Patent Grant
12295829
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
There may be benefits for a peripheral portion (e.g., haptic) of an intraocular lens (e.g., an Intraocular Collamer Lens (ICL)) to be adapted to prevent or minimize visual disturbances caused by the interaction between incident light and one or more surfaces of the lens. Additionally, or alternatively, there may be benefits to providing more customization or tuning options in the design of the optic, such as, without limitation, for one or more dimensions of the optic (e.g., optic diameter, optic central thickness, or optic peripheral thickness). The disclosure herein includes lenses and methods of manufacture that are adapted to provide one or more of these benefits.
One aspect of the disclosure is an ophthalmic implant, comprising: a transparent optic portion; and a peripheral non-optic portion coupled to the optic portion and extending peripherally therefrom, the peripheral portion sized and configured to engage a sulcus of an eye, the transparent optic portion made of a transparent optic material adapted to allow visible light to pass therethrough, and the peripheral non-optic portion made of a light absorbing material adapted to absorb visible light. This aspect may also include any suitably combinable feature from any implant or lens herein, including in any of the claims as filed.
One aspect of this disclosure is a monofocal ophthalmic implant, comprising: a transparent optic portion with a diameter from 4 mm to 7 mm; and a peripheral non-optic portion coupled to the optic portion and extending peripherally therefrom, the peripheral portion sized and configured to engage a sulcus of an eye, the transparent optic portion made of a transparent optic material adapted to allow visible light to pass therethrough, and the peripheral non-optic portion made of a light absorbing material adapted to absorb visible light. This aspect may also include any suitably combinable feature from any implant or lens herein, including in any of the claims as filed.
One aspect of this disclosure is an ophthalmic implant for treating presbyopia, comprising: a transparent optic portion configured as an extended depth of field optic to treat presbyopia; and a peripheral non-optic portion coupled to the optic portion and extending peripherally therefrom, the peripheral portion sized and configured to engage a sulcus of an eye, the transparent optic portion made of a transparent optic material adapted to allow visible light to pass therethrough, and the peripheral non-optic portion made of a light absorbing material adapted to absorb visible light. This aspect may also include any suitably combinable feature from any implant or lens herein, including in any of the claims as filed.
One aspect of this disclosure is a phakic intraocular lens, comprising: a transparent optic made of a transparent optic material, the optic having a power from −15 D to −30 D or from +5 D to +15 D, a diameter from 2 mm to 5 mm, and a difference between a central thickness and an edge thickness less than 500 microns; and an opaque peripheral non-optic portion made of a visible light absorbing material coupled to the optic and extending peripherally therefrom, the opaque peripheral portion sized and configured to engage a sulcus of an eye. This aspect may also include any suitably combinable feature from any implant or lens herein, including in any of the claims as filed.
One aspect of this disclosure is an intraocular lens, comprising: a transparent optic made of a transparent optic material, the optic having a diameter from 1 mm to 3 mm; and an opaque peripheral non-optic portion coupled to the optic and extending peripherally therefrom, the peripheral portion sized and configured to engage a sulcus of an eye and secure the lens in an eye. This aspect may also include any suitably combinable feature from any implant or lens herein, including in any of the claims as filed.
