Posterior chamber phakic intraocular lenses

Abstract

The present invention relates to a posterior chamber phakic intraocular lens 1 comprising a central optical portion 2, a peripheral haptic portion 3 having distal support elements 4 arranged to support the intraocular lens 1 on the ciliary body zonules, elongated flexible foot plates 5 attached to the support elements 4, each having a distal edge 53 arranged to stabilize the intraocular lens 1 within the ciliary body 98, and manipulation pockets 6 on a surface of the support elements 4, each associated with one of the elongated flexible foot plates 5.

Description

[Technical field]

[0001] The present invention relates to intraocular lenses (IOLs), and more particularly to posterior chamber phakic IOLs. [Background technology]

[0002] Generally speaking, phakic IOLs are IOLs that are intended to be placed in the eye to correct vision defects. These IOLs are usually implanted in young patients as a complement to the natural lens.

[0003] A posterior chamber phakic IOL is a phakic IOL that is intended to be implanted in the region of the eye between the posterior surface of the iris and the anterior surface of the lens and supported around the ciliary body of the eye.

[0004] The limitation of the implantation of such IOLs lies in the fact that they are likely to be placed in different positions from one eye to the other based on the posterior chamber anatomy, whose parameters, especially their size, usually vary by a few millimeters from patient to patient. In particular, the implantation of posterior chamber phakic IOLs, whose sizes may not be compatible, - for example, if the phakic IOL is too small for the size of the anatomical space of the posterior chamber available for IOL implantation: contact of the lens with the IOL, causing cataracts in the eye or loss of the corrective power of the phakic IOL or affecting the accuracy of vision; or, for example, if the phakic IOL is too large for the size of this anatomical space: pupillary block, glaucoma, inflammation, iris depigmentation, or a depression between the anterior and posterior chambers of the eye after pupillary block, There is a risk of causing more or less serious medical complications to the patient, such as:

[0005] The manufacture and use of phakic IOLs of various sizes based on typical ocular anatomy cannot completely overcome this deficiency, and in fact, shortcomings regarding the positional stability of such phakic IOLs after they are implanted in the eye can lead to the same medical complications.

[0006] In an attempt to solve this problem, WO 2020 / 035534 A1 discloses a posterior chamber phakic IOL that includes a dual-haptic structure made of a peripheral haptic portion that includes a support element arranged to rest on the ciliary zonules and an elongated haptic having a proximal end attached to a proximal portion of the peripheral haptic portion and a free distal end for hooking the IOL into the ciliary sulcus of the eye. These haptics make it possible to compensate for variations in the size of the anatomical space, and the dual-haptic structure allows for an overall stabilization of the IOL position in the eye.

[0007] Nevertheless, the elongated haptics of this IOL are difficult to see and manipulate during the implantation process in the eye. It is therefore desirable to provide a posterior chamber phakic IOL that is easy to implant, yet sufficiently stable in the implanted position. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] International Publication No. 2020 / 035534(A1) Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to provide a posterior chamber phakic IOL that is compatible with a wide class of ocular anatomies and is easy to implant in the eye. [Means for solving the problem]

[0010] To this end, the present invention provides a posterior chamber phakic IOL comprising: A front surface and a rear surface, A central optical portion including a lens, a central optical portion extending radially relative to an optical axis directed from the front surface to the rear surface; A peripheral tactile portion, It is attached circumferentially to the central optical part, a peripheral haptic portion including distal support elements extending radially outward and posteriorly relative to the central optical portion and positioned to support the IOL on the zonules when the IOL is in an implanted position within the eye; at least one elongated flexible foot plate, extending radially beyond the peripheral haptic portion; at least one elongated flexible foot plate including a first end attached to the peripheral haptic portion; Equipped with The long, flexible footplate a second end attached to one of the support elements; and a distal edge extending circumferentially and radially outwardly relative to the central optical portion and positioned to stabilize the IOL to the ciliary body when the IOL is in an implanted position within the eye; Including, Provide a posterior chamber phakic IOL. Said one of the support elements preferably includes an operating pocket on the anterior surface of the IOL that is at least partially radially aligned with the elongated flexible foot plate and is dimensioned to cooperate with the tip of an operating tool by (keyed) engagement of the tip into the pocket, such that movement of the elongated flexible foot plate can be caused by movement of the tool.

[0011] This IOL makes it possible to reach a suitable compromise between the need to improve the stability of the IOL in the implanted position and to implant it easily. Like the IOL of WO 2020 / 035534 A1, this IOL comprises a central optical part with two separate and complementary haptic structures: first, a peripheral haptic part including distal support elements, and second, at least one elongated flexible foot plate (hereinafter referred to as "foot plate", although the IOL preferably comprises two or four such elongated flexible foot plates). The peripheral haptic part forms together with the central optical part a "dome assembly". The feet of the dome assembly are support elements located distally to support the IOL at the ciliary zonules. As the foot plate extends radially beyond this dome assembly, it also stabilizes the IOL on the ciliary body. The shape and flexibility of the foot plate contribute entirely to the stability of this IOL in the implanted position. To facilitate the implantation of the IOL, the footplate is fully attached to the flexible haptics at the ends of the footplate. This slightly reduces the adaptability of the footplate compared to the long, free-ending footplate as in WO 2020 / 035534 A1, but this new shape of the footplate makes it much easier to manipulate during the implantation process. This feature is further enhanced by the favorable presence of a manipulation pocket on the support element to which at least one end of the footplate is attached. In particular, the shape and flexibility of the footplate allows the IOL to be adapted to a wide class of ocular anatomies, but any manipulation difficulties that this may cause are fully compensated for by the attachment of the ends of the footplate to the peripheral haptics and by the advantageous presence and location of the pocket.

[0012] The above technical effects are described in detail below. In particular, as explained below, the IOL is particularly stable in its implanted position in the axial (i.e., parallel to the optical axis), radial (i.e., perpendicular to the optical axis) and circumferential (i.e., rotation around the optical axis) directions.

[0013] The peripheral haptics allow the IOL to be stabilized parallel to the optical axis. Support elements are arranged at the distal ends of the peripheral haptics and are designed to support the IOL dome assembly at the ciliary zonules. The dome assembly is configured to be located anterior to the natural crystalline lens of the eye so as to surround the lens at least anteriorly. As a result, a distance called the "vault", measured along the optical axis between the anterior surface of the crystalline lens and the posterior surface of the IOL, is defined and stabilized. It can be assimilated to a safety distance necessary to avoid contact or excessive proximity between the crystalline lens and the IOL. The safety distance between the IOL and the iris of the eye is likewise defined and stabilized as the distance between the anterior surface of the IOL and the posterior surface of the iris (at the elevation aperture), considered as a virtual iris plane occupying the pupil.

[0014] The vault is preferably configurable and / or adjustable between 100-1000 μm, more preferably between 300-750 μm, with or without radial and / or axial compression. This allows sufficient space between the IOL and both the lens and the iris, compensating for potential anatomical size defects in the posterior chamber of the eye, or possible IOL placement defects, and significantly reducing the risk of patient complications. According to one embodiment of the invention, the vault is titrated by sculpting the posterior surface of the IOL to follow the contour of the natural lens in which it is intended to be implanted.

[0015] The structure of the dome assembly is adapted to a wide range of ocular anatomies based on the selection of a posterior surface that is more curved than any crystalline lens anterior surface, and the selection of the outer diameter of the peripheral haptic portion (measured perpendicular to the optical axis) to accommodate a wide range of posterior chamber anatomies. More specifically, this diameter is preferably comprised between 9.50 and 11.50 mm, for example, about 9.50, 9.60, 9.70, 9.80, 9.90, 10.00, 10.10, 10.20, 10.30, 10.40, 10.50, 10.60, 10.70, 10.80, 10.90, 11.00 or 11.10 mm. As explained below, the three diameter values ​​of 9.50, 10.40 and 11.10 mm are advantageously sufficient to cover any posterior chamber anatomies. The posterior surface of the dome assembly is preferably smooth and concave (towards the rear). The posterior surface of the dome assembly more preferably has a radius of curvature comprised between 8 and 11 mm, again more preferably comprised between 9 and 10 mm. The radius of curvature is preferably selected as the minimum mean radius of curvature of the anterior surface of the crystalline lens, typically 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9 or 10.0 mm. It is also noted that this radius of curvature is well defined, given that the posterior surface of the dome assembly is smooth and (mathematically) regular. In particular, the posterior surface of the junction between the central optical portion and the peripheral haptic portion preferably does not contain any irregularities or corners.

[0016] The dome assembly then rests on the crystalline lens when the IOL is in its implanted position in the eye (i.e., when the IOL is in normal use in the eye), resting on the ciliary body zonules and stabilizing the IOL parallel to the optical axis. The footplate extends radially, a portion of it substantially beyond the dome assembly in the posterior chamber of the eye, for placement on the ciliary body. The flexibility and shape of the footplate allows the IOL to accommodate changes in the internal size of the posterior chamber anatomical space available to the IOL (known as the "interciliary" measurement, preferably the interciliary distance taking into account the elastic penetration coefficient of the footplate into the ciliary body of the eye) over a range of intraocular dimensions, including those that cannot be accurately estimated preoperatively. While the outer diameter of the dome assembly is substantially constant at the IOL implanted position, the outer diameter of the entire IOL changes due to the flexibility of the footplate to accommodate the anatomical structure of the posterior chamber of the eye. Advantageously, the use of a single IOL model according to the present invention is sufficient for a wide range of patient ocular anatomies.

