Implant device and visual prosthesis having the same

Abstract

The application discloses an implant device and a visual prosthesis with the same, the implant device comprises: a ring-shaped shell, a containing cavity is defined in the ring-shaped shell, the ring-shaped shell is a metal shell and is provided with a gap; a cover body, the cover body covers the containing cavity; a coil, the coil is used for transmitting data and / or energy, the coil is arranged in the containing cavity; a stimulation circuit board, a first end of the stimulation circuit board is connected with the coil, a second end of the stimulation circuit board is a stimulation end, and the second end extends outward from the ring-shaped shell. Thus, the implant device is small in size, and by arranging the gap in the ring-shaped shell, the shielding existing in the containing cavity is reduced, the eddy current of the metal shell under electromagnetic induction is reduced, the heating caused by the eddy current is reduced, the efficiency of wireless transmission is ensured, and then the radio frequency signal of the coil can be stably and reliably transmitted.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, and in particular to an implantable device and a visual prosthesis having therein. Background Technology

[0002] Visual prostheses are implantable medical devices designed to help patients with retinal or other visual organ diseases regain sight and vision. Normal vision is formed when photoreceptor cells on the retina (such as cone cells and rod cells) convert light stimuli into electrical signals. After being encoded by cells in various layers of the retina (such as horizontal cells, bipolar cells, ganglion cells, etc.), nerve impulses are transmitted to the visual cortex.

[0003] A commonly used visual prosthesis design involves implanting microelectrodes onto the surface of the retina to help patients with outer retinal degenerative diseases such as retinitis pigmentosa and age-related macular degeneration. This visual prosthesis consists of two parts: the implant and the external component. The electronic package within the implant is sutured to the outer side of the sclera, and a flexible stimulation circuit board passes through the eyeball wall. The electrode array at its end is fixed to the retinal surface using pins. The external component includes a camera that captures video information. After data conversion, the video information is wirelessly transmitted to the electronic package within the implant. The electrode array then delivers electrical stimulation to the retina. The electrical pulses transmitted to the retina stimulate the neurons that still retain function, and this stimulation is transmitted to the brain via the optic nerve, enabling the patient to perceive vision.

[0004] In related technologies, 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 located in the circumferential front and back positions of the eyeball, which takes up a lot of space. The implant needs to cover two or even three or four quadrants of the sclera in the circumferential direction, which makes the surgery more difficult and the patient's foreign body sensation more obvious. Summary of the Invention

[0005] The present invention aims to at least solve one of the technical problems existing in the prior art. Therefore, one object of the present invention is to provide an implantation device that is compact in structure and occupies little space.

[0006] Another object of the present invention is to provide a visual prosthesis having the above-described implantation device.

[0007] An implantation device according to a first aspect of the present invention includes: an annular housing defining a receiving cavity, the annular housing being a metal housing and having a slit; a cover sealing the receiving cavity; a coil for transmitting data and / or energy, the coil being disposed within the receiving cavity; and a stimulation circuit board, a first end of the stimulation circuit board being connected to the coil, and a second end of the stimulation circuit board being a stimulation end extending outward from the annular housing.

[0008] Therefore, by embedding the coil inside the annular housing, the volume of the implantable device can be effectively reduced. Moreover, by setting a gap in the annular housing, the generation of eddy currents in the coil is avoided, the shielding in the accommodating cavity is reduced, the eddy current in the metal housing under electromagnetic induction is reduced, the heat generated by the eddy current is reduced, the efficiency of wireless transmission is guaranteed, and the signal communication is not affected. This allows the radio frequency signal of the coil to be transmitted stably and reliably.

[0009] According to some embodiments of the present invention, the first end is disposed within the accommodating cavity, the annular housing is provided with a wire-through hole, and the stimulation circuit board passes through the wire-through hole.

[0010] According to some embodiments of the present invention, the gap is connected to the wire hole and is in the shape of an inverted T-shaped hole, which penetrates the annular housing from top to bottom.

[0011] According to some embodiments of the present invention, the gap extends vertically through the top and bottom of the annular housing and is circumferentially spaced from the wire hole.

[0012] According to some embodiments of the present invention, a connecting post is provided on the inner surface of the annular shell, and the connecting post is connected to the ground wire of the first end to form an electrical stimulation circuit.

[0013] According to some embodiments of the present invention, the annular housing is provided with a suture hook for fixing the annular housing to the sclera by a suture thread. One end of the suture hook is connected to the annular housing, and the other end is a free end, so as to form an open loop between the annular housing and the suture hook.

