WO2012138426A2 - An implantable ophthalmic device with multiple static apertures - Google Patents

An implantable ophthalmic device with multiple static apertures Download PDF

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Publication number
WO2012138426A2
WO2012138426A2 PCT/US2012/025922 US2012025922W WO2012138426A2 WO 2012138426 A2 WO2012138426 A2 WO 2012138426A2 US 2012025922 W US2012025922 W US 2012025922W WO 2012138426 A2 WO2012138426 A2 WO 2012138426A2
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WO
WIPO (PCT)
Prior art keywords
static
ophthalmic device
implantable ophthalmic
apertures
image
Prior art date
Application number
PCT/US2012/025922
Other languages
French (fr)
Other versions
WO2012138426A3 (en
Inventor
Rudy Mazzocchi
Amitava Gupta
Ronald Blum
Original Assignee
Elenza, Inc.
Pixeloptics, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Elenza, Inc., Pixeloptics, Inc. filed Critical Elenza, Inc.
Publication of WO2012138426A2 publication Critical patent/WO2012138426A2/en
Publication of WO2012138426A3 publication Critical patent/WO2012138426A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648Multipart lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/15Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/16965Lens includes ultraviolet absorber
    • A61F2002/1699Additional features not otherwise provided for

Definitions

  • FIG. 1 shows a cross section of a healthy human eye 100.
  • the white portion of the eye is known as the sclera 110 and is covered with a clear membrane known as the conjunctiva 120.
  • the central, transparent portion of the eye that provides most of the eye's optical power is the cornea 130.
  • the iris 140 which is the pigmented portion of the eye and forms the pupil 150.
  • the sphincter muscles constrict the pupil 150 and the dilator muscles dilate the pupil 150.
  • the pupil 150 is the natural aperture of the eye 100.
  • the anterior chamber 160 is the fluid-filled space between the iris and the innermost surface of the cornea 130.
  • the crystalline lens 170 is held in the lens capsule 175 and provides the remainder of the eye's optical power.
  • the retina 190 which is separated from the back surface of the iris 140 by the posterior chamber 180, acts as the "image plane" of the eye 100 and is connected to the optic nerve 195, which conveys visual information to the brain.
  • a healthy eye can produce an image on the retina of an object in an object plane.
  • Objects in or near the object plane yield crisp, or focused images, whereas objects that are too far from the object plane appear blurry or out of focus.
  • the distance in front of and behind the object plane over which an object appears to be in focus on the image plane is called the "depth of field” and depends on both the eye's focal length (optical power) and aperture size.
  • a healthy eye can change its optical power (and its depth of field) to image objects at near distances (e.g., less than 1 m), intermediate distances (e.g., about 1 m to about 5 m), and far distances (e.g., more than about 5 m) to the front surface of the retina 190 in a process known as accommodation.
  • near distances e.g., less than 1 m
  • intermediate distances e.g., about 1 m to about 5 m
  • far distances e.g., more than about 5 m
  • accommodation There are two major conditions that affect an individual's ability to focus on near and intermediate distance objects: presbyopia and pseudophakia.
  • Presbyopia is the loss of accommodation of the crystalline lens of the human eye that often accompanies aging. In a presbyopic individual, this loss of accommodation first results in an inability to focus on near distance objects and later results in an inability to focus on intermediate distance objects. It is estimated that there are approximately 90 million to 100
  • the standard tools for correcting presbyopia are reading glasses, multifocal ophthalmic lenses, and contact lenses fit to provide monovision.
  • Reading glasses have a single optical power for correcting near distance focusing problems.
  • a multifocal lens is a lens that has more than one focal length (i.e., optical power) for correcting focusing problems across a range of distances.
  • Multifocal optics are used in eyeglasses, contact lenses, and intraocular lenses (IOLs).
  • Multifocal ophthalmic lenses work by means of a division of the lens's area into regions of different optical powers.
  • Multifocal lenses may be comprised of continuous surfaces that create continuous optical power as in a Progressive Addition Lens (PAL).
  • PAL Progressive Addition Lens
  • multifocal lenses may be comprised of discontinuous surfaces that create discontinuous optical power as in bifocals or trifocals.
  • Contact lenses fit to provide monovision are two contact lenses having different optical powers. One contact lens is for correcting mostly far distance focusing problems and the other contact lens is for correcting mostly near distance focusing problems.
  • Pseudophakia is the replacement of the crystalline lens of the eye with an IOL, usually following surgical removal of the crystalline lens during cataract surgery. For all practical purposes, an individual will get cataracts if he or she lives long enough.
  • Aphakia which is the absence of the crystalline lens, can be corrected using IOLs.
  • IOLs are monofocal spherical lenses that provide focused retinal images for far objects (e.g., objects over two meters away).
  • the focal length (or optical power) of a spherical IOL is chosen based on viewing a far object that subtends a small angle (e.g., about seven degrees) at the fovea.
  • Typical patients require spherical IOLs with optical powers between about +10 diopters (D) and about + 36 D. The most commonly required optical power is about +25 D or about +26 D.
  • D diopters
  • +36 D The most commonly required optical power is about +25 D or about +26 D.
  • all spherical surfaces, including spherical IOLs and the cornea suffer from spherical aberration, which limits image quality.
  • aspheric IOLs can be used to treat presbyopia and aphakia without introducing spherical aberration.
  • aspheric IOLs with constant negative spherical aberration can even be used to compensate spherical aberration introduced in the cornea.
  • these conventional aspheric IOLs provide better images for a wider range of far object scenarios than spherical IOLs, conventional aspheric IOLs do not improve image quality for near or intermediate objects. It has always been always accepted that patients with aspheric IOLs would wear glasses to see near and intermediate objects.
  • IOLs can result in one or more of: light scattering, glare, halos, ghosting, loss of contrast sensitivity, limited range of focus, and/or reduction of light hitting the retina.
  • An alternate approach to correcting presbyopia involves a implanting a corneal inlay with a small, fixed-diameter aperture in the eye.
  • limiting the diameter of the aperture of an optical system, such as the eye increases the system's depth of field.
  • the aperture increases the depth of field by blocking or attenuating at least some of the light rays that make a large angle with the lens's optical axis (i.e., the aperture blocks some of the non-paraxial light rays).
  • the aperture By blocking or attenuating some of the non- paraxial light rays, the aperture reduces the deviation of rays from the image plane, causing objects located within a fixed distance of the focal distance (i.e., within the depth of field) to appear in focus. Increasing the depth of field makes the sharpness decrease more gradually on either side of the focal plane.
  • a corneal inlay with a properly chosen aperture diameter may extend the depth of field to make near and intermediate objects appear in focus.
  • an implantable ophthalmic device (and associated methods of imaging with an implantable ophthalmic device) that includes an opaque structure and a plurality of prismatic elements.
  • the opaque structure defines a plurality of static apertures, each of which is in optical communication with a corresponding prismatic element in the plurality of prismatic elements.
  • One or more of the static apertures may be apodized, e.g., according to an apodization function that defines how the transmissivity of the static aperture varies as a function of position from the center of the static aperture.
  • the static apertures may have the same apodization function or a different apodization function.
  • the static apertures cover at least about 50% (e.g., 80% or 90%) of the implantable ophthalmic device's clear aperture, or effective size when implanted. They may be arranged in a regular array (e.g., a pattern having both short- and long-range order) or in an irregular array (e.g., a pattern that may have short-range order but not long- range order). In some cases, the irregular array may be a randomized array. [0014] One or more of the static apertures may be in the shape of a triangle, quadrilateral, hexagon, dodecagon, or circle.
