Additional intraocular lens

Abstract

The invention relates to an additional intraocular lens (1) of the posterior chamber type configured to be implanted in a pseudo-lenticular eye (9) and comprising: a central optical site (2); a peripheral haptic site (3) having a distal support element (4) arranged to support the intraocular lens (1) on the ciliary leucorrhea; elongated flexible pads (5) mounted on the support element (4), each having a distal lateral boundary (53) arranged to stabilize the intraocular lens (1) in the ciliary body (98); and manipulation pockets (6) located on the surface of the support element (4), each manipulation pocket being associated with one of the elongate flexible pads (5).

Description

Technical Field

[0001] The present invention relates to an intraocular lens (IOL). More particularly, the present invention relates to a posterior chamber IOL intended for implantation in a pseudophakic eye, ie, a posterior chamber add-on IOL. Background Art

[0002] Generally speaking, "pseudophakia" refers to the use of an IOL to replace the eye's natural lens. A "pseudophakic eye" is defined as an eye whose natural lens has been replaced with an IOL, usually during cataract surgery. In the context of this article, this IOL may be referred to as a "primary IOL." The primary IOL is implanted in the capsular bag of the eye.

[0003] Sometimes, it is necessary to complete the visual performance induced by the primary IOL by implanting another IOL in the pseudophakic eye. The additional IOL is then implanted in the pseudophakic eye as a supplement to (not a replacement for) the primary IOL. Technicians often refer to the additional IOL as an "add-on IOL" or "secondary IOL," and these terms are used interchangeably herein.

[0004] The add-on IOL is typically implanted in the posterior chamber of the eye, between the posterior surface of the iris and the anterior surface of the primary IOL (and / or capsular bag), but not in the capsular bag, making it known as a "posterior chamber add-on IOL." This type of IOL is typically supported around the ciliary body of the eye.

[0005] The additional IOL and the primary IOL can be implanted during the same surgery, for example, if it is determined that the visual performance induced by the primary IOL will need to be completed or corrected or adjusted for a particular patient (either at the time of implantation or thereafter). In this case, the additional IOL is implanted in the eye immediately after the natural lens is replaced with the primary IOL. Alternatively, the additional IOL can be implanted several years after the primary IOL, for example, when it is noted that the visual performance induced by the primary IOL needs to be completed or corrected or adjusted, for example, due to the patient's advanced age. The advantage of using such a posterior chamber additional IOL is that it significantly reduces the risk of medical complications for the patient, compared to replacing the primary IOL in the capsular bag.

[0006] However, the positioning of such an add-on IOL may vary from eye to eye based on the anatomy of the posterior chamber, the dimensions of which often vary by several millimeters from patient to patient. In particular, the implantation of an add-on IOL in an eye whose dimensions may not be appropriate may risk causing more or less severe medical complications for the patient, such as:

[0007] - For example, if the space between the add-on IOL and the primary IOL is too small (e.g., if the add-on IOL is too small relative to the size of the posterior chamber anatomical space available for IOL implantation), epithelial cell proliferation can result, which then leads to primary IOL opacification (also known as "secondary cataract");

[0008] - or, for example, where the add-on IOL is too large relative to the size of the anatomical space, pupillary obstruction, glaucoma, inflammation, iris depigmentation, or a depression between the anterior and posterior chambers of the eye following pupillary obstruction may result.

[0009] The production and use of various sizes of additional IOLs based on the usual eye anatomy cannot completely overcome this defect. In fact, once such additional IOLs are implanted in the eye, the disadvantages of the positional stability of such additional IOLs may lead to the same medical complications.

[0010] Another challenge in the design of add-on IOLs is making it easy to maneuver the add-on IOL in the posterior chamber during the process of implanting the add-on IOL in the eye. For example, using thin haptics, each elongated along a curve extending outward from the IOL lens and having a free end for hooking the add-on IOL into the eye, can compensate for the dimensional variations in the anatomical space, but the haptics would be difficult to see and manipulate, making it an unsuitable solution. Therefore, it would be desirable to provide an add-on IOL that is both easy to implant and sufficiently stable in position. Summary of the Invention

[0011] An object of the present invention is to provide a posterior chamber attachment IOL that is adaptable to a wide range of ocular anatomies and is easy to implant into the eye.

[0012] To this end, the present invention provides a posterior chamber addition IOL configured to be implanted in a pseudophakic eye and comprising:

[0013] -front and rear surfaces;

[0014] - a central optical part, comprising lenses, and

[0015] The central optical region extends radially relative to an optical axis directed from the front surface to the rear surface;

[0016] - peripheral tactile areas,

[0017] Peripheral haptics are mounted circumferentially on the central optic.

[0018] The peripheral haptics extend radially outward and posteriorly relative to the central optic, and

[0019] The peripheral haptic includes a distal support element arranged to support the IOL on the ciliary zonules when the IOL is in an implanted position in the eye;

[0020] - at least one elongated flexible pad,

[0021] at least one elongated flexible pad extending radially beyond the peripheral haptic, and

[0022] at least one elongated flexible pad including a first end mounted on the peripheral haptic;

[0023] The elongated flexible pad includes:

[0024] a second end, the second end being mounted on one of the support elements; and

[0025] - a distal lateral boundary extending circumferentially and radially outwardly relative to the central optic region, and the distal lateral boundary being arranged to stabilize the IOL in the ciliary body when the IOL is in an implanted position in the eye.

[0026] The one of the support elements preferably includes a manipulation pocket on the anterior surface of the IOL, the manipulation pocket being at least partially radially aligned with the elongated flexible pad, and the dimensions of the manipulation pocket being designed to cooperate with the tip of a manipulation tool by (keying) engaging the tip into the pocket such that movement of the tool can cause movement of the elongated flexible pad.

[0027] This IOL allows a good compromise to be reached between 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 ease of implantation of the IOL. The add-on IOL includes a central optical portion equipped with two different and complementary haptic structures: the first haptic structure is a peripheral haptic portion including a distal support element, and the second haptic structure is at least one elongated flexible pad (hereinafter referred to as a "pad", although the IOL preferably includes two or four such elongated flexible pads). The peripheral haptic portion and the central optical portion together form a "dome-shaped assembly", the foot of which is a support element arranged at the distal end to support the IOL on the ciliary zonules. When the pad extends radially beyond the dome-shaped assembly, the dome-shaped assembly also enables the IOL to be stabilized in the ciliary body. The geometry and flexibility of the pad contribute significantly to the stability of the IOL in the implanted position. To make the IOL easier to implant, the pad is completely mounted on the flexible haptic portion by its distal end. Although this approach slightly reduces the adaptability of the backing plate compared to the elongated, thin, free-ended haptics mentioned in the background section, this backing plate geometry makes it easier to manipulate the backing plate during implantation. This is further enhanced by the presence of a manipulation pocket, preferably on the support element, to which at least one end of the backing plate is attached. In particular, the backing plate geometry and flexibility still allow the IOL to be adapted to a wide variety of ocular anatomies, but any manipulation difficulties that may result from this are fully compensated by the attachment of the backing plate's ends to the peripheral haptics and the advantageous presence and location of the pocket.

[0028] Now, the above technical effects are explained in detail. Specifically, as described below, the IOL is particularly stable in its implanted position in the axial direction (i.e. parallel to the optical axis), radial direction (i.e. perpendicular to the optical axis) and circumferential direction (i.e. rotation around the optical axis).

[0029] The peripheral haptics enable the IOL to be stabilized parallel to the optical axis. A support element is arranged at the distal end of the peripheral haptics and is designed to support the IOL dome-shaped assembly on the ciliary zonules. The dome-shaped assembly is arranged to be located above the primary IOL in the front so that the dome-shaped assembly surrounds the primary IOL at least in the front. A distance called the "vault" measured between the front surface of the primary IOL and the rear surface of the additional IOL along the optical axis is defined and stabilized. This distance can be similar to the safety distance required to avoid contact or excessive proximity between the primary IOL and the additional IOL. A safety distance (typically less than 0.5 mm) between the IOL and the iris of the eye can be similarly defined and stabilized. This distance is the distance between the front surface of the IOL and the rear surface of the iris, with the rear surface of the iris being considered as a virtual iris plane occupying the pupil of the eye (in the convex opening).

[0030] Preferably, the vault is preferably adjustable between 100 μm and 1000 μm and / or between 100 μm and 1000 μm, more preferably between 300 μm and 7500 μm and / or between 300 μm and 750 μm, with or without radial and / or axial compression. Sufficient space is then available between the add-on IOL and the primary IOL and the iris of the eye, thereby compensating for potential anatomical size defects in the posterior chamber of the eye or possible positioning defects of the IOL, thereby significantly reducing the risk of complications for the patient.

