Patent Application
20220071762
The present invention relates to the fields of ophthalmology and surgical devices for operations on the eye. More specifically, the present invention relates to a device for functional and anatomical reconstruction of human lens capsules and for precise placement of an intraocular lens for any surgery that requires replacement and alignment of the crystalline lens.
An intraocular lens is a plastic lens that has substantially the same optical power as a natural lens it is intended to replace. Typically, during a cataract surgery, an ophthalmic surgeon removes a cataract impaired natural lens and replaces it with an artificial intraocular lens. There are generally three types of intraocular lenses including refractive lenses, diffractive lenses, and refractive-diffractive lenses. A refractive lens converges light towards a focal point on the optical axis by refraction, while a diffractive lens creates a diffraction pattern forming one focal point on the optical axis per diffraction order. A refractive-diffractive lens combines the features of both types. However, these purely refractive bi- or multi-focal lenses have some notable drawbacks. Firstly, their effectiveness is heavily dependent on the size and the centration of the pupil. Secondly, because they have several focal points, the resulting contrast is reduced. This may induce the formation of halos, in particular, in far vision, with reduced luminosity (see, for example, U.S. Pat. No. 8,636,796 B2).
Moreover, posterior capsule opacification (PCO or after cataract) remains a common problem after cataract surgery with implantation of an intraocular lens. Posterior capsule opacification generally results from the transition from intracapsular cataract extraction (ICCE) to extracapsular cataract extraction (ECCE), where the posterior lens capsule is left intact during surgery. Patients with posterior capsule opacification suffer from decreased visual acuity, impaired contrast sensitivity, and glare disability. Clinically, components of posterior capsule opacification are identified as a regeneratory component and a fibrotic component with a regeneratory posterior capsule opacification component much more common than the fibrotic component.
Regeneratory posterior capsule opacification results from residual lens epithelial cells (LECs) from the lens equator region, the so-called E-cells, migrating and proliferating into the space between the posterior capsule and the intraocular lens and forming layers of lens material and Elschnig pearls. In contrast, fibrotic posterior capsule opacification is caused by lens epithelial cells from the anterior capsule that undergo transformation to myofibroblasts and gain access to the posterior capsule, causing whitening and wrinkling of the capsule. This can lead to decentration of the intraocular lens and hinder visualization of the peripheral retina. Findl et al. (J Cataract Refract Surg 2003; 29(1):106-11) disclose that both components of posterior capsule opacification lead to a decrease in visual function when they affect the central region around the visual axis. A YAG or Nd laser, utilized in a YAG laser capsulotomy, is most commonly used to treat posterior capsule opacification. However, as disclosed in Georgalas et al. (Ther Clin Risk Manag. 2009; 5:133-137) laser capsulotomy may lead to other complications, such as retinal detachment or intraocular pressure rise.
European Patent No. 507292B1 describes the need of an “inhibiting device” for keeping the shape of the capsular bag substantially circular after a cataract extraction and inhibiting issues such as invasion of metamorphosed epithelial cells into a posterior capsular bag and further to inhibiting device wherein an intraocular lens can be retained in good state by forming a groove in the inner periphery thereof. He describes a steady circular shape of the device effective to inhibit capsular shrinking without referring to the actual diameter of the outer part of the ring.
US Publication No. 2006/0047339 A1 describes a device attached to natural lens capsule such that the lens capsule may be maintained in a configuration to avoid post-operative changes that are deleterious to vision. Single or dual optics system is provided, which may be accommodating. The role of the “postoperative contraction” of the empty capsule, in the displacement of the lens, resulting in optical changes and in induced astigmatism is emphasized. Therefore, there is a need to provide a device or apparatus and procedure to maintain the form of the lens capsule and to maintain the diameter a capsulotomy opening for the device.
International Publication No. WO 2007/044604 A1 describes the “spatial relationship of structures within the eye, such as the distance from the a surface of the cornea to a posterior surface of the crystalline lens capsule and from the cornea or the posterior surface of the lens capsule” to the retina is measured preoperatively, for example by using ultrasound, partial coherence interferometry, optical coherence tomography or laser measuring techniques or by any other means known to the art, thus establishing the preoperative anatomical relationships. A surgical procedure, such as an intraocular lens implantation is performed, and spacing means are provided to restore those premeasured spatial relationships or a predetermined new spacing. The spacing means may include, for example spacers, rings, inflatable structures or thick or multiple lenses. These means help with maintaining the normal depth of the patient's anterior and posterior capsule and prevent forward movement of the vitreous and retinal detachment that may occur as a result of such movement.
