Patent Application
20130238091
1. Field
This application relates generally to the field of intraocular devices. More particularly, this application is directed to small-aperture ocular devices that can be applied adjacent to an intraocular lens (IOL) and the surgical methods for implanting the ocular devices.
2. Description of the Related Art
Intraocular lenses (IOLs) are well known as a safe and effective means to treat aphakia following the removal of a cataract. IOLs are available in a variety of optical and mechanical designs, incorporating features that provide a fixed focus (conventional or “monofocal” lenses), multiple fixed foci (“multifocal” lenses), or variable focus (“accommodating” lenses). While some degree of success has been achieved with multifocal and accommodating lenses, they require compromises on the part of the patient or surgeon that many find objectionable.
Monofocal IOLs provide excellent vision at near or far, but not both. Patients with monofocal IOLs typically use spectacles (e.g., reading glasses) for the distances where they are not well focused. Multifocal IOLs provide the simultaneous ability to see near and far, but they also introduce contrast losses and symptoms, particularly at night. Accommodating IOLs are a more recent development showing promise, but so far, these lenses are large, complicated, and bear higher surgical risks than the alternatives. They also face a challenge in properly restoring accommodative function in all patients because of variations in the size and properties of the eye structures that participate in the accommodative action.
The inability to focus at different distances usually begins after age 40, but the onset of cataracts is much later, usually after age 65. Thus, a large number of patients between about age 40 and about age 65 often retain excellent distance vision, but can no longer read up close; a condition known as presbyopia. Vorosmarthy and Miller have taught how placing a small aperture in an intraocular lens can improve depth of focus, providing patients focused vision at distance with sufficient depth of field to read up close.
Certain aspects of this disclosure are directed toward an intraocular device including a mask. The intraocular device can include one or more of the features of the intraocular devices described herein. The mask can be configured to increase the depth of focus of a patient. The mask can include an aperture configured to transmit substantially all visible light. The mask can include a non-transmissive region surrounding the aperture. The non-transmissive region can be configured to be substantially opaque to visible light. The mask can include one or more connectors configured to attach the mask to an intraocular lens.
In the above mentioned intraocular device, the one or more of the connectors can include one or more spring clips.
In any of the above mentioned intraocular devices, one or more of the connectors can include one or more hooks. In certain aspects, at least a portion of each hook can include a curvature generally consistent with a curvature of the mask.
In any of the above mentioned intraocular devices, the one or more connectors can be configured to attach to one or more haptics of the intraocular lens.
In any of the above mentioned intraocular devices, the one or more connectors can be configured to engage an outer periphery of the intraocular lens.
In any of the above mentioned intraocular devices, the one or more connectors can be positioned at an outer periphery of the mask.
In any of the above mentioned intraocular devices, the one or more connectors can include at least two connectors spaced around an outer periphery of the mask.
In any of the above mentioned intraocular devices, the mask can include a plurality of holes disposed in the non-transmissive region, the plurality of holes positioned at irregular locations to reduce visible diffraction patterns due to the transmission of visible light through the holes.
In any of the above mentioned intraocular devices, at least a portion of the non-transmissive region can include a texturized surface. In certain aspects, the portion of the non-transmissive region can be at least about 50% of the non-transmissive region. In certain aspects, the texturized surface can include a surface roughness of less than about 125 microinches.
In any of the above mentioned intraocular devices, the mask can include a substantially transparent outer region surrounding at least a portion of the non-transmissive region.
In any of the above mentioned intraocular devices, the mask can include nanites configured to selectively transmit light.
In any of the above mentioned intraocular devices, the one or more connectors can be configured to removably attach the mask to the intraocular lens.
In any of the above mentioned intraocular devices, the mask can include a curvature.
In any of the above mentioned intraocular devices, the curvature of the mask can generally match the curvature of the intraocular lens.
In any of the above mentioned intraocular devices, the mask can include at least one haptic configured to support the mask within the eye of a patient.
In any of the above mentioned intraocular devices, the aperture of the mask can include a diameter of about 1.2 mm to about 2.0 mm.
In any of the above mentioned intraocular devices, the mask can include an outer diameter between about 3.2 mm and 3.8 mm.
In any of the above mentioned intraocular devices, the intraocular device can also include an intraocular lens connected to the mask by the one or more connectors.
In any of the above mentioned intraocular devices, the aperture can include a generally circular or generally oval shape. The aperture can include other shapes, examples of which are described in U.S. Pat. No. 7,628,810, issued Dec. 8, 2009, which is hereby incorporated by reference in its entirety.
Certain aspects of this disclosure are directed toward a method of implanting an intraocular device. The method can include one or more of the method steps described herein. In certain aspects, the method can include creating a surgical incision in an eye. In certain aspects, the method can include implanting an intraocular lens in an intraocular space. In certain aspects, the method can include implanting an intraocular device adjacent to the intraocular lens. In certain aspects, the intraocular device can include a mask configured to increase the depth of focus of a patient. The mask can include an aperture configured to transmit substantially all visible light and a non-transmissive region surrounding the aperture. The non-transmissive region can be configured to be substantially opaque to visible light.
In the above mentioned method aspect, implanting the intraocular lens can occur during a prior procedure completed before creating the surgical incision in the eye.
In any of the above mentioned method aspects, implanting the intraocular lens can occur before implanting the intraocular device.
In any of the above mentioned method aspects, the method can include removing the intraocular device. In certain aspects, the method can include removing the intraocular device and maintaining the position of the intraocular lens within the eye.
In any of the above mentioned method aspects, the method can include attaching the intraocular device to the intraocular lens. In certain aspects, attaching the intraocular device to the intraocular lens can occur before implanting the intraocular lens. In certain aspects, attaching the intraocular device to the intraocular lens can include attaching one or more intraocular device hooks to the intraocular lens. In certain aspects, attaching the intraocular device to the intraocular lens can include attaching one or more intraocular device clips to the intraocular lens. In certain aspects, attaching the intraocular device to the intraocular lens can include attaching the intraocular device to an outer periphery of the intraocular lens. In certain aspects, attaching the intraocular device to the intraocular lens can include attaching the intraocular device to one or more haptics of the intraocular lens.
In any of the above mentioned method aspects, implanting the intraocular device can include implanting the intraocular device in an anterior chamber of the eye.
In any of the above mentioned method aspects, implanting the intraocular device can include implanting the intraocular device within a lens capsule.
In any of the above mentioned method aspects, implanting the intraocular device can include implanting the intraocular device into a sulcus-region of the eye.
Certain aspects of this disclosure are directed toward an intraocular device configured to attach to an anterior surface of a lens capsule of a patient. The intraocular device can include any of the intraocular device features described herein. The intraocular device can include a mask. The mask can include a transmissive region configured to transmit light and a non-transmissive region configured to block at least some visible light incident thereon. The non-transmissive region can surround at least a portion of the transmissive region. The mask can include one or more protrusions positioned near an outer periphery of the mask. The one or more protrusions can be configured to attach to the anterior surface of the lens capsule of a patient.