[0031] Based on the selection of a rear surface that is at least as curved as the anterior surface of a primary IOL on average and based on the selection of a peripheral haptic site outer diameter (measured perpendicular to the optical axis) that is compatible with a wide range of eye posterior chamber anatomical structures, the structure of the dome-shaped assembly is suitable for a wide range of eye anatomical structures. In a more specific manner, this diameter is preferably between 8.00mm and 11.50mm, for example 8.50mm, 9.00mm, 9.50mm, 10.00mm, 10.50mm, 11.00mm or 11.50mm. The three preferred diameter values ​​of 8.00mm, 9.10mm and 10.2mm are advantageously sufficient to cover any posterior chamber anatomical structure, as will be explained below. Alternatively, for other IOL haptic implantation locations not described in detail, a diameter between 6.50mm and 8.00mm may also be considered. The rear surface of the dome-shaped assembly is preferably smooth and / or (backward) concave. This concave shape does not exclude that a portion of the rear surface (for example, the portion facing the optic site) may be substantially flat or almost flat. The posterior surface is preferably concave and curved at each point thereof. The radius of curvature of the posterior surface is then more preferably between 8 mm and 14 mm, and more preferably between 10 mm and 11 mm. The radius of curvature of the posterior surface may be greater than that of a corresponding phakic IOL, since the primary IOL is thinner (measured along the optical axis) than the natural lens, so that more anatomical space is available for implanting an add-on IOL. It should be noted that this radius of curvature is well defined, since the posterior surface of the dome-shaped component is smooth and (mathematically) regular. In particular, the posterior surface at the junction between the central optical portion and the peripheral haptic portion generally does not include any sharp irregularities. Although only one radius of curvature value is mentioned above for the posterior surface, it is not excluded that the surface curvature may be different at different points. In particular, optionally, the radius of curvature at any point of the posterior surface of the central optical region is between 5.0 mm and 100.0 mm, preferably between 8.0 mm and 14.0 mm, while the radius of curvature at any point of the remainder of the posterior surface of the dome-shaped component is approximately 11.0 mm.

[0032] 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 dome-shaped assembly sits on top of the primary IOL, resting on the ciliary zonules and stabilizing the IOL parallel to the optical axis. For its part, the backing plate extends generally radially beyond the dome-shaped assembly in the posterior chamber of the eye to rest within the ciliary body. The flexibility and geometry of the backing plate enable the IOL to adapt to variations in the internal dimensions of the posterior chamber anatomical space available to the IOL (referred to as the "ciliary body to ciliary body" measurement, preferably referred to as the ciliary body to ciliary body distance, to account for the elastic penetration factor of the backing plate into the eye's ciliary body) over a range of internal eye dimensions, including those that cannot be precisely estimated preoperatively. While the outer diameter of the dome-shaped assembly remains generally constant at the IOL implantation site, the overall outer diameter of the IOL can subsequently vary due to the flexibility of the backing plate to adapt to the posterior chamber anatomy of the eye. Advantageously, a single add-on IOL model according to the present invention is sufficient for use with a very wide range of patient eye anatomies.

[0033] The spacer also stabilizes the IOL during rotation in a plane perpendicular to the optical axis, thereby fully compensating for variations in the anatomical space (which is recognized to be larger in one direction than in another due to its "elliptical" shape). The spacer extends circumferentially and radially, such that the distal lateral boundaries of the spacer are adjusted to lay and / or hook and / or stabilize themselves in the ciliary body, thereby providing circumferential anchoring for the IOL.

[0034] This feature is particularly important in embodiments where the IOL is a toric implant, which includes an optic with a cylindrical body to correct 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 ensure the desired IOL optical outcome. In this case, the spacer allows the IOL lens to remain in the central optical zone, thereby avoiding possible decentration of the IOL relative to the eye's optical axis, which could affect the IOL's optical outcome.

[0035] The first and second ends of the pad are mounted on the peripheral haptic, which improves the maneuverability of the pad during IOL implantation. In addition, more specifically, at least the first end is mounted on a support element, in other words, on the distalmost end of the peripheral haptic, so that the pad length is reduced to reach the ciliary body. Advantageously, this reduced pad length means that the pad is more maneuverable during IOL implantation, making the IOL easier to implant. These unique innovative features make it possible to compensate for the slender geometry and flexibility of the pad, which are important for the stabilization purpose of the above-mentioned IOL. In fact, the pad is long, thin and transparent, making it difficult to see and manipulate under the iris of the eye. If the pad is too long and / or has a free end, it can easily flip over. Advantageously, the pad of the present invention overcomes these difficulties.

[0036] The first end and the second end are typically the only parts of the backing plate that are mounted on the peripheral haptic portion of the IOL. More generally, the backing plate is not mounted on the peripheral haptic portion over its (entire) length. When the first end and the second end of the backing plate are mounted on the peripheral haptic portion, the backing plate as a whole extends along a partial ring, radially outwardly extending from the second end relative to the optical axis, then radially inwardly extending to the first end relative to the optical axis, reaching the distal end of the ring at the outer diameter of the IOL. The distal lateral boundary subsequently forms that part of the partial ring that is arranged at the distal end, so that the IOL is stabilized in the ciliary body. Thus, the distal lateral boundary advantageously realizes a potential wide contact surface with the ciliary body.

[0037] Since the implantation position between the primary IOL and the iris is tricky, it is important to have an IOL that can be easily implanted. Fewer manipulations are required to position the IOL, making it possible to avoid errors that could negatively impact the patient. In order to further improve the maneuverability of the backing plate during implantation, the support element on which the second end of the backing plate is mounted preferably also has the aforementioned manipulation pocket. However, the present invention is not necessarily limited to the presence of a pocket, but a pocket is preferred since the features of the backing plate discussed above already advantageously distinguish the additional IOL according to the present invention from the prior art.

[0038] The pocket is arranged adjacent to the pad, in particular at least partially radially aligned with the pad. Since at least the second end of the pad is attached to the same support element, the position of the pad can be changed by moving the tip of the tool in a suitable manner in the pocket. There is no need to directly manipulate the pad, which greatly reduces the risk of manipulation errors. In fact, due to the thinness and transparency of the pad, it is easy to miss the pad and pass through the posterior surface of the IOL and come into contact with sensitive intraocular tissue or the primary IOL. By limiting the movement of the tip in this pocket to the anterior surface of the IOL, such handling errors cannot occur.

[0039] The pocket is also advantageous when the IOL has to be manipulated under an opaque iris. In fact, the pocket makes it possible to guide the tip of the tool on the front surface by keying the tip into the pocket. Thus, the surgeon does not need to see the pad under the iris (which is usually very difficult) in order to correctly position it. When the tip is engaged in the inverted pocket, it is advantageous for the surgeon to perform appropriate (known) movements with the tool to position the pad under the iris without having to see it. Preferably, the dimensions of the pocket are designed to be particularly suitable for these movements and to guide the surgeon during the implantation process.

[0040] Within the framework of this document, the "optical axis" of a pseudophakic eye preferably includes a vector running from one side of the eye to the other, directed from its "anterior segment," which in turn includes the cornea, iris, and primary IOL, to its "posterior segment," which includes the retina. For an IOL according to the present invention in its implanted position in the eye, the optical axis of the eye points from the anterior surface of the IOL to the posterior surface of the IOL, preferably corresponding to an optical axis inherently defined relative to the IOL. In particular, the term "optical axis" is preferably used herein as a reference axis relative to the eye and / or IOL.

[0041] In the context of this document, the "anterior" (or "posterior") side and / or surface of the eye or IOL site preferably includes the side and / or surface located upstream (or downstream) of the site relative to the vector defined by the optical axis. Such a definition naturally extends to the term "anterior" (or "posterior"). For example, in the eye, the iris is located anteriorly relative to the primary IOL; the posterior surface of the iris is the site of the iris closest to the primary IOL.

[0042] Likewise, when a side and / or surface is considered concave (or convex) by observing 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), such a side and / or surface is said to be "forwardly concave" (or "forwardly convex"). When a side and / or surface is considered concave (or convex) by observing the optical surface in the same direction and in the opposite sense as the vector defined by the optical axis, such a side and / or surface is said to be "rearwardly concave" (or "rearwardly convex"). In this document, the term "concave" is generally used to correspond to "rearwardly concave" when the context in which the term "concave" is used makes it clear to the skilled person that this is what is meant.

[0043] The concepts of anterior, posterior, or even optical axis relative to the location 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 such that the anterior surface of the IOL at least partially faces the iris of the eye and such that the posterior surface of the IOL at least partially faces the primary IOL.

[0044] Within the framework of this text, the terms "axial" and "axially" refer to a direction parallel to the optical axis.

[0045] Preferably, the IOL is positioned:

[0046] - "radially" if the IOL extends along a vector perpendicular to the optical axis,

[0047] - extends "radially outwardly" if a vector points from a point common to the optical axis to a point on a circle centered at that common point; and

[0048] - Extending "radially inwards" if the vector points in the opposite direction.

[0049] It is also preferred that the portion of the IOL extends "circumferentially" when the IOL preferably extends along an arc of a circle in a plane perpendicular to the optical axis, the arc of a circle being centered at the intersection of the plane and the optical axis. These concepts of radial extension and circumferential extension refer to a polar coordinate system known in each plane perpendicular to the optical axis.

[0050] As is well known to those skilled in the art, the adjective "distal" refers to a part of the body that is farthest from a reference organ or the body trunk, and the adjective "proximal" refers to a part of the body that is closest to a reference organ or the body trunk. In the framework of this document, these definitions also apply to parts of the eye and / or IOL relative to the distance relative to the reference optical axis. For example, preferably, the proximal part of the IOL according to the present invention may include the central optical part and / or the IOL part surrounding the central part, and the distal part of the IOL according to the present invention may include the backing plate, or at least the distal lateral boundary of the backing plate.