[0017] The footplate also allows for stabilization of the IOL as it rotates in a plane perpendicular to the optical axis, and thus is able to fully compensate for this change in anatomical space (which is recognized to be greater in some directions than in others due to its "elliptical" shape). This footplate extends circumferentially and radially such that its distal edge is tailored to rest and / or hook and / or stabilize itself against the ciliary body, acting as a circumferential anchor for the IOL.

[0018] This feature is important in the embodiment where the IOL is a toric implant that contains an optic with a cylinder to correct astigmatism. In this case, the stability of the angular position of the IOL lens in the vertical plane, called "rotational stability", is important to guarantee the expected IOL optical result. In this case, the footplate allows to keep the IOL lens in the central optical zone, avoiding the possibility of decentering the IOL with respect to the optical axis of the eye, which may affect the optical result of the IOL.

[0019] The first and second ends of the footplate are attached to the peripheral haptic portion, improving the maneuverability of the footplate during the IOL implantation process. Moreover, at least the first end is more specifically attached to one of the support elements, in other words the most distal of the peripheral haptic portion, so that the length of the footplate is shortened to reach the ciliary body. Advantageously, this shortening of the footplate length means that the footplate is more maneuverable during the IOL implantation process, making the IOL easier to implant. These distinctive and innovative features can compensate for the elongated shape and flexibility of the footplate, which are important for the aforementioned IOL stabilization purpose. Indeed, the footplate is long, thin and transparent, which makes it difficult to see and manipulate under the iris of the eye. If it is too long and / or has free ends, it can easily invert. Advantageously, the footplate of the present invention overcomes these problems.

[0020] The first and second ends are usually only parts of the footplate attached to the peripheral haptics of the IOL. More commonly, the footplate is not attached to the peripheral haptics over its (entire) length. Since the first and second ends of the footplate are attached to the peripheral haptics, the footplate extends entirely along the partial loop, extending radially outward from the second end relative to the optical axis and then radially inward relative to the optical axis to the first end, reaching the distal end of the loop at the outer diameter of the IOL. The distal edge is in the form of a portion of this partial loop that is located distally to stabilize the IOL on the ciliary body. The distal edge advantageously offers a potentially wide contact surface with the ciliary body.

[0021] Due to the difficulty of the implantation position between the natural lens of the eye and the iris, it is very important to have an IOL that is easy to implant. The positioning of the IOL requires fewer manipulations, which avoids errors that may have adverse effects on the patient. In order to further improve the maneuverability of the footplate during the implantation process, the support element to which the second end of the footplate is attached is preferably also provided with the above-mentioned manipulation pocket. Nevertheless, the present invention is not necessarily limited to the presence of a pocket, but the presence of a pocket is preferred, since the above-mentioned features of the footplate already make it possible to advantageously distinguish the IOL according to the invention from the prior art.

[0022] This pocket is located close to the foot plate and in particular at least partially radially aligned with it. Since at least the second end of the foot plate is attached to the same support element, the position of the foot plate can be changed by moving the tip of a tool in an appropriate way in the pocket. Since no direct manipulation of the foot plate is required, the risk of handling errors is significantly reduced. In fact, the foot plate is thin and transparent, so that it is easy to miss it, to pass the posterior surface of the IOL and to touch sensitive intraocular tissues, for example the crystalline lens. By restricting the movement of the tip in such a pocket at the level of the anterior surface of the IOL, such handling errors cannot occur.

[0023] This pocket is also advantageous when it is necessary to manipulate the IOL under the iris of an opaque eye. In fact, by keying the tip into the pocket, the tip of the tool can be guided anteriorly. So the surgeon does not need to see the footplate under the iris in order to position it correctly (which is generally very difficult). The advantage is that the surgeon only needs to make the appropriate (known) movements with the tool, without needing to see the footplate, in order to position it under the iris when the tip is engaged in the pocket. Preferably, the pocket is specifically dimensioned to accommodate these movements and to guide the surgeon during the implantation process.

[0024] In the framework of this specification, the "optical axis" of the eye is preferentially contained in a vector that crosses the eye from one side to the other and is directed from the "anterior segment" which successively comprises the cornea, the iris and the crystalline lens to the "posterior segment" which comprises the retina. In the case of a phakic IOL according to the invention in its implanted position in the eye, the optical axis of the eye is directed from the anterior surface of the IOL to the posterior surface of the IOL and preferably corresponds to the optical axis defined intrinsically with respect to the IOL. In particular, the term "optical axis" is preferably used herein as a reference axis relative to the eye and / or the IOL.

[0025] In the framework of this specification, it is preferred to be on the "anterior" (or "posterior") side and / or surface of an eye or IOL part, or on the side and / or surface located upstream (or downstream) of said part with respect to the vector defined by the optical axis. This definition naturally extends to the term "anterior" (or "posterior"). By way of example, in the eye, the iris is located anteriorly relative to the crystalline lens, and the posterior surface of the iris is the part of the iris closest to the crystalline lens.

[0026] Similarly, such sides and / or surfaces are referred to as "front concave" (or "front convex") if they are viewed as concave (or convex) by viewing the optical surface in the same direction and sense as the vector defined by the optical axis (i.e., following the propagation of the light rays). Such sides and / or surfaces are referred to as "rear concave" (or "rear convex") if they are viewed as concave (or convex) by viewing the optical surface in the same direction and opposite sense as the vector defined by the optical axis. In this specification, the term "concave" is generally used as corresponding to "rear concave" when it is clear to the skilled artisan from the context of its use that this is the meaning.

[0027] The aforementioned concepts of anteriority, posteriority, or even optical axis with respect to portions of the eye and / or IOL are well known to those skilled in the art. In particular, an IOL according to the present invention is configured to be placed in the posterior chamber of the eye such that its anterior surface at least partially faces the iris of the eye and its posterior surface at least partially faces the lens of the eye.

[0028] In the framework of this specification, the terms "axial" and "axially" refer to a direction parallel to the optical axis. "radially" if it extends along a vector perpendicular to the optical axis, "Radially outward" if the vector is directed from a point common to the optical axis to a point on a circle centered at this common point, If the vector points in the opposite direction, it is "radially inward" It is said to be extended. Preferably, a portion of an IOL is said to extend "circumferentially" if the portion extends according to a circular arc in a plane, preferably perpendicular to the optical axis, centered at the intersection of the plane with the optical axis. These concepts of radial and circumferential extension refer to known polar coordinate systems in the respective plane perpendicular to the optical axis.

[0029] It is well known to those skilled in the art that the adjective "distal" refers to the part of the body that is the furthest from a reference organ or trunk, and the adjective "proximal" refers to the part of the body that is the closest to a reference organ or trunk. In the framework of this specification, these definitions also apply to parts of the eye and / or IOL in relation to their distance with respect to the reference optical axis. By way of example, preferably, the proximal part of an IOL according to the invention may include the central optical part and / or the part of the IOL around the central part, and the distal part of an IOL according to the invention may include the footplate, or at least its distal edge.

[0030] In particular, the term "distal" with respect to the "distal edge" of the footplate preferentially refers to the set of points of the footplate that are each furthest from the optical axis along a radius perpendicular to the optical axis.

[0031] In the framework of this specification, the use of the indefinite article "a", "an" or the definite article "the" to introduce an element does not exclude the presence of a plurality of these elements. Similarly, the terms "first", "second", "third" and "fourth" are used only to distinguish elements and do not imply an order of these elements.

[0032] Within the framework of this specification, the use of the verbs "comprise", "include" or other variations and their conjugations cannot in any way exclude the presence of elements other than those mentioned.

[0033] The IOL, and particularly the peripheral haptics and footplate, are preferably made of a biocompatible, flexible, and highly resistant material, which is preferably a hydrophilic material.

[0034] The overall thickness of this material varies radially to provide more or less flexibility to portions of the IOL. In the framework of this specification, "thickness" is measured parallel to the optical axis. It is preferably greater in the peripheral haptics than in the footplate.

[0035] In fact, these two haptic structures constitute a compromise between, on the one hand, the need for stability and compliance of the intraocular structures, and, on the other hand, the need for rigidity to avoid exerting excessive forces and trauma to the delicate intraocular structures, many of which are complex and not visible during or before implantation. They are structured in such a way that the vault as described above is not significantly affected by the compression of the IOL exerted at its edge by the internal anatomical structures of the eye. In particular, the dome assembly has a "rigid" structure caused by a material thickness that is on average larger than that of the footplate and / or by the flared and / or wide and / or thick shape of the support elements. The rigidity and the geometrical characteristics of the dome assembly are adapted to a wide range of anatomical structures of the eye. In contrast, the "flexible" property of the footplate is preferably caused by the nature of this material combined with its elongated shape and its low average thickness, especially compared to the thickness of the dome assembly.

