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

Abstract

The present application discloses a neural stimulation electrode, an implant, a silicone packaging method, and a silicone packaging device, wherein the neural stimulation electrode comprises an electrode head; the electrode head is provided with a stimulation portion capable of contacting a target nerve region; the silicone packaging method comprises injection molding a silicone sleeve outside the electrode head in a manner of exposing at least a portion of the stimulation portion. The neural stimulation electrode, implant, silicone packaging method, and silicone packaging device provided in the present application can effectively protect the neural stimulation electrode and do not interfere with the stimulation function of the neural stimulation electrode.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a neural stimulation electrode, an implant, a silicone packaging method, and a silicone packaging device. Background Art

[0002] Implantable neurostimulators have a wide range of applications in medicine, such as cochlear implants, artificial retinas, and brain electrical stimulation systems. Microelectrodes, as an important tool for revealing the working mechanism of the nervous system and treating neurological diseases, are gaining more and more attention and have become an important research direction.

[0003] During the implantation process of active implantable medical devices, neural 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 damaged 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 using other intact visual pathways, it can also produce light perception in the cerebral cortex, thereby partially restoring the patient's vision. The stimulation signal generated by the stimulation electrode directly determines the intensity of the patient's light perception in the cerebral cortex.

[0004] After the active implantable medical device is implanted, its electronic components are particularly sensitive to water vapor and oxygen in body fluids. To ensure the performance and service life of the electronic components, they need to be packaged. During the packaging, the electrode stimulation points need to be exposed so that the electrode stimulation points can contact the nerve cells and generate stimulation signals. However, the existing packaging process is complicated and it is not easy to implant after packaging. In addition, the existing active implantable medical devices have low mechanical strength, which greatly affects their service life. Summary of the invention

[0005] The purpose of the present application is to provide a neural stimulation electrode, a silicone packaging method and a silicone packaging device, so as to effectively protect the neural stimulation electrode without interfering with the stimulation function of the neural stimulation electrode.

[0006] The technical solution of this application is as follows:

[0007] A silicone packaging method for a nerve stimulation electrode, the nerve stimulation electrode comprising an electrode head; the electrode head is provided with a stimulation part capable of contacting a target nerve area; the silicone packaging method comprises injection molding a silicone sleeve outside the electrode head in a manner of exposing at least a portion of the stimulation part.

[0008] As a preferred embodiment, the electrode head is provided with a first surface and a second surface facing each other; the stimulation part comprises two electrode stimulation areas respectively provided on the first surface and the second surface; the electrode stimulation area is provided with a plurality of electrode points;

[0009] Accordingly, the silica gel packaging method includes:

[0010] A silicone sleeve is injection molded outside the electrode head in a manner of exposing at least one electrode stimulation area.

[0011] As a preferred embodiment, the silica gel packaging method includes:

[0012] Placing the electrode head in a first groove of a first mold; wherein the first groove matches the shape of the electrode head;

[0013] 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; at least one of the first groove and the second groove is provided with a protrusion facing the bottom surface of the protruding groove of the stimulation part; the protrusion covers and shields the electrode stimulation area; the area of ​​the protrusion is not less than the area of ​​the electrode stimulation area;

[0014] The glue liquid is injected into the cavity through the glue injection hole on the second mold to form a silicone sleeve.

[0015] As a preferred embodiment, the bottom surface of the first groove is provided with the protrusion; the bottom surface of the second groove is not provided with the protrusion;

[0016] The silica gel packaging method comprises:

[0017] 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 a manner of exposing the electrode stimulation area.

[0018] As a preferred embodiment, the bottom surfaces of the first groove and the second groove are provided with the protrusion;

[0019] The silica gel packaging method comprises:

[0020] When the electrode head is located in the mold cavity, the electrode stimulation area is aligned with the protrusion; correspondingly, a silicone sleeve is injection molded outside the electrode head in a manner of exposing the two electrode stimulation areas.

[0021] As a preferred embodiment, the boss is provided with a recessed portion which is recessed in a direction opposite to the protruding direction of the boss; the boss forms a retaining wall on the peripheral side of the recessed portion;

[0022] The silica gel packaging method comprises:

[0023] When the electrode head is located in the cavity, the electrode stimulation area of ​​the electrode head is aligned with the recessed portion; the retaining wall surrounds the electrode stimulation area and fits with the surface of the electrode head.

[0024] 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;

[0025] The silica gel packaging method comprises:

[0026] When the electrode head is placed in the first groove of the first mold, the positioning protrusion is inserted into the positioning hole.