[0051] In particular, the term "distal" in relation to the "distal lateral boundary" of the backing plate preferably refers to a set of points of the backing plate, each point being farthest from the optical axis along a radius perpendicular to the optical axis.

[0052] In this document, the terms "configured to be implanted," "for implantation," and "intended for implantation" are interchangeable. The term "posterior chamber addition IOL" may be replaced by "posterior chamber pseudophakic addition IOL." The term "posterior chamber addition IOL for implantation in a pseudophakic eye" may 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 "additional IOL" and "secondary IOL" are interchangeable. In the disclosure of the present invention and in this specification, the term "IOL" generally refers to an addition IOL according to the present invention. In order to avoid any confusion, disclosure relating to or for a primary IOL will always be expressed using the term "primary" before "IOL."

[0053] In the framework of this document, the use of the indefinite article "a", "an" or the definite article "the" to introduce an element does not exclude the presence of a plurality of these elements. Similarly, the terms "first", "second", "third" and "fourth" are only used to distinguish between elements and do not imply any order of these elements. In the framework of this document, the use of the verbs "comprise", "include" or any other variants and their variations does not in any case exclude the presence of elements other than the aforementioned elements.

[0054] The IOL, particularly the peripheral haptics and the backing plate, are preferably made of a biocompatible, flexible, and high-resistance material. The material is preferably a hydrophilic material. The choice of this material helps to avoid primary IOL opacification.

[0055] The overall thickness of the material varies radially to provide more or less flexibility at various locations of the IOL. In the context of this document, "thickness" is measured parallel to the optical axis. Preferably, the thickness of the peripheral haptics is greater than the thickness of the backing plate.

[0056] In practice, the two haptic structures represent a compromise between the need for stability and compliance of the intraocular structures, on the one hand, and the need for rigidity, on the other, to avoid applying excessive forces and causing trauma to delicate intraocular structures, many of which are complex and not visible during or prior to implantation. The two haptic structures are configured to ensure that the dome, as described above, is not significantly affected by the compression of the IOL exerted on the edge of the IOL by the internal anatomy of the eye. In particular, the dome-shaped component has a "rigid" structure, which results from the average thickness of its material being greater than that of the backing plate material and / or from the flared and / or wide and / or thick shape of the support element. The rigidity and geometric characteristics of the dome-shaped component are suitable for a wide range of ocular anatomy. In contrast, the "flexible" nature of the backing plate is preferably due to a combination of the properties of this material, its slender geometry, and its small average thickness (particularly compared to the thickness of the dome-shaped component).

[0057] More specifically, according to a preferred embodiment of the IOL of the present invention, the thickness of the peripheral haptics decreases radially from the central optic to the pocket. Preferably, the thickness of the peripheral haptics is at least 50% greater than the thickness of the backing plate on average, and more preferably, at least twice as great. This average can be simply considered as a regular discrete or integrated average of the thicknesses in a plane perpendicular to the optical axis.

[0058] For example, the thickness of the peripheral haptic decreases radially from 0.70 mm to 0.30 mm, preferably about 0.50 mm, at its border with the central optic to 0.45 mm to 0.20 mm, preferably about 0.35 mm, at the proximal border of the pocket (but not inside the pocket).

[0059] For its part, the backing plate preferably has a constant thickness along all its extension, for example between approximately 0.10 mm and 0.40 mm, preferably approximately 0.25 mm, which contributes to its greater flexibility as discussed above.

[0060] Preferably, the thickness of the peripheral haptics is specifically oriented so that the IOL resides at a determined distance from the anterior surface of the primary IOL by selectively titrating the curvature of the anterior and / or posterior surface of the IOL so that the posterior surface at least partially mimics the (anterior) curvature of the primary IOL.

[0061] The radii of curvature of the anterior and posterior surfaces of the IOL are also optimized based on the target diopter, which is preferably between -6D and +6D. The central thickness of the central optical portion is generally not constant, preferably between 0.95mm and 0.20mm. Preferably, the central optical surface is generally convex forward and / or generally planar and / or perpendicular to the optical axis. This advantageously provides a vault without the need to compress and, therefore, bend the IOL forward.

[0062] In this document, the term "backing plate" generally refers to at least an elongated flexible backing plate. However, the IOL preferably includes additional backing plates. Preferably, the characteristics provided herein for "backing plate" also apply to the other backing plates.

[0063] Preferably, the IOL according to the present invention comprises two or four distal support elements and two or four elongated flexible pads, preferably at least partially symmetrically arranged, to ensure good stability of the IOL under axial and / or radial compression and when rotated. However, these numbers of support elements and elongated flexible pads do not limit the scope of the present invention. For example, the IOL may comprise only a single elongated flexible pad or a combination of a single elongated flexible pad and any other haptic structure known to those skilled in the art (e.g., an elongated haptic with a free distal end). Preferably, four elongated flexible pads are used that are symmetrically arranged (e.g., symmetrically arranged according to the corners of a rectangle) because this mitigates any possible tilting effect.

[0064] Each elongated flexible pad of the IOL is preferably associated with a specific manipulation pocket as claimed and described above, such that the number of pockets preferably corresponds to the number of elongated flexible pads. However, alternatively, a single pocket may be used to move two or more elongated flexible pads. Such a pocket may, for example, extend over one or more support elements via the proximal portion of the peripheral haptic, such that two or more elongated flexible pads need not be mounted on the same support element. A support element may also include multiple pockets, each located proximal to the end of a different elongated flexible pad. The first end of a pad, serving as the pad portion, may be mounted on the same support element as the second end, on another support element, or on the proximal portion of the peripheral haptic, for example, between two adjacent support elements. More generally, those skilled in the art will appreciate that, within the scope of the present invention, various IOL configurations are contemplated with respect to the number and / or positioning of support elements, elongated flexible pads, and manipulation pockets. Some preferred configurations are described below.

[0065] The "slender" feature of the pad refers to its thin geometry, which contributes to the flexibility of the pad as described above. In particular, the pad preferably has three dimensions, including the length of the pad along the main extension trajectory, the pad thickness, and the width measured orthogonally to these two other dimensions. This "slender" feature can be interpreted as a length that is greater than the (average) thickness and (average) width of the pad, i.e. at least twice as large, preferably at least three times as large, more preferably more than five times as large. This provides the pad with a large ability to deform under axial and / or radial compression of the IOL. As discussed above, this adaptability is advantageously achieved without significant implantation difficulties. In particular, the IOL according to the present invention reaches a very good compromise between obtaining an additional IOL with such adaptability and stability and obtaining an additional IOL that is easy to implant.

[0066] Since (preferably only) two ends of the backing plate are mounted on the peripheral haptic, the backing plate preferably abuts a cavity extending from the front surface to the rear surface. The cavity is typically an open cavity. The cavity is typically completely bounded by the backing plate and the peripheral haptic, preferably by the backing plate and one of the support elements.

[0067] Here, the term "cavity" is used as an equivalent to a space that is devoid of the material forming the IOL. This term is more convenient than "pore" because the cavity is preferably not a hole provided in the material, but rather a feature resulting from the geometry of the backing plate. However, IOL production methods that provide macropores in the material defining the backing plate are not excluded from the scope of the present invention.

[0068] The aforementioned cavity preferably has a maximum radial length that is greater than the maximum diameter of the backing plate's cross-section (considered along the backing plate's main extension trajectory), more preferably at least two times greater, even more preferably two to four times greater, and yet more preferably approximately three times greater. In other words, the radial length of the cavity is greater than both the width and thickness of the backing plate, such that the backing plate's thin, elongated geometry is adapted for dynamic and flexible access to the eye's ciliary body. In particular, the flexible haptic enables the haptic to deform upon (strong) radial compressive forces acting on the IOL, in such a way that the cavity partially collapses upon itself. In other words, in this case, the maximum radial length is preferably divided by 2, 3, or a larger value.

[0069] Optionally, the backing plate may include, for example, a fold of material and / or a lateral indentation at its distal end, which is arranged to facilitate and / or guide bending and / or orientation of the backing plate when axial and / or radial pressure is applied to the IOL. In particular, such a fold of material and / or lateral indentation may function as a failsafe mechanism arranged to prevent excessive forces from being transmitted from the backing plate to the central optic. Such a failsafe mechanism enables control of such forces applied by the backing plate to provide adequate fixation to the ciliary body and prevent erosion of delicate intraocular tissues.

[0070] Optionally, the distal lateral border of the backing plate includes a smooth corrugated portion configured to smoothly hook into the ciliary body of the eye. Advantageously, the corrugated portion facilitates stabilization of the IOL in the ciliary body when the IOL is in its implanted position in the eye. The corrugated portion acts as a pin for the distal lateral border, thereby making it easier to position and stabilize the distal lateral border in the ciliary body. These corrugated portions are preferably polished so that the contours of the corrugated portion do not irritate the ciliary body or other parts of the ocular anatomy.

