Hybrid Accommodating Intraocular Lens and Method of Use

Abstract

An intraocular lens having an air-filled collapsible cavity located between two optical elements, wherein air is transferred from the optical region of the collapsible cavity to its peripheral haptic region after being compressed by an external force.

Description

[0001] Citation of Related Applications

[0002] The present invention relates to the expandable lens / lens holder disclosed in the following international application publications of the applicant: International application publication number WO 2009 / 021327 entitled INFLATABLE INTRA-OCULAR LENS / LENS RETAINER published on February 19, 2009 and International application publication number WO 2014 / 021391 entitled EXPANDABLE SUSPENSION SYSTEMSFOR INTRA-OCULAR LENSES published on August 14, 2014 and International application publication number WO 2009 / 021326 entitled PNEUMATIC INTRA-OCULAR LENS published on February 19, 2009. Technical Field

[0003] The present invention relates to intraocular lenses that change curvature in response to tension exerted by the ciliary muscle / zonules / lens capsule complex on the natural lens space within the eye. Background Art

[0004] Intraocular lenses have emerged that have the ability to reawaken the natural dynamics of the ciliary muscle / zonules / lens capsule complex after lens removal, allowing presbyopes to regain their ability to change focus from distance to near. In this competitive field, the ability to insert these new lens types through a small corneal incision in the eye has received much attention.

[0005] Currently, liquid-filled intraocular lenses (such as those manufactured by Power Vision Corporation called FluidLens TM Research devices such as those that have been used in the past (such as those described in the literature) exhibit a variety of limitations. During daily activities as the eye changes focus from near to far, the fluid trapped inside these lens types is compressed and transferred to various areas of the device. This repetitive action makes the sealed edges that hold the device together susceptible to breakdown over time. This tendency is exacerbated by the tendency of the fluid to corrode and weaken the adhesive bond that holds the sealed edges of the device together. Further, liquid-filled intraocular lenses tend to be cumbersome and difficult to insert, making them particularly vulnerable to damage during the insertion process, which requires the fluid to be compressed and shunted through a narrow tube and then released into the natural lens space within the eye.

[0006] An air-filled intraocular lens is thinner than a liquid-filled intraocular lens and is thus generally easier to insert. It has no liquid to disrupt the integrity of the adhesive bonds holding its structural components together; however, it is inherently plagued by internal reflections and glare. In addition to this annoyance, even small changes in atmospheric pressure can potentially alter its refractive properties. Given the limitations faced by current accommodative intraocular lens design options, improvements are needed.

[0007] The foregoing examples of the related art are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of ordinary skill in the art upon reading the specification and studying the drawings. SUMMARY OF THE INVENTION

[0008] Systems, tools, and methods are described and illustrated in connection with embodiments and aspects thereof that are intended to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above problems have been reduced or eliminated, while other embodiments relate to other improvements.

[0009] According to one embodiment, a hybrid intraocular lens is provided that includes both a solid optical element and a fluid-filled optical element (such as an air-filled optical element) and that transitions from the solid optical element to a partially fluid- or air-filled optical element during accommodation. According to one embodiment, a partially air-filled intraocular lens includes a hollow air-filled lens compartment surrounded on one side by a relatively non-deformable optical element that meets a relatively deformable second optical element at its raised apex. The shape profile of the surface of the deformable optical element that contacts the apex of the non-deformable optical element can have various configurations: flat, convex, concave, multifocal, or aspheric, provided that: when the device is in its normal resting state, the air space is between the remaining portions of the optical elements. The haptics of the two optical elements converge to connect with each other and bond together around their perimeters, thereby defining the size and shape of the hollow air-filled compartment. Like the two optical elements, the air-filled compartment thus includes an optical zone and a haptic zone.