[0027] As a preferred embodiment, in the step of injecting glue into the cavity through the glue injection hole on the second mold to form the silicone sleeve: the glue injection is stopped when the glue injection pressure reaches a predetermined pressure.

[0028] As a preferred embodiment, in the step of injecting glue into the cavity through the glue injection hole on the second mold to form the silicone sleeve: the glue injection is stopped when the glue overflows from the glue injection hole.

[0029] As a preferred implementation, the first mold and the second mold are made of plastic or silicone.

[0030] As a preferred embodiment, the neural stimulation electrode is applied to one of the following implants: a pacemaker, an artificial retina, an artificial cochlear implant, a defibrillator, a vagus nerve stimulator, a spinal cord stimulator, a carotid sinus stimulator, a bladder stimulator, a gastrointestinal stimulator and a deep brain stimulator.

[0031] A nerve stimulation electrode is manufactured using the silicone encapsulation method described in any of the above embodiments.

[0032] An artificial retina implant comprises the neural stimulation electrode as described above.

[0033] A silicone packaging device for a nerve stimulation electrode, the nerve stimulation electrode comprising an electrode head; the electrode head is provided with a stimulation portion capable of contacting a target nerve area; the silicone packaging device comprises: a mold having a cavity, the cavity being used to accommodate the electrode head of the nerve stimulation electrode; the mold being configured to injection mold a silicone sleeve outside the electrode head in a manner of exposing at least a portion of the stimulation portion.

[0034] Beneficial effects:

[0035] The silicone packaging method in this embodiment can improve the mechanical strength of the nerve stimulation electrode and prevent mechanical damage during the implantation process by injection molding a silicone sleeve on the electrode head of the nerve stimulation electrode. Moreover, when implanted in the body, the silicone sleeve can also play a good protective role for 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 to facilitate the stimulation part to electrically stimulate nerve cells without affecting the normal stimulation function of the nerve stimulation electrode.

[0036] With reference to the following description and accompanying drawings, specific embodiments of the present invention are disclosed in detail, indicating the manner in which the principles of the present invention can be adopted. It should be understood that the embodiments of the present invention are not limited in scope. Within the spirit and scope of the appended claims, the embodiments of the present invention include many changes, modifications and equivalents.

[0037] Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments, combined with features in other embodiments, or substituted for features in other embodiments.

[0038] It should be emphasized that the term “include / comprises” when used herein refers to the presence of features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps or components. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without paying creative labor.

[0040] Figure 1 It is a partial structural schematic diagram of a nerve stimulation electrode provided in one embodiment of the present application;

[0041] Figure 2 Yes Figure 1 Encapsulated mold;

[0042] Figure 3 yes Figure 2 Schematic diagram of the second mold;

[0043] Figure 4 yes Figure 3 A partial enlarged view of

[0044] Figure 5 yes Figure 2 A schematic diagram of a first mold;

[0045] Figure 6 yes Figure 5 A partial enlarged view of

[0046] Figure 7 This is a schematic diagram of the state of double-sided packaging of an electrode head in one embodiment of the present application;

[0047] Figure 8 is a schematic diagram of a mold cavity provided by an embodiment of the present application;

[0048] Fig. 9 yes Figure 8 Schematic diagram of the double-sided packaging of the electrode head;

[0049] Fig.10 This is a schematic diagram of the structure of an artificial retinal implant provided in one embodiment of the present application. DETAILED DESCRIPTION

[0050] 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 clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0051] 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 centered thereon. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be another element centered thereon at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0053] See also Figures 1 to 10In an embodiment of the present application, a method for silicone packaging of a neural stimulation electrode 100 is provided. The neural stimulation electrode 100 is applied to one of the following implants: a cardiac pacemaker, an artificial retina, an artificial cochlear implant, a defibrillator, a vagus nerve stimulator, a spinal cord stimulator, a carotid sinus stimulator, a bladder stimulator, a gastrointestinal stimulator, and a deep brain stimulator.

[0054] like Figure 1 As shown. The nerve stimulation electrode 100 includes an electrode head 102. The electrode head 102 is provided with a stimulation portion that can contact the target nerve area. When the nerve stimulation electrode 100 is applied to an artificial retinal implant, the stimulation portion can contact the eyeball.

[0055] The silicone packaging method includes: injection molding a silicone sleeve 103 outside the electrode head 102 in a manner of exposing at least a portion of the stimulation part.

