RU2849698C2 - Intraocular lens with rotation resistance and negative disphotopia attenuation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: intra traocular lens may comprise a rear optical surface and a front optical surface, which may comprise a central optical element, a peripheral optical element, and a capsule rim separating the central optical element and the peripheral optical element. An optical edge may connect the rear optical surface to the peripheral optical element. The capsular rim may be symmetrical or asymmetrical in various embodiments. In more specific embodiments, the capsular rim may form a surface at an angle of at least ninety degrees to the peripheral optical element. In some embodiments, the central optical element may contain an optical axis, and the capsule rim may form a surface that is substantially parallel to the optical axis.

EFFECT: expansion of the arsenal of technical means

16 cl, 13 dwg

Description

CLAIM TO PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63/126,760, entitled "INTRAOCULAR LENS WITH ROTATION RESISTANCE AND NEGATIVE DYSPHOTOPSIA ALLEVIATION," filed December 17, 2020, and assigned to James M. Scott and Kamal K. Das, which is incorporated herein by reference in its entirety as if fully set forth herein.

AREA OF TECHNOLOGY

[0002] The invention set forth in the appended claims relates generally to ophthalmic lenses, including, without limitation, intraocular lenses.

BACKGROUND OF THE INVENTION

The human eye can suffer from a number of conditions, which can cause anything from mild impairment to complete vision loss in some cases. While contact lenses and glasses can compensate for some ailments, others may require eye surgery. In some cases, implants may be helpful or desirable. For example, an intraocular lens can replace a clouded natural lens in the eye to improve vision.

[0004] While the benefits of intraocular lenses and other implants are known, improvements in lenses, delivery systems, components, and processes continue to improve outcomes and benefit patients.

ESSENCE OF THE INVENTION

[0005] New and useful systems, devices, and methods for ophthalmic surgery are set forth in the appended claims. Illustrative embodiments are also provided that enable a person skilled in the art to make and use the claimed subject matter of the invention.

[0006] For example, some embodiments provide an intraocular lens that can benefit from precise capsulorhexis openings created by femtosecond lasers to improve rotational resistance and reduce negative dysphotopsia or visual disturbances. More specifically, some embodiments may provide for connecting the anterior capsule to the intraocular lens using a capsulorhexis opening, which can increase rotational resistance of the lens and isolate the edge of the capsulorhexis opening.

[0007] In a more general sense, an ophthalmic lens may comprise a posterior optical surface and a anterior optical surface, which may comprise a central optical element, a peripheral optical element, and a capsular rim separating the central optical element and the peripheral optical element. The optical edge may connect the posterior optical surface to the peripheral optical element. The capsular rim may be symmetrical or asymmetrical in various embodiments. In more specific embodiments, the capsular rim may form a surface at an angle of at least ninety (90) degrees to the peripheral optical element. In some embodiments, the central optical element may comprise an optical axis, and the capsular rim may form a surface that is substantially parallel to the optical axis.

[0008] The capsular rim may have a thickness that is at least the same size as the thickness of the anterior capsular bag. For example, a suitable thickness may range from approximately 19 micrometers to approximately 20 micrometers. In some embodiments, the thickness of the capsular rim may be up to five (5) times the thickness of the anterior capsular bag.

[0009] Additionally or alternatively, the central optical element or capsular rim may have a radius adapted to provide elastic stretch during capsulorhexis. A radius in the range of from about 2 millimeters to about 3 millimeters may be suitable for some embodiments.

[0010] Additionally or alternatively, some embodiments of the peripheral optical element may comprise a textured surface that may be configured to reduce the transmission or scattering of stray light.

[0011] In some embodiments, the capsular rim may comprise a closed curve having at least one convex arc and at least one concave arc.