[0010] When the peripheral regions of the optical zones of two optical elements are pressed together by an external force in the reverse direction, the deformable optical element bends to conform to the shape of the non-deformable optical element. During this process, the air that normally occupies the space between the two optical zones is displaced outward toward the air space between the haptics. When sufficient reverse force is delivered to the optical zones of the two optical elements, the inner surfaces of the optical zones align and join, and are then able to separate without sticking. At this point, two aspects of the present invention are achieved. First, the optical zones of the lens pair no longer have an air interface that produces internal reflections and glare. Second, the eye can remain focused on a distant object without being affected by changes in atmospheric pressure. This process can be achieved by one or two optical elements having deformable properties.

[0011] Radial slots may be provided in the lower surface of the deformable optical element around the periphery of the optical zone of the deformable optical element, connected to a circumferential channel in the deformable optical element to allow air to freely circulate between the optical zone and the haptic region of the air-filled compartment. This network of channels and radial slots is an optional feature of the design, which also provides a means for controlling the material deformation that may occur when the spherical housing is forced to change its shape. The width of the radial slots can be selected to vary the flow of air as needed.

[0012] More specifically, according to one embodiment, there is provided a partially air-filled intraocular lens comprising: a first non-deformable optical element that is sealed around its periphery to a second deformable optical element to form a sealed air-filled collapsible cavity, the first non-deformable optical element and the second deformable optical element each having a central optical zone and a first haptic zone and a second haptic zone, the first haptic zone and the second haptic zone being associated with a respective one of the first non-deformable optical element and the second deformable optical element and each being sealingly connected to the other to form the sealed periphery. The first optical element has a convex shape on its inner surface, and the apex of the convex inner surface bears against the central zone of the deformable optical element, leaving an air space in the remaining region between the optical zones of the first optical element and the second optical element.

[0013] According to another aspect, the sealed air-filled collapsible cavity may include: an optical region located between the optical regions of the first and second optical elements; and a haptic region located between the optical region and the sealed perimeter of the haptic region, wherein the air-filled collapsible cavity has at least one opening that communicates between the optical region and the haptic region. Thus, when an external force generated by ciliary muscle tension is directed towards the perimeter of the optical region of the optical element, the optical region of the air-filled cavity is compressed, thereby discharging the air therein towards the haptic region of the air-filled cavity through the communication channel, and the optical surfaces of the first and second optical elements are thereby compressed against each other, so as to focus the eye on a distant object. And thus, when the ciliary muscle tension decreases, the elasticity of the deformable optical element causes the compression to decrease. According to another aspect, the at least one opening that communicates between the optical region and the haptic region may include a circular channel that interconnects a plurality of radial channels.

[0014] According to another aspect, a method of providing an accommodative intraocular lens for replacement in the lens capsule of an eye is provided by providing a lens having the foregoing characteristics in combination with an intraocular structure for transmitting ciliary muscle tension to the lens.

[0015] With the optical configuration of the present invention, the only time this lens design is subject to internal reflection and glare is when air re-enters the space between the two optical elements. When the internal optical surfaces of the two optical elements are configured to have a relatively short radius of curvature, this glare potential can be reduced. By orienting the optical elements within the eye such that the non-deformable optical element is positioned in front of the deformable optical element, this glare potential can be further reduced.

[0016] In addition to the exemplary aspects and embodiments described above, other aspects and embodiments will become apparent by reference to the drawings and study of the following detailed description. Although air is described as the gas contained in the compartments of the hybrid lens, it may be replaced with other transparent gases or liquids (collectively referred to as fluids), thereby causing a change in the refractive index. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Exemplary embodiments are shown in the reference figures of the drawings. The embodiments and drawings disclosed herein are intended to be illustrative rather than restrictive.

[0018] Figure 1 is a plan view of an air-filled intraocular lens according to one embodiment.

[0019] Figure 2 is along Figure 1A detailed cross-sectional view taken along line A-A, which shows the intraocular lens in its static or low-energy configuration for focusing the eye on a near object.

[0020] Figure 3 is a detailed cross-sectional view taken along Figure 1 line A-A, which shows the intraocular lens in its compressed or high-energy configuration for focusing the eye on a distant object.

[0021] Figure 4 is a detailed cross-sectional view taken along Figure 1 line B-B, which shows the intraocular lens in its static or low-energy configuration for focusing the eye on a near object.

