Patent Application
20060116765
The present invention is directed to an artificial ocular lens (AOL), in particular a refractive correction lens (RCL). A preferred embodiment includes a foldable or deformable anterior chamber phakic refractive correction lens (pRCL) or aphakic refractive correction lens (apRCL) having multiple visual correction features or capabilities or otherwise a custom refractive correction lens (cRCL) configured for implantation through a very small incision in the eye.
The concept of implanting an artificial ocular lens (AOL) into the eye is old. The initial artificial lens was an intraocular lens (IOL) implanted in the eye to replace a damaged natural lens or cataract lens. The early intraocular lens was made of optical glass, and then the glass material was eventually replaced with a rigid optical grade plastic material such as polymethylmethacylate (PMMA). The rigid glass or plastic lens requires a substantially large incision to be made in the patient's eye for implantation therein.
With time, foldable or deformable intraocular lenses (IOLs) were proposed and made for insertion through a small incision in the eye of around three and one-half millimeters (3.5 mm) or less. It was found that the smaller the eye incision was made, the less surgical complications occurred and better the post surgical eye vision was obtained by the patient. Today, incisions on the order of two and one-half millimeters (2.5 mm) to two millimeters (2.0 mm), or less can be used for implanting foldable or deformable intraocular lenses using a forceps or lens injecting device.
Still today, most artificial ocular lenses (AOLs) being surgically implanted in the eye are intraocular lenses (IOLs) for the replacement of the natural lens due to cataract. In some instances, a clear non-cataract natural lens is removed (i.e. clear lensectomy), and replaced with an intraocular lens to improve or correct the patient's vision. The latest developments include phakic refractive correction lenses (pRCLs) such as the Kelman Duet anterior chamber lens for refractive correction of the eye.
The artificial ocular lenses (AOLs) including intraocular lenses (IOLs) and refractive correction lenses (RCLs) currently being made and surgically implanted in the eye today typically have only a single or one (1) visual correction factor or capability to provide power correction of the eye. A limited number of intraocular lenses (IOLs) made and implanted today have two (2) visual correction factors or capabilities for both power correction and astigmatic correction (e.g. toric adjustment) of the eye. The intraocular lens (IOLs) are manufactured in a limited number or increments of lens powers and a limited number or increments of sphere and cylinder for astigmatic correction. The “best fit” and “best available” intraocular lens (IOL) for a particular patient is selected by the eye surgeon after examination of the patient's eye. Specifically, the eye surgeon's choice of intraocular lens is limited to the “best fit” IOL available in the incremental series of both power and toric to best visually correct the patient's eye. Many times the particular intraocular lens selected and implanted by the eye surgeon does not visually correct the patient's eye to a suitable extent or degree.
The refractive correction lenses (RCLs) are still in the early stages of being proposed and in some instances are being researched and developed. Actual manufacturing and implantation of refractive correction lenses (RCLs) is very limited providing little clinical and statistical data. For example, the Kelman Duet anterior chamber phakic refractive correction lens (pRCL) is currently made in very small quantities and implanted in Europe. The Kelman Duet pRCL only provides for refractive correction of the power of the eye. Aphakic refractive correction lenses (apRCLs) have been proposed for use in combination with an artificial capsular lenses or intraocular lenses (IOLs), and may be the same or similar in design or configuration to phakic refractive correction lens (pRCLs).
There exists a need to be able to accurately and effectively visually or optically correct multiple visual defects or problems with a patient's eye using a custom artificial ocular lens (c-AOL) such as a custom intraocular lens (c-IOL) and/or a custom refractive correction lens (c-RCL) such as a custom phakic refractive correction lens (c-pPRCL) or a custom aphakic refractive correction lens (c-apRCL). The artificial ocular lenses (AOLs) according to the present invention address this need.
A first (1st) object of the present invention is to provide an improved artificial ocular lens (AOL) for implantation in the eye.
A second (2nd) object of the present invention is to provide an improved intraocular lens (IOL).
A third (3rd) object of the present invention is to provide an improved refractive correction lens (RCL).
A fourth (4th) object of the present invention is to provide an improved phakic refractive correction lens (pRCL).
A fifth (5th) object of the present invention is to provide an improved aphakic refractive correction lens (apRCL).
A sixth (6th) object of the present invention is to provide a custom artificial ocular lens (c-AOL).
A seventh (7th) object of the present invention is to provide a custom intraocular lens (c-IOL).
An eighth (8th) object of the present invention is to provide a custom refractive correction lens (c-RCL).
A ninth (9th) object of the present invention is to provide a custom phakic refractive lens (c-PRL).
A tenth (10th) object of the present invention is to provide a custom aphakic refractive correction lens (c-apRCL).
An eleventh (11th) object of the present invention is to provide an intraocular lens (IOL) configured to visually correct at least three (3) different types of visual defects or problems with a patient's eye.
A twelfth (12th) object of the present invention is to provide a refractive correction lens (RCL) configured to visually correct at least two (2) different types of visual defects or problems with a patient's eye.
A thirteenth (13th) object of the present invention is to provide an anterior chamber refractive correction lens (RCL) configured to visually correct at least two (2) different types of visual defects or problems with a patient's eye.
