There is a lens inside the back room.

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 an intraocular lens (IOL). More particularly, it relates to an posterior chamber phakic IOL.

Background Art

[0002] Generally speaking, phakic IOLs are IOLs intended to be implanted in the eye to correct visual impairment. These IOLs are usually implanted in younger patients as a complement to the natural lens.

[0003] Posterior chamber phakic IOLs are phakic IOLs intended to be implanted in the area of the eye between the back of the iris and the front of the lens and supported around the ciliary body of the eye.

[0004] The limitation of implanting such IOLs lies in the fact that the parameters, especially the size, of the posterior chamber anatomical structure usually vary by several millimeters for each patient, and there is a high possibility that they will be placed at different positions in one eye and the other eye. In particular, the implantation of a posterior chamber phakic IOL with a size that may not fit, - For example, when the phakic IOL is too small for the size of the anatomical space of the posterior chamber available for IOL implantation: contact between the lens and the IOL, which causes cataract of the eye, or loss of the corrective power of the phakic IOL, or affects the accuracy of vision, - Or, for example, when 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 chamber and the posterior chamber of the eye after pupillary block, has a risk of causing more or less serious medical complications for the patient.

[0005] The manufacture and use of phakic IOLs of various sizes based on general ocular anatomy cannot completely overcome this defect. In fact, the lack of stability in the position of such phakic IOLs after implantation in the eye can lead to the same medical complications.

[0006] As an attempt to solve this problem, International Publication No. 2020 / 035534(A1) discloses a posterior chamber phakic IOL including a dual tactile structure made of a peripheral tactile portion, which includes a support element positioned to be located on the ciliary zonules and an elongated tactile portion having a proximal end attached to the proximal portion of the peripheral tactile portion and a free distal end for hooking the IOL into the ciliary sulcus of the eye. These tactiles allow for compensation of variations in the size of the anatomical space, and the dual tactile structure allows for overall stabilization of the intraocular position of the IOL.

[0007] Nevertheless, the elongated tactile structure of this IOL is difficult to see and manipulate during the implantation process into the eye. Therefore, it is desirable to provide a posterior chamber phakic IOL that is easy to implant but is sufficiently stable at the implantation site. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] International Publication No. 2020 / 035534(A1) [Overview of the project] [Problems that the invention aims to solve]

[0009] The objective of the present invention is to provide a posterior chamber phakic IOL that is compatible with a wide range of ocular anatomical structures and is easy to implant in the eye. [Means for solving the problem]

[0010] For this purpose, the present invention is a posterior chamber phakic IOL, Front and rear, The central optical part, including the lens, A central optical portion extends radially with respect to the optical axis directed from the front to the rear, The peripheral tactile part, It is mounted circumferentially in the central optical section. A peripheral tactile portion comprising a distal support element that extends radially outward and posteriorly relative to the central optical portion and is positioned to support the IOL on the ciliary zonules when the IOL is implanted in the eye, At least one elongated flexible footplate, It extends radially beyond the peripheral tactile area, A first end attached to the peripheral tactile portion, including at least one elongated flexible footplate and Equipped with, The elongated, flexible footplate, A second end attached to one of the support elements, The distal lateral margin extends circumferentially and radially outward from the central optical portion and is positioned to stabilize the IOL in the ciliary body when the IOL is implanted in the eye. including, We provide a posterior chamber phakic IOL. The support element preferably includes an operating pocket on the front of the IOL, which is at least partially radially aligned with an elongated flexible footplate and is dimensioned to cooperate with the tip of an operating tool by a (locked) engagement of the tip into the pocket, so that the movement of the elongated flexible footplate may be triggered by the 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 at the implantation site and the ease of implantation. Like the IOL in International Publication No. 2020 / 035534(A1), this IOL comprises two separate complementary tactile structures: firstly, a peripheral tactile portion including distal support elements, and secondly, a central optical portion having at least one elongated flexible footplate (hereinafter referred to as "footplate," the IOL preferably includes two or four such elongated flexible footplates). The peripheral tactile portion together with the central optical portion forms a "dome assembly." The feet of the dome assembly are support elements positioned distally to support the IOL at the ciliary zonules. The footplate also stabilizes the IOL at the ciliary body as it extends radially beyond this dome assembly. The shape and flexibility of the footplate contribute entirely to the stability of this IOL at the implantation site. To facilitate IOL implantation, the footplate is fully attached to the flexible tactile portion at its end. While this slightly reduces the adaptability of the footplate compared to a long, freely terminating footplate as described in International Publication No. 2020 / 035534(A1), this new shape of the footplate makes manipulation during the implantation process much easier. This feature is further enhanced by the preferred presence of an operational pocket on a support element to which at least one end of the footplate is attached. In particular, the shape and flexibility of the footplate allow the IOL to be adapted to a wide class of ocular anatomical structures, but any potential operational difficulties arising from this are fully compensated for by attaching the end of the footplate to the peripheral tactile portion and by the favorable presence and location of the pocket.

[0012] The above technical effects will be explained in detail. In particular, as will be explained below, the IOL is especially stable in the axial direction (i.e., parallel to the optical axis), the radial direction (i.e., perpendicular to the optical axis), and the circumferential direction (i.e., rotation around the optical axis) at its implantation location.

[0013] The peripheral tactile portion allows the IOL to be stabilized parallel to the optical axis. The support element is located at the distal end of the peripheral tactile portion and is designed to support the IOL dome assembly with the ciliary zonule. The dome assembly is configured to be positioned anterior to the eye's natural lens, at least anteriorly, so as to surround the lens. As a result, a distance called the "vault," measured along the optical axis between the anterior surface of the lens and the posterior surface of the IOL, is defined and stabilized. This can be assimilated into the safety distance necessary to avoid contact or excessive proximity between the lens and the IOL. Similarly, the safety distance between the IOL and the iris of the eye is defined and stabilized as the distance between the anterior surface of the IOL and the posterior surface of the iris (at the rising opening), which can be considered as a virtual iris plane occupying the pupil.

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

[0015] The structure of the dome assembly is adapted to a wide range of ocular anatomy, corresponding to a wide range of posterior chamber anatomy, based on the selection of a posterior surface that is more curved than the anterior surface of any lens, and the selection of the outer diameter of the peripheral tactile portion (measured perpendicular to the optical axis). More specifically, this diameter preferably falls 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 described below, the three diameter values ​​of 9.50, 10.40, and 11.10 mm are advantageously sufficient to cover any posterior chamber anatomy. The posterior surface of the dome assembly is preferably smooth and concave (posteriorly). The rear surface of the dome assembly has a radius of curvature that is more preferably between 8 and 11 mm, and again more preferably between 9 and 10 mm. The radius of curvature is preferably selected as the minimum mean radius of curvature of the front surface of the lens, and is 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 should also be noted that this radius of curvature is clearly defined given that the rear surface of the dome assembly is smooth and (mathematically) regular. In particular, it is preferable that the rear surface of the junction between the central optical portion and the peripheral tactile portion is free from irregularities or angular points.

[0016] Next, the dome assembly is placed on the lens when the IOL is in the implanted position within the eye (i.e., when the IOL is in normal use within the eye), placed on the zonular fibers, and stabilizes the IOL parallel to the optical axis. The footplate has a portion that extends radially beyond the dome assembly in the posterior chamber of the eye to be disposed on the ciliary body. Due to the flexibility and shape of the footplate, the internal size of the posterior chamber anatomical space available for the IOL can be varied (known as the "inter-ciliary" measurement, preferably the inter-ciliary 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, and the IOL can be adapted thereto. The outer diameter of the dome assembly is substantially constant at the IOL implantation position, but the overall outer diameter of the IOL varies due to the flexibility of the footplate and adapts to 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 eye anatomical structures.

