This disclosure is generally directed to ocular devices. More specifically, this disclosure is directed to an artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule (or other intraocular lens implant) with one or more scleral prostheses for improved performance.
The natural crystalline lens of the eye may need alteration or replacement for any number of reasons. These reasons include, but are not limited to, opacification of the lens (causing cataract) or natural aging of the lens (causing presbyopia). Often times, these or other problems may require removal of the natural crystalline lens and replacement with an artificial intraocular lens (IOL) during a surgical eye procedure.
There are various types of intraocular lenses on the market today, including “accommodating” and “non-accommodating” lenses. “Accommodation” in this sense refers to the ability of the eye to dynamically focus on near objects, providing a range of multiple near focal points. The range of multiple focal points in a young person is provided by the crystalline lens, which changes shape in order to see various objects at near. However, as a person ages, the range of near focal points gradually diminishes, and the ability to see at near is typically diminished significantly by the age of 45 (a condition known as presbyopia).
Accommodating intraocular lenses typically provide (or claim to provide) a small amount of accommodation, allowing a patient to focus on more than one near focal point in a manner similar to that of a person 30 to 40 years old. However, in many existing accommodating intraocular lenses, the range of near focal points may be quite limited.
Non-accommodating intraocular lenses may be monofocal, having one fixed focal point that can be at distance or at near as determined by the prescription of the lens and provide no dynamic accommodation abilities. Another type of non-accommodating intraocular lens has multiple fixed focal points (typically one at distance and one at near), which are provided using non-spheric or diffractive optics. These are typically classified as multi-focal intraocular lenses.
Other techniques to alter the natural crystalline lens may also be used to treat lens disorders. These techniques could include the application of pharmaceutical agents to the lens. These techniques could also include the use of (i) laser, other light, or other electro-magnetic radiation and/or (ii) sound or ultrasound waves. These techniques could further include the removal and replacement of part or all of the lens material with a refilling type procedure.
It is also possible to treat presbyopia, glaucoma, and other eye disorders by implanting scleral prostheses within the sclera of a patient's eye. For each individual scleral prosthesis, an incision is made in the sclera of the patient's eye. The incision is then extended under the surface of the sclera to form a scleral “tunnel,” and a scleral prosthesis is placed within the tunnel. One or multiple scleral prostheses may be implanted in a patient's eye to (among other things) treat presbyopia, glaucoma, ocular hypertension, elevated intraocular pressure, or other eye disorders. This technique is described more fully in the related U.S. patents documents incorporated by reference above.
This disclosure provides an artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule (or other intraocular lens implant) with one or more scleral prostheses for improved performance.
In a first embodiment, a system includes an intraocular lens configured to replace a natural crystalline lens of an eye. The system also includes one or more scleral prostheses configured to be inserted into scleral tissue of the eye. The one or more scleral prostheses are configured to modify a structure of the eye to improve an accommodative ability of the eye with the intraocular lens.
In a second embodiment, a method includes inserting an intraocular lens into an eye to replace a natural crystalline lens of the eye. The method also includes inserting one or more scleral prostheses into scleral tissue of the eye. The one or more scleral prostheses modify a structure of the eye and improve an accommodative ability of the eye with the intraocular lens.
In a third embodiment, a method includes modifying a natural lens of an eye and inserting one or more scleral prostheses into scleral tissue of the eye. The one or more scleral prostheses modify a structure of the eye to improve an accommodative ability of the eye with the modified natural lens.
In a fourth embodiment, a method includes filling a crystalline lens capsule of an eye with one or more materials. The method also includes inserting one or more scleral prostheses into scleral tissue of the eye. The one or more scleral prostheses modify a structure of the eye to improve an accommodative ability of the eye with the filled crystalline lens capsule.
Other technical features may be readily apparent to one skilled in the art from the following figures, descriptions, and claims.
