Detailed Description
Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description, the same components are denoted by the same reference numerals, and redundant description thereof is omitted. The drawings are schematic and the ratio of the dimensions of the components and the shapes of the components may be different from the actual ones.
The artificial retina according to the embodiment of the present invention can be suitably used for patients with impaired vision such as Retinitis Pigmentosa (RP) and age-related macular degeneration (AMD). Specifically, the implantation device 1 for an artificial retina according to the embodiment of the present invention partially restores the vision of the patient by generating light sensation in the cerebral cortex by replacing the function of damaged photoreceptor cells (cone cells, rod cells) and preserving the visual pathways of intact bipolar cells, ganglion cells, and the like by the patient. In addition, the implantation device 1 for artificial retina can also be applied to other retinal pathological changes which cause blindness, as long as the visual pathways such as bipolar cells, ganglion cells, etc. can be effectively reserved in the retinal pathological changes.
Fig. 1 is a schematic view showing an artificial retina implantation device 1 according to an embodiment of the present invention mounted on an eyeball 2. Fig. 2 is a perspective view schematically showing an artificial retina implantation device 1 according to an embodiment of the present invention mounted on an eyeball 2. Fig. 3 is a schematic diagram showing a state in which the stimulating electrode structure 12 according to the embodiment of the present invention is attached to the retina. In fig. 2, a partial view of the receiving antenna 13 and a perspective view of the eyeball 2 are depicted for convenience of explanation.
In the present embodiment, as shown in fig. 1 and 2, the implant device 1 of the artificial retina mainly includes a base 10, and an electronic package 11, a stimulating electrode structure 12, and a receiving antenna 13 provided on the base 10. In addition, the base body 10 in the implant device 1 may be fixed to the eyeball 2 by, for example, suturing, and the stimulating electrode structure 12 may enter the vitreous cavity of the eyeball 2 through the incision 22 of the eyeball 2 and be close to the retina (see fig. 2).
Here, the incision 22 of the eyeball 2 may extend in the peripheral direction (limbus) of the pupil 21. The length of the incision 22 is not excessively long, and the length of the incision 22 is preferably 3mm to 10mm from the viewpoint of safety. In addition, the distance between the incision 22 and the pupil 21 is not particularly limited, and for example, the incision 22 may be 3mm to 8mm apart from the pupil 21.
In general, for example, in patients with Retinitis Pigmentosa (RP) and age-related macular degeneration (AMD), photoreceptor cells are degenerated or killed due to the RP and AMD, that is, the normal visual pathway is blocked by the pathological changes of the photoreceptor cell disease, and light normally entering eyes is not converted into electric signals, so that the patients lose vision. In the implantation device 1 for an artificial retina according to the present embodiment, the stimulation end 12c (electrode array 124) of the stimulation electrode structure 12 generates an electrical stimulation signal (for example, sends a bidirectional pulse current signal) to stimulate retinal ganglion cells or bipolar cells (see fig. 3). Since most of the retinal pigment degeneration (RP) and age-related macular degeneration (AMD) patients have their visual pathways other than photoreceptor cells well preserved, when ganglion cells or bipolar cells are stimulated, the electrical stimulation signal is transmitted to the cerebral cortex via the well preserved downstream visual pathways (optic nerves) and generates light sensation, thereby partially restoring the vision of the patients.
In addition, although the above example shows that the stimulation end 12c of the stimulation electrode structure 12 is attached on the retina, the implantation position of the stimulation electrode structure 12 of the present embodiment is not limited to the above-described example of "epiretinal". In other examples, the stimulation end 12c of the stimulation electrode structure 12 may also be arranged in a "subretinal" manner, i.e., the stimulation end 12c may be arranged between the photoreceptor cell and the choroid. Additionally, in other examples, the stimulation end 12c of the stimulation electrode structure 12 may also be disposed below the choroid and between the choroid and the sclera.
Referring again to FIG. 1, as shown in FIG. 1, the substrate 10 may be in the form of a non-closed loop. In other words, the base 10 is not a ring shape that completely surrounds the eyeball 2 and is closed, but a non-closed ring shape that covers only a part of the eyeball 2. The base member 10 is fixed to the eyeball 2 while covering the eyeball 2.
