Supplementary intraocular device

Abstract

The invention relates to supplementary intraocular device for implantation into the capsular bag of an eye in addition to a primary intraocular lens, the supplementary intraocular device comprising a body (1), wherein the body (1) is opaque at least for visible light, and wherein the body (1) has a pinhole (2) being placed in a central area (3) of the body (1). The invention further relates to an arrangement.

Description

[0001] 64424 / MB

[0002] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0003] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0004] Supplementary intraocular device

[0005] The present invention relates to a supplementary intraocular device having a pinhole and an arrangement of such supplementary intraocular device with a primary intraocular lens, as defined in the independent claims.

[0006] In recent years, presbyopia-correcting intraocular lenses (lOLs) have become increasingly popular and more frequently used in cataract surgery to treat presbyopia after removal of the cloudy lens. However, certain patients may experience suboptimal vision due to various issues such as residual refractive errors, astigmatism, or other visual aberrations, such as dysphotopsia, straylight, glare, or halo, even after primary IOL implantation. Supplementary devices or lenses, also known as add-on lenses, have been developed to address these issues by providing additional optical corrections.

[0007] Current supplementary devices primarily rely on optical designs that either add refractive power or utilize multifocal zones. However, these designs can also introduce unwanted visual side effects such as glare or halos, especially in low-light conditions. Additionally, many of these supplementary devices are not optimized for implantation alongside a primary IOL in a manner that ensures both implants remain properly positioned within the capsular bag. Known supplementary devices are attached to the sulcus using long haptics, i.e., outside the capsular bag, or they are not directly 64424 / MB

[0008] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0009] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT) connected to the primary lens, which can lead to issues connected with deplacement or tilt of the supplementary device.

[0010] A pinhole typically denotes a small circular hole, as could be made with the point of a pin. In optics, pinholes with various diameters are used as apertures in optical systems and can focus light or act as a kind of lens. This effect is used in solarigraphy and in pinhole cameras and the so-called camera obscura. The same effect is used in pinhole occluders, which are used by ophthalmologists to test visual acuity. The pinhole effect has also been successfully used in spectacles, contact lenses, and corneal inlays to improve reading.

[0011] Pinhole lOLs were developed to use the pinhole effect to improve reading by compensating for loss of accommodative function. The effect of paraxial rays is minimized by the small aperture of the pinhole, reducing the circle of blur and minimizing the effect of higher-order aberrations, enhancing depth of focus, and reducing the effect of refractive errors.

[0012] In the prior art, a small-aperture presbyopia-correcting IOL is known under the brand name IC-8® Apthera™ (Bausch & Lomb) that combines the proven principle of smallaperture optics with an aspheric monofocal lens to deliver a continuous range of vision from distance to near vision for patients with cataracts. The hydrophobic acrylic, ultraviolet-blocking one-piece lens is biconvex with an anterior aspheric surface and is built on a typical c-loop IOL platform. The lens has an opaque filtering ring made of polyvinylidene fluoride and carbon black with a pinhole in its center.

[0013] While this IOL has shown to provide good results, it also has some drawbacks. For example, it is not possible to modify previously implanted lOLs using this technology.

[0014] Application to an eye that has already undergone cataract surgery, but where a conventional IOL without said small-aperture optics has been implanted, therefore would require explantation of the existing IOL. Explantation is typically connected with high risk for the patient and complications may occur, which should be avoided. Nevertheless, the use of small-aperture optics may be desirable with some patients. 64424 / MB

[0015] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0016] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0017] An object of the present invention may therefore be seen in overcoming the disadvantages of the prior art and to provide an intraocular device, which exploits the pinhole-effect (i.e. , has small-aperture optics), and which allows safer implantation and / or use in connection with an already implanted IOL.

[0018] It has now been surprisingly found that these and other objects may be solved by providing an add-on intraocular device, which can be implanted into an eye in addition to an already existing primary intraocular lens.

[0019] Using this solution it may be possible to combine the beneficial effects of conventional lOLs with those of pinhole lOLs without requiring the explantation of a pre-existing IOL from the eye of a patient.

[0020] The invention therefore particularly relates to an add-on intraocular device (also referred to as “supplementary intraocular device” or “supplementary intraocular implant”), which is designed as a pinhole lens. The supplementary intraocular device particularly comprises or consists of a body, which body has an opening, namely a pinhole (also referred to as “aperture”) in a central region thereof. The supplementary intraocular device particularly has no optical power.

[0021] It may be particularly provided that the supplementary intraocular device is adapted to be implanted into the capsular bag of the eye.

[0022] The body of the supplementary intraocular device may be essentially disc-shaped and / or the pinhole may be a circular pinhole.