[0014] According to some embodiments of the present invention, the number of the suture hooks is two, and the two suture hooks are distributed on both sides of the gap.

[0015] According to some embodiments of the present invention, the implantation device further includes: an upper support and a lower support, the upper support and the lower support being disposed within the receiving cavity, the lower support being located below the upper support; the coil includes: a first coil and a second coil, the first coil being disposed on the upper support, the second coil being disposed on the lower support, the second coil being located below the first coil.

[0016] According to some embodiments of the present invention, the gap is one of a straight line, a wavy line, a V-shape, and a W-shape.

[0017] According to a second aspect of the present invention, a visual prosthesis includes: the implantation device for implantation into the brain or eye; and an external device comprising: a camera unit, a video processing unit, and a wireless signal transmitter, wherein the camera unit is electrically connected to the video processing unit, the video processing unit is electrically connected to the wireless signal transmitter, and the wireless signal transmitter is connected to the implantation device for energy and data via wireless coupling.

[0018] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0019] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0020] Figure 1 This is an exploded view of the implantation device according to an embodiment of the present invention;

[0021] Figure 2 yes Figure 1 A schematic diagram showing the implantable device after assembly;

[0022] Figure 3 yes Figure 1 A perspective view of the annular shell shown;

[0023] Figure 4 yes Figure 1 A top view of the annular housing and stimulation circuit board shown;

[0024] Figure 5 This is a schematic diagram of the implantation device according to an embodiment of the present invention being implanted into the eyeball;

[0025] Figure 6 This is a schematic diagram of the implantation device according to an embodiment of the present invention being implanted into the cerebral cortex;

[0026] Figure 7 This is a schematic diagram of a visual prosthesis according to an embodiment of the present invention.

[0027] Figure label:

[0028] 100: Implantable device;

[0029] 1: Outer shell;

[0030] 11: Annular shell; 111: Connecting post; 112: Gap; 113: Seam hook; 114: Thread hole;

[0031] 1131: Connecting part; 1132: Hook part;

[0032] 12: Top cover; 13: Bottom cover;

[0033] 2: Coil; 21: Upper support; 22: Lower support; 23: First coil; 24: Second coil;

[0034] 3: Stimulation circuit board; 31: Introduction part; 32: Stimulation part; 33: Cable;

[0035] 200: External device; 210: Camera unit;

[0036] 220: Video processing unit; 230: Wireless signal transmitter;

[0037] 1000: Eyeball; 1001: Retina; 2000: Fixation pin; 3000: Cerebral cortex. Detailed Implementation

[0038] The embodiments of the present invention are described in detail below. The embodiments described with reference to the accompanying drawings are exemplary. The embodiments of the present invention are described in detail below.

[0039] The following is for reference. Figures 1-4 An implantation device 100 according to an embodiment of the first aspect of the present invention is described. This implantation device 100 is applicable to medical devices implanted in the human body, such as cochlear implants, retinal implants, spinal cord stimulators (for pain treatment), cortical stimulators, and deep brain stimulators (brain pacemakers). In the following description of the present invention, the implantation device 100 for cortical stimulation visual prostheses and retinal implants are primarily described as examples.

[0040] like Figures 1-4 As shown, the implantation device 100 according to a first aspect embodiment of the present invention includes a housing 1, a coil 2, and a stimulation circuit board 3.

[0041] Specifically, the outer casing 1 includes an annular shell 11 and a cover, for example, referring to Figures 1-2 and combined Figure 3 The annular shell 11 defines a receiving cavity. The annular shell 11 can be generally formed as a circumferentially extending annular structure. The cover seals the receiving cavity, that is, the cover seals the open portion of the annular shell 11 (e.g., Figure 1 and Figure 3 (Top and bottom of the middle).

[0042] The annular housing 11 is a metal housing, that is, the annular housing 11 is made of metal material. The annular housing 11 made of metal material can effectively protect the coil 2 and the stimulation circuit board 3, and also has the function of corrosion prevention.

[0043] The coil 2 is used to transmit data and / or energy, and there can be one or more coils 2 disposed within the accommodating cavity. For example, 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 being a data coil, and the other of the first coil 23 and the second coil 24 being an energy coil. The data coil can be used to interact with the outside world, and the energy coil can be used to receive external energy.

[0044] The following explanation uses the example of the first coil 23 being the data coil and the second coil 24 being the energy coil.