[0017] The footplate can also fully compensate for this change in the anatomical space (where one direction has been observed to be larger than the other due to the "elliptical" shape) to enable stabilization of the IOL rotating in a plane perpendicular to the optical axis. The footplate extends circumferentially and radially so that its distal edge lies on, and / or engages with, and / or is adapted to stabilize itself on the ciliary body and serves as a circumferential anchor for the IOL.

[0018] This feature is important in embodiments where the IOL is a toric implant that includes an optical element having a cylinder for correcting astigmatism. In this case, the stability of the angular position of the IOL lens in the vertical plane, called "rotational stability", is important to ensure the expected IOL optical result. In this case, the footplate can maintain the IOL lens in the central optical region and avoid the possibility of decentration of the IOL with respect to the optical axis of the eye that could 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 operability of the footplate during the IOL implantation process. Further, at least the first end, more specifically, one of the support elements, or rather, is attached to the most distal of the peripheral haptic portions, so the length of the footplate is shortened to reach the ciliary body. Advantageously, the shortening of the footplate length in this way means that the footplate is easier to manipulate during the IOL implantation process, making the IOL implantation easier. These outstanding innovative features can complement the elongated shape and flexibility of the footplate, which are important for the aforementioned IOL stabilization purposes. In fact, the footplate is long, thin and transparent, making it difficult to see or manipulate under the iris of the eye. If it is too long and / or has a free end, it may easily invert. Advantageously, the footplate of the present invention overcomes these problems.

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

[0021] Because the implantation position between the natural lens and iris of the eye is difficult, having an IOL that is easy to implant is extremely important. Fewer operations required for IOL placement can avoid errors that could adversely affect the patient. To further improve the operability of the footplate during the implantation process, it is preferable that the support element to which the second end of the footplate is attached also be provided with the aforementioned operating pocket. Nevertheless, the present invention is not necessarily limited to the presence of the pocket, but the presence of the pocket is preferable because the aforementioned features of the footplate already make it possible to advantageously distinguish the IOL according to the present invention from the prior art.

[0022] This pocket is positioned near the footplate and, in particular, is radially aligned with the footplate, at least partially. Since at least the second end of the footplate is attached to the same support element, the position of the footplate can be changed by moving the tip of the tool within the pocket in an appropriate manner. The risk of operational error is greatly reduced because it is not necessary to directly manipulate the footplate. In fact, because the footplate is thin and transparent, it is easy to miss, pass through the posterior surface of the IOL, or touch sensitive intraocular tissue, such as the lens. By restricting the movement of the tip within 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 opaque iris of the eye. In fact, by locking the tip into the pocket, the tip of the instrument can be guided to the front. Thus, the surgeon does not need to see the footplate under the iris to position it correctly (which is generally very difficult). The surgeon has the advantage that, when the tip is engaged in the pocket, it is sufficient for the surgeon to make the appropriate (known) movements with the instrument to position the footplate under the iris without having to see the footplate. Preferably, the pocket is sized specifically to accommodate these movements and guide the surgeon during the implantation process.

[0024] Within the framework of this specification, the “optical axis” of the eye preferentially includes a vector traversing the eye from one side to the other, directed from the “anterior segment” which includes the cornea, iris, and lens in a continuous manner, to the “posterior segment” which includes the retina. In the case of a phakic IOL according to the present invention in an 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 an optical axis that is essentially defined with respect to the IOL. In particular, the term “optical axis” is preferably used herein as a reference axis with respect to the eye and / or IOL.

[0025] Within the framework of this specification, it is preferable that the "anterior" (or "posterior") side and / or surface of the eye or IOL portion, or the side and / or surface located upstream (or downstream) of the portion with respect to a vector defined by the optical axis. This definition naturally extends to the terms "anterior" (or "posterior"). For example, in the eye, the iris is located anterior to the lens, and the posterior surface of the iris is the part of the iris closest to the lens.

[0026] Similarly, such sides and / or surfaces are called “forward concave” (or “forward convex”) if they appear concave (or convex) when viewed on the optical surface in the same direction and in the same sense as the vector defined by the optical axis (i.e., following the propagation of light rays). Such sides and / or surfaces are called “backward concave” (or “backward convex”) if they appear concave (or convex) when viewed on the optical surface in the same direction and in the opposite sense as the vector defined by the optical axis. In this specification, the term “concave” is used generally to correspond to “backward concave” when it is clear from the context of its use that this is its meaning to those skilled in the art.

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

[0028] Within the framework of this specification, the terms “axial direction” and “in the axial direction” refer to a direction parallel to the optical axis. Preferably, a portion of the IOL is If it extends along a vector perpendicular to the optical axis, it is "radially." If the vector is directed from a point common to the optical axis to a point on a circle centered at this common point, then it is "radially outward". If the vectors are pointing in opposite directions, it means "radially inward". It is said to persist. Preferably, a portion of the IOL is said to extend "circumferentially" if it extends along a circular arc on a plane centered at the intersection of the plane and the optical axis, preferably perpendicular to the optical axis. These concepts of radial and circumferential extension refer to known polar coordinate systems in each 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 furthest from the reference organ or trunk, and the adjective “proximal” refers to the part of the body closest to the reference organ or trunk. Within the framework of this specification, these definitions also apply to parts of the eye and / or IOL in relation to the distance with respect to the reference optical axis. For example, preferably, the proximal portion of the IOL according to the present invention may include the central optical portion and / or a portion of the IOL around the central portion, and the distal portion of the IOL according to the present invention may include the footplate, or at least its distal lateral edge.

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

[0031] Within the framework of this specification, the use of the indefinite article "a," "an," or definite article "the" to introduce an element does not preclude the existence of multiple such elements. Similarly, the terms "first," "second," "third," and "fourth" are used solely to distinguish elements and do not imply any order of these elements.

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

[0033] The IOL, specifically the peripheral tactile portion and the footplate, is preferably made of a biocompatible, flexible, and highly resistant material. This material is preferably hydrophilic.

[0034] The overall thickness of this material varies radially to provide more or less flexibility to the IOL portion. Within the framework of this specification, "thickness" is measured parallel to the optical axis. It is preferable that the peripheral tactile portion is larger than the footplate.

[0035] In fact, these two tactile structures constitute a compromise between the need for stability and compliance with intraocular structures on the one hand, and the need for rigidity to avoid the application of excessive force and trauma to delicate intraocular structures, many of which are complex and invisible during or before implantation, on the other hand. They are structured so that the vaults described above are not significantly affected by the compression of the IOL applied to its edges by the internal anatomical structure of the eye. In particular, the dome assembly has a “rigid” structure due to its greater on average material thickness than the footplate, and / or the flared and / or wide and / or thick shapes of the supporting elements. The rigidity and geometric features of the dome assembly are adapted to the broad anatomical structure of the eye. In contrast, the “flexible” properties of the footplate are preferably due to the properties of this material, combined with its elongated shape and its lower 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 tactile portion decreases radially from the central optical portion to the pocket. The thickness of the peripheral tactile portion is preferably at least 50%, and more preferably twice, greater on average than the thickness of the footplate. This averaging can be simply considered as the usual discrete or integral averaging of thickness on a plane perpendicular to the optical axis.

