Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular 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
  • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular 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
  • A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
  • A61F2/1618—Multifocal lenses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2002/16965—Lens includes ultraviolet absorber
  • A61F2002/1699—Additional features not otherwise provided for
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS 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
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
  • A61F2009/00887—Cataract
  • A61F2009/00889—Capsulotomy

Definitions

• the human eye often suffers from aberrations such as defocus and astigmatism that must be corrected to provide acceptable vision to maintain a high quality of life. Correction of these defocus and astigmatism aberrations can be accomplished using a lens.
• the lens can be located at the spectacle plane, at the corneal plane (a contact lens or corneal implant) , or within the eye as a phakic (crystalline lens intact) or aphakic (crystalline lens removed) intraocular lens (IOL) .
• the eye In addition to the basic aberrations of defocus and astigmatism, the eye often has higher-order aberrations such as spherical aberration and other aberrations. Chromatic aberrations, aberrations due to varying focus with wavelength across the visible spectrum, are also present in the eye. These higher-order aberrations and chromatic aberrations negatively affect the quality of a person's vision. The negative effects of the higher-order and chromatic aberrations increase as the pupil size increases. Vision with these aberrations removed is often referred to as high definition (HD) vision.
• HD high definition
• Presbyopia is the condition where the eye loses its ability to focus on objects at different distances. Aphakic eyes have presbyopia.
• a standard monofocal IOL implanted in an aphakic eye will restore vision at a single focal distance. To provide good vision over a range of distances, a variety of options can be applied, among them, using a monofocal IOL combined with bi-focal or progressive addition spectacles.
• a monovision IOL system is another option to restore near and distance vision - one eye is set at a different focal length than the fellow eye, thus providing binocular summation of the two focal points and providing blended visions.
• IOLs Monovision is currently the most common method of correcting presbyopia by using IOLs to correct the dominant eye for distance vision and the non-dominant eye for near vision in an attempt to achieve spectacle-free binocular vision from far to near.
• IOLs can be bifocal or multifocal.
• Most IOLs are designed to have one or more focal regions distributed within the addition range.
• using elements with a set of discrete foci is not the only possible strategy of design: the use of elements with extended depth of field (EDOF) , that is, elements producing a continuous focal segment spanning the required addition, can also be considered. These methods are not entirely acceptable as stray light from the various focal regions degrade a person's vision.
• EEOF extended depth of field
• a virtual aperture integrated into an intraocular lens IOL
• the construction and arrangement permit optical rays which intersect the virtual aperture and are widely scattered across the retina, causing the light to be virtually prevented from reaching detectable levels on the retina.
• the virtual aperture helps remove monochromatic and chromatic aberrations, yielding high-definition retinal images. For a given definition of acceptable vision, the depth of field is increased over a larger diameter optical zone IOL. Eyes with cataracts can have secondary issues due to injury, previous eye surgery, or eye disorder that would not be well corrected with normal IOL designs.
• eyes with complications include: asymmetric astigmatism, keratoconus, postoperative corneal transplant, asymmetric pupils, very high astigmatism, and the like. Because of its ability to remove unwanted aberrations, our virtual aperture IOL design would be very effective in provided enhanced vision compared to normal large optic IOLs.
• An objective of the invention is to teach a method of making thinner IOLs since the optical zone can have a smaller diameter, which allows smaller corneal incisions and easier implantation surgery.
• Eyes with cataracts can have secondary issues due to injury, previous eye surgery, or eye disorder that would not be well corrected with normal IOL designs. Examples of eyes with complications include: asymmetric astigmatism, keratoconus, postoperative corneal transplant, asymmetric pupils, very high astigmatism, and the like. Because of its ability to remove unwanted aberrations, the disclosed virtual aperture IOL design is effective in providing enhanced vision compared to normal large optic IOLs .
• Another objective of the invention is to teach a virtual aperture IOL that exhibits reduced monochromatic and chromatic aberrations, as well as an extended depth of field, while providing sufficient contrast for resolution of an image over a selected range of distances.
• Still another objective of the invention is to teach a virtual aperture IOL that provides a smaller central thickness compared to other equal-powered IOLs.
• Another objective of the invention is to teach a virtual aperture that can be realized as alternating high-power positive and negative lens profiles.
