers and shields the electrode stimulation area; the area of the protrusion is not smaller than the electrode The area of the stimulation area;
通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套。Inject glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve.
作为一种优选的实施方式，所述第一凹槽的凹槽底面设有所述突台；所述第二凹槽的凹槽底面未设有所述突台；As a preferred embodiment, the bottom surface of the groove of the first groove is provided with the protrusion; the bottom surface of the groove of the second groove is not provided with the protrusion;
所述硅胶封装方法包括：The silicone encapsulation method includes:
所述电极头位于所述型腔内时，所述电极刺激区域与所述突台相对齐；相应的，在所述电极头外以露出一个所述电极刺激区域的方式注塑成型一硅胶套。When the electrode head is located in the cavity, the electrode stimulation area is aligned with the protrusion; correspondingly, a silicone sleeve is injection-molded outside the electrode head in such a way that one electrode stimulation area is exposed.
作为一种优选的实施方式，所述第一凹槽和所述第二凹槽的凹槽底面设有所述突台；As a preferred embodiment, the bottom surfaces of the grooves of the first groove and the second groove are provided with the protrusions;
所述硅胶封装方法包括：The silicone encapsulation method includes:
所述电极头位于所述型腔内时，所述电极刺激区域与所述突台相对齐；相应的，在所述电极头外以露出两个所述电极刺激区域的方式注塑成型一硅胶套。When the electrode head is located in the cavity, the electrode stimulation area is aligned with the protrusion; accordingly, a silicone sleeve is injection-molded outside the electrode head in a manner that exposes the two electrode stimulation areas .
作为一种优选的实施方式，所述突台设有沿与所述突台凸出方向相反方向凹陷的凹陷部；所述突台在所述凹陷部的周侧形成挡壁；As a preferred embodiment, the boss is provided with a recessed portion that is recessed in a direction opposite to the protrusion direction of the boss; the boss forms a blocking wall on the peripheral side of the recessed portion;
所述硅胶封装方法包括：The silicone encapsulation method includes:
所述电极头位于所述型腔时，所述电极头的电极刺激区域与所述凹陷部相对齐；所述挡壁围构在所述电极刺激区域周侧并与电极头的表面相贴合。When the electrode head is located in the cavity, the electrode stimulation area of the electrode head is aligned with the recessed portion; the baffle wall surrounds the electrode stimulation area and conforms to the surface of the electrode head .
作为一种优选的实施方式，所述第一凹槽设有定位凸起；所述电极头设有用于将所述神经刺激电极定位于眼球上的定位孔；As a preferred embodiment, the first groove is provided with a positioning protrusion; the electrode head is provided with a positioning hole for positioning the nerve stimulation electrode on the eyeball;
所述硅胶封装方法包括：The silicone encapsulation method includes:
将所述电极头放置于第一模具的第一凹槽中时，所述定位凸起***所述定位孔中。When the electrode head is placed in the first groove of the first mold, the positioning protrusion is inserted into the positioning hole.
作为一种优选的实施方式，在所述通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套步骤中：在注胶压力达到预定压力时停止注胶。As a preferred embodiment, in the step of injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve: stop glue injection when the glue injection pressure reaches a predetermined pressure.
作为一种优选的实施方式，在所述通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套步骤中：在所述注胶孔溢出胶液时停止注胶。As a preferred embodiment, in the step of injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve: stop glue injection when the glue injection hole overflows .
作为一种优选的实施方式，所述第一模具、第二模具的材质为塑料或硅胶。As a preferred embodiment, the material of the first mold and the second mold is plastic or silicone.
作为一种优选的实施方式，所述神经刺激电极应用于以下植入体之一：心脏起搏器、人造视网膜、人工耳蜗、除颤器、迷走神经刺激器、脊髓刺激器、颈动脉窦电刺激器、膀胱刺激器、肠胃刺激器和深脑刺激器。As a preferred embodiment, the nerve stimulation electrode is applied to one of the following implants: cardiac pacemaker, artificial retina, cochlear implant, defibrillator, vagal nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulation Device, bladder stimulator, gastrointestinal stimulator and deep brain stimulator.
一种神经刺激电极，应用于上述任一实施方式所述的硅胶封装方法制造。A nerve stimulation electrode is applied to the silicone packaging method described in any of the above embodiments.
一种人造视网膜植入体，包括如上所述的神经刺激电极。An artificial retinal implant includes the nerve stimulation electrode as described above.
一种神经刺激电极的硅胶封装设备，所述神经刺激电极包括电极头；所述电极头设有能与目标神经区域相接触的刺激部；所述硅胶封装设备包括：具有型腔的模具，所述型腔用于容纳所述神经刺激电极的电极头；所述模具被设置为在所述电极头外以露出至少部分所述刺激部的方式注塑成型一硅胶套。A silicone encapsulating device for nerve stimulation electrodes. The nerve stimulating electrode includes an electrode tip; the electrode tip is provided with a stimulation part that can contact a target nerve area; the silicone encapsulation device includes: a mold with a cavity. The cavity is used for accommodating the electrode tip of the nerve stimulation electrode; the mold is configured to injection mold a silicone sleeve outside the electrode head in such a manner that at least part of the stimulation portion is exposed.
有益效果：Beneficial effect:
本实施方式中的硅胶封装方法通过在神经刺激电极的电极头注塑成型一硅胶套， 能够提高神经刺激电极的机械强度，防止在植入过程中产生机械损伤，并且，在植入体内，硅胶套也可以对神经刺激电极起到很好的保护作用，提升神经刺激电极的使用寿命；同时，该硅胶套可以将电极头上的刺激部暴露出来，便于刺激部对神经细胞进行电刺激，并不影响神经刺激电极的正常刺激功能。The silicone encapsulation method in this embodiment can improve the mechanical strength of the nerve stimulation electrode by injection molding a silicone sleeve on the electrode tip of the nerve stimulation electrode to prevent mechanical damage during the implantation process. In addition, in the implanted body, the silicone sleeve It can also play a good role in protecting the nerve stimulation electrode and increase the service life of the nerve stimulation electrode. At the same time, the silicone sleeve can expose the stimulation part on the electrode head, which is convenient for the stimulation part to electrically stimulate the nerve cells. Affect the normal stimulation function of nerve stimulation electrodes.