[0056] The silicone packaging method in this embodiment can improve the mechanical strength of the nerve stimulation electrode 100 and prevent mechanical damage during the implantation process by injection molding a silicone sleeve 103 on the electrode head 102 of the nerve stimulation electrode 100. Moreover, when implanted in the body, the silicone sleeve 103 can also play a good protective role for the nerve stimulation electrode 100 and extend 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, which is convenient for the stimulation part to electrically stimulate nerve cells without affecting the normal stimulation function of the nerve stimulation electrode 100.

[0057] The silicone encapsulation method in this embodiment uses a silicone sleeve 103 to encapsulate the electrode head 102, thereby preventing the electrode plate of the nerve stimulation electrode 100 from contacting the body fluid, isolating the electrode plate from the body fluid, protecting the normal operation of the nerve stimulation electrode 100, and extending the service life.

[0058] In the embodiment of the present application, the silicone sleeve 103 is made of silicone with biocompatibility. Accordingly, the injection-molded nerve stimulation electrode 100 has biocompatibility and can be implanted for a long time. The test results are shown in Table 1 below:

[0059] Table 1 Cell relative proliferation rate (RGR) and toxicity grading results

[0060]

[0061] In this embodiment, the nerve stimulation electrode 100 includes an electrode plate. One end of the electrode plate is provided with a plurality of electrode points to form an electrode head 102. Accordingly, the free end of the electrode plate forms the electrode head 102. The width of the transmission section 101 of the electrode head 102 connected to the electrode plate can be smaller than the width of the electrode head 102 (when the reader is facing Figure 1In order to fully protect the nerve stimulation electrode 100, the transmission section 101 may also be encapsulated with a silicone sleeve, which is not particularly limited in the present application.

[0062] When the target nerve area is located on the eyeball, in order to make the electrode head 102 have a better fit with the eyeball and have a better nerve stimulation effect, the electrode head 102 can be an arc-shaped structure. Specifically, the arc radius of the electrode head 102 is 13mm-15mm. In this way, the electrode head 102 is tightly sealed and fit on 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, extending the service life.

[0063] 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 areas 104 respectively provided on the first surface and the second surface. The electrode stimulation area 104 is provided with a plurality of electrode points. The electrode stimulation area 104 is substantially flush with the first surface or the second surface, forming a roughly planar structure.

[0064] Correspondingly, the silicone packaging method includes: injection molding a silicone sleeve 103 outside the electrode head 102 in a manner of exposing at least one electrode stimulation area 104 .

[0065] The electrode points of the electrode stimulation area 104 can be arranged in an array. The silicone sleeve 103 formed by the silicone packaging method has a groove area, and the electrode stimulation area 104 is located in the groove area and exposed to facilitate stimulation of the target nerve.

[0066] In order to facilitate the injection molding of the electrode head 102, a mold 400 is provided in an embodiment 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 in a manner that at least a portion of the stimulation portion is exposed.

[0067] like Figures 2 to 6 As shown. The mold 400 includes a first mold 300 and a second mold 200. The first mold 300 and the second mold 200 are connected to form a cavity 401 for accommodating the electrode head 102. A first groove 301 is provided on the connecting surface of the first mold 300, and a second groove 201 is provided on the connecting surface of the second mold 200. The first groove 301 and the second groove 201 are aligned facing each other to form the cavity 401. The shapes of the first groove 301 and the second groove 201 can match the shape of the electrode head 102, and accordingly, the contours of the first groove 301 and the second groove 201 match the contours of the electrode head 102. As shown Fig. 9As shown, when the electrode head 102 is located in the cavity 401 , a filling space 410 is provided between the electrode head 102 and the inner wall of the cavity 401 to be filled with glue to form a silicone sleeve 103 .

[0068] The second mold 200 is provided with a glue injection hole 202. The glue injection hole 202 penetrates the second mold 200. A glue feed groove 302 is provided on the docking surface of the first mold 300. The glue feed groove 302 does not penetrate the second mold 200. An infusion groove 303 is provided between the first mold 300 and the first groove 301. When the second mold 200 is covered on the first mold 300, the infusion groove 303 is covered 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 feed groove 302. The glue injected into the glue injection hole 202 enters the glue feed groove 302, and then enters the mold cavity 401 through the infusion channel (infusion groove 303).

[0069] In the embodiment of the present application, the first mold 300 and the second mold 200 are made of plastic or silicone. Figure 2 As shown, the first mold 300 and the second mold 200 are rectangular parallelepiped structures, and both can be made of hard plastic or soft silicone. The first mold 300 and the second mold 200 can 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 the corners to insert bolts for connection.

