Intraocular lens

Abstract

An intraocular lens. The intraocular lens comprises a capsule body, a sealing valve, and a parylene layer. A cavity is formed within the capsule body; the sealing valve is disposed on the capsule body, the sealing valve being a silicone sealing valve; and the parylene layer is disposed on the outer surface of the sealing valve.

Description

intraocular lenses

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application entitled “Intraocular Lens” filed with the State Intellectual Property Office of China on January 3, 2024, with application number 202410011639.3, the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application relates to the technical field of ophthalmic medical devices, and in particular to an artificial lens. Background Art

[0004] Cataract extraction combined with intraocular lens implantation remains the only effective treatment for cataracts, and will continue to be for some time to come. While implanting a traditional monofocal intraocular lens after cataract surgery can provide excellent distance vision, the lack of focusing capability often leaves patients with hyperopia, requiring them to rely on glasses for various near-distance tasks.

[0005] Multifocal intraocular lenses use a unique optical design that can form two or more focal points in the eye at the same time. After surgery, patients can adjust the size of their pupils and choose different focal points to meet the needs of far and near vision, reducing the rate of cataract patients wearing glasses after surgery. However, the simultaneous existence of multiple focal points will cause disadvantages such as halo and glare to patients.

[0006] In recent years, many researchers have attempted to design accommodative intraocular lenses (IOLs). By varying the volume or type of optical fluid (such as silicone oil) within the capsular bag, they can alter the shape or optical path of the IOL itself, thereby adjusting the IOL's diopter. However, ensuring the long-term sealing of the optical fluid after injection remains a challenge for those skilled in the art.

[0007] Public content

[0008] The present application aims to solve at least one of the technical problems existing in the prior art. To this end, one object of the present application is to provide an intraocular lens that can effectively prevent leakage of an optical fluid medium filled in the intraocular lens capsule.

[0009] According to an embodiment of the present application, the intraocular lens includes: a capsule having a chamber formed therein; a sealing valve disposed on the capsule, the sealing valve being a silicone sealing valve; and a parylene layer disposed on an outer surface of the sealing valve.

[0010] Thus, by adjusting the amount of optical fluid inside the capsule or the type of optical fluid, the IOL's shape or optical path can be altered, thereby adjusting the IOL's diopter. Furthermore, the silicone sealing valve, protected by the rigid parylene layer, self-seals, providing a long-term leak-proof seal and preventing leakage of the optical fluid inside the capsule, thereby ensuring the reliability and safety of the IOL.

[0011] According to some embodiments of the present application, the parylene layer covers the outer surface of the sealing valve and also partially covers the outer surface of the balloon.

[0012] According to some embodiments of the present application, the sealing valve includes: a ring body and a body, the ring body is arranged on the capsule, the body is arranged in the ring body, and the hardness of the body is smaller than the hardness of the ring body.

[0013] According to some embodiments of the present application, the parylene layer is disposed on the outer surfaces of the ring body and the main body at the same time.

[0014] According to some embodiments of the present application, the ring body is a hard silicone body, and the main body is a soft silicone body.

[0015] According to some embodiments of the present application, the hardness of the ring body is between Shore 80A-90A, and the hardness of the main body is between Shore 20A-40A.

[0016] According to some embodiments of the present application, the hardness of the body is less than or equal to the hardness of the capsule.

[0017] According to some embodiments of the present application, the number of the sealing valves is two, the number of the parylene layers is two, and the two sealing valves and the two parylene layers are arranged in a one-to-one correspondence.

[0018] According to some embodiments of the present application, the two sealing valves are symmetrically arranged about the central axis of the capsule.

[0019] According to some embodiments of the present application, a groove recessed toward the chamber is provided in the middle portion of the rear side of the capsule, and the sealing valve is spaced apart from the groove.

[0020] According to some embodiments of the present application, the capsule has an equator, and the capsule includes: a front capsule and a rear capsule, the front capsule and the rear capsule are connected, and the connection between the front capsule and the rear capsule avoids the equator.

