Patent Description:
There are drawbacks associated with such existing ophthalmic devices, including injury to ocular tissues relating to device migration. If an ophthalmic device is not properly stabilized, this can lead to anterior capsular opacification, loss of capsule integrity, deformation of the shape of the capsulotomy, phimosis of the capsulotomy over time, tilt and decentration of the lens, and other undesirable effects.

There is a need or desire for an intraocular device that can be implanted in a patient's eye that minimizes damage to collateral tissues. There is a further need or desire for an intraocular device that can be implanted in a patient's eye that provides lens stability.

<CIT> discloses an intraocular lens with drug delivery system attached thereto. <CIT> discloses an intraocular lens, in particular capsular sac intraocular lens. <CIT> discloses a drug eluting member, a method of attaching the same and a method of fabricating the same, a device for holding the same and a drug eluting device. <CIT> discloses modular intraocular lens designs, tools and methods. <CIT> discloses modular intraocular lens designs, tools and methods.

An ophthalmic implant, as described herein, includes a primary intracapsular device coupled to a secondary device, wherein, when implanted in a patient's eye, the primary intracapsular device is held in place by the patient's capsular bag and the secondary device is held in place by the primary intracapsular device. Both the primary intracapsular device and the secondary device may be positioned inside the capsular bag in the patient's eye. Alternatively, the primary intracapsular device may be positioned inside the capsular bag while the secondary device may be positioned outside the capsular bag in the patient's eye, with the patient's anterior capsule or a portion of the patient's anterior capsule positioned between the primary intracapsular device and the secondary extracapsular device. The secondary device may be designed to hold a tertiary device that can be implanted either at the time of initial surgery or any time thereafter. The insertion of the ophthalmic implant into the patient's eye may lead to partial or full compression of the anterior capsule against the primary intracapsular device, which provides substantial lens stability. The present invention relates to an ophthalmic implant as set forth in the appended claims.

The primary intracapsular device is an intraocular lens. The secondary device is a ring. The secondary device is secured to one or more extensions extending from the primary device.

The secondary device is a drug delivery device that delivers one or more active pharmaceutical ingredients that can treat ocular disease. The secondary device may include a sheath that houses one or more drug delivery devices and one or more drugs.

The tertiary device may be in the form of a ring or one or more partial rings, for example, and may include a sheath that houses one or more drug delivery devices and one or more drugs. The tertiary device may deliver drugs, function as an artificial iris, or resolve dysphotopsia. Additionally or alternatively, the tertiary device may be an optical mask that can control the amount of light that enters a patient's eye.

The ophthalmic implant may be for use in a method of addressing ocular disease, which may include injecting the primary intracapsular device and the secondary device into the eye either before or after attaching the secondary device to the primary intracapsular device. As described above, the joined primary intracapsular device and secondary device may both be positioned inside the capsular bag in the patient's eye, with the secondary intracapsular device positioned between the patient's anterior capsule and the primary intracapsular device. Alternatively, the primary intracapsular device may be positioned inside the capsular bag while the secondary device may be positioned outside the capsular bag in the patient's eye, with the patient's anterior capsule or a portion of the patient's anterior capsule positioned between the primary intracapsular device and the secondary extracapsular device. Furthermore, a tertiary device may be implanted and attached at the time of surgery or anytime postoperatively.

In order to describe the manner in which the above-recited and other advantages and features can be obtained, a more particular description is set forth and will be rendered by reference to specific examples thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical examples and are not therefore to be considered to be limiting of its scope, implementations will be described and explained with additional specificity and detail through the use of the accompanying drawings.

The drawings have not necessarily been drawn to scale. Similarly, some components and/or operations may be separated into different blocks or combined into a single block for the purposes of discussion of some of the embodiments of the present technology. Moreover, while the technology is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the technology to the particular embodiments described.

An ophthalmic device, as described herein, can be implanted in a patient's eye to treat, diagnose, monitor or otherwise benefit ophthalmic or systemic diseases or conditions. The ophthalmic device includes a primary device coupled to a secondary device. In each of the embodiments, the primary device is implanted in the patient's capsular bag. While the primary intracapsular device is held in place by the capsular bag, the secondary capsular device is held in place, at least in part, by the primary intracapsular device. A tertiary device may be held in place by the secondary device and can be fully within the capsular bag, partially in and partially out of the capsular bag, or fully above the capsular bag.

According to one embodiment, the primary intracapsular device is positioned inside the patient's capsular bag, and a secondary device is a secondary extracapsular device that is positioned outside the patient's capsular bag in the patient's eye. The primary intracapsular device may be tethered to the secondary extracapsular device with the secondary extracapsular device transitioning from intracapsular attachment(s) to the supracapsular plane. When implanted in the patient's eye, the primary intracapsular device is held in place by the patient's capsular bag and the secondary extracapsular device is held in place by the primary intracapsular device, with the patient's anterior capsule or a portion thereof positioned between the primary intracapsular device and the secondary extracapsular device. The secondary extracapsular device may be at least partially held in place by the anterior capsule. The positioning of the ophthalmic implant in the patient's eye may lead to partial or full compression of the anterior capsule or portion thereof against the primary intracapsular device, which provides substantial lens stability.

By holding the secondary extracapsular device in place above the anterior capsule of the lens bag in the patient's eye, the ophthalmic device may also provide spacing between the secondary extracapsular device and the iris, ciliary sulcus tissue, and/or zonules. This positioning of the secondary extracapsular device prevents chafing or other discomfort caused by friction between the secondary extracapsular device and the eye tissues. The placement of the secondary extracapsular device can also reduce or prevent intraocular lens edge-related positive and negative dysphotopsias by stabilizing a capsulotomy, thus eliminating optical effects from the capsulotomy edge or the intraocular lens edge. The extensions in combination with the secondary extracapsular device may also act as a reservoir to hold a drug in place with or without control of elution rate.

