INTRAOCULAR LENS, INSERTION INSTRUMENT THEREFOR, ASSEMBLY PROVIDED THEREWITH, AND METHOD FOR MANUFACTURE

Abstract

An intraocular lens, instrument for insertion thereof, assembly of lens and instrument, and method for manufacture of such a lens. The lens includes an optical element of a flexible optical material and provided with a substantially circular periphery; and at least one haptic element provided with a haptic form-locking element. The optical element and the at least one haptic element with the haptic form-locking element are mutually connected by connection of the haptic element to the optical material.

Claims

1-25. (canceled)

26. An intraocular lens configured to be inserted into an eye, the lens comprising: an optical element of a flexible optical material and provided with a substantially circular periphery; and at least one haptic element provided with a haptic form-locking element; and wherein the optical element and the at least one haptic element with the haptic form-locking element are mutually connected by connection of the haptic element to the optical material.

27. The intraocular lens of claim 26, wherein the haptic element is provided with an opening or cut configured for placing the intraocular lens on both a front side and a rear side of the iris.

28. The intraocular lens of claim 26, wherein the haptic form-locking element comprises an opening which lies wholly or partially within the periphery of the optical element and can be filled with the flexible material of the optical element.

29. The intraocular lens of claim 26, wherein the haptic form-locking element comprises a hook-like element which is wholly or partially surrounded by the flexible material of the optical element.

30. The intraocular lens of claim 28, wherein the form-locking element lies substantially wholly within the substantially circular periphery of the optical element.

31. The intraocular lens of claim 30, wherein the optical material is hydrophobic, and wherein the haptic material comprises compression moulded polymethylmethacrylate (PMMA).

32. The intraocular lens of claim 26, wherein the peripheral edge of the lens is provided with an edge configuration wherein a first side is provided with a convex form and a second side is provided with a concave form.

33. An insertion instrument for inserting the lens according to claim 26 into an eye, the instrument comprising: a spatula configured to receive a lens; a folding mechanism configured to fold the lens; and a positioning mechanism configured to move the spatula for the purpose of inserting the lens.

34. The insertion instrument of claim 33, wherein the spatula is provided with a clamping element configured to hold the lens in a folded state.

35. The insertion instrument of claim 33, provided with a curved tip.

36. The insertion instrument of claim 35, wherein the tip is provided with a marking for positioning the tip during insertion of the lens.

37. The insertion instrument of claim 34, wherein the positioning mechanism is provided with a rotatable operating element for retracting and/or extending the spatula.

38. The insertion instrument of claim 34, wherein the folding mechanism comprises a folding and fixing clip.

39. The insertion instrument of claim 38, wherein the positioning mechanism comprises a guide which is configured for movement thereover of the folding and fixing clip during insertion of the lens.

40. The insertion instrument of claim 34, wherein the positioning mechanism is provided with a pressing element for retraction and/or extension of the spatula, wherein the positioning mechanism further comprises a spring element.

41. The insertion instrument of claim 34, further comprising a screening functioning as spatula and/or wherein the folding mechanism is provided with a pinch element and further comprising an operating lever for retracting and/or extending the spatula, wherein the operating lever is provided with fixing points.

42. The insertion instrument of claim 36, wherein the insertion element is provided with an intraocular lens to provide an assembly of insertion instrument and intraocular lens.

43. The insertion element of claim 42, further comprising a folding and fixing clip.

44. A method for manufacturing the lens of claim 26.

45. The method of claim 44, for inserting a lens according to any one of the foregoing claims in an eye, the method comprising the steps of: attaching the lens on or to an instrument; placing the insertion instrument with the lens in an arranged incision; and positioning and securing the lens.

Description

[0068] Further advantages, features and details of the invention are elucidated on the basis of preferred embodiments thereof, wherein reference is made to the accompanying drawings, in which:

[0069] FIGS. 1A-F show views of intraocular lenses according to the invention;

[0070] FIGS. 2A-B show views of lenses inserted into the eye;

[0071] FIG. 3 shows a view of a lens;

[0072] FIGS. 4A-B show a view of an insertion instrument provided with twist control;

[0073] FIGS. 5A-B show views of the curved tip element of the instrument of FIGS. 4;

[0074] FIGS. 6A-B show a view of an alternative insertion instrument according to the invention provided with a press control;

[0075] FIGS. 7A-H show a further alternative insertion instrument provided with a clip; and

[0076] FIGS. 8A-B show a view of a further alternative insertion instrument provided with a pinch element.

[0077] Intraocular lens 2 (FIG. 1A) is provided with optics 4 with peripheral edge 6 and haptic elements 8. In the shown embodiment haptic elements 8 are provided with clamp element or hook element 10, an arranged cut 12 for imparting some flexibility to haptics 8, opening 14 and intermediate part 16. Haptic element 8 is further provided with cast-in part 18 and cast-in opening 20, wherein cast-in opening 20 is provided between cast-in part 18 and intermediate part 16. Using cast-in opening 20 in particular, an effective form-locking element is obtained. More than one opening 20 is optionally provided per haptic element 8, for instance two or three. In the shown embodiment lens 2 is preferably manufactured by casting in haptics 8.