[0071] 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 on which the second end of the backing plate is mounted to the first portion of the distal lateral boundary. The chamfer extends over the support element and the first portion of the distal lateral boundary, providing a continuous and smooth lateral transition between the peripheral haptic and the backing plate through one end of the backing plate (e.g. the second end). This transition is particularly helpful for implanting the IOL because it preferably enables the backing plate to be smoothly inserted under the iris of the eye by using the manipulation pocket. In particular, the presence of such a chamfer also means that the one end of the backing plate is mounted laterally on one side of the support element in such a way that the distal lateral boundary smoothly continues this side of the support element.

[0072] Preferably, the smooth lateral chamfer also extends laterally adjacent the support element over all or part of the peripheral haptic. Preferably, the entire chamfer extends (substantially) orthogonal to the optical axis, and the aforementioned ring shape along the distal lateral boundary further extends circumferentially over the distal lateral boundary.

[0073] In addition, the entire lateral chamfer has a smooth outer surface, which is more preferably concave (posteriorly). The outer surface is generally oriented forward. Because the outer surface is concave, the outer surface does not include a turning point of curvature, so that the partial annular shape of the distal lateral boundary is turned from the lateral side of the support element to a more central position on the peripheral haptic, for example, converging toward an axis perpendicular to the optical axis, which advantageously makes it easier to handle and implant the IOL without the risk of causing damage to intraocular tissue.

[0074] In the framework of this article, 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 haptic, both diameters being measured perpendicular to the optical axis. The dome-shaped component is then constrained to a cylinder having the second diameter, with the backing plate further radially extending to the first diameter.

[0075] Preferably, the second diameter is between 9.50 mm and 11.10 mm and corresponds to a smaller ciliary body (or more precisely, a smaller available anatomical space) so that the dome-shaped component has a size that is compatible with a wide range of ocular anatomies. In particular, when the IOL is in the implanted position, the dome-shaped component is small enough to avoid itself experiencing some compression.

[0076] As such, in particular when no axial and / or radial compression is applied to the IOL, the first diameter is preferably between 12.50 mm and 14.00 mm, more preferably between 12.70 mm and 13.60 mm. The backing plate extends in particular over a radial length between the difference between the second diameter and the first diameter, which radial length corresponds to the haptic flexibility contribution that can be contracted to fill the gap between the dome-shaped component and the ciliary body. Consequently, an IOL according to the present invention having a planned dome that is stable and has little dependence on axial and / or radial compression of the backing plate is well adapted to a wide range of ocular anatomies.

[0077] To cover all ocular anatomy, multiple IOL sizes with different first and second diameters may be required. Two or three sizes of IOL are sufficient to cover all ocular anatomy, for example, an IOL with a first diameter of one of 12.7 mm, 13.2 mm, and 13.6 mm and a second diameter of one of 8.0 mm, 9.1 mm, and 10.2 mm. Preferably, the latter second diameters are associated with the first diameters in the same order as the first diameters were mentioned.

[0078] According to a preferred embodiment of the present invention, at least one distal support element, preferably each distal support element, is elongated along a circular arc having a central angle between 20° and 80°, preferably between 40° and 70°, and more preferably about 60°. As is well known, the term "central angle" refers to the angle subtended by an arc. Specifically, the central angle is the angle at the center of a triangle, where the vertices of the triangle are the center and the two ends of the arc.

[0079] Advantageously, the support element, which is the foot of the dome-shaped component, is relatively wide and circular, so as to provide a stable and rigid base for supporting the IOL on the ciliary zonules when the IOL is in the implanted position in the eye. The arc of the circle typically has a second diameter. Preferably, at least two pads are symmetrically mounted on each support element by their first and second ends.

[0080] The pocket is now discussed in more detail below. The pocket plays an advantageous role in the present invention as it helps to simplify the implantation of the IOL. As described above, in order to be able to manipulate the backing plate by engaging the tip of a tool into the pocket, the pocket is arranged on a support element, wherein the second end of the backing plate is mounted on the support element, and the pocket is at least partially radially aligned with the backing plate. In other words, preferably, the pocket is arranged adjacent to the backing plate, in particular adjacent to the backing plate end near the proximal end of the backing plate end, and / or the pocket is arranged to be radially aligned between the optical axis and the backing plate.

[0081] As described above, the first end of the backing plate can be mounted at different locations on the peripheral haptic. However, preferably, the first end of the backing plate is mounted on the same support element as the second end. As described above, this allows the backing plate to extend from and to the most distal portion of the peripheral haptic, thereby reducing the backing plate length to facilitate manipulation of the backing plate. In addition, the entire pocket is then close to both backing plate ends on the same support element, which again makes it easier to manipulate the backing plate during the IOL implantation procedure. In this case, the pocket is preferably aligned approximately radially between the first end and the second end, which further improves manipulation of the backing plate by engaging the tip of a tool into the pocket.

[0082] According to an embodiment of the IOL herein, the pocket defines or has the form of a circumferential groove on the front surface of the IOL, the circumferential groove extending parallel to the backing plate and the size of the circumferential groove being designed to accommodate the tip of a tool along the groove. More specifically, the groove is designed and dimensioned in such a way that the IOL can be moved by a tool to insert the IOL under the iris of the eye. Preferably, the groove extends circumferentially along the distal boundary of the support element from near the proximal end of the second end to near the proximal end of the first end. For example, the distance between these ends and the pocket is preferably less than 0.30 mm, more preferably less than 0.20 mm. Due to this proximity between the backing plate end and the pocket, the design of the groove can then be perfectly adjusted to accommodate the tip of the tool and allow the tip to be appropriately moved to position the backing plate.

[0083] Preferably, the groove is designed similarly to the backing plate and / or has similar geometric extension features. Preferably, the groove comprises two radially inward extensions at its two circumferential ends, which are radially mirror-symmetrical to the ends of the backing plate. This design of the pocket is particularly suitable for enabling the backing plate to be inserted under the iris by performing appropriate movement of the tip of the tool (as described below). Figure 10 shown).

[0084] Any other form of groove or bag-like portion is usually arranged on the front surface of IOL as a whole. In particular, the bag-like portion is not intended to be communicated with the rear surface of IOL. In fact, the goal is to avoid reaching the end of the tool via the IOL, which may damage the intraocular tissue.

[0085] According to an embodiment of an IOL pocket that is fully compatible with the aforementioned embodiments, the pocket comprises a lateral edge and a bottom surface as part of the anterior surface. The bottom surface is preferably roughened to increase friction and / or to hook the tip of a tool into the pocket. The edge preferably has a height, measured axially, that is between 25% and 75% of the thickness of the support element, more preferably about 50% (+ / - 5%) of the thickness of the support element, wherein the second end of the pad is mounted on the support element. Such a pocket is particularly easy to manufacture and fully meets the above-mentioned handling purposes. A pocket edge height of 50% (+ / - 5%) of the thickness of the support element is suitable for having a pocket that is deep enough to hook the tip of a tool and a part of the support element axially under the pocket and that is thick enough to ensure its resistance.

[0086] According to a preferred embodiment of the present invention, the distal lateral boundary of the backing plate extends from the second diameter to the first diameter and has a second portion extending along an arc of the first diameter. The second portion then specifically includes the most distal point of the IOL, i.e., the point furthest away in absolute radial value. Preferably, the length of the second portion is not negligible. Preferably, when no axial or radial compression is exerted on the IOL, the second portion has a central angle of between 5° and 25°, more preferably a central angle of approximately 10°, in order to firmly rotationally stabilize the IOL in the ciliary body. Furthermore, this central angle can increase to 45° when the IOL is in its implanted position, i.e., when axial and / or radial compression is exerted on the IOL.

[0087] Preferably, the second portion of the distal lateral boundary is attached to the aforementioned first portion; if the IOL includes a smooth lateral chamfer, the chamfer extends over the first portion. This attachment is achieved so that the distal lateral boundary extends continuously and smoothly along these first and second portions, providing a smooth lateral continuation of the support element on which the second end of the backing plate is mounted. This provides the backing plate with a smooth design that is easy to handle and insert beneath the iris. Preferably, the distal lateral boundary comprises these first and second portions. Preferably, the second portion of the distal lateral boundary is attached to a third portion of the backing plate, thereby connecting the second portion to the first end. This third portion preferably extends in an arcuate manner parallel to the first portion to increase the adaptability of the backing plate. This non-radial, curved extension reduces compressive forces exerted on the IOL when it is in its implanted position. Typically, when such compressive forces occur, the first and third portions flexibly deflect laterally, such that the second portion is significantly closer to the distal boundary of the corresponding support element, or in other words, the corresponding cavity size is reduced. For example, the second portion may be at least two or three times closer to the distal boundary when the compressive force is present than when no compressive force is applied to the IOL.

[0088] According to a preferred embodiment of the invention, the pad extends along a plane whose normal vector forms an angle with the optical axis of between -15° and 15°. This angle applies in particular when the IOL is in its implantation position so that the pad is oriented sufficiently to lay the pad into the ciliary body of the eye and stabilize the IOL. The normal vector is oriented in a manner similar to the optical axis and the sign of the angle is preferably considered in a conventional planar triangle orientation. Preferably, when the IOL is in production, at least before the IOL is implanted, the angle has a value of between +2° and -10°, more preferably of about -7°, which advantageously makes it easier to insert the pad under the iris.

