In various embodiments, the present invention relates generally to implantable intraocular lenses and, more specifically, to intraocular lenses with structural features for improved use during implantation, accommodation, reaccess, and explantation.
The crystalline lens of the human eye refracts and focuses light onto the retina. Normally the lens is clear, but it can become opaque (i.e., when developing a cataract) due to aging, trauma, inflammation, metabolic or nutritional disorders, or radiation. While some lens opacities are small and require no treatment, others may be large enough to block significant fractions of light and obstruct vision.
Conventionally, cataract treatments involve surgically removing the opaque lens matrix from the lens capsule using, for example, phacoemulsification and/or a femtosecond laser through a small incision in the periphery of the patient's cornea. An artificial intraocular lens (IOL) can then be implanted in the lens capsule bag—the sack-like structure remaining within the eye following extracapsular cataract extraction; the lens “capsule” is the thin clear membrane that surrounds the natural crystalline lens—to replace the natural lens. Generally, IOLs are made of a foldable material, such as silicone or uncrosslinked acrylics, to minimize the incision size and required stitches and, as a result, the patient's recovery time. The most commonly used IOLs are single-element lenses (or monofocal IOLs) that provide a single focal distance; the selected focal length typically affords fairly good distance vision. However, because the focal distance is not adjustable following implantation of the IOL, patients implanted with monofocal IOLs can no longer focus on objects at a close distance (e.g., less than 60 cm); this results in poor visual acuity at close distances. To negate this disadvantage, multifocal IOLs provide dual foci at both near and far distances. However, due to the optical design of such lenses, patients implanted with multifocal IOLs often suffer from a loss of vision sharpness (e.g., blurred vision, halos, glare, decreased contrast sensitivity). In addition, patients may experience visual disturbances, such as halos or glare, because of the simultaneous focus at two distances.
Recently, accommodating intraocular lenses (AIOLs) have been developed to provide adjustable focal distances (or “accommodations”), relying on the natural focusing ability of the eye (e.g., using contractions of ciliary muscles). Conventional AIOLs include, for example, a single optic that translates its position along the visual axis of the eye, dual optics that change the distance between two lenses, and curvature-changing lenses that change their curvatures to adjust the focus power. These designs, however, tend to be too complex to be practical to construct and/or have achieved limited success (e.g., providing a focusing power of only 1-2 diopters).
Consequently, much effort is devoted to developing IOLs that provide a high degree of accommodation and appropriate focusing power, and which can be easily manufactured and implanted in human eyes. There are many types of IOLs that are approved for use as well as in development. The most common IOLs are monofocal IOLs, multifocal IOLs, toric IOLs, and accommodating IOLs. Monofocal IOLs are not adjustable, and so provide vision at a specific focal plane. Multifocal IOLs, which provide simultaneous near and far focal points, were developed to solve this problem and provide the patient with an increased depth of visual field. Multifocal IOLs often provide near and far focusing percentages dependent on pupil size, i.e., the amount of near focus (add) varies with the pupil diameter. As a result, location relative to the pupil is critical for accurate functioning.
Toric IOLs correct astigmatism in the cornea and consequently require a specific angular orientation after implantation to ensure proper optical functioning. In the extreme case, when the toric is 90° from its intended angular position instead of correcting astigmatism, it increases astigmatism. Therefore, toric IOLs contain a fiducial marker to indicate the angular position of the IOL. After implantation, the toric IOL is rotated into the correct location. AIOLs focus in response to the eye's natural focusing muscle, the ciliary muscle. Like the youthful natural lens, these lenses eliminate the need for reading glasses. AIOLs often require coupling to the ciliary muscles of the eye or the lens capsular bag for actuation. Other AIOL designs monitor the pupillary diameter, or tonus of the ciliary muscles. Based on this they adjust, either passively by being acted upon by the muscles or actively as in the case of an electroactive lens.
In all scenarios the position of the IOL is critical for functioning. Tip, tilt, angular displacement or decentration reduce optical quality of the IOL. In addition, they can prevent a toric IOL, multifocal IOL, or accommodating IOL from functioning properly. In addition, maintaining the positioning of an IOL in the lens capsule is important after opening an aperture in the posterior capsule of the eye—for example, after the treatment for posterior capsular opacification. This additional opening in the lens capsule can lead to decentering of the lens, or possibly the lens falling out of the lens capsule into the posterior chamber of the eye.
