TWO-PIECE INTRAOCULAR LENSES WITH SHAPE-CHANGING OPTIC

Abstract

A two-piece intraocular lens (IOL) with an anterior shape-changing optic is provided. The shape-changing interchangeable optic includes an elastic anterior face located anterior to the equator and comprising anterior arms releasably connected to actuating haptics of a base.

Claims

1. A two-piece intraocular lens (IOL) having an optical axis extending in an anterior-posterior direction, an equator extending in a plane substantially perpendicular to the optical axis, an accommodated state, a dis-accommodated state, and states therebetween, the IOL comprising: a base comprising a plurality of actuating haptics, each having a lateral end, a medial end, and an intermediate section extending between the lateral end and the medial end; and an anterior shape-changing exchangeable optic comprising: an elastic anterior face located anterior to the equator and having a periphery; an attachment member located about the periphery or extending from the periphery and releasably connected to the medial end of at least some of the plurality of actuating haptics; a posterior face; an elastic side wall extending from the anterior face to the posterior face; and a chamber located between the anterior face and the posterior face and containing material.

2. The IOL of claim 1, wherein the attachment member comprises: a plurality of anterior arms extending from the periphery of the anterior face and each having a medial end extending from the anterior face and a lateral end releasably connected to the medial end of a respective one of the plurality of actuating haptics, and an intermediate section between the medial end and the lateral end.

3. The IOL of claim 1, wherein the anterior face is more resistant to deformational change than the material.

4. The IOL of claim 1, further comprising at least two opposing stabilizing, non-actuating haptics connected to a respective lateral end of at least two of the plurality of actuating haptics.

5. The IOL of claim 4, further comprising a posterior optic located between the at least two opposing stabilizing, non-actuating haptics.

6. The IOL of claim 5, wherein the posterior optic comprises a spherical, aspheric, toric, toroidal, multifocal, diffractive, extended depth of focus lens, or combinations thereof.

7. The shape-changing optic of claim 5, wherein the posterior optic comprises a fixed power(s) lens.

8. The IOL of claim 2, wherein the medial end of one or more of the plurality of actuating haptics and the lateral end of a respective one or more of the plurality of anterior arms comprises interlocking projections to releasably attach the medial end of the one or more plurality of actuating haptics and the lateral end of the respective one or more of the plurality of arms.

9. The IOL of claim 4, wherein at least one or more of the plurality of actuating haptics, the attachment member, one or more of the stabilizing haptics, or combinations thereof comprises a therapeutic agent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a side view of a two-piece IOL according to an aspect of the present disclosure.

[0015] FIG. 2 is a top view of a two-piece IOL according to an aspect of the present disclosure.

DETAILED DESCRIPTION

[0016] The present disclosure relates to an IOL such as, for example, an accommodative IOL. As used herein with respect to a described element, the terms a, an, and the include at least one or more of the described element(s) including combinations thereof unless otherwise indicated. Further the term a, an, and the can refer to one component performing a described functionality or more than more than component performing the same functionality. Further, the terms or and and refer to and/or and combinations thereof unless otherwise indicated. By substantially is meant that the shape or configuration of the described element need not have the mathematically exact described shape or configuration of the described element but can have a shape or configuration that is recognizable by one skilled in the art as generally or approximately having the described shape or configuration of the described element. As such substantially refers to the complete or nearly complete extent of a characteristic, property, state, or structure. The exact allowable degree of deviation from the characteristic, property, state, or structure will be so as to have the same overall result as if the absolute characteristic, property, state, or structure were obtained. As used herein, the terms anterior, posterior, superior, inferior, lateral, and medial refer to the position of elements when a patient is in a standard anatomical position unless otherwise indicated. The terms left, right, top and bottom refer to the position of elements as they are depicted in the drawings and the terms left and right can be interchanged unless indicated otherwise. The terms first, second, etc. are used to distinguish one element from another and not used in a quantitative sense unless indicated otherwise. Thus, a first element described below could also be termed a second element. A component operably coupled or connected to another component can have intervening components between the components so long as the IOL can perform the stated purpose. By integral or integrated is meant that the described components are fabricated as one piece or multiple pieces affixed during manufacturing or the described components are otherwise not separable using a normal amount of force without damaging the integrity (i.e. tearing) of either of the components. A normal amount of force is the amount of force a user would use to remove a component meant to be separated from another component without damaging either component. As used herein a patient includes a mammal such as a human being. All IOLs as described herein are used for medical purposes and are therefore sterile. Components of IOLs as described herein can be used with IOLs described herein as well as other IOLs. For example, an IOL as described herein can be placed anterior to an existing, previously placed IOL. IOLs include fixed power, multifocal, EDOF, diffractive and other variable focus lenses. Although the drawings show certain elements of an IOL in combination, it should be noted that such elements can be included (or excluded) in other embodiments or aspects illustrated in other drawings or otherwise described in the specification. In other words, each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments of the disclosure including patent applications incorporated by reference herein.

