WO2021238419A1 - 植入装置和具有其的视觉假体 - Google Patents

植入装置和具有其的视觉假体 Download PDF

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Publication number
WO2021238419A1
WO2021238419A1 PCT/CN2021/085670 CN2021085670W WO2021238419A1 WO 2021238419 A1 WO2021238419 A1 WO 2021238419A1 CN 2021085670 W CN2021085670 W CN 2021085670W WO 2021238419 A1 WO2021238419 A1 WO 2021238419A1
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WIPO (PCT)
Prior art keywords
coil
annular housing
circuit board
annular
implantation device
Prior art date
Application number
PCT/CN2021/085670
Other languages
English (en)
French (fr)
Inventor
戴聿昌
庞长林
Original Assignee
微智医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202020926400.6U external-priority patent/CN212395198U/zh
Priority claimed from CN202010459957.8A external-priority patent/CN111481345A/zh
Application filed by 微智医疗器械有限公司 filed Critical 微智医疗器械有限公司
Publication of WO2021238419A1 publication Critical patent/WO2021238419A1/zh

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    • 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
    • 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
    • A61F9/08—Devices or methods enabling eye-patients to replace direct visual perception by another kind of perception
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present disclosure relates to the technical field of implantable medical devices, and in particular to an implantation device and a visual prosthesis having the same.
  • Visual prosthesis is an implantable medical device designed to help patients with diseased retina or other visual organs regain light and vision.
  • the formation of normal vision is when the photoreceptor cells on the retina (such as cone cells and rod cells) convert light stimulation into electrical signals, which are encoded by cells in each layer of the retina (such as horizontal cells, bipolar cells, ganglion cells, etc.) , Which transmits nerve impulses to the visual cortex.
  • a commonly used visual prosthesis design is to implant microelectrode implants on the surface of the retina to help patients with outer retinal degeneration diseases such as retinitis pigmentosa and age-related macular degeneration.
  • the visual prosthesis includes two parts: an implant and an external component.
  • the electronic package in the implant is sutured on the outer side of the eyeball sclera, the flexible stimulation circuit board passes through the eyeball wall, and the electrode array at the end is fixed on the surface of the retina by fixing nails.
  • the external components include a camera that collects video information. After data conversion, the video information is wirelessly transmitted to the electronic package of the implant.
  • the electrode array transmits stimulation to the retina through electrical stimulation, and the electrical pulse signal transmitted to the retina stimulates the retina. Neurons that retain function, and transmit this stimulus to the brain through the optic nerve, so that the patient has visual perception.
  • the electronic package of the implant is generally connected to a coil.
  • the coil is used to transmit data and energy.
  • the coil is located outside the electronic package.
  • the electronic package and the coil are respectively located at the front and back of the eyeball, which takes up more space.
  • the implant needs to cover two or even three or four quadrants of the sclera in the circumferential direction, which makes the operation more difficult and the patient’s foreign body sensation is more obvious.
  • an objective of the present disclosure is to provide an implantation device, which has a compact structure and a small footprint.
  • Another object of the present disclosure is to provide a visual prosthesis with the above-mentioned implant device.
  • An implant device includes: a ring-shaped housing defining an accommodating cavity in the ring-shaped housing, the ring-shaped housing being a metal housing with gaps; a cover, the cover The body covers the accommodating cavity; a coil, the coil is used to transmit data and/or energy, the coil is arranged in the accommodating cavity; the stimulation circuit board, the first end of the stimulation circuit board is connected to the In the coil, the second end of the stimulation circuit board is the stimulation end, and the second end extends outward from the annular housing.
  • the volume of the implantation device can be effectively reduced, and by providing a gap in the annular housing, the generation of coil eddy currents is avoided, and the shielding in the accommodating cavity is reduced.
  • the eddy current of the metal shell under electromagnetic induction is reduced, the heat caused by the eddy current is reduced, the efficiency of wireless transmission is ensured, and the signal communication is not affected, so that the radio frequency signal of the coil can be transmitted stably and reliably.
  • the first end is disposed in the accommodating cavity
  • the ring-shaped housing is provided with a wire hole
  • the stimulation circuit board passes through the wire hole
  • the gap is connected to the cable hole and is an inverted T-shaped hole, and the inverted T-shaped hole penetrates the annular housing up and down.
  • the slit penetrates through the top and bottom of the annular housing up and down and is circumferentially spaced from the wire passing hole.
  • a connecting post is provided on the inner surface of the annular housing, and the connecting post is connected to the ground wire of the first end to form an electrical stimulation circuit.
  • the connecting column is integrally formed inside the annular housing, and the connecting column extends along the axial direction of the annular housing.
  • the first end of the stimulation circuit board is provided with a connecting hole
  • the connecting post is inserted through the connecting hole
  • the first end of the stimulation circuit board and the connecting post pass Connect with conductive glue.