• Yet still another objective of the invention is to teach a virtual aperture that can be realized as high-power negative lens surfaces.
• Another objective of the invention is to teach a virtual aperture that can be realized as high-power negative lens surfaces in conjunction with alternating high-power positive and negative lens profiles.
• Yet another objective of the invention is to teach a virtual aperture that can be realized as prism profiles in conjunction with alternating high-power positive and negative lens profiles.
• Still another objective of the instant invention is to overcome these limitations by providing a phakic or aphakic IOL which simultaneously: provides correction of defocus and astigmatism, decreases higher-order and chromatic aberrations, and provides an extended depth of field to improve vision quality .
• Another objective of the invention is to teach a virtual aperture that can be employed in phakic or aphakic IOLs, a corneal implant, a contact lens, or used in a cornea laser surgery (LASIK, PRK, etc.) procedure to provide an extended depth of field and/or to provide high-definition vision.
• LASIK cornea laser surgery
• Yet another objective is to provide an IOL for eyes with complications such as asymmetric astigmatism, keratoconus, postoperative corneal transplant, asymmetric pupils, very high astigmatism, and the like.
• Still another objective is to provide an IOL capable of removing unwanted aberrations to provide enhanced vision compared to normal large optic IOLs .
• Another objective of the invention is to teach replacement of the virtual aperture with an actual opaque aperture and realize the same optical benefits as the virtual aperture .
• Fig. 1 illustrates the basic method of reducing monochromatic aberrations using pupil size
• Fig. 2 illustrates the basic method of reducing chromatic aberrations using pupil size
• Fig. 3 illustrates the basic concept of the virtual aperture to limit the effective pupil size
• Fig. 4 illustrates the virtual aperture as a high- power lens section integrated into an IOL
• Fig. 5 illustrates the virtual aperture as a negative lens section
• Fig. 6 illustrates the virtual aperture as a negative lens (or prism) section in conjunction to a high-power lens section
• Fig. 7 illustrates using the virtual aperture to prevent the negative effect of a small optic zone
• Fig. 8 illustrates lens A example of an oblong shaped optical zone and lens B example of a circular shaped optical zone ;
• Fig. 10 illustrates symmetric radial profiles comparing elements A, B, C, D, & E;
• Fig. 11 illustrates two-dimensional lens regions
• Fig. 12 illustrates the geometry for one of the two- dimensional high-power lenses.
• Figure 1 illustrates a single converging lens 1 centered on an optical axis 2.
• An incident ray 3 is parallel to the optical axis and will intersect the focal point 4 of the lens. If the observation plane 5 is located a further distance from the focal point, the incident ray will continue until it intersects the observation plane.
• the optical principle represented here is that as the height of parallel incident rays is reduced, the corresponding blur circle is also reduced. This simple relationship is applicable to the human eye. Stated another way, for a given amount of defocus (dioptric error) in the eye, vision is improved as the height of incident rays is reduced. This principle is used when someone squints in an attempt to see an out-of-focus object more clearly.
• FIG. 1 The tracing in Figure 1 is for a single wavelength of incident light.
• three wavelengths in this case we have the situation in Figure 2. It is well known for the components of the eye and typical optical materials that, as wavelength increases, the refractive index decreases.
• a converging lens 21 has optical axis 22.
• An incident ray 23 consists of three wavelengths for blue (450 nm) , green (550 nm) , and red (650 nm) light. Due to different indices of refraction for the three wavelengths, the blue light ray 24 is refracted more than the green light ray 25, and the green light ray is refracted more than the red light ray 26.
• the green light ray If the green light ray is in focus, then it will cross the observation plane 27 at the optical axis. The chromatic spread of these three rays lead to a chromatic blur circle 28 on the observation plane.
• the incident chromatic ray 29 has a lower ray height than the chromatic ray 23 in 2A. This leads to the smaller chromatic blur circle 33 at the observation plane.
• chromatic blur is decreased as the chromatic ray height is decreased.
• Figures 1 and 2 illustrate that decreasing ray height (decreasing the pupil diameter) decreases both monochromatic and chromatic aberrations at the retina, thus increasing the quality of vision. Another way to describe this is that the depth of field is increased as the ray height is decreased.
• Figure 3A illustrates a converging lens 34 with optical axis 2 and aperture 35.