In any of the above mentioned intraocular devices, the mask can include one or more protrusions positioned at the outer periphery of the mask.
In any of the above mentioned intraocular devices, the mask can include one or more protrusions extending generally outwardly from an anterior surface of the mask.
In any of the above mentioned intraocular devices, the mask can include one or more protrusions integrally formed with the mask.
In any of the above mentioned intraocular devices, the mask can include one or more protrusions and each protrusion can include a curvature.
In any of the above mentioned intraocular devices, the mask can include one or more protrusions surrounding substantially the entire outer periphery of the mask.
Certain aspects of this disclosure are directed toward a method of implanting an intraocular device. The method can include any of the method steps described herein. The method can include creating a surgical incision in an eye to access an intraocular space. The method can include performing a capsulotomy procedure. The method can include mounting an intraocular device to a lens capsule of the eye. The intraocular device can include a mask configured to increase the depth of focus of a patient. The mask can include one or more protrusions near an outer periphery of the mask for mounting the mask to the lens capsule. In certain aspects, mounting the intraocular device to the lens capsule can include positioning the intraocular device within a capsulotomy incision on the lens capsule.
Certain aspects of this disclosure are directed to a small-aperture ocular device that allows patients to focus at a distance with sufficient depth of field to read up close. The ocular device of the present application is significantly improved over previous small-aperture devices at least because the ocular device can be an independent implant that can be inserted adjacent to any IOL that the surgeon prefers or any IOL required by the patient's particular clinical characteristics. For example, the ocular device can be inserted adjacent to monofocal IOLs, multifocal IOLs, accommodating IOLs, and toric IOLs. The ocular device can be implanted in a variety of locations along the optical pathway in the eye, including adjacent to the anterior surface of an IOL, the posterior surface of an IOL, adjacent to or within the capsular bag, or between the iris and cornea.
The ocular device can include a mask having a substantially annular non-transmissive region surrounding a relatively high transmissive central region, such as a clear lens or aperture. The device can have an annular mask with a small aperture for light to pass through to the retina to increase depth of focus, sometimes referred to herein as pinhole effect, pinhole imaging or pinhole vision correction. The ocular device can include at least one retention member, such as at least one haptic for example, to support the ocular device after implantation into an eye.
The ocular device can be implanted into an eye through a variety of methods. For example, the device can be joined to an IOL prior to implantation, and the device and IOL can be implanted simultaneously. In certain aspects, the device and an IOL can be implanted sequentially, although the implantation can occur through one incision during a single procedure. In certain aspects, the device can be implanted adjacent to a patient's previously implanted IOL.
Any of the ocular devices described herein can include a mask to increase the depth of focus of the patient. The mask can have a first and second surface, wherein one of the first or second surfaces can be shaped and configured to be placed adjacent to an IOL. One region of the mask can be non-transmissive, or substantially opaque to incident light. A central aperture of the mask can be transparent to substantially all light in the visible range.
The mask can include any of the features described herein. For example, one surface of the device can have a concave shape that substantially corresponds to a convex surface of an IOL. In certain aspects, the mask can include a small gap between at least some parts of the second surface of the device and the surface of the IOL. In certain aspects, one surface of the device can include a relatively planar or flat shape, such that when placed adjacent to an IOL a circle of contact can be formed between the second surface of the device and a surface of the IOL. In certain aspects, the non-transmissive region of the device can be substantially opaque to visible light, while remaining at least partially transparent to infrared (IR) light. Examples of devices at least partially transparent to IR light can be found in U.S. application Ser. No. 13/691,625, filed Nov. 30, 2012, titled “Ocular Mask Having Selective Spectral Transmission,” which is hereby incorporated by reference in its entirety.
The ocular devices disclosed in this specification can include any of the retention members described herein. In certain aspects, the device can comprise at least one retention member configured to support the device after implantation into an eye of a patient. The at least one retention member can substantially maintain centration of the central aperture along an optical axis of an eye, in some embodiments. In certain aspects, the retention member can comprise at least one haptic extending generally outwardly from the mask. The at least one haptic can be a separate piece attached to the mask by a connector. In certain aspects, the at least one haptic can be integrally formed with the mask.
In certain aspects, a mask can be applied on a surface of a transparent one-piece body. The transparent body can comprise at least one retention member, such as at least one haptic, extending generally outwardly from the mask. The mask may be printed, bonded, adhered, etched, or mechanically attached to the body, or may be embedded within the body. The mask can be applied in a generally annular shape so that a central, un-masked portion remains. The central un-masked portion can comprise material of the transparent body or an opening with no material in the transparent body.
In certain aspects, the central un-masked portion can have an optical power to correct refractive errors of the patient at the same time as providing the increased depth of field.
The ocular devices disclosed herein can be implanted in or affixed to any portion of the eye disclosed herein. The device can be configured for placement in the anterior chamber of the eye, fixating in the anterior chamber. The device can be configured to be attached to the iris using at least one haptic with at least one claw. The device can be configured for placement in the posterior chamber of the eye, wherein the device can be attached to the ciliary sulcus or fixated in the capsular bag. An ocular device with grooved edges or protrusions on or near the outer periphery of the device can be provided. The grooved edges can be configured such that the device can be attached to the anterior surface of a lens capsule. Hooks can be provided on or near the outer periphery of a mask. The hooks can be configured such that the mask can be attached to any of a variety of IOLs. The hooks can be configured so as to allow implantation of the mask adjacent to a previously implanted IOL.
The ocular devices disclosed herein can be implanted using any of the methods described herein. The device can be implanted through a small incision after being joined to an IOL. The device and IOL can be permanently joined. The device and IOL can be temporarily joined. An ocular device can be implanted sequentially with an IOL through one incision and during a single procedure. An ocular device can be implanted adjacent to an existing IOL that was implanted in a previous procedure.
For purposes of summarizing the disclosure, certain aspects, advantages and features of the inventions have been described herein. It is to be understood that not necessarily any or all such advantages will be achieved in accordance with any or all particular embodiments of the inventions disclosed herein.
Certain features, aspects, and advantages of the subject matter disclosed herein are described below with reference to the drawings, which are intended to illustrate and not to limit the scope of the disclosure. Various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. No structures, features, steps, or processes are essential or critical; any can be omitted in certain embodiments. The drawings comprise the following figures.
