Add-on intraocular lenses

Abstract

The present invention relates to a posterior chamber add-on intraocular lens (1) configured to be implanted in a pseudophakic eye (9), the posterior chamber add-on intraocular lens (1) comprising a central optic (2), peripheral haptic portions (3) having distal support elements (4) arranged to support the intraocular lens (1) at the ciliary body (98), elongated flexible foot plates (5) attached to the support elements (4), each having a distal side edge (53) arranged to stabilize the intraocular lens (1) on the ciliary body (98), and manipulation pockets (6) on the 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 IOLs, i.e., posterior chamber add-on IOLs, intended to be implanted in pseudophakic eyes. [Background technology]

[0002] Generally speaking, "pseudophakia" refers to replacing the eye's natural lens with an IOL. A "pseudophakia eye" is defined as an eye in which the natural lens has been replaced with an IOL, typically during cataract surgery. In the context of this document, such an IOL may be referred to as a "primary IOL." It is implanted in the eye's capsular bag.

[0003] In some cases, it may be necessary to supplement the visual capabilities induced by this primary IOL by implanting another IOL into the pseudophakic eye. This additional IOL is implanted in the pseudophakic eye as a supplement (not a replacement) to the primary IOL. It is commonly referred to by those skilled in the art as an "add-on IOL" or "secondary IOL," and these terms are used interchangeably in this document.

[0004] An add-on IOL is typically implanted in the posterior chamber of the eye, i.e., between the posterior surface of the iris and the anterior surface of the primary IOL (and / or the capsular bag), but not in the capsular bag, which is why it is referred to as a "posterior chamber add-on IOL." Such IOLs are typically supported around the ciliary body of the eye.

[0005] An add-on IOL and a primary IOL can be implanted in the same surgery, for example, if it is determined that the visual ability induced by the primary IOL needs to be supplemented, corrected, or adapted (at the time of implantation or thereafter) for a particular patient. In this case, the add-on IOL is implanted in the eye immediately after replacement of the natural lens with the primary IOL. Alternatively, the add-on IOL can be implanted several years after the primary IOL, for example, if it is determined that the visual ability induced by the primary IOL needs to be supplemented, corrected, or adapted, for example, due to the patient's advanced age. The advantage of using such a posterior chamber add-on IOL is that it significantly reduces the patient's risk of medical complications compared to replacing the primary IOL in the capsular bag.

[0006] Such add-on IOLs, however, may be positioned differently from eye to eye based on the anatomy of the posterior chamber, and the size of the posterior chamber typically varies by several millimeters from patient to patient. In particular, implantation of a posterior chamber add-on IOL of a size that may not be compatible with the eye risks less serious medical complications for the patient, such as: For example, if the space between the add-on and the primary IOL is too small (e.g., if the add-on IOL is too small relative to the amount of anatomical space in the posterior chamber available for implantation of the IOL), this can lead to proliferation of epithelial cells and subsequent opacification of the primary IOL (also called "secondary cataract"); or For example, if an add-on IOL is too large for the size of the anatomical space, it may result in pupillary block, glaucoma, inflammation, iris depigmentation, or a pocket between the anterior and posterior chambers of the eye after pupillary block. The manufacture and use of add-on IOLs of various sizes based on the general ocular anatomy cannot completely overcome this drawback, and in fact, the shortcomings of such add-on IOLs regarding the stability of their position when implanted in the eye can lead to similar medical complications.

[0007] Another challenge in the concept of an add-on IOL is making it easy to manipulate in the posterior chamber during its implantation process in the eye. For example, using thin haptics, each extending along a curve extending outward from the IOL lens, with free ends for hooking the add-on IOL to the eye, can compensate for the variations in the size of the anatomical space, but this makes the haptics difficult to see and manipulate, and therefore is not an adequate solution. Therefore, it is desirable to provide an add-on IOL that is easy to implant and sufficiently stable in the implanted position. Summary of the Invention [Problem to be solved by the invention]

[0008] It is an object of the present invention to provide a posterior chamber add-on IOL that is adapted to a wide range of ocular anatomies and is easy to implant in the eye. [Means for solving the problem]

[0009] To this end, the present invention provides a posterior chamber add-on IOL configured to be implanted in a pseudophakic eye, comprising: - front and rear faces; a central optical part having a lens and extending radially relative to an optical axis directed from the front surface to the rear surface; a peripheral haptic part circumferentially attached to the central optic and extending radially outward and posteriorly relative to the central optic, the peripheral haptic part including terminal support elements positioned to support the IOL at the ciliary zonules when the IOL is in an implanted position in the eye; at least one elongated flexible footplate extending radially beyond the peripheral haptic portion and having 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 lateral border that extends circumferentially and radially outward relative to the central optic and is positioned to stabilize the IOL against the ciliary body when the IOL is in an implanted position in the eye; Equipped with Provide an IOL. Said one of the support elements preferably comprises an operating pocket on the anterior surface of the IOL, the operating pocket being at least partially radially aligned with the elongated flexible footplate and dimensioned to cooperate with the tip of the operating instrument by (keyed) engagement of the tip into the pocket so that movement of the elongated flexible footplate can be caused by movement of the instrument.

[0010] This IOL satisfies both the need to improve the stability of the IOL in the implanted position in the space between the iris and the primary IOL and the need to easily implant it. The add-on IOL comprises two distinct but complementary haptic structures: first, a peripheral haptic portion with distal support elements; and second, a central optic portion equipped with at least one elongated flexible footplate (hereinafter referred to as a "footplate," although the IOL preferably comprises two or four such elongated flexible footplates). The peripheral haptic portion, together with the central optic portion, forms a "dome assembly," the legs of which are support elements disposed distally to support the IOL at the ciliary zonules. Because the footplate extends radially beyond the dome assembly, it also stabilizes the IOL on the ciliary body. The geometry and flexibility of the footplate significantly contribute to the stability of the IOL in the implanted position. To make the IOL easier to implant, the footplate is fully attached to the flexible haptics at its ends. While this slightly reduces the conformability of the footplate compared to the elongated, thin, free-ended haptics described in the Background section, this footplate geometry makes it much easier to manipulate during the implantation process. This is further enhanced by the preferred presence of a manipulation pocket in the support element to which at least one end of the footplate is attached. In particular, the footplate geometry and flexibility still allow the IOL to fit a wide range of ocular anatomical structures, but any potential manipulation difficulties this may cause are fully compensated for by the attachment of the footplate ends to the peripheral haptics and the advantageous presence and location of the pocket.

[0011] The above-mentioned technical effects will now be explained in detail. In particular, as explained below, the IOL is axially (i.e., parallel to the optical axis), radially (i.e., perpendicular to the optical axis), and circumferentially (i.e., in rotation about the optical axis), particularly in its implanted position.

[0012] The peripheral haptics allow for stabilization of the IOL parallel to the optical axis. Support elements are located 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 positioned anteriorly on the primary IOL, so that it surrounds the primary IOL at least anteriorly. A distance called the "vault," measured along the optical axis between the anterior surface of the primary IOL and the posterior surface of the add-on IOL, is defined and stabilized. It is similar to the safety distance required to avoid contact or excessive proximity between the primary IOL and the add-on IOL. A safety distance between the IOL and the iris of the eye (typically less than 0.5 mm) can also be defined and stabilized as the distance between the anterior surface of the IOL and the posterior surface of the iris, which is envisioned as the virtual iris plane that occupies the pupil of the eye (at the beginning of dilation).

[0013] The vault is preferentially configured and / or adjustable, with or without radial and / or axial compression, between 100 and 1000 μm, more preferably between 300 and 750 μm. Sufficient space is then available between the add-on IOL and both the primary IOL and the iris of the eye, thereby correcting potential anatomical size defects in the posterior chamber of the eye or possible positioning defects of the IOL and significantly reducing the risk of complications for the patient.

