Flexible ring electrode and ophthalmic device

The flexible ring electrode addresses the limitations of existing devices by enabling precise and sustained measurement and stimulation of ciliary muscle bioelectrical signals, enhancing diagnostic and therapeutic capabilities.

DE102024116619B3Active Publication Date: 2025-10-02HOCHSCHULE FURTWANGEN KOERPERSCHAFT DES OEFFENTLICHEN RECHTS
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Patent Information

Application Number
DE102024116619
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2024-06-13
Publication Date
2025-10-02
Estimated Expiration
2044-06-13

AI Technical Summary

Technical Problem

Existing ophthalmic devices for measuring and stimulating ciliary muscle bioelectrical signals are invasive, require lens replacement, or suffer from interference and poor contact, limiting their diagnostic and therapeutic effectiveness.

Method used

A flexible ring electrode implanted in the eye with electrodes on inner and outer surfaces, allowing for precise measurement and stimulation of ciliary muscle bioelectrical signals, compatible with or without an intraocular lens, reducing interference and enabling long-term use.

Benefits of technology

The flexible ring electrode provides accurate and sustained measurement and stimulation of ciliary muscle signals for both diagnostic and therapeutic purposes, minimizing interference and maintaining contact over a prolonged period.

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Abstract

The invention relates to a flexible ring electrode (10) for implantation into an eye (104), comprising a main body (12), a first electrode (14), and a second electrode (16), wherein the main body (12) is arcuate and has an inner surface (18) directed towards the center of the main body (12) and an outer surface (20) facing away from the center of the main body (12). The first electrode (14) extends along at least a portion of the inner surface (18) of the main body (12) and is fastened to the inner surface (18) of the main body (12). The second electrode (16) extends along at least a portion of the outer surface (20) of the main body (12) and is fastened to the outer surface (20) of the main body (12).
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Description

TECHNICAL FIELD

[0001] The invention relates to the medical field of ophthalmology. In particular, the invention relates to a flexible ring electrode and an ophthalmic device comprising such a flexible ring electrode. BACKGROUND

[0002] An eye enables the visual perception of a physical environment. Incoming light is projected onto the retina by a natural lens, where it is translated by photoreceptor cells into an electrical signal, which is then transmitted to the brain via nerve cells.

[0003] The human eye has the ability to accommodate, allowing it to see objects at different distances clearly. Accommodation occurs through the contraction or relaxation of the ciliary muscle, which extends in a ring around the lens of the eye and is connected to the lens by zonular fibers. The latter transmit movements of the ciliary muscle to the elastic lens, which deforms accordingly, changing the refractive power of the lens and allowing objects near or far to be seen clearly.

[0004] With age or due to disease, the ability to accommodate can decline. For example, the lens may lose elasticity (so-called presbyopia) and / or the ciliary muscle and / or zonular fibers may undergo degenerative changes. As a result, the lens can no longer deform sufficiently to see objects at different distances clearly.

[0005] For treatment, the eye's lens can be replaced with an artificial lens, a so-called intraocular lens (IOL), whereby only the capsular bag, i.e., the shell of the lens, remains in the eye. IOLs are generally hardly deformable. However, accommodation can be achieved by moving the IOL or by providing limited elasticity.

[0006] In cases of traumatic, surgical, or degenerative zonular weakness, a capsular tension ring can be used. This is usually inserted into the anterior chamber, rarely into the sulcus, so that it exerts radial pressure on the ciliary muscle, stretching it. This stretching is transferred to the lens or capsular bag, stabilizing it. Often, the IOL and capsular tension ring are inserted together.

[0007] Measuring the muscular bioelectrical signals of the ciliary muscle or the neural bioelectrical signals controlling it is of interest both therapeutically and diagnostically. With this data, diagnoses can be made regarding the presence and type of dysfunction or damage to the eye. The data can also be used for artificial accommodation or to support natural accommodation. The latter is conceivable with electrical stimulation of the ciliary muscle.

[0008] EP3773191A1 and EP3692949A1 disclose ophthalmological devices comprising electromyographic sensors that detect and record bioelectrical signals from the ciliary muscle. WO 2006 / 125556 A1 discloses an intraocular lens implanted in the capsular bag of an eye, the refractive power of which can be varied by applying a voltage using electrodes. US 2022 / 0176123 A1 discloses an electrode arrangement implanted in the suprachoroidal space of the eye for therapeutic electrical stimulation of the eye.

[0009] DE10155345A1 discloses a holder for an intraocular lens (IOL) with a receiving structure that surrounds the IOL in a ring-like manner at its peripheral edge and is connected to at least two separate electrode structures. The electrodes are attached to the outer surface and contact the ciliary muscle mechanically and electrically. Bioelectrical signals from the ciliary muscle can be derived or measured via the electrodes. A control unit processes these signals to instruct another technical structure to initiate appropriate accommodation.

[0010] Such devices can only be used therapeutically, usually after implantation of an IOL. Diagnostic use is of little use, since the lens must be replaced.

