Artificial lens capsule

Abstract

An artificial lens capsule is provided for use during cataract surgery or in cases of aphakia (absence of lens) or posterior capsule rupture (PCR). A common complication during cataract surgery is the rupture of the posterior capsule, preventing the placement of a monofocal intraocular lens in the lens capsule due to inadequate support. Typically, a 3-piece, long haptic intraocular lens can be placed in the ciliary sulcus or capsule if the monofocal intraocular lens is sufficient. However, for placing a toric (astigmatism correcting) or presbyopia-correcting intraocular lens (multifocal), there are currently no options for a 3-piece sulcus-fixated lens. The artificial capsule disclosed herein can be inserted and supported by the anterior capsular rim or sutured into the sclera if capsular support is inadequate. This provides a stable region for placing a single-piece toric or presbyopia-correcting intraocular lens, thereby enhancing the options for lens placement in cases of inadequate capsular support. The device can also be a reservoir for other future intraocular and / or drug-eluting devices.

Description

ARTIFICIAL LENS CAPSULECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 674,369, filed July 23, 2024. The entire disclosure of the foregoing application is incorporated by reference herein.TECHNICAL FIELD

[0002] The present disclosure relates generally to ophthalmic devices, and more specifically to artificial lens capsules used in cataract surgery, management of aphakia (absence of lens), posterior capsular rupture (PCR), or implantation of other intraocular devices. This disclosure is directed to artificial lens capsules that can be inserted through a small incision and then expanded within the eye to provide support and stability for intraocular lenses. The device does so either by residing in the ciliary sulcus on the anterior lens capsule or suture scleral fixation. The lens capsule described herein is designed to address the challenges associated with lens implantation in eyes with compromised or absent natural lens capsules, patient’s requiring lens exchanges, ensuring proper positioning and fixation of intraocular lenses while minimizing surgical complications and enhancing visual outcomes for patients with astigmatism, presbyopia and other refractive errors.BACKGROUND

[0003] Cataract surgery is the most commonly performed surgery worldwide, with an estimated 3.7 to 4 million cataract procedures performed each year in the United States alone. In a typical cataract procedure, the patient’s natural crystalline lens is removed and replaced with an artificial intraocular lens (IOL) implanted into the natural lens capsule. The implanted IOL unfolds andresides within the capsular bag, providing rotational stability and proper centration along the visual axis.

[0004] Many patients elect to receive a premium intraocular lens, such as a toric lens for astigmatism correction, an extended depth of focus (EDOF) lens, or a multifocal lens for presbyopia correction. Depending on the surgeon and practice, the percentage of patients selecting premium lenses can range from 20% to 40%, resulting in an estimated 800,000 to 1.6 million premium lenses implanted annually in the United States.

[0005] One of the most common complications of cataract surgery is rupture of the posterior lens capsule, also referred to as posterior capsular rupture (PCR). The risk of PCR varies with surgical experience: surgeons with less than five years of experience and residents may see rupture rates between 5% and 15%, while experienced surgeons typically have rates around 1% or lower. When PCR occurs, there is inadequate capsule support for securing a single-piece premium IOL, leaving the surgeon with limited options. In such cases, the fallback is to implant a standard three-piece monofocal IOL with long polymethyl methacrylate (PMMA) haptics positioned in the ciliary sulcus. However, these fallback lenses do not provide toric or multifocal functionality, eliminating the option for patients to receive a premium lens if PCR occurs.

[0006] This limitation is particularly significant in pediatric cataract surgeries, which are inherently complex and can involve intense capsular scarring that makes IOL exchange difficult as the child’s eye grows and their refractive needs change. Approximately 2,000 pediatric cataract surgeries are performed annually in the United States, some as early as six weeks of age. In many cases, a primary posterior capsulotomy is performed to reduce posterior capsular opacification caused by aggressive scarring, which can further complicate lens replacement in the future.

