Electrical devices and methods for use with the eye

Abstract

An electrical device for stimulating and / or monitoring a patient's eye is disclosed, comprising an implantable electrode device and a lead extending outwardly from the implantable device, the lead including a segment located outside the eye with at least one pre-formed bend. A lead connected to the implantable electrode device is also disclosed, the lead having one or more strips extending along at least a portion of the lead. An implantable device having a substrate and at least one electrode having at least one hole, the material of the substrate extending through the at least one hole to anchor the electrode to the substrate is also disclosed. Other disclosed features relate to, for example, foldable anchoring devices, flexible electrode substrates, and depth markers.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to Australian Provisional Patent Application No. 2019900739, filed on March 6, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This patent application relates to devices and methods for electrically stimulating and / or monitoring electrical activity in the eye. Background Technology

[0004] Electronic devices such as visual prostheses have been developed to restore vision to blind or partially blind patients. Visual prostheses, such as retinal prostheses, typically include an implantable component with an array of electrodes located on or within a substrate for placement on or near the retinal nerve cells in the eye. Electrical signals are transmitted via the electrodes to the retinal nerve cells, triggering light perception in the patient's brain. Therefore, prostheses can provide visual perception for patients, for example, with dysfunction or loss of retinal photoreceptors.

[0005] Typically, visual prostheses are used in conjunction with cameras. The image stream detected by the camera is converted into digital signals by an image processor, and electrical signals are applied to electrodes based on these digital signals.

[0006] Any discussion of documents, laws, materials, devices, articles of manufacture, etc. included in this specification should not be construed as an admission that any or all of these contents form part of the prior art or are common knowledge in the field relating to this disclosure, simply because they existed prior to the priority date of each claim of this application. Summary of the Invention

[0007] According to one aspect of this disclosure, an electrical device is provided for stimulating and / or monitoring a patient's eye, the device comprising:

[0008] An implantable device comprising one or more electrodes, the implantable device being implanted at a stimulation and / or monitoring location between the first and second tissue layers of the eye;

[0009] The lead includes one or more conductors connected to the electrode, and the lead extends outward from the implanted device;

[0010] The lead includes a first lead segment and a second lead segment located outside the eye when the implanted device is in a stimulation and / or monitoring position. The second lead segment is configured to extend around the orbital bone near the eye, and the first lead segment is located between the implanted device and the second lead segment.

[0011] The first lead segment has at least one pre-formed bend.

[0012] The implantable device can be configured to be inserted into the suprachoroidal space between the sclera and choroidal layers of the eye. The first and second tissue layers can be the sclera and choroid. However, the first and second tissue layers can be other layers, such as the choroid and retina.

[0013] At least one preformed bend may be a curved bend. At least one preformed bend may provide a lead orientation change of at least 90 degrees, at least 120 degrees, at least 150 degrees, or higher at the first lead segment. For example, at least one preformed bend may provide an orientation change of approximately 180 degrees. At least one preformed bend may be a U-shaped bend, a double U-shaped bend (e.g., an S-shaped bend), or a bend of other shapes. At least one preformed bend may lie in only one plane or in more than one plane.

[0014] When the implantable device is inserted into the eye, at least one pre-formed bend can be bent in a rearward direction. For example, when the first lead segment includes a U-shaped bend, the end of the U-shape can therefore be located in front of the middle segment, peak, or apex of the U-shape.

[0015] The first lead segment can be flexible and can have a length greater than the distance between the eye and the orbital bone. For example, the length of the first lead segment can be greater than the distance between a point on the eye and a point on the orbital bone, with the lead leaving the eye from the point on the eye (e.g., an incision) when the eye is in an forward-facing position and the lead contacting the point on the orbital bone.

[0016] During the use of the device, the eye can rotate. To allow for relatively unimpeded eye rotation when the implantable device is placed in the eye, the lead can exhibit a degree of flexibility and / or mobility. If the lead lacks flexibility and / or mobility, it can significantly impede or prevent eye movement in one or more rotational directions. For example, by providing a flexible first lead segment that is longer than the distance between the eye and the orbital bone, the eye is essentially able to move in all rotational directions. As the eye rotates, the area of ​​the first lead segment can bend and converge or straighten and extend apart, depending on the direction of rotation. By providing at least one pre-formed bend in the first lead segment, the force required for further bending or straightening of the lead can be significantly reduced, thereby reducing potential patient discomfort and / or potential eye damage.

[0017] The first lead segment may have a circular cross-section or other cross-sectional shapes. The diameter of the first lead segment may be smaller than the diameter of the second lead segment or may have other diameters.

[0018] One or more pre-formed bends in the first lead segment may be formed during or after molding the first lead segment. The first lead segment may include multiple conductors embedded or otherwise located within a surrounding overlay. The overlay may be formed of medical-grade silicone or other polymeric materials such as polyurethane that cure during molding. One or more bends may be formed using post-curing techniques. For example, at least one bend may be formed by rolling or holding the first lead segment around a bent or angled surface while subjecting it to heating for a period of time. The bent or angled surface may be cylindrical or partially cylindrical or other shaped. The radius of the bent surface may be at least 1.5 mm, at least 2 mm, at least 2.5 mm, at least 3 mm, or others. The pre-formed bend may have a corresponding radius of curvature. Heating may be performed at temperatures above 100°C, above 110°C, above 120°C, above 130°C, or others. For example, heating may be performed at a temperature of about 135°C. Heating may be performed for a period of time greater than about 30 minutes, greater than 60 minutes, greater than 90 minutes, or others. For example, heating can be carried out for a period of approximately 120 minutes.

[0019] The second lead segment may include a reinforcing device adapted for positioning at or near the orbital bone. The reinforcing device may have a first end and a second end, and may extend between the first and second ends. The reinforcing device may be, or provide, a thickening of the second lead segment. The reinforcing device may be adapted for positioning at or near the orbital bone. The reinforcing device may be attached to the orbital bone. For example, the reinforcing device may be located in a notch formed in the orbital bone to aid attachment. The notch may include a groove and an inlet for receiving the reinforcing device, through which the reinforcing device may be positioned in the groove. The inlet may be narrower than the groove. The reinforcing device may be squeezed through the inlet into the groove, in which the reinforcing device is substantially fixed in place at the orbital bone.

[0020] The point where the guide wire extends around the orbital bone, such as the point where the notch is located, can be above, below, or level with a transverse plane extending through the center of the eye. In the posterior direction, the notch (e.g., the groove) can be tilted downwards or upwards, for example, tilted upwards at about 15 degrees.

[0021] The reinforcing device can be integrally formed with the second lead segment, for example, by molding or other means, or it can be a discrete component. For example, the reinforcing device can be clamped and / or glued to a suitable position at the second lead segment.

[0022] Regardless of whether the second lead segment is associated with a reinforcing device, it can have at least one pre-formed bend. When a reinforcing device is provided, it may have a pre-formed bend that forms the pre-formed bend of the second lead segment when it is fixed in place at the second lead segment. However, alternative techniques can be used to form the pre-formed bend at the second lead segment. For example, the pre-formed bend can be formed by a post-curing technique, for example, in the same manner as forming the pre-formed bend at the first lead segment.

[0023] At least one pre-formed bend in the second lead segment can be configured to conform to and bend around the edge of the orbital bone (orbital rim). The angle of at least one pre-formed bend in the second lead segment can be smaller than the angle of at least one pre-formed bend in the first lead segment. For example, at least one pre-formed bend in the first lead segment can be a U-shaped bend as described above, and at least one pre-formed bend in the second lead segment can be an angled V-shaped bend.

