EYE IMPLANT FOR AN ACCOMMODATORY INTRAOCULAR LENS

Description

[0001] The invention relates to an eye implant for an accommodating intraocular lens.

[0002] Accommodation is the eye's ability to dynamically adjust its refractive power, thereby enabling it to see objects at different distances clearly. A change in the diameter of the eye's ciliary muscle is transmitted via zonular fibers to a flexible capsular bag containing a flexible lens. However, with increasing age, the ability to accommodate deteriorates, resulting in presbyopia. This is primarily due to a decrease in the elasticity of the lens, which hardens with age. An accommodating intraocular lens, which can be deformed by the ciliary muscle, is used to attempt to maintain the eye's ability to accommodate. However, all currently known accommodating intraocular lenses do not allow sufficient force to be transmitted from the ciliary muscle to the accommodating intraocular lens to enable accommodation.

[0003] US 2005 / 0251253 A1 discloses an intraocular lens assembly. US 2011 / 0029074 A1 discloses an ophthalmic device for implantation into the capsular bag of an eye. US 10,327,889 B2 discloses a tensioning means for attachment to a posterior capsule of an eye.

[0004] The object of the invention is therefore to create an eye implant with which force transmission from a ciliary muscle to an accommodating intraocular lens works well.

[0005] The first eye implant according to the invention comprises a lens shell that is configured to be inserted into a capsular bag of an eye, is elastic, defines a cavity in its interior, and has a through-hole through which the cavity is accessible from outside the lens shell, a plurality of reservoirs that are attached to the lens shell, project outward from the lens shell, have an adhesive in their interior, and are configured to release the adhesive when pressed onto the capsular bag, and at least two adapters that are attached to the lens shell, project inward from the lens shell, and are configured to engage a respective haptic of an accommodating intraocular lens. The lens shell can comprise or consist of silicone and / or polyurethane. The material of the lens shell or the reservoirs can comprise a shape memory material.The reservoirs can be made of or made of silicone and / or polyurethane. The reservoirs can be bladders, for example.

[0006] The adhesive can, for example, be a "superadhesive," as described at https: / / www.berlin-university-alliance.de / impressions / 20180110-mussel-basedsuper-adhesive / index.html. Alternatively, the adhesive can be a so-called "tissue adhesive" or HLAA (hydrophobic light-activated adhesive) from Geck Biomedical, Paris, see https: / / www.deutsche-apothekerzeitung.de / daz-az / 2014 / daz-3-2014 / chirurgischer-klebstoff. It is also conceivable that the adhesive is a two-component adhesive. The two components of the two-component adhesive can be arranged in two separate chambers in the reservoir and mix when the reservoirs are pressed onto the capsular bag. The adhesive can also be elastic.

[0007] The second eye implant according to the invention comprises a lens shell which is configured to be inserted into a capsular bag of an eye, is elastic, defines a cavity in its interior and has a through-hole via which the cavity is accessible from outside the lens shell, a plurality of protective shells which are attached to the lens shell and protrude outwards from the lens shell, a barb for each protective shell which is encapsulated in the interior of the associated protective shell, is connected to the lens shell, protrudes outwards from the lens shell and is configured, when the barb is pressed onto the capsular bag, to pierce the associated protective shell and hook into the capsular bag, and at least two adapters which are attached to the lens shell, protrude inwards from the lens shell and are configured to engage with a haptic of an accommodating intraocular lens.