  • the ring-shaped housing is provided with a suture hook for fixing the ring-shaped housing on the sclera by sutures, one end of the suture hook is connected to the ring-shaped housing, and the other end Is a free end to form an open loop between the annular housing and the sewing hook.
  • the number of the sewing hooks is two, and the two sewing hooks are distributed on both sides of the gap.
  • the suture hook includes a connecting part connected to the annular housing and a hook part connected to one end of the connecting part, and the hook part has a non-closed loop structure.
  • the implant device further includes: an upper stent and a lower stent, the upper stent and the lower stent are disposed in the accommodating cavity, and the lower stent is located on the upper stent.
  • the coil includes: a first coil and a second coil, the first coil is provided on the upper support, the second coil is provided on the lower support, the second coil is located on the first Below a coil.
  • one of the first coil and the second coil is a data coil
  • the other of the first coil and the second coil is an energy coil
  • the data coil is For data interaction with the outside
  • the energy coil is used to receive external energy.
  • the slit is one of a linear shape, a wave shape, a V shape, and a W shape.
  • the center line of the slit is parallel to the center line of the annular housing.
  • the gap penetrates through the top and bottom of the annular housing up and down.
  • the top and bottom of the ring-shaped housing are both open
  • the cover body includes: an upper cover and a lower cover
  • the upper cover is provided on the top of the ring-shaped housing
  • the lower cover It is arranged at the bottom of the annular casing.
  • the upper cover is formed in a curved shape that is concave toward a direction away from the lower cover; and/or the lower cover is formed in a curved shape that is concave toward the upper cover.
  • the upper cover and the lower cover are ceramic pieces, glass pieces, or polymer pieces.
  • the annular shell is a pure titanium piece, a titanium alloy piece, a platinum piece, a platinum alloy piece, or a platinum-iridium alloy piece.
  • a visual prosthesis includes: the implantation device, the implantation device is used to implant the brain or the eye; an external device, the external device includes: a camera unit, a video A processing unit and a wireless annunciator, the camera unit is electrically connected to the video processing unit, the video processing unit is electrically connected to the wireless annunciator, and the wireless annunciator is wirelessly coupled to the implanted device Make energy and data connections.
  • Figure 1 is an exploded view of an implant device according to an embodiment of the present disclosure
  • Fig. 2 is a schematic diagram of the implantation device shown in Fig. 1 after being assembled;
  • Figure 3 is a perspective view of the annular housing shown in Figure 1;
  • Fig. 4 is a top view of the annular housing and stimulation circuit board shown in Fig. 1;
  • Fig. 5 is a schematic diagram of the implantation device according to an embodiment of the present disclosure when the eyeball is implanted;
  • Fig. 6 is a schematic diagram of the implantation device according to an embodiment of the present disclosure when it is implanted into the cerebral cortex;
  • Fig. 7 is a schematic diagram of a visual prosthesis according to an embodiment of the present disclosure.
  • the implantation device 100 according to an embodiment of the first aspect of the present disclosure will be described below with reference to FIGS. 1 to 4.
  • the implant device 100 can be applied to implants such as cochlear implants, retinal implants, spinal cord stimulators (for the treatment of pain), cerebral cortex stimulators, deep brain stimulators (brain pacemakers), etc. Medical equipment.
  • the implantation device 100 and the retinal implant for cerebral cortex stimulation visual prosthesis are mainly described as examples.
  • the implantation device 100 includes a housing 1, a coil 2, and a stimulation circuit board 3.
  • the housing 1 includes a ring-shaped housing 11 and a cover.
  • the cover covers the accommodating cavity, that is, the cover covers the open part of the ring housing 11 (for example, the top and bottom in FIGS. 1 and 3).
  • the annular shell 11 is a metal shell, that is, the annular shell 11 is made of metal material.
  • the annular shell 11 made of metal material can effectively protect the coil 2 and the stimulation circuit board 3, and also has the effect of preventing corrosion.
  • the coil 2 is used to transmit data and/or energy, and the number can be one or more, and the coil 2 is arranged in the accommodating cavity.
  • the coil 2 may include a first coil 23 and a second coil 24, one of the first coil 23 and the second coil 24 is a data coil, and the other of the first coil 23 and the second coil 24 is an energy coil ,
  • the data coil can be used for data interaction with the outside, and the energy coil can be used for receiving external energy.
  • the first coil 23 is a data coil and the second coil 24 is an energy coil as an example.
  • the first end of the stimulation circuit board 3 is connected to the coil 2
  • the second end of the stimulation circuit board 3 is the stimulation end, and the second end extends outward from the annular housing 11 to facilitate attachment In the body to be implanted.
  • the coil 2 is connected to the first end of the stimulation circuit board 3 and forms an electronic device package.
  • the stimulation circuit board 3 includes an introduction part 31 and a stimulation part 32, the introduction part 31 constitutes the first end of the stimulation circuit board 3, and the stimulation part 32 constitutes the second end of the stimulation circuit board 3.
  • the lead-in part 31 can also be connected to, for example, an application specific integrated circuit (ASIC chip) and discrete components to realize corresponding circuit functions.