To implant an intraocular lens, an incision is made in the cornea, followed by a capsulorhexis, where a portion of the lens capsule is removed to provide surgical access to the natural lens. Most often, a central 5-6 mm capsulorhexis is made. The lens is removed using phacoemulsification in a process of fragmenting and aspirating the lens from the lens capsule. Finally, an intraocular lens is implanted into the empty lens capsule. A fluid-filled AIOL can be inserted through a small incision (under 3 mm) since it can fully collapse on itself. Once the AIOL is inserted into the eye, the surgeon can manipulate it into the correct general orientation. The AIOL is then filled, following which it will self-center within the capsule bag. The surgeon can also help manipulate the AIOL into the center of the capsule bag, but the AIOL will tend to self-center due to the dome shape of the optical zone. The surgeon can then rotate the AIOL into correct alignment. This can be important in the case of toric and asymmetric lenses used to correct aberrations of a patient's eye. Asymmetric lenses have a specific required orientation.
Some AIOLs include one or more peripheral fluid chambers surrounding the optical region of the lens, and which do not contribute to vision correction. Instead, these chambers help anchor the AIOL within the capsular bag and provide a storage reservoir into which optical fluid can accumulate when the eye's natural focusing action compresses the AIOL; this arrangement may make the AIOL more responsive, since the eye's ciliary muscles are not opposed by an incompressible optical liquid (e.g., silicone oil) within a fixed volume. A drawback of this design, however, is the distortive effect these chambers can have on the optical region of the lens as the chambers fill with liquid. In effect, a structure designed to make the lens more permissive for focusing can actually undermine optical performance.
In various embodiments, the invention relates to an AIOL that corrects vision and is optically responsive to the natural focusing mechanism of the patient's eye. The AIOL may comprise a central chamber that effects vision correction when implanted, and contains an optical fluid (such as silicone oil). The central chamber has an optical axis (which will be aligned with the patient's visual axis) extending through a vision-correcting optical zone, and a peripheral region at least partially surrounding the optical zone but not interfering with light passing therethrough. At least one peripheral chamber surrounds the central chamber at least partially and functions as a storage reservoir for optical fluid, receiving excess fluid when the central chamber is compressed. Associated with (e.g., within or surrounding) each peripheral chamber (if there is more than one), a shape-retention member resists collapse of the peripheral chamber in response to external force.
Accordingly, in a first aspect, the invention relates to an intraocular lens comprising, in various embodiments, a membrane defining a central chamber for containing an optical fluid and, when filled, to provide vision correction when implanted in a patient's eye, where the central chamber has an optical axis extending through a vision-correcting optical zone of the central chamber and a peripheral region at least partially surrounding the optical zone; a membrane defining at least one peripheral chamber at least partially surrounding the central chamber along the peripheral region thereof and outside the optical zone, where the peripheral chamber is in fluid communication with the central chamber; and associated with the at least one peripheral chamber, a shape-retention member for resisting collapse of the associated peripheral chamber in response to external force. For example, the shape-retention member may maintain the peripheral chamber at either of two conformal states (e.g., two elliptical states with different long-axis lengths).
In various embodiments, the shape-retention member is at least one spring. The spring may extend from an anterior inner surface of the intraocular lens to a posterior inner surface thereof. In some embodiments, the spring is oriented parallel to the optical axis of the lens.
Alternatively, the shape-retention member may be one or more buckling members or a hinged arrangement of struts. In some embodiments, the struts comprise living hinges, and the lens may have an anchor integral with the peripheral-chamber-defining membrane to which at least one of the struts is affixed. The struts may be configured to form a three-dimensional scaffold with the peripheral-chamber-defining membrane stretched thereover.
In some embodiments, the shape-retention member retains the associated peripheral chamber in an ellipsoidal configuration. The shape-retention member may be fabricated from, for example, metal or a polymer.
In a second aspect, the invention pertains to an intraocular lens comprising, in various embodiments, a membrane defining a central chamber for containing an optical fluid and, when filled, to provide vision correction when implanted in a patient's eye, where the central chamber has an optical axis extending through a vision-correcting optical zone of the central chamber and a peripheral region at least partially surrounding the optical zone; and a membrane defining at least one peripheral chamber at least partially surrounding the central chamber along the peripheral region thereof and outside the optical zone, where the peripheral chamber is in fluid communication with the central chamber. The membrane defining the central chamber comprises a plurality of concentric regions having different expansion properties. For example, the membrane defining a central chamber may become more convex and increase in optical power in response to increasing pressure within the central chamber. Alternatively, it may become less convex and decrease in optical power in response to increasing pressure within the central chamber. In some embodiments, in response to increasing pressure within the central chamber, a first concentric region increases in convexity and a second concentric region increases in concavity. This may result, for example, from different thicknesses and/or material elasticities (e.g., Young's modulus). In other embodiments, in response to increasing pressure within the central chamber, a first concentric region decreases in convexity and a second concentric region decreases in concavity.