Goldberg (Clin Ophthalmol. 2011; 5:1-7) states that “the crossing zonules cradle, shape stabilize the posterior lens. In the model, the anterior vitreous zonule is inserted in the Wieger's ligament, and the PIZ-LE zonule anchors the lens equator to the posterior insertion zone. The crossing zonules and Wieger's ligament maintain lens placement while the anterior and posterior zonules provide reciprocal accommodation and disaccommodation. Wieger's ligament representing the mid-peripheral zone of the posterior capsule is the most important area for stabilizing the lens position during the accommodation.
U.S. Publication No. 2010/0204790 A1 describes an intraocular lens device having a ring shape fixation platform, which can create a “frame” in which the intraocular lens of the present invention can be attached . . . and conclude the discovery of the present invention makes possible a surgical method for insertion and subsequent removal and exchange of an intraocular lens with reduced risk of injury to the eye or loss of sight.
Based on the Market Scope Report (2015 Comprehensive Report on the Global Intraocular Lens Market, June 2015), the premium intraocular lens market is going to reach the 9.3% of the global number and the 34% of the total revenues of the global intraocular lens market. The multifocal and Toric IOLs will dominate the premium intraocular lens market at the market share of almost 90%. Toric and multifocal are very sensitive to the exact centration and positioning inside the capsule.
Several patents and publications, including U.S. Pat. No. 9,339,375 B2, U.S. Pat. No. 4,710,194, U.S. Publication No. 2005/0085,907, U.S. Publication No. 2005/0209692, U.S. Publication No. 2010/0204790, U.S. Publication No. 2010/0228344, U.S. Publication No. 2011/0082543 and European Application No. 037,390 A2, disclose a variety of intracapsular rings for different purposes. However, these works describe rings that either have one standard size or a variety of sizes without any adjustability for accommodation. These devices generally comprise a ring and an optical system adapted to the ring. Some of the devices comprise a deformable ring that under the pressure of the ciliary body changes the shape of the central optical part and mimics an accommodation mechanism.
None of the previous works in the field take into consideration the modern theory of accommodation and the preservation of continuous change of the shape of the capsule, due to the complexity of zonular traction regarding the multifocal and toric intraocular lens, which are already in the market and expected to improve rapidly in the near future. Therefore, there is a recognized need in the art for a device and method for reconstructing the capsule. Particularly, the prior art is deficient in devices that enable precise placement and alignment of the intraocular lens post-surgically. The present invention fulfills this long-standing need and desire in the art.
The present invention is directed to a device for reconstructing a natural lens capsule of an eye after a cataract surgery. The device comprises a ring-shaped rigid component, a ring-shaped flexible component and a groove disposed on an inner surface of the rigid component. The rigid component comprises a distal end and a proximal end configured to contact a Wieger's ligament in the eye. The ring-shaped flexible component comprises a proximal end that is attached to the distal end of the rigid component, and a distal end disposed to contact with an anterior surface of a natural lens capsule. The groove is disposed on an inner surface of the rigid component and configured to receive optics on an intraocular lens. In a related invention, the device further comprises a ledge that is formed on an inner surface of the ring-shaped flexible component and is configured to secure haptics of the intraocular lens.
Other and further aspects, features, and advantages of the present invention will be apparent from the following description of the presently preferred embodiments of the invention. These embodiments are given for the purpose of disclosure.
So that the matter in which the above-recited features, advantages and objects of the invention, as well as others which will become clear, are attained and can be understood in detail, more particular descriptions and certain embodiments of the invention briefly summarized above are illustrated in the appended drawings. These drawings form a part of the specification. It is to be noted, however, that the appended drawings illustrate preferred embodiments of the invention and therefore are not to be considered limiting in their scope.
As used herein, the following terms and phrases shall have the meanings set forth below. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art.
As used herein, the term, “a” or “an” may mean one or more. As used herein in the claim(s), when used in conjunction with the word “comprising”, the words “a” or “an” may mean one or more than one. As used herein “another” or “other” may mean at least a second or more of the same or different claim element or components thereof. The terms “comprise” and “comprising” are used in the inclusive, open sense, meaning that additional elements may be included.
As used herein, the term “or” in the claims refers to “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or”.
As used herein, the term “about” refers to a numeric value, including, for example, whole numbers, fractions, and percentages, whether or not explicitly indicated. The term “about” generally refers to a range of numerical values (e.g., +1-5-10% of the recited value) that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In some instances, the term “about” may include numerical values that are rounded to the nearest significant figure.
As used herein, the term “distal end” refers to an end that is away from the posterior surface of the capsule; the term “proximal end” refers to an end that is toward the posterior surface of the capsule.