[0012] A method for implanting an intraocular lens into the capsular bag of an eye may include creating a capsulorhexis in the anterior portion of the capsular bag; removing a natural lens from the capsular bag; and inserting an intraocular lens into the capsular bag, wherein the intraocular lens comprises an anterior optical surface having a peripheral optical element located within the capsular bag, a capsular rim adjacent to the edge of the capsulorhexis, and a central optical element located in the capsulorhexis and substantially flush with the capsular bag. In some embodiments, the intraocular lens may comprise at least two haptic elements that engage the capsular bag to secure the intraocular lens. Additionally or alternatively, the central optical element may have a width greater than the width of the capsulorhexis to create a stretch in the capsulorhexis. Some embodiments of the peripheral optical element may further comprise a textured surface configured to reduce transmission or scattered light.

[0013] Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced with alternative features. Other features, objectives, advantages, and a preferred method for making and using the claimed subject matter are described in more detail below with reference to the accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0014] The accompanying drawings illustrate certain objects, advantages, and a preferred method of making and using certain embodiments of the claimed subject matter. Like reference numbers represent like parts in the examples.

[0015] Fig. 1 is a top view of an example lens illustrating various features that may be associated with some embodiments.

[0016] Fig. 2 is a side view of the lens shown in Fig. 1.

[0017] Fig. 3 is a detailed view of the lens shown in Fig. 2.

[0018] Fig. 4 is a top view of another example of a lens illustrating various features that may be associated with some embodiments.

[0019] Fig. 5 is a side view of the lens shown in Fig. 4.

[0020] Fig. 6 is an isometric view of the lens shown in Fig. 4.

[0021] Fig. 7 is a top view of another example of a lens illustrating additional or alternative details that may be associated with some embodiments.

[0022] Fig. 8 is a side view of the lens shown in Fig. 7.

[0023] Fig. 9 is a detailed view of a portion of the lens shown in Fig. 8.

[0024] Fig. 10 is a top view of another example of a lens illustrating additional details that may be associated with some embodiments.

[0025] Fig. 11 is a top view of an example of a lens according to Fig. 1.

[0026] Figs. 12A-12B are schematic views illustrating exemplary use of the lens with a detailed view according to Fig. 11.

DESCRIPTION OF APPROXIMATE IMPLEMENTATION OPTIONS

[0027] The following description of exemplary embodiments provides information that enables one skilled in the art to make and use the subject matter of the invention set forth in the appended claims, but may omit certain details already well known in the art. Accordingly, the following detailed description should be considered illustrative and not restrictive.

[0028] Exemplary embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the accompanying drawings. In general, such relationships or orientations imply a frame of reference corresponding to or relative to a patient in a position to receive an implant. However, as will be appreciated by those skilled in the art, these frames of reference are merely descriptive devices and not strict prescriptions.

[0029] Fig. 1 is a top view of an example lens 100 illustrating various features that may be associated with some embodiments. As illustrated in the example of Fig. 1, the lens 100 may comprise a front optical surface 105 that may comprise a central optical element 110, a peripheral optical element 115, and a capsular rim 120 separating the central optical element 110 and the peripheral optical element 115. In some embodiments, the capsular rim 120 may define at least a portion of the central optical element 110. Additionally or alternatively, some embodiments of the capsular rim 120 may be symmetrical, as illustrated in Fig. 1. More particularly, some embodiments of the capsular rim 120 may be circular.

[0030] Fig. 2 is a side view of the lens 100 shown in Fig. 1 illustrating additional features that may be associated with some embodiments. For example, the lens 100 shown in Fig. 2 comprises a posterior optical surface 205 and an optical edge 210 connecting the posterior optical surface 205 to the anterior optical surface 105. More particularly, as illustrated in Fig. 2, the optical edge 210 may connect the posterior optical surface 205 to the peripheral optical element 115 of the anterior optical surface 105. Additionally, Fig. 2 also illustrates a circular example of the capsular rim 120 shown in Fig. 1 having a radius X relative to the optical axis 215. A radius X in the range of from about 2 millimeters to about 3 millimeters may be suitable for some embodiments. Moreover, as illustrated in Fig. 2, the optical axis 215 may be substantially orthogonal to the central optical element 110 in some embodiments.

