Prosthetic capsular devices, systems, and methods

A prosthetic capsular device configured to be inserted in an eye after removal of a lens, in some embodiments, can comprise a housing structure comprising capable of containing an intraocular device and an equiconvex refractive surface. The housing structure can comprise an anterior portion comprising an anterior opening, a posterior portion comprising a posterior opening, and a continuous lateral portion between the anterior portion and the posterior portion.

BACKGROUND

Field

The present application relates to prosthetic capsular devices, systems, and methods for insertion into the eye.

Description

Cataract surgery is one of the most successfully and most frequently performed surgical procedures in the United States. Each year, millions of people achieve a dramatic improvement in their visual function thanks to this procedure. With the increasing proportion of the U.S. population reaching their retirement years, there is expected to be an almost doubling of the demand for cataract surgery over the next twenty years from 3.3 million to over 6 million annually. In response to the increased demand, more ophthalmologists may be trained and certified to perform cataract surgery, and each trained and certified ophthalmologist may perform more cataract surgeries each year.

SUMMARY

Various embodiments described herein relate to prosthetic capsular devices, systems, and methods for insertion into the eye. In some embodiments, a prosthetic capsular device that is configured to be inserted in an eye after removal of a lens comprises a housing structure capable of containing an intraocular device. In certain embodiments, the housing structure comprises an anterior portion, wherein the anterior portion comprises an anterior opening, wherein the anterior opening is capable of allowing at least one of insertion, removal, or replacement of the intraocular device, and wherein the anterior opening is further configured to be coupled to a refractive surface to cover the anterior opening; a posterior portion, wherein the posterior portion comprises a posterior opening wherein the posterior opening is capable of allowing at least one of insertion, removal, or replacement of the intraocular device, and wherein the posterior opening is further configured to be coupled to a refractive surface to cover the posterior opening; and a continuous lateral portion interposed between the anterior portion and the posterior portion, wherein the continuous lateral portion protrudes radially beyond the anterior portion and the posterior portion, wherein the continuous lateral portion fully encloses a lateral side of the housing structure, wherein an internal cavity of the continuous lateral portion forms a groove for containing the intraocular device, wherein the housing structure is symmetrical over a plane at a midpoint of the continuous lateral portion between the anterior portion and the posterior portion.

In certain embodiments, the prosthetic capsular device can be capable of holding a refractive surface and at least one additional intraocular device. In certain embodiments, the groove is configured to contain haptics of the intraocular device or a capsular tension ring potentially attached to another intraocular device. In certain embodiments, the intraocular device is at least one of an intraocular lens, intraocular pressure sensor, electronic intraocular pressure sensor, photovoltaic cells, solar cells, battery, computer, antennae, sensor, fixation device, capsular tension ring, electronic device, electronic accommodating intraocular lens, liquid crystal display optic, input/output device, or one or more components thereof. In certain embodiments, the prosthetic capsular device comprises at least one of silicone, hydrogel, collamer, acrylic, or an acrylic derivative. In certain embodiments, the prosthetic capsular device is self-expandable upon insertion in the natural capsular bag. In certain embodiments, the prosthetic capsular device is deformable for insertion in the natural capsular bag.

In certain embodiments, the continuous lateral portion comprises a straight-walled portion, a first curved portion, and a second curved portion. In certain embodiments, the straight-walled portion is substantially perpendicular to the anterior opening and the posterior opening. In certain embodiments, the first curved portion extends from the anterior portion, and wherein the second curved portion extends from the posterior portion. In certain embodiments, the intraocular device comprises at least one of a Galilean telescope or microscope. In certain embodiments, the intraocular device comprises an electronic accommodating intraocular lens.

In certain embodiments, the prosthetic capsular device further comprises an equiconvex refractive surface, wherein the refractive surface comprises a plurality of tabs for affixing the refractive surface to at least one of the circular anterior opening or the circular posterior opening, and wherein the plurality of tabs protrudes from the refractive surface in alternating posterior and anterior directions. In certain embodiments, the tabs are configured to be affixed to the interior of the device and the exterior of the device in alternating order. In certain embodiments, each of the plurality of tabs comprises an eyelet opening for affixing the tab to the device or to hold suture for scleral fixation. In certain embodiments, the refractive surface is capable of being inserted separately from the housing structure into the natural capsular bag without being attached to the housing structure.

In certain embodiments, the refractive surface comprises a refractive power between −35 D and +35 D. In certain embodiments, the refractive surface is affixed to at least one of the circular anterior opening or the circular posterior opening using a friction fit. In certain embodiments, the refractive surface is affixed to at least one of the circular anterior opening or the circular posterior opening using sutures. In certain embodiments, the refractive surface is usable as a reference point for selection of an intraocular lens for placement in the internal cavity of the continuous lateral portion. In certain embodiments, the refractive surface comprises a refractive power less than −35 D. In certain embodiments, the refractive surface comprises a refractive power greater than +35 D.

The methods summarized above and set forth in further detail below may describe certain actions taken by a practitioner; however, it should be understood that these steps can also include the instruction of those actions by another party. Thus, actions such as “inserting an intraocular lens into a prosthetic capsular device” include “instructing the insertion of an intraocular lens into a prosthetic capsular device.”

DETAILED DESCRIPTION

In addition to the increase in demand for cataract surgery, technological advances have increased patient expectations for the surgery. The procedure takes a short amount of time to perform, and patients expect quick recovery of visual function. Patients are also asking their ophthalmologist to give them the restoration of more youthful vision without glasses through the use multifocal intraocular lenses, presbyopia correcting lenses, toric lenses, and monovision, to name a few. Despite accurate preoperative measurements and excellent surgical technique, the desired refractive outcome requires a dose of good fortune as there are numerous uncontrolled variables involved. As many as 20-50% of post-operative cataract patients may benefit from glasses or follow-up refractive surgical enhancements to achieve their desired refractive endpoint. One of the main reasons for this high amount of refractive unpredictability is believed to be the final resting position of the lens implant in the eye, mathematically expressed as the effective lens position (ELP), which can be quite variable and unpredictable in the current state of cataract surgery. Recently, hundreds of millions of dollars have been invested into developing highly sophisticated femtosecond laser systems that are able to more precisely control the size and shape of the capsulotomy and corneal incisions with the stated goal of lessening the variability of the ELP and thus aiding in better refractive outcomes. Unfortunately, the increased precision of the femtosecond laser systems has not been able to account for the major problem plaguing the variability of the ELP, which is the volumetric difference between the cataract, natural capsular bag, and intraocular lens implant (IOL).

Devices and methods that help provide the desired refractive endpoint in cataract surgery are described in U.S. Pat. Nos. 8,900,300, 9,414,907, and 9,358,103, each of which is hereby incorporated by reference in its entirety. All patents, patent applications, and other documents referred to in this application are incorporated by reference herein in their entirety.

FIG. 1Aillustrates an anterior side perspective view of an example of a prosthetic capsular device100.FIG. 1Billustrates another anterior side perspective view of the example prosthetic capsular device100forFIG. 1A.

In some embodiments, the device100includes features described with respect to the devices described in U.S. Pat. No. 9,358,103, which is hereby incorporated by reference in its entirety, or modifications thereof. For example, the device100can comprise an anterior side102, a posterior side104, and one or more sidewalls106extending between the anterior side102and the posterior side104; a cavity or opening108defined by the anterior side102, posterior side104, and the one or more sidewalls106, and the posterior side104optionally comprises a refractive surface110. As such, the device100can be configured to comprise both a refractive surface110and a secondary or additional intraocular lens, electronic device, or other intraocular device held within the cavity108.

At least a portion of the posterior side104can comprise a refractive surface, which may, for example, allow a pseudophakic refraction to be performed intraoperatively with a known lens already inside the eye. The refractive surface110can comprise a refractive power of about +1 diopter. In other embodiments, the refractive surface110may comprise any and all lens powers and designs that are currently known in the art of intraocular lenses, including, but not limited to: spherical, aspheric, wavefront, convex, concave, multifocal (diffractive, refractive, zonal), toric, accommodative, ultraviolet (UV) filtering, diffractive chromatic aberration reducing lenses, light adjustable lenses (ultraviolet light adjustable, femtosecond phase wrapping), and optical powers ranging from any positive diopter value (e.g., including +35 D and above) to any negative diopter value (e.g., including −35 D and below).

The refractive surface110may advantageously reduce the refractive power of an IOL to be placed in the device100. For example, if the device did not include a refractive surface110(e.g., comprised a simple or modified ring), then one or more IOL devices would need to provide all of the refractive power, which could increase the volume of the IOL, leading to a larger incision and associated complications. A device100comprising a refractive surface110implanted in the eye can advantageously allow for a second refractive device or IOL to be coupled with (e.g., placed within, next to, and/or on top of) the refractive surface110. The posterior refractive surface110can allow the ELP of the eye to be determined along with any residual refractive error. If any further refractive error is discovered, a second refractive device or IOL can be added to the refractive surface110(e.g., immediately), which can neutralize the deficit and help ensure that the desired outcome is achieved. The posterior refractive surface110can be accurately placed and anchored and/or can inhibit or prevent shifting of lateral and/or posterior-anterior position, rotation, tilt, etc. of the posterior refractive surface110that could lead to degradation of vision.

Further, in certain embodiments, the device100includes one or more additional features. For example, the device100can comprise a generally lenticular or lens-like shape as opposed to a box-like design. In other words, the generally shape of the device100can be more like the shape of a natural lens. Risks of negative and/or positive dysphotopsia can be reduced due to the generally lenticular shape of the device100. Negative dysphotopsia is a common problem in cataract surgery, generally described by patients as a temporal dark crescent in their vision and is believed to occur either due to the optical phenomenon known as total internal reflection or by obstruction of light. This can occur either at the junction of the optic edge and the empty collapsed surrounding capsule forming a relatively planar surface, or due to the capsule overlapping a portion of the optic, most commonly the nasal aspect. In embodiments in which the implantable device100comprises an overall lens-like configuration, the capsule can be held open, preventing a relatively planar surface from being formed by fusion of the posterior and anterior capsule. More specifically, when light hits a curvilinear slice of the device100, which can be made from silicone for example, it may travel through the curvilinear slice instead of bouncing off and causing a negative shadow as it generally would for flat surfaces. This may be especially true in the horizontal meridian across the 180-degree plane. As such, in some embodiments, the device100does not comprise any flat edges or surfaces. In other words, every surface of the device100can be curvilinear. Flat optical surfaces can promote total internal reflection, and are not found in the natural human lens or lens capsule in the native state. One goal of some of the embodiments described herein is to reduce negative dysphotopsias by not having any flat optical surfaces.

In certain embodiments, one or more sidewalls106of the device100can extend from only a portion of the posterior104and/or anterior sides102instead of extending from the whole circumference of the posterior104and/or anterior sides102. The outer periphery of a sidewall106can comprise an arc of a circle. For example, in the illustrated embodiment, the device100comprises two sidewalls106A,106B each of which extend from only a portion of the circumference of the posterior side104and/or refractive surface110. In other words, certain portions of the anterior side102and posterior side104are not connected by a sidewall.

There can be a number of advantages for having only a portion of the sidewall present instead of having a sidewall encompass the whole circumference of the device100. For example, by not having a sidewall at some portions, the area behind the refractive surface110can be more accessible. This can be important during surgical implantation of the device100to facilitate removal of viscoelastic material from behind the lens or refractive surface110immediately or shortly after the device100is implanted. In devices in which a sidewall encompasses the whole device100, it can be difficult to maneuver between that space of the natural capsule and the sidewall capsular bag to get behind the lens or refractive surface110to vacuum out the viscoelastic material. Without having a sidewall present at least along some portions of the posterior side104, it can be substantially easier to reach the area behind the lens or refractive surface110for removal of viscoelastic material and substantially reduce risks of posterior capsular distension syndrome due to remaining viscoelastic material.

In addition, by not having a sidewall present at least along some portions of the posterior side104, the overall bulk of the device100can be reduced. As such, the device100can be compressed to fit into a smaller injector and incision in the eye compared to a device with sidewalls surrounding the whole device. In other words, the device100can be folded, rolled, or otherwise compressed over the longitudinal axis of the device, or line1G-1G ofFIG. 1E, such that line1-F-1F of the device100is compressed to allow the device100to be inserted into a small injector and/or incision in the eye for implantation. For example, in some embodiments, the device100can be inserted into the eye through an incision of about 2.2 mm. In other embodiments, the device100can be inserted into the eye through an incision of about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, and/or within a range defined by two of the aforementioned values.

Also, the reduced size of the device100can allow for use of a larger optic or lens, for example for use on the anterior side104and/or for placement within the cavity108. More specifically, a larger lens or refractive surface110can be used with the device100due to the reduced bulk of the device100itself by removal of some of the sidewalls. Use of a larger lens or refractive surface110can be advantageous to reduce halos and/or glare post-surgery. For example, when the pupil dilates more than 5 mm, such as at night, light that reaches the outer portions of the refractive surface110may not be focused. A larger lens or refractive surface110can be generally better to address such issues, specifically to prevent nighttime symptoms when the pupil dilates to 6 or 7 mm for example.

In some embodiments, substantially the whole device100, other than the lens or refractive surface110and/or one or more haptics112, can comprise silicone and/or a soft silicone polymer. In addition, in certain embodiments, substantially the whole device100, other than the lens or refractive surface110and/or one or more haptics112, can comprise a flexible and/or elastic material. As such, the device100can be foldable or collapsible for implantation into the eye through a small incision. Once inserted into the eye, the device100can naturally unfold and self-expand into its expanded configuration as illustrated inFIG. 1Awithin the natural capsular bag. In certain embodiments, the device100without having sidewalls encompassing the whole device100is collapsible to a point where the size of the optic or refractive surface110is the rate limiting factor for the incision size for surgical implantation of the device100.

The device100can comprise one or more capsular areas. The one or more capsular areas can be adapted to receive and/or hold a lens or a secondary lens in addition to a refractive surface110on the posterior side. By inserting a secondary lens, IOL, or other optical device into the device100, a Galilean and/or reverse Galilean telescope can be provided. For example, a portion of the posterior side104, a portion of the anterior side102, and a portion of the side wall106A,106B can define a capsular area. In the embodiment shown inFIGS. 1A-1G, the device100comprises two capsular areas. The first capsular area is defined by a portion of the posterior side104, a portion of the anterior side102, and a portion of the side wall106A. Similarly, a second capsular area is defined by another portion of the posterior side104, another portion of the anterior side102, and another portion of the side wall106B. In other embodiments, the device100can comprise one, three, four, five, six, seven, eight, nine, or ten separate capsular areas.

Similarly, the device100can comprise one, two, three, four, five, six, seven, eight, nine, or ten sidewalls106, each of which extend from only a portion of the circumference of the posterior side104and/or refractive surface110. In some embodiments, one or more sidewalls106of the device100can extend from about 120° of the circumference of the posterior side104and/or refractive surface110. In other embodiments, one or more sidewalls106of the device100can extend from about 15°, about 30°, about 45°, about 60°, about 75°, about 90°, about 105°, about 135°, about 150°, about 165°, about 180°, about 195°, about 210°, about 225°, about 240°, about 255°, about 270°, about 285°, about 300°, about 315°, about 330°, about 345°, and/or about 360° of the circumference of the posterior side104and/or refractive surface110. In certain embodiments, one or more sidewalls106of the device100can extend from a portion of the circumference of the posterior side104and/or refractive surface within a circumferential range defined by two of the aforementioned values.

In some embodiments, the one or more sidewalls106can comprise a concave shape. For example, an interior surface of the one or more sidewalls106and/or interior surface of the refractive surface110or posterior side104can form a cavity108. The cavity can be configured to hold an IOL, for example.

In some embodiments, the device100comprises one or more haptics112. The one or more haptics112can be made of a rigid or semi-rigid material, such as polyimide, PMMA, polypropylene, and nylon. The one or more haptics112can also or alternatively be made of a biocompatible material, such as silicone, silicone polymers, SIBS (poly(styrene-block-isobutylene-block-styrene)), acrylic, acrylic polymers, polypropylene, polycarbonate, and Gore-Tex. One or more haptics112of the device100can provide a place for surrounding epithelial cells to grow and latch on to provide support for the device100within the natural capsular bag.

In the illustrated embodiment, the device100comprises two haptics112, made of polyimide for example. In other embodiments, the device100can comprise one, three, four, five, six, seven, eight, nine, or ten haptics112. Further, in the illustrated embodiment, the one or more haptics112comprise the general shape of an outer periphery of a rectangular or substantially rectangular shape, which can be attached to the anterior side of a sidewall extension. As shown, the one or more haptics112can be positioned close and/or generally parallel to the posterior side102of the device100and do not extend radially outward of the device100. This can present advantages during surgical implantation as radially extending haptics can potentially get hung up on the iris and/or anterior portion of the natural capsular bag, which can present complications during surgical implantation. In other embodiments, one or more haptics112can comprise a different shape while being positioned close to and/or generally parallel to the posterior side102and/or anterior side104of the device100, such as circular, elliptical, round, square, triangular, or the like.

In some embodiments, a portion of a haptic112can be over-molded into the device100for maintaining the position of the haptic112and not exposing that portion of the haptic112. Another portion of the haptic112can be exposed to the underside of the anterior natural capsular bag. For example, a peripheral portion of the haptic can be over-molded while the central portion is exposed. The portion of the device100, for example made of silicone, underneath the central portion of the haptic112can be indented or recessed in some embodiments. As such, fibrotic bands can be formed over time to act as an anchor point and hold the whole device100in place, for example if a Yag capsulotomy is to be performed. More specifically, epithelial cells coating the anterior and/or posterior natural capsular bag can replicate and grow into the recessed area of the silicone device100underneath the haptic112and grow around the haptic112.

In certain embodiments, one or more haptics112of the device100can comprise a “monkey bar” type configuration. More specifically, a portion of the device100, for example a portion of a sidewall, can be recessed and/or indented. A haptic can extend across the recessed or indented portion. For example, one end of the haptic can be over-molded by silicone or other material of the device100at one end of the recessed or indented portion and the other end of the haptic can be over-molded by silicone or other material of the device100at the other end of the recessed or indented portion. As such, a haptic, for example made of polyimide, can be formed without radially extending out of the exterior surface of the device100while having void space all around the haptic. This can provide strands of exposed haptic or polyimide in some embodiments, while the haptic is stabilized as part of the overall device. Epithelial cells can grow around the haptic and latch on to provide lateral support along the monkey bar-type portion. One or more such haptics can be provided on each side of the device100in a symmetric manner.

In some embodiments, the device100comprises a single-molded design. In other words, the whole device100, or substantially the whole device100other than the lens or refractive surface110and/or one or more haptics112, can be molded from a single piece of material. For example, in some embodiments, substantially the whole device100can be molded of silicone using a silicone compression mold. In certain embodiments, one or more haptics112, made of polyimide for example, are placed in the mold before silicone or other material of the device100is poured into the mold and compressed. In other embodiments, the device100or any portion thereof can be manufactured by 3D laser cutting, two photon lithography, additive manufacturing, 3D printing, compression molding, and/or any combination of the aforementioned manufacturing processes or others.

FIG. 1Cillustrates a posterior side perspective view of the example prosthetic capsular device ofFIG. 1A.FIG. 1Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 1A.

The device100optionally comprises one or more posterior fins114. The device100shown includes two posterior fins114A,114B. The posterior fins114can be aligned along a diameter of the refractive surface110. In some implementations, a plurality of posterior fins114(e.g., 2, 3, 4, 5, 6, or more fins124) may be circumferentially offset (e.g., by about 180°, by about 120°, by about 90°, by about 72°, by about 60°, and the like). In some implementations, at least some or all of a plurality of posterior fins114(e.g., 2, 3, 4, 5, 6, or more fins114) may be unaligned.

In the illustrated embodiment, a line between the two posterior fins114forms an angle with a major axis of the device100. For example, the angle between a line connecting the posterior fins114and a major axis of the device100can be about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°, about 110°, about 120°, about 130°, about 140°, about 150°, about 160°, about 170°, about 180°, and/or within a range between two of the aforementioned values. In certain embodiments, the posterior fins114are aligned along a major axis of the device100. In other implementations, the posterior fins114may be aligned along a minor axis of the device100.

The posterior fin114may comprise the same material as the device100or a different material than the device100. The posterior fin114may help to space a posterior surface of a natural capsular bag from the posterior end104of the device100radially outward of the refractive surface110. Spacing the posterior surface of the natural capsular bag from the posterior end104of the device100radially outward of the refractive surface110may allow fluid to flow radially outward of the refractive surface110, which may help to reduce opacification. Spacing the posterior surface of the natural capsular bag from the posterior end104of the device100radially outward of the refractive surface110may reduce the chance of retaining viscoelastic that has some residual trapped fibrin or inflammatory precipitate contained within it. In some embodiments, the posterior fin114may extend anterior from the posterior of the device100into the cavity of the device100. In some embodiments, the posterior fin comprises a roughened or opacified interior and/or exterior surface of the device100(e.g., having the same thickness and material as the posterior wall radially outward of the refractive surface110but treated to provide an alignment mark).

The device100can be strategically aligned in an eye with use of the fins114. For example, if an eye has astigmatism, a device100in which the refractive surface110comprises a toric lens can be used to at least partially correct the astigmatism if the device100is properly oriented (e.g., with the steep axis of a cornea). In some implementations, at least one of the fins114can be different (e.g., different shape, dimensions, etc.) to indicate a top or bottom of the device100. In devices allowing any rotational orientation of an IOL inserted therein, a toric IOL can be rotated. Aligning the device100for alignment of a toric refractive surface110and/or a toric IOL contained in the device100can advantageously provide the advantages of limited IOL rotation, reduced volume, and astigmatism correction. For example, the optic haptic junction of a secondary IOL can be aligned or otherwise correlated with one or more fins114and allow a surgeon to align the device100in an optimal position for a secondary toric IOL to be placed. In some embodiments, the one or more fins114extending radially posterior or outward of the posterior of the device100can still be visualized from the interior of the refractive surface110to facilitate alignment of a secondary IOL or device, for example due to the transparent and/or semi-transparent nature of the posterior of the device100. In other embodiments, the one or more fins114extend radially anterior or inward of the posterior of the device100such that it the fins114are viewable for facilitating alignment of a secondary IOL or device.

FIG. 1Eillustrates an anterior plan view of the example prosthetic capsular device ofFIG. 1A.FIG. 1Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 1Aalong the line1F-1F ofFIG. 1E.FIG. 1Gillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 1Aalong the line1G-1G ofFIG. 1E.

In the illustrated embodiment, the device100comprises a refractive surface110with a diameter of about 5.5 mm. In other embodiments, the device100can comprise a refractive surface110with a diameter of about 5.0 mm. The refractive surface110110may have a diameter between about 4 mm and about 9 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, ranges between such values, etc.).

In such embodiments, the device100can be configured to be inserted through a small incision of about 2.2 mm or about 2.4 mm. In certain embodiments, the device100can be inserted through an incision between about 1.5 mm and about 3 mm (e.g., about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, ranges between such values, etc.).

Further, in the illustrated embodiment, a length of a major axis of the device100or a length measured from the outermost end of one sidewall106A to the outermost end of another sidewall106B along a major axis of the device100can be about 10.00 mm. In other embodiments, the length of the major axis of the device100can be about 5.00 mm, about 6.00 mm, about 7.00 mm, about 8.00 mm, about 9.00 mm, about 10.00 mm, about 11.00 mm, about 12.00 mm, about 13.00 mm, about 14.00 mm, about 15.00 mm, and/or within a range defined by two of the aforementioned values.

Furthermore, in the illustrated embodiment, a length of a minor axis of the device100or a length measured from one end of a sidewall106to the other end of the same sidewall106along a minor axis of the device100can be about 6.57 mm. In other embodiments, the length of a minor axis of the device100can be about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm, about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, and/or within a range defined by two of the aforementioned values.

As illustrated inFIG. 1G, in some embodiments, a thickness of a haptic112, made from polyimide for example, can be about 0.13 mm. In other embodiments, the thickness of the haptic112can be about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.10 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.20 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, a length of the haptic112across the cross section formed by line1G-1G or along a major axis of the device100can be about 1.4 mm. In other embodiments, a length of the haptic as seen in a cross section along a major axis of the device100can be about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.10 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.20 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the thickness of silicone or other material of the device100can be about 0.2 mm. In certain embodiments, the thickness of silicone or other material of the device100can be about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the thickness of the silicone or other material of the device100varies depending on the portion of the device100. In other words, some portions of the device100can be made of thinner materials while other portions of the device100can be made of thicker materials. For example, certain portions of the device that provide support to the anterior portion of the device100may be made with thicker materials for added support.

In some embodiments, a thickness of silicone or other material of the device100molded over the haptic112can be about 0.01 mm, about 0.02 mm, about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.10 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, the width of an opening of the cavity formed by each end of the two sidewalls106can be about 5.82 mm. In some embodiments, the width of the opening of the cavity formed by each end of the two sidewalls can be about 4.0 mm, about 4.2 mm, about 4.4 mm, about 4.6 mm, about 4.8 mm, about 5.0 mm, about 5.2 mm, about 5.4 mm, about 5.6 mm, about 5.8 mm, about 6.0 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7.0 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8.0 mm, and/or within a range defined by two of the aforementioned values.

Also, the height of the cavity as measured from a midpoint of the posterior refractive surface110to the top of the sidewall106opening can be about 3.21 mm in some embodiments. In certain embodiments, the height of the cavity as measured from a midpoint of the posterior refractive surface110to the top of the sidewall106opening can be about 2.0 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, 3.0 mm, 3.2 mm, 3.4 mm, 3.6 mm, 3.8 mm, 4.0 mm, 4.2 mm, 4.4 mm, 4.6 mm, 4.8 mm, 5.0 mm, and/or within a range defined by two of the aforementioned values.

FIG. 2Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 2Billustrates another anterior side perspective view of the example prosthetic capsular device ofFIG. 2A. The prosthetic capsular device ofFIG. 2Aincludes some or all of the features of the prosthetic capsular device ofFIG. 1A, and like reference numerals include like features. In particular, in some embodiments, the prosthetic capsular device ofFIG. 2Acan be similar to the prosthetic capsular device ofFIG. 1A, except for the configuration of the haptics202. All other features of the device200or haptics202, such as material, flexibility, function, or the like, can be similar to such features of the device100or haptics112described above in relation toFIGS. 1A-1G.

In some embodiments, the device200does not comprise haptics with a license plate or rectangular configuration as inFIGS. 1A-1G. Rather, the device200can comprise one or more haptics that connect the sidewalls106and expand radially to form a generally circular shape. For example, in the illustrated embodiment, one end of a haptic202A can be anchored or over-molded on one sidewall106A and the other end of the same haptic202A can be anchored or over-molded on another sidewall106B. Similarly, one end of a second haptic202B can be anchored or over-molded on one sidewall106A and the other end of the same haptic202B can be anchored or over-molded on another sidewall106B. The haptic202can form a radially outward shape or a substantially outwardly circular shape or loop. The haptic202202can extend radially outward from a cavity between two or more sidewalls106A,106B. Such configuration of the haptic202can provide for stability of the device200within the natural capsular bag.