[0089] According to an embodiment of the invention described below, an IOL comprises two diametrically opposed distal support elements and two pairs of diametrically opposed, flexible pads. Preferably, the orientation of the pads is determined by the direction of travel along the pads' primary extension trajectory, wherein the primary extension trajectory is from the second end to the first end. This symmetrical arrangement of the support elements and the elongated flexible pads provides the IOL with excellent stability in the axial, radial, and rotational directions. In particular, the dome is only partially dependent on lateral compressive forces applied by the IOL body. When such lateral compressive forces occur, the design of the IOL absorbs them at least partially, preferably almost completely, within the two pairs of elongated flexible pads, making the dome-shaped assembly very advantageously more stable in the axial direction with little or no axial movement possible.

[0090] Preferably, the IOL herein maintains its shape when rotated 180° about the optical axis. In other words, the paired elongated flexible pads are oriented so that they are imaged by each other as the IOL is rotated 180° about the optical axis. This is advantageous in the case of IOL lenses that include irregular curvatures to correct astigmatism, such as in the case of toric IOLs. Indeed, in such cases, it is often necessary to rotate the IOL preoperatively to position it on the appropriate axis. The design and rotational symmetry of the elongated flexible pads facilitate this rotational manipulation during implantation.

[0091] Preferably, the additional intraocular lens is also preferably shape-invariant under planar reflection in two orthogonal planes, each of which includes the optical axis. This provides the IOL with advantageous mirror symmetry, making it possible to avoid distortion of the IOL during and after implantation.

[0092] Preferably, the elongated flexible pads from two different pairs are spaced apart by a distance between 5% and 25% of the second diameter. Preferably, the elongated flexible pads are also oriented distally to converge toward an axis perpendicular to the optical axis. The distal orientation of each pad is achieved by naturally inducing that orientation at its distal lateral boundary. In other words, the elongated flexible pads are oriented generally inward from the distal corner of the IOL, rather than outward. This makes insertion of the elongated flexible pads beneath the iris easier during implantation, as the movement of each pad is more easily controlled.

[0093] According to another embodiment of the present invention, the central optical portion includes a through hole extending between the anterior and posterior surfaces of the IOL and arranged to allow fluid to flow between these surfaces when the IOL is in its implanted position. This hole prevents the presence of the IOL from creating a second artificial posterior chamber, which would undesirably restrict the flow of natural fluids between the spaces in front of and behind the IOL. This hole ensures complete and permanent fluid communication between the anterior and posterior chambers of the eye. The more curved the IOL, the more preferred this hole is. The hole is preferably located in the center of the central optical portion relative to the intersection of the central optical portion and the optical axis.

[0094] Optionally, the IOL further comprises peripheral optical holes arranged on the peripheral haptic portions, preferably, the peripheral optical holes are located on or adjacent to the proximal boundary between the peripheral haptic portions and the central optical portion. These peripheral optical holes pass through the anterior and posterior surfaces of the IOL, in particular to enable another fluid to flow through the IOL during implantation.

[0095] According to an embodiment of the IOL, the central optical region has at least one orientation mark on the front surface of the IOL. Since the central optical region remains substantially visible, the orientation mark is particularly useful for orienting the IOL during implantation. This is particularly advantageous for correctly orienting an additional toric IOL as described above. The orientation mark can take various forms. Preferably, the orientation mark comprises small surface holes aligned on the front surface of the IOL. These holes do not clearly pass through the IOL. The mark can also take the form of at least one surface line formed by laser, molding, or engraving on the front surface of the IOL.

[0096] Advantageously, the present invention enables the selection of a central optical region lens that is best suited to the patient's desired visual impairment. In particular, according to embodiments of the present invention, the central optical region lens comprises a monofocal lens that provides at least one of the following corrections: myopia correction, hyperopia correction, presbyopia correction, and corneal astigmatism correction. According to specific embodiments of the present invention, the lens comprises a refractive or diffractive lens with an extended depth of focus, preferably for treating presbyopia. The lens is preferably selected according to the prior art.

[0097] As disclosed above, the IOL according to the present invention preferably has a manipulation pocket closely associated with the backing plate. This association is achieved by an advantageous fit between the pocket and the tip of the tool, so that the tool itself contributes to the present invention.

[0098] Specifically, a tool is provided, comprising:

[0099] -handle;

[0100] - a straight rod comprising a first end fixed to the handle;

[0101] - a rounded curved rod extending smoothly from the second end of the straight rod;

[0102] - Tip, the tip is fixed to a round curved rod,

[0103] The tip extends tangentially from the circular curved stem, and

[0104] The tip is sized to cooperate with the pocket by (keying) the tip into the pocket so that movement of the tool can cause movement of the elongate flexible pad.

[0105] The tool facilitates the implantation of an IOL according to the present invention. Specifically, the tool alone is sufficient to perform all necessary steps of the implantation procedure. Furthermore, during the implantation procedure, there is no need to contact the backing plate with the tool tip to position the backing plate. This advantageously prevents the surgeon from making an incorrect manipulation, such as engaging the tip into the cavity enclosed by the backing plate, which could result in contact with delicate intraocular tissue or the primary IOL.

[0106] The design of this tool is particularly suitable for easily implanting an IOL into the posterior chamber of the eye. In particular, the circularly curved rod and the tip are preferably the only parts of the tool that penetrate the eye. The circularly curved rod makes it possible to avoid potential sharp angles between the straight rod and the tip. In particular, the circularly curved rod is sized so that the tip can smoothly reach the bag-shaped portion through the posterior chamber without damaging intraocular tissue and without contacting the IOL, wherein contacting the IOL may push the IOL backward, causing the IOL to deform undesirably and / or contact the primary IOL. Preferably, the circularly curved rod extends generally along a single arc, the radius of curvature of which is more preferably between 10 mm and 30 mm, for example, about 20 mm. However, within the framework of the present invention, the circularly curved rod may include multiple circularly curved portions with different radii of curvature, preferably including two such portions. For the two (connected) circularly curved portions, the first radius of curvature (of the first portion) is preferably between 10 mm and 30 mm, for example, about 20 mm, and the second radius of curvature (of the second portion) is preferably between 5 mm and 10 mm, for example, about 6 mm. Advantageously, the second portion has a steeper downward inclination, which makes it more suitable for reaching the pocket without the IOL coming into contact with another portion of the tool. More generally and more preferably, when the circularly curved rod comprises a plurality of circularly curved portions, the radius of curvature of each of the plurality of circularly curved portions decreases from the straight rod to the tip for similar reasons.

[0107] The tip is typically the only portion of the tool that is designed to fit and engage within the pocket. Preferably, the tip comprises a free end (or distal end) portion having a sharpened end edge configured to hook the tip into the pocket. Preferably, the outer portion is cylindrical. In particular, the design of the tool tip is very simple and the tool is easy to manufacture, even though the tool enables efficient keyed engagement within the pocket.

[0108] For a pocket corresponding to a groove on the anterior surface of the IOL, the groove width is typically precisely dimensioned to accommodate the distal tip, so that the tip engages in the groove and has approximately one degree of freedom of movement along the groove's extension trajectory. In particular, the groove may have a shape similar to that of the backing plate. In particular, the outer portion is typically arranged to engage axially into the pocket on the anterior surface of the IOL and subsequently move into the pocket.

[0109] Preferably, the tip includes a protruding portion fixed to (or connected to) the circularly curved rod. This protruding portion enables the circularly curved rod to extend relatively smoothly and defines a smooth angle between the circularly curved rod and the extension axis of the outer portion of the tip (which extension axis is preferably parallel to the optical axis when the tool is in use). The term "protruding" is used to refer to the form of this portion; more preferably, this portion is at least partially elliptical. Preferably, the cross-section of the protruding portion is larger than the constant cross-section of the terminal portion (e.g., in terms of diameter and / or area), such that only the terminal portion can engage the pocket. In particular, and very advantageously, the protruding portion acts as a barrier to prevent the tool from entering any IOL aperture or cavity. The cross-section of the protruding portion is typically elliptical (e.g., circular). Preferably, the first elliptical cross-section of the protruding portion is at least 25% larger than the second constant circular cross-section of the terminal portion, more preferably at least 50% larger, and even more preferably at least twice as large.

[0110] Preferably, the terminal portion is fixed directly and sharply to the bulge, in such a way that the tip can more easily hook onto the anterior surface of the IOL at the pocket. Alternatively, the terminal portion is smoothly fixed to the bulge by using an intermediate mechanical connection. This mechanical connection typically has a smoothly variable cross-sectional geometry, which can prevent the bulge from undesirably hooking onto the IOL during implantation.

[0111] Preferably, the convex portion includes a curved sub-portion oriented to mimic the anterior curvature of the peripheral haptic when the tip outer portion is extended axially. This sub-portion again provides the tool with an overall form that is more suitable for enabling the distal portion to reach the pocket without contacting the IOL with another portion of the tool.

[0112] Preferably, the straight stem, rounded curved stem and tip of the tool are made of a metal that provides it with resistance, such as stainless steel.

[0113] The present invention also provides a device comprising an IOL according to the present invention and a tool as described above. All embodiments of the IOL and / or tool mentioned above and their mutual advantages can be extended to this device after appropriate modifications. BRIEF DESCRIPTION OF THE DRAWINGS

[0114] Other features and advantages of the present invention will become apparent upon reading the following detailed description, for which reference is made to the accompanying drawings.

