CN117860432A

CN117860432A - Intraocular lens

Info

Publication number: CN117860432A
Application number: CN202410011639.3A
Authority: CN
Inventors: 姚阳屹; 陈方; 刘洋; 卞鸣锴
Original assignee: Intellimicro Medical Co ltd
Current assignee: Intellimicro Medical Co ltd
Priority date: 2024-01-03
Filing date: 2024-01-03
Publication date: 2024-04-12

Abstract

The invention discloses an intraocular lens, comprising: the bag body is internally provided with a cavity; the sealing valve is arranged on the bag body and is a silica gel sealing valve; and a parylene layer disposed on an outer surface of the sealing valve. Therefore, the silica gel sealing valve can be self-sealed under the protection of the rigid parylene layer, so that the sealing and leakage-preventing effects can be realized for a long time, the optical fluid medium filled in the capsule body can be prevented from leaking, and the reliability and the safety of the intraocular lens can be ensured.

Description

Intraocular lens

Technical Field

The invention relates to the technical field of ophthalmic medical equipment, in particular to an intraocular lens.

Background

Cataract extraction in combination with intraocular lens implantation remains the only effective means of treating cataract for some time now and in the future. Although the traditional single-focus intraocular lens implanted after cataract surgery can obtain good far vision, the single-focus intraocular lens does not have focusing capability, so that patients generally have presbyopia after surgery, and the requirements of different short-distance work are met by relying on glasses.

The multifocal intraocular lens adopts a unique optical design, can form two or more focuses in the eye simultaneously, and can select different focuses by adjusting the size of pupil after the operation of a patient, thereby meeting the requirements of far vision and near vision, reducing the lens wearing rate of the cataract patient after the operation, but simultaneously having the defects that a plurality of focuses can generate halation and glare for the patient, and the like.

In recent years, many students have attempted to design accommodating intraocular lenses by changing the filling amount of an optical fluid medium (e.g., silicone oil) in the capsular bag or changing the type of optical fluid medium, and thus the shape or optical path of the accommodating intraocular lens itself, to accommodate the refractive power of the intraocular lens. However, how to ensure a long-term seal of the optical fluid medium after the injection is completed is a difficult problem that the person skilled in the art needs to solve.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, an object of the present invention is to propose an intraocular lens which can effectively prevent leakage of the optical fluid medium filled in the capsule.

An intraocular lens according to an embodiment of the present invention includes: the bag body is internally provided with a cavity; the sealing valve is arranged on the bag body and is a silica gel sealing valve; and a parylene layer disposed on an outer surface of the sealing valve.

Thus, the intraocular lens may change the shape or optical path of the intraocular lens itself by filling the capsule with an optical fluid medium or changing the type of optical fluid medium, thereby allowing the refractive power of the intraocular lens to be adjusted. Further, the silica gel sealing valve can be self-sealed under the protection of the rigid parylene layer, so that the sealing and leakage-preventing effects can be realized for a long time, the optical fluid medium filled in the capsule body can be prevented from leaking, and the reliability and the safety of the intraocular lens can be ensured.

According to some embodiments of the invention, the parylene layer covers an outer surface of the sealing valve and also partially covers an outer surface of the bladder.

According to some embodiments of the invention, the sealing valve comprises: the device comprises a ring body and a body, wherein the ring body is arranged on the bag body, the body is arranged in the ring body, and the hardness of the body is smaller than that of the ring body.

According to some embodiments of the invention, the parylene layer is disposed on both the ring body and the outer surface of the body.

According to some embodiments of the invention, the ring body is a hard silica gel and the body is a soft silica gel.

According to some embodiments of the invention, the hardness of the ring body is between shore 80A-90A and the hardness of the body is between shore 20A-40A.

According to some embodiments of the invention, the hardness of the body is less than or equal to the hardness of the bladder.

According to some embodiments of the invention, 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.

According to some embodiments of the invention, the two sealing valves are symmetrically disposed about a central axis of the bladder.

According to some embodiments of the invention, the capsule has an equator, the capsule comprising: the device comprises a front bag body and a rear bag body, wherein the front bag body is connected with the rear bag body, and the equator is avoided at the connecting position of the front bag body and the rear bag body.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

The foregoing and/or additional aspects and advantages of the invention will become apparent and may be better understood from the following description of embodiments taken in conjunction with the accompanying drawings in which:

FIG. 1 is a cross-sectional view of an intraocular lens according to an embodiment of the present invention;

FIG. 2 is a cross-sectional view of an intraocular lens according to an embodiment of the present invention containing two sealing valves;

FIG. 3 is a cross-sectional view of an intraocular lens according to an embodiment of the present invention containing a groove;

FIG. 4 is a cross-sectional view of an intraocular lens incorporating an optical convex lens according to an embodiment of the present invention;

FIG. 5 is a schematic representation of an intraocular lens according to an embodiment of the present invention containing haptics;

FIG. 6 is a schematic view of an intraocular lens separation according to an embodiment of the present invention;

FIG. 7 is a schematic view of the configuration of the cooperation of the front and rear bladders in accordance with an embodiment of the invention;

FIG. 8 is a cross-sectional view of the cooperation of the front and rear bladders in accordance with an embodiment of the invention;

fig. 9 is a schematic view of an intraocular lens according to an embodiment of the present invention in an eye.