One aspect of this disclosure is a method of correcting vision, comprising: positioning a lens into a posterior chamber of an eye, the lens including, a transparent optic made of a transparent optic material, and an opaque peripheral non-optic portion coupled to the optic and extending peripherally therefrom, the peripheral non-optic portion made of a light absorbing material adapted to absorb visible light, and sized and configured to engage a sulcus of an eye and secure the lens in an eye, wherein positioning the lens into the posterior chamber comprises interfacing the peripheral portion with the sulcus of the eye to secure the lens in the eye, and causing the opaque peripheral non-optic portion to absorb visible light that is incident upon the opaque peripheral non-optic portion. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of implanting a monofocal lens, comprising: positioning a monofocal lens into a posterior chamber of an eye, the lens including a transparent optic portion made of a transparent optic material adapted to allow visible light to pass therethrough, the optic portion having a diameter from 4 mm to 7 mm, and an opaque peripheral non-optic portion made of a light absorbing material adapted to absorb visible light, the peripheral non-optic portion coupled to the optic portion and extending peripherally therefrom, wherein positioning the monofocal lens into the posterior chamber comprises interfacing the peripheral portion with the sulcus of the eye to secure the lens in the eye, and causing the peripheral portion to absorb visible light that is incident upon the peripheral portion. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of treating presbyopia, comprising: positioning a lens into a posterior chamber of an eye, the lens including a transparent optic portion configured as an extended depth of field optic to treat presbyopia, the optic portion made of a transparent optic material and having a diameter from 3 mm to 5 mm, and an opaque peripheral non-optic portion made of a light absorbing material adapted to absorb visible light, and the peripheral portion coupled to the optic portion and extending peripherally therefrom, wherein positioning the lens into the posterior chamber comprises interfacing the peripheral portion with the sulcus of the eye to secure the lens in the eye, and causing the peripheral portion to absorb visible light that is incident upon the peripheral portion. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of implanting a phakic lens, comprising: positioning a phakic lens into a posterior chamber of an eye, the phakic lens including a transparent optic portion made of a transparent optic material, the optic portion having a power from −15 D to −30 D or from +5 D to +15 D, a diameter from 2 mm to 5 mm, and a difference between a central thickness and an edge thickness less than 500 microns, and an opaque peripheral non-optic portion made of a visible light absorbing material and coupled to the optic portion and extending peripherally therefrom, wherein positioning the phakic lens into the posterior chamber comprises interfacing the peripheral portion with the sulcus of the eye to secure the lens in the eye, and causing the peripheral portion to absorb visible light that is incident upon the peripheral portion. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of providing vision correction to a patient, comprising: in a patient in which an eye is aberrated, positioning a lens into a posterior chamber of an eye, the lens including a transparent optic portion made of a transparent optic material, the optic portion having a diameter from 1 mm to 3 mm, and an opaque peripheral non-optic portion made of a visible light absorbing material and coupled to the optic portion and extending peripherally therefrom, wherein positioning the phakic lens into the posterior chamber comprises interfacing the peripheral portion with the sulcus of the eye to secure the lens in the eye, and causing the peripheral portion to absorb visible light that is incident upon the peripheral portion. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of manufacturing an ophthalmic lens, comprising: creating an optic rod of transparent optic material; creating a peripheral portion rod made of visible light absorbing material adapted to absorb light; forming a cylindrical channel in the peripheral portion rod; positioning the optic rod into the cylindrical channel; and adhering the optic rod to the peripheral portion rod to form an adhered rod with a central transparent region and a peripheral visible light absorbing region. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is a method of manufacturing an ophthalmic lens, the method comprising: positioning an optic rod into a cylindrical channel that extends through a peripheral non-optic portion rod, the optic rod made of transparent optic material and the peripheral portion rod made of a visible light absorbing material; and adhering the optic rod to the peripheral portion rod to form a composite rod with a central transparent region and a peripheral visible light absorbing region. This aspect may also include any suitably combinable feature from any method herein, including in any of the claims as filed.
One aspect of this disclosure is an intraocular lens, comprising: a transparent optic portion and a non-optic peripheral portion comprising a visible light absorbing material, wherein the optic portion has an axis that is offset from and parallel to a peripheral portion axis. This aspect may also include any suitably combinable feature from any lens herein, including in any of the claims as filed.
One aspect of this disclosure is an intraocular lens, comprising: a transparent optic portion and a non-optic peripheral portion comprising a visible light absorbing material, the non-optic peripheral portion comprising one or more apertures therethrough adjacent the optic, the one or more apertures angled towards the periphery of the lens. This aspect may also include any suitably combinable feature from any lens herein, including in any of the claims as filed.
One aspect of this disclosure is an intraocular lens, comprising: a transparent optic portion and a non-optic peripheral portion comprising a visible light absorbing material, the non-optic peripheral portion comprising one or more apertures therethrough and adjacent the optic, the one or more apertures each having an axis that is not parallel with an optic portion axis. This aspect may also include any suitably combinable feature from any lens herein, including in any of the claims as filed.
