The structure of the lens in the eye

By designing an intraocular lens structure with posterior and anterior support, the problem of difficulty in fixing existing IOLs in the capsule bag is solved, and more stable fixation and safe positioning is achieved, reducing damage to the capsule bag.

CN105722475BActive Publication Date: 2025-05-16TELEON HLDG BV
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Patent Information

Application Number
CN201480043123.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2014-04-18
Filing Date
2014-07-28
Publication Date
2025-05-16
Estimated Expiration
2034-07-28

AI Technical Summary

Technical Problem

Placement of existing intraocular lens structures (IOLs) can be very difficult and can easily damage the capsule, resulting in the IOLs not maintaining a stable position.

Method used

A new IOL structure is designed, including an optical structure and a support, with a perimeter around the optical structure, the rear and front support connected to the perimeter of the optical structure and extending outward from the perimeter to provide a support surface engaging the capsule cover to ensure that the IOL is secured in the capsule.

Benefits of technology

With this structure, the IOL can be more stable in the capsule, reducing damage to the capsule, and allowing safe positioning and optimal alignment of the optical structure, avoiding capsule rupture and IOL dislocation.

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Abstract

The present invention provides an intraocular lens structure (IOL) for placement in a capsular bag, wherein the IOL is fixed in an opening in the front of the capsular bag, and its front capsular bag cover surrounds the opening, wherein the IOL has a front side and a rear side, wherein the front side faces the cornea when in use when the IOL is implanted in the eye, and the rear side faces the retina when in use when the IOL is implanted in the eye; the IOL comprises: an optical structure; at least two rear supports, wherein the rear supports are located in the capsular bag and extend outwardly from the optical structure when the IOL is implanted in the capsular bag, and wherein the rear supports are adapted to provide a support surface for the rear surface of the front capsular bag cover when in use; and at least two front supports, wherein the front supports are located outside the capsular bag and extend outwardly from the optical structure when the IOL is implanted in the capsular bag, and wherein the front supports are adapted to provide a support surface for the front surface of the front capsular bag cover when in use.
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Description

Technical Field

[0001] The present invention relates to intraocular lens structures (IOLs), and methods for inserting such IOLs. Background Art

[0002] In modern cataract surgery, which is also called extracapsular cataract extraction, a hole is cut in the anterior capsular bag. This can be done using a laser device. Subsequently, the natural lens is removed. In many proposed procedures, an IOL is placed in the remaining part of the capsular bag. The IOL is located almost in the empty bag.

[0003] Typically, an IOL is provided with haptics that extend radially from the lens of the IOL. After implantation of the IOL, the haptics typically engage the inner periphery of the remaining capsular bag portion to substantially center and position the optics (e.g., lens) of the IOL in the capsular bag.

[0004] In order to improve the fixation of the IOL position, many designs have been proposed. US6027531 describes in its abstract "an intraocular lens for extracapsular cataract extraction, having a haptic portion surrounding the optical portion of the lens, and also comprising a groove having a shape that can adapt to the anterior and posterior capsules of the lens bag after anterior capsulotomy, extracapsular cataract extraction and posterior capsulotomy. The lens is preferably inserted in a calibrated, circular and continuously combined anterior and posterior capsule tear, which is slightly smaller than the inner circumference of the groove to cause an extension of the edge of the capsule opening. This new method is believed to prevent the occurrence of secondary opacification of the capsule, fix the intraocular lens very stably and ensure a close separation between the anterior and posterior segments of the eye. This new insertion principle is called the bag-in-the-lens technique, as opposed to the classic lens in-the-bag technique". Placing such an IOL requires skill, and the capsular bag may be damaged. If the capsular bag ruptures after insertion, the IOL will not maintain its position.

[0005] In US6881225, an intraocular lens structure for reducing complications is described. According to the abstract, the intraocular lens structure includes an optical element, a support and a closed fixture. The closed fixture is a groove or valley formed on the side portion of the optical element of the intraocular lens. The valley is formed by the optical element and a protrusion extending from the rear of the optical element. The groove or valley in the optical element is engaged with the posterior capsule opening, which usually exceeds the entire circumference of the groove or valley, to close the posterior capsule opening. Like most current IOL structures, the structure also uses its tentacles to keep the structure in the capsular bag. The groove fixes the rear of the capsular bag.

[0006] US5171320 describes in its abstract an intraocular lens system adapted to be implanted in a generally circular opening in the anterior wall of a capsular bag, which generally contains the lens of the eye. The intraocular lens system comprises a lens body having an annular groove formed in a peripheral portion of the lens body in a plane substantially perpendicular to the optical axis of the lens body. The lens body comprises an optically active portion radially located inside the annular groove, and an anterior lens portion and a posterior lens portion located in front of and behind the annular groove, respectively. The intraocular lens system is fixed in position in the circular opening so that an annular flap portion of the capsular bag surrounding the circular opening adapts to the annular groove in the lens body.

[0007] EP2422746 discloses, according to its abstract, an intraocular implant placed in the eye (e.g. as part of cataract surgery or lens removal refractive surgery) having a groove in the peripheral portion of the implant, the groove engaging the edge of a single capsule formed only in the lens capsule of the eye. The implant is typically a lens, but may also be replaced by a cap or plug to block an opening made in the capsule. The groove may be a continuous groove around the implant, or may form a series of separate spatially separated grooves in the form of protrusions extending from the periphery. Instead of a single groove, a pair of axially spatially separated grooves may be provided, the pair of grooves engaging the capsule formed in the front and rear of the capsule, respectively. Preferably, the average diameter of the rear groove is smaller than the front groove. The specification shows an embodiment, namely "a series of protrusions extending from the periphery of the lens portion", referring to a very specific embodiment in the drawings. Summary of the invention

[0008] A disadvantage of the prior art is that placement of the IOL may be very difficult, there is a high probability of damaging the capsular bag during the medical procedure, or damaging the capsular bag after placement of the IOL, or there is still room for improvement.

[0009] Therefore, one aspect of the present invention is to provide an alternative IOL, which preferably further at least partially avoids one or more of the above-mentioned drawbacks. Specifically, the IOL of the present invention allows for proper and direct placement. In addition, it is less damaging to the capsular bag and allows for secure positioning.

[0010] The present invention provides an intraocular lens structure (IOL) for placement in a capsular bag, the IOL being fixed in an opening in the front of the capsular bag, with its anterior capsular bag cover surrounding the opening; the IOL having an anterior side and a posterior side, the anterior side facing the cornea in use when the IOL is implanted in the capsular bag of the eye, and the posterior side facing the retina of the eye in use when the IOL is implanted in the capsular bag of the eye. The IOL may include an optical structure including a perimeter. The IOL may also include at least two posterior supports connected to the perimeter of the optical structure and extending outwardly from the perimeter of the optical structure. The posterior supports are provided for providing a support surface to engage the posterior surface of the anterior capsular bag cover in use. When the IOL is implanted in the capsular bag, the posterior supports are located inside the capsular bag in use.

[0011] The IOL may further comprise at least two anterior supports connected to and extending from the periphery of the optical structure, which are located outside the capsular bag and extend outwardly from the optical structure when in use. The anterior supports are adapted to provide a support surface to engage the anterior surface of the anterior capsular bag cover when in use.

[0012] In one embodiment, the posterior plane is defined by the support surface of the posterior support, and the anterior plane is defined by the support surface of the anterior support. These planes are adapted to be separated by a distance in use, the distance being suitable for holding the anterior capsular cover between these surfaces to secure the IOL in the opening.

[0013] It has been found that due to the geometry and limited depth (about 0.2 mm) of the peripheral groove of the prior art, in known IOLs, the anterior capsule cover can easily break away from the groove, resulting in IOL dislocation. In addition, due to the geometry of the groove in the prior art, the rotational stability of the lens structure may not be optimal.

[0014] The IOL can be inserted into the capsular bag. The anterior and posterior supports allow the IOL to be fixed in the capsular bag, with the optical structure of the IOL aligned with the opening, in particular the hole or aperture.

[0015] The terms "anterior" and "posterior" refer to the arrangement of features relative to the propagation of light into the eye. Thus, light enters the cornea and passes through the iris via the pupil. The cornea and iris are considered the anterior of the eye in this article. The light then propagates to the retina, which is located at the back of the eye.

[0016] The axis of an eye may be the optical axis, or may be the visual axis, line of sight, or pupil axis.

