JP2009082497A - Manufacture process of stimulation unit used for sight regeneration aid - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide the manufacture process of a stimulation unit used for sight regeneration aid which improves the durability of long-time implantation and appropriately gives electric stimulations. <P>SOLUTION: The manufacture process of the stimulation unit of sight regeneration aids to be installed within the body of a patient, for which a plurality of electrodes are provided, includes a first step to connect lead wires with the plurality of electrodes respectively, a second step to arrange nearly on the same level as all the electrodes connected with respective lead wires formed in the first step, and a third step to obtain the board including these lead wires embedded in the form of a flat plate by means of a bio-compatible material with the plurality of electrodes arranged in the second step being in the state where their tips are masked. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a method for producing a stimulation unit used in an internal device of a visual reproduction assisting device for reproducing the vision of a patient.

In recent years, as one of the techniques for treating blindness, research on visual regeneration assisting devices that attempt to regenerate vision by implanting in-vivo devices with a substrate on which multiple electrodes are formed and electrically stimulating cells that make up the retina Has been. Such a visual reproduction assist device, for example, converts an image captured using an extracorporeal device into a predetermined signal and transmits it to an in-vivo device installed in the body, outputs a stimulation pulse signal from the electrode, and An apparatus that attempts to reproduce vision by electrically stimulating constituent cells is known (see, for example, Patent Document 1).
JP 2003-230590 A

  Such a device requires an electrode that has durability to withstand long-term implantation in the body and that can suitably stimulate the cells that make up the retina. In the apparatus of Patent Document 1, since the electrode is usually manufactured by a thin film forming method, it is difficult to give the electrode a thickness and it is difficult to increase the surface area of the electrode. As a result, there is a problem that the amount of current that can be output is limited and it is difficult to perform electrical stimulation suitably.

  In view of the above-mentioned problems of the prior art, it is an object of the present invention to provide a method for producing a stimulation unit for a visual reproduction assisting device that can improve the durability of long-term implantation and can suitably perform electrical stimulation. .

In order to solve the above technical problem, the present invention is characterized by having a method comprising the following steps.
(1) A first step of connecting a lead wire to each of the plurality of electrodes in a method for producing a stimulation unit for a visual reproduction assisting device for producing a plurality of electrodes in a stimulation unit for the visual reproduction assisting device installed in a patient's body. And a second step in which the electrodes to which the conductive wires formed in the first step are connected are arranged in substantially the same plane, and the tips of the plurality of electrodes arranged in the second step are masked. And 3rd step of obtaining the board | substrate which included the said conducting wire by embedding conducting wire in flat form with the raw material which has biocompatibility, It is characterized by the above-mentioned.
(2) In the method for producing a stimulation unit for a visual reproduction assisting device according to (1), the third step is to fit the electrodes into a jig provided with a plurality of recesses for fitting the plurality of electrodes, respectively. By doing so, the tip of the electrode is masked.
(3) In the stimulation unit manufacturing method for a visual reproduction assisting device according to (2), the flat plate is formed by vapor deposition.
(4) In the stimulation unit manufacturing method for a visual reproduction assisting device according to (3), the conductive wire is covered with a material having biocompatibility and insulating properties.

  According to the present invention, durability of long-term implantation can be improved and electrical stimulation can be suitably performed.

  Embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a schematic diagram showing an external appearance of a visual reproduction assistance device, and FIG. 2 is a diagram showing an in-vivo device in the visual reproduction assistance device.

  As shown in FIGS. 1 and 2, the visual reproduction assisting device 1 includes an extracorporeal device 10 for photographing the outside world, and an in-vivo device 20 that promotes visual reproduction by applying electrical stimulation to cells constituting the retina. The extracorporeal device 10 includes a visor 11 on which a patient is placed, an imaging device 12 including a CCD camera attached to the visor 11, an external device 13, a transmission unit 14 including a primary coil, and the like.