For a more complete understanding of this disclosure and its features, reference is now made to the following description, taken in conjunction with the accompanying drawings, in which:
In accordance with this disclosure, an artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule and one or more scleral prostheses can be used in a patient's eye. For example, an artificial intraocular lens and one or more scleral prostheses could be inserted into the patient's eye at the same time or at different times. Also, the natural crystalline lens may or may not be altered, or the natural crystalline lens capsule may or may not be refilled, at the same time that the one or more scleral prostheses are inserted into the patient's eye. The artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule could be accommodating or non-accommodating. The one or more scleral prostheses could (i) improve the accommodative abilities of an accommodating intraocular lens, (ii) provide accommodation for a non-accommodating intraocular lens, or (iii) improve or provide an accommodating effect to an altered natural crystalline lens or to a refilled natural crystalline lens capsule. Any suitable lens alteration technique or lens capsule refilling technique could be used here, or any suitable intraocular lens could be used here. Similarly, any suitable scleral prosthesis could be used here, such as any of the scleral prostheses disclosed in the U.S. patent documents incorporated by reference above.
As shown in
The ciliary muscles 112 are attached to the crystalline lens capsule 102 by various fibers known as zonules 114a-114c, which pass through the ciliary processes 110 before reaching the lens capsule 102. In response to changes in the position of the ciliary muscles 112, the zonules 114a-114c can manipulate the lens capsule 102, causing the crystalline lens 103 to change shape and become more convex. When the lens 103 becomes more convex, its refractive power increases, changing how rays of light fall on the retina and allowing the eye 100 to focus at near. However, as the eye ages, the working distance between the outer diameter of the crystalline lens 103 and the ciliary muscles 112 diminishes. This eventually causes relaxation in the tension that the zonules 114a-114c can exert on the crystalline lens 103. For most people (typically by the age of 45), the loss of tension on the zonules becomes great enough that changes in the position of the ciliary muscles 112 can no longer adequately change the shape of the crystalline lens 103 for near vision without additional optical correction. By age 65, most people lose the ability to focus at near altogether. The eye 100 shown in
The zonules 114a-114c here include anterior zonules 114a, equatorial zonules 114b, and posterior zonules 114c (which are based on where the zonules connect to the crystalline lens capsule 102). In general, the anterior zonules 114a typically connect to the lens capsule 102 approximately 1.5-2.0 mm anterior to the equatorial plane of the crystalline lens 103. The equatorial zonules 114b typically connect to the lens capsule 102 at approximately the lens equator itself. The posterior zonules 114c typically connect to the lens capsule 102 approximately 1.5-2.0 mm posterior to the lens equator.
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The Helmholtz theory of presbyopia postulates that the movement of the ciliary muscles (or the ciliary body) is mostly inward directly towards the center of the crystalline lens 103, releasing tension on all zonules evenly and allowing the crystalline lens 103 to “round-up” during accommodation. However, recent research indicates that the ciliary muscles 112 move both upward and inward during accommodation (during focusing on near objects) to a smaller minor circle of the globe of the eye, which is illustrated in
Moreover, in
In
In accordance with this disclosure, the insertion of one or more scleral prostheses 116 into a patient's eye can also help to provide accommodative power to an artificial lens implanted into the patient's eye.
As shown in
A non-accommodating intraocular lens 502, such as one made from some form of acrylic, silicone or other material, is often (but not always) folded into an “injector” similar to a hypodermic needle. The injector is inserted through the small incision in the cornea 106 and through the incision made in the center of the lens capsule 102. The plunger on the injector is actuated, forcing the folded intraocular lens 502 out of the injector into the lens capsule 102 where it slowly unfolds. Eventually, the lens capsule 102 shrinks and forms itself to the shape of the particular intraocular lens 502. Nonetheless, the zonules 114a-114c remain attached to the lens capsule, such as 1.5-2.0 mm from the far edge of the intraocular lens 502. The intraocular lens 502 also includes “haptics” or small arms that are connected to the intraocular lens 502. The haptics help center the intraocular lens 502 in the lens capsule 102 so that the lens 502 remains directly in the optic axis.