[0007] There is therefore a need for an artificial lens capsule that can be used during cataract surgery when capsular support is inadequate or absent, to enable secure placement and stabilization of premium intraocular lenses. Such an artificial lens capsule can provide surgeons with an additional option to maintain desired IOL positioning, support lens exchanges over time, and help optimize refractive outcomes for both adult and pediatric patients. The device may also act as a reservoir for drug-eluting devices or future intraocular devices, in combination with the intraocular lens.SUMMARY

[0008] The present disclosure describes a flexible, artificial lens capsule designed for use during cataract surgery or in cases of aphakia. This capsule can be folded and inserted into an eye through a small incision (e.g., 2.2 mm to 2.4 mm) in a folded or rolled up configuration and then unfolded or unrolled within the eye. The capsule can rest on the anterior lens capsule of the eye or be sutured into position with scleral fixation.

[0009] The artificial lens capsule may include a plurality (e.g., 2 or more) of leaflets, which may have a cloverleaf-like shape (i.e., a leaf with two cojoined curves at a distal end). Each of the leaflets may also include one or more eyelets for suture passage. This design supports the capsule and any suitable intraocular lens, implant or device. The capsule has an anterior opening that permits the insertion of a foldable intraocular lens and a posterior opening that allows light to pass through unimpeded. Both openings are smaller than the intraocular lens to prevent the intraocular lens from migrating anteriorly or posteriorly. In its unfolded configuration, the lens capsule may include a tapered wall structure that defines a frustoconical cavity sized to receive the intraocular lens. Notches along the interior circumference of the capsule also provide rotational stability forthe intraocular lens. As used herein, the term “frustoconical” refers to a generally conical shape whose tip has been truncated by a plane, resulting in a base and sidewalls that taper inward at an acute angle toward the truncated tip.

[0010] According to one embodiment of the present disclosure, an artificial lens capsule is disclosed. The artificial lens capsule includes a flexible body having a substantially frustoconical shape and defining an anterior opening. The capsule also includes a plurality of leaflets disposed around the anterior opening and extending radially from the anterior opening for securing the flexible body within the eye. The artificial lens capsule is configured to be folded and inserted through a small incision in a folded configuration and then expanded within the eye to provide support for an intraocular lens.

[0011] Implementations of the above embodiment may include one or more of the following features. According to one aspect of the above embodiment, the body and the plurality of leaflets may be formed from a biocompatible material including one of polysiloxane, polymethyl methacrylate, phenylethyl acrylate, phenylethyl methacrylate, and 1,4-butanediol diacrylate, and combinations thereof. The body includes a base having a posterior opening aligned with the anterior opening to allow for light to pass through the intraocular lens disposed inside the body. The artificial lens capsule may include a plurality of notches disposed along the circumference of the base to provide rotational stability for the intraocular lens. The body also includes sidewalls extending from the base at an acute angle toward the anterior opening. Each leaflet of the plurality of leaflets may include at least one eyelet for suture passage. Each leaflet and the at least one eyelet may be reinforced. The body and / or the plurality of leaflets may be coated with at least one of an anti-inflammatory, antibiotic, intraocular lowering or an anti-fibrotic agent. The body may also act as a reservoir for drug-eluting implants or future intraocular devices. The plurality of leaflets maybe attached to the body using ultrasonic welding. The body may be configured to support the intraocular lens or other intraocular device weighing up to about 35 mg to 40 mg.

[0012] According to another embodiment of the present disclosure, a method of implanting an artificial lens capsule in an eye is disclosed. The method includes inserting an artificial lens capsule in a folded configuration through a corneal incision into an anterior chamber of an eye, where the artificial lens capsule includes a flexible body having a substantially frustoconical shape and defining an anterior opening. The method also includes unfolding and positioning the artificial lens capsule within the eye such that the artificial lens capsule rests within the ciliary sulcus. The method further includes deploying a plurality of leaflets disposed around the anterior opening and extending radially from the anterior opening. The method additionally includes securing the artificial lens capsule within the eye using the plurality of leaflets and inserting an intraocular lens into the artificial lens capsule through the anterior opening of the artificial lens capsule.