The disclosure is related to ophthalmic implants, such as lenses that are configured for placement into an eye. By way of example only, some lenses herein may be configured to be placed in a posterior chamber of an eye, between an iris and a capsular bag. Lenses herein may optionally be configured as extended depth of field lenses. Concepts herein may also be applicable to lenses implanted in other parts of an eye, and may be applicable to lenses configured for a variety of types of vision correction (e.g., presbyopia, myopia, astigmatism, corneal damage or disease, lenticular damage or disease etc.).
One aspect of this disclosure is related to implantable lenses configured for correcting vision, wherein the optic is tunable, or adaptable as needed for a particular therapeutic application. Lenses herein may include a peripheral, non-optic portion coupled to a transparent optic. The peripheral portions herein may generally be referred to herein as haptic portions, and they may comprise one or more haptics. The peripheral portions generally provide structural support to the ophthalmic implant, and are generally sized and disposed relative to the optic to engage tissue (e.g., the sulcus) and centrally locate the optic.
The lenses described herein also include a transparent optic that comprises a transparent optic material adapted to allow light to pass therethrough and to the retina. The transparent material may comprise, for example, silicone, acrylics, or hydrogels. The transparent material may comprise hydrophobic or hydrophilic material. The transparent material may comprise Collamer®.
The lenses herein may include a peripheral non-optic portion that is made of a visible light absorbing material adapted to absorb visible light. The visible light absorbing material of the peripheral portions may include one or more constituent components or agents that impart visible light absorbing properties to the light absorbing material, such as one or more of titanium, obsidian, gold, titanium dioxide, silicon carbide, carbon, charcoal or soot or organic chromophores that absorb light across the visible part of the electromagnetic spectrum.
In some mere examples, the peripheral non-optic portions may include one or more of the same components or agents as the optic portion, while also including the one or more visible light absorbing components or agents. For example only, peripheral portions herein may comprise silicone, acrylics, or hydrogels, as well as one or more of titanium, obsidian, gold, titanium dioxide, silicon carbide, carbon, charcoal or soot or organic chromophores. In some examples only, the optic and peripheral material may comprise the same or substantially the same components, except that the peripheral portion material may include the one or more visible light absorbing components or agents. For example only, an optic may comprise Collamer®, while the peripheral portion may comprise Collamer® as well as one or more visible light absorbing components or agents.
In some examples only, the optic material and the peripheral material may comprise the same or substantially the same components, except that the peripheral portion (which includes the one or more visible light absorbing components or agents) may not include an ultraviolet blocking chromophore that is included in the optic portion material. Since the peripheral portion includes one or more visible light absorbing components or agents, the peripheral portion may not need to include an ultraviolet radiation blocking chromophore, for example. For example only, an optic portion may comprise Collamer® while the peripheral portion may comprise Collamer® without an ultraviolet radiation blocking chromophore (as well as the one or more visible light absorbing components or agents). In some embodiments, however, it may be advantageous that the visible light blocking chromophore in the peripheral non-optic portion also blocks ultraviolet radiation. For example only, for some vision correction applications, the peripheral non-optic portion of lens may extend within the pupil (e.g.,
In some examples only, the organic or inorganic chromophores that provide the visible light blocking in the peripheral portion may be crosslinked with the base polymer of the peripheral portion.
The peripheral non-optic portions herein generally provide structural support to the ophthalmic implant, and are generally sized, configured and disposed relative to the optic to engage tissue (e.g., the sulcus) and centrally locate the optic (in some, embodiments below, however, the optic may not be centrally located). The peripheral portions herein may thus also be referred to as structural support portions. In some applications, it may be desired that the peripheral structural support portions of the lens have different mechanical properties than the optic portion of the lens. For example, the optic portion and the peripheral structural support portion may be made from two different materials that have different optical properties as well as different mechanical properties. For example only, it may be desired to provide peripheral portions that are stiffer than the optic portion, or it may be desired for the peripheral portions to be less stiff than the optic portion. The material for the optic and peripheral portions may thus be selected to impart the desired optical and mechanical properties for the different portions of the lens. For example only, the peripheral portion material may be substantially different than the material for the optic portion, and the peripheral portion can also include the one or more light absorbing materials.