According to another embodiment, a primary intracapsular device is positioned inside the patient's capsular bag, and a secondary device is a secondary intracapsular device that is joined to the primary intracapsular device and is also positioned inside the patient's capsular bag in the patient's eye. A tertiary device may be held in place by the secondary intracapsular device and can be fully within the capsular bag, partially in and partially out of the capsular bag, or fully above the capsular bag. More particularly, the secondary intracapsular device is positioned between the primary intracapsular device and the anterior capsule of the patient's eye within the capsular bag. In this manner, the intraocular device is positioned to receive the tertiary device without having to manipulate the primary intracapsular device or the secondary intracapsular device. Unless specified, the secondary devices described in the embodiments below may be either intracapsular secondary devices or extracapsular secondary devices.

According to certain embodiments, as shown in <FIG>, the intraocular device <NUM> includes a primary intracapsular device <NUM> in the form of an intraocular lens <NUM> or optic. As described in greater detail below, as an alternative, the primary intracapsular device <NUM> may be a device other than an intraocular lens. For example, the primary intracapsular device <NUM> may be a capsular tension ring, or a capsular scaffold. Various configurations can be used to join the secondary device to the primary intracapsular device <NUM>. As shown in the embodiment in <FIG>, the primary intracapsular device <NUM> may be equipped with one or more extensions <NUM> extending from an anterior side <NUM> of the intraocular lens <NUM>. These extensions <NUM> may be used to join the secondary device to the primary intracapsular device <NUM>.

The intraocular lens <NUM> may be held in place in a lens bag of a patient's eye with an intraocular lens haptic <NUM> or any other suitable attachment device. Once the intraocular lens <NUM> is implanted in the patient's eye, the one or more extensions <NUM> extending from the anterior side <NUM> of the intraocular lens <NUM> are each at least partially intracapsular and may terminate either below or above a position of an anterior capsule of the lens bag in the patient's eye. In embodiments in which the one or more extensions <NUM> terminate above a position of an anterior capsule of the lens bag, each of the one or more extensions <NUM> may also be partially supracapsular.

One or more extensions may extend from the primary intracapsular device to engage the secondary extracapsular device, thereby sandwiching the anterior capsule between the primary intracapsular device and the secondary extracapsular device. If the anterior capsule were not sandwiched in this manner, the anterior capsule may deform at the supracapsular pressure points, which could lead to anterior capsular opacification, loss of capsulotomy integrity, deformation of the shape of the capsulotomy, phimosis of the capsulotomy over time, tilt and decentration of the lens, and other possible unfavorable side effects. Furthermore, the positioning of the primary intracapsular device and the secondary extracapsular device, in combination, may stabilize a capsulotomy. More particularly, compressing the capsulotomy edge between the primary intracapsular device and the secondary extracapsular device allows for stability of the capsulotomy edge with prevention of phimosis while acting as a barrier to cellular proliferation from the anterior capsule to the anterior surface of the optic.

One or more extensions may extend from the primary intracapsular device to engage the secondary intracapsular device, thereby joining the primary intracapsular device to the secondary intracapsular device, with the secondary intracapsular device positioned between the primary intracapsular device and an anterior capsule of the lens bag. A tertiary device may be held in place by the secondary device and can be fully within the capsular bag between the secondary intracapsular device and the anterior capsule of the lens bag, partially in and partially out of the capsular bag, or fully above the capsular bag.

As alternatives to the embodiments described above, rather than the extensions <NUM> extending from the intraocular lens <NUM>, the one or more extensions <NUM> may extend from the secondary device <NUM> device to engage the primary intracapsular device <NUM>.

The extensions <NUM> may be in the form of tabs, hooks, pegs, rings, a planar surface with indentations, pins, polygons, or other configurations adapted to receive a secondary extracapsular device or a secondary intracapsular device, or if extending from a secondary device, adapted to receive a primary intracapsular device. As shown in <FIG>, the extensions <NUM> may be tabs, in this case diametrically opposite one another, facing away from a center of the intraocular lens <NUM>. Alternatively, the extensions <NUM> may be tabs or indentations that face toward the center of the intraocular lens <NUM> (not shown). According to certain embodiments, the extensions <NUM> may be deformable to allow for easier manipulation when attaching the secondary extracapsular or intracapsular device. Flexibility in the extensions <NUM> can also be beneficial during insertion of the intraocular device <NUM> into the patient's eye, such that in certain embodiments the primary intracapsular device <NUM> can be folded and the extensions <NUM> can hold the primary intracapsular device <NUM> in the folded position for easier insertion.

A secondary device <NUM>, as shown in <FIG>, may be affixed to the primary intracapsular device <NUM>. As described above, the secondary device <NUM> may be positioned above the anterior capsule of the lens bag in the patient's eye, such that the secondary extracapsular device <NUM> and the extensions <NUM> reside above the lens bag. The secondary extracapsular device <NUM> may contact the anterior capsule or be positioned just above the anterior capsule without contacting any structure other than the extensions <NUM>, wherein any other structure refers to the iris, ciliary sulcus tissue, and/or zonules. In particular, the secondary device <NUM> may be affixed to one or more tabs positioned outside of a visual axis of the intraocular lens <NUM>. The secondary extracapsular or intracapsular device <NUM> may be non-permanently attached to the extensions <NUM> such that the secondary device <NUM> may be replaced as desired or as needed. According to certain embodiments, the secondary device <NUM> may be biodegradable.

The secondary extracapsular or intracapsular device <NUM> may be virtually any device affixed anterior or posterior to the lens capsule to treat, diagnose, monitor or otherwise benefit ophthalmic or systemic diseases or conditions. The secondary device <NUM> can perform optic functions, including refraction correction and presbyopia correction, such as providing extended depth of focus. For example, the secondary device <NUM> may be a drug delivery device, an optical mask, a pinhole mask, a refractive mask, a toric mask, a multifocal mask, a trifocal mask, an opaque light-blocking surface, a partial light-blocking surface, and/or a dyspho ring. In certain cases, the secondary device <NUM> may act as an artificial iris, such as in cases of trauma to the iris, or in cases of albinism or aniridia, for example. The secondary device <NUM> may be any suitable form, such as a ring, a partial ring or ring segment, multiple ring segments, or a polygon.