[0014] The dome assembly design accommodates a wide range of ocular anatomies by selecting a posterior surface that is, on average, at least as curved as the anterior surface of the primary IOL and by selecting an outer diameter (measured perpendicular to the optical axis) of the peripheral haptics that accommodates a wide range of ocular posterior chamber anatomies. More specifically, this diameter is preferably between 8.00 and 11.50 mm, e.g., 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, or 11.50 mm. For example, three preferred diameter values ​​of 8.00, 9.10, and 10.2 mm are advantageously sufficient to cover any posterior chamber anatomical structure, as described hereinafter. Optionally, a diameter between 6.50 and 8.00 mm may also be considered for other, unspecified, implantation locations of IOL haptics. The posterior surface of the dome assembly is preferably smooth and / or concave (posteriorly). This concave surface does not exclude that the portion of the posterior surface, for example, facing the optic, may be substantially flat or nearly flat. The posterior surface, however, is preferably concave and curved at each of its points. It then has a radius of curvature comprised, inclusively, of more preferably 8 to 14 mm, and even more preferably 10 to 11 mm. It may be larger than that of a corresponding phakic IOL, since primary IOLs are less thick (measured along the optical axis) than the natural lens, and thus more anatomical space is available for implanting an add-on IOL. It can be seen that the radius of curvature is well defined, since the posterior surface of the dome assembly is smooth and (mathematically) regular. In particular, the posterior surface at the junction between the central optic and the peripheral haptics typically does not have any abrupt irregularities. Although only one radius of curvature value is mentioned above for the posterior surface, it does not exclude that the surface curvature may vary from point to point. In particular, optionally, the radius of curvature at any point on the posterior surface of the central optical portion is comprised between 5.0 and 100.0 mm, preferably between 8.0 and 14.0 mm, while the radius of curvature at any point on the remainder of the posterior surface of the dome assembly is approximately 11.0 mm.

[0015] The dome assembly, therefore, overlies the primary IOL and rests on the ciliary zonules, stabilizing the IOL parallel to the optical axis when the add-on IOL is in its implanted position in the eye (i.e., when the IOL is in normal use in the eye). The footplate, for its part, extends substantially radially beyond the dome assembly into the posterior chamber of the eye to anchor to the ciliary body. The flexibility and geometry of the footplate enable the IOL to adapt to variations in the internal dimensions of the posterior chamber anatomical space available for the IOL (preferably known as the "ciliary body-to-ciliary body" measurement, which is the distance from the ciliary body to the ciliary body, taking into account the elasticity penetration factor of the footplate into the eye's ciliary body) across a range of internal eye dimensions, including those that cannot be accurately estimated preoperatively. While the outer diameter of the dome assembly remains substantially constant at the IOL's implanted position, the overall outer diameter of the IOL subsequently changes due to the flexibility of the footplate to adapt to the anatomical structure of the posterior chamber of the eye. Advantageously, the use of a single add-on IOL model according to the present invention is therefore suitable for a very wide range of patient ocular anatomies.

[0016] The footplate also allows for stabilization of the IOL in rotation in a plane perpendicular to the optical axis, so that variations in this anatomical space (which, due to its "elliptical" shape, are perceived as being larger in one orientation than another) can be fully compensated for. The footplate is circumferentially and radially extended so that its distal edges anchor and / or hook and / or stabilize itself in the ciliary body, and serve as circumferential anchors for the IOL.

[0017] This feature is important in embodiments where the IOL is a toric implant, with a cylindrical optic for correcting astigmatism. In this case, the stability of the angular position of the IOL lens in the vertical plane, referred to as "rotational stability," is crucial to guarantee the expected optical outcome of the IOL. In this case, the footplate allows the IOL lens to be maintained in the central optical zone, thus avoiding possible decentration of the IOL relative to the optical axis of the eye, which could affect the optical outcome of the IOL.

[0018] The first and second ends of the footplate are attached to the peripheral haptic portion, thereby improving the maneuverability of the footplate during the IOL implantation process. Additionally, at least the first end is attached more specifically to one of the support elements, i.e., the peripheral haptic portion, at the most distal end, thereby reducing the length of the footplate to reach the ciliary body. Advantageously, this reduced footplate length means that the footplate is more maneuverable during the IOL implantation process, resulting in easier IOL implantation. These distinctively innovative features allow for the compensation of the elongated geometry 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 and manipulate under the iris of the eye. It can easily invert if it is excessively long and / or has free ends. Advantageously, the footplate of the present invention overcomes these difficulties.

[0019] The first and second ends are typically the only portions of the footplate that are attached to the peripheral haptics of the IOL. More commonly, the footplate is not attached to the peripheral haptics along its entire length. When the first and second ends of the footplate are attached to the peripheral haptics, the footplate extends radially outward relative to the optical axis from the second end and then radially inward relative to the optical axis to the first end, generally along the partial annulus, reaching the distal end of the annulus at the outer diameter of the IOL. The distal edge thus has the form of a portion of this partial annulus that is disposed distally to stabilize the IOL on the ciliary body. The distal edge advantageously thereby provides a potentially wide contact surface with the ciliary body.

[0020] Due to the awkward implantation location between the primary IOL and the iris, having an easily implantable IOL is very important. Fewer manipulations are required to position the IOL, thereby avoiding errors that could adversely affect the patient. 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 aforementioned manipulation pocket. The present invention is not necessarily limited to the presence of a pocket, however, since the above-discussed footplate features already advantageously distinguish the add-on IOL according to the present invention from the prior art.

[0021] This pocket is positioned near the footplate, in particular in at least partial radial alignment with it. Since at least the second end of the footplate is attached to the same support element, it is possible to change the position of the footplate by moving the tip of the instrument in an appropriate manner in the pocket. There is no need to directly manipulate the footplate, thereby significantly reducing the risk of mishandling. Indeed, since the footplate is thin and transparent, it is easy to miss it, penetrate the posterior surface of the IOL, and touch sensitive intraocular tissues or the primary IOL. By limiting the movement of the tip in such a pocket at the level of the anterior surface of the IOL, the possibility of such mishandling is eliminated.

[0022] This pocket is also advantageous when an IOL needs to be manipulated under the iris of an opaque eye. Indeed, it allows the tip of the instrument to be guided to the anterior surface by the keyed engagement of the tip into the pocket. Therefore, the surgeon does not need to visualize the footplate under the iris (which is generally very difficult) to accurately position the footplate. Advantageously, the surgeon can simply perform the appropriate (known) movements with the instrument to position the footplate under the iris when the tip is engaged in the pocket, without having to visualize it. Preferably, the pocket is specially dimensioned to accommodate these movements and guide the surgeon through the implantation process.

[0023] Within the framework of this document, the "optical axis" of a pseudophakic eye consists of a vector that traverses the eye from one side to the other, directed by its "anterior compartment" comprising the cornea, iris, and primary IOL, successively to its "posterior compartment" comprising the retina. With an 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. It preferably coincides with the optical axis originally defined for the IOL. In particular, the term "optical axis" is preferably used in this document as a reference axis for the eye and / or for the IOL.

[0024] Within the framework of this document, the "anterior" (or "posterior", respectively) side and / or surface of a part of the eye or IOL preferably consists of the side and / or surface that is located upstream (or downstream, respectively) of said part with respect to the vector defined by the optical axis. This definition naturally also extends to the term "anteriorly" (or "posteriorly", respectively). By way of illustration, in the eye, the iris is located anteriorly with respect to the primary IOL, and the posterior surface of the iris is then the part of the iris that is closest to the primary IOL.

[0025] Similarly, such a side and / or surface is said to be "forwardly concave" (respectively "forwardly convex") if it is viewed as concave (respectively 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). It is said to be "backwardly concave" (respectively "backwardly convex") if it is viewed as concave (respectively convex) by viewing the optical surface in the same direction and opposite sense as the vector defined by the optical axis. In this document, the term "concave" is used generically as corresponding to "backwardly concave" when the context of its use makes it clear to a person skilled in the art that this is the meaning.

[0026] The aforementioned concepts of anterior, posterior, or intermediate of the optical axis relative 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 positioned in the posterior chamber of the eye with its anterior surface at least partially facing the iris of the eye and its posterior surface at least partially facing the primary IOL.

[0027] Within the framework of this document, the terms "axial" and "axially" refer to a direction parallel to the optical axis. Preferably, the parts of the IOL are: - "radially" if it extends according to 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, and - "radially inward" when the vectors are directed in the opposite sense It is said to extend. Also preferably, a portion of the IOL is said to extend "circumferentially" if it extends according to an arc in a plane perpendicular to the optical axis, preferably centered at the intersection of this plane with the optical axis. These concepts of radial and circumferential extension refer to the well-known polar coordinate system in each plane perpendicular to the optical axis.