Reference numerals:

100. an intraocular lens;

10. a bladder; 11. a groove; 12. a front balloon; 13. a rear bladder; 14. an equator; 15. an optical convex lens;

20. a sealing valve; 21. a ring body; 22. a body;

30. parylene layer;

40. a haptic body; 41. a front connecting arm; 42. a rear connecting arm; 43. a free end;

50. and (5) a seam line.

Detailed Description

Embodiments of the present invention will be described in detail below, with reference to the accompanying drawings, which are exemplary.

An intraocular lens 100 according to an embodiment of the present invention is described below with reference to fig. 1-9, comprising: the capsule body 10, the sealing valve 20 and the parylene layer 30, wherein a cavity is formed in the capsule body 10, the sealing valve 20 is arranged on the capsule body 10, the sealing valve 20 is a silica gel sealing valve 20, and the parylene layer 30 is arranged on the outer surface of the sealing valve 20. The capsule body 10 may be made of silica gel, silicone, fluorosilane, hydrophilic or hydrophobic acrylate, preferably silica gel.

Specifically, as shown in fig. 1, a valve hole is provided in the capsule 10, and a sealing valve 20 is provided in the valve hole. The outer surface of the sealing valve 20 is provided with a parylene layer 30 (preferably parylene C, and a vapor deposition process may be adopted), the young's modulus and hardness of the parylene layer 30 are obviously higher than those of the silica gel sealing valve 20, and the adhesion between the parylene layer 30 and the silica gel sealing valve 20 is better, which is equivalent to a reinforcing baffle plate outside the silica gel sealing valve 20. Therefore, after the injection needle is withdrawn, the optical fluid medium (silicone oil) in the sealing valve 20 can generate an outward pressure on the silicone sealing valve 20, and the outward pressure can enable the silicone sealing valve 20 to self-close under the protection of the rigid parylene layer 30, so that the sealing and leakage-preventing effects can be realized for a long time.

The intraocular lens 100 of the present embodiment may change the shape or optical path of the intraocular lens 100 itself by filling the capsule 10 with an optical fluid medium or changing the type of optical fluid medium, thereby allowing the diopter adjustment of the intraocular lens 100. Further, the arrangement of the sealing valve 20 and the parylene layer 30 on the capsule body 10 can prevent the optical fluid medium filled in the capsule body 10 from leaking, and can also prevent the capsule body 10 from deforming and concentrating stress, thereby ensuring the reliability and safety of the intraocular lens 100.

As shown in fig. 1, 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 10, which increases the contact area between the parylene layer 30 and the sealing valve 20 and can avoid stress concentration at the junction of the sealing valve 20 and the bladder 10.

The sealing valve 20 includes: ring body 21 and body 22, ring body 21 sets up on the bag body 10, and body 22 sets up in ring body 21, and the hardness of body 22 is less than the hardness of ring body 21. The body 22 is preferably circular and the ring body 21 is preferably circular. When it is desired to inject the optical fluid medium from the inside of the sealing valve 20, the hardness of the body 22 is small, so that the injection needle can be conveniently introduced into the capsule 10, and sealing is more easily achieved after the injection needle is withdrawn, preventing the optical fluid medium from leaking. The hardness of the body 22 is high, so that deformation and stress concentration on the capsule body 10 during injection can be avoided, and the injection is simpler and more reliable.

The parylene layer 30 is disposed on the outer surfaces of the ring body 21 and the body 22 at the same time, and the contact area is larger. Preferably, the ring body 21 is a hard silica gel body, the body 22 is a soft silica gel body, and the soft silica gel body and the hard silica gel body can be organically combined to form a closed whole. Specifically, the hardness of the ring body 21 is between shore 80A and shore 90A, and the hardness of the body 22 is between shore 20A and shore 40A, so that the body 22 and the capsule 10 can be prevented from being deformed. Further, the hardness of the body 22 may be less than or equal to the hardness of the bladder 10. Preferably, the body 22 and the capsule 10 are made of the same material, so that the processing and the manufacturing are convenient.

