The present invention relates to ophthalmological instruments and, more particularly, to an intraocular lens having a posterior aspheric surface with mechanically-modifiable curvature and a continuously alterable focal length.
The invention will be more fully understood by referring to the following Detailed Description in conjunction with the generally not-to-scale Drawings, of which:
Embodiments of the invention provide an intraocular lens that includes a first rotationally symmetric optical portion that has an optical axis and a focal length and that is defined by a first oblate aspheric surface and a deformable prolate aspheric surface. Such first optical portion is operable to gradually change the focal length in response to deformation of the prolate aspheric surface. The intraocular lens further includes first and second flexible haptic wings, each wing having proximal and distal sides. The proximal side of each wing is integrated with the first rotationally symmetric optical portion at least along a perimeter thereof. The lens is dimensioned to be placed, in operation, in mechanical cooperation with a ciliary body muscle of an eye of a subject such that, in response to tension applied to a at least one of zonules and capsular membrane of a natural lens of the eye by the ciliary body muscle, such as to change a curvature of the prolate aspheric surface substantially without axial repositioning of said lens.
An embodiment of the lens may be dimensioned to be placed, during the implantation of said lens in the eye, inside the capsular membrane, while each of the haptic wings may be curved to conform to a shape of said capsular membrane. Alternatively or in addition, an embodiment of the lens may be dimensioned to enable positioning of a distal side of each of the haptic wings, during the implantation of said lens in the eye, in a sulcus between a root of the iris of the eye and ciliary body muscle of the eye. Alternatively or in addition, the lens may be configured such that a curvature of an axial portion of the prolate aspheric surface is changed, in response to the force applied along the optical axis to a haptic, more than a curvature of a peripheral portion of the prolate aspheric surface. Alternatively or in addition, the lens is configured to take advantage of natural miosis during the accommodation of the implanted lens. The lens is configured such that, with pupillary constriction during the accommodation, the refractive power of the lens is substantially restricted to the central, axial portions of the lens where the maximum curvature of the prolate aspheric surface of the lens occurs, which further increases the power of the lens during the accommodation and reduces the force required to deform a lens's surface to achieve the desired change in optical power.
Embodiments of the invention further provide a method for correcting vision with the use of an intraocular lens (IOL). Such method includes implanting an IOL in an eye of the patient, which IOL has (i) a central optical portion having an optical axis (the central optical portion being formed by first and second optical elements) and (ii) at least two flexible curved haptics, each of said haptics having proximal and distal sides, the proximal side being integrated with the central optical portion along a perimeter thereof. Each of the first and second optical elements of the IOL being implanted is defined by a respectively corresponding outer surface and an oblate aspheric surface that the first and second elements have in common, such that an outer surface of a first optical element being a prolate aspherical surface. Each of the haptics has a surface curved in two planes that are transverse to one another. The method further includes juxtaposing the at least two flexible haptics and the prolate aspherical surface of the first optical element against an interior surface of a capsule membrane of a natural lens of the eye such as to place distal side of each of said haptics in mechanical cooperation with the capsule membrane. The method may further include changing a curvature of the prolate aspheric surface in response to a force applied to at least one of said haptics during naturally occurring miosis.
The clouding of the natural lens of an eye, which is often age-related, is referred to as a cataract. Visual loss, caused by the cataract, occurs because opacification of the lens obstructs light from traversing the lens and being properly focused on to the retina. The cataract causes progressive decreased vision along with a progressive decrease in the individual's ability to function in daily activities. This decrease in function with time can become quite severe, and may lead to blindness. The cataract is the most common cause of blindness worldwide and is conventionally treated with cataract surgery, which has been the most common type of surgery in the United States for more than 30 years and the frequency of use of which is increasing. As a result of cataract surgery, the opacified, clouded natural crystalline lens of an eye is removed and replaced with a synthetic and clear, optically transparent substitute lens (often referred to as an intraocular lens or IOL) to restore the vision.