[0037] For example, the peripheral tactile portion decreases radially by 0.70 to 0.50 mm, preferably about 0.60 mm, at the boundary with the central optical portion, and by 0.25 to 0.15 mm, preferably about 0.18 mm, at the level of the proximal boundary of the pocket (but not inside the pocket).

[0038] The footplate, as part of its structure, has a consistent thickness along its entire length, for example, between approximately 0.10 and 0.20 mm, preferably about 0.15 mm, which contributes to its excellent flexibility as described above.

[0039] Preferably, the thickness of the peripheral tactile portion is specifically targeted to allow the IOL to be located 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 so that the posterior surface mimics the (anterior) curvature of the lens.

[0040] The radii of curvature of the front and rear surfaces of the IOL are also optimized with respect to the target refractive power so that the central thickness of the central optical portion remains substantially constant across the entire diopter range. The radii of curvature of the front and rear surfaces of the IOL are preferably between 0.20 and 0.40 mm. For example, approximately 0.20 mm when the lens refractive power is between -5 and -20 D, and approximately 0.40 to 0.20 mm when the lens refractive power is between -0.5 and -5 D. The central optical surface is preferably substantially convex forward and / or substantially planar and / or perpendicular to the optical axis. This allows the IOL to bend forward, as this advantageously delivers the vault without requiring compression.

[0041] The term “footplate” generally refers herein to at least an elongated flexible footplate; however, the IOL preferably includes additional footplates. Preferably, the characterization of “footplate” provided herein also applies to other footplates.

[0042] The IOL according to the present invention comprises, preferably, either two or four distal support elements and either two or four elongated flexible footplates, preferably arranged at least partially symmetrically, to ensure good stability of the IOL not only during rotation but also under axial and / or radial compression. However, these numbers of support elements and elongated flexible footplates do not limit the scope of the present invention. For example, the IOL may comprise a single elongated flexible footplate alone or in combination with any other tactile structure known to those skilled in the art, elongated tactile with a free distal end disclosed in International Publication No. 2020 / 035534(A1). It is preferable to use four symmetrically arranged elongated flexible footplates (e.g., rectangular corners) because this mitigates any possible tilting effects.

[0043] Each of the elongated flexible footplates of the IOL is preferably associated with a specific operating pocket as claimed and described above, and as a result, the number of pockets preferably corresponds to the number of elongated flexible footplates. However, one pocket can be used to move two or more elongated flexible footplates. Such pockets may extend to one or more support elements via the proximal portion of the peripheral tactile portion, for example, so that two or more elongated flexible footplates do not necessarily have to be attached to the same support element. The support element may also have several pockets, each adjacent to the end of a different elongated flexible footplate. The first end of a footplate may, as part of it, be attached to the same support element as the second end, to another support element, and on the proximal portion of the peripheral tactile portion, 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 invention with respect to the support elements, elongated flexible footplates, and the number and / or arrangement of operating pockets. Some of these preferred configurations will be introduced hereafter.

[0044] The “elongated” characteristic of the footplate refers to its thin shape, which contributes to its flexibility, as described above. In particular, the footplate preferably has three dimensions: length along the main extension trajectory, thickness, and width measured perpendicular to the other two dimensions. This “elongated” characteristic can be interpreted as a length greater than the (average) thickness and (average) width of the footplate, i.e., at least twice, preferably at least three times, and more preferably more than five times. This provides the footplate with superior ability to deform under axial and / or radial compression of the IOL. Compared to standard commercially available posterior chamber phakic IOLs with a significantly reduced distal footplate, this IOL footplate allows for greater flexibility and stability, and further enables adaptability to a class of ocular anatomical structures estimated to be more than 50% wider (as commented in consideration of Figure 9, presented below). While the improved adaptability is slightly lower than that of the IOL disclosed in International Publication No. 2020 / 035534(A1), it is advantageously achieved without the significant implantation difficulties described above. In particular, the IOL according to the present invention constitutes a very good compromise between obtaining a phakic IOL with such improved adaptability and stability and obtaining a phakic IOL that is easy to implant.

[0045] Since the two ends of the footplate are attached (preferably only) to the periphery tactile portion, the footplate is preferably adjacent to a cavity that extends from the front to the rear. This cavity is usually an open cavity. The cavity is generally completely enclosed by the footplate and the periphery tactile portion, preferably by the footplate and one of the support elements.

[0046] The term "cavity" is used herein to refer to a space without material that constitutes an IOL. This term is more convenient than "hole" because a cavity is a feature arising simply from the geometric characteristics of the footplate, rather than preferably a hole made in the material. However, a method of manufacturing an IOL by making a large hole in the material to define the footplate cannot be excluded from the scope of the present invention.

[0047] The aforementioned cavity preferably has a maximum radial length that is larger than the maximum diameter of the footplate cross-section, more preferably at least twice as large (considered along the main extension trajectory). In other words, the radial length of the cavity is greater than the width and thickness of the footplate, and as a result, the thin and elongated shape of the footplate is adapted to dynamically and flexibly reach the ciliary body of the eye. In particular, the flexible tactile sensation is such that, if a (strong) radial compressive force is applied to the IOL, the tactile sensation deforms and the cavity partially collapses on its own. In other words, in this case, the maximum radial length is preferably divided by 2, 3, or more.

[0048] The footplate may optionally include folds and / or transverse recesses of material, for example at its ends, arranged to promote 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 and / or transverse recesses of material can serve as a fail-safe mechanism arranged to prevent the transmission of excessive force from the footplate to the central optical portion. This allows for control of such forces applied by the footplate, providing fixation adapted to the ciliary body and preventing erosion of delicate intraocular tissues.

[0049] The distal lateral edge of the footplate optionally includes smooth ripples positioned to smoothly engage with the ciliary body of the eye. Advantageously, the ripples facilitate the stabilization of the IOL to the ciliary body when the IOL is in its intraocular implantation position. The ripples provide a pin-like action to the distal lateral edge to allow for easy descent and stabilization within the ciliary body. These ripples are preferably polished so that their contours do not irritate the ciliary body or other parts of the ocular anatomical structure.

[0050] According to a preferred embodiment of the present invention, the IOL has a smooth lateral chamfer that extends smoothly and continuously from the support element to which the second end of the footplate is attached to the first portion of the distal lateral edge. This chamfer extends over the support element and over the first portion of the distal lateral edge, providing a continuous and smooth lateral transition between the peripheral tactile portion and the footplate via one of the footplate ends, e.g., the second end. This transition is particularly useful for implanting the IOL, as it allows for smooth insertion of the footplate under the iris of the eye, preferably using an operating pocket. In particular, the presence of such a chamfer also means that one of the footplate ends is attached laterally to the side of the support element, and the distal lateral edge smoothly continues to this side of the support element.

[0051] Preferably, the smooth lateral chamfer also extends laterally proximal to the support element over all or part of the peripheral tactile portion. Preferably, the entire chamfer extends perpendicular to the optical axis and further extends circumferentially on the distal lateral edge, following the latter loop shape described above.

[0052] The entire lateral chamfer has a smooth outer surface that is more preferably concave (posteriorly). The outer surface is typically angled forward. Because it is concave, the outer surface does not contain a point of curvature change, and converges toward an axis perpendicular to the optical axis, for example, so that the partial loop shape of the distal lateral margin changes from the side of the support element to a more central position in the surrounding tactile portion, thus favorably facilitating IOL manipulation and implantation without the risk of damage to intraocular tissue.