This application is directed to an ocular device for implantation adjacent to an IOL for improving the depth of focus of an eye of a patient and surgical methods for implanting the ocular device. The ocular device can include a mask configured to be positioned adjacent to an intraocular lens (IOL). The masks can comprise an annular shape with a small aperture to provide vision correction. The device may be applied to the eye in any of a variety of manners and in any location along the optical path. For example, the device can be implanted in the anterior chamber or the posterior chamber. As a further example, in the posterior chamber, the device can be attached to the ciliary sulcus (“sometimes referred to herein as “sulcus-fixated”). As a further example, the device can be implanted within an eye's lens capsule or on an outer surface of the lens capsule. The device can be positioned adjacent to an IOL. The ocular device can be implanted into an eye adjacent to any type of IOL, including monofocal IOLs, multifocal IOLs, and accommodating IOLs. A variety of techniques can be used to make the ocular device suitable for positioning adjacent an IOL, such as selecting a complementary curvature, selecting a material that is particularly compatible with eye tissue and fluids, or selecting suitable thickness or range of thicknesses. These features are discussed further below.
As shown in
In certain embodiments, the mask 100 can have an inner periphery 104 and an outer periphery 102. The outer periphery 102 can take any suitable form. In some embodiments, the outer periphery 102 can be generally circular, being defined by an outer circumference of the ocular device. In some embodiments, the circumference defining the outer periphery 102 can be at least about 8 mm and/or less than or equal to about 30 mm. In some embodiments, the circumference defining the outer periphery 102 can be at least about 10 mm and/or less than or equal to about 20 mm. The inner periphery 104 can also take any suitable form. In some embodiments, the inner periphery 104 can be generally circular, being defined by a circumference of a small inner aperture 106 of the mask 100. In some embodiments, the circumference defining the inner periphery 104 can be greater than zero and/or less than or equal to about 8 mm. In some embodiments, the circumference defining the inner periphery 104 can be between at least about 1 mm and/or less than or equal to about 4.5 mm, or in some embodiments the circumference of the inner periphery 104 can be at least about 3 mm and/or less than or equal to about 6 mm.
In some embodiments, the mask 100 can have a diameter of at least about 3 mm and/or less than or equal to about 8 mm, often within the range of from about 3.5 mm to about 6 mm. In some embodiments, the mask 100 can be substantially circular and can include a diameter of at least 3.5 mm and/or less than or equal to 4 mm. In some embodiments, the mask 100 can be substantially circular and can include a diameter of less than 4 mm. The outer periphery 102 of the mask 100 can have a diameter of about 3.8 mm in some embodiments.
The mask 100 can have dimensions that allow the mask to be inserted into the patient's eye and improve the patient's vision. For example, the thickness of the mask 100 can vary depending on the intended location of the mask 100 within the eye. In certain embodiments, the mask 100 can have a thickness of at least about 0.001 mm and/or less than or equal to about 0.5 mm. In some embodiments, the mask 100 has a thickness of less than about 0.25 mm. In some embodiment, the mask 100 has a thickness of at least about 0.01 mm and/or less than or equal to about 0.02 mm, or from about 0.001 mm to about 0.01 mm. In some embodiments, the mask 100 can have a thickness of less than about 0.001 mm.
The mask 100 can have a constant thickness, as discussed below. However, in some embodiments, the thickness of the mask 100 may vary between an inner periphery 104 and an outer periphery 102. For example, the mask 100 can have a gradually decreasing thickness from the inner periphery 104 to the outer periphery 102. In another example, the mask 100 can have a gradually increasing thickness from the inner periphery 104 to the outer periphery 102. Other cross-sectional profiles of the mask 100 are also possible.
In certain embodiments, the mask 100 can have a first surface 126 extending between the inner periphery 104 and the outer periphery 102. The mask 100 can also have a second surface 128 extending between the inner periphery 104 and outer periphery 102. As discussed further below, the mask's 100 surfaces can be shaped and configured to reside near or conform to adjacent lens surfaces.
In some embodiments, the first surface 126 of the mask 100 can have a generally convex shape, as illustrated in
In some embodiments, the first and second surfaces of the mask 100 can be substantially planar or flat, so that very little or no uniform curvature can be measured across the planar surfaces. In one embodiment, a substantially flat mask 100 can be placed in a variety of positions in the eye, including posterior to the IOL, anterior to the IOL, or between the iris and cornea. In some embodiments the substantially flat mask 100 can also be positioned to abut the IOL, so that a portion of the mask 100 touches the IOL. In certain embodiments, the substantially flat mask 100 can touch the IOL so that a substantially circle-shaped contact area between the mask and the IOL is created. A substantially flat mask can have several advantages over a non-planar mask. For example, a substantially planar mask can be fabricated more easily than one that has to be made to a particular curvature. In particular, the process steps involved in inducing curvature in the mask 100 can be eliminated.
In some embodiments, the first and second surfaces of the mask 100 can both be substantially circular in shape from a frontal view. In certain embodiments, the mask comprises a substantially annular non-transmissive region surrounding a relatively high transmissive central region, such as a clear lens or aperture, discussed further below. In some embodiments, the mask can also have a substantially transparent outer region surrounding the non-transmissive region.
Any of the implants described herein can be formed, or be treated, or be coated, to minimize foreign body response, such as that associated with posterior capsule opacification (PCO). In general, PCO can be minimized or avoided by providing the implant (the mask, the IOL or both, corneal inlay or any other implant intended for implantation within the optical path) with a texturized surface. The texturized surface may be provided over at least about 50%, in some implementations at least about 75% and often at least about 85% or 90% or more of at least one surface of the implant. The texturization can be omitted from the surface of the implant at the point of the intended intersection with the optical axis.
The texture can be measured on a microinch scale. The texturization can include an average surface roughness of at least about 8 microinches and/or less than or equal to about a 125 microinch surface roughness average may be used. In some implementations, texturization may be less than about 8 microinches, less than about 16 microinches, less than about 32 microinches, or less than about 64 microinches. Texturization in the range of from at least about 8 microinches, often at least about 16 microinches and in some implementations at least about 32 microinches may be formed or applied, depending upon the desired clinical performance. In some implementations, texturization in the range of from at least about 16 microinches and/or less than or equal to about 64 microinches may be formed or applied.
Texturization may be achieved in any of a variety of ways, such as by chemical treatment, application of energy by an energy source, polishing, plasma etching, die casting, sand blasting, forming the device using a textured mold, or other mechanical treatment such as imprinting the device with a textured plate or other suitable imprinting tool.
The mask portion can be formed of any suitable material, including at least one of an open cell foam material, an expanded solid material, and a substantially opaque material. In some embodiments, the material used to form the mask has relatively high water content. In some embodiments, the materials that can be used to form the mask include any of a variety of polymers (e.g., PMMA, PVDF, polypropylene, polycarbonate, PEEK, polyethylene, acrylic copolymers (e.g., hydrophobic or hydrophilic), polystyrene, PVC, polysulfone), hydrogels, silicone, metals, metal alloys, or carbon (e.g., graphene, pure carbon) and those materials further discussed below. Fibrous materials such as a Dacron mesh can also be used. The material should be biocompatible.