In one embodiment, the secondary device <NUM> may be inserted into the eye and positioned over the anterior capsule <NUM> with one or more extensions <NUM> going under the anterior capsule <NUM> to stabilize the secondary device <NUM> in place prior to injecting a primary intracapsular device <NUM> through the opening of the secondary device <NUM> directly into the capsular bag. In this embodiment, the primary intracapsular device <NUM> may further secure the secondary device <NUM> within the supracapsular space through one or more supracapsular or intracapsular extensions <NUM>.

As another technique to assist in installing the secondary device <NUM> on the intraocular lens <NUM> or scaffold, the extensions <NUM> and the secondary device <NUM> may be color-coded to assist in proper positioning. More particularly, when the extensions <NUM> and the secondary device <NUM> are color-coded, the secondary device <NUM> can be positioned onto the extensions <NUM> to either reveal or conceal a specific color that indicates proper positioning of the secondary device <NUM> to the supracapsular portions of the extensions <NUM>. According to certain embodiments, other portions of the primary intracapsular device <NUM>, instead of or in addition to the extensions <NUM>, may be color-coded along with the secondary device <NUM> to assist with proper visualization and positioning of the secondary device <NUM> with respect to the primary intracapsular device <NUM>.

<FIG> shows the secondary extracapsular device <NUM> affixed to the extensions <NUM> above the anterior capsule of the lens bag <NUM>, while the intraocular lens <NUM> and haptics <NUM> reside inside the lens bag <NUM>. The attached secondary extracapsular device <NUM> may reside along the remaining anterior capsule <NUM>, post creation of a <NUM> to <NUM> capsulotomy, of the lens bag <NUM> after the intraocular lens <NUM> has been implanted and the extensions <NUM> positioned over the anterior capsule <NUM>. Attaching the secondary extracapsular device <NUM> to the intraocular lens <NUM> may compress the secondary extracapsular device <NUM> against the anterior capsule <NUM>, with the anterior capsule <NUM> compressed between the secondary extracapsular device <NUM> and the intraocular lens <NUM>, which may create an enhanced barrier to anterior capsular opacification (ACO).

Additionally, the primary intracapsular device <NUM> and/or the secondary extracapsular or intracapsular device <NUM> may contain fenestrations or openings that allow for evacuation of the viscoelastic from the capsular bag <NUM> at the conclusion of surgery. Without such fenestrations or passageways, the viscoelastic may displace the lens and cause refractive surprises. In addition to providing an evacuation route for the viscoelastic to exit the capsular bag <NUM> at the conclusion of surgery, such fenestrations or holes may serve to increase the surface area of the secondary device <NUM> in order to tune the drug elution when the secondary device <NUM> is a drug delivery device.

In <FIG>, the secondary extracapsular device <NUM> is a pinhole mask. According to certain embodiments, the pinhole can be turned on and off, such that the pinhole may provide a partial or <NUM>% light transmittance pinhole to reduce the effects of astigmatism. Also according to certain embodiments, when a pinhole mask is placed over an implanted intraocular lens <NUM>, the mask may be movable in the x,y plane to position the pinhole over an optimal site in relation to the center of the pupil. The mask may be removed in the case of retinal surgery if the pinhole blocks the view. The pinhole may also be composed of a material that is transparent to non-visible light (infrared light for example) so that scanning imaging devices commonly used in ophthalmology, namely optical coherence tomography imaging (OCT), can still image the posterior pole through the mask. According to some embodiments, the materials used for the primary intracapsular device <NUM> and/or the secondary device <NUM> may each include a material that is partially or fully opaque to OCT imaging to assist with image-guided docking.

<FIG>, and <FIG> show various views of one embodiment of the intraocular device <NUM> implanted in a lens bag <NUM>. In this embodiment, the primary intracapsular device <NUM> is a one-piece mechanism that forms an intracapsular scaffold <NUM> with supracapsular extensions <NUM>. The scaffold <NUM> may be formed of one piece, as shown, or may be formed of multiple pieces. As shown in the drawings, an intraocular lens may be omitted, with the intracapsular scaffold <NUM> and its supracapsular extensions <NUM> affixing the secondary device <NUM> in place. According to certain embodiments, the scaffold <NUM> may reside entirely within the sulcus. In another embodiment, a capsular tension ring may also serve as the intracapsular scaffold <NUM>, from which supracapsular extensions <NUM> may extend. In yet another embodiment, the secondary device <NUM>, which may be a drug delivery device, may be attached to a sulcus fixated ring, sulcus fixated optic, or similar device, so that the entire device resides within the ciliary sulcus plane without extending into the capsular bag <NUM>.

In the side view of <FIG>, one can clearly see the anterior capsule <NUM> of the lens bag <NUM>, with the supracapsular extensions <NUM> extending above the anterior capsule <NUM> and holding the secondary device <NUM> in place above the anterior capsule <NUM> while the intraocular scaffold <NUM> is positioned within the lens bag <NUM>.

The secondary extracapsular or intracapsular device <NUM>, such as in the form of a ring or partial ring, may include one or more ridges <NUM> on the inside surface or on the outside surface, or micro-patterns, that help secure the secondary device <NUM> into place on the extensions <NUM>. For example, micro-patterns on the secondary device <NUM> may attach to corresponding micro-patterns on the extensions <NUM>. Additionally, or alternatively, the extensions <NUM> may include one or more step features <NUM>, as shown in <FIG>, that help secure the extensions <NUM> to the secondary device <NUM>. The embodiment illustrated in <FIG> is identical to the embodiment shown in <FIG>, but with the addition of an additional step feature <NUM> on the extensions <NUM>. In particular, the additional step feature <NUM> in <FIG> assists in keeping the secondary device <NUM> spaced apart from the anterior capsule <NUM> of the lens bag <NUM>. The anterior capsule <NUM> may be positioned under this step feature <NUM>, as shown in <FIG>. Alternatively, the step feature <NUM> may be positioned under the anterior capsule <NUM>. This step feature <NUM> may reside only under the extension <NUM> or continue around the intraocular device <NUM> for <NUM> degrees, or any portion. According to certain embodiments, ridges and/or micro-patterns may be present on any surface of the extensions <NUM> and/or the secondary device <NUM> to help secure the extensions <NUM> to the secondary device <NUM>.