In
In some embodiments, the non-accommodating lens 502 represents a monocular intraocular lens, meaning it has one fixed focal point. Without the scleral prosthesis 116, there has been no indication (by manufacturers or researchers) that there is even moderate improvement in near vision with normal non-accommodating monocular intraocular lenses as the ciliary muscles 112 attempt to accommodate. Near vision could often be improved with a normal monocular non-accommodating intraocular lens only if dioptric power (or “add”) is built into the prescription of the intraocular lens itself. Whatever focal length or near vision acuity is built into the prescription of the monocular intraocular lens is fixed once implanted in the patient and does not change. Conversely, even a normal monocular intraocular lens 502 can achieve some moderate to substantial accommodative effect due to vertex distance change if combined with the use of one or more scleral prostheses 116.
In other embodiments, multi-focal intraocular lenses 502 (such as refractive multi-focal intraocular lenses with concentric optic circles, diffractive multifocal lenses with concentric diffractive steps, or other aspheric designs allowing for both distance and near focal points with the same lens) could be used. A multi-focal intraocular lens 502 could be vaulted forward in a fashion similar to a normal monocular intraocular lens since their mechanical structures are very similar. This likewise may provide an accommodative effect as the ciliary muscles 112 contract in combination with one or more sclera prostheses 116. Example manufacturers of multi-focal intraocular lenses on the market today are ALCON (RESTORE) and AMO (REZOOM).
In this example, the intraocular lens 902 represents a dual-optic accommodating lens or any other lens that changes its effective dioptric power through mechanical, hydraulic, laser, electrical, refractive index manipulation, chemical, or other means. As a particular example, the intraocular lens 902 could represent an intraocular lens by VISIOGEN. This type of lens could have approximately the same volume and dimensions as the natural crystalline lens 103. In particular embodiments, there may be a “negative” lens on the posterior side of the intraocular lens 902 and a very high-power “positive” lens on the anterior side of the intraocular lens 902. When these get farther apart, there is an increase in near vision magnification, allowing a patient to focus on near objects more clearly.
The VISIOGEN lens design (or other similar designs) creates manufactured tension at the rounded edges where the zonules 114a-114c attach, acting somewhat like a spring to allow the lens 902 to expand and increase its refractive power. The inward pointing arrows in
As mentioned above, the increased distance between the anterior surface and the posterior surface of the lens 902 in the center of the “visual axis” increases the overall refractive power of the lens 902, allowing the eye to focus on near objects clearly. The presence of the scleral prosthesis 116 could help to improve the performance of the lens 902 or any other dual-optic or multi-optic accommodating intraocular lens or any lens (artificial or natural) that changes its effective dioptric power through mechanical, hydraulic, laser, electrical, refractive index manipulation, chemical, or any other means. The presence of the scleral prosthesis 116 could also help to improve the performance of an altered natural crystalline lens or a refilled natural crystalline lens capsule by restoring the natural tension on the zonules 114a-114c at near.
To summarize, one or more scleral prostheses 116 can be used beneficially with various types of intraocular lenses, altered natural crystalline lenses, or refilled natural crystalline lens capsules. For example, the scleral prostheses 116 could be used with any accommodating intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule to improve the natural triggering mechanism for accommodation in the eye, thereby helping to improve the performance of the accommodating lens, altered natural crystalline lens, or refilled natural crystalline lens capsule. The scleral prostheses 116 could also be used with any non-accommodating lens to vault the lens forward and provide an increase in dioptric power due to the vertex distance effect. There are many accommodating and non-accommodating intraocular lens designs currently on the market or in development (some with very complex mechanics) that could be coupled with the scleral prostheses 116.
While the use of scleral prostheses 116 in conjunction with intraocular lenses, altered natural crystalline lenses, or refilled natural crystalline lens capsules have been described above, other techniques could also be used to increase the effectiveness of intraocular lenses. For example, as noted in various ones of the U.S. patent documents incorporated by reference above, it is possible to perform laser ablations (or other laser techniques) to remove portions of the scleral tissue from an eye, which allows the sclera in those areas to have an altered rigidity and to possibly expand and increase the diameter of sclera over the ciliary muscles 112. It is also possible to fill in the ablation or other area with a collagen block, collagen shield, or other component to prevent healing and to keep the increased scleral volume intact. This type of technique could also be used in conjunction with intraocular lenses to provide increased accommodation. In fact, any suitable technique for increasing accommodation through scleral expansion, scleral manipulation, scleral relaxation, or other mechanisms could be used in conjunction with an artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule.