[0028] It is well known to those skilled in the art that the adjective "distal" refers to the part of the body part that is farthest from the reference organ or from the trunk, and the adjective "proximal" refers to the part of the body part that is closest to the reference organ or trunk. Within the framework of this document, these definitions also apply to parts of the eye and / or IOL with respect to their distance to the optical axis of reference. 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.

[0029] In particular, the term "distal" with respect to the "distal side edge" of the footplate refers preferentially to the set of points of the footplate that are each furthest from the optical axis along a radius perpendicular to the optical axis.

[0030] In this document, the terms "configured to be implanted," "for implantation," and "intended to be implanted" are interchangeable. The term "posterior chamber add-on IOL" can be replaced with "posterior chamber pseudophakic add-on IOL." The term "posterior chamber add-on IOL for implantation in a pseudophakic eye" can also be interchangeable with "posterior chamber secondary IOL for use in an eye in combination with a pseudophakic primary IOL implanted in the capsular bag of the eye." In general, the terms "add-on IOL" and "secondary IOL" are interchangeable. In the present disclosure and herein, the term "IOL" generally refers to an add-on IOL according to the present invention. Disclosures about or relating to primary IOLs will always be phrased with the term "primary" before "IOL" to avoid confusion.

[0031] Within the framework of this document, the use of the indefinite article "a", "an" or the definite article "the" to present 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 any order among these elements. Within the framework of this document, the use of the verbs "comprise", "include" or any other variations and conjugations thereof in no way excludes the presence of elements other than those stated.

[0032] The IOL, and in particular the peripheral haptics and footplate, are preferably made from a biocompatible, flexible, and highly durable material, which is preferably hydrophilic. The material selection contributes to avoiding opacification of the primary IOL.

[0033] The overall thickness of this material varies radially to provide some flexibility to the portion of the IOL. Within the framework of this document, "thickness" is measured parallel to the optical axis. It is preferably greater for the peripheral haptics than for the footplate.

[0034] In fact, these two haptic structures balance the requirements for stability and conformability with intraocular structures on the one hand with the requirement for rigidity on the other, avoiding excessive force and trauma to delicate intraocular structures, many of which are complex and not visible before or during implantation. They are constructed to ensure that the vault described above is not significantly affected by the compression exerted at the edge of the IOL by the internal anatomical structures of the eye. In particular, the dome assembly has a "rigid" structure, which is achieved by a material thickness that is, on average, greater than the thickness of the footplate and / or by the flared and / or wide and / or thick shape of the support elements. The rigidity and geometric characteristics of the dome assembly are adapted to a wide range of ocular anatomical structures. In contrast, the "flexible" characteristics of the footplate are preferably caused by the properties of this material, combined with its elongated geometry and its low average thickness, especially compared to that of the dome assembly.

[0035] More specifically, in accordance with preferred embodiments of the present IOL, the thickness of the peripheral haptics decreases radially from the central optic to the pocket, and is preferably at least 50% greater, and more preferably two times greater, on average than the thickness of the footplate. This averaging can be simply considered as a discrete or integral averaging of the thickness across a plane perpendicular to the optical axis.

[0036] Illustratively, the thickness of the peripheral haptic portion decreases radially from 0.70 to 0.30 mm, preferably about 0.50 mm, at its boundary with the central optical portion to 0.45 to 0.20 mm, preferably about 0.35 mm, at the level of the proximal boundary of the pocket (but not inside the pocket).

[0037] The footplate, for its part, preferably has a constant thickness along its entire length, for example about 0.10-0.40 mm, preferably about 0.25 mm, which contributes to its great flexibility as discussed above.

[0038] Preferably, the thickness of the peripheral haptics is intended to allow the IOL to be at a defined distance from the anterior surface of the primary IOL, in particular by selectively adjusting the curvature of the anterior and / or posterior surfaces of the IOL so that the posterior surface at least locally mimics the (anterior) curvature of the primary IOL.

[0039] The radii of curvature of the anterior and posterior surfaces of the IOL are also optimized with respect to the target dioptric power, which is preferably between -6D and +6D. The central thickness of the central optic is generally not constant and is preferably between 0.95 and 0.20 mm. The central optical surface is preferably substantially anteriorly convex and / or substantially planar and / or perpendicular to the optical axis. This advantageously allows for the creation of a vault without the need to compress and therefore bend the IOL anteriorly.

[0040] The term "footplate" generally refers in this document to at least an elongated flexible footplate. However, the IOL preferably includes additional footplates. Preferably, the characteristics provided herein with respect to a "footplate" also apply to the other footplates.

[0041] The IOL according to the present invention preferably comprises either two or four end support elements and either two or four elongated flexible foot plates, preferably arranged at least partially symmetrically, to ensure good stability of the IOL under axial and / or radial compression and in rotation. These numbers of support elements and elongated flexible foot plates nevertheless do not limit the scope of the present invention. For example, the IOL may comprise a single elongated flexible foot plate, alone or in combination with any other haptic structure known to those skilled in the art, such as elongated haptics with free ends. The use of four elongated flexible foot plates arranged symmetrically (e.g., according to the corners of a rectangle) is preferred, as this mitigates the effects of any possible tilting.

[0042] Each elongated flexible footplate 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 footplates. However, one pocket can optionally be used to move two or more elongated flexible footplates. Such a pocket can extend over one or more support elements, for example, through the proximal portion of the peripheral haptics, so that two or more elongated flexible footplates need not be attached to the same support element. A support element may also include multiple pockets, each proximal to a different elongated flexible footplate end. The first end of a footplate, as part thereof, may be attached to the same support element as the second end, to a different support element, or to the proximal portion of the peripheral haptics, for example, between two adjacent support elements. More generally, those skilled in the art will understand that various configurations of IOLs may be considered within the framework of the present invention with regard to the number and / or location of support elements, elongated flexible footplates, and manipulation pockets. Some of the preferred ones are presented hereinafter.

[0043] The "elongated" feature of the footplate refers to its thin geometric shape, which contributes to its flexibility as explained above. In particular, the footplate preferably has three dimensions, including its length along its main path of extension, its thickness, and its width measured perpendicular to the other two dimensions. This "elongated" feature can be interpreted as a length greater than the (average) thickness and (average) width of the footplate, i.e., at least two times greater, preferably at least three times greater, and more preferably five times greater. This gives the footplate excellent ability to deform under axial and / or radial compression of the IOL. This adaptability is advantageously obtained without major implantation difficulties, as discussed above. In particular, the IOL according to the present invention provides an excellent compromise between obtaining an add-on IOL with such adaptability and stability and also obtaining an add-on IOL that is easy to implant.

[0044] Since the two (preferably only) ends of the footplate are attached to the peripheral haptics, the footplate preferably borders a cavity extending from the front to the rear. This cavity is typically an open cavity. It is generally completely bordered by the footplate and the peripheral haptics, preferably by said one of the footplate and the support element.

[0045] The term "void" is used herein as an equivalent to a space free of the material that makes up the IOL. This term is more appropriate than "hole" because the void is preferably not a hole in the material, but rather a feature that arises simply from the geometric characteristics of the footplate. However, methods of manufacturing IOLs by drilling large holes in the material to define the footplate cannot be excluded from the scope of this invention.

[0046] The aforementioned cavity preferably has a maximum radial length greater than the maximum diameter of the cross section of the footplate (considered along its main path), more preferably at least twice as large, even more preferably 2-4 times larger, and even more preferably about 3 times larger. 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 geometric shape of the footplate is adapted to dynamically and flexibly reach the ciliary body of the eye. In particular, the flexible haptics are such that, when (strong) radial compressive forces are generated on the IOL, the haptics can deform so that the cavity partially collapses inward. In other words, in this case, the maximum radial length is preferably half, one-third, or even smaller.

[0047] The footplate may optionally comprise material folds and / or lateral indentations, for example at its edges, 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 material folds and / or lateral indentations may serve as fail-safe mechanisms arranged to prevent the transmission of excessive forces from the footplate to the central optic, which allows controlling such forces applied by the footplate to provide adapted fixation to the ciliary body and prevent erosion of delicate intraocular tissues.

[0048] The distal edge of the footplate optionally includes smooth ripples positioned 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 its implanted position in the eye. The ripples provide the distal edge with pins that the ciliary body can more easily seat and stabilize. These ripples are preferably polished so that their contours do not irritate the ciliary body or other parts of the ocular anatomy.