[0045] like Figure 1 and Figure 2 As shown, the first end of the stimulation circuit board 3 is connected to the coil 2, and the second end of the stimulation circuit board 3 is the stimulation end. The second end extends outward from the annular shell 11 so as to be attached to the implantation site on the human body.

[0046] Coil 2 is connected to the first end of stimulation circuit board 3 to form an electronic device package. Stimulation circuit board 3 includes an inlet portion 31 and a stimulation portion 32. Inlet portion 31 constitutes the first end of stimulation circuit board 3, and stimulation portion 32 constitutes the second end of stimulation circuit board 3. In addition to connecting the aforementioned first coil 23 and second coil 24, inlet portion 31 can also connect to applications such as application-specific integrated circuits (ASIC chips) and discrete components to achieve corresponding circuit functions. Discrete components may also include electronic components such as capacitors, inductors, resistors, oscillators, filters, and memory chips, which may be provided according to the circuit design. The electronic device package is located within the space formed by the annular housing 11 and the cover (i.e., the aforementioned accommodating cavity). As an alternative embodiment, the first end of stimulation circuit board 3 may not be located within the accommodating cavity, but may be connected to the outside of the annular housing 11 and electrically connected to the coil 2 inside the annular housing 11, which is also within the scope of the present invention.

[0047] The stimulation portion 32 may include a flexible substrate and multiple stimulation electrodes disposed on the flexible substrate. The flexible substrate can support and protect the stimulation electrodes. The ends of the multiple stimulation electrodes can be exposed on one side surface of the flexible substrate to stimulate the implantation site in the human body (e.g., retina 1001, cerebral cortex 3000, etc.). The multiple stimulation electrodes can be arranged in an array (e.g., in rows) within the flexible substrate, and the number of stimulation electrodes can be tens, hundreds, or thousands, such as 256 or 512.

[0048] Among them, such as Figure 3and Figure 4 As shown, a slit 112 is also provided on the annular housing 11. A closed annular housing would affect the normal communication of the coil 2, while the annular housing 11 with the slit 112 of the present invention will not hinder signal communication. It can avoid the influence of coil eddy currents on the magnetic field distribution, reduce the heat generated by eddy currents, and ensure the efficiency of wireless transmission, thereby ensuring the stable and reliable transmission of the radio frequency signal of the coil 2. For example, when the implantation device 100 is implanted into 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.

[0049] Therefore, the implantation device 100 according to the embodiments of the present invention, by embedding the coil 2 inside the annular housing 11, can significantly reduce the size of the implantation device 100 while ensuring the stable and reliable function of each part. For example, the part of the implantation device 100 located outside the eye only needs to cover one quadrant of the sclera (generally the superior temporal quadrant) for implantation. Moreover, since the annular housing 11 also has a slit 112, coil eddy currents can be avoided, which will not affect signal communication, thereby ensuring the stable and reliable transmission of the radio frequency signal of the coil 2.

[0050] According to a further embodiment of the present invention, referring to Figure 2 A wire hole 114 is formed on the annular shell 11, through which the stimulation circuit board 3 can pass. The wire hole 114 facilitates the passage of the stimulation circuit board 3.

[0051] The slit 112 and the wire-passing hole 114 are interconnected and form an inverted T-shape. In this case, the inverted T-shaped hole penetrates the top and bottom of the annular housing 11, so that the annular housing 11 can effectively avoid coil eddy currents while allowing the stimulation circuit board 3 to extend to the outside through the wire-passing hole 114. Of course, the slit 112 can also penetrate the top and bottom of the annular housing 11 and be circumferentially spaced from the wire-passing hole 114 (not shown in the figure).

[0052] According to some embodiments of the present invention, with reference to Figure 4 and combined Figure 3 A connecting post 111 is provided inside the annular shell 11. For example, in Figures 3-4 In the example, the connecting post 111 can be integrally formed inside the annular housing 11, and the connecting post 111 can extend along the axial direction of the annular housing 11. The connecting post 111 is connected to the ground wire at 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 connection hole, and the connecting post 111 passes through the connection hole. The two can be connected by conductive adhesive.

[0053] When the implantation device 100 is implanted into the eyeball 1000, the specific electrical stimulation process driven by the positive voltage can be as follows: After receiving the external radio frequency signal, the electronic device package inside the housing 1 sends electrical pulse signals to multiple stimulation electrodes on the second end of the stimulation circuit board 3. The 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, it flows through the eyeball wall to the bottom end of the annular housing 11 fixed on the sclera. 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.