[0036] More specifically, according to a preferred embodiment of the IOL of the present invention, the thickness of the peripheral haptics decreases in a radial direction from the central optical portion to the pocket. The thickness of the peripheral haptics is preferably on average at least 50% greater than the thickness of the footplate, more preferably two times greater. This averaging can be simply considered as a conventional discrete or integral averaging of the thickness on a plane perpendicular to the optical axis.

[0037] By way of example, the peripheral haptic portion radially tapers at its boundary with the central optical portion by between 0.70 and 0.50 mm, preferably about 0.60 mm, and at the level of the proximal boundary of the pocket (but not inside the pocket) by between 0.25 and 0.15 mm, preferably about 0.18 mm.

[0038] The foot plate, for its part, has a preferably constant thickness along its entire extension, for example between about 0.10 and 0.20 mm, preferably about 0.15 mm, which contributes to its excellent flexibility, as explained above.

[0039] Preferably, the thickness of the peripheral haptics is specifically targeted to allow the IOL to reside at a determined distance from the anterior surface of the lens by selectively adjusting the curvature of the anterior and / or posterior surfaces of the IOL such that the posterior surface mimics the (anterior) curvature of the lens.

[0040] The radii of curvature of the anterior and posterior surfaces of the IOL are also optimized with respect to the target power, so that the central thickness of the central optic remains substantially constant over the entire diopter range. The radii of curvature of the anterior and posterior surfaces of the IOL are preferably comprised between 0.20 and 0.40 mm. For example, about 0.20 mm for lens powers comprised between -5 and -20 D, and about 0.40 to 0.20 mm for lens powers between -0.5 and -5 D. The central optical surface is preferably substantially anteriorly convex and / or substantially planar and / or perpendicular to the optical axis. This allows advantageous delivery of the vault without the need for compression, so that the IOL can be bent forward.

[0041] The term "footplate" generally refers herein to at least an elongated, flexible footplate. However, the IOL preferably includes additional footplates. Preferably, the characterizations provided herein for a "footplate" also apply to the other footplates.

[0042] The IOL according to the invention preferably comprises either two or four distal support elements and either two or four elongated flexible foot plates, preferably arranged at least partially symmetrically, in order to ensure good stability of the IOL under axial and / or radial compression as well as during rotation. However, these numbers of support elements and elongated flexible foot plates do not limit the scope of the invention. For example, the IOL may comprise a single elongated flexible foot plate alone or in combination with any other haptic structure known to the skilled artisan, for example the elongated haptics with free distal ends disclosed in WO 2020 / 035534 A1. It is preferable to use four elongated flexible foot plates arranged symmetrically (for example the corners of a rectangle), since this mitigates any possible tilting effect.

[0043] Each of the elongated flexible foot plates of the IOL is preferably associated with a specific manipulation pocket as claimed and described above, so that the number of pockets preferably corresponds to the number of elongated flexible foot plates. However, one pocket can be used to move more than one elongated flexible foot plate. Such a pocket can extend to one or more support elements, for example through the proximal part of the peripheral haptic part, so that two or more elongated flexible foot plates do not necessarily have to be attached to the same support element. The support element may also comprise several pockets, each adjacent to the end of a different elongated flexible foot plate. The first end of the foot plate can be attached, as part of it, to the same support element as the second end, to another support element, as well as on the proximal part of the peripheral haptic part, for example between two adjacent support elements. More generally, it will be understood by those skilled in the art that various configurations of the IOL can be considered within the framework of the present invention with regard to the number and / or arrangement of the support elements, the elongated flexible foot plates and the manipulation pockets. Some of the preferred ones are presented hereafter.

[0044] The "elongated" feature of the footplate refers to its thin shape, which contributes to its flexibility as mentioned above. In particular, the footplate preferably has three dimensions, among which are the length along the main extension trajectory, the thickness, and the width measured at right angles to the other two dimensions. This "elongated" feature can be interpreted as a length that is greater than the (average) thickness and the (average) width of the footplate, i.e. at least twice, preferably at least three times, more preferably more than five times. This provides a better ability of the footplate to deform under axial and / or radial compression of the IOL. Compared to standard commercialized posterior chamber phakic IOLs with reduced distal footplate mass, the present IOL footplate allows for greater flexibility and stability, and even allows for adaptability to a class of ocular anatomies that is estimated to be 50% wider (as commented in view of FIG. 9 introduced below). The improved adaptability, although slightly lower than that of the IOL disclosed in WO2020 / 035534(A1), is advantageously obtained without major implantation difficulties as mentioned above. In particular, the IOL according to the invention thus constitutes a very good compromise between obtaining a phakic IOL with improved accommodation and stability, and obtaining a phakic IOL that is easy to implant.

[0045] Since the two ends of the foot plate (preferably only) are attached to the peripheral haptic portion, the foot plate preferably adjoins a cavity extending from the front to the rear surface. This cavity is usually an open cavity. The cavity is generally completely surrounded by the foot plate and the peripheral haptic portion, preferably by said one of the foot plate and the support element.

[0046] The term "void" is used herein to correspond to a space free of the material that constitutes the IOL. This term is more convenient than "hole" since the cavity is preferably not a hole in the material, but simply a feature resulting from the geometric characteristics of the footplate. However, a method of manufacturing an IOL by creating a large hole in the material to define the footplate cannot be excluded from the scope of the present invention.

[0047] The above-mentioned cavity preferably has a maximum radial length (considered along the main extension trajectory) that is greater than the maximum diameter of the cross section of the footplate, more preferably at least twice as large. In other words, the radial length of the cavity is greater than the width and thickness of the footplate, so that the thin and elongated shape of the footplate is adapted to reach the ciliary body of the eye dynamically and flexibly. In particular, the flexible haptics are such that, when (strong) radial compressive forces occur on the IOL, the haptics deform and the cavity partially collapses on itself. In other words, in this case, said maximum radial length is preferably divided by 2, 3 or more.

[0048] The footplate may optionally include, for example at its ends, folds of material and / or lateral indentations arranged to facilitate and / or direct the curvature and / or orientation of the footplate when axial and / or radial pressure is applied to the IOL. In particular, such folds of material and / or lateral indentations may act as fail-safe mechanisms arranged to prevent the transmission of excessive forces from the footplate to the central optic portion, thereby controlling such forces applied by the footplate to provide adaptive fixation to the ciliary body and prevent erosion of delicate intraocular tissues.

[0049] The distal edge of the footplate optionally includes smooth ripples arranged to smoothly hook onto the ciliary body of the eye. Advantageously, the ripples facilitate stabilization of the IOL to the ciliary body when the IOL is in an implanted position within the eye. The ripples provide the distal edge with a pin to easily lie against and stabilize the ciliary body. These ripples are preferably polished so that their contours do not irritate the ciliary body or other parts of the ocular anatomy.

[0050] According to a preferred embodiment of the invention, the IOL has a smooth lateral chamfer that extends smoothly and continuously from said support element to which the second end of the footplate is attached to the first part of the distal edge. This chamfer extends on the support element and on the first part of the distal edge and provides a continuous and smooth lateral transition between the peripheral haptic part and the footplate via one of the footplate ends, for example the second end. This transition is particularly useful for the implantation of the IOL, since it allows the footplate to be smoothly inserted under the iris of the eye, preferably using an operating pocket. In particular, the presence of such a chamfer also means that said one of the footplate ends is attached laterally to the side of the support element, such that the distal edge smoothly continues to this side of the support element.

[0051] Preferably, smooth lateral chamfers also extend laterally proximally of the support element on all or part of the peripheral haptics, and preferably the entire chamfer extends perpendicular to the optical axis and further circumferentially on the distal edge, following the latter aforementioned loop shape.

[0052] The entire lateral chamfer has a smooth outer surface that is preferably concave (posteriorly). The outer surface is typically in an anterior tilt. Being concave, the outer surface does not include a turning point of curvature such that the partial loop shape of the distal edge changes from the side of the support element to a more central position of the peripheral haptic portion, e.g., converging toward an axis perpendicular to the optical axis, advantageously facilitating manipulation and implantation of the IOL without risk of intraocular tissue damage.

[0053] In the framework of this specification, the term "first diameter" refers to the outer diameter of the IOL and the term "second diameter" refers to the outer diameter of the peripheral haptics, these two diameters being measured perpendicular to the optical axis. The dome assembly is contracted into a cylinder of the second diameter, and the footplate extends further radially to the first diameter.

[0054] The second diameter is preferably comprised between 9.50 and 11.10 mm to accommodate the smaller size of the ciliary body (or more precisely the smaller available anatomical space) and to allow the dome assembly to have a size that fits a wide range of ocular anatomies, in particular the dome assembly being small enough to avoid subjecting itself to any compression when the IOL is in the implanted position.

[0055] The first diameter is preferably comprised between 12.50 and 14.00 mm, more preferably between 12.70 and 13.60 mm, especially when no axial and / or radial compression is applied to the IOL. The footplate extends with a radial length comprised between the difference between the second diameter and the first diameter, which corresponds in particular to the contribution of the flexibility of the haptics that can contract to fill the gap between the dome assembly and the ciliary body. Thus, the IOL according to the invention is particularly well adapted to a wide range of ocular anatomies with a planned resulting vault that is very low dependent on axial and / or radial compression of the footplate and is stable.