[0008] The ocular implant is designed to be inserted into the capsular bag of the eye after the natural lens of the eye has been crushed and suctioned out by a surgeon using phacoemulsification. The ocular implant is inserted into the capsular bag when the cavity of the lens shell is as empty as possible, thus requiring minimal space. The lens shell is then inflated by forcing surgical fluid into the cavity via a cannula through the through-hole. For this purpose, the through-hole is conceivably designed to seal the cannula so that little or no surgical fluid can escape from the cavity while the lens shell is being inflated. Because the lens shell is flexible, it can adapt to different sized capsular bags. The ocular implant is attached to the capsular bag using adhesive or barbs.By providing the reservoirs according to the first ocular implant according to the invention, the adhesive is retained within the reservoirs during insertion of the ocular implant into the capsular bag, making it possible to compress and / or fold the ocular implant without the adhesive sticking the ocular implant together. By compressing and / or folding the ocular implant, the ocular implant can be inserted into the capsular bag via only a small incision in the cornea. For example, it is conceivable to insert the ocular implant via the same incision in the cornea of ​​the eye through which the natural lens was suctioned out. Analogously, by providing the protective sheaths according to the second ocular implant according to the invention, the ocular implant can be compressed and / or folded without the barbs damaging the ocular implant.After the lens shell has been inflated, the surgeon creates an insertion opening in the lens shell, for example, using a knife or tweezers. The accommodating intraocular lens is then inserted into the lens shell through the insertion opening, and the surgeon engages the haptics with one of the adapters, thereby attaching the accommodating intraocular lens to the ocular implant. Because the ocular implant is attached to the capsular bag, there is good force transmission from the ciliary muscle of the eye to the ocular implant. Because the accommodating intraocular lens is attached to the ocular implant, force transmission from the ocular implant to the accommodating intraocular lens is good, resulting in good overall force transmission from the ciliary muscle to the accommodating intraocular lens.The ocular implant can be attached to the capsular bag while the lens shell is inflated and / or while the accommodating intraocular lens is inserted into the lens shell.

[0009] For the first embodiment of the invention, it is preferred that the reservoirs each have a predetermined breaking point that is configured to be opened when the reservoirs are pressed onto the capsular bag, or wherein the reservoirs each have a reservoir opening that is configured to allow the adhesive to pass through when the reservoirs are pressed onto the capsular bag.

[0010] For the first embodiment of the invention, it is preferred that the lens shell has a shell opening for each of the reservoirs, and that one of the adapters is arranged at each of the shell openings, which contacts the adhesive. When the haptics engage with the respective adapter, the adapter presses the adhesive onto the capsular bag. This advantageously allows the ocular implant to be particularly firmly attached to the capsular bag.

[0011] For the second embodiment of the invention, it is preferred that each of the barbs extends through the lens shell and is attached to one of the adapters. When the haptics engage with the respective adapters, the adapter presses the barb onto the capsular bag. This advantageously allows the ocular implant to be attached particularly firmly to the capsular bag. Furthermore, the barb is attached particularly firmly by means of the adapter, especially compared to if the barb were attached only to the lens shell.

[0012] For the second embodiment of the invention, it is preferred that the protective covers are designed to decompose after insertion of the eye implant into the capsular bag.

[0013] For both embodiments of the invention, it is preferred that the lens shell be disc-shaped. This shape of the lens shell is advantageously easy to manufacture. Alternatively, it is preferred for both embodiments of the invention that the lens shell be toroidal. This advantageously allows the lens shell to be designed in a space-saving manner. This is particularly relevant when it is compressed and / or folded in order to be inserted into the capsular bag. Furthermore, it is possible to position the toroidal embodiment of the lens shell in the beam path of the eye such that little or no light that previously passed through the lens shell hits the retina.

[0014] For both embodiments of the invention, it is preferred that the lens shell has a lens shell thickening arranged around the through-hole. This can reduce the risk of damage to the lens shell during inflation. Particularly preferably, the lens shell thickening is arranged on the outside of the lens shell. This makes it possible to keep the cannula stable within the lens shell thickening while the surgical fluid is forced into the cavity.

[0015] For both embodiments, it is preferred that the lens shell has a valve having the through-hole. If the lens shell thickening is provided, the lens shell thickening can be arranged around the valve or be part of the valve.