参照后文的说明和附图，详细公开了本发明的特定实施方式，指明了本发明的原理可以被采用的方式。应该理解，本发明的实施方式在范围上并不因而受到限制。在所附权利要求的精神和条款的范围内，本发明的实施方式包括许多改变、修改和等同。With reference to the following description and drawings, specific embodiments of the present invention are disclosed in detail, and the manner in which the principles of the present invention can be adopted is indicated. It should be understood that the embodiments of the present invention are not thus limited in scope. Within the scope of the spirit and terms of the appended claims, the embodiments of the present invention include many changes, modifications, and equivalents.
针对一种实施方式描述和/或示出的特征可以以相同或类似的方式在一个或更多个其它实施方式中使用，与其它实施方式中的特征相组合，或替代其它实施方式中的特征。Features described and/or illustrated for one embodiment may be used in one or more other embodiments in the same or similar manner, combined with features in other embodiments, or substituted for features in other embodiments .
应该强调，术语“包括/包含”在本文使用时指特征、整件、步骤或组件的存在，但并不排除一个或更多个其它特征、整件、步骤或组件的存在或附加。It should be emphasized that the term "comprising/comprising" as used herein refers to the presence of features, whole pieces, steps or components, but does not exclude the presence or addition of one or more other features, whole pieces, steps or components.
附图说明BRIEF DESCRIPTION
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。In order to more clearly explain the embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required in the embodiments or the description of the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those skilled in the art, without paying any creative labor, other drawings can be obtained based on these drawings.
图1是本申请一种实施方式提供的神经刺激电极的部分结构示意图；FIG. 1 is a partial structural schematic diagram of a nerve stimulation electrode provided by an embodiment of the present application;
图2是对图1封装的模具；FIG. 2 is a mold for encapsulating FIG. 1;
图3是图2第二模具示意图；3 is a schematic diagram of the second mold of FIG. 2;
图4是图3的局部放大图；4 is a partial enlarged view of FIG. 3;
图5是图2的第一模具示意图；5 is a schematic diagram of the first mold of FIG. 2;
图6是图5的局部放大图；6 is a partial enlarged view of FIG. 5;
图7是本申请一种实施例对电极头双侧封装的状态示意图；7 is a schematic diagram of a state of double-sided packaging of an electrode head according to an embodiment of the present application;
图8是本申请一种实施例提供的模具型腔示意图；8 is a schematic view of a mold cavity provided by an embodiment of the present application;
图9是图8对电极头双侧封装的状态示意图；9 is a schematic view of the state of the double-sided packaging of the electrode head of FIG. 8;
图10是本申请一种实施例所提供的人造视网膜植入体结构示意图。10 is a schematic structural diagram of an artificial retinal implant provided by an embodiment of the present application.
具体实施方式detailed description
为了使本技术领域的人员更好地理解本发明中的技术方案，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都应当属于本发明保护的范围。In order to enable those skilled in the art to better understand the technical solutions in the present invention, the technical solutions in the embodiments of the present invention will be described clearly and completely in conjunction with the drawings in the embodiments of the present invention. Obviously, the described The embodiments are only a part of the embodiments of the present invention, but not all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.
需要说明的是，当元件被称为“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的另一个元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中另一个元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。It should be noted that when an element is referred to as being “disposed on” another element, it may be directly on the other element or there may be another element in the middle. When an element is considered to be "connected" to another element, it may be directly connected to another element or it may be present to center another element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and are not meant to be the only embodiments.
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的 技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present invention. The terminology used in the description of the present invention herein is for the purpose of describing specific embodiments, and is not intended to limit the present invention. The term "and/or" as used herein includes any and all combinations of one or more related listed items.
请参阅图1至图10。本申请实施方式中提供一种神经刺激电极100的硅胶封装方法。其中，所述神经刺激电极100应用于以下植入体之一：心脏起搏器、人造视网膜、人工耳蜗、除颤器、迷走神经刺激器、脊髓刺激器、颈动脉窦电刺激器、膀胱刺激器、肠胃刺激器和深脑刺激器。Please refer to Figure 1 to Figure 10. The embodiment of the present application provides a method for encapsulating the nerve stimulation electrode 100 in silicone. The nerve stimulation electrode 100 is applied to one of the following implants: cardiac pacemaker, artificial retina, cochlear implant, defibrillator, vagus nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulator, and bladder stimulator , Gastrointestinal stimulator and deep brain stimulator.
如图1所示。所述神经刺激电极100包括电极头102。所述电极头102设有能与目标神经区域相接触的刺激部。在神经刺激电极100应用于人造视网膜植入体时，刺激部能与眼球相接触。As shown in Figure 1. The nerve stimulation electrode 100 includes an electrode head 102. The electrode head 102 is provided with a stimulation part that can contact the target nerve area. When the nerve stimulation electrode 100 is applied to an artificial retinal implant, the stimulation part can contact the eyeball.
所述硅胶封装方法包括：在所述电极头102外以露出至少部分所述刺激部的方式注塑成型一硅胶套103。The silicone encapsulation method includes: injection molding a silicone sleeve 103 outside the electrode head 102 so as to expose at least part of the stimulation portion.
本实施方式中的硅胶封装方法通过在神经刺激电极100的电极头102注塑成型一硅胶套103，能够提高神经刺激电极100的机械强度，防止在植入过程中产生机械损伤，并且，在植入体内，硅胶套103也可以对神经刺激电极100起到很好的保护作用，延长神经刺激电极100的使用寿命；同时，该硅胶套103可以将电极头102上的刺激部暴露出来，便于刺激部对神经细胞进行电刺激，并不影响神经刺激电极100的正常刺激功能。The silicone packaging method in this embodiment can improve the mechanical strength of the nerve stimulation electrode 100 by injection molding a silicone sleeve 103 on the electrode head 102 of the nerve stimulation electrode 100, and prevent mechanical damage during the implantation process. In vivo, the silicone sleeve 103 can also play a good role in protecting the nerve stimulation electrode 100 and prolong the service life of the nerve stimulation electrode 100; at the same time, the silicone sleeve 103 can expose the stimulation part on the electrode head 102 to facilitate the stimulation part Electrical stimulation of nerve cells does not affect the normal stimulation function of nerve stimulation electrode 100.