[0022] Figure 5 is a detailed cross-sectional view taken along Figure 1 line B-B, which shows the intraocular lens in its compressed or high-energy configuration for focusing the eye on a distant object.

[0023] Figure 6 is Figure 1 a top left perspective view of the air-filled intraocular lens shown.

[0024] Figure 7 is Figure 1 a bottom left perspective view of the air-filled intraocular lens shown. Detailed Description

[0025] Throughout the following description, specific details are set forth in order to provide a more thorough understanding to those skilled in the art. However, well-known elements may not be shown or described in detail so as not to unnecessarily obscure the present disclosure. Accordingly, the description and drawings are to be regarded in an illustrative rather than a restrictive sense. In this description and the claims, when the term "liquid" is used, it includes air and other gases as well as liquids.

[0026] Figure 1 A plan view showing the air-filled intraocular lens 10. The intraocular lens 10 can be formed by a deformable optical element 30 having a central circular transparent optical zone and a non-deformable optical element 32 having a central circular transparent optical zone. The intraocular lens 10 can be formed substantially or entirely of a transparent material. The deformable optical element 30 of the intraocular lens 10 circumscribes a circular groove or channel 12 on its lower surface 33. The circular groove or channel 12 is connected to a network of radial slots 14 formed in the lower surface 33 of the optical element 30. The perimeter of the intraocular lens 10 circumscribes a seal 16 that seals the outer edges of the haptics 20 and 22. The haptics 20, 22 of the deformable optical element 30 and the non-deformable optical element 32 of the intraocular lens 10 extend respectively between the seal 16 and the channel 12.

[0027] Figure 2 A cross-sectional view is shown of an air-filled intraocular lens 10 taken along line A-A Figure 1 in its accommodated or resting state in which the eye is focused on a near object. In this state, the deformable optical element 30 and the non-deformable optical element 32 contact only at the apex 40 of the non-deformable optical element 32. Similarly, this is shown in Figure 4 , Figure 4 which is a cross-sectional view of the air-filled intraocular lens 10 taken along line B-B Figure 1 in its accommodated or resting state.

[0028] Figure 3 A cross-sectional view is shown of an air-filled intraocular lens 10 taken along line A-A Figure 1 wherein the ciliary muscle applies a force vector X on the intraocular lens 10 (as described in the cited International Application Publication No. WO 2009 / 021327 entitled "INFLATABLE INTRA-OCULAR LENS / LENS RETAINER") to adjust the lens to focus on a distant object or a near object.

[0029] In operation, Figure 2 the accommodated configuration shown represents the normal low energy state of the intraocular lens 10. The presence of air within the optical zone of the annular air-filled compartment 18 serves as an "air lens". When the deformable optical element 30 bends in response to an external force as shown by the force vector X in Figure 3 to conform to the shape of the upper surface 35 of the non-deformable optical element 32, the inner surface 33 of the deformable optical element 30 becomes more concave while, at the same time, the outer surface 31 becomes more convex. These corresponding curvature changes nullify each other's refractive effects. However, while the shape of the deformable optical element 30 changes, the air lens 18 sandwiched between the optical elements 30, 32 correspondingly becomes more concave, and the shape of the liquid-water interface juxtaposed with the outer surface 31 of the deformable optical element 30 also becomes more convex. The refractive index difference across the air lens / optical element interface is more than two and a half times greater than the refractive index difference across the water / optical element interface. Thus, as the convexity of the outer surface 31 of the deformable optical element 30 increases (as it does in its high energy configuration as shown in Figure 3 and Figure 5 ), the result is a significant reduction in the overall lens diopter. Thus, an apparent paradox is revealed; as the central thickness of the intraocular lens increases, the eye focuses on a distant object.