The use of such customized synthetic IOLs that are properly sized for a given individual—often referred to as intraocular lenses—has proven very successful at restoring vision for a predetermined, fixed focal distance. The most common type of IOL for cataract treatment is known as pseudophakic IOL that is used to replace the clouded over crystalline lens. (Another type of IOL, more commonly known as a phakic intraocular lens (PIOL), is a lens which is placed over the existing natural lens used in refractive surgery to change the eye's optical power as a treatment for myopia or nearsightedness.) An IOL usually includes of a small plastic lens with plastic side struts (referred to as “haptics”), which hold the IOL in place within the capsular bag inside the eye. IOLs were traditionally made of an inflexible material (such as PMMA, for example), although this is being superseded by the use of flexible materials. Such lenses, however, are not adapted to restore the eye's ability to accommodate, as most IOLs fitted to an individual patient today are monofocal lenses that are matched to “distance vision”.
Accommodation is the eye's natural ability to change the shape of its lens and thereby change the lens's focal distance. The accommodation of the eye allows an individual to focus on an object at any given distance within the field-of-view (FOV) with a feedback response of an autonomic nervous system. Accommodation of an eye occurs unconsciously, without thinking, by innervating a ciliary body muscle in the eye. The ciliary muscle adjusts radial tension on the natural lens and changes the lens's curvature which, in turn, adjusts the focal distance of the eye's lens.
Without the ability to accommodate one's eye, a person has to rely on auxiliary, external lenses (such as those used in reading glasses, for example) to focus his vision on desired objects. Typically, cataract surgery will leave an individual with a substantially fixed focal distance, usually greater than 20 feet. This allows the individual to participate in critical activities, such as driving, without using glasses. For activities such as computer work or reading (which require accommodation of eye(s) at much shorter distance), the individual then needs a separate pair of glasses.
Several attempts have been made to restore eye accommodation as corollary to cataract surgery. The most successful of used methodologies relies on using a substitute lens that has two or three discrete focal lengths to provide a patient with limited visual accommodation in that optimized viewing is provided at discrete distances—optionally, both for distance vision and near vision. Such IOLs are sometimes referred to as a “multifocal IOLs”. The practical result of using such IOLs has been fair, but the design compromises the overall quality of vision. Indeed, such multifocal IOLs use a biconvex lens combined with a Fresnel prism to create two or more discreet focal distances. The focal distance to be utilized is in focus while there is a superimposed defocused image from the other focal distances inherent in the lens. Also, the Fresnel prism contains a series of imperfect dielectrical boundary-related discontinuities, which create scatter perceived as glare by the patient. Some patients report glare and halos at night time with these lenses.
Another methodology may employ altering the position of a fixed-focal-length substitute lens (often referred to as an “accommodating IOL”) with contraction of a ciliary muscle to achieve a change in the working distance of the eye. These “accommodating IOLs” interact with ciliary muscles and zonules, using hinges at both ends to “latch on” and move forward and backward inside the eye using the same natural accommodation mechanism. In other words, while the fixed focal length of such IOL does not change in operation, the focal point of an “accommodating IOL” is repositioned (due to a back-and-forth movement of the IOL itself) thereby changing the working distance between the retina and the IOL and, effectively, changing the working distance of the IOL. Such IOL typically has an approximately 4.5-mm square-edged optical portion and a long hinged plate design with polyimide loops at the end of the haptics. The hinges are made of an advanced silicone (such as BioSil). While “accommodating IOLs” have the potential to eliminate or reduce the dependence on glasses after cataract surgery and, for some, may be a better alternative to refractive lens exchange (RLE) and monovision, this design has diminished in popularity due to poor performance and dynamic range of movement that is not sufficient for proper physiological performance of the eye.
Therefore, there remains an unresolved need in an IOL that is structured to be, in operation, continuously accommodating, with gradually, non-discretely and/or monotonically adjustable focal length.