FIG. 2Cillustrates a posterior side perspective view of the example prosthetic capsular device ofFIG. 2A.FIG. 2Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 2A.FIG. 2Eillustrates an anterior plan view of the example prosthetic capsular device ofFIG. 2A.FIG. 2Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 2Aalong the line2F-2F ofFIG. 2E.FIG. 2Gillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 2Aalong the line2G-2G ofFIG. 2E.

As shown inFIG. 2E, in some embodiments, an outer or under certain circumstances maximum diameter of the device200, for example accounting for extension of the haptics202, may be about 10 mm. In certain embodiments, the outer or maximum diameter of the device200can be about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, and/or within a range defined by two of the aforementioned values.

As shown inFIG. 2F, in some embodiments, an outer or under certain circumstances maximum thickness of the device200, for example accounting for the thickness of the refractive surface110, may be about 3.65 mm. In certain embodiments, the outer or maximum thickness of the device200can be about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4.0 mm, about 4.1 mm, and/or within a range defined by two of the aforementioned values.

FIG. 3Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 3Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 3A.FIG. 3Cillustrates a side plan view of the example prosthetic capsular device ofFIG. 3A.FIG. 3Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 3Aalong the line3D-3D ofFIG. 3B.

The prosthetic capsular device ofFIG. 3Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A and/or 2A, and like reference numerals include like features. In particular, in some embodiments, the prosthetic capsular device ofFIG. 3Acan be similar to the prosthetic capsular devices ofFIGS. 1A and/or 2A, except for the haptics112,202and sidewalls302.

More specifically, in the illustrated embodiment, the device300does not comprise any haptics, such as haptics112,202described above in relation toFIGS. 1A and 2A. In other embodiments, the device300can comprise one or more haptics112,202described above in relation toFIGS. 1A and 2A.

Further, in certain embodiments, one or more sidewalls302of the device300can extend from only about 90° of the circumference of the posterior side104and/or refractive surface110. In other words, a single capsular area defined by a portion of the anterior side102, a portion of the posterior side104, and a sidewall302A,302B, can cover about 90° of the circumference of the device300.

The sidewalls302can include any and all other features of sidewalls106described above in relation toFIGS. 1A-1G. In some embodiments, all of the sidewalls302A,302B each extend from a substantially equal portion of the circumference of the posterior side104and/or refractive surface110, for example each at about 90°. In other embodiments, some of the sidewalls302can extend from different amounts of portions of the circumference of the posterior side104and/or refractive surface110. For example, one of a plurality of sidewalls302can extend from about 45° while another of the plurality of sidewalls302extends from about 90° of the circumference of the posterior side104and/or refractive surface110.

In some embodiments, a single device300can be configured to be implanted into the eye with or without a second lens being placed inside the cavity108. In certain embodiments, two devices300are configured to be coupled together prior to and/or during surgical implantation. More specifically, a first device300can be coupled with a second device300that is placed upside down to form a lens assembly with itself. In certain patients, this combination of lenses may move relative to one another creating a variable effective power of the lens system, enhancing the range of vision provided. A lens may be placed inside the empty cavity formed by the two devices300.

FIG. 4Aillustrates an anterior side perspective view of two (2) example prosthetic capsular devices ofFIG. 3Acoupled together.FIG. 4Billustrates a posterior side perspective view of two (2) example prosthetic capsular devices ofFIG. 3Acoupled together.FIG. 4Cillustrates an anterior plan view of two (2) example prosthetic capsular devices ofFIG. 3Acoupled together.FIG. 4Dillustrates a side plan view of two (2) example prosthetic capsular devices ofFIG. 3Acoupled together.FIG. 4Eillustrates a cross-sectional view along the line4E-4E ofFIG. 4Cof two (2) example prosthetic capsular devices ofFIG. 3Acoupled together.

In some embodiments, one device300can be coupled with another device300to form a closed cavity108inside an assembly400the two devices300. To do so, one device300can coupled with another device300that is placed upside down. In certain embodiments, each device300can comprise two sidewalls that each extend from roughly 90° of the circumference of the posterior side104and/or refractive surface110. As such, when coupled together, sidewalls of the two devices300can, in combination, form a sidewall that substantially covers all 360°.

In certain embodiments, a gap may be present between the end of a sidewall302of one device300and the refractive surface110of a second device300. Instead of forming a complete seal, a gap between the two devices300when coupled together to form an assembly400can be advantageous to allow for fluid to pass to and from the cavity.

In some embodiments, this gap between the two devices300when coupled to form an assembly400(or more specifically, the gap between an end of a sidewall302of a first device300and the refractive surface110of a second device300when the first device300and second device300are coupled together) can be about 0.25 mm. In certain embodiments, this gap can be about 0.05 mm, about 0.10 mm, about 0.15 mm, about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, and/or within a range defined by two of the aforementioned values. The precise thickness of the gap can depend on the shape and/or volume of the natural capsular bag in some embodiments.

In certain embodiments, one device300is implanted into the eye first, followed by optional implantation and positioning of a refractive lens inside the cavity108, and then the second device300is implanted into the eye to form a closure of the assembly400. In some embodiments, the two devices300are coupled together first before implantation into the eye.

FIG. 5Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 5Billustrates a posterior side perspective view of the example prosthetic capsular device ofFIG. 5A. The prosthetic capsular device ofFIG. 5Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A-4A, and like reference numerals include like features.

More specifically, in some embodiments, the device500can comprise one or more sidewalls302which can include some or all of the features of the sidewalls302of device300. For example, in certain embodiments, one or more sidewalls302of the device500can extend from only about 90° of the circumference of the posterior side104and/or refractive surface110. The sidewalls302can also include any and all other features of sidewalls106described above in relation toFIGS. 1A-4A.

Similarly, the device500can comprise one or more haptics502which can include some or all of the features of the haptics202of device200. For example, one or more haptics502of the device500can connect two sidewalls302A,302B. Moreover, one or both ends of a haptic502can be anchored or over-molded on a sidewall302A,302B of the device500.

FIG. 5Cillustrates an anterior plan view of the example prosthetic capsular device ofFIG. 5A.FIG. 5Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 5A.FIG. 5Eillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 5Aalong the line5E-5E ofFIG. 5C.FIG. 5Fillustrates another side plan view of the example prosthetic capsular device ofFIG. 5A.FIG. 5Gillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 5Aalong the line5G-5G ofFIG. 5F.

In certain embodiments, only one end of a haptic502is anchored or over-molded on a sidewall302A,302B of the device500. For example, in the embodiment illustrated inFIG. 5A, one of a haptic502A can be over-molded onto a sidewall302A, while the other end of the haptic502A is not molded or rigidly anchored to the other sidewall302B. Likewise, only one end of haptic502B can be molded or rigidly anchored to the same sidewall302A that haptic502A is anchored to, while the other end of the haptic502B is not rigidly anchored to the other sidewall302B. The other end of the haptic502B can be configured to be tucked into the interior of the other sidewall302B similar to a safety-pin-like configuration.

In some embodiments, the device500comprises a ridge504on one or more sidewalls302A,302B for receiving and/or embedding the haptics502without rigidly anchoring the haptic502. For example, in certain embodiments, only one of two sidewalls302B comprises said ridge504. The other sidewall302A does not comprise a ridge504in some embodiments. Within the ridge504, the haptics502A,502B can be free to move along the ridge504. For example, the end of a haptic502can be allowed to move up and down along the length of the ridge504as the exposed portion of the haptic502is compressed or allowed to expand.

In certain embodiments, a device500that comprises a ridge504on only one of two sidewalls302B can be configured to be injected into the eye in a general direction from the other sidewall302A without a ridge towards the sidewall302B with the ridge504. Insertion into the eye in this general direction will allow the exposed portion of the haptics502to compress more closely towards the refractive surface110as the ends of the haptics502will be allowed to move more into the ridge504.

Once implanted within the eye, the device500can be allowed to unfold naturally. The haptics502can be allowed to naturally decompress as well, moving the ends of the haptics502more towards the openings of the ridge504. Accordingly, the device500can comprise radially extending haptics502to maintain the shape and/or size of the natural capsular bag without the ends thereof adding complications to the surgical procedure. In some embodiments, when in an expanded or relaxed state, the outermost perimeter or portion of the sidewalls302A,302B and the haptics502A,502B can form a perfect or substantially perfect circle with a constant radius or diameter. For example, in some embodiments, an outer or maximum diameter of the device500, accounting for the haptics502, may be about 10 mm. In certain embodiments, the outer or maximum diameter of the device500can be about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, because portions of the haptics502can be squeezed and/or hidden during the surgical implantation, the device500can be injected in a manner substantially similar to those used for devices without such radially extending haptics, such as the device100illustrated inFIG. 1A. At the same time, because the haptics502are allowed to radially expand once the device500is implanted, the haptics502, made of polyimide for example, can provide sufficient points of attachment for epithelial cells to anchor the device500.

FIG. 6Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 6Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 6A.FIG. 6Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 6Aalong the line6C-6C ofFIG. 6B.FIG. 6Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 6Aalong the line6D-6D ofFIG. 6B.

The prosthetic capsular device600ofFIG. 6Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A-5A, and like reference numerals include like features. In particular, the prosthetic capsular device600ofFIG. 6Acan be similar to the prosthetic capsular devices ofFIGS. 1A and 2A, except for the haptics112,202and/or other additional features.

More specifically, the device600can comprise one or more haptics602that extend radially outward from and to a single or same sidewall106. For example, one end of a haptic602can be over-molded or otherwise be anchored to a portion of one sidewall106, and the other end of the same haptic602can be over-molded or otherwise be anchored to another portion of the same sidewall106, the portion of the haptic602in between the two ends forming a loop extending out of the sidewall106. Each of the haptics602can form a closed loop. As a result, epithelial cells can be promoted to grow around the haptics602to substantially affix the device600within the eye.

In certain embodiments, one or more haptics602can be made of Gore-Tex or other soft material, and the rest of the device600can be made of silicone. The whole device600can be made exclusively of soft material in some embodiments, which can resolve concerns with implanting sharp or rigid materials. Also, cellular ingrowth can be facilitated, for example due to Gore-Tex's high biocompatibility in some embodiments. Accordingly, in some embodiments, a haptic comprises a single Gore-Tex string or tether, for example extending in a loop-like configuration out of a sidewall. Such Gore-Tex string or tether can provide a natural place for a fibrotic anchor to attach and also prevent the device600from slipping. As such, in certain embodiments, the natural capsular bag can be maintained in an open position due to the structural integrity of the device600and the Gore-Tex without need of a sharp or rigid material such as polyimide.

The device600can comprise a major axis, for example from a horizontal outermost portion of one haptic602A to a horizontal outermost portion of another haptic602B. The distance between horizontal outermost portions of the two haptics602A,602B can be about 11.15 mm in some embodiments. In other embodiments, the distance between horizontal outermost portions of the two haptics602A,602B can be about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, and/or within a range defined by two of the aforementioned values.

The device600can comprise a minor axis, for example from a vertical outermost portion of one haptic602A,602B to a vertical outermost portion of the same haptic602A,602B. The distance between vertical outermost portions of a single haptics602A,602B can be about 7.95 mm in some embodiments. In other embodiments, the distance between vertical outermost portions of a single haptic602A,602B can be about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 13 mm, about 14mm, about 15 mm, and/or within a range defined by two of the aforementioned values. The device600can also comprise one or more notches604. For example, in the illustrated embodiment, each capsular area comprises a notch604A,604B along the interior of each capsular area or sidewall106A,106B. The notch604can comprise one or more recessed areas or slots for insertion of one or more additional devices. For example, in some embodiments, the notch604can comprise one or more slots configured for insertion of a secondary IOL, an electronic device, and/or haptics of the secondary IOL electronic device or other secondary device. By providing a slot or recessed area, a secondary device can be inserted into the device600at a precise location within the device600and be stabilized at that location by preventing movement of the secondary device laterally, anteriorly and/or posteriorly within the device600. For example, a secondary IOL can be inserted into the device600such that a distance between the secondary IOL and the refractive surface110is known and/or predetermined. Accordingly, one can determine an optimal or particular power of a secondary IOL based on the known refractive power of the refractive surface110and the known distance between the secondary IOL and the refractive surface110. One or more functional aspects of an electronic device to be inserted into the device600may also depend on the particular location of the electronic device within the device600and/or particular distance from the refractive surface110, which can be predetermined and/or controlled utilizing the one or more notches604.

The device600can comprise a plurality of notches or slots604on the interior surface of each capsular area or sidewall106A,106B. Referring to the cross-section view along line6D-6D as illustrated inFIG. 6Dfor example, a plurality of vertical notches or slots604can be formed generally parallel to one another. In other words, in addition to the vertical notch or slot604shown inFIG. 6D, one or more additional vertical notches or slots can be provided to the left and/or right of the illustrated notch or slot604. This can allow for one or more secondary IOLs, electronic devices, or other devices to be inserted into the device600at varying locations or distances from the refractive surface110. By doing so, one can control the particular location of insertion of a secondary device in the device600by selecting one of the plurality of notches or slots to hold the secondary device. In other words, the secondary device can be adjusted anteriorly and/or posteriorly within the device600when being inserted.

In some embodiments, a width of a notch or slot604can be about 0.142 mm wide. In certain embodiments, the width of a notch or slot604can be about 0.05 mm, about 0.1 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.2 mm, about 0.21 mm, about 0.22 mm, about 0.23 mm, about 0.24 mm, about 0.25 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, a length of a notch or slot604can be about 3.77 mm. In certain embodiments, the length of a notch or slot604can be about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, and/or within a range defined by two of the aforementioned values.

The sidewalls106A,106B when viewed in the direction illustrated inFIG. 6Ccan be separated by about 42° in some embodiments. In certain embodiments, the angle formed between the sidewalls106A,106B when viewed in the direction illustrated inFIG. 6Ccan be about 36°, about 37°, about 38°, about 39°, about 40°, about 41°, about 42°, about 43°, about 44°, about 45°, about 46°, about 47°, and/or within a range defined by two of the aforementioned values.

FIG. 7Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 7Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 7A.FIG. 7Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 7Aalong the line7C-7C ofFIG. 7B.FIG. 7Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 7Aalong the line7D-7D ofFIG. 7B.

The prosthetic capsular device700ofFIG. 7Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A-6A, and like reference numerals include like features. In particular, the prosthetic capsular device700ofFIG. 7Acan be similar to the prosthetic capsular device ofFIGS. 1A, 2A, and 6A, except for the haptics112,202,602.

As with device600ofFIG. 6A, the device700can comprise one or more haptics702that extend radially outward from and to a single or same sidewall106. However, unlike the device600ofFIG. 6A, each sidewall106of the device700can comprise more than one such haptics702. For example, in the illustrated embodiment, each sidewall106or capsular area comprises two haptics702in a closed loop configuration. By having more than one haptics extending from each sidewall106or capsular area, epithelial cells can attach to the more than one haptics and prevent or substantially prevent the device700from sliding into a disadvantageous position, which may be a higher risk for the device600ofFIG. 6A.

More specifically, a sidewall106A can comprise a first haptic702A that extends radially outward from one end of the sidewall106A towards a center of the sidewall. The same sidewall106A can also comprise a second haptic702B that extends radially outward from another end of the sidewall106A towards the center of the sidewall. Similarly, a second sidewall106B can comprise a third haptic702C that extends radially outward from one end of the sidewall106B towards a center of the sidewall. The sidewall106B can also comprise a fourth haptic702D that extends radially outward from another end of the sidewall106B towards the center of the sidewall. In other embodiments, a single sidewall106can comprise three, four, five, six, seven, eight, nine, or ten haptics702. Any one or more feature of the haptics702, such as material, flexibility, rigidity, attachment to the device700, or the like, can be similar to the haptics602of the device600inFIG. 6A.

When viewed in the direction illustrated inFIG. 7B, a distance between a bottom end of one haptic702A,702D and a top end of another haptic702B,702C can be about 1 mm. In certain embodiments, the distance between a bottom end of one haptic702A,702D and a top end of another haptic702B,702C when viewed in the direction illustrated inFIG. 7Bcan about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, and/or within a range defined by two of the aforementioned values.

FIG. 8Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 8Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 8A.FIG. 8Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 8Aalong the line8C-8C ofFIG. 8B.FIG. 8Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 8Aalong the line8D-8D ofFIG. 8B.

The prosthetic capsular device800ofFIG. 8Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A-7A, and like reference numerals include like features. In particular, the prosthetic capsular device800ofFIG. 8Acan be similar to the prosthetic capsular device ofFIG. 2A, except for the haptics202and shape or configuration of the one or more sidewalls106.

More specifically, the one or more sidewalls802of the device800can be larger than those of the device200ofFIG. 2A. For example, the one or more sidewalls802can extend vertically upwards and/or downwards when viewed in an anterior side plan view as illustrated inFIG. 8B. As a result, the curvature of the outer periphery of the one or more sidewalls802can be larger than sidewalls106of the device200ofFIG. 2Afor example. The general shape of the outer periphery of the device800can be substantially circular when viewed from an anterior or posterior plan view, compared to the lenticular shape of some of the other devices described above in relation toFIG. 1Afor example.

Similar to sidewalls106A,106B illustrated in other embodiments, the sidewalls802A,802B, when viewed in the direction illustrated inFIG. 8Ccan be separated by about 41° in some embodiments. In certain embodiments, the angle formed between the sidewalls802A,802B, when viewed in the direction illustrated inFIG. 8C, can be about 36°, about 37°, about 38°, about 39°, about 40°, about 41°, about 42°, about 43°, about 44°, about 45°, about 46°, about 47°, about 48°, about 49°, about 50°, and/or within a range defined by two of the aforementioned values.

In some embodiments, a substantially circular outermost periphery of the device800can comprise a diameter of about 9.68 mm. In certain embodiments, the outermost periphery of the device800can comprise a substantially circular shape with a diameter of about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm, and/or within a range defined by two of the aforementioned values.

In addition, due to the larger curvature of the one or more sidewalls802, the one or more haptics804can comprise an arc of a substantially circular configuration from one end to the other end. In contrast, the one or more haptics202of the device200ofFIG. 2Acan comprise different curvatures along the haptic202. More specifically, the curvature of the haptic202can be relatively flat on one or both ends of the haptic202located inside or behind a sidewall106or capsular area compared to the curvature of the central portion of the haptic202.

Similar to the device500ofFIG. 5A, the one or more haptics804can be over-molded or otherwise anchored to only one sidewall. For example, in the illustrated embodiment, a first end of the haptics804A,804B can be over-molded or otherwise anchored to one sidewall802B. A second end of the haptics804A,804B can be configured to be tucked into the interior of the other sidewall802A without being rigidly anchored to the sidewall802A. As such, the second end of the haptics804A,804B can be inserted freely more or less into the other sidewall802A as the exposed central portion of the haptics804A,804B is compressed or allowed to expand.

Also similar to the device500ofFIG. 5A, the device800can be configured to be injected into the eye in a general direction from the sidewall802B to which the haptics804is anchored towards the other sidewall802B to which the haptics804is configured to be tucked into. Insertion into the eye in this general direction will allow the exposed portion of the haptics804to compress more closely towards the refractive surface110during insertion.

Once implanted within the eye, the device800can be allowed to unfold naturally, allowing the haptics804to naturally decompress. Because portions of the haptics804can be squeezed and/or hidden during the surgical implantation, the device500can be injected in a manner substantially similar to those used for devices without such radially extending haptics, such as the device100illustrated inFIG. 1A. At the same time, because the haptics804are allowed to radially expand once the device800is implanted, the haptics804, made of polyimide for example, can provide sufficient points of attachment for epithelial cells to anchor the device800. Any one or more other feature of the haptics804, such as material, flexibility, rigidity or the like, can be similar to the haptics602of the device600inFIG. 6A.

FIG. 9Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 9Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 9A.FIG. 9Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 9Aalong the line9C-9C ofFIG. 9B.FIG. 9Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 9Aalong the line9D-9D ofFIG. 9B.

The prosthetic capsular device900ofFIG. 9Aincludes some or all of the features of the prosthetic capsular devices ofFIGS. 1A-8A, and like reference numerals include like features. In particular, the prosthetic capsular device900ofFIG. 9Acan be similar to the prosthetic capsular device ofFIG. 8A, except for the haptics804. More specifically, the haptics902of the device900can comprise a substantially vertical arm that extends radially inward towards the refractive surface110from a midpoint or a portion in between the two ends of the haptics902that is exposed. A first end of the vertical arm can be connected to the exposed portion of the haptics902, while a second end of the vertical arm can be connected to one or more holes or openings904.

The one or more holes or openings904can allow a surgical instrument, such as a Sinskey Hook, a Lester Hook or the like, to hook on and engage the device900. For example, a surgical instrument can be coupled to one or more holes904to adjust the positioning of the device900in the eye. This can be advantageous during surgery because of the limited visual field, which can be for example about 5-6 mm. By coupling a surgical instrument to the one or more holes904, the positioning of the device900can be adjusted so that it is viewable without risking damaging or tearing the capsule. Any other one or more features of the device900and/or haptics902, such as size, material, flexibility, rigidity, attachment to the device900or the like, can be similar to the device800and/or haptics804of the device800inFIG. 8A.

FIG. 10Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 10Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 10A.FIG. 10Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 10Aalong the line10C-10C ofFIG. 10B.FIG. 10Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 10A. The prosthetic capsular device1000ofFIG. 10Aincludes some or all of the features of the prosthetic capsular devices ofFIG. 1A-9A, and like reference numerals include like features.

Unlike some of the devices ofFIGS. 1A-9A, the device1000can comprise a sidewall1002that covers substantially or almost the entire side circumference of the device1000. The sidewall1000can continuously cover almost the entire side of the device1000except for a small opening or gap1010. In the illustrated embodiment, the small opening or gap1010can comprise a width of about 1.00 mm. In other embodiments, this gap1010in the sidewall1002can be about 0.50 mm, about 1.50 mm, about 2.00 mm, about 2.50 mm, about 3.00 mm, about 3.50 mm, about 4.00 mm, about 4.50 mm, about 5.00 mm, and/or within a range defined by two of the aforementioned values. One or more other features of the sidewall, such as material, flexibility, rigidity, or the like can be similar to those of one or more devices ofFIGS. 1A-9A. In other embodiments, the sidewall1002may not comprise a gap1010. For example, additional portions of silicone may extend over the gap1010in the illustrated embodiment.

The device1000can comprise a capsular tension ring1004coupled to the sidewall. For example, the capsular tension ring1004can be over-molded into the sidewall1002. The capsular tension ring1004can comprise a rigid or semi-rigid material, such as polyimide, PMMA, polypropylene, and/or nylon. The capsular tension ring1004can provide rigidity and maintain the structure and/or position of the device1000inside the eye after implantation. The capsular tension ring1004can generally follow the shape of the circumference of the sidewall1002as in the illustrated embodiment. Each end of the capsular tension ring1004can extend from each end of the sidewall1002where the gap1010in the sidewall1002is present. Each or one end of the capsular tension ring1004can comprise an opening or a hole1008, similar to the holes904in the device900ofFIG. 9Aand be used in a similar manner to position the device1000after implantation in the eye.

The device1000can comprise one or more recessed areas1006along the exterior of the sidewall1002. The one or more recessed areas can expose portions of the capsular tension ring1004. The exposed portions of the capsular tension ring1004can provide areas for epithelial cells to attach to. Accordingly, with the attachment or growth of epithelial cells around the exposed capsular tension ring1004, the device1000can be substantially fixed and stabilized in a particular position within the eye. The recessed areas1006can also be used to suture the device as necessary. In the illustrated embodiment, the device1000or exterior sidewall1002thereof comprises seven recessed areas1006. In other embodiments, the device1000can comprise one, two, three, four, five, six, eight, nine, or ten recessed areas1006. The number of recessed areas1006in the device1000can also be between a range defined two of the aforementioned values.

As illustrated in the view ofFIG. 10B, the length of each recessed area1006along the circumference of the sidewall1002or the length of each exposed portion1006of the capsular tension ring1004can be about 1.00 mm. In certain embodiments, the length of each recessed area1006along the circumference of the sidewall1002or the length of each exposed portion1006of the capsular tension ring1004can be about 0.50 mm, about 1.50 mm, about 2.00 mm, about 2.50 mm, about 3.00 mm, about 3.50 mm, about 4.00 mm, about 4.50 mm, about 5.00 mm, and/or within a range defined by two of the aforementioned values.

As illustrated in the view ofFIG. 10D, the width of each recessed area1006, when viewed from a side plan view, can be about 0.49 mm. In certain embodiments, the width of each recessed area1006, when viewed from a side plan view, can be about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, about 0.70 mm and/or within a range defined by two of the aforementioned values.

The refractive surface110can be connected to the sidewall1002at only a portion of the sidewall. For example, in the illustrated embodiment, the refractive surface100comprises a hinge portion1010which is connected to the sidewall1002. A gap1012can exist between all other portions of the refractive surface110other than the hinge portion1010and the sidewall1002. As such, the entire device1000can comprise a single piece, rather than a multi-piece assembly. Alternatively, in other embodiments, the device1000can be a multi-piece assembly comprising multiple pieces that are coupled together after the initial manufacturing.

The sidewall1002and the capsular tension ring1004can be configured to be twisted without breaking. Also, the sidewall1002can be foldable or capable of being rolled into a more compact configuration. The refractive surface1010and the hinge portion1010can also be foldable or capable of being rolled into a more compact configuration.

As discussed above, one advantage of removing portions of the sidewall, for example in the device100ofFIG. 1A, can be to allow the device to be folded or rolled in a more compact configuration for insertion through a small incision during surgery. Even though the device1000ofFIG. 10Acomprises a near continuous sidewall, it can still be configured to be inserted through a small incision, for example no larger than required for insertion of the device100ofFIG. 1A, without removing portions of the sidewall1002, due to the structure and method of insertion as described herein.

More specifically, instead of squeezing the device1000for insertion, the device1000or the sidewall1002and/or capsular tension ring1004of the device1000can be inserted into the eye in a rotational fashion segment by segment through a standard injector. For example, the sidewall1002can be folded or rolled around the length of the capsular tension ring1004into a tube-like configuration. The sidewall1002and capsular tension ring1004can be optionally twisted or otherwise partially straightened. A portion of the sidewall1002and/or capsular tension ring1004can be fed into a small incision in the eye, advancing one portion at a time rotationally, for example as each portion is substantially straightened at the point of insertion, allowing the capsular tension ring1004to retain its memory and curl around upon insertion.

The end of the sidewall1002and capsular tension ring1004away from the hinge portion1010can be inserted first towards the other end where the hinge portion1010is attached to. Upon reaching the portion of the sidewall1002and capsular tension ring1004where the hinge portion1010is attached, the refractive surface110can be slid into the injector and into the eye in a linear fashion. In other words, the sidewall1002and capsular tension ring1004can be inserted through a small incision into the eye in a rotational manner first and the lens or refractive surface110can be subsequently inserted in a longitudinal manner.