<FIG> is a cross-sectional view of the intraocular device <NUM> attached to a lens bag <NUM>. In this embodiment, the intraocular scaffold <NUM> interfaces with the anterior capsule <NUM> attached within the capsulotomy or capsulorhexis. The intraocular scaffold <NUM> is open in the middle, with no lens. As indicated above, the feature <NUM> above the anterior capsule serves to keep the secondary device <NUM> from contacting the anterior capsule <NUM>, thereby eliminating any potential for adhesion.

According to certain embodiments, micro-patterned surfaces may be present on the secondary device <NUM> and/or on the intraocular lens <NUM> and/or on the intraocular scaffold <NUM> to decrease the surface area available to contact the anterior capsule <NUM>. A micro-pattern on the secondary device <NUM> may also allow for increased surface area from which to elute a drug. More particularly, the use of micro-patterns on the secondary device <NUM> is a way to tune release rate of drugs when the secondary device <NUM> is a drug delivery device.

In one embodiment, the anterior extensions <NUM> from the intraocular lens <NUM> or scaffold <NUM> to the anterior capsule <NUM> leads to the secondary device <NUM> being positioned between the anterior capsule <NUM> and the iris without touching anything but the anterior extensions <NUM> from the intraocular lens <NUM> or scaffold <NUM>.

The secondary device <NUM> may be in the form of a ring, as shown in <FIG>, or a partial ring, as shown in <FIG>, or one or more ring segments. A cross-sectional view of an embodiment of the secondary device <NUM> taken along line A-A of either <FIG> is shown in <FIG>, not necessarily to scale.

One benefit of using a partial ring or ring segment as the secondary device <NUM>, rather than a full ring, is that the partial ring can be more easily manipulated both when installing and removing the secondary device <NUM>. More particularly, the partial ring can be wrapped into place on the extensions <NUM>, rather than having to be stretched over or compressed under the extensions <NUM> as may be required with a full ring. Also, when using a partial ring or ring segment as the secondary device <NUM>, rather than a full ring, the partial ring can be detached from the extensions <NUM> by grasping one free end and directing the ring away from the extensions <NUM>, essentially unwinding the device to free the device from the extensions <NUM> without the need to stretch or compress the device in order to displace it. This would be less traumatic than removing a full ring, and would lead to less movement of the optic in the process of exchanging the ring when drug elution is complete thus requiring a new ring to be installed.

The ring or partial ring may contain a nitinol wire or prolene suture material, which allows the ring to be wrapped into place reliably. More particularly, the nitinol wire or prolene suture material can direct folding and unfolding of the ring to enhance connection with the primary intraocular device. This can take the form of biasing the ring towards bending in one direction when compressed or stretched. Thus, the nitinol wire or prolene suture material enhances positioning of the secondary device <NUM> on the supracapsular extensions <NUM>.

According to certain embodiments, the secondary device <NUM> may have one or more indentations or other pre-formed areas that help with bending or folding and unfolding the secondary device <NUM> in a controlled manner at specific points along a body of the secondary device <NUM> in relation to installing the secondary device <NUM> relative to the extensions <NUM> and/or the primary intracapsular device <NUM>.

As another technique for controlling the bending or folding and unfolding of the intraocular device <NUM> during insertion, the primary intracapsular device <NUM> and the secondary device <NUM> may be made out of different materials that unfold at different rates. This material difference facilitates placement of the primary intracapsular device <NUM> in the bag and the secondary extracapsular device <NUM> outside of the bag. Suitable materials include essentially any polymer material suitable for implantation into the eye, including but not limited to acrylic and non-acrylic polymers, silicone materials, and hydrogels. The materials may be hybrid hydrophobic, hydrophilic, or various polymers in different ratios to effect the appropriate modulus needed for the specific application.

The thickness of the secondary device <NUM> may taper toward an inner diameter <NUM> of the ring or partial ring, as shown in <FIG>. Similarly, the thickness of the secondary device <NUM> may taper toward an outer diameter <NUM> of the ring or partial ring, as shown in <FIG>, to avoid the iris tissue, which drapes over this area during normal iris movements. As shown in <FIG>, the thickness of the ring or partial ring may taper from a central portion of the body to both the inner diameter <NUM> and the outer diameter <NUM>, with the thickness of the secondary device <NUM> being smallest along the inner diameter <NUM> and the outer diameter <NUM>, and the thickness of the secondary device <NUM> being greatest between the inner diameter <NUM> and the outer diameter <NUM> of the ring or partial ring. This wedge shape allows the secondary device <NUM> to slide in to an optic fixation point on the primary intracapsular device <NUM> or extensions since the narrowest part of the inner diameter <NUM> or outer diameter <NUM> of the ring or partial ring, depending on whether a corresponding wedge of the extensions is facing inward or outward, will go in the widest opening in the wedge of the extensions <NUM>, as shown in <FIG>. The complementary wedge shapes also cinch down the anterior capsule <NUM> to the primary intracapsular device <NUM> or optic more reliably than certain non-wedged configurations.

<FIG> shows the intraocular device <NUM> with the secondary device <NUM> positioned in place on the primary intracapsular device <NUM> and secured with the supracapsular extensions <NUM>. <FIG> is a cross-sectional view of the intraocular device <NUM> of <FIG> taken along line B-B. <FIG> are cross-sectional plan views of various embodiments of the intraocular device <NUM> of <FIG> taken along line B-B. In each of these embodiments, the secondary device <NUM> may be a ring or a partial ring.