[0013] Implementations of the above embodiment may include one or more of the following features. According to one aspect of the above embodiment, the body and the plurality of leaflets are formed from a biocompatible material including one of polysiloxane, polymethyl methacrylate, phenylethyl acrylate, phenylethyl methacrylate, 1,4-butanediol diacrylate, and combinations thereof. The body may include a base having a posterior opening aligned with the anterior opening to allow for light to pass through the intraocular lens disposed inside the body. The body may also include a plurality of notches disposed along the circumference of the base to provide rotational stability for the intraocular lens. The body may further include sidewalls extending from the base at an acute angle toward the anterior opening. Each leaflet of the plurality of leaflets may include at least one eyelet for suture passage. The artificial lens capsule may be secured by passing sutures through at least one eyelet of each leaflet on the plurality of leaflets to achieve multi-point scleralfixation. At least one of the body or the plurality of leaflets may be coated with at least one of an anti-inflammatory, antibiotic, intraocular lowering or an anti-fibrotic agent. The plurality of leaflets may be attached to the body using ultrasonic welding. The body may be configured to support the intraocular lens or other intraocular device weighing up to about 35 mg to 40 mg.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various embodiments of the present disclosure are described below with reference to the following figures:

[0015] FIG. 1 shows a top view of an artificial lens capsule according to an embodiment of the present disclosure;

[0016] FIG. 2 shows a side cross-sectional view of the artificial lens capsule of FIG. 1 according to an embodiment of the present disclosure;

[0017] FIG. 3 shows a perspective, cross-sectional view of an eye with the artificial lens capsule in an expanded configuration according to an embodiment of the present disclosure;

[0018] FIG. 4 shows a perspective, cross-sectional view of the artificial lens capsule of FIG. 1 according to an embodiment of the present disclosure;

[0019] FIG. 5 shows a mold for forming the artificial lens capsule of FIG. 1 according to an embodiment of the present disclosure;

[0020] FIG. 6 shows a top view of the artificial lens capsule of FIG. 1 formed using the mold of FIG. 5 according to an embodiment of the present disclosure;

[0021] FIG. 7 shows a perspective view of artificial lens capsules of FIG. 1 formed using a 3D printer according to an embodiment of the present disclosure; and

[0022] FIG. 8 shows a flow chart of using the artificial lens capsule of FIG. 1 according to an embodiment of the present disclosure.DETAILED DESCRIPTION

[0023] The following detailed description of embodiments of the disclosure will be made in reference to the accompanying drawings. Explanation about related functions or constructions known in the art are omitted for the sake of clearness in understanding the concept of the disclosure to avoid obscuring the disclosure with unnecessary detail.

[0024] As used herein the term “anterior” refers to the front portion of the eye and is used in describing procedures or anatomical features located in the front part of the eye, such as the anterior chamber, which is the fluid-filled space between the cornea and the iris. As used herein the term “posterior” refers to the back portion of the eye and is used to describe anatomical features and surgical procedures that are located or performed in the back part of the eye, such as the posterior chamber, which lies behind the iris and in front of the lens and vitreous body.

[0025] With reference to FIGS. 1-4, an artificial lens capsule 10 includes a flexible body 12 allowing for the lens capsule 10 to be folded or rolled up for delivery. The lens capsule 10 is shown in an unfolded or expanded configuration in FIGS. 1-4 and in this configuration the body 12 takes an approximately frustoconical shape, such that the body 12 has a conical shape whose tip has been truncated by a plane on which an anterior portion 18 is disposed.

[0026] As shown in FIGS. 2-4, the body 12 defines a cavity 13 designed to hold securely an intraocular lens or intraocular device inside itself. The lens capsule 10 is configured to support an artificial intraocular lens (IOL) 15 weighing up to about 35-40 mg. The IOL 15 may have an optic that is about 6 mm and may have a total length of about 13 mm.