[0023] It is preferable that the body is opaque, i.e., not transmissible, at least for visible light. Visible light may particularly refer to electromagnetic radiation with a wavelength of between 380 nm and 700 nm. Opacity of the body may be obtained for example by providing a surface coating, which contains a pigment, or by adding a pigment to the bulk material of the body. The pigment may be selected in type and amount based on the specific requirements, but in one example, the pigment may be carbon black. The 64424 / MB

[0024] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0025] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT) coating, if provided, may contain or consist of a fluoropolymer, such as polyvinylidene fluoride (PVDF) with a suitable amount of carbon black or another pigment, which is biocompatible and generally suitable for intraocular use.

[0026] The body of the supplementary intraocular device may have a curvature, such that a convex surface and a concave surface are provided. When implanted into the eye, the convex surface is in particular the anterior surface of the body of the IOL, and the concave surface is in particular the posterior surface of the IOL. Generally, the terms anterior and posterior denote anatomical positions, wherein anterior refers to the front and posterior refers to the back. In case of the IOL as described here, the concave posterior surface of the body may be the surface that faces the already implanted primary IOL and / or the vitreous of the eye.

[0027] Haptics, such as at least two haptics may be provided in the supplementary intraocular device disclosed herein. In contrast to haptics of prior art lOLs, which are designed to provide a locking effect for the IOL with an anatomical feature of the eye, such as the capsular bag, the haptics of the supplementary intraocular device described herein are in particular provided to establish a connection between the supplementary intraocular device and a primary intraocular lens.

[0028] This connection may for example be a positive-locking connection.

[0029] The haptics may be designed such that they form protrusions from the body of the supplementary intraocular device, wherein the protrusions particularly run in the axial direction of the disc-shaped body.

[0030] In a specific example, the haptics may be two essentially arc-shaped protrusions, which extend in axial direction of the disc-shaped body, wherein the two haptics are provided in a manner opposing each other in the area of the outer edge of the body.

[0031] The haptics may have inner surfaces, which point towards each other in radial direction of the body. This way, the haptics may preferably be used to establish an interlocking, 64424 / MB

[0032] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0033] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT) such as a positive-locking, connection between the supplementary intraocular device and an edge portion of the primary intraocular lens.

[0034] The haptics may be provided with gripping means, especially on said inner surface thereof. The gripping means may have a structure, which enhances friction, such as a multitude of teeth. This may enhance fixation of the device relative to the primary intraocular lens and reduce the risk of shifting.

[0035] The body may be provided with additional openings at a distance from the pinhole, such as in an edge portion if the body. The edge portion of the body may for example be an area with a distance of less than 2 mm, such as less than 1 mm, from the other edge of the body.

[0036] The supplementary intraocular device described herein is preferably adapted such that it can be completely inserted and / or implanted into the capsular bag of an eye. In other words, this intraocular device I implant particularly does not have constructional features, which cannot be fitted into the capsular bag, such as haptics, which protrude from the body in a radial direction thereof.

[0037] The body and / or the supplementary intraocular device may be foldable, such that it can be accommodated in an IOL injection device, as it is known in the art. In order to achieve this, the supplementary intraocular device may be relatively thin, such as below 1 ,0 mm, and it may be formed of a foldable material, such as an hydrophilic or hydrophobic acrylic polymer.

[0038] In general, the term acrylic polymer in connection with this disclosure encompasses all suitable polymers, which are derived from monomers that contain an acrylic group. Acrylic polymers may encompass acrylic homopolymers and acrylic copolymers. The acrylic polymer may contain suitable additives if required.

[0039] The supplementary intraocular device described herein may be implanted or may be implantable into the capsular bag of an eye using a very clear corneal incision having a length of less than 2 mm. 64424 / MB

[0040] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0041] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0042] When attached to a primary intraocular lens, the haptics may hold the supplementary intraocular device in the intended position. However, haptics are not necessary and a supplementary intraocular device may also be devoid of haptics, wherein the attachment of the supplementary intraocular device to the primary intraocular lens is in particular achieved using adhesion.

[0043] In the latter case, i.e., if no haptics are provided, the supplementary intraocular device may be a disc, in particular a curved disc.

[0044] Typically, the primary intraocular lens has an optical power other than zero. The primary intraocular lens may have at least a convex anterior surface, on which the supplementary intraocular device disclosed herein can be or is attached.

[0045] When attached to the primary intraocular lens, it may be particularly provided that at least a part of the concave posterior surface of the supplementary intraocular device is in contact with the convex anterior surface of the primary intraocular lens.