[0030] As shown in the cross-section in Figures 2 to 5 , when the optical zone of the deformable optical element 30 is Figure 3 and Figure 5When compressed by an external force represented by the force vector X, the air discharged from the optical region 17 of the air-filled chamber 18 is transferred to the tactile region 28 of the air-filled chamber 18. During this process, the air that normally occupies the space 17 between the lower surface 33 of the optical region 30 and the upper surface 35 of the optical region 32 is displaced outward toward the air space 28 between the tactile elements 20 and 22. When a sufficient reverse force is delivered to the optical regions of the two optical elements 30 and 32, the inner surfaces 33 and 35 of the optical regions are aligned and connected, causing the space 17 to collapse and then be able to separate without adhesion to recreate the space 17. At this time, two aspects of the present invention are achieved. First, the optical regions of the lens pair no longer have an air interface that generates internal reflections and glare. When the opposing optical surfaces 33 and 35 of the two optical elements 30 and 32 are configured to have a relatively short radius of curvature, this glare potential can be reduced. By orienting the optical elements within the eye such that the non-deformable optical element is positioned in front of the deformable optical element, this glare potential can be further reduced. Second, the eye can remain focused on a distant object without being affected by atmospheric pressure changes. This process can also be achieved by two optical elements 30 and 32 with deformable characteristics. When the ciliary muscle tension decreases, the elasticity of the deformable optical element 30 causes a reduction in compression, resulting in the surfaces 33 and 35 returning to the rest state that focuses the eye on a nearby object.

[0031] The rapid and uniform transfer of air from the periphery of the optical region of the deformable optical element 30 near the surface 33 is achieved through the radial slots 14, which carry the air to the channel 12 and then evenly distribute the air around the annular tactile region 28 of the air-filled chamber 18 via the circular channel 12. Thus, the radial slots 14 connected to the circumferential channel 12 can surround the periphery of the optical region of the optical element 30 to allow air to freely circulate between the optical region 17 and the tactile region 28 of the air-filled chamber 18. Alternatively or additionally, the radial slots 14 or the circumferential channel 12 or both can be formed in the upper surface of the periphery of the optical region of the non-deformable optical element 32 to similarly allow air to freely circulate between the optical region 17 and the tactile region 28 of the air-filled chamber 18. This network of channels and radial slots is an optional feature of the design, which also provides a means for controlling the material deformation that may occur when the spherical housing is forced to change its shape. The widths of the radial slots 14 and the channel 12 can be selected to vary the air flow as needed.

[0032] Optical surfaces of various shapes lining the hollow cavity can be selected to match the specific optical requirements of any individual eye to adjust the optical resolution of the image focused within the eye or to extend the focusing range of the eye.

[0033] The cross-sectional shape profile of the deformable optical element 30 can be customized to accelerate its shape recovery time. For example, the shape profile of the lower surface 33 of the deformable optical element 30 that contacts the upper surface 33 of the non-deformable optical element 32 at its vertex can have various configurations: flat, convex, concave, multifocal, or aspherical, provided that: when the device is in its normal resting state, an air space is present between the remaining portions of the optical elements.

[0034] A soft support structure can be mounted on the periphery of the optical zone of either of the two optical interfaces to reduce the risk of adsorption or adhesion occurring between them, which could potentially bond their optical surfaces together and thus prevent the deformable optical element 30 from moving.

[0035] Although in Figure 2 and Figure 4 the illustrated embodiment the deformable optical element 30 and the non-deformable optical element 32 only contact at the vertex 40 of the non-deformable optical element 32 when in the resting state, in other embodiments the contact points in the resting state can be located at other positions (such as on the periphery) in addition to being at the central vertex of the optical element. See, for example, the structure shown in International Application Publication No. WO 2013 / 126986 A1 of the applicant entitled "Method and Apparatus for Modulating Prism and Curvature Change of Refractive Interfaces", which international application is incorporated herein by reference.

[0036] The materials required to construct the optical elements are elastic fabrics having strong memory properties such that they readily recover their original size and shape after being compressed, stretched, or otherwise deformed. Materials having good shape memory properties commonly used in the manufacture of intraocular lenses include, but are not limited to, the following classifications: silicones, silicone hydrogels, hydrophobic and hydrophilic acrylates, polyethylenes, polypropylenes, polyurethanes, and co-block polymers of these materials.

[0037] The general intent of the present invention is to remove and replace the air optical interface within the optical zone of the intraocular lens as needed to allow the human eye to regain its inherent ability to effectively and predictably shift the focus from far to near and all points in between.