Once completely inserted into the eye, the device1000can return to its substantially circular configuration. By doing so, the device1000can be inserted through a small incision, while maintaining the structural integrity necessary for the device1000to remain intact and centered in the eye for a substantial period of time.

The device1000can be configured to protect the entire capsule and preserve the entire capsular space. More specifically, all or substantially the entire the circular or substantially circular sidewall1002or outer circumference of the device1000can be configured to contact the natural capsular bag and maintain the general space of the natural capsular bag without collapsing in the vitreous. Also, the device1000eliminates any trail in the haptics, with the capsular tension ring1004embedded inside the device. The generally circular shape of the device1000can also follow the physiological shape of the capsule and preserve the volume of the capsule unlike certain devices that decrease the open volume inside after implantation. Also, the device and/or secondary lens to be placed inside the device1000may be freely rotated, which may not be possible with certain devices.

The refractive surface110can also comprise one or more tabs extending radially outward from the outer circumference of the refractive surface110. The one or more tabs can be configured to be placed or tucked underneath the sidewall1002after insertion to prevent the refractive surface110from being tilted over. The one or more tabs can comprise the same material as the sidewall1002, for example silicone.

Alternatively, the refractive surface110can be circumferentially surrounded by a flange of soft material, such as silicone. The width of the flange can be about 0.25 mm, about 0.50 mm, 0.75 mm, 1.00 mm, or between a range defined by two of the aforementioned values. The outer flange of the refractive surface110or some portion thereof can be configured to be tucked underneath the bottom of the sidewall1002upon insertion into the eye.

Both the refractive surface110and the flange can be made of the same material, such as silicone. In other embodiments, the refractive surface110can be acrylic while the flange can be made of silicone. Acrylic can provide a higher index of refraction while allowing the refractive surface110to be thinner than when made from silicone. Also, the optical properties and power of an acrylic lens or refractive surface110can be altered using one or more laser treatments, such as phase wrapping to alter the hydrophilicity or hydrophobicity of the acrylic and causing the lens to either swell and increase in power or shrink and decrease in power. The lens or refractive surface110can also be made from any other biocompatible and optically clear materials known in the art. The refractive surface110may have a refractive power between −35 D and +35 D.

FIG. 11Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 11Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 11A.FIG. 11Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line11C-11C ofFIG. 11B.FIG. 11Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line11D-11D ofFIG. 11B.

The prosthetic capsular device ofFIG. 11Aincludes some or all of the features of the prosthetic capsular device ofFIG. 1A-10A, and like reference numerals include like features. In particular, the prosthetic capsular device ofFIG. 11Acan be similar to the prosthetic capsular device ofFIG. 1AandFIG. 6A, except for the configuration of notches1104and/or sidewalls1106A,1106B. All or some other features of the device1100, notches1104, and/or sidewalls1106A,1106B, such as material, flexibility, function, or the like, can be similar to such features described above in relation toFIGS. 1A-10A.

More specifically, the device1100can comprise one or more notches1104along the interior of each capsular area or sidewall1106A,1106B, similar to notches604. A notch1104can comprise one or more recessed areas or slots to facilitate insertion of one or more additional devices, such as a secondary IOL, an electronic device, and/or a haptics thereof. Similar to the notch604and device600ofFIG. 6A, a secondary device can be inserted into the device1100at a precise location within the device1100and be stabilized at that location by insertion of the secondary device or a portion thereof into the notch1104. By doing so, a secondary device can be prevented from moving laterally, anteriorly and/or posteriorly within the device1100. The notches1104can be molded together with the device1100at the same time as a single piece assembly. In other embodiments, the notches1104can be formed separately from the device1100and be subsequently attached to the device1100.

When viewed in the cross section depicted inFIG. 11D, the one or more notches1104can comprise a generally elongated shape along the short axis, or the axis parallel to line11F-11F ofFIG. 11B. The one or more notches1104can be located at a predetermined and/or known distance from the anterior of the device110. For example, in the embodiment illustrated inFIG. 11C, a distance between a center of the one or more notches1104and a top end of the interior anterior or refractive surface110can be about 1.23 mm, for example for a20D lens. This distance can be different depending on the power and/or thickness of the lens or the refractive surface110. For example, depending on the power of the lens or refractive surface110, this distance can be about 0.50 mm, about 0.60 mm, about 0.70 mm, about 0.80 mm, about 0.90 mm, about 1.00 mm, about 1.10 mm, about 1.20 mm, about 1.30 mm, about 1.40 mm, about 1.50 mm, about 1.60 mm, about 1.70 mm, about 1.80 mm, about 1.90 mm, about 2.00 mm, and/or within a range defined by two of the aforementioned values.

The particular location of the one or more notches1104with respect to the overall device1100can also be measured in terms of a distance between the center of the one or more notches1104and the split point of the optic110. For example, in certain embodiments, the two thirds of the power of the optic110can be configured to be placed inside the device1100while one third of the power of the optic110is located external to the device1100. The split point, for example the ⅓, ⅔ split point, can be configured to be constant in the device1100regardless of the power of the lens110. In other embodiments, the split point of the optic110may be ¼, ¾ or ½, ½. In other words, ¼, ½, or ¾ of the refractive power of the optic110can be configured to be located external to the device1100while ¾, ½, or ¼ of the refractive power of the optic110can be configured to be located internal to the device1100.

The distance measured from the center of the notches1104to a split point of the optic110, when viewed in the cross-sectional view illustrated inFIG. 11C, can be about 1.38 mm. This distance from the center of the notches1104to a split point of the optic110can be constant regardless of the power or thickness of the refractive surface110. In certain embodiments, this distance can be about 0.50 mm, about 0.60 mm, about 0.70 mm, about 0.80 mm, about 0.90 mm, about 1.00 mm, about 1.10 mm, about 1.20 mm, about 1.30 mm, about 1.40 mm, about 1.50 mm, about 1.60 mm, about 1.70 mm, about 1.80 mm, about 1.90 mm, about 2.00 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, each of the notches1104A,1104B can comprise a vertical width of about 0.15 mm when viewed in the direction ofFIG. 11C. In certain embodiments, each of the notches1104A,1106B, when viewed in the direction ofFIG. 11C, can comprise a width of about 0.05 mm, about 0.1 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.2 mm, about 0.21 mm, about 0.22 mm, about 0.23 mm, about 0.24 mm, about 0.25 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, each of the notches1104can comprise an angular length of about 60° when measured from the center of the refractive110in an anterior plan view as illustrated inFIG. 11B. In certain embodiments, the angular length of each of the notches1104, when measured from the center of the refractive110in an anterior plan view as illustrated inFIG. 11B, can be about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°, about 110°, about 120°, about 130°, about 140°, about 150°, about 160°, about 170°, and/or within a range defined by two of the aforementioned values.

The sidewalls1106A,1106B, when viewed in the direction illustrated inFIG. 11C, can be separated by about 25° in some embodiments. In certain embodiments, the angle formed between the sidewalls1106A,1106B, when viewed in the direction illustrated inFIG. 11C, can be about 10°, about 15°, about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about 55°, about 60°, about 65°, about 70°, about 75°, about 80°, and/or within a range defined by two of the aforementioned values.

The device1100can be configured to be folded, rolled, or otherwise compressed and injected into the eye through a small incision and/or small injector as device100described above in relation toFIG. 1A. For example, in some embodiments, the device1100can be inserted through an incision of about 2.75 mm or less. In other embodiments, the device1100can be inserted into the eye through an incision of about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, and/or within a range defined by two of the aforementioned values.

FIG. 12Aillustrates another anterior plan view of the example prosthetic capsular device ofFIG. 11A.FIG. 12Billustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12B-12B ofFIG. 12A.FIG. 12Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12C-12C ofFIG. 12A.FIG. 12Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12D-12D ofFIG. 12A.FIG. 12Eillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12E-12E ofFIG. 12A.FIG. 12Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12F-12F ofFIG. 12A.FIG. 12Gillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Aalong the line12G-12G ofFIG. 12A.

In some embodiments, the cross-sectional area of the device1100along the line12B-12B can be about 2.67 mm2. Similarly, in some embodiments, the cross-sectional area of the device1100along the line12C-12C can be about 4.83 mm2. In some embodiments, the cross-sectional area of the device1100along the line12D-12D can be about 4.24 mm2. In some embodiments, the cross-sectional area of the device1100along the line12E-12E can be about 3.65 mm2. In some embodiments, the cross-sectional area of the device1100along the line12F-12F can be about 2.42 mm2. In some embodiments, the cross-sectional area of the device1100along the line12G-12G can be about 4.34 mm2. As such, the amount of material of the device1100may not necessarily depend on the size of the total outermost periphery of a cross section of the device1100.

FIG. 13Aillustrates an anterior side perspective view of the example prosthetic capsular device ofFIG. 11Awith a secondary device inserted therein.FIG. 13Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 11Awith a secondary device inserted therein.FIG. 13Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Awith a secondary device inserted therein along the line13C-13C ofFIG. 13B.FIG. 13Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 11Awith a secondary device inserted therein along the line13D-13D ofFIG. 13B. The secondary device can comprise acrylic or other haptics that are configured to be inserted into the one or more notches1104.

In some embodiments, the device1100can be configured to be used in conjunction with a secondary device1302, such as a secondary IOL, electronic device, and/or other device. The secondary device1302can be any device that is configured to take advantage of the notches1104. For example, the secondary device1302can comprise one or more haptics and/or other features that are configured to be inserted into the notches1104. The secondary device1302can be inserted into the device1100prior to implantation of the device1100. Alternatively, the secondary device1302can be inserted into the device1100after the device1100has been implanted into the eye. As illustrated and as discussed above, the secondary device1302can be inserted and stabilized at a particular location within the device1100by attaching, inserting, or otherwise fixating the secondary device1302or a feature thereof into the one or more notches1104.

FIG. 14Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 14Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 14A.FIG. 14Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line14C-14C ofFIG. 14B.FIG. 14Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line14D-14D ofFIG. 14B.FIG. 15Aillustrates another anterior side perspective view of the example prosthetic capsular device ofFIG. 14A.FIG. 15Billustrates another anterior plan view of the example prosthetic capsular device ofFIG. 14A.FIG. 15Cillustrates another cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line15C-15C ofFIG. 15B.FIG. 15Dillustrates another cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line15D-15D ofFIG. 15B.

The prosthetic capsular device ofFIG. 14Aincludes some or all of the features of the prosthetic capsular device ofFIG. 1A-11A, and like reference numerals include like features. In particular, the prosthetic capsular device ofFIG. 14Acan be similar to the prosthetic capsular device ofFIG. 1Aand/orFIG. 11A, except for the configuration of notches1404and/or haptics1402. All or some other features of the notches1404, such as material, flexibility, function, or the like, can be similar to such features of the notches604described above in relation toFIGS. 6A-6Dand/or the notches1104described above in relation toFIGS. 11A-11D. All or some other features of the haptics1402, such as material, flexibility, function, or the like, can be similar to such features of the haptics112described above in relation toFIGS. 1A-1Gand/or the haptics1102described above in relation toFIGS. 11A-11D.

In particular, the device1400can comprise notches1404with alternating tabs instead of continuous notches1104as described above in relation toFIGS. 11A-11D. For example, each of the notches1404located on the interior of each capsular area or sidewall106A,106B can comprise a set of large tabs1404B and a set of small tabs1404A to provide an anterior ridge and a posterior ridge. The set of small tabs1404A can be located further away from the refractive surface110compared to the set of large tabs1404B as illustrated inFIG. 14C. In other words, the set of small tabs1404A can be positioned closer to the posterior102of the device1400than the set of larger tabs1404B. The particular location of the set of small tabs1404A and/or the set of large tabs1404B in relation to the device1400can be similar to the location of notches1104of the device1100as described above in relation toFIGS. 11A-11D. The set of small tabs1404A and/or the set of large tabs1404B can prevent movement of a secondary device laterally, anteriorly and/or posteriorly within the device1400. The set of small tabs1404A and/or the set of large tabs1404B can be molded together with the device1400at the same time as a single piece assembly. In other embodiments, the set of small tabs1404A and/or the set of large tabs1404B can be formed separately from the device1400and be subsequently attached to the device1400.

The two sets of tabs1404A,1404B can provide two distinct shelves, such as a posterior ridge and an anterior ridge, for supporting the insertion and positioning of a secondary device or a portion thereof such as haptics of the secondary device. For example, in the embodiment illustrated inFIG. 14D, a first shelf or ridge can be formed between a lower end of the set of small tabs1404A closer to the posterior104of the device and an upper end of the set of large tabs1404B closer to the anterior102of the device. This first shelf or ridge can be about 0.16 mm in width along a posterior-anterior axis of the device1400. This first shelf or ridge can be configured to fit a proline haptic, for example, from a three piece secondary IOL such as a Bausch and Lomb Li61A0. In certain embodiments, this first shelf or ridge can comprise a width of about 0.10 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.20 mm, about 0.21 mm, about 0.22 mm, about 0.23 mm, about 0.24 mm, about 0.25 mm, and/or within a range defined by two of the aforementioned values.

In addition, in the embodiment illustrated inFIG. 14D, a second shelf or ridge can be formed between an interior portion of the set of small tabs1404A and an interior portion of the set of large tabs1404B. This second shelf or ridge can be about 0.50 mm in width along a posterior-anterior axis of the device1400. This second shelf or ridge can be configured to fit an acrylic or other haptic of a secondary device for example. In certain embodiments, this second shelf or ridge can comprise a width of about 0.10 mm, about 0.15 mm, about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, about 0.70 mm, about 0.75 mm, about 0.80 mm, about 0.85 mm, about 0.90 mm, about 0.95 mm, about 1.00 mm, and/or within a range defined by two of the aforementioned values.

Notches1404with alternating tabs1404A,1404B can comprise less material compared to continuous notches1104as described above in relation toFIGS. 11A-11D. For example, notches1404with alternating tabs1404A,1404B can require only about 50 percent of the material required for continuous notches1104. In certain embodiments, the amount of material necessary to provide notches1404with alternating tabs1404A,1404B, when compared to the amount of material necessary to provide continuous notches1104, can be about 10 percent, about 15 percent, about 20 percent, about 25 percent, about 30 percent, about 35 percent, about 40 percent, about 45 percent, about 50 percent, about 55 percent, about 60 percent, about 65 percent, about 70 percent, about 75 percent, about 80 percent, about 85 percent, about 90 percent, about 95 percent, and/or between a range defined by two of the aforementioned values.

As such, the device1400comprising notches1404with alternating tabs1404A,1404B can comprise less mass and volume compared to the device1100comprising continuous notches1104while providing the same or similar functionality. When the device1400is compressed for insertion, the alternative tabs1404A,1404B can be configured to fold into a void space between two tabs, thereby decreasing the volume. Accordingly, the device1400comprising notches1404with alternating tabs1404A,1404B can be inserted through a smaller injector and incision in the eye compared to the device1100comprising continuous notches1104. For example, in some embodiments, the device1400can be inserted through an incision of about 2.20 mm or less. In certain embodiments, the device1400can be inserted into the eye through an incision of about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, and/or within a range defined by two of the aforementioned values.

The device1400can also comprise one or more haptics1402. The one or more haptics1402can comprise a general shape similar to the Greek alphabet omega or Ω. All or some other features of the haptics1402can be similar to those of the haptics112described above in relation toFIGS. 1A-1G.

In the embodiment illustrated inFIGS. 14A-14D, the device1400comprises two haptics1402A,1402B each attached to the exterior surface of each capsular area or side wall106A,106B. Both ends of the omega-shaped haptic1402A,1402B can be over-molded or otherwise affixed to the exterior surface of each capsular area or side wall106A,106B. The central portion of each omega-shaped haptic1402A,1402B can be surrounded by void space, for example due to a recessed area of the device1400underneath the central portion, to facilitate cellular growth as discussed above.

In comparison to the haptics112A,112B ofFIG. 1, the continuously curved configuration of the haptics1402A,1402B can reduce kinking and may also better accommodate stretching that may occur when the device1400is compressed through an injection cartridge for implantation into the eye. In contrast, haptics112A,112B with generally straight segments may be more likely to tear away from the body of the lens when stretched. Also, the curved configuration of the haptics1402A,1402B can allow for the length of the haptics to be longer than that of a generally rectangular haptic112while covering a similar or substantially similar amount of space. In other words, a curved haptics of a device, such as the omega-shaped haptics1402, can provide redundancy in the material for the haptics. Accordingly, cellular growth may be better facilitated due to the additional length of the haptics1402A,1402B.

FIG. 16Aillustrates another anterior plan view of the example prosthetic capsular device ofFIG. 14A.FIG. 16Billustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16B-16B ofFIG. 16A.FIG. 16Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16C-16C ofFIG. 16A.FIG. 16Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16D-16D ofFIG. 16A.FIG. 16Eillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16E-16E ofFIG. 16A.FIG. 16Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16F-16F ofFIG. 16A.FIG. 16Gillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16G-16G ofFIG. 16A.FIG. 16Hillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Aalong the line16H-16H ofFIG. 16A.

In some embodiments, the cross-sectional area of the device1400along the line16B-16B can be about 3.39 mm2. Similarly, in some embodiments, the cross-sectional area of the device1400along the line16C-16C can be about 4.03 mm2. In some embodiments, the cross-sectional area of the device1400along the line16D-16D can be about 4.26 mm2. In some embodiments, the cross-sectional area of the device1400along the line16E-16E can be about 4.10 mm2. In some embodiments, the cross-sectional area of the device1400along the line16F-16F can be about 3.50 mm2. In some embodiments, the cross-sectional area of the device1400along the line16G-16G can be about 2.42 mm2. In some embodiments, the cross-sectional area of the device1400along the line16H-16H can be about 4.43 mm2. As such, the amount of material of the device1400may not necessarily depend on the size of the total outermost periphery of a cross section of the device1400.

FIG. 17Aillustrates an anterior side perspective view of an example haptics configured to be used in conjunction with a prosthetic capsular device, such as for example the example prosthetic capsular device1400ofFIG. 14A.FIG. 17Billustrates an anterior plan view of the example haptics ofFIG. 17A.FIG. 17Cillustrates a side view of the example haptics ofFIG. 17A.

As illustrated inFIGS. 17A-17C, the generally omega-shaped haptics1402can comprise a continuously curved configuration. A central portion and/or a substantially large portion of the haptics1402configured for cellular ingrowth can comprise a curvature in a first general direction. The central portion can extend generally at both ends along a curvature in a second general direction that is flipped or opposite to the first general direction terminating at two ends of the haptics1402. The two ends of the haptics1402can be configured to be over-molded or otherwise attached to the device1400and sealed off.

In some embodiments, the haptics1402can comprise a thickness of about 0.08 mm when viewed from a side view as illustrated inFIG. 17C. In certain embodiments, when viewed from the side, the haptics1402can comprise a thickness of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.10 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, when viewed in an anterior plan view as illustrated inFIG. 17B, the haptics1402can comprise a total height of about 2.41 mm when measured from the top of the haptics1402to the bottom. In some embodiments, the total height of the haptics1402when viewed in an anterior plan view can be about 1.50 mm, about 1.60 mm, about 1.70 mm, about 1.80 mm, about 1.90 mm, about 2.00 mm, about 2.10 mm, about 2.20 mm, about 2.30 mm, about 2.40 mm, about 2.50 mm, about 2.60 mm, about 2.70 mm, about 2.80 mm, about 2.90 mm, about 3.00 mm, about 3.10 mm, about 3.20 mm, about 3.30 mm, about 3.40 mm, about 3.50 mm, and/or within a range defined by two of the aforementioned values.

Further, when viewed in an anterior plan view, the haptics1402can comprise a total width of about 1.65 mm. In certain embodiments, when viewed in an anterior plan view, the total width of the haptics1402can be about 1.00 mm, about 1.10 mm, about 1.20 mm, about 1.30 mm, about 1.40 mm, about 1.50 mm, about 1.60 mm, about 1.70 mm, about 1.80 mm, about 1.90 mm, about 2.00 mm, about 2.10 mm, about 2.20 mm, about 2.30 mm, about 2.40 mm, about 2.50 mm, and/or within a range defined by two of the aforementioned values.

In addition, when viewed in an anterior plan view, a vertical distance between the two terminal ends of the haptics1402can be about 1.66 mm. In certain embodiments, when viewed in an anterior plan view, the vertical distance between the terminal ends of the haptics1402can be about 1.00 mm, about 1.10 mm, about 1.20 mm, about 1.30 mm, about 1.40 mm, about 1.50 mm, about 1.60 mm, about 1.70 mm, about 1.80 mm, about 1.90 mm, about 2.00 mm, about 2.10 mm, about 2.20 mm, about 2.30 mm, about 2.40 mm, about 2.50 mm, and/or within a range defined by two of the aforementioned values.

Moreover, when viewed in an anterior plan view, a thickness of the haptics1402can be about 0.12 mm. In certain embodiments, when viewed from the top or in an anterior plan view, the haptics1402can comprise a thickness of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.10 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, and/or within a range defined by two of the aforementioned values.

FIG. 18Aillustrates an anterior side perspective view of the example prosthetic capsular device ofFIG. 14Awith a secondary device inserted therein.FIG. 18Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 14Awith a secondary device inserted therein.FIG. 18Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Awith a secondary device inserted therein along the line18C-18C ofFIG. 18B.FIG. 18Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 14Awith a secondary device inserted therein along the line18D-18D ofFIG. 18B.FIG. 18Eillustrates an anterior plan view of a portion of the example prosthetic capsular device ofFIG. 14A.

As previously discussed, the device1400can be configured to be used in conjunction with a secondary device1802, such as a secondary IOL, electronic device, and/or other device. The secondary device1802can be any device that is configured to take advantage of the set of small tabs1404A and/or the set of large tabs1404B of the notches1404. For example, the secondary device1802can comprise one or more haptics and/or other features that are configured to be inserted into one or more ridges or shelves formed by the set of small tabs1404A and/or the set of large tabs1404B of the notches1404. The secondary device1802can be inserted into the device1400prior to and/or after implantation of the device1400in the eye.

FIG. 19Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 19Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 19A.FIG. 19Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 19Aalong the line19C-19C ofFIG. 19B.FIG. 19Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 19Aalong the line19D-19D ofFIG. 19B.FIG. 19Eillustrates a side plan view of the example prosthetic capsular device ofFIG. 19A.FIG. 19Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 19Aalong the line19F-19F ofFIG. 19D.

The prosthetic capsular device1900ofFIG. 19Aincludes some or all of the features of the prosthetic capsular device ofFIG. 10A and/or 14A, and like reference numerals include like features. Some or all features of the prosthetic capsular device1900can be similar to those of other prosthetic capsular devices disclosed herein. For example, the prosthetic capsular device1900can comprise one or more notches1404with alternating tabs. Some or all features of the one or more notches1404, alternating tabs, and/or functions, characteristics and/or materials thereof can be similar to those discussed above in relation toFIG. 14A. In certain embodiments, the one or more alternating tabs1404can all comprise the same or similar size and/or shape.

The prosthetic capsular device1900can comprise a continuous sidewall portion1902that encompasses the whole perimeter of the device1900. The overall general shape or configuration of the prosthetic capsular device1900can be similar to the overall general shape of the prosthetic capsular device1000ofFIG. 10A. However, in contrast to the prosthetic capsular device ofFIG. 10A, the sidewall1902of the prosthetic capsular device1900ofFIG. 19Amay not comprise a break or void space.

By providing a continuous sidewall1902, the prosthetic capsular device1900can be more effective than certain other embodiments in keeping the natural capsular bag of the eye open upon insertion. That is, because there is no void space along the side wall, the tendency of the prosthetic capsular device1900to fold or collapse within the natural capsular bag can be lower than certain other embodiments. However, at the same time, the continuous configuration of the sidewall1902can present technical difficulties in inserting the device1900through a small incision.

Accordingly, to address this potential shortcoming, some embodiments of the example prosthetic capsular device1900do not comprise a pre-existing posterior surface. Rather, some embodiments of the example prosthetic capsular device1900can comprise an empty or void posterior and/or anterior side. As such, the device1900can be configured to be coupled with a posterior and/or anterior refractive surface or optic after insertion in the eye. In other words, rather than comprising a single piece assembly that includes both a framework and a posterior refractive surface, the prosthetic capsular device1900may comprise a two-piece assembly, in which the framework and posterior refractive surface are provided and/or inserted separately into the natural capsular bag or eye.

More specifically, upon implantation, the framework or prosthetic capsular device1900can be inserted into the eye first, which can keep the entire natural capsule stinted open. An optic or refractive surface can be subsequently inserted into the eye and be placed or coupled with the framework or prosthetic capsular device1900, for example near or at the posterior and/or anterior side of the device. By separating the framework1900from the posterior refractive surface, the volume of a single insertion, for example the framework or device1900, can be smaller.

In addition, because the posterior optic is inserted separately, the posterior optic can be rather easily replaced in the future. At the same time, by placing this optic near or at the posterior end of the prosthetic capsular device1900, an additional lens, technology device, and/or other component can be placed in the interior and/or anterior side of the device1900as well.

An optic can be attached or coupled to the device1900in a number of ways. For example, an optic can be sutured to a posterior side or other portion of the device1900or can be attached or coupled via a friction fit, chemical adhesive, mechanical locking, and/or a combination of the above. In particular, in some embodiments, the void posterior and/or anterior end or opening of the device1900can comprise a lip1904. In other words, the posterior or anterior opening or end of the device1900can comprise two layers of extended material1904that create a groove in between the two layers. This groove formed by the extended material1904can extend throughout the posterior and/or anterior opening of the device1900, for example to create a circular annulus. Each of the extended material1904can comprise one or more triangular fixations configured to maintain a position of the optic. The optic or periphery or portion thereof, such as a tongue portion, can be configured to be inserted into the groove formed by the two layers of extended material1904, for example made of silicone.

In certain embodiments, the lip portion1904surrounding the posterior and/or anterior opening can comprise a certain thickness when viewed from an anterior plan view as illustrated inFIG. 19F. As such, the diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening of the device1900, excluding the lip portion1904, can be about 7.00 mm and/or larger than the posterior and/or anterior opening. In certain embodiments, the diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening of the device1900, excluding the lip portion1904, can be about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, about 7.0 mm, about 7.1 mm, about 7.2 mm, about 7.3 mm, about 7.4 mm, about 7.5 mm, about 8.0 mm, about 8.1 mm, about 8.2 mm, about 8.3 mm, about 8.4 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10 mm, about 10.5 mm and/or within a range defined by two of the aforementioned values.

In some embodiments, the device1900can comprise a plurality of notches1404placed circumferentially throughout the interior of the sidewall1902. Each or some of the plurality of notches1404can comprise an angular width of about 8° when viewed in an anterior plan view as illustrated inFIG. 19B. In certain embodiments, when viewed in an anterior plan view, each or some of the plurality of notches1404can comprise an angular width of about 1°, about 2°, about 3°, about 4°, about 5°, about 6°, about 7°, about 8°, about 9°, about 10°, about 11°, about 12°, about 13°, about 14°, about 15°, about 20°, about 25°, about 30°, about 40°, about 45°, about 60°, about 75°, about 90°, and/or within a range defined by two of the aforementioned values.FIG. 20Aillustrates an anterior side perspective view of an example optic configured to be used in conjunction with a prosthetic capsular device, such as the example prosthetic capsular device ofFIG. 19Aor any other example prosthetic capsular device described herein.FIG. 20Billustrates an anterior plan view of the example optic ofFIG. 20A.FIG. 20Cillustrates a side plan view of the example optic ofFIG. 20Aalong a major axis of the anterior plan view illustrated inFIG. 20B.FIG. 20Dillustrates a side plan view of the example optic ofFIG. 20Aalong a minor axis of the anterior plan view illustrated inFIG. 20B.