[0046] The curvature of the concave posterior surface of the supplementary intraocular device may be smaller than the curvature of the convex anterior surface of the primary intraocular lens, such that when attached to each other, a gap is formed in a part of the area between said surfaces.

[0047] The invention generally relates to a supplementary intraocular device.

[0048] It may be provided that the body of the supplementary intraocular device is opaque at least for visible light, wherein the body has a pinhole being placed in a central area of the body.

[0049] It may be provided that the body of the supplementary intraocular device has a concave posterior surface and a convex anterior surface. 64424 / MB

[0050] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0051] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0052] It may be provided that the body of the supplementary intraocular device is essentially disc-shaped.

[0053] It may be provided that at the circumference of the body of the supplementary intraocular device at least two haptics are provided, wherein the haptics are designed such that a positive-locking connection between the supplementary intraocular device and the primary intraocular lens can be established, and / or wherein the haptics protrude from the body in an axial direction thereof.

[0054] It may be provided that each of the haptics of the supplementary intraocular device has an inner surface, wherein the inner surfaces are facing each other, and wherein the inner surfaces are aligned in the radial direction of the body, and wherein optionally gripping means are provided on the inner surfaces.

[0055] It may be provided that the supplementary intraocular device has an optical power of 0 (zero).

[0056] It may be provided that the supplementary intraocular device is adapted to be placed completely within the capsular bag of an eye.

[0057] It may be provided that the body of the supplementary intraocular device has a diameter of between 4.0 mm and 8.0 mm, such as of between 5.0 mm and 7.0 mm, preferably of approximately 6.0 mm.

[0058] It may be provided that the body of the supplementary intraocular device has a thickness of below 0.5 mm, such as below 0.3 mm.

[0059] It may be provided that the pinhole of the supplementary intraocular device has a circular shape.

[0060] It may be provided that the pinhole of the supplementary intraocular device has a diameter of between 1.0 mm and 2.0 mm, such as of between 1.2 mm and 1 .6 mm, preferably of approximately 1 .4 mm. 64424 / MB

[0061] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0062] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0063] It may be provided that the haptics of the supplementary intraocular device protrude from the concave posterior surface of the body in its axial direction.

[0064] It may be provided that at least one edge of the pinhole of the supplementary intraocular device has a rounded shape, wherein preferably the edge to the convex anterior surface of the body has a rounded shape.

[0065] It may be provided that the body of the supplementary intraocular device consists of or contains an acrylate polymer and / or contains carbon black as pigment.

[0066] It may be provided that the body of the supplementary intraocular device has a surface coating, in particular on its concave anterior surface, wherein the surface coating consists of or contains a fluoropolymer, such as polyvinylidene fluoride.

[0067] It may be provided that the body of the supplementary intraocular device consists of or contains a hydrophilic acrylate polymer with a water content of more than 15 wt.-%, or consists of or contains a hydrophobic acrylate polymer with a water content of less than 10 wt.-%.

[0068] It may be provided that an arrangement comprises a supplementary intraocular device with a primary intraocular lens.

[0069] It may be provided that the primary intraocular lens in the arrangement has an optical power other than 0.

[0070] It may be provided that the haptics of the supplementary intraocular device in the arrangement are in positive-locking contact with the primary intraocular lens.

[0071] It may be provided that a posterior concave surface of the body of the supplementary intraocular device is in contact with an anterior convex surface of the primary intraocular lens. 64424 / MB

[0072] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0073] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0074] Further features of the invention will become apparent from the claims, the drawings, and the description of the exemplary embodiments of the invention. The latter are intended for illustrative purposes only to describe beneficial aspects of the invention and shall not limit the scope of protection as defined by the patent claims.

[0075] In the drawings:

[0076] Fig. 1 shows a schematic drawing of a supplementary intraocular device according to a first embodiment;

[0077] Fig. 2 shows a schematic sectional view of the supplementary intraocular device according to the first embodiment;

[0078] Fig. 3 shows a schematic sectional view of a supplementary intraocular device according to a second embodiment; and

[0079] Fig. 4 shows a schematic sectional view of the supplementary intraocular device according to the first embodiment arranged with a primary intraocular lens.

[0080] Except otherwise mentioned or clear from the context, the following features / elements are shown: Body 1 ; pinhole 2; central area 3; concave posterior surface 4 (of the body 1 ); convex anterior surface 5 (of the body 1 ); circumference 6 (of the body 1 ); haptics 7 ; axial direction 8 (of the body 1 ); edge 9 (of the pinhole 2); inner surface 10 (of the haptics 7); radial direction 11 (of the body 1 ); gripping means 12; convex anterior surface 13 (of the primary intraocular lens 14); primary intraocular lens 14.