  • the static apertures may all be the same shape (e.g., circles), or they may be different shapes (e.g., dodecagons and squares).
  • One or more of the static apertures may have a maximum transverse dimension (e.g., a diameter for a circle) of about 100 microns to about 2.0 millimeters.
  • the opaque structure may define the thickness of one or more static apertures to be about 10 microns to about 500 microns.
  • each prismatic element may include a surface whose gradient forms an angle with an optical axis of the implantable ophthalmic device. Each gradient may be oriented along a radius extending from the optical axis of the implantable ophthalmic device.
  • the plurality of prismatic elements may include a first prismatic element with a first prism angle and a second prismatic element with a second prism angle that is greater than the first prism angle. The second prismatic element may be located farther from the optical axis of the implantable ophthalmic device than the first element.
  • the implantable ophthalmic device may also include a lens in optical
  • the plurality of static apertures and the plurality of prismatic elements may increase the lens's optical power by about 1.0 Diopters to about 3.0 Diopters. They may also increase the lens's depth of field by about 0.5 Diopters to about 3.0 Diopters.
  • the implantable ophthalmic device may also include a plurality of microlenses, each of which is in optical communication with a corresponding static aperture in the plurality of static apertures.
  • an exemplary implantable ophthalmic device may include a plurality of optical elements, each of which is in optical communication with a corresponding static aperture in the plurality of static apertures.
  • Each optical element may be thick enough to compensate for a phase mismatch among two or beams transmitted through two or more static apertures in the plurality of static apertures.
  • the implantable ophthalmic device includes a plurality of static apertures, which, when implanted in the eye, produce a plurality of second image beams from a first image beam.
  • the implantable ophthalmic device also includes a plurality of prismatic elements, which, when implanted in the eye, refract each second image beam towards the center of the retina to form a single retinal image. In refracting each second image beam, the plurality of prismatic elements may form a third image beam that has a smaller divergence angle than the first image beam so as to increase the depth of field of the eye.
  • Each static aperture may be further configured to attenuate light according to an apodization function.
  • the device may also include at least one lens (e.g., a microlens) to focus at least one second image beam in the plurality of second image beams.
  • the device may also include an optical element that is configured to shift a phase of at least one second image beam to compensate for phase mismatch among two or more of the second image beams.
  • FIG. 1 is a cross section of a healthy human eye.
  • FIG. 2 is a perspective view of an exemplary implantable ophthalmic device.
  • FIGS. 3A-3E are plan views of implantable ophthalmic devices with different arrangements of static apertures.
  • FIG. 3F is a cross section of an implantable ophthalmic device that includes a plurality of microlenses in optical communication with the static apertures.
  • FIG. 3G is a cross section of an implantable ophthalmic device that includes a plurality of optical elements in optical communication with the static apertures.
  • FIGS. 4A ⁇ tC are plots of apodization functions for static apertures in exemplary implantable ophthalmic devices.
  • FIGS. 5 A and 5B are diagrams that illustrate intraocular imaging with a monofocal lens (FIG. 5 A) and an exemplary implantable ophthalmic device (FIG. 5B).
  • FIG. 2 is a perspective view of an exemplary implantable ophthalmic device 200 that can be used to increase the depth of field in a presbyopic patient or to replace the crystalline lens in an aphakic patient.
  • the device 200 includes an opaque structure 210 that defines two or more apertures 212 whose shape, size, and position are fixed.
  • the opaque structure 210 (and static apertures 212) can be formed in any number of suitable ways.
  • the static apertures 212 may be punched into or etched out of a sheet or film of biocompatible material, such as polyvinyldene fluoride or non-hydrogel microporous perflouroether, that blocks or severely attenuates light at visible wavelengths (i.e., from about 450 nm to about 700 nm).
  • biocompatible material such as polyvinyldene fluoride or non-hydrogel microporous perflouroether
  • the film or sheet may be of uniform thickness (e.g., of about 10 microns to about 500 microns), or it may be of varying thickness (e.g., thicker in the center and thinner on the edges). The thickness may be chosen to increase or reduce vignetting by one or more of the apertures 212.
  • the resulting opaque structure 210 scan be embedded in plastic (e.g., acrylic, polyimide, PMMA, PVDF, or any other suitable polymer or fluorocarbon) or glass (e.g., BK7), sandwiched between transparent substrates, or adhered to a transparent substrate to form part of the device 200.
  • the device 200 can also be coated (e.g., with SiO x ) to prevent material from escaping into the eye.
  • the opaque structure 210 can also be etched or burned into or onto a transparent substrate.
  • the opaque structure 210 may be burned into a piece of glass or plastic with femtosecond laser pulses focused to the piece's surface or its interior or etched into the piece's surface using a suitable lithographic or etching technique. Etching or burning could be used to create apertures 212 at different depths within a substrate or to create apertures 212 of different thicknesses (e.g., from about 10 microns thick to about 500 microns thick).
  • the static apertures 212 may cover 50%, 80%, 90%, or more of the implantable ophthalmic device's clear aperture, which is the area through which light can pass when the device 200 is implanted in an eye.
  • Each static aperture 212 may be in the shape of a triangle (e.g., like apertures 212"' in FIG. 3D), quadrilateral (e.g., a parallelogram, rectangle, or square), hexagon, dodecagon, circle, or any other suitable shape, including both regular and irregular shapes. They can also be in the shape of concentric rings (i.e., annularly shaped), e.g., as in the device 200' with apertures 212' shown in FIG. 3A.
  • Each aperture 212 may have a maximum transverse dimension (diameter) of about 100 microns to about 2.0 millimeters.
  • a single device 200 may include apertures 212 of only single shape or of a variety of shapes; likewise, a single device 100 may include apertures 212 of only single size (transverse dimension) or of a variety of sizes (e.g., like apertures 212" in FIG. 3C).
  • the static apertures 212 can be arranged in a regular array as in the devices 200", 200"', and 200"" of FIGS. 3B, 3C, and 3D, respectively. For instance, they may be tiled in tessellated pattern.
  • the static apertures 212 can be arranged in an irregular array, such as a sparse array or an array in which the apertures are arranged in a random or semi-random manner, as shown in FIG. 3E.
  • the implantable ophthalmic device 100 also includes one or more prismatic elements 220a-220n (collectively, prismatic elements 220), each of which is in optical communication with a corresponding static aperture 212. That is, there is at least one ray path that intersects the principal planes of a given static aperture 212 and the corresponding prismatic element 220.
  • FIG. 2 shows a one-to-one correspondence between static apertures 210 and prismatic elements 220, other devices may include more static apertures 210 than prismatic elements 220 or vice versa.
  • a single aperture 212 may be in optical communication with more than one prismatic element 220, and a prismatic element 220 may be in optical communication with more than one single aperture 212.
  • the prismatic elements 220 may be selected and arranged to correct for any lateral shift in the image location induced by the corresponding static aperture 212.
  • FIG. 2 shows that each prismatic element 220 has a corresponding surface 222 in the principal ray's path.
  • FIG. 2 shows planar surfaces 222
  • other implantable ophthalmic devices may include one or more prismatic elements with warped or stepped surfaces.
  • Each surface 222 can be characterized by a gradient 224, or line of steepest descent, whose slope depends on the prism angle of the prismatic element 220.