[0016] For both embodiments, the lens shell preferably has a predetermined breaking point. By opening the predetermined breaking point, the insertion opening can be created particularly easily. For example, the predetermined breaking point can be a perforation. If the lens shell thickening is provided, the predetermined breaking point can be arranged around the lens shell thickening. This allows the lens shell thickening to be grasped with tweezers to create the insertion opening.

[0017] Particularly preferably, two predetermined breaking points are provided, located opposite each other on the lens shell. This allows the insertion opening to be created regardless of how the ocular implant is positioned in the capsular bag.

[0018] For both embodiments, it is preferred that each of the adapters has a first adapter arm and a second adapter arm, which are configured such that the haptics engage between them. By means of the first adapter arm and the second adapter arm, it is possible to expand the capsular bag. In particular, this makes it possible to prevent the anterior region of the capsular bag and the posterior region of the capsular bag from touching each other. By expanding the capsular bag, the likelihood of a secondary cataract occurring and the intensity of the secondary cataract can be reduced. By expanding the capsular bag, the transformation and growth factors released by the equatorial cells are diluted by circulating aqueous humor. Fewer equatorial cells then transform into fibroblasts, which also reduces fibrosis.

[0019] For both embodiments, it is preferred that the eye implant has at least two magnets or magnetizable eye implant regions, each configured to attach one of the haptics to the eye implant. This allows the intraocular lens to be particularly firmly attached to the eye implant. The magnets or the magnetizable eye implant regions can be arranged in the lens shell and / or in the adapters. If magnets are provided, the haptics can have magnetizable haptic regions or magnets. If magnetizable eye implant regions are provided, the haptics can have magnets. It is conceivable that the magnets in the eye implant and / or in the haptics are present in the form of magnetic nanoparticles.

[0020] In both embodiments, the lens shell preferably has a scale on its outside. This indicates how far the lens shell is inflated.

[0021] In both embodiments, the adapters are preferably configured so that the intraocular lens can always have the same radial diameter regardless of the size of the capsular bag.

[0022] In both embodiments, the surgical fluid preferably contains a lubricant and / or a physiological saline solution or consists of the lubricant and / or the physiological saline solution. The lubricant can be a so-called ophthalmic viscoelastic device (OVD).

[0023] A kit according to the invention comprises the eye implant and the accommodating intraocular lens.

[0024] The invention is explained in more detail below with reference to the attached schematic drawings. Figure 1 shows a section through an eye with a first embodiment of an eye implant according to the invention at three different points in time, the first point in time being shown on the left, the second point in time being shown in the middle, and the third point in time being shown on the right, the section at the third point in time being arranged perpendicular to the sections at the first point in time and the second point in time. Figure 2 shows a section through an eye with a second embodiment of the eye implant according to the invention at three different points in time, with the first point in time being shown on the left, the second point in time in the middle and the third point in time on the right, with the section at the third point in time being arranged perpendicular to the sections at the first point in time and the second point in time. Figure 3shows a plan view of two different embodiments of a lens shell of the eye implant, wherein the lens shell has a lens shell thickening. Figure 4 shows a plan view of two different embodiments of a lens shell of the eye implant, wherein the lens shell has a predetermined breaking point. Figure 5 shows a section through an eye with an embodiment of the eye implant, in which an adapter of the eye implant has a first adapter arm and a second adapter arm.

[0025] How it turns out Figure 1 As can be seen, an eye implant 23 according to a first embodiment comprises a lens shell 1, a plurality of reservoirs 3 and at least two adapters 2.

[0026] The lens shell 1 is designed to be inserted into a capsular bag 6 of an eye. In addition, the lens shell 1 defines a cavity in its interior and has a through hole 18 (only in Figure 3shown) via which the cavity is accessible from outside the lens shell 1. Furthermore, the lens shell 1 is elastic. The reservoirs 3 are attached to the lens shell 1 and protrude outwards from the lens shell 1. Furthermore, the reservoirs 3 have an adhesive 4 inside them and are designed to release the adhesive 4 when pressed onto the capsular bag 6. The adapters 2 are attached to the lens shell 1 and protrude inwards from the lens shell 1. Furthermore, the adapters 2 are designed to engage with a haptic 11 of an accommodating intraocular lens 10.