• Incident ray 36 clears the aperture and thus passes through the lens focal point 37 and intersects the observation plane 38 where it traces a small blur circle 39.
• Incident ray 40 is blocked by the aperture, and thus it cannot continue to the observation plane to cause a larger blur circle 41.
• An aperture which limits the incident ray height reduces the blur on the observation plane.
• Figure 3B we illustrate what we describe as a "virtual aperture". That is, it is not really an aperture that blocks rays, but the optical effect is nearly the same.
• the virtual aperture 48 is positioned further in the periphery and the IOL haptic 50 is located in the far periphery.
• the virtual aperture is connected to the optical zone by transition region 47 and the haptic is connected to the virtual aperture by transition region 49.
• the transition regions 47 and 49 are designed to ensure zero-order and first-order continuity of the surface on either side of the transition region. A common method to implement this is a polynomial function such as a cubic Bezier function. Transition methods such as these are known to those skilled in the art .
• the virtual aperture zone 48 is a sequence of high-power positive and negative lens profiles.
• These profiles could be realized as sequential conics, polynomials (such as Bezier functions), rational splines, diffractive profiles, or other similar profiles, as long as the entire region properly redirects and/or disperses the refracted rays.
• the preferred use is smooth high-power profiles over diffractive profiles as this simplifies manufacturing the IOL on a high-precision lathe or with molds.
• the posterior side of the haptic should include a square edge to inhibit cell growth leading to posterior capsule opacification.
• Figure 5 illustrates another profile for the virtual aperture zone 51, namely a diverging lens profile. Note that this requires a thicker edge profile than the approach in Figure 4.
• Figure 6A we show a close up of the preferred high-powered alternating positive and negative lens profiles with the incident and transmitted rays.
• Figure 6B illustrates the effect of combining the profile in 6A with either an underlying prism or negative lens. In this case not only are the emergent rays scattered widely, they are directed away from the eye's macula, or central vision section of the retina, again, at the cost of a wider lens edge.
• HD high definition
• EEOF extended depth of field
• FIG. 4 The basic layout of the virtual aperture IOL is illustrated in Figure 4.
• the diameter of the central optical zone 46 is 3.0 mm and the width of the virtual aperture 48 is 1.5 mm.
• the combination of central optical zone and virtual aperture is a 6.0-mm diameter optic, which is similar to common commercially available IOLs.
• the toric correction is easily made by those skilled in the art by providing two principle powers at two principle directions which would be aligned with the eye's corneal astigmatic powers.
• the spherical aberrations for either the spherical or toric lens are corrected by employing a conic profile on one or more surfaces of the lens.
• a conic profile is said to have zero aberrations as there are zero monochromatic aberrations in the lens for an on-axis, distant object.
• the apical radius Ra of the conic profile is computed as usual for the desired paraxial power of the lens.
• a conic constant K is then selected based upon the lens material index of refraction, the lens center thickness, and the shapes of the front and back surface of the lens .
• the toric optic has an equal biconvex surface design where each surface is biconic.
• the non-toric optic has an equal biconvex surface design where each surface is conic.
• the optimal conic constant K for the surfaces is determined using optical ray tracing known to those skilled in the art.
• Multiple focal points Some patients may prefer a multi-focal point optic providing vision correction for specific distances.
• One example is a bifocal optic which generally provides focusing power for both near and distant vision.
• FIG. 9 illustrated is azimuthally symmetric radial profiles.
• the profiles can be all the same or adjusted in the azimuth direction. These profiles can be refractive or diffractive in nature. Although, eight distinct radial profiles are illustrated, the radial profiles are continuous in the azimuth direction.
• the radial profiles can have alternating positive and negative power, all positive power, or all negative power sections. The connections between all the power regions are smooth to prevent visual artifacts.
• FIG 10 illustrated are other symmetric radial profiles include combinations of planar, negative power, and ramp base shapes in addition to or instead of the high-power curves indicated in Figure 8.
• element A depicts a simple plane base shape.
• element B depicts a negative power base shape.
• This generally negative power curved profile can be represented by a portion of a sphere, a conic, or higher order curve such as a polynomial.
• element C depicts a segmented negative power profile of element B, where the curve has been segmented similar to a Fresnel lens, to keep the overall lens thickness small.