[0017] The eye has a capsular bag which normally holds the natural lens. In the event that the natural lens needs to be removed, the empty capsular bag remains. Typically, in order to remove the natural lens, an opening is first made in the front of the capsular bag. Part of the capsular bag membrane is removed. A through hole is left which is surrounded by a peripheral edge defining the perimeter. Such an opening may be circular or oval, for example. A front capsular bag membrane having a hole is thus provided, thereby providing an orifice to enter the capsular bag.

[0018] The portion of the capsular bag closest to the cornea is also referred to herein as the anterior capsular bag. The remaining anterior capsular bag surrounding the mentioned opening is referred to as the anterior capsular bag lid. It can also be considered as a ring of the capsular bag membrane.

[0019] The capsular bag also has a posterior portion. This is the portion of the capsular bag closest to the retina. The average capsular bag thickness for the posterior portion of the capsular bag is 4 to 9 microns, and the average capsular bag thickness for the anterior portion of the capsular bag is 10 to 20 microns.

[0020] In surgery to remove the natural lens, a laser cutting device can be used to make an opening in the anterior capsule bag. This surgery to make an opening in the capsule bag is also called a crystalline capsule cut. This laser-assisted surgery allows very accurate positioning and shape of the opening in the capsule bag. In addition, after the natural lens is removed, an opening can then be made in the back of the capsule bag - the posterior opening. This prevents postoperative opacification of the posterior capsule. The two openings can be accurately aligned. The shape of the posterior opening can be smaller than the anterior capsule cut. The shape of the opening can match the shape of the periphery of the IOL (or more accurately, the periphery around the optical structure of the IOL). Therefore, the IOL can perfectly match the opening. Ultimately, the opening can perfectly match the optical axis of the eye. In addition, if the optical axis of the IOL is aligned at a predetermined position in the periphery of the IOL, the optical structure of the IOL can be positioned in the eye in an optimal manner. Therefore, the optical elements of the optical structure can be aligned in a predetermined manner in the eye. For example, the optical axis can be aligned, but other predetermined configurations are also possible, for example, taking into account the quality of the retinal portion.

[0021] The support surfaces can be bounded areas on the front and rear supports, respectively, that engage the pouch surfaces. In one embodiment, at least one front support includes a rear side that substantially completely engages the front surface of the pouch front. In one embodiment, at least one rear support includes a front side that substantially completely engages the rear surface of the pouch front.

[0022] In one embodiment, the IOL comprises a depression in the periphery, providing an axially extending groove in the surrounding surface of the periphery.

[0023] The recess provides an axial fluid passage. The recess is substantially axial. The recess allows fluid communication through the eye.

[0024] The present invention also relates to an intraocular lens structure (IOL) for placement in a capsular bag, the IOL being fixed in an opening in the front of the capsular bag, the anterior capsular bag cover at least partially surrounding the opening; the IOL having an anterior side and a posterior side, the anterior side being directed towards the cornea in use when the IOL is implanted in the eye, and the posterior side being directed towards the retina of the eye in use when the IOL is implanted in the eye, the IOL comprising:

[0025] - Optical structure;

[0026] - at least two posterior supports located in the capsular bag and extending outwardly from the optical structure when the IOL is implanted in the capsular bag, the posterior supports being adapted to provide a support surface for engaging a posterior surface of the anterior capsular bag cover in use, and

[0027] at least two anterior supports, which are located outside the capsular bag and extend outwardly from the optical structure when the IOL is implanted in the capsular bag, the anterior supports being adapted to provide a support surface for engaging an anterior surface of an anterior capsular bag cover in use,

[0028] Wherein a posterior plane defined by the support surface of the posterior support and an anterior plane defined by the support surface of the anterior support are adapted to be separated by a distance in use, the distance being suitable for retaining the anterior capsular bag cover between these surfaces to secure the IOL in the opening.

[0029] The present invention also relates to an intraocular lens structure (IOL) for placement in a capsular bag, the IOL being fixed in an opening in the front of the capsular bag, the front capsular bag cover surrounding the opening, the IOL having an anterior side and a posterior side, the anterior side being directed towards the cornea in use when the IOL is implanted in the eye, and the posterior side being directed towards the retina of the eye in use when the IOL is implanted in the eye, the IOL comprising:

[0030] - Optical structure;

[0031] - at least two posterior supports located in the capsular bag and extending outwardly from the optical structure when the IOL is implanted in the capsular bag, the posterior supports being adapted to provide a support surface for engaging a posterior surface of the anterior capsular bag cover in use, and

[0032] at least two anterior supports, which are located outside the capsular bag and extend outwardly from the optical structure when the IOL is implanted in the capsular bag, the anterior supports being adapted to provide a support surface for engaging an anterior surface of an anterior capsular bag cover in use,

[0033] Wherein the IOL comprises a depression in the periphery, providing an axially (A) extending groove in the peripheral surface of the periphery. The axially extending groove provides a fluid passageway allowing passage of ocular fluid.

[0034] In one embodiment, the IOL is one part. In one embodiment, the IOL is made of a polymer material. In one embodiment, the IOL is foldable. The polymer material allows the IOL to be rolled into a roll with a diameter less than 2.5 mm. In order to clamp the front of the capsular bag, at least the front support is flexible, allowing the IOL to be inserted into the capsular bag, and then the front support is passed through the opening of the front of the capsular bag and engaged with its front surface. In practice, this allows the IOL to be kept in place.

[0035] In one embodiment, at least two rear supports extending outwardly from the optical structure are located in functionally opposite directions to each other. In one embodiment, at least two front supports extending outwardly from the optical structure are located in functionally opposite directions to each other.

[0036] In one embodiment, the front plane and the rear plane are spaced 5-100 microns apart, particularly when the capsular bag is clamped during use. In particular, the rear plane and the front plane are spaced 5-70 microns apart, more particularly 5-50 microns apart.

[0037] If the support surfaces are substantially parallel, this distance allows the front pocket cover to be clamped.

[0038] The rear support or at least its support surface may be at an angle to the front side of the IOL. In this way, after implantation in the capsular bag, the rear support can rest against the rear surface of the capsular bag lid. The angle at which the rear support is located may be up to 10°.

[0039] Alternatively or in combination, the front support or at least its support surface may be at an angle to the rear side of the IOL. In this way, after implantation in the capsular bag, the front support can rest against the front surface of the capsular bag lid. The angle of the front support may be up to 10°.

[0040] In summary, the posterior support and the anterior support thus provide support surfaces which are positioned (particularly spaced at a distance) suitable for holding the anterior capsular bag lid between them. Prior to insertion of the IOL (particularly prior to positioning the IOL in the capsular bag), the one or more anterior support surfaces in the axial direction may thus even be located behind the one or more posterior support surfaces. Once the IOL is implanted and positioned, the support surfaces will hold the anterior capsular bag lid between them.

[0041] In one embodiment, the rear support and the front support are displaced relative to each other in the perimetricalsense or azimuthal direction. This makes manufacturing easier, in particular using techniques such as tooling or moulding. Furthermore, it allows simpler placement and fixing in the capsular bag opening.

[0042] In one embodiment, the rear support and the front support extend in the peripheral direction or azimuthal direction of the optical structure, thereby providing good support of the capsular cover and even fixing the IOL.

[0043] In one embodiment, the rear support and the front support do not overlap. In fact, when viewed from the front side, if the front and rear supports do not overlap, the stamping can be simplified. In addition, the distance between the front plane and the rear plane can be even smaller. In fact, the support surface of the front support can be displaced beyond the support surface of the rear support by -100 microns. In one embodiment, the displacement can be -70 microns. In particular, when the rear support and the front support are elastic, the rear support and the front support can clamp the capsular bag cover between them, thereby fixing the IOL in the opening. Therefore, when the supports do not overlap, the distance between the front plane and the rear plane can be -100 to 100 microns. In one embodiment, the distance can be -70 to 100 microns. In particular, the distance can be -70 to 70 microns. A negative value means that the front support can be placed in a further rearward direction, beyond the rear support, when not in use. However, in use, when the bladder is secured, the front support will be located at the front of the front of the bladder and the rear support will be located at the rear of the front of the bladder.

[0044] In one embodiment, the IOL comprises a peripheral surface surrounding the optical structure, and a posterior support and an anterior support extending from the peripheral surface. Specifically, the peripheral surface defines a radial surface for engaging a peripheral edge of the anterior capsule cover defining the perimeter of the opening when it is implanted.