[0056] To cover all ocular anatomies, multiple IOL sizes with different first and second diameters may be required. To cover all ocular anatomies, two or three IOL sizes are sufficient, for example, first diameters of 12.7, 13.2, and 13.6 mm and second diameters of 9.5, 10.4, and 11.1 mm. Preferably, the latter second diameters are related to the aforementioned first diameters in the same order, respectively. This number of IOL sizes is particularly reduced compared to known phakic IOLs that include a large distal footplate, given that each of the current IOLs is adapted to a wider class of ocular anatomies.

[0057] According to a preferred embodiment of the invention, at least one, and preferably each, of the distal support elements is elongated along a circular arc having a central angle comprised between 20° and 80°, preferably between 40° and 70°, more preferably about 60°. As is known, the term "central angle" refers to the angle subtended by a circular arc, in particular the angle at the centre of a circle of a triangle whose vertices are said centre and the two ends of the arc.

[0058] Advantageously, the support elements as feet of the dome assembly are wide and circular, providing a stable and rigid base for supporting the IOL on the ciliary zonules when the IOL is in an implanted position in the eye. The circular arc is usually of a second diameter. Preferably, at least two foot plates are symmetrically attached by the first and second ends of each support element.

[0059] In the following, the pocket will be described in more detail. The pocket plays an advantageous role in the present invention since it contributes to a simplified IOL implantation. As mentioned above, the pocket is arranged on the support element to which the second end of the foot plate is attached and is at least partially radially aligned with the foot plate, in order to be able to manipulate the foot plate by engaging the tool tip with the pocket. In other words, preferably, the pocket is arranged near the foot plate, in particular near the ends of the foot plate, and is radially aligned in their proximal vicinity and / or between the optical axis and the foot plate.

[0060] As previously mentioned, the first end of the foot plate can be attached to various locations on the peripheral haptics. However, it is preferably attached to the same support element as the second end. As explained above, this allows the foot plate to extend from and to the most distal portion of the peripheral haptics, shortening the length of the foot plate and making it easier to manipulate. Furthermore, the pocket is in close proximity to both foot plate ends on the same support element, again making it easier to manipulate the foot plate during the IOL implantation process. In this case, the pocket is preferably substantially radially aligned between the first end and the second end, which further improves manipulation of the foot plate via engagement of a tool tip into the pocket.

[0061] According to one embodiment of the present IOL, the pocket defines or has the form of a circumferential trench on the IOL, with an anterior surface extending parallel to the footplate and dimensioned to receive the tip of a tool along the trench. More specifically, the trench is designed and dimensioned to allow the IOL to be moved with a tool for inserting the IOL under the iris of the eye. The trench preferably extends circumferentially along the distal boundary of the support element from proximal proximity of the second end to proximal proximity of the first end. For example, the distance between these ends and the pocket is preferably less than 0.30 mm, more preferably less than 0.20 mm. This proximity between its ends and the pocket allows the trench design to be perfectly tailored to receive the tip of a tool and move appropriately to place the footplate.

[0062] Preferably, the trench is designed similarly to the foot plate and / or has similar geometrical extension characteristics. Preferably, the trench is provided at its two circumferential ends with two radially inward extensions that are radially mirror symmetrical to the foot plate ends. This design of the pocket is especially adapted to perform the appropriate movement at the tool tip, allowing the foot plate to be inserted under the iris (as shown in FIG. 11, which will be presented later).

[0063] The trench, or any other shaped pocket, is usually provided as one piece on the anterior surface of the IOL. In particular, the pocket is not intended to communicate with the posterior surface of the IOL. In fact, the goal is to avoid reaching the tip of a tool through the IOL, which could damage the intraocular tissue.

[0064] According to an embodiment of the IOL pocket, fully compatible with the previous embodiment, the IOL pocket comprises a bottom surface and side edges as part of the front surface. The bottom surface is preferably rough to increase friction and / or to increase the hooking of the tool tip into the pocket. The edges are preferably comprised between 25-75% of the thickness of the support element to which the second end of the foot plate is attached, measured axially, more preferably with a height of about 50% (+ / - 5%). Such a pocket is particularly easy to manufacture and is quite satisfactory for the above mentioned operational purposes. The height of the pocket edges as 50% (+ / - 5%) of the support element thickness is suitable to have a pocket deep enough to hook the tool tip and a part of the support element axially below the pocket thick enough to guarantee its resistance.

[0065] According to a preferred embodiment of the invention, the footplate distal edge has a second portion extending from said second diameter to the first diameter and extending along the arc of the first diameter. The second portion in particular consists of the most distal point of the IOL, i.e. the furthest point in absolute radial value. The length of the second portion is preferably not negligible. The second portion has a central angle, preferably comprised between 5° and 25°, more preferably about 10°, when no axial or radial compression is applied to the IOL, providing a strong stabilization of the IOL in rotation towards the ciliary body. Moreover, this central angle can be increased up to 45° when the IOL is in its implanted position, i.e. when the IOL is subjected to axial and / or radial compression.

[0066] Preferably, the second part of the distal edge, if the IOL includes such a chamfer, is attached to the above-mentioned first part along which the smooth lateral chamfer extends. This attachment is made so that the distal edge extends continuously and smoothly along these first and second parts and smoothly continues laterally the support element to which the second end of the foot plate is attached. This provides a foot plate with a smooth design that is easy to manipulate and to insert under the iris. The distal edge preferably consists of these first and second parts. Preferably, the second part of the distal edge is attached to a third part of the foot plate connecting it to the first end. This third part preferably extends (only) radially along a direction having a smaller angle comprised between 5 and 60°, more preferably between 7.5 and 40°, for example 7.5°, 10°, 15° or 20°, and has an axis of (mirror) symmetry of the IOL perpendicular to the optical axis. This angle advantageously allows to reduce the compressive forces exerted on the IOL when it is in the implanted position. In particular, the larger the angle, the less compressive the force on the IOL. Typically, when such high compressive forces occur, the first and third portions flexibly shift laterally such that the second portions move significantly closer to the distal boundaries of the corresponding support elements, or in other words, the corresponding cavity sizes are significantly reduced. For example, the second portions are at least two or three times closer to the distal boundaries than they would be if no compressive force were applied to the IOL.

[0067] According to a preferred embodiment of the invention, the footplate extends along a plane whose normal vector forms an angle with the optical axis comprised between -15° and 15°. This angle applies in particular when the IOL is in the implanted position, allowing an orientation of the footplate sufficient to place the IOL in the ciliary body of the eye and to stabilize it. Said normal vector is oriented in the same way as the optical axis, the angle sign being preferably considered in the traditional plane trigonometric sense. Preferably, the value of the angle is comprised between -5° and -10°, more preferably about -7°, in order to advantageously facilitate the insertion of the footplate under the iris, at least when the IOL is manufactured prior to its implantation.

[0068] According to the embodiment of the invention shown below, the IOL comprises two diametrically opposed distal support elements and two pairs of diametrically oriented elongated flexible foot plates. The orientation of the foot plates is preferably determined by the sense of movement along the main trajectory of the foot plates from the second end to the first end. This symmetrically distributed arrangement of the support elements and the elongated flexible foot plates provides the IOL with excellent axial, radial and rotational stability. In particular, the vault is only partially dependent on lateral compressive forces exerted through the IOL body. When such lateral compressive forces occur, the design of the IOL absorbs them at least partially, preferably almost completely, in the two pairs of elongated flexible foot plates, so that the dome assembly is very advantageously more stable axially with little axial movement.

[0069] The IOL is preferably shape-invariant even when rotated 180° around the optical axis. In other words, the pair of elongated flexible footplates are oriented such that they are images of each other by rotating the IOL 180° around the optical axis. This is advantageous in the case of IOL lenses that contain a curvature irregularity to correct astigmatism, for example, in the case of phakic toric IOLs. Indeed, in this case, it is often necessary to rotate the IOL to the proper axis before surgery. The design and rotational symmetry of the elongated flexible footplates facilitate such rotational manipulation during the implantation process.

[0070] Phakic intraocular lenses are also preferably shape-invariant under planar reflection by two orthogonal planes, each of which contains the optical axis, which provides the IOL with advantageous mirror symmetry and avoids twisting of the IOL during and after implantation.

[0071] Preferably, the nearest elongated flexible footplates from the two different pairs are separated by a distance comprised between 5% and 25% of the second diameter. The elongated flexible footplates are also preferably directed distally to converge towards an axis perpendicular to the optical axis. The distal orientation of each footplate is obtained by a natural guidance of said orientation at its distal edge. In other words, the elongated flexible footplates are generally directed inwards and not outwards from the distal corner of the IOL. This makes it easier to control the movement of each footplate and therefore easier to insert the elongated flexible footplates under the iris during the implantation process.

[0072] According to a generally preferred embodiment of the invention, the central optical portion includes a through hole extending between the anterior and posterior surfaces of the IOL and positioned to allow fluid flow between these surfaces when the IOL is in its implanted position. This hole advantageously prevents the presence of the IOL from inducing a second artificial posterior chamber that would undesirably restrict the natural fluid flow between the anterior and posterior spaces of the IOL. The hole ensures complete and permanent fluid communication between the anterior and posterior chambers of the eye. Preferentially, the through hole is positioned in the center of the central optical portion, near the intersection with the optical axis.