[0054] Therefore, a circuit loop can be formed without the need for dedicated loop electrodes. This design results in an implantable device 100 with fewer components, a simpler structure, and easier manufacturing. Furthermore, because the stimulation current penetrates the eyeball wall and can deeply reach retinal cells, compared to the traditional method of placing loop electrodes on the stimulation circuit board, achieving the same stimulation effect requires only a smaller current intensity. This extends battery life, saves energy, and the stimulation electrodes on the stimulation part 32 only need to withstand a smaller load, extending the lifespan of the stimulation circuit board 3.

[0055] According to some embodiments of the present invention, such as Figure 3 As shown, the annular housing 11 is provided with a suture hook 113 for fixing the annular housing 11 to the sclera via a suture. One end of the suture hook 113 is connected to the annular housing 11, and the other end is a free end, forming an open loop between the annular housing 11 and the suture hook 113. This open loop structure also avoids coil eddy currents. For example, in Figure 3 The example shows two stitching hooks 113, which are distributed on both sides of the gap 112.

[0056] The outer shell 1 can be securely sewn to the tissue to be sutured (such as the sclera) using suture hooks 113. The opposite side of the suture hooks 113 on the annular shell 11 (e.g., Figure 3 The upper part of the implant (usually located between the two rectus muscles in the superior temporal quadrant) can be fixed by wrapping the conjunctiva outside the sclera, ensuring 100% fixation of the implant while reducing the number of suture points. Specifically, refer to... Figure 3 Each stitching 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, coil eddy currents can be further avoided.

[0057] like Figure 1As shown, the implantation device 100 also includes a support, comprising an upper support 21 and a lower support 22. The upper support 21 is positioned above the lower support 22. Both the upper support 21 and the lower support 22 are located within the accommodating cavity. The first coil 23 is positioned on the upper support 21, and the second coil 24 is positioned on the lower support 22, located below the first coil 23. In other words, there are two supports: the upper support 21 supports the first coil 23, and the lower support 22 supports the second coil 24. The upper support 21 is also positioned above the lower support 22. This support arrangement allows for efficient use of the internal space of the implantation device 100 and ensures a reasonable overall layout of the first coil 23 and the second coil 24. Optionally, the positions of the second coil and the first coil can be interchanged.

[0058] Optionally, the slit 112 can be straight, or it can be curved (such as arc, wave, etc.), or broken (such as V-shape, W-shape, etc.). Various slit 112 forms can meet different usage requirements. The centerline of the slit 112 can be parallel to the centerline of the annular shell 11, or it can form a certain angle, both of which can achieve the technical effects of the present invention. Furthermore, there can be multiple slits 112, but only one of them can penetrate the annular shell 11 vertically to ensure that the annular shell 11 is a single, integral structure.

[0059] The top and bottom of the annular housing 11 are open. The cover includes an upper cover 12 and a lower cover 13. The upper cover 12 is located at the top of the annular housing 11, and the lower cover 13 is located at the bottom of the annular housing 11.

[0060] For example, in Figure 1 , Figure 3 and Figure 4 In the example, the upper cover 12 and the lower cover 13 respectively enclose the top and bottom of the annular shell 11. The upper cover 12 can be formed as a curved surface concave away from the lower cover 13, and the lower cover 13 can be formed as a curved surface concave towards the upper cover 12. Thus, when the implantation device 100 is implanted into the eyeball 1000, since the lower cover 13 is constructed as a curved surface that matches the sclera, it can better fit the sclera. Furthermore, since the upper cover 12 also has a corresponding curved surface structure and is located between the eyelid and the sclera, it can reduce the patient's foreign body sensation.

[0061] Optionally, the annular shell 11 may be made of pure titanium or other metal materials, such as titanium alloy, platinum, platinum alloy, platinum-iridium alloy, etc., and the upper cover 12 and lower cover 13 may be made of ceramic, glass or polymer (such as polyetheretherketone) parts, but are not limited thereto.

[0062] According to a specific embodiment of the present invention, a cable 33 is connected between the introduction portion 31 and the stimulation portion 32 of the stimulation circuit board 3, such as... Figures 1-2As shown. During installation, cable 33 can pass through wire hole 112 to extend outside housing 1. Optionally, stimulation circuit board 3 is a flexible electrode, but not limited thereto.