[0115] The figures are listed below:

[0116] - Figure 1 Shows an overall three-dimensional front view and side view of an IOL according to a preferred embodiment of the present invention;

[0117] - Figure 2 Shown Figure 1 A planar top view of the IOL is shown;

[0118] - Figure 3 Shown Figure 1 a side shadow view of the illustrated IOL showing the dome caused by the IOL and the relative positioning of the schematic primary IOL;

[0119] - Figure 4 Shown Figure 1 Full lateral three-dimensional view of the IOL shown;

[0120] - Figure 5 Shows the installation Figure 1 a cross-sectional view of a portion of an eye with an IOL shown, wherein the IOL is shown in a side shadowed view;

[0121] - Figure 6 Shown Figure 1 The IOL shown is along Figure 2 A cross-sectional view of plane VI shown;

[0122] - Figure 6a Shown Figure 6 Magnified view of the circled portion;

[0123] - Figure 7 Shown Figure 1 A three-dimensional enlarged view of a cross section of the support element and backing plate of the illustrated IOL;

[0124] - Figure 8 Shown Figure 1 The IOL shown is along Figure 2 A cross-sectional view of plane VIII is shown;

[0125] - Figure 9 and Figure 9A shows an overall plan side view of a tool according to a preferred embodiment of the present invention;

[0126] - Figure 10 Shown in Figure 1 The IOL implantation process shown in Figure 9 or Figure 9A A schematic top view of the tip movement of the tool is shown;

[0127] - Figure 11 Shown Figure 9 or Figure 9A An overall three-dimensional view of a first embodiment of the tip of the tool is shown;

[0128] - Figure 12 Shown Figure 9 or Figure 9AAn overall three-dimensional view of a second embodiment of the tip of the tool is shown;

[0129] - Figure 13 Shown in Figure 1 The IOL implantation process shown is Figure 9 or Figure 9A A simplified cross-sectional view of a portion of a tool shown passing through a portion of an eye, with an IOL shown in a side shadowed view.

[0130] The accompanying drawings are not generally drawn to scale. Similar elements are generally designated by similar reference numerals. Within the framework of this document, identical or similar elements may have the same reference numerals. In addition, the presence of reference numerals in the accompanying drawings (including when these reference numerals are indicated in the claims) is not to be construed as limiting. DETAILED DESCRIPTION

[0131] This section of the present invention provides a complete description of specific and preferred embodiments of the present invention with reference to the accompanying drawings. However, the present invention is not limited to these accompanying drawings. In particular, the drawings introduced above are only illustrative and are by no means restrictive.

[0132] Some figures provide abstract geometric symbols and corresponding reference numerals (e.g., 81 to 89B, X, Y, Z, K, P, k, k', k", 7A, 7B, 71A, 72A, 72B, 73A, α to δ, θ), which are generally used to quantify or visualize technical features of embodiments of the present invention, such as measurements or geometric features. These geometric symbols generally do not correspond to specific physical objects.

[0133] The present invention provides a posterior chamber addition IOL 1 configured to be implanted in a pseudophakic eye 9, i.e., an eye whose 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, is easy to implant, and, in its postoperative implanted position in the eye 9, is axially stable along the optical axis Z, radially stable, and rotationally stable in a plane perpendicular to the optical axis Z and based on vectors (or axes) X and Y. Figure 1 As shown, the axes X, Y and Z particularly form an orthogonal reference of the so-called Euclidean three-dimensional space. As conventionally represented, the optical axis Z is directed from the anterior surface 11 of the IOL 1 to the posterior surface 12 (refer to FIG. Figure 1 and Figure 3 ).

[0134] like Figure 5 As shown, IOL 1 is intended to be positioned in the posterior chamber 96 of a pseudophakic eye 9 . Figure 5Other elements of the anatomy of the eye 9 are also shown: the cornea 91 , the iris 92 , the pupil 93 , the primary IOL 94 , the anterior chamber 95 , the ciliary zonules 97 , the ciliary body 98 of the eye 9 .

[0135] like Figure 1 and Figure 2 As shown, the IOL 1 has a central optic portion 2 extending radially relative to the optical axis Z, with a maximum outer diameter of the central optic portion 2 ranging from 4.5 mm to 7.2 mm, preferably approximately 6.5 mm. The central optic portion 2 may include a through hole 21 extending along the optical axis Z between the anterior surface 11 and the posterior surface 12 (through hole 21 is optional for a less curved IOL as shown), enabling fluid communication between these surfaces. The central optic portion 2 also includes an orientation marker 22 in the form of two diametrically opposed surface lines parallel to the axis Y, which may be formed on the anterior surface 11 of the IOL by laser, molding, or engraving. The marker 22 can be used to orient the IOL 1 during implantation. An exemplary diameter of the through hole 21 is 0.36 mm. An exemplary length of each line of the marker 22, measured along the axis Y, is 0.90 mm.

[0136] The central optic 2 is surrounded by a haptic structure, wherein the peripheral haptic 3 is mounted circumferentially and proximally on the central optic 2. The peripheral haptic 3 extends radially outward and rearward relative to the central optic 2. However, as Figure 2 As shown, the peripheral haptics 3 extend radially further along axis Y than along axis X, such that the IOL has an overall planar form that is elongated along axis Y.

[0137] The peripheral haptic 3 comprises a main proximal portion 34 and two diametrically opposed distal support elements 4. The main proximal portion 34 comprises two peripheral optical holes 33 arranged proximally, along the axis Y, on or adjacent to the boundary with the central optical portion 2, and symmetrically arranged with respect to the optical axis Z. These peripheral optical holes 33 pass through the IOL 1 via the anterior surface 11 and the posterior surface 12, so that these peripheral optical holes 33 enable fluid flow during the implantation of the IOL 1. Figure 2 As shown, the peripheral optical hole 33 is located in a portion of the IOL 1 having a third diameter 83, which is between 5.8 mm and 7.2 mm, preferably about 6.70 mm. Preferably, the peripheral optical hole 33 is very similar in size to the through hole 21.

[0138] The support elements 4 are attached to the two diametrically opposite distal ends of the main proximal portion 34, mirror-symmetrically with respect to a plane based on the axis X and the optical axis Z. The support elements 4 have the form of annular segments extending circumferentially around the optical axis Z, each along an arc of a circle with a central angle β of approximately 60° (at Figure 2 In particular, the distal edge 41 of each support element 4 extends along an arc having a second diameter 82 ranging from 8.0 mm to 10.2 mm, for example, approximately 9.2 mm. The distal edge 41 includes a lateral recess 42 in the form of a partial hole to increase the flexibility of the distal edge 41.

[0139] In particular, the entire peripheral haptic 3 and the central optical part 2 are embedded in a cylinder having a second diameter 82 extending around the optical axis Z, in such a way as to form a dome K (or a dome-shaped assembly) supported at the rear by the support element 4. Figure 3 and Figure 5 As shown, the dome K has a posterior surface intended to be placed over the primary IOL 94 implanted in the capsular bag 99 when the IOL 1 is in its implanted position in the eye 9. The distal support element 4 is then arranged to support the IOL 1 on the ciliary zonules 97 of the eye 9.

[0140] The posterior surface of dome K is concave, smooth, and curved, preferably with a radius of curvature k of about 10 mm to match the curvature of the anterior surface of primary IOL 94, ensuring that the dome 89B between IOL 1 and primary IOL 94 can be adjusted between 300 μm and 750 μm when IOL 1 is in the implanted position, as explained in the disclosure of the present invention and as described in detail below. Figure 5 shown.

[0141] exist Figure 3 The intrinsic height 89A (referred to as the "intrinsic vault") measured axially of the dome K visible on the lens constitutes the height of the intrinsic vault of the IOL 1. The value of the intrinsic height 89A is typically between 0.5 mm and 1.5 mm, preferably between 0.7 mm and 1.3 mm. For example, if the diameter pair consisting 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 is approximately 0.75 mm, 1.00 mm, or 1.25 mm, respectively.

[0142] like Figure 8 As shown, the lateral sides of the peripheral haptic 3, where the support element 4 is not mounted distally, comprise a bevel terminating in a rearwardly and radially directed distal corner 35. The corner 35 may be rounded and polished to avoid any damage to the intraocular tissue.

[0143] As explained in the disclosure of the present invention, a certain wall thickness provides rigidity to the dome K so that the dome K resists axial and / or radial compression when the IOL 1 is in its implanted position. Figure 6 As shown, the dome K may have a thickness 84B near its center, for example, of approximately 0.70 mm, which thickness then decreases radially following the optical portion 2 and the peripheral haptic portion 3 until the support element 4 (not taking into account the pocket introduced below), where it has a thickness 84A typically between 0.45 mm and 0.20 mm.

[0144] These values ​​are selected so that dome K forms a sufficiently rigid and broad structure to surround and anteriorly overlie primary IOL 94, thereby enabling implantation in a wide range of ocular anatomies while remaining stable parallel to optical axis Z.

[0145] like Figure 1 、 Figure 2 and Figure 7 As clearly shown in FIG, the IOL 1 further comprises two diametrically opposed pairs of elongated flexible pads 5 mounted on the distal support element 4, extending radially beyond the peripheral haptics 3 along the axis Y. Each such pad 5 has a first end 51 and a second end 52 mounted on the same support element 4 such that the pad has the form of a partial ring adjacent to the cavity 32 extending from the anterior surface 11 to the posterior surface 12.