[0078] An alternative intraocular lens 22 (FIG. 1B) is provided with optical element 24 with peripheral edge 26. Haptic element 28 is provided with clamp or hook element 30, preferably provided with cut 32, and opening 34 provided between intermediate part 36 and element 30. A number of hook-like element 38 are arranged in optical element 24, wherein space 40 is provided between hook-like element 38 and intermediate part 36.

[0079] A further alternative intraocular lens 42 (FIG. 1C) is provided with optical element 44 with peripheral edge 46. Haptic element 48 is provided with clamp or hook element 50, wherein a cut 52 is preferably provided to increase flexibility. Opening 54 is defined between hook element 50 and intermediate part 56. In this embodiment of lens 42 intermediate part 56 is cast wholly into the material of optical element 44.

[0080] In a further alternative embodiment intraocular lens 62 (FIG. 1D) is provided with optical element 64 with peripheral edge 66. In this embodiment haptic elements 68 are cast in and provided with clamp or hook element 70 provided with cut 72 to enable lens 62 to be secured. Opening 74 is provided between hook element 70 and intermediate part 76.

[0081] Peripheral edge 66 (FIGS. 1E, 1F) of lens 62 is provided on first side 78 with a convex form and provided on second side 80 with a concave form, which converge at the position of transition 82. Light rays or light beams 84 are guided such using peripheral edge 66 of lens 62 that irritating glare is kept outside the focal point of the retina and particularly macula 85 as far as possible. This achieves that only desired images are projected onto the retina. In a shown embodiment (FIG. 1F) peripheral rays 62a are guided by peripheral edge 66 with transition 82 such that rays 84a are scattered, and no undesired focal point is created.

[0082] Lens 2, 22, 42, 62 can be arranged in eye 84 in both pupillary (FIG. 2A) and retropupillary (FIG. 2B) manner. In the case of retropupillary placement d.sub.2 is for instance about 3.33 mm, while d.sub.1 amounts to about 2.21 mm in the case of pupillary placement. The placement of lens 2, 22, 42, 62 in eye 84 is adapted to the case of the person in question.

[0083] It will be apparent that other embodiments and combinations of shown embodiments for lens 2, 22, 42, 62 according to the invention are likewise possible.

[0084] Lens 2, 22, 42, 62 (FIG. 3) can be manufactured in diverse ways. Use can for instance be made here of a mould or mould parts. Optical material can here for instance be poured over haptic element 68. It will be apparent that alternative methods are also possible.

[0085] In a first embodiment insertion instrument 202 (FIGS. 4A-B) is provided with holder 204 in which spatula 206 is arranged for movement in direction A. Movement of spatula 206 is realized using rotating operating element 208 on which grip-enhancing element 210 is arranged in the shown embodiment. Rotation of operating element 208 in rotation direction B results in a translation movement of spatula 206 in direction A.

[0086] Arranged on the front side of tool 202 is tip 212 with outer end 214. For the purpose of inserting lens 2, 22, 42, 62 into an eye the lens will be retracted into holder 204 only once the lens has been placed on the tip of spatula 206. During retraction the lens will be folded on the spatula by narrowed portion 216 of tip 212. This preferably takes place during production so that the lens is already pre-positioned. Unfolding of the lens takes place after exiting from narrowed portion 216, which is preferably placed in or through the incision at that moment.

[0087] In the shown embodiment of tip 212 (FIGS. 5A-B), tip 212 is provided with curve 218. Curve 218 provides for an improved convenience of use for a user. In the shown embodiment marking 220 is arranged in order to indicate positioning of the lens in tip 212 for a user. Tip 212 can be connected to holder 204 of insertion instrument 202 using connecting element 222.

[0088] A lens is pre-placed on spatula 206 during use of insertion instrument 202. Alternatively, the lens has already been pre-placed on spatula 206. After a quantity of viscous material has been applied, a user will retract the lens into holder 204. Rotation of operating part 208 by the user makes it possible to place spatula 206 forward. As soon as the front side thereof protrudes from tip 212, instrument 202 can be placed in or against the incision. By then continuing rotation of operating part 208 in rotation direction B spatula 206 will protrude further through narrowed portion 214 and be moved further into the eye, such that lens 2, 22, 42, 62 will unfold and can then be positioned in the eye.

[0089] An alternative insertion instrument 302 (FIGS. 6A-B) is provided with holder 304 in which film 306 functioning as spatula is arranged. Lens 2, 22, 42, 62 can be provided at or on film 306. Insertion instrument 302 is further provided with operating element 308 which can be pressed in or otherwise moved in direction C for the purpose of moving film 306. Shown schematically is spring element 310 which is operatively connected to operating element 308 and film 306. Lens 2, 22, 42, 62 is moved inward by tensioning of spring element 310. Film 306 is here retracted into tip 314, wherein lens 2, 22, 42, 62 is folded. In the shown embodiment film 306 is provided for protection during insertion of lens 2, 22, 42, 62. A viscous material is preferably applied to the lens by the user for the purpose of retracting lens 2, 22, 42, 62 into tip 314. Movement of pressing element 308 in direction C enables spring element 310 to slacken and film 306 to extend and protrude from tip 314 through opening 318 therein, whereby lens 2, 22, 42, 62 can be inserted into the eye and can there be unfolded into the position of use.