[0053] Within 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 tactile portion, and these two diameters are measured perpendicular to the optical axis. The dome assembly is contracted into a cylinder of the second diameter, and the footplate further extends radially to the first diameter.

[0054] The second diameter preferably falls between 9.50 and 11.10 mm to accommodate a smaller ciliary body (or more precisely, a smaller available anatomical space) and to ensure that the dome assembly is sized to fit the broad anatomical structure of the eye. In particular, the dome assembly is small enough to avoid being subjected to some compression itself when the IOL is in implantation position.

[0055] The first diameter is preferably between 12.50 and 14.00 mm, and 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 that falls within the difference between the second and first diameters, particularly corresponding to the contribution of tactile flexibility that can contract to fill the gap between the dome assembly and the ciliary body. Thus, the IOL according to the present invention is particularly well suited to a wide range of ocular anatomical structures having a vault with a planned result that is very low in dependence on axial and / or radial compression of the footplate and is stable.

[0056] To cover the anatomical structures of all eyes, multiple IOL sizes with different first and second diameters may be required. To cover the anatomical structures of all eyes, two or three IOL sizes, e.g., first diameters of 12.7, 13.2, and 13.6 mm and second diameters of 9.5, 10.4, and 11.1 mm, may suffice. Preferably, the latter second diameters are associated with the aforementioned first diameters in the same order. This number of IOL sizes is particularly reduced compared to known phakic IOLs, which include large distal footplates, given that each of the current IOLs fits a broader class of ocular anatomical structures.

[0057] According to a preferred embodiment of the present invention, at least one, preferably each, of the distal support elements is extended along an arc having a central angle between 20° and 80°, preferably between 40° and 70°, and more preferably about 60°. As is known, the term “central angle” refers to the angle defined by the arc. In particular, it is the angle at the center of the circle of the arc of a triangle whose vertices are the center and the two ends of the arc.

[0058] Advantageously, the support elements as feet of the dome assembly are broad and circular, providing a stable, rigid base for supporting the IOL on the ciliary zonules when the IOL is in its intraocular implantation position. The arc is typically a second diameter. Preferably, at least two footplates are attached symmetrically by the first and second ends of each support element.

[0059] The pocket will be described in more detail below. The pocket plays an advantageous role in the present invention because it contributes to simplified IOL implantation. As described above, in order to enable the footplate to be operated by engaging the tool tip with the pocket, the pocket is positioned on a support element to which the second end of the footplate is attached and is at least partially radially aligned with the footplate. In other words, preferably the pocket is positioned near the footplate, particularly near the end of the footplate, and radially aligned in their proximal vicinity and / or between the optical axis and the footplate.

[0060] As mentioned above, the first end of the footplate can be attached to various positions on the peripheral tactile portion, but preferably to the same support element as the second end. As described above, this allows the footplate to extend from and to the most distal part of the peripheral tactile portion, shortening the length of the footplate and facilitating operation. Furthermore, since the pocket is close to both ends of the footplate on the same support element, it again facilitates the manipulation of the footplate during the IOL implantation process. In this case, the pocket is preferably substantially radially aligned between the first and second ends, which further improves the manipulation of the footplate via the engagement of the tool tip into the pocket.

[0061] In one embodiment of the IOL, the pocket defines or has the form of a circumferential trench on the IOL, the front 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 near the proximal end of a second end to near the proximal end of a 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. The trench design is perfectly tuned by this proximity between its ends and the pocket to receive the tip of a tool and move appropriately to position the footplate.

[0062] Preferably, the trench is designed similarly to the footplate and / or has similar geometric extension features. Preferably, the trench has two radially inward extensions at its two circumferential ends that are radially mirror symmetric with the ends of the footplate. This design of the pocket is adapted in particular to perform proper movement at the tool tip, and the footplate can be inserted under the iris (as shown in Figure 11, which will be discussed later).

[0063] A trench, or any other shape of pocket, is typically supplied as a single piece on the anterior surface of the IOL. In particular, the pocket is not intended to communicate with the posterior surface of the IOL. The goal, in fact, is to avoid reaching the tip of a tool through the IOL, which could potentially damage intraocular tissue.

[0064] According to an embodiment of an IOL pocket fully compatible with the previously described 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 grip of the tool tip into the pocket. The edge is preferably, measured axially, between 25 and 75 percent of the thickness of the support element to which the second end of the footplate is attached, and more preferably about 50 percent (+ / -5%) in height. Such a pocket is particularly easy to manufacture and is well satisfactory for the above operational purposes. The height of the pocket edge as 50 percent (+ / -5%) of the thickness of the support element is suitable for having a pocket deep enough to grip the tool tip and a portion of the support element axially below the pocket that is thick enough to ensure its resistance.

[0065] According to a preferred embodiment of the present invention, the distal edge of the footplate has a second portion extending from the second diameter to the first diameter and extending along the arc of the first diameter. The second portion is particularly composed of the most distal point of the IOL, i.e., the farthest point in the absolute radius value. The length of the second portion is preferably not negligible. When the IOL is not subjected to axial or radial compression, the second portion preferably has a central angle between 5° and 25°, more preferably about 10°, which strongly stabilizes the IOL during rotation to the ciliary body. Furthermore, when the IOL is in its implanted position, i.e., when the IOL is subjected to axial and / or radial compression, this central angle can be increased up to 45°.

[0066] Preferably, the second portion of the distal lateral edge is attached to the aforementioned first portion, to which a smooth lateral chamfer extends, if the IOL includes such a chamfer. This attachment is made such that the distal lateral edge extends continuously and smoothly along these first and second portions, smoothly continuing laterally to the support element to which the second end of the footplate is attached. This provides a footplate with a smooth design that is easy to operate and insert under the iris. The distal lateral edge preferably consists of these first and second portions. Preferably, the second portion of the distal lateral edge is attached to a third portion of the footplate that connects it to the first end. This third portion preferably extends radially (only) along a direction having a smaller angle between 5 and 60°, more preferably between 7.5 and 40°, for example, 7.5°, 10°, 15°, or 20°, and has an axis of (spectral) symmetry of the IOL perpendicular to the optical axis. This angle can advantageously reduce the compressive force applied to the IOL when it is in the implanted position. In particular, the larger the angle, the lower the compressive force applied to the IOL. Typically, when such high compressive forces occur, the first and third parts shift laterally flexibly so that the second part approaches the distal boundary of the corresponding support element, or in other words, the corresponding cavity size is significantly reduced. For example, the second part is at least twice, or even three times, closer to the distal boundary than when no compressive force is applied to the IOL.

[0067] According to a preferred embodiment of the present invention, the footplate extends along a plane that forms an angle in which the normal vector is located between -15° and 15° with respect to the optical axis. This angle is particularly applicable when the IOL is in the implantation position, allowing for an orientation of the footplate sufficient to position it within the ciliary body of the eye and stabilize the IOL. The normal vector is oriented similarly to the optical axis, and the angle sign is preferably considered in the sense of conventional plane trigonometry. Preferably, the angle value is located between -5° and -10°, more preferably about -7°, so that insertion of the footplate under the iris is advantageously easy if the IOL has been manufactured at least before its implantation.

[0068] According to the embodiments of the present invention described below, the IOL comprises two opposite distal support elements and two pairs of elongated flexible footplates oriented in opposite directions. The orientation of the footplates is preferably determined by the sense of movement along the main extension trajectory of the footplate from the second end to the first end. This symmetrically distributed arrangement of the support elements and elongated flexible footplates provides the IOL with excellent axial, radial, and rotational stability. In particular, the vault relies only partially on the lateral compressive forces exerted through the IOL body. When such lateral compressive forces occur, the IOL design absorbs them at least partially, preferably almost completely, within the two pairs of elongated flexible footplates, so that the dome assembly has little axial movement and is much more axially stable.