[0070] In order to make the first mold 300 and the second mold 200 fit tightly, facilitate accurate alignment of the first mold 300 and the second mold 200, and avoid damage to the electrode points, the first mold 300 and the second mold 200 have a curved surface area on their mating surfaces. The curved surface area 304 of the first mold 300 is a concave structure, and the curved surface area of ​​the second mold 200 is a convex structure. The first groove 301 is located in the curved surface area 304 of the concave structure, and the second groove 201 is located in the curved surface area of ​​the convex structure.

[0071] Specifically, the first groove 301 matches the shape of the electrode head 102. The second groove 201 on the second mold 200 and the first groove 301 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 boss 420 facing the bottom surface of the protruding groove of the stimulation portion. The boss 420 can fit with the surface of the electrode head 102. The boss 420 can cover and shield at least part of the stimulation portion. Preferably, the area of ​​the boss 420 is not less 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 prevent the glue from entering.

[0072] In the mold cavity 401, a filling space 410 is formed outside the protrusion 420. The side wall 421 of the protrusion 420 blocks the glue, so that the glue cannot form a silicone layer in 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 neural stimulation electrode 100 is implanted in the body, the silicone sleeve 103 fits the target nerve area, and the groove on the silicone sleeve 103 forms a closed area, thereby preventing body fluids from entering, reducing the impact on the electrode points in the electrode stimulation area 104, extending the service life, and ensuring the normal operation of the neural stimulation electrode 100.

[0073] In the embodiment of the present application, the shape of the protrusion 420 matches the shape of the electrode stimulation area 104. Figure 1 , Figure 6 As shown, the electrode stimulation area 104 is rectangular in shape, and is distributed with a plurality of electrode points arranged in an array. The protrusion 420 is also rectangular in shape, and the area of ​​the protrusion 420 is slightly larger than the area of ​​the electrode stimulation area 104 . Figure 7 As shown, the boss 420 is pressed onto the electrode head 102 , and the glue enters the filling space 410 outside the boss 420 to form a silicone sleeve 103 wrapped around the electrode head 102 .

[0074] When the second mold 200 is covered on the first mold 300, the protrusion 420 is covered above the electrode stimulation area 104, and the edge of the protrusion 420 can be pressed against the surface of the electrode head 102 on the side of the electrode stimulation area 104 to form a seal to prevent the glue from entering. In this way, after the glue solidifies 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.

[0075] In a specific embodiment, the silica gel packaging method comprises the following steps:

[0076] S100, placing the electrode head 102 in the first groove 301 of the first mold 300;

[0077] S200, covering the second mold 200 on the first mold 300;

[0078] S300 , injecting glue into the mold cavity 401 through the glue injection hole 202 on the second mold 200 to form a silicone sleeve 103 .

[0079] In order to facilitate the positioning of the electrode head 102 in the mold, the first groove 301 is provided with a positioning protrusion 306. The electrode head 102 is provided with a positioning hole 105 for positioning the neural stimulation electrode 100 on the eyeball. The positioning protrusion 306 can be a cylindrical structure, which can be inserted into the positioning hole 105 of the electrode head 102. The positioning hole 105 of the electrode head 102 is located in other areas of the electrode stimulation area 104 in the first surface or the second surface. A docking protrusion 204 is also provided in the second groove 201. When the first mold 300 and the second mold 200 are docked, the positioning protrusion 306 and the docking protrusion 204 are docked to form a corresponding through hole on the silicone sleeve 103.

[0080] 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 force is applied to make the positioning protrusion 306 pass through the positioning hole 105 to achieve the initial positioning of the electrode head 102, and then the second mold 200 is covered on the first mold 300.

[0081] In step S300, in order to avoid damage to the nerve stimulation electrode 100, the injection of glue is stopped when the injection pressure reaches a predetermined pressure. The predetermined pressure can be determined according to the pressure that the electrode head 102 can withstand, and this application does not specifically limit it. In other embodiments, the injection of glue can be stopped when the glue overflows from the injection hole 202.

[0082] In one embodiment, the bottom surface of the groove of the first groove 301 is provided with the protrusion 420. The bottom surface of the groove of the second groove 201 is not provided with the protrusion 420. The side wall 421 of the protrusion 420 can form a barrier to 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 a manner of exposing one of the electrode stimulation areas 104. In this embodiment, the electrode stimulation area 104 on the other side of the electrode head 102 is covered with the silicone sleeve 103, and only the electrode stimulation area 104 on one side is exposed to stimulate the target nerve.