[0073] Optionally, the IOL also includes peripheral optical holes disposed in the peripheral haptics, preferably near the proximal boundary with the central optical portion. These peripheral optical holes traverse the anterior and posterior surfaces of the IOL and also allow for additional fluid flow through the IOL, particularly during the implantation process.

[0074] According to one embodiment of the IOL, the central optic portion has at least an orientation mark on the anterior surface of the IOL. This orientation mark is particularly useful for orienting the IOL during the implantation process, since the central optic portion remains primarily visible. This is particularly advantageous for properly orienting phakic toric IOLs as explained above. The orientation mark can take a variety of forms. Preferably, the orientation mark consists of aligned small surface holes on the anterior surface of the IOL. These holes do not obviously cross the IOL. The mark can also take the form of at least one superficial line created by laser, light or engraving on the anterior surface of the IOL.

[0075] The present invention advantageously allows the selection of a central optical part lens that best matches the patient's vision defect to be corrected. In particular, according to an embodiment of the present invention, the central optical part lens consists of a monofocal lens that allows at least one of the following corrections: myopia correction, hyperopia correction, presbyopia correction, and corneal astigmatism correction. According to a particular embodiment of the present invention, the lens consists of a refractive or diffractive lens with an extended depth of focus, preferably for treating presbyopia. Preferentially, the lens is selected according to the state of the art.

[0076] As disclosed above, the IOL according to the invention preferably comprises a manipulation pocket in close association with the footplate, the association being achieved through advantageous cooperation between the pocket and said tool tip, so that the tool itself contributes to the invention.

[0077] especially, A handle and a straight rod including a first end secured to the handle; a circularly curved rod extending smoothly from the second end of the straight rod; A tip fixed to a circularly curved rod, Extending from the circularly curved rod in a secant direction, a tip portion sized to cooperate with the pocket by (keyed) engaging the tip portion with the pocket such that movement of the elongated flexible foot plate can be caused by movement of the tool; A tool comprising:

[0078] The tool allows for an easy implantation of the IOL according to the invention. In particular, this single tool is sufficient to carry out all necessary steps of the implantation process. Moreover, during the latter, there is no need to touch the footplate with the tool tip in order to position it. This advantageously prevents the surgeon from making an operating error such as engaging the tip in a cavity surrounded by the footplate with the risk of touching delicate intraocular tissues, for example the crystalline lens.

[0079] The design of the tool is specially adapted to easily implant the IOL in the posterior chamber of the eye. In particular, the circularly curved rod and the tip are preferably the only parts of the tool that penetrate the eye. The circularly curved rod allows to avoid a potentially sharp angle between the straight rod and the tip. It is dimensioned in particular so that the tip can smoothly reach the pocket through the posterior chamber without damaging the intraocular tissue and without touching the IOL, which may push it backwards, deform it in an undesirable way and / or touch the crystalline lens, which may lead to cataracts of the eye. The circularly curved rod preferably extends substantially along a single arc, more preferably with a radius of curvature comprised between 10 and 30 mm, for example about 20 mm. Nevertheless, the circularly curved rod may comprise several circularly curved parts, preferably two such parts, with different radii of curvature in the framework of the present invention. In the case of two circularly curved (connected) parts, the first radius of curvature (of the first part) is preferably comprised between 10 and 30 mm, for example about 20 mm, and the second radius of curvature (of the second part) is preferably comprised between 5 and 10 mm, for example about 6 mm. In an advantageous manner, the second part has a steeper downward slope, which makes it more suitable to reach the pocket without contacting the IOL with another part of the tool. More generally and more preferably, if the circularly curved rod comprises several circularly curved parts, their respective radii of curvature decrease from the straight rod towards the tip for similar reasons.

[0080] The tip is usually the only part of the tool that is arranged to cooperatively engage the pocket. Preferably, the tip comprises a free end (or distal) portion having a distal sharp edge configured to hook the tip into the pocket. This outer portion is preferably cylindrical in shape. In particular, the design of the tool tip is very simple, making the tool easy to manufacture while allowing efficient keying engagement into the pocket.

[0081] In the case of a pocket corresponding to a trench on the anterior surface of the IOL, the width of the trench is typically precisely dimensioned to receive the tip, such that the tip engages the trench and has substantially one degree of freedom of movement along the extension trajectory of the trench. The latter may in particular have a shape similar to that of the footplate. In particular, the outer portion is typically arranged to axially engage and then move into the pocket on the anterior surface of the IOL.

[0082] Preferably, the tip comprises a bulging portion fixed (or connected) to the circularly curved rod. This bulging portion allows a very smooth extension of the circularly curved rod and allows a smooth angle to be defined between the axis of extension of the circularly curved rod and the outer portion of the tip (preferably parallel to the optical axis when the tool is used). The term "bulging" is used to refer to the shape of this portion, the latter being more preferably at least partially ellipsoidal. The cross section of the bulging portion is preferably larger (e.g. in terms of diameter and / or area) than the constant cross section of the terminal portion so that only the terminal portion can engage the pocket. In particular, very advantageously, the bulging portion acts as a stopper to prevent the tool from entering any IOL hole or cavity. The cross section of the bulging portion is typically elliptical (e.g. circular). The first elliptical portion of the bulging portion is preferably at least 25% larger, more preferably at least 50% larger, more preferably again at least twice as large as the second constant circular portion of the terminal portion.

[0083] The terminal portion is preferably directly and sharply secured to the bulging portion so that the tip can more easily hook onto the anterior surface of the IOL at the pocket level. Alternatively, the terminal portion is smoothly secured to the bulging portion by using an intermediate mechanical connection. This mechanical connection typically has a smoothly varying cross-sectional shape that can prevent undesired hooking of the bulging portion on the IOL during the implantation process.

[0084] Preferably, the bulging portion includes a curved sub-portion oriented to mimic the forward curvature of the peripheral haptics as the outer portion of the tip extends axially, providing the tool with an overall shape more suited to allowing the distal portion to reach the pocket without touching the IOL with another portion of the tool.

[0085] The straight rod, the circularly curved rod and the tool tip are preferably made of metal, for example stainless steel, and are durable.

[0086] The present invention also provides a set comprising an IOL according to the invention and a tool as introduced above. All embodiments of the IOL and / or tool described above, and their mutual advantages, extend mutatis mutandis to this set.

[0087] Other characteristics and advantages of the invention will become apparent from a reading of the following detailed description, for an understanding of which reference is made to the accompanying drawings, a list of which is given below: [Brief description of the drawings]

[0088] [Figure 1] 1 is a general three-dimensional anterior and lateral view of an IOL according to a preferred embodiment of the present invention. [Diagram 2] FIG. 2 is a plan, top view of the IOL shown in FIG. 1. [Diagram 3] 2 is a side view of the IOL shown in FIG. 1, along with the relative positioning of the IOL guide dome and the eye's lens. [Figure 4] FIG. 2 is a three-dimensional exact side view of the IOL shown in FIG. 1. [Diagram 5] FIG. 2 is a cross-sectional view of a portion of an eye fitted with the IOL shown in FIG. 1, the latter shown in a side view. [Figure 6] 3 shows a cross-sectional view of the IOL shown in FIG. 1 taken along plane VI shown in FIG. 2. [Figure 6a] FIG. 7 is an enlarged view of the circled portion in FIG. 6. [Figure 7]FIG. 2 is a three-dimensional close-up view of a portion of the support element and footplate of the IOL shown in FIG. 1. [Figure 8] 8 is a cross-sectional view of the IOL shown in FIG. 1 taken along plane VIII shown in FIG. 2. [Figure 9] FIG. 2 illustrates a graphical representation of the axial displacement of the IOL shown in FIG. 1 depending on the anatomical space of the posterior chamber. [Figure 10] 1 is a general plan side view of a tool according to a preferred embodiment of the present invention; [Figure 10A] 1 is a general plan side view of a tool according to a preferred embodiment of the present invention; [Figure 11] 11 is a schematic top view of the movement of the tip of the tool shown in FIG. 10 during the implantation process of the IOL shown in FIG. 1. [Figure 12] FIG. 11 is a general three-dimensional view of a first embodiment of the tip of the tool shown in FIG. 10. [Figure 13] FIG. 11 is a general three-dimensional view of a second embodiment of the tool tip shown in FIG. 10. [Figure 14] 11 is a simplified cross-sectional view of a portion of an eye crossed by a portion of the tool shown in FIG. 10 during the implantation process of the IOL shown in FIG. 1, the latter being shown in a side shadow view. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0089] The drawings are generally not drawn to scale. Similar elements are generally assigned similar references. Within the framework of this specification, identical or similar elements may have the same reference. Moreover, the presence of references in the drawings cannot be considered limiting, including when these references are presented in the claims.

[0090] This part of the specification presents a complete description of certain preferred embodiments of the invention with reference to the drawings, in which the invention is not, however, limited by these references. The figures introduced above are particularly schematic and in no way limiting.