[0069] It is preferable that the IOL remains shape-independent even when rotated 180° around the optical axis. In other words, the pair of elongated flexible footplates have orientations such that each image exists when the IOL is rotated 180° around the optical axis. This is advantageous in the case of IOL lenses that contain curvature variations to correct astigmatism, for example, in the case of phakic toric IOLs. In fact, in this case, it is often necessary to rotate the IOL preoperatively to position it on the correct axis. The design and rotational symmetry of the elongated flexible footplate facilitate such rotational operations during the implantation process.

[0070] The phakic intraocular lens is also preferably shape-invariant under planar reflection by two orthogonal planes, each containing the optical axis. This provides favorable specular symmetry for the IOL and avoids twisting of the IOL during and after implantation.

[0071] Preferably, the nearest elongated flexible footplates from two different pairs are separated by a distance that falls between 5% and 25% of the second diameter. The elongated flexible footplates are also preferably oriented distally to converge toward an axis perpendicular to the optical axis. The distal orientation of each footplate is obtained by the natural induction of the said orientation at its distal lateral edge. In other words, the elongated flexible footplates are generally inward-facing and not outward-facing from the distal corners of the IOL. This makes it easier to control the movement of each footplate, thus facilitating insertion of the elongated flexible footplates under the iris during the implantation process.

[0072] According to a generally preferred embodiment of the present invention, the central optical portion includes a through-hole extending between the front and rear surfaces of the IOL, arranged to allow fluid flow between these surfaces when the IOL is in its embedded position. This hole advantageously prevents the induction of a second artificial posterior chamber, which would undesirably restrict the natural fluid flow between the anterior and posterior spaces of the IOL, due to the presence of the IOL. The hole ensures complete and permanent fluid communication between the anterior and posterior chambers of the eye. Preferably, the through-hole is located in the center of the central optical portion, near the intersection with the optical axis.

[0073] Optionally, the IOL may also include optical peripheral holes located in the peripheral tactile portion, preferably near the proximal boundary with the central optical portion. These optical peripheral holes traverse the front and rear surfaces of the IOL and also allow for additional fluid flow through the IOL, particularly during the implantation process.

[0074] In one embodiment of the IOL, the central optical portion has at least a directional mark on the front surface of the IOL. This directional mark is particularly useful for aligning the IOL during the implantation process, as the central optical portion remains largely visible. This is particularly advantageous for correctly oriented a phakic toric IOL as described above. The directional mark can take various forms. Preferably, the directional mark consists of aligned small surface holes on the front surface of the IOL. These holes clearly do not cross the IOL. The mark can also take the form of at least one surface line created on the front surface of the IOL by laser, light, or engraving.

[0075] The present invention advantageously allows for the selection of a central optical partial lens that best suits the patient's visual impairment to be corrected. In particular, according to embodiments of the present invention, the central optical partial lens consists of a monofocal lens that enables correction of at least one of the following: myopia, hyperopia, presbyopia, and corneal astigmatism. According to specific embodiments of the present invention, the lens preferably consists of a refractive or diffractive lens with an extended depth of focus to treat presbyopia. Preferably, the lens is selected in accordance with the latest technology.

[0076] As disclosed above, the IOL according to the present invention preferably comprises an operating pocket closely associated with the footplate. This association is achieved through advantageous cooperation between the pocket and the tool tip, so the tool itself contributes to the present invention.

[0077] especially, The handlebars and A straight rod including a first end fixed to the handle, A smoothly curved, circular rod extending from the second end of a straight rod, A tip fixed to a circularly curved rod, Extending in the direction of the secant line from a circularly curved rod, The tip is sized to work in cooperation with the pocket by engaging it (with a key), and the movement of the elongated flexible footplate can be triggered by the movement of the tool, A tool equipped with this is provided.

[0078] The tool facilitates the easy implantation of the IOL according to the present invention. In particular, this single tool is sufficient to perform all the necessary steps of the implantation process. Furthermore, during the latter, it is not necessary to touch the footplate with the tip of the tool to position the footplate. This advantageously prevents the surgeon from making operational errors, such as engaging the tip with the cavity surrounded by the footplate, which carries the risk of touching delicate intraocular tissue, such as the lens.

[0079] The tool design is specifically tailored to easily implant the IOL into the posterior chamber of the eye. In particular, the circularly curved rod and tip are preferably the only part of the tool that penetrates the eye. The circularly curved rod avoids a potentially sharp angle between the straight rod and the tip. This is dimensioned so that the tip can smoothly reach the pocket through the posterior chamber without damaging intraocular tissue and without touching the IOL, which could lead to cataracts of the eye, such as pushing the IOL backward, deforming it in an undesirable way, and / or touching the lens. The circularly curved rod preferably extends along a substantially single arc, more preferably with a radius of curvature between 10 and 30 mm, for example, about 20 mm. Nevertheless, the circularly curved rod may include multiple circularly curved portions, preferably two such portions, having different radii of curvature within the framework of the present invention. In the case of two circularly curved (connected) sections, the first radius of curvature (of the first section) is preferably between 10 and 30 mm, for example, about 20 mm, and the second radius of curvature (of the second section) is preferably between 5 and 10 mm, for example, about 6 mm. In an advantageous manner, the second section has a steeper downward bend, which makes it more suitable for reaching the pocket without contact with the IOL by another part of the tool. More generally and more preferably, if a circularly curved rod includes multiple circularly curved sections, the radius of curvature of each of them decreases from a straight rod toward the tip for similar reasons.

[0080] The tip is typically the sole part of the tool, arranged to work together to engage with the pocket. Preferably, the tip has a free end (or distal) portion with a sharp edge of the end 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 and the tool is easy to manufacture while allowing for efficient key engagement with the pocket.

[0081] For pockets corresponding to trenches on the front of an IOL, the width of the trench is typically precisely dimensioned to accommodate the tip so that it engages with the trench and has substantially one degree of freedom of movement along the trench's extension trajectory. The latter may have a shape particularly similar to that of a footplate. In particular, the outer portion is typically positioned to engage axially within the pocket on the front of the IOL and then move within the pocket.

[0082] Preferably, the tip includes a bulging portion fixed to (or connected to) a circularly curved rod. This bulging portion allows the circularly curved rod to extend very smoothly and defines a smooth angle between the circularly curved rod and the extension axis of the outer portion of the tip (preferably parallel to the optical axis when the tool is in use). The term “bulging” is used to refer to the shape of this portion, the latter more preferably at least partially ellipsoidal. The cross-section of the bulging portion is preferably larger (e.g., with respect to diameter and / or area) than a certain cross-section of the end portion so that only the end portion engages with the pocket. Particularly advantageous, 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, and more preferably again at least twice as large, than the second certain circular portion of the end portion.

[0083] The end portion is preferably fixed directly and sharply to the bulge so that the tip can more easily catch on the front of the IOL at the height of the pocket. Alternatively, the end portion is smoothly fixed to the bulge by using an intermediate mechanical connection. This mechanical connection typically has a smoothly changing cross-sectional shape that can prevent undesirable snagging of the bulge 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 tactile portion as the outer portion of the tip extends axially. This sub-portion provides the tool with a more adapted overall shape so that the terminal portion can reach the pocket without touching the IOL with another part of the tool.