[0024] When a single pre-formed bend is provided at the first lead segment and a single pre-formed bend is provided at the second lead segment, these bends can be combined to provide an S-shaped or L-shaped configuration for the lead (i.e., its shape can be generally similar to the number 2). Therefore, the bends at the first and second lead segments can be bent in opposite directions. For example, the bend at the first lead segment can be bent in a rearward direction, and the bend at the second lead segment can be bent in a forward direction.

[0025] The first lead segment of the lead may include one or more strips extending along at least a portion of the lead.

[0026] In fact, according to one aspect, this disclosure provides an electrical device for stimulating and / or monitoring a patient's eye, the device comprising:

[0027] An implantable device comprising one or more electrodes, the implantable device being implanted at a stimulation and / or monitoring location between the first and second tissue layers of the eye;

[0028] and leads, the leads including one or more conductors connected to electrodes, the leads extending outward from the implanted device;

[0029] One or more strips extend along at least a portion of the lead.

[0030] One or more strips can aid in lead placement during the implantation of the stimulation device. Specifically, one or more strips can provide the surgeon implanting the stimulation device with a visual indication of whether the lead is distorted. In cases where the lead comprises a first segment and a second segment as described above, one or more strips can extend at least along the first lead segment. In some embodiments, one or more strips can extend along the entire length of the lead. One or more strips can be formed of a titanium dioxide layer or other material with a contrasting color to the adjacent portion of the lead. In some embodiments, two strips may be provided, each located on substantially opposite sides of the lead.

[0031] In any aspect disclosed herein, the implantable device may include a substrate, with one or more electrodes located in or on the substrate. The electrodes may be at least partially embedded in the substrate. The substrate may include a first non-conductive material, such as a medical-grade polymer material, such as a silicone elastomer or polyurethane. Each electrode may include a second conductive material, such as a metal, such as a noble metal, such as platinum. A portion of the substrate may provide a lip around the contact surface of each electrode. The lip may cover the outer peripheral edge of the contact surface and expose a central region of the contact surface for electrical contact with ocular tissue. The lip may help anchor the electrode to the substrate.

[0032] The substrate may be an elongated substrate having a distal end, a proximal end, a first side, a second side, and a first opposing surface and a second opposing surface, each extending between the distal and proximal ends and the first and second sides. Electrodes may be at least partially embedded in the substrate and exposed at one or both of the first and second surfaces, such as the second surface, for electrical contact with ocular tissue. In some embodiments, the electrodes may be at least partially embedded in the substrate by forming an initially flowable substrate material around them prior to material solidification. In some alternative embodiments, the electrodes may be positioned on the substrate and embedded by a coating provided over the electrodes. A portion of the coating covering the electrodes may be removed (e.g., by photolithography) to expose the underlying electrodes (or portions thereof) for electrical contact with ocular tissue. Electrodes may be uniformly distributed across the substrate or positioned at the distal end, which is typically closer to the substrate than the proximal end. The substrate may be configured to initially insert the distal end via an incision into stimulation and / or monitoring sites between layers of the eye, such as the sclera and choroid.

[0033] According to one aspect of this disclosure, an implantable device for stimulating and / or monitoring a patient's eye is provided, the implantable device comprising:

[0034] A substrate comprising a first non-conductive material; and

[0035] The electrode includes at least one electrode of a second conductive material, the at least one electrode being at least partially embedded in a first material of a substrate and including at least one hole through which the first material of the substrate extends at least partially to anchor the electrode to the substrate.

[0036] The first non-conductive material can be a flowable material that solidifies during the manufacturing process to form a substrate. While in a flowable state and before solidification, the first material can flow into at least one hole to completely or partially fill the hole.

[0037] The first material can be a polymeric material that solidifies through curing. For example, the first material can be a medical-grade polymeric material, such as a silicone elastomer or polyurethane. The second conductive material can be a metal, such as a precious metal, like platinum.

[0038] Generally, polymeric materials used in the substrate, such as silicone elastomers or polyurethanes, may not form a strong bond with the noble metal materials used in the electrodes. Therefore, it has been found that metal electrodes embedded on or near the surface of the elastomer substrate may easily detach from the substrate, for example, "pop" out of a recess in the substrate. By anchoring the electrodes to the substrate in the manner described above, the risk of electrode misalignment or popping out can be significantly reduced.

[0039] The first material of the substrate may provide all or at least most of the substrate. A portion of the first material extending at least partially through the holes of the electrodes may be integral and homogeneous with all or most of the first material forming the substrate.

[0040] At least one hole may be a drilled hole in the electrode. At least one hole may have opposing first and second open ends. A first material may fill, for example, completely fill the hole.

[0041] A first material may extend out of the hole via a first end and a second end. At one or both open ends, the first material may extend partially transversely to the hole as it extends out of the hole, for example, across an electrode surface. The first material may form a continuous loop extending through the hole. The continuous loop may extend through the hole and surround the outer periphery of the electrode or through another hole in the electrode.

[0042] By providing a lateral extension portion of the first material and / or a continuous ring of the first material, at least one electrode can be fixed between portions of the first material, thereby facilitating electrode anchoring.

[0043] At least one electrode may include multiple holes to increase anchoring strength.

[0044] At least one electrode may be substantially flat. The electrode may have a first opposing surface and a second opposing surface. The electrode may have a disk shape. The first surface of the electrode may face away from the substrate and may be at least partially exposed to achieve electrical contact between the first surface and the tissue of the eye. The second surface of the electrode may be embedded within the substrate, for example, embedded within a first material of the substrate.

[0045] The substrate may include a lip of a first material that extends around the outer periphery of a first surface of the electrode to help anchor the electrode to the substrate while exposing a region of the first surface (e.g., the central region).

[0046] At least one hole may extend between a first opposing surface and a second opposing surface of the electrode. The first opening end of the hole may be located on the first surface of the electrode, and the second opening end of the hole may be located on the second surface of the electrode. The hole may be located near the outer peripheral edge of the electrode. For example, at least one hole may be located within 33%, 25%, 15%, or 10% of the electrode diameter. In the case of providing multiple holes, each hole may be located near the outer peripheral edge of the electrode. For example, each hole may be located within 33%, 25%, 15%, or 10% of the electrode diameter. The holes may be located in an annular pattern near the outer peripheral edge of the electrode. The holes may be uniformly spaced. By providing holes near the outer peripheral edge of the electrode, the first non-conductive material can extend through the electrode only at the outer peripheral edge, thereby ensuring that the central region of the first surface of the electrode remains exposed for electrical contact with tissue. Each hole may have a diameter, for example, less than 20%, less than 15%, or less than 10% of the electrode diameter. For example, each hole may have a diameter between 100 μm and 800 μm. Each hole may be circular, but other hole shapes may also be used.

[0047] When a lip is provided, a first material can extend from the lip through a hole at the outer periphery of the electrode. The hole can enhance the function of the lip as a means of helping to anchor the electrode to the substrate.

[0048] In addition to providing one or more holes extending between the first and second opposing surfaces of the electrode, or alternatively, at least one hole may be defined by a protrusion on the second surface of the electrode. The first and second opposing ends of the hole may be defined by the protrusion. The protrusion may be a ring, a shank, and / or a clamp, the center of which provides the hole. The protrusion may be formed of a band. The protrusion may be U-shaped, but may engage with the second surface of the electrode to provide a closed loop. Multiple protrusions may be provided on the second surface of the electrode, each protrusion defining at least one hole.