[0011] Contact lens electrodes and needle electrodes are also state-of-the-art diagnostic devices for measuring bioelectrical signals in the ciliary muscle. Measurements using contact lens electrodes are often distorted by surrounding muscle, poor electrical contact, or poor centration. Needle electrodes are invasive and can only be used temporarily.

[0012] It is an object of the present invention to eliminate the aforementioned disadvantages of the prior art by providing a device which enables the measurement of bioelectrical signals at the ciliary muscle and / or the electrical stimulation of the ciliary muscle for both therapeutic and diagnostic purposes. SUMMARY OF THE INVENTION

[0013] According to the invention, the object is achieved by providing a flexible ring electrode for implantation in an eye, comprising a main body, a first electrode and a second electrode, wherein the main body is arcuate and has an inner surface directed towards the center of the main body and an outer surface facing away from the center of the main body, and wherein the first electrode extends along at least a part of the inner surface and is fastened to the inner surface and wherein the second electrode extends along at least a part of the outer surface and is fastened to the outer surface.

[0014] The flexible ring electrode according to the invention advantageously enables the measurement of bioelectrical signals as close as possible to the ciliary muscle. This makes the measurement less susceptible to interference from other bioelectrical signals from surrounding muscles or nerves. Furthermore, the combination of a flexible ring electrode, the use of which does not necessarily require an IOL and which can easily remain in the eye for an extended period, enables measurement or stimulation over an extended period and for theragnostic purposes, i.e., both diagnostic and therapeutic purposes, or possibly both simultaneously.

[0015] The problem is completely solved by the present invention.

[0016] In a preferred embodiment, the main body is C-shaped.

[0017] This advantageously allows for the measurement of bioelectrical signals or stimulation of the ciliary muscle over a significant portion of its circumference. Furthermore, the flexible ring electrode can be used, if necessary or desired, to tension or stretch the ciliary muscle and / or the zonular fibers according to a capsular tension ring.

[0018] In a preferred embodiment, the first electrode and / or the second electrode are arc-shaped.

[0019] This advantageously allows the electrodes to conform to the shape of the main body, which reduces the risk of injury and increases the contact area between the electrodes and the ciliary muscle and adjacent tissue.

[0020] In a preferred embodiment, the main body is circularly arc-shaped, the center of the main body is located in the center point of the main body and a central angle α of the main body is at least 250°, preferably at least 270°, more preferably at least 320°.

[0021] A circular arc is to be understood as part of a circular line.

[0022] As is known to those skilled in the art, a central angle is an angle whose vertex lies at the center of a circle and which lies between two line segments which each connect the center of the circle to a point on the circumference of the circle.

[0023] Such a central angle of the main body advantageously allows the measurement of bioelectrical signals or stimulation of the ciliary muscle over a significant portion of the circumference of the ciliary muscle.

[0024] In a preferred embodiment, the first electrode extends along a part of at least 80% of the inner surface of the main body and the second electrode extends along a part of at least 80% of the outer surface of the main body.

[0025] This enables the uniform measurement of bioelectrical signals or stimulation of the ciliary muscle over a significant portion of its circumference. It also advantageously ensures a sufficiently large contact area between the electrodes and the ciliary muscle or adjacent tissue.

[0026] In a preferred embodiment in which the main body is circularly arc-shaped and the center of the main body is located at the center of the main body, the first electrode extends along a part of the inner surface of the main body with a central angle of at least 80% of the central angle α and the second electrode extends along a part of the outer surface of the main body with a central angle of at least 80% of the central angle α.

[0027] In a preferred embodiment, the first electrode extends along the entire inner surface of the main body and the second electrode extends along the entire outer surface of the main body.

[0028] This advantageously maximizes the contact area between the electrodes and the ciliary muscle or adjacent tissue.

[0029] In a preferred embodiment, the second electrode extends along the same part of the main body along which the first electrode extends.

[0030] This advantageously allows a uniform measurement or stimulation by means of the first electrode and / or second electrode along the circumference of the lens.

[0031] In a preferred embodiment, the first electrode and / or the second electrode comprise a conductive material containing, for example, gold or an electrically conductive polymer. Preferably, the first electrode and / or the second electrode consist of a conductive material containing gold.

[0032] The first electrode is attached to the inner surface of the main body, and the second electrode is attached to the outer surface of the main body. The attachment of the first electrode to the inner surface of the main body and / or the attachment of the second electrode to the outer surface of the main body can be achieved by gluing, clamping, or interlocking the main body and the first or second electrode, or by coating the main body with the first and / or second electrodes, or with a conductive material that includes the first and second electrodes, or from which the first and second electrodes are made.

[0033] In a preferred embodiment, the main body is coated with the first electrode on the inner surface of the main body and / or coated with the second electrode on the outer surface of the main body. This is to be understood as meaning that the inner surface of the main body is coated with a conductive material that forms the first electrode and / or the outer surface of the main body is coated with a conductive material that forms the second electrode.

[0034] In a preferred embodiment, the main body has at least one opening, wherein the at least one opening is arranged between the inner surface of the main body and the outer surface of the main body and extends completely through the main body.

