Stabilized intraocular drug delivery system and method of use - Patents.com

Abstract

The disclosed embodiments generally relate to a stabilized intraocular drug delivery system for implantation in a subject's eye. The system can include an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly can include a lens and a haptic. The haptic can include an outer end, an inner end opposite the outer end, a retention tab at the inner end, and a connection tab positioned between the outer end and the inner end and adjacent the lens. The drug delivery component can include at least one therapeutic agent and a fixation portion having an opening for receiving the haptic and fixing the drug delivery component to the IOL assembly. The fixation portion of the drug delivery component can be fixed to the connection tab of the haptic such that the retention tab restrains movement of the drug delivery component relative to the IOL assembly.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to the field of intraocular drug delivery systems, implantation and stabilization of intraocular drug delivery systems, and methods of use. [Background technology]

[0002] An intraocular lens (IOL) is an artificial lens for the eye that can be implanted to replace the natural lens of a patient's eye after the natural lens has been removed. As an example, a patient's natural lens may be removed because it is affected by cataracts, and an IOL can be implanted to provide the patient with sharp vision and some degree of focusing. Intraocular lenses can also be implanted in patients without removing the natural lens (phakic intraocular lens or PIOL) to correct extreme myopia or hyperopia.

[0003] For example, it may be advantageous to administer a therapeutic agent to the eye simultaneously with the implantation of the IOL to alleviate various side effects of the IOL or to treat other conditions of the eye that may be present at the same time as the conditions that result in, for example, cataracts and glaucoma. Pre-existing conditions or side effects of the introduction of the IOL (e.g., infection and inflammation) may be treated with a therapeutic agent incorporated into the IOL or other device that may be secured to the IOL. In addition to IOLs, lens-free ocular implants may be implanted to address a variety of conditions.

[0004] Previous attempts have disclosed various configurations of drug delivery components for use in conjunction with IOLs, including placement of drug delivery components on the haptics of the IOL. The devices and methods described below provide a more efficient and / or robust approach for securing drug delivery components to an IOL, as well as related drug delivery systems. Summary of the Invention

[0005] Certain aspects of the present disclosure include a stabilized intraocular drug delivery system that can be implanted in a subject's eye. According to these aspects, the system can include an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly can include a lens and haptics extending outwardly from the lens. The haptics can engage the drug delivery component, and the haptics can include an outer end, an inner end opposite the outer end, a retention tab at the inner end, and a connection tab positioned between the outer end and the inner end and adjacent the lens. The retention tab can overhang from the connection tab. The drug delivery component can include a therapeutic agent and a fixation portion having an opening sized and dimensioned to receive the haptics and fix the drug delivery component to the IOL assembly. The fixation portion of the drug delivery component can be fixed to the connection tab of the haptics such that the retention tab inhibits movement or movement of the drug delivery component relative to the IOL assembly.

[0006] In one embodiment, the drug delivery component may further comprise a drug delivery pad or drug pad comprising one or more therapeutic agents. The fastener may be adjacent to the drug delivery pad.

[0007] In one embodiment, the fastening portion of the drug delivery component includes a pair of structures and a band. The pair of structures can extend from the drug delivery pad. The pair of structures can be connected by the band to form the aperture.

[0008] In one embodiment, when the drug delivery component is secured to the connection tab of the haptic, one of the pair of structures interfaces with the retention tab, a first surface of the connection tab, and a first portion of the lens.

[0009] In one embodiment, the connection tab includes a first surface adjacent the retention tab and a second surface opposite the first surface. The second surface can be adjacent a portion of the haptic. The haptic can further include a gusset formed in the portion of the haptic. The gusset can interact with at least a portion of the drug delivery component to inhibit movement or migration of the drug delivery component relative to the IOL assembly.

[0010] In one embodiment, a portion of the drug delivery component can include one of a pair of structures of the anchoring portion. In one embodiment, the opening in the anchoring portion of the drug delivery component defines a generally rectangular cross-section.

[0011] In one embodiment, the connection tab includes a first surface adjacent the retention tab and a second surface opposite the first surface. The second surface can be adjacent a portion of the haptic. The first and second surfaces can be curved and can define a waist. In other embodiments, the waist is the narrowest portion of the connection tab.

[0012] In some embodiments, the haptic includes a first haptic and a second haptic. In one embodiment, the stabilized intraocular drug delivery system can be sized and shaped to be implanted in the lens capsule or ciliary sulcus of the eye.

[0013] Aspects of the present disclosure may include a stabilized intraocular drug delivery system that may be implanted in a subject's eye. The system may include an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly may include a lens and haptics extending outwardly from the lens. The haptics may engage the drug delivery component, and the haptics may include an outer end, an inner end opposite the outer end, and a connection tab positioned between the outer end and the inner end and adjacent the lens. The drug delivery component may include a drug delivery pad and a fixation portion coupled to the drug delivery pad. The drug delivery pad may include one or more therapeutic agents. The fixation portion may include first and second structures extending from the drug delivery pad, a band coupled to the first and second structures, and an opening formed between the drug delivery pad, the first and second structures, and the band. The opening may be sized and dimensioned to receive the haptics and fix the drug delivery component to the IOL assembly. The first and second structures may be different shapes from each other. The fixation portion of the drug delivery component can be fixed to the connection tab of the haptic to restrict movement or migration of the drug delivery component relative to the IOL assembly.

[0014] In one embodiment, the inner ends of the haptics are free and overhang the connection tabs. In one embodiment, the inner end of the haptic includes a retention tab extending from the connection tab. The retention tab can include a curved surface for interacting with at least one of the first and second structures of the anchor portion of the drug delivery component.

