WO2021238418A1 - 植入装置及其组装方法 - Google Patents

植入装置及其组装方法 Download PDF

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Publication number
WO2021238418A1
WO2021238418A1 PCT/CN2021/085666 CN2021085666W WO2021238418A1 WO 2021238418 A1 WO2021238418 A1 WO 2021238418A1 CN 2021085666 W CN2021085666 W CN 2021085666W WO 2021238418 A1 WO2021238418 A1 WO 2021238418A1
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housing
electronic device
device package
annular
assembling
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PCT/CN2021/085666
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English (en)
French (fr)
Inventor
戴聿昌
庞长林
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微智医疗器械有限公司
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Publication of WO2021238418A1 publication Critical patent/WO2021238418A1/zh

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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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • the present disclosure relates to the technical field of implantable medical devices, and in particular to an implantation device and an assembly method thereof.
  • Visual prostheses can generally be divided into retinal prostheses, optic nerve prostheses, and cerebral cortex prostheses according to the location where the electrode array is implanted. That is, it is possible to achieve visual repair by stimulating the retina, optic nerve or cerebral visual cortex through electrodes.
  • the implant device has to face the complex environment in the body and withstand the erosion of corrosive body fluids for a long time; on the other hand, in order to meet the requirements of safe use, it must also have excellent performance. The biocompatibility.
  • the second vision company's Argus II implant device includes a coil, an electronic package and a flexible electrode.
  • the flexible electrode penetrates the sclera and enters the eyeball.
  • the electronic package is provided at one end of the flexible electrode.
  • the electronic package is connected to the coil to communicate with external devices.
  • the other end of the flexible electrode is provided with a microelectrode that sends stimulation pulses to retinal cells.
  • the implantation device occupies a large space on the periphery of the eyeball, the implantation procedure is cumbersome, and the operation time is long. Therefore, researchers are constantly seeking solutions for miniaturized devices. However, the miniaturization of devices will inevitably bring about an increase in the difficulty of assembly. How to take into account the miniaturization of size and the feasibility of assembly, and to ensure the requirements for corrosion resistance, sealing and biocompatibility of the implanted device, is facing the field technical challenge.
  • an objective of the present disclosure is to provide an assembling method of an implant device, which can effectively ensure the sealing and corrosion resistance of the implant device, and the assembly method is simple.
  • Another objective of the present disclosure is to provide an implant device assembled by the above assembly method.
  • the assembling method is used to encapsulate an electronic device package in a housing, the electronic device package at least including a coil, and the housing includes a metal and An annular casing with a gap and a cover for closing the annular casing,
  • the assembly method includes the following steps:
  • the sealing property and corrosion resistance of the implant device can be effectively ensured, and the assembling method is simple.
  • the implant device includes an introduction part, a stimulation part, and a cable connected between the introduction part and the stimulation part, the introduction part is located in the housing, and the housing also A cable hole communicating with the gap is formed, and the cable extends through the cable hole to the outside of the housing.
  • glue is also injected into the casing of the electronic device package through the via hole.
  • the step S20 specifically includes:
  • the air bubbles in the colloid are removed by means of vacuuming.
  • step S202 vacuuming is realized in a vacuum box.
  • a tooling is provided in the vacuum box, and the tooling is used to support the housing and make the The gap and the wire passing hole are located on the top of the entire housing.
  • the assembly method further includes: S30, removing the glue attached to the outer surface of the housing.
  • the assembling method before the step S20, further includes: S11. Adjusting the direction of the housing equipped with the electronic device package so that the gap and the via hole are located The entire top of the shell.
  • the cover includes an upper cover provided on the top of the annular casing and a lower cover provided on the bottom of the annular casing, and the step S10 specifically includes:
  • the lower cover is adhered to the bottom of the annular housing; in the step S103, the upper cover is adhered to the top of the annular housing.
  • the glue injected into the shell is silica gel.
  • the implant device according to the embodiment of the second aspect of the present disclosure is assembled using the assembly method according to the embodiment of the first aspect of the present disclosure.
  • the electronic device package includes at least a coil.
  • the housing is further formed with a wire hole communicating with the gap
  • the implant device further includes an introduction part, a stimulation part, and a connection between the introduction part and the stimulation part
  • the lead-in part is located in the housing, and the cable extends out of the housing through the cable hole.
  • a connecting column is provided in the annular housing, and the lead-in part of the flexible electrode is electrically connected to the connecting column.
  • An electrical stimulation circuit from the current drive output port in the electronic device package, the introduction part, the stimulation part, the stimulated tissue, the ring housing to the current drive circuit ground in the electronic device package in sequence .
  • the cover includes an upper cover and a lower cover, the upper cover is arranged on the top of the annular housing and is formed in an upwardly convex curved shape, and the lower cover is arranged on the The bottom of the annular casing is formed in a curved upward concave shape.