[0049] As described above, the second surface of the electrode can be embedded within the substrate. By providing a protrusion at the second surface defining the hole, when the second surface is embedded within the substrate during the manufacture of the device, for example, when the first material of the substrate is in a flowable state as described above, the first material of the substrate can extend through the hole.

[0050] In the device disclosed herein, an anchoring device can be provided to anchor a lead to the outer surface of the eye, at or near an opening in the eye, such as a cut through which the lead extends. The anchoring device may include a proximal end portion secured to the lead and a distal end portion connected to the proximal end portion. The anchoring device can be releasably secured in a folded configuration. The anchoring device can be adjusted from a folded configuration to an extended configuration.

[0051] In fact, according to one aspect of this disclosure, an electrical device for stimulating and / or monitoring a patient's eye is provided, the electrical device comprising:

[0052] An implantable device comprising one or more electrodes, the implantable device being implanted at a stimulation and / or monitoring site between a first and a second tissue layer of the eye; and

[0053] Leads, including one or more conductors connected to electrodes, extending outward from the implanted device; and

[0054] An anchoring device for anchoring a lead to the outer surface of the eye, at or near the opening through which the lead extends, the anchoring device comprising a proximal end portion fixed to the lead and a distal end portion connected to the proximal end portion, the anchoring device being releasably secured in a folded configuration.

[0055] Furthermore, on the other hand, a method for securing the lead to the outer surface of a patient's eye is provided.

[0056] The lead is connected to an implantable device implanted at a stimulation and / or monitoring location between the first and second tissue layers of the eye, the implantable device including one or more electrodes, and the lead extends through an opening on the outer surface of the eye.

[0057] An anchoring device is provided, which includes a proximal end portion fixed to the lead wire and a distal end portion connected to the proximal end portion, the anchoring device being releasably fixed in a folded configuration;

[0058] The method includes adjusting the anchoring device from a folded configuration to an extended configuration by releasing the anchoring device's fixation.

[0059] In the folded configuration, the anchoring device may be double-folded, bent, rolled back, or otherwise varied. The distal end portion (e.g., its distal tip) may protrude toward the proximal end portion. On the other hand, in the extended configuration, the distal end portion (e.g., its distal tip) may protrude away from the proximal end portion.

[0060] The anchoring device can be releasably secured in a folded configuration by releasably securing the distal end portion to the proximal end portion. The distal end portion can be releasably secured to the proximal end portion by one or more sutures, adhesives, and / or other fixation methods. To adjust the anchoring device from a folded configuration to an extended configuration, the surgeon can release the fixation between the distal and proximal end portions by, for example, cutting or loosening one or more sutures and / or by applying tension to overcome adhesive forces.

[0061] By releasably securing the anchoring device in a folded configuration, the distal end portion of the anchoring device can be temporarily held away from an opening (e.g., an incision) in the outer surface of the eye through which the suture exits the eye. Therefore, the distal end portion does not obstruct or impede access to the opening in the outer surface of the eye. By maintaining this access to the opening, sutures can be applied relatively easily at the opening in the outer surface of the eye, for example, to suture the incision, and / or other treatments can be applied at or near the opening. Once these steps have been completed, the fixation of the distal end portion to the proximal end portion can be released, so that the distal end portion can protrude automatically or by manipulation away from the proximal end portion. The distal end portion can then at least partially cover the opening in the outer surface of the eye. Generally, the anchoring device can extend above the suture and can cover at least a portion or all of the opening in the outer surface of the eye. The distal end portion and / or the proximal end portion of the anchoring device can be secured to the outer surface of the eye using one or more sutures or other fixation methods. In some embodiments, the proximal end portion can be secured to the outer surface of the eye before being released from the folded configuration.

[0062] In any aspect disclosed herein, when secured to the outer surface of the eye, the anchoring device can provide support and stability for the lead as it extends from an opening in the outer surface of the eye. Furthermore, the anchoring device can conceal the opening in the outer surface of the eye. The anchoring device can also be used to arrange the lead in a suitable direction away from the anchoring device and the eye, for example, across the extraocular muscles of the eye and toward the lateral orbital rim. To achieve this wiring, the anchoring device can cause the lead to follow a tortuous path or assist the lead in following a tortuous path. The lead can be bent at the anchoring device, for example, by 45 to 135 degrees. In one embodiment, the bend in the lead at the anchoring device can be a substantially right-angled bend (90-degree bend). In another embodiment, the bend can be about 50 to 70 degrees, for example, about 55 or about 60 degrees.

[0063] Anchoring devices can be substantially flexible. Anchoring devices may include polymeric materials, such as medical-grade silicone or polyurethane. Anchoring devices may include embedded reinforcing elements, such as meshes, for example, polyethylene terephthalate (PET) mesh (Dacron). TM (Grid). The anchoring device can be in the form of a patch or flap. The anchoring device can be planar. The anchoring device can have a pre-formed shape, such as a channel or recess, adapted to receive a portion of the lead and / or one or more suture knots when the lead is secured to the outer surface of the eye, thereby preventing the knots from exerting pressure or friction on the anchoring device. For example, the anchoring device can have one or more pre-formed suture knot recesses, separated from the channel or recess adapted to receive a portion of the lead. Each suture knot recess can be adapted to receive one or more corresponding suture knots. One or more suture knot recesses can be configured as recessed portions on the top surface of the anchoring device. Additionally or alternatively, one or more suture knot recesses can be provided on the underside of the anchoring device to form a pocket between the anchoring device and the outer surface of the eye. In some embodiments, the suture knot recesses can be provided on both the top and underside of the anchoring device. During surgery, after the suture knot is tied, the suture can be rotated to position the knot in the recess.

[0064] In any of the foregoing aspects, the lead can travel from the implanted device, exiting an opening in the outer surface of the eye, to a communication interface remote from the eye. The communication interface may include a wireless transmitter / receiver or an electrical connector (e.g., a plug-and-receptor or "base"), thereby allowing a wired or wireless connection between the implanted device and electrical components (such as signal generators, signal monitors, etc.). The communication interface may be directly connected to or formed part of the electrical component, or it may be separate from the electrical component. In one embodiment, the communication interface may include a connection point between a conductor and a signal generator, such as an implantable signal generator. The communication interface may be attached to or implanted wholly or partially on one side of the patient's head, or in another part of the patient's anatomy.

[0065] Conductors extending from one or more electrodes in the substrate through leads and / or other components described herein may have a helical or wavy shape. Therefore, in the event of device buckling, the conductors can expand or contract along their length as needed, thereby preventing damage to components of the device, including the conductors themselves.

[0066] In aspects and embodiments of this disclosure, the substrate of the implantable device may have a curved first surface, and the degree of curvature of the first surface may increase in the longitudinal direction of the substrate from the central region of the substrate at least toward the distal end of the substrate. Furthermore, in the width direction of the substrate, the first surface may be curved, and the degree of curvature of the first surface may increase in the width direction from the central region of the substrate at least toward one of a first side and a second side of the substrate.

[0067] In fact, according to one aspect of this disclosure, an implantable device for stimulating and / or monitoring a patient's eye is provided, the implantable device comprising:

[0068] An elongated substrate has a distal end, a proximal end, a first side, a second side, a first surface, and a second surface, the first surface and the second surface extending on opposite sides of the substrate between the distal end and the proximal end and between the first side and the second side, the longitudinal direction of the substrate extending between the distal end and the proximal end of the substrate, and the width direction of the substrate extending between the first side and the second side of the substrate.