[0027] The body 12 includes sidewalls 14 and a posterior, circular base portion 16, which may be formed from any biocompatible (i.e., not harmful to living tissue), such as polysiloxane, poly(methyl methacrylate) (PMMA), phenylethyl acrylate (PEA); phenylethyl methacrylate (PEMA); 1,4-butanediol diacrylate (BDDA), and the like. In embodiments, where the IOL 15 is acrylic, the body 12 may be formed from a non-acrylic material prevent formation of an interface haze due to contact between two acrylic objects.

[0028] The sidewalls 14 and the base portion 16 may have a thickness from about 0.1 mm to about 0.5 mm. The base portion 16 may have a diameter of about 10 mm to 15 mm, and in embodiments from about 12 mm to about 13 mm. The sidewalls 14 extend from the base portion 16 at an acute (i.e., less than 90°) angle toward an anterior portion 18, which helps maintain the intended frustoconical shape and prevents posterior capsular opacification. In one embodiment, the angle may be from about 20° to about 60°, defining a generally frustoconical profile that conforms to the size and shape of the intraocular lens. As shown schematically in FIGS. 1-3 and in greater cross-sectional detail in FIG. 4, the frustoconical body may include an integrated base portion 16 and angled sidewalls 14 that help position and stabilize the IOL 15 within the lens capsule 10.

[0029] The anterior portion 18 also defines an anterior opening 20 having a diameter from about 5 mm to about 6 mm. The anterior opening 20 may extend to the sidewalls 14, such that the anterior portion 18 is defined by the anterior opening 20. In further embodiments, the anterior opening 20 may be circumscribed by a circular border (not shown). The anterior opening 20 is sized to allow for insertion of the IOL 15 into the cavity 13.

[0030] The base portion 16 also includes a posterior opening 17, which may be a through opening or a clear windowed opening. The posterior opening 17 is disposed on a plane substantially parallel to a plane of the anterior opening 20. In addition, the posterior opening 17 is aligned withthe anterior opening 20. The posterior opening 17 may have a diameter of from 4 mm to 6 mm to allow for light to pass through the IOL 15 disposed inside the body 12. The distance between the anterior opening 20 and the posterior opening 17 may be from about 1 mm to 3 mm. This distance provides for effective positions of the IOL 15 from the ciliary sulcus of the eye to where the IOL 15 resides in the cavity 13 of the lens capsule 10.

[0031] The interior surface of the base portion 16 also includes a plurality of raised notches 22 disposed along the circumference of the base portion 16. The notches 22 support the IOL 15 inserted into the cavity 13 and provide rotational stability for the IOL 15. The notches 22 may be tapered (i.e., angled radially) towards the posterior opening 17. The notches 22 may be disposed at regular intervals along the circumference, which may be from 1 degree to 120 degrees. In one embodiment, the notches 22 may be disposed every 10 degrees providing for a total of 36 notches. In lieu of notches any other structural features may be implemented on the base portion 16, such as micro-textures, ridges, and the like to enhance the frictional interface between the IOL 15 and the lens capsule 10, thereby preventing rotation and ensuring stable positioning of the IOL 15.

[0032] To aid in fixation of the lens capsule 10, the base portion 16 of the body 12 may include anchoring features 19 (FIGS. 2 and 3) such as micro-hooks or grooves disposed on the outer surface of the base portion 16 as well as the body 12 that engage with the remaining natural capsular bag or ciliary sulcus to provide additional stability.

[0033] The lens capsule 10 also includes a plurality of leaflets 26 coupled to and extending from the anterior portion 18 of the body 12. The leaflets 26 may be formed from any suitable biocompatible material, such as polysiloxane, PMMA, PEA; PEMA; BDDA, and combinations thereof and may have a thickness from about 0.1 mm to about 0.5 mm. The leaflets 26 may beattached to the body 12 using an adhesive or fixated using any other suitable fixation means, e.g., ultrasonic welding.