[0049] 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 edge. This chamfer extends at the support element and at the first portion of the distal edge, providing a continuous, smooth lateral transition between the peripheral haptics and the footplate via one of the ends of the footplate, 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, preferably with the use of a manipulation pocket. In particular, the presence of such a chamfer also implies that one of the ends of the footplate is laterally attached to the support element at this side, such that the distal edge smoothly merges with the side of the support element.

[0050] Preferably, the smooth sided chamfer also extends laterally proximal to the support element at all or part of the peripheral haptics, preferably the entire chamfer extending (approximately) perpendicular to the optical axis and further circumferentially at the distal edges, following the above-discussed hoop shape at the distal edges.

[0051] The entire lateral chamfer then preferably has a smooth outer surface that is concave (posteriorly). It is typically oriented anteriorly. Because it is concave, the outer surface therefore does not have a curvature turning point, so that the shape of the partial annulus of the distal edge converges, for example, toward an axis perpendicular to the optical axis, turning from the side of the support element to a more central position of the peripheral haptics, thereby advantageously facilitating manipulation of the IOL and implantation without risk of injury to intraocular tissue.

[0052] Within the framework of this document, 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 then narrows into a cylinder of the second diameter, while the footplate extends further radially to the first diameter.

[0053] The second diameter is preferably between 9.50 and 11.10 mm to accommodate the smaller ciliary body size (or, more precisely, the smaller available anatomical space), resulting in a dome assembly sized to accommodate a wide range of ocular anatomies. In particular, the dome assembly is small enough to avoid any compression when the IOL is in the implanted position.

[0054] The first diameter, for that portion, is preferably 12.50-14.00 mm, more preferably 12.70-13.60 mm, particularly when no axial and / or radial compression is applied to the IOL. The footplate extends a radial length between the difference between the second and first diameters, depending on the contribution of the haptics to flexibility, which can be shortened to fill the gap between the dome assembly and the ciliary body. The IOL according to the present invention is therefore particularly well adapted to a wide range of ocular anatomies, with the resulting vault designed to be stable and largely insensitive to axial and / or radial compression of the footplate.

[0055] To cover all ocular anatomies, multiple IOL sizes with different first and second diameters may be required. Two or three IOL sizes may be sufficient to cover all ocular anatomies, e.g., first diameters of 12.7 mm, 13.2 mm, and 13.6 mm, and second diameters of 8.0 mm, 9.1 mm, and 10.2 mm. Preferably, the latter second diameters are associated with the respective stated first diameters in the same order.

[0056] According to a preferred embodiment of the present invention, at least one, and preferably each, of the end support elements extends 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, it is the angle at the center of a triangular arc circle whose vertices are said center and the two ends of the arc.

[0057] Advantageously, the support elements, serving as legs of the dome assembly, are then wide and circular, providing a stable and rigid base for supporting the IOL at the zonules when the IOL is in implanted position in the eye. The circular arc is typically of a second diameter. At least two footplates are preferably symmetrically attached to each support element by their first and second ends.

[0058] The pocket, which will now be discussed in more detail below, plays an advantageous role in the present invention, since it contributes to simplifying the implantation of the IOL. As explained above, to be able to manipulate the footplate via engagement of the tip of the instrument with the pocket, the pocket is arranged on the support element to which the second end of the footplate is attached, and it is at least partially radially aligned with the footplate. In other words, and preferably, the pocket is arranged near the footplate, in particular near the end of the footplate, in close proximity thereto, and / or radially aligned between the optical axis and the footplate.

[0059] As noted above, the first end of the foot plate can be attached to a different position 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 the most distal portion of the peripheral haptics to the most distal portion, thereby reducing the length of the foot plate and facilitating its manipulation. In addition, the pockets are then proximal to both ends of the foot plate on the same support element, thereby making the foot plate even easier to manipulate during the IOL implantation process. In this case, the pockets are preferably aligned substantially radially between the first and second ends, thereby further improving manipulation of the foot plate via engagement of the tip of an instrument with the pockets.

[0060] According to an embodiment of the IOL of the present invention, the pocket defines or has the form of a circumferential trench in the anterior surface of the IOL, extending parallel to the footplate and dimensioned to receive the tip of an instrument along the trench. More specifically, the trench is designed and dimensioned to allow the instrument to move the IOL for insertion under the iris of the eye. The trench extends circumferentially from very close to the second end to very close to the first end, preferably along the distal edge of the support element. For example, the distance between those ends and the pocket is preferably less than 0.30 mm, more preferably less than 0.20 mm. The trench design is then perfectly tailored to receive the tip of the instrument and, due to this proximity between its end and the pocket, move it appropriately to position the footplate.

[0061] Preferably, the trench is designed similarly to the footplate and / or has similar geometrical extension features. Preferably, the trench comprises two radially inward extensions at its two circumferential ends, in radial mirror symmetry with the ends of the footplate. This design of the pocket is particularly adapted for proper operation at the tip of the instrument, allowing the footplate to be inserted under the iris (as shown in FIG. 10 presented hereinafter).

[0062] The trench, or any other form of pocket, is typically integral with the anterior surface of the IOL. In particular, the pocket is not intended to communicate with the posterior surface of the IOL. In fact, its purpose is to avoid the tip of the instrument penetrating the IOL, which could damage intraocular tissue.

[0063] According to an embodiment of the IOL pocket, fully compatible with the previous embodiment, it comprises a bottom surface and side edges as part of the anterior surface. The bottom surface is preferably roughened to increase friction and / or to allow the tip of an instrument to be hooked into the pocket. The edges preferably have a height, measured axially, of 25-75%, more preferably about 50% (±5%) of the thickness of the support element to which the second end of the footplate is attached. Such a pocket is particularly easy to manufacture and satisfactorily fulfills the above-mentioned operational objectives. A pocket edge height of 50% (±5%) of the support element thickness is appropriate to provide a pocket deep enough to allow the tip of an instrument to be hooked, and a portion of the support element extending axially below the pocket that is thick enough to ensure its resistance.

[0064] 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 then particularly comprises the IOL's most distal point, i.e., its most distal point in absolute radial terms. The second portion preferably has a non-negligible length. It has a central angle of preferably 5° to 25°, more preferably about 10°, when no axial or radial compression is applied to the IOL, so as to rotate the IOL against the ciliary body and provide robust stability. Additionally, this central angle can be increased to 45° when the IOL is in its implanted position, i.e., when axial and / or radial compression is applied to the IOL.

[0065] Preferably, the second portion of the distal edge is attached to the first portion along which the chamfer extends if the IOL includes a smooth lateral chamfer. This attachment is made so that the distal edge extends continuously and smoothly along these first and second portions and smoothly continues laterally into the support element to which the second end of the footplate is attached. This provides the footplate with a smooth design that is easy to manipulate and insert under the iris. The distal edge is preferably comprised of these first and second portions. Preferably, the second portion of the distal edge is attached to a third portion of the footplate that connects with the first end. This third portion preferably extends parallel to the first portion in an arcuate manner to improve the conformability of the footplate. This curved, non-radial extension makes it possible to reduce the compressive forces applied to the IOL when it is in its implanted position. Typically, when such a compressive force is exerted, the first and third portions are flexibly displaced laterally such that the second portions are significantly closer to the distal edges of the corresponding support elements, or in other words, such that the size of the corresponding cavities is reduced, e.g., the second portions are at least two or three times closer to the distal edges than when no compressive force is applied to the IOL.

[0066] According to a preferred embodiment of the present invention, the footplate extends along a plane whose normal vector forms an angle with the optical axis comprised between -15° and 15°. This angle is applied to enable an orientation of the footplate that is appropriate for anchoring to the ciliary body of the eye and for stabilizing the IOL, particularly when the IOL is in its implanted position. The normal vector is oriented in the same way as the optical axis, and the angle sign is preferably considered in the conventional planar trigonometric sense. Preferably, the angle is comprised between +2° and -10°, more preferably about -7°, when the IOL is in manufacturing, at least before its implantation, so that insertion of the footplate under the iris is advantageously easier.