In some embodiments, the optic or refractive surface2000can comprise a diameter of about 6.00 mm. In certain embodiments, the optic of refractive surface2000can comprise a diameter of about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, about 9.50 mm, about 10.00 mm, and/or within a range defined by two of the aforementioned values.

An optic or refractive surface2000can comprise one or more tongue portions2002. The one or more tongue portions2002can extend outwardly from the refractive portion of the optic2000. The one or more tongue portions2002can be configured to be inserted into a groove of a prosthetic capsular device. For example, the one or more tongue portions2002can be inserted into the groove formed by the two layers of extended material1904in device1900.

An optic2000can comprise one, two, three, four, five, six, seven, eight, nine, or ten tongue portions2002. Each of the one or more tongue portions2002of an optic2000can extend radially from about 20°, about 40°, about 60°, about 80°, about 100°, about 120°, about 140°, about 160°, about 180°, about 200°, about 220°, about 240°, about 260°, about 280°, about 300°, about 320°, about 340°, about 360° of the circumference of the refractive portion of the optic2000and/or within a range defined by two of the aforementioned values.

A tongue portion2002of an optic2000can comprise one or more eyelets2004. The one or more eyelets2004can be used to fasten or fixate the optic2000in a particular location or configuration within a prosthetic capsular device, such as device1900. In some embodiments, each of the eyelets2004can comprise a diameter and/or thickness of about 0.25 mm. In certain embodiments, each of the eyelets2004can comprise a diameter and/or thickness of about 0.05 mm, about 0.10 mm, about 0.15 mm, about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, and/or within a range defined by two of the aforementioned values.

FIG. 21Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 21Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 21A.FIG. 21Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 21Aalong the line21C-21C ofFIG. 21B.FIG. 21Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 21Aalong the line21D-21D ofFIG. 21B.

The example prosthetic device ofFIG. 21Acan comprise one or more similar features as the example prosthetic device ofFIG. 19A. The example prosthetic device ofFIG. 21Acan be configured to be used in conjunction with a refractive surface or an IOL2200as depicted inFIG. 21A. For example, an example prosthetic device2100can comprise a posterior refractive surface2200, similar to one or more other embodiments described herein. The posterior refractive surface2200can be configured to be attachable or selectively removable from a prosthetic device2100.

In some embodiments, the device2100can comprise an overall diameter of about 9.650 mm when viewed in an anterior plan view as illustrated inFIG. 21B. In certain embodiments, when viewed in an anterior plan view, the device2100can comprise an overall diameter of about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10.0 mm, about 10.5 mm, about 11.0 mm, about 11.5 mm, about 12.0 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the device2100, from a cross-sectional view along the line21D-21D as illustrated inFIG. 21D, can comprise a thickness of about 3.5 mm excluding the refractive surface2200. Depending on the thickness of the refractive surface2200, the total thickness of the device2100including the refractive surface2200can be about 3.980 mm. In certain embodiments, the thickness of the device2100, from a cross-sectional view along the line21D-21D and/or from a side view and including and/or excluding the refractive surface2200, can be about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, a lip portion can surround the posterior and/or anterior opening with a certain thickness when viewed from an anterior plan view as illustrated inFIG. 21B. The diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening of the device2100, excluding the lip portion, can be about 7.00 mm and/or larger than the posterior and/or anterior opening. In certain embodiments, the diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening of the device2100, excluding the lip portion can be about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, about 7.0 mm, about 7.1 mm, about 7.2 mm, about 7.3 mm, about 7.4 mm, about 7.5 mm, about 8.0 mm, about 8.1 mm, about 8.2 mm, about 8.3 mm, about 8.4 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10 mm, about 10.5 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the device2100can comprise a plurality of notches1404placed circumferentially throughout the interior of the sidewall1902. Each or some of the plurality of notches1404can comprise an angular width of about 8° when viewed in an anterior plan view as illustrated inFIG. 21B. In certain embodiments, when viewed in an anterior plan view, each or some of the plurality of notches1404can comprise an angular width of about 1°, about 2°, about 3°, about 4°, about 5°, about 6°, about 7°, about 8°, about 9°, about 10°, about 11°, about 12°, about 13°, about 14°, about 15°, about 20°, about 25°, about 30°, about 40°, about 45°, about 60°, about 75°, about 90°, and/or within a range defined by two of the aforementioned values.

FIG. 22Aillustrates an anterior side perspective view of an example refractive surface or intraocular lens that can be configured to be used in conjunction with a prosthetic capsular device, such as the prosthetic capsular device ofFIG. 21Aor any other example prosthetic capsular device described herein.FIG. 22Billustrates an anterior plan view of the example refractive surface or intraocular lens ofFIG. 22A.FIG. 22Cillustrates a side plan view of the example refractive surface or intraocular lens ofFIG. 22A.FIG. 22Dillustrates another side plan view of the example refractive surface or intraocular lens ofFIG. 22A.

The example refractive surface or intraocular lens2200ofFIG. 22Acan be configured to be used in conjunction with one or more example prosthetic devices disclosed herein. For example, the example refractive surface or intraocular lens2200ofFIG. 22Acan be attached to and/or selectively removed from the prosthetic capsular device ofFIG. 21A.

In some embodiments, the optic or refractive surface2200can comprise a diameter of about 6.250 mm. In certain embodiments, the optic of refractive surface2200can comprise a diameter of about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, about 9.50 mm, about 10.00 mm, and/or within a range defined by two of the aforementioned values.

An example refractive surface or intraocular lens2200can comprise one or more tabs2206to facilitate attachment of the refractive surface or intraocular lens2200to a prosthetic capsular device and/or to fixate the two. For example, in some embodiments, a refractive surface or intraocular lens2200can comprise four tabs2206. Each of the tabs2206can comprise a curvature when viewed from a side plan view as illustrated inFIG. 22D. For example, in certain embodiments, a refractive surface or intraocular lens2200can comprise two upwardly curved tabs2206A and two downwardly curved tabs2206B. As such, two of the four tabs2206can be configured to be placed in the interior of a posterior or anterior end of a prosthetic capsular device and the other two tabs2206can be configured to be placed exterior to the posterior or anterior end of the prosthetic capsular device. This way, the refractive surface or intraocular lens2200can be held substantially in place with respect to the posterior end of a prosthetic capsular device.

Each of the plurality of tabs2206can extend from the refractive surface2200at an angle when viewed from a side plan view as illustrated inFIG. 22D. For example, in some embodiments, each or some of the plurality of tabs2206can initially extend from the refractive surface2200at an angle of about 45° in either direction. In certain embodiments, each or some of the plurality of tabs2206can initially extend from the refractive surface2200at an angle of about +/−10°, about +/−20°, about +/−25°, about +/−30°, about +/−35°, about +/−40°, about +/−45°, about +/−50°, about +/−55°, about +/−60°, about +/−70°, about +/−80°, about +/−90°, and/or within a range defined by two of the aforementioned values.

In some embodiments, each or some of the tabs2206, when viewed from a side plan view as illustrated inFIG. 22D, can comprise a height of about 0.50 mm. In certain embodiments, each or some of the tabs2206, when viewed from a side plan view as illustrated inFIG. 22D, can comprise a height of about 0.10 mm, about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm, about 0.60 mm, about 0.70 mm, about 0.80 mm, about 0.90 mm, about 1.0 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the optic2200can comprise one, two, three, four, five, six, seven, eight, nine, or ten tabs2206. In certain embodiments, each or some of the one or more tabs2206can extend radially from about 30° of the circumference of the refractive portion of the optic2200. In some embodiments, each of the one or more tabs2206of an optic2000can extend radially from about 20°, about 40°, about 60°, about 80°, about 100°, about 120°, about 140°, about 160°, about 180°, about 200°, about 220°, about 240°, about 260°, about 280°, about 300°, about 320°, about 340°, about 360° of the circumference of the refractive portion of the optic2000, and/or within a range defined by two of the aforementioned values.

In some embodiments, each or some of the tabs2206, when viewed from an anterior plan view as illustrated inFIG. 22B, can comprise a width of about 2.0 mm. In certain embodiments, each or some of the tabs2206, when viewed from an anterior plan view as illustrated inFIG. 22B, can comprise a width of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, and/or within a range defined by two of the aforementioned values.

A refractive surface or intraocular lens2200can comprise two convex portions2200A,2200B. One of the two convex portions2200A can be configured to be placed in the interior of a prosthetic capsular device and the other convex portion2200B can be configured to be placed exterior to the prosthetic capsular device upon attachment thereto. In some embodiments, the two convex portions2200A,2200B can comprise substantially the same shape, area, and/or refractive power. This way, a refractive surface or intraocular lens2200can be configured such that the posterior-anterior configuration thereof does not matter when attaching to a prosthetic capsular device. In other words, the refractive surface or intraocular lens2200can be flipped when attaching to a prosthetic capsular device and still obtain substantially the same function.

Some embodiments described herein are directed to and/or can be used in conjunction with an accommodating optic system, device, and/or method for controlling the same. An accommodating optic or lens can generally refer to an optic or lens that helps a user view clearly at varying distances. In other words, an accommodating optic or lens can provide varying refractive or optical powers to correct the vision of the user to varying degrees as the visual needs of the user changes. Accommodating optics or lenses can comprise a number of different forms and/or designs. One example is an electronic or electro-accommodating lens, which is also known as an electroactive accommodating lens, electroactive lens, or electroactive intraocular lens. An electroactive accommodating lens, for example, can comprise liquid crystals that are configured to change in configuration according to an electrical signal or input to alter the optical or focal power of the lens. An electroactive accommodating lens can be configured to be implanted into the eye as an intraocular lens (IOL).

One common problem that arises in connection with electroactive accommodating IOLs relates to the size and overall configuration of the electroactive accommodating IOL. For example, electroactive accommodating lenses or LCD power-changing lenses generally comprises liquid crystals placed between two wafers of Plexiglas, which is not foldable. At the same time, an IOL generally requires an optic comprising a diameter or width of at least 5 mm in order to provide a lens that functions in most environments, for example to avoid the halo effect and/or mismatch when the pupil is larger than the optic when in darker or other environments. In addition, it is generally advantageous to insert an IOL through a small incision, for example smaller than 3 mm. As such, in order to address and balance such criteria, certain electroactive accommodating IOLs comprise a generally rectangular or elongated bar shape to allow a rigid or semi-rigid electroactive accommodating IOL with a length or width of about 5 mm or larger, or larger than at least 3 mm, to be inserted through a small incision in the eye. This is contrast to most IOLs, which generally comprise a round or circular shape.

Certain accommodating optic systems, devices, and methods herein address these shortcomings.FIG. 23Aillustrates an anterior plan view of an example accommodating optic device configured to be used in conjunction with a prosthetic capsular device.FIG. 23Billustrates an anterior plan view of an example accommodating optic system comprising the example accommodating optic device ofFIG. 23Aused in conjunction with a prosthetic capsular device.FIG. 23Cillustrates a cross-sectional view of the example accommodating optic system ofFIG. 23Balong a short axis of the prosthetic capsular device.

In particular, the example accommodating optic2300is configured to be used in conjunction with any of the prosthetic capsular devices described herein. For example, the accommodating optic2300can be configured to be placed or inserted inside the prosthetic capsular device1400. The accommodating optic2300can be configured to be placed anterior to the posterior refractive surface of a prosthetic capsular device, in which the posterior refractive surface can act as a base lens that can be supplemented by the accommodating optic2300to effectively change the focal point of a human optical system.

The accommodating optic2300can be configured to provide varying refractive or optical power in a similar manner as electroactive accommodating optics. A key difference is that the accommodating optic2300is configured to be used in conjunction with one or more of the prosthetic capsular devices described herein, which comprises a posterior refractive surface. In other words, because the accommodating optic2300is configured to be used in conjunction with a separate refractive surface or lens, the accommodating optic2300does not need to comprise an optic with a diameter or width of about 5 mm or larger as in certain electroactive accommodating optics.

The accommodating optic2300can comprise an optic2302that is only about 3 mm or smaller in diameter while being able to mitigate the halo effect or mismatch when the pupil is larger than the optic by use with a separate base lens or posterior refractive surface. As such, the accommodating optic2300can comprise a generally round or circular optic2302due to the smaller size. In certain embodiments, the optic or refractive portion2302of the accommodating optic2300can comprise a diameter of about 4.5 mm, about 4.0 mm, about 3.5 mm, about 3.0 mm, about 2.5 mm, about 2.0 mm, about 1.5 mm, about 1.0 mm, about 0.5 mm, and/or within a range defined by two of the aforementioned values.

Due to the smaller size, a substantially circular or round accommodating optic2300can be inserted through a small incision that is about the same or slightly larger than the diameter of the optics portion2302. For example, an accommodating optic2300with an optics2302diameter of about 3 mm can be inserted through an incision of about 3 mm in the eye. As another example, an accommodating optic2300with an optics2302diameter of about 1 mm can be inserted through an incision of about 1 mm in the eye.

As discussed above, the accommodating optic2300can be configured to be placed anterior to the posterior refractive surface of a prosthetic capsular device. In other words, the posterior refractive surface of the prosthetic capsular device can act as a base lens that can be supplemented by the accommodating optic2300. The accommodating optic2300can be capable of providing a variety of optical or refractive power. For example, the accommodating optic2300can be configured to provide an optical or refractive power of about 0 diopters, about 0.25 diopters, about 0.50 diopters, about 0.75 diopters, about 1.00 diopters, about 1.25 diopters, about 1.50 diopters, about 1.75 diopters, about 2.00 diopters, about 2.25 diopters, about 2.50 diopters, about 2.75 diopters, about 3.00 diopters, about 3.25 diopters, about 3.50 diopters, about 3.75 diopters, about 4.00 diopters, about 4.25 diopters, about 4.50 diopters, about 4.75 diopters, about 5.00 diopters, and/or within a range defined by any two of the aforementioned values. The accommodating optic2300can also be configured to correct wavefront higher order aberrations and/or correct or induce astigmatism.

As an illustrative example, the accommodating optic2300can be clear when in its non-powered or resting state so it would have an effective power of 0 diopters. However, based on input for example, the refractive power of the accommodating optic2300may be changed from 0 diopters through about 1, about 2, about 3, about 4, or about 5 diopters to provide an accommodated shift. As the accommodating optic2300is placed anterior to a posterior refractive surface of base optic, the vision of the user would effectively be corrected according to the power of the accommodating optic2300.

The refractive or optical power of the accommodating optic2300can be changed based on user input in some embodiments. For example, the accommodating optic2300can be configured to change or alter its power based on user input received from a smartphone or other electronic device. The user input could be a particular value or range of optical power. The user input can be received through a dial or representation of a dial, in which the user can make a gradual selection from lower power and higher power and vice versa. If the user has two accommodating optics2300implanted, one in each eye, the user can control the power of just one or both of the accommodating optics2300at once. For instance, a user may control an accommodating optic2300of one eye to accommodate for far vision, while the accommodating optic2300in the other eye is controlled to accommodate for near vision, creating a monovision effect.

In addition, in certain embodiments, the accommodating optic2300may comprise or be configured to be used in conjunction with one or more other sensors, eye tracking software, and/or artificial intelligence. For example, one or more sensors or electrodes may detect muscle contracting, pupil retracting, head tilt or position tracking, or the like to control or contribute to automatic controlling the focal power of the accommodating optic2300. However, there is a general risk that the one or more sensor may be imperfect and/or a user is not satisfied with the automatically determined power of the accommodating lens2300. In such situations, a user may manually override the automated system by controlling the refractive or focal power of the accommodating optic2300using a user input device to fine tune the user's vision. The user input device can be a smartphone, smartwatch, electronic ring, electronic bracelet, or the like or other electronic device capable of communicating with the accommodating optic2300, for example through wireless communication.

By using the accommodating lens in conjunction with a separate base lens, halo effects can also be mitigated despite the smaller size of the optics portion2302of the accommodating lens2300. Generally speaking, the size of a human pupil in ambient lighting conditions can be said to be around 3 mm or less. In most functional states, the human pupil will likely be smaller than 3 mm. In dark environments, however, the pupil can become larger than 3 mm. In embodiments in which the optics portion2302of an accommodating optic2300has a diameter of 3 mm, some unfocused light may come in around the periphery of the optics2302of the accommodating optic2300. This light will still be focused by the base lens or posterior refractive surface of the prosthetic capsular device. As such, similar to a multi-focal lens, light coming into the central portion through the accommodating lens2300will be focused at a different point than light coming in around the accommodating lens2300and going through just the posterior refractive surface or base lens. In darker environments, and in situations where the user does not require a near focus, for example while driving at nighttime or watching a concert, the user can tune the refractive power of the accommodating lens to adapt their needs. In other words, a user can easily eliminate halos by turning the accommodating lens2300into its resting state, thereby obtaining essentially a single focus distance lens.

To attach or otherwise couple the accommodating lens2300to a prosthetic capsular device, the accommodating lens2300can comprise one or more arm portions2304and/or haptics2306configured to be attached to the prosthetic capsular device. For example, one or more arm portions2304can extend radially outward from an optics portion2302of the accommodating lens2300. Each of the arm portions2304can also comprise one or more haptics2306at the end, which can be configured to be inserted or attached to a groove or other locking mechanism or feature of the prosthetic capsular device.

In the embodiment illustrated inFIGS. 23A-23C, the accommodating lens2300can comprise two arm portions2304extending from the optics portion2302, wherein each of the two arm portions2304comprises a curved anchor-shaped haptics2306that is configured to be inserted into a slot or groove located along the interior of the sidewall of a prosthetic capsular device. The optics portion2302can be configured to be centrally placed anterior to the posterior refractive surface of the prosthetic capsular device upon fixation of the haptics2306. For example, a 3 mm optics portion2302can be placed substantially in the center anterior to a posterior 5.5 mm refractive surface. An accommodating lens2300can comprise one, two, three, four, five, six, seven, eight, nine, or ten arm portions2304. Each of the arm portions2304can extend radially outward from the optics portion2302, for example separated from each other by a similar angle. Each of the arm portions2304can comprise one, two, three, four, five, six, seven, eight, nine, or ten haptics2306.

The length of accommodating lens2300along a longitudinal axis can be about 9.5 mm, including a 3 mm diameter of the optics portion2302for example. In certain embodiments, the length of the accommodating lens2300along a longitudinal axis can be about 8.0 mm, about 8.5 mm, about 9.0 mm, about 10.0 mm, about 10.5 mm, about 11.0 mm, about 11.5 mm, about 12.0 mm, and/or within a range defined by two of the aforementioned values.

One or more other components, such as electronic components can be placed within the haptics. For example, in addition to the optics portion2302, the accommodating lens2300can also comprise one or more batteries or other power sources, one or more induction coils, one or more capacitors, one or more wireless antennas, wireless receivers, and/or one or more microprocessors. The one or more wireless antennas and/or receivers can be one or more of a radiofrequency antenna, Bluetooth antenna, Wi-Fi antenna, or the like that is configured to wirelessly communicate with a user input device or other electronic device.

Once user input or other electronic signal is received by the wireless antenna and/or receiver, a microprocessor or microchip can be configured to receive the input and determine an input/output decision for controlling a state of the LCD optics portion to control the focal power. The determined output can be transmitted to a capacitor that is configured to output an electric charge to appropriately change the refractive index of the optics portion as desired.

FIG. 23Dis a block diagram depicting an example control process for an accommodating optic system. As illustrated inFIG. 23D, in some embodiments, the system can be configured to receive one or more inputs at block2312. The input can be a user input or an automated input. For example, the input received by the system may be from a user-initiated input through a user access point system. In addition or alternatively, the input received by the system can be from one or more sensors, such as an intraocular sensor and/or external light sensor that automatically determine a desired refractive power for the accommodating lens at a particular time and/or situation.

Once the input is received, the system can be configured to further process the input at block2314. In certain embodiments, the system can be configured to combine or otherwise process a plurality of inputs, for example an automated input and a user input. In some embodiments, the system can be configured to process a single input, whether a user input or an automated input.

Processing one or more inputs by the system can involve one or more processes. In some embodiments, the system can be configured to process one or more inputs to determine whether to initiate one or more additional processes configured to increase and/or decrease the refractive power or other characteristic of an accommodating optic system or device. For example, if an input received by the system comprises data that corresponds to instructions and/or a determined need to increase the refractive power, the system can be configured to initiate one or more processes that are expected to increase the refractive power. Conversely, if an input received by the system comprises data that corresponds to instructions and/or a determined need to decrease the refractive power, the system can be configured to initiate one or more processes that are expected to decrease the refractive power.

If an input received by the system comprises data showing that the current refractive power and/or other characteristic of the accommodating optic system or device is optimal or operable, the system can be configured not to initiate any processes to change the refractive power and/or other characteristic of the accommodating optic device or system.

Based on such determination, the system can be further configured to generate one or more instruction commands for transmission to one or more electronic device components of the system implanted in the eye at block2316. Each electronic device component that received an instruction command can be further configured to perform one or more processes according to the received instruction command. Optionally, in some embodiments, the system can be further configured to determine whether the one or more electronic device components that received an instruction command in fact performed the corresponding one or more processes at block2318. If confirmation and/or a current status input are received by the system that the one or more corresponding processes were performed, the process can end at block2320in some embodiments. However, if such confirmation and/or a current status input is not received, the system can be configured to repeat one or more processes from blocks2312to2318.

Further, in some embodiments, the system can be configured to repeat one or more processes described in relation toFIG. 8periodically, in real-time, or in near real-time. For example, the system can be configured to repeat processes2312through2316and/or processes2312through2318periodically, in real-time, or in near real-time. The one or more processes can be repeated every about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 20 seconds, about 30 seconds, about 40 seconds, about 50 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, and/or within a range defined by two of the aforementioned values.

FIG. 23Eis a block diagram depicting another example control process for an accommodating optic system. In some embodiments, an electronic system component of the accommodating lens system, for example a control unit, can receive one or more inputs at block2324. The one or more inputs can comprise a user input or data relating to the strain on the eye, external lighting conditions, muscular contractions, or any other data that can be indicative of a need or desire to increase or decrease the refractive power of the accommodating optic system or device. The user input can be achieved by a user through a user access point system, such as a smartphone or other handheld electronic device. Other data can be collected and/or received from one or more intraocular and/or external sensors for use in conjunction with the accommodating optic system.

The system component can be configured to further process the received input at block2326. The system may determine that the received input corresponds to increasing, decreasing, and/or maintaining the refractive power and/or other characteristic of the accommodating optic system or device. If the system determines that the received input requires or corresponds to changing the state and/or power of the accommodating optic system or device, the system can be configured to generate an instruction command to appropriately change the state and/or power of the accommodating optic system or device at block2328A. If the system determines that the received input requires or corresponds to maintain a current state and/or power of the accommodating optic system or device, the system can be configured to generate an instruction command to maintain state and/or power of the accommodating optic system or device at block2328B.

The system component can be further configured to electronically transmit the generated instruction command to the same or another electronic device component of the accommodating lens or optic system at block2330. In some embodiments, the generated instruction command can be transmitted through a wired connection. In certain embodiments, the generated instruction command can be transmitted through a wireless connection.

In some embodiments, the system component can be further configured to receive confirmation and/or a current status input from the accommodating optic system at block2332. At block2334, the accommodating lens or optic system or device can increase, decrease, and/or maintain a refractive power and/or other characteristic of the system based on the system instructions.

FIG. 24Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 24Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 24A.FIG. 24Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 24Aalong the line24C-24C ofFIG. 24B.FIG. 24Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 24Aalong the line24D-24D ofFIG. 24B.FIG. 24Eillustrates a side plan view of the example prosthetic capsular device ofFIG. 24A.FIG. 24Fillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 24Aalong the line24F-24F ofFIG. 24D.

The example prosthetic capsular device2400illustrated inFIG. 24Aincludes some or all of the features of the example prosthetic capsular devices illustrated inFIGS. 1A-21A, and like reference numerals include like features. For example, similar to the example prosthetic capsular device600ofFIG. 6A, the example prosthetic capsular device2400ofFIG. 24Acan include one or more ridges2404. Also, similar to the example prosthetic capsular device1000ofFIG. 10A, the example prosthetic capsular device2400ofFIG. 24Acan include a single, continuous sidewall2402.

In particular, the example prosthetic capsular device2400can comprise a single continuous sidewall2402without any breaks or void spaces. The sidewall2402can be made of silicone. The device2400can comprise an anterior opening and a posterior opening. A void space or cavity108can be formed through the device2400connecting the anterior opening and the posterior opening. Accordingly, the device2400can comprise a substantially tire or doughnut-like shape or configuration.

The device2400can be configured such that the anterior side102and the posterior side104are substantially the same. As such, it may not matter whether the anterior side102and the posterior side104are flipped. In other words, an anterior half of the device2400can substantially be a mirror image of the posterior half of the device2400. The device2400can be configured to be used in conjunction with one or more refractive surfaces or IOLs. For example, a refractive surface or IOL can be configured to be placed to cover the anterior opening102and/or posterior opening104. A refractive surface or IOL configured to be affixed to the anterior opening102and/or posterior opening104can also be symmetrical along the posterior-anterior axis. In other words, in some embodiments, a refractive surface or IOL configured to be affixed to the anterior opening102and/or posterior opening104can comprise the same power on both sides of the lens or refractive surface. As such, both the refractive surface or IOL and the device2400can be fully reversible over a plane that divides the anterior and posterior portions of the device and lens, for example for ease of use during surgery and to decrease risk related to the configuration of the device and/or lens. A refractive surface, IOL, electronic device, and/or other intraocular device can also be placed inside the cavity108of the device in between the anterior opening102and the posterior opening104.

Further, the device2400can comprise one or more ridges2404. The one or more ridges2404can be configured to provide mechanical support or otherwise affix an additional IOL, electronic device, or the like to be placed inside the device2400. For example, haptics or other anchoring mechanisms of an IOL, electronic device, or the like can be configured to be slid into the one or more ridges2404. The one or more ridges2404can be located in between the anterior opening102and the posterior opening104. For example, the one or more ridges2404can be located at a substantially midpoint location between the anterior opening1202and the posterior opening104.

As such, the device2400can comprise three or more planes or positions within the device2400for affixing or placing an intraocular device, such as an IOL, electronic device, or the like. For example, a first intraocular device can be placed or affixed at the anterior end or opening102, a second intraocular device can be placed or affixed at the posterior end or opening104, and a third intraocular device can be placed or affixed at the one or more ridges2404and/or in the cavity108of the device. In certain embodiments, the device2400can be configured to hold more than one intraocular device inside the cavity108of the device, for example by providing more than one ridges2404. As such, in some embodiments, the device2400can be configured to hold three or more IOLs, refractive surfaces, other intraocular devices, and/or combination thereof within a single device2400.