[0146] First end 51 is centrally disposed along distal boundary 41, whereas second end 52 is laterally disposed along the distal boundary in continuation of the lateral sides of peripheral haptic 3. In other words, first end 51 is closer to axis Y than second end 52. Figure 2 As shown, the distal boundary 41 extends between the first end 51 and the second end 52 along an arc having a second diameter 82 with a central angle δ of between 15° and 45°, preferably approximately 20° to 25°.

[0147] In terms of area perpendicular to the optical axis Z, each cavity 32 extends further than the corresponding backing plate 5. In particular, Figure 7As shown, the maximum radial length 86 of each cavity 32 is (far) greater than the maximum diameter 87 of any cross-section C of the elongated flexible backing. This radial length 86 is between 0.7 mm and 1.3 mm, preferably about 1.0 mm, and the radial length of the cross-section C is preferably between 0.2 mm and 0.5 mm, preferably about 0.35 mm. Thus, the surface of the IOL 1 that extends radially farther than the second diameter 82 is less filled with solid material than the surface that is filled with solid material. Each backing 5 has a substantially constant thickness 83A (e.g., Figure 3 As shown), the thickness 83A is between 0.10 mm and 0.40 mm, preferably about 0.25 mm. All these data contribute to giving the pad 5 greater flexibility.

[0148] Prior to implantation, when no axial or radial compression is applied to the IOL 1, the IOL 1 is entirely embedded in a cylindrical body having the first diameter 81, preferably a value between 12.7 mm and 13.6 mm. Specifically, each spacer extends between the second diameter 82 and the first diameter 81, so that when the IOL 1 is in its implanted position, the flexibility of the spacer allows compensation for variations in the size of the anatomical space available for the IOL 1 in the posterior chamber 96 of the eye, as explained above in the disclosure of the present invention.

[0149] In particular, the backing plate 5 is designed to fold and / or bend when compression is exerted axially and / or radially on the IOL 1, in such a way that the adjustable angle α between the optical axis Z and the normal vector of the extension plane P of the backing plate 5 is typically between -15° and 15°, as shown in FIG. Figure 6 shown.

[0150] Each backing plate 5 comprises a distal lateral boundary 53 which extends circumferentially and radially outwards relative to the support element 4 on which the backing plate is mounted. Figure 5 As shown, the distal lateral boundary 53 is specifically arranged to stabilize the IOL 1 in the ciliary body 98 when the IOL 1 is in its implanted position. As described in detail in the disclosure of the present invention, the distal lateral boundary 53 serves as an anchor for rotationally stabilizing the IOL 1 in a plane perpendicular to the optical axis Z. Alternatively, the distal lateral boundary 53 may be arranged to stabilize the IOL 1 in the ciliary sulcus of the eye 9, so that the term "ciliary body" herein may optionally be replaced with "ciliary body and / or ciliary sulcus."

[0151] Especially in Figure 1 and Figure 4 As can be seen in FIG, the distal lateral boundary 53 includes a first portion 54 and a second portion 55. Figure 2As shown, the second portion 55 extends along an arc having a first diameter 81, wherein the arc has a central angle γ of between 7.5° and 20°, typically about 10°, when no axial or radial compression is applied to the IOL 1. Thus, the second portion 55 is located at the most distal portion of the distal lateral boundary 53. For its part, the first portion 54 extends from the second end 52 to the second portion 55.

[0152] Advantageously, the first portion 54 has a smooth lateral chamfer 31. The lateral chamfer 31 extends laterally, smoothly, and continuously over the first portion 54, over the support element to which the second end 52 is attached, and over all or a portion of the main proximal portion 34 of the peripheral haptic 3. As described in detail in the present disclosure, this chamfer 31 facilitates insertion of the backing plate 5 beneath the iris 92 during implantation of the IOL 1.

[0153] The backing plate 5 itself generally comprises three parts: a first portion 54 of natural first width extension, a second portion 55 of natural second width extension, and a Figure 1 Visible above is a third portion 56 connecting the natural second width extension and the first end 51. The main extension paths of these shim portions extend circumferentially and radially, substantially only circumferentially and substantially only arcuately, respectively, extending parallel to the first portion.

[0154] The overall design of the elongated flexible pads 5 is determined to facilitate the implantation process of the IOL 1. In particular, the chamfer 31 has a smooth, concave outer surface, which orients each pad 5 distally in a manner converging toward the axis Y. This facilitates insertion of the elongated flexible pads 5 beneath the iris 92. The distal edge 41 of each distal support element 4 further extends along an arc having a second diameter 82 between the first ends 51 of the elongated flexible pads 5 in the two different pairs of elongated flexible pads, wherein the arc has a central angle of approximately 15° to 20°.

[0155] The dual haptic structure based on the distal support element 4 and the elongated flexible backing plate 5 makes the IOL 1 particularly stable in its implanted position and covers a wide range of ocular anatomies in a stable manner. Figure 5 ) can accommodate the dimensional changes in the anatomical space as described above so that the IOL 1 remains stable and well positioned between the iris 92 and the primary IOL 94.

[0156] Considering that the elongated flexible pad 5 is particularly flexible, it is advantageous to provide the IOL 1 with a structure that helps control the movement of the elongated flexible pad 5 during implantation and properly insert the elongated flexible pad 5 under the iris 92. To this end, as can be seen in FIG. Figure 1 、 Figure 2 、 Figure 6a and Figure 7 As seen from above, the support element 4 comprises a steering pocket 6 located on the anterior surface 11 of the IOL.

[0157] Each pocket 6 is associated with the backing plate 5 in terms of structural and functional characteristics. Specifically, structurally, each pocket 6 faces the associated backing plate 5, such that only the distal boundary 41 separates the cavity 32 from the pocket 6. Additionally, the pocket 6 is radially aligned between the first end 51 and the second end 52 of the backing plate 5. The pocket 6 defines a circumferential groove 63 on the anterior surface 11 of the IOL, which extends parallel to the backing plate 5 and includes radially inward extensions 64, which are arranged at the two circumferential ends of the groove 63, mirror-symmetrical to the ends 51 and 52 of the backing plate.

[0158] Groove 63 has a roughened bottom surface 61 and lateral edges 62, with axial height 85 of lateral edges 62 being approximately 50% of the thickness 84A of the corresponding support element 4. In other words, axial height 85 is between 0.07 mm and 0.13 mm, preferably approximately 0.10 mm. Depending on the thickness 84A of the support element 4, height 85 may decrease slightly in the radial direction. The distal-most lateral edge 65, adjacent to distal boundary 41, may be shaped as a semi-cylinder with a radius between 0.00 mm and 0.10 mm (e.g., 0.06 mm).

[0159] These geometric features of the pocket 6 are particularly provided so that functional cooperation with the tip 71 of the manipulation tool 7 can be achieved by geometrically bonding it into the pocket 6, so that during the implantation of the IOL 1, appropriate movement of the slender flexible pad 5 can be caused by the movement of the tool 7.

[0160] Figure 10 This fit is schematically illustrated during the implantation process of the IOL 1. The figure specifically shows the movement (by arrows) of the tool 7 used to insert each pad 5 beneath the iris 92 of the right eye 9. The elongated flexible pads 5 are numbered from 5A to 5D in the order in which they are manipulated through the pocket 6.

[0161] The insertion process for (right distal) pad 5A includes the following actions: pulling toward puncture site (i.e., small incision) P1, pushing downward to insert pad 5A beneath iris 92, and pushing radially outward and forward. The insertion process for (left distal) pad 5B includes the following actions: pushing toward puncture site P2, pushing downward to insert pad 5B beneath iris 92, and pulling radially outward. For (left proximal) pad 5C, the insertion process includes the following actions: pulling toward puncture site P2, pushing downward to insert pad 5C beneath iris 92, and pushing radially outward and forward. Finally, for (left distal) pad 5D, the insertion process includes the following actions: pushing toward puncture site P1, pushing downward to insert pad 5D beneath iris 92, and pulling radially outward.

[0162] Figure 13 Shown during implantation of IOL 1 Figure 5 As can be seen, the tip 71 of the tool 7 is particularly configured to cooperate with the pocket 6 and then enable the above-mentioned insertion of the elongated flexible pads 5A to 5D.

[0163] consider Figure 9 、 Figure 9A 、 Figure 11 、 Figure 12 or Figure 13 , the tool 7 is described in more detail. The tool 7 comprises a handle 70, a straight rod 73 fixed to the handle, a rounded curved rod 72 smoothly fixed to the straight rod 73, and a tip 71 fixed tangentially to the rounded curved rod 72. The tip 71 has a cylindrical free (distal) end portion 74, which is arranged to engage in the pocket 6.