[0021] According to some embodiments of the present application, the distance from the connection between the anterior capsule and the posterior capsule to the equator is d, and d satisfies the relationship: 1 mm ≤ d ≤ 1.5 mm.

[0022] According to some embodiments of the present application, the intraocular lens further includes a haptic, which is connected to the equator.

[0023] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become obvious from the description below, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0025] FIG1 is a cross-sectional view of an intraocular lens according to an embodiment of the present application;

[0026] FIG2 is a cross-sectional view of an intraocular lens including two sealing valves according to an embodiment of the present application;

[0027] FIG3 is a cross-sectional view of an intraocular lens containing a groove according to an embodiment of the present application;

[0028] FIG4 is a cross-sectional view of an intraocular lens including an optical convex lens according to an embodiment of the present application;

[0029] FIG5 is a schematic structural diagram of an intraocular lens including haptics according to an embodiment of the present application;

[0030] FIG6 is a schematic structural diagram of an intraocular lens separation according to an embodiment of the present application;

[0031] FIG7 is a schematic diagram of the structure of the front capsule and the rear capsule according to an embodiment of the present application;

[0032] FIG8 is a cross-sectional view of the front bladder and the rear bladder in cooperation with each other according to an embodiment of the present application;

[0033] FIG9 is a schematic diagram of the structure of an intraocular lens in an eye according to an embodiment of the present application.

[0034] Figure numerals: 100, intraocular lens; 10, capsule; 11, groove; 12, anterior capsule; 13, posterior capsule; 14, equator; 15, optical convex lens; 16, chamber; 20, sealing valve; 21, ring body; 22, body; 30, parylene layer; 40, haptic; 41, anterior connecting arm; 42, posterior connecting arm; 43, free end; 50, suture line. DETAILED DESCRIPTION

[0035] The following describes in detail embodiments of the present application, and the embodiments described with reference to the accompanying drawings are exemplary.

[0036] An intraocular lens 100 according to an embodiment of the present application is described below with reference to Figures 1-9 . The intraocular lens 100 includes a capsule 10, a sealing valve 20, and a parylene layer 30. A chamber 16 is formed within the capsule 10. The sealing valve 20 is disposed on the capsule 10 and is a silicone sealing valve. The parylene layer 30 is disposed on the outer surface of the sealing valve 20. The capsule 10 can be made of silicone, siloxane, fluorosilane, or a hydrophilic or hydrophobic acrylic, preferably silicone.

[0037] Specifically, as shown in Figure 1, the capsule 10 is provided with a valve hole, and the sealing valve 20 is disposed within the valve hole. A parylene layer 30 (preferably Parylene C, which can be vapor-deposited) is applied to the outer surface of the sealing valve 20. The Young's modulus and hardness of the parylene layer 30 are significantly higher than those of the silicone sealing valve 20. Furthermore, the parylene layer 30 adheres well to the silicone sealing valve 20, effectively creating a reinforcing barrier around the silicone sealing valve 20. Therefore, when the injection needle is withdrawn, the optical fluid (silicone oil) within the sealing valve 20 exerts outward pressure on the silicone sealing valve 20. This outward pressure causes the silicone sealing valve 20 to self-seal under the protection of the rigid parylene layer 30, thereby providing a long-term leak-proof seal.

[0038] The intraocular lens 100 of the present embodiment can adjust the shape or optical path of the intraocular lens 100 by adjusting the amount of optical fluid medium filled in the capsule 10 or changing the type of optical fluid medium, thereby adjusting the refractive power of the intraocular lens 100. Furthermore, the provision of the sealing valve 20 and the parylene layer 30 on the capsule 10 prevents leakage of the optical fluid medium filled in the capsule 10 and also avoids deformation and stress concentration in the capsule 10, thereby ensuring the reliability and safety of the intraocular lens 100.

[0039] As shown in FIG1 , the parylene layer 30 covers the outer surface of the sealing valve 20 , and the parylene layer 30 also partially covers the outer surface of the bladder body 10 , thereby increasing the contact area between the parylene layer 30 and the sealing valve 20 and avoiding stress concentration at the connection between the sealing valve 20 and the bladder body 10 .