In the present embodiment, the base 10 may be fixed to the eyeball 2 by suturing or bonding. Specifically, in some examples, the base 10 may be fixed to the outer surface of the eyeball 2 by suturing, i.e., suturing holes on the base 10 to the outside of the sclera of the eyeball 2. In other examples, the substrate 10 may be secured to the outer surface of the eyeball 2 by adhesive means, such as by applying a bio-gel or the like between the substrate 10 and the eyeball 2.
In addition, in some examples, the base 10 may be shaped like a belt of about a quarter of a circular arc, i.e., the base 10 extends like a belt along the outer surface of the eyeball 2. In some examples, the band-shaped base 10 may be arranged on the outer surface of the eyeball 2 in a direction substantially parallel to the peripheral direction of the pupil 21, that is, the band-shaped base 10 extends in a direction substantially parallel to the peripheral direction of the pupil 21.
Preferably, the base body 10 can be matched to the outer contour of the eyeball 2. This allows the base 10 to be fixed to the outer surface of the eyeball 2 while being bonded to the outer surface of the eyeball 2 without any gap. Specifically, the base 10 fixed to the outer surface of the eyeball 2 may be matched to the curvature of the outer contour of the eyeball 2. Here, the curvature of the outer contour to which the eyeball 2 is fixed is, for example, a curvature near the maximum diameter portion of the eyeball 2.
In the present embodiment, the substrate 10 is an insulator. The material of the substrate 10 is not particularly limited, and may be formed of silica gel or the like. For example, the base body 10 may be injection molded from silicone. In this case, since silicone has good flexibility and biocompatibility, the base 10 can be made to fit the eyeball 2 better and be suitable for long-term implantation in the eye.
In the present embodiment, as shown in fig. 1, the electronic package 11 is mounted on the base 10. In some examples, a rubber sleeve for mounting the electronic package 11 is disposed on the base 10, and the electronic package 11 is mounted on the base 10 by inserting the rubber sleeve, and the rubber sleeve may cover at least a portion of the electronic package 11. Further, in order to firmly attach the electronic package 11 to the base 10, a biocompatible adhesive may be applied between the electronic package and the base 10. Here, the adhesive is not particularly limited, and may be a silicone resin, an epoxy resin, or the like.
The electronic package 11 according to the present embodiment includes at least a processing circuit (not shown) for processing an electric signal. Specifically, the electronic package 11 may include a sealed case 11a and a substrate 11b (see fig. 7 described later) accommodated within the sealed case 11 a. In some examples, the sealed housing 11a is made of a biocompatible metal such as titanium, titanium alloy, etc., thereby forming a housing that is both air-tight and biocompatible to facilitate long-term implantation of the sealed housing 11a in the eye.
In addition, in some examples, the substrate 11b accommodated in the hermetic case 11a may include a Printed Circuit Board (PCB) and electronic components such as resistors, inductors, and capacitors and Application Specific Integrated Circuits (ASICs), microprocessors, etc. provided on the printed circuit board, whereby the substrate 11b is formed with the above-described processing circuit for processing an electric signal.
In the present embodiment, the outer shape of the seal housing 10 is preferably a cylindrical shape, but the present embodiment is not limited thereto, and in some examples, the outer shape of the seal housing 10 may be a square column shape. In addition, the outer shape of the hermetic case 10 may also take other suitable shapes.
In addition, in some examples, the bottom of the hermetic case 10 has a plurality of feedthrough holes and a plurality of feedthrough electrodes (not shown) filling the plurality of feedthrough holes. These feed-through electrodes are electrically connected to the base end 12a (specifically, the pad array 125) of the stimulation electrode structure 12 described later. In the present embodiment, the number of feed-through electrodes of the electronic package 1 includes the number of electrode arrays 124 (which may also be referred to as "electrode stimulation channels") of the stimulation end 12c of the stimulation electrode structure 12 and the number of return electrodes 120 described later.
In the present embodiment, as shown in fig. 2, the receiving antenna 13 may be embedded inside the base 10. That is, the receiving antenna 13 is embedded in the base body 10, so that the receiving antenna 13 can be electrically insulated from the outside, and the reliability of the receiving antenna 13 can be ensured.
The receiving antenna 13 is a two-dimensional coil formed by winding a metal wire. In the above-described example, when the base 10 has a band-like structure, the receiving antenna 13 is arranged along the extending direction of the band, whereby the coil area of the receiving antenna 13 can be increased, and the receiving efficiency of the receiving antenna 13 can be improved.