本实施方式中的硅胶封装方法利用硅胶套103将电极头102封装，避免神经刺激电极100的电极板与体液接触，将电极板和体液相隔离，保护神经刺激电极100的正常工作，延长使用寿命。The silicone encapsulation method in this embodiment uses a silicone sleeve 103 to encapsulate the electrode head 102 to avoid contact between the electrode plate of the nerve stimulation electrode 100 and body fluids, and to isolate the electrode plate from the body fluid phase to protect the normal operation of the nerve stimulation electrode 100 and extend its use. life.
在本申请实施方式中，硅胶套103采用具有生物兼容性能的硅胶制成。相应的，注塑后的神经刺激电极100具有生物兼容性，可以长期植入。测试结果如下表1所示：In the embodiment of the present application, the silicone sleeve 103 is made of silicone with biocompatibility. Correspondingly, the injection-molded nerve stimulation electrode 100 is biocompatible and can be implanted for a long time. The test results are shown in Table 1 below:
表1细胞相对增值率(RGR)及毒性反应分级结果Table 1 Relative cell growth rate (RGR) and toxic reaction classification results
Figure PCTCN2019121493-appb-000001
Figure PCTCN2019121493-appb-000001
在本实施例中，神经刺激电极100包括电极板。电极板的一端设有多个电极点形成电极头102。相应的，电极板的自由端形成电极头102。电极板连接的电极头102的传输段101 宽度可以小于电极头102的宽度(在读者面对图1时的左右方向的长度即为宽度)。为对神经刺激电极100进行完整保护，传输段101也可以封装有硅胶套，本申请并不作特别的限制。In this embodiment, the nerve stimulation electrode 100 includes an electrode plate. A plurality of electrode spots are formed on one end of the electrode plate to form an electrode tip 102. Correspondingly, the free end of the electrode plate forms the electrode tip 102. The width of the transmission section 101 of the electrode head 102 connected to the electrode plate may be smaller than the width of the electrode head 102 (the length in the left-right direction when the reader faces FIG. 1 is the width). In order to completely protect the nerve stimulation electrode 100, the transmission section 101 may also be encapsulated with a silicone sleeve, which is not particularly limited in this application.
在目标神经区域位于眼球上时，为使得电极头102与眼球具有较佳的贴合度，以具有较佳的神经刺激效果，电极头102可以为弧形结构。具体的，电极头102的弧形半径为13mm-15mm。如此使得电极头102紧密的密封贴合于眼球上，使得位于硅胶套103的凹槽内的电极点密封于硅胶套103和眼球之间并与视网膜直接接触，延长使用寿命。When the target nerve area is located on the eyeball, in order to make the electrode head 102 and the eyeball have a better fit, so as to have a better nerve stimulation effect, the electrode head 102 may have an arc-shaped structure. Specifically, the arc radius of the electrode tip 102 is 13mm-15mm. In this way, the electrode head 102 is tightly sealed to the eyeball, so that the electrode point located in the groove of the silicone sleeve 103 is sealed between the silicone sleeve 103 and the eyeball and directly contacts the retina, prolonging the service life.
在本申请实施方式中，所述电极头102设有相背对的第一表面和第二表面。所述刺激部包括分别设置于所述第一表面和第二表面上的两个电极刺激区域104。所述电极刺激区域104设有多个电极点。电极刺激区域104与第一表面或第二表面基本持平，形成大致的平面结构。In the embodiment of the present application, the electrode head 102 is provided with a first surface and a second surface facing each other. The stimulation part includes two electrode stimulation regions 104 respectively provided on the first surface and the second surface. The electrode stimulation area 104 is provided with multiple electrode points. The electrode stimulation area 104 is substantially flat with the first surface or the second surface, forming a substantially planar structure.
相应的，所述硅胶封装方法包括：在所述电极头102外以露出至少一个所述电极刺激区域104的方式注塑成型一硅胶套103。Correspondingly, the silicone encapsulation method includes: injection molding a silicone sleeve 103 outside the electrode head 102 so as to expose at least one electrode stimulation area 104.
电极刺激区域104的电极点可以呈阵列排布。通过该硅胶封装方法所形成的硅胶套103具有凹槽区域，电极刺激区域104位于该凹槽区域中，暴露出来，方便与目标神经进行刺激。The electrode points of the electrode stimulation area 104 may be arranged in an array. The silicone sleeve 103 formed by the silicone encapsulation method has a groove area, and the electrode stimulation area 104 is located in the groove area, which is exposed to facilitate stimulation with the target nerve.
为方便对电极头102进行注塑封装，本申请实施方式中提供一种模具400。其中，该模具400具有型腔401。所述型腔401用于容纳所述神经刺激电极100的电极头102。所述模具被设置为在所述电极头102外以露出至少部分所述刺激部的方式注塑成型一硅胶套103。To facilitate injection molding of the electrode head 102, a mold 400 is provided in the embodiments of the present application. The mold 400 has a cavity 401. The cavity 401 is used to accommodate the electrode head 102 of the nerve stimulation electrode 100. The mold is configured to injection mold a silicone sleeve 103 outside the electrode head 102 so as to expose at least part of the stimulation portion.
如图2至图6所示。该模具400包括第一模具300和第二模具200。第一模具300和第二模具200相对接形成容纳电极头102的型腔401。第一模具300的对接表面上设有第一凹槽301，第二模具200的对接表面上设有第二凹槽201。第一凹槽301和第二凹槽201相面对对齐形成型腔401。第一凹槽301和第二凹槽201的形状可以和电极头102的形状相匹配，相应的，第一凹槽301和第二凹槽201的轮廓与电极头102的轮廓相匹配。如图9所示，在电极头102位于型腔401中时，电极头102与型腔401的内壁之间具有填充空间410以充入胶液，形成硅胶套103。As shown in Figure 2 to Figure 6. The mold 400 includes a first mold 300 and a second mold 200. The first mold 300 and the second mold 200 abut against each other to form a cavity 401 that houses the electrode head 102. The butt surface of the first mold 300 is provided with a first groove 301, and the butt surface of the second mold 200 is provided with a second groove 201. The first groove 301 and the second groove 201 are aligned facing each other to form a cavity 401. The shapes of the first groove 301 and the second groove 201 may match the shape of the electrode head 102, and accordingly, the contours of the first groove 301 and the second groove 201 match the contour of the electrode head 102. As shown in FIG. 9, when the electrode head 102 is located in the cavity 401, there is a filling space 410 between the electrode head 102 and the inner wall of the cavity 401 to be filled with glue to form a silicone sleeve 103.