[0164] Non-limiting exemplary dimensional values ​​of the tool 7 are provided such that the axis of rotation about which the free end portion 74 extends cylindrically is substantially parallel to the optical axis Z when the lower surface of the end portion 74 is in surface contact with the bottom surface 61. Under these conditions, as Figure 9 and Figure 9A As shown, the tool 7 having the handle 70 has an axial length 7A of about 15.00 mm, an axial length 7B of the circular curved rod 72 and the tip 71 of about 2.34 mm, an extended length 73A of the straight rod 73 of about 14.30 mm, an extended length 72A of the circular curved rod 72 of about 11.30 mm, and a curvature radius k' of between 15 mm and 30 mm, preferably about 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, or 26 mm. The width of the tool tends to decrease along the extension trajectory of the straight rod 73 and the circular curved rod 72, from about 0.60 mm, to about 0.24 mm near the junction with the tip 71 (this width corresponds to the width described later). Figure 11 and Figure 12These values ​​are chosen so that the tool has the appropriate orientation and position in the eye 9, as shown in FIG. Figure 13 shown.

[0165] like Figure 9 and Figure 9A As described and shown, the circularly curved rod 72 extends along a single arc of a circle having a radius of curvature k'. Figure 9A As shown, the circular curved rod 72 may also include two portions with different radii of curvature. The second portion 72' is more curved than the first portion, which constitutes the majority of the circular 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. Figure 9 Other features of the embodiments are applicable to Figure 9A , for example the entire length of the circular curved rod 72. Approximately 10% to 20% of this length comes from the second portion 72'.

[0166] Different tips 71 may be provided on the tool 7 and, optionally, may be removable. Figure 11 and Figure 12 , two embodiments of the tip 71 are shown. In both embodiments, the end portion 74 has a sharp end edge 75 for easily hooking the tip 71 onto the rough bottom surface 61 of the pocket 6. In particular, the cylindrical shape of the end portion 74 is dimensioned to fit the dimensions of the pocket 6. The cylindrical shape of the end portion 74 has a diameter of approximately 0.25 mm and is oriented at a small angle θ relative to the extension direction of the circular curved rod 72 near the junction of the end portion 74 and the tip 71, the angle θ preferably being between 40° and 85°, for example, approximately 50°, 60°, 70°, or 80°, and more preferably approximately 51°.

[0167] Tip 71 includes a protrusion 76 that connects end portion 74 to rounded curved rod 72. This connection via protrusion 76 can be achieved in different ways according to different embodiments, wherein Figure 11 and Figure 12 . In each of these two embodiments, the first variable elliptical cross section C1 of the protruding portion 76 is larger than the second constant circular cross section C2 of the free end portion 74, which makes it possible to prevent the protruding portion 76 from entering the pocket 6 and also prevent the tip 71 from entering an undesired position, for example, into the peripheral optical aperture 33 or the cavity 32.

[0168] The protrusion 76 is smoothly fixed to the circular curved rod 72, so that the top surface of the circular curved rod 72 and the tip 71 in at least the axial direction is smooth as a whole. Advantageously, this enables smooth insertion and removal of the tool 7 through a small incision (or the puncture portions P1 and P2), thereby making the above-mentioned insertion process and manipulation of the tool 7 easier.

[0169] exist Figure 11 In the embodiment of FIG, the end portion 74 is fixed directly and sharply to the projection 76, thereby improving the hooking of the tip 71 on the anterior surface of the IOL 1 near the pocket 6. Figure 12 In the embodiment of FIG. 7 , the end portion 74 is differently and smoothly secured to the protruding portion 76 by a smooth intermediate mechanical connection 77 .

[0170] Preferably, the axial length 71A of the end portion 74 is from, for example Figure 11 The example of about 0.13 mm varies to, for example Figure 12 In the embodiment of the present invention, the axial length 71B of the entire tip 71 is preferably less than 0.75 mm, more preferably between 0.45 mm and 0.60 mm, for example, about 0.53 mm. In particular, this limited axial length is designed to enable smooth entry through the small incision (or the puncture portions P1 and P2) during insertion.

[0171] In other words, the present invention relates to a posterior chamber addition IOL 1 that is configured to be implanted in a pseudophakic eye 9 and includes: a central optical portion 2; a peripheral haptic portion 3 having a distal support element 4, the distal support element 4 being arranged to support the IOL 1 on the ciliary zonules 97 of the eye 9; slender flexible pads 5 mounted on the support element 4, each slender flexible pad having a distal lateral boundary 53, the distal lateral boundary 53 being arranged to stabilize the IOL 1 in the ciliary body 98 of the eye 9; and steering pockets 6 located on a surface of the support element 4, each pocket 6 being associated with one of the slender flexible pads 5.

[0172] The present invention has been described with reference to specific embodiments. The values ​​in these specific embodiments are purely illustrative and should not be construed as limiting. In general, it will be apparent to those skilled in the art that the present invention is not limited to the examples or measurements described and illustrated above. In particular, all values ​​mentioned in this specification are subject to a 10% error margin. The present invention includes each of the described novel features and all combinations thereof.

Claims

1. A posterior chamber attachment intraocular lens (IOL) (1) for implantation in a pseudophakic eye (9), comprising: - a front surface (11) and a rear surface (12); - a central optical part (2), said central optical part comprising a lens, and The central optical region extends radially relative to an optical axis (Z) directed from the front surface (11) to the back surface (12); - peripheral tactile areas (3), The peripheral haptic portion is circumferentially mounted on the central optical portion (2), The peripheral haptics extend radially outwardly and rearwardly relative to the central optic (2), and The peripheral haptic comprises a distal support element (4) arranged to support the IOL (1) on the ciliary zonules (97) when the IOL (1) is in an implantation position in the eye (9); - at least one elongated flexible pad (5) extending radially beyond the peripheral haptic (3) and comprising a first end (51) mounted on the peripheral haptic (3); It is characterized in that The elongated flexible pad (5) comprises: - a second end (52) mounted on one of the support elements (4); and - distal lateral border (53), The distal lateral boundary extends circumferentially and radially outwardly relative to the central optical region (2), and The distal lateral boundary is arranged to stabilize the IOL (1) in the ciliary body (98) when the IOL (1) is located in the implantation position in the eye (9); Furthermore, one of the support elements (4) includes a manipulation pocket (6) located on the front surface (11), the manipulation pocket being at least partially radially aligned with the elongated flexible pad (5), and the size of the manipulation pocket being designed to cooperate with the tip (71) of a manipulation tool (7) by keying the tip (71) into the pocket (6), so that movement of the tool (7) can cause movement of the elongated flexible pad (5).

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

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

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

5. The IOL (1) according to any one of the preceding claims, wherein Each of the support elements (4) extends along a circular arc, and the central angle (β) of the circular arc is between 20° and 80°.

6. The IOL (1) according to any one of claims 1 to 5, wherein The first end (51) is mounted on the one of the support elements (4).

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

8. The IOL (1) according to any one of claims 6 or 7, wherein The pocket (6) defines a circumferential groove (63) on the anterior surface (11) of the IOL (1), the circumferential groove extending parallel to the elongated flexible pad (5) and sized to accommodate the tip (71) of the tool (7) along the groove (63).

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

10. The IOL (1) according to any one of the preceding claims, wherein: - a first diameter (81), The first diameter comprises the outer diameter of the IOL (1) measured perpendicular to the optical axis (Z), The first diameter is between 12.5 mm and 14.0 mm; - a second diameter (82), The second diameter comprises an outer diameter of the peripheral haptic (3) measured perpendicular to the optical axis (Z), The second diameter is between 8.0 mm and 10.2 mm.

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

12. The IOL (1) according to any one of the preceding claims, wherein The IOL (1) comprises two diametrically opposed support elements (4) and two pairs of diametrically opposed oriented elongated flexible pads (5) such that the IOL (1) remains in shape when rotated 180° around the optical axis (Z).

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

14. The IOL (1) according to any one of the preceding claims, wherein The thickness of the peripheral haptic (3), measured parallel to the optical axis (Z), decreases radially from the central optical region (2) to the pocket (6) and is on average at least 50% greater than the thickness (83A) of the elongated flexible pad (5), also measured parallel to the optical axis (Z).

15. The IOL (1) according to any one of the preceding claims, wherein The elongated flexible pad (5) extends along a plane (P), and the angle (α) formed by the normal vector of the plane and the optical axis (Z) is between -15° and 15°.

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) having a smooth concave posterior surface.

17. A device comprising a posterior chamber addition intraocular lens (1) according to any one of the preceding claims and a manipulation tool (7), the manipulation tool comprising: - a handle (70); - a straight rod (73) comprising a first end fixed to the handle (70); - a circular curved rod (72) extending smoothly from the second end of the straight rod (73); - a tip (71) fixed to the circular curved rod (72), The tip extends tangentially from the circular curved rod (72), and The tip is sized to mate with the pocket (6) by keying the tip (71) into the pocket (6), The movement of the elongated flexible pad (5) is enabled by the movement of the tool (7).

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

19. The device according to claim 18, wherein The tip (71) includes a protruding portion (76) fixed to the circular curved rod (72) and having a first elliptical cross-section (C1) at least 25% larger than a second constant circular cross-section (C2) of the free end portion (74), and The free end portion (74) is fixed directly and sharply to the protruding portion (76), or is fixed smoothly to the protruding portion (76) via an intermediate mechanical connection portion (77).

20. The device according to any one of claims 17 to 19, wherein The circular curved rod (72) includes one or more circular curved portions, and the one or more circular curved portions have different radii of curvature.

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