[0034] The leaflets 26 may be supported on the anterior capsular rim. Each of the leaflets 26 may include one or more eyelets 28 that are used to attach the lens capsule 10 using sutures for multipoint scleral fixation. The leaflets 26 have a flat, sheetlike structure with rounded edges and in one embodiment, may have a cloverleaf-like shape. The rounded design prevents posterior iris chafing, pigment dispersion and uveitis, glaucoma, hyphema syndrome (UGH), and other complications.

[0035] Each leaflet 26 may incorporate reinforcement ribs or embedded fibers to enhance structural integrity and resistance to tearing during suturing and post-operative movements. The eyelets 28 on the leaflets 26 can be reinforced with metallic or polymeric rings to prevent suture pull-through and provide a secure attachment point for scleral fixation.

[0036] The lens capsule 10 may be formed using any suitable process depending on the materials used and the desired features of the final product, such as injection molding, additive manufacturing, laser cutting and welding, dip coating, and the like. For example, additive manufacturing may include fused filament fabrication (FFF), stereolithography (SLA), digital light processing (DLP), or other resin-based 3D printing methods capable of producing fine features and thin sections suitable for ophthalmic implants. The selected additive manufacturing system may be configured to produce the capsule body 12, leaflets 26, and integrated eyelets 28 as a single piece or as subcomponents that may be bonded or welded together. Reinforcement elements may be incorporated during the additive manufacturing process, such as by using composite filaments or multi -material printing techniques. The reinforcement elements may also be added to the polymer used in forming the lens capsule 10 during a molding or casting process.

[0037] FIG. 5 shows an example mold 30 that may be used to form the artificial lens capsule 10. The mold 30 itself may be manufactured using any suitable process described herein, such as injection molding, additive manufacturing (e.g., fused filament fabrication, stereolithography, or digital light processing), laser cutting, or other precision fabrication methods. In the illustrated embodiment, the mold 30 includes multiple sections that together define the cavity and core features for forming the intended shape and structural details of the lens capsule 10. For example, the mold 30 may include two complementary mold halves 32 and 34 positioned on the left side in FIG. 5, and an opposing mold section 36 on the right side. The mold section 36 may function as a cap that encloses the mold cavity and includes a central core 20' that forms the anterior opening 20 in the capsule body 12.

[0038] When assembled, the mold halves 32, 34, and mold section 36 together enclose a mold cavity that defines the exterior shape of the capsule body 12 and leaflets 26. The interior surfaces of the mold sections may include recessed regions and tapered surfaces that form the frustoconical sidewalls of the capsule body 12. The mold section 36 may further include multiple core pins 28' that project into the mold cavity to form the integrated eyelets 28 in each leaflet 26, ensuring that the eyelets are dimensioned for secure suture passage without tearing. In certain embodiments, the mold halves 32 and 34 may be joined using guide pins or interlocking edges to maintain alignment and consistent wall thickness during the molding process. The mold 30 may be configured for use with a biocompatible material, e.g., elastomer, described above. The material may be introduced through one or more injection ports and cured in place to produce the final lens capsule 10.

[0039] FIG. 6 shows a top view of an example molded artificial lens capsule 10 formed using the mold 30 of FIG. 5. The prototype demonstrates how the molded part defines the central anterior opening 20, the posterior opening 17, the peripheral leaflets 26, and the integrated eyelets 28 forsuture passage. The molded prototype further illustrates the approximate wall thickness, the frustoconical body shape, and the relative positioning of the leaflets 26 around the anterior portion 18, showing how the mold cavity and internal cores 20' and 28' cooperate to produce the desired structural features in a single manufacturing step.