第二模具200上设有注胶孔202。注胶孔202将第二模具200贯通。第一模具300的对接表面上设有进胶槽302。进胶槽302并未将第二模具200贯通。第一模具300和第一凹槽301之间设有输液槽303。在第二模具200盖合在第一模具300上时，将输液槽303盖合形成输液通道。第二模具200和第二模具200压合时，注胶孔202与进胶槽302相对齐。注胶孔202注入的胶液进入进胶槽302，再通过输液通道(输液槽303)进入型腔401中。The second mold 200 is provided with a glue injection hole 202. The glue injection hole 202 penetrates the second mold 200. A glue inlet 302 is provided on the mating surface of the first mold 300. The glue inlet 302 does not penetrate the second mold 200. An infusion tank 303 is provided between the first mold 300 and the first groove 301. When the second mold 200 is closed on the first mold 300, the infusion tank 303 is closed to form an infusion channel. When the second mold 200 and the second mold 200 are pressed together, the glue injection hole 202 is aligned with the glue inlet 302. The glue solution injected into the glue injection hole 202 enters into the glue tank 302, and then enters the cavity 401 through the infusion channel (infusion tank 303).
在本申请实施方式中，所述第一模具300、第二模具200的材质为塑料或硅胶。如图2所示，第一模具300和第二模具200为长方体结构，二者均可以为硬质塑料材质也可以为软质硅胶材质。第一模具300和第二模具200可以通过螺栓连接，通过螺栓的旋紧程度控制第一模具300和第二模具200之间的压合程度。第一模具300和第二模具200在边角位置设有相应的螺栓孔203、305，以***螺栓进行连接。In the embodiment of the present application, the material of the first mold 300 and the second mold 200 is plastic or silicone. As shown in FIG. 2, the first mold 300 and the second mold 200 have a rectangular parallelepiped structure, and both of them may be made of hard plastic material or soft silicone material. The first mold 300 and the second mold 200 may be connected by bolts, and the degree of pressing between the first mold 300 and the second mold 200 is controlled by the tightening degree of the bolts. The first mold 300 and the second mold 200 are provided with corresponding bolt holes 203 and 305 at corners to insert bolts for connection.
为使的第一模具300和第二模具200贴合紧密，方便第一模具300和第二模具200准确对准，避免对电极点形成破坏，第一模具300和第二模具200的对接表面具有弧面区域。其中，第一模具300的弧面区域304为凹面结构，第二模具200的弧面区域为凸面结构。第一凹槽301位于凹面结构的弧面区域304，第二凹槽201位于凸面结构的弧面区域。In order to make the first mold 300 and the second mold 200 fit closely, it is convenient for the first mold 300 and the second mold 200 to be accurately aligned, and to avoid damage to the electrode points, the butt surfaces of the first mold 300 and the second mold 200 have Curved area. The arc area 304 of the first mold 300 has a concave structure, and the arc area of the second mold 200 has a convex structure. The first groove 301 is located in the arc area 304 of the concave structure, and the second groove 201 is located in the arc area of the convex structure.
具体的，所述第一凹槽301与所述电极头102形状相匹配。所述第二模具200上的第二凹槽201与所述第一凹槽301形成容纳所述电极头102的型腔401。所述第一凹槽301和所述第二凹槽201中的至少一个设有面对所述刺激部凸出凹槽底面的突台420。突台420能与电极头102的表面贴合。所述突台420能将至少部分所述刺激部覆盖遮挡。优选的，所述突台420的面积不小于所述电极刺激区域104的面积。在第一模具300和第二模具200相对接时，突台420能与电极头102的表面相压合，避免胶液进入。Specifically, the first groove 301 matches the shape of the electrode head 102. The second groove 201 and the first groove 301 on the second mold 200 form a cavity 401 for accommodating the electrode head 102. At least one of the first groove 301 and the second groove 201 is provided with a protrusion 420 facing the stimulation portion and protruding from the bottom surface of the groove. The boss 420 can be attached to the surface of the electrode head 102. The protrusion 420 can cover and block at least part of the stimulation portion. Preferably, the area of the protrusion 420 is not smaller than the area of the electrode stimulation area 104. When the first mold 300 and the second mold 200 are in contact with each other, the boss 420 can be pressed against the surface of the electrode head 102 to avoid the entry of glue.
在型腔401中，在突台420外形成填充空间410。突台420的侧壁421将胶液阻挡，从而胶液无法在电极刺激区域104形成硅胶层，以此将电极刺激区域104暴露。相应的，硅胶套103对应电极刺激区域104形成凹槽。该神经刺激电极100植入体内时，硅胶套103与目标神经区域贴合，硅胶套103上的凹槽形成密闭区域，从而避免体液进入，降低对电极刺激区域104的电极点的影响，延长使用寿命，保证神经刺激电极100的正常工作。In the cavity 401, a filling space 410 is formed outside the boss 420. The side wall 421 of the boss 420 blocks the glue, so that the glue cannot form a silicone layer on the electrode stimulation area 104, thereby exposing the electrode stimulation area 104. Correspondingly, the silicone sleeve 103 forms a groove corresponding to the electrode stimulation area 104. When the nerve stimulation electrode 100 is implanted in the body, the silicone sleeve 103 is attached to the target nerve area, and the groove on the silicone sleeve 103 forms a closed area, thereby avoiding the entry of body fluids, reducing the impact on the electrode points of the electrode stimulation area 104, and extending the use The life span ensures the normal operation of the nerve stimulation electrode 100.