[0091] In some figures, abstract geometric symbols and corresponding references are provided that are substantially used to quantify and / or visualize technical features of embodiments of the present invention, such as scales and geometric features (e.g., 81-89B, X, Y, Z, K, P, k, k', 7A, 7B, 71A, 72A, 72B, 73A, α-ε, and θ). These geometric symbols do not usually correspond to concrete objects.

[0092] The present invention provides a posterior chamber phakic IOL 1 that is simultaneously adapted to a wide range of ocular anatomies, is easy to implant, and is post-operatively stable at an implanted position within eye 9 axially along optical axis Z, radially and rotationally in a plane perpendicular to optical axis Z based on vectors (or axes) X and Y. In particular, as shown in Figure 1, axes X, Y, and Z form an orthogonal basis in Euclidean three-dimensional space. Conventionally, optical axis Z is directed from anterior surface 11 to posterior surface 12 of IOL 1 (see Figures 1 and 3).

[0093] As shown in Figure 5, the IOL 1 is intended to be placed in the posterior chamber 96 of the eye 9. Other elements of the anatomy of the eye 9 are shown in Figure 5, namely the cornea 91, iris 92, pupil 93, lens 94, anterior chamber 95, ciliary zonules 97 and ciliary body 98 of the eye 9.

[0094] As shown in Figures 1 and 2, the IOL 1 has a central optical portion 2 extending radially with respect to the optical axis Z on a maximum outer diameter comprised between 4.5 and 6.7 mm, preferably about 5.8 mm. The central optical portion 2 comprises a through hole 21 extending along the optical axis Z between the anterior surface 11 and the posterior surface 12, allowing fluid communication between these surfaces. The central optical portion 2 also comprises orientation symbols 22 in the form of two pairs of diametrically opposed small surface holes aligned along the axis Y on the anterior surface 11. These symbols 22 can be used to orient the IOL 1 during implantation. Exemplary diameter values ​​of the through hole 21 and each surface hole are about 0.36 and 0.12 mm, respectively.

[0095] The central optic portion 2 is surrounded by a haptic structure in which peripheral haptics 3 are attached circumferentially and proximally to the central optic portion 2. The peripheral haptics 3 extend radially outward and posteriorly relative to the central optic portion 2. Nevertheless, the IOL extends further radially along axis Y than along axis X such that it has an overall planar shape elongated along axis Y, as shown in FIG.

[0096] The peripheral haptic portion 3 is composed of a main proximal portion 34 and two diametrically opposed distal support elements 4. The main proximal portion 34 is provided with two peripheral optical holes 33 located proximally near the border with the central optical portion 2, symmetrically along the axis Y, and symmetrically with respect to the optical axis Z. The peripheral optical holes 33 traverse the IOL 1 through the anterior surface 11 and the posterior surface 12 so as to allow fluid flow during the implantation process of the IOL 1. As shown in FIG. 2, the peripheral optical holes 33 are included in the IOL 1 portion of the third diameter 83, which is comprised between 7.2 and 8.0 mm, and preferably about 7.45 mm. The peripheral optical holes 33 are preferably very similar in size to the through holes 21.

[0097] The support elements 4 are attached to two diametrically opposite distal ends of the main proximal portion 34, mirror-symmetrically with respect to a plane based on the axis X and the optical axis Z. The support elements 4 are in the form of ring segments extending circumferentially around the optical axis Z, each along an arc with a central angle β of approximately 60° (as shown in FIG. 2). The distal boundary 41 of each support element 4 extends along an arc of a second diameter 82, in particular comprised between 9.5 and 11.1 mm, for example approximately 10.4 mm. The support elements 4 are provided with a lateral recess 42 in the form of a partial hole that increases the flexibility of the distal boundary 41.

[0098] In particular, the entire peripheral haptic portion 3 and the central optical portion 2 are inscribed in a cylinder of second diameter 82 extending about the optical axis Z in such a way as to form a dome K (or dome assembly) supported posteriorly by the support elements 4. As shown in Figures 3 and 5, the dome K has a posterior surface that is intended to rest on the crystalline lens 94 when the IOL 1 is in an implanted position in the eye 9. The distal support elements 4 are then positioned to support the IOL 1 on the ciliary zonules 97 of the eye 9.

[0099] The posterior surface of the dome K is concave, smooth, and curved with a preferred radius of curvature k of approximately 10 mm to match the curvature of the anterior surface of the lens 94, such that a vault 89B adjustable between 300 and 750 μm can be ensured between the IOL 1 and the lens 94 when the IOL 1 is in its implanted position as described in this disclosure and shown in FIG. 5.

[0100] The intrinsic height 89A of the dome K visible in FIG. 3 is measured in the axial direction and is called the "intrinsic vault" and constitutes the intrinsic vault height of the IOL 1. The intrinsic vault height typically has a value comprised between 1.0 and 2.0 mm, preferably between 1.3 and 1.75 mm. For example, if the pair of the first diameter 81 and the second diameter 82 of the IOL 1 is (12.7 mm, 9.5 mm), (13.2 mm, 10.4 mm), or (13.6 mm, 11.1 mm), the intrinsic height 89A is approximately 1.30, 1.40, or 1.75 mm, respectively.

[0101] As shown in Fig. 8, the side of the peripheral haptic portion 3 to which the support element 4 is not distally attached includes a bevel having an angle ε of about -45° with respect to a plane perpendicular to the optical axis Z. The bevel has a length 88 comprised between 0.8 and 1.3 mm, preferably about 1.06 mm. The bevel terminates in a distal rounded polished corner 35 directed backwards and radially.

[0102] As explained in the present disclosure, the particular wall thickness provides the dome K with rigidity, making it resistant to axial and / or radial compression when the IOL 1 is in its implanted position. In particular, as shown in Fig. 6, the thickness 84C around the center of the dome K may be about 0.20 mm, then increases radially until it reaches the proximal boundary of the peripheral haptic portion 3, which has a thickness 84B of, for example, about 0.60 mm, and finally decreases radially to the support element 4, which has a thickness 84A (not considering the pockets introduced later) generally comprised between 0.15 and 0.25 mm.

[0103] These values ​​are selected to enable the dome K to construct a structure that is sufficiently stiff and wide to surround and anteriorly over the crystalline lens 94, thereby enabling it to be embedded in a wide range of ocular anatomical structures while remaining stable parallel to the optical axis Z.

[0104] 1, 2, and 7, the IOL 1 also includes two pairs of diametrically opposed elongated flexible foot plates 5 that are attached to the distal support elements 4 and extend radially along axis Y beyond the peripheral haptics 3. Each such foot plate 5 has a first end 51 and a second end 52 attached to the same support element 4 such that the foot plate has the form of a partial loop adjacent a cavity 32 that extends from the anterior surface 11 to the posterior surface 12.

[0105] The first end 51 is disposed centrally along the distal boundary 41, and the second end 52 is disposed laterally along the distal boundary, being a lateral continuation of the peripheral haptic portion 3. In other words, the first end 51 is closer to the axis Y than the second end 52. As shown in FIG. 2, the distal boundary 41 extends between the first end 51 and the second end 52 along an arc of a second diameter 82 with a central angle δ comprised between 15° and 45°, preferably between about 20° and 25°.

[0106] Each cavity 32 is more extended in terms of the area perpendicular to the optical axis Z than the corresponding foot plate 5. In particular, as shown in FIG. 7, the maximum radial length 86 of each cavity 32 is (much) greater than the maximum diameter 87 of any cross section C of the elongated flexible foot plate. This radial length 86 is comprised between 0.7 and 0.9 mm, preferably about 0.8 mm, the radial length of said cross section C being preferably comprised between 0.2 and 0.4 mm. As a result, the surface of the IOL 1 extending radially further than the second diameter 82 is less solid than filled with solids. Each foot plate 5 has a substantially constant thickness 83A (shown in FIG. 3) comprised between 0.10 and 0.20 mm, preferably about 0.15 mm. All these data contribute to giving the foot plate 5 a good flexibility.

[0107] Prior to implantation, IOL1 is generally cut into a cylinder of said first diameter 81 with a preferred value comprised between 12.7 and 13.6 mm when no axial or radial compression is applied to IOL1. In particular, each footplate extends between second diameter 82 and first diameter 81, which allows its flexibility to compensate for size variations in the anatomical space available within the posterior chamber 96 of the eye for IOL1 when IOL1 is in its implanted position as described above in this disclosure.

[0108] The foot plate 5 is specifically designed to fold and / or curve when axial and / or radial compression is applied to the IOL 1 such that an adjustable angle α between the optical axis Z and a normal vector to the extension plane P of the foot plate 5 is generally comprised between −15° and 15°, as shown in FIG. 6 .

[0109] Each foot plate 5 includes a distal edge 53 that extends both circumferentially and radially outwardly relative to the support element 4 to which it is attached. This distal edge 53 is arranged to stabilize the IOL 1 within the ciliary body 98, particularly when the IOL 1 is in its implanted position as shown in FIG. 5. It serves as an anchor for stabilizing the IOL 1 as it rotates in a plane perpendicular to the optical axis Z, as detailed in this disclosure. The distal edge 53 may optionally be arranged to stabilize the IOL 1 within the ciliary sulcus of the eye 9, such that the term "ciliary body" herein may be optionally replaced by "ciliary body and / or sulcus."