[0017] Unlike shape changing accommodating IOLs described by way of background, IOLs are provided herein that can mimic the gradient elastic properties of a natural youthful human lens during accommodation and include a shape-changing optic where components of the optic change shape as the IOL transitions from an accommodated state to a dis-accommodated state and vice versa. Without wishing to be bound by a specific mechanism of action, it is considered by some that the lens capsules' elasticity controls and shapes the lens as a whole (the lens nucleus and cortex). On this basis, the lens contents are considered pliable. However, the volume of the lens contents compared to the thickness and known modulus of elasticity of the lens capsule predicts that the lens capsule cannot solely control and alter the shape of the lens nucleus and cortex. Finite element analysis (FEA) predicts that radial tension about the equatorial region of a lens capsule filled with a soft pliable solid or liquid does not result in significant shape change to either the anterior or posterior surface of the lens compared to what is known to occur with the natural youthful human lens. It has been shown that application of a radial force anterior or posterior to the equator of a flexible optic results is significantly greater dioptric power change than application of that force about the equator. In other words, providing radial tension directed specifically to at least the anterior face of an accommodating IOL; having that tension directed at points anterior to the equator of the IOL; the anterior face of the IOL being more resistant to deformational change than the content(s) of a chamber underlying the anterior face; the anterior face demonstrating elastic properties in so much as the anterior face deforms when a force is applied to the anterior face and the anterior face will return to its original shape with the removal of the force, results in a greater amount of anterior face shape change and therefore accommodating dioptric power change than can be achieved with a similar force applied at points at or more near the equator of the IOL (e.g. equatorial). In addition, a force applied to the anterior face at points anterior to the equator of the IOL requires less diameter change of the anterior face per diopter of power change of the IOL compared to a similar force applied at points at or more near the equator of the IOL thereby allowing the anterior face of the IOL to shape change even with very small amounts of anterior face diameter change when going from an accommodated state, a dis-accommodated state, and states in between.

[0018] In particular, in an aspect, an IOL comprising a shape changing optic that can assume an accommodated state, a dis-accommodated state, and states therebetween is provided. Components of the shape-changing optic can be deformable such that radially directed ocular compression force(s) or tensile force(s) applied to the optic caused by ciliary muscle contraction or relaxation causes one or more components of the optic to change shape and allows the optic to change dioptric power. None of the described IOLs above apply a radially outward tensile force that is directly transferred to the anterior surface at point(s) anterior to the equator of the optic.

[0019] As such, components of a shape-changing optic can deform or change shape when a force is applied. If a component is less resistant to deformational change than another component, the former component is more likely to, or to a greater degree, deform for a given amount of applied or removed force than the latter component. A component is more resistant to deformational change than another component, if the former component is less likely to, or to a lesser degree, deform for a given amount of applied or removed force than the latter component. It is understood that for any given component resistant to deformational change, the force applied/removed to such component does not exceed the force that results in breakage of the component such that it is no longer useful for its therapeutic purpose.

[0020] With reference to an exemplary IOL, FIG. 1 depicts a central or optical axis CA extending in an anterior-posterior direction and an equator E extending in a plane substantially perpendicular to the central axis. The equator is an imaginary line drawn around the circumference of a lens perpendicular to the optical axis, equally distant from the anterior face of the lens and the posterior face of the lens, dividing the lens into an anterior half and a posterior half. Referring to FIGS. 1-2, an IOL 10 is provided with an optical axis extending in an anterior-posterior direction, an equator extending in a plane substantially perpendicular to the optical axis, an accommodated state, a dis-accommodated state, and states therebetween. IOL 10 can comprise base 12, with or without an optic, and an anterior shape-changing exchangeable optic 14 releasably connected to base 12. By having the anterior optic releasably connected to the base, the anterior optic can be replaced or exchanged for another anterior optic having different optical properties.