  • Discrete components may also include capacitors, inductors, resistors, oscillators, filters, memory chips, and other electronic components that may be set according to circuit design.
  • the electronic device package is located in the space formed by the annular casing 11 and the cover (that is, the above-mentioned accommodating cavity).
  • the first end of the stimulation circuit board 3 may not be arranged in the accommodating cavity, but connected to the outside of the annular housing 11 and electrically connected to the coil 2 inside the annular housing 11, which is also covered in Within the scope of this disclosure.
  • the stimulation part 32 may include a flexible substrate and a plurality of stimulation electrodes arranged on the flexible substrate.
  • the flexible substrate may support and protect the stimulation electrodes, and the ends of the plurality of stimulation electrodes may be exposed to one part of the flexible substrate.
  • the side surface is suitable for stimulating the implanted part of the human body (for example, the retina 1001, the cerebral cortex 3000, etc.).
  • a plurality of stimulation electrodes may be arranged in an array (for example, in rows and columns) in the flexible substrate, and the number of stimulation electrodes may be tens, hundreds, or thousands, such as 256 or 512.
  • a gap 112 is also opened on the annular shell 11.
  • the closed toroidal shell will affect the normal communication of the coil 2, and the toroidal shell 11 provided with the gap 112 of the present disclosure will not hinder the signal communication, which can prevent the coil eddy current from affecting the magnetic field distribution and reduce the heating caused by the eddy current , To ensure the efficiency of wireless transmission, so as to ensure the stable and reliable transmission of the radio frequency signal of the coil 2.
  • the implanting device 100 is implanted in the eyeball 1000, even if the eyeball 1000 moves or the distance between the external device 200 and the electronic device package is large, the implantation device 100 can still ensure stable and reliable signal transmission.
  • the size of the implantation device 100 can be significantly reduced, for example, the implantation
  • the part of the device 100 located outside the eye only needs to cover one quadrant of the sclera (generally the supratemporal quadrant) for implantation.
  • the annular shell 11 is also provided with a gap 112
  • the eddy current of the coil can be avoided, and the signal communication will not be affected, so that the stable and reliable transmission of the radio frequency signal of the coil 2 can be ensured.
  • a wire hole 114 is formed on the annular housing 11, the stimulation circuit board 3 can pass through the wire hole 114, and the wire hole 114 can facilitate the passage of the stimulation circuit board 3.
  • the gap 112 and the wire passage hole 114 are in communication with each other and are in an inverted T shape.
  • the inverted T-shaped hole penetrates the top and bottom of the annular shell 11, so that the annular shell 11 can effectively avoid the eddy current of the coil and stimulate the circuit board 3 at the same time. It can extend to the outside through the cable 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).
  • a connecting post 111 is provided in the annular housing 11.
  • the connecting column 111 may be integrally formed inside the annular housing 11, and the connecting column 111 may extend along the axial direction of the annular housing 11.
  • the connecting post 111 is connected with the ground wire of the first end of the stimulation circuit board 3 to form an electrical stimulation circuit.
  • the first end of the stimulation circuit board 3 is provided with a connecting hole, the connecting post 111 is inserted through the connecting hole, and the two can be connected by conductive glue.
  • the forward voltage driving specific electrical stimulation process can be as follows: After the electronic device package in the housing 1 receives the external radio frequency signal, Multiple stimulation electrodes send electrical pulse signals, and multiple stimulation electrodes apply current stimulation to the surface of the retina 1001 to help the patient obtain visual perception. At the same time, the current flows in the direction of low potential, that is, flows through the eyeball wall to the annular shell fixed on the sclera At the bottom end of 11, since the ground wire of the first end of the stimulation circuit board 3 is electrically connected to the connecting post 111 of the annular housing 11, it can further flow to the electronic device package.
  • a circuit loop can be formed without the need to provide a special loop electrode, and the implant device 100 provided in this way has fewer parts, simple structure, and easy processing and manufacturing.
  • the stimulation current passes through the eyeball wall and can penetrate deeply into the retinal cells, compared with the traditional method of setting loop electrodes on the stimulation circuit board, the same stimulation effect only needs to provide a smaller current intensity, which can extend
  • the use time of the battery saves electric energy, and the stimulation electrode on the stimulation part 32 only needs to bear a small load, which prolongs the service life of the stimulation circuit board 3.
  • the annular housing 11 is provided with a suture hook 113 for fixing the annular housing 11 on the sclera through sutures, and one end of the suture hook 113 is connected to the annular housing 11 , The other end is a free end to form an open loop between the annular housing 11 and the sewing hook 113, and the open loop structure can also avoid coil eddy current.
  • two suture hooks 113 are shown, and they are distributed on both sides of the slit 112.
  • each sewing hook 113 may include a connecting portion 1131 connected to the annular housing 11 and a hook portion 1132 connected to one end of the connecting portion 1131. Since the hook portion 1132 adopts a non-closed loop structure, the eddy current of the coil can be further avoided.