Moreover, recent research indicates that the posterior zonules 114c in the eye may attach to the Hyaloid membrane, which separates the posterior chamber of the eye (filled with aqueous) from the vitreous cavity of the eye (filled with vitreous). The posterior zonules 114c may then continue along the surface of the Hyaloid membrane and down the posterior surface of the lens capsule 103 to their ultimate attachment points further down the capsule. In some embodiments, the zonules' attachment to the Hyaloid membrane can be used to enlist the strength and total coverage of the Hyaloid membrane itself to pull-up the attachment points for the posterior zonules 114c, triggering accommodation.
In addition, the movement of the ciliary muscles 112 during accommodation and the arrangement/orientation of the zonules 114a-114c shown in the figures above are based on recent research. However, the actual movement of the ciliary muscles 112 during accommodation and the actual arrangement/orientation of the zonules 114a-114c remain subject to further research (by both the assignee referenced above and others in the field) and may eventually be shown to be different than that shown above. Even if it is unclear how the precise mechanics of the eye operate in conjunction with one or more scleral prostheses 116 and an artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule, it can be shown that the presence of one or more scleral prostheses 116 in the eye can help to improve the effectiveness of the artificial intraocular lens, altered natural crystalline lens, or refilled natural crystalline lens capsule. This improved effectiveness could take the form of providing accommodation to a non-accommodating IOL or by improving accommodation of an accommodating IOL, altered natural crystalline lens, or refilled natural crystalline lens capsule.
A location for one or more scleral prostheses is determined at step 1104, one or more scleral tunnels are formed in the patient's eye at step 1106, and one or more scleral prostheses are inserted into the one or more scleral tunnels at step 1108. Various tools and techniques for identifying a location for a scleral prosthesis are disclosed in the U.S. patent documents incorporated by reference above. Also, various tools and techniques for forming a scleral tunnel are disclosed in the U.S. patent documents incorporated by reference above. In addition, various scleral prostheses are disclosed in the U.S. patent documents incorporated by reference above. The one or more scleral prostheses can be used to provide accommodative abilities to a non-accommodating IOL. The one or more scleral prostheses can also be used to improve the accommodative abilities of an accommodating IOL, a modified natural lens, or a refilled lens capsule.
Although
It may be advantageous to set forth definitions of certain words and phrases used throughout this patent document. The terms “include” and “comprise,” as well as derivatives thereof, mean inclusion without limitation. The term “or” is inclusive, meaning and/or. The phrases “associated with” and “associated therewith,” as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like.
While this disclosure has described certain embodiments and generally associated methods, alterations and permutations of these embodiments and methods will be apparent to those skilled in the art. Accordingly, the above description of example embodiments does not define or constrain this disclosure. Other changes, substitutions, and alterations are also possible without departing from the spirit and scope of this disclosure, as defined by the following claims.