[0027] How it turns out Figure 2As can be seen, an eye implant 23 according to a second embodiment comprises a lens shell 1, a plurality of protective shells 14, a barb 13 for each of the protective shells 14, and at least two adapters 2. The lens shell 1 is designed to be inserted into a capsular bag 6 of an eye. In addition, the lens shell 1 defines a cavity in its interior and has a through-hole 18 through which the cavity is accessible from outside the lens shell 1. In addition, the lens shell 1 is elastic. The protective shells 14 are attached to the lens shell 1 and protrude outwardly from the lens shell 1. Each barb 13 is encapsulated in the interior of the associated protective shell 14, connected to the lens shell 1, and protrudes outwardly from the lens shell 1. In addition, each barb 13 is designed to pierce the associated protective shell 14 and hook into the capsular bag 6 when the barb 13 is pressed onto the capsular bag 6.The adapters 2 are attached to the lens shell 1 and protrude inward from the lens shell 1. Furthermore, the adapters 2 are each configured to engage with a haptic 11 of an accommodating intraocular lens 10.

[0028] Figures 1 and 2show the eye implant 23 arranged in the capsular bag 6 at three different points in time, with the first point in time being shown on the left, the second point in time in the middle, and the third point in time on the right. At the first point in time, the cavity of the lens shell 1 is filled with an operating fluid 7, which was introduced into the cavity via the through-hole 18. At the second point in time, even more of the operating fluid 7 was introduced into the cavity, as a result of which the lens shell 1 is stretched further than at the first point in time. According to the first embodiment, the reservoirs 3 are thereby pressed onto the capsular bag 6, as a result of which the reservoirs 3 release the adhesive 4 and the eye implant 23 is thus glued to the capsular bag 6. The eye implant 23 glued to the capsular bag 6 is shown at the second point in time.By further stretching the lens shell 1, according to the second embodiment, the barb 13 is pressed onto the capsular bag 6, whereby the barb 13 pierces the protective shell 14 and hooks into the capsular bag 6. The eye implant 23, hooked into the capsular bag 6 by the barbs 13, is shown at the second time. At the third time, it is shown that an insertion opening 12 can be made in the capsular bag 6, through which the accommodating intraocular lens 10 can be inserted into the cavity. In addition to the capsular bag 6, the ciliary muscle 8 of the eye and the zonular fibers 9 of the eye are shown. A state is shown in which the ciliary muscle 8 has stretched the capsular bag 6 via the zonular fibers 9 and has thus deformed the accommodating intraocular lens 10. It is conceivable that the reservoirs 3 or the barbs 13 are all arranged in one plane.It is also conceivable that this plane is arranged in the capsular bag 6 so that it lies in the equatorial plane of the natural lens of the eye.

[0029] Figure 1shows that the reservoirs 3 can each have a predetermined breaking point 5, which is designed to be opened when the reservoirs 3 are pressed onto the capsular bag 6. The predetermined breaking points 5 can be dimensioned such that they tear under a first pressure, such as occurs when the reservoirs 3 are pressed onto the capsular bag 6, but do not tear under a second pressure that is lower than the first pressure and occurs when the eye implant 23 is pushed through a cannula of an injector. The skilled person can conduct experiments to determine how the predetermined breaking points 5 must be dimensioned. For this purpose, they can manufacture the eye implants 23 with differently sized predetermined breaking points 5 and subject them to the first pressure and the second pressure.

[0030] As an alternative to the predetermined breaking point 5, it is conceivable that the reservoirs 3 each have a reservoir opening configured to allow the adhesive 4 to pass through when the reservoirs 3 are pressed onto the capsular bag 6. For this purpose, the reservoir openings can, for example, be dimensioned such that, before being pressed onto the capsular bag 6, they are so small that no adhesive 4 can pass through them, but when they are pressed onto the capsular bag 6, the reservoirs 3, together with the reservoir openings, are stretched such that the adhesive 4 can pass through the reservoir openings.