[0035] The at least one opening reduces the mass of the flexible ring electrode and its stiffness, which is advantageous for the implantation process because the flexible ring electrode gains flexibility and is compressible or foldable.

[0036] In a preferred embodiment, no opening opens onto a part of the inner surface of the main body or the outer surface of the main body to which the first electrode or the second electrode is attached. In other words, the inner surface and / or the outer surface are preferably both free of openings, i.e., they are closed.

[0037] This is advantageous because it does not reduce the contact area between the electrodes and the ciliary muscle or adjacent tissue.

[0038] In a preferred embodiment, the main body has a rectangular cross-section.

[0039] In a preferred embodiment, two opposite sides of the rectangular cross-section form the inner surface of the main body and the outer surface of the main body.

[0040] This advantageously allows the first electrode and the second electrode to be flat and at a uniform, defined distance from each other, which enables uniform bipolar measurements.

[0041] In a preferred embodiment, the rectangular cross-section has a long side and a short side, wherein the long side is longer than the short side, preferably 2 to 8 times as long, more preferably 2 to 6 times as long, most preferably 3 to 5 times as long.

[0042] This advantageously allows increased radial stability of the flexible ring electrode.

[0043] In a preferred embodiment, the inner surface of the main body and the outer surface of the main body are each formed by a short side of the rectangular cross-section.

[0044] Advantageously, in relation to the dimensions of the flexible ring electrode, the greatest possible distance between the first electrode and the second electrode is ensured while at the same time the overall height of the flexible ring electrode is low.

[0045] In a preferred embodiment, the main body has a fenestration area in which at least two first openings are arranged.

[0046] A volume enclosed by the at least two first openings corresponds to a substantial proportion of the volume of the fenestration area, preferably from 50% to 95%, particularly preferably from 70% to 95%, most preferably from 90% to 95%.

[0047] This advantageously saves material and weight and is advantageous with regard to the implantation process, since the flexible ring electrode thus gains flexibility, i.e. becomes more easily deformable.

[0048] In a preferred embodiment, the at least two first openings are arranged regularly and in an arc along the main body.

[0049] This enables a largely uniform radial stability of the flexible ring electrode.

[0050] In a preferred embodiment, the fenestration region extends along a part of at least 80% of the main body.

[0051] This is advantageous because it maximizes flexibility and material savings due to the at least two first openings while maintaining sufficient stability of the flexible ring electrode.

[0052] In a preferred embodiment in which the main body is circularly arc-shaped and the center of the main body is located at the center point of the main body, the fenestration region extends along a part of the main body with a central angle of at least 80% of the central angle α of the main body.

[0053] In a preferred embodiment, the main body has a contacting region in which at least one opening group is arranged with a second opening for attaching a signal cable that electrically contacts the first electrode or the second electrode, and at least one third opening for strain relief of the signal cable, wherein all openings of an opening group are configured to enclose different regions of a single signal cable.

[0054] The second opening for attaching a signal cable that electrically contacts the first electrode or the second electrode is preferably configured such that a signal cable passing through the second opening at least once can be wound around the first electrode and a part of the main body that lies between the second opening and the first electrode, or the second electrode and a part of the main body that lies between the second opening and the second electrode, wherein the signal cable electrically contacts the wound electrode.

[0055] Such a second opening is advantageous because it allows a stable electrical connection to be established between the first electrode or second electrode and the signal cable, and it provides a certain degree of fastening.

[0056] The at least one third opening for strain relief of the signal cable is configured such that the signal cable attached to the second opening also passes through this at least one third opening, preferably only once.

[0057] Such a third opening advantageously reduces the risk that the signal cable attached to the second opening becomes detached from the flexible ring electrode, e.g. due to tensile forces acting on the signal cable and / or the flexible ring electrode.

[0058] In a preferred embodiment, the main body has a single contacting area.

[0059] This advantageously leads to a concentration of the at least one opening group in a defined area of ​​the flexible ring electrode. Concentrating all opening groups in one contacting area advantageously facilitates handling of the flexible ring electrode when at least two opening groups are provided, since each signal cable to which the first opening of an opening group is configured to be connected is thus secured in a defined area of ​​the flexible ring electrode, enabling a more compact spatial arrangement of the signal cables.

[0060] In a preferred embodiment, the contacting area is formed at the end of the main body.

[0061] Advantageously, such positioning of the contact area facilitates implantation. Another advantage is that the stability of the contact area of ​​the flexible ring electrode is increased at the same time.

[0062] In a preferred embodiment, the contacting region extends along a part of the main body of at most 20% of the main body, preferably at most 15%, more preferably at most 10%.

[0063] Such a limited extension of the contacting area advantageously leads to a more compact spatial arrangement if at least two opening groups are provided, since signal cables which an opening group is configured to enclose are thus located closer to one another.

[0064] In a preferred embodiment in which the main body is circularly arc-shaped and the center of the main body is located in the center of the main body, the contacting region extends along a part of the main body with a central angle of at most 20% of the central angle α of the main body, preferably at most 15%, more preferably at most 10%.

[0065] In another aspect of the present invention, the object is achieved by an ophthalmological device for implantation into an eye socket, comprising a flexible ring electrode according to the invention.