  • At least one sewing hook is provided on the outer wall of the annular housing, and the at least one sewing hook is only arranged on one side of the annular housing.
  • the gap and the wire-passing hole communicate with each other and form an inverted T-shaped hole together to form an inverted T-shaped hole, and the inverted T-shaped hole penetrates the top and bottom of the annular housing.
  • each of the suture hooks includes a connecting part connected to the annular housing and a hook part connected to a free end of the connecting part, and the hook part adopts a non-closed loop structure.
  • Fig. 1 is a flowchart of an assembling method of an implant device according to an embodiment of the present disclosure
  • FIG. 2 is a schematic diagram of the electronic device package of the implantation device according to an embodiment of the present disclosure after being placed in a housing;
  • Figure 3 is an exploded view of the implant device shown in Figure 2;
  • Figure 4 is a perspective view of the annular housing of the implant device shown in Figure 3;
  • Figure 5 is a schematic diagram of injecting glue into the shell through the gap of the annular shell
  • Fig. 6 is a schematic diagram of the implantation device according to an embodiment of the present disclosure when the eyeball is implanted;
  • Fig. 7 is a schematic diagram of the implantation device according to an embodiment of the present disclosure when it is implanted into the cerebral cortex.
  • the implantation device 100 can be suitable for implantation of cochlear implants, retinal implants, spinal cord stimulators (for the treatment of pain), cerebral cortex stimulators, deep brain stimulators (brain pacemakers), etc. Of medical equipment.
  • the implantation device 100 and the retinal implant for cerebral cortex stimulation visual prosthesis are mainly described as examples.
  • the assembling method is used to encapsulate an electronic device package 3 in a housing 1.
  • the electronic device package 3 includes at least a coil 31.
  • the housing 1 includes an annular housing 11 made of metal and having a gap 112 and a cover that closes the annular housing 11. body.
  • the annular shell 11 is a metal shell
  • the annular shell 11 may be substantially formed as a circumferentially extending annular structure
  • the gap 112 penetrates the annular shell along the thickness direction of the annular shell 11. 11's side wall.
  • the gap 112 will not hinder the signal communication, can avoid the eddy current of the coil 31, and ensure the stable and reliable transmission of the radio frequency signal of the coil 31.
  • the cover body closes the open part of the annular casing 11 (for example, the top and bottom in FIG. 3) to jointly define the accommodating cavity with the annular casing 11.
  • the electronic device package 3 such as the coil 31 is placed in the accommodating cavity.
  • the coil 31 is used to receive data and energy, and the number of the coil 31 may be one or more.
  • the coil 31 may include an internal data coil and an internal energy coil for receiving data and energy from the external coil, respectively.
  • the assembling method of the above-mentioned implant device 100 includes the following steps:
  • step S10 the electronic device package 3, such as the coil 31, etc., can be put into the housing 1 through the open part of the annular housing 11, and then the open part of the annular housing 11 is closed with a cover.
  • step S20 after the glue is injected into the housing 1 through the gap 112, the glue is filled between the inner wall of the housing 1 and the electronic device package 3 to realize the packaging of the electronic device package 3 so that the electronic device package 3 It is isolated from the external environment (such as corrosive body fluids in the body, etc.), thereby improving the sealing performance and corrosion resistance of the electronic device package 3.
  • This embodiment has a simple process and a compact structure.
  • step S20 specifically includes:
  • the space between the electronic device package 3 and the housing 1 is made of colloid and is basically free of bubbles, which avoids the influence of factors such as bubble expansion on the connection reliability between the housing 1 and the electronic device package 3, and ensures The tightness and service life of the implant device 100.
  • step S202 the air bubbles in the colloid are removed by means of vacuuming. Putting the entire implant device 100 into a vacuum box (not shown in the figure) and then vacuuming, the defoaming effect is good.
  • the implantation device 100 includes a flexible electrode.
  • the flexible electrode includes an introduction part, a stimulation part 21, and a cable 22 connected between the introduction part and the stimulation part 21.
  • the lead-in part is located inside the housing 1, and the cable 22 and the stimulation part 21 are located outside the housing 1.
  • the introduction part and the coil 31 together form the electronic device package 3.
  • the stimulation part 21 may include a substrate and a plurality of stimulation electrodes arranged on the substrate.
  • the substrate may support and protect the stimulation electrodes.
  • the end portion may be exposed on one side surface of the flexible substrate to be suitable for stimulating a site to be implanted in the human body (for example, the retina 1001, the cerebral cortex 3000, etc.).
  • the cable 22 can extend out of the housing 1 through the cable hole 114.
  • step S202 vacuuming is realized in a vacuum box.
  • a tooling is provided in the vacuum box. The tooling is used to support the housing 1 and make the gap 112 located on the top of the entire housing 1.