[0110] The distal edge 53 is composed of a first portion 54 and a second portion 55, which can be seen in particular in Figures 1 and 4. As shown in Figure 2, the second portion 55 extends along an arc of a first diameter 81, with a central angle γ comprised between 7.5° and 20°, typically about 10°, when the IOL 1 is not subjected to axial or radial compression. Thus, the second portion 55 is at the most distal portion of the distal edge 53. The first portion 54, for its part, extends from the second end 52 to the second portion 55.

[0111] The first portion 54 advantageously comprises a smooth lateral chamfer 31. The latter extends smoothly and continuously laterally over the first portion 54, over the support element to which the second end 52 is attached, and over all or part of the main proximal portion 34 of the peripheral haptic portion 3. As will be detailed in the present disclosure, this chamfer 31 contributes to aid in the insertion of the foot plate 5 under the iris 92 during implantation of the IOL 1.

[0112] The footplate 5 itself is substantially composed of three parts, namely a natural first width extension of the first part 54, a natural second width extension of the second part 55 and a third part 56, which can be seen in FIG. 1 and connects the natural second width extension with the first end 51. The main extension trajectories of these footplate parts extend respectively in both the circumferential and radial directions, substantially only in the circumferential direction and substantially only in the radial direction, in a direction that is comprised between 5 and 60° and that is, for example, about 7.5°, an angle with the axis Y (which usually corresponds to (1 / 2)(β-2δ)). This angle advantageously allows to reduce the compressive forces exerted on the IOL 1 when it is in the implanted position. In particular, angles greater than 7.5°, such as 10°, 12.5°, 15°, 17.5°, 20°, 25°, 30° or 40°, are also preferred, since the higher the value, the lower the compressive forces exerted on the IOL 1.

[0113] The overall design of the elongated flexible foot plates 5 is determined to facilitate the IOL1 implantation process. In particular, the chamfers 31 have a concave smooth outer surface such that each foot plate 5 is oriented distally to converge towards the axis Y. In that case, the movement of inserting the elongated flexible foot plate 5 under the iris 92 is greatly facilitated. The distal boundary 41 of each distal support element 4 further extends between the first ends 51 of the two different pairs of elongated flexible foot plates 5 along an arc of a second diameter 82 having a central angle of about 15-20°.

[0114] The double haptic structure from the distal support element 4 and the elongated flexible foot plate 5 allows the IOL 1 to be particularly stable in its implanted position. Curve 103 in FIG. 9 represents the vault 89B (shown in FIG. 5 ), shown on axis 102 and measured in mm, as a function of the size of the anatomical space in the posterior chamber 96 corresponding to the “interciliary” measurement, shown on axis 101 and measured in mm, for an IOL 1 having a first diameter 81 value of 13.2 mm. Values ​​of 0.3 to 0.8 mm for the vault 89B are considered as extreme values ​​to ensure that the IOL 1 is axially stable and properly positioned between the iris 92 and the crystalline lens 94. As can be seen in curve 103, this is the case for the IOL 1, with a variation in the anatomical space size ranging around 1.1 mm (reference number 105).

[0115] A similar curve 104 of known commercially available posterior chamber phakic IOLs with reduced large distal footplate and less flexibility compared to curve 103 is depicted in FIG. 9. As can be seen in curve 104, the adaptability of these IOLs to the size changes of the anatomical space extends by about 0.7 mm (reference number 106) and is then significantly lower than 1.1 mm. Thus, the IOL 1 according to the invention can cover a wider range of ocular anatomical structures in a more stable manner. This graphical comparison shows the performance and improvement regarding axial stability of the present invention.

[0116] Given that the elongated flexible foot plates 5 are particularly flexible, it is advantageous to provide the IOL 1 with structures that help control the movement of the elongated flexible foot plates 5 during the implantation process and to properly insert them under the iris 92. To this end, the support element 4 is provided with a manipulation pocket 6 on the anterior IOL surface 11, as can be seen in Figures 1, 2, 6a and 7.

[0117] Each pocket 6 is associated with the foot plate 5 in terms of structural and functional features. In particular, structurally speaking, each pocket 6 faces the associated foot plate 5, so that only the distal boundary 41 separates the cavity 32 from the pocket 6. The pocket 6 is furthermore radially aligned between a first end 51 and a second end 52 of the foot plate 5. It defines a circumferential trench 63 on the anterior IOL surface 11, which extends parallel to the foot plate 5 and includes radially inner extensions 64 arranged at the two circumferential ends of the trench 63, in mirror symmetry with the foot plate ends 51 and 52.

[0118] The trench 63 has a rough bottom surface 61 and side edges 62 with an axial height 85 of about 50% of the thickness 84A of the corresponding support element 4. In other words, the axial height 85 is comprised between 0.075 and 0.125 mm, preferably between 0.08 and 0.09 mm. The height 85 may be slightly reduced in the radial direction depending on the thickness 84A of the support element 4. The most distal side edge 65, which borders the distal boundary 41, may be molded in a semi-cylindrical shape with a radius of 0.06 mm.

[0119] These geometric features of the pocket 6 are specifically provided to enable functional cooperation with the tip 71 of the operating tool 7 by geometric key engagement of the tip 71 into the pocket 6, such that appropriate movement of the elongated flexible foot plate 5 during the implantation process of the IOL 1 can be caused by movement of the tool 7.

[0120] Such cooperation during the IOL1 implantation process is shown diagrammatically in Figure 11, which illustrates the specific movements (by arrows) of the tool 7 for inserting each of the foot plates 5 under the iris 92 of the right eye 9. The elongated flexible foot plates 5 are numbered 5A-5D in the order of their manipulation through the pocket 6.

[0121] The insertion process for the (right distal) foot plate 5A involves pulling towards the puncture (i.e., small incision) P1, pushing down to insert the foot plate 5A under the iris 92, and pushing radially outwardly forward. The insertion process for the (left distal) foot plate 5B involves pushing towards the puncture P2, pushing down to insert the foot plate 5B under the iris 92, and pulling radially outwardly. For the (left proximal) foot plate 5C, the insertion process involves pulling towards the puncture P2, pushing down to insert the foot plate 5C under the iris 92, and pushing radially outwardly forward. Finally, for the (left distal) foot plate 5D, the insertion process involves pushing towards the puncture P1, pushing down to insert the foot plate 5D under the iris 92, and pulling radially outwardly.

[0122] Figure 14 shows the eye 9 of Figure 5 during implantation of the IOL 1. As can be seen, the tip 71 of the tool 7 is specially configured to cooperate with the pocket 6, thereby allowing the above-mentioned insertion of the elongated flexible foot plates 5A-5D.

[0123] The tool 7 will be described in more detail with reference to Figures 10, 12 and 13. The tool 7 comprises a handle 70, a straight rod 73 fixed to the handle, a circularly curved rod 72 smoothly fixed to the straight rod 73, and a tip 71 secantly fixed to the circularly curved rod 72. The tip 71 has a cylindrical free (distal) end portion 74 arranged to engage the pocket 6.

[0124] Non-limiting exemplary dimensional values ​​of the tool 7 are provided when the lower surface of the end portion 74 is in surface contact with the bottom surface 61, so that the axis of rotation around which the free end portion 74 extends cylindrically is substantially parallel to the optical axis Z. In these conditions, as shown in FIG. 10, the tool 7 with the handle 70 has an axial length 7A of about 15.00 mm, the circularly curved rod 72 and the tip 71 have an axial length 7B of about 2.34 mm, the extension length 73A of the straight rod 73 is about 14.30 mm, the extension length 72A of the circularly curved rod 72 is about 11.30 mm, and its radius of curvature k' is comprised between 15 and 30 mm, preferably about 20, 21, 22, 23, 24, 25 or 26 mm. The width of the tool tends to decrease along the extension trajectory of the straight rod 73 and the circularly curved rod 72 near the junction with the tip 71 from about 0.60 mm to about 0.24 mm (the latter width corresponds to reference number 72B in Figures 12 and 13). These values ​​are selected to allow for proper orientation and positioning of the tool within the eye 9, as shown in Figure 14.

[0125] As described and shown in FIG. 10, the circularly curved rod 72 extends along a single arc of radius of curvature k'. Nevertheless, as shown in FIG. 10A, the circularly curved rod 72 may also include two portions with different radii of curvature. The second portion 72' is more curved than the first portion, which constitutes the majority of the circularly curved rod 72. In this case, the radius of curvature is preferably about k', and the radius of curvature k'' of the second portion is preferably about 6 mm. Other features of the embodiment of FIG. 10, such as the overall length of the circularly curved rod 72, are consistent with FIG. 10A. Approximately 10-20% of this length comes from the second portion 72'.

[0126] Another tip 71 may be provided on the tool 7, and may be optionally removable. Two embodiments of the tip 71 are shown in Figs. 12 and 13. In both embodiments, the end portion 74 has a sharp distal edge 75 for easily hooking the tip 71 into the rough bottom surface 61 of the pocket 6. The cylindrical shape of the end portion 74 is specifically dimensioned to fit the size of the pocket 6. It has a diameter of about 0.25 mm and is preferably oriented at a smaller angle θ comprised between 40° and 85°, for example about 50°, 60°, 70° or 80°, more preferably at about 51° with respect to the extension direction of the circularly curved rod 72 near the junction with the tip 71.