  • each prismatic element 220 is oriented such that, when the device 200 is viewed along its optical axis, its gradient 224 appears to radiate from the optical axis.
  • each gradient 224 is co-planar with a radius that extends perpendicularly from the optical axis.
  • the prismatic elements 220 may have gradients 224 of the same slope (prism angle) or of different slopes (prism angles) when viewed along a cross section of the device 200 (e.g., as shown in FIG. 5B). Each prismatic element 220 may have a prism angle of about 1 degree to about 75 degrees (e.g., 15 degrees, 30 degrees, 45 degrees, 60 degrees, or any other value between 1 and 75 degrees). If the gradients 224 are of different slopes, the prismatic elements 220 may be arranged according to increasing slope (prism angle) and distance from the device's optical axis.
  • prismatic elements 220 with smaller prism angles may be disposed closer to the optical axis, and prismatic elements 220 with larger prism angles (slopes) may be disposed farther from the optical axis.
  • the prismatic elements 220 may appear to form a Fresnel phase plate.
  • the prismatic elements 220 may be formed from glass (e.g., BK7), plastic (e.g., acrylic, polyimide, PMMA, PVDF, or any other suitable polymer or fluorocarbon), or any other suitable biocompatible material that is substantially transparent and has suitable dispersion characteristics at visible wavelengths.
  • Each element 220 may be about 100 microns to about 2.0 millimeters wide (e.g., about 1.0 millimeters).
  • the prismatic elements 220 may have the same or different refractive indices, which may be about 1.45 to about 1.80 (e.g., about 1.51 to about 1.67), or dispersion characteristics characterized by Abbe number of 25 and above (e.g., 30, 40, 50, 60, 100).
  • the prismatic elements 220 may be formed as individual pieces, groups of pieces, or as a single piece by injection molding, grinding, polishing, or any other suitable method. They can also be formed by selectively melting or nonlinearly altering regions within a transparent substrate, e.g., with focused or shaped pulses of light from a pulsed laser. For a device 200 where the prismatic elements 220 and the opaque structure 210 are separate pieces, the prismatic elements 220 may be bonded to the opaque structure 210 using a suitable adhesive (e.g., a UV-curable adhesive) or any other suitable bonding method.
  • a suitable adhesive e.g., a UV-curable adhesive
  • the implantable ophthalmic device 200 may also include a transparent element 230 that encapsulates the opaque structure 210 and the prismatic elements 220.
  • the transparent element 230 may be formed of two or more individual pieces that are bonded or sealed together around the opaque structure 210, the prismatic elements 220, or both.
  • the transparent element 230 is a single piece that bonds to or mates with the opaque structure 210, the prismatic elements 220, or both.
  • the opaque structure 210, the prismatic elements 220, or both are etched, burned, or melted into or onto the transparent element 230.
  • a suitable transparent element 230 may be made of glass, plastic, or any other suitable biocompatible material, such as a hydrophobic acrylic elastomer of glass with a transition temperature in the range of about 0° C to about 20° C (e.g., about 5° C to 10° C), that is substantially transparent at visible wavelengths.
  • the transparent element's refractive index is lower than that of the prismatic elements 220.
  • the transparent element 230 may have no optical power of its own, or it may have static optical power thanks to one or more curved surfaces or a graded index (GRIN) profile.
  • the transparent element 230 may be a planoconvex or biconvex lens with an optical power of between about 1.0 Diopters and about 36.0 Diopters (e.g., 20 Diopters, 25 Diopters, 30 Diopters, 35 Diopters, or any other value between 1.0 Diopters and 36.0 Diopters.
  • the static apertures 210 and the prismatic elements 220 may be configured to increase the lens's optical power by about 1.0 Diopters to about 3.0 Diopters (e.g., 1.5 Diopters, 2.0 Diopters, 2.5 Diopters, or any other value between 0.5 Diopters to about 3.0 Diopters) and its depth of field by about 0.5 Diopters to about 3.0 Diopters (e.g., 1.0
  • FIG. 3F shows an implantable ophthalmic device 202 that includes one or more microlenses 240, each of which is in optical communication with a corresponding static aperture 220.
  • Each microlens 240 may be an individual piece disposed within a
  • the microlenses 240 may also be formed as an array that is mated or bonded to the opaque structure 210 such that each microlens 240 aligns with a corresponding static aperture 220.
  • the size (diameter) of each microlens 240 may about 50 microns to about 2.0 millimeters (e.g., about 100 microns to about 1.5 millimeters).
  • the opaque structure 210 may be deposited or disposed between
  • microlenses 240 in a microlens array may all have the same focal length, or they may have different focal lengths.
  • the microlens focal length may depend on each microlens's position with respect to the device's optical axis.
  • FIG. 3G shows an implantable ophthalmic device 204 that includes one or more optical elements 250.
  • the optical elements 250 can be formed, mated, and aligned in the same fashions as the microlenses described above.
  • Each optical element 250 is in optical communication with a corresponding static aperture and is made of a transparent material, such as glass or plastic, whose refractive index is different that the refractive index of the surrounding material (e.g., air, vacuum, microlens material, or substrate material).
  • the refractive index and thickness of each optical element 250 may be chosen to compensate for a phase mismatch among two or beams transmitted through two or more of the static apertures 212 in the device. For a static aperture 212 that is filled with air or vacuum, phase mismatch can be compensated by selecting the thickness of the static aperture 212 to achieve the desired the optical path length.
  • Each static aperture may be apodized according to a particular apodization function whose amplitude varies smoothly from the static aperture's center to its edge.
  • Each static aperture may be perfectly transmissive (or nearly perfectly transmissive) over a central region and perfectly opaque (or nearly perfectly opaque) at its edge.
  • the opaque structure may include or define a boundary region that extends from the static aperture's central region to its edge.
  • the boundary region may have a transmissivity that varies smoothly from about 100% at the central region to about 0% at the edge.
  • FIGS. 4A-4C illustrate transmission profiles along the cross-sections of different implantable ophthalmic devices. Each profile has multiple transmission windows, each of which corresponds to a different static aperture in the device.
  • Each static aperture is apodized according to a corresponding apodization function, such as a power law function (e.g., with a coefficient of about 1.6), a Gaussian or super-Gaussian function, a Harming window, or any other suitable apodization function.
  • the static apertures may have identical, identically spaced apodization functions as shown in FIG. 4A. They may also have identical apodization functions spaced at unequal intervals, as shown in FIG. 4B; different apodization functions spaced at equal intervals, as shown in FIG. 4C; or different apodization functions spaced at unequal intervals.
  • FIGS. 5 A and 5B illustrate intraocular imaging with a monofocal intraocular lens (IOL) 30 (FIG. 5 A) and intraocular imaging with an implantable ophthalmic device 200 that includes multiple static apertures 212 and prismatic elements 220 (FIG. 5B).
  • IOL intraocular lens
  • FIGS. 5 A and 5B illustrate intraocular imaging with a monofocal intraocular lens (IOL) 30 (FIG. 5 A) and intraocular imaging with an implantable ophthalmic device 200 that includes multiple static apertures 212 and prismatic elements 220 (FIG. 5B).
  • a first beam 3 of light from an object 1 impinges on the monofocal lens 30, which produces a second beam 5 that illuminates a retinal plane 9 of a presbyopic or psueodophakic eye.
  • the object 1 is at far distances (e.g., distances greater than 5 m)
  • the second beam 5 comes into focus at the retinal plane 9
  • the image 7 may appear blurry when the object 1 is at near distances (e.g., distances closer than 1 m) or intermediate distances (e.g., distances of about 1 m to about 5 m) due to the IOL's limited depth of field and its inability to accommodate for changes in object position.