  • the above assembly method further includes:
  • the above assembly method further includes:
  • the cover body includes an upper cover 12 provided on the top of the annular casing 11 and a lower cover 13 provided on the bottom of the annular casing 11.
  • the upper cover 12 may be formed in an upwardly convex curved shape
  • the lower cover 13 may be formed in an upwardly concave curved shape.
  • the annular shell 11 is a pure titanium piece, but is not limited to this.
  • the material of the annular shell 11 can also be metals such as titanium alloy, platinum, platinum alloy, platinum-iridium alloy, etc.
  • the upper cover 12 and the lower cover 13 It is a ceramic piece, a glass piece or a polymer (such as polyether ether ketone, etc.) piece, but it is not limited thereto.
  • step S10 specifically includes:
  • the electronic device package 3 can be conveniently and accurately put into the assembly formed by the ring housing 11 and the lower cover 13 through the top of the ring housing 11 and supported on the lower cover 13. Moreover, by dividing the housing 1 into three independent parts, the upper cover 12, the annular housing 11 and the lower cover 13, the structure is simple, the processing and manufacturing are convenient, and the cost can be reduced.
  • step S101 the lower cover 13 is adhered to the bottom of the annular housing 11; in step S103, the upper cover 12 is adhered to the top of the annular housing 11. Therefore, by adopting the bonding method, the connection is reliable and the sealing effect is good.
  • the glue injected into the housing 1 is silica gel.
  • the silica gel has good corrosion resistance and biocompatibility, and the material is relatively soft, which can well protect the electronic device package 3 inside it.
  • the injected glue can also be epoxy glue or the like.
  • the implantation device 100 As shown in FIGS. 2 to 4, the implantation device 100 according to the embodiment of the second aspect of the present disclosure includes a housing 1 and an electronic device package 3. The implant device 100 is assembled using the assembling method according to the above-mentioned embodiment of the first aspect of the present disclosure.
  • the housing 1 includes a ring-shaped housing 11 made of metal and having a gap 112 and a cover that closes the ring-shaped housing 11.
  • the electronic device package 3 is disposed in the housing 1, and the space between the electronic device package 3 and the housing 1 is filled with sealant (ie, the above-mentioned glue), and the electronic device package 3 at least includes a coil 31.
  • the bottom of the slot 112 is connected with a threaded hole 114, the slot 112 and the threaded hole 114 communicate with each other and form an inverted T-shaped hole together to form an inverted T-shaped hole.
  • the inverted T-shaped hole penetrates the annular shell.
  • the flexible electrode can extend out of the housing 1 through the wire hole 114.
  • the gap 112 can also penetrate through the top and bottom of the annular housing 11 and be circumferentially spaced from the wire via 114 (not shown in the figure).
  • the lead-in part of the flexible electrode may be electrically connected to the connecting post 111 in the annular housing 11, and the implantation device 100 will be formed sequentially from the electronic device package 3 when it is driven by the forward voltage after being implanted.
  • each suture hook 113 is provided on the outer wall of the annular casing 11.
  • the side with the suture hook 113 (for example, the upper side in FIG. 4) can be fixed by a conjunctival wrap outside the sclera (usually located between the two rectus muscles in the superior temporal quadrant), reducing the suture point.
  • each suture hook 113 may include a connecting portion 1131 and a hook portion 1132.
  • the connecting portion 1131 is connected to the annular housing 11, and the hook portion 1132 is connected to the free end of the connecting portion 1131.
  • the non-closed loop structure can further avoid the eddy current of the coil 31.
  • the following describes the process of implanting the implant device 100 in the eyeball 1000 (that is, as a retinal implant) according to an embodiment of the present disclosure with reference to FIG. 6.
  • the annular shell 11 is sutured to the supratemporal quadrant of the sclera, and the distance between the suture hook 113 and the limbus is ensured. Then vitrectomy is performed, and the sclera is cut in the superior temporal quadrant to form an incision.
  • the stimulating part 21 of the flexible electrode is introduced into the eyeball 1000 from the incision, and the stimulating part 21 is fixed to the macular area on the surface of the retina 1001 through the fixing nail 2000.
  • the implantation operation is simple, has little trauma to the eyes, avoids the compression of the ocular vortex vein, has fewer postoperative complications, and can reduce the patient's foreign body sensation.
  • the stimulation part 21 is implanted on the surface of the cerebral cortex 3000, and the shell 1 is implanted in the hollow part of the skull, or on the skull or under the scalp.
  • the stimulation part 21 with stimulation electrodes can be implanted in the V1 area of the visual cortex of the brain, and can also partially cover the V2 or V3 area. It is worth noting that the V1, V2, and V3 areas of the visual cortex of the brain mentioned here are common areas in the visual field of the brain, and will not be explained in detail here.

