Retinal stimulation electrode and implantable retinal electrical stimulator

Abstract

The utility model discloses a kind of retinal stimulating electrode and implantable retinal electric stimulator.The retinal stimulating electrode includes: stimulating electrode main body, the stimulating electrode main body includes introduction end, stimulating end and the connecting portion connected between the introduction end and the stimulating end, the stimulating end forms electrode array, the front surface of the electrode array is convex and the convex is provided with microelectrode for being contacted with retinal surface, the back surface of the electrode array is configured with first camber surface;Support body, the support body is set to the stimulating end, the bottom of the support body is configured with second camber surface, the second camber surface is attached to the first camber surface, the top of the support body is configured with reference surface, to make the thickness of the support body decrease from middle to periphery.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a retinal stimulation electrode and an implantable retinal electrical stimulator. Background Technology

[0002] In some retinal diseases, such as retinitis pigmentosa (RP) and age-related macular degeneration (AMD), the degeneration of photoreceptor cells caused by these conditions obstructs the normal visual pathways. Light entering the eye cannot be converted into visual signals, leading to a loss of light perception and vision. Fortunately, the functions of bipolar cells and ganglion cells in the retina of patients with retinal diseases like RP and AMD are largely preserved. Currently, artificial retina products partially restore vision by replacing the function of photoreceptor cells damaged by retinal damage caused by RP and AMD. This is achieved, for example, by using stimulating electrodes to generate signals to stimulate retinal ganglion cells or bipolar cells, and by utilizing other intact visual pathways to generate light perception in the cerebral cortex.

[0003] In related technologies, the flexible substrate supporting the electrodes used in implantation devices is unstable due to the uniform arc design of the flexible substrate. The electrode's shape and curvature are difficult to maintain. During implantation surgery, external forces such as surgical tools can easily deform the electrode, affecting its fit to the retina. This results in increased impedance between the electrode and the retina, reducing electrical stimulation efficiency. If the electrode does not fit properly to the retina (e.g., one side of the electrode is raised, the tail is raised, or the gap is too large), in severe cases, it may reduce the effectiveness of the implantation device or cause it to fail. Utility Model Content

[0004] This invention aims to solve at least one of the technical problems existing in the prior art. To this end, this invention proposes a retinal stimulation electrode, in which the middle part of the flexible support is thickened, which can strengthen the electrode array and enhance the support of the arc surface of the electrode array.

[0005] This invention further proposes an implantable retinal electrical stimulator.

[0006] A retinal stimulation electrode according to a first aspect of the present invention includes: a stimulation electrode body, the stimulation electrode body including an inlet end, a stimulation end, and a connecting portion connecting the inlet end and the stimulation end, the stimulation end forming an electrode array, the front side of the electrode array being convex and microelectrodes disposed on the convex surface for contact with the retinal surface, the back side of the electrode array having a first arc surface; a support body disposed on the stimulation end, the bottom of the support body having a second arc surface disposed on the first arc surface, the second arc surface being attached to the first arc surface, and the top of the support body having a reference surface, such that the thickness of the support body decreases from the middle to the outer periphery.

[0007] According to the embodiments of the present invention, the retinal stimulation electrode has a thickened middle portion of the flexible support member, which can strengthen the electrode array and enhance the support of the arc surface of the electrode array.

[0008] According to some embodiments of the present invention, the reference surface is constructed as a plane or a corrugated surface.

[0009] According to some embodiments of the present invention, the edge of the reference surface away from the connecting part is constructed as a first arc edge, and the edge of the reference surface near the connecting part is constructed as a second arc edge. The first arc edge and the second arc edge are symmetrically arranged about the center of the reference surface and their ends are connected to the outer peripheral edge of the support.

[0010] According to some embodiments of the present invention, a clamping portion is provided on the side edge of the support body away from the connecting portion, the clamping portion protruding from the top of the support body and extending in a direction away from the stimulation end.

[0011] According to some embodiments of the present invention, the clamping part includes: a connecting post, the bottom end of which is connected to the side edge of the support body away from the connecting part, the connecting post protruding from the top of the support body and extending in a direction away from the stimulation end; and a clamping end, which is connected to the top end of the connecting post and extends in a direction away from the connecting part.

[0012] According to some embodiments of this utility model, the support body is constructed as an integrally molded silicone part.

[0013] According to some embodiments of the present invention, the stimulation electrode body includes a substrate, wherein the substrate is a parylene substrate.