• element D depicts a ramp base shape profile
• element E depicts a segmented version of the ramp base shape, where the ramp has been segmented similar to a Fresnel lens, to keep the overall lens thickness small.
• segmented profiles of elements C and E are illustrated with sharp discontinuities, in practice, the boundaries of the segments are implemented using smooth functions such as filets or Bezier curves to prevent observable artifacts caused by the sharp discontinuities. Additionally, a smooth transition region is placed between the optic zone and the virtual aperture as described elsewhere in this document.
• These base shapes can be used in conjunction with or instead of the high-power features to improve the effectiveness of the virtual aperture.
• Figure 11 illustrates two-dimensional lens regions oriented in a polar sampling.
• the high-power lenses alternate in positive and negative power in both the radial and azimuthal directions.
• Two positive power lenses and two negative power lenses are illustrated in the figure.
• the actual geometry of these two-dimensional polar lenses is on the order of the radial profiles .
• the two-dimensional high-power lenses could be all positive or all negative lenses.
• the high-power lenses are separated by small smooth transition regions (for example, a continuous polynomial interpolator such as a Bezier curve) to prevent visual artifacts.
• This is the preferred two-dimensional high-power lens structure when there is more than one lens sample rate in the azimuth direction.
• the individual lenses look like small pillows where the pillows are above the base surface for positive power lenses and are below the surface for negative power lenses.
• Figure 12 illustrates the geometry for one of the two- dimensional high-power lenses.
• the upper right portion of the figure we show a front view of the high-power lens.
• the radial extent of this region is given by r
• the width of the transition region is given by t
• the azimuthal subtense is given by theta.
• the lower left portion of the figure we show a side view of one of the profiles of the lens.
• the central part represents the high-power optical zone and the two side curves represent the transition zones.
• the interface between the optical zone and the transition zones has zero- and first-order continuity.
• the transition is coincident with the virtual aperture base shape (which is typically a vertical line on the IOL) .
• the virtual aperture base shape which is typically a vertical line on the IOL
• the transition curve typically a polynomial curve
• the shape of this small high-power lens region is set so that the radial extent r is approximately equal to the arc-length of the center portion of the region.
• the central optical zone can be designed using standard IOL design concepts to provide sphere, cylinder, and axis correction, as well as higher-order correction such as spherical aberration control. These design concepts are known to those skilled in the art.
• the preferred virtual aperture profiles illustrated in Figure 4 have alternating positive and negative lens profiles with focal lengths on the order of +/- 1.5 mm. These lens surface profiles can be generated using conics, polynomials (such as cubic Bezier splines), rational splines, and combinations of these and other curves.
• the geometry of the lens profiles is selected to adequately disperse the transmitted optical rays across the retina and at the same time be relatively easy to manufacture on a high-precision lathe or with a mold process. It is also possible to place a smooth surface on one profile (for example the front surface) and the small high-power lens profiles on the other surface profile (for example the back surface) .
• the edge thickness of the IOL and the center thickness of the central optical zone can be quite small, even for high-power IOLs.
• the material of the lens is the same as those used for other soft or hard IOL designs.
• the IOL design provides very good, high-definition, distance vision and the range of "clear vision” can be controlled by specification of what is meant by “clear vision” (e.g., 20/40 acuity) , and the relative size of the central optic zone and the virtual aperture width.
• clear vision e.g. 20/40 acuity
• a simple equation [Smith G, Relation between spherical refractive error and visual acuity, Optometry Vis. Sci. 68, 591-8, 1991] for estimating the acuity given the pupil diameter and spherical refractive error is given in equation (la and lb) . -k D E (la)
• Equation (lb) tells us the acuity A given the range of depth of field (E x 2) in diopters and the pupil diameter D.
• Equation (2) tells the range of depth of field in diopters given the acuity A and the pupil diameter D. For example, for:
• the concept of the virtual aperture can be employed in phakic or aphakic IOLs, a corneal implant, a contact lens, or used in a cornea laser surgery (LASIK, PRK, etc.) procedure to provide an extended depth of field and/or to provide high- definition vision. Also, it would be possible to replace the virtual aperture with an actual opaque aperture and realize the same optical benefits as the virtual aperture.
• LASIK cornea laser surgery

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• 2020
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