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Abstract

一种植入装置(100)及其组装方法，组装方法用于将电子器件封装体(3)封装在外壳(1)内，电子器件封装体(3)至少包括线圈(31)，外壳(1)包括金属制成且具有缝隙(112)的环形壳体(11)和封闭环形壳体(11)的盖体，组装方法包括以下步骤：S10、将电子器件封装体(3)放入外壳(1)内，并使盖体封闭环形壳体(11)；S20、通过缝隙(112)向装有电子器件封装体(3)的外壳(1)内注胶，直至胶体充满外壳(1)与电子器件封装体(3)之间的空间。

Description

植入装置及其组装方法 技术领域
本公开涉及植入式医疗器械技术领域，尤其是涉及一种植入装置及其组装方法。
背景技术
理论上讲，从视网膜到脑部视觉皮层之间的视路上任意一处进行电刺激都可能引发视觉。视觉假体按照电极阵列植入的部位一般可分为视网膜假体、视神经假体、脑皮层假体，即通过电极刺激视网膜、视神经或大脑视觉皮层都可能实现视觉修复。然而，无论在哪个位置进行视觉假体的植入，植入装置一方面要面临体内复杂的环境，长期承受腐蚀性体液的侵蚀；另一方面，为满足安全使用的要求，还必须具有非常优异的生物相容性。
相关技术中，作为一种已上市的商品化视网膜假体，第二视觉公司ArgusⅡ的植入装置包括线圈、电子封装体和柔性电极。柔性电极穿过巩膜进入眼球内，电子封装体设置在柔性电极的一端，电子封装体连接至线圈以与外部装置进行通讯，柔性电极的另一端设置有向视网膜细胞发送刺激脉冲的微电极。然而，该植入装置在眼球外周占用的空间较大，植入手术过程繁琐，手术时间长。因此，研究人员正在不断寻求微型化器件的解决方案。然而，器件的微型化必然带来组装难度的增加，如何兼顾尺寸微型化及组装可行性，并能保证植入装置对防腐蚀性、密封性及生物相容性的要求，是本领域面临的技术难题。
发明内容
本公开旨在至少解决现有技术中存在的技术问题之一。为此，本公开的一个目的在于提出一种植入装置的组装方法，能够有效保证植入装置的密封性和防腐蚀性，且组装方法简单。
本公开的另一个目的在于提出一种采用上述组装方法组装而成的植入装置。
根据本公开第一方面实施例的植入装置的组装方法，所述组装方法用于将电子器件封装体封装在外壳内，所述电子器件封装体至少包括线圈，所述外壳包括金属制成且具有缝隙的环形壳体和封闭所述环形壳体的盖体，
所述组装方法包括以下步骤：
S10、将所述电子器件封装体放入所述外壳内，并使所述盖体封闭所述环形壳体；
S20、通过所述缝隙向前述步骤装有所述电子器件封装体的所述外壳内注胶，直至胶体充满所述外壳与所述电子器件封装体之间的空间。
根据本公开实施例的植入装置的组装方法，能够有效保证植入装置的密封性和防腐蚀性，且组装方法简单。
根据本公开的一些实施例，所述植入装置包括引入部分、刺激部分和连接在所述引入部分和所述刺激部分之间的电缆，所述引入部分位于所述外壳内，所述外壳还形成有与所述缝隙 连通的过线孔，所述电缆穿过所述过线孔伸出到所述外壳外，在所述步骤S20中，除了通过所述缝隙向所述电子器件封装体的所述外壳内注胶之外，还通过所述过线孔向所述电子器件封装体的所述外壳内注胶。
根据本公开的一些实施例，所述步骤S20具体包括：
S201、通过所述缝隙和所述过线孔向所述外壳内注胶；
S202、在前述步骤向所述外壳内注胶后，去除所述胶体内的气泡；
S203、重复所述步骤S201和S202，直至所述胶体充满所述外壳与所述电子器件封装体之间的空间。
根据本公开的一些实施例，所述步骤S202中，通过抽真空的方式去除所述胶体内的气泡。
根据本公开的一些实施例，所述步骤S202中，抽真空是在真空箱内实现的，抽真空之前，所述真空箱内设有工装，所述工装用于支撑所述外壳并使得所述缝隙和所述过线孔位于整个所述外壳的顶部。
根据本公开的一些实施例，在所述步骤S20之后，所述组装方法还包括：S30、去除附着在所述外壳的外表面上的胶体。
根据本公开的一些实施例，所述步骤S20之前，所述组装方法还包括：S11、调整装有所述电子器件封装体的所述外壳的方向，使所述缝隙和所述过线孔位于整个所述外壳的顶部。
根据本公开的一些实施例，所述盖体包括设在所述环形壳体顶部的上盖和设在所述环形壳体底部的下盖，所述步骤S10具体包括：
S101、将所述下盖封闭所述环形壳体的底部；