[0069] One or more electrodes positioned at or near the distal end of the substrate;

[0070] The distal end of the substrate is configured to be inserted via an incision into a stimulation and / or monitoring location between the first and second tissue layers of the eye; and wherein:

[0071] In the longitudinal direction of the substrate, the first surface is curved, and the degree of curvature of the first surface increases in the longitudinal direction from the central region of the substrate at least towards the distal end of the substrate; and / or

[0072] In the width direction of the substrate, the first surface is curved and the degree of curvature of the first surface increases in the width direction from the central region of the substrate toward at least one of the first side and the second side of the substrate.

[0073] In one embodiment, the curvature of the first surface increases in the longitudinal direction from the central region of the substrate toward the distal and proximal ends of the substrate.

[0074] In one embodiment, the curvature of the first surface increases in the width direction from the central region of the substrate toward both the first and second sides of the substrate.

[0075] The increase in curvature can be a continuous increase or a stepwise increase. For example, the first surface along the longitudinal and / or width directions can have different regions, each with a constant radius of curvature, but the radii of curvature of the regions are different from each other.

[0076] The curvature at any one or more curved regions of the substrate can be partially spherical. The curvature at the central region of the substrate can be partially spherical and can substantially follow the spherical curvature of the eye.

[0077] The first and second tissue layers can be the sclera and choroid of the eye, respectively. A first surface can be configured to be close to the inner side of the scleral layer. The relatively low curvature of the first surface in the central region reduces the amount of static pressure on the sclera. However, the relatively high curvature of the first surface towards the ends and / or sides of the substrate helps to insert the substrate between the first and second tissue layers of the eye. The substrate can be pushed into the appropriate position between the first and second tissue layers, thereby separating them. The relatively high curvature helps to separate the first and second tissue layers. Generally, the curvature of the substrate can mitigate placement and force during surgery. Furthermore, the curvature can help support the incision in the eye through which the implantable device is inserted.

[0078] The curvature of the substrate can cause the substrate thickness to gradually decrease from the center region toward the ends and / or sides of the substrate. Generally, in any aspect and embodiment disclosed herein, the substrate thickness can gradually decrease from the center region toward the ends and / or sides of the substrate.

[0079] In implantable devices of this disclosure that include multiple electrodes for electrically stimulating the eye, in some embodiments, current can be applied to multiple electrodes simultaneously. For example, the electrodes can be configured as an array comprising one or more groups of electrodes, such as electrodes grouped by line or other arrangement. Current can be applied simultaneously to the electrodes in that group. For example, an electrode group may include at least two electrodes, at least three electrodes, or at least four electrodes. The electrodes in the group can be electrically addressed in parallel or can be combined together.

[0080] Simultaneous addressing of electrodes can provide increased penetration of the electric field into ocular tissues, resulting in better efficacy. Furthermore, lower impedance and lower charge required per electrode enable reduced power loss.

[0081] In any aspect described herein, the substrate of the implantable device may include one or more navigation markers to aid in the implantation of the implantable device. The navigation markers may serve as indicators of the depth to which the implantable device is inserted through an incision in the eye and / or as indicators of the orientation of the implantable device relative to the incision.

[0082] In fact, according to one aspect of this disclosure, an implantable device for stimulating and / or monitoring a patient's eye is provided, the implantable device comprising:

[0083] An elongated substrate has a distal end, a proximal end, a first side, a second side, a first surface, and a second surface, the first surface and the second surface extending on opposite sides of the substrate between the distal end and the proximal end and between the first side and the second side, the longitudinal direction of the substrate extending between the distal end and the proximal end of the substrate, and the width direction of the substrate extending between the first side and the second side of the substrate.

[0084] One or more electrodes positioned at or near the distal end of the substrate;

[0085] The distal end of the substrate is configured to be inserted via an incision into a stimulation and / or monitoring location between the first and second tissue layers of the eye; and wherein:

[0086] The substrate includes one or more navigation marks, each navigation mark providing at least one of the following: (i) an indication of the depth of insertion of the implanted device through the incision and (ii) an indication of the orientation of the implanted device relative to the incision.

[0087] At least one of the navigation marks can be a line. The line can be printed on the substrate. Alternatively, for example, the line can be etched or molded into the substrate. The line can be disposed on a first surface or a second surface of the substrate. The line can be a straight line. The line can extend in the width direction of the substrate, perpendicular to the longitudinal direction of the substrate.

[0088] A first navigation marker can be provided to mark the alignment of the implantable device with the incision in the eye when fully implanted. When positioned at the incision, the first marker indicates that the implantable device has been inserted through the incision to the full implantation depth. Positioning the first marker at the incision also indicates the orientation of the implantable device relative to the incision at the full implantation depth. When the first marker is positioned directly below and parallel to the incision, proper orientation at the full implantation depth is achieved.

[0089] A second navigation mark may be provided in the navigation markings to indicate that the implantable device has been inserted through the incision to a predetermined intermediate implantation depth, such as at least half of the full implantation depth. The second navigation mark may be located distal to the first navigation mark (if the first navigation mark is also present). The second mark, when positioned at the incision, can indicate that the implantable device has been inserted through the incision to the intermediate implantation depth. The second mark, when positioned at the incision, can indicate the orientation of the implantable device relative to the incision at the intermediate implantation depth. When the second mark is positioned directly below the incision and extends parallel to the incision, it can have an appropriate orientation at the intermediate implantation depth.

[0090] Additional markings, such as lines, may be provided to provide additional indication of the insertion depth of the implanted device and / or to ensure the proper orientation of the implanted device at these different depths.

[0091] Throughout this specification, the word “comprising” or its variations such as “including” or “containing” shall be understood to imply that the stated element, integer or step, or group of elements, integer or steps is included, without excluding any other element, integer or step, or group of elements, integer or steps. Attached Figure Description

[0092] By way of example only, embodiments of the present disclosure are now described with reference to the accompanying drawings, in which:

[0093] Figure 1 A top view of an electrical device according to an embodiment of the present disclosure is shown, including an implantable device, a lead wire, and an anchoring device for implantation in the eye;

[0094] Figure 2a and Figure 2b Demonstrates implantation in the eye Figure 1 Implantable devices;

[0095] Figure 3a , Figure 3b and Figure 3c They are shown respectively Figure 1 Side view, end view and perspective view of the substrate of the implantable device;

[0096] Figure 4a and Figure 4b The positioning relative to the skull is shown respectively. Figure 1 Perspective and side views of the equipment.

[0097] Figure 5 It shows Figure 1 An oblique view of the equipment, in which the anchoring device is in a partially pre-folded configuration;

[0098] Figure 6a and Figure 6b It shows the folded configuration. Figure 1 The anchoring device, and Figure 6c It shows the extended configuration. Figure 1 Anchoring device;

[0099] Figure 7a It shows Figure 1 A perspective view of the electrodes of the implantable device; Figure 7b It shows Figure 7a Electrode embedding Figure 1 In the substrate of the implantable device; Figure 7c An oblique view of a substrate in which multiple electrodes are embedded is shown, and Figure 7dThe embedded substrate is shown Figure 7c A sectional oblique view of the electrode.