In some embodiments, the anterior end102and/or posterior end104can be configured to affix a refractive surface110, intraocular lens, or other intraocular device specifically designed for use with the device2400. In contrast, the cavity108of the device2400can be configured to hold any generic and/or third-party designed or manufactured intraocular device and/or IOL.

In some embodiments, the device2400, when viewed from an anterior plan view as illustrated inFIG. 24B, can comprise a generally circular shape with an outer diameter of about 9.650 mm. In certain embodiments, the device2400, when viewed from an anterior plan view, can comprise a substantially circular shape with an outer diameter of about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10.0 mm, about 10.5 mm, about 11.0 mm, about 11.5 mm, about 12.0 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, the device2400, when viewed from a side view, can comprise a thickness, excluding any refractive surface or IOL attached, of about 3.50 mm. In some embodiments, the device2400, when viewed from a side view and excluding any refractive surface or IOL, can comprise a thickness of about 0.50 mm, about 1.00 mm, about 1.50 mm, about 2.00 mm, about 2.50 mm, about 3.00 mm, about 3.50 mm, about 4.00 mm, about 4.50 mm, about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the device2400can comprise an anterior opening102and/or posterior opening, for example to receive a refractive surface or IOL, comprising a diameter of about 6.350 mm. In certain embodiments, the device2400can comprise an anterior opening102and/or posterior opening, for example to receive a refractive surface or IOL, comprising a diameter of about 3.00 mm, about 3.50 mm, about 4.00 mm, about 4.50 mm, about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, the one or more ridges2404, when viewed from an anterior plan view as illustrated inFIG. 24B, can comprise an outer diameter of about 9.150 mm and an inner diameter of about 8.60 mm. In certain embodiments, the one or more ridges2404, when viewed from an anterior plan view, can comprise an outer diameter and/or inner diameter of about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10.0 mm, about 10.5 mm, about 11.0 mm, about 11.5 mm, about 12.0 mm, and/or within a range defined by two of the aforementioned values. In certain embodiments, the one or more ridges2404, when viewed from a side view, can comprise a thickness of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, and/or within a range defined by two of the aforementioned values.

Similar to the device illustrated inFIG. 19A, the device2400can also comprise a lip portion2406surrounding the posterior and/or anterior opening102,104to receive one or more tongue portions, one or more tabs, and/or one or more haptics of a refractive surface or IOL. The lip portion2406can comprise a certain thickness when viewed from an anterior plan view as illustrated inFIG. 24F. As such, the diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening102,104of the device2400, excluding the lip portion2406, can be about 7.00 mm and/or larger than the posterior and/or anterior opening. In certain embodiments, the diameter of a circular portion formed around the interior circumference of the anterior and/or posterior opening102,104of the device2400, excluding the lip portion2406can be about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, about 7.0 mm, about 7.1 mm, about 7.2 mm, about 7.3 mm, about 7.4 mm, about 7.5 mm, about 8.0 mm, about 8.1 mm, about 8.2 mm, about 8.3 mm, about 8.4 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10 mm, about 10.5 mm and/or within a range defined by two of the aforementioned values.

FIG. 25Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 25Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 25A.FIG. 25Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 25Aalong the line25C-25C ofFIG. 25B.FIG. 25Dillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 25Aalong the line25D-25D ofFIG. 25B.

The example prosthetic capsular device2500ofFIG. 25Aincludes some or all of the features of the example prosthetic capsular device2400illustrated inFIG. 24A, and like reference numerals include like features. For example, similar to the example prosthetic capsular device2400ofFIG. 24A, the example prosthetic capsular device2500ofFIG. 25Acan include one or more ridges2404, a single continuous sidewall2402, a posterior opening or end104, and an anterior opening or end102.

The example prosthetic capsular device2500shown inFIG. 25Afurther comprises a refractive surface or IOL2600attached thereto. The refractive surface or IOL2600can be attached to the posterior end104and/or substantially cover the posterior opening104. Similarly, the refractive surface or IOL2600can be attached to the anterior end102and/or substantially cover the anterior opening102. Due to the fact that the device2600, when separated from the refractive surface or IOL2600, comprises an anterior half that is substantially equal to the posterior half, it may not matter functionally whether the refractive surface or IOL2600is attached to the posterior end104or the anterior end102. In other words, the device2500can be said to comprise a posterior refractive surface or an anterior refractive surface. As discussed above in relation toFIG. 24A, one or more additional refractive surfaces or IOLs, electronic devices, or other intraocular devices can further be attached to the device, for example at the posterior or anterior end and/or along one or more ridges.

FIG. 26Aillustrates an anterior side perspective view of an example refractive surface or intraocular lens that can be configured to be used in conjunction with a prosthetic capsular device, such as the prosthetic capsular device ofFIG. 25Aand/or any other prosthetic capsular device described herein.FIG. 26Billustrates an anterior plan view of the example refractive surface or intraocular lens ofFIG. 26A.FIG. 26Cillustrates a cross-sectional view of the example refractive surface or intraocular lens ofFIG. 26Aalong the line26C-26C ofFIG. 26B.FIG. 26Dis a side plan view of the example refractive surface or intraocular lens ofFIG. 26A.

The refractive surface or IOL2600can comprise one or more similar features as those described in relation to the refractive surface2200in relation toFIG. 22A. The refractive surface or IOL2600can be configured to be attached to any one of the example prosthetic capsular devices disclosed herein. In particular, the refractive surface or IOL2600can be configured to be attached to the anterior and/or posterior end of the prosthetic capsular devices2400,2500.

In some embodiments, the optic or refractive surface2600can comprise a diameter of about 6.250 mm. In certain embodiments, the optic of refractive surface2600can comprise a diameter of about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, about 9.50 mm, about 10.00 mm, and/or within a range defined by two of the aforementioned values.

The refractive surface or IOL2600can comprise an anterior side or end2602and a posterior side or end2604. In some embodiments, the anterior side2602can be substantially equal to the posterior side2604, such that the anterior-posterior configuration of the refractive surface of IOL2600does not affect the operability or functionalities when affixing to a prosthetic capsular device. In other embodiments, the anterior side2602and the posterior side2604can have one or more different features, such as thickness, curvature, refractive power, or the like.

The refractive surface or intraocular lens2600can comprise two convex portions2600A,2600B. One of the two convex portions2600A can be configured to be placed in the interior of a prosthetic capsular device and the other convex portion2600B can be configured to be placed exterior to the prosthetic capsular device upon attachment thereto. In some embodiments, the two convex portions2600A,2600B can comprise substantially the same shape, area, and/or refractive power. This way, a refractive surface or intraocular lens2600can be configured such that the posterior-anterior configuration does not matter when attaching to a prosthetic capsular device. In other words, the refractive surface or intraocular lens2600can be flipped when attaching to a prosthetic capsular device and still obtain substantially the same function.

In some embodiments, the refractive surface or IOL2600comprises one or more tabs2600to facilitate attachment of the refractive surface or IOL2600to a prosthetic capsular device. For example, in the embodiment illustrated in theFIG. 26A, the refractive surface or IOL2600comprises four tabs2606. In other embodiments, a refractive surface or IOL2600can comprise one, two, three, five, six, seven, eight, nine, or ten tabs2606.

Each of the tabs2606can comprise a flap that is curved. Each of the tabs2606can comprise a flap that is curved in the same direction. Alternatively, some of the tabs2606can be curved in one direction and certain other tabs2606can be curved in another direction. For example, in the illustrated embodiment, two tabs2606A can extend towards the anterior end2602curving towards the posterior end2604, and the other two tabs2606B can extend towards the posterior end2604curving towards the anterior end2602. In other embodiments, the tabs2606can be substantially flat or planar.

In attaching a refractive surface or IOL2600to a prosthetic capsular device, one or more of the tabs can be configured to be placed through to the anterior end102or posterior end104of the device. Accordingly, as shown inFIG. 25A, two of four tabs2606can be placed in the interior of the device2500, while the other two tabs2606are placed exterior to a posterior end104of the device. Similarly, one tab2606can be placed in the interior of the device2500, while other tabs2606are placed exterior to the device.

Each of the plurality of tabs2606can extend from the refractive surface2600at an angle when viewed from a side plan view as illustrated inFIG. 26D. For example, in some embodiments, each or some of the plurality of tabs2606can initially extend from the refractive surface2600at an angle of about 45° in either direction. In certain embodiments, each or some of the plurality of tabs2606can initially extend from the refractive surface2600at an angle of about +/−10°, about +/−20°, about +/−25°, about +/−30°, about +/−35°, about +/−40°, about +/−45°, about +/−50°, about +/−55°, about +/−60°, about +/−70°, about +/−80°, about +/−90°, and/or within a range defined by two of the aforementioned values.

In some embodiments, each or some of the tabs2606, when viewed from a side plan view as illustrated inFIG. 26D, can comprise a height of about 0.50 mm. In certain embodiments, each or some of the tabs2606, when viewed from a side plan view as illustrated inFIG. 22D, can comprise a height of about 0.10 mm, about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm, about 0.60 mm, about 0.70 mm, about 0.80 mm, about 0.90 mm, about 1.0 mm, and/or within a range defined by two of the aforementioned values.

In certain embodiments, each or some of the one or more tabs2606can extend radially from about 30° of the circumference of the refractive portion of the optic2600. In some embodiments, each of the one or more tabs2606of an optic2600can extend radially from about 20°, about 40°, about 60°, about 80°, about 100°, about 120°, about 140°, about 160°, about 180°, about 200°, about 220°, about 240°, about 260°, about 280°, about 300°, about 320°, about 340°, about 360° of the circumference of the refractive portion of the optic2600, and/or within a range defined by two of the aforementioned values.

In some embodiments, each or some of the tabs2606, when viewed from an anterior plan view as illustrated inFIG. 26B, can comprise a width of about 2.0 mm. In certain embodiments, each or some of the tabs2606, when viewed from an anterior plan view as illustrated inFIG. 26B, can comprise a width of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, and/or within a range defined by two of the aforementioned values.

The refractive surface or IOL2600can comprise equal refractive power on each of the anterior and posterior halves. In other words, the refractive surface or IOL2600can be an equi-convex lens. As such, the orientation or direction in which the lens2600is inserted into the device can be disregarded as the lens can be reversible and symmetric along the anterior-posterior axis.

FIG. 27Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 27Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 27A.FIG. 27Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 27Aalong the line27C-27C ofFIG. 27B.FIG. 27Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 27A.

FIG. 28Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 28Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 28A.FIG. 28Cis a cross-sectional view of the example prosthetic capsular device ofFIG. 28Aalong the line28C-28C ofFIG. 28B.FIG. 28Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 28A.

The devices2700,2800can include some or all of the features of the example prosthetic capsular device2400illustrated inFIG. 24A, and like reference numerals include like features. The devices2700,2800can be self-expandable to keep the capsule fully open. The devices2700,2800can comprise three different planes. For example, a first plane can correspond with the posterior end104of the device, where a refractive surface or IOL can be attached. A second plane can correspond with the anterior end102of the device, where another refractive surface or IOL can be attached. A third plane can be positioned in between the posterior end and the anterior end, for example along ridges2704,2804.

The ridges2704,2804can be formed by the shape or curvature of the device2700,2800. In other words, instead of adding material to form the ridges, material can be removed from the device2700,2800to form ridges2704,2804. For example, a central portion of the device2700,2800when viewed from the view inFIG. 27D, can comprise a vertical portion that extends substantially perpendicular to anterior and posterior portions. The thickness of this vertical portion can be controlled to provide a slot or ridge of varying thickness.

In some embodiments, a prosthetic capsular device configured to be inserted in a natural capsular bag of an eye after removal of a lens can comprise a housing structure2700,2800capable of containing an intraocular device and/or an equiconvex refractive surface. In particular, the housing structure can comprise an anterior portion, wherein the anterior portion comprises a circular anterior opening, wherein the circular anterior opening is capable of allowing at least one of insertion, removal, or replacement of the intraocular device, and wherein the anterior opening is further configured to be coupled to a refractive surface to cover the circular anterior opening; a posterior portion, wherein the posterior portion comprises a circular posterior opening wherein the circular posterior opening is capable of allowing at least one of insertion, removal, or replacement of the intraocular device, and wherein the posterior opening is further configured to be coupled to a refractive surface to cover the circular posterior opening; and a continuous lateral portion interposed between the anterior portion and the posterior portion, wherein the continuous lateral portion protrudes radially beyond the anterior portion and the posterior portion, wherein the continuous lateral portion fully encloses a lateral side of the housing structure, wherein an internal cavity of the continuous lateral portion forms a groove for containing the intraocular device. The continuous lateral portion may not have any openings, for example along the lateral portion of the device in some embodiments. The housing structure2700,2800can be symmetrical over a plane at a midpoint of the continuous lateral portion between the anterior portion and the posterior portion. In certain embodiments, the equiconvex refractive surface can comprise a plurality of tabs for affixing the refractive surface to at least one of the circular anterior opening or the circular posterior opening, wherein the plurality of tabs protrudes from the refractive surface in alternating posterior and anterior directions.

As discussed above, one or more refractive surfaces, IOLs, lenses, optics, and/or other intraocular devices can be placed in the device2700,2800at the posterior opening104and/or anterior opening102. For example, a surgeon may initially insert a device with a posterior refractive surface into an eye of a patient. Depending on the outcome, the surgeon may insert a secondary IOL on the anterior opening of the device2700,2800to obtain better results. In other words, a secondary IOL can be placed on the anterior opening for fine tuning. Moreover, a diametric sensor and/or another IOL can be placed in the interior of the device2700,2800as well, for example along the ridges on the third plane.

The devices2700,2800can be symmetric and/or reversible so that they are the same right side up as upside down along the anterior-posterior axis. This can be advantageous in that the devices2700,2800can have a tendency to want to flip around as they are being inserted and a surgeon would not need to worry about the device flipping way or the other. In other words, the anterior half and the posterior half of the device2700,2800can be mirror images of each other. The device2700,2800can be made of silicone, while a refractive surface or IOL can be made of acrylic, and cut with a lathe such as CNC Lathing for example. It can be advantageous for the device2700,2800to be made of a material that can accommodate for stretching without tearing, but also has a sufficiently high durometer rating so that it maintains sufficient rigidity and stiffness inside the eye. For example, Med6210silicone can be used in some embodiments. In some embodiments, the device2700,2800can be substantially clear. In other embodiments, the device2700,2800can be made of opaque silicone and/or may comprise different colors, for example to accommodate for dysphotopsias from angles and/or ridges of the device2700,2800. A mold for the device2700,2800can be sandblasted so that the silicone forming the device2700,2800can comprise some texture in certain embodiments. It can be advantageous for the device to comprise a texturized surface to reduce glare and to diffuse light. In other embodiments, the device2700,2800can comprise a smooth surface.

The refractive surface or IOL ofFIG. 26A, for example, can be attached to the devices2700,2800. For example, a refractive surface or IOL can have four tabs, two of which can be placed in the interior of the device and two of which can be placed exterior to the device to lock the refractive surface or IOL in place. To secure the refractive surface or IOL with respect to the device2700,2800, two tabs can be pushed down to the exterior of the device2700,2800using an irrigation-aspiration (IA) device tip for example while the other two tabs remain inside the device2700,2800. In some embodiments, the tabs of the refractive surface or IOL, as shown inFIG. 26A, can be curved. The curvature of the refractive surface or IOL and/or the rigidity of the device2700,2800and tabs can substantially keep the lens in place with respect to the device2700,2800.

The tabs can comprise one or more eyelet openings in some embodiments. The one or more eyelet openings of each tab can be used for dialing or rotating the lens to a specific meridian. In addition, or alternatively, a surgeon may use the one or more eyelet openings to suture the optic to the device as necessary.

As discussed above, the device2700,2800and a lens for insertion into the device can both be symmetric and reversible along the posterior-anterior axis. Because the lens or refractive surface, for example shown inFIG. 26A, can comprise the equal refractive power on the anterior and posterior portions, there is no refractive surprise. Accordingly, the orientation or direction in which the device2700,2800and/or lens2600is inserted will not matter in some embodiments. A surgeon would not need to flip the device2700,2800or lens2600over too obtain the correct orientation, as either orientation, whether anterior-posterior or posterior-anterior, will be the same.

In some embodiments, the device2700,2800can be made in a number of different sizes or scales to accommodate for different patient biometry. For example, there can be a large, medium, and small sized device2700,2800(or any other combination of sizes) to accommodate for patients with different sized cataracts. By providing a number of devices2700,2800of varying sizes, surgeons can be able to select a particular device and/or optic for insertion in a particular patient.

In some embodiments, the devices2700,2800can comprise an anterior portion2750, a central portion2760, and a posterior portion2770. The anterior portion2750and the central portion2760can be mirror images of each other. The central portion2760can comprise a midline along which one-half of the central portion2760can be a mirror image of the other half of the central portion2760. The central portion2760can extend radially outward from the anterior portion2750and/or posterior portion2770. The central portion2760can extend from the anterior portion2750and/or posterior portion2770at an angle of substantially 90°, for example to prevent or substantially prevent post-operative capsular opacification (PCO). In certain embodiments, the central portion2760can extend from the anterior portion2750and/or posterior portion2770at an angle of about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, and/or within a range defined by two of the aforementioned values.

As such, as a non-limiting example, the device2700,2800can allow implantation of three or more lenses to obtain an optimal refractive power and/or a refractive power that is desired. Also, due to the symmetrical nature and/or configuration of the device2700,2800across a horizontal line, a surgeon can easily implant the device2700,2800without risk of inserting the device2700,2800in the wrong anterior-posterior orientation. Further, the optics or lens to be used in conjunction with the device2700,2800can also comprise a symmetrical configuration to allow for ease of implantation as discussed herein. Further, tabs on the lens or IOL can also be fully reversible.

As discussed herein, by providing one or more grooves and/or a central portion2760, it can be possible to exactly the pinpoint the location of an IOL or other intraocular device to be placed in the central portion2760and/or elsewhere in the device2700,2800. Further, the device2700,2800can also be used in conjunction with drug release devices, which can be placed inside the device2700,2800for example, to release drugs within the eye. As previously discussed, the device2700,2800can also provide a stable device for housing lenses and easy removal and/or insertion of lenses and/or other intraocular devices. Moreover, by use of lenses with positive and/or negative refractive powers, for example greater than +35 D and/or less than −35 D, a Galilean and/or reverse Galilean telescope can be provided within the eye by utilizing the space between the lenses within the device2700,2800. In other words, by using high powered plus and/or minus lenses, Galilean telescopes and/or microscopes can be created, for example for the purpose of object magnification and/or minimization. As non-limiting examples, such embodiments can have applications for certain conditions, such as macular degeneration and/or other conditions that cause loss of central vision. In certain embodiments, complex optical systems as such can be obtained by utilizing the ability of the device to separate lens optics within the capsule of the device. Such complex optical system can also be further fine-tuned over time by adjusting one or more optics placed inside the device through exchange.

In some embodiments, the anterior portion2750and/or posterior portion2770can comprise an outer diameter of about 8 mm and an inner diameter within the device2700,2800of about 7.50 mm. The opening(s) of the anterior portion2750and/or posterior portion2770can comprise a diameter of about 6.35 mm. In some embodiments, the central portion2760can comprise an outer diameter of about 10.0 mm and an inner diameter within the interior of the device2700,2800of about 9.50 mm. In certain embodiments, the outer diameter of the anterior portion2750and/or posterior portion2770, the inner diameter of the anterior portion2750and/or posterior portion2770within the device2700,2800, the opening(s) of the anterior portion2750and/or posterior portion2770, the outer diameter of the central portion2760, and/or the inner diameter of the central portion2760within the interior of the device2700,2800can be about 3.00 mm, about 4.00 mm, about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, about 9.50 mm, about 10.00 mm, about 10.50 mm, about 11.00 mm, about 11.50 mm, about 12.00 mm, about 12.50 mm, about 13.00 mm, about 14.00 mm, about 15.00 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, a thickness of the device2700,2800when viewed from a side view and measured from an outer end of the anterior portion2750to an outer end of the posterior portion2770can be about 3.50 mm. In other embodiments, a thickness of the device2700,2800, when viewed from a side view and measured from an outer end of the anterior portion2750to an outer end of the posterior portion2770, can be about 3.00 mm. In certain embodiments, a thickness of the device2700,2800, when viewed from a side view and measured from an outer end of the anterior portion2750to an outer end of the posterior portion2770, can be about 0.50 mm, about 1.00 mm, about 1.50 mm, about 2.00 mm, about 2.50 mm, about 3.00 mm, about 3.50 mm, about 4.00 mm, about 4.50 mm, about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 8.00 mm, about 9.00 mm, about 10.00 mm, and/or within a range defined by two of the aforementioned values.

In some embodiments, when viewed from a side view, the anterior portion1750, central portion2760, and/or posterior portion1770can comprise an inner thickness, as measured between two internal surfaces of the device2700,2800, of about 1.25 mm. In certain embodiments, the anterior portion1750, central portion2760, and/or posterior portion1770, when viewed from a side view, can comprise an inner thickness, as measured between two internal surfaces of the device2700,2800, of about 0.25 mm, about 0.50 mm, about 0.75 mm, about 1.00 mm, about 1.25 mm, about 1.50 mm, about 1.75 mm, about 2.00 mm, about 2.25 mm, about 2.50 mm, about 2.75 mm, about 3.00 mm, and/or within a range defined by two of the aforementioned values.

FIG. 29Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 29Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 29A.FIG. 29Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 29Aalong the line29C-29C ofFIG. 29B.FIG. 29Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 29A.

The device2900can include some or all of the features of the example prosthetic capsular devices2700,2800illustrated inFIGS. 27A and 28A, and like reference numerals include like features. The device2900is shown with an IOL2901placed in the interior of the device2900and/or a central portion thereof, for example along the ridges therein. As illustrated, one or more haptics of the IOL2901can be configured to be placed within the ridge of the device2900.

FIG. 30Aillustrates an anterior plan view of another example prosthetic capsular device.FIG. 30Billustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 30Aalong the line30B-30B ofFIG. 30A.

FIG. 31Aillustrates an anterior side perspective view of another example prosthetic capsular device.FIG. 31Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 31A.FIG. 31Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 31Aalong the line31C-31C ofFIG. 31B.FIG. 31Dillustrates a side plan view of the example prosthetic capsular device ofFIG. 31A.

The device3100can include some or all of the features of the example prosthetic capsular devices2700,2800illustrated inFIGS. 27A and 28A, and like reference numerals include like features. In contrast to the devices2700,2800, a central portion of the device3100that extends upwards and downwards, when viewed in the orientation ofFIG. 31D, may not be perpendicular to the posterior portion and/or the anterior portion. Rather, this central portion or the outer surface thereof can be angled, for example at 70 degrees. This can be advantageous for providing additional rigidity and structure to the device; however, this configuration may add to the amount of material to the device. All other features of the device3100can be similar to those described in conjunction with devices2700,2800.

FIG. 32Aillustrates an anterior side perspective view of another example refractive surface or intraocular lens that can be configured to be used in conjunction with a prosthetic capsular device.FIG. 32Billustrates an anterior plan view of the example refractive surface or intraocular lens ofFIG. 32A.FIG. 32Cillustrates a cross-sectional view of the example refractive surface or intraocular lens ofFIG. 32Aalong the line32C-32C ofFIG. 32B.FIG. 32Dillustrates a side plan view of the example refractive surface or intraocular lens ofFIG. 32A.

FIG. 32illustrates an anterior plan view of another example refractive surface or intraocular lens. The refractive surface, IOL, lens, or optic3200shown inFIG. 32can be configured to be attached to any prosthetic capsular device disclosed herein, such as the devices2400,2500,2700,2800,3100illustrated inFIGS. 24, 25, 27, 28, and 31among others. In particular, the refractive surface or IOL3200can be configured to be attached to the anterior and/or posterior end of a prosthetic capsular device2400,2500,2700,2800,3100.

The optic3200can include one or more features as the optic2600ofFIG. 26A. For example, in some embodiments, the refractive portion of the optic3200can comprise a diameter of about 6.250 mm. In certain embodiments, the refractive portion of the optic3200can comprise a diameter of about 5.00 mm, about 5.50 mm, about 6.00 mm, about 6.50 mm, about 7.00 mm, about 7.50 mm, about 8.00 mm, about 8.50 mm, about 9.00 mm, about 9.50 mm, about 10.00 mm, and/or within a range defined by two of the aforementioned values.

Similar to the optic2600, the refractive surface or IOL3200can comprise an anterior side or end3202and a posterior side or end3204. In some embodiments, the anterior side3202can be substantially equal to the posterior side3204, such that the anterior-posterior configuration of the refractive surface of IOL3200does not affect the operability or functionality when affixing to a prosthetic capsular device. In other embodiments, the anterior side3202and the posterior side3204can have one or more different features, such as thickness, curvature, refractive power, or the like.

The refractive surface or intraocular lens3200can comprise two convex portions3200A,3200B. One of the two convex portions3200A can be configured to be placed in the interior of a prosthetic capsular device and the other convex portion3200B can be configured to be placed exterior to the prosthetic capsular device upon attachment thereto. In some embodiments, the two convex portions3200A,3200B can comprise substantially the same shape, area, and/or refractive power. In other words, the optic3200can be an equiconvex lens and/or be symmetrical along the anterior-posterior axis. This way, a refractive surface or intraocular lens3200can be configured such that the posterior-anterior configuration thereof does not matter when attaching to a prosthetic capsular device. In other words, the refractive surface or intraocular lens3200can be flipped when attaching to a prosthetic capsular device and still obtain substantially the same function.

In contrast to the optic2600ofFIG. 26A, the optic3200can include six tabs3206in some embodiments. For example, three of the six tabs3206A can be curved towards the posterior end of the lens, and the other three tabs3206B can be curved towards the anterior end of the lens. One or more tabs3206can facilitate attachment of the refractive surface or IOL3200to a prosthetic capsular device. In certain embodiments, a refractive surface or IOL3200can comprise one, two, three, four, five, six, seven, eight, nine, or ten tabs2606.

Each of the tabs3206can comprise a flap that is curved in the same or alternating direction. For example, in the illustrated embodiment, three tabs3206B can extend from the anterior side3202, and the other three tabs3606A can extend from the posterior end3204. In other embodiments, the tabs2606can be substantially flat or planar.

In attaching a refractive surface or IOL3200to a prosthetic capsular device, one or more of the tabs can be configured to be placed through the anterior end102or posterior end104of the device. For example, three of the six tabs3206can be placed in the interior of the device, while the other tabs can be placed exterior to the device.

In certain embodiments, each or some of the one or more tabs3206can extend radially from about 30° of the circumference of the refractive portion of the optic3200. In some embodiments, each or some of the one or more tabs3206of an optic3200can extend radially from about 20°, about 40°, about 60°, about 80°, about 100°, about 120°, about 140°, about 160°, about 180°, about 200°, about 220°, about 240°, about 260°, about 280°, about 300°, about 320°, about 340°, about 360° of the circumference of the refractive portion of the optic3200, and/or within a range defined by two of the aforementioned values.