[0090] In the shown embodiment lens 2, 22, 42, 62 is pulled inward when spring element 310 is tensioned, wherein film 306 is in this embodiment folded around lens 2, 22, 42, 62 and the lens is brought into folded state in tip 314. For the purpose of arranging lens 2, 22, 42, 62 in an eye the user will place the front side of insertion instrument 302 with tip 314 into the incision and then move pressing element 308 in direction C in order to pass spatula 306 with lens 2, 22, 42, 62 at least partially through the incision, wherein the lens will unfold and can be positioned in the eye.

[0091] A further alternative insertion instrument 402 (FIGS. 7A-H) is provided with handle 404. Spatula 406 is arranged movably. Lens 2, 22, 42, 62 can be held on the front side of spatula 406. In the shown embodiment insertion instrument 402 can be positioned in packaging or container or blister 408.

[0092] When insertion instrument 402 is removed from packaging 408, the user will move holder 404 upward in direction D. In the shown embodiment instrument 402 is here arranged with fixing points 411 in somewhat clamping manner between clamping elements 410 of packaging 408, such that a rotating movement around rotation axis 412 defined by elements 410 is performed in rotation direction E. Lens 2, 22, 42, 62 can be arranged on or at spatula 406, or at least the tip thereof.

[0093] Owing to the movement in directions D, E, insertion instrument 402 is pressed downward into clip 414 which is provided in packaging 408 in the shown embodiment. Clip 414 is provided with first part 416 and second part 418. Parts 416, 418 are pivotally connected on one side via hinge element 420 and provided on the side with snap element 422 in order to thereby be fixed and be able to hold lens 2, 22, 42, 62 in a folded state. In the shown embodiment spatula 406 is provided with guide 424, wherein in the shown embodiment spatula 406 functions as guide, whereby clip 414 can be slid in direction F relative to spatula 406.

[0094] For the purpose of arranging lens 2, 22, 42, 62 using insertion instrument 402 a quantity of viscous material is preferably first applied to the lens by a user. Holder 404 is then picked up and rotated in direction D, wherein insertion instrument 402 will rotate around rotation axis 412 in rotation direction E. Spatula 406 with lens 2, 22, 42, 62 is hereby pressed into clip 414 (FIG. 7G for closed position and FIG. 7H for open position) which will fold up using hinging element 420 and will snap together using snap connection 422, such that lens 2, 22, 42, 62 is inserted into clip 414 in a folded state. By integrating the folding process with removal of hand instrument 402 from packaging 408 instrument 402 can take a relatively simple form, whereby a better view and more control are also possible for the user during insertion and implantation of the lens. In the shown embodiment this folding up of the clip is realized by arranging a narrowed portion 426 in packaging 408. The instrument which has been removed from packaging 408 is then brought to the incision in eye 84. Base 428 is here preferably placed against the eye for additional support during implantation. Base 428 is for this purpose provided with a shape corresponding substantially with the shape of eye 84 in order to optimize the support and minimize strain on the incision. By then pressing spatula 406 through the incision clip 414 will as it were slide back in direction F via guide 424 over spatula 406. The tip of spatula 406 with lens 2, 22, 42, 62 will protrude through the incision in the eye, where the lens will unfold. Spatula 406 can then be safely removed from the incision.

[0095] Lens 2, 22, 42, 62 can optionally be attached to spatula 406 in two ways. In the case of so-called lens replacement, wherein the natural lens of the eye is intact, lens 2, 22, 42, 62 is preferably pre-positioned on spatula 406 instead of as it were hanging down therefrom. This prevents undesired rotation of lens 2, 22, 42, 62 in the eye.

[0096] In a further alternative embodiment insertion instrument 502 (FIGS. 8A-B) is provided with holder 504 in which spatula 506 is arranged. Pinch elements 508 are movable in direction G owing to flexible connection 510. Folding elements 514 are moved toward or away from each other in direction G using pinch elements 508. Snap elements 516, 518 are provided to fix pinch elements 508 relative to each other.

[0097] When inserting lens 2, 22, 42, 62 arranged on the front side of spatula 506, instrument 502 is removed from the packaging and viscous material is preferably applied to the lens by a user. By squeezing together pinch elements 508 the lens is folded on spatula 506 with folding elements 514 and preferably fixed with snap elements 516, 518. Instrument 502 is then placed in front of the incision in the eye. By pressing operating lever 512 a rotation movement will be performed around pivot points 513 in direction H, whereby spatula 506 moves out of folding elements 514 and protrudes through the incision in the eye, whereby the lens will unfold and can be position. The user can then retract the instrument.

[0098] The present invention is by no means limited to the above described preferred embodiments thereof. The rights sought are defined by the following claims, within the scope of which many modifications can be envisaged. The shown embodiments of the insertion instrument can thus for instance also be applied to more conventional lenses.