[0045] This can provide alignment of the IOL. For example, if the opening is not circular, such as an ellipse, and the perimeter of the IOL matches the opening shape, the azimuthal direction of the IOL can be fixed. Thus, a specific optical structure can be aligned.

[0046] In one embodiment, at least one selected from the rear support and the front support is a tentacle. In particular, the outer diameter of the tentacle is 8-12 mm.

[0047] It has been found that the IOL thus fits into the capsular bag. It can act as a fail-safe if it is misaligned with the opening.

[0048] In one embodiment, the IOL is formed in one piece and has a thickness and flexibility suitable for inserting the IOL into the eye in a folded manner via microinsertion.

[0049] In one embodiment, the IOL further comprises a peripheral groove located at least partially behind the posterior support. In particular, when the IOL is implanted in the eye, the posterior groove is radially open to receive at least one edge of the posterior capsular bag cover surrounding the posterior opening of the posterior portion of the capsular bag. In one embodiment, the posterior groove has a depth of 0.1 to 0.3 mm. In particular, the posterior groove has a width of 0.05-0.2 mm. More particularly, the posterior groove is tapered.

[0050] The present invention also relates to a method of securing an intraocular structure (IOL) as described above in an eye, wherein the IOL has a periphery around the optical structure, the method comprising:

[0051] - forming an opening in the anterior capsular bag of the eye, the contour of the opening matching the periphery of the IOL, the opening being surrounded by the anterior capsular bag cover remaining after forming the opening;

[0052] - inserting the IOL into the eye with the posterior support extending in the capsular bag; and

[0053] - removing the anterior support from the capsular bag, the anterior support surface resting on the anterior surface of the remaining anterior part of the capsular bag surrounding the opening, and leaving the posterior support inside the capsular bag, the remaining part of the anterior part of the capsular bag surrounding the opening between the anterior and posterior supports, thereby fixing the IOL in the opening in the anterior part of the capsular bag. The opening may also be formed in a separate step. The method thus only involves the placement of the IOL.

[0054] In one embodiment of the method, the opening is aligned with the eye axis and / or with the optical structure of the IOL. If the optical structure is a lens, it is usually aligned with the optical axis of the lens.

[0055] In one embodiment of the method, the opening is aligned with the axis and / or azimuthal axis of the eye, and the optical axis and / or azimuthal axis of the optical structure of the IOL.

[0056] In one embodiment of the method, the opening is circular with its center aligned with the axis of the eye, and / or the optical structure comprises an optical axis aligned with the periphery of the IOL.

[0057] In one embodiment of the method, the perimeter is circular.

[0058] In one embodiment of the method, the pouch further comprises a rear portion, the method further comprising:

[0059] - forming a rear opening at the rear of the pouch, the rear opening being surrounded by the rear pouch cover remaining after forming the rear opening;

[0060] - When the IOL is fixed in the anterior opening of the capsular bag, the IOL is pushed in the posterior direction in the direction of the retina of the eye until the inner periphery of the posterior capsular bag cover defining the posterior opening surrounds the posterior groove in the IOL and it at least partially surrounds the optical structure behind the posterior support, thereby fixing it. Thus, the posterior capsular bag cover is fixed to the IOL, located behind the posterior support.

[0061] In one embodiment, the IOL comprises a depression in the periphery, providing an axially extending groove in the surrounding surface of the periphery.

[0062] In one embodiment, the recess is located between the posterior support and the anterior support. When positioned in the opening of the capsular bag, as explained, the peripheral edge of the capsular bag will be located around the periphery of the IOL. The recess will then provide a channel for the fluid.

[0063] Those skilled in the art will understand the term "substantially" herein, for example in "substantially the opposite" or "consisting essentially of". The term "substantially" may also include embodiments of "exhaustively", "completely", "entirely", etc. Therefore, in embodiments, the adverb "substantially" may also be removed. Where applicable, the term "substantially" may also relate to 90% or higher, such as 95% or higher, in particular 99% or higher, even more particularly 99.5% or higher, including 100%. The term "comprising" also includes embodiments in which the term "comprising" means "consisting of".

[0064] A person skilled in the art will understand the term "functionally" herein, for example in "functionally opposite". The term includes, for example, completely opposite, but also includes deviations from the exact positioning, as long as in operation, the feature functionally manifests or has, for example, a substantially opposite effect. The term "functionally" may therefore also include embodiments of "completely", "completely", "all", etc. Therefore, in embodiments, the adverb "functionally" may also be removed. Where applicable, the term "functionally" may also relate to 90% or higher, such as 95% or higher, in particular 99% or higher, even more in particular 99.5% or higher, including 100%.

[0065] In addition, the terms first, second, third, etc. in the specification and claims are used to distinguish between similar elements, and are not necessarily used to describe a sequential or temporal order. It should be understood that the terms used in this way are interchangeable where appropriate, and the embodiments of the invention described herein can be implemented in a sequence different from that described or illustrated herein.

[0066] The devices or apparatuses herein are located within other devices or apparatuses described in the implementation process. It is obvious to those skilled in the art that the present invention is not limited to the implementation method or the apparatus in the implementation.

[0067] It should be noted that the above-mentioned embodiments illustrate rather than limit the present invention, and those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses should not be construed as limiting the claims. The use of the verb "comprise" and its variations does not exclude the presence of elements or steps other than those described in the claims. The article "a" or "an" before an element does not exclude the presence of a plurality of said elements.

[0068] The fact that certain steps are recited only in mutually different dependent claims does not indicate that a combination of these steps cannot be used to advantage. Indeed, many features of current IOLs can be combined to further improve simple implantation or fixation.

[0069] The present invention also applies to a device or apparatus comprising one or more characteristic features described in the specification and / or shown in the drawings. The present invention also relates to a method or process comprising one or more characteristic features described in the specification and / or shown in the drawings.

[0070] The various aspects discussed in this patent may be combined to provide other advantages. In addition, some features may form the basis of one or more divisional applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference numerals indicate corresponding parts and in which:

[0072] Figure 1 An embodiment of an IOL front view is schematically depicted;

[0073] Figure 2 express Figure 1 side view of the embodiment;

[0074] Figure 3 Indicates Figure 2 Details;

[0075] Figure 4 express Figure 1 An embodiment showing a perspective view of the front side;

[0076] Figure 5 Schematically describes Figure 1 The posterior side of the IOL, which has alternative posterior features;

[0077] Fig. 6A express Figure 1 A cross section of an IOL with Figure 1 The rear features of

[0078] Figure 6B express Figure 5 Cross-section of an IOL with alternative posterior features;

[0079] Fig. 7A Indicates Fig. 6A Details;

[0080] Figure 7B Indicates Figure 6B Details;

[0081] Figure 8 Another alternative embodiment showing an anterior view of an IOL;

[0082] Fig. 9 represents an eye with an IOL;

[0083] Fig.10 Indicates that Figure 1 The IOL is shown Fig. 9 Details;

[0084] Fig.11 Indicates Fig. 9 details, but the IOL has alternative posterior features and an intact posterior capsular bag;

[0085] Fig.12 Represents the eye as viewed from above, showing the axis in the eye;

[0086] Fig.13 and 14 express Figure 8 An alternative embodiment of an IOL of , shown in a front view and in a partial perspective view from the back;

[0087] Figure 15-18 A perspective view, a detail view, a front view, and a back view, respectively, showing an alternative embodiment of an IOL;

[0088] Fig.19A and 19B schematically show a cross section through the eye before and after removal of the natural lens, Fig.19C yes Fig.19B Front view of

[0089] Figure 20-21 is another embodiment of an IOL, which is a perspective view and a front view viewed at the front side of the IOL;

[0090] Figure 22-23 is yet another embodiment of an IOL, which is a perspective view and a front view viewed at the front side of the IOL; and

[0091] Figure 24-25 ] is yet another embodiment of an IOL, which is a perspective view and a front view viewed at the front side of the IOL.

[0092] The drawings are not necessarily to scale. DETAILED DESCRIPTION

[0093] In this specification, the first relevant part of the eye will be Fig.19A , 19B and 19C. Figure 1-11 In this paper, we will describe the structure of the intraocular lens (IOL) and its location in the eye ( Figure 9-11 ) and the steps for placing such an IOL in an eye.