S102、将所述电子器件封装体放入前述步骤得到的包括所述环形壳体和所述下盖的组件内；
S103、将所述上盖封闭前述步骤完成后的所述环形壳体的顶部。
根据本公开的一些实施例，所述步骤S101中，所述下盖粘接在所述环形壳体的底部；所述步骤S103中，所述上盖粘接在所述环形壳体的顶部。
根据本公开的一些实施例，所述步骤S20中，向所述外壳内注入的胶为硅胶。
根据本公开第二方面实施例的植入装置，采用根据本公开上述第一方面实施例的组装方法进行组装，所述植入装置包括：外壳，所述外壳包括金属制成且具有缝隙的环形壳体和封闭所述环形壳体的盖体；电子器件封装体，所述电子器件封装体设在所述外壳内，且所述电子器件封装体和所述外壳之间的空间充满密封胶，所述电子器件封装体至少包括线圈。
根据本公开的一些实施例，所述外壳还形成有与所述缝隙连通的过线孔，所述植入装置还包括引入部分、刺激部分和连接在所述引入部分和所述刺激部分之间的电缆，所述引入部分位于所述外壳内，所述电缆穿过所述过线孔伸出到所述外壳外。
根据本公开的一些实施例，所述环形壳体内设有连接柱，所述柔性电极的所述引入部分与所述连接柱电连接，所述植入装置植入后在正向电压驱动时形成依次从所述电子器件封装体 内的电流驱动输出端口、所述引入部分、所述刺激部分、被刺激组织、所述环形壳体到所述电子器件封装体内的电流驱动电路地线的电刺激回路。
根据本公开的一些实施例，所述盖体包括上盖和下盖，所述上盖设在所述环形壳体的顶部且形成为向上凸出的曲面形，所述下盖设在所述环形壳体的底部且形成为向上凹入的曲面形。
根据本公开的一些实施例，所述环形壳体的外壁上设置有至少一个缝合钩，所述至少一个缝合钩仅设置于所述环形壳体一侧。
根据本公开的一些实施例，所述缝隙与所述过线孔彼此连通且共同呈倒T形以形成倒T形孔，所述倒T形孔贯通所述环形壳体的顶部和底部。
根据本公开的一些实施例，每个所述缝合钩包括与所述环形壳体连接的连接部和连接在所述连接部的自由端的钩部，所述钩部采用非闭环结构。
本公开的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本公开的实践了解到。
附图说明
本公开的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解，其中：
图1是根据本公开实施例的植入装置的组装方法的流程框图；
图2是根据本公开实施例的植入装置的电子器件封装体放入外壳内之后的示意图；
图3是图2中所示的植入装置的分解图；
图4是图3中所示的植入装置的环形壳体的立体图；
图5是通过环形壳体的缝隙向外壳内注胶的示意图；
图6是根据本公开实施例的植入装置植入眼球时的示意图；
图7是根据本公开实施例的植入装置植入脑皮层时的示意图。
附图标记：
100：植入装置；1：外壳；11：环形壳体；111：连接柱；112：缝隙；113：缝合钩；114：过线孔；1131：连接部；1132：钩部；12：上盖；13：下盖；21：刺激部分；22：电缆；3：电子器件封装体；31：线圈；1000：眼球；1001：视网膜；2000：固定钉；3000：脑皮层。
具体实施方式
下面详细描述本公开的实施例，参考附图描述的实施例是示例性的，下面详细描述本公开的实施例。
下面参考图1-图7描述根据本公开实施例的植入装置100的组装方法。其中，植入装置100可适用于人工耳蜗植入体、视网膜植入体、脊髓刺激器(用于治疗疼痛)、脑皮层刺激器、 深部脑刺激器(脑起搏器)等植入人体内的医疗器械中。在本公开的以下描述中，主要以用于脑皮层刺激视觉假体的植入装置100以及视网膜植入体为例进行描述。
参照图1并结合图2-图6，描述根据本公开第一方面实施例的植入装置100的组装方法。该组装方法用于将电子器件封装体3封装在外壳1内，电子器件封装体3至少包括线圈31，外壳1包括金属制成且具有缝隙112的环形壳体11和封闭环形壳体11的盖体。
例如，在图2-图4的示例中，环形壳体11为金属壳体，环形壳体11可以大体形成为周向延伸的环形结构，缝隙112沿环形壳体11的厚度方向贯穿环形壳体11的侧壁。缝隙112不会阻碍信号通信，可以避免线圈31涡流，保证线圈31的射频信号稳定可靠地传输。例如，当植入装置100植入眼球1000时，即使眼球1000转动，或者外部线圈(图未示出)与电子器件封装体3之间的距离较大时，依然能保证信号稳定可靠地传输。盖体封闭环形壳体11的敞开部分(例如，图3中的顶部和底部)以与环形壳体11共同限定出容置腔。电子器件封装体3如线圈31等置于容置腔内。