[0081] The supplementary intraocular device of the first embodiment, which is shown in Fig. 1 and 2, has a disc-shaped body 1 . The body 1 is curved, such that it has a concave posterior surface 4 and a convex anterior surface 5 (not visible in Fig. 1 ). Here, the terms “anterior” and “posterior” refer to the position of the supplementary intraocular device when implanted into an eye, as will be explained later.

[0082] In addition to the body 1 , the supplementary intraocular device comprises two haptics 7, which are arranged at the circumference of the body 1 , and which have an arcuate shape. The haptics 7 are arranged opposite to each other and they protrude from the body 1 in its axial direction 8. 64424 / MB Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT) Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0083] The haptics 7 have inner surfaces 10, which point towards each other, and which are equipped with gripping means 12 as best seen in Fig. 1. The gripping means 12 are teeth.

[0084] Body 1 and haptics 7 are integrally formed of a hydrophilic acrylate polymer with a water content of approx. 25 wt.-%, as it is known to be used for the production of intraocular devices.

[0085] In the central area 3 of the body 1 , a pinhole 2 is provided, which essentially is a circular opening in the material of the body 1 . The pinhole 2 is not filled with material. Between the anterior surface 5 of the body 1 and the circumference of the pinhole 2, an edge 9 is formed. In this exemplary embodiment, the edge 9 is a sharp edge.

[0086] The body 1 is opaque at least to visible light, meaning that it does not let visible light pass. Opacity of the body 1 is achieved by providing a coating to the anterior surface 5 of the body 1 made of polyvinylidene fluoride and carbon black as pigment.

[0087] The only part of the body 1 that lets light pass is the pinhole 2.

[0088] The supplementary intraocular device acts as a pinhole lens, without having optical power.

[0089] The supplementary intraocular device of this embodiment has a body diameter of approx. 6.0 mm and a pinhole diameter of approx. 1 .4 mm. The thickness of the body 1 is approx 0.2 mm.

[0090] Fig. 3 shows a schematic sectional view of a supplementary intraocular device according to a second embodiment. This embodiment is similar to the first embodiment, with the difference that the edge 9 is rounded. This may reduce problems in relation to straylight and glare.

[0091] In another exemplary embodiment of the supplementary intraocular device, no haptics 7 are provided, i.e. , the supplementary intraocular device essentially consists of 64424 / MB

[0092] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0093] Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)

[0094] Fig. 4 shows a schematic sectional view of the supplementary intraocular device according to the first embodiment arranged with a primary intraocular lens 14. The primary intraocular lens 14 is a lens that can be implanted into the capsular bag of an eye. It has haptics, which are not shown here for simplification of the drawing.

[0095] The primary intraocular lens 14 has a convex anterior surface 13, which is partly in direct contact with the concave posterior surface 4 of the supplementary intraocular device. As the curvature of the concave posterior surface 4 of the body 1 of the supplementary intraocular device is lower than the curvature of the convex anterior surface 13 of the lens 14, there is no full contact between said surfaces, a gap is formed between the outer parts of these surfaces. In order to avoid inclusions of air or other fluids, further openings may be provided in the outer part of the body 1 (not shown).

[0096] As can be seen in Fig. 4, the inner surface 10 of the haptics 7 is in positive-locking contact with the primary intraocular lens 14. Friction is improved by the gripping means 12 described above.

[0097] The supplementary intraocular device of the second embodiment may be used in connection with the primary intraocular lens 14 in the same manner.

[0098] In case the supplementary intraocular device is not provided with haptics 7, the connection between the convex anterior surface 13 of the primary intraocular lens 14 and the concave posterior surface 4 of body 1 of the supplementary intraocular device may be achieved solely by adhesive forces.

[0099] The supplementary intraocular devices of these embodiments are adapted for implantation into the capsular bag of an eye. Said eye, into which such supplementary intraocular device is implanted, typically has already undergone cataract surgery, with a primary intraocular lens having been implanted into the capsular bag.

[0100] The supplementary intraocular device can be loaded to an injection device, which is well known in the art. Here, the device is folded, such that it can be implanted into the 64424 / MB

[0101] Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT) Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT) capsular bag via a relatively small incision in the cornea, having a length of approx. 1 .8 mm. After injection, the device unfolds in the capsular bag.

[0102] The haptics 7, if provided, engage in a positive-locking contact with the primary intraocular lens 14.