[0066] The ophthalmic device is configured to be implanted into an eye socket. This does not preclude the ophthalmic device from being configured to be partially or completely implanted into an eye located in an eye socket.

[0067] In a preferred embodiment, the ophthalmological device comprises a power source, a control unit, a wireless data interface and at least one signal cable, wherein the at least one signal cable electrically connects the first electrode and the second electrode to the control unit, and wherein the first electrode and the second electrode are each connected to the control unit by no more than one signal cable.

[0068] The energy source supplies the ophthalmic device with the energy necessary for its operation and is electrically connected to at least the control unit. The energy source can be a rechargeable battery, which can preferably be charged inductively. An inductively charged rechargeable battery advantageously allows repeated surgical interventions for replacing or recharging the energy source to be avoided.

[0069] The control unit is suitable for receiving and recording and / or evaluating electrical signals and / or converting them into a data set, which are transmitted to the control unit via the first electrode and / or the second electrode and the at least one signal cable electrically connected to them. Additionally, the control unit can be suitable for generating electrical signals and transmitting them to the ciliary muscle via the first electrode and / or the second electrode and the at least one signal cable electrically connected to them. The control unit can be a microelectronic assembly having a processor (CPU).

[0070] The wireless data interface advantageously enables the sending of data sets generated by the control unit to an external entity and / or the receiving of data sets from an external entity. The external entity can be, for example, a computer or a mobile phone. The wireless data interface can be a Bluetooth device.

[0071] In a preferred embodiment, the ophthalmic device further comprises a reed switch. The reed switch can preferably be connected between the energy source and the other components of the ophthalmic device. Advantageously, the reed switch facilitates the handling of the ophthalmic device with an energy source that is an accumulator or a battery, since more time is available for sterilization and other preparatory steps before implantation without the energy source, i.e. the accumulator or the battery, losing any operating time. In addition, the reed switch makes it possible to electrically connect the energy source to the other components of the ophthalmic device only when necessary, so that the operating time of the energy source is preserved even after implantation, wear on the energy source is minimized and the service life of the ophthalmic device is thus increased.

[0072] In a preferred embodiment, the ophthalmic device comprises a flexible ring electrode having a first opening group, a second opening group, a first signal cable having a first uninsulated end and a first insulated portion, and a second signal cable having a second uninsulated end and a second insulated portion, wherein the first uninsulated end extends through the second opening of the first opening group and electrically contacts the first electrode and the first insulated section extends through the at least one third opening of the first opening group, and the second uninsulated end extends through the second opening of the second opening group and electrically contacts the second electrode and the second insulated section extends through the at least one third opening of the second opening group.

[0073] Running the first signal cable through the at least one third opening of the first opening group is advantageous because it minimizes the effect of potential tensile forces to which the first signal cable and / or the flexible ring electrode is exposed on the first uninsulated end and the point where it electrically contacts the first electrode. The same applies to running the second signal cable through the at least one third opening of the second opening group.

[0074] In a preferred embodiment, the first insulated end is wound at least once, preferably three times, around the first electrode and a part of the main body located between the first electrode and the second opening of the first opening group, and the second insulated end is wound at least once, preferably three times, around the second electrode and a part of the main body located between the second electrode and the second opening of the second opening group.

[0075] This advantageously contributes to the attachment of an insulated end to an electrode and to the electrical contacting of an electrode by a signal cable.

[0076] In a preferred embodiment, the first opening group has at least two third openings and the second opening group has at least one third opening.

[0077] This advantageously allows for a staggered arrangement of the second openings along the flexible ring electrode while closely arranging the third openings, to which the first signal cable and the second signal cable lead from the periphery, are arranged. Any possible thickening of the surrounding tissue at the points where the first signal cable contacts the first electrode and the second signal cable contacts the second electrode is distributed along the flexible ring electrode, while the advantageous spatially close arrangement of the signal cables is achieved, and increased mobility of the first signal cable is avoided by the additional third opening of the first opening group.

[0078] In a preferred embodiment, the first uninsulated end is attached to the first electrode by means of a conductive adhesive and the second uninsulated end is attached to the second electrode by means of a conductive adhesive.

[0079] Attaching the signal cables to the electrodes with an adhesive is advantageous because it reduces the risk of a signal cable becoming detached from an electrode. Electrically conductive adhesive is advantageous because it prevents the adhesive from blocking the electrical contact between the electrode and the signal cable and also minimizes the resistance between the electrode and the signal cable.

[0080] In another aspect of the present invention, the object is achieved by a flexible ring electrode according to the invention for use in the therapy and / or diagnosis of an ophthalmological disease or malfunction.

[0081] In another aspect of the present invention, the object is achieved by a medical method for the therapy and / or diagnosis of an ophthalmological disease or malfunction, comprising implanting a flexible ring electrode according to the invention into an eye or implanting an ophthalmological device according to the invention into an eye socket.