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

[0086] The present invention also provides a set comprising the IOL and / or tools introduced above. All embodiments of the above IOL and / or tools, as well as their mutual advantages, extend to this set with necessary modifications.

[0087] Other features and advantages of the present invention will become apparent from the detailed description below and from the accompanying drawings for understanding. A list of these drawings is as follows: [Brief explanation of the drawing]

[0088] [Figure 1] These are overall three-dimensional front and side views of an IOL according to a preferred embodiment of the present invention. [Figure 2] Figure 1 is a top view of the IOL shown in the diagram. [Figure 3] Figure 1 shows a lateral view of the IOL, with the relative positioning of the IOL induction dome and the lens of the eye. [Figure 4] Figure 1 is a precise three-dimensional side view of the IOL. [Figure 5] Figure 1 shows a cross-sectional view of a portion of the eye with an IOL implanted, the latter of which is shown in a lateral retinal view. [Figure 6] Figure 2 shows a cross-sectional view of the IOL shown in Figure 1, along the plane VI shown in Figure 2. [Figure 6a] This is a magnified view of the area circled in Figure 6. [Figure 7]Figure 1 is a three-dimensional enlarged view of the support element and footplate portion of the IOL shown. [Figure 8] This is a cross-sectional view of the IOL shown in Figure 1, along plane VIII shown in Figure 2. [Figure 9] This figure shows a graph of the axial displacement of the IOL, as shown in Figure 1, which depends on the anatomical space of the posterior chamber. [Figure 10] This is an overall plan view and side view of a tool according to a preferred embodiment of the present invention. [Figure 10A] This is an overall plan view and side view of a tool according to a preferred embodiment of the present invention. [Figure 11] Figure 10 is a schematic top view of the movement of the tool tip during the IOL implantation process shown in Figure 1. [Figure 12] Figure 10 is an overall three-dimensional view of the tip of the tool as shown in the first embodiment. [Figure 13] Figure 10 is an overall three-dimensional view of the tip of the tool as shown in the second embodiment. [Figure 14] Figure 1 shows a simplified cross-sectional view of a portion of the eye where a part of the tool shown in Figure 10 crossed during the IOL implantation process, the latter of which is shown by a lateral retinal view. [Modes for carrying out the invention]

[0089] Drawings are generally not scaled. Similar elements are generally assigned by similar references. Within the framework of this specification, identical or similar elements may have the same references. Furthermore, the presence of references in the drawings cannot be considered limiting, including when those references are indicated in the claims.

[0090] This portion of this specification provides a complete description of certain preferred embodiments of the invention with reference to the drawings. However, the invention is not limited by these references. The figures mentioned above are particularly illustrative and not limiting.

[0091] Some figures provide abstract geometric symbols and corresponding references that are substantially used to quantify and / or visualize the technical features of embodiments of the 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 typically correspond to concrete objects.

[0092] The present invention provides a posterior chamber phakic IOL1 that is simultaneously adaptable to a wide range of ocular anatomical structures, is easy to implant, and is postoperatively stable at the implantation site in the eye 9 in the axial direction along the optical axis Z, and radially and rotationally in a plane perpendicular to the 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, the optical axis Z is directed from the anterior surface 11 to the posterior surface 12 of the IOL1 (see Figures 1 and 3).

[0093] As shown in Figure 5, IOL1 is intended to be located in the posterior chamber 96 of eye 9. Other elements of the anatomical structure of eye 9, namely the cornea 91, iris 92, pupil 93, lens 94, anterior chamber 95, ciliary zonules 97, and ciliary body 98 of eye 9, are shown in Figure 5.

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

[0095] The central optical portion 2 is surrounded by a tactile structure, within which the peripheral tactile portion 3 is attached circumferentially and proximal to the central optical portion 2. The peripheral tactile portion 3 extends radially outward and posteriorly relative to the central optical portion 2. Nevertheless, the IOL extends further radially along axis Y than along axis X, so as shown in Figure 2, it has an overall planar shape that extends along axis Y.

[0096] The peripheral tactile portion 3 consists of a main proximal portion 34 and two opposite distal support elements 4. The main proximal portion 34 has two optical peripheral holes 33 located proximal to the boundary with the central optical portion 2, symmetrically with respect to the optical axis Z along axis Y. The optical peripheral holes 33 traverse the IOL 1 through the front surface 11 and rear surface 12 to allow fluid flow during the IOL 1 embedding process. As shown in Figure 2, the optical peripheral holes 33 are included in portions of the IOL 1 with a third diameter 83 of about 7.45 mm, preferably between 7.2 and 8.0 mm. The optical peripheral holes 33 are preferably very similar in size to the through holes 21.

[0097] The support elements 4 are mounted on the two opposite distal ends of the principal proximal portion 34 in a mirror-symmetric manner 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 portions that extend circumferentially around the optical axis Z, each following an arc with a central angle β of approximately 60° (shown in Figure 2). The distal boundary 41 of each support element 4 extends along an arc with a second diameter 82, in particular, between 9.5 and 11.1 mm, for example, approximately 10.4 mm. The support elements 4 are provided with lateral recesses 42 in the form of partial holes to enhance the flexibility of the distal boundary 41.

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

[0099] The rear surface of the dome K is concave and smooth, and curved with a preferred radius of curvature k of about 10 mm, which matches the curvature of the front surface of the lens 94, thereby ensuring a vault 89B adjustable between 300 and 750 μm between the IOL 1 and the lens 94 when the IOL 1 is in its embedded position as described in the disclosure of the present invention and shown in Figure 5.

[0100] The intrinsic height 89A of the dome K shown in Figure 3 is measured axially and is called the “intrinsic vault” and constitutes the intrinsic vault height of IOL1. The intrinsic vault height typically has a value between 1.0 and 2.0 mm, preferably between 1.3 and 1.75 mm. For example, if the pairs of the first diameter 81 and the second diameter 82 of IOL1 are (12.7 mm, 9.5 mm), (13.2 mm, 10.4 mm), or (13.6 mm, 11.1 mm), the intrinsic heights 89A are approximately 1.30, 1.40, or 1.75 mm, respectively.

[0101] As shown in Figure 8, the side of the peripheral tactile portion 3, to which the support element 4 is not attached distally, includes a slope having an angle ε of approximately -45° with respect to a plane perpendicular to the optical axis Z. The slope is between 0.8 and 1.3 mm in length, preferably about 1.06 mm. The slope ends at a distally rounded, polished corner 35 oriented posteriorly and radially.

[0102] As described in the disclosure of the present invention, a specific wall thickness provides rigidity to the dome K, making it resistant to axial and / or radial compression when the IOL 1 is in its embedded position. In particular, as shown in Figure 6, the thickness 84C around the center of the dome K may be about 0.20 mm, then increasing radially until it reaches the proximal boundary of the peripheral tactile portion 3 having a thickness 84B of, for example, about 0.60 mm, and finally decreasing radially to a support element 4 (not considering the pocket introduced later) having a thickness 84A that generally falls between 0.15 and 0.25 mm.

[0103] These values ​​are selected so that the dome K can constitute a structure with sufficient rigidity and breadth to surround and cover the lens 94 anteriorly, thereby allowing it to be embedded in a wide range of ocular anatomical structures while remaining stable parallel to the optical axis Z.

[0104] As clearly shown in Figures 1, 2, and 7, the IOL1 also comprises two pairs of opposite, elongated, flexible footplates 5 attached to the distal support element 4 and extending radially along axis Y beyond the periphery tactile portion 3. Each such footplate 5 has a first end 51 and a second end 52 attached to the same support element 4, and as a result, the footplate has the form of a partial loop adjacent to a cavity 32 extending from the front surface 11 to the rear surface 12.