在本申请实施方式中，突台420的形状与电极刺激区域104的形状相匹配。如图1、图6所示，电极刺激区域104呈矩形形状，分布有阵列排布的多个电极点。突台420同样呈矩形，突台420的面积稍大于电极刺激区域104的面积。图7所示突台420压合在电极头102的状态，突台420外的填充空间410进入胶液形成包裹在电极头102上的硅胶套103。In the embodiment of the present application, the shape of the boss 420 matches the shape of the electrode stimulation area 104. As shown in FIGS. 1 and 6, the electrode stimulation area 104 has a rectangular shape, and a plurality of electrode points arranged in an array are distributed. The boss 420 is also rectangular, and the area of the boss 420 is slightly larger than the area of the electrode stimulation area 104. As shown in FIG. 7, the protrusion 420 is pressed against the electrode tip 102, and the filling space 410 outside the protrusion 420 enters the glue solution to form a silicone sleeve 103 wrapped on the electrode tip 102.
在第二模具200盖合在第一模具300上时，突台420盖合在电极刺激区域104的上方，突台420的边缘可以与电极刺激区域104周侧的电极头102表面相接触压合，形成密封，避免胶液进入。如此，胶液凝固形成硅胶套103后，在电极刺激区域104形成一凹槽，电极点暴露在该凹槽中。When the second mold 200 covers the first mold 300, the protrusion 420 covers the electrode stimulation area 104, and the edge of the protrusion 420 may be in contact with the surface of the electrode head 102 on the periphery of the electrode stimulation area 104 To form a seal to avoid the entry of glue. In this way, after the gel is solidified to form the silicone sleeve 103, a groove is formed in the electrode stimulation area 104, and the electrode point is exposed in the groove.
在一个具体的实施例中，所述硅胶封装方法包括以下步骤：In a specific embodiment, the silicone encapsulation method includes the following steps:
S100、将所述电极头102放置于第一模具300的第一凹槽301中；S100. Place the electrode head 102 in the first groove 301 of the first mold 300;
S200、将第二模具200盖合在所述第一模具300上；S200. Cover the second mold 200 with the first mold 300;
S300、通过所述第二模具200上的注胶孔202向所述型腔401中注入胶液形成硅胶套103。S300. Inject glue into the cavity 401 through the glue injection hole 202 on the second mold 200 to form a silicone sleeve 103.
为方便将电极头102定位在模具中，所述第一凹槽301设有定位凸起306。所述电极头102设有用于将所述神经刺激电极100定位于眼球上的定位孔105。定位凸起306可以为圆柱形结构，可以***电极头102的定位孔105中。电极头102的定位孔105位于第一表面或第二表面中电极刺激区域104的其他区域。第二凹槽201中还设有对接凸起204。在第一模具300和第二模具200对接时，定位凸起306和对接凸起204相对接，以在硅胶套103上形成相应的贯通孔。To facilitate positioning the electrode head 102 in the mold, the first groove 301 is provided with positioning protrusions 306. The electrode head 102 is provided with a positioning hole 105 for positioning the nerve stimulation electrode 100 on the eyeball. The positioning protrusion 306 may be a cylindrical structure, and may be inserted into the positioning hole 105 of the electrode head 102. The positioning holes 105 of the electrode head 102 are located in other areas of the electrode stimulation area 104 in the first surface or the second surface. The second groove 201 is also provided with a docking protrusion 204. When the first mold 300 and the second mold 200 are butted, the positioning protrusion 306 and the butt protrusion 204 are butted to form corresponding through holes in the silicone sleeve 103.
在步骤S100中，将所述电极头102放置于第一模具300的第一凹槽301中时，所述定位凸起306***所述定位孔105中。具体的，在放置电极头102时将定位凸起306与定位孔105相对齐，施力将定位凸起306穿过定位孔105，实现电极头102的初定位，再将第二模具200盖合在第一模具300上。In step S100, when the electrode head 102 is placed in the first groove 301 of the first mold 300, the positioning protrusion 306 is inserted into the positioning hole 105. Specifically, when the electrode head 102 is placed, the positioning protrusion 306 is aligned with the positioning hole 105, and the positioning protrusion 306 is forced to pass through the positioning hole 105 to achieve the initial positioning of the electrode head 102, and then the second mold 200 is closed On the first mold 300.
在步骤S300中，为避免对神经刺激电极100形成破坏，在注胶压力达到预定压力时停止注胶。预定压力可以根据电极头102的承受压力确定，本申请并不作具体限定。其他实施例中，可以在所述注胶孔202溢出胶液时停止注胶。In step S300, in order to avoid damage to the nerve stimulation electrode 100, the glue injection is stopped when the glue injection pressure reaches a predetermined pressure. The predetermined pressure may be determined according to the withstand pressure of the electrode head 102, which is not specifically limited in this application. In other embodiments, the glue injection may be stopped when the glue injection hole 202 overflows with glue.
在一个实施例中，所述第一凹槽301的凹槽底面设有所述突台420。所述第二凹槽201的凹槽底面未设有所述突台420。突台420的侧壁421能对胶液形成阻挡。在本申请实施 方式所提供的硅胶封装方法中，所述电极头102位于所述型腔401内时，所述电极刺激区域104与所述突台420相对齐。相应的，在所述电极头102外以露出一个所述电极刺激区域104的方式注塑成型一硅胶套103。在该实施例中，电极头102另一侧的电极刺激区域104覆盖有硅胶套103，只暴露出一侧的电极刺激区域104，对目标神经进行刺激。In one embodiment, the bottom surface of the groove of the first groove 301 is provided with the protrusion 420. The protrusion 420 is not provided on the bottom surface of the second groove 201. The side wall 421 of the boss 420 can block the glue. In the silicone packaging method provided in the embodiment of the present application, when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 is aligned with the protrusion 420. Correspondingly, a silicone sleeve 103 is injection-molded outside the electrode head 102 in such a way that one electrode stimulation area 104 is exposed. In this embodiment, the electrode stimulation area 104 on the other side of the electrode head 102 is covered with a silicone sleeve 103, and only the electrode stimulation area 104 on one side is exposed to stimulate the target nerve.
优选的，为防止对电极点上的纳米结构形成破坏，保护电极点，所述突台420设有沿与所述突台420凸出方向相反方向凹陷的凹陷部425。所述突台420在所述凹陷部425的周侧形成挡壁426。Preferably, in order to prevent the nanostructures on the electrode dots from being damaged and protect the electrode dots, the boss 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protrusion direction of the boss 420. The boss 420 forms a blocking wall 426 on the peripheral side of the recessed portion 425.