  The external device 13 is provided with a data modulation means 13a having an arithmetic processing circuit such as a CPU, and a battery 13b for supplying power to the visual reproduction auxiliary device 1 (external device 10 and internal device 20). The data modulation unit 13a performs image processing on the subject image captured by the image capturing device 12, and further converts the obtained image processed data into electrical stimulation pulse data for reproducing vision. The transmission means 14 transmits the electrical stimulation pulse data converted by the data modulation means 13a and the power for driving the in-vivo device 20 described later to the in-vivo device 20 side as a predetermined signal, in this embodiment, an electromagnetic wave ( Wireless transmission). On this electromagnetic wave, electrical stimulation pulse data and power are superimposed. A magnet (not shown) is attached to the center of the transmission means 14. The magnet is used to fix the position with the receiving means 31 described later.

  The visor 11 has an eyeglass shape, and can be used by being mounted in front of the patient's eyes as shown in FIG. The photographing device 12 is attached to the front surface of the visor 11 and can photograph a subject to be visually recognized by the patient.

  Next, the configuration of the intracorporeal device 20 will be described. 2A shows an external appearance of the in-vivo device 20, and FIG. 2B shows a cross section of the stimulation unit 40. As shown in FIG. The in-vivo device 20 is roughly divided into a receiving unit (receiving unit) 30 that receives data and electric power for electrical stimulation pulse signals transmitted from the extracorporeal device 10 by electromagnetic waves, and a stimulating unit (stimulating unit) that electrically stimulates cells constituting the retina. ) 40. The receiving unit 30 is provided with a receiving unit 31 including a secondary coil that receives electromagnetic waves from the extracorporeal device 10 and a control unit 32. The control unit 32 separates the electrical stimulation pulse data and the power received by the receiving unit 31, and based on the electrical stimulation pulse data, an electrical stimulation pulse signal for obtaining vision, an electrical stimulation pulse signal, It has a role for converting to a control signal including an electrode designation signal for designating a corresponding electrode (for outputting an electrical stimulation pulse signal) and transmitting the control signal to the stimulation unit 40.

  These receiving means 31 and control unit 32 are formed on a substrate 33. The receiving unit 30 is provided with a magnet (not shown) for fixing the position of the transmitting unit 14. The counter electrode (return electrode) 34 is a member for opposing each electrode 44 to efficiently electrically stimulate cells and the like.

  The stimulation unit 40 includes a plurality of electrodes 44 that output electrical stimulation pulse signals, a stimulation control unit 42 (control means), and a substrate 43 on which these are installed. Each electrode 44 is connected to the stimulation control unit 42 by a manufacturing method (connection form) described later (details will be described later). The stimulation control unit 42 has a multiplexer function that distributes the corresponding electrical stimulation pulse signal to each of the electrodes 44 based on the control signal (including the electrode designation signal) sent from the control unit 32. For the electrode 44, a metal having high biocompatibility, for example, gold, platinum, titanium nitride, iridium oxide, or the like is used. Each electrode 44 has an outer diameter of 100 to 500 μm and a height of 100 to 500 μm. Since the substrate 43 used in the present embodiment is installed in the eye, particularly in a layered eye tissue, it preferably conforms to the shape of the eyeball, and even if it is implanted in the interlayer (in the layer) for a long period of time, it is a burden on the patient. It is preferable that there is little. For this reason, the board | substrate 43 uses what was processed into the flat plate shape extended in the longitudinal direction, such as parylene, a polypropylene, a polyimide, etc., which has high biocompatibility, and was bendable (flexible) in predetermined thickness. The thickness of the substrate 43 is 10 to 100 μm. On this substrate 43, a wire 41, which is a conductive wire that electrically connects the electrode 44 and the stimulation control unit 42, is disposed. The wire 41 is formed from a metal having high biocompatibility, such as gold or platinum, and the surface thereof is covered with a material having biocompatibility and insulation properties, such as a resin such as parylene or polyimide. The thickness (diameter) of the wire 41 is set to a thickness that is preferable for the flexibility and long-term installation property of the substrate 43 including the covered portion, for example, 5 to 100 μm. The stimulation control unit 42 mounted on the substrate 43 is connected to a plurality of electrodes 44 formed on the substrate 43 through wires 41. Since the wire 41 is covered with the substrate 43 by a method for manufacturing the electrode 44 described later, the metal portion of the wire 41 is doubly covered with an insulating coating, so that infiltration of body fluid or the like is infiltrated into the wire 41 portion. However, the possibility of leakage etc. is reduced.