According to embodiments of the invention, the problem of accommodating the focal length of an IOL is solved by utilizing a force mechanism supplied by the eye's ciliary muscle. The IOL is provided with a flexible aspherical surface and is juxtaposed in such spatial relation with respect to the ciliary muscle that force, transferred to the IOL by the muscle, applies pressure on the posterior surface of the accommodating IOL to changes the curvature of the posterior surface and, thereby, the power of the IOL as well. Specifically, according to an idea of the invention, an embodiment of the accommodating IOL is structured to utilize, when implanted into an eye, gradually-changing radial tension caused by the relaxing ciliary muscle thus creating an anteriorly-directed force applied to alter the posterior curvature of the IOL and, as a result, the overall lens's power. The change in radial tension associated with the implanted IOL enables the patient who has undergone cataract surgery to gradually vary the focal length of the IOL through the eye's natural mechanism of ciliary body muscle tension, i.e. in substantially the same way as the focal length of the natural, crystalline lens of an eye is varied. Such variation of the focal length is achieved without repositioning of the IOL itself.
The optical portion may be optionally enhanced and complemented with a stabilizing plate 118 (made, for example, with Acrylic) disposed in front of the first lenticle 116 (as viewed from the apex 112a of the anterior surface 112) such as to share an optical interface 114 with the first lenticle 116. The plate 118 is defined by the anteriorly intermediate surface 114, which it shared with the first lenticle or lenslet 116, and a front outer or posterior surface 119. It is appreciated, that in a specific implementation and depending on the curvatures of the surfaces 114, 119, the stabilizing plate 118 may be structured as a second lenticle or lenslet 118 disposed in front of the first lenslet 116. The elements 116, 118 aggregately define an optical portion 110 of the IOL 100.
As shown, both the first lenslet 116 and the plate 118 are radially extended, on the outboard side of the optical portion 110, by at least two haptics 120, 122 that are interconnected by the stabilizing plate 118. In the embodiment 100, the haptics 120, 122 are shown integrated with the plate 118 and, in particular, with the front outer surface 119 such as to form a spatially-continuous structure formed by the elements 120, 118, 122. This spatially-continuous structure, which carries the lenslet 116, is configured as a lenslet 116 supporting structure that contains a central optical portion 118 and the haptic wings 120, 122. In one implementation the haptics are symmetric about an optical axis 126 of the lenticle 116. In a related implementation (not shown in
In further reference to
As shown in
The centripetal tightening in the x-y plane of both the zonules 220 and/or the capsule 250 which have been placed under slight tonic tension by the IOL/haptics displacing the capsule posteriorly in the +z direction. The conical displacement of the capsule 250 and zonules 220 with its apex in the +z direction (posteriorly) causes any additional centripetal tension supplied by relaxation of the ciliary muscle 214 provides pressure, through the zonules and capsule, to the deformable surface 112 of the IOL 110. The net vector of this applied pressure, shown in
Consequently to flattening of the surface 112, optical imaging conditions are formed that correspond to a distant object within the FOV of the IOL 100 becoming an optical conjugate of the retina (not shown in
During the contraction of the ciliary muscle 214, on the other hand, the tension on the zonules 220 and the membrane of the capsule 250 is being reduced, thereby causing decrease in pressure on the posterior surface 112 and restoring the posterior surface 112 from its flattened condition towards a more curved one and towards that of a prolate asphere corresponding to the relaxed condition of the muscle 214. As a result, the overall power of the optical portion 110 of the IOL 100 is increased, thereby defining the retina and a near-by object located within the FOV of the IOL 100 as optical conjugates. As the degree of steepening of the curvature of the surface 112 and, therefore, increase of the optical power of the lenticle 110 depend on the gradually and continuously varying degree of contraction of the ciliary muscle 214, the accommodation of the vision at near-by objects is also gradual and continuous.
Accommodation of the vision on near-by objects is accompanied with miosis (pupillary constriction). Embodiments of the IOL of the invention are structured to take advantage of this physiological process. With constriction of the pupil and during the optical accommodation of the embodiment of the IOL, the optical performance of the IOL is substantially restricted to the area of the optical portion of the IOL that is located centrally and that is adjacent to the apex 112a of the lenslet 110, because the clear optical aperture defined by the pupil is being reduced in size. As the curvature of the prolate aspheric surface 112 in its central, neighboring the apex 112a portion is higher than in any other portion of the surface 112, the change in the overall resulting optical power of the IOL 100 achieved due to the accommodating of the ciliary muscle 214 during the miosis is larger than during a period of time when the pupil of the eye is not constricted.