Because the mask has a very high surface to volume ratio and is exposed to a great deal of sunlight following implantation, the mask preferably comprises a material which has a good resistance to degradation, including from exposure to ultraviolet (UV) or other wavelengths of light. Polymers including a UV absorbing component, including those comprising UV absorbing additives or made with UV absorbing monomers (including co-monomers), may be used in forming masks as disclosed herein which are resistant to degradation by UV radiation. Examples of such polymers include, but are not limited to, those described in U.S. Pat. Nos. 4,985,559 and 4,528,311, the disclosures of which are hereby incorporated by reference in their entireties. In some embodiments, the mask comprises a material which itself is resistant to degradation by UV radiation. In one embodiment, the mask comprises a polymeric material which is substantially reflective of or transparent to UV radiation. The lens body may include a UV absorbing component in addition to the mask being resistant to degradation by UV radiation or the mask may not be resistant to degradation by UV radiation since the UV absorbing component in the lens body may prevent degradation of the mask by UV radiation.
The mask may include a component which imparts a degradation resistive effect, or may be provided with a coating, at least on the anterior surface, which imparts degradation resistance. Such components may be included, for example, by blending one or more degradation resistant polymers with one or more other polymers. Such blends may also comprise additives which provide desirable properties, such as UV absorbing materials. In some embodiments, blends can include a total of about 1-20 wt. %, including about 1-10 wt. %, 5-15 wt. %, and 10-20 wt. % of one or more degradation resistant polymers. In some embodiments, blends can include a total of about 80-100 wt. %, including about 80-90 wt. %, 85-95 wt. %, and 90-100 wt. % of one or more degradation resistant polymers. In some embodiments, the blend has more equivalent proportions of materials, comprising a total of about 40-60 wt. %, including about 50-60 wt. %, and 40-50 wt. % of one or more degradation resistant polymers. Masks may also include blends of different types of degradation resistant polymers, including those blends comprising one or more generally UV transparent or reflective polymers with one or more polymers incorporating UV absorption additives or monomers. These blends include those having a total of about 1-20 wt. %, including about 1-10 wt. %, 5-15 wt. %, and 10-20 wt. % of one or more generally UV transparent polymers, a total of about 80-100 wt. %, including about 80-90 wt. %, 85-95 wt. %, and 90-100 wt. % of one or more generally UV transparent polymers, and a total of about 40-60 wt. %, including about 50-60 wt. %, and 40-50 wt. % of one or more generally UV transparent polymers. The polymer or polymer blend may be mixed with other materials as discussed below, including, but not limited to, opacification agents, polyanionic compounds and/or wound healing modulator compounds. When mixed with these other materials, the amount of polymer or polymer blend in the material which makes up the mask can be about 50%-99% by weight, including about 60%-90% by weight, about 65-85% by weight, about 70-80% by weight, and about 90-99% by weight.
Degradation resistant polymers can include halogenated polymers, such as fluorinated polymers, that is, polymers having at least one carbon-fluorine bond, including highly fluorinated polymers as described in U.S. Pat. No. 7,976,577, issued Jul. 12, 2011, which is incorporated by reference herein in its entirety. The term “highly fluorinated” as it is used herein, is a broad term used in its ordinary sense, and includes polymers having at least one carbon-fluorine bond (C—F bond) where the number of C—F bonds equals or exceeds the number of carbon-hydrogen bonds (C—H bonds). Highly fluorinated materials also include perfluorinated or fully fluorinated materials, materials which include other halogen substituents such as chlorine, and materials which include oxygen- or nitrogen-containing functional groups. For polymeric materials, the number of bonds may be counted by referring to the monomer(s) or repeating units which form the polymer, and in the case of a copolymer, by the relative amounts of each monomer (on a molar basis).
Highly fluorinated polymers can include, but are not limited to, polytetrafluoroethylene (PFTE or Teflon®), polyvinylidene fluoride (PVDF or Kynar®), poly-1,1,2-trifluoroethylene, and perfluoroalkoxyethylene (PFA). Other highly fluorinated polymers include, but are not limited to, homopolymers and copolymers including one or more of the following monomer units: tetrafluoroethylene —(CF2-CF2)-; vinylidene fluoride —(CF2-CH2)-; 1,1,2-trifluoroethylene —(CF2-CHF)—; hexafluoropropene —(CF(CF3)-CF2)-; vinyl fluoride —(CH2-CHF)— (homopolymer is not “highly fluorinated”); oxygen-containing monomers such as —(O—CF2)-, —(O—CF2-CF2)-, —(O—CF(CF3)-CF2)-; chlorine-containing monomers such as —(CF2-CFCl)—. Other fluorinated polymers, such as fluorinated polyimide and fluorinated acrylates, having sufficient degrees of fluorination are also contemplated as highly fluorinated polymers for use in masks according to some embodiments. The homopolymers and copolymers described herein are available commercially and/or methods for their preparation from commercially available materials are widely published and known to those in the polymer arts.
Although highly fluorinated polymers are discussed herein, polymers having one or more carbon-fluorine bonds but not falling within the definition of “highly fluorinated” polymers as discussed above, may also be used. Such polymers include co-polymers formed from one or more of the monomers in the preceding paragraph with ethylene, vinyl fluoride or other monomer to form a polymeric material having a greater number of C—H bonds than C—F bonds. Other fluorinated polymers, such as fluorinated polyimide, may also be used. Other materials that could be used in some applications, alone or in combination with a fluorinated or a highly fluorinated polymer, are described in U.S. Pat. No. 4,985,559 and in U.S. Pat. No. 4,528,311, both of which are hereby incorporated by reference herein in their entirety.
The preceding definition of highly fluorinated is best illustrated by means of a few examples. One UV-resistant polymeric material is polyvinylidene fluoride (PVDF), having a structure represented by the formula: —(CF2-CH2)n-. Each repeating unit has two C—H bonds, and two C—F bonds. Because the number of C—F bonds equals or exceeds the number of C—H bonds, PVDF homopolymer is a “highly fluorinated” polymer. Another material is a tetrafluoroethylene/vinyl fluoride copolymer formed from these two monomers in a 2:1 molar ratio. Regardless of whether the copolymer formed is block, random or any other arrangement, from the 2:1 tetrafluoroethylene:vinyl fluoride composition one can presume a “repeating unit” comprising two tetrafluoroethylene units, each having four C—F bonds, and one vinyl fluoride unit having three C—H bonds and one C—F bond. The total bonds for two tetrafluoroethylenes and one vinyl fluoride are nine C—F bonds, and three C—H bonds. Because the number of C—F bonds equals or exceeds the number of C—H bonds, this copolymer is considered highly fluorinated.