[0067] According to an embodiment of the present invention exemplified hereinafter, an IOL comprises two diametrically opposed end support elements and two pairs of diametrically opposed, elongated, flexible footplates. The footplates are preferably oriented in terms of progression along a trajectory along which the footplates primarily extend from the second end to the first end. This symmetrically distributed arrangement of the support elements and elongated, flexible footplates provides the IOL with significant axial, radial, and rotational stability. In particular, the vault is only partially susceptible to lateral compressive forces applied through the IOL body. When such lateral compressive forces occur, the IOL design at least partially, and preferably nearly completely, absorbs them within the two pairs of elongated, flexible footplates, resulting in a highly advantageously more axially stable dome assembly with little potential axial movement.

[0068] The IOL of the present invention preferably retains its shape even when rotated 180° around the optical axis. In other words, the pair of elongated flexible footplates are oriented such that a 180° rotation of the IOL around the optical axis results in one image being present on the other. This is advantageous in the case of IOL lenses with irregular curvatures for correcting astigmatism, such as add-on toric IOLs. In fact, in this case, preoperative rotation of the IOL is often necessary to position the IOL on the proper axis. The design and rotational symmetry of the elongated flexible footplates facilitate such rotational manipulation during the implantation process.

[0069] The add-on intraocular lens also preferably does not change shape when planarly reflected by two orthogonal planes, each containing the optical axis, which provides the IOL with advantageous mirror symmetry that makes it possible to avoid twisting of the IOL during and after implantation.

[0070] Preferably, the closest elongated flexible footplates from two different pairs are spaced apart by a distance comprised 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 achieved by natural guidance toward said orientation at its distal edge. In other words, the elongated flexible footplates are oriented generally inward, not outward, from the distal corner of the IOL. This facilitates insertion of the elongated flexible footplates under the iris during the implantation process, since the movement of each footplate is more easily controlled.

[0071] According to another embodiment of the present invention, the central optic comprises 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 allows a second, artificial posterior chamber to be induced by the presence of the IOL, thereby preventing unnecessary restriction of the natural fluid flow between the spaces before and after the IOL. The hole ensures sufficient and permanent fluid communication between the anterior and posterior chambers of the eye. The more curved the IOL, the more preferable it is. Preferentially, the hole is located in the center of the central optic, centered on the intersection of the optical axis and the central optic.

[0072] Optionally, the IOL also includes peripheral optical holes located in the peripheral haptics, preferably at or near their proximal interface with the central optic. These peripheral optical holes traverse the anterior and posterior surfaces of the IOL and allow for additional fluid flow through the IOL, particularly during the implantation process.

[0073] According to an embodiment of the IOL, the central optic has at least an orientation mark on the anterior surface of the IOL. This orientation mark is useful for orienting the IOL during the implantation process, especially when the central optic remains primarily visible. This is particularly advantageous for properly orienting add-on toric IOLs, as described above. The orientation mark can take various forms. Preferably, it consists of small surface holes aligned on the anterior surface of the IOL. These holes do not clearly cross the IOL. The mark can take the form of at least one surface line created by laser, mild, or engraving on the anterior surface of the IOL.

[0074] The present invention advantageously allows the selection of a central optic lens that is best adapted to the visual defects to be corrected in the patient. In particular, according to an embodiment of the present invention, the central optic lens is composed of a monofocal lens that allows for 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 is composed 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.

[0075] As disclosed above, the IOL according to the invention is preferably provided with a manipulation pocket closely associated with the footplate, this association being achieved through advantageous cooperation between the pocket and the tip of the instrument, so that the instrument contributes to the invention in its own right.

[0076] In particular, such an instrument comprises: - Handle and - a straight rod having a first end fixed to the handle; a circularly curved rod extending smoothly from the second end of the straight rod; and - a tip fixed to the circularly curved rod, extending in a secant direction from the circularly curved rod and dimensioned to cooperate with a pocket by (keyed) engagement of the tip in the pocket such that movement of the elongated flexible footplate can be caused by movement of the instrument; and An apparatus is provided comprising:

[0077] The instrument allows for easy implantation of an IOL according to the present invention. In particular, the instrument alone is sufficient to perform all necessary steps of the implantation process. In addition, the implantation process does not require contact between the tip of the instrument and the footplate to position the footplate. This advantageously prevents the surgeon from making an error, such as engaging the tip into the cavity surrounded by the footplate, which could potentially touch delicate intraocular tissue or the primary IOL.

[0078] The design of the device is specifically adapted for easy implantation of an IOL in the posterior chamber of the eye. In particular, the circularly curved rod and tip are preferably the only parts of the device that penetrate the eye. The circularly curved rod avoids the sharp angle that can occur between a straight rod and the tip. It is specifically dimensioned to allow the tip to smoothly pass through the posterior chamber and into the pocket without injuring intraocular tissue and without touching the IOL, thereby pushing it backward, unnecessarily deforming it, and / or potentially touching the primary IOL. The circularly curved rod preferably extends substantially along a single arc, more preferably with a radius of curvature comprised between 10 and 30 mm, e.g., about 20 mm. Nevertheless, within the framework of the present invention, the circularly curved rod may comprise multiple circularly curved portions, preferably two such portions, with different radii of curvature. For two circularly curved (connected) sections, the first radius of curvature (of the first section) is preferably comprised between 10 and 30 mm, e.g., about 20 mm, and the second radius of curvature (of the second section) is preferably comprised between 5 and 10 mm, e.g., about 6 mm. In an advantageous manner, the second section has a steeper downward slope, thereby being better adapted to reach the pocket without touching the IOL with another part of the device. More typically, and more preferably, when the circularly curved rod comprises multiple circularly curved sections, their respective radii of curvature decrease from the straight rod to the tip, for similar reasons.

[0079] The tip is typically the only part of the instrument that is arranged to cooperate with and engage the pocket. Preferably, it comprises a free end (or distal) portion having a terminal protruding edge configured to hook the tip into the pocket. This outer portion is preferably cylindrical. In particular, the design of the tip of the instrument is then very simple, and the instrument is easy to manufacture, yet allows for efficient keyed engagement into the pocket.

[0080] For pockets corresponding to trenches on the anterior surface of the IOL, the width of the trench is typically precisely dimensioned to receive the tip, so that the tip engages in the trench and has essentially one degree of freedom of movement along the trajectory of the trench. The latter may have a shape similar to that of a footplate, among other things. In particular, the outer portion is typically positioned to axially engage the pocket on the anterior surface of the IOL and then move into the pocket.

[0081] Preferably, the tip comprises a bulging portion fixed (or connected) to the 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 axis along which the outer portion of the tip extends (preferably parallel to the optical axis when the device is in use). The term "bulging" is used to refer to the shape of this portion, which is 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 end portion so that only the end portion can engage in the pocket. In particular, very advantageously, the bulging portion functions as a stop that prevents the device from entering the hole or cavity of the IOL. The cross section of the bulging portion is typically elliptical (e.g., circular). The first elliptical cross section of the bulging portion is preferably at least 25%, more preferably at least 50%, and even more preferably at least twice as large as the second constant circular cross section of the end portion.

[0082] The end portion preferably projects and is secured directly to the bulging portion so that the tip can more easily hook onto the anterior surface of the IOL at the level of the pocket. Alternatively, the end portion is smoothly secured to the bulging portion through the use of an intermediate mechanical connection. This mechanical connection typically has a smoothly deformable cross-sectional geometry that can prevent unwanted hooking of the bulging portion onto the IOL during the implantation process.

[0083] Preferably, the bulging portion comprises a curved lower portion that is oriented to mimic the anterior curvature of the peripheral haptics when the outer portion of the tip extends axially, providing the device with an overall shape that is even more adapted to allow the end portion to reach the pocket without touching the IOL with another part of the device.

[0084] The straight rod, circularly curved rod and tip of the instrument are preferably made from metal, for example stainless steel, thereby increasing its durability.

[0085] The present invention also provides a set comprising an IOL according to the invention and the device presented above. All the embodiments of the IOL and / or the device described above, as well as their mutual advantages, apply mutatis mutandis to this set.

[0086] Other features and advantages of the present invention will become apparent from a reading of the following detailed description, for the understanding of which reference should be made to the accompanying drawings.