所述硅胶封装方法包括：所述电极头102位于所述型腔401时，所述电极头102的电极刺激区域104与所述凹陷部425相对齐。所述挡壁426围构在所述电极刺激区域104周侧并与电极头102的表面相贴合并与电极头102的表面相贴合。电极刺激区域104位于凹陷部425中，挡壁426围绕在电极刺激区域104周围。在本实施例中，突台420的侧壁421能对胶液形成阻挡，避免胶液将电极刺激区域104覆盖。The silicone encapsulation method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 of the electrode head 102 is aligned with the concave portion 425. The blocking wall 426 surrounds the electrode stimulation area 104 and is in contact with the surface of the electrode head 102 and the surface of the electrode head 102. The electrode stimulation area 104 is located in the depression 425, and the blocking wall 426 surrounds the electrode stimulation area 104. In this embodiment, the side wall 421 of the boss 420 can form a barrier to the glue to prevent the glue from covering the electrode stimulation area 104.
在另一个实施例中，所述第一凹槽301和所述第二凹槽201的凹槽底面设有所述突台420。相应的，所述硅胶封装方法包括：所述电极头102位于所述型腔401内时，所述电极刺激区域104与所述突台420相对齐；相应的，在所述电极头102外以露出两个所述电极刺激区域104的方式注塑成型一硅胶套103。In another embodiment, the protrusions 420 are provided on the bottom surfaces of the first groove 301 and the second groove 201. Correspondingly, the silicone encapsulation method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 is aligned with the protrusion 420; correspondingly, outside the electrode head 102 A silicone sleeve 103 is injection molded by exposing the two electrode stimulation areas 104.
在该实施例中，电极头102两侧的电极刺激区域104均被暴露出来，以对目标神经进行刺激。如此可以暴露出更多的电极点，形成更广泛的电极刺激。In this embodiment, the electrode stimulation areas 104 on both sides of the electrode head 102 are exposed to stimulate the target nerve. In this way, more electrode points can be exposed to form a wider range of electrode stimuli.
在本实施例中，所述突台420设有沿与所述突台420凸出方向相反方向凹陷的凹陷部425。所述突台420在所述凹陷部425的周侧形成挡壁426。所述硅胶封装方法包括：所述电极头102位于所述型腔401时，所述电极头102的电极刺激区域104与所述凹陷部425相对齐；所述挡壁426围构在所述电极刺激区域104周侧并与电极头102的表面相贴合。电极刺激区域104位于凹陷部425中，挡壁426围绕在电极刺激区域104周围。在本实施例中，突台420的侧壁421能对胶液形成阻挡，避免胶液将电极刺激区域104覆盖。In this embodiment, the boss 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protrusion direction of the boss 420. The boss 420 forms a blocking wall 426 on the peripheral side of the recessed portion 425. The silicone packaging method includes: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 of the electrode head 102 is aligned with the recessed portion 425; the blocking wall 426 surrounds the electrode The stimulation area 104 surrounds and contacts the surface of the electrode head 102. The electrode stimulation area 104 is located in the depression 425, and the blocking wall 426 surrounds the electrode stimulation area 104. In this embodiment, the side wall 421 of the boss 420 can form a barrier to the glue to prevent the glue from covering the electrode stimulation area 104.
本申请实施方式中还提供一种神经刺激电极，应用于上述任一所述的硅胶封装方法制造。该神经刺激电极可以应用于如图10示出的人造视网膜植入体中。The embodiment of the present application further provides a nerve stimulation electrode, which is applied to any of the above-mentioned silicone packaging methods. The nerve stimulation electrode can be applied to an artificial retinal implant as shown in FIG.
如图10所示。本申请实施方式中还提供一种硅胶封装的人造视网膜植入体，其包括：线圈基体1，其包括传输线圈和与眼球形状相匹配的硅胶片套11，所述传输线圈封装于所述硅胶片套11内，所述硅胶片套11的两端由绷带4连接，所述硅胶片套11通过所述绷带4能固设于眼球；集成封装体2，其固设于所述线圈基体1上，所述集成封装体2包括硅胶筒套21和封装于所述硅胶筒套21内的钛筒，所述钛筒内设有基板，所述传输线圈与所述基板电连接；神经电极3，其包括硅胶弧套31和电极板32，所述电极板32设于所述硅胶弧套31内，所述硅胶弧套31的一端与所述集成封装体2的侧壁相连，所述硅胶弧套31的另一端与所述眼球的形状相匹配并设有凹槽，所述电极板32的一端伸出所述硅胶弧套31并与所述集成封装体2内的所述基板相连，所述电极板32的另一端设有能与所述眼球相接触的刺激部321，所述刺激部321位于所述凹槽311内。As shown in Figure 10. An embodiment of the present application further provides a silicone-encapsulated artificial retinal implant, which includes: a coil base 1, which includes a transmission coil and a silicone sleeve 11 matching the shape of the eyeball, the transmission coil being encapsulated in the silicone In the sheet sleeve 11, both ends of the silicone sheet sleeve 11 are connected by a bandage 4, and the silicone sheet sleeve 11 can be fixed to the eyeball through the bandage 4; the integrated package 2 is fixed to the coil base 1 Above, the integrated package 2 includes a silicone sleeve 21 and a titanium sleeve encapsulated in the silicone sleeve 21, the titanium sleeve is provided with a substrate, the transmission coil is electrically connected to the substrate; the nerve electrode 3 , Which includes a silicone arc sleeve 31 and an electrode plate 32, the electrode plate 32 is provided in the silicone arc sleeve 31, one end of the silicone arc sleeve 31 is connected to the side wall of the integrated package 2, the silicone The other end of the arc sleeve 31 matches the shape of the eyeball and is provided with a groove, and one end of the electrode plate 32 extends out of the silicone arc sleeve 31 and is connected to the substrate in the integrated package 2, The other end of the electrode plate 32 is provided with a stimulation part 321 that can contact the eyeball, and the stimulation part 321 is located in the groove 311.
在神经电极3可以应用如上任一实施方式或实施例披露的神经刺激电极100，此处不再赘述。As the nerve electrode 3, the nerve stimulation electrode 100 disclosed in any of the above embodiments or examples may be used, and details are not described herein again.