[0038] Although several exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof. For example, although air has been described as the fluid contained within the compartment 18, other transparent gases or liquids may be substituted therefor, resulting in a change in the refractive index. Accordingly, the appended claims and the claims hereafter introduced are intended to be construed to include all such modifications, permutations, additions, and subcombinations consistent with the broadest interpretation of the entire specification.

Claims

1. An accommodative intraocular lens (10), which comprises: A first non-deformable optical element (32) that is sealed around its perimeter to a second deformable optical element (30). The first non-deformable optical element (32) and the second deformable optical element (30) each have a central transparent optical zone and a first haptic zone and a second haptic zone (22, 20). The first haptic zone and the second haptic zone are associated with a respective one of the first non-deformable optical element (32) and the second deformable optical element (30) and are each sealingly connected to the other at the perimeter. Wherein the first non-deformable optical element (32) has a first contact surface (35) including a raised contact area that contacts a second contact surface (33) of the second deformable optical element (30). Wherein a sealed air-filled compartment (18) is defined between the first non-deformable optical element (32) and the second deformable optical element (30) at a location between the central transparent optical zone and the first haptic zone and the second haptic zone (22, 20). The sealed air-filled compartment (18) includes an optical zone portion (17) and a haptic zone portion (28). Wherein, in a static state where the eye is focused on a near object, the optical zone portion (17) forms an air interface between a peripheral portion of the optical zone of the first non-deformable optical element (32) and a peripheral portion of the optical zone of the second deformable optical element (30). And wherein, in a non-static state where the eye is focused on a distant object, air shifts outward from the optical zone portion (17) to the haptic zone portion (28) to remove the air interface and cause the inner surfaces of the optical zones to contact each other to form a solid optical lens element. Wherein, in the non-static state, compression of the first contact surface (35) of the first non-deformable optical element (32) against the second contact surface (33) of the second deformable optical element (30) changes the curvature of the second deformable optical element (30). Wherein when a sufficient reverse force is transmitted to the peripheral portion of the optical zone, the intraocular lens (10) can be adjusted from the static state to the non-static state. Wherein when the reverse force decreases, the intraocular lens (10) can be adjusted from the non-static state to the static state.

2. The accommodative intraocular lens (10) according to claim 1, wherein the intraocular lens (10) is implanted in the eye and the reverse force is applied by the tension caused by the ciliary muscle.

3. The accommodative intraocular lens (10) according to claim 2, wherein when the reverse force decreases due to a decrease in the ciliary muscle tension, the elasticity of the second deformable optical element (30) causes the intraocular lens (10) to move to the static state.

4. The accommodative intraocular lens (10) according to any one of claims 1-3, wherein the air-filled compartment (18) comprises at least one passage communicating between the optical zone portion (17) and the haptic zone portion (28).

5. The accommodative intraocular lens (10) according to claim 1, wherein the first contact surface (35) of the first non-deformable optical element (32) that contacts the second contact surface (33) of the second deformable optical element (30) is the apex of the raised contact area.

6. The accommodative intraocular lens (10) according to claim 4, wherein the at least one passage communicating between the optical zone portion (17) of the sealed air-filled compartment (18) and the haptic zone portion (28) of the sealed air-filled compartment (18) comprises a circular passage (12) formed in the lower surface of the second deformable optical element (30), the circular passage being interconnected with a plurality of radial passages (14) formed in the lower surface of the second deformable optical element (30).

7. The accommodative intraocular lens (10) according to claim 4, wherein the at least one passage communicating between the optical zone portion (17) and the haptic zone portion (28) comprises a circular passage formed in the upper surface of the first non-deformable optical element (32), the circular passage being interconnected with a plurality of radial passages formed in the upper surface of the first non-deformable optical element (32).

8. The accommodative intraocular lens (10) according to claim 1, wherein the first contact surface (35) comprises the raised contact area of the first non-deformable optical element (32), and the second contact surface (33) of the second deformable optical element (30) is configured to have a short radius of curvature.

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