The term “substantially” or “approximately” means ±10% (e.g., by weight or by volume), and in some embodiments, ±5%. Reference throughout this specification to “one example,” “an example,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example of the present technology. Thus, the occurrences of the phrases “in one example,” “in an example,” “one embodiment,” or “an embodiment” in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, routines, steps, or characteristics may be combined in any suitable manner in one or more examples of the technology. The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the claimed technology.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, with an emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
As the interior region 102 fills with liquid, internal pressure forces the membrane 104 to assume a domed shape along the optical axis that focuses light to the back of the retina. As the pressure within the lens interior 102 increases, the optical zone 103 changes in diameter and its radius of curvature changes, thus changing the point at which light is focused and enabling the patient to see at different distances. Although in
The AIOL 100 is shaped to form a pair of opposed side chambers 1081, 1082 that provide haptic surfaces and store optical fluid; these may be defined, along with the interior region 102, by a single membrane, or may be one or more separate structures surrounding and in fluid communication with a central lens structure defining the interior region 102. Optical fluid is pumped between the optical zone 102 the and chambers 108 by fluctuating pressures within the AIOL 100—e.g., as a result of accommodative effort by the ciliary muscles of the eye that forces fluid from the chambers 108 and thereby deforms the optical zone 102 to shift the eye's focus. Although two chambers 108 are illustrated in
The zonules 204 lie at the edges of the capsule bag 202, which interfaces (i.e., makes contact with) the lateral portions of the circular chambers 108.
The effects on the chambers 108 of the pressures changes that result from the accommodative activity of the eye are illustrated in
In
In another embodiment, the spring member 410 at least partially surrounds the chamber 302 externally, e.g., as a vertically oriented band or collar following at least a portion of the vertical circumference of the chamber. The vertical band or collar has a stiffness that resists deformation in the manner of a spring, and has a rest conformation corresponding to the elliptical shape of the chamber 302. The band or collar may, if desired, be overmolded by an additional coating (e.g. silicone, parylene).
In still other embodiments, the spring 410 is a buckling member—i.e., a column, piston or corrugated diaphragm that buckles recoverably under compressive axial load. In this case the force exerted by the member 410 does not vary linearly with compression. Instead, the member 410 prevents any shape distortion of the chamber 108 until the critical buckling load is reached. This load is set to discourage but not prevent a change in chamber shape. Although the figure shows simplified struts for ease of illustration, the contact points between the membrane and hinges may have continuity and suitable smoothing structures to minimize any puncturing forces. Specific spring designs such as a C-spring, S-spring or wave-spring may be employed, for example.
As shown in
The strut arrangement 510 is retained within the chamber 108 by a series of support members 515 that reach, and in some embodiments are mechanically or adhesively affixed to, the interior surface of the chamber 108. These support members 515 may be made of the same material as that of the struts or a different material. To prevent movement of the strut arrangement 510 and support members 515 within the chamber 108, one or more of the support members 515 may be affixed to an anchor 520 integral with (i.e., affixed to or embedded within) the membrane 302. The anchor 520 may also participate in the mechanical action of the strut arrangement 510. In some embodiments, the anchor is a stiff ring through which optical fluid can pass. The anchor may additionally incorporate features of a flow restrictor or check valve to control the flow of fluid between the lens interior region 102 and one or more chambers 108 (see
Alternatively or in addition to above-described structures, one or more of the flexible membranes may be designed to amplify or reverse the impact of additional fluid in the inner region 102. Conventionally, as shown in
As shown in
The membrane can be designed to exhibit multiple transitions to provide a desired overall contour. In
Reference throughout this specification to “one example,” “an example,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example of the present technology. Thus, the occurrences of the phrases “in one example,” “in an example,” “one embodiment,” or “an embodiment” in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, routines, steps, or characteristics may be combined in any suitable manner in one or more examples of the technology. The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the claimed technology.
The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive.
This application claims priority to, and the benefits of, U.S. Ser. No. 62/129,401, filed on Mar. 6, 2015, the entire disclosure of which is hereby incorporated by reference.
Number | Date | Country | |
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62129401 | Mar 2015 | US |