[0083] Preferably, in order to prevent the nanostructure on the electrode point from being damaged and protect the electrode point, the protrusion 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protruding direction of the protrusion 420. The protrusion 420 forms a retaining wall 426 around the recessed portion 425.

[0084] 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 recessed portion 425. The retaining wall 426 surrounds the electrode stimulation area 104 and is in contact with the surface of the electrode head 102 and is in contact with the surface of the electrode head 102. The electrode stimulation area 104 is located in the recessed portion 425, and the retaining wall 426 surrounds the electrode stimulation area 104. In this embodiment, the side wall 421 of the protrusion 420 can block the glue to prevent the glue from covering the electrode stimulation area 104.

[0085] In another embodiment, the bottom surfaces of the first groove 301 and the second groove 201 are provided with the protrusion 420. Accordingly, the silicone packaging method comprises: when the electrode head 102 is located in the cavity 401, the electrode stimulation area 104 is aligned with the protrusion 420; accordingly, a silicone sleeve 103 is injection molded outside the electrode head 102 in a manner that the two electrode stimulation areas 104 are exposed.

[0086] In this embodiment, the electrode stimulation areas 104 on both sides of the electrode head 102 are exposed to stimulate the target nerve, so that more electrode points can be exposed to form a wider range of electrode stimulation.

[0087] In the present embodiment, the protrusion 420 is provided with a recessed portion 425 that is recessed in a direction opposite to the protruding direction of the protrusion 420. The protrusion 420 forms a retaining wall 426 around the recessed portion 425. The silicone encapsulation method comprises: 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 retaining wall 426 surrounds the electrode stimulation area 104 and fits the surface of the electrode head 102. The electrode stimulation area 104 is located in the recessed portion 425, and the retaining wall 426 surrounds the electrode stimulation area 104. In the present embodiment, the side wall 421 of the protrusion 420 can form a barrier to the glue to prevent the glue from covering the electrode stimulation area 104.

[0088] In an embodiment of the present application, a neural stimulation electrode is also provided, which is manufactured by any of the above-mentioned silicone packaging methods. The neural stimulation electrode can be used in Fig.10 An artificial retina implant is shown.

[0089] like Fig.10The present application also provides a silicone-encapsulated artificial retinal implant in an embodiment, which includes: a coil base 1, which includes a transmission coil and a silicone sheet cover 11 that matches the shape of the eyeball, the transmission coil is encapsulated in the silicone sheet cover 11, the two ends of the silicone sheet cover 11 are connected by a bandage 4, and the silicone sheet cover 11 can be fixed to the eyeball through the bandage 4; an integrated packaging body 2, which is fixed on the coil base 1, the integrated packaging body 2 includes a silicone tube cover 21 and a titanium tube encapsulated in the silicone tube cover 21, the titanium tube is provided with a substrate, the transmission coil and the The substrate is electrically connected; the neural electrode 3 includes a silicone arc sleeve 31 and an electrode plate 32, the electrode plate 32 is arranged 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 other end of the silicone arc sleeve 31 matches the shape of the eyeball and is provided with a groove, 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.

[0090] The neural electrode 3 may be a neural stimulation electrode 100 as disclosed in any of the above implementations or examples, which will not be described in detail here.

[0091] Among them, the artificial retinal implant can refer to the patent application "2017113637331" entitled "Silicone encapsulated artificial retinal implant", the contents of which are incorporated herein by reference in their entirety and will not be repeated here.

[0092] In an embodiment of the present application, a silicone packaging device for a nerve stimulation electrode is also provided, wherein the nerve stimulation electrode comprises an electrode head. The electrode head is provided with a stimulation portion capable of contacting a target nerve region. The silicone packaging device comprises: a mold having a cavity, wherein the cavity is used to accommodate the electrode head of the nerve stimulation electrode. The mold is configured to injection mold a silicone sleeve outside the electrode head in a manner that at least a portion of the stimulation portion is exposed.

[0093] All articles and references disclosed, including patent applications and publications, are incorporated herein by reference for all purposes. The term "consisting essentially of..." to describe a combination should include the identified elements, ingredients, parts or steps and other elements, ingredients, parts or steps that do not substantially affect the basic novel characteristics of the combination. The use of the terms "comprising" or "including" to describe a combination of elements, ingredients, parts or steps herein also contemplates embodiments that consist essentially of these elements, ingredients, parts or steps. By using the term "may", it is intended to indicate that any attribute described that "may" include is optional.