[0100] Figure 8a , Figure 8b and Figure 8c Top view, oblique view and side view of alternative electrodes for use in an implantable device according to an embodiment of the present disclosure are shown respectively;

[0101] Figure 9a , Figure 9b and Figure 9c A top view, a perspective view, and a side view are shown, respectively, for another alternative electrode in an implantable device according to an embodiment of the present disclosure;

[0102] Figure 10 It shows including according to Figures 8a to 8c and according to Figures 9a to 9c A perspective view of an implantable electrode device;

[0103] Figure 11a and Figure 11b Cross-sectional and inclined bottom views of an anchoring device according to an embodiment of the present disclosure are shown respectively; and

[0104] Figure 12a and Figure 12b A cross-sectional view and a top-view of an anchoring device according to another embodiment of the present disclosure are shown respectively. Detailed Implementation

[0105] Embodiments of this disclosure relate to electrical devices for applying stimulation to any eye of a patient and / or monitoring the patient's eye. Such electrical devices can provide a "visual prosthesis device" for improving a patient's vision (or at least providing improved visual "perception") and are understood to include devices also referred to as bionic eyes, artificial eyes, retinal prostheses, and retinal stimulators or similar devices. However, the features of this disclosure can be used with any type of device implanted in the eye for vision restoration or other purposes, or with entirely different types of implantable devices, including devices adapted to stimulate or monitor brain activity. Generally, monitoring as described herein may include, for example, measuring signals, such as those from the eye, recording signal data, processing signal data, and / or analyzing signal data.

[0106] Figure 1 A top view of an electrical device according to an embodiment of the present disclosure is shown, the device including an implanted device 1, an anchoring device 2, and a lead wire 3.

[0107] The implantable device has a flexible substrate 10 having a distal end 11, a proximal end 12, a first side 13, and a second side 14. When viewed from above, the substrate 10 is substantially rectangular with curved corners to minimize surgical trauma. The longitudinal direction (length) of the substrate extends between the distal end 11 and the proximal end 12, and the transverse direction (width) of the substrate extends between the first side 13 and the second side 14. The substrate 10 includes a first opposing surface 15 and a second opposing surface 16, each extending between the distal end 11 and the proximal end 12 and between the first side 13 and the second side 14 (see still). Figure 3a Electrode 17 is partially embedded in the substrate and is used to apply current to the tissues of the eye to induce visual perception in a subject, and / or to monitor eye characteristics by receiving current from the eye tissues. In this embodiment, 44 electrodes 17 are provided, arranged in an alternating pattern, wherein the electrodes 17 are offset in rows extending in the longitudinal direction of the substrate but aligned in the transverse direction of the substrate. The electrodes 17 are exposed at a second surface 16 of the substrate.

[0108] The length of substrate 10 is between approximately 16 mm and 20 mm, for example, approximately 17 mm, 18 mm, or 19 mm, but other lengths are also possible. The width of substrate 10 is between approximately 6 and 10 mm, for example, approximately 8 mm, but other widths are also possible. Electrode 17 is a disc-shaped electrode with a circular outer perimeter, but other shapes are also possible. The diameter of electrode 17 is between approximately 0.4 mm and 2.5 mm, for example, approximately 1.05 mm for the stimulation electrode 17b in this embodiment and approximately 2.1 mm for the current return electrode 17a (i.e., approximately 0.13 mm). 2 and 4.91mm 2 The first surface area, approximately 0.87 mm² 2 However, as discussed in more detail below, the lip edge 101 surrounds the electrode 17 such that only a portion of each electrode is exposed from the substrate, for example, having a diameter of about 1.00 mm (i.e., about 0.79 mm) for the stimulation electrode 17b. 2 The area of ​​the current return electrode 17a is approximately 2.0 mm (i.e., approximately 3.14 mm). 2 (area).

[0109] In addition to covering a large area of ​​substrate 10, the size and distribution of electrodes 17 are designed to maintain the flexibility of implantable device 1.

[0110] Each electrode 17 is connected to one or more individual electrical conductors 33, such as biocompatible metal wires, like platinum wires. The conductors 33 extend through the substrate and beyond the substrate, passing through the lead 3. Although in Figure 1Only a basic representation of conductor 33 is provided, but in reality, conductor 33 can be configured in a helical configuration to allow the conductor to adapt to the buckling of implanted device 1 and / or lead 3.

[0111] The substrate 10 of the implantable device includes one or more navigation marks 1011, 1012 to aid in the implantation of the implantable device 1. The navigation marks 1011, 1012 can serve as indicators of the depth of insertion of the implantable device 1 through an incision in the eye and / or as indicators of the orientation of the implantable device 1 relative to the incision. In this embodiment, at least two navigation marks 1011, 1012 are provided, each navigation mark on a first (rear) surface 15 of the substrate 10. In this embodiment, the navigation marks 1011, 1012 are provided in the form of lines. The lines are printed on the back surface 15 of the substrate 10, but in alternative embodiments, for example, the lines may be etched or molded into the substrate. The lines are straight lines extending in the lateral (width) direction of the substrate 10, perpendicular to the longitudinal (length) direction of the substrate 10.

[0112] A first navigation mark in navigation mark 1011 is provided to mark the position of the implanted device 1 aligned with the incision in the eye when fully implanted. When positioned at the incision, the first navigation mark 1011 not only indicates that the implanted device 1 has been inserted through the incision to the full implantation depth, but also provides a manner to ensure proper orientation of the implanted device 1 relative to the incision when at the full implantation depth. In this embodiment, proper orientation at the full implantation depth is achieved when the first mark is positioned directly below and parallel to the incision. Note that the first mark is positioned slightly distal to the proximal end of the substrate 10 because the implanted device 1 is configured to extend on either side of the incision when fully implanted. The main portion (distal) of the implanted device 1 will be located on one side of the incision, and the remaining smaller portion (proximal) of the implanted device 1 will be pushed into the opposite side of the incision (see, for example...). Figures 6a to 6c Lead 3 extends from implanted device 1 at a position aligned with the first navigation mark 1011, because the lead is arranged to extend immediately from implanted device 1 through the incision.

[0113] A second navigation mark, located distal to the first navigation mark in navigation mark 1012, provides an intermediate mark. This intermediate mark provides, for example, an indication that the implanted device 1 has been inserted through the incision to a predetermined intermediate implantation depth, such as at least half of the full implantation depth. Furthermore, it provides an indication of the proper orientation of the implanted device 1 relative to the incision at the intermediate implantation depth. In this embodiment, proper orientation at the intermediate implantation depth is achieved when the second navigation mark 1012 is positioned directly below and parallel to the incision. Additional marks, such as lines, may be provided to provide additional indication of the insertion depth of the implanted device and / or to ensure proper orientation of the implanted device 1 at these different depths.

[0114] Now about Figure 2a and Figure 2b An exemplary method for implanting the implantable device 1 into the eye 5 is discussed. An incision 50 is formed in the sclera 51 of the eye 5 using a scalpel 52. The width of the incision 50 is slightly larger than the width of the substrate 10 of the implantable device 1. For example, the width of the incision can be approximately 7 mm to 12 mm. The incision 50 is formed between the superior rectus muscle 53 and the lateral rectus muscle 54 of the eye 5. The incision is located approximately 4 mm to 5 mm posterior to the intermuscular septum. Using soft-tipped forceps, the distal end 11 of the substrate 10 is pushed into the incision 50, through the sclera 51, and into the pocket between the sclera 51 and the choroid 56 (see [link to relevant documentation]). Figure 2b Once fully inserted, the opening of incision 50 is closed with sutures. When implanted, the implantable device 1 of this embodiment is located entirely between the superior rectus muscle 53 and the lateral rectus muscle 54 of the eye 5, in the superior anterior temporal position of the eye (e.g., in the superior anterior temporal octant). In an alternative embodiment, a portion of the implantable device may be located between the superior and lateral rectus muscles of the eye, and a portion of the implantable device may be located below one or both of the superior and lateral rectus muscles of the eye.