[0021] In particular, base 12 can be configured to be placed in the capsular bag of a patient's eye and can comprise a plurality of actuating haptics 16 configured to response to radial forces applied by the ciliary muscle, via the lens zonules, to the lens capsule. Each of the plurality of actuating haptics 16 can have a lateral end 18, a medial end 20, and an intermediate section 22 extending between lateral end 18 and medial end 20. Although FIG. 2 illustrates only four actuating haptics, the base can comprise any suitable number of haptics, such as, for example, eight circumferentially extending haptics. Anterior shape-changing exchangeable optic 14 can comprise an elastic anterior face 24 located anterior to the equator and having a periphery. A plurality of anterior arms 26 (or other attachment member(s) (e.g. a ring) with attachment locations or points for the actuating haptics 16) can extend from the periphery of anterior face. In the case of a plurality of anterior arms, each arm can have a medial end 28 extending from anterior face 24, a lateral end 30 releasably connected to medial end 20 of a respective one of the plurality of actuating haptics 16, and an intermediate section 32 between medial end 28 and lateral end 30. The anterior shape-changing optic can be releasably connected to the base in a number of different ways. For example, the medial end of one or more of the plurality of actuating haptics or ring located about the periphery of the anterior surface of the anterior optic, and the lateral end of a respective one or more of the plurality of arms can comprise interlocking projections as shown in FIG. 1. Anterior shape-changing optic 14 can also have a posterior face 34 and an elastic side wall 36 extending from anterior face 24 to posterior face 34. A chamber 38 can be located between anterior face 24 and posterior face 34 and can contain a material as described in more detail below. The anterior optic can be spherical, aspheric, toric, multifocal, extended depth of focus, or have any other suitable optical properties, or combinations thereof. In certain aspects, the IOL can further comprise at least two opposing stabilizing, non-actuating haptics 40 connected to a respective lateral end 18 of at least two of the plurality of actuating haptics 16. A posterior optic 42 can be located between the at least two opposing stabilizing, non-actuating haptics (e.g. 40a and 40b). The posterior optic can be spherical, aspheric, toric, multifocal, extended depth of focus, or have any other suitable optical properties, or combinations thereof

[0022] Components of the shape-changing optic can be made to be more or less resistant to deformational change by altering the thickness of the component, the type of material from which the component is fabricated, or by altering the chemical/material properties of the component material itself, for example. In certain aspects, the anterior face of the anterior exchangeable optic is more resistant to deformational change than the material in the chamber.

[0023] Regarding specific components of an IOL, the anterior face, as stated above, can have elastic properties. Elastic properties can allow for the anterior face to change shape with an applied force, but also to return to its original configuration when the force is removed. It is beneficial that the anterior face be more resistant to deformational change (e.g. less pliable, firmer) than the contents or material contained within the chamber because when an outward radial force is applied to the anterior face, the contents of the chamber can more easily deform to allow flattening of the anterior face. Exemplary fabrication materials for the anterior face include silicone, an acrylic (hydrophobic or hydrophilic) polymer, polymethylmethalcryalate (PMMA), silastic, collamer, a suitable optical thermoplastic polymer, another suitable optical material, and suitable combinations thereof. The anterior face and/or the posterior face can comprise a lens with a variety of optical properties, such as, for example, a spherical, aspheric, toric, toroidal, multifocal, diffractive, extended depth of focus, or combinations thereof.

[0024] Regarding the side wall, as stated above, the side wall can have elastic properties. In certain aspects, the side wall can be fabricated from a material that is equal to or less resistant to deformational change than the anterior face. Such features can allow for the contents contained within the chamber to expand the area of the side wall to allow the volume of the contents of the chamber to remain the same when the anterior surface is flattened. Having the side wall deform can facilitate and allow for a greater amount of shape change to the anterior face of the shape-changing optic. Exemplary fabrication materials for the side wall include silicone, an acrylic (hydrophobic or hydrophilic) polymer, polymethylmethalcryalate (PMMA), silastic, collamer, a suitable optical thermoplastic polymer, another suitable material, or a suitable combination thereof. The side wall can also be equal to or less resistant to deformational change than the anterior face or the posterior face by being thinner than the anterior face or the posterior face.

[0025] Regarding the chamber, the chamber can be defined by the posterior surface of the anterior face, the anterior surface of the posterior face, and an inner surface of the side wall. The interior contents or material of the chamber can comprise a soft solid, a gel, a viscoelastic material, a flowable fluid, or a gas, or other suitable material. Exemplary materials that can be contained within the interior of the chamber include a soft silicone, or other soft material subject to deformational change, air or other gas, silicone oil (of various refractive indices), an aqueous solution of saline or hyaluronic acid, a viscoelastic polymer, polyphenyl ether, or other optical fluid, solid or gases, or suitable combinations thereof. The chamber can have an internal layer or coating, such as a parylene coating for example, to seal the contents of the chamber from the anterior face, the side wall and/or the posterior face. The chamber can be pre-loaded (e.g. by a manufacturer) with a suitable material. Alternatively, the chamber can be loaded with a suitable material by a clinician.