[0094] Eye

[0095] exist Fig.19A 19B, a cross section through the eyeball 20 is schematically depicted. Fig.19A In FIG. 1 , the eyeball 20 has a cornea 21, an iris 25, a pupil 26, and a capsular bag 22 having a natural lens 31. The capsular bag 22 has a front portion 23 and a rear portion 24. Fig.19B , an eyeball 20 is shown after the natural lens 31 has been removed, leaving an empty capsular bag 22 with an opening 32, which is generally circular or oval. The opening 32 is in the front portion 23 of the capsular bag 22. In many cases, the center of the opening 32 is on the axis of the eye. Fig.12 The eye axis is defined.

[0096] Fig.19CA portion of the eyeball is shown in a front view, showing the iris 25, the front part of the capsular bag 23 with the opening 32 and the edge 52 of the opening. This edge 52 is also called the "peripheral edge" 52.

[0097] In some patients, the posterior portion 24 of the capsular bag 22 may no longer be clear. In these cases or generally to avoid postoperative posterior capsular opacification, an opening may also be made in the posterior portion 24 or capsular bag 22, referred to as a posterior opening, or the posterior portion 24 of the capsular bag may be removed.

[0098] In the previous paragraphs, the adjectives "anterior" and "posterior" were used. As explained before, the terms "anterior" and "posterior" refer to the arrangement of features relative to the propagation of light into the eye. Thus, light enters the cornea and iris, which are the front of the eye, and propagates to the retina, which is located at the back of the eye. Thus, for example, the capsular bag 22 has an anterior portion 23 and a posterior portion 24. Accordingly, the anterior portion has a surface directed toward the cornea 21 and the iris 25. This surface will be referred to as the anterior surface of the anterior portion 23 of the capsular bag 22. Inside the capsular bag 22, the opposite surface will therefore be referred to as the posterior surface of the anterior portion 23 of the capsular bag 22.

[0099] Intraocular lens structure (IOL)

[0100] Next, some embodiments of intraocular lens structures (IOLs) will be described. Figure 1 A front view of an embodiment of an intraocular lens structure (IOL) 1 is schematically depicted. The front side is the side of the IOL 1 that points toward the cornea 21 when the IOL 1 is placed in the eye. The side of the IOL 1 that points toward the retina after the IOL is implanted in the eye is referred to herein as the rear side of the IOL 1. When the natural lens 31 has been removed from the eye, an opening 32 is typically made in the front 23 of the capsular bag 22. The natural lens 31 is then removed. In certain cases, such as pediatric patients, a rear opening may also be made in the rear 24 of the capsular bag 22, the portion of the capsular bag 22 that is located between the natural lens 31 and the retina. The opening 32 and the rear opening are typically aligned. When a laser-assisted capsulotomy is used, the opening is typically circular, but other shapes are possible. The opening is typically aligned with the optical axis of the eye, but other locations may be used. Around the opening, a ring of capsular bag tissue or membrane is retained. This ring is also referred to as a capsular bag cover. The ring or cover has an edge 52 that defines the perimeter of the opening 32 or actually defines the opening 32. The opening 32 has an axial direction extending outwardly from the center of the opening 32 to a periphery 52 thereof.

[0101] IOL 1 comprises an optical structure 2. In many cases, the optical structure 2 is a lens, in fact the anterior lens and the posterior lens. Figure 1 In the embodiment shown, the optical structure 2 has a front lens structure surface 3 and a rear lens structure surface 4, see Figure 2. Any type of optical structure known in IOLs may also be provided. In the present specification, the nature of the optical structure should not be considered to be limiting. The optical structure may include a lens or a closure cap. In one embodiment, a front side and a rear side with a curved surface are provided to provide one or more lenses. Examples of lens optical elements are monofocal lenses, astigmatic lenses, multifocal lenses, accommodative lenses or sector bifocal lenses, such as those disclosed in PCT / NL2012 / 050115, which are incorporated herein by reference as if fully set forth. The optical element may be refractive, diffractive or a combination of the two. In addition or in combination, the optical structure may include filters and / or functional layers known to the skilled person. The optical structure may include active and / or passive elements. Examples of active elements are, for example, liquid crystal optical elements.

[0102] IOL 1 is generally a substantially flat structure. Its thickness is about 0.1-1 mm. The diameter of IOL 1 is generally about 7-12 mm. The optical structure is generally 4-7 mm in diameter. In most embodiments, the optical structure is 5-7 mm in diameter. The optical structure is generally biconvex.

[0103] In such a substantially flat structure, an axial direction Ax can be distinguished, which can have a posterior and an anterior direction. Furthermore, a radial direction Ra can be distinguished. Finally, an azimuthal direction Az can be distinguished, which can have a clockwise and an anticlockwise direction. If the optical structure is a simple monofocal lens, the axial direction is the optical axis and the radial direction is the radial direction of the lens. Figure 1 and 2 In case of other optical configurations, the axial, radial and azimuthal directions will be clear to the skilled person.

[0104] In one embodiment, the IOL 1 is made of a polymer material. In particular, the IOL 1 is from a foldable polymer material. In particular, the support is elastic. In one embodiment, the IOL 1 is integrally formed. In particular, the IOL 1 is flexible to allow it to be rolled into a small roll with a diameter less than 2.5 mm. In particular, it is allowed to roll the IOL into a roll with a diameter less than 1.8 mm at most. On the other hand, the IOL is dimensionally stable, particularly flexible so that it can be unfolded from its rolled state and restored to its original shape after it is inserted into the capsular bag.

[0105] exist Figure 2-4 Further details are shown in Figure 1 An implementation scheme in which Figure 2 express Figure 1A side view of an embodiment of Figure 3 Indicates Figure 2 shown Figure 2 Details, Figure 4 express Figure 1 A perspective view of an embodiment of the invention as viewed from the front side.

[0106] The IOL comprises a perimeter 7 around the optical structure 2. The perimeter 7 has a peripheral surface. The perimeter 7 can match the shape of the opening in the capsular bag. If, for example, the opening is circular, the perimeter can be circular. The size of the perimeter is such that it may be slightly larger to stretch the size of the capsular bag opening a little, or to match the size of the opening. Figure 1 In an embodiment of the invention, the optical structure 2 comprises a surface that provides a curvature of the lens. The lens in this embodiment is circular and has an optical axis. The peripheral surface extends parallel to the optical axis. The periphery here provides a cylindrical surface. In the case of a circular periphery 7, the peripheral surface is cylindrical and in Figure 1 In some embodiments, the shape of the lens may be a straight cylinder. A non-circular opening and periphery 7 may have the advantage of preventing the IOL 1 from rotating about the optical axis. For example, the opening may be elliptical and the periphery 7 may be elliptical, matching the elliptical shape of the opening. Alternatively, an alignment feature, such as a cam, may be provided at the periphery 7 and a matching feature of the opening may be provided. In the case of an astigmatic optical element, for example, rotational fixation may be advantageous. In one embodiment, for example Figure 1 and Figure 8 As shown, the diameter of the periphery 7 is greater than the diameter of the periphery 10 of the optical structure 2. For example, the diameter of the periphery 7 is greater than the diameter of the periphery 10 of the optical structure 2 by 0.5-2 mm.

[0107] The IOL 1 described here comprises a rear support 5, 5' located on the opposite side of the optical structure 2. The rear support 5, 5' extends outward from the optical structure. In particular, the rear support 5, 5' extends outward in the lateral direction of the optical structure 2. The rear support 5, 5' has a support surface 13, 13', which is also referred to as the support surface of the rear support 5, 5'. These support surfaces 13, 13' here are in one plane, which is referred to as the rear plane. Figure 1 In a specific embodiment in which the periphery discussed above is cylindrical, the rear plane is perpendicular to the cylindrical surface of the periphery 7.

[0108] The rear supports 5 , 5 ′ here form a ring having two ends connected to the periphery 7 .

[0109] The diameter of the optical structure 2 is typically 4-7 mm. The diameter of the periphery 7 is typically 4-7 mm. In the embodiment shown in the figures, the front supports 6 , 6 ′ and the rear supports 5 , 5 ′ are connected to the periphery 7 .

[0110] When the IOL 1 is implanted, the support surfaces 13, 13' of the posterior supports 5, 5' engage the posterior surface of the anterior portion 23 of the capsular bag 22. In one embodiment, the posterior supports 5, 5' and at least part of the support surfaces may be angled 0-10 degrees to the anterior direction. In one embodiment, when implanted, the surface of the periphery 7 engages or nearly engages the edge 52 of the anterior capsular bag opening and the support surfaces 13, 13' of the posterior supports 5, 5' are in fact pressed against the posterior surface of the anterior capsular bag. For this purpose, the support surfaces 13, 13' may be adapted to be fixed to the capsular bag surface. For example, a cam or rim may be provided.