A fourteenth (14th) object of the present invention is to provide a refractive correction lens (RCL) configured to visually correct at least three (3) different types of visual defects or problems with a patient's eye.
A fifteenth (15th) object of the present invention is to provide an anterior chamber refractive correction lens (RCL) configured to correct at least three (3) different types of visual defects or problems with a patient's eye.
A sixteenth (16th) object of the present invention is to provide an artificial ocular lens (AOL) capable of visually correcting a patient's vision to 20:20 or best correctable vision.
A seventeenth (17th) object of the present invention is to provide an artificial ocular lens (AOL) capable of correcting a patient's vision to 20:10 or best correctable vision.
An eighteenth (18th) object of the present invention is to provide an artificial ocular lens (AOL) capable of correcting a patient's vision to 20:7 or best correctable vision.
A nineteenth (19th) object of the present invention is to provide a refractive correction lens (RCL) configured to correct the power and astigmatism of the eye.
A twentieth (20th) object of the present invention is to provide an anterior chamber refractive correction lens (acRCL) configured to correct the power and astigmatism of the eye.
A twenty-first (21st) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or cornea, iris, natural lens, retina and/or other inner eye structure imperfections of the eye.
A twenty-second (22nd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of the natural lens of the eye.
A twenty-third (23rd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of the cornea of the eye.
A twenty-fourth (24rd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of the natural lens and cornea of the eye.
A twenty-fifth (25rd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of a prior implanted intraocular lens (IOL).
A twenty-sixth (26rd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of a prior implanted refractive correction lens (RCL).
A twenty-seventh (27rd) object of the present invention is to provide an artificial ocular lens (AOL) configured to correct for aberrations and/or surface imperfections of a prior implanted intraocular lens (IOL) and refractive correction lens (RCL).
A twenty-eight (28th) object of the present invention is to provide an artificial ocular lens (AOL) configured to visually correct a patient's eye for power, astigmatism and aberrations.
A twenty-ninth (29th) object of the present invention is to provide an intraocular lens (IOL) configured to visually correct a patient's eye for power, astigmatism and aberrations.
A thirtieth (30th) object of the present invention is to provide a refractive correction lens (RCL) configured to visually correct a patient's eye for power, astigmatism and aberrations.
A thirty-first (31th) object of the present invention is to provide an anterior chamber refractive correction lens (acRCL) configured to visually correct a patient's eye for power, astigmatism and aberrations.
The present invention is directed to an artificial ocular lens (AOL), for example, an intraocular lens (IOL) (i.e. implantable artificial ocular lens (AOL) or implant for replacement of the natural eye lens) and a refractive correction lens (RCL) (i.e. implantable artificial ocular lens (AOL) or implant for refractive correction of the natural lens or a prior implanted intraocular lens (IOL) and/or a prior implanted refractive correction lens (RCL)).
A preferred embodiment of the artificial ocular lens (AOL) according to the present invention is a foldable or deformable phakic refractive correction lens (pRCL) (i.e. refractive lens added to to eye having a substantially healthy natural crystalline lens) or aphakic supplemental refractive correction lens (ap-sRCL) (i.e. refractive lens added to an eye having a replacement IOL lens) configured to be implanted through a very small incision in the eye (i.e. less than 2 mm and preferably 1 mm). A more preferred embodiment is a foldable or deformable anterior chamber phakic refractive correction lens (ac-pRCL) or aphakic supplemental refractive correction lens (ap-sRCL) configured to be implanted through a very small incision in the eye. A most preferred embodiment is a foldable or deformable custom anterior chamber phakic refractive correction lens (c-ac-pRCL) or aphakic supplemental refractive correction lens (ap-sRCL) configured to be implanted through a very small incision in the eye.
The intraocular lens (IOL) and refractive correction lens (RCL) according to the present invention preferably correct at least two, and more preferably at least three visual problems or defects (e.g. refractive problems, tissue problems, impairments, abnormalities, disease or other factors or conditions impairing or negatively affecting a patient's vision). In a preferred embodiment of the artificial ocular lens (AOL) according to the present invention, a patient's vision is corrected to 20:20, more preferably to 20:10, and even possibly to 20:7 and/or best correctable vision. In a most preferred embodiment, the artificial ocular lens (AOL) according to the present invention visually or optically corrects, protects, or otherwise overcomes any and all visual problems or defects.
The customized anterior chamber intraocular lens according to the present invention is manufactured or designed after thoroughly examining, measuring and mapping the patient's eye or eye vision. This information is compiled and then processed to custom manufacture or make the artificial ocular lens (AOL), in particular an anterior chamber phakic refractive correction lens (ac-pRCL) for the particular patient. For example, the patient's eye is evaluated for power correction, astigmatism correction, abnormal surface correction, abnormal refractive correction, abnormal tissue correction, and disease correction. For example, abnormal surface profiles or blemishes of the front and/or back surface of the
cornea and lens (e.g. natural lens or IOL) are analyzed by wavefront mapping of the vision of the eye, measuring the internal dimensions of the eye, including cornea, anterior chamber, iris, pupil, posterior chamber, capsular bag, retina, to determine the condition of the eye.