其中，该人造视网膜植入体可以参考专利申请“2017113637331”名称为“硅胶封装 的人造视网膜植入体”，其内容通过援引全部结合于此，此处不再一一赘述。Among them, the artificial retinal implant can refer to the patent application “2017113637331” titled “silicone encapsulated artificial retinal implant”, the contents of which are incorporated herein by reference, and will not be repeated here.
本申请实施方式中还提供一种神经刺激电极的硅胶封装设备，所述神经刺激电极包括电极头。所述电极头设有能与目标神经区域相接触的刺激部。所述硅胶封装设备包括：具有型腔的模具，所述型腔用于容纳所述神经刺激电极的电极头。所述模具被设置为在所述电极头外以露出至少部分所述刺激部的方式注塑成型一硅胶套。Embodiments of the present application also provide a silicone encapsulation device for nerve stimulation electrodes, where the nerve stimulation electrodes include electrode tips. The electrode head is provided with a stimulation part that can contact the target nerve area. The silicone encapsulation device includes a mold having a cavity for accommodating the electrode tip of the nerve stimulation electrode. The mold is configured to injection mold a silicone sleeve outside the electrode head in such a manner that at least part of the stimulation portion is exposed.
披露的所有文章和参考资料，包括专利申请和出版物，出于各种目的通过援引结合于此。描述组合的术语“基本由…构成”应该包括所确定的元件、成分、部件或步骤以及实质上没有影响该组合的基本新颖特征的其他元件、成分、部件或步骤。使用术语“包含”或“包括”来描述这里的元件、成分、部件或步骤的组合也想到了基本由这些元件、成分、部件或步骤构成的实施方式。这里通过使用术语“可以”，旨在说明“可以”包括的所描述的任何属性都是可选的。All articles and references disclosed, including patent applications and publications, are incorporated by reference for various purposes. The term "consisting essentially of" describing a combination should include the identified elements, ingredients, components or steps and other elements, ingredients, components or steps that do not substantially affect the basic novel features of the combination. The use of the terms "comprising" or "including" to describe combinations of elements, ingredients, components or steps herein also contemplates embodiments that consist essentially of these elements, ingredients, components or steps. By using the term "may" here, it is intended to illustrate that any attributes described in "may" are optional.
多个元件、成分、部件或步骤能够由单个集成元件、成分、部件或步骤来提供。另选地，单个集成元件、成分、部件或步骤可以被分成分离的多个元件、成分、部件或步骤。用来描述元件、成分、部件或步骤的公开“一”或“一个”并不说为了排除其他的元件、成分、部件或步骤。Multiple elements, ingredients, components or steps can be provided by a single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step may be divided into separate multiple elements, ingredients, components or steps. The disclosure of "a" or "an" used to describe an element, ingredient, component or step is not intended to exclude other elements, ingredients, components or steps.
应该理解，以上描述是为了进行图示说明而不是为了进行限制。通过阅读上述描述，在所提供的示例之外的许多实施方式和许多应用对本领域技术人员来说都将是显而易见的。因此，本教导的范围不应该参照上述描述来确定，而是应该参照所附权利要求以及这些权利要求所拥有的等价物的全部范围来确定。出于全面之目的，所有文章和参考包括专利申请和公告的公开都通过参考结合在本文中。在前述权利要求中省略这里公开的主题的任何方面并不是为了放弃该主体内容，也不应该认为发明人没有将该主题考虑为所公开的发明主题的一部分。It should be understood that the above description is for illustration and not for limitation. From reading the above description, many embodiments and many applications beyond the provided examples will be apparent to those skilled in the art. Therefore, the scope of the present teaching should not be determined with reference to the above description, but should be determined with reference to the appended claims and the full scope of equivalents possessed by these claims. For comprehensive purposes, all articles and references including patent applications and publications of publications are incorporated herein by reference. The omission of any aspect of the subject matter disclosed herein in the preceding claims is not intended to abandon the subject matter, nor should it be considered that the inventor did not consider the subject matter as part of the disclosed subject matter.

Claims (14)

  1. 一种神经刺激电极的硅胶封装方法，其特征在于，所述神经刺激电极包括电极头；所述电极头设有能与目标神经区域相接触的刺激部；所述硅胶封装方法包括在所述电极头外以露出至少部分所述刺激部的方式注塑成型一硅胶套。A silicone encapsulation method for nerve stimulation electrodes, characterized in that the nerve stimulation electrode includes an electrode tip; the electrode tip is provided with a stimulation part that can contact the target nerve area; and the silicone encapsulation method includes the electrode A silicone sleeve is injection molded outside the head in such a way that at least part of the stimulation part is exposed.
  2. 如权利要求1所述硅胶封装方法，其特征在于，所述电极头设有相背对的第一表面和第二表面；所述刺激部包括分别设置于所述第一表面和第二表面上的两个电极刺激区域；所述电极刺激区域设有多个电极点；The method of claim 1, wherein the electrode head is provided with a first surface and a second surface facing away from each other; the stimulation part includes a first surface and a second surface, respectively Two electrode stimulation areas; the electrode stimulation area is provided with multiple electrode points;
    相应的，所述硅胶封装方法包括：Correspondingly, the silicone encapsulation method includes:
    在所述电极头外以露出至少一个所述电极刺激区域的方式注塑成型一硅胶套。A silicone sleeve is injection-molded outside the electrode head in such a manner that at least one electrode stimulation area is exposed.
  3. 如权利要求2所述硅胶封装方法，其特征在于，所述硅胶封装方法包括：The method of encapsulating silica gel according to claim 2, wherein the method of encapsulating silica gel comprises:
    将所述电极头放置于第一模具的第一凹槽中；其中，所述第一凹槽与所述电极头形状相匹配；Placing the electrode head in the first groove of the first mold; wherein the first groove matches the shape of the electrode head;
    将第二模具盖合在所述第一模具上；所述第二模具上的第二凹槽与所述第一凹槽形成容纳所述电极头的型腔；所述第一凹槽和所述第二凹槽中的至少一个设有面对所述刺激部凸出凹槽底面的突台；所述突台将所述电极刺激区域覆盖遮挡；所述突台的面积不小于所述电极刺激区域的面积；The second mold is covered on the first mold; the second groove on the second mold and the first groove form a cavity for accommodating the electrode head; the first groove and the At least one of the second grooves is provided with a protrusion facing the bottom surface of the protrusion protruding groove; the protrusion covers and shields the electrode stimulation area; the area of the protrusion is not smaller than the electrode The area of the stimulation area;
    通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套。Inject glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve.