[0087] A list of these drawings follows: [Brief explanation of the drawings]

[0088] [Figure 1] 1A-1C are overall three-dimensional anterior and lateral views of an IOL in accordance with a preferred embodiment of the present invention. [Figure 2] FIG. 2 is a plan top view of the IOL illustrated in FIG. 1. [Figure 3] 2 is a side projection view of the IOL illustrated in FIG. 1, with the relative positioning of the IOL-induced dome and the schematic primary IOL. [Figure 4] FIG. 2 is a three-dimensional strict side view of the IOL illustrated in FIG. 1. [Figure 5] 2 is a cross-sectional view of a portion of an eye in which the IOL illustrated in FIG. 1 is placed, the IOL being illustrated in side projection. [Figure 6] 6 is a cross-sectional view of the IOL illustrated in FIG. 1 taken along plane VI shown in FIG. 2. [Figure 6a] FIG. 7 is an enlarged view of the circled portion of FIG. 6. [Figure 7] 2 is a three-dimensional enlarged view of a cross section of the support element and footplate of the IOL illustrated in FIG. 1. [Figure 8] 8 is a cross-sectional view of the IOL illustrated in FIG. 1 taken along plane VIII shown in FIG. 2. [Figure 9] 1 is a general plan side view of an apparatus in accordance with a preferred embodiment of the present invention; [Figure 9A] 1 is a general plan side view of an apparatus in accordance with a preferred embodiment of the present invention; [Figure 10] 9A-9C are schematic top views of the movement of the tip of the instrument illustrated in FIG. 9 or FIG. 9A during the implantation process of the IOL shown in FIG. 1. [Figure 11] FIG. 9B is a general three-dimensional view of a first embodiment of the tip of the instrument illustrated in FIG. 9 or FIG. 9A. [Figure 12] FIG. 9B is a general three-dimensional view of a second embodiment of the tip of the instrument illustrated in FIG. 9 or FIG. 9A. [Figure 13] 9A or 9B is a simplified cross-sectional view of a portion of an eye traversed by a portion of the instrument illustrated in FIG. 9 or 9A during the implantation process of the IOL illustrated in FIG. 1, the IOL being illustrated in side projection. DETAILED DESCRIPTION OF THE INVENTION

[0089] The drawings are typically not to scale. Similar elements are generally assigned similar reference numerals. Within the framework of this document, identical or similar elements may have the same reference numerals. Furthermore, the presence of reference numerals in the drawings shall not be considered limiting when these reference numerals are indicated in the claims.

[0090] This part of the present document presents a complete description of particular and preferred embodiments of the invention, with reference to the drawings, the invention is not, however, limited by these references, and the figures presented above are in particular merely schematic and in no way limiting.

[0091] Some of the figures are provided with abstract geometric marks and corresponding symbols (e.g., 81-89B, X, Y, Z, K, P, k, k', k'', 7A, 7B, 71A, 72A, 72B, 73A, α-δ, and θ) that are substantially used to quantify or visualize technical characteristics of embodiments of the present invention, such as scale or geometric properties. These geometric marks generally do not correspond to concrete real-world objects.

[0092] The present invention provides a posterior chamber add-on IOL 1 configured to be implanted in a pseudophakic eye 9, i.e., an eye in which the natural lens has been replaced by another IOL, the primary IOL. The IOL 1 according to the present invention is simultaneously compatible with a wide range of ocular anatomies, easy to implant, and postoperatively stable in its implanted position in the eye 9 axially along the optical axis Z, radially, and in rotation in a plane perpendicular to the optical axis Z according to vectors (or axes) X and Y. As shown in FIG. 1 , axes X, Y, and Z form, inter alia, a so-called Cartesian basis in Euclidean three-dimensional space. Conventionally, the optical axis Z is oriented from the anterior surface 11 to the posterior surface 12 of the IOL 1 (see FIGS. 1 and 3 ).

[0093] As depicted in Figure 5, IOL 1 is intended to be positioned in the posterior chamber 96 of a pseudophakic eye 9. Other elements of the anatomy of the eye 9, including the cornea 91, iris 92, pupil 93, primary IOL 94, anterior chamber 95, ciliary zonules 97, ciliary body 98, and lens capsule 99 of the eye 9, are also shown in Figure 5.

[0094] As illustrated in FIGS. 1 and 2, IOL 1 has a central optic 2 extending radially relative to optical axis Z with a maximum outer diameter comprised between 4.5 and 7.2 mm, preferably about 6.5 mm. It may have through-holes 21 extending along optical axis Z between anterior surface 11 and posterior surface 12 so that fluid communication is possible between these surfaces (which is optional in less curved IOLs, as illustrated). Central optic 2 also has orientation marks 22 in the form of two diametrically opposed surface lines parallel to axis Y, which may be created by laser, mild, or engraving on the anterior surface 11 of the IOL. These marks 22 may be used to orient IOL 1 during implantation. An illustrative diameter value of through-holes 21 is 0.36 mm. An illustrative length measured along axis Y for each line of marks 22 is 0.90 mm.

[0095] The central optic 2 is surrounded by a haptic structure, within which peripheral haptics 3 are circumferentially attached proximally to the central optic 2. The peripheral haptics 3 extend radially outward and posteriorly relative to the central optic 2. It nevertheless extends radially further along axis Y rather than along axis X, so that the IOL has a generally planar configuration extending along axis Y, as illustrated in FIG.

[0096] The peripheral haptic portion 3 is comprised of a main proximal portion 34 and two diametrically opposed distal support elements 4. The main proximal portion 34 includes two peripheral optical holes 33 located symmetrically about the optical axis Z along axis Y at or near the proximal border of the central optic portion 2. The peripheral optical holes 33 traverse the IOL 1 through the anterior surface 11 and posterior surface 12, allowing for fluid flow during the implantation process of the IOL 1. As shown in FIG. 2, the peripheral optical holes 33 span a portion of the IOL 1 with a third diameter 83, which is comprised between 5.80 and 7.20 mm, preferably approximately 6.70 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 opposed ends of the main proximal portion 34, mirror-symmetrically with respect to a plane based on the axis X and the optical axis Z. They have the form of annular portions extending circumferentially around the optical axis Z, each along an arc having a central angle β of approximately 60° (visible in FIG. 2). The end edge 41 of each support element 4 extends along an arc of a second diameter 82, in particular comprised between 8.0 and 10.2 mm, for example approximately 9.2 mm. It is provided with a lateral recess 42 in the form of a partial hole, which increases the flexibility of the end edge 41.

[0098] In particular, the entire peripheral haptic portion 3 and central optic portion 2 are inscribed in a cylinder of second diameter 82 extending about optical axis Z to form a dome K (or dome assembly) supported posteriorly by support elements 4. As shown in Figures 3 and 5, dome K has a posterior surface that is intended to overlie a primary IOL 94 implanted in a capsular bag 99 when IOL 1 is in an implanted position in eye 9. Distal support elements 4 are then positioned to support IOL 1 at the ciliary zonules 97 of 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 primary IOL 94 so that a vault 89B adjustable from 300 to 750 μm can be secured between the IOL 1 and the primary IOL 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, measured axially and referred to as the "intrinsic vault," constitutes the height of the intrinsic vault of the IOL 1. It typically has a value comprised between 0.5 and 1.5 mm, preferably between 0.7 and 1.3 mm. For example, if the pair comprised of the first diameter 81 and the second diameter 82 of the IOL 1 is (12.7 mm, 8.0 mm), (13.2 mm, 9.1 mm), or (13.6 mm, 10.2 mm), the intrinsic height 89A would then be approximately 0.75 mm, 1.00 mm, or 1.25 mm, respectively.

[0101] 8, the sides of the peripheral haptics 3 where the support elements 4 are not distally attached comprise beveled surfaces that terminate in rearwardly and radially oriented distal corners 35. The corners 35 may be rounded and polished to avoid any damage to intraocular tissue.

[0102] As explained in this disclosure, a certain wall thickness provides rigidity to the dome K so that it can withstand axial and / or radial compression when the IOL 1 is in its implanted position. In particular, as depicted in FIG. 6, the thickness 84B of the dome K near its center may be, for example, about 0.70 mm, which then decreases radially through the optic 2 and peripheral haptic elements 3 to the support elements 4, which have a thickness 84A that is typically comprised between 0.45 and 0.20 mm (not considering pockets as presented hereinafter).