Referring again to
It is worth noting that one operational shortcoming of (other) mechanical structures of accommodating IOLs of the related art is that the small force applied by the capsule 116 has to be sufficient to actuate the lens and alter its shape and power. (The small actuating/accommodating force of about 1 gram is applied most effectively to the present design as opposed to other designs). In contradistinction with accommodating IOLs of the related art, embodiments of the present invention are structured to directly transfer the force, caused by flexing of the ciliary body muscle, to a posterior surface 112 of the optical portion of the embodiment to alter its shape, causing substantially no loss of force upon transmission that would otherwise occur if the force were transferred to any other an internal or anterior surface of the optical portion of the embodiment.
It will be understood by those of ordinary skill in the art that modifications to, and variations of, the illustrated embodiments may be made without departing from the inventive concepts disclosed in this application. For example, in reference to
It is appreciated that the design for near/short distance accommodation was set to a specific object distance (in this case—40 mm,
In reference to
Additional and/or alternative details of structure of haptic(s) for embodiments of an IOL presented in this application are discussed in a co-pending application PCT/US13/55093, the disclosure of which is incorporated herein by reference in its entirety for all purposes. To the extent that any inconsistency or conflict exists in a definition or use of a term between a document incorporated herein by reference and that in the present disclosure, the definition or use of the term in the present disclosure shall prevail.
It is appreciated that material composition of IOL embodiments of the invention allows the IOLs to be folded and inserted into the eye through a small incision (which make them a better choice for patients who have a history of uveitis and/or have diabetic retinopathy requiring vitrectomy with replacement by silicone oil or are at high risk of retinal detachment).
References throughout this specification to “one embodiment,” “an embodiment,” “a related embodiment,” or similar language mean that a particular feature, structure, or characteristic described in connection with the referred to “embodiment” is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. It is to be understood that no portion of disclosure, taken on its own and in possible connection with a figure, is intended to provide a complete description of all features of the invention.
In addition, it is to be understood that no single drawing is intended to support a complete description of all features of the invention. In other words, a given drawing is generally descriptive of only some, and generally not all, features of the invention. A given drawing and an associated portion of the disclosure containing a description referencing such drawing do not, generally, contain all elements of a particular view or all features that can be presented is this view, for purposes of simplifying the given drawing and discussion, and to direct the discussion to particular elements that are featured in this drawing. A skilled artisan will recognize that the invention may possibly be practiced without one or more of the specific features, elements, components, structures, details, or characteristics, or with the use of other methods, components, materials, and so forth. Therefore, although a particular detail of an embodiment of the invention may not be necessarily shown in each and every drawing describing such embodiment, the presence of this detail in the drawing may be implied unless the context of the description requires otherwise. In other instances, well known structures, details, materials, or operations may be not shown in a given drawing or described in detail to avoid obscuring aspects of an embodiment of the invention that are being discussed. Furthermore, the described single features, structures, or characteristics of the invention may be combined in any suitable manner in one or more further embodiments.
The invention as recited in claims appended to this disclosure is intended to be assessed in light of the disclosure as a whole. Disclosed aspects, or portions of these aspects, may be combined in ways not listed above. Accordingly, the invention is not intended and should not be viewed as being limited to the disclosed embodiment(s).
The present U.S. Patent application is a divisional from the U.S. patent application Ser. No. 14/193,301 filed on Feb. 28, 2014 and now published as U.S. 2014/0257479, which in turn claims priority from and benefit of the U.S. Provisional Patent Application No. 61/775,752 filed on Mar. 11, 2013 and titled “Aspheric Intraocular Lens With Continuously Variable Focal Length.” The disclosure of each of the above-identified patent documents is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61775752 | Mar 2013 | US |
Number | Date | Country | |
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Parent | 14193301 | Feb 2014 | US |
Child | 15217536 | US |