  • the implantation device 100 further includes a stent.
  • the stent includes an upper stent 21 and a lower stent 22.
  • the upper stent 21 is arranged above the lower stent 22, and the upper stent 21 and the lower stent 22 are both arranged in the accommodating cavity.
  • the first coil 23 is disposed on the upper support 21, the second coil 24 is disposed on the lower support 22, and the second coil 24 is located below the first coil 23. That is to say, the number of brackets is two, the upper bracket 21 is used to support the first coil 23, the lower bracket 22 is used to support the second coil 24, and the upper bracket 21 is also arranged above the lower bracket 22.
  • the stent thus arranged can make reasonable use of the internal space of the implant device 100, and can also make the overall layout of the first coil 23 and the second coil 24 reasonable.
  • the positions of the second coil and the first coil can be exchanged.
  • the gap 112 may also be a curve (such as an arc shape, a wave shape, etc.), a broken line (such as a V shape, a W shape, etc.), and the like.
  • the center line of the gap 112 may be parallel to the center line of the annular casing 11, or may form a certain angle, both of which can achieve the technical effects of the present disclosure.
  • the number of the slits 112 can be multiple, but only one of them can penetrate the annular casing 11 up and down to ensure that the annular casing 11 is an integral structure.
  • the top and bottom of the annular shell 11 are open.
  • the cover includes an upper cover 12 and a lower cover 13.
  • the upper cover 12 is arranged on the top of the annular shell 11 and the lower cover 13 is arranged on the bottom of the annular shell 11.
  • the upper cover 12 and the lower cover 13 respectively close the top and bottom of the annular housing 11, and the upper cover 12 may be formed as a curved surface that is concave toward the direction away from the lower cover 13.
  • the lower cover 13 may be formed into a curved shape that is concave toward the upper cover 12. Therefore, when the implant device 100 is implanted in the eyeball 1000, since the lower cover 13 is configured as a curved surface that matches the sclera, it can better fit the sclera, and because the upper cover 12 also has a corresponding curved structure, and Located between the eyelid and sclera, it can reduce the patient's foreign body sensation.
  • the annular shell 11 is made of pure titanium, or other metal materials, such as titanium alloy, platinum, platinum alloy, platinum-iridium alloy, etc.
  • the upper cover 12 and the lower cover 13 are made of ceramic, glass or polymer (such as Polyetheretherketone, etc.), but not limited to this.
  • a cable 33 is connected between the lead-in portion 31 and the stimulation portion 32 of the stimulation circuit board 3, as shown in FIGS. 1 to 2. During installation, the cable 33 can pass through the cable hole 112 to extend out of the housing 1.
  • the stimulation circuit board 3 is a flexible electrode, but it is not limited thereto.
  • the following describes the process of implanting the implant device 100 in the eyeball 1000 (that is, as a retina 1001 implant) according to an embodiment of the present disclosure in conjunction with FIG. 5.
  • 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 a vitrectomy is performed, and the sclera is cut in the superior temporal quadrant to form an incision.
  • the second end of the stimulation circuit board 3 is introduced into the eyeball 1000 from the incision, and the second end is fixed to the macular area on the surface of the retina 1001 by a fixing nail 2000.
  • the implantation operation is simple, has little trauma to the eyes, avoids compression of the 1000 vortex veins of the eyeball, has fewer postoperative complications, and can reduce the patient's foreign body sensation.
  • the second end of the stimulation circuit board 3 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 second end with the stimulation electrode can be implanted in the V1 area of the brain's visual cortex, or it can partially cover the V2 or V3 area.
  • 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.
  • a visual prosthesis according to an embodiment of the second aspect of the present disclosure includes an implant device 100 and an external device 200.
  • the implant device 100 is the implant device 100 according to the embodiment of the first aspect of the present disclosure.
  • the implant device 100 is used to implant the brain or the eye.
  • the second end of the stimulation circuit board 3 can be used to treat the visual cortex or the retina. The cells are stimulated.
  • the external device 200 includes a camera unit 210, a video processing unit 220, and a wireless annunciator 230.
  • the camera unit 210 is electrically connected to the video processing unit 220
  • the video processing unit 220 is electrically connected to the wireless annunciator 230
  • the wireless annunciator 230 is connected to the implant device 100.
  • the energy and data connection is performed by wireless coupling, for example, the external coil 2 and the coil 2 in the implant device 100 are used for wireless transmission of data and energy.