In addition, the metal coil of the receiving antenna 13 is preferably made of gold or the like from the viewpoint of transmission efficiency and biocompatibility. The winding method of the receiving antenna 16 is not particularly limited, and may be, for example, a two-dimensional coil wound in a spiral shape.
In addition, the receiving antenna 13, which is a two-dimensional coil, can be matched to the curvature of the base body 10. That is, in the present embodiment, the base body 10 is covered on the outer surface of the eyeball 2 so as to match the curvature of the eyeball 2. In this case, too, the receiving antenna 13 is correspondingly bent along with the base body 10. With such a design, even if the patient to which the implant device 1 according to the present embodiment is attached turns the eye right and left to slightly shift the position of the base 10 when in use, the receiving antenna 13 can effectively receive the external signal transmitted by the transmitting antenna 33 (see fig. 9 described later).
In addition, in the present embodiment, the receiving antenna 13 can receive, for example, an energy signal and a data signal from an extracorporeal device (specifically, a transmitting antenna 33 described later) by way of wireless coupling. These energy signals or data signals (including image information) are received by the receiving antenna 13 and transmitted to the electronic package 11. In this case, the processing circuit inside the electronic package 11 obtains the above-mentioned energy signal as a power supply source, and processes the received data signal, thereby generating an electrical stimulation signal that can be used to stimulate ganglion cells or bipolar cells of the retina.
As described above, the electronic package 11 is electrically connected to both the stimulating electrode structure 12 and the receiving antenna 13, thereby forming an electrical connection path from the receiving antenna 13 to the electronic package 11 and then to the stimulating electrode structure 13. In some examples, the stimulating electrode structure 12 (the base end 12a) and the receiving antenna 13 may be distributed on both sides of the band-shaped base 10, respectively, for example. By distributing the stimulating electrode structure 12 (base end 12a) and the receiving antenna 13 on both sides of the base 10, interference between the receiving antenna 13 and the electronic package 11 (particularly, the internal circuit) can be suppressed.
In the electronic package 11, the electronic package 11 converts a signal (e.g., a data signal) received from the receiving antenna 13 into an electrical stimulation signal. The electrical stimulation signal is transmitted to the stimulation electrode structure 12 through the feed-through electrode, and the stimulation electrode structure 12 transmits the electrical stimulation signal from the base end 12a to the stimulation end 12c through the electronic cable 12b, whereby the stimulation end 12c attached to the retina stimulates the ganglion cells or bipolar cells, thereby causing the patient to feel light.
The stimulating electrode structure 12 according to the present embodiment will be described in more detail below. Fig. 4 is a perspective view showing a configuration of the stimulation electrode structure 12 of the artificial retina implant device 1 according to the embodiment of the present invention when it is deployed. Fig. 5 is a schematic view showing a stimulation electrode structure side (hereinafter referred to as "back side", see D2 in fig. 4) of the artificial retina according to the embodiment of the present invention. Fig. 6 is a schematic view showing the other side (hereinafter, referred to as "front side", see D1 of fig. 2) of the stimulating electrode structure of the artificial retina according to the embodiment of the present invention. Fig. 7 is a schematic diagram showing a cross-section of a stimulating electrode structure of an artificial retina according to an embodiment of the present invention.
In fig. 5 and 6, the electronic package 11 is not shown for convenience of explanation. In the present specification, the side of the stimulating electrode structure 12 including the electrode array 124 is referred to as "front side" D1, and the other side (i.e., the side including the return electrode 120) is referred to as "back side" D2.
In the present embodiment, as shown in fig. 4 and 5, the stimulating electrode structure 12 includes a base end 12a, an electronic cable 12b, and a stimulating end 12 c. Specifically, the base end 12a and the stimulation end 12c are provided at both ends of the stimulation electrode structure 12, respectively, and the electronic cable 12b connects (electrically connects) the base end 12a and the stimulation end 12 c. In this case, the electrical stimulation signal received by the base end 12a can be smoothly transmitted from the base end 12a to the stimulation end 12c along the electrical cable 12b, thereby stimulating the ganglion cells or bipolar cells of the retina.
As shown in fig. 4, the base end 12a of the stimulating electrode structure 12 is connected to the electronic package 11. Specifically, as described above, in some examples, the pad array 125 of the base end 12a of the stimulation electrode structure 12 is connected with the feedthrough electrode of the electronic package 11. In addition, the electronic cable 12b and the stimulation end 12c of the stimulation electrode structure 12 are led out from the position of the base body 10 where the electronic package 11 is fixed.