  The stimulus control unit 42 is a semiconductor integrated circuit that performs a function by a combination of semiconductor elements, and is bonded to the surface of the semiconductor substrate on which the pattern wiring for functioning the integrated circuit is formed. Although detailed description is omitted, the stimulus control unit 42 is covered with plating or the like to reduce infiltration from a living body. The stimulus control unit 42 may be configured to be sealed using an airtight case formed of ceramics or metal. In such a case, the stimulus control unit 42 is connected to the wire 41 via a via provided in the case.

  In addition, the receiving unit 30 and the stimulating unit 40 placed at positions separated from each other in the body are electrically connected by a plurality of wires (conductive wires) 50. The wire 50 preferably has elasticity and durability corresponding to eye movement when placed in the body, and is made of the same material as the wire 41 described above. The wire 50 having one end connected to the receiving unit 30 is connected to a pad (not shown) of the stimulation control unit 42 disposed on the substrate 43. Although illustration is omitted, the wire 50 and the stimulus control unit 42 are connected by welding, pressure bonding, or the like, and the connection portion is covered with a resin having biocompatibility and insulation. Further, the wire 50 is housed in a cable 51 made of a material having high biocompatibility, for example, silicone, parylene, etc. so as to be easily handled.

  In addition, although illustration is abbreviate | omitted, the receiving part 30 takes out the cable 51 and the counter electrode 34, and is stored in a case with high airtightness, and the lid | cover of the case is sealed. Furthermore, the case is coated with a resin having good biocompatibility and insulating properties. Thereby, the receiver 30 is hermetically sealed.

  Next, the electrode 44 will be described. FIG. 3 is a schematic cross-sectional view near the electrode 44. FIG. 4 is a diagram showing step by step a method for producing the electrode 44 (a method for producing the stimulation unit). In the figure, the scale of each member is schematic for ease of explanation.

  On the substrate 43, an electrode 44 and a conductive wire (wire 41) connected thereto are arranged. The electrode 44 is an electrode member 45 for directly contacting a living body and outputting an electrical stimulation pulse signal, and a washer (washer for connecting the wire 41 to the electrode member 45 and preventing the electrode member 45 from being detached from the substrate 43. , Eyelet) 46. The electrode member 45 includes a rounded head portion 45a (protruding hemispherically), a base portion 45c for joining the wire 41, and a direction opposite to the head portion 45a from the vicinity of the center of the base portion 45c. And a column member 45b extending a predetermined length. The base portion 45c is formed in a convex shape on the bottom surface of the head portion 45a (having a step so that the center of the bottom surface rises with respect to the periphery of the bottom surface). Such an electrode member 45 has biocompatibility and is formed of a plastic or malleable conductor, for example, a metal such as platinum or gold. The column member 45 b is used for passing a washer 46 described later, and its length (the height of the column) is long enough to pass the washer 46. The base portion 45c has a thickness H1 of 10 to 70 [mu] m, and the base portion 45c has a role of accommodating (positioning) the wire 41 in the substrate 43 when the substrate is to be described later. The head portion 45a has an outer diameter of about 100 to 500 μm and a height of 100 to 500 μm.

  The washer 46 is an annular member that is integrated with the electrode member 45 by penetrating the column member 45b and caulking the tip of the column member 45b (plastic deformation). As with the electrode member 45, the washer 46 has biocompatibility and is preferably formed of a plastic or malleable conductor, for example, a metal such as platinum or gold. Etc. may be formed. The washer 46 clamps the wire 41 connected to the electrode member 45 by being caulked with the column member 45b. In this way, the electrode 44 is configured. The outer diameter of the electrode 44 is 100 to 500 μm (similar to the head portion 45 a), and the height of the portion protruding from the substrate 43 is 100 to 300 μm (the height at which the head portion 45 a embedded in the substrate 43 protrudes from the substrate 43. ). The electrode member 45 and the washer 46 are formed by pressing or cutting.

  Next, a method for producing a substrate (stimulation unit) on which the electrode 44 is formed will be described with reference to FIG. FIG. 4A shows a step of connecting the wire 41 to the electrode member 45.