[0105] The first end 51 is centrally located along the distal boundary 41, and the second end 52 is a continuation of the side of the peripheral tactile portion 3 and is positioned laterally along the distal boundary. In other words, the first end 51 is closer to axis Y than the second end 52. As shown in Figure 2, the distal boundary 41 extends between the first end 51 and the second end 52 along a circular arc of second diameter 82 with a central angle δ that falls between 15° and 45°, preferably between approximately 20° and 25°.

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

[0107] IOL1 is engraved as a whole into the first diameter 81 cylinder, to a preferred value between 12.7 and 13.6 mm prior to implantation, provided that no axial or radial compression is applied to IOL1. In particular, each footplate extends between the second diameter 82 and the first diameter 81, thereby allowing its flexibility to compensate for size variations in the anatomical space available for IOL1 within the posterior chamber 96 of the eye when IOL1 is in its implantation position as described above in the disclosure of the present invention.

[0108] As shown in Figure 6, the footplate 5 is specifically designed to fold and / or curve when compression is applied to the IOL1 in the axial and / or radial directions, such that the adjustable angle α between the optical axis Z and the normal vector to the extension plane P of the footplate 5 generally falls between -15° and 15°.

[0109] Each footplate 5 is provided with a distal edge 53 that extends both circumferentially and radially outward with respect to the support element 4 to which it is attached. This distal edge 53 is positioned to stabilize the IOL 1 within the ciliary body 98, in particular when the IOL 1 is in its implanted position as shown in Figure 5. It acts as an anchor to stabilize the IOL 1 as it rotates in a plane perpendicular to the optical axis Z, as detailed in the disclosure of the present invention. The distal edge 53 may be optionally positioned to stabilize the IOL 1 within the ciliary groove of the eye 9, and as a result, the term “ciliary body” as used herein may optionally be replaced by “ciliary body and / or groove.”

[0110] The distal lateral margin 53 is composed of a first portion 54 and a second portion 55, which are particularly visible in Figures 1 and 4. As shown in Figure 2, the second portion 55 extends along a circular arc of the first diameter 81, with a central angle γ between 7.5° and 20°, typically about 10° when no axial or radial compression is applied to IOL1. Thus, the second portion 55 is the most distal part of the distal lateral margin 53. The first portion 54 extends as part of itself from the second end 52 to the second portion 55.

[0111] The first portion 54 is advantageously provided with 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 tactile portion 3. As detailed in the disclosure of the present invention, this chamfer 31 helps to insert the footplate 5 under the iris 92 during implantation of the IOL 1.

[0112] The footplate 5 itself consists of substantially three parts: 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, as seen in Figure 1, which connects the natural second width extension to the first end 51. The main extension trajectories of these footplate parts are located between 5 and 60° in both the circumferential and radial directions, substantially only in the circumferential direction, and substantially only in the radial direction, and extend in the direction of a small angle with axis Y (usually corresponding to (1 / 2)(β-2δ)), which in the illustrated embodiment of the present invention is, for example, about 7.5°. This angle can favorably reduce the compressive force applied to IOL1 when IOL1 is in the implanted position. In particular, angles greater than 7.5° are also preferred, such as 10°, 12.5°, 15°, 17.5°, 20°, 25°, 30°, or 40°, as the larger the value, the lower the compressive force on IOL1.

[0113] The overall design of the elongated flexible footplate 5 is determined to facilitate the IOL 1 implantation process. In particular, the chamfered portion 31 has a concave, smooth outer surface so that each footplate 5 is oriented distally so that it converges toward axis Y. In this case, the movement of inserting the elongated flexible footplate 5 under the iris 92 becomes very easy. The distal boundary 41 of each distal support element 4 extends further between the first ends 51 of two different pairs of elongated flexible footplates 5 along a circular arc with a second diameter 82 having a central angle of approximately 15-20°.

[0114] The dual tactile structure from the distal support element 4 and the elongated flexible footplate 5 allows the IOL1 to be particularly stable in its implantation position. Curve 103 in Figure 9 shows the vault 89B (shown in Figure 5), shown on axis 102 and measured in mm, as a function of the size of the anatomical space of the posterior chamber 96, shown on axis 101 and measured in mm, for an IOL1 with a first diameter 81 value of 13.2 mm. Values ​​of vault 89B between 0.3 and 0.8 mm are considered extreme values ​​to ensure that the IOL1 is axially stable and properly positioned between the iris 92 and the lens 94. As seen in curve 103, this is for the IOL1, and the variation in anatomical space size is approximately 1.1 mm (reference no. 105).

[0115] In comparison to curve 103, a similar curve 104 of a known commercially available posterior chamber phakic IOL is depicted in Figure 9, which has a larger distal footplate and lower flexibility. As seen in curve 104, the adaptability of these IOLs to the size changes of the aforementioned anatomical space is only about 0.7 mm (reference no. 106) and then considerably less than 1.1 mm. Thus, the IOL 1 according to the present invention can cover a wider range of ocular anatomical structures in a more stable manner. This graphical comparison demonstrates the performance and improvement in axial stability of the present invention.

[0116] Given the particular flexibility of the elongated flexible footplates 5, it is advantageous to provide the IOL1 with a structure that helps control the movement of the elongated flexible footplates 5 during the implantation process and to properly insert them under the iris 92. For this purpose, the support element 4 is provided with an operating pocket 6 on the front surface 11 of the IOL, as seen in Figures 1, 2, 6a and 7.

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

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

[0119] These geometric features of pocket 6 are provided in particular to enable functional cooperation with the tip 71 of the operating tool 7 by geometric key engagement of the tip 71 into pocket 6, so that the proper movement of the elongated flexible footplate 5 during the IOL 1 embedding process may be caused by the movement of the tool 7.

[0120] Such cooperation during the IOL1 implantation process is schematically shown in Figure 11. This figure shows the specific movements (indicated by arrows) of the tool 7 for inserting each of the footplates 5 under the iris 92 of the right eye 9. The elongated flexible footplates 5 are numbered 5A to 5D in the order of operation via the pocket 6.

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

[0122] Figure 14 shows eye 9 of Figure 5 during implantation of IOL 1. As can be seen from the figure, the tip 71 of the tool 7 is specially configured to cooperate with the pocket 6, and then allows for the aforementioned insertion of the elongated flexible footplates 5A-5D.

[0123] Tool 7 will be described in more detail with reference to Figures 10, 12, and 13. 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 positioned to engage with the pocket 6.

[0124] Non-limiting exemplary dimensions of the tool 7 are provided when the lower surface of the end portion 74 is in surface contact with the bottom surface 61, and as a result the axis of rotation around which the free end portion 74 extends cylindrically is substantially parallel to the optical axis Z. Under these conditions, as shown in Figure 10, the tool 7 with the handle 70 has an axial length 7A of about 15.00 mm, the circularly curved rod 72 and tip 71 have an axial length 7B of about 2.34 mm, the extended length 73A of the straight rod 73 is about 14.30 mm, the extended length 72A of the circularly curved rod 72 is about 11.30 mm, and its radius of curvature k' is between 15 and 30 mm, preferably about 20, 21, 22, 23, 24, 25, or 26 mm. The width of the tool tends to decrease from approximately 0.60 mm to approximately 0.24 mm near the joint with the tip 71, along the extension trajectory of the straight rod 73 and the circularly curved rod 72 (the latter width corresponds to reference no. 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 illustrated and shown in Figure 10, the circularly curved rod 72 extends along a single arc with a radius of curvature k'. Nevertheless, as shown in Figure 10A, the circularly curved rod 72 may also include two parts having different radii of curvature. The second part 72' is more curved than the first part 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 part is preferably about 6 mm. Other features of the embodiment in Figure 10, for example, the overall length of the circularly curved rod 72, are shown in Figure 10A. About 10-20% of this length comes from the second part 72'.