In some examples, the stimulation electrode structure 12 may be elongated. Further, in some examples, the elongated stimulation electrode structure 12 may be generally orthogonal to the direction of extension of the strip-shaped substrate 10. In this case, by making the base body 10 and the stimulation electrode structure 12 orthogonal to each other, not only can the implantation space be saved, but also the general implantation orientation and position of the stimulation electrode structure 12 can be limited by the fixed position of the base body 10 on the eyeball 2.
In this embodiment, after the base body 10 has been fixed to the outer surface of the eyeball 2, for example by means of stitching, the stimulation electrode structure 12 may be passed through an incision 22 in the eyeball 2 into the site to be implanted, for example the macular area (fovea).
Here, the number of pads 125a of the pad array 125 of the base end 12a is not particularly limited, and may be, for example, a pad array 125 having 20 pads 125a arranged in 5 rows and 4 columns (see fig. 5). The pad array 125 of the base end 12a allows the base end 12a of the stimulation electrode structure 12 to be connected to the feed-through electrode of the electronic package 11, thereby allowing signals processed by the electronic package 11 to be smoothly transmitted to the stimulation electrode structure 12.
In addition, the number of the pad arrays 125 should include the number of the electrodes of the electrode array 124 and the number of the electrodes of the return electrode 120. In other words, the number of pad arrays 125 should be greater than or equal to the sum of the number of electrodes of electrode array 124 and the number of electrodes of return electrode 120.
As described above, in the stimulating electrode structure 12, the base end 12a may be used to receive an electrical stimulation signal. Specifically, as shown in fig. 5, the base end 12a may have a pad array 125 for receiving an electrical stimulation signal (e.g., a bidirectional current pulse signal) output by the electronic package 11. That is, the pad array 125 of the base end 12a is electrically connected to the electronic package 11, and receives a stimulus signal (e.g., a current pulse) transmitted from the electronic package 11. In some examples, the base end 12a may be made in a sheet shape such as a rectangle or a circle.
Additionally, the stimulation end 12c of the stimulation electrode structure 12 may include an electrode array 124 (see fig. 6) having a plurality of stimulation electrodes 124a arranged therein. Here, the number of stimulation electrodes 124a in the electrode array 124 is not particularly limited, and may be, for example, 16 stimulation electrodes 124a arranged in 4 rows and 4 columns.
In the present embodiment, the constituent material of the stimulating electrode 124a is not particularly limited, and for example, the electrode 124a may be composed of at least one selected from gold, platinum, iridium, and alloys thereof.
As shown in fig. 6, the stimulation end 12c may be provided with a through hole 126. That is, the through hole 126 penetrates the stimulation end 12c, and thus the stimulation electrode structure 12 (mainly the stimulation end 12c) is fixed at an implantation position in the eyeball 2, for example, a macular region, and is brought close to the retina, through the through hole 126 by, for example, a medical titanium nail or the like.
In addition, the stimulating electrode structure 12 has flexibility. In this case, the stimulating electrode structure 12 can be easily bent and enter the vitreous cavity 23 of the eyeball 2 via the incision 22 of the eyeball 2 to be close to the implantation site such as the macular region (see fig. 8 described later).
In the present embodiment, the electronic cable 12b includes an electrode lead electrically connected to the base end 12a and the stimulation end 12c, and a flexible insulating layer having biocompatibility covering the electrode lead (see fig. 7). The electrode lead is used to transmit a stimulation signal from the base end 12a to the stimulation end 12 c. On the other hand, the flexible insulating layer wraps the electrode lead in the electrode lead, so that the electrode lead is prevented from contacting other parts of the eyeball.
The flexible insulating layer is in the form of a flexible film. In some examples, the flexible insulating layer may serve as a carrier, and may also extend to carry the electrode leads, electrode array 124, and pad array 125 within stimulation electrode structure 12. That is, the body of the stimulation electrode structure 12 is composed of a flexible insulating layer, the electrode leads, the electrode array 124, and the pad array 125 are covered by the flexible insulating layer, and the electrode array 124 and the pad array 125 are exposed to the flexible insulating layer.
In some examples, the electrode array 124 may be disposed on the front side of the stimulating electrode structure 12 (see D1 of fig. 4), while the return electrode 120 may be disposed on the back side of the stimulating electrode structure 12 (see D2 of fig. 4). That is, the electrode array 124 and the return electrode 120 are located on two opposing surfaces of the stimulation electrode structure 12, respectively. However, the present embodiment is not limited thereto, and in other examples, for example, the electrode array 124 and the return electrode 120 may be located on the same side.