[0040] FIG. 7 shows an example of multiple artificial lens capsules 10 produced using additive manufacturing, such as 3D printing with a biocompatible resin. The printed prototypes illustrate that the capsule body 12, leaflets 26, and integrated eyelets 28 can be fabricated with consistent dimensions and surface detail. Additive manufacturing may be used for prototyping, pre- production units, or final parts, and allows rapid iteration of design features such as the shape of the leaflets, placement of the eyelets, or thickness of the frustoconical sidewalls. The examples of FIGS. 5-7 demonstrate that the lens capsule 10 may be fabricated using either mold-based or mold- free processes while maintaining the required geometry for insertion, expansion, and stable fixation of the IOL 15.

[0041] In embodiments, the lens capsule 10 (e.g., in its entirety or partially) may be coated with a coating including an anti-inflammatory and / or anti-fibrotic agent to minimize post-operative complications such as inflammation and fibrosis. Suitable anti-inflammatory agents include betamethasone, dexamethasone, fluoromethalone, hydrocortisone acetate, prednisolone, rimexolone, loteprednol etabonate, and the like. The lens capsule 10 may also elute antiinflammatory, intraocular pressure lowering, or antibiotic drugs gradually over a specified period post-implantation. This can be achieved by embedding drug-laden nanoparticles within the material of the body 12 or coating the inner surfaces with a drug-eluting polymer. The body 10 can also act as a reservoir for drug eluting devices.

[0042] FIG. 8 shows an example method 40 for implanting the lens capsule 10. At step 42 one or more corneal incisions are made, which may be between 2.2 mm to 2.4 mm, to allow access to the anterior chamber of the eye. At step 44, the cataract is removed if it has not been removed previously. Capsulorhexis is performed to create an opening in the anterior capsule and phacoemulsification is used to remove the cataractous lens material. The capsular bag may be removed as well.

[0043] At step 46, the lens capsule 10 is inserted. The lens capsule 10 is folded and / or rolled into a compact configuration and is then inserted through the corneal incision into the anterior chamber. At step 48, the lens capsule 10 is unfolded and positioned into desired location within the eye. The lens capsule 10 is allowed to unfold within the eye by manipulation using any suitable graspers, hooks or forceps. The lens capsule 10 is positioned such that the base portion 16 rests on the remaining natural posterior capsule and with the leaflets 26 within the ciliary sulcus. At step 50, the leaflets 26 are deployed such that they extend radially from the anterior opening 20. The leaflets 26 can be secured by passing sutures through the eyelets 28 if needed. Any suitable scleral fixation techniques may be used to secure the lens capsule 10 in place, ensuring multi-point fixation for optimal stability.

[0044] Once lens capsule 10 is secured within the eye, at step 52, the IOL 15 is inserted into the lens capsule 10. The IOL 15 may be folded and / or rolled into a compact configuration and is then inserted through the corneal incision. The folded IOL 15 is inserted through the anterior opening 20 of the lens capsule 10 into the cavity 13. Once inside the cavity 13 and unfolded, the IOL 15 is positioned and centered within the cavity 13. The IOL 15 is positioned on the notches 22 or other structure features within the cavity 13 to achieve rotational stability of the IOL 15, preventing its displacement. Afterwards, the position and stability of both the lens capsule 10 and the IOL 15may be verified with observation through the operative microscope. If needed, any adjustments to the sutures or the position of the IOL 15 may be made to ensure optimal alignment and fixation. Thereafter, the corneal incision may be hydrated to ensure it is self-sealing and sutured may be used to close the incision securely. Additionally, antibiotic and / or anti-inflammatory drops may be used to prevent infection and reduce inflammation. By following this detailed method, the artificial lens capsule and IOL 15 can be successfully implanted, providing enhanced support and stability for patients with compromised or absent natural lens capsules, and improving their overall visual outcomes.

[0045] This artificial lens capsule provides a significant advantage over current options like laser refractive surgery or intraocular lens exchange surgeries, which are challenging and carry higher risks. This device can also be used in routine surgeries, providing a backup in case of complications during cataract surgery, especially in teaching institutions.

[0046] The disclosed artificial lens capsule may be used by cataract surgeons as well as vitreoretinal surgeons who operate on eyes that have had complications during cataract surgery, so this device may also be used in any patient who would benefit from a premium intraocular lens.