In some embodiments, each or some of the tabs3206, when viewed from an anterior plan view can comprise a width of about 2.0 mm. In certain embodiments, each or some of the tabs3206, when viewed from an anterior plan view, can comprise a width of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, and/or within a range defined by two of the aforementioned values.

Each of the tabs can further comprise one or more eyelet openings3204. The one or more eyelets3204can be used to fasten or fixate the optic3200in a particular location or configuration relative to a prosthetic capsular device. In some embodiments, an angle between the center points of two eyelet openings3204can be about 60°. In certain embodiments, an angle between the center points of two eyelet openings3204can be about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°, about 110°, about 120°, about 130°, about 140°, about 150°, about 160°, about 170°, about 180°, and/or within a range defined by two of the aforementioned values.

Tubular Devices, Systems, and Methods

FIG. 33Aillustrates an anterior side perspective view of an example prosthetic capsular device.FIG. 33Billustrates an anterior plan view of the example prosthetic capsular device ofFIG. 33A.FIG. 33Cillustrates a cross-sectional view of the example prosthetic capsular device ofFIG. 33Aalong the line33C-33C ofFIG. 33B.

In some embodiments, the device3300includes features described with respect to the devices described in U.S. Pat. No. 9,358,103, which is hereby incorporated by reference in its entirety, or modifications thereof. For example, the device3300can comprise an anterior side3302, a posterior side3304, and sidewalls3306extending between the anterior side3302and the posterior side3304; the anterior side3302comprises an opening3308; the posterior side3304optionally comprises a refractive surface3310; the prosthetic device3300comprises a ring structure3320(e.g., comprising ring structure portions3320A,3320B,3320C,3320D) coupled to a housing structure3312comprising the anterior side3302, posterior side3304, and sidewalls3306; and the ring portions3320A,3320B,3320C,3320D comprising aperture sections3327comprising openings3328, which may also or alternatively be slits.

The device3300comprises openings3326A,3326B in the posterior side3304of the housing structure3312. Each of the openings3326A,3326B may be the same as the others of the openings3326A,3326B. At least one of the openings3326A,3326B may be different than at least one of the other openings3326A,3326B. The openings3326A,3326B may inhibit or prevent entrapment of fluid or potentially residual viscoelastic material after implantation of the device3300, for example by allowing anterior-posterior fluid flow along with the anterior opening3308.

The openings3326A,3326B may be formed during formation of the housing structure3312(e.g., as part of a molding process) and/or formed after formation of the housing structure3312(e.g., by a laser, chemical, or mechanical removal process). In some implementations, the housing structure3312may comprise a different material around the openings3326A,3326B (e.g., the housing structure3312comprising silicone and the opening surrounding material comprising polyimide). In some implementations, the housing structure3312may comprise thicker material around the openings3326A,3326B (e.g., to buttress the openings3326A,3326B, for example if another device is to be anchored to the openings3326A,3326B). In some implementations, the housing structure3312may comprise thinner material around the openings3326A,3326B (e.g., for easier removal of material and/or opening formation).

The openings3326A,3326B can allow evacuation of prosthetic capsular device3300viscoelastic material from behind the refractive surface3310and/or the posterior wall of the housing structure3312. The openings3326A,3326B can provide access to the posterior capsule. For example, if a primary posterior capsulotomy was created (e.g., using a femtosecond laser after implantation of the device3300), the openings3326A,3326B could allow use of forceps to grab a cut posterior capsulorhexis and remove it from the eye. Openings3326A,3326B on each side of the refractive surface3310may allow the refractive surface3310to tilt (e.g., along the major axis if the openings3326A,3326B are on opposite sides of the major axis), which may allow greater access to an area posterior to the refractive surface3310.

The openings3326A,3326B can hold or otherwise interact with a drug eluting device. The openings3326A,3326B can allow a medicament access to the posterior capsule (e.g., for treatment of retinal and/or uveal diseases). The openings3326A,3326B may allow a drug contained in the device3300to reach a posterior segment of the eye (e.g., vitreous, retina, choroid). The openings3326A,3326B may allow a slow release anti-VEGF injectable (e.g., ranibizuman (e.g., Lucentis® from Genentech), aflibercept (e.g., Eylea® from Regerneron Pharmacueticals) or anti-VEGF produced from cells (e.g., from Neurotech) contained in the device3300to reach a posterior segment of the eye (e.g., vitreous, retina, choroid) for treatment of macular degeneration.

The refractive surface3310may have a diameter between about 4 mm and about 9 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, ranges between such values, etc.). In some embodiments, the openings3326A,3326B are spaced from the outer circumference of the refractive surface3310by between about 0.2 mm and about 1 mm (e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, ranges between such values, etc.). In some embodiments, the openings3326A,3326B comprise arcs of a circle having a diameter3330between about 4.5 mm and about 9.5 mm (e.g., about 4.5 mm, about 5.5 mm, about 4.5 mm, about 4.5 mm, about 4.5 mm, about 9.5 mm, ranges between such values, etc.). For example, if the refractive surface3310has a diameter of 5 mm and the openings3326A,3326B are spaced from the outer circumference of the refractive surface3310by 0.5 mm, the openings3326A,3326B would have a diameter3330of 5.5 mm.

The outer or under certain circumstances maximum diameter3332of the device3300, for example accounting for extension of the ring structure3320, may be between about 9 mm and about 12 mm (e.g., about 9 mm, about 9.5 mm, about 10 mm, about 10.3 mm, about 10.5 mm, about 11 mm, about 12 mm, ranges between such values, etc.).

The openings3326A,3326B may have a thickness or width3334between about 0 mm (e.g., being slits as described with toFIG. 33F) and about 0.5 mm (e.g., about 0 mm, about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, ranges between such values, etc.). In some embodiments, the openings3326A,3326B are sized such that there is little or no pressure gradient from posterior to anterior, for example during anterior decompression. The openings3326A,3326B may be small enough in size that there is a low likelihood of vitreous prolapse through the openings3326A,3326B.

In some embodiments, the openings3326A,3326B comprise arcs of a circle. The openings3326A,3326B may comprise a circumferential angle between about 30° and about 120° (e.g., about 30°, about 45°, about 60°, about 75°, about 90°, about 105°, about 120°, ranges between such values, etc.). The openings3326A,3326B are illustrated as being mirror-image circular arc openings, but other shapes are also possible (e.g., polygonal (e.g., rectangular), arcuate (e.g., circular, ellipsoid, oval), slits, combinations thereof, and the like). The openings3326A,3326B are illustrated as being on opposite sides of the major axis, but openings can also or alternatively be on opposite sides of the minor axis, on one side of an axis, crossing one or more axes, etc.

In some embodiments, the device3300comprises a bulge3316. In some embodiments, the bulge3316extends radially outward of the sidewalls3306(e.g., as shown inFIGS. 33A and 33B). In some embodiments, the bulge3316extends radially inward of the sidewalls3306. In some embodiments, the bulge3316extends radially inward and radially outward of the sidewalls3306. The device3300includes a bulge3316on each end portion. In some embodiments, the bulge3316can be limited to portions around ring structure portion anchors. The housing structure3312may comprise the bulge3316(e.g., the bulge3316being integral with the housing structure3312). In some implementations, the ring structure3320is placed in a mold and the housing structure3312is over-molded around the ring structure3320. The bulge3316may be coupled to the housing structure3312. The bulge3316may comprise the same material as the housing structure3312or a different material than the housing structure3312. The bulge3316may allow the anchors to be substantially radially aligned with, radially outward of, or radially inward of the sidewalls3306. The bulge3316may provide extra material in which the ring structure3320may anchor, for example maintaining a wall thickness (e.g., about 0.2 mm) on one or both sides of the ring structure3320with or without the use of a primer. The bulge3316may allow the material of the housing structure3312to surround (e.g., completely surround) the anchoring portions of the ring structure portion3320, which can avoid an area of weakness and/or discontinuity of the housing structure3312. The device3300includes bulges3316that extend along the entire edge portions of the housing structure3312, even beyond the termination of the anchor portions. In some implementations, the device includes bulges3316that extend slightly beyond the termination of the anchor portions.

The device3300optionally comprises a posterior fin3324. The device3300shown includes two posterior fins3324. The posterior fins3324are aligned along a diameter of the refractive surface3310and in line with the major axis of the prosthetic device3300. In some implementations, a plurality of posterior fins3324(e.g., 2, 3, 4, 5, 6, or more fins3324) may be circumferentially offset (e.g., by about 180°, by about 120°, by about 90°, by about 72°, by about 60°, and the like). In some implementations, at least some or all of a plurality of posterior fins3324(e.g., 2, 3, 4, 5, 6, or more fins3324) may be unaligned. The posterior fins3324are aligned along a major axis of the device3300. In some implementations, the posterior fins3324may be aligned along a minor axis of the device3300. In some implementations, the posterior fins3324may be unaligned along an axis of the device3300(e.g., at an angle with respect to the major axis and/or the minor axis). The housing structure3312may comprise the posterior fin3324(e.g., the posterior fin3324being integral with the housing structure3312). The posterior fin3324may be coupled to the housing structure3312. The posterior fin3324may comprise the same material as the housing structure3312or a different material than the housing structure3312. The posterior fin3324may help to space a posterior surface of a natural capsular bag from the posterior end3304of the housing structure3312radially outward of the refractive surface3310. Spacing the posterior surface of the natural capsular bag from the posterior end3304of the housing structure3312radially outward of the refractive surface3310may allow fluid flow radially outward of the refractive surface3310, which may help to reduce opacification. Spacing the posterior surface of the natural capsular bag from the posterior end3304of the housing structure3312radially outward of the refractive surface3310may reduce the chance of retaining viscoelastic that has some residual trapped fibrin or inflammatory precipitate contained within it. In some embodiments, the posterior fin3324may extend anterior from the posterior of the housing structure3312into the cavity of the housing structure3312. In some embodiments, the posterior fin comprises a roughened or opacified interior and/or exterior surface of the housing structure3312(e.g., having the same thickness and material as the posterior wall radially outward of the refractive surface3310but treated to provide an alignment mark).

In embodiments in which the fins3324are aligned with the major axis of the device3300, the device3300can be strategically aligned in an eye. For example, if an eye has astigmatism, a device3300in which the refractive surface3310comprises a toric lens can be used to at least partially correct the astigmatism if the device3300is properly oriented (e.g., with the steep axis of a cornea). In some implementations, at least one of the fins3324can be different (e.g., different shape, dimensions, etc.) to indicate a top or bottom of the device3300. In devices allowing any rotational orientation of an IOL inserted therein, a toric IOL can be rotated. The device3300includes truncated sides, reducing volume and in some cases advantageously limiting rotation of an IOL inserted therein. Aligning the device3300for alignment of a toric refractive surface3310and/or a toric IOL contained in the device3300can advantageously provide the advantages of limited IOL rotation, reduced volume, and astigmatism correction.

FIG. 34illustrates an anterior side perspective view of another example prosthetic capsular device3400. The device3400includes some or all of the features of the device3300, and like reference numerals include like features. The device3400additionally comprises a first side aperture3330A and a second side aperture3330B. The side apertures3330A,3330B are configured to couple a tubular device to the housing structure3312of the capsular device3400.

In some embodiments, the device3400may comprise a single side aperture3330. In some embodiments, the device3400may comprise more than two side apertures3330. The side apertures3330A,3330B are shown on flat sides of the housing structure3312, although other locations (e.g., including towards ends of flat sides, on arcuate sidewalls, on the anterior side3302, on the posterior side3304, and combinations thereof) are also possible. The side apertures3330A,3330B are show as through-holes. In some embodiments, the side apertures3330A,3330B may also or alternatively comprise slits.

FIG. 35Ais a side perspective view of an example tubular device3500. The tubular device3500is configured to be coupled to a side aperture3330of the device3400. The tubular device3500provides a fluid flow pathway from inside the cavity3306of the device3400to a second location. In some embodiments, the second location is through the pars plana and on top of the sclera, which can be beneath the Tenon's capsule and conjunctiva.

The tubular device3500comprises a tubular portion3532. The tubular portion3532has a generally cylindrical shape that is flexible enough to bend and rigid enough to resist collapsing and kinking. The tubular portion3532can be made of a biologically compatible material including but not limited to silicone, silicone polymers, SIBS (poly(styrene-block-isobutylene-block-styrene)), acrylic, acrylic polymers, polypropylene, polycarbonate, and Gore-Tex.

The tubular portion3532at least partially defines a lumen3536configured to allow fluid flow. The lumen3536and/or tubular portion3532may have an internal diameter between about 30 and about 100 microns. In certain embodiments, the lumen3536and/or tubular portion3532may have an internal diameter between about 1 micron and about 200 microns. The lumen3536and/or tubular portion3532may also have a length between 3 mm and 10 mm. In certain embodiments, the lumen3536and/or tubular portion3532may have a length between about 1 mm and about 20 mm. The lumen3536and/or tubular portion3532may also be longer with the ability for the implanting surgeon to trim the length to the appropriate size for a given patient.

In some embodiments, the tubular device3500is a “dumb” or passive tubular device in that the lumen3536is not restricted and can allow fluid flow therethrough at all times. The tubular portion3532can comprise an inflow end and an outflow end. The inflow end can be located at or near the device3400to allow inflow of fluid from inside the device3400or the eye. The outflow end can be located at or near the second location to allow outflow of fluid to the second location.

The tubular device3500is also illustrated as comprising an optional flange3534. The optional flange3534can have a generally cylindrical shape with a diameter larger than the diameter of the tubular portion3532. The flange3534can be configured to be inserted into a side aperture3330to couple the tubular device3500to a housing structure3312of a capsular device3400. The circumference of the flange3534can be substantially the same or slightly smaller than the circumference of a side aperture3330of a housing structure3312.

In some embodiments, the flange3534is made of the same material as the tubular portion3532. In certain embodiments, however the flange3534may also or alternatively be made of a combination of biocompatible materials including but not limited to silicone, silicone polymers, SIBS (poly(styrene-block-isobutylene-block-styrene)), acrylic, acrylic polymers, polypropylene, polycarbonate, and Gore-Tex. A diameter of the flange3534can be between approximately 1 mm and 3 mm. In certain embodiments, the diameter of the flange3534can be between about 0.1 mm and about 10 mm.

The flange3534can be configured to be substantially anchored in place in a side aperture3330by friction or chemical glue to substantially fixate the tubular device3500. In some embodiments, the flange3534can comprise a deformable material that can be compressed to fit the flange3534in a side aperture3330. Once fit inside a side aperture3330, the flange can expand to substantially anchor the flange3534in place inside the side aperture3330.

In certain embodiments, the circumference of the flange3534can be larger than the circumference of a side aperture3330of a housing structure312. As such, only the tubular portion3532can be configured to be inserted into a side aperture3330, while the flange3534remains inside the cavity of the housing structure3312. A flange3534with a circumference that is larger than a circumference of a side aperture3330can substantially prevent the tubular device3500from being pushed out of the side aperture3330in a general direction away from the cavity of the housing structure3312. The larger circumference of the flange3534can provide a stopping mechanism to prevent the tubular device3500from falling out of the side aperture3330with a smaller circumference.

FIG. 35Bis a side perspective view of another example tubular device3502. Similar to the tubular device3500illustrated inFIG. 35A, the tubular device3502is configured to be coupled to a side aperture3330of the device3400. The tubular device3502includes some or all of the features of the tubular device3500, and like reference numerals include like features. The tubular device3502can be similar to the tubular device3500except for the flange3538and fluid control3540.

In some embodiments, the shape of the flange3538can comprise a trapezoidal cylinder shape. For example, the flange3538can comprise a top surface and a bottom surface, in which the top surface, and/or a diameter or circumference thereof, is larger than the bottom surface, and/or a diameter or circumference thereof. In other embodiments, the top surface, and/or a diameter or circumference thereof, can be smaller than the bottom surface and/or a diameter or circumference thereof. Both the top and bottom surfaces, and/or diameters or circumferences thereof, can be larger than the tubular portion3532and/or a diameter or circumference thereof.

The flange3538can be configured to be inserted into a side aperture3330to couple the tubular device3500to a housing structure3312of a capsular device3400. The side aperture3330, and/or a diameter or circumference thereof, can be larger than a bottom surface of the flange3538, and/or a diameter or circumference thereof, and smaller than a top surface of the flange3538and/or a diameter or circumference thereof. Similarly, in other embodiments, a side aperture3330can be smaller than a bottom surface of the flange3538, and/or a diameter or circumference thereof, and larger than a top surface of the flange3538and/or a diameter or circumference thereof. In some embodiments, the size of a side aperture3330, and/or a diameter or circumference thereof, can be substantially equal to an average of a top surface and a bottom surface of the flange3538, and/or diameters or circumferences thereof.

In embodiments in which the top surface of the flange3538is larger than the bottom surface of the flange3538, the tubular device3502can be configured to be inserted into a side aperture3330starting with the bottom surface of the flange3538towards the top surface. As the tubular device3502is being inserted into a side aperture3330, the flange3538may become stuck in the side aperture3330at a point between the bottom surface and the top surface of the flange3538, for example where the diameter or circumference of the side aperture3330is substantially equal to that of the flange3538. Accordingly, the tubular device3502can be substantially anchored or fixated in place in a side aperture3330by friction and/or mechanical fitting.

In some embodiments, the tubular device3502is a “smart” tubular device comprising a fluid control3540. The fluid control3540can be configured to alter the lumen3536between an open configuration and a restricted configuration to allow or disallow fluid flow therethrough. In addition or alternatively, the fluid control3540can be configured to alter between a configuration that actively facilitates fluid flow through the lumen3536and a configuration that does not.

More specifically, the fluid control3540can be a valve that is configured to open or close to allow or disallow fluid flow through the lumen3536. The valve can be located anywhere along the lumen3536. For example, the valve can be located at or near an inflow end of the lumen3536, at or near an outflow end of the lumen3536, in between the inflow end and outflow end of the lumen3536, or a substantially midpoint of the lumen3536between the inflow end and outflow end thereof.

The valve can be configured to be open and close based on an intraocular pressure setting. For example, if the intraocular pressure is too high or is above a predetermined level, the valve can be configured to open to allow fluid flow from the inside of the eye to the outside of the eye to decrease the intraocular pressure. Conversely, if the intraocular pressure is too low or is below a predetermined level, the valve can be configured to close to prevent fluid flow. In some embodiments, one or more intraocular pressure sensors of the device3400and/or tubular device3500can be configured to detect the intraocular pressure and electronically transmit the detected pressure to a processor configured to open and/or close the valve.

In some embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or above about 20 mmHg. In certain embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or above about 10 mmHg, 11 mmHg, 12 mmHg, 13 mmHg, 14 mmHg, 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, and/or within a range defined by two of the above-identified values.

In some embodiments, the valve can be configured to close when the intraocular physiologic pressure is at or below about 6 mmHg. In certain embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or below about 1 mmHg, about 2 mmHg, about 3 mmHg, about 4 mmHg, about 5 mmHg, about 6 mmHg, about 7 mmHg, about 8 mmHg, about 9 mmHg, about 10 mmHg, about 11 mmHg, about12 mmHg, about 13 mmHg, about 14 mmHg, about 15 mmHg, about 16 mmHg, about17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, and/or within a range defined by two of the above-identified values. The fluid control3540can also or alternatively be a pump or micro pump. The pump or micro pump can be located at or near an inflow end of the lumen3536, at or near an outflow end of the lumen3536, in between the inflow end and outflow end of the lumen3536, or a substantially midpoint of the lumen3536between the inflow end and outflow end thereof. The pump or micro pump can be configured to actively force fluid from inside of the eye to the outside of the eye. For example, if the intraocular pressure is too high or is above a predetermined level, the pump or micro pump can be configured to actively force fluid to flow from the inside of the eye to the outside of the eye to decrease the intraocular pressure. Conversely, if the intraocular pressure is too low or is below a predetermined level, the pump or micro pump can be configured to stop. In some embodiments, one or more intraocular pressure sensors of the device3400and/or tubular device3500can be configured to detect the intraocular pressure and electronically transmit the detected pressure to a processor configured to turn the pump or micro pump on or off.

In some embodiments, the pump or micro pump can be configured to actively facilitate fluid removal when the intraocular physiologic pressure is at or above about 20 mmHg. In certain embodiments, the pump or micro pump can be configured to actively facilitate fluid removal when the intraocular physiologic pressure is at or above about 10 mmHg, 11 mmHg, 12 mmHg, 13 mmHg, 14 mmHg, 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, and/or within a range defined by two of the above-identified values.

In some embodiments, the pump or micro pump can be configured to stop facilitating fluid removal when the intraocular physiologic pressure is at or below about 6 mmHg. In certain embodiments, the pump or micro pump can be configured to stop facilitating fluid removal when the intraocular physiologic pressure is at or below about 1 mmHg, about 2 mmHg, about 3 mmHg, about 4 mmHg, about 5 mmHg, about 6 mmHg, about 7 mmHg, about 8 mmHg, about 9 mmHg, about 10 mmHg, about 11 mmHg, about 12 mmHg, about 13 mmHg, about 14 mmHg, about 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, and/or within a range defined by two of the above-identified values.

FIG. 35Cis a side perspective view of another example tubular device3504. Similar to the tubular devices3500,3502illustrated inFIGS. 35A and 35B, the tubular device3504is configured to be coupled to a side aperture3330of the device3400. The tubular device3504includes some or all of the features of the tubular devices3500,3502, and like reference numerals include like features. The tubular device3504can be similar to the tubular devices3500,3502except for the tubular portion3540, through holes3544, and tab or plate3546.

In some embodiments, the tubular portion3540and/or lumen3536is tapered towards the outflow end, for example to prevent conjunctival erosion. The tubular device3504can also comprise one or more tabs or plates3544. The one or more tabs3544can be coupled to an outflow end of the tubular portion3532. The one or more tabs3544can be configured to prevent encapsulation of the outflow end of the tubular portion3532, for example in the pars plana. In some embodiments, the tubular device3504can comprise only one tab3544. In certain embodiments, the tubular device3504can comprise two tabs3544in a substantially flat or planar configuration, in which an angle between the two tabs3544is about 180°. In other embodiments, the tubular device3504can comprise three tabs3544, in which an angle between any two of the three tabs can be about 120°. In certain embodiments, the tubular device3504can comprise four, five, six, seven, eight, nine, or ten tabs, in which the angle between any two tabs can be substantially equal or different.

The one or more tabs3544may comprise one or more eyelets3548. For example, one tab3544can comprise one, two, three, four, or five eyelets3548. In some embodiments, each tab3544can comprise one eyelet3548. The eyelet3548can be configured to fixate the outflow end of the tubular portion3532. For example, the eyelet3548can be configured to fixate the outflow end of a sub-conjunctival tube to the sclera. The one or more eyelets3548can allow for sutures for fixating the outflow end of the tubular portion3532.

The flange3542can comprise one or more through holes3544. For example, the flange3542can comprise one, two, three, four, or five through holes3544. The one or more through holes3544can be configured to fixate the inflow end of the tubular device3504. For example, one or more screws, nuts, sutures, or the like can be inserted through the one or more through holes3544to fixate the tubular device3504to the housing structure3312.

FIG. 35Dis a side perspective view of another example tubular device3506. Similar to the tubular devices3500,3502,3504illustrated inFIGS. 35A, 35B, and 35C, the tubular device3506is configured to be coupled to a side aperture3330of the device3400. The tubular device3506includes some or all of the features of the tubular devices3500,3502,3504, and like reference numerals include like features. The tubular device3506can be similar to the tubular devices3500,3502,3504except for comprising a plurality of flanges3534,3538.

In some embodiments, the tubular device3506comprises a plurality of flanges3534,3538. For example, the tubular device3506can comprise two, three, four, or five flanges. In some embodiments, the plurality of flanges can have the same or substantially same shape. In other embodiments, one or more of the plurality of flanges can have a different shape.

In the depicted embodiment, the tubular device3506comprises a first flange3534and a second flange3538. The first flange3534can be similar to the flange described above in connection withFIG. 35A. The second flange3538can be similar to the flange described above in connection withFIG. 35B.

The tubular device3506can be inserted through a side aperture3330of the device3400in a general direction starting with the second flange3538towards the first flange3534. The first flange3534, the second flange3538, and/or both can be made of a deformable or compressible material. For example, as the tubular device3506is being inserted through a side aperture3330, the second flange3538can be configured to be compressed. The tapered configuration or trapezoidal cylinder shape of the second flange3538can allow the second flange3538to be inserted completely through the side aperture3330. The first flange3354, however, can be configured not to be inserted through the side aperture3330due its cylindrical shape and/or non-compressible material. Accordingly, the periphery of the side aperture3330can be configured to be located between the first flange3534and the second flange3538when the tubular device3536is coupled to the housing structure3312, thereby preventing the tubular device3506from moving in either direction.

FIG. 35Eis a side perspective view of another example tubular device3508. Similar to the tubular devices3500,3502,3504,3506illustrated inFIGS. 35A, 35B, 35C, and 35D, the tubular device3508is configured to be coupled to a side aperture3330of the device3400. The tubular device3508includes some or all of the features of the tubular devices3500,3502,3504, and3506, and like reference numerals include like features. The tubular device3508can be similar to the tubular devices3500,3502,3504,3506except that the tubular device3508does not comprise a flange and that the tubular device3508comprises one or more tabs3546a,3546bat each end of the tubular device3508.

In some embodiments, the tubular device3508does not comprise a flange. Instead, the tubular device3508can comprise one or more other structures for fixating the tubular device3508with respect to the housing structure3312and/or eye. For example, the tubular device3508can comprise one or more tabs or plates3546a,3546b.

In the depicted embodiment, the tubular device3508comprises one tab or plate3546a,3546bat each end of the tubular portion3536. In other words, the inflow end of the tubular portion can comprise a tab or plate3546a, and the outflow end of the tubular portion can comprise a tab or plate3546b. In certain embodiments, the inflow end and/or outflow end of the tubular portion can each comprise one, two, three, four, or five tabs or plates.

Each tab or plate3546a,3546bcan comprise one or more eyelets3548. For example, one tab can comprise one, two, three, four, or five eyelets3548. In the depicted embodiment, each tab3546a,3546bcomprises one eyelet3548. The eyelet3548can be configured to fixate the inflow end and/or outflow end of the tubular portion3532. For example, one or more screws, nuts, sutures, or the like can be inserted through an eyelet3548of a tab3546alocated at or near the inflow end to fixate the inflow end to the housing structure3312, side aperture3330, and/or natural capsular bag. Similarly, one or more screws, nuts, sutures, or the like can be inserted through an eyelet3548of a tab3546blocated at or near the outflow end to fixate the outflow end to the second location, such as the sub-Tenon's space.