可选地，线圈31用于接收数据及能量，线圈31的数量可以为一个或多个。例如，线圈31可以包括一个内部数据线圈和一个内部能量线圈，以分别用于接收外部线圈的数据及能量。
上述植入装置100的组装方法包括以下步骤：
S10、将电子器件封装体3放入外壳1内，并使盖体封闭环形壳体11；
S20、通过缝隙112向前述步骤装有电子器件封装体3的外壳1内注胶，直至胶体充满外壳1与电子器件封装体3之间的空间。
在步骤S10中，电子器件封装体3如线圈31等可以通过环形壳体11的敞开部分放入到外壳1内，然后用盖体封闭环形壳体11的敞开部分。
在步骤S20中，通过缝隙112向外壳1内注胶完毕后，胶体填充在外壳1的内壁和电子器件封装体3之间，以实现对电子器件封装体3的封装，使电子器件封装体3与外部环境(如体内的腐蚀性体液等)隔离开，从而提高了电子器件封装体3的密封性和防腐蚀性，该实施例工艺简单，且结构紧凑。
根据本公开的一些实施例，步骤S20具体包括：
S201、通过缝隙112向外壳1内注胶；
S202、在前述步骤向外壳1内注胶后，去除胶体内的气泡；
S203、重复步骤S201和S202，直至胶体充满外壳1与电子器件封装体3之间的空间。
由此，使电子器件封装体3与外壳1之间的空间均为胶体而基本无气泡，避免了因气泡膨胀等因素而影响外壳1与电子器件封装体3之间的连接可靠性，保证了植入装置100的密封性及使用寿命。
可选地，步骤S202中，通过抽真空的方式去除胶体内的气泡。将植入装置100整体放入真空箱(图未示出)后进行抽真空，除泡效果好。
根据本公开的一些实施例，参照图2-图3并结合图5，植入装置100包括柔性电极，柔性 电极包括引入部分、刺激部分21和连接在引入部分和刺激部分21之间的电缆22，引入部分位于外壳1内，电缆22和刺激部分21位于外壳1外。引入部分与线圈31一起形成电子器件封装体3，刺激部分21可以包括衬底和设在衬底上的多个刺激电极，衬底可以起到支撑和保护刺激电极的作用，多个刺激电极的端部可以暴露于柔性衬底的一侧表面以适于对人体的待植入部位(例如视网膜1001、脑皮层3000等)产生刺激。组装时，电缆22可以穿过过线孔114伸出到外壳1外。
进一步地，步骤S202中，抽真空是在真空箱内实现的，抽真空之前，真空箱内设有工装，该工装用于支撑外壳1并使得缝隙112位于整个外壳1的顶部。
当在真空箱内抽真空时，胶体气泡内的空气可以在外界负压的作用下向外逸出。之后，可将工装从真空箱中移出，然后重复前述步骤S201和S202。
根据本公开的一些实施例，在步骤S20之后，上述组装方法还包括：
S30、去除附着在外壳1的外表面上的胶体，以使外壳1表面平整清洁，且不会影响植入装置100的正常工作。
根据本公开的一些实施例，参照图2-图4，步骤S20之前，上述组装方法还包括：
S11、调整装有电子器件封装体3的外壳1的方向，使缝隙112位于整个外壳1的顶部，以便于后续通过缝隙112从上朝下向外壳1内注胶。胶体可在重力作用下流入外壳1与电子器件封装体3之间的空间。
根据本公开的一些实施例，如图3和图4所示，盖体包括设在环形壳体11顶部的上盖12和设在环形壳体11底部的下盖13。上盖12可以形成为向上凸出的曲面形，下盖13可以形成为向上凹入的曲面形，当植入装置100植入眼球1000时，由于下盖13构造为与巩膜相匹配的曲面，从而可以更好地与巩膜贴合，且由于上盖12也具有对应的曲面结构，并位于眼皮与巩膜之间，能减轻患者的异物感。
可选地，环形壳体11为纯钛件，但不限于此，例如，环形壳体11的材料也可以为钛合金、铂、铂合金、铂铱合金等金属，上盖12和下盖13为陶瓷件、玻璃件或聚合物(如聚醚醚酮等)件，但不限于此。具体而言，步骤S10具体包括：
S101、将下盖13封闭环形壳体11的底部；
S102、将电子器件封装体3放入前述步骤得到的包括环形壳体11和下盖13的组件内；
S103、将上盖12封闭前述步骤完成后的环形壳体11的顶部。
由此，在上述组装过程中，电子器件封装体3可以方便且准确地通过环形壳体11的顶部放入环形壳体11和下盖13构成的组件内，并支撑在下盖13上。而且，通过将外壳1分为上盖12、环形壳体11和下盖13三个独立部件，结构简单，便于加工制造，可以降低成本。