The information from the eye examination, measurements and mapping are processed through a mathematical formula or algorithm embodied in a computer program to calculate the biological, chemical, and physical parameters or characteristics of the artificial ocular lens (AOL) to be manufactured or made. Specifically, the exact lens size, lens thickness, lens length, lens width, optic location, optic shape, material, material physical properties, material chemistry, material surface chemistry, material refractive index, material hardness, material resilience, material elasticity, material finish, front lens surface conformation, back lens surface conformation, lens curvature, and other processing factors or parameters are determined, and then transformed into machine language for controlling highly precise and accurate computer operated manufacturing equipment (e.g. digitally operated tools) such as lathes, mills, grinding machinery, laser, surface finishing machinery, or any other type of machinery or processes that can be computer operated and controlled.
A preferred embodiment of the anterior chamber phakic refractive correction lens (ac-pRCL) according to the present invention adjusts the overall or macro power of the eye and corrects the astigmatism of the eye. Specifically, the lens optic is provided with 1) a lens optic for changing the overall or macro power of the eye; and 2) a lens optic for correction astigmatism of the eye. For example, the power correction of the lens optic can be obtained by cutting or contouring the main overall or macro shape and thickness of the lens optic and/or the lens optic can be multi-focal. The lens optic can be multi-focal by providing one or both surfaces of the lens optic with a multi-focal surface(s). The astigmatic correction of the lens optic can be obtained by providing a toric lens optic. For example, one or both surfaces of the lens optic to be toric surfaces.
A more preferred embodiment of the anterior chamber phakic refractive correction lens (ac-pRCL) according to the present invention adjusts the power of the eye, corrects the astigmatism of the eye, and corrects the fine or micro optics of eye based on wavefront analysis and mapping of the eye. For example, the power correction of the lens optic can be obtained by cutting or contouring the main overall or macro shape and thickness of the lens optic and/or the lens optic can be multi-focal and/or diffractive. The astigmatic correction of the lens optic can be obtained by providing a toric and/or diffractive lens optic. For example, one or both surfaces of the lens optic can be toric surfaces. Further; the lens optic can be made to provide point-to-point optical modification, adjustment, change or fine tuning of the structure and/or shape of the lens optic throughout the three dimensions (3-D) of the optical lens to micro fine tune or make micro modifications, micro adjustments or micro changes to lens optic on a micro basis to eliminate any and all optical aberrations and provide for full wavefront optical corrections.
A most preferred embodiment of the anterior chamber refractive correction lens (ac-pRCL) according to the present invention includes macro power adjustment, micro power adjustment, multi-focal, toric, and wavefront optics adjustment or correction on one or both sides of the lens optic, and/or within the interior of the lens optic.
The anterior chamber phakic refractive corrections lens (pRCL) according to the present invention is preferably custom made to correct any and all vision or optical problems or defects of the eye, including power correction, astigmatism correction, corneal surface and interior aberrations, lens surface and interior aberrations (natural or replacement lens, IOL), and other optical aberrations from other eye structure, eye aqueous and/or eye vitreous. In order to provided a custom anterior chamber phakic refractive correction lens (pRCL), it is required that the vision or optical defects of the eye are carefully measured, for example, by a visual field analyzer, slit lamp, biomicrosope and opthalmoscope. The goal is to provide an accurate and precise “eye assessment” to correct macro vision or optical defects or problems, and micro vision or optical defects or problems such as higher-order aberrations. The wavefront analysis based on adaptic measures of light deviations and aberrations can be measured to 0.01 microns (μm) equivalent to approximately 0.001 diopter (D) adjustment by root mean square deviations (RMS units). Standard refraction methods are used to measure macro visual or optical defects or problems such as low-order aberrations (second-order sphere or defocus and cylinder in 0.25 diopter (D) steps. Up to twenty percent (20%) of the higher-order aberrations come from the corneal, aqueous, lens, and/or vitreous accounting for numerous changes in the indices of refraction of light rays moving through the eye.
The higher-order aberrations require measuring equipment exceeding standard or conventional refractive measuring instruments. The higher-order aberrations include coma (third-order), trefoil (third-order), spherical aberrations and quadra foil (fourth-order), and irregular astigmatism (fifth-order to eighth-order). These higher-order aberrations provide refractive abnormalities well below 0.25 diopter (D unit) translating to three microns (μm) of tissue change within the eye. The wavefront analysis and mapping desired utilizes adaptive optics for measuring root mean square deviation (RMS) using measuring sensors such as a deformable “lenslent” systems to calculate RMS coefficients. The RMS coefficients are then converted into a polynomial pyramid (e.g. Zernike Pyramid). The three dimensional (3-D) models or two dimensional (2-D) color maps indicate lower and higher order aberrations of the eye. The Zernike polynomial measure aberrations up to the eleventh (11th) order, and can virtually analyze a hundred percent (100%) of the aberrations of the eye. Above the sixth (6th) order, only noise is created. Point spread functions (PSF) are used to measure and assess higher-orders aberrations in the human vision. These higher-order aberrations include distortions, haloes, tails, and/or double (overlapping) images.