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Abstract

一种植入装置(100)，包括：环形壳体(11)，环形壳体(11)内限定出容置腔，环形壳体(11)为金属壳体且开设有缝隙(112)；盖体，盖体封盖容置腔；线圈(2)，线圈(2)用于传递数据和/或能量，线圈(2)设置于容置腔内；刺激电路板(3)，刺激电路板(3)的第一端连接线圈(2)，刺激电路板(3)的第二端为刺激端，第二端从环形壳体(11)向外延伸。

Description

植入装置和具有其的视觉假体 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和具有其的视觉假体。
背景技术
视觉假体是为了帮助视网膜或者其它视觉器官发生病变的患者重新获得光明和视觉的植入式医疗器械。正常视觉的形成是视网膜上的感光细胞(如视锥细胞和视杆细胞)将光刺激转换成电信号，在视网膜的各层细胞(如水平细胞、双极细胞、神经节细胞等)编码之后，将神经冲动传输到视皮层。
目前常用的一种视觉假体设计是将微电极植入物植入视网膜表面，从而帮助视网膜色素变性和老年性黄斑变性等外层视网膜变性疾病患者。该视觉假体包括植入件和外部件两个部分。植入件中的电子封装体缝合在眼球巩膜外侧，柔性刺激电路板穿过眼球壁，其端部的电极阵列通过固定钉固定在视网膜表面。外部件包括采集视频信息的摄像头，视频信息经过数据转换后无线传输给植入件的电子封装体，电极阵列通过电刺激的方式向视网膜传递刺激，传送到视网膜上的电脉冲信号刺激视网膜上仍保留功能的神经元，并将此刺激通过视觉神经传送到大脑，使患者产生视觉感知。
相关技术中，植入件的电子封装体一般与线圈相连，线圈用于传输数据和能量，线圈位于电子封装体的外部，电子封装体和线圈分别位于眼球的周向前后位置，这样占用空间较大，植入件需要覆盖巩膜周向两个象限甚至三个、四个象限，导致手术难度较大，而且病人的异物感较明显。
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，所述植入装置结构紧凑，占用空间小。
本公开的另一个目的在于提出一种具有上述植入装置的视觉假体。
根据本公开第一方面实施例的植入装置，包括：环形壳体，所述环形壳体内限定出容置腔，所述环形壳体为金属壳体且开设有缝隙；盖体，所述盖体封盖所述容置腔；线圈，所述线圈用于传递数据和/或能量，所述线圈设置于所述容置腔内；刺激电路板，所述刺激电路板的第一端连接所述线圈，所述刺激电路板的第二端为刺激端，所述第二端从所述环形壳体向外延伸。
由此，通过将线圈内置于环形壳体内，可以有效减小植入装置的体积，而且通过在环形壳体设置缝隙，避免了线圈涡流的产生，减小了容置腔内存在的屏蔽，减小了金属壳体在电磁感应下的涡流电流，降低了由于涡流电流导致的发热，保证了无线传输的效率，不会影响信 号的通信，进而使得线圈的射频信号能稳定可靠地传输。
根据本公开的一些实施例，所述第一端设置于所述容置腔内，所述环形壳体设置有过线孔，所述刺激电路板经过所述过线孔。
根据本公开的一些实施例，所述缝隙与所述过线孔相连且呈倒T形孔，所述倒T形孔上下贯穿所述环形壳体。
根据本公开的一些实施例，所述缝隙上下贯穿所述环形壳体的顶部和底部且与所述过线孔周向间隔。
根据本公开的一些实施例，所述环形壳体的内表面设置有连接柱，所述连接柱与所述第一端的地线相连接，以形成电刺激回路。
根据本公开的一些实施例，所述连接柱一体形成在所述环形壳体的内部，所述连接柱沿所述环形壳体的轴向延伸。
根据本公开的一些实施例，所述刺激电路板的第一端设置有连接孔，所述连接柱穿设在所述连接孔内，所述刺激电路板的第一端和所述连接柱通过导电胶相连接。
根据本公开的一些实施例，所述环形壳体设置有缝合钩，用于通过缝合线将所述环形壳体在巩膜上固定，所述缝合钩的一端与所述环形壳体连接，另一端为自由端，以在所述环形壳体和所述缝合钩之间形成开环。
根据本公开的一些实施例，所述缝合钩的数量为两个，两个所述缝合钩分布于所述缝隙的两侧。
根据本公开的一些实施例，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一端的勾部，所述勾部为非闭环结构。
根据本公开的一些实施例，所述植入装置还包括：上支架和下支架，所述上支架和所述下支架设置于所述容置腔内，所述下支架位于所述上支架的下方；所述线圈包括：第一线圈和第二线圈，所述第一线圈设置于所述上支架上，所述第二线圈设置于所述下支架上，所述第二线圈位于所述第一线圈的下方。
根据本公开的一些实施例，所述第一线圈和所述第二线圈中的一个为数据线圈，所述第一线圈和所述第二线圈中的另一个为能量线圈，所述数据线圈用于与外部进行数据交互，所述能量线圈用于接收外部能量。
根据本公开的一些实施例，所述缝隙为直线状、波浪状、V形和W形中的一种。
根据本公开的一些实施例，所述缝隙的中心线与所述环形壳体的中心线平行。
根据本公开的一些实施例，所述缝隙上下贯穿所述环形壳体的顶部和底部。
根据本公开的一些实施例，所述环形壳体的顶部和底部均敞开，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，所述下盖设在所述环形壳体的底部。