Certain highly fluorinated polymers, such as PVDF, have one or more desirable characteristics, such as being relatively chemically inert and having a relatively high UV transparency as compared to their non-fluorinated or less highly fluorinated counterpart polymers. Although the applicant does not intend to be bound by theory, it is postulated that the electronegativity of fluorine may be responsible for many of the desirable properties of the materials having relatively large numbers of C—F bonds.
In some embodiments, at least a portion of the highly fluorinated polymer material forming the mask comprises an opacification agent which imparts a desired degree of opacity. In some embodiments, the opacification agent provides sufficient opacity to produce the depth of field improvements described herein, e.g., in combination with a transmissive aperture. In some embodiments, the opacification agent renders the material opaque. In some embodiments, the opacification agent prevents transmission of about 90 percent or more of incident light. In some embodiments, the opacification agent renders the material opaque. In some embodiments, the opacification agent prevents transmission of about 80 percent or more of incident light. Opacification agents can include, but are not limited to organic dyes and/or pigments, such as black ones, such as azo dyes, hematoxylin black, and Sudan black; inorganic dyes and/or pigments, including metal oxides such as iron oxide black and ilmenite, silicon carbide and carbon (e.g. carbon black, submicron powdered carbon). Although black materials are used in some embodiments, the agents can comprise any of a variety of different colors. The foregoing materials may be used alone or in combination with one or more other materials. The opacification agent may be applied to one or more surfaces of the mask on all or some of the surface, or it may be mixed or combined with the polymeric material (e.g. blended during the polymer melt phase). Although any of the foregoing materials may be used, carbon has been found to be especially useful in that it does not fade over time as do many organic dyes, and that it also aids the UV stability of the material by absorbing UV radiation. In one embodiment, carbon may be mixed with polyvinylidene fluoride (PVDF) or other polymer composition comprising highly fluorinated polymer such that the carbon comprises about 2% to about 20% by weight of the resulting composition, including about 10% to about 15% by weight, including about 12%, about 13%, and about 14% by weight of the resulting composition.
Some opacification agents, such as pigments, which are added to blacken, darken or opacify portions of the mask may cause the mask to absorb incident radiation to a greater degree than mask material not including such agents. Because the matrix polymer that carries or includes the pigments may be subject to degradation from the absorbed radiation, the mask, which is thin and has a high surface area making it vulnerable to environmental degradation, can be made of a material which is itself resistant to degradation such as from UV radiation, or that it be generally transparent to or non-absorbing of UV radiation. Use of a highly UV resistant and degradation resistant material, such as PVDF, which is highly transparent to UV radiation, allows for greater flexibility in choice of opacification agent because possible damage to the polymer caused by selection of a particular opacification agent is greatly reduced.
A number of variations of the foregoing embodiments of degradation resistant constructions are contemplated. In one variation, a mask is made almost exclusively of a material that is not subject to UV degradation. For example, the mask can be made of a metal, a highly fluorinated polymer, carbon (e.g., graphene, pure carbon), or another similar material. Construction of the mask with metal is discussed in more detail in U.S. Pat. No. 7,491,350, issued Feb. 17, 2009, and also in U.S. application Ser. No. 11/107,359 filed Apr. 14, 2005 and entitled “Method of Making an Ocular Implant”, both of which are incorporated herein in their entirety by reference. As used in this context, “exclusively” is a broad term that allows for the presence of some non-functional materials (e.g., impurities) and for an opacification agent, as discussed above. In some embodiments, the mask can include a combination of materials. For example, in one variation, the mask is formed primarily of any implantable material and is coated with a UV resistant material. In another variation, the mask includes one or more UV degradation inhibitors and/or one or more UV degradation resistant polymers in sufficient concentration such that the mask under normal use conditions will maintain sufficient functionality in terms of degradation to remain medically effective for at least about 5 years, at least about 10 years, and in certain implementations at least about 20 years.
In additional embodiments, a photochromic material can be used with the mask or in addition to the mask. Under bright light conditions, the photochromic material can darken, thereby creating a mask and enhancing near vision. Under dim light conditions, the photochromic material lightens, which allows more light to pass through to the retina. In certain embodiments, the photochromic material may be transparent to IR light at all times.
In embodiments where the ocular device has retention members, for example haptic portions, the retention members may also be formed of any suitable material, including those listed above. In embodiments where the ocular device has connector portions to connect retention members to the mask, the connector portions can be formed of any suitable material, including those listed above.
III. Ocular Devices with Retention Members
As illustrated in
The haptics can be a variety of shapes and sizes, depending on the location the ocular device is implanted in the eye and depending on the clinical characteristics of the patient. The haptics may be C-shaped, J-shaped, plate design, or any other design. The haptics may be of open or closed configuration and may be planar, angled, or step-vaulted. The haptics can have a width, the width being measured from an anterior surface to a posterior surface of the haptic, or in other words, the width being measured parallel to the patient's line of sight. The width can be in the range of at least about 0.10 mm and/or less than or equal to about 0.35 mm. In some embodiments, the haptics can have a width from about 0.10 mm to about 0.25 mm. In some embodiments, the haptics can have a width from about 0.25 mm to about 0.35 mm. The haptics can include a width of less than 0.25 mm. In some embodiments the haptics have a constant width between a proximal section and a distal end. In some embodiments, the width of the haptics can vary along their length. In some embodiments, the haptic portions can have a length of at least about 1.0 mm and/or less than or equal to about 4.5 mm measured from a peripheral edge of the implant body. In some embodiments, the haptics can be about 1.0 mm to 2.5 mm long. In some embodiments, the haptics can be about 2.5 mm to 4.5 mm long. In some embodiments, the haptics are greater than 3.0 mm long. The haptics can be flexible and can bend within the plane of the ocular device. In some embodiments, the haptics can bend out of the plane of the ocular device.
Where the ocular device comprises haptics, the radially outwardly directed force of the haptics is sufficient for stability of the ocular device within the eye, but is not so large as to cause irritation or pupil ovaling. The ocular device can exhibit a force response of approximately less than 0.5 mN, or approximately less than 0.3 mN, when the ocular device is compressed 1.0 mm according to industry standard test ISO/DIS 11979-3.
The haptics can be separate pieces attached to a mask, or the haptics can be formed integrally with the mask. As shown in
The connector can also be made in a variety of shapes. In one embodiment, best shown in
As mentioned above, haptics can also be formed integrally with a mask.
In some embodiments of the ocular device, a mask 500, 600 can be applied to a transparent body 550, 650 to form a non-transmissive region with a small central transmissive un-masked optical aperture, as best illustrated in
The ocular device can also be implanted in the anterior chamber of a patient's eye, and various retention members can be used in this location, as described in U.S. Patent Publication No. 2011/0040376 (corresponding to U.S. patent application Ser. No. 12/856,492, filed Aug. 13, 2010), which is incorporated by reference herein in its entirety.