[0014] According to some embodiments of the present invention, it further includes: a silicone adhesive layer, wherein the second arc surface is attached to the first arc surface through the silicone adhesive layer.

[0015] According to some embodiments of the present invention, the stimulation end is provided with a first fixing hole, and the support body is provided with a second fixing hole. The second fixing hole is located on the side of the reference surface near the connecting part, and the second fixing hole is arranged opposite to the first fixing hole so that a fixing nail can be inserted.

[0016] An implantable retinal electrical stimulator according to a second aspect of the present invention includes: an external component; and an implant for the implantable retinal electrical stimulator, wherein the implant for the implantable retinal electrical stimulator includes a coil and the retinal stimulation electrode, the implant for the implantable retinal electrical stimulator being electrically connected to the external component through the coil, and the coil being electrically connected to the retinal stimulation electrode.

[0017] Additional aspects and advantages of this 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

[0018] The above and / or additional aspects and advantages of this utility model will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a schematic diagram showing the interaction between the implant of the implantable retinal electrostimulator according to an embodiment of the present invention and the human eyeball; Figure 2 This is a first-view structural schematic diagram of the implant of an implantable electrical stimulator according to an embodiment of the present invention; Figure 3 This is a structural schematic diagram of the implant of an implantable electrical stimulator according to an embodiment of the present invention from a second perspective. Figure 4 This is a schematic diagram of the structure of the stimulation electrode body of the retinal stimulation electrode according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the cooperation between the stimulation electrode body and the support body of the retinal stimulation electrode according to an embodiment of the present invention; Figure 6 This is a schematic diagram of the support for the retinal stimulation electrode according to an embodiment of the present invention from a first-view perspective. Figure 7 This is a schematic diagram of the support for the retinal stimulation electrode according to an embodiment of the present invention from a second perspective. Figure 8 This is a cross-sectional schematic diagram of the support body of the retinal stimulation electrode according to an embodiment of the present invention.

[0019] Figure label: 100. Stimulating electrode; 1. Stimulating electrode body; 11. Inlet end; 12. Stimulating end; 13. Connecting part; 14. Electrode array; 1401. Convex surface; 1402. Microelectrode; 1403. First arc surface; 15. First fixing hole; 2. Support body; 21. Second arc surface; 22. Reference surface; 23. First arc edge; 24. Second arc edge; 25. Clamping part; 2501. Connecting column; 2502. Clamping end; 26. Second fixing hole; 3. Fixing nail; 4. Coating layer; 200, outer shell; 1000, eyeball; 1001, retina. Detailed Implementation

[0020] 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.

[0021] The following is for reference. Figures 1-8 This invention describes a retinal stimulation electrode and an implantable retinal electrical stimulator according to embodiments of the present invention. The implantable retinal electrical stimulator involves implanting electrodes into the retinal region and sending electrical pulses of a certain frequency to stimulate the region, thereby stimulating functional neurons on the retina and transmitting this stimulation to the brain via the optic nerve, thus enabling the patient to perceive vision. The implantable retinal electrical stimulator includes an implant containing the stimulation electrodes described below, the implant being placed into the eyeball, and the electrode terminals being fixed to the retinal surface on the inner wall of the eyeball.

[0022] like Figures 1-8 As shown, the retinal stimulation electrode 100 includes: a stimulation electrode body 1 and a support 2.

[0023] The stimulation electrode body 1 includes an inlet end 11, a stimulation end 12, and a connecting portion 13 connecting the inlet end 11 and the stimulation end 12. The stimulation end 12 forms an electrode array 14. The front side of the electrode array 14 is a convex surface 1401, and microelectrodes 1402 are disposed on the convex surface 1401 for contact with the surface of the retina 1001. The reverse side of the electrode array 14 is constructed with a first arc surface 1403.

[0024] Specifically, the implant can wirelessly receive external energy and / or data, and through the introduction end 11, drive several microelectrodes 1402 on the stimulation end 12 to apply electrical stimulation to the surface of the retina 1001, thereby enabling the patient to experience visual perception. Figure 3 and Figure 4As shown, the stimulation end 12 forms an electrode array 14, which may include 256 microelectrodes 1402. This electrode array 14 provides a visual region (diagonal) of equal to or greater than 20 degrees. The electrode array 14 has a front and a back side. Figure 3 The image shows the front side of the electrode array 14, which is a convex surface 1401. The ends of several microelectrodes 1402 are exposed on the convex surface 1401 for safe and effective contact with the retinal nerve cells 1001. Figure 4 The image shows the reverse side of the electrode array 14, which has a first arc surface 1403 that is adapted to naturally conform to the curved surface of the retina 1001 on the inner wall of the eyeball 1000.