[0115] The stimulation provided by the implanted device 1 can restore visual function by causing the perception of light as a direct result of the stimulation.

[0116] By implanting the device 1 on the choroid and at the superior anterior temporal location of the eye (e.g., in the superior anterior temporal octave of the eye), effective stimulation and / or monitoring of ocular tissues can be achieved. Positioning the implanted device 1 on the choroid provides a safe and stable method that does not require minimally invasive surgery.

[0117] In addition to providing electrical stimulation or as an alternative, the implantable device 1 can be used to monitor the electrical properties of the eye, such as voltage, impedance, or others. In one embodiment, the implantable device 1 is used to perform electroretinography (ERG) monitoring.

[0118] In addition to the positioning of the implantable device 1 in the eye, the need for safety, stability, and minimally invasive surgery is partly provided by the shaping of the substrate 10 of the implantable device. Figure 3a , Figure 3b and Figure 3c Side view, end view, and oblique view of substrate 10 are provided. It can be seen that the first surface 15 of the substrate is curved. When positioned on the choroid, the first surface 15 is designed to abut against the inner surface of the sclera 51, as... Figure 2b As shown.

[0119] refer to Figure 3a The curvature of the first surface 15 increases in the longitudinal direction from the central region 151 of the first surface 15 of the substrate 10 toward the distal end 11 of the substrate 10. The curvature of the first surface 15 also increases in the longitudinal direction from the central region 151 toward the proximal end 12 of the substrate 10. Similarly, refer to... Figure 3b The curvature of the first surface 15 increases in the transverse direction from the center region 151 of the first surface 15 towards the first side 13 of the substrate 10. The curvature of the first surface 15 also increases in the longitudinal direction from the center region 151 towards the second side 14 of the substrate 10. The curvature of the first surface 15 of the substrate 10 causes the thickness of the substrate 10 to gradually decrease from the center region of the substrate 10 towards the ends and sides of the substrate 10.

[0120] In this embodiment, the curvature of the first surface 15 varies in a stepwise manner, but in an alternative embodiment, a continuous variation can be provided. By gradually increasing the curvature, the first surface 15 has discrete regions, each with a constant radius of curvature, but the radii of curvature of the regions are different from each other. Specifically, in embodiments of the invention, at least three curved regions are provided: a central region 151, a first outer region 152, and a second outer region 153, wherein the first outer region 152 is located between the central region 151 and the second outer region 153. The central region 151 has a first radius of curvature R1, the first outer region 152 has a second radius of curvature R2, and the second outer region 153 has a third radius of curvature R3, where R1 > R2 > R3.

[0121] The curvature of any one or more of the curved regions 151, 152, and 153 may be partially spherical. In this embodiment, the curvature at the central region 151 is partially spherical and substantially follows the spherical curvature of the eye. The first surface 15 is configured to abut against the inner side of the sclera. When the implanted device 1 is in the implantation position between the sclera and choroid, the relatively low partially spherical curvature of at least the central region 151 of the first surface 15 reduces the amount of static pressure applied to the sclera. However, the relatively high curvature of the outer regions 152 and 153 of the first surface can facilitate the insertion of the substrate 10 between the tissue layers of the eye. The substrate 10 can be pushed into the appropriate position between the tissue layers, thereby separating the tissue layers. The relatively high curvature helps to separate the tissue layers, essentially opening the pocket through which the implanted device is located. The curvature of the substrate 10 can reduce surgical placement and force. Furthermore, the curvature can help support the incision 50 in the eye 5 through which the implanted device 1 is inserted into the eye 5.

[0122] refer to Figure 4a and Figure 4b Lead 3 is arranged to extend from the implanted device 1, through an incision in the sclera 51 of the eye 5, extend from the eye 5 to the adjacent orbital bone 61, surround the orbital bone 61, and extend along the side of the patient's skull 62 to a communication interface (in this embodiment, an implanted stimulator 63). Return electrode 64 is connected to stimulator 63. The communication interface allows for connection between the implanted device and electronic components such as signal generators, signal monitors, etc.

[0123] Also refer to Figure 5 The lead 3 includes a first lead segment 31 and a second lead segment 32, which are located outside the eye when the implantable device 1 is implanted in place. The second lead segment 32 is configured to extend around the orbital bone 61, and the first lead segment 31 is configured to be located between the implantable device 1 and the second lead segment 32. In this embodiment, the first lead segment 31 has a pre-formed bend, and specifically, a pre-formed U-shaped bend. The pre-formed bend provides approximately 180 degrees of lead direction change at the first lead segment, but other angles may also be used. The radius of the pre-formed bend is approximately 1.5 mm to 3 mm, but other radii may be used. Furthermore, more than one pre-formed bend may be provided at the first lead segment 31.

[0124] like Figure 4a As shown, when the implantable device is implanted into the eye, the pre-formed bend of the first lead segment 31 bends in the rearward direction. Therefore, the ends 311, 313 of the U-shaped bend are located in front of the middle segment 312 of the U-shape.

[0125] The first lead segment 31 is flexible and has a length greater than the distance between the eye 5 and the orbital bone 61, and more specifically, has a length greater than the distance between the incision 50 of the eye 5 and a point on the orbital bone 61 from which the lead 3 leaves the eye when the eye is in an anterior position, and contacts the point as the lead 3 extends around the orbital bone 61.

[0126] During use of the device, the eye 5 can rotate. To allow the eye 5 to rotate relatively unimpeded when the implantable device 1 is implanted in the eye 5, the lead wire flexes and moves. Without flexion and movement of the lead wire 3, the lead wire 3 will impede or prevent movement of the eye 5 in one or more rotational directions. Essentially, it can fix the position of the eye 5 relative to the orbital bone 61. By providing a flexible first lead wire segment 31 with a length greater than the distance between the eye 5 and the orbital bone 61, the eye can move substantially in all rotational directions. When the eye rotates, depending on the direction of rotation, the area of ​​the first lead wire segment 31 either folds together (accordion fold) or extends apart (straightens). By providing a pre-formed bend to the first lead wire segment 31, the force required for the accordion folding or straightening of the first lead wire segment 31 is significantly reduced, reducing patient discomfort and / or potential eye injury.

[0127] In an embodiment of the invention, the pre-formed bend of the first lead segment 31 is formed after the first lead segment 31 has been molded. The first lead segment 31 includes a conductor 33 embedded in a surrounding sheath. The sheath is formed of silicone resin or other polymeric material such as polyurethane that cures during molding. The pre-formed bend is formed using a post-curing technique and specifically by rolling or holding the first lead segment around a bent or angled surface while subjecting it to heating for a period of time. In this embodiment, the bent or angled surface is at least partially cylindrical and has a radius of curvature of about 1.5 mm to 3 mm. Heating is performed at a temperature of about 135°C for about 120 minutes, but other curvatures, temperatures, and timings may be used.