[0063] The following is combined Figure 5 The process of implanting the implantation device 100 according to an embodiment of the present invention into the eyeball 1000 (i.e., as a retinal implant 1001) is described.

[0064] First, the annular shell 11 is sutured to the superior temporal quadrant of the sclera, ensuring the distance between the suture hook 113 and the limbus is maintained. Then, a vitrectomy is performed, and an incision is made in the superior temporal quadrant of the sclera. The second end of the stimulation circuit board 3 is introduced into the eyeball 1000 through this incision and fixed to the macular region of the retina 1001 using fixation pins 2000. This implantation procedure is simple, minimally invasive, avoids compression of the vortex veins of the eyeball 1000, has few postoperative complications, and reduces the patient's foreign body sensation.

[0065] The following is combined Figure 6 The process of implanting the implantation device 100 according to an embodiment of the present invention into the cerebral cortex 3000 is described.

[0066] First, a portion of the skull is removed to create a hollowed-out area. Then, the second end of the stimulation circuit board 3 is implanted into the surface of the cerebral cortex 3000, and the outer shell 1 is implanted into the hollowed-out area of ​​the skull, or onto the skull and below the scalp. Generally, the second end with the stimulation electrode can be implanted into the V1 area of ​​the visual cortex, or it can partially cover the V2 or V3 areas. It is worth noting that the V1, V2, and V3 areas of the visual cortex mentioned here are common regional divisions within the brain's visual domain, and will not be explained in detail here.

[0067] like Figure 7 As shown, a visual prosthesis according to a second aspect embodiment of the present invention includes an implantation device 100 and an external device 200. The implantation device 100 is the same as the implantation device 100 described in the first aspect embodiment of the present invention. The implantation device 100 is for implantation into the brain or eye, and the second end of the stimulation circuit board 3 can be used to stimulate the visual cortex or retinal cells.

[0068] The external device 200 includes a camera unit 210, a video processing unit 220, and a wireless signal transmitter 230. The camera unit 210 is electrically connected to the video processing unit 220, and the video processing unit 220 is electrically connected to the wireless signal transmitter 230. The wireless signal transmitter 230 is connected to the implanted device 100 for energy and data through wireless coupling, for example, through an external coil 2 to wirelessly transmit data and energy to the coil 2 in the implanted device 100.

[0069] Other components and operations of the implantation device 100 and visual prosthesis according to embodiments of the present invention are known to those skilled in the art and will not be described in detail here.

[0070] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. An implantable device, characterized in that, include: An annular shell, wherein an accommodating cavity is defined within the annular shell, and the annular shell is a metal shell with a slit; A cover body that seals the accommodating cavity; A coil for transmitting data and / or energy, the coil being disposed within the accommodating cavity; A stimulation circuit board, the first end of which is connected to the coil, and the second end of which is a stimulation end, extending outward from the annular shell; Wherein, the first end is disposed in the accommodating cavity, the annular shell is provided with a wire passage hole, the stimulation circuit board passes through the wire passage hole, and the gap is connected to the wire passage hole; The gap and the wire hole form an inverted T-shape, and the inverted T-shaped hole penetrates the annular shell from top to bottom; The annular shell is provided with a suture hook for fixing the annular shell to the sclera by a suture. One end of the suture hook is connected to the annular shell, and the other end is a free end, so as to form an open loop between the annular shell and the suture hook.

2. The implantation device according to claim 1, characterized in that, The inner surface of the annular shell is provided with a connecting post, which is connected to the ground wire at the first end to form an electrical stimulation circuit.

3. The implantation device according to claim 1, characterized in that, The number of suture hooks is two, and the two suture hooks are distributed on both sides of the gap.

4. The implantation device according to claim 1, characterized in that, Also includes: An upper support and a lower support are disposed within the receiving cavity, with the lower support located below the upper support. The coil includes a first coil and a second coil, the first coil being disposed on the upper support, the second coil being disposed on the lower support, and the second coil being located below the first coil.

5. The implantable device according to any one of claims 1-4, characterized in that, The gap can be either straight or wavy.

6. A visual prosthesis, characterized in that, include: The implantable device according to any one of claims 1-5 is used for implantation in the brain or eye; An external device, comprising: a camera unit, a video processing unit, and a wireless signal transmitter, wherein the camera unit is electrically connected to the video processing unit, the video processing unit is electrically connected to the wireless signal transmitter, and the wireless signal transmitter is connected to the implanted device for energy and data via wireless coupling.

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