[0111] At least one surface of the rear support may be roughened, for example sandblasted, to prevent reflection of light.

[0112] The IOL 1 also includes anterior supports 6, 6'. The anterior supports 6, 6' also extend in the lateral direction of the optical structure 2. The anterior supports provide support surfaces 14, 14' of the anterior supports 6, 6'. When the IOL 1 is implanted, these anterior supports are located outside the capsular bag 22 of 6, 6'. The support surfaces 14, 14' are designed and suitable for (when the IOL 1 is implanted) engaging the anterior surface of the anterior part of the capsular bag. In addition, these support surfaces 14, 14' are located on a plane, which is referred to as the anterior plane. In one embodiment, when implanted, the surface of the periphery 7 engages or almost engages the edge 52 of the anterior capsular bag opening, and in fact, the support surfaces 14, 14' of the anterior supports 5, 5' can be made to be close to the anterior surface of the anterior capsular bag. Therefore, the two surfaces are almost completely in physical contact. For this purpose, the support surfaces 14, 14' can be made suitable for fixing the capsular bag surface. In order for the anterior support to actually reach the outside of the capsular bag and fit snugly against the anterior surface of the anterior capsular bag, some manipulation by the person implanting the IOL 1 is usually required.

[0113] The front plane is functionally parallel to the back plane. Side view Figure 2This feature is shown. In particular, these planes are parallel when the capsular bag 22 is fixed between them. The distance between the rear support surfaces 14, 14' of the front supports 6, 6' and the front support surfaces 13, 13' of the rear supports 5, 5' enables them to fix the front 23 of the capsular bag 22 between them. The front supports 6, 6' and the rear supports 5, 5' are positioned so that their support surfaces include a spacing 11 between them. In fact, the distance between the rear plane and / or the front plane is suitable for fixing the front capsular bag cover 23 between them to fix the IOL 1 into the opening when the IOL 1 is implanted. In fact, the distance between the rear plane and the front plane can be adapted to the thickness of the front of the capsular bag. It has been found that if the distance is 5-100 microns, the rear supports 5, 5' and the front supports 6, 6' are able to fix the front capsular bag cover between them. In particular, the rear plane and the front plane are spaced 15-50 microns. The distance provides the spacing 11. If the distance is less than 20 micrometers, in particular less than 10 micrometers, the cap will be firmly clamped and prevent possible rotation of the lens.

[0114] exist Figure 1 In the embodiment of the invention, the rear supports 5, 5' and the front supports 6, 6' are staggered. In fact, when viewed from the front, the rear supports 5, 5' and the front supports 6, 6' do not overlap. This can also be referred to as the rear supports 5, 5' and the front supports 6, 6' in the circumferential direction or azimuthal direction (Az, Figure 1 ) are staggered. In this sense, staggering is used in a "staggered junction".

[0115] In particular, when the rear supports 5, 5' and the front supports 6, 6' are staggered, the rear plane and the front plane are parallel or substantially parallel when the front of the bladder is secured therebetween.

[0116] exist Figure 1 In the embodiment of the present invention, the rear support 5, 5' of the IOL 1 is a closed ring. Figure 1 In an embodiment of the invention, the diameter of the rear support 5, 5' of the IOL 1 is about (in other words, an IOL is provided having a diameter of) 8-12 mm, in particular 7-12 mm. The thickness of the rear support may be 0.15-0.4 mm. In particular, the thickness may be 0.2-0.4 mm. Furthermore, the thickness may be in particular 0.20-0.35 mm. The thickness of the rear support may in particular be 0.25-0.35 mm.

[0117] Alternatively, the ends of the ring can be removed, so that each of the posterior supports 5, 5' is in fact two posterior supports, resulting in four posterior supports 5, 5'. If for some reason it is not possible to place the IOL 1 in the opening 32, the radially extending posterior supports or ring supports can in fact act as a protective measure.

[0118] The thickness of the rear support 6, 6' may be 0.04-0.25 mm. In particular, the thickness may be 0.04-0.20 mm. More particularly, the thickness may be 0.05-0.20 mm. In particular, the thickness may be 0.05-0.10 mm.

[0119] exist Figure 1 In the embodiment of the invention, the IOL 1 located at or near the periphery 7 has at least one space 19 extending in the periphery or azimuth direction between the posterior support 5, 5' and the anterior support 6, 6'. This space facilitates manufacturing and also facilitates obtaining the anterior support 6, 6' passing through the opening 32 and outside the capsular bag, because the space provides room for insertion equipment when inserting and positioning the IOL 1. Figure 1 In the embodiment of , there is an azimuthal space 19 in each transition from the front support 6, 6' to the rear support 5, 5'.

[0120] It has been found that in order to support the rear side of the front of the capsular bag, the rear supports 5, 5' extend radially outwards from the periphery by at least about 0.5 mm. In particular, the rear supports 5, 5' extend radially by at least 1.0 mm.

[0121] It has been found that in order to support the front side of the front of the bladder, at least one front support 6, 6' extends radially outward from the periphery by at least about 0.3 mm. In particular, the front support 6, 6' may extend at least 0.4 mm. More particularly, the front support may extend radially by at least 0.5 mm.

[0122] exist Figure 1In an embodiment of the IOL 1 of the invention, the IOL 1 has additional anterior supports 8, 8'. These anterior supports are referred to herein as anterior lips 8, 8'. These anterior supports also extend out of the capsular bag 22 when in use. They complement the other anterior supports 6, 6' and provide additional clamping of the anterior part 23 of the capsular bag. The anterior lips 8, 8' have a rear surface 17, 17', which rests against the outside of the capsular bag 22 and against the anterior surface of the anterior part 23 of the capsular bag. The anterior lips 8, 8' extend here by about 0.1-2 mm in the peripheral (or azimuthal) direction. The anterior lips 8, 8' extend radially (i.e. in the direction away from the optical structure 2 and the periphery 7) by about 0.1-1.3 mm. In particular, about 0.4-1.0 mm. In particular, about 0.4-0.6 mm. In this embodiment, the anterior lips 8, 8' extend by about 0.3 mm.

[0123] exist Figure 8 In FIG. 1 , an embodiment of an IOL 1 is shown in which the front support 6, 6' has an alternative shape. In this embodiment, an anterior support 6, 6' with a support opening 18, 18' is provided. Through these support openings 18, 18', an instrument can be inserted after the IOL is inserted into the capsular bag to pull the anterior support 6, 6' back through the opening 32 in the capsular bag. The anterior support 6, 6' thus reaches outside the capsular bag. The diameter of the support opening 18, 18' can be 0.2-1.5 mm. In particular, the diameter can be 0.2-1.0 mm.

[0124] exist Fig. 6A and 6B In FIG. 1 , two different embodiments of posterior features can be seen that affect the posterior portion of the capsular bag.

[0125] exist Figure 5 , 6B 7B and 7B show a perspective view, a cross section and a Figure 6B Detail of the cross section of the IOL 1, providing a posterior side of the IOL 1 at or near the periphery with a clear edge 16 to prevent growth of tissue from the posterior portion of the capsular bag. Such tissue growth can cause posterior capsule opacification.

[0126] exist Figure 2 , 3 , 6A and 7A, alternative embodiments of the rear features are shown. Figure 2 represents a side view, Figure 3 Indicates the details shown, Fig. 6A express Figure 1 Cross-sectional view of the IOL, and Fig. 7A Indicates Fig. 6A Details shown.

[0127] The IOL of this embodiment has a surrounding rear groove 12, extending behind the rear support 5, 5' and the front support 6, 6'. In fact, the rear groove 12 is provided here behind the rear surface 15, 15' of the rear support 5, 5'. The rear groove 12 is provided to receive and fix the edge around the rear opening (i.e. the opening in the rear capsular bag). As explained, the rear opening can be made by performing a second capsulotomy on the rear part 24 of the capsular bag 22. After the IOL1 is positioned in the opening in the front part of the capsular bag, the edge around the rear opening slides into the rear groove 12. To achieve this purpose, the IOL can be pushed back slightly until the edge of the rear opening slides into the rear groove 12. The depth of the rear groove 12 here is 0.1-0.3mm. The shape of the rear groove 12 can receive the edge around the rear opening. The rear groove 12 can be a rectangular groove. Here it is wedge-shaped. The angle of its walls is 10-60 degrees, in particular about 30-60 degrees, in particular 40-50 degrees. This posterior groove 12 will seal the posterior opening, preventing capsule opacification and / or vitreous leakage.