[0082] Further advantages and features will become apparent from the following description and the accompanying drawings. It is understood that the features mentioned above and those to be explained below can be used not only in the respective combinations specified, but also in other combinations without departing from the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWING

[0083] Non-limiting embodiments are explained in detail below with reference to the drawings. The drawings show: Fig. 1 a flexible ring electrode for implantation into an eye as a top view. Fig. 2 a flexible ring electrode for implantation into an eye as a side view. Fig. 3 is a schematic representation of an ophthalmic device for implantation into an eye socket in the implanted state, showing an arrangement of the flexible ring electrode in the eye. Fig. 4 is a schematic representation of an ophthalmic device for implantation into an eye socket in the implanted state, showing an arrangement of the ophthalmic device in the eye socket. Fig. 5 is an enlarged plan view of a contacting area of ​​the flexible ring electrode of an ophthalmic device. DETAILED DESCRIPTION

[0084] Fig. 1 and Fig. 2 show a flexible ring electrode 10 for implantation into an eye. The flexible ring electrode 10 has a main body 12, a first electrode 14, and a second electrode 16.

[0085] An outer diameter of the flexible ring electrode can be 10 mm. In other preferred embodiments, the outer diameter can be from 5 mm to 15 mm, preferably from 6 mm to 12 mm, most preferably from 9 mm to 11 mm.

[0086] The main body 12 is arcuate and has an inner surface 18 directed towards the center of the main body 12 and an outer surface 20 facing away from the center of the main body 12.

[0087] The main body 12 can be circularly arc-shaped. The central angle α of the main body can be 300°. In other preferred embodiments, the central angle α of the main body can be at least 250°, preferably at least 270°, more preferably at least 320°. In other preferred embodiments, the main body 12 can be generally arc-shaped or C-shaped.

[0088] The inner surface 18 of the main body 12 may be directed toward the center of the main body 12. In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the inner surface 18 of the main body 12 may be directed toward the center of the main body 12.

[0089] The outer surface 20 of the main body 12 may face away from the center of the main body 12. In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the outer surface 20 of the main body 12 may face away from the center of the main body 12.

[0090] In another preferred embodiment, the main body 12 may include at least one opening 22. An opening 22 may be disposed between the inner surface 18 of the main body 12 and the outer surface 20 of the main body 12 and may extend completely through the main body 12.

[0091] At least one opening 22 may be substantially rectangular, arcuate, circular, rectangular, or circular, or have the shape of a right-angled trapezoid.

[0092] In other preferred embodiments, at least one opening 22 may be round or polygonal, preferably arcuate, circular, rectangular or trapezoidal.

[0093] In some embodiments, no opening 22 may open onto a portion of the inner surface 18 of the main body 12 or the outer surface 20 of the main body 12 on which the first electrode 14 or the second electrode 16 is mounted, respectively; that is, the inner surface 18 and / or the outer surface are preferably closed. In other preferred embodiments, at least one opening 22 may open onto a portion of the inner surface 18 of the main body 12 or the outer surface 20 of the main body 12 on which the first electrode 14 or the second electrode 16 is mounted.

[0094] In the illustrated embodiment, the main body 12 has a rectangular cross-section. Two opposite sides of the rectangular cross-section can form the inner surface 18 of the main body 12 and the outer surface 20 of the main body 12.

[0095] In other embodiments, the main body may have a round or polygonal cross-section, or a polygonal cross-section with rounded corners, preferably a circular, elliptical, or rectangular cross-section, or a rectangular cross-section with rounded corners. In such embodiments, two symmetrically opposite poles, sides, or ends of the cross-section, or two substantially opposite poles, sides, or ends of the cross-section, preferably form the inner surface 18 of the main body 12 and the outer surface 20 of the main body 12.

[0096] The rectangular cross-section can have a long side and a short side. The long side is longer than the short side and can be 5 times as long as the short side. In other preferred embodiments, the long side can preferably be 2 to 8 times as long, more preferably 2 to 6 times as long, most preferably 3 to 5 times as long. The short side can form the inner surface 18 of the main body 12 or the outer surface 20 of the main body 12, respectively.

[0097] The main body 12 may have a fenestration area 34.

[0098] Fourteen first openings 36 can be arranged in the fenestration area 34. In other preferred embodiments, at least two first openings 36 can be arranged in the fenestration area 34, preferably from 4 to 30, particularly preferably from 8 to 20, most preferably from 12 to 16.

[0099] A volume enclosed by the at least two first openings 36 may correspond to a substantial portion of the volume of the fenestration region 34. In other preferred embodiments, the volume enclosed by the at least two first openings 36 may correspond to 50% to 95% of the volume of the fenestration region 34, more preferably 70% to 95%, most preferably 90% to 95%.

[0100] The first openings 36 can be arranged regularly and in a circular arc along the main body 12. In other preferred embodiments, the first openings 36 can be arranged in any desired manner along the main body 12, preferably in an arcuate manner.

[0101] The first openings 36 may be identical and circular and / or substantially rectangular with rounded corners. In other preferred embodiments, at least one of the at least two first openings 36 may not be identical to at least one other first opening 36 and / or at least one of the at least two first openings 36 may be round, polygonal, or polygonal with rounded corners, preferably circular, elliptical, substantially rectangular, circular, or rectangular.