The flexible insulating layer according to the present embodiment may be formed of at least one selected from Polydimethylsiloxane (PDMS), poly (paraphenylene) C, and Polyimide.
As described above, when the implantation device 1 of the artificial retina of the present embodiment is implanted in the eyeball, the stimulation end 12c enters the vitreous body 23 cavity of the eyeball 2 through the incision 22 on the eyeball 2, so that the stimulation end 12c is brought close to the retina in the eyeball 2 (see fig. 3). Thus, the electrode array 124 of the stimulation tip 12c can be brought into close proximity with the retina in the eyeball 2 and can deliver electrical stimulation signals to ganglion cells or bipolar cells of the retina for stimulation.
In the present embodiment, as shown in fig. 4 and 5, the return electrode 120 may be arranged in plural, and the plural return electrodes 120 may be distributed at intervals along the extending direction of the electronic cable 12 b. For example, in some examples, on the electronic cable 12b of the stimulation electrode structure 12, three return electrodes, namely, return electrode 121, return electrode 122, and return electrode 123 are provided. In addition, the three loop electrodes 121,122,123 are spaced apart along the extending direction of the electronic cable 12 b.
As described above, the return electrode 120 (the return electrode 121, the return electrode 122, and the return electrode 123) is also electrically connected to the electronic package 11 via the feed-through electrode of the electronic package 11. In this case, the stimulation electrodes 124a of the stimulation electrode structure 12 can form a stimulation circuit with the circuit electrodes 120 when stimulation of ganglion cells or bipolar cells of the retina is desired.
In the present embodiment, the return electrode 120 is covered with the above-described flexible insulating layer, and the return electrode 120 (the return electrodes 121,122,123 in the present embodiment) is exposed to the flexible insulating layer.
Additionally, in some examples, the return electrode 120 entering the vitreous cavity 23 of the eyeball 2 may be directed towards the inside of the eyeball 2. That is, the return electrodes 120 are distributed on the side (back side) of the electronic cable 12b away from the retina. In this case, the circuit electrode 120 distant from the retina can suppress the formation of the stimulation path with the stimulation electrode 124a in the vicinity close to the retina, and thereby can suppress the adverse effect of the stimulation path formed by the circuit electrode 120 and the stimulation electrode 124a on other positions of the retina, and thereby can improve the stimulation effect on the ganglion cells or the bipolar cells.
Additionally, the area of return electrode 120 may be larger than the area of stimulation electrode 124 a. In this case, the area of the return electrode 120 is larger than the area of the stimulation electrode 124a, thereby improving the ability of the return electrode to accommodate electrons when the return electrode 120 and the stimulation electrode 124a form a stimulation path.
In addition, the return electrode 120 may be formed of at least one selected from gold, platinum, titanium, iridium, titanium nitride, iridium oxide, and alloys thereof. In this case, the life span and biocompatibility of the return electrode 120 can be improved.
In addition, in some examples, the return electrode 121, the return electrode 122, and the return electrode 123 provided in the electronic cable 12b may each operate independently, i.e., as mutually independent return electrodes. In addition. In still other examples, return electrode 121, return electrode 122, and return electrode 123 disposed in electronics cable 12b may be connected in series to form connected return electrode 120. This can further improve the electron storage capacity of the return electrode 120.
Fig. 8 is a schematic view showing a state in which the stimulating electrode structure 12 of the artificial retina 1 according to the embodiment of the present invention is implanted into the eyeball 2.
In the artificial retina implantation device 1 according to the present embodiment, as shown in fig. 8, stimulation signals (for example, bidirectional current pulse signals) generated by the electronic package 11 stimulate retinal ganglion cells or bipolar cells via, for example, the stimulation electrode structure 12, thereby partially restoring the vision of the patient instead of the function of photoreceptor cells damaged by retinal pigment degeneration and age-related macular degeneration.
In the present embodiment, on the electronic cable 12b, the return electrode 120 is arranged. When the electronic cable 12b is inserted into the eyeball 2 through the incision 22 on the eyeball 2, the return electrode 120 is located inside the vitreous body 23 cavity of the eyeball 2. Wherein symbol S in fig. 8 indicates the approximate position of the return electrode 120.
