Posterior Chamber Phakic Intraocular Lens
20230123616 · 2023-04-20
Assignee
Inventors
Cpc classification
A61F2002/1681
HUMAN NECESSITIES
A61F2/1602
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to a posterior chamber phakic intraocular lens (1) comprising a central optical part (2), a peripheral haptic part (3) having distal support elements (4) arranged for supporting the intraocular lens (1) on a ciliary zonule, elongated flexible footplates (5) mounted on the support elements (4), each having a distal lateral border (53) arranged for stabilizing the intraocular lens (1) into a ciliary body (98), and manipulation pockets (6) on a surface of the support elements (4), each being associated with one of the elongated flexible footplates (5).
Claims
1. Posterior chamber phakic intraocular lens (IOL) comprising: an anterior surface and a posterior surface; a central optical part comprising a lens, and extending radially relative to an optical axis directed from the anterior surface to the posterior surface; a peripheral haptic part circumferentially mounted on the central optical part, extending radially outward and posteriorly relative to the central optical part, and comprising distal support elements arranged for supporting the IOL on a ciliary zonule when the IOL is in an implantation position in an eye; at least one elongated flexible footplate extending radially beyond the peripheral haptic part, and comprising a first extremity mounted on the peripheral haptic part; wherein the elongated flexible footplate comprises: a second extremity mounted on one of the support elements; and a distal lateral border extending circumferentially and radially outward relative to the central optical part, and arranged for stabilizing the IOL into a ciliary body when the IOL is in the implantation position in the eye; and wherein said one of the support elements comprises a manipulation pocket on the anterior surface, at least partially radially aligned with the elongated flexible footplate, and dimensioned for cooperating with a tip of a manipulation tool by a keyed engagement of the tip into the pocket, so that a moving of the elongated flexible footplate can be induced by a moving of the tool.
2. IOL according to claim 1, wherein a smooth lateral chamfer extends smoothly and continuously from said one of the support elements to a first portion of the distal lateral border.
3. IOL according to claim 2, wherein the whole chamfer has a concave smooth external surface.
4. IOL according to claim 1, wherein the elongated flexible footplate borders a cavity extending from the anterior to the posterior surfaces and having a maximal radial length greater than a maximal diameter of a cross section of the elongated flexible footplate.
5. IOL according to claim 1, wherein each of the support elements is elongated along a circular arc with a central angle comprised between 20 and 80°.
6. IOL according to claim 1, wherein the first extremity is mounted on said one of the support elements.
7. IOL according to claim 6, wherein the pocket is substantially radially aligned between the first and second extremities.
8. IOL according to claim 6, wherein the pocket defines a circumferential trench on the IOL anterior surface extending in parallel to the elongated flexible footplate and dimensioned for receiving the tip of the tool along the trench.
9. IOL according to claim 1, wherein the pocket has a bottom surface and lateral edges as part of the anterior surface, the edges being of an height measured in parallel to the optical axis comprised between 25 and 75% of a thickness of said one of the support elements measured in parallel to the optical axis.
10. IOL according to claim 1, wherein: a first diameter, consisting in an IOL external diameter measured perpendicularly to the optical axis, is comprised between 12.5 and 14.0 mm; a second diameter, consisting in a peripheral haptic part external diameter measured perpendicularly to the optical axis, is comprised between 9.5 and 11.5 mm.
11. IOL according to claim 10, wherein the distal lateral border extends from the second to the first diameters and has a second portion extending along an arc of circle of the first diameter with a central angle comprised between 5 and 25°.
12. IOL according to claim 1, wherein the IOL comprises two diametrically opposed support elements and two pairs of diametrically opposed oriented elongated flexible footplates, so that the IOL is shape invariant under rotation of 180° around the optical axis.
13. IOL according to claim 12, wherein closest elongated flexible footplates from two different pairs are spaced by a distance comprised between 5% and 25% of a second diameter, and distally oriented in a convergent way toward an axis perpendicular to the optical axis, said second diameter consisting in a peripheral haptic part external diameter measured perpendicularly to the optical axis.
14. IOL according to claim 1, wherein a thickness of the peripheral haptic part measured in parallel to the optical axis radially decreases from the central optical part to the pocket, and is at least 50% larger on average than a thickness of the elongated flexible footplate also measured in parallel to the optical axis.