  The tip of the wire 41 with insulation coating is placed on the base portion 45c of the electrode member 45, and connection (welding) is performed using a welding technique such as laser welding or resistance welding. Under the present circumstances, the welding location of the wire 41 is electrically connected by the heat | fever at the time of welding in the state from which the coating | cover with the resin for insulation was removed. The connection between the electrode member 45 and the wire 41 may be a mechanical connection using a crimping process or the like.

  Next, in a state where the wire 41 is connected to the electrode member 45 as described above, the washer 46 is passed through the column member 45 b until it comes into contact with the wire 41. The inner diameter of the washer 46 is slightly larger than the outer diameter of the column member 45b. Further, the distal end portion of the column member 45b has such a length that the distal end portion of the column member 45b protrudes when inserted into the washer 46.

  Thereafter, by pressing the tip of the column member 45b, the column member 45b and the washer 46 are caulked, and the electrode member 45 and the washer 46 are fixed (connected) while sandwiching the wire 41. Thereby, the connection between the wire 41 and the electrode 44 (electrode member 45) is strengthened (see FIG. 4A). Such a step is performed for each electrode, and the electrode member 45 is connected to each wire 41. The fixing of the washer 46 and the electrode member 45 is not limited to mechanical processing such as pressing, but welding or the like may be used.

  FIG. 4B is a diagram showing a step of arranging a plurality of electrodes 44 each connected to the wire 41 on a predetermined jig. An electrode 44 to which a wire 41 is connected is disposed on the jig 70. The jig 70 is formed with a hole 71 having a diameter in which the head portion 45a can be accommodated. For the jig 70, for example, a flat metal or the like in which holes are formed by laser processing or machining is used. The diameter of the hole 71 is preferably set such that there is no gap between the hole 71 and the head part 45a in a state where the head part 45a is accommodated. Further, the depth of the hole 71 is the same as the height of the head portion 45a or slightly shallower than that. In addition, the wire 41 is preferably arranged so as not to contact the jig 70, and although not shown, tension may be applied to the end of the wire 41. At this time, the base portion 45 c is provided with the above-described thickness so that the wire 41 does not contact the jig 70. Such a step is performed for each electrode member 45, and all the electrode members 45 are arranged on the jig 70. As shown in the figure, each electrode 44 is disposed on the jig 70 so as to enter the hole 71 from the tip side (see FIG. 4B).

  FIG. 4C shows a step of forming the substrate 43 using the CVD (chemical vapor deposition) method with the electrode 44 placed on the jig 70. Growth of the material to be the substrate 43 is performed from the washer 46 side (the bottom surface side of the electrode member 45). Specifically, the jig 70 on which the electrode 44 is disposed is placed in a growth apparatus (evaporation apparatus), and a substrate material having high biocompatibility and high insulation, such as parylene, is grown on the jig 70. Since the jig 70 is flat, the formed substrate 43 is also flat. By adjusting the processing time and the like, the substrate 43 is formed with the thickness described above. As a result, the flexible substrate 43 that can be bent is formed into a flat plate shape with the wire 41 included in the substrate 43. In addition, since the electrode 44 (electrode member 45) is put in the hole 71 of the jig 70, it is in a masked state, and the adhesion of the resin to the electrode 44 after the production of the substrate 43 is suppressed. Thereby, the process (for example, the process of removing resin from the electrode 44) can be shortened by producing the electrode 44. In the present embodiment, the substrate 43 is formed using the chemical vapor deposition method. However, the present invention is not limited to this, and the substrate 43 may be formed by a vapor deposition method such as a chemical meteorological vapor deposition method. In such a case, the processing method is changed depending on the material used as the substrate 43. In the case where the substrate 43 is formed in a flat plate shape, a forming method may be used in which a side wall extending upward from the flat plate surface is provided on the jig 70 and a resin or the like is poured. In this manner, by peeling the formed substrate 43 from the jig 70, the wire 41 is included in the substrate 43, and the electrode 44 is exposed on the substrate. Further, unnecessary portions of the formed substrate 43 are cut and removed. Note that the distal end of the wire 41 is opposite to the electrode 44 formation direction so that the proximal end of the wire 41 (opposite to the electrode 44) is exposed to the opposite side of the electrode forming surface of the substrate 43. It is bent to the side, and its tip is masked to prevent vapor deposition. After the substrate 43 is formed, the stimulus control unit 42 is connected to the exposed proximal end of the wire 41, and the stimulus control unit 42 is covered with parylene or the like. Through such a procedure, the stimulation unit 40 having the substrate 43 on which a plurality of stimulation control units 42 and electrodes 44 are arranged is manufactured (see FIG. 2).