The anterior chamber phakic refractive correction lens (ac-pRCL) can be made by selecting a material capable of being machined, and then cutting or contouring the front and back surface of the lens from a blank using a digital lathe, digital mill, laser, or by use of microlithography to form or make lens structure or markings. For materials that can be molded, the lens can be made by machining and polishing a mold cavity, and then molding the lens from a desired material. In a preferred embodiment, the lens mold utilizes a replaceable insert, in particular a replaceable molding pin for molding the lens optic portion of the lens. In this manner, the molding pin can be replaced each time a lens is molded to make a one of a kind custom lens optic for a particular patient. The remaining portions of the mold (e.g. to mold plate haptic portion) can be of a standard size and shape, and otherwise not customized.
The molding pin for molding the lens optic portion of the lens can be made by machining the molding pin surface thereof, and then highly polishing the molding pin surface. In a more preferred embodiment, the surface of the molding pin is machined, and then treated to provide a thin metal oxide layer thermally and/or electromagnetically deposited (e.g. vacuum deposited) to eliminate the need for the step of polishing the surface. Specifically, the molding pin is made of a copper/nickel alloy and the molding surface is diamond machined, and then a layer of corundum or aluminum oxide (e.g. sapphire, ruby, diamond (carboneaous)) is vacuum deposited on the molding surface to increase smoothness and durability thereof. The layer is preferably in the thickness range of fifty (50) to four-hundred (400) angstroms (Å).
A preferred embodiment of a phakic refractive correction lens (pRCL) according to the present invention includes two (2) separate pieces or parts, including a lens optic and a lens haptic. Preferably, the lens haptic is “V” shaped, and features two (2) relatively more rigid haptic arms formed of relatively higher modulus (harder) material(s), which haptic arms are flexibly resilient when thin. The lens haptic may also comprise less rigid haptic arms formed of relatively lower modulus (softer) materials bridging a discontinuity separating the haptic arms. The discontinuity may be coated with a lower modulus coating. The “V” shaped lens haptic allows for insertion of the lens haptic through a small incision in the eye, as small as about one millimeter (1 mm), without deforming the thin haptic frame. The lens haptic also features a fastening structure for fastening with the separate lens optic, preferably a fastening cleat. The foldable or deformable lens optic is then inserted into the eye through the same small incision (i.e. 2 mm or less), or more preferably ultra small incision (i.e. 1 mm or less), and attached to the lens haptic by the fastening cleat, by way of an aperture or eyelet provided in or on the lens optic.
The higher modulus resilient polymeric material may be selected from polyimide, polyetheretherketone, polycarbonate, polymethlypentene, polymethylmethmethl methacrylate, polypropylene, polyvinylidene fluoride, polysulfone, and polyether sulfone. Preferably, the higher modulus material is polyphenylsulfone (PPSU) or polyester or modified polyester such as liquid crystal polymer (LCP) liquid that can be molded into as thin or narrow as about 0.05 to 0.25 millimeters (mm). Preferably, the higher modulus material has a modulus of elasticity of about 100,000 to about 500,000 psi, even more preferably about 340,000 psi and has a hardness of about 60 to 95 on the shore D hardness scale, but more specifically a Rockwell R hardness of 120 to 130. The lower modulus resilient material may be an elastomer selected from silicones, urethanes, or hydrophobic or hydrophilic acrylics. Preferably, the lower modulus elastomeric material has a modulus of about 100 to 1000 psi (unit load at 300% elongation). Preferably, the lower modulus material has a hardness of about 15 to 70 on the shore A hardness scale. Preferably, the lower modulus material is a dispersion or optical silicone such as NUSIL MED 6400, 6600, 6604, 6605, 6607, 6640, 6755 and 6820, Nusil Technology, Carpinteria, Calif., USA, or the like.
In one embodiment of the phakic refractive correction lens (pRCL) according to the present invention, the relatively more rigid haptic arms define a “V”-shaped haptic frame. The haptic frame having two (2) haptic arms can be formed from a single uniform piece of material. The haptic arms may include fastening cleats for attachment of the lens optic. The haptic arms may additionally contain a slot open on one side to form a hinge which is bendable at the slot. The haptic arms may alternatively be provided each with a groove to form a hinge which is bendable at the groove.
The lower modulus material may partially or completely cover the haptic legs, or just the hinge area. In one embodiment, the lower modulus material is extended beyond the tip of the haptic legs to produce a softer contact point for the eye tissue. The lower modulus material may be applied by first surface treating the higher modulus material, and then molding the lower modulus material onto the treated surface. Preferably, the surface treatment is a corona or plasma or acid etched or a combination of treatment and additionally a primer. Preferably, the molding performed by dip molding, cast molding, or injection molding. Primers such as Nusil Med (product #CF1135) may also be used singly or in combination.
The lens optic may be any type of lens optic. Preferably, the lens optic is a refractive correction lens optic, or an interference (diffractive) lens optic to provide a thin optic. The lens optic can be toric, aspheric, multi-element, positive or negative, or other variable power focusing lens optic.
The present invention is also direct to a method for making an artificial ocular lens (AOL) with a haptic, including the steps of forming a thin frame lens haptic, coating a location of the lens haptic, and then breaking the lens haptic at the location of the coating. Further, the present invention is directed to a method of mounting a refractive correction lens (RCL) in the anterior chamber of an eye, including the steps of supporting a lens optic on a thin plate lens haptic extending between the angle of the anterior chamber; and then bending the lens haptic at a preferential hinge line to reduce pressure against the angle of the anterior chamber.