可选地，步骤S101中，下盖13粘接在环形壳体11的底部；步骤S103中，上盖12粘接在环形壳体11的顶部。由此，通过采用粘接的方式，连接可靠，且密封效果好。
可选地，步骤S20中，向外壳1内注入的胶为硅胶。硅胶耐腐蚀性和生物相容性好，且材 质较软，能够很好地保护位于其内的电子器件封装体3。此外，注入的胶还可以为环氧胶等。
如图2-图4所示，根据本公开第二方面实施例的植入装置100，包括外壳1和电子器件封装体3。植入装置100采用根据本公开上述第一方面实施例的组装方法进行组装。
具体而言，外壳1包括金属制成且具有缝隙112的环形壳体11和封闭环形壳体11的盖体。电子器件封装体3设在外壳1内，且电子器件封装体3和外壳1之间的空间充满密封胶(即上述的胶体)，电子器件封装体3至少包括线圈31。
例如，参照图4，缝隙112的底部连接有过线孔114，缝隙112与过线孔114彼此连通且共同呈倒T形，以形成倒T形孔，此时该倒T形孔贯通环形壳体11的顶部和底部，这样在有效避免线圈31涡流的同时，使得柔性电极可以穿过过线孔114伸出到外壳1外。当然，缝隙112还可以贯穿环形壳体11的顶部和底部且与过线孔114周向间隔开(图未示出)。
根据本公开的一些实施例，柔性电极的引入部分可以与环形壳体11内的连接柱111电连接，植入装置100植入后在正向电压驱动时形成依次从电子器件封装体3内的电流驱动输出端口、柔性电极的引入部分、刺激部分21、被刺激组织、环形壳体11到电子器件封装体3内的电流驱动电路地线的电刺激回路。
根据本公开的一些实施例，如图4所示，环形壳体11的外壁上设置有至少一个缝合钩113，至少一个缝合钩113仅设置于环形壳体11一侧，环形壳体11的不具有缝合钩113的一侧(例如，图4中的上侧)可以通过巩膜外的结膜包裹被固定(一般位于颞上象限两条眼直肌之间)，减少了缝合点。具体而言，参照图4，每个缝合钩113可以包括连接部1131和钩部1132，连接部1131与环形壳体11连接，钩部1132连接在连接部1131的自由端，由于钩部1132采用非闭环结构，从而可以进一步避免线圈31涡流。
下面结合图6描述根据本公开实施例的植入装置100植入在眼球1000(即作为视网膜植入体)内的过程。
首先，将环形壳体11缝合在巩膜的颞上象限，并保证缝合钩113与角膜缘之间的距离。然后进行玻璃体切除，并在颞上象限切开巩膜形成切口，将柔性电极的刺激部分21从该切口引入眼球1000内，并通过固定钉2000将刺激部分21固定在视网膜1001表面的黄斑区域。该植入手术简单，对眼睛创伤小，且避免了压迫眼球涡静脉，术后并发症少，并且能减轻患者的异物感。
下面结合图7描述根据本公开实施例的植入装置100植入在脑皮层3000内的过程。
先去除一部分颅骨，使其形成镂空部分。然后将刺激部分21植入脑皮层3000的表面，并将外壳1植入颅骨的镂空部分、或者颅骨上、头皮下方。一般来说，具有刺激电极的刺激部分21可以植入脑部视觉皮层的V1区，也可以部分覆盖V2或V3区。值得注意的是，这里提到的脑部视觉皮层的V1、V2、V3区为脑部视觉领域内常见的区域划分，在此不做详细解释。
根据本公开实施例的植入装置100的其他构成以及操作对于本领域普通技术人员而言都是已知的，这里不再详细描述。
尽管已经示出和描述了本公开的实施例，本领域的普通技术人员可以理解：在不脱离本公开的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本公开的范围由权利要求及其等同物限定。

Claims (17)

  1. 一种植入装置的组装方法，其特征在于，所述组装方法用于将电子器件封装体封装在外壳内，所述电子器件封装体至少包括线圈，所述外壳包括金属制成且具有缝隙的环形壳体和封闭所述环形壳体的盖体，
    所述组装方法包括以下步骤：
    S10、将所述电子器件封装体放入所述外壳内，并使所述盖体封闭所述环形壳体；
    S20、通过所述缝隙向前述步骤装有所述电子器件封装体的所述外壳内注胶，直至胶体充满所述外壳与所述电子器件封装体之间的空间。
  2. 根据权利要求1所述的植入装置的组装方法，其特征在于，所述植入装置包括引入部分、刺激部分和连接在所述引入部分和所述刺激部分之间的电缆，所述引入部分位于所述外壳内，
    所述外壳还形成有与所述缝隙连通的过线孔，所述电缆穿过所述过线孔伸出到所述外壳外，
    在所述步骤S20中，除了通过所述缝隙向所述电子器件封装体的所述外壳内注胶之外，还通过所述过线孔向所述电子器件封装体的所述外壳内注胶。