As shown in fig. 2, the number of sealing valves 20 is two, the number of parylene layers 30 is two, and the two sealing valves 20 and the two parylene layers 30 are arranged in one-to-one correspondence. The number of the sealing valves 20 is two, one can be used for injection, and the other can be used as a valve body for compensation and balancing in mechanics. Moreover, the two sealing valves 20 can be arranged at different positions on the capsule body 10, so that different injection paths can be formed, and the injection can be performed in different directions, thereby being convenient for flexible operation. Preferably, the two sealing valves 20 are symmetrically disposed about the central axis of the capsule 10, so that the optical area of the upper surface of the capsule 10 is uniformly deformed.

As shown in fig. 3, a groove 11 recessed toward the chamber is provided in the middle of the rear side of the bladder 10, and a sealing valve 20 is provided at a distance from the groove 11. The provision of grooves 11 reduces tissue contact of the intraocular lens 100 with the posterior wall of the lens capsule and avoids the effects of allograft tissue proliferation. The light path sealing valve 20 is spaced from the groove 11, and stress concentration can be further avoided.

As shown in fig. 5 and 6, the capsule 10 includes: the front bag body 12 and the rear bag body 13, the front bag body 12 and the rear bag body 13 are connected, the sealing valve 20 is arranged on the front bag body 12, and the middle part of the rear bag body 13 is provided with a groove 11. The anterior capsule 12 and the posterior capsule 13 may be integrally formed by bonding, and integrally form a near-ellipsoidal structure of the human lens.

In addition, the middle of the front bladder 12 may also be provided with a groove 11. Wherein, the middle part of the anterior capsule body 12 is concavely arranged inwards to form a groove 11, and the space area of the inward concave groove 11 can reduce the tissue contact with the anterior wall of the lens capsule, thereby avoiding affecting the light path.

The groove 11 may be formed by a silicone membrane layer having an initial degree, and the silicone membrane layer may be slightly deformed by the liquid filled in the capsule 10, so that the degree of the whole intraocular lens 100 may be adjusted. As shown in fig. 4, the bottom of the groove 11 of the front capsule 12 and/or the rear capsule 13 is configured as an optical convex lens 15, and the optical convex lens 15 can help focusing, and can be set according to actual needs.

The optical convex lens 15 is preferably a PMMA (polymethyl methacrylate-polymethyl methacrylate) film layer, has the characteristics of high transparency and low refractive index, and has the hardness of between 80A and 90A, so that the PMMA film layer can be prevented from being deformed.

The outer radius of curvature of the optical convex mirror 15 on the front capsule 12 is ρ1, ρ1 satisfies the relation: the outer curvature radius of the optical convex mirror 15 on the rear capsule body 13 is ρ2, and ρ2 satisfies the relation: ρ2 is less than or equal to 5mm and less than or equal to 7mm. In the process of filling the optical fluid medium, the PMMA film layer of the optical convex lens 15 at the grooves 11 of the front capsule body 12 and the rear capsule body 13 is hardly deformed, and the distance between the PMMA film layer at the grooves 11 of the front capsule body 12 and the PMMA film layer at the grooves 11 of the rear capsule body 13 can be changed only by adjusting the deformation of the capsule body 10, so that the optical path of the intraocular lens 100 can be adjusted, and the focus change is realized.

As shown in fig. 6, the capsule 10 has an equator 14, and the capsule 10 includes: the front bag body 12 and the rear bag body 13 are connected, the connection part of the front bag body 12 and the rear bag body 13 avoids the equator 14, namely the connection part of the front bag body 12 and the rear bag body 13 has an area smaller than the area of the equator 14. The whole of the capsule body 10 is in an asymmetric ellipsoid shape, the radial line from front to back is continuously increased, the radial line is reduced after reaching the maximum value, the middle maximum value is the equator 14, and the equator 14 is easy to generate stress concentration or slight deformation so as to influence the refraction effect, so that the connection between the front capsule body 12 and the rear capsule body 13 is arranged by avoiding the equator 14, and the deformation of the capsule body 10 can be avoided.

As shown in fig. 7, the distance d from the equator 14 at the junction of the front capsule body 12 and the rear capsule body 13 satisfies the relationship: d is more than or equal to 1mm and less than or equal to 1.5mm. Specifically, the junction is parallel to the plane of the equator 14 and the distance from the equator 14 is in the range of 1mm to 1.5mm, the junction may be positioned to form a seam line 50, the seam line 50 is formed in an overall annular shape, and the junction of the anterior capsule 12 and the posterior capsule 13 is preferably disposed on the posterior side of the equator 14 or on the anterior side of the equator 14, and may be selected according to the circumstances. Further, the junction of the anterior capsule 12 and the posterior capsule 13 is set so as to avoid the equator 14, and stress concentration can be reduced and good mechanical properties can be obtained by mechanical analysis, so that the refractive effect of the intraocular lens 100 can be adjusted easily.