Specifically, when the stimulation electrode structure 12 is implanted into the eyeball 2, the return electrode 120 disposed on the electronic cable 12b of the stimulation electrode structure 12 is located within the vitreous body 23 cavity of the eyeball 2. That is, the return electrode 120 (specifically including the return electrode 121, the return electrode 122, and the return electrode 123) disposed on the electronic cable 12b is positioned within the vitreous body 23 cavity of the eyeball 2 while the stimulating end 12c of the stimulating electrode structure 12 is fixed to the retina and is in close proximity to the retina. Since the stimulation end 12c of the stimulation electrode structure 12 is also located at a position in the eyeball 2 close to the retina, the stimulation circuit formed by the stimulation end 12c (the electrode array 124) of the stimulation electrode structure 12 and the circuit electrode 120 is basically limited in the cavity of the vitreous body 23 of the eyeball 2, and the stimulation circuit formed by the stimulation electrode and the circuit electrode avoids nerve tissues which are possibly stimulated by mistake, such as facial nerve and the like, thereby being capable of inhibiting the stimulation electrode structure from causing unnecessary nerve electrical stimulation to the tissues and ensuring the use safety of the artificial retina.
In the present embodiment, the stimulating end 12c of the stimulating electrode structure 1 including the stimulating electrode 124a is placed at the implantation site of the retina, for example, near the fovea.
It is believed that each receptor in the fovea is associated with a separate bipolar cell, which in turn is associated with a separate ganglion cell. Thus, each cone in the foveal region has a direct path to the brain, which provides the brain with an accurate location of input. Therefore, by attaching the stimulating end 12c of the stimulating electrode structure 12 according to the present embodiment to the foveal region, the efficiency of the stimulation of the retina by the stimulating electrode structure can be more effectively improved.
In addition, the electrode array 124 composed of the plurality of stimulating electrodes 124a may be matched to the curvature of the retina at the implantation site, for example, near the fovea. In this case, the plurality of stimulating electrodes 124a can be made to better conform to the retina, resulting in more effective stimulation of the retina.
Generally, the vitreous body 23 in the eyeball 2 is formed of a colorless transparent gel before the implantation operation of the implantation device 1. The vitreous body 23 fills the space between the crystalline lens 24 and the retina, and has the functions of refraction, retina fixation and the like. Since the vitreous body 23 has no blood vessels therein and its required nutrients come from the aqueous humor and the choroid, the vitreous body 23 is slowly metabolized and cannot regenerate, and if the vitreous body 23 is defective, its space will be filled with aqueous humor. Thus, in some instances, a substitute, such as silicone oil, is injected during the implantation procedure while the vitreous body within the cavity of the vitreous body 23 is being extracted, at which time the vitreous body within the eyeball will be removed and the space left by the removed vitreous body filled with the injected substitute. Shortly after the operation the cavity will gradually be filled with aqueous humor through the metabolic vitreous 23.
After the stimulating electrode structure 12 enters the eyeball 2 along the incision 22 of the eyeball 2, the stimulating end 12c of the stimulating electrode structure 12 is moved to the macular region of the retina (here, the surgical procedure is omitted). Next, the stimulating end 12c is fixed on the retina and brought close to the retina through the through hole 126 provided in the stimulating end 12c by, for example, a medical titanium nail or the like, so that the electrode array 124 of the stimulating end 12c can be brought close to the retina. As shown in fig. 8, the electrode array 124 of the stimulating end 12c is attached to the macular region (fovea). In some examples, stimulation electrode 124a is capable of delivering, for example, a bi-directional pulsed current signal as the electrical stimulation signal. Here, interstitial fluid (e.g., aqueous humor) exists in the gap between the post-operative stimulation electrode 124a and the implantation site, and the electrical stimulation signal delivered by the stimulation electrode 124a is conducted through the interstitial fluid to electrically stimulate ganglion cells of the retina or bipolar cells adjacent to the ganglion cells. After the ganglion cells or bipolar cells are stimulated, the resulting stimulation signals create light sensation in the cerebral cortex via the visual pathway.
In the present embodiment, on the one hand, the stimulation electrode 124a of the stimulation end 12c and the loop electrode 120 of the electronic cable 12b form a stimulation loop, so that the ganglion cells or bipolar cells of the retina can be effectively electrically stimulated; on the other hand, the return electrode 120 (specifically, the return electrode 121, the return electrode 122 and the return electrode 123) is confined within the cavity of the vitreous body 23 of the eyeball 2, and therefore, the stimulation return formed by the stimulation electrode 124a of the stimulation end 12c and the return electrode 120 of the electronic cable 12b is substantially confined within the cavity of the vitreous body 23 of the eyeball 2, thereby making it possible to prevent adverse effects such as facial twitching, etc. occurring in the prior art from being produced.