[0031] The optical edge 210 shown in Fig. 2 is a straight edge. In other examples, the optical edge 210 may be a curved edge or may provide more than one curved edge. For example, the optical edge 210 may comprise a plurality of separate curved surfaces that may be tangentially connected to each other. In some embodiments, each of the curved surfaces may have a different radius of curvature. Additionally, the peripheral optical element 115 may be tangentially connected to the optical edge 210 in some examples.

[0032] The front optical surface 105 and the back optical surface 205 shown in Fig. 2 are both convex. In other embodiments, the front optical surface 105 and the back optical surface 205 may have any suitable combination of concave, convex, or flat surface profiles. The front optical surface 105, the back optical surface 205, or both may provide any suitable spherical, aspherical, refractive, diffractive, or phase-shifting features for focusing and directing light.

[0033] In some examples, the lens 100 may be an intraocular lens, and the anterior optical surface 105 may have a anterior optical diameter in the range of 4.5 millimeters to 7 millimeters. The thickness of the optical edge 210 (measured along the optical axis 215 of the lens 100) may be in the range of 0.15 millimeters to 0.45 millimeters or higher. The posterior optical surface 205 may have a posterior optical diameter in the range of 5.0 millimeters to 8.5 millimeters. The posterior optical diameter may depend on the anterior optical diameter, and in some embodiments, the posterior optical diameter may be greater than the anterior optical diameter.

[0034] The anterior optical diameter and posterior optical diameter may be selected based on the size of the patient's eye or pupil. For example, visual disturbances such as positive and negative dysphotopsia may occur more frequently in patients with larger pupil sizes. A relatively large anterior optical diameter and posterior optical diameter may reduce or eliminate glare and other visual disturbances, allowing the lens to receive and focus more light on the retina.

[0035] Fig. 3 is a detailed view of the lens 100 shown in Fig. 2 illustrating additional features that may be associated with some embodiments. In the example shown in Fig. 3, the capsular rim 120 has a thickness Y from edge to edge. The thickness Y may vary, but a thickness Y in the range of from about 19 micrometers to about 20 micrometers may be suitable for many applications. For example, the thickness Y may be approximately 19.5 micrometers in some embodiments. The capsular rim 120 of suitable dimensions may be manufactured by modifying the front optical surface 105 to add a step-down from the central optical element 110 through turning or by imparting these properties to molded lenses, for example. Additionally, the capsular rim 120 shown in Fig. 3, forms a surface at an angle Z relative to the peripheral optical element 115. An angle Z of at least 90 degrees may be advantageous for some embodiments. Additionally or alternatively, the capsular rim 120 may form a surface that is substantially parallel to the optical axis 215. In other embodiments, the central optical element 110 may be recessed relative to the peripheral optical element 115, and the capsular rim 120 may provide a step-down from the peripheral optical element 115 to the central optical element 110.

[0036] Fig. 4 is a top view of another example of a lens 100 illustrating additional or alternative details that may be associated with some embodiments. As illustrated in the example of Fig. 4, the peripheral optical element 115 may have a textured surface 405 in some embodiments. The textured surface 405 may comprise or consist primarily of a pattern, which in some examples may be transferred from tools or injection molded plates. In some examples, the textured surface 405 may be directly created by machining in the lens 100 and/or created by etching in the lens 100 during known manufacturing processes. Accordingly, the textured surface 405 may range from less than a nanometer to hundreds of microns in depth.

[0037] Fig. 5 is a side view of the lens 100 shown in Fig. 4, and Fig. 6 is an isometric view of the lens 100 shown in Fig. 4, illustrating the textured surface 405 in additional detail.