Further, as shown in fig. 5, the intraocular lens 100 further includes: a haptic body 40, the haptic body 40 being attached to the equator 14. The haptics 40 serve to support the capsule 10 within the lens capsule, and in connection with the action of the ciliary muscle, adjust the shape of the capsule 10, and perform a zooming action. Haptic 40 may be made from polyvinylidene fluoride (PVDF), polymethyl methacrylate (PMMA), polyimide, acrylic, and the like.

As shown in FIGS. 6-8, a haptic body 40 of another embodiment of the present invention comprises: front connecting arm 41, back connecting arm 42 and free end 43, front connecting arm 41 connects on the surface of preceding bag body 12, back connecting arm 42 connects on the surface of back bag body 13, the tip of front connecting arm 41 and back connecting arm 42 forms free end 43, moreover, has the contained angle between front connecting arm 41 and the back connecting arm 42. The whole haptic body 40 is Y-shaped, the joint of the front connecting arm 41 and the front bag body 12 is positioned near the 1/2 position of the thickness of the front bag body 12, and the specific joint position can be verified by mechanical simulation analysis and experiments, so that the optimal stress position can be found out as the joint position of the haptic body 40.

In the refraction adjustment, the structural design that the front connecting arm 41 and the rear connecting arm 42 have included angles can be beneficial to the balance of stress of the capsule body 10 in the refraction adjustment, and the deformation can be controlled, so that the accuracy and the effectiveness of the refraction adjustment can be improved. Further, the haptic body 40 may be formed separately into anterior and posterior connecting arms 41, 42, with the free ends 43 of the anterior and posterior connecting arms 41, 42 then bonded together with silicone, or the haptic body 40 may be formed integrally with stainless steel molds, and then bonded to the anterior and posterior capsules 12, 13, respectively, with silicone to enhance the efficiency of the intraocular lens 100.

The number of haptics 40 is at least two with at least two haptics 40 being evenly distributed about the center of the capsule 10. In this way, the capsule 10 can be further stressed uniformly, and deformation controllability can be realized, so that the accuracy and the effectiveness of refractive adjustment can be increased.

According to some embodiments of the present invention, intraocular lens 100 further comprises: the prefill filling is arranged in the cavity. Among them, the prefilled material, that is, the above-mentioned optical fluid medium, may be introduced into the chamber of the capsule body 10 by injection, and silicone oil, silicone methane, sterile heavy water for ophthalmic use (perfluorodecalin C10F 18), sodium hyaluronate (sealon GV), and the like may be selected as the prefilled material, and silicone oil is preferable. Wherein, during operation, the cavity of the bag body 10 can be supplemented with filling materials until the set shape or the light path is met.

While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. An intraocular lens, comprising:

the bag body is internally provided with a cavity;

the sealing valve is arranged on the bag body and is a silica gel sealing valve; and

and the parylene layer is arranged on the outer surface of the sealing valve.

2. The intraocular lens of claim 1, wherein the parylene layer overlies an outer surface of the sealing valve and also partially overlies an outer surface of the capsule.

3. The intraocular lens of claim 1, wherein the sealing valve comprises: the device comprises a ring body and a body, wherein the ring body is arranged on the bag body, the body is arranged in the ring body, and the hardness of the body is smaller than that of the ring body.

4. The intraocular lens of claim 3, wherein the parylene layer is disposed on both the annulus and the outer surface of the body.

5. The intraocular lens of claim 3 wherein the ring body is a hard silicone body and the body is a soft silicone body.

6. The intraocular lens of claim 5, wherein the ring body has a hardness of between 80 shore a-90A and the body has a hardness of between 20 shore a-40A.

7. The intraocular lens of claim 3, wherein the hardness of the body is less than or equal to the hardness of the capsule.

8. The intraocular lens according to any one of claims 1 to 7, wherein the number of sealing valves is two, the number of parylene layers is two, and two sealing valves and two parylene layers are arranged in one-to-one correspondence.

9. The intraocular lens of claim 8, wherein two of said sealing valves are symmetrically disposed about a central axis of said capsule.

10. The intraocular lens according to any one of claims 1 to 7, wherein the capsule has an equator, the capsule comprising: the device comprises a front bag body and a rear bag body, wherein the front bag body is connected with the rear bag body, and the equator is avoided at the connecting position of the front bag body and the rear bag body.