15. IOL according to claim 1, wherein the elongated flexible footplate extends along a plane whose normal vector forms an angle comprised between −15° and 15° with the optical axis.
16. IOL according to claim 1, wherein the central optical part and the peripheral haptic part form a dome having a concave smooth posterior surface.
17. Set comprising an IOL according to claim 1 and a manipulation tool, wherein the manipulation tool comprises: an handle; a straight rod comprising a first extremity fixed to the handle; a circularly curved rod smoothly extending from a second extremity of the straight rod; a tip fixed to the circularly curved rod, secantly extending from the circularly curved rod, and dimensioned for cooperating with the pocket by a keyed engagement of the tip into the pocket, so that a moving of the elongated flexible footplate can be induced by a moving of the tool.
18. Set according to claim 17, wherein the tip has a free extremal portion cylindrically shaped with an ending sharp edge for hooking the tip into the pocket.
19. Set according to claim 18, wherein the tip comprises a bulged portion fixed to the circularly curved rod and having a first elliptical section at least 25% larger than a second constant circular section of the free extremal portion, and wherein the free extremal portion is either directly and sharply fixed on the bulged portion or smoothly fixed to the bulged portion by an intermediate mechanical connection.
20. Set according to claim 17, wherein the circularly curved rod comprise one or more of circularly curved parts with different radii of curvature.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0106] Other features and advantages of the present invention will appear on reading the detailed descript that follows, for the understanding of which, it is referred to the attached drawings.
[0107] The list of these drawings is the following:
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[0123] The drawings are typically not scaled. Similar elements are generally assigned by similar references. In the framework of this document, identical or analogous elements may have the same references. Moreover, the presence of reference in the drawings cannot be considered to be limiting, comprising when these references are indicated in the claims.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0124] This part of this document presents a full description of specific and preferred embodiments of the present invention with references to the drawings. The invention is however not limited by these references. The Figures that were introduced above are in particular only schematic and not limiting in any way.
[0125] Some of the Figures are provided with abstract geometric marks and corresponding references (e.g. 81 to 89B, X, Y, Z, K, P, k, k′, 7A, 7B, 71A, 72A, 72B, 73A, α to ε, and θ) substantially used to quantify and/or visualize technical characteristics of embodiments of the invention such as measures or geometric characteristics. These geometric marks generally do not correspond to concrete material objects.
[0126] The invention provides a posterior chamber phakic IOL 1 that is at the same time adapted to a broad range of eye anatomies, easy to implant and postoperatively stable in an implantation position in an eye 9, axially along an optical axis Z, radially and in rotation in a plane perpendicular to the optical axis Z based on vectors (or axis) X and Y. In particular, as illustrated in
[0127] As represented on
[0128] As illustrated in
[0129] The central optical part 2 is surrounded by haptic structures among which a peripheral haptic part 3 circumferentially and proximally mounted on the central optical part 2. The peripheral haptic part 3 extends radially outward and posteriorly relative to the central optical part 2. It extends nevertheless further radially along axis Y than along axis X, so that the IOL has a global planar form elongated along axis Y as illustrated on
[0130] The peripheral haptic part 3 is composed of a main proximal portion 34 and two diametrically opposed distal support elements 4. The main proximal portion 34 comprises two pen-optical holes 33 arranged proximally close to the boundary with central optical part 2, along axis Y, symmetrically with respect to the optical axis Z. The pen-optical holes 33 cross the IOL 1 through the anterior 11 and the posterior 12 surfaces so that they allow a fluid flow during the IOL 1 implantation process. As represented on
[0131] The support elements 4 are attached on two diametrically opposed distal extremities of main proximal portion 34, in mirror symmetry with respect to a plane based on axis X and on the optical axis Z. They have the form of a ring portion extending circumferentially around the optical axis Z, each along an arc of circle with a central angle β of about 60° (visible on
[0132] In particular, the whole peripheral haptic part 3 and the central optical part 2 are inscribed in a cylinder of the second diameter 82 extending around the optical axis Z, in such a way to form a dome K (or dome assembly) that is supported posteriorly by the support elements 4. As shown on
[0133] The dome K posterior surface is concave, smooth, and curved with a preferred radius k of curvature of about 10 mm compatible with the curvature of the crystalline lens 94 anterior surface, so that a vault 89B adjustable between 300 and 750 μm can be ensured between the IOL 1 and the crystalline lens 94 when the IOL 1 is in its implantation position as explained in the disclosure of the invention and shown on
[0134] A inherent height 89A of the dome K visible on
[0135] As shown on
[0136] As explained in the disclosure of the present invention, a certain wall thickness confers rigidity to the dome K so that it is resistant under axial and/or radial compression when the IOL 1 is in its implantation position. In particular, as represented on
[0137] These values are selected so that the dome K is able to constitute a sufficiently rigid and broad structure to surround and top anteriorly a crystalline lens 94, and thereby to be implanted in a broad range of eye anatomies, while being stable in parallel to the optical axis Z.