It is noted that
The lenses herein, including peripheral portions made of visible light absorbing material, may impart one or more advantages or benefits to the lens, as well as creating more options for tuning or adapting the optic design as desired. For example, previous peripheral portions that transmit visible light, for example transition zones, may occasionally cause visual disturbances, such as glare or halos. For example, at night, pupils will dilate to let in more light, and light interacting with the non-optical peripheral portion surfaces of the lens may cause halos or other disturbances, symptoms or dysphotopsias. Peripheral portions described herein that absorb visible light prevent light from passing therethrough and thereby prevent the visual disturbances caused by the interaction between incident light and the non-optical surfaces of the peripheral portion.
An additional exemplary benefit of incorporating light absorbing peripheral portions into the lenses herein is that it may allow for more customization or tuning in the design of the optic, such as allowing more design options for one or more dimensions of the optic portion of the lens (e.g., diameter, optic central thickness, optic peripheral thickness). In some particular applications, the lenses herein may be placed in the sulcus between the iris and the capsular bag (with the native lens or a replacement IOL in the bag). This may be a region of the eye where there is limited space, and it may be beneficial to have a relatively very thin optic portion (e.g., 200 microns or less) to occupy as little space as possible and apply as little force on the iris as possible, and to avoid contacting the crystalline lens altogether, and for the rest of the lens to also be as thin as possible to occupy as little space as possible and apply as little force on the iris, and avoid contacting the crystalline lens altogether. For example, applying forces on the iris may reduce the angle and thereby reduce the aqueous drainage through Schlemm's canal, increasing intraocular pressure. Additionally contacting the crystalline lens may induce traumatic cataract. Additionally or alternatively, for some lenses (and treatments), it may be beneficial for the optic to have a relatively small optic diameter. With respect to peripheral portions that do not include any visible light absorbing components, decreasing the diameter of the optic inherently increases the radially inward extent of the peripheral portion, which extends the non-optic surfaces of the peripheral portion further radially inward, and thereby increases the likelihood of unwanted light scattering. Incorporating one or more light absorbing components into the peripheral portion, however, as is described herein, creates a peripheral portion that prevents visible light scattering in the peripheral non-optic portion. Peripheral portions that incorporate one or more visible light absorbing components may thus extend further radially inward without causing unwanted visible light scattering. In fact, when the peripheral portion includes visible light absorbing component(s), the optic portion diameter may be decreased as much as desired without having to worry about visible light scattering off the non-optical surfaces of the peripheral portion.
As an illustration of the aforementioned design options, while optic portions in a monofocal lens (e.g., as shown in
Monofocal ophthalmic lenses function via refracting light from anterior and posterior curved surfaces. Generally, the anterior and posterior surfaces are curved in different ways to each other that cause the lens thickness to vary across the surface of the optic, generally from thin at the center to thicker at the periphery for negatively powered lenses such as those added to the eye to correct myopia (such as those shown in
An additional aspect of the disclosure is lenses with a transparent optic and opaque peripheral non-optic portions as described herein, wherein the optic has a relatively much smaller optic diameter, such as from 1 mm to 3 mm, such as 1 mm, 1.5 mm, 2 mm, 2.5 mm, or 3 mm, an example of which is shown in lens 500 in
The ICL 200 in
The ICL 300 in
The ICL 400 in
The ICL 500 in
In some embodiments, the lenses herein with peripheral opaque regions may also be adapted to provide correction of astigmatism through the use of a lens that includes cylindrical power. Such lenses are not radially symmetrical but have an axis about which the lens thickness varies. Such lenses can benefit from the innovative concepts described herein in the same way that the spherical lenses benefit.
The exemplary benefits set forth directly above illustrate the design and tuning options provided by incorporating an opaque peripheral portion to the ICLs herein.