The refractive correction lens according to the present invention can also be used to correct vision or optical defects or problems from prior surgical procedures and/or implants (e.g. after LASIK refractive correction of the cornea, after implantation of an IOL).
FIGS. 4A-C are broken away top sequential view of one of the lens optic ears provided with an eyelet of the lens optic being connected to a modified haptic cleats having gripping ears of the lens haptic.
FIGS. 5A-E are sequential top planar views of the refractive correction lens (RCL) shown in
FIGS. 5F-H are sequential top planar views of the refractive correction lens (RCL) shown in
A preferred embodiment of a refractive correction lens (RCL) 100 according to the present invention is shown in
The refractive correction lens 100 is a two (2) part or piece lens, including a lens optic 102 connectable to a lens haptic 104. The lens optic 102 is made with a pair of lens optic ears 102a provided with lens optic eyelets 103. The lens haptic 104 has a “V” shape, and is preferably a thin film frame. The lens haptic 104 is insertable through a very small incision in the eye (i.e. one millimeter (1 mm) or smaller without deformation of the haptic). This lens haptic 104 is also lightweight, resilient, non-irritating, low cost, surgically implantable with a minimum of trauma to the eye, aesthetically pleasing, and does not support fibrous tissue growth in the anterior chamber 16 of the eye. The refractive correction lens 100 can be positioned in the anterior or posterior chamber of the eye as a phakic or aphakic lens. The lens haptic 104 includes a fastener for connecting to the separate piece lens optic 102. Preferably, the fastener is configured to allow the lens optic 102 to be assembled with the lens haptic 104 within the eye (e.g. anterior chamber).
The “V” shaped lens haptic 104 is a haptic system preferably made of a high modulus material. The lens haptic 104 may optionally be assembled with low modulus, soft, elastomeric and flexible hinge portions or zones. The more rigid frame of the lens haptic 104 in combination with the soft flexible hinges ensures that the lens optic 102 and lens haptic 104 assembly will maintain its shape and stay ideally situated or fixated in the angle 17 of the anterior chamber 16 of the eye, or in the posterior chamber depending on the application. While a lens haptic made of a soft material will not maintain a desirable shape and cannot properly support the lens optic from movement, the optional flexible hinge arrangement can automatically adjust to the normal movements of an eye.
As shown in
The lens optic 102 of the refractive correction lens 100 includes a separate centrally located optical zone, and may be configured for implantation into either the anterior chamber 16 or posterior chamber 18, and again may be used for a phakic or aphakic procedure. The lens haptic 104 of the refractive correction lens 100 extends radially outward in the center transverse plane of the lens optic 102.
As shown in
The lens optic 102 when connected onto the lens haptic 104 is placed under a slight tension by the lens haptic 104. Specifically, the lens haptic arms 106a and 106b are moved slightly towards each other during the step of connecting the lens optic 102, and then released to slightly spring bias the lens optic eyelets 103 apart. Alternatively, the spacing between the lens optic eyelets 103 is such that when the lens optic eyelets 103 are looped over or connected to the haptic cleats 108 of the lens haptic 104, the lens optic eyelets 103 are distorted from round to oval and remain slightly oval in shape after the connection is made due to the tension force applied by the lens haptic 104 onto the lens optic eyelets 103. This tension force is convey through the lens optic 102 maintaining the lens optic 102 slightly under tension and the lens haptic 104 slightly under compression between the haptic arms 106a and 106b to prevent the lens haptic 104 from moving relative to the lens haptic 104 or being disconnected therefrom during implantation and use in the eye 10.
As noted in
In other alternative embodiments, the lens optic 104 is made off center (e.g. along X axis and/or Y axis, i.e. decentered) during manufacturing thereof. Alternatively, the the lens optic 102 and lens optic 104 can be made to be adjustable on-center or off-center after implantation in the eye by using a surgical instrument, or by using a light or heat source internal or external to the eye (e.g. using laser light to deform lens hatpic arms 106a, 106b or changing the haptic arm angle 121 or shortening or lengthening one or both of the lens haptic arms 106a, 106b by using laser light to further cross-link or decross-link the polymer material of the lens haptic 104). In the embodiment shown in
In a preferred embodiment shown in
The lens optic 102 (
As shown in
The lens optic 102 can be attached to the lens haptic 104 in a variety of ways. A preferred embodiment is shown in
In a more preferred embodiment, as shown in FIGS. 4A-C, the haptic cleat 108′ is provided with haptic cleat ears 110′ shaped in such a manner to prevent the lens optic eyelets 103 from unfastening or disconnecting after assembly. The haptic cleats 108′ still allow the eye surgeon to attach the lens optic 102 to the lens haptic 104 within the eye using a forceps while providing improved anchoring. The lens haptic 104 is inserted through the very small incision through the eye, and then positioned in the eye as desired, as shown in
In a preferred embodiment, the lens optic 102 is produced of a material with a lower modulus than the lens haptic 104, thus allowing the lens eyelet 103 to be slightly stretched while the lens haptic 104 is rigid by slightly resilient to provide for a stronger attachment of the optic eyelets 103 to the haptic cleats 108 provided on the lens haptic 104. In one embodiment, one side of the lens optic 102 can be fastened to the lens haptic 104 before insertion of the refractive correction lens 100 into the eye. The lens optic 100 can be made with very thin edges (as thin as about 0.001 mm to reduce edge glare). The haptic cleats 108 again can be provided with prongs or ears to maintain the assembly of the optic eyelets 103 of the lens optic 102 on the haptic cleats 108 of the lens haptic 104 during use.