根据本公开的一些实施例，所述上盖形成为朝向远离所述下盖的方向凹入的曲面形；和/或所述下盖形成为朝向所述上盖方向凹入的曲面形。
根据本公开的一些实施例，所述上盖和所述下盖为陶瓷件、玻璃件或聚合物件。
根据本公开的一些实施例，所述环形壳体为纯钛件、钛合金件、铂件、铂合金件、或铂铱合金件。
根据本公开第二方面实施例的视觉假体，包括：所述的植入装置，所述植入装置用于植入脑部或眼部；外部装置，所述外部装置包括：摄像单元、视频处理单元和无线信号器，所述摄像单元与所述视频处理单元电连接，所述视频处理单元和所述无线信号器电连接，所述无线信号器与所述植入装置通过无线耦合的方式进行能量和数据连接。
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分解图；
图2是图1中所示的植入装置装配完成后的示意图；
图3是图1中所示的环形壳体的立体图；
图4是图1中所示的环形壳体和刺激电路板的俯视图；
图5是根据本公开实施例的植入装置植入眼球时的示意图；
图6是根据本公开实施例的植入装置植入脑皮层时的示意图；
图7是根据本公开实施例的视觉假体的原理图。
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4描述根据本公开第一方面实施例的植入装置100。该植入装置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。
如图1-图4所示，根据本公开第一方面实施例的植入装置100，包括外壳1、线圈2、刺激电路板3。
具体而言，外壳1包括环形壳体11和盖体，例如，参照图1-图2并结合图3，环形壳体11内限定出容置腔，环形壳体11可以大体形成为周向延伸的环形结构，盖体封盖容置腔，即盖体封盖环形壳体11的敞开部分(例如，图1和图3中的顶部和底部)。
环形壳体11为金属壳体，即环形壳体11由金属材料制成，金属材料制成的环形壳体11可以 有效保护线圈2和刺激电路板3，而且还具有防腐蚀的作用。
其中，线圈2用于传递数据和/或能量，数量可以为一个或多个，线圈2设置于容置腔内。例如，线圈2可以包括一个第一线圈23和一个第二线圈24，第一线圈23和第二线圈24中的一个为数据线圈，第一线圈23和第二线圈24中的另一个为能量线圈，数据线圈可以用于与外部进行数据交互，能量线圈可以用于接收外部能量。
下面以第一线圈23为数据线圈且第二线圈24为能量线圈为例进行说明。
如图1和图2所示，刺激电路板3的第一端与线圈2连接，刺激电路板3的第二端为刺激端，第二端从环形壳体11向外延伸，以便于贴附于人体的待植入部位。
线圈2与刺激电路板3的第一端连接并形成电子器件封装体。刺激电路板3包括引入部分31和刺激部分32，引入部分31构成刺激电路板3的第一端，刺激部分32构成刺激电路板3的第二端。引入部分31除了连接前述第一线圈23和第二线圈24外，还可连接如专用集成电路(ASIC芯片)和分立元器件等，以实现相应的电路功能。分立元器件还可以包括电容器、电感器、电阻器、振荡器、滤波器、内存芯片等根据电路设计而可能设置的电子元器件。电子器件封装体位于环形壳体11和盖体形成的空间(即上述容置腔)内。作为一个可替代的实施例，刺激电路板3的第一端可不设置于容置腔内，而是连接于环形壳体11的外侧并与环形壳体11内部的线圈2电连接，同样涵盖在本公开的范围之内。
刺激部分32可以包括柔性衬底和设在柔性衬底上的多个刺激电极，柔性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。多个刺激电极可以以阵列方式(例如，成排成列)设在柔性衬底内，刺激电极的数量可以为数十、数百或数千个，如256或512等。
其中，如图3和图4所示，环形壳体11上还开设有缝隙112。封闭式的环形壳体将影响线圈2的正常通信，而本公开的设置有缝隙112的环形壳体11将不会阻碍信号通信，其可以避免线圈涡流影响磁场分布，降低由于涡流电流导致的发热，保证无线传输的效率，从而可以保证线圈2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移动，或者外部装置200与电子器件封装体之间距离较大时，植入装置100依然能保证信号稳定可靠地传输。
由此，根据本公开实施例的植入装置100，通过在环形壳体11内内置线圈2，在保证各部分功能稳定可靠的同时，还能显著减少植入装置100的尺寸，例如，植入装置100位于眼外的部分仅需要覆盖巩膜一个象限(一般为颞上象限)即可植入。而且，由于环形壳体11上还开设有缝隙112，可以避免线圈涡流，不会影响信号的通信，从而可以保证线圈2的射频信号稳定可靠地传输。
根据本公开的进一步实施例，参照图2，环形壳体11上形成有过线孔114，刺激电路板3可以穿过过线孔114，过线孔114可以方便刺激电路板3的经过。