  3. 根据权利要求2所述的植入装置的组装方法，其特征在于，所述步骤S20具体包括：
    S201、通过所述缝隙和所述过线孔向所述外壳内注胶；
    S202、在前述步骤向所述外壳内注胶后，去除所述胶体内的气泡；
    S203、重复所述步骤S201和S202，直至所述胶体充满所述外壳与所述电子器件封装体之间的空间。
  4. 根据权利要求3所述的植入装置的组装方法，其特征在于，所述步骤S202中，
    通过抽真空的方式去除所述胶体内的气泡。
  5. 根据权利要求4所述的植入装置的组装方法，其特征在于，
    所述步骤S202中，抽真空是在真空箱内实现的，抽真空之前，所述真空箱内设有工装，所述工装用于支撑所述外壳并使得所述缝隙和所述过线孔位于整个所述外壳的顶部。
  6. 根据权利要求1所述的植入装置的组装方法，其特征在于，在所述步骤S20之后，还包括：
    S30、去除附着在所述外壳的外表面上的胶体。
  7. 根据权利要求2所述的植入装置的组装方法，其特征在于，所述步骤S20之前，还包括：
    S11、调整装有所述电子器件封装体的所述外壳的方向，使所述缝隙和所述过线孔位于整个所述外壳的顶部。
  8. 根据权利要求1-7中任一项所述的植入装置的组装方法，其特征在于，所述盖体包括 设在所述环形壳体顶部的上盖和设在所述环形壳体底部的下盖，
    所述步骤S10具体包括：
    S101、将所述下盖封闭所述环形壳体的底部；
    S102、将所述电子器件封装体放入前述步骤得到的包括所述环形壳体和所述下盖的组件内；
    S103、将所述上盖封闭前述步骤完成后的所述环形壳体的顶部。
  9. 根据权利要求8所述的植入装置的组装方法，其特征在于，所述步骤S101中，所述下盖粘接在所述环形壳体的底部；
    所述步骤S103中，所述上盖粘接在所述环形壳体的顶部。
  10. 根据权利要求1-7中任一项所述的植入装置的组装方法，其特征在于，所述步骤S20中，向所述外壳内注入的胶为硅胶。
  11. 一种植入装置，其特征在于，采用上述权利要求1-10中任一项所述的组装方法进行组装，所述植入装置包括：
    外壳，所述外壳包括金属制成且具有缝隙的环形壳体和封闭所述环形壳体的盖体；
    电子器件封装体，所述电子器件封装体设在所述外壳内，且所述电子器件封装体和所述外壳之间的空间充满密封胶，所述电子器件封装体至少包括线圈。
  12. 根据权利要求11所述的植入装置，其特征在于，所述外壳还形成有与所述缝隙连通的过线孔，所述植入装置还包括引入部分、刺激部分和连接在所述引入部分和所述刺激部分之间的电缆，所述引入部分位于所述外壳内，所述电缆穿过所述过线孔伸出到所述外壳外。
  13. 根据权利要求12所述的植入装置，其特征在于，所述环形壳体内设有连接柱，所述柔性电极的所述引入部分与所述连接柱电连接，所述植入装置植入后在正向电压驱动时形成依次从所述电子器件封装体内的电流驱动输出端口、所述引入部分、所述刺激部分、被刺激组织、所述环形壳体到所述电子器件封装体内的电流驱动电路地线的电刺激回路。
  14. 根据权利要求11-13中任一项所述的植入装置，其特征在于，所述盖体包括上盖和下盖，所述上盖设在所述环形壳体的顶部且形成为向上凸出的曲面形，所述下盖设在所述环形壳体的底部且形成为向上凹入的曲面形。
  15. 根据权利要求11-13中任一项所述的植入装置，其特征在于，所述环形壳体的外壁上设置有至少一个缝合钩，所述至少一个缝合钩仅设置于所述环形壳体一侧。
  16. 根据权利要求12或13所述的植入装置，其特征在于，所述缝隙与所述过线孔彼此连通且共同呈倒T形以形成倒T形孔，所述倒T形孔贯通所述环形壳体的顶部和底部。
  17. 根据权利要求15所述的植入装置，其特征在于，每个所述缝合钩包括与所述环形壳体连接的连接部和连接在所述连接部的自由端的钩部，所述钩部采用非闭环结构。
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CN111588985B (zh) * 2020-05-27 2021-02-19 微智医疗器械有限公司 植入装置及其组装方法
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