[0047] Another advantage of the disclosed lens capsule is in pediatric cataract surgeries, where surgeons have difficulty selecting intraocular lens, and intraocular lens exchanges are especially difficult. Children are either left aphakic and a secondary surgery is done to implant an intraocular lens, or the children have to use aphakic glasses or contact lens. Implanting the artificial lens capsule will give surgeons the ability to exchange intraocular lens throughout a child’s life. Therefore, this would be especially useful for a younger cataract patient who would want to exchange the lens in the future or when their glasses prescription changes over time.

[0048] Furthermore, the artificial lens capsule may be used during routine surgery where a lens can be easily explanted and replaced in the future. Currently, once a patient decides what type of lens implant they want during the preoperative visit, there are few options for replacing the lens if the patient changes their mind after surgery, or if the patient ends up with an unexpected refraction i.e., glasses prescription. Options include laser refractive surgery (LASIK / PRK) or intraocular lens exchange or explantation. Intraocular lens exchange can be a challenging surgery as there are higher risks involved than the original surgery. Using an artificial capsule during the initial surgery can give the patient the flexibility of exchanging the lens in the future if they are unsatisfied with the current intraocular lens, or if in the future a new intraocular lens technology is available that the patient desires.

[0049] Lastly, the capsule may be made with drug-embedded materials that may elute drug overtime such as anti-inflammatory, antibiotic, or intraocular pressure lowering medications. The capsule may also act as a reservoir for drug-eluting implants or future intraocular devices to reside in along with the intraocular lens.

[0050] Alternate embodiments may be devised without departing from the spirit or the scope of the present technology. Additionally, well-known elements of embodiments of the systems, apparatuses, and methods have not been described in detail or have been omitted so as not to obscure the relevant details of the systems, apparatuses, and methods.

[0051] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms “comprises,” “comprising,” or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Anelement proceeded by “comprises ... a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. The terms “including” and / or “having,” as used herein, are defined as comprising (i.e., open language). The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The description may use the terms “embodiment” or “embodiments,” which may each refer to one or more of the same or different embodiments.

[0052] When the terms “coupled” and “connected,” along with their derivatives, are used, these terms are not intended as synonyms for each other. For example, “connected” may be used to indicate that two or more elements are in direct physical or electrical contact with each other. “Coupled” may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled) or that two or more elements are not in direct contact with each other but yet still cooperate or interact with each other (e.g., indirectly coupled).

[0053] For the purposes of the description, a phrase in the form “A / B” or in the form “A and / or B” or in the form “at least one of A and B” means (A), (B), or (A and B), where A and B are variables indicating a particular object or attribute. When used, this phrase is intended to and is hereby defined as a choice of A or B or both A and B, which is similar to the phrase “and / or”. Where more than two variables are present in such a phrase, this phrase is hereby defined as including only one of the variables, any one of the variables, any combination of any of the variables, and all of the variables, for example, a phrase in the form “at least one of A, B, and C” means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C).

[0054] Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring orimplying any actual such relationship or order between such entities or actions. The description may use perspective-based descriptions such as up / down, back / front, top / bottom, and proximal / distal. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of disclosed embodiments. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments; however, the order of description should not be construed to imply that these operations are order dependent.

[0055] As used herein, the term “about” or “approximately” applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. As used herein, the terms “substantial” and “substantially” means, when comparing various parts to one another, that the parts being compared are equal to or are so close enough in dimension that one skill in the art would consider the same. Substantial and substantially, as used herein, are not limited to a single dimension and specifically include a range of values for those parts being compared. The range of values, both above and below (e.g., “+ / -” or greater / lesser or larger / smaller), includes a variance that one skilled in the art would know to be a reasonable tolerance for the parts mentioned.

[0056] Various embodiments of the systems, apparatuses, and methods have been described, and in many of the different embodiments many features are similar. To avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later describedsimilar feature and each respective description, therefore, is to be incorporated therein without such repetition.