[0138] As illustrated clearly in
[0139] The first extremity 51 is arranged centrally along the distal border 41, while the second extremity 52 is arranged laterally along the distal border, in the continuation of a lateral side of the peripheral haptic part 3. In other words, the first extremity 51 is closer to axis Y than the second extremity 52. As shown on
[0140] Each cavity 32 is more extended in terms of area perpendicularly to the optical axis Z than the corresponding footplate 5. In particular, as shown on
[0141] The IOL 1 is globally inscribed in a cylinder of said first diameter 81 with a preferred value comprised between 12.7 and 13.6 mm prior to implantation, when no axial or radial compression is exerted on the IOL 1. In particular, each footplate extends between the second 82 and the first 81 diameters, so that its flexibility allows to compensate size variations of an anatomical space available in the eye posterior chamber 96 for the IOL 1 when the latter is in its implantation position as explained above in the disclosure of the invention.
[0142] The footplate 5 is in particular designed for folding and/or for curving when compression is exerted axially and/or radially on IOL 1, in such a way that an adjustable angle α between the optical axis Z and a normal vector to a plane P of extension of the footplate 5 is generally comprised between −15° and 15°, as illustrated in
[0143] Each footplate 5 comprises a distal lateral border 53 extending both circumferentially and radially outward relative to the support element 4 on which it is mounted. This distal lateral border 53 is in particular arranged for stabilizing the IOL 1 into the ciliary body 98 when the IOL 1 is in its implantation position as illustrated on
[0144] The distal lateral border 53 is composed of a first 54 and a second 55 portions particularly visible on
[0145] The first portion 54 is advantageously endowed with a smooth lateral chamfer 31. The latter extends laterally, smoothly and continuously on the first portion 54, on the support element at which is attached the second extremity 52 and on all or part of the main proximal portion 34 of the peripheral haptic part 3. As detailed in the disclosure of the invention, this chamfer 31 contributes to help to insert the footplate 5 under an iris 92 during the implantation of the IOL 1.
[0146] The footplate 5 itself consists substantially in three portions: a natural first width extension of the first portion 54, a natural second width extension of the second portion 55, and a third portion 56 visible on
[0147] The global design of the elongated flexible footplates 5 is determined to facilitate the IOL 1 implantation process. In particular, the chamfer 31 has a concave smooth external surface so that each footplate 5 is distally oriented in a convergent way toward the axis Y. Movements to insert the elongated flexible footplates 5 under the iris 92 are then greatly easier. The distal border 41 of each distal support element 4 extends further between the first extremities 51 of elongated flexible footplates 5 of two different pairs along a circular arc of the second diameter 82 with a central angle of about 15 to 20°.
[0148] The double haptic structure from the distal support elements 4 and the elongated flexible footplates 5 allows the IOL 1 to be particularly stable in its implantation position. A curve 103 in
[0149] In comparison to curve 103, a similar curve 104 is drawn on
[0150] Given that the elongated flexible footplates 5 are particularly flexible, it is advantageous to provide the IOL 1 with a structure for helping to control the elongated flexible footplates 5 movements during the implantation process and to insert them appropriately under the iris 92. To this end, the support elements 4 comprises manipulation pockets 6 on the IOL anterior surface 11 as it can be seen on
[0151] Each pocket 6 is associated with a footplate 5 in terms of structural and functional features. In particular, structurally speaking, each pocket 6 faces the associated footplate 5, so that only the distal border 41 separates the cavity 32 from the pocket 6. The pocket 6 is additionally radially aligned between the first 51 and second 52 extremities of the footplate 5. It defines a circumferential trench 63 on the IOL anterior surface 11 extending in parallel to the footplate 5 and comprising radially inwards extensions 64 arranged at two circumferential extremities of the trench 63, in mirror symmetries with the footplate extremities 51 and 52.