缝隙112与过线孔114彼此连通且呈倒T形，此时该倒T形孔贯通环形壳体11的顶部和底部，这样环形壳体11在有效避免线圈涡流的同时，使得刺激电路板3可以穿过过线孔114伸到外部。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，参照图4并结合图3，环形壳体11内设有连接柱111。例如，在图3-图4的示例中，连接柱111可以一体形成在环形壳体11内部，且连接柱111可以沿环形壳体11的轴向延伸。连接柱111与刺激电路板3的第一端地线相连接，以形成电刺激回路。其中，刺激电路板3的第一端设置有连接孔，连接柱111穿设在连接孔内，两者之间可以通过导电胶连接。
当植入装置100植入眼球1000时，正向电压驱动具体的电刺激过程可以如下：外壳1内的电子器件封装体接收到外部的射频信号后，向刺激电路板3的第二端上的多个刺激电极发送电脉冲信号，多个刺激电极向视网膜1001表面施加电流刺激，以帮助患者获得视觉感知，同时电流朝向低电位方向流动，即穿过眼球壁流向固定在巩膜上的环形壳体11的底端，由于刺激电路板3的第一端的地线与环形壳体11的连接柱111电连接，从而可以进一步流向电子器件封装体。
由此，无需设置专门的回路电极就可以形成电路循环，如此设置的植入装置100零部件少，结构简单且易于加工制造。此外，由于刺激电流穿过眼球壁，能深度穿入视网膜细胞，与传统的在刺激电路板上设置回路电极的方式相比，实现同样的刺激效果只需提供更小的电流强度，从而能延长电池的使用时间，节省电能，且刺激部分32上的刺激电极只需承受较小的负载，延长了刺激电路板3的使用寿命。
根据本公开的一些实施例，如图3所示，环形壳体11设置有缝合钩113，用于通过缝合线将环形壳体11在巩膜上固定，缝合钩113的一端与环形壳体11连接，另一端为自由端，以在环形壳体11和缝合钩113之间形成开环，该开环结构也能避免线圈涡流。例如，在图3的示例中示出了两个缝合钩113，且分布于缝隙112的两侧。
外壳1可以通过缝合钩113采用缝线的方式牢靠地缝合在待缝合组织(如巩膜等)上，环形壳体11上缝合钩113的相对一侧(例如，图3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)，在保证对植入装置100固定的同时，减少了缝合点。具体而言，参照图3，每个缝合钩113可以包括与环形壳体11连接的连接部1131和连接在连接部1131的一端的勾部1132。由于勾部1132采用非闭环结构，从而可以进一步避免线圈涡流。
如图1所示，植入装置100还包括支架，支架包括上支架21和下支架22，上支架21设置于下支架22的上方，上支架21和下支架22均设置于容置腔内，第一线圈23设置于上支架21上，第二线圈24设置于下支架22上，第二线圈24位于第一线圈23的下方。也就是说，支架的数量为两个，上支架21用于支撑第一线圈23，下支架22用于支撑第二线圈24，上支架21还设置于下支架22的上方。如此设置的支架可以合理利用植入装置100的内部空间，也可以使得第一线圈23和第二线圈24整体布局合理。可选的，第二线圈和第一线圈可以互换位置。
可选地，缝隙112除了可以为直线状之外，还可以为曲线(如弧形、波浪形等)、折线(如V形、W形等)等。多种缝隙112形式可以满足不同的使用要求。缝隙112的中心线可以与环形壳体11的中心线平行，也可以形成一定夹角，均可以实现本公开的技术效果。此外，缝隙112的数量可以为多条，但仅其中一条能上下贯通环形壳体11，以保证环形壳体11为一体结构。
环形壳体11的顶部和底部均敞开，盖体包括上盖12和下盖13，上盖12设在环形壳体11的 顶部，下盖13设在环形壳体11的底部。
例如，在图1、图3和图4的示例中，上盖12和下盖13分别封闭环形壳体11的顶部和底部，上盖12可以形成为朝向远离下盖13的方向凹入的曲面形，下盖13可以形成为朝向上盖12方向凹入的曲面形。由此，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，或其它金属材料，如钛合金，铂，铂合金，铂铱合金等，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。
根据本公开的一个具体实施例，刺激电路板3的引入部分31和刺激部分32之间连接有电缆33，如图1-图2所示。安装时，电缆33可以穿过过线孔112以伸出到外壳1外。可选地，刺激电路板3为柔性电极，但不限于此。
下面结合图5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1001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，将刺激电路板3的第二端从该切口引入眼球1000内，并通过固定钉2000将第二端固定在视网膜1001表面黄斑区域。该植入手术简单，对眼睛创伤小，且避免了压迫眼球1000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6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。然后将刺激电路板3的第二端植入脑皮层3000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，具有刺激电极的第二端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。