  • near distances e.g., distances closer than 1 m
  • intermediate distances e.g., distances of about 1 m to about 5 m
  • the implantable ophthalmic device 200 produces a relatively sharp single image 7 over a depth of field that may extend over near and intermediate object distances.
  • light propagating from the object 1 forms an incident beam, or first beam 3, that illuminates each of the static apertures 212.
  • Each static aperture 212 projects a second, shifted image beam 5' towards the retinal plane 9. Because each static aperture 212 is at a different position from the optical axis, each shifted image beam 5' forms an image on the retina 9 that is shifted with respect to the other beams 5' from the other static apertures 212. Unless these shifts are corrected or compensated, these shifted images may be blurred beyond recognition.
  • the prismatic elements 220 correct for the shifts in the image beams 5 ' by referacting the image beams 5' slightly.
  • the prismatic elements 220 do not necessarilty produce constructively interfering beams; rather, they shift the shifted image beams 5' such that beams' modulation transfer functions (MTFs) add together.
  • the prismatic elements 220 align the shifted image beams 5' such that the beams' intensities add at the retinal plane 9 to form a single image 7.
  • the prismatic elements 220 convert the shifted beams 5' into a third beam 11 whose divergence angle is smaller than that of the image beam 5 produced by the monofocal IOL 30.
  • the third beam 11 has a wider waist and is more nearly collimated than the image beam 5 produced by the monofocal IOL 30.
  • the static apertures 212 and prismatic elements 220 spread the single focal point of the lens 230 over about three Diopters in image space. This increases the depth of field, but it may also reduce the spatial resolution and contrast sensitivity of the lens. Even though the opaque structure 210 blocks some of the incident light, it does not block nearly as much light an opaque structure used to define a single aperture. As a result, an implantable ophthalmic device 200 with multiple static apertures 212 and prismatic elements 220 offers the depth-of-field increase associated with a single aperture without the dramatic decrease in light throughput associated with a single aperture.
  • two or more of the refracted beams from the prismatic elements 220 may interfere to create an aberrated image in the retinal plane 5. These aberrations can be reduced or eliminated by adjusting the optical path length associated with one or more of the static apertures, e.g., by adding one or more optical elements as in FIG. 3G to compensate for phase mismatch. In other words, the prismatic elements 220 and optical elements 250 manage only the complex part of wavefront.
  • Inventive implantable ophthalmic devices may take the form of IOLs, intraocular optics (IOOs), corneal inlays, and corneal onlays.
  • the IOL may have optical power provided by a transparent or translucent element with one or more curved surfaces or one or more graded refractive index profiles as described above.
  • the implantable ophthalmic device may be an IOO, which has little to no optical power except when actuated as described herein.
  • An inventive implantable ophthalmic device may be inserted or implanted in the anterior chamber or posterior chamber of the eye, into the capsular sac, or the stroma of the cornea (similar to a corneal inlay), or into the epithelial layer of the cornea (similar to a corneal onlay), or within any anatomical structure of the eye.
  • An inventive implantable ophthalmic device may have one or more thin, hinge-like sections that allow the implantable ophthalmic device to be folded before implantation and unfolded once positioned properly in a patient's eye. When implanted, any partially transparent or opaque elements (other than the opaque element 210 that defines the static apertures 212) may be disposed out of the patient's line of sight.
  • any two components so associated can also be viewed as being “operably connected,” or “operably coupled,” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable,” to each other to achieve the desired functionality.
  • operably couplable include but are not limited to physically mateable components and physically interacting components.

Abstract

An implantable ophthalmic device, such as an intraocular lens, includes two or more apertures whose sizes, shapes, and positions are fixed with respect to the device itself. Each of these static apertures replicates an incident image beam as a shifted image beam, where the direction and magnitude of the shift depend on the static aperture's position with respect to the device's optical axis. The device also includes a prismatic element optically coupled to each static aperture. Each prismatic element receives the shifted image beam from its corresponding static aperture and refracts the shifted image beam such that the resulting refracted beams form a single image at the image plane (retina). Together, the static apertures and the prismatic elements increase the device's effective depth of field (e.g., by up to three Diopters).

Description

AN IMPLANTABLE OPHTHALMIC DEVICE WITH MULTIPLE
STATIC APERTURES
CROSS-REFERENCE TO RELATED PATENT APPLICATION
[0001] This application claims the benefit of U.S. Provisional Application No. 61/471,223, filed on April 4, 2011 , and entitled "An Intraocular Lens with Multiple Apertures," which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] FIG. 1 shows a cross section of a healthy human eye 100. The white portion of the eye is known as the sclera 110 and is covered with a clear membrane known as the conjunctiva 120. The central, transparent portion of the eye that provides most of the eye's optical power is the cornea 130. The iris 140, which is the pigmented portion of the eye and forms the pupil 150. The sphincter muscles constrict the pupil 150 and the dilator muscles dilate the pupil 150. The pupil 150 is the natural aperture of the eye 100. The anterior chamber 160 is the fluid-filled space between the iris and the innermost surface of the cornea 130. The crystalline lens 170 is held in the lens capsule 175 and provides the remainder of the eye's optical power. The retina 190, which is separated from the back surface of the iris 140 by the posterior chamber 180, acts as the "image plane" of the eye 100 and is connected to the optic nerve 195, which conveys visual information to the brain.
[0003] Under normal circumstances, a healthy eye can produce an image on the retina of an object in an object plane. Objects in or near the object plane yield crisp, or focused images, whereas objects that are too far from the object plane appear blurry or out of focus. The distance in front of and behind the object plane over which an object appears to be in focus on the image plane is called the "depth of field" and depends on both the eye's focal length (optical power) and aperture size. A healthy eye can change its optical power (and its depth of field) to image objects at near distances (e.g., less than 1 m), intermediate distances (e.g., about 1 m to about 5 m), and far distances (e.g., more than about 5 m) to the front surface of the retina 190 in a process known as accommodation. [0004] There are two major conditions that affect an individual's ability to focus on near and intermediate distance objects: presbyopia and pseudophakia. Presbyopia is the loss of accommodation of the crystalline lens of the human eye that often accompanies aging. In a presbyopic individual, this loss of accommodation first results in an inability to focus on near distance objects and later results in an inability to focus on intermediate distance objects. It is estimated that there are approximately 90 million to 100 million presbyopes in the United States. Worldwide, it is estimated that there are approximately 1.6 billion presbyopes.
[0005] The standard tools for correcting presbyopia are reading glasses, multifocal ophthalmic lenses, and contact lenses fit to provide monovision. Reading glasses have a single optical power for correcting near distance focusing problems. A multifocal lens is a lens that has more than one focal length (i.e., optical power) for correcting focusing problems across a range of distances. Multifocal optics are used in eyeglasses, contact lenses, and intraocular lenses (IOLs). Multifocal ophthalmic lenses work by means of a division of the lens's area into regions of different optical powers. Multifocal lenses may be comprised of continuous surfaces that create continuous optical power as in a Progressive Addition Lens (PAL). Alternatively, multifocal lenses may be comprised of discontinuous surfaces that create discontinuous optical power as in bifocals or trifocals. Contact lenses fit to provide monovision are two contact lenses having different optical powers. One contact lens is for correcting mostly far distance focusing problems and the other contact lens is for correcting mostly near distance focusing problems.