As used herein, the term “sharp” refers interchangeably to “tapering to an edge” or “tapered”.
In one embodiment of the present invention, there is provided a device for reconstructing a natural lens capsule of an eye after a cataract surgery, comprising a ring-shaped rigid component comprising: a distal end in contact with an anterior surface of the capsule; and a proximal end disposed against a Wieger's ligament in the eye; a ring-shaped flexible component substantially concentric with the rigid component and flexibly fitted against an inner surface of the capsule, comprising: a proximal end formed on an outer surface of the proximal end of the rigid component; and a distal end extending away from the rigid component; and a groove disposed on an inner surface of the rigid component configured to receive haptics on an intraocular lens.
Further to this embodiment the device may comprise a ledge formed from a top of the distal end of the rigid component. In this further embodiment, the ledge may comprise a plurality of markers disposed on a top surface thereof, configured to guide a toric lens alignment. Also in this embodiment the ledge may have a width of about 0.1 mm to about 1 mm wide.
In both embodiments, the proximal end of the rigid component may have a thickness of about 0.2 mm to about 1 mm. Also, the distal end of the rigid component may have a thickness of about 0.1 mm to about 0.5 mm. In addition, the rigid component may be made of or may comprise, but are not limited to, silicon, acryl, poly(methyl methacrylate), hydrogel, or a combination thereof.
Also in both embodiments, the ring-shaped rigid component may be substantially perpendicular in relation to an anterior surface of the natural lens capsule when fitted inside. In both embodiments the ring-shaped flexible component may be configured to flex away from the rigid component, when ciliary muscles are relaxed and zonules are tense, and to flex toward the rigid component, when the ciliary muscles are contracted and the zonules are relaxed.
Further to both embodiments, the ring-shaped flexible component may comprise a plurality of gaps disposed around a circumference thereof. Also, the gaps each may have a width of about 0.1 mm to about 5 mm. In addition, the ring-shaped flexible component may have a thickness of about 0.05 mm to about 0.75 mm. Furthermore, the ring-shaped flexible component may be made of or may comprise, but are not limited to, silicon, acryl, poly(methyl methacrylate), hydrogel, or a combination thereof. Further still in this embodiment, the ring-shaped rigid component and the ring-shaped flexible component form an angle of about 2 degree to about 90 degree when fitted inside the natural lens capsule.
In another embodiment of the present invention, there is provided a device for flexibly restoring tension for a natural lens capsule after a cataract surgery, comprising: a ring-shaped rigid component comprising: a distal end disposed in a supporting relationship with an anterior surface of the capsule and; a proximal end disposed in a supporting relationship with an posterior surface of the capsule and disposed against a Wieger's ligament of the eye; and a ledge formed from a top of the distal end of the rigid component; a ring-shaped flexible component substantially concentric with the rigid component and flexibly fitted against an inner surface of the capsule, configured to flex away from the rigid component when ciliary muscles are relaxed and zonules are tense, and flex toward the rigid component when the ciliary muscles are contract and the zonules are relaxed, the flexible component comprising: a proximal end formed on an outer surface of the proximal end of the rigid component; and a distal end extending away from the rigid component; and a groove disposed on an inner surface of the rigid component configured to receive haptics on an intraocular lens.
Further to this embodiment, the device may comprise a plurality of markers disposed on a top surface of the ledge configured to guide toric lens alignment. In another further embodiment the device may comprise a plurality of gaps disposed around a circumference of the ring-shaped flexible component configured to improve flexibility thereof. In this further embodiment, the gaps each may have a width of about 0.1 mm to about 5 mm wide.
In all embodiments, the ledge may have a width about 0.1 to about 1 mm. Also, the proximal end of the rigid component may have a thickness of about 0.2 mm to about 1 mm and the distal end of the rigid component may have a thickness of about 0.1 mm to about 0.5 mm. In addition, the ring-shaped rigid component may be made of or may comprise, but are not limited to, silicon, acryl, poly(methyl methacrylate), hydrogel, or a combination thereof. Furthermore, the ring-shaped rigid component may be substantially perpendicular in relation to an anterior surface of the natural lens capsule when fitted inside. Further still, the ring-shaped rigid component and the ring-shaped flexible component form an angle of about 2 degrees to about 90 degrees when disposed inside the natural lens capsule.
In yet another embodiment of the present invention, there is provided a device for reconstructing a natural lens capsule of an eye after a cataract surgery, comprising a ring-shaped rigid component comprising a distal end and a proximal end configured to lie against a Wieger's ligament when fitted within the natural lens capsule of the eye; a ring-shaped flexible component comprising a proximal end that is attached to the distal end of the rigid component and a distal end configured to contact an anterior surface of a natural lens capsule when fitted therein and a groove disposed on an inner surface of the rigid component and configured to receive optics on an intraocular lens.