[0031] Figure 1shows that the lens shell 1 can have a shell opening 27 for each of the reservoirs 3 and that one of the adapters 2 can be arranged at each of the shell openings 27, which adapter contacts the adhesive 4. It is conceivable that the adapter 2 presses on the adhesive 4 when the cavity is filled with the operating fluid 7 in such a way that the reservoirs 3 are pressed onto the capsular bag 6, that the adhesive 4 is pressed out of the reservoir opening or that the predetermined breaking point 5 is caused to tear. In addition, Figure 1 It can be seen that the reservoir 3 can extend through the shell opening 27 into the interior of the lens shell 1. The adapter 2 can thus be connected to the reservoir 3 particularly easily, so that no adhesive 4 can penetrate into the interior of the lens shell 1.

[0032] Figure 2shows that each of the barbs 13 can extend through the lens shell 1 and can be attached to one of the adapters 2. In addition, the barb 13 can have a hook tip 24, a shaft 25 and an anchor 26, wherein the hook tip 24 is arranged at one longitudinal end of the shaft 25 and the anchor 26, which can be attached to the adapter 2, is arranged at another longitudinal end of the shaft 25. The anchor 26 can be arranged inside the lens shell 1 and the hook tip 24 can be arranged outside the lens shell 1. Either the anchor 26 or the shaft 25 can extend through the lens shell 1.

[0033] How it turns out Figures 3 or 4As can be seen, the lens shell 1 can be disc-shaped 15 or torus-shaped 16, with the disc-shaped 15 embodiment shown on the left and the torus-shaped 16 embodiment shown on the right. The torus-shaped 16 embodiment can, for example, be created by rotating a surface around a rotation axis, with the surface lying entirely in a plane in which the rotation axis also lies. For example, it is conceivable for the surface to have the shape of a circle, although other shapes, such as an ellipse, are also conceivable.

[0034] Figure 3shows that the lens shell 1 can have a lens shell thickening 17 arranged around the through-hole 18. The lens shell 1 can also have a valve having the through-hole 18. Here, the lens shell thickening 17 can be part of the valve. This applies to both the disc-shaped 15 embodiment and the toroidal 16 embodiment.

[0035] How it turns out Figure 4 As can be seen, the lens shell 1 can have a predetermined breaking point 19. By opening the predetermined breaking point 19, the insertion opening 12 can be formed. The predetermined breaking point 19 can be a perforation, for example. The predetermined breaking point 19 can, for example, have the shape of a closed curve, as is also the case for both embodiments according to Figure 4is shown. As a result, in the disc-shaped 15 embodiment, the lens shell 1 arranged within the predetermined breaking point 19 can be removed from the capsular bag 6, thereby reducing the amount of material remaining in the capsular bag 6. In the case that the lens shell thickening 17 is provided, it is therefore advantageous to provide the lens shell thickening 17 within the predetermined breaking point 19 in order to remove a particularly large amount of material from the capsular bag 6. In the torus-shaped 16 embodiment, the predetermined breaking point 19 can be provided on an end face of the lens shell 1, as is also the case in Figure 4 Alternatively, it is conceivable that the predetermined breaking point 19 is provided on the inside of the lens shell 1. Alternatively, it is conceivable that the predetermined breaking point 19 has the shape of a line that has a starting point and an end point and that can be straight and / or curved.

[0036] Figure 5shows that each of the adapters 2 can be designed as an open adapter 20 and can have a first adapter arm 21 and a second adapter arm 22, which are configured such that the haptic 11 engages between them with the first adapter arm 21 and the second adapter arm 22. The first adapter arm 21 and the second adapter arm 22 are arranged in a V-shape, wherein the distance between the first adapter arm 21 and the second adapter arm 22 becomes increasingly longer the further the first adapter arm 21 and the second adapter arm 22 protrude inward.