[0006] Pseudophakia is the replacement of the crystalline lens of the eye with an IOL, usually following surgical removal of the crystalline lens during cataract surgery. For all practical purposes, an individual will get cataracts if he or she lives long enough.
Furthermore, most individuals with cataracts will have a cataract operation at some point in their lives. It is estimated that approximately 1.2 million cataract surgeries are performed annually in the United States, and many of these surgeries involve removal and replacement of the crystalline lens. The absence of the crystalline lens causes a complete loss of accommodation, which results in an inability to focus on either near or intermediate distance objects.
[0007] Aphakia, which is the absence of the crystalline lens, can be corrected using IOLs. Conventional IOLs are monofocal spherical lenses that provide focused retinal images for far objects (e.g., objects over two meters away). Generally, the focal length (or optical power) of a spherical IOL is chosen based on viewing a far object that subtends a small angle (e.g., about seven degrees) at the fovea. Typical patients require spherical IOLs with optical powers between about +10 diopters (D) and about + 36 D. The most commonly required optical power is about +25 D or about +26 D. Unfortunately, all spherical surfaces, including spherical IOLs and the cornea, suffer from spherical aberration, which limits image quality.
[0008] Fortunately, aspheric IOLs can be used to treat presbyopia and aphakia without introducing spherical aberration. In fact, aspheric IOLs with constant negative spherical aberration can even be used to compensate spherical aberration introduced in the cornea. Although these conventional aspheric IOLs provide better images for a wider range of far object scenarios than spherical IOLs, conventional aspheric IOLs do not improve image quality for near or intermediate objects. It has always been always accepted that patients with aspheric IOLs would wear glasses to see near and intermediate objects.
[0009] Conventional approaches for correcting presbyopia and aphakia suffer other drawbacks as well, some of which are more severe than others. For example, while spectacle eyewear is capable of correcting one's vision for far, near and intermediate distances, this approach requires wearing a device that takes away from one's natural appearance. Also, in some cases, certain multifocal lenses may cause the user to perceive distortion and experience vertigo. Approaches for correcting presbyopia or aphakia that include the use of contact lenses can cause discomfort and can also result in one or more of: halos, doubling of vision, light scattering, glare, loss of contrast sensitivity, limited range of focus, and reduction of light hitting the retina. Approaches that include the use of IOLs can result in one or more of: light scattering, glare, halos, ghosting, loss of contrast sensitivity, limited range of focus, and/or reduction of light hitting the retina. These drawbacks, or compromises to one's vision, can be very problematic especially, by way of example only, when driving at night, driving in the rain, or working on a computer.
[0010] An alternate approach to correcting presbyopia involves a implanting a corneal inlay with a small, fixed-diameter aperture in the eye. As is well known in the art of optics, limiting the diameter of the aperture of an optical system, such as the eye, increases the system's depth of field. The aperture increases the depth of field by blocking or attenuating at least some of the light rays that make a large angle with the lens's optical axis (i.e., the aperture blocks some of the non-paraxial light rays). By blocking or attenuating some of the non- paraxial light rays, the aperture reduces the deviation of rays from the image plane, causing objects located within a fixed distance of the focal distance (i.e., within the depth of field) to appear in focus. Increasing the depth of field makes the sharpness decrease more gradually on either side of the focal plane. When implanted in an eye, a corneal inlay with a properly chosen aperture diameter may extend the depth of field to make near and intermediate objects appear in focus.
[0011] Although smaller aperture diameters yield larger depths of field, reducing the aperture diameter also decreases the amount of light available for detection, e.g., by 75% to 90%. If the aperture is too small, then the resulting image may be too dim to see. This reduction in transmitted light may also reduce the contrast ratio. In addition, reducing the number of non-paraxial rays transmitted through the lens may degrade the spatial resolution of any image formed by the lens.
SUMMARY
[0012] One embodiment of the present disclosure relates to an implantable ophthalmic device (and associated methods of imaging with an implantable ophthalmic device) that includes an opaque structure and a plurality of prismatic elements. The opaque structure defines a plurality of static apertures, each of which is in optical communication with a corresponding prismatic element in the plurality of prismatic elements. One or more of the static apertures may be apodized, e.g., according to an apodization function that defines how the transmissivity of the static aperture varies as a function of position from the center of the static aperture. The static apertures may have the same apodization function or a different apodization function.
[0013] In at least one example, the static apertures cover at least about 50% (e.g., 80% or 90%) of the implantable ophthalmic device's clear aperture, or effective size when implanted. They may be arranged in a regular array (e.g., a pattern having both short- and long-range order) or in an irregular array (e.g., a pattern that may have short-range order but not long- range order). In some cases, the irregular array may be a randomized array. [0014] One or more of the static apertures may be in the shape of a triangle, quadrilateral, hexagon, dodecagon, or circle. The static apertures may all be the same shape (e.g., circles), or they may be different shapes (e.g., dodecagons and squares). One or more of the static apertures may have a maximum transverse dimension (e.g., a diameter for a circle) of about 100 microns to about 2.0 millimeters. The opaque structure may define the thickness of one or more static apertures to be about 10 microns to about 500 microns.
[0015] In addition, each prismatic element may include a surface whose gradient forms an angle with an optical axis of the implantable ophthalmic device. Each gradient may be oriented along a radius extending from the optical axis of the implantable ophthalmic device. The plurality of prismatic elements may include a first prismatic element with a first prism angle and a second prismatic element with a second prism angle that is greater than the first prism angle. The second prismatic element may be located farther from the optical axis of the implantable ophthalmic device than the first element.
[0016] The implantable ophthalmic device may also include a lens in optical
communication with the plurality of static apertures. Together, the plurality of static apertures and the plurality of prismatic elements may increase the lens's optical power by about 1.0 Diopters to about 3.0 Diopters. They may also increase the lens's depth of field by about 0.5 Diopters to about 3.0 Diopters.
[0017] The implantable ophthalmic device may also include a plurality of microlenses, each of which is in optical communication with a corresponding static aperture in the plurality of static apertures. Alternatively, or in addition, an exemplary implantable ophthalmic device may include a plurality of optical elements, each of which is in optical communication with a corresponding static aperture in the plurality of static apertures. Each optical element may be thick enough to compensate for a phase mismatch among two or beams transmitted through two or more static apertures in the plurality of static apertures.
[0018] Another embodiment relates to a method of imaging in an eye and a corresponding implantable ophthalmic device. The implantable ophthalmic device includes a plurality of static apertures, which, when implanted in the eye, produce a plurality of second image beams from a first image beam. The implantable ophthalmic device also includes a plurality of prismatic elements, which, when implanted in the eye, refract each second image beam towards the center of the retina to form a single retinal image. In refracting each second image beam, the plurality of prismatic elements may form a third image beam that has a smaller divergence angle than the first image beam so as to increase the depth of field of the eye.
[0019] Each static aperture may be further configured to attenuate light according to an apodization function. The device may also include at least one lens (e.g., a microlens) to focus at least one second image beam in the plurality of second image beams. The device may also include an optical element that is configured to shift a phase of at least one second image beam to compensate for phase mismatch among two or more of the second image beams.
[0020] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the following drawings and the detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosed technology and together with the description serve to explain principles of the disclosed technology. The drawings are not necessarily to scale.
[0022] FIG. 1 is a cross section of a healthy human eye.
[0023] FIG. 2 is a perspective view of an exemplary implantable ophthalmic device.