[0128] In an embodiment of the invention, the second lead segment 32 includes a reinforcing device 4 that provides a thickening to the second lead segment. The reinforcing device 4 guides the lead to the orbital bone 61 around the eye socket, such as... Figure 4a and Figure 4b As shown, it also provides protection for the leads and their conductors to prevent high stress in this area. The reinforcing device 4 has a bending region 402, a first segment 401 on the implantable device side of the bending region 402, and a second segment 403 on the communication interface side of the bending region 402.

[0129] The reinforcing device 4 is arranged to attach to the orbital bone 61. For example, the reinforcing device may be located in a notch formed in the orbital bone 61 to aid in attachment to the orbital bone 61. The notch may include a groove and an inlet for receiving the reinforcing device 4, through which the reinforcing device 4 may be positioned in the groove. The inlet may be narrower than the groove. The reinforcing device may be squeezed through the inlet into the groove, in which the reinforcing device is substantially fixed in place at the appropriate position on the orbital bone. The point where the guide wire extends around the orbital bone 61 (where the notch is located) is above a transverse plane extending through the center of the eye. In the posterior direction, the groove of the notch is inclined upward at approximately 15 degrees.

[0130] In this embodiment, the reinforcing device 4 is integrally formed with the second lead segment 32, for example by molding or other means, but in alternative embodiments it may be a discrete component. For example, in an alternative embodiment, the reinforcing device may be clamped and / or glued to a suitable position on the second lead segment 32.

[0131] The second lead segment 32 and the reinforcing device 4 at the second lead segment 32 have at least one pre-formed bend, which is configured to conform to the angle of the orbital bone 61, thereby guiding the second lead segment 32 around the orbital bone 61. The pre-formed bend at the second lead segment 32 is formed by a post-curing technique, for example, in the same manner as the pre-formed bend of the first lead segment 31.

[0132] The angle of the pre-formed bend in the second lead segment 32 is smaller than the angle of the pre-formed bend in the first lead segment 31. Specifically, the pre-formed bend in the second lead segment 32 is a V-shaped bend. Combined, the bends at the first lead segment 31 and the second lead segment 32 provide an S-shaped configuration for the lead 3 or more specifically a 2-shaped configuration (i.e., a shape substantially similar to the number 2). The bends at the first lead segment and the second lead segment bend in opposite directions. As described above, the bend at the first lead segment 31 bends in the rearward direction, and the bend at the second lead segment 32 bends in the forward direction.

[0133] refer to Figure 5 The lead 3 has one or more strips 331, 332 extending along it. The one or more strips 331, 332 assist in the placement of the lead 3 during implantation of the implantable device 1. Specifically, strip 331 provides the surgeon implanting the device with a visual indication of whether the lead 3 is twisted. Figure 5As shown, one or more strips 331, 332 extend at least along the first lead segment, but they may extend along the entire length of the lead 3. Strips 331, 332 may be formed of a titanium dioxide layer or other material having a contrasting color to the adjacent portion of the lead. Two strips 331, 332 may be provided, each strip 331, 332 located on substantially opposite sides of the lead 3.

[0134] As described above, the electrical device includes an anchoring device 2. The anchoring device 2 is provided to anchor the lead 3 to the outer surface of the eye 5, at or near a cutout 50 in the eye 5 through which the lead 3 extends, and to position the lead 3 away from the eye wiring. The anchoring device 2 is flexible and formed of a polymeric material such as medical-grade silicone or polyurethane, with reinforcing elements such as meshes, for example, polyethylene terephthalate mesh (Dacron), embedded in one or more portions thereof. TM (Mesh). The anchoring device 2 is in the form of a patch or flap with a pre-formed shape (e.g., channel 23), which is adapted to receive a portion of the lead 3 when the lead 3 is secured to the outer surface of the eye 5.

[0135] The anchoring device 2 includes a proximal end portion 21 fixed to the lead wire 3 and a distal end portion 22 connected to the proximal end portion. Before implantation of the implantable device 1, for example during manufacturing, the anchoring device 2 is releasably fixed in a folded configuration, wherein the distal end portion 22 protrudes toward the proximal end portion 21, as... Figure 6a As shown. The anchoring device 2 can be releasably secured in a folded configuration by providing at least one suture 241 to suture the distal end portion 22 to the proximal end portion 21, but other releasable securing methods, such as adhesives, may also be used.

[0136] When the anchoring device 2 is in the folded configuration, the proximal end portion 21 can be fixed to the outer surface of the eye 5, for example, using one or more sutures 242.

[0137] By releasably securing the anchoring device 2 in a folded configuration, the distal end portion 22 of the anchoring device 2 can be temporarily held away from the incision 50 in the outer surface of the eye 5 through which the lead 3 exits the eye. Therefore, the distal end portion 22 does not obstruct or hinder access to the incision 50 in the outer surface of the eye 5. By maintaining this access to the incision 50, the suture 243 can be more easily applied to the incision 50 in the outer surface of the eye 5, for example, to suture the incision 50 (see...). Figure 6b This allows for easier application of additional treatments at or near the incision site. Once these steps are completed, the sutures 241 securing the distal end portion 22 to the proximal end portion 21 can be released, thus allowing the distal end portion 22 to protrude automatically or by manipulation away from the proximal end portion 21 (see [link to original text]). Figure 6cThe distal end portion 22 can then at least partially cover the cut 50 on the outer surface of the eye 5. Generally, the anchoring device 2 can extend above the lead 3 and cover at least a portion or all of the cut 50 in the outer surface of the eye 5.

[0138] The proximal end portion 21 and / or distal end portion 22 of the anchoring device 2 can be secured to the outer surface of the eye 5 using one or more sutures 242, 244 or other fixation methods. In some embodiments, alternatively or additionally, one or more sides of the anchoring device 2 can be secured to the outer surface of the eye 5 using one or more sutures or other fixation methods.

[0139] refer to Figure 11a , Figure 11b , Figure 12a and Figure 12b Any anchoring device 2', 2'" according to this disclosure, whether folded or otherwise constructed, may include one or more recesses 25', 25'", each recess configured to receive a corresponding suture knot 246', 246'" for securing the device to the surface of the eye 5. The recesses 25', 25'" may be discrete recesses as shown, or otherwise connected together. For example, in Figure 11a and Figure 11b In one embodiment, the recesses 25' are all configured as recessed portions on the top surface of the anchoring device 2', for example, on the side of the anchoring device 2'. In an alternative embodiment, such as Figure 12a and Figure 12b As shown, a recess 25” is provided on the underside of the anchoring device 2”, for example, on the side of the anchoring device 2”, to form a pocket between the anchoring device 2” and the outer surface of the eye 5. In use, once each suture 242', 242” is knotted, the suture can be rotated to position the suture knots 246', 246” in the corresponding recesses 25', 25”. Figure 11a and Figure 11b In one implementation, the suture knot 246' can be pulled through the material of the anchoring device to approach the bag.

[0140] Generally, when fixed to the outer surface of the eye 5, the anchoring devices 2, 2', 2" provide support and stability for the lead wire as it extends from the cutout 50 in the outer surface of the eye 5. Furthermore, the anchoring devices shield the cutout 50 in the outer surface of the eye 5. The anchoring device 2 also serves to direct the lead wire 3 away from the anchoring device 2 and the eye 5 wiring in an appropriate direction, for example, passing through the extraocular muscles of the eye and towards the lateral orbital rim. To achieve this wiring, the lead wire 3 at the anchoring device follows a tortuous path.