[0040] The sealing valve 20 comprises a ring body 21 and a body 22. The ring body 21 is mounted on the capsule 10, while the body 22 is positioned within the ring body 21. The hardness of the body 22 is less than that of the ring body 21. The body 22 is preferably circular, while the ring body 21 is preferably a torus. When an optical fluid medium is to be injected into the sealing valve 20, the lower hardness of the body 22 facilitates the entry of the injection needle into the capsule 10. Furthermore, after the injection needle is removed, a seal is more easily achieved, preventing leakage of the optical fluid medium. The higher hardness of the ring body 21 prevents deformation and stress concentration on the capsule 10 during injection, making injection easier and more reliable.

[0041] The parylene layer 30 is disposed on the outer surfaces of both the ring body 21 and the body 22, increasing the contact area. Preferably, the ring body 21 is made of hard silicone, while the body 22 is made of soft silicone. The two silicones are organically combined to form a closed, integrated structure. Specifically, the hardness of the ring body 21 is between 80A and 90A on the Shore Scale, and the hardness of the body 22 is between 20A and 40A on the Shore Scale, which prevents deformation of the body 22 and the capsule 10. Furthermore, the hardness of the body 22 can be equal to or less than that of the capsule 10. The body 22 and the capsule 10 are preferably made of the same material for ease of processing and manufacturing.

[0042] As shown in FIG2 , there are two sealing valves 20 and two parylene layers 30, and the two sealing valves 20 and the two parylene layers 30 are arranged in a one-to-one correspondence. Of the two sealing valves 20, one can be used for injection, while the other serves a mechanical compensation and balancing function, and can also serve as a spare valve body. Furthermore, the two sealing valves 20 can be arranged at different positions on the capsule 10, thereby forming different injection paths and allowing injection in different directions for flexible operation. Preferably, the two sealing valves 20 are symmetrically arranged about the central axis of the capsule 10, so that the optical area on the upper surface of the capsule 10 undergoes uniform deformation.

[0043] As shown in Figure 3, a groove 11 is provided in the middle of the rear side of the capsule 10, recessed toward the interior of the chamber 16. A sealing valve 20 is spaced apart from this groove 11. The provision of groove 11 reduces contact between the intraocular lens 100 and the posterior wall of the lens capsule, thus preventing the effects of foreign tissue proliferation. The spacing of the optical path sealing valve 20 from the groove 11 further reduces stress concentration.

[0044] As shown in Figures 5 and 6, capsule 10 includes an anterior capsule 12 and a posterior capsule 13. Anterior capsule 12 and posterior capsule 13 are connected, a sealing valve 20 is provided in anterior capsule 12, and a groove 11 is provided in the middle of posterior capsule 13. Anterior capsule 12 and posterior capsule 13 can be bonded together to form a nearly ellipsoidal structure that mimics the human lens.

[0045] In addition, a groove 11 may also be provided in the middle of the anterior capsule 12. The middle of the anterior capsule 12 is recessed inwardly to form the groove 11. The recessed space of the groove 11 can reduce tissue contact with the anterior wall of the lens capsule, thereby avoiding affecting the optical path.

[0046] The groove 11 can be formed of a silicone membrane with an initial diopter. Liquid within the capsule 10 can be used to slightly deform the silicone membrane, thereby adjusting the diopter of the entire intraocular lens 100. As shown in FIG4 , the bottom of the groove 11 of the anterior capsule 12 and / or the posterior capsule 13 is configured as an optical convex lens 15, which can aid in focusing and can be configured as needed.

[0047] The optical convex mirror 15 is preferably a PMMA (polymethyl methacrylate) film layer, which has the characteristics of high transparency and low refractive index. The hardness of the optical convex mirror 15 is between 80A and 90A on Shore A, thereby preventing the PMMA film layer from being deformed.