[0024] FIGS. 3A-3E are plan views of implantable ophthalmic devices with different arrangements of static apertures.
[0025] FIG. 3F is a cross section of an implantable ophthalmic device that includes a plurality of microlenses in optical communication with the static apertures.
[0026] FIG. 3G is a cross section of an implantable ophthalmic device that includes a plurality of optical elements in optical communication with the static apertures. [0027] FIGS. 4A^tC are plots of apodization functions for static apertures in exemplary implantable ophthalmic devices.
[0028] FIGS. 5 A and 5B are diagrams that illustrate intraocular imaging with a monofocal lens (FIG. 5 A) and an exemplary implantable ophthalmic device (FIG. 5B).
DETAILED DESCRIPTION
[0029] Presently preferred embodiments of the invention are illustrated in the drawings. An effort has been made to use the same or like reference numbers to refer to the same or like parts.
[0030] Multiple Static Apertures to Increase Depth of Field
[0031] FIG. 2 is a perspective view of an exemplary implantable ophthalmic device 200 that can be used to increase the depth of field in a presbyopic patient or to replace the crystalline lens in an aphakic patient. The device 200 includes an opaque structure 210 that defines two or more apertures 212 whose shape, size, and position are fixed. The opaque structure 210 (and static apertures 212) can be formed in any number of suitable ways. For instance, the static apertures 212 may be punched into or etched out of a sheet or film of biocompatible material, such as polyvinyldene fluoride or non-hydrogel microporous perflouroether, that blocks or severely attenuates light at visible wavelengths (i.e., from about 450 nm to about 700 nm).
[0032] The film or sheet may be of uniform thickness (e.g., of about 10 microns to about 500 microns), or it may be of varying thickness (e.g., thicker in the center and thinner on the edges). The thickness may be chosen to increase or reduce vignetting by one or more of the apertures 212. The resulting opaque structure 210 scan be embedded in plastic (e.g., acrylic, polyimide, PMMA, PVDF, or any other suitable polymer or fluorocarbon) or glass (e.g., BK7), sandwiched between transparent substrates, or adhered to a transparent substrate to form part of the device 200. The device 200 can also be coated (e.g., with SiOx) to prevent material from escaping into the eye.
[0033] The opaque structure 210 can also be etched or burned into or onto a transparent substrate. For instance, the opaque structure 210 may be burned into a piece of glass or plastic with femtosecond laser pulses focused to the piece's surface or its interior or etched into the piece's surface using a suitable lithographic or etching technique. Etching or burning could be used to create apertures 212 at different depths within a substrate or to create apertures 212 of different thicknesses (e.g., from about 10 microns thick to about 500 microns thick).
[0034] Together, the static apertures 212 may cover 50%, 80%, 90%, or more of the implantable ophthalmic device's clear aperture, which is the area through which light can pass when the device 200 is implanted in an eye. Each static aperture 212 may be in the shape of a triangle (e.g., like apertures 212"' in FIG. 3D), quadrilateral (e.g., a parallelogram, rectangle, or square), hexagon, dodecagon, circle, or any other suitable shape, including both regular and irregular shapes. They can also be in the shape of concentric rings (i.e., annularly shaped), e.g., as in the device 200' with apertures 212' shown in FIG. 3A. Each aperture 212 may have a maximum transverse dimension (diameter) of about 100 microns to about 2.0 millimeters.
[0035] A single device 200 may include apertures 212 of only single shape or of a variety of shapes; likewise, a single device 100 may include apertures 212 of only single size (transverse dimension) or of a variety of sizes (e.g., like apertures 212" in FIG. 3C). The static apertures 212 can be arranged in a regular array as in the devices 200", 200"', and 200"" of FIGS. 3B, 3C, and 3D, respectively. For instance, they may be tiled in tessellated pattern. Alternatively, the static apertures 212 can be arranged in an irregular array, such as a sparse array or an array in which the apertures are arranged in a random or semi-random manner, as shown in FIG. 3E.
[0036] The implantable ophthalmic device 100 also includes one or more prismatic elements 220a-220n (collectively, prismatic elements 220), each of which is in optical communication with a corresponding static aperture 212. That is, there is at least one ray path that intersects the principal planes of a given static aperture 212 and the corresponding prismatic element 220. Although FIG. 2 shows a one-to-one correspondence between static apertures 210 and prismatic elements 220, other devices may include more static apertures 210 than prismatic elements 220 or vice versa. In addition, a single aperture 212 may be in optical communication with more than one prismatic element 220, and a prismatic element 220 may be in optical communication with more than one single aperture 212. As explained below, the prismatic elements 220 may be selected and arranged to correct for any lateral shift in the image location induced by the corresponding static aperture 212.
[0037] FIG. 2 shows that each prismatic element 220 has a corresponding surface 222 in the principal ray's path. Although FIG. 2 shows planar surfaces 222, other implantable ophthalmic devices may include one or more prismatic elements with warped or stepped surfaces. Each surface 222 can be characterized by a gradient 224, or line of steepest descent, whose slope depends on the prism angle of the prismatic element 220. In the device 200 shown in FIG. 2, each prismatic element 220 is oriented such that, when the device 200 is viewed along its optical axis, its gradient 224 appears to radiate from the optical axis. In other words, each gradient 224 is co-planar with a radius that extends perpendicularly from the optical axis.
[0038] The prismatic elements 220 may have gradients 224 of the same slope (prism angle) or of different slopes (prism angles) when viewed along a cross section of the device 200 (e.g., as shown in FIG. 5B). Each prismatic element 220 may have a prism angle of about 1 degree to about 75 degrees (e.g., 15 degrees, 30 degrees, 45 degrees, 60 degrees, or any other value between 1 and 75 degrees). If the gradients 224 are of different slopes, the prismatic elements 220 may be arranged according to increasing slope (prism angle) and distance from the device's optical axis. For instance, prismatic elements 220 with smaller prism angles (slopes) may be disposed closer to the optical axis, and prismatic elements 220 with larger prism angles (slopes) may be disposed farther from the optical axis. In the approximation when the prismatic elements 220 become infmitesimally small and infinitely numerous, the prismatic elements 220 may appear to form a Fresnel phase plate.
[0039] The prismatic elements 220 may be formed from glass (e.g., BK7), plastic (e.g., acrylic, polyimide, PMMA, PVDF, or any other suitable polymer or fluorocarbon), or any other suitable biocompatible material that is substantially transparent and has suitable dispersion characteristics at visible wavelengths. Each element 220 may be about 100 microns to about 2.0 millimeters wide (e.g., about 1.0 millimeters). The prismatic elements 220 may have the same or different refractive indices, which may be about 1.45 to about 1.80 (e.g., about 1.51 to about 1.67), or dispersion characteristics characterized by Abbe number of 25 and above (e.g., 30, 40, 50, 60, 100). The prismatic elements 220 may be formed as individual pieces, groups of pieces, or as a single piece by injection molding, grinding, polishing, or any other suitable method. They can also be formed by selectively melting or nonlinearly altering regions within a transparent substrate, e.g., with focused or shaped pulses of light from a pulsed laser. For a device 200 where the prismatic elements 220 and the opaque structure 210 are separate pieces, the prismatic elements 220 may be bonded to the opaque structure 210 using a suitable adhesive (e.g., a UV-curable adhesive) or any other suitable bonding method.