[0057] From the foregoing, it will be appreciated that specific embodiments of the disclosure have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the disclosure. Accordingly, the disclosure is not limited except as by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. An artificial lens capsule, comprising: a flexible body having a substantially frustoconical shape and defining an anterior opening; and a plurality of leaflets disposed around the anterior opening and extending radially from the anterior opening for securing the flexible body within the eye; wherein the artificial lens capsule is configured to be folded and inserted through a small incision in a folded configuration and then expanded within the eye to provide support for an intraocular lens.

2. The artificial lens capsule of claim 1, wherein the body and the plurality of leaflets are formed from a biocompatible material selected from the group consisting of polysiloxane, polymethyl methacrylate, phenylethyl acrylate, phenylethyl methacrylate, 1,4-butanediol diacrylate, and combinations thereof.

3. The artificial lens capsule of claim 1, wherein the body includes a base having a posterior opening aligned with the anterior opening to allow for light to pass through the intraocular lens disposed inside the body.

4. The artificial lens capsule of claim 3, further comprising a plurality of notches disposed along the circumference of the base to provide rotational stability for the intraocular lens.

5. The artificial lens capsule of claim 3, wherein the body includes sidewalls extending from the base at an acute angle toward the anterior opening.

6. The artificial lens capsule of claim 1, wherein each leaflet of the plurality of leaflets includes at least one eyelet for suture passage.

7. The artificial lens capsule of claim 6, wherein each leaflet and the at least one eyelet are reinforced.

8. The artificial lens capsule of claim 1, wherein at least one of the body or the plurality of leaflets is coated with at least one of an anti-inflammatory, antibiotic, intraocular pressure lowering, or an anti-fibrotic agent.

9. The artificial lens capsule of claim 1, wherein the plurality of leaflets is attached to the body using ultrasonic welding.

10. The artificial lens capsule of claim 1, wherein the body is configured to support the intraocular lens weighing up to about 35 mg to 40 mg.

11. A method of implanting an artificial lens capsule in an eye, comprising: inserting an artificial lens capsule in a folded configuration through a corneal incision into an anterior chamber of an eye, wherein the artificial lens capsule includes a flexible body having a substantially frustoconical shape and defining an anterior opening;unfolding and positioning the artificial lens capsule within the eye such that the artificial lens capsule rests within the ciliary sulcus; deploying a plurality of leaflets disposed around the anterior opening and extending radially from the anterior opening; securing the artificial lens capsule within the eye using the plurality of leaflets; and inserting an intraocular lens or device into the artificial lens capsule through the anterior opening of the artificial lens capsule.

12. The method of claim 11, wherein the body and the plurality of leaflets are formed from a biocompatible material selected from the group consisting of polysiloxane, polymethyl methacrylate, phenylethyl acrylate, phenylethyl methacrylate, 1,4-butanediol diacrylate, and combinations thereof.

13. The method of claim 11, wherein the body includes a base having a posterior opening aligned with the anterior opening to allow for light to pass through the intraocular lens disposed inside the body.

14. The method of claim 13, wherein the body includes a plurality of notches disposed along the circumference of the base to provide rotational stability for the intraocular lens.

15. The method of claim 13, wherein the body includes sidewalls extending from the base at an acute angle toward the anterior opening.

16. The method of claim 11, wherein each leaflet of the plurality of leaflets includes at least one eyelet for suture passage.

17. The method of claim 16, wherein the artificial lens capsule is secured by passing sutures through at least one eyelet of each leaflet on the plurality of leaflets to achieve multi-point scleral fixation.

18. The method of claim 11, wherein at least one of the body or the plurality of leaflets is coated with at least one of an anti-inflammatory or an anti-fibrotic agent.

19. The method of claim 11, wherein the plurality of leaflets is attached to the body using ultrasonic welding.

20. The method of claim 11, wherein the body is configured to support the intraocular lens weighing up to about 35 mg to 40 mg.

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