[0025] Combination Figures 5-8 As shown, the support body 2 is disposed on the stimulation end 12. The bottom of the support body 2 is constructed with a second arc surface 21, which is attached to the first arc surface 1403. The top of the support body 2 is constructed with a reference surface 22 so that the thickness of the support body 2 decreases from the middle to the outer periphery.

[0026] Specifically, the support 2 is a flexible support 2, which can be made of silicone material. The bottom of the support 2 has a second arc surface 21 to fit and conform to the first arc surface 1403 of the electrode array 14, thereby supporting and protecting the stimulation end 12. Furthermore, the top of the support 2 has a reference surface 22, so that the thickness of the support 2 decreases from the middle to the outer periphery, that is, the middle part of the support 2 is thickened to form the reference surface 22, thereby strengthening the electrode array 14 and maintaining its arc surface, which can effectively solve the problem of mismatch between the electrode array 14 and the curved surface of the retina 1001 caused by deformation.

[0027] Therefore, the stimulation electrode 100 of this utility model, by gradually increasing the thickness of the support body 2 from the outer periphery to the middle, makes the middle part of the support body 2 more stable, thereby strengthening the electrode array 14 and maintaining its curved surface, ensuring that the electrode array 14 is not easily deformed, effectively solving the problem of misfit between the electrode array 14 and the retina 1001 caused by deformation, and ensuring the effectiveness of the product.

[0028] Furthermore, the reference surface 22 is constructed as a plane or a corrugated surface. For example... Figure 8 As shown, the reference surface 22 is constructed as a plane, which is not easily deformed, has a smooth surface, and is easy to manufacture. The reference surface 22 can also be constructed as a corrugated surface, that is, the surface of the reference surface 22 is not flat and has a certain degree of ductility. In the event of external tensile / bending deformation during the implantation surgery, the corrugated surface of the support body 2 can absorb it.

[0029] Furthermore, the edge of the reference surface 22 away from the connecting portion 13 is constructed as a first arc edge 23, and the edge of the reference surface 22 near the connecting portion 13 is constructed as a second arc edge 24. The first arc edge 23 and the second arc edge 24 are symmetrically arranged about the center of the reference surface 22, and their ends are connected to the outer peripheral edge of the support body 2.

[0030] like Figure 7 As shown, the edges of the reference surface 22 furthest from the connecting portion 13 and the edges closest to the connecting portion 13 form symmetrical arc edges relative to the center of the reference surface 22, making the reference surface 22 approximately circular. This circular surface covers the microelectrode 1402 area, thereby ensuring a reinforced support for the electrode array 14. Furthermore, the outer peripheral edge of the support body 2 connects to the end of the reference surface 22; that is, the reference surface 22 is the main functional area, and the outer peripheral edge of the support body 2 surrounding the end of the reference surface 22 is an auxiliary functional area. This auxiliary functional area can improve the overall flexibility and durability of the support body 2 while protecting the main functional areas (such as the microelectrodes). Additionally, clamping and fixing areas can be designed for the outer peripheral edge of the support body 2, as described below.

[0031] Furthermore, a clamping part 25 is provided on the edge of the support body 2 away from the connecting part 13. For example... Figure 6 As shown, a clamping portion 25 is provided on the edge of the support body 2 away from the connecting portion 13. Compared with the prior art where a clamping structure is provided on the edge of the electrode array 14, which can easily lead to cracking at the junction of the clamping structure and the electrode array 14, and the cracks may expand and damage the microelectrode 1402, causing it to be eroded faster, the clamping portion 25 in this embodiment is physically completely separated from the electrode array 14, making operation more convenient and less likely to damage the electrode array 14. Therefore, during the operation, the operating force is first distributed to the stronger support body 2, effectively protecting the electrode array 14 from damage and solving the problem of electrode substrate cracking. The clamping portion 25 protrudes from the top of the support body 2 and extends in a direction away from the stimulation end 12, thereby having a certain clamping force to clamp the inner wall of the eyeball 1000.