[0040] The implantable ophthalmic device 200 may also include a transparent element 230 that encapsulates the opaque structure 210 and the prismatic elements 220. In some cases, the transparent element 230 may be formed of two or more individual pieces that are bonded or sealed together around the opaque structure 210, the prismatic elements 220, or both. In other cases, the transparent element 230 is a single piece that bonds to or mates with the opaque structure 210, the prismatic elements 220, or both. In still other cases, the opaque structure 210, the prismatic elements 220, or both are etched, burned, or melted into or onto the transparent element 230. A suitable transparent element 230 may be made of glass, plastic, or any other suitable biocompatible material, such as a hydrophobic acrylic elastomer of glass with a transition temperature in the range of about 0° C to about 20° C (e.g., about 5° C to 10° C), that is substantially transparent at visible wavelengths. In the device 200 shown in FIG. 2, the transparent element's refractive index is lower than that of the prismatic elements 220.
[0041] The transparent element 230 may have no optical power of its own, or it may have static optical power thanks to one or more curved surfaces or a graded index (GRIN) profile. For instance, the transparent element 230 may be a planoconvex or biconvex lens with an optical power of between about 1.0 Diopters and about 36.0 Diopters (e.g., 20 Diopters, 25 Diopters, 30 Diopters, 35 Diopters, or any other value between 1.0 Diopters and 36.0 Diopters. The static apertures 210 and the prismatic elements 220 may be configured to increase the lens's optical power by about 1.0 Diopters to about 3.0 Diopters (e.g., 1.5 Diopters, 2.0 Diopters, 2.5 Diopters, or any other value between 0.5 Diopters to about 3.0 Diopters) and its depth of field by about 0.5 Diopters to about 3.0 Diopters (e.g., 1.0
Diopters, 1.5 Diopters, 2.0 Diopters, 2.5 Diopters, or any other value between 0.5 Diopters to about 3.0 Diopters). [0042] FIG. 3F shows an implantable ophthalmic device 202 that includes one or more microlenses 240, each of which is in optical communication with a corresponding static aperture 220. Each microlens 240 may be an individual piece disposed within a
corresponding static aperture 220. The microlenses 240 may also be formed as an array that is mated or bonded to the opaque structure 210 such that each microlens 240 aligns with a corresponding static aperture 220. The size (diameter) of each microlens 240 may about 50 microns to about 2.0 millimeters (e.g., about 100 microns to about 1.5 millimeters). In another example, the opaque structure 210 may be deposited or disposed between
microlenses 240 in a microlens array. The microlenses 240 may all have the same focal length, or they may have different focal lengths. For instance, the microlens focal length may depend on each microlens's position with respect to the device's optical axis.
[0043] FIG. 3G shows an implantable ophthalmic device 204 that includes one or more optical elements 250. The optical elements 250 can be formed, mated, and aligned in the same fashions as the microlenses described above. Each optical element 250 is in optical communication with a corresponding static aperture and is made of a transparent material, such as glass or plastic, whose refractive index is different that the refractive index of the surrounding material (e.g., air, vacuum, microlens material, or substrate material). The refractive index and thickness of each optical element 250 may be chosen to compensate for a phase mismatch among two or beams transmitted through two or more of the static apertures 212 in the device. For a static aperture 212 that is filled with air or vacuum, phase mismatch can be compensated by selecting the thickness of the static aperture 212 to achieve the desired the optical path length.
[0044] Apodized Static Apertures
[0045] Each static aperture may be apodized according to a particular apodization function whose amplitude varies smoothly from the static aperture's center to its edge. Each static aperture may be perfectly transmissive (or nearly perfectly transmissive) over a central region and perfectly opaque (or nearly perfectly opaque) at its edge. The opaque structure may include or define a boundary region that extends from the static aperture's central region to its edge. The boundary region may have a transmissivity that varies smoothly from about 100% at the central region to about 0% at the edge. [0046] FIGS. 4A-4C illustrate transmission profiles along the cross-sections of different implantable ophthalmic devices. Each profile has multiple transmission windows, each of which corresponds to a different static aperture in the device. Each static aperture is apodized according to a corresponding apodization function, such as a power law function (e.g., with a coefficient of about 1.6), a Gaussian or super-Gaussian function, a Harming window, or any other suitable apodization function. The static apertures may have identical, identically spaced apodization functions as shown in FIG. 4A. They may also have identical apodization functions spaced at unequal intervals, as shown in FIG. 4B; different apodization functions spaced at equal intervals, as shown in FIG. 4C; or different apodization functions spaced at unequal intervals.
[0047] Imaging with Multiple Static Apertures
[0048] FIGS. 5 A and 5B illustrate intraocular imaging with a monofocal intraocular lens (IOL) 30 (FIG. 5 A) and intraocular imaging with an implantable ophthalmic device 200 that includes multiple static apertures 212 and prismatic elements 220 (FIG. 5B). A first beam 3 of light from an object 1 impinges on the monofocal lens 30, which produces a second beam 5 that illuminates a retinal plane 9 of a presbyopic or psueodophakic eye. When the object 1 is at far distances (e.g., distances greater than 5 m), the second beam 5 comes into focus at the retinal plane 9 to produce an image 7 of the object 1. The image 7 may appear blurry when the object 1 is at near distances (e.g., distances closer than 1 m) or intermediate distances (e.g., distances of about 1 m to about 5 m) due to the IOL's limited depth of field and its inability to accommodate for changes in object position.
[0049] In contrast, the implantable ophthalmic device 200 produces a relatively sharp single image 7 over a depth of field that may extend over near and intermediate object distances. As in in FIG. 5 A, light propagating from the object 1 forms an incident beam, or first beam 3, that illuminates each of the static apertures 212. Each static aperture 212 projects a second, shifted image beam 5' towards the retinal plane 9. Because each static aperture 212 is at a different position from the optical axis, each shifted image beam 5' forms an image on the retina 9 that is shifted with respect to the other beams 5' from the other static apertures 212. Unless these shifts are corrected or compensated, these shifted images may be blurred beyond recognition. [0050] The prismatic elements 220 correct for the shifts in the image beams 5 ' by referacting the image beams 5' slightly. The prismatic elements 220 do not necessarilty produce constructively interfering beams; rather, they shift the shifted image beams 5' such that beams' modulation transfer functions (MTFs) add together. In other words, the prismatic elements 220 align the shifted image beams 5' such that the beams' intensities add at the retinal plane 9 to form a single image 7. In doing so, the prismatic elements 220 convert the shifted beams 5' into a third beam 11 whose divergence angle is smaller than that of the image beam 5 produced by the monofocal IOL 30. The third beam 11 has a wider waist and is more nearly collimated than the image beam 5 produced by the monofocal IOL 30.
[0051] Together, the static apertures 212 and prismatic elements 220 spread the single focal point of the lens 230 over about three Diopters in image space. This increases the depth of field, but it may also reduce the spatial resolution and contrast sensitivity of the lens. Even though the opaque structure 210 blocks some of the incident light, it does not block nearly as much light an opaque structure used to define a single aperture. As a result, an implantable ophthalmic device 200 with multiple static apertures 212 and prismatic elements 220 offers the depth-of-field increase associated with a single aperture without the dramatic decrease in light throughput associated with a single aperture.
[0052] In some cases, two or more of the refracted beams from the prismatic elements 220 may interfere to create an aberrated image in the retinal plane 5. These aberrations can be reduced or eliminated by adjusting the optical path length associated with one or more of the static apertures, e.g., by adding one or more optical elements as in FIG. 3G to compensate for phase mismatch. In other words, the prismatic elements 220 and optical elements 250 manage only the complex part of wavefront.