  4. 如权利要求3所述硅胶封装方法，其特征在于，所述第一凹槽的凹槽底面设有所述突台；所述第二凹槽的凹槽底面未设有所述突台；The method of claim 3, wherein the bottom surface of the groove of the first groove is provided with the protrusion; the bottom surface of the groove of the second groove is not provided with the protrusion;
    所述硅胶封装方法包括：The silicone encapsulation method includes:
    所述电极头位于所述型腔内时，所述电极刺激区域与所述突台相对齐；相应的，在所述电极头外以露出一个所述电极刺激区域的方式注塑成型一硅胶套。When the electrode head is located in the cavity, the electrode stimulation area is aligned with the protrusion; correspondingly, a silicone sleeve is injection-molded outside the electrode head in such a way that one electrode stimulation area is exposed.
  5. 如权利要求3所述硅胶封装方法，其特征在于，所述第一凹槽和所述第二凹槽的凹槽底面设有所述突台；The method of claim 3, wherein the protrusions are provided on the bottom surfaces of the grooves of the first groove and the second groove;
    所述硅胶封装方法包括：The silicone encapsulation method includes:
    所述电极头位于所述型腔内时，所述电极刺激区域与所述突台相对齐；相应的，在所述电极头外以露出两个所述电极刺激区域的方式注塑成型一硅胶套。When the electrode head is located in the cavity, the electrode stimulation area is aligned with the protrusion; accordingly, a silicone sleeve is injection-molded outside the electrode head in a manner that exposes the two electrode stimulation areas .
  6. 如权利要求4或5所述硅胶封装方法，其特征在于，所述突台设有沿与所述突台凸出方向相反方向凹陷的凹陷部；所述突台在所述凹陷部的周侧形成挡壁；The method of claim 4 or 5, wherein the boss is provided with a recessed portion that is recessed in a direction opposite to the protrusion direction of the boss; the boss is on the peripheral side of the recessed portion Forming a barrier;
    所述硅胶封装方法包括：The silicone encapsulation method includes:
    所述电极头位于所述型腔时，所述电极头的电极刺激区域与所述凹陷部相对齐；所述挡壁围构在所述电极刺激区域周侧并与电极头的表面相贴合。When the electrode head is located in the cavity, the electrode stimulation area of the electrode head is aligned with the recessed portion; the baffle wall surrounds the electrode stimulation area and conforms to the surface of the electrode head .
  7. 如权利要求3所述硅胶封装方法，其特征在于，所述第一凹槽设有定位凸起；所述电极头设有用于将所述神经刺激电极定位于眼球上的定位孔；The method of claim 3, wherein the first groove is provided with a positioning protrusion; the electrode head is provided with a positioning hole for positioning the nerve stimulation electrode on the eyeball;
    所述硅胶封装方法包括：The silicone encapsulation method includes:
    将所述电极头放置于第一模具的第一凹槽中时，所述定位凸起***所述定位孔中。When the electrode head is placed in the first groove of the first mold, the positioning protrusion is inserted into the positioning hole.
  8. 如权利要求3所述硅胶封装方法，其特征在于，在所述通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套步骤中：在注胶压力达到预定压力时停止注胶。The method of claim 3, wherein in the step of injecting glue into the cavity through the glue injection hole in the second mold to form a silicone sleeve: when the glue injection pressure reaches a predetermined pressure Stop glue injection.
  9. 如权利要求3所述硅胶封装方法，其特征在于，在所述通过所述第二模具上的注胶孔向所述型腔中注入胶液形成硅胶套步骤中：在所述注胶孔溢出胶液时停止注胶。The method of claim 3, wherein in the step of injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve: overflowing the glue injection hole Stop glue injection when glue is applied.
  10. 如权利要求3所述硅胶封装方法，其特征在于，所述第一模具、第二模具的材质为塑料或硅胶。The method of claim 3, wherein the material of the first mold and the second mold is plastic or silicone.
  11. 如权利要求1所述硅胶封装方法，其特征在于，所述神经刺激电极应用于以下植入体之一：心脏起搏器、人造视网膜、人工耳蜗、除颤器、迷走神经刺激器、脊髓刺激器、颈动脉窦电刺激器、膀胱刺激器、肠胃刺激器和深脑刺激器。The silicone encapsulation method according to claim 1, wherein the nerve stimulation electrode is applied to one of the following implants: cardiac pacemaker, artificial retina, cochlear implant, defibrillator, vagus nerve stimulator, spinal cord stimulator , Carotid sinus electrical stimulator, bladder stimulator, gastrointestinal stimulator and deep brain stimulator.
  12. 一种神经刺激电极，其特征在于，应用于上述权利要求1-11任一所述的硅胶封装方法制造。A nerve stimulation electrode, characterized in that it is applied to the silicone packaging method of any one of claims 1-11.
  13. 一种人造视网膜植入体，其特征在于，包括如权利要求12所述的神经刺激电极。An artificial retinal implant, characterized by comprising the nerve stimulation electrode according to claim 12.
  14. 一种神经刺激电极的硅胶封装设备，其特征在于，所述神经刺激电极包括电极头；所述电极头设有能与目标神经区域相接触的刺激部；所述硅胶封装设备包括：具有型腔的模具，所述型腔用于容纳所述神经刺激电极的电极头；所述模具被设置为在所述电极头外以露出至少部分所述刺激部的方式注塑成型一硅胶套。A silicone encapsulating device for nerve stimulation electrodes, characterized in that the nerve stimulating electrode includes an electrode head; the electrode head is provided with a stimulation part that can contact the target nerve area; and the silicone encapsulation device includes: a cavity The mold cavity is used for accommodating the electrode head of the nerve stimulation electrode; the mold is configured to inject a silicone sleeve outside the electrode head so as to expose at least part of the stimulation part.
PCT/CN2019/121493 2018-12-12 2019-11-28 Nerve stimulation electrode, implant, silicone packaging method, and silicone packaging device WO2020119466A1 (en)

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