[0038] Fig. 7 is a top view of another example of a lens 100 illustrating additional or alternative details that may be associated with some embodiments. For example, some embodiments of a capsular rim 120 may have an alternative profile. Some embodiments of a capsular rim 120 may be a closed curve having at least one convex arc and one concave arc. In the example of Fig. 7, the capsular rim 120 has two concave arcs 705 and two convex arcs 710 that are oriented to maintain symmetry in the profile of the capsular rim 120. The convex arcs 710 may be concentric with respect to the optical edge 210 in some examples, as illustrated in Fig. 7. The capsular rim 120 shown in Fig. 7, may additionally or alternatively be characterized by an outer width W1 between two convex arches 710 and an inner width W2 between two concave arches 705. In other examples, the capsular rim 120 may have an asymmetric profile. The width W1 and the width W2 may vary in accordance with anatomical or procedural requirements. For example, a width W1 in the range of about 3 millimeters to about 6.5 millimeters or about 0.5 millimeters less than the optical diameter, and more specifically about 5.5 millimeters for a 6-millimeter optical product may be suitable for many applications. The width W2 is generally smaller than the width W1. A ratio W2/W1 in the range of about 1 to about 0.5 may be suitable for some examples.

[0039] Fig. 8 is a side view of the lens 100 shown in Fig. 7, and Fig. 9 is a detailed view of a portion of the lens 100 shown in Fig. 8, illustrating additional details that may be associated with some embodiments. For example, at least a portion of the capsular rim 120 shown in Fig. 9 is curved. In some embodiments, the capsular rim 120 may comprise a plurality of separate curved surfaces that may be tangentially connected to one another. In some embodiments, each of the curved surfaces may have a different radius of curvature. Additionally, the capsular rim 120 may be tangentially connected to the central optical element 110, the peripheral optical element 115, or both in some examples.

[0040] Fig. 10 is a detailed view of another example of a lens 100 that illustrates additional or alternative details that may be associated with some embodiments. For example, as illustrated in Fig. 10, some embodiments of a lens 100 may further provide a transition zone 1005 for diffusing or redirecting light in a direction away from the capsular rim 120. The transition zone 1005 may be located internally relative to the capsular rim 120. As illustrated in Fig. 10, for example, the transition zone 1005 may be located between the central optical element 110 and the capsular rim 120. In some embodiments, the transition zone 1005 may comprise or consist essentially of a transition rim 1010 and a transition 1015. The transition rim 1010 may be parallel to the capsular rim 120, and the transition 1015 may connect the leading edge 1020 of the capsular rim 120 with the trailing edge 1025 of the transition rim 1010. In some examples, the transition rim 1010 and the transition 1015 may be flat surfaces, as illustrated in Fig. 10; in other examples, the transition rim 1010, the transition 1015, or both may be curved. For example, the transition rim 1010, the transition 1015, or both may be convex, concave, or a combination of convex surfaces, convex surfaces, or both. Additionally or alternatively, the capsular rim 120 may provide a step-down from the peripheral optical element 115 in some embodiments, and one or more of the central optical element 110, the transition rim 1010, and the transition 1015 may be at least partially recessed relative to the peripheral optical element 115.

[0041] Fig. 11 is a top view of another example of a lens 100 illustrating additional details that may be associated with some embodiments. For example, some embodiments may further comprise one or more haptic elements 1105 that may be connected to the optical edge 210.

[0042] Fig. 12A-12B are schematic illustrations that further illustrate an exemplary use of lens 100. As illustrated, incision 1205 may be made in eye 1210 by a surgeon, for example. In some cases, incision 1205 may be made through sclera 1215 of eye 1210. In other cases, incision may be made in cornea 1220 of eye 1210. Capsulorhexis opening 1225 may be made in the anterior portion of capsular bag 1230. For example, a femtosecond laser may be used to create capsulorhexis opening 1225 with very precise dimensions. The radius of the capsulorhexis for an average-sized eye may be approximately 2.25 millimeters. The incision 1205 may be sized to allow the natural lens to be removed from the capsular bag 1230. The tip 1235 may also be at least partially inserted through the incision 1205 to deliver the lens 100 into the capsular bag 1230. For example, in some cases, the size of the incision 1205 may have a length of less than about 3000 microns (3 millimeters). In other cases, the incision 1205 may have a length of from about 1000 microns to about 1500 microns, from about 1500 microns to about 2000 microns, from about 2000 microns to about 2500 microns, or from about 2500 microns to about 3000 microns.