[0048] The outer radius of curvature of the optical convex mirror 15 on the anterior capsule 12 is ρ1, and ρ1 satisfies the relationship: 9mm≤ρ1≤11mm. The outer radius of curvature of the optical convex mirror 15 on the posterior capsule 13 is ρ2, and ρ2 satisfies the relationship: 5mm≤ρ2≤7mm. During the process of filling the optical fluid medium, the PMMA film layer of the optical convex mirror 15 at the groove 11 of the anterior capsule 12 and the posterior capsule 13 hardly deforms. By simply adjusting the deformation of the capsule 10, the distance between the PMMA film layer at the groove 11 of the anterior capsule 12 and the PMMA film layer at the groove 11 of the posterior capsule 13 can be changed, thereby adjusting the optical path of the intraocular lens 100 and achieving a change in focus.

[0049] As shown in FIG5 , the capsule 10 has an equator 14 and includes an anterior capsule 12 and a posterior capsule 13. The anterior capsule 12 and the posterior capsule 13 are connected, and the connection between the anterior capsule 12 and the posterior capsule 13 avoids the equator 14. That is, the area of ​​the connection between the anterior capsule 12 and the posterior capsule 13 is smaller than the area of ​​the equator 14. The capsule 10 is an asymmetric ellipsoid, with its diameter increasing from front to back, reaching a maximum value, and then decreasing backward. This maximum value in the middle is the equator 14. Because the location of the equator 14 is prone to stress concentration or slight deformation, which can affect the refractive effect, the connection between the anterior capsule 12 and the posterior capsule 13 avoids the equator 14 to prevent deformation of the capsule 10.

[0050] As shown in FIG7 , the distance d from the connection between the anterior capsule 12 and the posterior capsule 13 to the equator 14 satisfies the relationship: 1 mm ≤ d ≤ 1.5 mm. Specifically, the connection is parallel to the plane of the equator 14 and the distance from the equator 14 ranges from 1 mm to 1.5 mm. The position of the connection can form a seam line 50, which forms an integral ring. The connection between the anterior capsule 12 and the posterior capsule 13 is preferably located on the posterior side of the equator 14, or it can be located on the anterior side of the equator 14, and the choice can be made based on actual conditions. Furthermore, the connection between the anterior capsule 12 and the posterior capsule 13 is located away from the equator 14. Through mechanical analysis, it can reduce stress concentration and obtain good mechanical properties, thereby facilitating adjustment of the refractive effect of the intraocular lens 100.

[0051] Furthermore, as shown in FIG5 , intraocular lens 100 also includes haptics 40 connected to equator 14 . Haptics 40 are used to support lens capsule 10 within the lens capsule and, in conjunction with the movement of the ciliary muscles, adjust the shape of lens capsule 10 to achieve zooming. Haptics 40 can be made of polyvinylidene fluoride (PVDF), polymethyl methacrylate (PMMA), polyimide, acrylate, or the like.

[0052] As shown in Figures 6-8, another embodiment of the present application includes a haptic 40 comprising a front connecting arm 41, a rear connecting arm 42, and a free end 43. The front connecting arm 41 is connected to the outer surface of the front capsule 12, and the rear connecting arm 42 is connected to the outer surface of the rear capsule 13. The ends of the front connecting arm 41 and the rear connecting arm 42 form the free end 43. Furthermore, an angle is formed between the front connecting arm 41 and the rear connecting arm 42. The haptic 40 is Y-shaped as a whole, and the connection between the front connecting arm 41 and the front capsule 12 is located approximately 1 / 2 of the thickness of the front capsule 12. The specific connection position can be verified through mechanical simulation analysis and experiments to find the optimal force-bearing position as the connection position of the haptic 40.

[0053] During diopter adjustment, the angled design of the anterior connecting arm 41 and the posterior connecting arm 42 facilitates balanced force on the capsule 10 during diopter adjustment and allows for controllable deformation, thereby increasing the accuracy and effectiveness of diopter adjustment. Furthermore, the haptic 40 can be manufactured separately from the anterior connecting arm 41 and the posterior connecting arm 42, with the free ends 43 of the anterior and posterior connecting arms 41, 42 then bonded together using silicone. Alternatively, the haptic 40 can be integrally formed using a stainless steel mold and then bonded separately to the anterior capsule 12 and the posterior capsule 13 using silicone, thereby improving the manufacturing efficiency of the intraocular lens 100.