Further to this embodiment the device comprises a ledge formed on an inner surface of the flexible component and is configured to secure haptics of the intraocular lens. In this further embodiment the ledge may have a width from about 0.1 mm to about 1 mm.
In both embodiments, the ring-shaped rigid component may be made of silicon, an acrylic, a poly(methyl methacrylate), or a hydrogel or a combination thereof. Also, in these embodiments, the ring-shaped rigid component may be substantially concentric with the ring-shaped flexible component or is non-coaxial to the ring-shaped flexible component. In addition, the ring-shaped rigid component may be substantially perpendicular in relation to an anterior surface of the natural lens capsule when fitted inside. Alternatively, the distal end of the ring-shaped rigid component may be disposed at an angle to an anterior surface of the natural lens capsule when fitted inside.
Furthermore, in both embodiments the ring-shaped rigid component may comprise a plurality of markers disposed on a top surface configured to guide a toric lens alignment. Further still, the proximal end of the rigid component may be configured to have a thickness ranging from about 0.2 mm to about 1 mm, and the distal end of the rigid component may be configured to have a thickness ranging from about 0.1 mm to about 0.5 mm.
Further still in these embodiments, the ring-shaped rigid component may comprise a plurality of openings may be disposed on an inner surface thereof that are configured to reduce total volume of the ring-shaped rigid component. Further still, the ring-shaped rigid component may comprise sharp edges at the distal end.
In one aspect of both embodiments the ring-shaped rigid component may comprise an inner part and an outer part in a concentric relationship. In this aspect a relative rotational position of the inner part and the outer part may be indicated by markers placed at the distal end of both inner and outer part this is not in the claim. The inner part and outer part may be made from the same material or different materials. For example, the materials may be as described supra. In another aspect the ring-shaped rigid component may comprise an inner part and an outer part disposed in a non-coaxial relationship.
In both embodiments, the ring-shaped flexible component may be configured to flex away from the rigid component when ciliary muscles are relaxed and zonules are tense, and flex toward the rigid component when the ciliary muscles are contracted and the zonules are relaxed when fitted inside a natural lens capsule. Also, the flexible component may have any thickness from about 0.05 mm to about 0.75 mm. In addition the ring-shaped flexible component may be made of the materials as described supra.
Furthermore the flexible component may comprise a plurality of gaps disposed around a circumference. Representative gaps have a width from about 0.1 mm to about 5 mm. Further still, the rigid component and the flexible component may form an angle from about 2 degrees to about 90 degrees when fitted inside the natural lens capsule.
In addition in another aspect of both embodiments, the groove is continuous circumferentially. Further to this aspect the groove may comprise a plurality of slits disposed around the groove configured to allow passage and relaxation of haptics formed on the optics of the intraocular lens. In both of these aspects each of the plurality of slits may have a width from about 1 degree to about 180 degrees rotationally. In yet another aspect the groove is discontinuous circumferentially. Further to this aspect the groove may comprise at least one opening disposed around a circumference thereof. In both these aspects each of the openings may have a width from about 0 degrees to about 180 degrees rotationally.
Provided herein are devices for reconstruction of the capsule 1 after a cataract surgery. As described below, the invention provides a number of advantages and uses, however such advantages and uses are not limited by such description. Embodiments of the present invention are better illustrated with reference to the Figure(s), however, such reference is not meant to limit the present invention in any fashion. The embodiments and variations described in detail herein are to be interpreted by the appended claims and equivalents thereof.
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The present invention is well adapted to attain the ends and advantages mentioned as well as those that are inherent therein. The particular embodiments disclosed above are illustrative only, as the present invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations are intended to the details of construction or design herein shown, other than as described in the claims below. It is therefore evident that the particular illustrative embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the present invention. Also, the terms in the claims have their plain, ordinary meaning unless otherwise explicitly and clearly defined by the patentee.
This application is a continuation under 35 U.S.C. § 120 of application U.S. Ser. No. 16/216,142, filed Dec. 11, 2018, which is a continuation-in-part application under 35 U.S.C. § 120 of non-provisional application U.S. Ser. No. 15/446,121, filed Mar. 1, 2017, now U.S. Pat. No. 10,548,719, the entirety of both of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16216142 | Dec 2018 | US |
| Child | 17529894 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15446121 | Mar 2017 | US |
| Child | 16216142 | US |