The ocular device of the present application can also be implanted in a position between the IOL and an iris or between the iris and a cornea. In some embodiments, the ocular device can be secured to the iris, and various retention members can be used to secure the device to the iris.
In certain embodiments, the ocular device can be positioned adjacent to an IOL by attaching the device directly to an IOL through one of a variety of methods. Advantageously, the device can be attached to an IOL prior to implantation of the IOL or the device can be attached to an IOL that was previously implanted into the patient's eye. In some embodiments, best illustrated in
Features of some embodiments of the hooks 902 can be best seen in
In some embodiments, the ocular device of the present application can move forward and backward along the optical axis inside of an eye. For example, the haptics can support the device within the eye, while also allowing the device to move slightly. Such movement of the device, in some embodiments, may be advantageous, particularly when the device is placed in a position adjacent to an accommodating IOL, which may move forward and backward inside the eye as the patient focuses on certain near or far objects.
In some embodiments, best illustrated by
The illustrated embodiment of
IV. Ocular Device with a Mask Configured to Reduce Diffraction Patterns
In certain embodiments, the mask includes a transmissive zone or region, and a non-transmissive zone or region. For example, in
In some embodiments, the transmissive region can be implanted at least partially in an optical zone of the eye, such that light entering through the cornea passes through the transmissive region before reaching the retina. In certain embodiments, the transmissive region can be substantially centered on the optical axis of the eye, such as the line of sight and an axis passing through the center of the entrance pupil and the center of the patient's eye. In some embodiments, the transmissive region can transmit a majority of light in the visible range. In one embodiment, the transmissive region transmits all or nearly all of the light in the visible range. In one embodiment, the transmissive region transmits at least about 90% of the light in the visible range. In some embodiments, the transmissive region transmits at least about 80% of the light in the visible range. In some embodiments, the transmissive region can be completely transparent and can transmit all of the light in the visible range.
The transmissive region can be sized to cover a substantial portion of the optical zone of the IOL in one embodiment. For example, the transmissive region can cover more than half of the optical zone when the iris is fully dilated. In some embodiments, the transmissive region can cover substantially the entire optical zone when the iris is fully dilated. In some embodiments, the transmissive region can cover the entire optical zone when the iris is fully dilated. In some embodiments, the transmissive region can cover more than half of the optical zone when the iris is fully constricted. In some embodiments, the transmissive region can cover substantially the entire optical zone when the iris is fully constricted. In another embodiment, the transmissive region can cover the entire optical zone when the iris is fully constricted.
A transmissive region can be formed with any suitable transverse dimension, e.g. a diameter in the range of about 0.5 mm to about 1.8 mm. In one embodiment, the transmissive zone can have a transverse dimension of at least about 0.7 mm. Some embodiments can include a smaller transmissive region, e.g., a diameter less than 1.3 mm. In one embodiment, the mask can have a transmissive region with a transverse dimension greater than that which would produce a pinhole effect. Such an arrangement allows more light to reach the retina which may be advantageous, particularly in dark conditions or while driving at night. Such an arrangement may also be particularly advantageous for patients who do not have difficulty with accommodation.
In addition to a transmissive region, some embodiments also have a non-transmissive region as mentioned above, and as further discussed below. In some embodiments, a relatively sharp boundary or demarcation can be provided between an outer periphery of the transmissive region and the inner periphery of the non-transmissive region. For example, in some embodiments, the outer periphery of the transmissive region and the inner periphery of the non-transmissive region coincide, and create a sharp boundary between the two regions. In some embodiments, the mask can display a more gradual change in opacity from the transmissive region to the non-transmissive region. For example, various apodization techniques can be applied to portions of the mask, such that there is a gradual increase in opacity between the transmissive region and the non-transmissive region, examples of which are described in U.S. Pat. No. 7,628,810, issued Dec. 8, 2009, and U.S. Patent Publication 2012/0143325 (corresponding to U.S. patent application Ser. No. 13/390,080, filed Feb. 10, 2012), both of which are incorporated by reference herein in their entireties. In one embodiment, an apodization technique can also be used to create a sharp boundary between a transmissive region and a non-transmissive region where the sharp boundary between the regions varies in distance from the central axis of the mask, e.g., the boundary is undulating or wavy. A variety of other apodization techniques are set forth in U.S. Pat. Nos. 5,662,706; 5,905,561; and 5,965,330, which are all incorporated by reference herein in their entireties.
In some embodiments, the non-transmissive region can be defined by an outer periphery and an inner periphery. As illustrated in
The non-transmissive region can have different degrees of opacity. In some embodiments, the non-transmissive region can block all of visible light or substantially all of visible light incident on the anterior surface of the non-transmissive region. In one embodiment, the non-transmissive region blocks more than 50% of the visible light incident on the anterior surface of the non-transmissive region. In some embodiments, the non-transmissive region blocks at least about 60% of the visible light incident on the anterior surface of the non-transmissive region. In some embodiments, the non-transmissive region blocks at least about 70% of the visible light incident on the anterior surface of the non-transmissive region. In some embodiments, the non-transmissive region blocks at least about 80% of the visible light incident on the anterior surface of the non-transmissive region. In some embodiments, the non-transmissive region blocks about 90% or 95% or more of the visible light incident on the anterior surface of the non-transmissive region. In an alternate embodiment, the non-transmissive region is an opaque region that transmits no more than 20% of the visible light incident on the anterior surface of the non-transmissive region. In some embodiments, the non-transmissive region may be completely opaque.
The opacity of the non-transmissive region may also vary in different parts of the mask. For example, in certain embodiments, the opacity near the outer periphery or inner periphery of the mask can be less than a central part of the non-transmissive region as described in U.S. Pat. No. 7,628,810, issued Dec. 8, 2009, and U.S. application Ser. No. 13/390,080, filed Feb. 10, 2012, both of which are incorporated by reference herein in their entireties. The opacity in different parts of the non-transmissive region may transition abruptly or have a gradient transition. Additional examples of opacity transitions can be found in U.S. Pat. Nos. 5,662,706, 5,905,561 and 5,965,330, which are incorporated in their entirety herein by reference.
Opacity of the non-transmissive region can be achieved in any of several different ways. For example, in some embodiments, the material used to make a mask may be naturally opaque. In some embodiments, the material used to make the mask 100 may be substantially clear, but treated with a dye or other pigmentation agent to render the non-transmissive region substantially opaque. In some embodiments, the dye is selected from those providing low transmission in some wavelengths, and greater transmission in other wavelengths. Such a dye may be advantageous for use with various diagnostic technique and instruments. For example, common contemporary diagnostic techniques can utilize Scanning Laser Ophthalmoscopy/Optical Coherence Tomography (SLO/OCT), which typically have an illumination source in the near-infrared (NIR) range e.g. 850 nm. Therefore, it may be desirable for the mask to block visible light (e.g. wavelengths between about 400 nm and about 700 nm) while retaining a high transmission at a diagnostic instrument's operational wavelengths of NIR light. In one embodiment, the non-transmissive region can be configured of a material absorbent in an appropriate range of wavelengths to provide opacity in visible light, but also transparent to NIR light, as disclosed in U.S. application Ser. No. 13/691,625, filed Nov. 30, 2012, and titled “Ocular Mask Having Selective Spectral Transmission,” which is incorporated by reference herein in its entirety. Such a material composition may desirably minimize the visibility of the mask during an examination using diagnostic instruments with infrared light sources.