  In addition, after connecting the stimulation control part 42 and each wire 41, the manufacturing method of the stimulation part 40 which forms the electrode 44 in each wire 41 in the above-mentioned procedure, and embeds the stimulation control part 42 and the wire 41 in the board | substrate 43. It is good. In this case, the stimulus control unit 42 and the electrode 44 are arranged on the same surface of the substrate 43.

  The wire 41 is not limited to the configuration included in the substrate 43. Since the wire 41 has an insulating film, a part of the wire 41 may be exposed outside the substrate 43. Any configuration may be used as long as the wires 41 are gathered on the substrate 43 and the stimulating unit 40 is easy to handle (here, the electrode 44 is disposed in a flat plate shape).

  The column member 45b and the base portion 45c have a small step with respect to the diameter of the bottom surface of the head portion 45a, so that a space (resin is embedded) is formed in the substrate 43. Therefore, the wire 41 connected to another electrode 44 can be passed through this space during the electrode placement step in FIG. Thereby, the electrodes 44 can be arranged at high density. Further, the space is filled with resin, so that the electrode 44 is not easily pulled out of the substrate 43. The electrode 44 only needs to have a structure that does not easily come out of the substrate 43. For example, the electrode 44 is not a combination of the electrode member 45 and the washer 46, and the electrode 44 is integrally formed with a metal or the like in the shape described above. It is good.

  Thereby, the outer diameter of the electrode 44 is set to 100 to 500 μm, and the height of the portion protruding from the substrate 43 is set to 100 to 300 μm. Such an electrode 44 has a larger surface area than a thin film electrode having the same diameter. In addition, it is not easy to produce an electrode having a size like the electrode 44 by repeatedly forming a thin film layer by a thin film forming method.

  As described above, a large surface area (large volume) electrode (bulk electrode) 44 is formed on the substrate 43. As a result, even if the stimulation unit 40 is implanted in the body for a long period of time and an electrical stimulation pulse signal is continuously output from the electrode 44 and a part of the electrode 44 is dissolved by an electrochemical reaction or the like, the surface area (volume) of the electrode 44 is Almost no change. Therefore, even during long-term implantation, an electrical stimulation pulse signal having a sufficient charge amount can be output from the electrode 44 (a sufficient amount of charge can be injected), and cells, tissues, and the like can be preferably electrically stimulated. it can.

  Further, when compared with a thin film electrode having the same diameter, the electrode 44 is produced by projecting three-dimensionally on the substrate 43, so that it has a large surface area and a large contact area with cells and the like. Here, since the amount of charge that can be injected by the electrode is proportional to the surface area of the electrode, the amount of charge that can be injected from the electrode 44 can be increased by increasing the surface area of the electrode 44. Thereby, a cell etc. can be electrically stimulated suitably.

  Further, when the electrical stimulation pulse signal having the same charge amount is output by the electrode 44 and the thin film electrode, the electrode 44 having a larger surface area can reduce the charge density. For this reason, an electrode with a large surface area is less likely to concentrate charges on specific cells or the like, even with the same amount of electrical stimulation as in the case of a thin film electrode. Therefore, by increasing the surface area of the electrode, the burden on cells and the like due to electrical stimulation can be reduced. In addition, since the tip of the electrode 44 has a rounded shape, electric charges are less likely to be biased to the corners of the electrode during electrical stimulation. For this reason, electric charges are evenly discharged from the electrode 44, and the cells and the like around the electrode 44 are evenly electrically stimulated. In other words, since the charge is not concentrated on a specific portion of one electrode, the burden on the cell or the like is reduced.