[0141] As described above, the implantable device 1 according to this disclosure includes a substrate 10 and electrodes 17 partially embedded in the substrate 10. The substrate 10 is primarily formed of a first non-conductive material; and the electrodes are formed of a second conductive material. Reference will now be made to... Figures 7a to 7d As described, each electrode 17 includes a hole 171 through which a first material of the substrate 10 extends at least partially to anchor the electrode 17 to the substrate 10.

[0142] Each electrode 17 is substantially flat and has a first surface 172 and an opposing second surface. Each electrode 17 has a disk shape. The first surface 172 of the electrode faces away from the substrate 10 and is partially exposed from the substrate 10 to achieve electrical contact with the tissue of the eye 5. The second surface of the electrode 17 is embedded within the substrate 10 and is specifically a first non-conductive material of the substrate 10. Each hole 171 of the electrode 17 has an open end at the first and second surfaces of the electrode 17.

[0143] In this embodiment, a plurality of holes 171 are disposed in each electrode 17, near the outer peripheral edge of the electrode 17. The holes 171 are evenly spaced and positioned in a ring pattern near the outer peripheral edge of the electrode 17, and positioned within 10% or 15% of the outer diameter of the electrode 17. The diameter of each hole 171 is less than 15% of the diameter of the electrode 17. For example, each hole may have a diameter between 100 μm and 800 μm. Each hole may be circular, but other hole shapes may also be used.

[0144] The first non-conductive material is a flowable polymer, such as a silicone elastomer or polyurethane that cures during manufacturing to form the substrate 10. When in a flowable state and before solidification, the first material can flow into each hole 171 to fill the hole, typically as follows: Figure 7d As indicated by arrow 102. The first material can extend out of the hole 171 through the open end of the hole 171, so that the first material can extend laterally across the surface of the electrode 17 to the hole 171. The first material can be formed into a continuous loop that extends through each hole 171 and around the outer periphery of the electrode 17, and through the other holes 171. Thus, each electrode 17 is secured between portions of the first material, which helps to anchor the electrode 17 to the substrate 10.

[0145] like Figure 7b and Figure 7d As shown, substrate 10 provides a lip 101 of a first material that extends around the outer periphery of a first surface 172 of each electrode 17 to help anchor the electrode 17 to the substrate, while exposing a central region 173 of the first surface 172 of each electrode 17. In this embodiment, the first material extends through a hole 171 beneath the lip 101. Therefore, the hole 171 enhances the function of the lip 101 in helping to anchor the electrode 17 to substrate 10.

[0146] In addition to providing a hole 171 extending between the first and second opposing surfaces of the electrode 17, or alternatively, at least one hole may be defined by a protrusion on the second surface of the electrode. For example, see reference... Figures 8a to 8c The second surface 1701 of the electrode 1700 may include protrusions such as rings, handles, and / or clamps 1702, the centers of which provide a hole 1703 through which the first material of the substrate 10 extends. The second surface 1701 of the electrode 170 is embedded within the substrate. By providing protrusions 1702 at the second surface defining the hole 1703, when the second surface is embedded within the substrate during the manufacture of the device, for example, when the first material of the substrate is in a flowable state as described above, the first material of the substrate can extend through the hole 1703. In some embodiments, such as Figures 9a to 9c As shown, multiple protrusions 1702 may be provided, each protrusion defining at least one hole 1703. (Reference) Figure 10 Multiple protrusions 1702 can be provided on relatively large electrodes, such as on current return electrode 17a, while single (or fewer) protrusions 1702 can be provided on relatively small electrodes, such as on stimulation electrode 17b. Since electrodes near the outer edge of the substrate may be more prone to misalignment or popping out of the substrate, protrusions 1702 can be provided only to the outer electrode 17b to help anchor electrode 17b to substrate 10.

[0147] The implantable device disclosed herein includes multiple electrodes that can be used to electrically stimulate the eye. In some embodiments, current can be applied to multiple electrodes simultaneously. For example, Figure 1 The two or more electrodes 17 shown can be electrically grouped. Current can be applied to the electrodes in the group simultaneously. The electrodes in the group can be electrically addressed in parallel or combined together. Simultaneous addressing of the electrodes 17 can provide increased penetration of the electric field into the tissue, resulting in better efficiency. Furthermore, power loss can be reduced due to lower impedance and lower charge required per electrode.

[0148] Those skilled in the art will understand that numerous variations and / or modifications can be made to the above embodiments without departing from the broad general scope of this disclosure. Therefore, embodiments of the invention are to be considered illustrative rather than restrictive in all respects.

Claims

1. An electrical device for stimulating and / or monitoring a patient's eye, said electrical device comprising: An implantable device comprising one or more electrodes, the implantable device being implanted at a stimulation and / or monitoring location between a first and a second tissue layer of the eye; Leads, the leads including one or more conductors connected to the electrodes, the leads extending outward from the implanted device; The lead includes a first lead segment and a second lead segment located outside the eye when the implanted device is in the stimulation and / or monitoring position, the second lead segment being configured to extend around the orbital bone near the eye, and the first lead segment being positioned between the implanted device and the second lead segment. The first lead segment is flexible and has at least one pre-formed bend, wherein the at least one pre-formed bend provides at least a 90-degree change in the direction of the lead at the first lead segment, wherein the first lead segment is configured to have a length greater than the distance between the eye and the orbital bone, and wherein the first lead segment, including the at least one pre-formed bend, is configured to flex when the eye moves in one or more rotational directions, such that the movement of the eye is relatively unimpeded by the first lead segment.

2. The device of claim 1, wherein the at least one preformed bend provides a change in the orientation of the lead of at least 120 degrees or at least 150 degrees at the first lead segment.

3. The device of claim 1 or 2, wherein the at least one preformed bend provides a change in the orientation of the lead wire by about 180 degrees.

4. The device as claimed in claim 1 or 2, wherein the at least one preformed bending portion is a U-shaped bending portion.

5. The device of claim 1 or 2, wherein the device includes a reinforcing device adapted to be positioned at or near the orbital bone.

6. The device of claim 5, wherein the reinforcing device provides thickening of the second lead segment.

7. The device of claim 5, wherein the reinforcing device is integrally formed with or attached to the second lead segment.

8. The device of claim 1 or 2, wherein the second lead segment includes at least one pre-formed bend.

9. The device of claim 8, wherein the at least one preformed bend of the second lead segment is configured to conform to the edge of the orbital bone and bend around the edge of the orbital bone.

10. The device of claim 8, wherein the at least one preformed bend of the first lead segment is bent in a direction substantially opposite to the at least one preformed bend of the second lead segment.

11. The device of claim 8, wherein the at least one pre-formed bend in the first lead segment and the at least one pre-formed bend in the second lead segment provide an S-shaped or "2"-shaped configuration for the lead.

12. The device of claim 1 or 2, wherein the first tissue layer and the second tissue layer are the sclera and the choroid.

13. The device of claim 1 or 2, wherein at least the first lead segment of the lead comprises one or more strips.

14. The device of claim 13, wherein the device comprises at least two strips, each strip being located on substantially opposite sides of the lead.

15. The device of claim 1 or 2, wherein the implantable device includes a substrate, and the one or more electrodes are at least partially embedded in the substrate.

16. The device of claim 15, wherein the substrate comprises a first non-conductive material, and the at least one electrode comprises a second conductive material, and wherein one or more of the electrodes comprises at least one hole, the first material of the substrate extending at least partially through the at least one hole to anchor the electrode to the substrate.

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