[0103] These values ​​are selected so that the dome K forms a sufficiently rigid and wide structure to surround and anteriorly overlay the primary IOL 94, and thereby be able 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, IOL 1 also includes two pairs of diametrically opposed, elongated, flexible footplates 5 that are attached to the distal support elements 4 and extend radially along axis Y beyond the peripheral haptics 3. Each such footplate 5 has a first end 51 and a second end 52 that are attached to the same support element 4, such that the footplates have the form of partial annulus bordering a cavity 32 that extends from the anterior surface 11 to the posterior surface 12.

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

[0106] Each cavity 32 is more elongated in terms of area perpendicular to the optical axis Z than the corresponding footplate 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 footplate. This radial length 86 is preferably 0.7 to 1.3 mm, and preferably approximately 1.0 mm, and the radial length of said cross-section C is preferably 0.2 to 0.5 mm, and preferably approximately 0.35 mm. As a result, the surface of the IOL 1 extending radially beyond the second diameter 82 is less solid-material-filled than solid-material-filled. Each footplate 5 has a constant thickness 83A (shown in FIG. 3) substantially 0.10 to 0.40 mm, and preferably approximately 0.25 mm. All of these data contribute to the high flexibility of the footplate 5.

[0107] Prior to implantation, IOL1 is generally inscribed within a cylinder of first diameter 81, having 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, thereby providing flexibility that allows it to compensate for variations in the amount of anatomical space available in the posterior chamber 96 of the eye for IOL1 when IOL1 is in its implanted position as described above in this disclosure.

[0108] The footplate 5 is designed to fold and / or bend when compression is applied axially and / or radially to the IOL 1, in particular such that the adjustable angle α between the optical axis Z and the normal vector to the plane P in which the footplate 5 extends is generally comprised between −15° and 15°, as illustrated in FIG. 6 .

[0109] Each footplate 5 includes a distal edge 53 that extends both circumferentially and radially outward relative to the support element 4 to which it is attached. This distal edge 53 is positioned to stabilize the IOL 1 in the ciliary body 98, particularly when the IOL 1 is in the implanted position as illustrated in FIG. 5 . It functions as an anchor to stabilize the IOL 1 in rotation in a plane perpendicular to the optical axis Z, as detailed in this disclosure. The distal edge 53 may optionally be positioned to stabilize the IOL 1 in the ciliary sulcus of the eye 9, such that the term "ciliary body" in this document may optionally be replaced with "ciliary body and / or sulcus."

[0110] Distal edge 53 is comprised of a first portion 54 and a second portion 55, which are particularly visible in Figures 1 and 4. As depicted in Figure 2, second portion 55 extends along an arc of a first diameter 81 having a central angle γ comprised between 7.5° and 20°, and typically about 10°, when no axial or radial compression is applied to IOL 1. It therefore comprises the most distal portion of distal edge 53. First portion 54 extends from second end 52 to second portion 55 with respect to its portion.

[0111] First portion 54 is advantageously provided with a smooth lateral chamfer 31 that smoothly continues laterally at first portion 54, at the support element to which second end 52 is attached, and at all or part of main proximal portion 34 of peripheral haptics 3. As will be described in detail in this disclosure, this chamfer 31 contributes to facilitating insertion of footplate 5 under iris 92 during implantation of IOL 1.

[0112] The footplate 5 itself is essentially made up of three parts: a first part 54 extending at a first natural width, a second part 55 extending at a second natural width, and a third part 56 visible in Figure 1 which connects the second natural width part to the first end 51. The main extension paths of these footplate parts are parallel to the first part, both circumferentially and radially, and substantially only in an arc in the circumferential direction, respectively.

[0113] The overall design of the elongated flexible foot plates 5 is determined to facilitate the implantation process of the IOL 1. In particular, the chamfers 31 have a concave, smooth outer surface such that each foot plate 5 is oriented distally to converge toward the axis Y. The act of inserting the elongated flexible foot plates 5 under the iris 92 is consequently significantly easier. The distal edge 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 approximately 15-20°.

[0114] The dual haptic structure of the distal support elements 4 and the elongated flexible footplate 5 allows the IOL 1 to be particularly stable in its implanted position and to stably cover a wide range of ocular anatomical structures. The vault 89B (shown in FIG. 5) can be adapted to the variations in size of the anatomical spaces as described above so that the IOL remains stable and well-positioned between the iris 92 and the primary IOL 94.

[0115] Given that the elongated flexible foot plates 5 are particularly flexible, it is advantageous to provide the IOL 1 with structure to control the movement of the elongated flexible foot plates 5 during the implantation process and to aid in their proper insertion under the iris 92. To this end, the support elements 4 include a manipulation pocket 6 on the anterior surface 11 of the IOL, as can be seen in Figures 1, 2, 6a and 7.

[0116] Each pocket 6 is associated with a foot plate 5 in terms of structural and functional features. In particular, in terms of structure, each pocket 6 faces the associated foot plate 5, so that only a terminal edge 41 separates the cavity 32 from the pocket 6. The pocket 6 is additionally radially aligned between a first end 51 and a second end 52 of the foot plate 5. It defines a circumferential trench 63 in the anterior surface 11 of the IOL, extending parallel to the foot plate 5 in a mirror image of the ends 51 and 52 of the foot plate, with radially inward extensions 64 located at the two circumferential ends of the trench 63.

[0117] The trench 63 has a roughened bottom surface 61 and side edges 62 with an axial height 85 of approximately 50% of the thickness 84A of the corresponding support element 4. In other words, the axial height 85 is comprised between 0.07 and 0.13 mm, preferably about 0.10 mm. The height 85 may decrease slightly in the radial direction depending on the thickness 84A of the support element 4. The most distal side edges 65 may be formed in the form of a semi-cylindrical shape at the boundary with the distal edge 41, with a radius comprised between 0.00 and 0.10 mm, for example 0.06 mm.

[0118] These geometric features of the pocket 6 are specially provided to enable functional cooperation with the tip 71 of the operating instrument 7 by geometric key-like engagement of the tip 71 into the pocket 6, so that appropriate movement of the elongated flexible footplate 5 can be caused by movement of the instrument 7 during the implantation process of the IOL1.

[0119] Such cooperation in the implantation process of IOL 1 is illustrated schematically in Figure 10, which particularly illustrates (by arrows) the movement of instrument 7 to insert each of the footplates 5 under the iris 92 of the right eye 9. The elongated flexible footplates 5 are numbered 5A through 5D in the order of their manipulation through the pocket 6.

[0120] The insertion process for the (right-distal) footplate 5A includes the following actions: pulling toward perforation (i.e., small incision) P1, pushing down to insert footplate 5A under the iris 92, and pushing radially outward. The insertion process for the (left-distal) footplate 5B includes the following actions: pushing toward perforation 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 the following actions: pulling toward perforation P2, pushing down to insert footplate 5C under the iris 92, and pushing radially outward. Finally, for the (left-distal) footplate 5D, the insertion process includes the following actions: pushing toward perforation P1, pushing down to insert footplate 5D under the iris 92, and pulling radially outward.

[0121] Figure 13 illustrates the eye 9 of Figure 5 during implantation of the IOL 1. As can be seen, the tip 71 of the instrument 7 is particularly configured to cooperate with the pocket 6, thereby enabling the above-mentioned insertion of the elongated flexible foot plates 5A-5D.

[0122] The instrument 7 will be described in more detail with reference to Figures 9, 9A, 11, 12 or 13. It 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 fixed in a secant direction to the circularly curved rod 72. The tip 71 has a cylindrical free (distal) end portion 74 arranged to engage the pocket 6.

[0123] Non-limiting, illustrative dimensional values ​​for instrument 7 are provided for when the underside of end portion 74 is in surface contact with bottom surface 61 such that the axis of rotation about which free end portion 74 extends cylindrically is substantially parallel to optical axis Z. Under these conditions, as shown in Figures 9 and 9A, instrument 7 with handle 70 has an axial length 7A of approximately 15.00 mm, circularly curved rod 72 and tip 71 have an axial length 7B of approximately 2.34 mm, straight rod 73 extends along length 73A of approximately 14.30 mm, circularly curved rod 72 extends along length 72A of approximately 11.30 mm, and radius of curvature k' is comprised between 15 and 30 mm, preferably approximately 20, 21, 22, 23, 24, 25, or 26 mm. The width of the device tends to decrease along the trajectories of the straight rods 73 and the circularly curved rods 72 from about 0.60 mm to about 0.24 mm near the junction with the tip 71 (the width of said tip 71 corresponds to 72B in FIGS. 11 and 12). These values ​​are selected to allow for proper orientation and positioning of the device in the eye 9, as illustrated in FIG.