[0032] Furthermore, the clamping portion 25 includes a connecting post 2501 and a clamping end 2502. The bottom end of the connecting post 2501 is connected to the edge of the support body 2 away from the connecting portion 13. The connecting post 2501 protrudes from the top of the support body 2 and extends in a direction away from the stimulation end 12. The clamping end 2502 is connected to the top end of the connecting post 2501 and extends in a direction away from the connecting portion 13.

[0033] like Figure 6As shown, a protruding connecting post 2501 is formed on the side edge of the support body 2 away from the connecting part 13 and extends in the direction away from the stimulation end 12. A clamping end 2502 is formed at the top of the connecting post 2501 and extends in the direction away from the connecting part 13, so that the clamping part 25 is roughly "inverted L" shaped, so that the clamping end 2502 is firmly clamped on the inner wall of the eyeball 1000, so that the tail of the electrode array 14 will not stick up, thereby ensuring that the electrode array 14 fits and matches the curved surface of the retina 1001.

[0034] Furthermore, the support 2 is constructed as a one-piece molded silicone component. That is, the entire support 2 is formed into a complete, seamless structure through a single molding process such as injection molding or compression molding. The silicone component typically refers to medical-grade silicone elastomers, such as PDMS or addition-cure silicone, which possess excellent biocompatibility, flexibility, chemical stability, and transparency. The one-piece molding process avoids secondary connection processes such as adhesives and welding, reducing the risk of inflammation and rejection reactions, minimizing bacterial growth, and making it suitable for long-term implantation or contact with human tissue. Because silicone itself has a low elastic modulus (softness), it can be designed into complex curved structures to achieve conformal contact with the retina 1001. Therefore, the one-piece molded silicone component can be bent, stretched, and compressed as a whole without breaking, adapting to dynamic eye movements 1000, reducing mechanical mismatch, and minimizing damage to fragile tissues.

[0035] Furthermore, the stimulation electrode body 1 includes a substrate, which is a parylene substrate. This configuration ensures that the parylene substrate exhibits excellent biocompatibility and long-term safety, remaining stable in vivo without causing significant inflammation or rejection. It is also less prone to adsorbing proteins or cells, contributing to the long-term stability of the electrode-tissue interface. Simultaneously, it possesses excellent electrical insulation properties, high reliability, and outstanding mechanical flexibility and conformal fit. Its film is flexible, bendable, and stretchable (especially when combined with elastomers), making it suitable for fabricating flexible electrode arrays 14. These arrays can conform to the complex curved surface of the retina 1001, achieving low-stress, high-fidelity contact and reducing tissue damage and signal drift caused by mechanical mismatch. In addition, it provides a strong environmental barrier, effectively protecting the internal leads from corrosion by bodily fluids, delaying the aging and performance degradation of the electrode materials, and ensuring long-term stable stimulation.

[0036] Furthermore, the stimulation electrode 100 also includes a silicone adhesive layer, through which the second arc surface 21 is attached to the first arc surface 1403. Thus, the silicone adhesive layer, as a soft, elastic, and biocompatible layer, fills and bonds the interface between the two arc surfaces, achieving a tight fit across the entire area and avoiding gaps or localized stress concentrations. The silicone adhesive layer forms a continuous, non-porous barrier, effectively preventing the intrusion of moisture, body fluids, oxygen, and corrosive substances, effectively improving the seal and fit. In particular, the silicone is in a fluid state before curing, automatically filling micron-level unevenness or tiny gaps between the two arc surfaces, exhibiting good tolerance for processing errors, surface roughness, or slight curvature deviations.

[0037] Furthermore, the stimulation end 12 is provided with a first fixing hole 15, and the support body 2 is provided with a second fixing hole 26. The second fixing hole 26 is located on the side of the reference surface 22 near the connecting part 13, and the second fixing hole 26 is arranged opposite to the first fixing hole 15 to allow the fixing nail 3 to pass through. Figure 1 , Figure 4 and Figure 6 As shown, during the implantation surgery, when the electrode array 14 is implanted into the inner wall of the eyeball 1000, it is nailed into the surface of the retina 1001 of the inner wall of the eyeball 1000 after the fixation nail 3 passes through the second fixation hole 26 and the first fixation hole 15 in sequence.

[0038] An implantable retinal electrostimulator 1001 according to a second aspect embodiment of the present invention includes: an external component and an implant for the implantable retinal electrostimulator. The implant for the implantable retinal electrostimulator includes a coil (not shown in the figures) and a retinal stimulation electrode 100. The implant for the implantable retinal electrostimulator is electrically connected to the external component through the coil, and the coil is electrically connected to the retinal stimulation electrode 100. The implant for the implantable retinal electrostimulator also includes a housing 200. The lead-in end 11 of the coil and the stimulation electrode 100 is built into the housing 200, so that the coil is signal-connected to the stimulation electrode 100 formed by the stimulation end 12 through the lead-in end 11.