[0043] The tip 1235 may be inserted through the incision 1205 into the interior 1240 of the capsular bag 1230. The lens 100 may then be ejected through the tip 1235 into the capsular bag 1230. In some applications, the lens 100 may be delivered in a folded configuration and may return to its original unfolded state within the capsular bag 1230, as shown in Fig. 12B. The capsular bag 1230 may hold the lens 100 in the eye 1210 in a certain relationship to the eye 1210 such that the lens 100 refracts light directed toward the retina (not shown). In some embodiments, haptic elements, such as haptic elements 1105, may engage the capsular bag 1230 to secure the lens 100 therein.

[0044] After the lens 100 has been released into the capsular bag 1230, the tip 1235 may be withdrawn from the eye 1210 through the incision 1205, and the eye 1210 may be allowed to heal for a period of time.

[0045] Fig. 13 is a detailed view of Fig. 12B illustrating additional details of the lens 100 positioned in the capsular bag 1230. In the example shown in Fig. 13, the capsular rim 120 is configured to isolate the capsulorhexis opening 1225. For example, in Fig. 13, the capsular rim 120 is positioned adjacent to the edge of the capsulorhexis opening 1225, and the central optical element 110 is positioned in the capsulorhexis opening 1225. The precision of the capsulorhexis opening 1225 created by the femtosecond laser may allow the capsular rim 120 to interact with the edges of the capsulorhexis opening 1225.

[0046] As shown in the example of Fig. 13, the central optical element 110 may be positioned to be substantially flush with the outer surface of the capsular bag 1230, which may substantially reduce or eliminate a step change or other non-uniformity between the capsular bag 1230 and the anterior optical surface 105. As illustrated in Fig. 13, the capsular bag 1230 may not overlap any portion of the central optical element 110. In some embodiments, the central optical element 110 may be positioned posteriorly relative to the outer surface of the capsular bag 1230, which may redirect a large amount of off-axis light and further reduce the effects of glare and dysphotopsia. The peripheral optical element 115 may be recessed into the capsular bag 1230. In some embodiments, the peripheral optical element 115 may interact with the inner surface of the capsular bag 1230.

[0047] In some embodiments, the thickness Y (see Fig. 3) of the capsular rim 120 may be substantially equal to the thickness of the edge of the capsulorhexis opening 1225, as illustrated in the example shown in Fig. 13. In other examples, the thickness Y may be up to about five (5) times greater than the thickness of the edge of the capsulorhexis opening 1225, so that the central optic 110 remains substantially flush with the outer surface of the capsular bag 1230, and the capsular rim 120 may extend posteriorly relative to the capsulorhexis opening 1225.

[0048] In some embodiments, the radius X (see Fig. 2) of the capsular rim 120 may be slightly larger than the radius of the capsulorhexis opening 1225 to provide elastic stretch. For example, if the capsulorhexis opening 1225 has a radius of 2.25 millimeters, the capsular rim 120 may have a radius of approximately 2.5 millimeters. In other examples, the capsular rim 120 may not be symmetrical and may provide elastic stretch along one or more selected axes. For example, some embodiments of the capsular rim 120 may provide elastic stretch orthogonally relative to the haptic elements.

[0049] Additionally or alternatively, some embodiments may have a textured surface 405 that may scatter transmitted light from the periphery and edge of the lens 100.