<FIG> and <FIG> each show an embodiment in which the thickness of the secondary device <NUM> tapers toward the inner diameter <NUM> of the ring in a wedge shape, and the corresponding wedge shape of the supracapsular extensions <NUM> faces outward. The complementary wedge shapes of the secondary device <NUM> and the supracapsular extensions <NUM> provide a stable configuration of the primary intracapsular device <NUM> coupled to the secondary device <NUM> with the anterior capsule <NUM> sandwiched between the primary intracapsular device <NUM> and the secondary device <NUM>.

The intraocular device <NUM> in <FIG> is very similar to the embodiment shown in <FIG>, but in <FIG> the secondary device <NUM> tapers toward the inner diameter <NUM> of the ring and also tapers toward the outer diameter <NUM> of the ring forming a wedge along each edge, with the thickness of the secondary device <NUM> being greatest between the inner diameter <NUM> and the outer diameter <NUM> of the ring.

In <FIG>, the secondary device <NUM> has a waveform surface configuration along a body of the ring. This waveform can interlock with the corresponding shape of the supracapsular extensions <NUM>. This particular waveform is just one embodiment of a waveform. Other waveforms may be used. For example, the supracapsular extensions <NUM> in <FIG> have a wedge that faces inward and the waveform surface configuration of the secondary device <NUM> has a wedge portion that fits together with the wedge of the supracapsular extensions. Alternatively, the supracapsular extensions <NUM> may have a wedge that faces outward and the waveform surface configuration of the secondary device <NUM> may have a wedge portion that fits together with the wedge of the supracapsular extensions, in a configuration opposite of <FIG>, for example.

The intraocular device <NUM> in <FIG> is very similar to the embodiment shown in <FIG>, but in <FIG> the primary intracapsular device <NUM> includes a step feature <NUM>, similar to the step feature <NUM> shown in <FIG>. However, unlike the embodiment shown in <FIG>, the step feature <NUM> in <FIG> is positioned within the capsular bag <NUM> beneath the anterior capsule <NUM>. This step feature <NUM> may help secure the extensions <NUM> to the secondary device <NUM>.

The intraocular device <NUM> in <FIG> is very similar to the embodiment shown in <FIG>, but in <FIG> the secondary device <NUM> includes a nitinol or plastic ring <NUM> that can be used as a drug delivery device, described in greater detail below.

The intraocular device <NUM> in <FIG> is also very similar to the embodiment shown in <FIG>, but in <FIG> the secondary device <NUM> includes a micro-pattern <NUM> on a bottom surface. The micro-pattern <NUM> may decrease the surface area available to contact the anterior capsule <NUM> while simultaneously helping to secure the secondary device <NUM> in place.

Multiple secondary devices <NUM> may be stacked either radially, as shown in <FIG>, or vertically, as shown in <FIG>, when the secondary devices <NUM> are connected to the supracapsular extensions <NUM>. According to some embodiments, the first innermost or bottommost ring may touch the extensions <NUM> while the second and any subsequent rings may either be stacked abutting the first ring or may also connect directly to the extensions <NUM>. This configuration allows for the delivery of different therapeutics using multiple rings as needed. In some embodiments, the rings may have gaps between them when stacked so that each ring is easily accessible with a surgical tool, such as a Sinskey hook, to remove each ring from the docked position without requiring excessive manipulation.

According to certain embodiments, the secondary device <NUM> may have a non-circular inner rim geometry and/or a non-circular outer rim geometry. An alternative inner rim geometry allows for positioning the ring over the extensions <NUM> without stretching the ring by aligning a maximum or larger inner diameter <NUM> of the ring over the extensions <NUM> and then rotating the ring relative to the extensions <NUM> until a shorter inner diameter <NUM> of the ring aligns with the extensions <NUM>, which then fixes the ring in place by compression force. Likewise, an alternative outer rim geometry allows for positioning the ring between inward facing extensions <NUM> without compressing the ring by aligning a minimum or shorter outer diameter <NUM> of the ring between the extensions <NUM> and then rotating the ring relative to the extensions <NUM> until a larger diameter <NUM> of the ring aligns between the extensions <NUM>, which then fixes the ring in place by compression force.

The secondary device <NUM> may be oval so that it locks into one or more tabs or other form of extensions <NUM> when rotated clockwise or counterclockwise after being positioned over the already-implanted intraocular lens <NUM>. For example, the longer dimension of the oval ring may form wings that can be pulled up over the capsule and the shorter dimension of the oval ring may contain fenestrations that can be locked onto the extensions <NUM>. This configuration facilitates injecting the intraocular device into the capsular bag followed by pulling the wings up over the anterior capsule with a Sinskey hook or similar device. Alternatively, the short dimension of the oval ring may be in the same axis as the haptics <NUM> so that the haptics <NUM> can open up and be visualized going into the capsular bag easily, as the ring does not obstruct the view of the haptics <NUM> opening up in the capsular bag.

For example, as shown in <FIG>, the inner diameter <NUM> of the secondary device <NUM> may be oval in combination with outward facing extensions <NUM>. In <FIG>, the maximum inner diameter <NUM> of the oval ring is aligned with the extensions <NUM>. In <FIG>, the ring has been rotated such that a shorter inner diameter <NUM> of the ring aligns with and is held in place by the extensions <NUM>. If the extensions <NUM> were inward facing and the outer diameter <NUM> of the secondary device <NUM> were oval, the minimum outer diameter <NUM> of the oval ring could be aligned between the extensions <NUM>, and the ring subsequently rotated to align the larger outer diameter <NUM> between the extensions <NUM> in a stable and secure interlocking configuration.

As another example, <FIG> show the inner diameter <NUM> of the secondary device <NUM> having a hexagon shape in combination with outward facing extensions <NUM>. In <FIG>, a maximum inner diameter <NUM> of the hexagonal ring is aligned with the extensions <NUM>. In <FIG>, the ring has been rotated such that a shorter inner diameter <NUM> of the ring aligns with and is held in place by the extensions <NUM>. As in the previous embodiments, if the extensions <NUM> were inward facing and the outer diameter <NUM> of the secondary device <NUM> were hexagonal, the minimum outer diameter <NUM> of the hexagonal ring could be aligned between the extensions <NUM>, and the ring subsequently rotated to align the larger outer diameter <NUM> between the extensions <NUM> in a stable and secure interlocking configuration.