As shown in
The haptic cleats 300 are designed or configured to positively connect or securely fasten the lens optic 102 onto the lens haptic 104. This fastening system can be used to attach any type of refractive correction lens optic before insertion or after insertion into the eye. In addition, this arrangement will allow the eye surgeon a choice of lenses and lens powers to insert, and the surgeon can fasten one or more lenses onto the haptic cleats 108. Further, the haptic cleats 108 and/or the lens optic eyelets 103 can be tinted to further aid to the eye surgeon so as to be more visually identifiable to the eye surgeon during the implantation surgery.
The lens haptic 104 is preferably manufactured from a high modulus material. High modulus materials are generally relatively stiff, or hard, but resilient or springy, and permit relatively little bending before they break. Such materials are often brittle and have a high permanent set, but retain their shape after formation. Preferably, the high modulus material is a biocompatible thermoplastic film such as polyimide, polyester, polyetheretherketone, polycarbonate, polymethpentene, polymethymethyl methacrylate, polypropylene, polyvinylidene fluoride, polysulfone, polyether, and polyphenylsulfone. These are often referred to as “engineering plastics”. They have high tensile strength and are biocompatible, hydrolytically stable, and autoclavable for sterility, and have a high modulus ranging from a tensile modulus of about 100,000 to 500,000 psi (using test method D 638 of the ASTM). The material can be clear, opaque, or tinted, but is preferably clear. However, in many cases, even a tinted material if produced thinly enough, will appear clear in the eye. The lens haptic 104 can be made from a thin film sheet material cut by CNC machining, stamping, chemical etching, water jet cutting, and/or photo machining with an Eximer or YAG laser. The thin film sheet material may also be punched, stamped, perforated, photo-chemically or photo-optically shaped. An alternative method for production of the thin film frame lens haptic 104 includes molding the high modulus material into the desired shape. It is generally known in the plastics industry to identify thin film sheets of plastic material of less than 0.10 inches thick as “films”, and that definition is used herein. The lens optic eyelet 103 is provided with an aperture or hole of about 0.1 mm to 1.2 mm, preferably 0.5 mm in diameter. The thickness can be 0.001 to 0.010 inches, preferably 0.002 to 0.003 inches.
After cutting the shape of the lens haptic 104, the lens haptic 104 is shaped to be arcuate or vaulted by mounting the lens haptic 104 on a dihedral shaped tool or equivalent, and then baking the lens haptic 104 in an oven between 150° F. up to 550° F.
The thin film frame lens haptic 104 is typically then polished to remove any rough edges. The preferred method of polishing involves abrasive tumble or agitation polishing with glass beads. An alternative method for polishing the thin film frame lens haptic 104 and haptic feet 121 includes flame polishing. For embodiments of the phakic refractive lens provided with flexible haptic hinge portions 320 (
In a preferred embodiment of the refractive correction lens 100 according to the present invention, the lens haptic 104 is made of polyphenylsulfone material, which has a tensile modulus of about 340,000 psi (using test method D638 of the ASTM), is clear, and exhibits a natural UV light absorbance property below 400 nanometers (nm) resulting in a yellowish or amber tint. The thin film frame lens haptic 104 is preferably made from thin film, which is generally 0.025 cm (0.010 inches) thick, preferably about 0.001 to about 0.005 inches thick, or can be as thick as about 0.012 inches or as thin as 0.0005 inches. In a preferred embodiment, the haptic feet 121 are identical, but a non-identical haptic feet 121 configuration can be provided for use in an alternative embodiment depending on application. The thickness of the thin film frame lens haptic 104 contributes to its resilience or springiness, and lightness which is advantageous so that the refractive correction lens 100 is less likely to be disrupted from its initial positioning.
The refractive correction lens 100 is preferably thin and light in weight (e.g. approximately one-half (½) the weight of a standard lens, and can be between 2 to 10 milligrams and as low as 1 milligram in weight (in air) and 10% of this weight when in the aqueous of the eye. Preferably, the lens optic 102 is flexible, but may be made of a hard, stiff, low memory material. However, in the preferred embodiment, the lens optic 102 is made of silicone (e.g. a preferred silicone can be as low as 15 shore A hardness and the refractive index (N) value can be 1.430 to 1.460).
FIGS. 5A-E illustrate the sequence in which the lens haptic 104 can be inserted or manipulated through a very small incision 50 in the eye 10 without deformation. This substantially rigid lens haptic 104 arrangement is preferable a configuration which may possess a hinge or be “foldable” because it requires no lateral movement or unfolding within the very narrow confines of the anterior chamber 16 of the eye 10, which could contact the inner surfaces of the anterior chamber 16 and cause damage to the eye 10. In FIGS. 5A-E, the “L”-shaped lens haptic 104 allows for insertion through a very small incision 50 in the eye 10 by rotating the lens haptic 104 as it is inserted and manipulated within the eye 10. The dimensions of the lens haptic 104 preferably are such that the largest cross-sectional dimension at any point along the lens haptic 104 is less than 2 mm.