[0039] like Figure 1As shown, the outer shell 200 can be implanted into the outer sclera of the eyeball 1000 through standard scleral ophthalmic surgery, and the stimulation end 12 (electrode array 14) of the stimulation electrode 100 is fixed to the surface of the retina 1001 on the inner wall of the eyeball 1000 by fixation pins 3. The introduction end 11 and the stimulation end 12 are connected to each other by a connector 13, such as a cable, passing through the wall of the eyeball 1000. The implant wirelessly receives energy and data (commands and data feedback) from an external component. In response to certain commands, the implant returns status or diagnostic data to the external component. The external component may include a camera unit, a video processing unit, and a wireless signal transmitter. The camera unit is electrically connected to the video processing unit, and the video processing unit is electrically connected to the wireless signal transmitter. The wireless signal transmitter is wirelessly coupled to the implant of the implantable electrical stimulator for energy and data transmission, for example, through an external coil and a coil within the implant for wireless data and energy transmission. After data conversion, the video information is wirelessly transmitted to the coil of the implant. The coil receives the signal and emits electrical stimulation pulses to drive the stimulation electrode 100. These pulses are transmitted from the inlet 11 of the stimulation electrode 100 to the stimulation end 12, causing several microelectrodes 1402 on the stimulation end 12 to send electrical pulse signals. The microelectrodes 1402 apply electrical stimulation to the surface of the retina 1001 and transmit this stimulation to the brain via the optic nerve, enabling the patient to experience visual perception.

[0040] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0041] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example.

[0042] Although embodiments of the present 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 present invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A retinal stimulation electrode, characterized in that, include: The stimulation electrode body includes an inlet end, a stimulation end, and a connecting part connecting the inlet end and the stimulation end. The stimulation end forms an electrode array. The front side of the electrode array is convex and microelectrodes are disposed on the convex surface for contact with the retinal surface. The back side of the electrode array is constructed with a first arc surface. A support body is disposed at the stimulation end. The bottom of the support body has a second arc surface, which is attached to the first arc surface. The top of the support body has a reference surface, so that the thickness of the support body decreases from the middle to the outer periphery.

2. The retinal stimulation electrode according to claim 1, characterized in that, The reference surface is constructed as a plane or a corrugated surface.

3. The retinal stimulation electrode according to claim 1, characterized in that, The edge of the reference surface away from the connecting part is constructed as a first arc edge, and the edge of the reference surface near the connecting part is constructed as a second arc edge. The first arc edge and the second arc edge are symmetrically arranged about the center of the reference surface and their ends are connected to the outer peripheral edge of the support.

4. The retinal stimulation electrode according to claim 1, characterized in that, The support body has a clamping portion on one edge away from the connecting portion, the clamping portion protruding from the top of the support body and extending in a direction away from the stimulation end.

5. The retinal stimulation electrode according to claim 4, characterized in that, The clamping part includes: A connecting post, the bottom end of which is connected to the edge of the support body away from the connecting portion, the connecting post protruding from the top of the support body and extending in a direction away from the stimulation end; The clamping end is connected to the top of the connecting post and extends away from the connecting portion.

6. The retinal stimulation electrode according to claim 1, characterized in that, The support structure is a one-piece molded silicone part.

7. The retinal stimulation electrode according to claim 1, characterized in that, The stimulation electrode body includes a substrate, which is a parylene substrate.

8. The retinal stimulation electrode according to claim 1, characterized in that, Also includes: A silicone adhesive layer is used to attach the second arc surface to the first arc surface.

9. The retinal stimulation electrode according to claim 1, characterized in that, The stimulation end is provided with a first fixing hole, and the support body is provided with a second fixing hole. The second fixing hole is located on the side of the reference surface near the connecting part. The second fixing hole is arranged opposite to the first fixing hole so that a fixing nail can be inserted.

10. An implantable retinal electrical stimulator, characterized in that, include: External components; An implantable retinal electrical stimulator includes a coil and a retinal stimulation electrode as described in any one of claims 1-9. The implantable retinal electrical stimulator is electrically connected to the external component via the coil, and the coil is electrically connected to the retinal stimulation electrode.

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