The intraocular device <NUM> may include one or more of the aforementioned features designed to secure the secondary device <NUM> and the extensions <NUM>. For example, in the embodiments shown in <FIG>, the inner diameter <NUM> of the ring may include a micro-pattern to enhance fixation post rotation into place.

Rather than securing the secondary device <NUM> to the primary intracapsular device <NUM> with extensions <NUM>, according to certain embodiments, the secondary device <NUM> can be coupled directly to the primary intracapsular device <NUM> by fit and/or by adhesive. In such embodiments, the primary intracapsular device <NUM> can be virtually any conventional intraocular lens <NUM> with the secondary device <NUM> formed separately and subsequently attached to the intraocular lens <NUM>. In the embodiment shown in <FIG>, the secondary device <NUM> is in the form of two partial rings or ring segments. Each of the ring segments may have a snap-fit or other mechanical fit onto the primary intracapsular device <NUM>, or the ring segments may be secured to the primary intracapsular device <NUM> with an adhesive.

The secondary device <NUM> may be designed to hold a tertiary device <NUM> that can be implanted either at the time of initial surgery or any time postoperatively. The tertiary device <NUM> may be in the form of a ring or one or more partial rings, for example, and may include a sheath that houses one or more drug delivery devices and one or more drugs. Ideally, the intraocular device <NUM> is positioned to receive the tertiary device <NUM> without having to manipulate the primary intracapsular device <NUM> or the secondary intracapsular device <NUM>.

As noted above, the secondary device <NUM> may be a drug delivery device. For example, the secondary device <NUM> in <FIG> can contain one or more drugs, such as within drug pads integrated into the secondary device <NUM>, and can release the drug or drugs over time after the intraocular device <NUM> is fully implanted in the capsular bag. After the initial drug in the secondary device <NUM> is fully released, a new drug refill, in the form of a tertiary device <NUM>, which may be in a ring form or other suitable form, can be implanted to fit in the concave sections of the two opposing parts of the secondary device <NUM>. If the tertiary device <NUM> is a drug contained within a ring, as shown in <FIG>, the tertiary device <NUM> can be held in place by elastic force within the concave sections of the secondary device <NUM>. The tertiary device <NUM> may be a ring in a classic circle shape or the tertiary device <NUM> may be made in other shapes that can extend beyond an outer diameter of the optic in order to leverage some of the space where the secondary device <NUM> is not present.

The tertiary device <NUM> may be virtually any device affixed to the secondary device <NUM> to treat, diagnose, monitor or otherwise benefit ophthalmic or systemic diseases or conditions. When present, like the secondary device <NUM>, the tertiary device <NUM> can perform optic functions, including refraction correction, presbyopia correction, such as providing extended depth of focus, and resolving dysphotopsia. For example, the tertiary device <NUM> may be a drug, a drug delivery device, an optical mask, a pinhole mask, a refractive mask, a toric mask, a multifocal mask, a trifocal mask, an opaque light-blocking surface, a partial light-blocking surface, and/or a dyspho ring. In certain cases, the tertiary device <NUM> may act as an artificial iris, such as in cases of trauma to the iris, or in cases of albinism or aniridia, for example. The tertiary device <NUM> may be any suitable form, such as a ring, a partial ring or ring segment, multiple ring segments, or a polygon.

<FIG> shows the intraocular device <NUM> in <FIG> with a tertiary device <NUM> attached on top of the secondary device <NUM>. In this particular embodiment, the tertiary device <NUM> is in the form of drug pads. The drug pads of the tertiary device <NUM> can be positioned over the ring segments of the secondary device <NUM>, as shown. Alternatively, the tertiary device <NUM> can be positioned over part or all of the secondary device <NUM>.

When the secondary device <NUM> is a secondary intracapsular device, as shown in <FIG>, the tertiary device <NUM> held in place by the secondary intracapsular device can either be positioned beneath an anterior capsule of the patient's eye within the capsular bag, or positioned outside the capsular bag with an anterior capsule of the patient's eye positioned between the tertiary device and the secondary intracapsular device, or positioned partially within the capsular bag and partially above an anterior capsule of the patient's eye.

The secondary device <NUM> itself can extend both beneath and above the primary intracapsular device <NUM> as a way to join the secondary device <NUM> to the primary intracapsular device <NUM>, as shown in <FIG>. This sort of attachment can be used in the form of one or more ring segments, as shown in <FIG>, as well as with a secondary device <NUM> in the form of a full ring. <FIG> shows another embodiment in which the secondary device <NUM> extends both beneath and above the primary intracapsular device <NUM>, but in this embodiment the secondary device <NUM> is in the form of a full ring on the anterior side of the primary intracapsular device <NUM> with ring segments extending around the posterior side of the primary intracapsular device <NUM>. According to certain embodiments, the primary intracapsular device <NUM> may be molded, lathed, printed or otherwise manufactured in one piece with the secondary device <NUM> and, optionally, with the tertiary device <NUM>. For example, the primary intracapsular device <NUM> and the secondary intracapsular device <NUM> may be formed together in a single structure, or the primary intracapsular device <NUM> and the secondary extracapsular device <NUM> may be formed together in a single structure. Additionally or alternatively, the secondary device <NUM> may be coupled to the primary intracapsular device <NUM> by one or more extensions <NUM> or haptics <NUM> extending from the primary intracapsular device <NUM> through one or more holes in the secondary device <NUM>.

<FIG> shows one embodiment of a primary intracapsular device <NUM> that can be joined to the secondary device <NUM>. In <FIG>, the intraocular device <NUM> includes a flare <NUM> in the optic haptic junction on each of the diametrically opposed sides of the primary intracapsular device <NUM> that act as the supracapsular extensions. Any of the described embodiments of the secondary device <NUM> can be held in place by the flares <NUM>.