[0126] Another tip portion 71 may be provided on the tool 7 and may be optionally removable. Two embodiments of the tip portion 71 are shown in Figures 12 and 13. In both embodiments, the end portion 74 has a sharp edge 75 at the end for easily hooking the tip portion 71 onto 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 an angle θ smaller than 40° to 85°, for example, about 50°, 60°, 70°, or 80°, and more preferably oriented at about 51° with respect to the extending direction of the circularly curved rod 72 near the joint with the tip portion 71.

[0127] The tip portion 71 includes a bulging portion 76 that connects the end portion 74 to a 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 elliptic circular cross-section C1 that is larger than the second constant circular cross-section C2 of the free end portion 74, thereby preventing the bulging portion 76 from entering the pocket 6 and preventing the tip portion 71 from entering an undesirable location such as the optical peripheral hole 33 or cavity 32.

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

[0129] In the embodiment shown in Figure 12, the end portion 74 is directly and sharply fixed to a bulging portion 76 that improves the grip of the tip portion 71 on the front surface of the IOL 1 adjacent to the pocket 6. In the embodiment shown in Figure 13, the end portion 74 is differently and smoothly fixed to the bulging portion 76 by an intermediate smooth mechanical connection 77.

[0130] The axial length 71A of the terminal portion 74 varies from, for example, about 0.13 mm in the embodiment of Figure 12 to about 0.26 mm in the embodiment of Figure 13. The axial length 71B of the entire tip portion 71 is, in both embodiments, preferably less than 0.75 mm, more preferably between 0.45 and 0.60 mm, for example, about 0.53 mm. This limited axial length is specifically designed to allow smooth passage through small incisions (or 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 tactile portion 3 having a distal support element 4 positioned to support the IOL 1 on the ciliary zonules 97 of the eye 9, an elongated flexible footplate 5 attached to the support element 4, each having a distal lateral edge 53 positioned to stabilize the IOL 1 within the ciliary body 98 of the eye 9, and an operating pocket 6 on the surface of the support element 4, each pocket 6 being associated with one of the elongated flexible footplates 5.

[0132] The present invention is described in relation to specific embodiments having purely illustrative values ​​and should not be considered limiting. Generally speaking, it will be apparent 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 herein are provided with a tolerance 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), Front (11) and rear (12), A central optical portion (2) including a lens and extending radially with respect to the optical axis (Z) directed from the front surface (11) to the rear surface (12), Peripheral tactile portion (3), The central optical portion (2) is mounted in the circumferential direction, The central optical portion (2) extends radially outward and backward, When the IOL (1) is implanted in the eye (9), the peripheral tactile portion (3) includes a distal support element (4) positioned on the ciliary zonules (97) to support the IOL (1), Extending radially beyond the peripheral tactile portion (3) and including a first end (51) attached to the peripheral tactile portion (3), at least one elongated flexible footplate (5) Equipped with, The aforementioned elongated flexible footplate (5) A second end (52) attached to one of the support elements (4), The distal lateral edge (53), The central optical portion (2) extends outward in the circumferential and radial directions, When the IOL (1) is in the implantation position within the eye (9), the distal lateral edge (53) and Includes, One of the support elements (4) is an operating pocket (6) on the front surface (11), which is at least partially radially aligned with the elongated flexible footplate (5), The operating pocket (6) is characterized by being sized to cooperate with the tip (71) of the operating tool (7) by engaging the tip (71) of the operating tool (7) with a key, so that the movement of the elongated flexible footplate (5) can be caused by the movement of the tool (7), Posterior chamber phakic intraocular lens (IOL).

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

3. The IOL (1) according to claim 2, wherein the entire chamfered portion (31) has a concave, smooth outer surface.

4. The IOL (1) according to any one of claims 1 to 3, wherein the elongated flexible footplate (5) is adjacent to a cavity (32) that extends from the front surface (11) to the rear surface (12), and has a maximum radius length (86) that is greater than the maximum diameter (87) of the cross-section (C) of the elongated flexible footplate (5).

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

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

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

8. The IOL (1) according to claim 6, wherein the pocket (6) defines a circumferential trench (63) that extends parallel to the elongated flexible footplate (5) on the front surface (11) of the IOL (1), and is sized to receive the tip (71) of the tool (7) along the trench (63).

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

10. The first diameter (81), which is the outer diameter of the IOL (1) measured perpendicular to the optical axis (Z), is included in the range of 12.5 to 14.0 mm. The second diameter (82), which is formed by the outer diameter of the peripheral tactile portion (3) measured perpendicular to the optical axis (Z), is included in the range of 9.5 to 11.5 mm. IOL(1) according to any one of claims 1 to 3.

11. The distal lateral edge (53) extends from the second diameter (82) to the first diameter (81) and has a second portion (55) that extends along the arc of the first diameter (81) and has a central angle (γ) between 5 and 25°, according to claim 10.

12. The IOL (1) according to any one of claims 1 to 3, comprising two oppositely oriented support elements (4) and two pairs of oppositely oriented elongated flexible footplates (5), wherein the IOL (1) remains unchanged in shape even when rotated 180° around the optical axis (Z).

13. The IOL (1) according to claim 12, dependent on claim 10, wherein the closest elongated flexible footplate (5) from two different pairs is located at a distance between 5% and 25% of the second diameter (82) and is directed distally to converge toward an axis (Y) perpendicular to the optical axis (Z).

14. The IOL (1) according to any one of claims 1 to 3, wherein the thickness (84A, 84B) of the peripheral tactile portion (3), measured parallel to the optical axis (Z), decreases radially from the central optical portion (2) to the pocket (6), and is on average at least 50% greater than the thickness (83A) of the elongated flexible footplate (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 -15° to 15° with respect to the optical axis (Z).

16. The IOL (1) according to any one of claims 1 to 3, wherein the central optical portion (2) and the peripheral tactile portion (3) form a dome (K) having a concave, smooth rear 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), wherein the operating tool (7) is Handle (70) and A straight rod (73) including a first end fixed to the handle (70), A circularly curved rod (72) extends smoothly from the second end of the straight rod (73), The tip portion (71) is fixed to the circularly curved rod (72), Extending in a cross direction from the circularly curved rod (72), The tip portion (71) is sized to cooperate with the pocket (6) by engaging it with the pocket (6) with a key. The tip portion (71) and the elongated flexible footplate (5) are provided so that the movement of the tool (7) can be caused by the movement of the tool (7). A set that includes [the following components].

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

19. The tip portion (71) is fixed to the circularly curved rod (72) and has a bulging portion (76) having a first elliptical portion (C1) that is at least 25% larger than a second certain circular portion (C2) of the free end portion (74), The free end portion (74) is fixed to the bulging portion (76) by a direct and sharp transition, or to the bulging portion (76) by an intermediate mechanical connection (77) by a smooth transition. The set according to claim 18.

20. The set according to claim 17, wherein the circularly curved rod (72) includes a plurality of circularly curved portions having different radii of curvature.

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