In some embodiments, the non-transmissive region can comprise a light absorbing material embedded within or combined with another material. For example, the non-transmissive region can be formed by mixing together a suitable polymer material and sufficient quantity of an opacification agent. Such a mixture may provide adequate absorption of light and prevent noticeable refractive difference across the transition from the transmissive region to the non-transmissive region. As discussed above, carbon is one example of a suitable opacification agent, although others can be used. In one embodiment, carbon can include carbon black and/or small, e.g., submicron, powdered carbon particles.
In some embodiments, the surface of the mask may be treated with a particulate deposited thereon. For example, a particulate of titanium, gold or carbon may be deposited on the surface of the mask provide opacity. In some embodiments, the particulate may be encapsulated within the interior of the mask. Some embodiments employ different ways of controlling light transmission through the mask. In one embodiment, the mask may comprise a gel, such as hydrogel or collagen, or other suitable material. The gel within the mask can further include a particulate suspended within the gel. Examples of suitable particulate are gold, titanium, and carbon particulate.
Thus, as shown in
Nano-devices or nanites are crystalline structures grown in laboratories. The nanites may be treated such that they are receptive to different stimuli such as light. In accordance with one aspect of certain embodiments, the nanites can be imparted with energy where, in response to a low light and high light environments, they rotate in the manner described above and generally shown in
Nanoscale devices and systems and their fabrication are described in Smith et al., “Nanofabrication,” Physics Today, February 1990, pp. 24-30 and in Craighead, “Nanoelectromechanical Systems,” Science, Nov. 24, 2000, Vol. 290, pp. 1502-1505, both of which are incorporated by reference herein in their entirety. Tailoring the properties of small-sized particles for optical applications is disclosed in Chen et al. “Diffractive Phase Elements Based on Two-Dimensional Artificial Dielectrics,” Optics Letters, Jan. 15, 1995, Vol. 20, No. 2, pp. 121-123, also incorporated by reference herein in its entirety.
In some embodiments, the surface of the mask can be treated physically or chemically (such as by etching) to alter the refractive and transmissive properties of the mask and to alter the transmission of light.
Although in certain embodiments the non-transmissive region is a peripheral region and is described as an “opaque” region, any construction that substantially prevents light from passing through the region could provide at least some of the advantages described herein, such as reducing glare or other distracting visual effect caused by the ocular device. Other optical phenomena that can be used to prevent transmission of light at the non-transmissive region are described in U.S. Pat. No. 6,554,424, which is incorporated by reference herein in its entirety. Such phenomena can include one or more of reflection of light in the non-transmissive region, diffraction of light in the non-transmissive region, and scattering of light in the non-transmissive region, alone or in combination with light absorption to provide at least one of the advantages described herein.
The non-transmissive region can provide an advantage of preventing distracting visual effects from being visible to the patient, in some embodiments. For example, the non-transmissive region can block enough light to eliminate distracting visual effects at a periphery of the ocular device. Some configurations of the non-transmissive region can also reduce glare and other distracting visual effects at a boundary between the ocular device and the IOL, particularly the IOL portion that resides adjacent to the outer periphery of the mask. Glare can occur due to the difference in refraction of the light that passes through the ocular device and the light that passes through the adjacent IOL and not through the ocular device. Such refractive difference can be significant enough to be noticed by a patient, and thus can be distracting. In some embodiments, glare can be reduced by making the width of the non-transmissive region large enough to provide sufficient distance between the light passing through the transmissive region and the light passing through the lens outside of the ocular device.
As mentioned above, the non-transmissive region can be configured to reduce a noticeable difference in refraction of light that passes through the transmissive region of the device and a central optical zone of the IOL and light that passes through the optical zone of the IOL but around the device, e.g., outside the outer periphery of the device. In one embodiment, the non-transmissive region can be annular and can surround the transmissive region. In one embodiment, the non-transmissive region comprises an annular shape in which at least one periphery thereof is substantially circular. In some embodiments, the non-transmissive region has an inner periphery and an outer periphery, at least one of which is circular. In some embodiments, an annular non-transmissive region can also have an irregular or wavy inner or outer periphery that varies in distance from the central optical axis of the device. In some embodiments, the inner periphery of the non-transmissive region may coincide with an outer periphery of the transmissive region.
In some embodiments, the non-transmissive region is generally annular. The non-transmissive region may have a transverse dimension that can include the width of the annulus. In certain embodiments, the non-transmissive region can have a transverse dimension that is approximately two times the width of the transmissive region. In certain embodiments, the inner periphery of the non-transmissive region can have a diameter between about 0.5 mm and about 1.8 mm. In one embodiment, the inner periphery of the non-transmissive region can have a diameter of at least about 1.0 mm. In one embodiment, the combined width of the two portions of the non-transmissive region on opposite sides of the transmissive region is about 1.5 mm or more. In some embodiments, the combined width of the two portions of the non-transmissive region on opposite sides of the transmissive region is about 1.3 mm or more. In some embodiments, the combined width of the two portions of the non-transmissive region on opposite sides of the transmissive region is at least about 0.8 mm or more. In some embodiments, a transverse dimension of the transmissive region is greater than a transverse dimension of the non-transmissive region. In some embodiments, a transverse dimension of the transmissive region is less than a transverse dimension of the non-transmissive region. In one embodiment, the mask can be configured such that an inner periphery of the non-transmissive region has a transverse dimension that is greater than that which would produce a pinhole effect. Such an arrangement allows more light to enter the eye and may be advantageous, particularly in dark conditions. Such an arrangement may also be particularly advantageous for patients that do not have difficulty with accommodation.
In some embodiments, the non-transmissive region may have a transverse dimension sufficient to extend to a projection of a pupil of the eye. For example, the width of the non-transmissive region extending across the transmissive region can be about 8 mm or more. Here, the non-transmissive region can substantially reduce glare by preventing light from being transmitted through adjacent corneal tissue.
The ocular device of the present invention can be surgically implanted through a wide variety of methods. The device can be applied to the eye in any manner. For example, the ocular device can be joined to an IOL prior to surgical implantation, so that the device and the IOL can be implanted simultaneously during a single procedure. The device and IOL can also be implanted sequentially, in any order, during a single procedure. In some embodiments, the device can be implanted adjacent to a patient's previously implanted IOL. Advantageously, a surgical incision of no more than about 4.5 mm, no more than about 4.0 mm, and in some implementations, no more than about 3.55 mm is required to insert the device in any of the few sample procedures described in more detail below. In some embodiments, a central axis of the device is positioned within the eye to be in line with the eye's optical axis.