The method for manufacturing the stimulating electrode structure 12 according to the present embodiment will be briefly described below. In the following description, conventional microelectronic or MEMS fabrication processes are not described in detail herein, as they are well known to those skilled in the art.
First, a base layer, for example, made of Polydimethylsiloxane (PDMS), poly (paraphenylene C), or Polyimide (Polyimide) is formed through a conventional thin film process (step S1). The thin film process may be, for example, chemical vapor deposition or the like. In step S1, the thickness of the base layer is, for example, 10 μm to 100 μm.
Next, metal wirings are formed on the base layer (step S2). The method of forming metal wiring on the base layer includes, for example, sputtering, electroplating, electroless plating, vapor deposition, and the like, followed by etching to form a specific wiring pattern. Here, the wiring pattern includes, for example, a distribution pattern of a portion of the array body.
Next, a cover layer made of, for example, Polydimethylsiloxane (PDMS), poly (p-xylylene) or Polyimide (Polyimide) is formed on the base layer having the metal wiring pattern again by a thin film process or the like (step S3).
Then, openings are formed in the cover layer to expose the portions where the stimulation electrodes are to be formed (step S4). Here, the base layer forms a flexible insulating layer together with the cover layer.
Finally, a stimulation electrode having a three-dimensional shape is formed at a position where the stimulation electrode is desired to be formed by means of electroplating or electroless plating (step S5). Here, by controlling the time of the electroplating or electroless plating, the height of the electrode formed by the three-dimensional stimulating electrode can be controlled. In general, by uniformly controlling the formation time of all the stimulation electrodes, three-dimensional stimulation electrodes having approximately the same height can be formed.
An example in which the stimulating electrode structure 2 according to the embodiment of the present invention is applied to an artificial retina will be described below.
Fig. 9 shows a schematic view of an artificial retina according to an embodiment of the present invention. As shown in fig. 9, the artificial retina (also sometimes referred to as an "artificial retina system") includes an extracorporeal portion, i.e., an extracorporeal device 3, in addition to the above-mentioned artificial retina implantation apparatus 1. That is, the artificial retina (or "artificial retina system") includes an implant device 1 of the artificial retina and an extracorporeal apparatus 3. In the artificial retina according to the present embodiment, the implant device 1 and the extracorporeal apparatus 3 may be coupled via wireless. That is, the implant device 1 of the artificial retina and the extracorporeal apparatus 3 may be coupled with the transmission antenna 33 via the reception antenna 11.
In the present embodiment, the extracorporeal apparatus 3 includes an
image pickup device 31, a
video processing device 32, and a
transmission antenna 33. The
camera 31 is used to capture a video image and convert the video image into a visual signal. In some examples, the
image pickup device 31 may be an apparatus having an image pickup function such as a video camera, a still camera, or the like. In addition, for convenience of use, a camera with a small volume may be designed on glasses, and a patient may also capture a video image by wearing light glasses with a camera function as the
camera device 31. In addition, Google can be used as the
image pickup device 31
Etc.
The video processing device 32 is connected to the imaging device 31. The video processing device 32 has a power supply. For example, the power supply may transmit energy to the implant device 1 in the body via a transmitting antenna described later, so that the implant device 1 is powered. In addition, the image captured by the camera 31 is transmitted to the video processing device. The video processing device 32 processes the visual signal obtained by the image pickup device 31.
The transmitting antenna 33 transmits the power signal and the processed visual signal (also referred to as "data signal") supplied from the video processing device 32 to the receiving antenna 11 of the artificial retina implanting device 1. Then, the receiving antenna 3 transmits the data received by the receiving antenna 11 to the subsequent electronic package for processing, and finally transmits the electrical stimulation signal generated by the electronic package 12 to the stimulation electrode 124a of the electrode array 124, so that the ganglion cells or bipolar cells of the retina can be stimulated.
While the invention has been specifically described above in connection with the drawings and examples, it will be understood that the above description is not intended to limit the invention in any way. Those skilled in the art can make modifications and variations to the present invention as needed without departing from the true spirit and scope of the invention, and such modifications and variations are within the scope of the invention.