<FIG> shows an embodiment of the secondary device <NUM> joined to the primary intracapsular device <NUM> implanted in a patient's eye. The secondary device <NUM> is shown in greater detail in <FIG>. Pads <NUM> on the secondary device <NUM>, as can be seen in <FIG>, can be reinforced or more sturdy than a remainder of the secondary device <NUM>, thereby providing suitable locations for locking into the extensions <NUM>. For example, the pads <NUM> may be formed of a non-permeable material while a remainder of the secondary device <NUM> is permeable; however, the pads may contain some surface area that is permeable as well as non-permeable. The entire pad <NUM> may also be permeable. The degree of permeability is controlled by surface area, mix of permeable and non-permeable areas, as well as rate of permeability of the particular material that forms the outer structure of the pad <NUM>.

<FIG> together show another embodiment for joining the secondary device <NUM> to the primary intracapsular device <NUM>. In <FIG>, the primary intracapsular device <NUM> includes extensions <NUM> each having a hole <NUM>. In <FIG>, the secondary device <NUM> includes protrusions <NUM>. The secondary device <NUM> can be joined to the primary intracapsular device <NUM> by aligning the ring of the secondary device <NUM> atop the primary intracapsular device <NUM> and rotating the ring counterclockwise to fit the protrusions <NUM> into the corresponding holes <NUM> for enhanced attachment. This embodiment may be altered to adapt to a clockwise rotation as well. This embodiment may also be modified with the holes provided in the secondary device <NUM> and corresponding protrusions <NUM> extending from the extensions <NUM>.

The primary intracapsular device <NUM> in <FIG> can also be used in combination with a ring-shaped secondary device <NUM>. More particularly, the ring can be affixed to the extensions <NUM> through the holes <NUM>, provided the holes <NUM> extend fully through each extension <NUM>, so that the ring makes a full circle that is connected by glue or other adhesive and is not detachable from the supracapsular extensions <NUM> without cutting the ring in one or more areas. Similarly, as shown in <FIG>, the ring can be held in place beneath the extensions <NUM>. Alternatively, the ring could be fed through the loops of the extensions <NUM> in <FIG>, just as the ring could be fed through the holes <NUM> in the extensions <NUM> in <FIG>. In order to feed the ring through the loops or holes, the ring would need to be opened or cut for assembly, and then the ends would need to be reattached by adhesive or hooks or interference fit or any other suitable form of re-connecting the ends of the ring to one another.

The secondary device <NUM> can also be joined to the primary intracapsular device <NUM> using magnetic forces. For example, one or more magnets can be provided in the extensions <NUM>, which can be aligned with a corresponding magnet or magnets in the secondary device <NUM>. The magnetic force can lock the secondary device <NUM> into place on the primary intracapsular device <NUM>.

As noted, the secondary device <NUM>, and in some cases the tertiary device <NUM>, may serve as a drug delivery device for holding and releasing active pharmaceutical ingredients to treat the eye, such as beta blockers, alpha agonists, prostaglandin analogs, pilocarpine, rock-inhibitors, ethacrynic acid, CNP/BNP/ANP, carbonic anhydrase inhibitor, steroids, NSAIDs, antibiotics, biologic therapeutics, tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinoids or other molecules derived from the cannabis plant, small or large molecule active ingredients, anti-fibrotic, miotic, mydriatic, anti-neoplastic, <NUM>-epi-PGF2α, and/or other active ingredients that can treat ocular disease. For example, the secondary device <NUM> may provide long-term drug delivery, such as for treating glaucoma or macular degeneration, or short-term delivery of steroids, NSAIDS, or antibiotics following intraocular surgery. The secondary device <NUM> and tertiary device <NUM> may also be used to deliver biologic/non-biologic molecules for the treatment of any disease or disorder. The secondary device <NUM> and tertiary device <NUM> may contain more than one drug if a patient requires more than one type of therapy.

According to some embodiments, the secondary device <NUM> may include a sheath in which a tertiary device <NUM> in the form of a drug delivery device may be contained, as shown in <FIG> shows the sheath, and <FIG> shows a drug delivery device contained in the sheath. In particular, the drug delivery device that is embedded in a silicone outer shell of the secondary device <NUM> may be designed so that the modulus of the drug delivery sheath causes enhanced compression or attachment against a supracapsular or intracapsular extension off of the primary intracapsular device <NUM> for greater lens stability. After an initial drug housed in the sheath is gone, a new drug delivery device can be implanted in the sheath. Furthermore, the sheath can contain a drug delivery device that can house a plurality of drugs. Optionally, the sheath can contain a plurality of drug delivery devices.

In some embodiments, the ring sheath may have surface areas that are not permeable to water or drugs so that a greater surface area can be used to enhance attachment of the sheath to the extensions but without greater surface area to elute.

According to certain embodiments, the secondary device <NUM> may include a refillable reservoir. The reservoir can be refilled with a fluid or solid. For example, the reservoir may be refilled every <NUM>-<NUM> months after the drug therein diffuses through the walls of the reservoir, such as by either Fickian or non-Fickian diffusion or through micro-holes or through a "sweating balloon" mechanism or any other suitable method for eluting the drug. As another example, the reservoir may receive a solid pellet, such as a sustained-release biodegradable implant, and hold the pellet in place while the pellet degrades. In this case, the reservoir need not be flow limiting. The entire reservoir may be made from a nitinol mesh or prolene suture material, which would allow for depositing of a pellet and keeping the pellet in place during eluting. Holding the pellet in place would prevent the pellet from harming intraocular tissues such as the back surface of the cornea.

<FIG> shows a secondary device <NUM> in the form of a refillable reservoir. More particularly, the secondary device <NUM> includes a drug delivery bleb reservoir <NUM>. The reservoir <NUM> may include a docking port <NUM> in order to refill the reservoir <NUM>. The reservoir <NUM> may be formed of a polymer or other suitable materials. The docking port <NUM> is the entry point to refill the reservoir <NUM> with either a fluid or a solid. The docking port <NUM> may be a one-way valve or a swing door, depending on the drug and its intended release. For example, the docking port <NUM> can be akin to a Hickman catheter port. The ring portion of the secondary device <NUM> may or may not be included in combination with the drug delivery bleb reservoir <NUM>.