The ocular device can also be implanted in any location within the eye, including the anterior chamber or the posterior chamber. For example, the device can be implanted in the posterior chamber by attaching the device to the ciliary sulcus. As a further example, the device can be implanted within an eye's lens capsule or mounted on an outer surface of the lens capsule. The device can be positioned adjacent to an IOL. The ocular device can be implanted adjacent to any type of IOL, including monofocal IOLs, multifocal IOLs, and accommodating IOLs.
In one method of implantation, an ocular device and an IOL can be inserted simultaneously into an eye through one incision during a single procedure. To use this implantation method, the device and the IOL can be joined together at some time prior to the procedure to form an IOL construct. For example, the device and the IOL can be joined during the manufacturing process. In another example, the device and the IOL can be joined by a surgeon or other appropriate individual at the clinical site prior to the surgery. Further, the device and IOL can be joined by use of a machine during the manufacturing process, or the device and IOL can also be joined by any individual using a tool specially adapted for joining the device and IOL. The device and the IOL can be permanently joined. In some embodiments, the device and the IOL can be only temporarily joined, so that at some time after insertion the device and IOL are no longer joined. Where the device and IOL are temporarily joined, the device and IOL can be separately removable if the patient needs one of the implants removed.
The device and IOL can be joined to each other through various methods. In one embodiment, the device has its own haptics and the IOL has its own haptics. In one embodiment, some or all of the haptics of the device can be formed into one or two or more hooks or clips and can be used to attach the device to the IOL. In some embodiments, some or all of the haptics of the lens can be used to join the lens to the device. As described above, the shape and curvature of the device and IOL may correspond, further improving attachment and positioning of the device adjacent to the IOL. In some embodiments, an adhesive can be used to join the device to the IOL.
After the device and IOL are joined to form an implantable body, the implantable body can then be folded, rolled, or otherwise deformed for insertion through a small incision in an eye. For example, the body may be implanted by rolling up the body and inserting the rolled-up body into a tube. The tube is then inserted into an incision in the eye, and the body is ejected out of the tube deployed within the eye. Using this method, the body can be implanted within the lens capsule after removal of the natural lens. Using this method, the body can also be implanted in the anterior chamber, posterior chamber, and can also be coupled with or attached to the ciliary sulcus (sometimes referred to as “sulcus-fixated”).
Once inserted into the eye, the shape memory material or other properties of the IOL component of the body will cause the body to unroll and expand. The body can be positioned and fixed in place using any surgical technique used to position and fix IOLs. One or more haptics of the IOL can be used to secure the body to the eye. In some embodiments, one or more haptics of the ocular device can be used to secure the body to the eye. In some embodiments, haptics from both the IOL component and the device component can be used to secure the body to the eye. Surgeons and patients may find this procedure advantageous, as it requires only one incision and one implantation procedure to position both an IOL and the ocular device of the present application.
When joining the device and the IOL together, the retention members of the device can be rotationally offset from the retention members of the IOL. For example, any connectors or haptics extending from the periphery of the device may have a greater thickness than the device itself. For example, in the embodiment of
In one method of implantation, an ocular device and an IOL can be inserted sequentially into an eye through one incision during a single procedure. It is envisioned that the mask and the IOL can be inserted in any order, depending on the surgeon's preference and the clinical characteristics of the patient. For example, the surgeon can insert the IOL, position and secure the IOL, and then insert the device, and position and secure the device. In some embodiments, the surgeon can insert the device, and position and secure the device, and then insert the IOL, and position and secure the IOL. The surgeon can also insert both the IOL and the device, in any order, prior to positioning and securing the IOL and the device, in any order.
The IOL can be implanted through any suitable procedure. The device can also be implanted through any suitable method. For example, the surgeon can slide the device through the incision and into place, without rolling or otherwise deforming the device. If desired, the device can be folded, rolled, or otherwise deformed for insertion through a small incision in an eye. The device may then be inserted into a restraint, such as a tube. The tube is then inserted into an incision in the eye, and the device is ejected out of the tube and deployed within the eye. Using this method, the device can be implanted within the lens capsule adjacent to an IOL. Using this method, the device can also be implanted in the anterior chamber, posterior chamber, and can also be coupled with or attached to the ciliary sulcus (sometimes referred to as “sulcus-fixated”).
In one embodiment, both the device and IOL can have retention members, such as haptics or hooks or clips or protrusions, for example. Thus, the device and the IOL can be secured and positioned in the eye in a variety of ways. For example, the IOL can be secured to a portion of the eye and the device can be secured to the IOL. In certain aspects, the IOL can be secured to a portion of the eye and the device can be separately secured to any portion or structure of the eye. In certain aspects, the device can be secured to a portion of the eye and the IOL can be secured to the device. When positioning the device and the IOL within the eye, the retention members of the device can be rotationally offset from those of the IOL. Advantageously, the device can be removed from the eye if the patient needs to have the device removed.
In one method of implantation, an ocular device can be inserted into an eye in a position adjacent to a previously implanted IOL. This method is advantageous in that it permits a patient who already has an IOL to receive the device during a separate, later procedure. Implantation of the device can be accomplished at least one day, at least one month, or at least one year or more following implantation of the IOL.
The device can be implanted through any suitable method. For example, the surgeon can slide the device through the incision and into place, without rolling or otherwise deforming the device. If desired, the device can be folded, rolled, or otherwise deformed for insertion through a small incision in an eye. The device may then be inserted into a restraint such as a tube. The tube is then inserted into an incision in the eye, and the device is ejected out of the tube and deployed within the eye. Using this method, the device can be implanted within the lens capsule adjacent to an IOL. Using this method, the device can also be implanted in the anterior chamber, posterior chamber, and can also be coupled with or attached to the ciliary sulcus (sometimes referred to as “sulcus-fixated”).
The surgeon can use the retention members, such as haptics or hooks or clips, of the device to secure the device in place. The device can be secured to any appropriate structure in the eye. When positioning the device in the eye, each retention member of the device can be rotationally offset from those of the IOL. Advantageously, the device can be removed from the eye if the patient needs to have the device removed.
Although the ophthalmic devices disclosed herein have been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the ophthalmic devices extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying ophthalmic devices. Accordingly, it is intended that the scope of the soap dispenser herein-disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
This application claims a priority benefit under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/599,850, filed Feb. 16, 2012, entitled “MASKED OCULAR DEVICE FOR IMPLANTATION ADJACENT TO AN INTRAOCULAR LENS,” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61599850 | Feb 2012 | US |