As described in more detail below, lenses herein may include a transparent optic and a peripheral non-optic portion made of a visible light absorbing material that is different than the optic portion material. Lenses, when made from hydrophylic materials, when implanted into the aqueous environment of the eye, or when stored in a fluid for transportation, for instance balanced salt solution, will swell to some extent relative to the lens in its unhydrated state. If one of the optic and peripheral non-optic portions swells more than the other, the coupling region between the optic and non-optic portions may be stressed or otherwise compromised after implantation. This may cause the lens, including the optic and/or the peripheral portion, to assume an undesired configuration after implantation, such as due to buckling between the optic and the non-optic portions, which may cause the lens to perform sub-optimally. Additionally, different relative swelling may apply forces to the bond between the optic and periphery, which may cause the optic and peripheral portion to detach from each other. The optic and peripheral portions herein may thus have swell indices that are the same or substantially the same so that when they are manufactured, packaged and/or implanted, they will swell to as close to the same extent as possible. The phrase swell index as used herein may also be referred to as an expansion factor, or other similar phrase. Swell index as used herein generally refers to the extent to which a material swells after being exposed to the natural aqueous humor of the eye, or similar solution such as Balanced Salt Solution (BSS), and may optionally be characterized generally by a change in linear dimensions, or volume, or change in weight, before and after swelling.
In any of the examples herein, the transparent optic material and the visible light absorbing material may have swell indices that are the same as each other. In any of the examples herein, the transparent optic material and the visible light absorbing material may have linear swell indices that are within about 5% of each other, such as within 5% of each other, or preferably within 1% of each other. As set forth above, the material of the optic portion may be substantially the same as the material of the peripheral portion. As an example, an optic may comprise Collamer®, and the peripheral portion may comprise Collamer® and may or may not include an ultraviolet radiation blocking chromophore. In these examples, the materials may not be exactly the same, but they may have swell indices within about 5% of each other. When the disclosure herein refers to materials that have swell indices that are within a certain percentage of each other, such as within 5% of each other, or preferably within 1% of each other, it is referring to the linear swell index, or how much bigger the material becomes in the linear direction. To measure a swell index in a particular fluid, for example, a material can be prepared (dry), then exposed to the fluid, and then measured to determine how much larger it has become in the linear direction.
For example only, a first optic material may have a swell index of 1.21 in BSS. Swell indices within 5% of 1.21 would include from 1.15-1.27 in BSS. Swell indices within 1% of 1.21 would include from 1.20-1.22. These are merely examples of swell indices that are within 5% and 1% of each other, respectively.
The central hole 140 (and other lens holes herein, central or otherwise) allows aqueous humor to flow throughout the eye in a manner similar to the flow of aqueous humor in an eye that does not contain a lens as described herein. The central hole is positioned centrally in order to minimize optical disturbances that occur due to visible light scatter from the walls or entry or exit of the hole but its position does not eliminate scatter entirely. In order to allow the flow of aqueous humor, the hole must be positioned within the pupil of the eye during most of the time as the iris changes size. For lenses that have relatively smaller optic regions (for example only, lens 500 in
The disclosure herein also includes methods of manufacturing any of the lenses herein.
It is also understood that methods of manufacturing that are described and claimed herein need not necessarily include all of the steps from
As an alternative to the peripheral portions herein that are made of one or more light absorbing materials, the peripheral portions may optionally have one or more surfaces adapted to scatter light, and adapted such that the scattered light is not incorrectly focused. For example, the scattering surfaces may be adapted to cause incident light to scatter in a generally random manner such that no particular direction is preferred. Peripheral portions with one or more scattering surfaces may optionally be made of the same material as the optic, and the lenses may be manufactured as a one-piece lens. After the lens is manufactured, one of more of the peripheral portion surfaces may then be modified such that it is adapted to scatter light. An exemplary non-limiting manner to create the scattering surfaces is to, generally speaking, roughen the surfaces. One or both of an anterior surface and a posterior surface of the peripheral portion may be adapted for scattering as set forth herein.
This application claims priority to U.S. Provisional Application 63/262,073, filed Oct. 4, 2021, the entire disclosure of which is incorporated by reference herein for all purposes. The following references are incorporated by reference herein in their entireties for all purposes: U.S. Pat. No. 10,485,655; PCT Pub. No. WO/2017/156077; and U.S. Pub. No. 2019/0076242.
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