  Moreover, it is preferable that the visual resolution (resolution) perceived by the patient is improved. Therefore, it is necessary to arrange the electrodes at high density while reducing the range of cells and tissues that are electrically stimulated by one electrode. For this reason, it is necessary to increase the surface area of the electrode while reducing the diameter of the electrode as much as possible. In response, the outer diameter of the head portion 45a (electrode member 45) is reduced and the height is increased. As a result, an electrode 44 having a small diameter and a long protrusion length onto the substrate 43 can be produced. Thereby, while the range which one electrode stimulates can be made small, the density of the electrode 44 arrange | positioned on the board | substrate 43 can be improved, and the visual resolution which a patient perceives can be improved.

  In addition, since the electrode 44 has a large surface area, it is possible to inject an equivalent amount of charge with the same charge density in a shorter time compared to the injection of charge using a thin film electrode. For this reason, the time width of the electrical stimulation pulse signal can be shortened, and the stimulation frequency can be increased. Thereby, the visual temporal resolution (frame rate) perceived by the patient can be increased.

  In the present embodiment described above, the substrate 43 has a flat plate shape, but is not limited thereto. Any shape suitable for the installation position of the substrate 43 (electrode 44) may be used. For example, the shape may be curved without tension. In such a case, the jig 70 may have a curved surface.

  FIG. 5 is a schematic view showing a state in which the stimulating unit 40 is implanted in the eye. The counter electrode 34 is placed at a position near the anterior eye part in the center of the eye as shown in the figure. As a result, the retina E1 is positioned between the electrode 44 and the counter electrode 34 (counter electrode). The electrical stimulation pulse signal current from the electrode 44 efficiently penetrates the retina.

  On the other hand, the receiving means 31 is installed at a predetermined position in the living body that can receive signals (electric stimulation pulse data and power) from the transmitting means 14 provided in the extracorporeal device 10. For example, as shown in FIG. 1, the receiving unit 30 (only the receiving unit 31 is shown in the figure) is embedded under the skin of the patient's temporal region and transmitted to a position facing the receiving unit 30 through the skin. The means 14 is installed. Since the magnet is attached to the receiver 30 in the same manner as the transmitter 14, the transmitter 14 and the receiver 30 are attracted by the magnetic force by positioning the transmitter 14 on the implanted receiver 30. The transmission means 14 is held on the temporal region.

  The cable 51 in which the wires 50 are bundled extends from the receiving unit 30 embedded in the temporal region under the skin toward the patient's eye along the temporal region, and is inserted into the eye socket through the inside of the patient's upper eyelid. As shown in FIG. 5, the cable 51 placed in the eye socket passes through the outer side of the sclera E <b> 3 and is connected to the stimulation control unit 42 installed on the substrate 43.

  In the present embodiment, the position where the intracorporeal device 20 (stimulation unit 40) is installed is located on the sclera E3 side, and the cells constituting the retina E1 are electrically stimulated from the sclera E3 side (choroid side). However, it is not limited to this. It is only necessary that the electrode can be placed at a position where the cells constituting the retina of the patient's eye can be suitably stimulated at a site where the substrate on which the electrode is placed is preferably flexible. For example, an electrode and a substrate may be provided between the layers. The internal device is placed in the eye of the patient (on the retina or subretinal) and the tip of the substrate on which the electrode is formed is placed under the retina (between the retina and choroid) or on the retina. You can also.

  The operation of the visual reproduction assisting apparatus having the above configuration will be described with reference to the control system block diagram shown in FIG. The photographing data (image data) of the subject photographed by the photographing device 12 shown in FIG. 1 is sent to the data modulation means 13a. The data modulation means 13a converts the photographed subject into predetermined data parameters (electric stimulation pulse data) necessary for the patient to recognize, and further generates and transmits a modulation signal suitable for transmission as an electromagnetic wave. The electromagnetic wave is transmitted from the means 14 to the in-vivo device 20 side as electromagnetic waves.

  At the same time, the data modulation means 13a transmits the power supplied from the battery 13b to the in-vivo device 20 side together with the modulation signal as an electromagnetic wave having a band different from the band of the modulation signal (electric stimulation pulse data) described above. .

  On the in-vivo device 20 side, the modulation signal and power sent from the extracorporeal device 10 are received by the receiving means 31 and sent to the control unit 32. The control unit 32 extracts a signal in a band used by the modulation signal from the received signal, forms an electrical stimulation pulse parameter signal and a control signal based on the modulation signal, and generates a control signal as an electrode designation signal. It transmits to the stimulus control unit 42.