[0127] The tip 71 includes a bulging portion 76 that connects the end portion 74 to the circularly curved rod 72. This connection through the bulging portion 76 can be made in different ways according to different embodiments, two of which are shown in Figures 12 and 13. In each of the two embodiments, the bulging portion 76 has a first variable elliptical circular cross section C1 that is larger than a second constant circular cross section C2 of the free end portion 74, which can prevent the bulging portion 76 from entering the pocket 6 and can also prevent the tip 71 from entering undesirable locations such as the optical peripheral hole 33 or cavity 32.

[0128] The bulging portion 76 is smoothly secured to the circularly curved rod 72 such that at least the upper axial surface of the circularly curved rod 72 and the tip 71 is generally smooth. This advantageously allows for smooth insertion and removal of the tool 7 through small incisions (or the punctures P1 and P2), making the insertion process and manipulation of the tool 7 easier.

[0129] In the embodiment of Fig. 12, distal portion 74 is directly and sharply secured to bulging portion 76 which improves the hooking of tip 71 on the anterior surface of IOL 1 adjacent pocket 6. In the embodiment of Fig. 13, distal portion 74 is differently and smoothly secured to bulging portion 76 by an intermediate smooth mechanical connection 77.

[0130] The axial length 71A of the distal portion 74 preferably varies from about 0.13 mm, for example in the embodiment of Fig. 12, to about 0.26 mm, for example in the embodiment of Fig. 13. The axial length 71B of the entire tip 71, part of which, is preferably less than 0.75 mm, more preferably comprised between 0.45 and 0.60 mm, for example about 0.53 mm, for both embodiments. This limited axial length is specifically designed to allow smooth passage through small incisions (or said punctures P1 and P2) during the insertion process.

[0131] In other words, the present invention relates to a posterior chamber phakic IOL 1 comprising a central optical portion 2, a peripheral haptic portion 3 having distal support elements 4 arranged to support the IOL 1 on the ciliary body zonules 97 of the eye 9, elongated flexible foot plates 5 attached to the support elements 4, each having a distal edge 53 arranged to stabilize the IOL 1 within the ciliary body 98 of the eye 9, and operating pockets 6 on the surface of the support elements 4, each pocket 6 being associated with one of the elongated flexible foot plates 5.

[0132] The present invention is described with respect to specific examples having purely exemplary values ​​and should not be considered as limiting. Generally speaking, it will be clear to those skilled in the art that the present invention is not limited to the examples or measurements shown and described above. In particular, all values ​​mentioned in this specification are provided with a margin of error of 10%. The present invention includes each of the novel features described, as well as all combinations thereof.

Claims

1. A posterior chamber phakic intraocular lens (IOL) (1), A front surface (11) and a rear surface (12), a central optical portion (2) including a lens and extending radially with respect to an optical axis (Z) directed from said front surface (11) to said rear surface (12); A peripheral tactile portion (3), circumferentially attached to said central optical portion (2); extending radially outward and posteriorly relative to said central optical portion (2); a peripheral haptic portion (3) comprising distal support elements (4) arranged to support the IOL (1) on the ciliary zonules (97) when the IOL (1) is in an implanted position within the eye (9); at least one elongated flexible foot plate (5) extending radially beyond said peripheral haptic portion (3) and including a first end (51) attached to said peripheral haptic portion (3); Equipped with The elongated flexible foot plate (5) a second end (52) attached to one of the support elements (4); A distal edge (53), extending circumferentially and radially outwardly with respect to said central optical portion (2); a distal edge (53) configured to stabilize the IOL (1) within the ciliary body (98) when the IOL (1) is in the implanted position within the eye (9); Including, said one of said support elements (4) being an operating pocket (6) on said front surface (11) and at least partially radially aligned with said elongated flexible foot plate (5); characterised in that it comprises an operating pocket (6) dimensioned to cooperate with a tip (71) of an operating tool (7) by keyed engagement of said tip (71) with said pocket (6) so that a movement of said elongated flexible foot plate (5) can be caused by a movement of said tool (7), Posterior chamber phakic intraocular lens (IOL).

2. 2. The IOL (1) of claim 1, wherein a smooth lateral chamfer (31) extends smoothly and continuously from said one of said support elements (4) to a first portion (54) of said distal edge (53).

3. The IOL (1) of claim 2, wherein the entire chamfer (31) has a concave, smooth outer surface.

4. 4. The IOL (1) according to any one of claims 1 to 3, wherein the elongated flexible foot plate (5) is adjacent to a cavity (32) extending from the anterior surface (11) to the posterior surface (12) and having a maximum radial length (86) greater than a maximum diameter (87) of a cross-section (C) of the elongated flexible foot plate (5).

5. 4. The IOL (1) according to claims 1 to 3, wherein each of said support elements (4) is elongated along a circular arc having a central angle (β) comprised between 20 and 80°.

6. 4. The IOL (1) according to any one of claims 1 to 3, wherein said first end (51) is attached to said one of said support elements (4).

7. 7. The IOL (1) of claim 6, wherein the pocket (6) is substantially radially aligned between the first end (51) and the second end (52).

8. 7. The IOL (1) of claim 6, wherein the pocket (6) defines a circumferential trench (63) on the anterior surface (11) of the IOL (1) extending parallel to the elongated flexible foot plate (5) and dimensioned to receive the tip (71) of the tool (7) along the trench (63).

9. 4. An IOL (1) according to any one of claims 1 to 3, wherein the pocket (6) has a bottom surface (61) as part of the front surface (11) and side edges (62), the side edges (62) having a height (85) measured parallel to the optical axis (Z) and comprised between 25 and 75% of the thickness (84A) of one of the support elements (4) measured parallel to the optical axis (Z).

10. a first diameter (81) consisting of an outer diameter of the IOL (1) measured perpendicular to said optical axis (Z) is comprised between 12.5 and 14.0 mm; a second diameter (82) consisting of the outer diameter of the peripheral haptic portion (3) measured perpendicular to the optical axis (Z) is comprised between 9.5 and 11.5 mm; An IOL (1) according to any one of claims 1 to 3.

11. 11. The IOL (1) of claim 10, wherein the distal edge (53) extends from the second diameter (82) to the first diameter (81) and has a second portion (55) extending along an arc of the first diameter (81), the second portion (55) having a central angle (γ) comprised between 5 and 25°.

12. 4. The IOL (1) according to claim 1, wherein the IOL (1) comprises two diametrically opposed support elements (4) and two pairs of diametrically oriented elongated flexible foot plates (5), the IOL (1) remaining shape-invariant even when rotated 180° around the optical axis (Z).

13. 13. The IOL (1) according to claim 12 when dependent on claim 10, wherein the closest elongated flexible foot plates (5) from two different pairs are separated by a distance between 5% and 25% of the second diameter (82) and are oriented distally to converge towards an axis (Y) perpendicular to the optical axis (Z).

14. 4. The IOL (1) according to any one of claims 1 to 3, wherein a thickness (84A, 84B) of the peripheral haptic portion (3), measured parallel to the optical axis (Z), decreases in a radial direction from the central optical portion (2) to the pocket (6) and is on average at least 50% greater than a thickness (83A) of the elongated flexible foot plate (5), also measured parallel to the optical axis (Z).

15. The IOL (1) according to any one of claims 1 to 3, wherein the elongated flexible footplate (5) extends along a plane (P) whose normal vector forms an angle (α) of between -15° and 15° with respect to the optical axis (Z).

16. 4. The IOL (1) according to any one of claims 1 to 3, wherein the central optic portion (2) and the peripheral haptic portion (3) form a dome (K) having a concave smooth posterior surface.

17. A posterior chamber phakic intraocular lens (1) according to any one of claims 1 to 3, A set comprising an operating tool (7), the operating tool (7) comprising: A handle (70); a straight rod (73) including a first end fixed to the handle (70); a circularly curved rod (72) extending smoothly from a second end of the straight rod (73); A tip (71) fixed to the circularly curved rod (72), Extending in a secant direction from the circularly curved rod (72), said tip (71) being dimensioned to cooperate with said pocket (6) by keyed engagement therewith; a tip (71) that allows the movement of the elongated flexible foot plate (5) to be caused by the movement of the tool (7); A set that includes:

18. 18. A set according to claim 17, wherein said tip (71) has a cylindrical free end portion (74) with a sharp end edge (75) for hooking said tip (71) into said pocket (6).

19. said tip (71) is fixed to said circularly curved rod (72) and comprises a bulging portion (76) having a first elliptical portion (C1) that is at least 25% larger than a second constant circular portion (C2) of said free end portion (74); said free end portion (74) is either directly and sharply attached to said bulging portion (76) or smoothly attached to said bulging portion (76) by an intermediate mechanical connection (77); 20. The set according to claim 18.

20. 18. The set of claim 17, wherein the circularly curved rod (72) includes one or more circularly curved portions having different radii of curvature.

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