[0050] The systems, devices, and methods described herein can provide significant advantages. For example, the lens 100 can provide greater resistance to rotation than other lenses, including open-loop designs, one-piece designs, which can be particularly advantageous for toric lenses, in which each degree of rotation can cause a significant loss of cylinder power. Some embodiments of the lens 100 provide significant resistance to rotation and can substantially eliminate rotation of the lens until the capsular bag regains integrity. Additionally, features, such as the capsular rim 120, can seal the edges of the capsulorhexis opening, which, unlike other designs, can prevent the anterior capsule from covering the central optic. Such features can substantially reduce or eliminate reflections from the capsule, which can substantially reduce or eliminate the spread of negative dysphotopsia that occurs when light enters the eye at very large visual angles and reaches the edge of the capsulorhexis opening 1225.

[0051] Although shown in several illustrative embodiments, one skilled in the art will understand that the systems, devices, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. For example, various features, such as the capsular rim 120 and the textured surface 405, may be included in a plate or multi-component lenses made of hydrophobic or hydrophilic materials. Moreover, descriptions of various alternatives using words such as "or" do not require mutual exclusion unless the context clearly requires it, and the singular forms do not limit the subject to a single instance unless the context clearly requires it. Components may also be combined or excluded in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the features of the capsular rim 120 and the textured surface 405 may be combined in various ways.

The claims may also encompass additional subject matter not specifically described in detail. For example, certain features, elements, or aspects may be excluded from the claims if there is no need to distinguish novelty and inventive features from what is already known to those skilled in the art. Features, elements, and aspects described in the context of certain embodiments may also be omitted, combined, or replaced with alternative features serving the same, equivalent, or similar purpose, without departing from the scope of the present invention as defined by the appended claims.

Claims (25)

1. An intraocular lens comprising: rear optical surface; a front optical surface comprising a central optical element, a peripheral optical element and a capsular rim separating the central optical element and the peripheral optical element; and an optical edge connecting the rear optical surface with the peripheral optical element, wherein the capsule rim has a first radius, the central optical element has a second radius, and the second radius is less than or equal to the first radius. 2. The intraocular lens of claim 1, wherein the capsular rim is symmetrical. 3. The intraocular lens of claim 1, wherein the capsular rim is asymmetrical. 4. An intraocular lens according to any preceding claim, wherein the capsular rim forms a surface at an angle of at least 90 degrees to the peripheral optical element. 5. An intraocular lens according to any preceding claim, wherein the central optical element comprises an optical axis and the capsular rim defines a surface that is substantially parallel to the optical axis. 6. An intraocular lens according to any preceding claim, wherein the capsular rim has a thickness in the range of 19 micrometers to 20 micrometers. 7. An intraocular lens according to any preceding claim, wherein the capsular rim has a thickness substantially equal to the thickness of the anterior capsular bag. 8. An intraocular lens according to any preceding claim, wherein the capsular rim has a radius in the range of 2 millimeters to 3 millimeters. 9. An intraocular lens according to any preceding claim, wherein the peripheral optical element comprises a textured surface. 10. An intraocular lens according to claim 9, wherein the textured surface is configured to scatter light. 11. An intraocular lens according to any preceding claim, further comprising a transition zone configured to scatter or redirect light. 12. An intraocular lens according to any preceding claim, in which the central optical element is recessed. 13. An intraocular lens according to any preceding claim, wherein the capsular rim is configured to isolate the edge of the capsulorhexis opening. 14. An intraocular lens comprising: rear optical surface; a front optical surface comprising a central optical element, a peripheral optical element and a capsular rim separating the central optical element and the peripheral optical element; and an optical edge connecting the rear optical surface with the peripheral optical element; wherein the capsular rim comprises a closed curve having at least one convex arc and at least one concave arc; wherein said capsule rim has a first width, said central optical element has a second width, and the second width is less than or equal to the first width. 15. The intraocular lens of claim 14, wherein the capsular rim is symmetrical. 16. The intraocular lens of claim 14, wherein the capsular rim is asymmetrical.