FIG. 36is an anterior side perspective view of an example prosthetic capsular device system3600including the device3400ofFIG. 34Aand the tubular device3500ofFIG. 35A. As illustrated, the tubular device3500is coupled to the device3400through a side aperture3330B of the device3400. More specifically, a flange3534of the tubular device3500can be fixated in the side aperture3330B, providing a first opening of the tubular portion3532to be in fluid connection with inside of the device3400and providing a second opening of the tubular portion3532in a second location.

FIG. 37is an anterior side perspective view of the example prosthetic capsular device system ofFIG. 36in an eye. As illustrated, a flange3534of the tubular device3500can be fixated in the side aperture3330B, providing a first opening of the tubular portion3532to be in fluid connection with inside of the device3400. The tubular portion3532can be configured to extend away from the device3400implanted in the natural capsular bag of the eye. The tubular portion3532can extend through a puncture in a sidewall of the natural capsular bag3700and inserted through the pars plana. As such, a second opening or end of the tubular portion3532can be located in the sub-Tenon's space, for example 2-4 mm posterior to the limbus, but without reaching the conjunctiva3702. Through the first and second openings, fluid can be configured to flow from inside of the device3400to the sub-Tenon's space through the lumen3536.

After cataract surgery and implantation of the prosthetic device into the natural capsular bag, a fornix based limbal conjunctival peritomy can be performed in the quadrant that was planned to receive the tubular device3500. The Tenon's capsule can be dissected from the sclera, and limited cautery can be performed for hemostasis. Mitomycin at variable concentrations can be placed on the sclera, for example using soaked sponges for a variable amount of time (ranging from 10 seconds to a five minutes), and can then copiously be washed away using balanced salt solution (BSS). A pars plana sclerostomy can be created with a sharp device such as a myringovitreorednal (MVR) blade. In some cases, a trochar can be inserted through the sclera.

Other sclerostomies can be made through the conjunctiva in other quadrants for light and/or BSS infusion. Typically, a limited pars plana vitrectomy can be performed to clear vitreous away from the sclerostomy site, preventing retinal traction during the surgical intervention. In some cases, a vitrectomy would not need to be performed. A sharp instrument, possibly an MVR type blade, with the tubular device3500loaded overtop and downshaft can be inserted through the sclerostomy, and can sharply incise the natural capsule, docking with the prosthetic device. Using grasping forceps, the end of the tubular device3500can be held in place inside the prosthetic device, while the sharp instrument can be removed using a modified Seldinger technique. The internal end of the tubular portion can be seated within the prosthetic device3400, and the external end of the tubular portion can be trimmed and/or fixated to the sclera using a suture (such as an 8-0 vicryl) or glue (such as Tisseel). The Tennon's capsule and conjunctive can be sutured back to the limbus using suture (such as 8-0 vicryl) or glue (such as Tisseel).

FIG. 38Ais an anterior side perspective partially-exploded view of an example prosthetic capsular device system3800including the device3400ofFIG. 34A, the tubular device3500ofFIG. 35A, and a containment structure3802.FIG. 38Bis an anterior side perspective view of the example prosthetic capsular device system3800ofFIG. 38A.

The containment structure3802can be configured to be coupled or attached to the device3400. In some embodiments, the containment structure3802can comprise a foldable or otherwise deformable structure that can be inserted through an opening and into the interior of the device3400. For example, the containment structure3802or a portion thereof can comprise a foldable or collapsible wire structure that allows for easy insertion of the containment structure3802through an opening of the device3400. Once inserted, the containment structure3802can expand into an expanded state. The expanded state of the containment structure3802can be configured to fixate or anchor the containment structure3802within the interior of the device3400. For example, a wire frame of the containment structure3802can be expanded in some embodiments to a configuration that substantially matches the shape of the interior of the device3400. In certain embodiments, the containment structure3802in its expanded state can comprise two substantially straight portions and two arcuate portions to match the shape of the interior of the device3400. The containment structure3802can be made of a semi-rigid material, such as PMMA, polyimide, polypropylene, and nylon. The containment structure can also or alternatively be made of a biocompatible material, such as silicone, silicone polymers, SIBS (poly(styrene-block-isobutylene-block-styrene)), acrylic, acrylic polymers, polypropylene, polycarbonate, and Gore-Tex.

The containment structure3802can comprise one or more fluid controls3804. The one or more fluid controls3804can be located on one or more sides of the containment structure3802. The one or more fluid controls3804can be configured to be coupled to the tubular device3500once the containment structure3802is coupled to the device3400. For example, a fluid control3804of the containment structure3804can be located on the containment structure3804such that it covers a side aperture3330A,3330B of the device3400, which can be coupled to a tubular device3500, when the containment structure3804is installed. The number of fluid controls3804located on a containment structure3804can be equal to the number of side apertures3330A,3330B and/or number of tubular devices3500coupled to the device3400. For example, if one tubular device3500is coupled to the device3400, the containment structure3802can comprise one fluid control3802. If device3400is coupled to two tubular devices3500, for example to each of two side apertures3330A,3330B, a containment structure3802with two fluid controls3804can be implanted.

By providing a fluid control3804for the system3800through implantation of the containment structure3802, fluid flow through the tubular device3500can be controlled even if the tubular device3500itself is a “dumb” or passive tubular device in that the lumen3536is not restricted and can allow fluid flow therethrough at all times.

The fluid control3804can be a valve that is configured to open or close to allow or disallow fluid flow through the tubular device3500. The valve can be configured to be open and close based on an intraocular pressure setting. For example, if the intraocular pressure is too high or is above a predetermined level, the valve can be configured to open to allow fluid flow from the inside of the eye to the outside of the eye to decrease the intraocular pressure. Conversely, if the intraocular pressure is too low or is below a predetermined level, the valve can be configured to close to prevent fluid flow. The fluid control3804can also comprise an intraocular pressure sensor configured to detect the intraocular pressure and electronically transmit the detected pressure to a processor configured to open or close the valve.

In some embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or above about 20 mmHg. In certain embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or above about 10 mmHg, 11 mmHg, 12 mmHg, 13 mmHg, 14 mmHg, 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, and/or within a range defined by two of the above-identified values.

In some embodiments, the valve can be configured to close when the intraocular physiologic pressure is at or below about 6 mmHg. In certain embodiments, the valve can be configured to open when the intraocular physiologic pressure is at or below about 1 mmHg, about 2 mmHg, about 3 mmHg, about 4 mmHg, about 5 mmHg, about 6 mmHg, about 7 mmHg, about 8 mmHg, about 9 mmHg, about 10 mmHg, about 11 mmHg, about 12 mmHg, about 13 mmHg, about 14 mmHg, about 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, and/or within a range defined by two of the above-identified values.

The fluid control3804can also or alternatively be a pump or micro pump. The pump or micro pump can be configured to actively force fluid from inside of the eye to the outside of the eye. For example, if the intraocular pressure is too high or is above a predetermined level, the pump or micro pump can be configured to actively force fluid to flow from the inside of the eye to the outside of the eye to decrease the intraocular pressure. Conversely, if the intraocular pressure is too low or is below a predetermined level, the pump or micro pump can be configured to stop. The fluid control3804can also comprise an intraocular pressure sensor configured to detect the intraocular pressure and electronically transmit the detected pressure to a processor configured to turn the pump or micro pump on or off.

In some embodiments, the pump or micro pump can be configured to actively facilitate fluid removal when the intraocular physiologic pressure is at or above about 20 mmHg. In certain embodiments, the pump or micro pump can be configured to actively facilitate fluid removal when the intraocular physiologic pressure is at or above about 10 mmHg, 11 mmHg, 12 mmHg, 13 mmHg, 14 mmHg, 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, and/or within a range defined by two of the above-identified values.

In some embodiments, the pump or micro pump can be configured to stop facilitating fluid removal when the intraocular physiologic pressure is at or below about 6 mmHg. In certain embodiments, the pump or micro pump can be configured to stop facilitating fluid removal when the intraocular physiologic pressure is at or below about 1 mmHg, about 2 mmHg, about 3 mmHg, about 4 mmHg, about 5 mmHg, about 6 mmHg, about 7 mmHg, about 8 mmHg, about 9 mmHg, about 10 mmHg, about 11 mmHg, about 12 mmHg, about 13 mmHg, about 14 mmHg, about 15 mmHg, about 16 mmHg, about 17 mmHg, about 18 mmHg, about 19 mmHg, about 20 mmHg, and/or within a range defined by two of the above-identified values.

FIG. 39is an anterior side perspective view of another example prosthetic capsular device system in an eye. The prosthetic capsular device system illustrated inFIG. 39includes some or all of the features of the prosthetic capsular device system illustrated inFIG. 37, and like reference numerals include like features. The prosthetic capsular device system ofFIG. 39can be similar to that ofFIG. 37except for including a control unit3902, an intraocular pressure sensor3904, and a fluid control3540.

In some embodiments, the prosthetic capsular device system can comprise a control unit3902. The control unit3902can be configured to receive one or more inputs and control a fluid control3540. The system can also comprise one or more intraocular pressure sensors3904configured to detect the intraocular pressure. The one or more intraocular pressure sensors3904can be built into the housing structure3312and/or a containment structure3802coupled to the housing structure3312.

The one or more intraocular pressure sensors3904can be configured to detect and electronically transmit the detected intraocular pressure to the control unit3902repeatedly, periodically, and/or in real-time or near real-time. For example, the one or more intraocular pressure sensors3904can be configured to detect and/or transmit the detected intraocular pressure to the control unit3902every about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 20 seconds, about 30 seconds, about 40 seconds, about 50 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, and/or within a range defined by two of the aforementioned values.

The intraocular pressure detected by the one or more sensors3904can be electronically transmitted to the control3902through a wired connection3906and/or a wireless connection. For example, in some embodiments, the one or more pressure sensors3904can comprise a wireless transceiver configured to wirelessly transmit detected pressure data to the control unit3902. Similarly, the control unit3902can comprise a wireless receiver configured to receive detected pressure data from the pressure sensor3904.

The control unit3902can also or alternatively be configured to receive a user input, for example through wireless communication. In some embodiments, the user can input instructions to remove fluid from the eye, for example through a user input device such as a smartphone or other user access point system. Not to be limited to theory, glaucoma, a condition that causes loss of vision over time, can be treated by lowering eye pressure. As such, in some embodiments, patients suffering from glaucoma may control and/or lower intraocular pressure to prevent vision loss from glaucoma by inputting instructions to a user access point system to facilitate removal of fluid from the eye. The control unit3902can also or alternatively be configured to receive input from one or more other physiological sensors, for example through wireless communication.

Based on the received user input and/or detected intraocular pressure data, the control unit3902can be configured to instruct a fluid control3540to allow, disallow, actively facilitate, and/or not actively facilitate removal of fluid through the tubular device3500. For example, if the intraocular pressure is above or at a predetermined level and/or the control unit3902receives corresponding user input, the control unit can be configured to instruct the fluid control3540to allow and/or actively facilitate fluid removal. Conversely, if the intraocular pressure is below or at a predetermined level and/or the control unit3902does not receive corresponding user input, the control unit can be configured to instruct the fluid control3540to disallow and/or not to actively facilitate fluid removal.

The control unit3902can be configured to electronically transmit instructions to allow and/or disallow fluid removal to the fluid control3540through a wired connection3908and/or a wireless connection. For example, in some embodiments, the control unit3902can comprise a wireless transceiver configured to transmit instructions to the fluid control3540. Similarly, the fluid control3540can comprise a wireless receiver configured to receive instructions from the control unit3902. The fluid control3540can be a valve and/or pump or micro-pump as described above.

FIG. 40is a block diagram depicting an example control process for a prosthetic capsular device system. As illustrated inFIG. 40, in some embodiments, the system can be configured to receive one or more inputs at block4004. The input can be a user input or an automated input. For example, the input received by the system may be from a user-initiated input through a user access point system. In addition or alternatively, the input received by the system can be from one or more sensors, such as an intraocular pressure sensor configured to detect the intraocular pressure and/or other physiological sensors.

Once the input is received, the system can be configured to further process the input at block4004. In certain embodiments, the system can be configured to combine or otherwise process a plurality of inputs, for example an automated input and a user input. In some embodiments, the system can be configured to process a single input, whether a user input or an automated input.

Processing one or more inputs by the system can involve one or more processes at block4006. In some embodiments, the system can be configured to process one or more inputs to determine whether to initiate one or more additional processes configured to lower intraocular pressure. For example, if an input received by the system comprises data that corresponds to intraocular pressure at or above a predetermined level, the system can be configured to initiate one or more additional processes configured to remove fluid from the eye, thereby lowering the intraocular pressure. Similarly, in an input received by the system comprises a user input corresponding to removal of fluid from the eye and/or lowering intraocular pressure, the system can be configured to initiate one or more additional processes configured to remove fluid from the eye, thereby lowering the intraocular pressure.

Conversely, if an input received by the system comprises data that corresponds to intraocular pressure at or below a predetermined level, the system can be configured not to initiate any additional processes and/or stop one or more currently operating processes that are configured to remove fluid from the eye and/or lower intraocular pressure. Similarly, in an input received by the system comprises a user input corresponding to stopping removal of fluid from the eye and/or lowering intraocular pressure, the system can be configured to stop one or more currently operating processes that are configured to remove fluid from the eye and/or lower intraocular pressure.

The system can be further configured to generate one or more instruction commands for transmission to one or more electronic device components of the system implanted in the eye at block4008. If the system determined that one or more processes to lower intraocular pressure should be initiated based on the processed input(s), the system can be further configured to generate one or more specific instruction commands and transmit the same to one or more electronic device components implanted in the eye. In such circumstances, the system can be configured to generate and transmit instructions to an electronically controlled pump or micro pump to initiate and/or increase the rate of fluid removal from the eye through the tubular device. In addition or alternatively, in such circumstances, the system can be configured to generate and transmit instructions to an electronically controlled valve to open and/or widen an opening of the valve to increase the rate of fluid removal from the eye through the tubular device.

Conversely, if the system determined that one or more processes to lower intraocular pressure should not be initiated or that one or more currently operating processes to lower intraocular pressure should be stopped based on the processed input(s), the system can also be further configured to generate one or more specific instruction commands and transmit the same to one or more electronic device components implanted in the eye. In such circumstances, the system can be configured to generate and transmit instructions to an electronically controlled pump or micro pump to stop and/or decrease the rate of fluid removal from the eye through the tubular device. In addition or alternatively, in such circumstances, the system can be configured to generate and transmit instructions to an electronically controlled valve to close and/or narrow an opening of the valve to decrease the rate of fluid removal from the eye through the tubular device.

Each electronic device component that received an instruction command can be further configured to perform one or more processes according to the received instruction command. Optionally, in some embodiments, the system can be further configured to determine whether the one or more electronic device components that received an instruction command in fact performed the corresponding one or more processes at block4010. If confirmation and/or a current status input is received by the system that the one or more corresponding processes were performed, the process can end at block4012in some embodiments. However, if such confirmation and/or a current status input is not received, the system can be configured to repeat one or more processes from blocks4004to block4010.

Further, in some embodiments, the system can be configured to repeat one or more processes described in relation toFIG. 40periodically, in real-time, or in near real-time. For example, the system can be configured to repeat processes4004through4008and/or processes4004through4010periodically, in real-time, or in near real-time. The one or more processes can be repeated every about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 20 seconds, about 30 seconds, about 40 seconds, about 50 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, and/or within a range defined by two of the aforementioned values.

FIG. 41is a block diagram depicting another example control process for a prosthetic capsular device system. In some embodiments, an electronic device in the capsular device, for example a control unit, can receive one or more inputs at block4104. The one or more inputs can comprise a user input or data relating to intraocular pressure (TOP). The user input can be achieved by a user through a user access point system, such as a smartphone or other handheld electronic device. The IOP-related data can be detected and/or received from one or more pressure sensors implanted in the eye.

The electronic device in the capsular device can be configured to further determine the received input at block4106. The electronic device may determine that the received input corresponds to lowering the IOP and/or removal of fluid from the eye. For example, the received input may be a user input indicating discomfort in the eye or other input corresponding to lowering the IOP and/or removal of fluid from the eye. The received input may also be IOP data that is at or above a certain level.

Conversely, the electronic device in the capsular device may determine that the received input corresponds to maintaining the IOP and/or preventing or stopping removal of fluid from the eye. For example, the received input may be a user input indicating alleviation of discomfort in the eye or other input corresponding to maintaining current IOP and/or preventing or stopping removal of fluid from the eye. The received input may also be TOP data that is at or below a certain level.

If the electronic device in the capsular device determines that the received input corresponds to lowering the TOP and/or removal of fluid from the eye, the electronic device can be further configured to generate an instruction command to cause fluid flow through a tubular device at block4108a. Conversely, if the electronic device in the capsular device determines that the received input corresponds to maintaining the TOP and/or preventing or stopping removal of fluid from the eye, the electronic device can be further configured to generate an instruction command to prevent and/or stop fluid flow through a tubular device at block4108b.

The electronic device in the capsular device can be further configured to electronically transmit the generated instruction command to an electronic device component of the tubular device at block4110. In some embodiments, the generated instruction command can be transmitted through a wire connection between the electronic device in the capsular device and the electronic device in the tubular device. In certain embodiments, the generated instruction command can be transmitted through a wireless connection between a wireless transceiver of the electronic device in the capsular device and a wireless transceiver and/or receiver of the electronic device in the tubular device.

In some embodiments, the electronic device in the capsular device can be further configured to receive confirmation and/or a current status input from an electronic device of the tubular device at block4112. At block4114, the electronic device of the tubular device can further be configured to initiate a change in the state of the tubular device in accordance with the instruction. For example, the electronic device of the tubular device can cause a valve to open or close and/or cause a pump to cause or prevent fluid flow from inside of the eye to a second location.

FIG. 42is an anterior side perspective view of another example prosthetic capsular device system in an eye. As illustrated inFIG. 42, a prosthetic capsular device4200can be implanted in the eye. The prosthetic capsular device4200can comprise a housing structure4202and one or more rings or haptics4204. The one or more rings or haptics4204can be configured to be in contact with the natural capsular bag3710of the eye.

The prosthetic capsular device4200can further comprise an aperture4206that is configured to allow fluid connection between the interior and exterior of the housing structure4202. A tubular device can be coupled to the aperture4206. More specifically, a tubular portion3532of the tubular device can be configured to provide fluid connection between the interior of the housing structure4202and a second location. For example, a first opening of the tubular portion3532can be connected to the interior of the housing structure4202to provide the fluid connection. A second opening of the tubular portion3532can be located at the second location. The tubular portion3532can be configured to extend away from the device4200implanted in the natural capsular bag of the eye3710.

In some embodiments, a first puncture or incision3712can be made in a sidewall of the natural capsular bag3712of the eye and the tubular portion3532can be inserted through the first puncture3712. A second puncture or incision3704can also be made in the sclera3700of the eye. The tubular portion3532can further be inserted through the second puncture or incision3704. By inserting the tubular portion through the first puncture or incision3712and the second puncture or incision3704, the second opening of the tubular portion3532can be located in the sub-Tenon's space, thereby allowing fluid connection between inside of the housing structure4202of the device4200implanted in the eye and the sub-Tenon's space. For example, the second opening of the tubular portion3532can be located 2-4 mm posterior to the limbus, but without reaching the conjunctiva. As such, fluid from inside of the eye can enter through the first opening of the tubular portion3532inside the housing structure4202, flow through the tubular portion3532, and exit through the second opening of the tubular portion3532and into the Sub-Tenon's space.

With the development of technology, augmented reality (AR) and virtual reality (VR) devices are able to provide users with AR and VR. For example, AR devices can provide a user with a multitude of information, such as for example directions, locations of particular areas of interest, data, instructions, messages, entertainment, images, videos, content, and the like, based on the current location of the user and the visual range of the user. Some AR devices are in the form of glasses that allow a user to view directions, locations of convenience stores, restaurants, gas stations, or the like, as imposed on the user's normal visual field. Some other uses of AR devices may include providing a head-up display (HUD) of any information, such as directions, GPS, email, notes, presentations, video, graphics, text messages, or the like.

However, one shortcoming of existing technologies is that the AR must be viewed through or from a device or display means located between the eyes of the user and the location of interest. In certain existing AR devices, information or other graphics are projected onto or otherwise displayed on an intermediary display which must be positioned between the user's eyes and the location or object that the user is viewing. For example, some AR devices display the AR images on glasses or goggles to be worn by the user. Similarly, for certain AR devices, a user may be required to hold and view a smartphone or other device in order to view the information or other graphics. Otherwise, the AR information and/or graphics must be projected directly onto the macula of the user, but this would generally require a projector to be positioned generally within the central visual field of the user in order for the device to directly project the image onto the retina of the user to provide a clear image. Existing VR devices share similar shortcomings. In either case, the user's visual field is occluded or blocked, either partially or entirely, in one way or another by such AR or VR devices.

Such technical limitations lie in the fact that some device must be located directly within a central portion of the visual field of a user in order for that device to display or project an image that is clearly viewable by the user. A projector or other source of display must generally be located within the central visual field of the user, which will necessarily occlude the user's visual field. As a result, many technical or design limitations exist for AR and VR devices and certain safety concerns may arise as well from obstructing the user's visual field. As such, it can be advantageous for a user to be able to view AR and/or VR without the use of a device that occludes or obstructs the user's direct visual field. Accordingly, some embodiments of the devices, systems, and methods described herein are configured to provide AR and/or VR to a user without occluding or obstructing the direct or central visual field of the user.

In some embodiments, the information or other graphics to be projected or displayed must be viewable by the user without occluding or obstructing the user's direct visual field. In other words, in some embodiments, the projector that projects the information or other graphics, whether in AR or VR, is not located generally along the direct line of vision of the user. Rather, the projector can be located elsewhere, for example near the peripheral visual field of the user. However, if the projector is not located along the user's direct line of vision and is located near the user's peripheral view, the projected information will likely reach the peripheral retina and not the macula of the user. As a result, the user may not be able to view a clear image.

To remedy such technical problem, some embodiments of the devices, methods, and systems disclosed herein comprise one or more prisms or prism bars that are configured to be implanted within the user's eye(s). The implanted one or more prisms or prism bars can be strategically located within the user's eye(s) to bend or redirect information or other graphics projected from a peripherally located projector or projector or other display means that is not located at a substantially central position within the user's visual field. The bended or redirected information or other graphics can then reach the macula of the user after traveling through the one or prisms or prism bars. By doing so, a clear image of augmented or virtual information, text, graphics, or other display can be viewable by a user without the need of a device being placed along the direct line of sight of the user or at a central location within the user's visual field.

In some embodiments, the system comprises one projection device located or placed near the peripheral vision field of the user and one prism device or prism bar implanted inside the user's eye. The implanted prism device or prism bar can effectively bend or redirect light or image projected by the projection device onto the macula of the user to provide a clear display without occluding the central visual field of the user. In certain embodiments, the system comprises one or more projection devices and/or one or more prism devices or prism bars. For example, the system can comprise one or more prism devices or prism bars implanted within both eyes of the user and one or more projection devices configured to project light or images through the one or more prism devices or prism bars onto the macula of both eyes of the user. In such embodiments, the system can be configured impose certain light and/or images bilaterally in both eyes to create three-dimensional effects viewable by the user.

In some embodiments, the system or devices disclosed herein can comprise one or more projection devices and one or more prisms or prism bars. The one or more prisms or prism bars can be configured to be implanted into the user's eye(s). The one or more projection devices can be configured to be placed not along the direct line of sight of the user or a central portion of the user's visual field. Rather, the one or more projection devices can be configured to be placed at a location near or along the peripheral visual field of the user.

The one or more projection devices can comprise a device housing. The device housing can be configured to comprise one or more electronic and/or computer components for processing the information or other graphics to be displayed to the user and for projecting such information or other graphics into the user's eye and through the one or more prisms or prism bars to cause the information or other graphics to reach the macula or substantially near the macula of the user.

In some embodiments, the device housing can comprise one or more different materials. For example, the device housing or a portion thereof can be made of wire, plastic, deformable rubber, deformable foam, silicone, silicone elastomers, polymers, polypropylene, Styrofoam, acrylics, heat deformable laminates, thermoplastics, one or more corrugated forms of plastic, polyimide, propylene, shape memory alloys (SMA), or the like. It can be advantageous for the device housing to comprise moldable and/or flexible material in some embodiments. For example, moldable and/or flexible materials can allow the device housing to be adapted and placed along curved or movable surfaces, such as over the user's nose bridge, cheekbones, eyebrows, forehead, or the like. Moldable and/or flexible materials can also be advantageous for placing the device housing on or at locations that can differ in shape or configuration among different users. In certain embodiments, the device housing or a portion thereof can comprise a material that provides thermal and/or electrical insulation. In some embodiments, the device housing can comprise one or more flexible circuits.

In certain embodiments, the device housing or a portion thereof can comprise a rigid material. For example, the device housing can comprise a rigid plastic, metal, alloy, wood, polymers, acrylics, resins, polysiloxane, polymethyl methacrylate (PMMA), or the like. In some embodiments, the device housing or a portion thereof can comprise one or more materials that are oxygen-permeable, rigid gas permeable, and/or chemically inert. Such rigid material can be advantageous for embodiments in which the device housing is configured to be placed on or at locations that allow for the device housing to generally retain its configuration. For example, in embodiments where the device housing is to be placed on peripheral areas of glasses, such as on the stems of a pair of glasses, the device housing can comprise a rigid material.

In certain embodiments, the device housing can comprise one or more components of the system. For example, the system can comprise one or more projectors, cameras, power sources or battery sources, CPUs, communication modules, sensors, gyroscopes, GPS modules, accelerometers, or the like. The one or more projectors can be a DLP type projector, LED type projector, LCD type projector, laser projector and/or any other type of projector. The one or more projectors can comprise a light source, wherein the light source can be an LED or standard lamp. The power source or battery source can comprise a stretchable battery for flexible circuits. The system can also comprise one or more computer components as described herein. The system can also be configured to communicate with one or more computer components of other computer systems to implement one or more embodiments. In some embodiments, the device housing comprises a subset of the components of the system. In certain embodiments, a subset of the components of the system can be located elsewhere, for example as part of another device or as a standalone device, such as a smartphone, computer, laptop computer, personal electronic device, or the like.

FIG. 43illustrates an embodiment in which the projection device4300comprises one or more battery power sources4308, CPUs4304, communication modules4306such as Wi-Fi or Bluetooth receivers, cameras4302, and/or AR projectors4310.

In some embodiments, the system or projection device4300can comprise one or more cameras4302. The one or more cameras4302can be configured to scan and/or view the surroundings of a user. For example, one or more cameras4302can be configured to view objects and/or points of reference generally viewable by the user and within the visual field of the user. In certain embodiments, the one or more cameras4302can be moved to point in different directions as desired by the user. For example, in some embodiments, the one or more cameras4302can comprise and/or be configured to be moved by one or more motors or actuators to be pointed in different directions in response to an input by a user via a user device. In other embodiments, the one or more cameras4302can be moved by mechanical input by a user, such as by physically altering the direction in which the one or more cameras4302is pointing.