[0094] Multiple elements, ingredients, parts or steps can be provided by a single integrated element, ingredient, part or step. Alternatively, a single integrated element, ingredient, part or step can be divided into separate multiple elements, ingredients, parts or steps. The disclosure "one" or "an" used to describe an element, ingredient, part or step is not intended to exclude other elements, ingredients, parts or steps.

[0095] It should be understood that the above description is for illustration and not for limitation. Many embodiments and many applications beyond the examples provided will be apparent to those skilled in the art upon reading the above description. Therefore, the scope of the present teachings 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 such claims. For the purpose of comprehensiveness, all articles and references, including disclosures of patent applications and 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 be a waiver of the subject matter, nor should it be considered that the inventors did not consider the subject matter to be part of the disclosed inventive subject matter.

Claims

1. A method for packaging nerve stimulation electrodes with silicone, characterized in that: The nerve stimulation electrode comprises an electrode head; the electrode head is provided with a stimulation portion capable of contacting a target nerve region; the silicone packaging method comprises injection molding a silicone sleeve outside the electrode head in a manner of exposing at least a portion of the stimulation portion; The electrode head is provided with a first surface and a second surface facing each other; the stimulation part comprises two electrode stimulation areas respectively provided on the first surface and the second surface; the electrode stimulation area is provided with a plurality of electrode points; accordingly, the silicone encapsulation method comprises: injection molding a silicone sleeve outside the electrode head in a manner of exposing at least one of the electrode stimulation areas; The silicone encapsulation method includes: placing the electrode head in the first groove of the first mold; wherein the first groove matches the shape of the electrode head; covering the first mold with the second mold; the second groove on the second mold and the first groove form a cavity for accommodating the electrode head; at least one of the first groove and the second groove is provided with a protrusion facing the bottom surface of the protruding groove of the stimulation part; the protrusion covers and shields the electrode stimulation area; the area of ​​the protrusion is not less than the area of ​​the electrode stimulation area; and injecting glue into the cavity through the glue injection hole on the second mold to form a silicone sleeve.

2. The silica gel encapsulation method according to claim 1, characterized in that: The bottom surface of the first groove is provided with the protrusion; the bottom surface of the second groove is not provided with the protrusion; the silicone packaging method comprises: 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 a manner of exposing the electrode stimulation area.

3. The silica gel encapsulation method according to claim 2, characterized in that: The bottom surfaces of the first groove and the second groove are provided with the protrusions; the silicone packaging method comprises: when the electrode head is located in the cavity, the electrode stimulation area is aligned with the protrusions; correspondingly, a silicone sleeve is injection molded outside the electrode head in a manner of exposing the two electrode stimulation areas.

4. The silica gel encapsulation method according to claim 2 or 3, characterized in that: The boss is provided with a recessed portion which is recessed in a direction opposite to the protruding direction of the boss; the boss forms a retaining wall around the recessed portion; the silicone packaging method comprises: when the electrode head is located in the cavity, the electrode stimulation area of ​​the electrode head is aligned with the recessed portion; the retaining wall surrounds the electrode stimulation area and fits with the surface of the electrode head.

5. The silica gel packaging method according to claim 1, characterized in that: 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 packaging method includes: when the electrode head is placed in the first groove of the first mold, the positioning protrusion is inserted into the positioning hole.

6. The silica gel packaging method according to claim 1, characterized in that: In the step of injecting glue into the cavity through the glue injection hole on the second mold to form the silicone sleeve: the glue injection is stopped when the glue injection pressure reaches a predetermined pressure.

7. The silica gel packaging method according to claim 1, characterized in that: In the step of injecting glue into the cavity through the glue injection hole on the second mold to form the silicone sleeve: when the glue overflows from the glue injection hole, glue injection is stopped.

8. The silica gel packaging method according to claim 1, characterized in that: The first mold and the second mold are made of plastic or silicone.

9. The silica gel packaging method according to claim 1, characterized in that: The neural stimulation electrode is applied to one of the following implants: a cardiac pacemaker, an artificial retina, an artificial cochlear implant, a defibrillator, a vagus nerve stimulator, a spinal cord stimulator, a carotid sinus stimulator, a bladder stimulator, a gastrointestinal stimulator and a deep brain stimulator.

10. A neural stimulation electrode, characterized in that: The method for manufacturing the silicone encapsulation is applied to any one of claims 1 to 9.

11. An artificial retinal implant, characterized in that: Comprising the neural stimulation electrode as claimed in claim 10.

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