This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 61/199,726 filed on Nov. 19, 2008, which is hereby incorporated by reference. This application is related to the following U.S. patent documents: (1) U.S. Pat. No. 6,007,578 entitled “Scleral Prosthesis for Treatment of Presbyopia and Other Eye Disorders” issued on Dec. 28, 1999;(2) U.S. Pat. No. 6,280,468 entitled “Scleral Prosthesis for Treatment of Presbyopia and Other Eye Disorders” issued on Aug. 28, 2001;(3) U.S. Pat. No. 6,299,640 entitled “Scleral Prosthesis for Treatment of Presbyopia and Other Eye Disorders” issued on Oct. 9, 2001;(4) U.S. Pat. No. 5,354,331 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Oct. 11, 1994;(5) U.S. Pat. No. 5,465,737 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Nov. 14, 1995;(6) U.S. Pat. No. 5,489,299 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Feb. 6, 1996;(7) U.S. Pat. No. 5,503,165 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Apr. 2, 1996;(8) U.S. Pat. No. 5,529,076 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Jun. 25, 1996;(9) U.S. Pat. No. 5,722,952 entitled “Treatment of Presbyopia and Other Eye Disorders” issued on Mar. 3, 1998;(10) U.S. Pat. No. 6,197,056 entitled “Segmented Scleral Band for Treatment of Presbyopia and Other Eye Disorders” issued on Mar. 6, 2001;(11) U.S. Pat. No. 6,579,316 entitled “Segmented Scleral Band for Treatment of Presbyopia and Other Eye Disorders” issued on Jun. 17, 2003;(12) U.S. Pat. No. 6,926,727 entitled “Surgical Blade for Use with a Surgical Tool for Making Incisions for Scleral Eye Implants” issued on Aug. 9, 2005;(13) U.S. Pat. No. 6,991,650 entitled “Scleral Expansion Device Having Duck Bill” issued on Jan. 31, 2006;(14) U.S. patent application Ser. No. 10/080,877 entitled “System and Method for Making Incisions for Scleral Eye Implants” filed on Feb. 22, 2002;(15) U.S. patent application Ser. No. 10/443,122 entitled “System and Method for Determining a Position for a Scleral Pocket for a Scleral Prosthesis” filed on May 20, 2003;(16) U.S. patent application Ser. No. 11/137,085 entitled “Scleral Prosthesis for Treatment of Presbyopia and Other Eye Disorders” filed on May 24, 2005;(17) U.S. patent application Ser. No. 11/199,591 entitled “Surgical Blade for Use with a Surgical Tool for Making Incisions for Scleral Eye Implants” filed on Aug. 8, 2005;(18) U.S. patent application Ser. No. 11/252,369 entitled “Scleral Expansion Device Having Duck Bill” filed on Oct. 17, 2005;(19) U.S. patent application Ser. No. 11/323,283 entitled “Surgical Blade for Use with a Surgical Tool for Making Incisions for Scleral Eye Implants” filed on Dec. 30, 2005;(20) U.S. patent application Ser. No. 11/323,284 entitled “System and Method for Making Incisions for Scleral Eye Implants” filed on Dec. 30, 2005;(21) U.S. patent application Ser. No. 11/322,728 entitled “Segmented Scleral Band for Treatment of Presbyopia and Other Eye Disorders” filed on Dec. 30, 2005;(22) U.S. patent application Ser. No. 11/323,752 entitled “Segmented Scleral Band for Treatment of Presbyopia and Other Eye Disorders” filed on Dec. 30, 2005;(23) U.S. Provisional Patent Application No. 60/819,995 entitled “Apparatuses, Systems, and Methods Related to Treating Presbyopia and Other Eye Disorders” filed on Jul. 11, 2006;(24) U.S. patent application Ser. No. 11/827,444 entitled “Apparatus and Method for Securing Ocular Tissue” filed on Jul. 11, 2007;(25) U.S. patent application Ser. No. 11/827,382 entitled “Scleral Prosthesis for Treating Presbyopia and Other Eye Disorders and Related Devices and Methods” filed on Jul. 11, 2007;(26) U.S. Provisional Patent Application No. 61/001,593 entitled “Apparatuses and Methods for Forming Incisions in Ocular Tissue” filed on Nov. 2, 2007;(27) U.S. Provisional Patent Application No. 61/065,149 entitled “Scleral Prosthesis for Ocular Drug Delivery to Treat Glaucoma, Macular Degeneration, and Other Eye Disorders or Diseases and Related Method” filed on Feb. 8, 2008; and(28) U.S. Provisional Patent Application No. 61/072,757 entitled “System and Method for Identifying a Position to Insert a Scleral Prosthesis into an Eye” filed on Apr. 2, 2008. All of these patents and patent applications are hereby incorporated by reference.
Number | Date | Country | |
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61199726 | Nov 2008 | US |