[0152] The trench 63 has a rough bottom surface 61 and lateral edges 62 of an axial height 85 of about 50% of the thickness 84A of the corresponding support elements 4. In other words, the axial height 85 is comprised between 0.075 and 0.125 mm, preferably between 0.08 and 0.09 mm. The height 85 may decrease slightly radially, depending on the support element 4 thickness 84A. The most distal lateral edge 65, at the boundary with the distal border 41, may be shaped in a half cylindrical form with radius 0.06 mm.
[0153] These geometrical features of the pockets 6 are especially provided in order to allow a functional cooperation with a tip 71 of a manipulation tool 7 by a geometrical keyed engagement of the tip 71 into the pocket 6, so that an appropriate moving of the elongated flexible footplate 5 during the implantation process of the IOL 1 can be induced by a moving of the tool 7.
[0154] Such cooperation during the IOL 1 implantation process is illustrated schematically on
[0155] The insertion process of the (right distal) footplate 5A comprises the following movements: pull towards a paracentesis (i.e. a small incision) P1, push down to insert the footplate 5A under the iris 92, push forward radially outwards. The insertion process of the (left distal) footplate 5B comprises the following movements: push towards a paracentesis P2, push down to insert the footplate 5B under the iris 92, pull radially outwards. For the (left proximal) footplate 5C, the insertion process comprises as movements: pull towards the paracentesis P2, push down to insert the footplate 5C under the iris 92, push forward radially outwards. Finally, concerning the (left distal) footplate 5D, the insertion process comprises the following movements: push towards the paracentesis P1, push down to insert the footplate 5D under the iris 92, pull radially outwards.
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[0157] The tool 7 is described in more details in view of
[0158] It is provided non limitative exemplary dimensional values for the tool 7 when an inferior surface of the extremal portion 74 is in surface contact with the bottom surface 61, so that a revolution axis around which the free extremal portion 74 extends cylindrically is substantially parallel to the optical axis Z. In these conditions, as illustrated in
[0159] As described and shown on
[0160] Different tip 71 may be provided on the tool 7, and may optionally be removable. Two embodiments of the tip 71 are illustrated on
[0161] The tip 71 comprises a bulged portion 76 connecting the extremal portion 74 with the circularly curved rod 72. This connection through the bulged portion 76 may be made in different ways according to different embodiments among which two embodiments are illustrated in
[0162] The bulged portion 76 is fixed smoothly to the circularly curved rod 72 so that at least an axially top surface of the circularly curved rod 72 and the tip 71 is globally smooth. This allows advantageously to insert and to remove smoothly the tool 7 through small incisions (or said paracentesis P1 and P2), making then the above described insertion process and the tool 7 maneuverings easier.
[0163] On the embodiment of
[0164] The axial length 71A of the extremal portion 74 varies preferably from about 0.13 mm, e.g. for the embodiment of
[0165] In other words, this invention relates to a posterior chamber phakic IOL 1 comprising a central optical part 2, a peripheral haptic part 3 having distal support elements 4 arranged for supporting the IOL 1 on a ciliary zonule 97 of an eye 9, elongated flexible footplates 5 mounted on the support elements 4, each having a distal lateral border 53 arranged for stabilizing the IOL 1 into a ciliary body 98 of the eye 9, and manipulation pockets 6 on a surface of the support elements 4, each pocket 6 being associated with one of the elongated flexible footplates 5.
[0166] The invention was described in relation to the specific embodiments which have a value that is purely illustrative and should not be considered to be limiting. Generally speaking, it will seem obvious for the person skilled in the art that the invention is not limited to the examples or measured values illustrated or described above. In particular, all the values mentioned in this description are provided with an error margin of 10%. The invention comprises each of the new characteristics described, as well as all their combinations.