[0037] The operating fluid 7 may contain a lubricant and / or a physiological saline solution, or may consist of the lubricant and / or the physiological saline solution. The lubricant may be a so-called ophthalmic viscoelastic device (OVD). List of reference symbols

[0038] 1Lens shell 2Adapter 3Reservoir 4Adhesive 5Break point 6Capsular bag 7Operating fluid 8Ciliary muscle 9Zonular fibers 10Accommodating intraocular lens 11Haptic 12Insertion opening 13Barb 14Protective shell 15Sphere 16Torus 17Lens shell thickening 18Through hole 19Shield break point 20Open adapter 21First adapter arm 22Second adapter arm 23Eye implant 24Hook tip 25Shaft 26Anchor 27Shield opening

Claims

1. Eye implant having a lens sheath (1) which is configured to be inserted into a capsular bag (6) of an eye, which is elastic, which delimits a cavity in its interior and which has a through hole (18), via which the cavity is accessible from outside the lens sheath (1), and which is discus-shaped or toroidal, and having at least two adapters (2) which are secured to the lens sheath (1), which project inwardly from the lens sheath (1) and which are configured to engage with a respective haptic (11) of an accommodating intraocular lens (10), characterized in that the eye implant (23) comprises a plurality of reservoirs (3) which are secured to the lens sheath (1), which project outwardly from the lens sheath (1), which comprise an adhesive (4) in their interior and which are configured to release the adhesive (4) when pressed against the capsular bag (6).

2. Eye implant according to Claim 1, wherein the reservoirs (3) each have a predetermined breaking point (5) which is configured to be opened when the reservoirs (3) are pressed against the capsular bag (6), or wherein the reservoirs (3) each have a reservoir opening which is configured to allow the adhesive (4) to pass when the reservoirs (3) are pressed against the capsular bag (6).

3. Eye implant according to Claim 1 or 2, wherein the lens sheath (1) has a sheath opening (27) for each of the reservoirs (3) and one of the adapters (2) which is in contact with the adhesive (4) is arranged at each of the sheath openings (27).

4. Eye implant having a lens sheath (1) which is configured to be inserted into a capsular bag (6) of an eye, which is elastic, which delimits a cavity in its interior and which has a through hole (18), via which the cavity is accessible from outside the lens sheath (1), and which is discus-shaped or toroidal, and having at least two adapters (2) which are secured to the lens sheath (1), which project inwardly from the lens sheath (1) and which are configured to engage with a respective haptic (11) of an accommodating intraocular lens (10), characterized in that the eye implant (23) comprises a plurality of protective sheaths (14) which are secured to the lens sheath (1) and project outwardly from the lens sheath (1) and comprises a respective barb (13) for each protective sheath (14), said barb being encapsulated in the interior of the associated protective sheath (14), being connected to the lens sheath (1), protruding outwardly from the lens sheath (1) and being configured to pierce the associated protective sheath (14) and hook into the capsular bag (6) when said barb (13) is pressed against the capsular bag (6).

5. Eye implant according to Claim 4, wherein each of the barbs (13) extends through the lens sheath (1) and is secured to one of the adapters (2).

6. Eye implant according to Claim 4 or 5, wherein the lens sheath (1) is discus-shaped (15) or toroidal (16).

7. Eye implant according to any of Claims 1 to 6, wherein the lens sheath (1) has a lens sheath swelling (17) arranged around the through hole (18) and / or comprises a valve which contains the through hole (18).

8. Eye implant according to any of Claims 1 to 7, wherein the lens sheath (1) has a predetermined sheath breaking point (19).

9. Eye implant according to any of Claims 1 to 8, wherein each of the adapters (2) comprises a first adapter arm (21) and a second adapter arm (22) which are configured such that the haptic (11) engages therebetween.

10. Eye implant according to any of Claims 1 to 9, wherein the eye implant (23) comprises at least two magnets which are configured to each secure one of the haptics (11) to the eye implant (23).