After the lens haptic 104 is inserted through the small eye incision 50 and positioned within the eye 10 (See FIGS. 5A-E), the separate lens optic 102 is rolled or folded as required and inserted into the eye 10 with forceps, and attached to the furthest haptic cleat 108 from the small eye incision 50, as shown in the sequence of
As shown in
The haptic feet 321 include haptic hinge portions 320. The haptic hinge portions 320 permit the haptic toe portions 350 to have a relaxed position, which can be at a slight angle to the plane of the thin film frame lens haptic 304 and the rest on the haptic feet 321. This slight angle permits each haptic foot 321 to fit into the anterior chamber 16 of the eye 10 in a manner so that the refractive correction lens 100 will be gently secured using low mechanical loads exerted by the flexible haptic hinge portions 120 combined with flexible haptic arms 106a and 106b. The flexible thin film frame haptic arms 106a, 106b can additionally be arcuately curved or shaped with a dihedral angle to more closely approximate the eye shape. More specifically, the haptic toe portions 350 are preferably made to define loops 323 (
As shown in
After coating, the haptic hinge portions 320 may be produced by breaking the high modulus material at the haptic hinge portions 320 by using scores or notches. This may be done by bending the haptic hinge portions 320 until the high modulus material hardens and breaks. Alternatively, the haptic hinge portions 320 may not need to be broken.
Alternative embodiments of the phakic refractive lens according to the present invention is shown in FIGS. 8A-H.
In
In a further embodiment of the refractive correction lens 600 shown in
The lens optic 102 (
A two (2) mm small incision is made near the limbus of the eye. Buffers are injected into the anterior chamber of the eye 10. The lens haptic 104 is inserted as shown in FIGS. 5A-H by a rotation action. The eye surgeon grasps the folded lens optic 102 with the outside (distal) lens optic eyelet 103 leading forward. The eye surgeon then pushes the lens optic 102 through the small incision and hooks the distal lens optic eyelet 103 onto the distal haptic cleat 108 of the lens haptic 104. Then, the eye surgeon slowly opens the forceps while maintaining slight tension. The lens optic 104 is then grasped near or onto the closest lens optic eyelet 103 (proximal), and pulls it over the closer haptic cleat 108 of the lens haptic 104.
Therefore, the refractive correction lens 100 according to the present invention presents a number of advantages. It is inserted in two separate pieces significantly reducing the bulk so that the small incision can be as narrow as 1 mm. It is lightweight and reduces corneal chafing and pupilary block. In addition, because of the flexible haptic hinge portions 320 (
One advantage of the refractive correction lens 100 of the present invention is that the refractive correction lens 100 is a multi-part assembly and the characteristic or properties of each part of the refractive correction lens 100 can be retained. For example, the lens haptic 104 is rigidly and slightly resilient, and can be made to fit through a very narrow incision in the eye without deformation. The lens optic 102, preferably between 4 mm and 7 mm in diameter, can be inserted through the very small incision because it is constructed of a more pliable soft material that can be folded, squeezed or rolled, more so than it could be with the lens haptic 104 attached to be inserted into a considerably smaller incision. Therefore a multi-part refractive correction lens 100 according to the present invention allows for insertion into a much smaller incisions than an assembled lens.
The refractive correction lens 100 can be implanted into the eye 10 using a variety of surgical implant techniques known in the art. Although the preferred embodiment is a refractive correction lens 100 to be implanted into the anterior chamber 16 of the eye 10, using the inner angle 17 of the anterior chamber 16, the refractive correction lens 100 can also be implanted in the posterior chamber.
Additionally, any combination of the materials used will result in a refractive correction lens 100 that can be sterilized by a variety of standard methods such as ethylene oxide (ETO) or steam autoclaving at 250° F. or any other acceptable method and the lens will show long term biocompatibility and hydrolytic stability.
s 30 followed by implantation of an artificial lens involves a capsulorhexis incision in the capsular bag 28 that encloses the natural crystalline lens 30 located in the posterior chamber 18 of the eye 10 followed by phakoemulsification of the diseased natural crystalline lens 30 through a small incision 50 in the eye 10. The lens implant is then implanted back through the small incisiona and through the capsulorhexus into the capsular bag 28. For other types of procedures, the natural crystalline lens 30 is not removed, and a phakic refractive lens (PRL) is implanted in the anterior chamber 16 or in front of the natural lens 30 in the posterior chamber 18 of the eye 10.
The artificial ocular lens (AOL) according to the present invention can be an intraocular lens (IOL) designed or configured for replacement of the natural crystalline lens and/or a refractive correction lens (RCL) for refractive correction of the natural crystalline lens or refractive correction of a replacement lens or IOL.
The refractive correction lens according to the present invention is designed or configured to visually or optical correct multiple visual or optical problems of the eye.