[0102] The fenestration region 34 may extend along a portion of the main body 12 with a central angle of 250°. In other preferred embodiments, the fenestration region 34 may extend along a portion of the main body 12 with a central angle of at least 80% of the central angle α of the main body 12.

[0103] In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the fenestration region 34 may extend along a portion of the main body 12 of at least 80% of the main body 12.

[0104] The main body 12 may have a single contacting area 38.

[0105] In other preferred embodiments, the main body 12 may have at least one contacting area 38, preferably not more than two.

[0106] A first opening group 24a and a second opening group 24b can be arranged in the contacting area 38. In other preferred embodiments, at least one opening group 24a, 24b can be arranged in the contacting area 38, preferably one or two opening groups 24a, 24b.

[0107] The first opening group 24a may have a second opening 26a and at least one, preferably two third openings 28a, 28b.

[0108] The second opening group 24b may have a second opening 26 and at least one third opening 28c.

[0109] Each opening group 24a, 24b has a second opening 26a, 26b and at least one third opening 28a, 28b, 28c. The second opening 26 is configured to secure a signal cable and to enclose a portion of the same signal cable. The at least one third opening 28a, 28b, 28c is configured to provide strain relief for the same signal cable and to enclose another portion of the same signal cable.

[0110] The second opening 26a, 26b may have the shape of a rectangular trapezoid. In other preferred embodiments, the second opening 26a, 26b may be round, polygonal, or polygonal with rounded corners, preferably circular, rectangular, or trapezoidal.

[0111] Each of the at least one third opening 28a, 28b, 28c may be circular. In other preferred embodiments, at least one of the at least one third opening 28a, 28b, 28c may be round, polygonal, or polygonal with rounded corners, preferably circular or rectangular.

[0112] The contacting region 38 can be formed terminally on the main body 12. In other preferred embodiments, the contacting region 38 can be formed non-terminally, ie, centrally or laterally on the main body 12.

[0113] The contacting region 38 can extend along a portion of the main body 12 with a central angle of 35°. In other preferred embodiments, the contacting region 38 can extend along a portion of the main body 12 with a central angle of at most 20% of the central angle α of the main body 12, preferably at most 15%, particularly preferably at most 10%.

[0114] In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the contacting region may extend along a part of the main body 12 of at most 20% of the main body 12, preferably at most 15%, particularly preferably at most 10%.

[0115] The first electrode 14 extends along at least a portion of the inner surface 18 of the main body 12. The first electrode 14 may extend along the entire inner surface 18 of the main body 12.

[0116] In another preferred embodiment, the first electrode 14 may extend along a portion of the inner surface 18 of the main body 12 with a central angle of at least 80% of the central angle α of the main body 12.

[0117] In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the first electrode 14 may extend along a portion of at least 80% of the inner surface 18 of the main body 12.

[0118] The first electrode 14 may be circularly arc-shaped. In other preferred embodiments, the first electrode 14 may be C-shaped or arc-shaped.

[0119] The first electrode 14 is attached to the inner surface 18 of the main body 12. The attachment can be achieved by coating the inner surface 18 of the main body 12 with a conductive material that forms the first electrode 14. In other preferred embodiments, the attachment can be achieved by gluing, clamping, or nesting the main body 12 and the first electrode 14.

[0120] The first electrode 14 may be made of a conductive material containing gold or an electrically conductive polymer.

[0121] The second electrode 16 extends along at least a portion of the outer surface 20 of the main body 12. The second electrode 16 may extend along the entire outer surface 20 of the main body 12.

[0122] The second electrode 16 may extend along the same portion of the main body 12 as the first electrode 14. In another preferred embodiment, the second electrode 16 may extend along a different portion of the main body 12 than the first electrode 14.

[0123] In another preferred embodiment, the second electrode 16 may extend along a portion of the outer surface 20 of the main body 12 with a central angle of at least 80% of the central angle α of the main body 12.

[0124] In this embodiment and other preferred embodiments in which the main body 12 is arcuate or C-shaped, the second electrode 16 may extend along a portion of at least 80% of the outer surface 20 of the main body 12.

[0125] The second electrode 16 may be circularly arc-shaped. In other preferred embodiments, the second electrode 16 may be C-shaped or arc-shaped.

[0126] The second electrode 16 is attached to the outer surface 20 of the main body 12. The attachment can be achieved by coating the outer surface 20 of the main body 12 with a conductive material that forms the second electrode 16. In other preferred embodiments, the attachment can be achieved by gluing, clamping, or nesting the main body 12 and the second electrode 16.

[0127] The conductive material of the second electrode 16 may be identical to the conductive material of the first electrode 14. In other preferred embodiments, the second electrode 16 is made of a different conductive material than the first electrode 14.

[0128] Fig. 3 and Fig. 4 shows a schematic representation of an ophthalmic device 100 for implantation into an eye socket in an implanted state.

[0129] The ophthalmic device 100 includes a flexible ring electrode 10 and may include a power source 106, a control unit 108, a wireless data interface (not shown), and a first signal cable 110 and a second signal cable 112.