[0128] IOL positioned in the eye

[0129] Fig. 9 A cross-sectional view of an eyeball with an IOL 1 in an inserted position inside a capsular bag 22 is shown. The eyeball 20 has a cornea 21, an iris 25 with a pupil 26, and a capsular bag 22.

[0130] exist Fig.12 , a cross section through the eye viewed from above is shown (N=nasal, T=temporal), defining several axes of the eye 20:

[0131] 1. The visual axis 51, which passes through the fixed object point of the eye and the nodal point N. If the function of the nodal point is considered, the light rays representing the visual axis 51 pass through the fovea 48 to the retina.

[0132] 2. The optical axis 47 is perpendicular to the corneal surface and passes through the midpoint of the iris 25 and pupil 26. Since the fovea 48 is not located at the center of the eyeball 20, the optical axis 47 is different from the visual axis 51. The optical axis 51 is the geometric symmetry axis of the eyeball system and is different from the central ray, which reaches the center point of the fovea and passes through the eyeball system obliquely.

[0133] 3. The line of sight 50 is the axis that passes through the object point and the center of the entrance pupil 26. It is the ray that passes through the centroid of the beam and is the axis of the light cone that enters the eye 20. The angle between the line of sight and the optical axis 47 is typically in the range of 3° to 8°. Due to asymmetric imaging through the corneal system and the off-axis position of the fovea, the center of the entrance pupil 26 is offset toward the nasal side.

[0134] 4. The pupil axis 49, which passes through the center of the entrance pupil 26 and is perpendicular to the anterior surface of the cornea.

[0135] The field of view of monocular vision covers the entire retina, without a small blind spot. Normally humans tend to rotate the eye to the best position to generate an image in the fovea 48. If the eye 20 is moved in this way to the position of the best orientation so that the image is in the center of the fovea, the optical system of the eye is not used as a central system. However, the tilt is small and spherical aberration and astigmatism are the main deviations of the eye.

[0136] exist Fig.10 In the Fig. 9 Details of which have been inserted Figure 1 In this embodiment, an IOL 1 having the above-mentioned posterior groove 12 is provided.

[0137] Here, the rear bladder 24 has the rear opening explained above. The edge of the rear opening is located in the rear groove 12. The front bladder cover (a ring of bladder film material) - which remains after the opening is made in the bladder front 23 - is fixed between the front support 6 and the rear support 5. The support surface of the front support 6 and the support surface of the rear support 5 both rest on the front bladder cover, and in fact, although it may not be in the way described, it can even still clamp the front bladder cover between them.

[0138] exist Fig.11 In the figure, a similar Fig. 9 , but the IOL 1 has alternative posterior features. In this case, the capsular bag posterior portion 24 does not have an opening: the capsular bag posterior portion 24 is complete and rests on the posterior surface 4 of the IOL 1.

[0139] exist Fig.10 and 11 However, by the cooperation of the anterior and posterior supports, possibly in combination with the periphery 7 and the perimeter length of the opening 32, the IOL 1 is positioned in the opening 32. Thus, the radial dimension of the posterior supports 5, 5' can be reduced.

[0140] IOL Insertion into the Eye

[0141] The insertion of the IOL 1 described so far will be explained below. An example of a procedure for making an incision and implanting an IOL is described, for example, in US5376115, which is incorporated herein by reference as if fully set forth. In particular, it states:

[0142] A popular surgical procedure is phacoemulsification, which uses ultrasonic vibrations to break up the lens nucleus, thus allowing the lens material to be removed through an incision about 3 mm long. The benefits of a small incision are faster recovery of vision, faster healing, and less astigmatism than conventional large incisions. A hollow titanium needle about 1 mm in diameter is activated to produce vibrations by a magnetostrictive ultrasonic mechanical device. The mechanical vibrations convert the lens into an emulsion, hence the name phacoemulsification.

[0143] As phacoemulsification techniques have improved, incision configurations have evolved to allow for wound closure without the need for sutures—"self-sealing incisions."

[0144] According to references, the technique is described in, for example, J Cataract Refract Surg 16 (5) (1990) pp. 567-577 by Menapace, R. et al, and Ophthalmology (US) 100 (2) (1993) pp. 159-163 by Ormerod, LD et al.

[0145] US 5376115 also describes an example of inserting an IOL.

[0146] This can be combined with the following surgery. Before the IOL 1 is inserted into the capsular bag, an opening is first made in the anterior portion of the capsular bag. Using, for example, a laser device such as a femtosecond laser, an opening or hole can be made in the anterior membrane or anterior bag of the capsular bag, which has a precise shape and a precise location. This procedure is also known as "capsulotomy", although recent literature refers to laser-based procedures as "capsulotomy" and the term is used differently from "capsulotomy" - it is used to refer to a mechanical tear or cut in the capsular bag. Other laser-based procedures are also currently in development. In these procedures, a laser beam is directed through the cornea and into the eye, and its energy is absorbed by internal structures to cut the structure. In one of these procedures, the anterior capsular bag membrane is stained using a light absorbing agent. The absorption properties of the light absorbing agent are selected to absorb the laser beam energy.

[0147] In many cases, such as in the case of cataracts, the cloudy natural lens is removed in a next step through an opening in the capsular bag. In this step, the natural lens is first treated with a laser before removal, for example using a placo emulsification device. The removal of the natural lens is known to the skilled person.

[0148] In an optional next step, a posterior opening may be made in the posterior portion of the capsular bag, the posterior capsular bag membrane, or the posterior capsule.

[0149] Examples of such classic capsulorhexis procedures and the use of laser devices in such procedures are described in US8409182, which is incorporated herein by reference as if fully set forth. For example, in column 3, examples of steps in a capsulorhexis procedure, or more specifically a capsulotomy procedure, are described. The laser-assisted steps allow for accurate positioning and shaping of the opening. In addition, the procedure is able to leave a relatively solid edge 52 around the opening created on the capsular bag. In particular, the following is a laser-based procedure.

[0150] Methods: Capsulotomies performed with optical coherence tomography-guided femtosecond laser were evaluated in porcine and human cadaver eyes. The procedure was subsequently performed in 39 patients as part of a prospective, randomized study of femtosecond laser-assisted cataract surgery. The accuracy of capsulotomy size, shape, and centration was quantified in porcine eyes, and capsulotomy strength was assessed.

[0151] Results: The laser-generated capsulotomies were significantly more precise in size and shape than the manually-generated capsulorhexases. In patients' eyes, the deviation from the expected diameter of the removed capsular disc was 29 μm ± 26 (SD) for the laser technique and 337 ± 258 μm for the manual technique. The mean deviation from circularity was 6% and 20%, respectively. The center of the laser capsulotomy was within 77 ± 47 μm of the expected position. All capsulotomies were complete with no radial notches or lacerations. The intensity of the laser capsulotomy (pig subgroup) decreased with increasing pulse energy: 152 ± 21 mN for 3 mJ, 121 ± 16 mN for 6 mJ, and 113 ± 23 mN for 10 mJ. The intensity of the manual capsulorhexases was 65 ± 21 mN.

[0152] Conclusions: Femtosecond laser-produced capsulotomies are more precise, accurate, reproducible, and more robust than those produced using conventional manual techniques.

[0153] Source: J. Cataract Refract. Surg. 2011;37:1189–1198 Q 2011 ASCRS and ESCRS.

[0154] The test also showed the following results.

[0155] Methods: Ten fresh porcine eyes were randomly assigned to undergo either femtosecond laser-assisted capsulotomy or manual capsulotomy. The capsular bag was immersed in hyaluronic acid, and a retractor was fixed in the capsular bag opening using a tensile force measurement device. The force required to make the capsulotomy cut was measured in millinewtons (mN); the maximum stretch ratio was also evaluated.

[0156] Results: The mean rupture force (maximum force measured just before tissue rupture) observed was 113 mN ± 12 (SD) in laser-assisted surgery and 73 ± 22 mN in manual surgery (P < 0.05). The stretch ratios were 1.60 ± 0.10 (femtosecond) and 1.35 ± 0.04 (manual) (P < 0.05).

[0157] Conclusions: In this laboratory's porcine eye study, femtosecond laser-assisted capsulotomy resulted in a significantly more stable anterior capsulotomy than standard manually performed capsulotomy.