[0053] Implanting an Implantable Ophthalmic Device with Multiple Static Apertures
[0054] Inventive implantable ophthalmic devices may take the form of IOLs, intraocular optics (IOOs), corneal inlays, and corneal onlays. In cases where the implantable ophthalmic device is an IOL, the IOL may have optical power provided by a transparent or translucent element with one or more curved surfaces or one or more graded refractive index profiles as described above. Alternatively, the implantable ophthalmic device may be an IOO, which has little to no optical power except when actuated as described herein. [0055] An inventive implantable ophthalmic device may be inserted or implanted in the anterior chamber or posterior chamber of the eye, into the capsular sac, or the stroma of the cornea (similar to a corneal inlay), or into the epithelial layer of the cornea (similar to a corneal onlay), or within any anatomical structure of the eye. An inventive implantable ophthalmic device may have one or more thin, hinge-like sections that allow the implantable ophthalmic device to be folded before implantation and unfolded once positioned properly in a patient's eye. When implanted, any partially transparent or opaque elements (other than the opaque element 210 that defines the static apertures 212) may be disposed out of the patient's line of sight.
[0056] Conclusion
[0057] The herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. Such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively "associated" such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as "associated with" each other such that the desired functionality is achieved, irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being "operably connected," or "operably coupled," to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being "operably couplable," to each other to achieve the desired functionality. Specific examples of operably couplable include but are not limited to physically mateable components and physically interacting components.
[0058] With respect to the use of substantially any plural and singular terms herein, those having skill in the art can translate from the plural to the singular and from the singular to the plural as is appropriate to the context or application. The various singular and plural permutations may be expressly set forth herein for sake of clarity.
[0059] It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations.
[0060] However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to inventions containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations).
[0061] Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together, etc.). In those instances where a convention analogous to "at least one of A, B, or C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together, etc.).
[0062] It will be further understood by those within the art that virtually any disjunctive word or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A," "B," and "A and B."
[0063] The foregoing description of illustrative embodiments has been presented for purposes of illustration and of description. It is not intended to be exhaustive or limiting with respect to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosed embodiments. It is intended that the scope of the invention be defined by the claims appended hereto and their equivalents.

Claims

WHAT IS CLAIMED IS:
1. An implantable ophthalmic device comprising:
an opaque structure defining a plurality of static apertures; and
a plurality of prismatic elements, each prismatic element in the plurality of prismatic elements in optical communication with a corresponding static aperture in the plurality of static apertures.
2. The implantable ophthalmic device of claim 1 wherein at least one static aperture in the plurality of static apertures is apodized.
3. The implantable ophthalmic device of claim 1 wherein the plurality of static apertures is configured to produce a plurality of second image beams from a first image beam when implanted in an eye.
4. The implantable ophthalmic device of claim 1 wherein the plurality of static apertures covers at least about 50% of a clear aperture of the implantable ophthalmic device.
5. The implantable ophthalmic device of claim 1 wherein the static apertures in the plurality of static apertures are arranged in a regular array.
6. The implantable ophthalmic device of claim 1 wherein the static apertures in the plurality of static apertures are arranged in an irregular array.
7. The implantable ophthalmic device of claim 6 wherein the irregular array is a randomized array.
8. The implantable ophthalmic device of claim 1 wherein the plurality of static apertures comprises at least one static aperture in the shape of a triangle, quadrilateral, hexagon, dodecagon, or circle.
9. The implantable ophthalmic device of claim 1 wherein the plurality of static apertures comprises at least one static aperture having a maximum transverse dimension of about 100 microns to about 2.0 millimeters.
10. The implantable ophthalmic device of claim 1 wherein the plurality of static apertures comprises at least one static aperture having a thickness of about 10 microns to about 500 microns.
11. The implantable ophthalmic device of claim 1 wherein the plurality of prismatic elements is configured to refract a plurality of first image beams towards the center of the retina to form a single retinal image.
12. The implantable ophthalmic device of claim 1 wherein each prismatic element in the plurality of prismatic elements includes a surface whose gradient forms an angle with an optical axis of the implantable ophthalmic device.
13. The implantable ophthalmic device of claim 12 wherein each gradient is oriented along a radius extending from the optical axis of the implantable ophthalmic device.
14. The implantable ophthalmic device of claim 1 wherein the plurality of prismatic elements comprises:
a first prismatic element having a first prism angle;
a second prismatic element having a second prism angle greater than the first prism angle, the second prismatic element being located farther from the optical axis of the implantable ophthalmic device than the first element.
15. The implantable ophthalmic device of claim 1 further comprising:
a lens in optical communication with the plurality of static apertures.
16. The implantable ophthalmic device of claim 15 wherein the plurality of static apertures and the plurality of prismatic elements increase the optical power of the lens by about 1.0 Diopters to about 3.0 Diopters.
17. The implantable ophthalmic device of claim 15 wherein the plurality of static apertures and the plurality of prismatic elements increase the depth of field of the lens by about 0.5 Diopters to about 3.0 Diopters.
18. The implantable ophthalmic device of claim 1 further comprisinj a plurality of microlenses, each microlens in the plurality of microlenses in optical communication with a corresponding static aperture in the plurality of static apertures.
19. The implantable ophthalmic device of claim 1 further comprising:
a plurality of optical elements, each optical element in the plurality of optical elements in optical communication with a corresponding static aperture in the plurality of static apertures and having a thickness to compensate for a phase mismatch among two or beams transmitted through two or more static apertures in the plurality of static apertures.
20. A method of imaging in an eye, the method comprising:
producing, with a plurality of static apertures implanted in the eye, a plurality of second image beams from a first image beam; and
refracting each second image beam towards the center of the retina with a respective prismatic element to form a single retinal image.
21. The method of claim 20, wherein refracting each second image beam forms a third image beam having a smaller divergence angle than the first image beam so as to increase the depth of field of the eye.
22. The method of claim 20, wherein producing the plurality of second image beams further comprises attenuating light at an edge of each static aperture according to an apodization function.
23. The method of claim 20, further comprising:
focusing at least one second image beam in the plurality of second image beams.
24. The method of claim 20, further comprising:
shifting a phase of at least one second image beam to compensate for phase mismatch among two or more of the second image beams.
25. A implantable ophthalmic device comprising:
an opaque structure defining a plurality of static apertures, which, when implanted in an eye, produce a plurality of second image beams from a first image beam; and a plurality of prismatic elements, which, when implanted in the eye, refract each second image beam towards the center of the retina to form a single retinal image.
26. The implantable ophthalmic device of claim 25, wherein the opaque structure, when implanted in the eye, attenuates light at an edge of each static aperture according to an apodization that varies as a function of each static aperture's distance from the optical axis of the eye.
27. The implantable ophthalmic device of claim 25, wherein the plurality of prismatic elements is further configured to form a third image beam having a smaller divergence angle than the first image beam when implanted in the eye.
28. The implantable ophthalmic device of claim 25, further comprising:
a microlens, which, when implanted in the eye, focuses one second image beam in the plurality of second image beams.
29. The implantable ophthalmic device of claim 25, further comprising:
an optical element, which, when implanted in the eye, shifts a phase of at least one second image beam to compensate for phase mismatch among two or more of the second image beams.
PCT/US2012/025922 2011-04-04 2012-02-21 An implantable ophthalmic device with multiple static apertures WO2012138426A2 (en)

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