[0130] The ophthalmic device 100 is configured to be implanted into an eye socket 102. The flexible ring electrode 10 is configured to be implanted into an eye 104 located in the eye socket 102. In other preferred embodiments, at least the flexible ring electrode 10, ie, possibly also the entire ophthalmic device 100, can be configured to be implanted into the eye 104.

[0131] The energy source 106 may be configured to be implanted into an eye socket 102 outside the eye 104. In other preferred embodiments, the energy source 106 may be configured to be implanted into the eye 104.

[0132] The energy source 106 can be electrically connected to the control unit 108 and, at least indirectly, via the control unit 108 to the wireless data interface. In other preferred embodiments, the energy source 106 can be directly electrically connected to the wireless data interface.

[0133] The energy source 106 can be an accumulator, which can preferably be charged inductively. In other preferred embodiments, the energy source 106 can be a battery, a solar cell, or a heat-dependent energy source.

[0134] The control unit 108 may be configured to be implanted into the eye socket 102 outside the eye 104. In other preferred embodiments, the control unit 108 may be configured to be implanted into the eye 104.

[0135] The control unit 108 can be electrically connected to the wireless data interface and to the signal cables 110, 112.

[0136] The control unit 108 may be a microelectronic assembly having a processor (CPU).

[0137] The wireless data interface may be configured to be implanted into the eye socket 102 outside the eye 104. In other preferred embodiments, the wireless data interface may be configured to be implanted into the eye 104. The wireless data interface may be a Bluetooth device.

[0138] The flexible ring electrode 10 can extend in a ring-like manner within the sulcus 114 of the eye 104 or be placed therein and contact the ciliary muscle 116 or the ciliary muscle 116 and the zonular fibers 118. When implanted, the flexible ring electrode 10 exerts a radial force on the ciliary muscle 116 and the zonular fibers 118, thus establishing and maintaining good contact with the ciliary muscle. The radial force is preferably lower than a radial force typically exerted by a capsular tension ring and is not suitable for tensioning or stretching the ciliary muscle and / or the zonular fibers.

[0139] The first signal cable 110 and the second signal cable 112 can extend from the interior of the eye 104 through an incision in the tissue of the eye 104, preferably at the limbus 122 (junction of cornea and sclera). In other preferred embodiments, in which the ophthalmic device 100 is implanted entirely within the eye 104, this is not necessary.

[0140] Fig. 5 shows an enlarged view of a contacting area 38 of a flexible ring electrode 10, which is part of an ophthalmological device 100.

[0141] The flexible ring electrode 10 may have a contacting area 38 and conductive adhesive 113.

[0142] A first opening group 24a and a second opening group 24b can be arranged in the contacting area 38.

[0143] The first opening group 24a may have a second opening 26a and at least two third openings 28a, 28b.

[0144] The second opening group 24b may have a second opening 26 and at least one third opening 28c.

[0145] The first signal cable 110 may have a first uninsulated end 128 and a first insulated portion 126.

[0146] The first uninsulated end 128 can extend through the second opening 26a of the first opening group 24a and electrically contact the first electrode 14. In this embodiment, the first signal cable 110 is the only signal cable that electrically connects the first electrode 14 and the control unit 108.

[0147] The first uninsulated end 128 may be wrapped three times around the first electrode 14 and a portion of the main body 12 located between the first electrode 14 and the second opening 26a of the first opening group 24a. In other preferred embodiments, the first uninsulated end 128 may or may not be wrapped at least once around the first electrode 14 and a portion of the main body 12 located between the first electrode 14 and the second opening 26a of the first opening group 24a.

[0148] The first uninsulated end 128 can be attached to the first electrode 14 using a conductive adhesive 113a, so that the first signal cable 110 electrically connects the first electrode 14 and the control unit 108. In other preferred embodiments, the first signal cable 110 can be electrically connected to the first electrode 14 using a plug-in mechanism, a screw mechanism, or soldering.

[0149] The first insulated section 126 may extend through the two third openings 28a, 28b of the first opening group 24a.

[0150] The second signal cable 112 may have a second uninsulated end 130 and a second insulated portion 132.

[0151] The second uninsulated end 130 can extend through the second opening 26b of the second opening group 24b and electrically contact the second electrode 16. In this embodiment, the first signal cable 110 is the only signal cable that electrically connects the second electrode 16 and the control unit 108.

[0152] The second uninsulated end 130 may be wrapped three times around the second electrode 16 and a portion of the main body 12 located between the second electrode 16 and the second opening 26b of the second opening group 24b. In other preferred embodiments, the second uninsulated end 130 may or may not be wrapped at least once around the second electrode 16 and a portion of the main body 12 located between the second electrode 16 and the second opening 26b of the second opening group 24b.

[0153] The second uninsulated end 130 can be attached to the second electrode 16 using a conductive adhesive 113b, so that the second signal cable 112 electrically connects the second electrode 16 and the control unit 108. In other preferred embodiments, the second signal cable 112 can be electrically connected to the second electrode 16 using a plug-in mechanism, a screw mechanism, or soldering.