[0158] Source: J. Cataract Refract. Surg. 2013;39:105–109 Q 2013 ASCRS and ESCRS.

[0159] The very accurate positioning of the opening 32 in the capsular bag 22 and the very accurate shape of the opening 32 allow for an accurate positioning and orientation of the IOL 1, which is particularly advantageous when using the present IOL or IOL / S-IOL combination.

[0160] The IOL 1 can be used in the following manner. Typically, the IOL 1 is inserted into the capsular bag through a micro-incision in the eye. Via an insertion device, the IOL outside the eye is rolled up and pushed forward through the incision in the eye via a matching nozzle. The rolled up IOL 1 enters the capsular bag via an opening. The rolled up IOL 1 is unfolded inside the capsular bag.

[0161] Next, using a small tool, the anterior support 6, 6' is manipulated to fold back through the opening 32 of the anterior portion 23 of the capsular bag to extend outside the capsular bag 22. Using the same or identical tool, the lips 8, 8' are manipulated to also extend through the opening 32 and outside the capsular bag 22. The posterior surfaces 17 and 17' of the lips 8, 8' will then be located on the anterior surface of the anterior portion 23 of the capsular bag 22. If the posterior capsule is also opened, the posterior cover will be secured in the posterior groove 12 by gently pushing the IOL down a little in a second operation.

[0162] exist Fig.13 and 14 In the Figure 8 An alternative embodiment of an IOL 1. Fig.13 , shown in a perspective view partially from the rear Fig.14 Likewise, like reference numerals denote like elements.

[0163] Capsular bag bulge syndrome (CBDS) is an uncommon but recognized cause of vision loss after cataract surgery. It usually develops shortly after surgery and manifests as shallowing of the anterior chamber, unexpected myopic refraction, and accumulation of fluid material between the implanted lens and the posterior capsule.

[0164] The most likely mechanism of CBDS is the production of collagen from residual lens epithelial cells or autolyzed lens epithelial cells that are necrotic and / or apoptotic, or from the accumulation of viscoelastics retained from the surgical procedure behind the intraocular lens (IOL) as the IOL optic closes the anterior capsular bag opening created by the capsulotomy. This postoperative complication can be avoided by creating a small opening in the lens to avoid complete closure of the capsular bag. The opening can be in the form of a notch located at the edge of the optic, or a small hole created in the optic. When the capsular bag opening is created in the anterior or posterior capsular bag cover, a small capsulotomy can also be created to avoid complete closure of the capsular bag opening during early use of the above-mentioned IOL.

[0165] exist Fig.13 and 14 In the embodiment of the invention, another method is selected. In this embodiment, a depression 53 is produced in the peripheral surface 7. This depression 53 provides an axial (Ax) groove located in the periphery 7 around the IOL. Here, the groove is straight along the axial direction (Ax), but modifications can be made to control the flow of fluid. After the IOL 1 is inserted, the depression 53 creates a channel between the peripheral surface 7 and the edge 52 of the opening 32 in the front part of the capsular bag 23. Therefore, once the IOL is inserted into the opening 32 of the capsular bag, a channel for the fluid is provided. In fact, even if a rear groove 12 is provided in the IOL, once the rear part of the capsular bag is inserted into the rear groove 12, this groove can provide a channel for the fluid part. In fact, the radial extension of the depression can control the channel.

[0166] In order to provide an easy passage, radial recesses 53 are provided beside the rear supports 5, 5' or the front supports 6, 6'. In the embodiment shown in the figures, recesses 53 are provided between the rear supports 5, 5' or the front supports 6, 6'. In this embodiment, two recesses 53 are provided, opposite each other. Here, the diameter of the recesses 53 is selected to allow the passage of ocular fluids. In this embodiment, the width of the recesses 53 here is 0.2-0.6 mm. In particular, the width is 0.25-0.5 mm. The depth of the recesses 53 here is 0.05-0.4 mm. In particular, the depth is 0.1-0.3 mm.

[0167] exist Figure 15-18, are perspective views, detail views, front views and rear views of alternative embodiments of the IOL, respectively. Likewise, identical reference numerals refer to features that are at least functionally equivalent. More specifically, in this embodiment, the depression 53 is modified. In this embodiment, the position (circumferential or tangential direction T) of the depression 53 is changed. In addition, three depressions 53 are provided here. It was found that the depressions 53 lead to interruptions of the rear edge 16. As already explained, the rear side of the IOL 1 located at or near the periphery with a clear edge 16 is provided to prevent tissue growth from the rear of the capsular bag. Such tissue growth can lead to posterior capsule opacification. Fig.13 and 14 The depression 53 of the earlier embodiment of the invention interrupts the edge 16 and thus presents a risk of tissue growth that may lead to opacification of the posterior capsule. This tissue may, for example, block the depression, preventing fluid exchange.

[0168] Here, the depression opens on the anterior side of the IOL. The depth is chosen (in axial direction A, for reasons of clarity in Fig.15 1, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 47, 48, 49, 50, 51, 62, 63, 64, 65, 66, 67, 68, 69, 71, 72, 73, 46, 47, 48, 49, 51, 64, 66, 67, 68, 69, 70, 71, 72, 73, 46, 48, 49, 50, 51, 64, 6 ...9, 50, 51, 64, 66, 69, 70, 71, 72, 73, 46, 49,

[0169] Figure 20-25 Various other embodiments of IOLs are presented which allow for simpler production, as well as simpler implantation and fixation in the eye.

[0170] In these embodiments, there are multiple rear supports and multiple front supports. No ' mark is used to illustrate them separately. The same parts or features also have the same reference numbers and will not be discussed further. Fig. 20 Represents a perspective view, Fig.21 Represents an anterior view, showing the anterior side of the IOL.

[0171] The IOL has three tentacles that remain in the (remaining part of) the capsular bag. The tentacles actually provide six posterior supports 5 that are paired two by two at their radial ends. They extend further in the radial direction (Ra) to the anterior support 6. Fig.21 When viewed as in FIG. 5 , it is apparent that the supports 5, 6 do not overlap. The through hole 18 in the front support 6 allows the front support 6 to be easily brought out of the bladder bag. This can provide better centering in the bladder bag.

[0172] exist Fig. 22 and 23 In the embodiment of the present invention, the bottom 54 of the axial depression 53 is further in the posterior direction than the front surface 13 of the posterior support. This provides a more reliable fluid passage. The axial depression 53 (also referred to as the axial groove 53) in the periphery 7 can also taper in the posterior direction. This can make it easier to stamp or mold such a lens.

[0173] Likewise, the rear supports 5 connected in pairs can also provide the functionality of the tentacles. Another definition can be that there are three rear supports with through holes. The rear supports 5 and the front supports 6 do not overlap either. They vary in azimuth.

[0174] Fig.24 and 25 Implementation plan and Fig. 22 and 23 In this embodiment, the rear support 5 is angled with respect to the front direction. Thus, a portion of its rear surface 15 is at Fig.24 The lens can be seen in the side view of the lens. Thus, in some cases, the fixation in the capsular bag can be improved. In the embodiment with an angle to the anterior direction, the lens can be pressed a little in the posterior direction and can be made to rest on the posterior part of the capsular bag. A more stable push against the capsular bag can prevent posterior capsule opacification. When a through hole is also provided in the posterior part of the capsular bag, as explained before, the fixation in said hole can be improved.

[0175] It is obvious that the above description and drawings are included to illustrate some embodiments of the present invention and do not limit the scope of protection. From this disclosure, more embodiments will be obvious to the technician. These embodiments are within the scope of the present invention and the essence of the present invention, and are obviously a combination of the prior art and the disclosure of this patent.