[0054] There are at least two haptics 40, which are evenly distributed about the center of the capsule 10. This can further make the capsule 10 evenly stressed and controllable in deformation, thereby increasing the accuracy and effectiveness of diopter adjustment.

[0055] According to some embodiments of the present application, the intraocular lens 100 further includes a pre-filled filler, which is disposed within the chamber 16. The pre-filled filler is the aforementioned optical fluid medium, which can be injected into the chamber 16 of the capsule 10. The pre-filled filler can be silicone oil, silane, ophthalmic sterile heavy water (perfluorodecalin C10F18), sodium hyaluronate (healon GV), etc., with silicone oil being preferred. During surgery, the chamber 16 of the capsule 10 can be replenished with filler until the desired shape or optical path is achieved.

[0056] Although the embodiments of the present application have been shown and described, those skilled in the art will appreciate that various changes, modifications, substitutions, and variations may be made to the embodiments without departing from the principles and purpose of the present application, and that the scope of the present application is defined by the claims and their equivalents.

Claims

1. An intraocular lens (100), characterized in that, Comprising: A bladder (10) with a chamber (16) formed therein; A sealing valve (20) disposed on the bladder (10), and the sealing valve (20) is a silicone sealing valve (20); And A parylene layer (30) disposed on the outer surface of the sealing valve (20).

2. The intraocular lens (100) according to claim 1, characterized in that, The parylene layer (30) covers the outer surface of the sealing valve (20) and also partially covers the outer surface of the bladder (10).

3. The intraocular lens (100) according to claim 1 or 2, characterized in that, The sealing valve (20) includes an annular body (21) and a body (22). The annular body (21) is disposed on the bladder (10), and the body (22) is disposed within the annular body (21). The hardness of the body (22) is less than that of the annular body (21).

4. The intraocular lens (100) according to claim 3, characterized in that, The parylene layer (30) is disposed on the outer surfaces of both the annular body (21) and the body (22) simultaneously.

5. The intraocular lens (100) according to claim 3 or 4, characterized in that, The annular body (21) is a hard silicone body, and the body (22) is a soft silicone body.

6. The intraocular lens (100) according to claim 5, characterized in that, The hardness of the annular body (21) is between Shore 80A - 90A, and the hardness of the body (22) is between Shore 20A - 40A.

7. The intraocular lens (100) according to any one of claims 3-6, characterized in that, The hardness of the body (22) is less than or equal to the hardness of the bladder (10).

8. The intraocular lens (100) according to any one of claims 1-7, characterized in that, The number of the sealing valves (20) is two, and the number of the parylene layers (30) is two. The two sealing valves (20) and the two parylene layers (30) are arranged in one-to-one correspondence.

9. The intraocular lens (100) according to claim 8, characterized in that, The two sealing valves (20) are symmetrically arranged about the central axis of the bladder (10).

10. The intraocular lens (100) according to any one of claims 1-9, characterized in that, A groove (11) recessed towards the interior of the chamber (16) is provided in the middle of the rear side of the bladder (10), and the sealing valve (20) is spaced apart from the groove (11).

11. The intraocular lens (100) according to any one of claims 1-10, characterized in that, The bladder (10) has an equator (14). The bladder (10) includes a front bladder (12) and a rear bladder (13). The front bladder (12) and the rear bladder (13) are connected, and the connection portion between the front bladder (12) and the rear bladder (13) avoids the equator (14).

12. The intraocular lens (100) according to claim 11, characterized in that, The distance from the connection portion between the front bladder (12) and the rear bladder (13) to the equator (14) is d, and d satisfies the relation: 1mm ≤ d ≤ 1.5mm.

13. The intraocular lens (100) according to claim 11 or 12, characterized in that, The intraocular lens (100) further includes a haptic (40) connected to the equator (14).

Images