如图7所示，根据本公开第二方面实施例的视觉假体，包括植入装置100和外部装置200。植入装置100为根据本公开上述第一方面实施例的植入装置100，植入装置100用于植入脑部或眼部，刺激电路板3的第二端可以用于对视觉皮层或视网膜细胞进行刺激。
外部装置200包括摄像单元210、视频处理单元220和无线信号器230，摄像单元210与视频处理单元220电连接，视频处理单元220和无线信号器230电连接，无线信号器230与植入装置100通过无线耦合的方式进行能量和数据连接，例如通过外部线圈2与植入装置100中的线圈2进行数据和能量的无线传输。
根据本公开实施例的植入装置100和视觉假体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 (20)

  1. 一种植入装置，其特征在于，包括：
    环形壳体，所述环形壳体内限定出容置腔，所述环形壳体为金属壳体且开设有缝隙；
    盖体，所述盖体封盖所述容置腔；
    线圈，所述线圈用于传递数据和/或能量，所述线圈设置于所述容置腔内；
    刺激电路板，所述刺激电路板的第一端连接所述线圈，所述刺激电路板的第二端为刺激端，所述第二端从所述环形壳体向外延伸。
  2. 根据权利要求1所述的植入装置，其特征在于，所述第一端设置于所述容置腔内，所述环形壳体设置有过线孔，所述刺激电路板经过所述过线孔。
  3. 根据权利要求2所述的植入装置，其特征在于，所述缝隙与所述过线孔相连且呈倒T形孔，所述倒T形孔上下贯穿所述环形壳体。
  4. 根据权利要求2所述的植入装置，其特征在于，所述缝隙上下贯穿所述环形壳体的顶部和底部且与所述过线孔周向间隔。
  5. 根据权利要求1所述的植入装置，其特征在于，所述环形壳体的内表面设置有连接柱，所述连接柱与所述第一端的地线相连接，以形成电刺激回路。
  6. 根据权利要求5所述的植入装置，其特征在于，所述连接柱一体形成在所述环形壳体的内部，所述连接柱沿所述环形壳体的轴向延伸。
  7. 根据权利要求5所述的植入装置，其特征在于，所述刺激电路板的第一端设置有连接孔，所述连接柱穿设在所述连接孔内，所述刺激电路板的第一端和所述连接柱通过导电胶相连接。
  8. 根据权利要求1所述的植入装置，其特征在于，所述环形壳体设置有缝合钩，用于通过缝合线将所述环形壳体在巩膜上固定，所述缝合钩的一端与所述环形壳体连接，另一端为自由端，以在所述环形壳体和所述缝合钩之间形成开环。
  9. 根据权利要求8所述的植入装置，其特征在于，所述缝合钩的数量为两个，两个所述缝合钩分布于所述缝隙的两侧。
  10. 根据权利要求8所述的植入装置，其特征在于，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一端的勾部，所述勾部为非闭环结构。
  11. 根据权利要求1所述的植入装置，其特征在于，还包括：上支架和下支架，所述上支架和所述下支架设置于所述容置腔内，所述下支架位于所述上支架的下方；
    所述线圈包括：第一线圈和第二线圈，所述第一线圈设置于所述上支架上，所述第二线圈设置于所述下支架上，所述第二线圈位于所述第一线圈的下方。
  12. 根据权利要求11所述的植入装置，其特征在于，所述第一线圈和所述第二线圈中的一个为数据线圈，所述第一线圈和所述第二线圈中的另一个为能量线圈，所述数据线圈用于与外部进行数据交互，所述能量线圈用于接收外部能量。
  13. 根据权利要求1-12中任一项所述的植入装置，其特征在于，所述缝隙为直线状、波浪状、V形和W形中的一种。
  14. 根据权利要求1-12中任一项所述的植入装置，其特征在于，所述缝隙的中心线与所述环形壳体的中心线平行。
  15. 根据权利要求1-12中任一项所述的植入装置，其特征在于，所述缝隙上下贯穿所述环形壳体的顶部和底部。
  16. 根据权利要求1-12中任一项所述的植入装置，其特征在于，所述环形壳体的顶部和底部均敞开，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，所述下盖设在所述环形壳体的底部。
  17. 根据权利要求16所述的植入装置，其特征在于，所述上盖形成为朝向远离所述下盖的方向凹入的曲面形；和/或
    所述下盖形成为朝向所述上盖方向凹入的曲面形。
  18. 根据权利要求16所述的植入装置，其特征在于，所述上盖和所述下盖为陶瓷件、玻璃件或聚合物件。
  19. 根据权利要求1-12中任一项所述的植入装置，其特征在于，所述环形壳体为纯钛件、钛合金件、铂件、铂合金件、或铂铱合金件。
  20. 一种视觉假体，其特征在于，包括：
    根据权利要求1-19中任一项所述的植入装置，所述植入装置用于植入脑部或眼部；
    外部装置，所述外部装置包括：摄像单元、视频处理单元和无线信号器，所述摄像单元与所述视频处理单元电连接，所述视频处理单元和所述无线信号器电连接，所述无线信号器与所述植入装置通过无线耦合的方式进行能量和数据连接。
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