Another embodiment of the primary device in the form of an intraocular scaffold <NUM> is shown in <FIG>. In this embodiment, the intraocular scaffold <NUM> resides entirely in the supra-capsular space. More particularly, the scaffold <NUM> is implanted over the anterior capsule <NUM> and then the secondary device <NUM> attaches to one or more support features <NUM>, which may be in the form of tabs, hooks, pegs, rings, a planar surface with indentations, pins, polygons, or other configurations adapted to receive the secondary device <NUM>. One or more stabilizing features <NUM> that provide stability in the sulcus may be in the form of haptics, as shown in <FIG>, or in the form of any other suitable attachment features that couple with surrounding tissues other than the sulcus. In one form, the device shown in <FIG> may attach to the anterior capsule <NUM> using clips with some portion of the clips extending both above and below the anterior capsule <NUM>.

Methods of implanting and using the intraocular devices <NUM> described herein can be performed using currently known surgical steps. According to one embodiment, a primary intracapsular device <NUM>, such as the device shown in <FIG> and <FIG>, can be injected into a patient's eye. The primary intracapsular device <NUM> can be held in place and stabilized with haptics <NUM> extending from the primary intracapsular device <NUM> or any other suitable device for securing the primary intracapsular device <NUM> within the capsular bag. The secondary device <NUM> can then be implanted in the patient's eye and attached to the primary intracapsular device <NUM>, such as with extensions <NUM> extending from an anterior side of the primary intracapsular device <NUM>. Alternatively, the secondary device <NUM> may include retention features that can cross the anterior capsule plane into the capsular bag and attach to the already-implanted primary intracapsular device <NUM>, which itself has complementary attachment features. The joined secondary device and primary intracapsular device <NUM> can then be positioned within the patient's eye with the extensions <NUM> terminating above a position of the anterior capsule <NUM> of the lens bag <NUM> in the patient's eye as supracapsular extensions <NUM>, and the primary intracapsular device <NUM> held in place by the capsular bag of the patient's eye and the secondary device held in place by the primary intracapsular device <NUM>.

According to another embodiment, the secondary device <NUM> can be attached to the primary intracapsular device <NUM>, such as with extensions <NUM>. The joined secondary device <NUM> and primary intracapsular device <NUM> can then be injected into a patient's eye with the primary intracapsular device <NUM> held in place by the capsular bag of the patient's eye and the secondary device <NUM> held in place above the anterior capsule <NUM> by the primary intracapsular device <NUM>. According to certain embodiments, the secondary device <NUM> may be positioned between the anterior capsule <NUM> and an iris without the secondary device <NUM> touching either the anterior capsule <NUM> or the iris. Alternatively, the joined secondary device <NUM> and primary intracapsular device <NUM> can be injected into a patient's eye with both the primary intracapsular device <NUM> and the secondary device <NUM> positioned fully inside in the patient's capsular bag.

As shown in <FIG>, the haptics <NUM> from the primary intracapsular device <NUM> can be placed within a gap between the primary intracapsular device <NUM> and the secondary device <NUM> to be injected as one assembly. When injected in the patient's eye, the secondary device <NUM> is supported by the anterior capsule followed by displacing the haptics <NUM> manually, by the surgeon, so that the haptics <NUM> slide out of the slots and open up in the capsular bag, as shown in <FIG>. The gap or gaps between the primary intracapsular device <NUM> and the secondary device <NUM> may be formed from undulations or micro-patterns in a bottom surface of the secondary device <NUM> facing the primary intracapsular device <NUM>.

A tertiary device <NUM> can be attached to the secondary device <NUM> either before or after the intraocular device <NUM> is implanted in the patient's eye. Since the tertiary device <NUM> can be easily attached to the secondary device <NUM>, when the intraocular device <NUM> has already been implanted, the tertiary device <NUM> can be attached to the secondary device <NUM> without having to manipulate the primary intracapsular device <NUM> or the secondary device <NUM>.

The implantation of the intraocular devices <NUM> can be performed during or after intraocular surgery, such as cataract surgery. More particularly, after removing the cataract lens, the primary intracapsular device <NUM> can be implanted, such as with haptics, and the extensions <NUM> can extend from the primary intracapsular device <NUM> through the opening from which the cataract was removed.

As explained above, the secondary device <NUM> can be used to treat, diagnose, or monitor ophthalmic or systemic diseases or conditions. For example, the secondary device <NUM> can be used for long-term drug delivery, short-term drug deliver, and/or the delivery of biologic or non-biologic molecules to the eye. In certain embodiments, the secondary device may include a refillable reservoir, which may be filled with a fluid or a solid. Additionally, the secondary device <NUM> can be used as an artificial iris. When necessary or beneficial, the secondary device <NUM> may be removed. Also, when necessary or beneficial, after removal the secondary device <NUM> may be replaced with either the same type of secondary device <NUM> or another secondary device <NUM> that may be deemed more beneficial under the circumstances. Likewise, a tertiary device <NUM> can be used to treat, diagnose, or monitor ophthalmic or systemic diseases or conditions.

Claim 1:
An ophthalmic implant, comprising:
a primary intracapsular device (<NUM>) coupled to a secondary device;
wherein the primary intracapsular device is an intraocular lens (IOL); and
the secondary device comprises a drug delivery device (<NUM>) in the form of a ring;
wherein one or more haptics (<NUM>) extend radially outward from the lens such that said haptic is configured to hold the primary device in place within the capsular bag;
wherein, when implanted in a patient's eye, the secondary device is held in place by the primary device by one or more tabs (<NUM>) extending from the primary intracapsular device, wherein the tabs are each at least partially intracapsular and join the drug delivery device to the primary intracapsular device;
wherein the secondary device is coupled to the primary device by the one or more tabs extending from the primary intracapsular device through one or more holes in the secondary device.