  The stimulus control unit 42 extracts power and a control signal based on the received signal. The stimulation control unit 42 distributes the electrical stimulation pulse signal supplied from the control unit 32 to each electrode 44 based on the control signal, and outputs it. The cells constituting the retina E1 are electrically stimulated by the electrical stimulation pulse signal output from each electrode 44, and the patient obtains vision (pseudo light sensation). The control unit 32 obtains electric power for driving the in-vivo device 20 by the receiving unit 31.

  In the embodiment described above, the substrate 43 is placed on the sclera E3 of the patient's eye and the retina E1 is electrically stimulated via the sclera E3. However, the present invention is not limited to this. Any structure may be used as long as it electrically stimulates cells or tissues constituting the visual nervous system that forms the vision of the patient. For example, a stimulation unit having an electrode for outputting an electrical stimulation pulse signal is arranged in the optic nerve head in the eye or the optic nerve part outside the eye, and a transmission unit for supplying power to the stimulation unit or sending a command signal is used for the subcutaneous part of the patient. It is good also as a structure which arrange | positions in a distant place and electrically stimulates an optic nerve. Alternatively, a stimulating unit having electrodes may be arranged in a tissue that performs higher-order visual processing of the visual nervous system such as the optic chiasm, outer knee, and cerebral cortex, and stimulates the cells that constitute each tissue. For example, in the case of the occipital lobe of the cerebral cortex, it stimulates pyramidal cells or the like, or stimulates the visual cortex V1, V2, etc. In the present embodiment described above, the image data from the imaging device is converted into a predetermined signal by the data modulation means, and the signal is sent from the transmission means to the inside of the body, and the signal from the extracorporeal device is received. An example of an external imaging type visual reproduction trapping device that includes an in-vivo device that receives an electrical stimulation pulse signal from each electrode based on the signal is given as an example. However, the present invention is not limited thereto. It may be an in-vivo imaging type visual reproduction auxiliary device in which an imaging device, data modulation means, etc. are implanted in the eye.

It is the schematic which showed the external appearance of the visual reproduction auxiliary | assistance apparatus. It is the schematic which showed the in-vivo apparatus of the visual reproduction assistance apparatus in this embodiment. 3 is a schematic cross-sectional view in the vicinity of an electrode 44. FIG. It is the figure which showed the procedure which produces the electrode 44 typically. It is the figure which showed the state which installed the in-vivo apparatus in the body. It is the block diagram which showed the control system of the visual reproduction auxiliary | assistance apparatus in this embodiment.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Visual reproduction | regeneration assistance apparatus 10 Extracorporeal apparatus 20 In-vivo apparatus 30 Receiving part 31 Receiving means 32 Control part 34 Counter electrode 40 Stimulation part 41 Wire 42 Stimulation control part 43 Substrate 44 Electrode 45 Electrode member 46 Washer 50 Wire 51 Tube 70 Jig 71 Hole

Claims (4)

In the stimulating unit production method of the visual reproduction assisting device for producing a plurality of electrodes in the stimulation unit of the visual reproduction assisting device installed in the body of the patient,
A first step of connecting a conductor to each of the plurality of electrodes;
A second step of arranging the electrodes to which the conductive wires formed in the first step are connected substantially in the same plane;
Third step of obtaining a substrate including the conductive wires by embedding the conductive wires in a plate shape with a biocompatible material in a state where the tips of the plurality of electrodes arranged in the second step are masked. When,
A stimulating unit manufacturing method for a visual reproduction assisting device, comprising: 2. The stimulation unit manufacturing method for a visual reproduction assisting device according to claim 1, wherein the third step includes fitting the electrodes to a jig provided with a plurality of recesses for fitting the plurality of electrodes. A stimulating unit manufacturing method for a visual reproduction assisting device, characterized in that the tip of the electrode is masked. 3. The stimulating unit manufacturing method for a visual reproduction assisting device according to claim 2, wherein the flat plate is formed by vapor deposition. 4. The stimulating unit for a visual reproduction assisting device according to claim 3, wherein the conductor is covered with a material having biocompatibility and insulating properties. Manufacturing method.

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