[0154] The second insulated portion 132 may extend through the third opening 28c of the second opening group 24b.

[0155] In other preferred embodiments, the ophthalmic device 100 may include a signal cable that connects both the first electrode 14 and the second electrode 16 to the control unit 108. In this embodiment, this signal cable is the only signal cable that electrically connects the first electrode 14 and the control unit 108 and the only signal cable that electrically connects the second electrode 16 and the control unit 108.

[0156] The ophthalmic device 100 may further include a reed switch (not shown). The reed switch may be connected between the power source 106 and the remaining components of the ophthalmic device 100.

Claims

[1] Flexible ring electrode (10) for implantation in an eye comprising a main body (12), a first electrode (14) and a second electrode (16), wherein the main body (12) is arcuate and has an inner surface (18) directed towards the centre of the main body (12) and an outer surface (20) facing away from the centre of the main body (12), and wherein the first electrode (14) extends along at least a portion of the inner surface (18) and is secured to the inner surface (18), and wherein the second electrode (16) extends along at least a portion of the outer surface (20) and is secured to the outer surface (20). [2] Flexible ring electrode (10) according to claim 1, wherein the main body (12) is circular arc-shaped, the center of the main body (12) is located at the center point of the circular arc-shaped main body (12), and a central angle α of the main body (12) is at least 250°. [3] Flexible ring electrode (10) according to one of the preceding claims, wherein the first electrode (14) extends along a part of at least 80% of the inner surface (18) of the main body (12) and the second electrode (16) extends along a part of at least 80% of the outer surface (20) of the main body (12). [4] Flexible ring electrode (10) according to one of the preceding claims, wherein the main body (12) has at least one opening (22), wherein the at least one opening (22) is arranged between the inner surface (18) of the main body (12) and the outer surface (20) of the main body (12) and extends completely through the main body (12). [5] Flexible ring electrode (10) according to one of the preceding claims, wherein the main body (12) has a rectangular cross-section. [6] Flexible ring electrode (10) according to claim 5, wherein the rectangular cross-section has a long side (30) and a short side (32), wherein the long side (30) is longer than the short side (32), preferably 2 to 8 times as long, more preferably 2 to 6 times as long, most preferably 3 to 5 times as long. [7] Flexible ring electrode (10) according to one of the preceding claims, wherein the main body (12) has a fenestration region (34) in which at least two first openings (36) are arranged, wherein the at least two first openings (36) are preferably arranged regularly and in an arc along the main body (12), preferably in a circular arc. [8] Flexible ring electrode (10) according to claim 7, wherein the fenestration region (34) extends along a part of the main body (12) of at least 80% of the main body (12). [9] Flexible ring electrode (10) according to one of the preceding claims, wherein the main body (12) has a contacting region (38) in which at least one opening group (24) with a second opening (26) for fastening a signal cable that electrically contacts the first electrode (14) or the second electrode (16) and with at least a third opening (28) for strain relief of the signal cable is arranged, wherein the contacting region (38) is preferably formed at the end of the main body (12) and wherein all openings (22) of an opening group (24) are configured to enclose different regions of a single signal cable. [10] Flexible ring electrode (10) according to claim 9, wherein a first opening group (24a) with at least two third openings (28a, 28b) and a second opening group (24b) with at least one third opening (28c) are arranged in the contacting region (38). [11] Flexible ring electrode (10) according to claim 9 or 10, wherein the contacting region (38) extends along a part of the main body (12) of at most 20% of the main body (12), preferably at most 15%, particularly preferably at most 10%. [12] An ophthalmic device (100) for implantation into an eye socket (102), comprising a flexible ring electrode (10) according to any one of the preceding claims. [13] The ophthalmic device (100) of claim 12, comprising a power source (106), a control unit (108), a wireless data interface, and at least one signal cable, wherein the at least one signal cable electrically connects the first electrode (14) and the second electrode (16) to the control unit (108), and wherein the first electrode (14) and the second electrode (16) are each connected to the control unit (108) by no more than one signal cable. [14] Ophthalmological device (100) according to claim 12 or 13, comprising a flexible ring electrode (10) according to one of claims 9 to 11, a first opening group (24a), preferably with two third openings (28a, 28b), a second opening group (24b), preferably with a single third opening (28c), a first signal cable (110) with a first uninsulated end (128) and a first insulated section (126) and a second signal cable (112) with a second uninsulated end (130) and a second insulated section (132), wherein - the first uninsulated end (128) extends through the second opening (26a) of the first opening group (24a) and electrically contacts the first electrode (14) and the first insulated section (126) extends through the at least one third opening (28) of the first opening group (24a), and - the second uninsulated end (130) extends through the second opening (26b) of the second opening group (24b) and electrically contacts the second electrode (16) and the second insulated section (132) extends through the at least one third opening (28) of the second opening group (24b). [15] The ophthalmic device (100) of any one of claims 12 to 14, wherein the first uninsulated end (128) is attached to the first electrode (14) by means of a conductive adhesive (113a) and wherein the second uninsulated end (130) is attached to the second electrode (16) by means of a conductive adhesive (113b).

Citation Information

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