[0026] Regarding the plurality of actuating haptics of the base, such actuating haptics are the portion of the IOL that are configured to interact with the lens capsule, the lens zonules, the ciliary muscle, or other parts of a patient's eye. The shape-changing optic can change shape in response to an ocular force, specifically a force generated by the contraction or relaxation of the ciliary muscle of the patient's eye. The plurality of actuating haptics, interacting with the lens capsule, can apply radial outward tension to the anterior face of the anterior optic when the ciliary muscle relaxes and radial outward tension is placed on the lens capsule via the lens zonules. The plurality of actuating haptics can be elastic but can be more resistant to deformational change than the anterior face of the optic. An advantage to this is that the actuating haptics can be firmer to provide a linear, radially directed force from the actuating haptics that is directly transferred to the periphery of the anterior face. Without wishing to be bound by any particular mechanism of action, if the actuating haptics were less resistant to deformational change than the anterior face, the radial tension could result in stretching of the actuating haptics and less tension on the periphery of the anterior face. Thus, the anterior face may not shape change as much for a given force applied to the haptics. Exemplary fabrication materials for the actuating haptics include silicone, an acrylic (hydrophobic or hydrophilic) polymer, polymethylmethalcryalate (PMMA), silastic, collamer, a suitable optical thermoplastic polymer, another suitable material, or suitable combinations thereof.

[0027] When implanted and when the ciliary muscles of a patient's eye relax (such as when the eye is in a dis-accommodated state), the ciliary muscles apply tensile force to the plurality of actuating haptics (via the lens capsule with lens zonule attachments between the lens capsule and the ciliary muscles, for example). The plurality of actuating haptics, in turn, can apply tensile force to the periphery of the anterior face of the anterior optic at each site (referred to herein as a connection site) where a respective actuating haptic releasably connects with an anterior arm or other attachment member(s) such as, for example a ring of the anterior face of the anterior optic. The net result can be that the anterior face of the anterior optic can be pulled radially outward substantially perpendicular to the optical axis from several connection sites and functionally result in relatively symmetric radial tension placed on the periphery of the anterior face of the anterior shape-changing optic. The plurality of actuating haptics can engage the inner surface of the lens capsule or the outer surface of the lens capsule.

[0028] Further regarding the actuating haptics, in certain aspects, each of the plurality of actuating haptics can be non-rotatable in response to axial compression along the optical axis on the shape-changing optic. In certain aspects, each of the plurality of actuating haptics has a peripheral portion having a posterior face and an anterior face, with the posterior face being curved. In other aspects, the medial portion of each of the plurality of actuating haptic is releasably connected to each of the respective plurality of anterior arms or peripheral ring, for example, of the anterior face of the anterior optic such that the plurality of actuating haptics changes the shape of the anterior face of the anterior optic via application of radial tension to the periphery of the anterior face in a direction perpendicular to the optical axis. For example, the shape change of the anterior face is not via compressive forces along the optical axis on the shape-changing optic.

[0029] Regarding the stabilizing, non-actuating haptics, the stabilizing haptics can facilitate the proper positioning of the actuating haptics in the periphery of the lens capsule. The stabilizing haptics can also facilitate proper centration of the base and a base optic, if present.

[0030] The posterior optic (in embodiments including a posterior optic) can comprise a fixed power, multifocal, EDOF, diffractive or other variable focus lenses. The posterior lens can have a variety of optical properties, such as, for example, a spherical, aspheric, toric, toroidal, multifocal, diffractive, extended depth of focus, or combinations thereof.

[0031] In certain aspects, the actuating haptics, the non-actuating haptics and/or the arms of the optic can contain a therapeutic agent. Non-limiting examples of therapeutic agents include an intraocular steroid, an antibiotic or combinations thereof, to mitigate post-operative inflammation/infection such that pharmacologic eye drops or periocular injections may not be necessary, a therapeutic agent for improving glaucoma or macular degeneration, or combinations thereof. For example and with respect to chronic conditions such as glaucoma or macular degeneration, the therapeutic agent can be placed in the recessed areas of the haptics (in embodiments having such recessed areas) for long-term of sustained release of the therapeutic agent.

[0032] Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments as well as with respect to other intra-ocular lenses, such as IOLs disclosed in U.S. patent application Ser. No. 16/288,723 filed on Feb. 28, 2019 and incorporated by reference in its entirety and U.S. Provisional Application No. 62/842,788 filed on May 3, 2019 and incorporated by reference in its entirety. In addition, orientations of a shape-changing optic can be modified. For example, when implanted, the lens can be flipped such that the anterior face is facing in a posterior direction and the posterior face is facing in an anterior direction. Further, the IOL can be configured such that it is foldable for insertion. Further, while certain features of embodiments may be shown in only certain figures, such features can be incorporated into or deleted from other embodiments shown in other figures or otherwise disclosed in the specification. Additionally, when describing a range, all points within that range are included in this disclosure.