The lens optic 102 is provided with a front side, shown in
A variety of different embodiments of the lens optic of the refractive correction lens (RCL) according to the present invention is shown in FIGS. 10A-B through
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
Diopter
Blue blocking up to 400 up to 450 up 500 up to 550 nanometer (50% transmisson of 450 nm)
Yellow
No uv inhibitor, or uv inhibitor
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
For a presbyopic embodiment of the refractive correction lens 1402 according to the present invention, for example, the central additions for the lens surface 1401a should be +3.00 diopters (D). Similar but slightly different refractive correction lenses 1402 can be made for early presbyopes and late presbyopes. For example, for early presbyopes, lens surface 1401a should be +0.5 diopters (D) and for late presbyopes, lens surface 1401a should be +3.0 diopters (D). The central lens surface 1401a should be around 3 millimeters (3 mm).
As a further embodiment, the refractive correction lens 1402 can be provided with a third multifocal surface or zone 1401c to provide a trifocal (e.g. −1, 0, +1). For example, three (3) object distances, the type of structure (e.g. sine wave, trapezoid and/or rectangle), and the lens material can be specified for making the trifocal embodiment. In other embodiment, more than three (3) multifocal surfaces or zone (e.g. concentric, symmetric, asymmetric, matrix arrangements of surfaces or zones) can be used for particular applications or custom made for a particular eye. Alternatively, lithography can be used to print marks or a pattern on one or both surfaces of the lens (e.g. grid, rings, matrix) to cause light diffraction to make a diffractive lens optic, or lithography combined with etching (e.g. lens mold surface) can be used to make nanometer to angstrom dimension profiles, protrusions, patterns, contours on lens surfaces to provide multifocal and/or defractive lens surfaces.
To make the custom refractive correction lens (RCL) according to the present invention, the patient's eye must be carefully analyzed, measured and mapped to determine the specifications of the refractive correction lens (RCL) to be manufactured. Specifically, the following is a list of specifications of the refractive correction lens (RCL) to be considered and then specified:
The following is an example of a patient information request form to gather information for prescribing and specifying a custom refractive correction lens (RCL) according to the present invention.
At the eye surgeon's office, the patient's eye is measured using visual field analyzers, eye charts and a topographer/abberometer. The abberometer measures the aberrations in the patient's eye and provides the eye surgeon with a topography map outlining all the aberrations. The eye surgeon uses the abberometer to check where the aberrations are coming from and analyze the data for different pathologies and make changes to the data where necessary. The abberometer is then used to generate a topography map and digital data that will be transferred to the manufacturer in the form of a customized lens order via satellite, internet, telephonic down load, CD ROM, DVD or mail or fax. Abberometer obtains the necessary information by using the Shack Hartman or means, which analyzes multiple beams of light transferred to the retina and then returned back through the eye. Variations of the light are measured against a light standard that would give perfect vision if all the parameters are met. The variation of the light is then compared against the Zerkeny polynomial to determine whether the variations are in the form of low order aberrations usually spherical and cylinder (toric) or high order aberrations such coma; trefoil (shapes showing in the optic system that look like a starburst usually around the periphery of the eye extending toward the center.
This information will then be received by the manufacturer, analyzed for completeness and any other kind of transmission errors. The data received is in the form of data points to be run through a program that to invert or reverse the information, since to correct an optic system requires making points or corrections that are opposite of the actual data received. This data will be run through the program to convert the data converted into machine language that will form a JFL file that will tell any equipment that can have varying cut (the Presitech Optiform with a variable forming tools or the DAC system with its toric generator) to cut a mold pin or optic in a form based on the information received from the eye surgeon's topography/aberrameter, Zydekia Chart etc.
The order depending on the method of manufacturing can create a lens optic as part of the shop order or create a mold pin for the shop order in case of silicone manufacturing. The shop order would then go through the manufacturing process for developing lenses and a final lens optic would be made. During the process the lens would be marked in a manner so that the eye surgeon doing the surgery can tell where on the lens optic the changes are made. One side of the optic can contain all the changes needed for a multifocal, toric and/or wavefront corrections, or some changes can be on the front side and some on the back side of the refractive correction lens (RCL) depending on the patient and manufacturing constraints. In order to know that what was manufactured is what was ordered, similar equipment would be used to generated the data such as an abberometer using the same theoretical method to measure the reverse aberrations created in the lens and compare it with the original input information. The refractive correction lens (RCL) is then sterilized and sent to the eye surgeon.
The manufactured lens data can be sent back with the lens to the eye surgeon, including data points and topography map with a manufacturing certificate for the eye surgeon and patient similar to a patient ID card, instead it would have a topography of the lens on the card.
The eye surgeon then inserts the lens haptic and lens optic into the patient's eye and places the refractive correction lens (RCL) where needed based on what was ordered received. Minor adjustments in the lens optic and lens haptic can be made to obtain the appropriate axis of the optic. It is possible to make and optic off center in a mold pin combination if it were determined up front exactly where and if the optic needed to be changed from its center point. It is also possible to put adjustments items on the optic and haptic whereby the optic could be shifted up, down or side ways so that the multifocal, toric, wave front can be lined up to give the patient better vision.
While this invention has been described with respect to various specific examples and embodiments, it is to be understood that the invention is not limited thereto and that it can be variously practiced within the scope of the following claims.
This is a continuation-in-part (CIP) of U.S. patent application Ser. No. 09/631,576, entitled “TWO PART “L”-SHAPED PHAKIC IOL”, filed on Aug. 4, 2000, fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09631576 | Aug 2000 | US |
| Child | 11249358 | Oct 2005 | US |