The objects, locations, and/or points of reference captured by the one or more cameras4302can be identified by the one or more CPUs4304. The one or more CPUs4304can be configured to process the objects, locations, and/or points of reference or portion(s) thereof captured by the one or more cameras4302. In some embodiments, the one or more CPUs4304can be configured to process additional information provided by one or more other electronic and/or computer components described herein.

In certain embodiments, the system or projection device4300can comprise one or more GPS modules. The one or more GPS modules can be configured to detect the current location of the user in substantially real-time, near real-time and/or periodically. In some embodiments, the system or projection device4300can comprise one or more gyroscopes and/or accelerometers. The one or more gyroscopes and/or accelerometers can be configured to detect the current positioning of a user in substantially real-time, near real-time, and/or periodically.

In some embodiments, information or data collected by the one or more cameras4302, GPS modules, gyroscopes, and/or accelerometers can be combined by the system4300to enhance accuracy. For example, in certain embodiments, one or more CPUs4304of the system or projection device4300can be configured to receive and/or combine the information or data collected by the one or more cameras4302, GPS modules, gyroscopes, and/or accelerometers to determine and/or provide more accurate data to be displayed and/or imposed onto the user's visual field.

In certain embodiments, the system or projection device4300can comprise one or more communication modules4306. For example, the one or more communication modules4306can comprise Bluetooth, Wi-Fi, LTE, NFC, or other receivers and/or transceivers for electronic communication. In some embodiments, the information or data collected by the one or more cameras4302, GPS modules, gyroscopes, and/or accelerometers can be electronically communicated to the one or more CPUs4304by the one or more communication means4306. For example, in embodiments where the GPS module is not within the projection device4300but is located as part of a separate device, such a smartphone, the location detected by the GPS module can be electronically received by a communication module4306of the projection device4300. In turn, the location information can be transmitted to a CPU module4304within the projection device4300.

Based on the information or data collected by the one or more cameras4302, GPS modules, gyroscopes, and/or accelerometers, the system, projection device,4300and/or CPU module4304can be configured to determine the particular information or graphics to be displayed to the user. Once determined, data relating to the determined information or graphics can be transmitted to the one or more projectors4310, which can then project such into the user's eye(s).

In some embodiments, the system and/or device4300can comprise one or more infrared light sources, radar/sonar transceivers, and/or one or more cameras for night vision. By use of one or more infrared light sources and/or radar/sonar transceivers, the system4300can be configured to process a more robust environmental mapping system, for example in combination with the information gathered from the one or more cameras4302. For instance, the system4300can be configured to map areas and generate a three-dimensional AR of the physical surroundings, even in total darkness, by use of one or more infrared light sources, radar/sonar transceivers, and/or one or more cameras for night vision.

More specifically, in some embodiments, the radar and/or sonar transceivers can be configured to transmit signals of various frequencies and/or receive signals in response. The response signals can then be transmitted to a CPU, which could then process the data to generate a map. The generated map can be overlaid with GPS, gyroscope, and/or accelerometer data, in certain embodiments, to produce a more robust map. In some embodiments, the generated map can be overlaid without GPS data when used in an unknown indoor or outdoor environment.

One or more systems and/or devices described herein can also be used to measure and/or estimate distances, identify moving and/or non-moving objects, such as other people, animals, cars, or the like, map obstacles, and/or assist with covert operations in total or near darkness. In certain embodiments, one or more systems and/or devices described herein can be configured to be used to assist with aiming a weapon at a target. For example, some embodiments are configured to determine an estimated and/or exact trajectory, type and position of the weapon, type of weapon ammunition, and/or distance to and speed of an object of target and relay one or more such information to be viewable by a user.

Positioning

In some embodiments, the system can comprise one or more non-occluding projection devices and one or more prisms or prism bars. The particular location or positioning of the one or more projection devices and one or more prisms or prism bars, as well as their locations relative to one another, can be important to provide a clear image or projection viewable by a user while ensuring that the one or more projection devices themselves do not occlude the direct or central visual field of the user. As such, the user can be allowed to maintain his or her entire visual field, even while utilizing one or more AR or VR devices, methods, or systems disclosed herein.

In certain embodiments, one or more projection devices can be located near or along the peripheral field of vision of the user and not along the user's general direct line of vision or near the central portion of the user's visual field. For example, in certain embodiments, the one or more projection devices can be configured to be located or placed near or on the user's nose, nose bridge, cheekbone, forehead, eyebrows, lips or the like.

In certain embodiments, the system can comprise one or more projection devices located near or along the nasal periphery of the user's visual field. For example, one or more projection devices can be configured to be placed or located on the nose and/or one or both sides of a user's nose. Similarly, one or more projection devices can be configured to be placed over a user's nose or nose bridge. In such embodiments, one or more prisms or prism bars can be placed vertically within a user's eye. For example, in embodiments in which one or more projection devices are configured to be placed on the user's nose or generally along the nasal periphery of the user's visual field, one or more prisms or prism bars can be configured to be placed temporally in a vertical manner within one or both eyes of the user. More specifically, in certain embodiments, the one or more prisms or prism bars can be placed vertically at the right end within the user's right eye and/or vertically at the left end within the user's left eye.

FIG. 43illustrates an embodiment in which a projection device4300is configured to be placed over the nose bridge of a user. As depicted inFIG. 43, in some embodiments, the projection device4300comprises two projectors4310or AR projectors that are configured to project light or image(s) to the eye(s) of a user from a nasal location.

In other embodiments, the system can comprise one or more projection devices located near or generally within the temporal periphery of the user's visual field. For example, one or more projection devices can be configured to placed or located temporally. One or more projection devices can be configured to be placed near or generally near the user's temporal field of vision, such as on one or more legs of a pair of standard or specially produced glasses. In such embodiments, one or more prisms or prism bars can be placed nasally in a vertical manner within a user's eye(s). In certain embodiments, the system can comprise one or more prisms or prism bars located vertically at the left end within the user's right eye and/or one or more prisms or prism bars located vertically at the right end within the user's left eye.

In some embodiments, the system can comprise one or more projection devices located near or generally along the lower periphery of the user's field of vision. For example, one or more projection devices can be configured to be placed near or generally near the user's lower field of vision, such as on or generally near the user's cheekbone and/or along the bottom of the frame of glasses. In such embodiments, one or more prisms or prism bars can be placed horizontally within a user's eye(s). In certain embodiments, the system can comprise one or more prisms or prism bars located horizontally at or near the top end within the user's eye(s).

In certain embodiments, the system can comprise one or more projection devices located near or generally along the upper periphery of the user's field of vision. In other words, one or more projection devices can be configured to placed or located generally above a user's eye(s). For example, one or more projection devices can be configured to be placed near or generally near the user's upper peripheral field of vision, such as on or generally near the user's eyebrow(s) or forehead or along the top of the frame of glasses. In such embodiments, one or more prisms or prism bars can be placed horizontally within a user's eye(s) at or near the bottom end within the user's eye(s).

However, in some embodiments, an issue of double vision may arise. The probabilities and/or risks related to double vision may be higher in certain embodiments than others, such as due to the relative location or placement of the one or more projection devices and one or more prisms or prism bars. For example, in embodiments in which the one or more projection devices are to be placed on or near the temporal periphery of a user's field of vision, the one or more prisms or prism bars can generally be placed inside the user's eye(s) in a vertical configuration near the nasal end. In such case, when the one or more projection devices are not projecting any light and/or the one or more projection devices are not installed, for example onto the stem(s) of a pair of glasses, the prism or prism bar may still bend natural light entering from the temporal periphery of the user's visual field. Such light can then reach the macula after exiting through the one or more prisms or prism bars and produce a double vision effect to the user. Similar effects or risks relating to double vision can also be present or more attenuated in embodiments in which the one or more projection devices are to be placed near or at the top or bottom of the periphery of the user's visual field.

In contrast, embodiments in which the one or more projection devices are to be placed nasally or near or at the nasal periphery of the user's field of vision, such risks relating to double vision may be mitigated. More specifically, in such embodiments, the one or more prisms or prism bars can generally be located or placed in a vertical configuration near or at the temporal end(s) within the user's eye(s). The one or more prisms located in such manner may substantially only bend light that is entered from the nasal periphery of the user's field of vision. In such case, however, the user's nose can effectively block most or a substantial amount of the user's nasal periphery view. Accordingly, the probability or risk arising from double vision may be mitigated.

As described herein, in some embodiments, the projection device(s) and prism(s) or prism bar(s) can be strategically placed in locations relative to one another in order to effectively redirect light and/or an image projected by the projector(s) onto the macula or near the macula of the user. By doing so, the system can be configured to provide an overlay of information to a user's vision without requiring a projection device to occlude the user's visual field. However, in certain situations, it may not be desirable for the light and/or image projected by the one or more projection devices to end up at or substantially at the center of the user's macula. Also, in some situations, the angle of the projected light and/or image may be altered unexpectedly, for example due to movement of the user and/or movement of the projection device or a portion thereof relative to the location of the one or more prisms or prism bars. In such circumstances, the projected image and/or light may not be redirected or bent in an ideal angle through the one or prisms or prism bars and may not be clearly viewable by the user. As such, it can be advantageous for the one or more projection devices and/or one or more prisms or prism bars and/or angles thereof to be movable or altered as desired by the user.

As such, in some embodiments, the particular location(s) and/or angle(s) the one or more prisms or prism bars and/or one or more projection devices can be manipulated by the user. In certain embodiments, the one or more prisms or prism bars and/or one or more projection devices comprise a motor and/or actuator. The motor and/or actuator can be configured to alter the location(s) and/or angle(s) of the one or more prisms or prism bars and/or the one or more projection devices as desired by the user. As such, the motor and/or actuator can allow the user to change the location of the imposed image or light within the user's visual field and/or allow the user to alter the definition of the projected image or light viewable by the user.

In certain embodiments, the motor and/or actuator for moving the one or more prisms or prism bars and/or one or more projection devices can be configured to be manipulated electronically by a user, for example by inputting certain instructions into a user device. In some embodiments, the angle and/or location of the one or more prisms or prism bars and/or one or more projection devices can be altered mechanically by the user, for example via a manual slider.

In certain embodiments, the one or more projection devices and/or one or more prisms or prism bars can be configured to alter its location and/or angle automatically relative to one another. In other words, the one or more projection devices and/or one or more prisms or prism bars can be configured to automatically track the location, angle, or other configuration of the other and/or location, angle, or other configuration of itself relative to the other and alter its location, angle, or other configuration accordingly.

In some embodiments, one or more prisms or prism bars can be configured to be implanted into a user's eye(s). For example, in certain embodiments, one or more prisms or prism bars can be configured to be implanted directly into the natural capsular bag of a user's eye(s). In some embodiments, one or more prisms or prism bars can be configured to be implanted into the capsular bag of a user's eye indirectly, for example by being placed inside an implant housing structure or device. The implant housing structure or device can be configured to be implanted into a user's capsular bag and substantially hold the one or more prisms or prism bars in place. The implant housing structure can provide stability to the placement of the one or more prisms. In some embodiments, the one or more prisms or prism bars can be configured to be implanted into a user's eyes after the implant housing structure or device is first implanted.

FIG. 44depicts an embodiment of an implantable housing4402configured to be implanted into the eye of a user with a prism or prism bar4400placed inside the implantable housing4402. As illustrated, a prism bar4400can be configured to be placed vertically within an implantable device housing4402, which itself is configured to be implanted into the capsular bag of a user. Light or images projected by one or more projectors can be bent or redirected by the prism or prism bar4400inside the implantable housing4402to reach the retina or macula of the user.

In some embodiments, the prism and/or prism bar4400itself is foldable for implanting the prism and/or prism bar4400into the eye(s) of a user. In certain embodiments, the prism and/or prism bar4400is rigid. The prism and/or prism bar4400can comprise one or more haptics or closed loops. For example, the one or more haptics or closed loops can be self-expanding or otherwise configured to expand once the prism and/or prism bar4400is implanted into the natural capsular bag to anchor and/or hold the prism and/or prism bar4400in place within the capsular bag. The one or more haptics or closed loops can be foldable.

In certain embodiments, the prism and/or prism bar4400is configured to be injected into the eye(s) of a user through an injector. The injector can comprise one or more similar aspects of a standard intraocular lens injector. In some embodiments, the prosthetic device or implantable housing4402comprises one or more openings. For example, the prosthetic device or implantable housing4402can comprise an opening on a sidewall of the prosthetic device or implantable housing4402. In some embodiments, the prism and/or prism bar4400can be configured to be injected into the opening of the prosthetic device or implantable housing4402. The size and/or configuration of an opening of the prosthetic device or implantable housing4402and the size and/or configuration of the prism or prism bar4400can be substantially the same as to hold or anchor the prism or prism bar4400in place without the need for a haptic. In other words, in certain embodiments, a prism or prism bar4400can be configured to be inserted or slid into an opening on a sidewall of the prosthetic device4402, extending into the recess of the natural capsular bag.

In some embodiments, a prism and/or prism bar4400do not comprise any haptics or closed loops. For example, the prism or prism bar4400can be configured to be inserted into an opening of a prosthetic device4402, which is configured to anchor or hold the prism or prism bar4400in place. In certain embodiments, the prism or prism bar4400can be self-expanding and/or self-retaining, either by use of a haptic system or by fitting into an opening.

The one or more prisms or prism bars4400can be a Fresnel prism or a regular prism. It can be advantageous for the one or more prisms or prism bars4400to comprise a Fresnel prism to save space within the user's eye or implant device. In some embodiments, one or more Fresnel prisms can be used in conjunction with one or more regular prisms. In some embodiments, one or more prisms4400can be stacked before and/or after implanting into the eye(s) of a user. For example, one or more prisms4400can be stacked to form a prism bar or other configuration. In certain embodiments, one or more prisms4400can be configured to be binocular, monocular, or both.

In some embodiments, the one or more prisms or prism bars4400can be configured to bend or redirect the projected image by about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°, about 110°, about 120°, about 130°, about 140°, about 150°, about 160°, and/or about 170°. In certain embodiments, the one or more prisms4400can be configured to bend or redirect the projected image by an angle within a range defined by two of the angles identified above.

In certain embodiments, the one or more prisms4400can comprise a general configuration of a bar, cube, rectangle, square, or the like. In some embodiments, the one or more prisms or prism bars4400can comprise a width of about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, and/or about 10 mm. In some embodiments, the width of the one or more prisms4400can be within a range defined by two of the aforementioned values.

In some embodiments, the one or more prisms or prism bars4400can comprise a length of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, and/or about 30 mm. In certain embodiments, the length of the one or more prisms or prism bars4400can be within a range defined by two of the aforementioned values.

In certain embodiments, the particular size and/or shape of one or more prisms or prism bars4400to be implanted into the eye(s) of a user can vary. For example, the particular size and/or shape of one or more prisms or prism bars4400to be implanted into the eye of a user can depend on the particulars of the user's eyes, such as the size of the user's natural capsular bag, size of an implantable housing4402, and the like.

In some embodiments, the projected image from the one or more projectors can be configured to enter one of the hypotenuse sides of the one or more prisms or prism bars4400and exit through the other hypotenuse side of the prism or prism bar4400.FIG. 45depicts an embodiment of a prism or prism bar4400configured to be implanted into the eye of a user. As illustrated inFIG. 45, in certain embodiments, a self-retained prism lens or bar implant4400is configured to receive an image(s) or light projected from a projector and bends or redirects the image or light onto the retina of a user.

Prism Performance Characteristics

As discussed above, with one or more prisms4400being implanted inside a user's capsular bag, the user may in some situations encounter double vision when the one or more projectors is not projected an image into the prism4400. For example, even if the one or more projectors is not currently generating and projecting an image, the one or more prisms or prism bars4400may still function to bend or redirect light entering into the prism or prism bar4400. As a result, the user may encounter double vision to various degrees depending on the location or placement of the one or more prisms4400. As such, it can be advantageous to provide a way for the one or prisms or prism bars4400not to bend or redirect light when one or more projectors is not in operation.

Accordingly, in some embodiments, the one or more prisms or prism bars4400can comprise a particular color and/or coating configured to allow only particular light to enter through the prism or prism bars4400and be bended or redirected onto the macula of the user. In other words, in certain embodiments, the one or more prisms or prism bars4400can be configured to allow only light generated by the one or more projection devices to enter into the prism4400and/or be redirected onto the macula of the user. For example, the angle, color, opacity, polarity, certain photo gray characteristics of the one or more prisms4400can be utilized to prevent the one or more prisms from bending or redirecting light when the one or more projection devices are not projecting an image or light.

Safety Features

Some safety concerns may be present if the projection device continuously projects light onto the macula of the user at damaging levels. Accordingly, in some embodiments, the one or more projection devices does not continuously project light, but projects light at a flicker rate to protect against continuously damaging the retina. For example, the flicker rate can be about 10 Hz, about 20 Hz, about 30 Hz, about 40 Hz, about 50 Hz, about 60 Hz, about 70 Hz, about 80 Hz, about 90 Hz, about 100 Hz, about 110 Hz, about 120 Hz, and/or within a range defined by two or more aforementioned rates. Although the projected light or image is at a particular flicker rate, this may not be perceptible by the user.

In certain embodiments, the flicker rate can be selectable by a user. In some embodiments, the brightness of the projected light or image can be selected by the user. For example, in certain embodiments, the projection device and/or other user device can comprise a flicker rate, dimmer switch, timer, and/or on/off switch that allows the user the control the manner and/or amount of time in which the light and/or image is projected by the projection device(s).

Projected Image

In some embodiments, the projected light or image can be imposed onto the visual field of the user to generate AR or VR effects. In certain embodiments, the projected image or light can be a single color or light. In some embodiments, the type of image and/or color to be projected into the prism or prism bar can be user-selectable. For example, the user can in some embodiments select the mode or particular light or image to be projected via a user input device. The CPU can be configured process and electronically transmit the user selection to the one or more projectors. In certain embodiments, the user input device can be a separate device, handheld or otherwise. The selection made by a user can be communicated via Wi-Fi, Bluetooth or other means of communication via a communications means that is receivable by the projection device(s).

In certain embodiments, the projection device can be configured to project a single color, light, or other image to be portrayed and visible on the user retina via the one or more prisms. For example, in some embodiments, the projection device can be configured to project a single color of light within the visible spectrum or any other color. In certain embodiments, the projector can be configured to project a striped pattern, checkered pattern, concentric circles, and/or any other shape. In other configurations, the projector may be configured to project images such as pictures, text, diagrams, or any other graphical display of data.

The projected image or color can be portrayed onto the user's iris and be viewable by a third person. For example, if a particular color is projected onto the user's iris directly, the projected color may be viewable by others and have a cosmetic effect. As such, in certain embodiments, the user can be able to change the color of his or her irises to be viewable by others, for example for cosmetic purposes.

Medical Signals

In some embodiments, the system can be configured to detect the medical or health status of a user and display such on the user's eyes. For example, in certain embodiments, the system can comprise one or more sensors and/or be configured to communicate with one or more sensors that detect the medical, health, and/or distress status of a user. Some sensors can include intraocular pressure sensors, drug delivery sensors, SpO2 sensors, heart rate monitors, blood pressure monitors, glucose sensors, blood alcohol concentration sensors, temperature sensors (thermometers), or the like. In some embodiments, one or more sensors can be embedded into a contact lens(es) to be worn by the user and configured to detect glucose levels or the like.

In certain embodiments, the medical or health status of a user can be detected by one or more sensors and be transmitted electronically to the CPU of the projection device. For example, the communications module of the projection device can receive detected medical or health status signals and transmit such to the CPU.

In certain embodiments, the CPU can be configured to process the detected health or medical status of the user and assign one or more colors or other visual signals. For example, a mapping table or process can assign a color red if the medical or health status of a user is within a particular predetermined range that corresponds to a serious health risk of the user. Similarly, a yellow or orange color can be assigned if the medical or health status of a user is within a particular predetermined range that corresponds to an intermediate status. If the health or medical status of the user is within a predetermined range that corresponds to a normal state, no color can be assigned.

The assigned color or other visual signal can be projected by one or more projectors onto the retina or macula of a user via one or more implanted prisms. As a result, the assigned color or other visual signal can be recognizable by a third party immediately by viewing the eye(s) of the user. From the particular color or other visual signal that is projected onto and viewable from the eye(s) of the user, a medical personnel or other person may be able to easily and immediately assess the health or medical status of the user. For example, the system can be configured to make the user's eye(s) appear red when the temperature of the user is above a predetermined level or when the user is overheated. Similarly, the system can be configured to make the user's eye(s) appear blue when the user is showing low blood oxygen concentration. The system can also be configured to make the user's eye(s) appear yellow when the user's blood sugar levels are above a predetermined level.

Computer System

In some embodiments, the systems, processes, and methods described herein are implemented using a computing system, such as the ones illustrated inFIGS. 46, 47, and 48. The computing systems illustrated inFIGS. 46, 47, and 48include certain similar features, and like reference numerals include like features.

Each of the example computer systems4602,4702,4802are in communication with one or more computing systems4620and/or one or more data sources4622via one or more networks4618. WhileFIGS. 46-48illustrate embodiments of computing systems4602,4702,4802, it is recognized that the functionality provided for in the components and modules of a computer system may be combined into fewer components and modules, or further separated into additional components and modules.

The computer system4602includes a tubular device control module4614that carries out one or more functions, methods, acts, and/or processes described herein relating to tubular devices, systems, and methods, for example described in connection withFIGS. 33A-42. The computer system4702includes an accommodating lens control module4714that carries out one or more functions, methods, acts, and/or processes described herein relating to accommodating lens devices, systems, and methods, for example described in connection withFIGS. 23A-23E. The computer system4802includes an AR/VR control module4814that carries out one or more functions, methods, acts, and/or processes described herein relating to AR/VR devices, systems, and methods, for example described in connection withFIGS. 43-45. Each of the tubular device control module4614, accommodating lens control module4714, and AR/VR control module4814is executed on a computer system4602,4702,4802by a central processing unit4610discussed further below.

In general the word “module,” as used herein, refers to logic embodied in hardware or firmware or to a collection of software instructions, having entry and exit points. Modules are written in a program language, such as JAVA, C or C++, or the like. Software modules may be compiled or linked into an executable program, installed in a dynamic link library, or may be written in an interpreted language such as BASIC, PERL, LUA, or Python. Software modules may be called from other modules or from themselves, and/or may be invoked in response to detected events or interruptions. Modules implemented in hardware include connected logic units such as gates and flip-flops, and/or may include programmable units, such as programmable gate arrays or processors.

Generally, the modules described herein refer to logical modules that may be combined with other modules or divided into sub-modules despite their physical organization or storage. The modules are executed by one or more computing systems, and may be stored on or within any suitable computer readable medium, or implemented in-whole or in-part within special designed hardware or firmware. Not all calculations, analysis, and/or optimization require the use of computer systems, though any of the above-described methods, calculations, processes, or analyses may be facilitated through the use of computers. Further, in some embodiments, process blocks described herein may be altered, rearranged, combined, and/or omitted.

Each of the computer systems4602,4702,4802include one or more processing units (CPU)4606, which may include a microprocessor. Each of the computer systems4602,4702,4802further include a physical memory4610, such as random access memory (RAM) for temporary storage of information, a read only memory (ROM) for permanent storage of information, and a mass storage device4604, such as a backing store, hard drive, rotating magnetic disks, solid state disks (SSD), flash memory, phase-change memory (PCM), 3D XPoint memory, diskette, or optical media storage device. Alternatively, the mass storage device may be implemented in an array of servers. Typically, the components of a computer system4602,4702,4802are connected to the computer using a standards based bus system. The bus system can be implemented using various protocols, such as Peripheral Component Interconnect (PCI), Micro Channel, SCSI, Industrial Standard Architecture (ISA) and Extended ISA (EISA) architectures.

A computer system4602,4702,4802can include one or more input/output (I/O) devices and interfaces4612, such as a keyboard, mouse, touch pad, and printer. The I/O devices and interfaces4612can include one or more display devices, such as a monitor, that allows the visual presentation of data to a user. More particularly, a display device provides for the presentation of GUIs as application software data, and multi-media presentations, for example. The I/O devices and interfaces4612can also provide a communications interface to various external devices. A computer system4602,4702,4802may include one or more multi-media devices4608, such as speakers, video cards, graphics accelerators, and microphones, for example.

A computer system4602,4702,4802may run on a variety of computing devices, such as a server, a Windows server, a Structure Query Language server, a Unix Server, a personal computer, a laptop computer, and so forth. A computing system4602,4702,4802is generally controlled and coordinated by an operating system software, such as z/OS, Windows, Linux, UNIX, BSD, SunOS, Solaris, MacOS, or other compatible operating systems, including proprietary operating systems. Operating systems control and schedule computer processes for execution, perform memory management, provide file system, networking, and I/O services, and provide a user interface, such as a graphical user interface (GUI), among other things.

Each of the computer systems4602,4702,4802is coupled to a network4618, such as a LAN, WAN, or the Internet via a communication link4616(wired, wireless, or a combination thereof). Network4618communicates with various computing devices and/or other electronic devices. Network4618is communicating with one or more computing systems4620and one or more data sources4622. Each of the tubular device control module4614, accommodating lens control module4714, and AR/VR control module4814may access or may be accessed by computing systems4620and/or data sources4622through a web-enabled user access point. Connections may be a direct physical connection, a virtual connection, and other connection type. The web-enabled user access point may include a browser module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network4618.

The output module may be implemented as a combination of an all-points addressable display such as a cathode ray tube (CRT), a liquid crystal display (LCD), a plasma display, or other types and/or combinations of displays. The output module may be implemented to communicate with input devices4612and they also include software with the appropriate interfaces which allow a user to access data through the use of stylized screen elements, such as menus, windows, dialogue boxes, tool bars, and controls (for example, radio buttons, check boxes, sliding scales, and so forth). Furthermore, the output module may communicate with a set of input and output devices to receive signals from the user.

A computing system4602,4702,4802may include one or more internal and/or external data sources (for example, data sources4622). In some embodiments, one or more of the data repositories and the data sources described above may be implemented using a relational database, such as DB2, Sybase, Oracle, CodeBase, and Microsoft® SQL Server as well as other types of databases such as a flat-file database, an entity relationship database, and object-oriented database, and/or a record-based database.

A computer system4602,4702,4802may also access one or more databases4622. The databases4622may be stored in a database or data repository. A computer system4602,4702,4802may access the one or more databases4622through a network4618or may directly access the database or data repository through110devices and interfaces4612. The data repository storing the one or more databases4622may reside within a computer system4602,4702,4802.

Although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while several variations of the embodiments of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes of the embodiments of the disclosed invention. Any methods disclosed herein need not be performed in the order recited. Thus, it is intended that the scope of the invention herein disclosed should not be limited by the particular embodiments described above.

Further, while the methods and devices described herein may be susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but, to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various implementations described and the appended claims. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an implementation or embodiment can be used in all other implementations or embodiments set forth herein. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inserting an intraocular lens into a prosthetic capsular device” include “instructing the insertion of an intraocular lens into a prosthetic capsular device.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 3.5 mm” includes “3.5 mm.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially constant” includes “constant.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.