[0103] Such arrangement may provide one or more of the following benefits:

[0104] - Easy and stable positioning - same centered position of pinhole as center of primary IOL optic

[0105] - Complete and close contact to the existing IOL to prevent dysphotopsia, as often the case in typical supplementary lOLs, which are placed in the sulcus

[0106] - No additional manipulation in the capsular bag

[0107] - No additional risks for tears I capsular defects

[0108] - Very small incision size (<2.0mm) and smooth implantation

[0109] - Lower risk for iatrogenic astigmatism, postoperative infection, endophthalmitis, wound healing problems etc.

Claims

64424 / MB Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT) Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)Claims1. A supplementary intraocular device for implantation into the capsular bag of an eye in addition to a primary intraocular lens, the supplementary intraocular device comprising a body (1 ), wherein the body (1 ) is opaque at least for visible light, and wherein the body (1 ) has a pinhole (2) being placed in a central area (3) of the body (1 ).

2. The supplementary intraocular device according to claim 1 , wherein the body (1 ) has a concave posterior surface (4) and a convex anterior surface (5).

3. The supplementary intraocular device according to claim 1 or 2, wherein the body (1 ) is essentially disc-shaped.

4. The supplementary intraocular device according to any of claims 1 to 3, wherein in at the circumference (6) of the body (1 ) at least two haptics (7) are provided,- which haptics (7) are designed such that a positive-locking connection between the supplementary intraocular device and the primary intraocular lens can be established, and / or- which haptics (7) protrude from the body (1 ) in an axial direction (8) thereof.

5. The supplementary intraocular device according to claim 4, wherein each of the haptics (7) has an inner surface (10), which inner surfaces (10) are facing each other, and which inner surfaces (10) are aligned in radial direction (11 ) of the body (1 ), wherein gripping means (12) are provided on the inner surfaces (10).

6. The supplementary intraocular device according to any of claims 1 to 5, wherein the supplementary intraocular device has an optical power of 0.

7. The supplementary intraocular device according to any of claims 1 to 6, wherein the supplementary intraocular device is adapted to be placed completely within the capsular bag of an eye.64424 / MBEva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT)Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)8. The supplementary intraocular device according to any of claims 1 to 7, wherein the body (1 ) has a diameter of between 4,0 mm and 8,0 mm, such as of between 5,0 mm and 7,0 mm, preferably of approximately 6,0 mm.

9. The supplementary intraocular device according to any of claims 1 to 8, wherein the body (1 ) has a thickness of below 0,5 mm, such as below 0,3 mm.

10. The supplementary intraocular device according to any of claims 1 to 9, wherein the pinhole (2) has a circular shape.11 . The supplementary intraocular device according to any of claims 1 to 10, wherein the pinhole (2) has a diameter of between 1 ,0 mm and 2,0 mm, such as of between 1 ,2 mm and 1 ,6 mm, preferably of approximately 1 ,4 mm.

12. The supplementary intraocular device according to any of claims 4 to 11 , wherein the haptics (7) protrude from the concave posterior surface (4) of the body (1 ) in its axial direction (8).

13. The supplementary intraocular device according to any of claims 1 to 12, wherein at least one edge (9) of the pinhole (2) has a rounded shape, wherein preferably the edge (9) to the convex anterior surface (5) of the body (1 ) has a rounded shape14. The supplementary intraocular device according to any of claims 1 to 13,- wherein the body (1 ) consists of or contains an acrylate polymer and / or- wherein the body (1 ) contains carbon black as pigment.

15. The supplementary intraocular device according to any of claims 1 to 14, wherein the body (1 ) has a surface coating, in particular on its concave anterior surface (5), which surface coating consists of or contains a fluoropolymer, such as polyvinylidene fluoride.64424 / MB Eva-Maria Borkenstein, Kreuzgasse 35, 8010 Graz (AT) Andreas Borkenstein, Kreuzgasse 35, 8010 Graz (AT)16. The supplementary intraocular device according to any of claims 1 to 15, wherein the body (1 ) consists of or contains a hydrophilic acrylate polymer with a water content of more than 15 wt.-%, or wherein the body (1 ) consists of or contains a hydrophobic acrylate polymer with a water content of less than 10 wt.-%.

17. An arrangement of a supplementary intraocular device according to any of claims 1 to 16 with a primary intraocular lens (14).

18. The arrangement according to claim 17, wherein the primary intraocular lens (14) has an optical power other than 0.

19. The arrangement according to claim 17 or 18, wherein the supplementary intraocular device is according to any of claims 4 to 16, and wherein the haptics (7) of the supplementary intraocular device are in positive-locking contact with the primary intraocular lens (14).

20. The arrangement according to any of claims 17 to 19, wherein a posterior concave surface (4) of the body (1 ) of the supplementary intraocular device is in contact with an anterior convex surface (13) of the primary intraocular lens (14).

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