[0124] As depicted and shown in FIGS. 9 and 9A, the circularly curved rod 72 extends along a single arc with a radius of curvature k'. As shown in FIG. 9A, however, the circularly curved rod 72 may also comprise two portions with different radii of curvature. The second portion 72' is more curved than the first portion, which comprises 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. 9, such as the overall length of the circularly curved rod 72, apply in FIG. 9A. Approximately 10-20% of this length comes from the second portion 72'.

[0125] A different tip 71 may be provided on the instrument 7 and may optionally be removable. Two embodiments of the tip 71 are illustrated in FIGS. 11 and 12. In both embodiments, the end portion 74 has a terminal protruding edge 75 for easily hooking the tip 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, near its junction with the tip 71, is oriented at a smaller angle θ, preferably comprised between 40° and 85° (e.g., it may be about 50°, about 60°, about 70°, or about 80°; more preferably, it may be about 51°), relative to the direction in which the circularly curved rod 72 extends.

[0126] The tip 71 comprises a bulging portion 76 that connects the arcuately curved rod 72 and the end portion 74. This connection through the bulging portion 76 can be made in different ways in different of the two embodiments illustrated in Figures 11 and 12. In each of the two embodiments, the bulging portion 76 has a first deformable elliptical circular cross section C1 that is larger than the second constant circular cross section C2 of the free end portion 74, thereby making it possible to prevent the bulging portion 76 from entering the pocket 6 and similarly the tip 71 from entering undesired locations, such as into the peripheral optical hole 33 or cavity 32.

[0127] The bulging portion 76 is smoothly secured to the circularly curved rod 72 such that at least the upper axial surfaces of the circularly curved rod 72 and the tip 71 are generally smooth. This advantageously allows for smooth insertion and removal of the instrument 7 through small incisions (or the perforations P1 and P2), thereby making the insertion process and manipulation of the instrument 7 easier.

[0128] In the embodiment of Figure 11, end portion 74 protrudes and is secured directly to bulging portion 76, which improves the grip of tip 71 on the anterior surface of IOL 1 adjacent pocket 6. In the embodiment of Figure 12, end portion 74 is secured to bulging portion 76 in a different, smooth manner, by an intermediate smooth mechanical connection 77.

[0129] The axial length 71A of the end portion 74 preferably varies from, for example, about 0.13 mm in the embodiment of Fig. 11 to, for example, about 0.26 mm in the embodiment of Fig. 12. The axial length 71B of the entire tip 71, for that portion, is preferably less than 0.75 mm in both embodiments, more preferably comprised between 0.45 and 0.60 mm, for example about 0.53 mm. This limited axial length is specifically designed to allow smooth entry through small incisions (or the perforations P1 and P2) during the insertion process.

[0130] In other words, the present invention relates to a posterior chamber add-on IOL1 configured to be implanted in a pseudophakic eye 9, comprising a central optical portion 2, a peripheral haptic portion 3 having terminal support elements 4 arranged to support the IOL1 on the ciliary zonules 97 of the eye 9, elongated flexible foot plates 5 attached to the support elements 4, each having a terminal side edge 53 arranged to stabilize the IOL1 on the ciliary body 98 of the eye 9, and operation pockets 6 on the surface of the support elements 4, each pocket 6 being associated with one of the elongated flexible foot plates 5.

[0131] The present invention has been described in relation to specific embodiments, the values ​​of which are purely illustrative and should not be considered 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 illustrated or described above. In particular, all values ​​stated in this description are given with a 10% margin of error. The present invention includes each of the novel features described, as well as all combinations thereof.

Claims

1. A posterior chamber add-on intraocular lens (IOL) (1) for implantation in a pseudophakic eye (9), comprising: a front face (11) and a rear face (12), a central optical part (2) comprising a lens and extending radially relative to an optical axis (Z) directed from said front face (11) to said rear face (12); a peripheral haptic portion (3) circumferentially attached to the central optical portion (2) and extending radially outwardly and posteriorly relative to the central optical portion (2), the peripheral haptic portion (3) comprising distal support elements (4) arranged to support the IOL (1) at the zonules (97) when the IOL (1) is in an implanted position in the eye (9); at least one elongated flexible footplate (5) extending radially beyond said peripheral haptics (3) and having a first end (51) attached to said peripheral haptics (3); Equipped with The elongated flexible foot plate (5) a second end (52) attached to one of said support elements (4), and a distal rim (53) extending circumferentially and radially outward relative to the central optical portion (2) and arranged to stabilize the IOL (1) on the ciliary body (98) when the IOL (1) is in the implanted position in the eye (9); and said one of the support elements (4) comprises an operating pocket (6) on its front face (11), said operating pocket (6) being at least partially radially aligned with said elongated flexible foot plate (5) and dimensioned to cooperate with a tip (71) of said operating instrument (7) by key-like engagement of said tip (71) in said pocket (6), such that movement of said elongated flexible foot plate (5) can be caused by movement of said instrument (7). IOL (1).

2. 2. The IOL (1) of claim 1, wherein a smooth sided 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. 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 claim 1, wherein the elongated flexible footplate (5) extends from the anterior surface (11) to the posterior surface (12) and borders a cavity (32) having a maximum radial length (86) greater than a maximum diameter (87) of a cross section (C) of the elongated flexible footplate (5).

5. IOL (1) according to any one of claims 1 to 4, wherein each of said support elements (4) extends along an arc having a central angle (β) comprised between 20 and 80°.

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

9. 9. An IOL (1) according to any one of claims 1 to 8, wherein the pocket (6) has a bottom surface (61) and side edges (62) as part of the anterior surface (11), the edges (62) having a height (85) measured parallel to the optical axis (Z) that is comprised of 25 to 75% of the thickness (84A) of the one of the support elements (4) measured parallel to the optical axis (Z).

10. a first diameter (81), constituted by the outer diameter of the IOL (1) measured perpendicular to said optical axis (Z), comprised between 12.5 and 14.0 mm; a second diameter (82) consisting of the outer diameter of the peripheral haptics (3) measured perpendicular to said optical axis (Z) consisting of 8.0 to 10.2 mm; IOL (1) according to any one of claims 1 to 9

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

12. 12. The IOL (1) according to any one of claims 1 to 11, wherein the IOL (1) comprises two diametrically opposed support elements (4) and two pairs of diametrically opposed, elongated, flexible foot plates (5), such that the IOL (1) does not change shape when rotated 180° around the optical axis (Z).

13. 13. An IOL (1) according to claim 12 when dependent on claim 10, wherein the nearest elongated flexible foot plates (5) from two different pairs are spaced apart by a distance comprised 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. 14. An IOL (1) according to any one of claims 1 to 13, wherein the thickness of the peripheral haptic 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. 15. An IOL (1) according to any one of claims 1 to 14, wherein the elongated flexible footplate (5) extends along a plane (P), the normal vector of which forms with the optical axis (Z) an angle (α) comprised between -15° and 15°.

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

17. A posterior chamber add-on intraocular lens (1) according to any one of claims 1 to 16 and an operating instrument (7), a handle (70), a straight rod (73) with a first end fixed to said handle (70); a circularly curved rod (72) extending smoothly from the second end of said straight rod (73); a tip (71) fixed to said circularly curved rod (72), extending from said circularly curved rod (72) in a secant direction and dimensioned to cooperate with said pocket (6) by keyed engagement of said tip (71) in said pocket (6) so that movement of said elongated flexible footplate (5) can be caused by movement of said instrument (7); A set including an operating device (7) comprising:

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

19. the tip (71) comprises a bulging portion (76) fixed to the circularly curved rod (72) and having a first elliptical cross section (C1) that is at least 25% larger than the second constant circular cross section (C2) of the free end portion (74); 19. The set according to claim 18, wherein the free end portion (74) projects directly onto the bulge portion (76) and is fixed thereto, or is smoothly fixed thereto by an intermediate mechanical connection (77).

20. 20. The set according to any one of claims 17 to 19, wherein the circularly curved rod (72) comprises one or more circularly curved portions with different radii of curvature.

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