[0176] Reference Number List

[0177] 1 Intraocular lens structure (IOL)

[0178] 2 Optical structure

[0179] 3 Anterior surface of the IOL

[0180] 4 Posterior surface of the IOL

[0181] 5,5' rear support

[0182] 6,6' front support

[0183] 7 IOL periphery

[0184] 8,8' additional front lip

[0185] 9 External perimeter of the optical structure

[0186] 10 Periphery of optical structure

[0187] 11 Space between the rear and front planes

[0188] 12 Rear groove of the rear bag cover

[0189] 13,13' Front support surface of rear support

[0190] 14,14' Rear support surface of the front support

[0191] 15 15' Rear surface of rear support

[0192] 16 Back edge

[0193] 17,17' Additional front lip rear surface

[0194] 18,18' Holes in front support

[0195] 19 Azimuth (Az) space between front and rear supports

[0196] 20 Eyeball

[0197] 21 Cornea

[0198] 22 Pouch

[0199] 23 Anterior part of the bladder

[0200] 24 Posterior part of the bladder

[0201] 25 Iris

[0202] 26 Pupil

[0203] 31 Natural lens

[0204] 32 Opening (in front of the pouch)

[0205] 47 Optical axis

[0206] 48 Fovea

[0207] 49 pupil axis

[0208] 50 Sight

[0209] 51 Visual axis

[0210] 52 Around the edge of the front bladder flap

[0211] 53 Depression

[0212] 54 Concave end

Claims

1. An intraocular lens structure (IOL) adapted to be inserted into a capsular bag during implantation in a folded configuration, the IOL being intended to be placed in the capsular bag and to secure the IOL in an opening in the front of the capsular bag, with an anterior capsular bag cover surrounding the opening, the IOL having an anterior side and a posterior side, the anterior side being directed toward the cornea in use when the IOL is implanted in the capsular bag of the eye, and the posterior side being directed toward the retina of the eye in use when the IOL is implanted in the eye, the IOL comprising: - an optical structure comprising a perimeter; - at least three posterior supports connected to and extending outwardly from the periphery of the optical structure, the posterior supports being adapted, in use, to provide a support surface for engaging the posterior surface of the anterior capsular bag lid, the posterior supports being located in the capsular bag when the IOL is implanted in the capsular bag, and - at least three front supports connected to and extending from the periphery of the optical structure, the front supports being located outside the pocket and extending outwardly from the optical structure, the front supports being adapted to provide a support surface for engaging a front surface of a front pocket cover when in use, wherein a posterior plane defined by the support surface of the posterior support and an anterior plane defined by the support surface of the anterior support are adapted to be separated in use by a distance suitable for retaining the anterior capsular bag cover between these surfaces to secure the IOL in the opening, wherein the rear support and the front support are displaced relative to each other in a circumferential or azimuthal direction, and wherein the front support and the rear support do not overlap in the axial direction, The IOL is integrally formed, and its thickness and flexibility are suitable for inserting the IOL into the eye in a folded manner via micro-insertion, The rear support and the front support are elastic, The IOL is dimensionally stable and flexible so as to be able to unfold from its rolled state and return to its original shape after it is inserted into the capsular bag, The support surface of the rear support and the support surface of the front support are shifted relative to each other in the azimuth direction (Az), and the support surface of the rear support and the support surface of the front support are alternately provided in the azimuth direction (Az).

2. The IOL of claim 1, wherein said anterior and posterior supports are mutually positioned on said periphery to secure an anterior capsular bag cover therebetween when said IOL is implanted in the capsular bag, thereby securing said IOL in said opening in the anterior portion of the capsular bag.

3. The IOL of any one of claims 1-2, wherein the anterior plane and the posterior plane are separated by 5 to 70 microns.

4. The IOL of claim 3, wherein the posterior plane and the anterior plane are separated by 5 to 50 microns.

5. The IOL of any one of claims 1-2 and 4, wherein the posterior support and the anterior support extend around the optical structure in a peripheral direction or an azimuthal direction.

6. The IOL of claim 3, wherein said posterior support and said anterior support extend around said optical structure in a circumferential direction or an azimuthal direction.

7. The IOL of any one of claims 1-2, 4 and 6, wherein the IOL comprises a peripheral surface surrounding the optical structure and the posterior support and the anterior support extending from the peripheral surface, the peripheral surface defining a radial surface for engaging a peripheral edge of an anterior capsule cover defining a perimeter of an opening when the IOL is implanted.

8. The IOL of claim 3, wherein said IOL comprises a peripheral surface surrounding said optical structure and said posterior support and said anterior support extending from said peripheral surface, said peripheral surface defining a radial surface for engaging a peripheral edge of an anterior capsule cover defining a perimeter of an opening when said IOL is implanted.

9. The IOL of claim 5, wherein said IOL comprises a peripheral surface surrounding said optical structure and said posterior support and said anterior support extending from said peripheral surface, said peripheral surface defining a radial surface for engaging a peripheral edge of an anterior capsule cover defining a perimeter of an opening when said IOL is implanted.

10. The IOL of any one of claims 1-2, 4, 6, and 8-9, wherein the anterior support comprises a through hole or opening.

11. The IOL of claim 3, wherein the anterior support comprises a through hole or opening.

12. The IOL of claim 5, wherein the anterior support comprises a through hole or opening.

13. The IOL of claim 7, wherein the anterior support comprises a through hole or opening.

14. The IOL of any of claims 1-2, 4, 6, 8-9 and 11-13, further comprising an at least partial peripheral groove posterior to the posterior support.

15. The IOL of claim 3, further comprising an at least partial peripheral groove posterior to the posterior support.

16. The IOL of claim 5, further comprising an at least partial peripheral groove posterior to the posterior support.

17. The IOL of claim 7, further comprising an at least partial peripheral groove posterior to the posterior support.

18. The IOL of claim 10, further comprising an at least partial peripheral groove posterior to the posterior support.

19. The IOL of claim 14, wherein the at least partially peripheral groove is radially open for receiving at least one edge of a posterior capsular bag cover surrounding a posterior opening in a posterior portion of the capsular bag when the IOL is implanted in the eye.

20. The IOL of any one of claims 15-18, wherein when the IOL is implanted in the eye, the at least partially peripheral groove is radially open for receiving at least one edge of a posterior capsular bag cover surrounding a posterior opening in a posterior portion of the capsular bag.

21. The IOL of claim 14, wherein the at least partial peripheral groove has a depth of 0.1-0.3 mm.

22. The IOL of any one of claims 15-19, wherein the at least partial peripheral groove has a depth of 0.1-0.3 mm.

23. The IOL of claim 20, wherein the at least partial peripheral groove has a depth of 0.1-0.3 mm.

24. The IOL of claim 14, wherein the at least partial peripheral groove has a width of 0.05-0.2 mm.

25. The IOL of any one of claims 15-19, 21 and 23, wherein the at least partial peripheral groove has a width of 0.05-0.2 mm.

26. The IOL of claim 20, wherein the at least partial peripheral groove has a width of 0.05-0.2 mm.

27. The IOL of claim 22, wherein the at least partial peripheral groove has a width of 0.05-0.2 mm.

28. The IOL of claim 14, wherein said at least partially peripheral groove is tapered.

29. The IOL of any one of claims 15-19, 21, 23-24 and 26-27, wherein the at least partially peripheral groove is tapered.

30. The IOL of claim 20, wherein said at least partially peripheral groove is tapered.

31. The IOL of claim 22, wherein said at least partially peripheral groove is tapered.

32. The IOL of claim 25, wherein said at least partially peripheral groove is tapered.

33. The IOL of any one of claims 1-2, 4, 6, 8-9, 11-13, 15-19, 21, 23-24, 26-28, and 30-32, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

34. The IOL of claim 3, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

35. The IOL of claim 5, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

36. The IOL of claim 7, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

37. The IOL of claim 10, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

38. The IOL of claim 14, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

39. The IOL of claim 20, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

40. The IOL of claim 22, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

41. The IOL of claim 25, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

42. The IOL of claim 29, wherein said posterior support and said anterior support of said IOL extend in an azimuthal direction (Az) surrounding said optical structure.

43. The IOL of any one of claims 1-2, 4, 6, 8-9, 11-13, 15-19, 21, 23-24, 26-28, 30-32 and 34-42, wherein the IOL comprises a depression in the periphery providing a groove extending in an axial direction (Ax) in a peripheral surface of the periphery.

44. The IOL of claim 3, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

45. The IOL of claim 5, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

46. ​​The IOL of claim 7, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

47. The IOL of claim 10, wherein said IOL comprises a depression in said perimeter providing an axially (Ax) extending groove in a peripheral surface of said perimeter.

48. The IOL of claim 14, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

49. The IOL of claim 20, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

50. The IOL of claim 22, wherein said IOL comprises a depression in said perimeter providing an axially (Ax) extending groove in a peripheral surface of said perimeter.

51. The IOL of claim 25, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

52. The IOL of claim 29, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

53. The IOL of claim 33, wherein said IOL comprises a depression in said perimeter providing a groove extending in an axial direction (Ax) in a peripheral surface of said perimeter.

Citation Information

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