[0015] In one embodiment, an axis extends from the first structure, through the band, to the second structure, the first structure including a body angled relative to the axis. In one embodiment, the body of the first structure is elliptical.

[0016] In one embodiment, the opening in the fastener is generally rectangular in cross section. In one embodiment, the anchoring portion may be formed from or may be a polymer. In one embodiment, an inner end of the haptic includes a retention tab extending from a connection tab, the connection tab including a first surface adjacent the retention tab and a second surface opposite the first surface. The second surface can be adjacent a portion of the haptic. The first and second surfaces can be curved and can define a waist. In one embodiment, the waist is the narrowest portion of the connection tab.

[0017] In one embodiment, the haptics include a first haptic and a second haptic. In one embodiment, the stabilized intraocular drug delivery system can be sized and shaped to be implanted in the lens capsule or ciliary sulcus of a subject's eye.

[0018] In one embodiment, the present disclosure relates to an intraocular drug delivery system including an ocular implant and a drug delivery component connected in a configuration that stabilizes relative movement of the ocular implant and the drug delivery component. In one embodiment, the ocular implant can be an intraocular lens assembly.

[0019] Aspects of the present disclosure may include a stabilized intraocular drug delivery system. According to these aspects, the intraocular drug delivery system includes an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly includes a lens and haptics extending outward from a plane of the lens and configured to engage the drug delivery component, the IOL assembly being configured for implantation into a subject's eye. The drug delivery component includes a therapeutic agent and a fixation portion having an opening sized and shaped to receive the haptics and secure the drug delivery component to the IOL assembly. In one embodiment, the haptics include a retention tab on the haptics, the retention tab having an outer surface and an inner surface to provide an inner portion at the interface of the haptics to the lens. The haptics further include a gusset on a surface opposite the inner portion at the interface of the haptics to the optic / lens. In some embodiments, the fixation portion of the drug delivery component and the retention tab, inner portion, and gusset of the haptics are configured to secure the drug delivery component to the IOL assembly in a manner that stabilizes the relative movement of the ocular implant and the drug delivery component.

[0020] In some embodiments, attachment of the drug delivery component to the intraocular lens assembly or other intraocular implant can be accomplished by releasable or non-releasable means and can be achieved at the time of manufacture of the IOL assembly, perioperatively just before or just after implantation, or intraoperatively in the same procedure as when the IOL assembly is implanted.

[0021] In one embodiment, the drug delivery component can include a first and a second drug delivery component and can be configured to allow placement of the second drug delivery component within the first drug delivery component. Placement of the second drug delivery component within the first drug delivery component can be accomplished during manufacture of the IOL assembly, perioperatively immediately prior to or immediately after implantation, intraoperatively, or in the same procedure in which the IOL assembly is implanted. The first and / or second drug delivery components are subject to wear and, when worn, can be removed and replaced in a procedure that can be accomplished well after the surgery in which the IOL assembly is initially inserted.

[0022] Aspects of the present disclosure include a stabilized intraocular drug delivery system configured for implantation into a subject's eye. The system can include an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly can include haptics and an optic. The haptics can extend outwardly from the optic at an optic-haptic junction. The haptics can include a pair of recesses defining a waist at the optic-haptic junction. The drug delivery component can include one or more therapeutic agents and a fixation portion having an opening sized and shaped to receive the haptics through the drug delivery component. The fixation portion of the drug delivery component is configured to be fixed to the waist of the haptics to inhibit movement of the drug delivery component relative to the IOL assembly.

[0023] In one embodiment, the pair of depressions can be positioned on opposing surfaces, hi one embodiment, each of the pair of depressions includes a concave surface. In one embodiment, the haptics further include an outer end, an inner end opposite the outer end, and a retention tab at the inner end. The optic-haptic interface can be positioned between the inner end and the outer end.

[0024] In one embodiment, the retention tab extends from the waist portion to define one of the pair of recesses. In one embodiment, the haptic includes a rear surface, a front surface opposite the rear surface, a first side end, and a second side end opposite the first side end. The first and second side ends can extend between the rear surface and the front surface, with a first recess of a pair of recesses defined on the first side end and a second recess of the pair of recesses defined on the second side end.

[0025] In one embodiment, the fastener is formed from a polymer or other suitable material. In one embodiment, the drug delivery component further comprises a drug delivery pad. In other embodiments, one or more therapeutic agents are included in at least one of the drug delivery pad and the fixed portion. In some embodiments, the drug delivery pad and the fixed portion can include one or more therapeutic agents, which may be the same or different therapeutic agents.

[0026] Aspects of the present disclosure may include a stabilized intraocular drug delivery system configured for implantation in a subject's eye. The system may include an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly may include an optic and a haptic extending outward from the optic at an optic-haptic junction. The haptic may include an anterior surface, a posterior surface opposite the anterior surface, and a first depression on the posterior surface or on the anterior surface at the optic-haptic junction. The drug delivery component may include one or more therapeutic agents and a fixation portion having an opening sized and shaped to receive the haptic through the drug delivery component. The fixation portion of the drug delivery component is configured to be fixed to the haptic at the first depression at the optic-haptic junction to inhibit movement of the drug delivery component relative to the IOL assembly.

[0027] In one embodiment, the first depression is on the posterior surface and the haptic further includes a second depression on the anterior surface. In one embodiment, the haptic further includes a first side end extending between the anterior and posterior surfaces and a second side end opposite the first side end and extending between the anterior and posterior surfaces. The first side end can include a second recess at the optic-haptic junction and the second side end can include a third recess at the optic-haptic junction.

[0028] In one embodiment, each of the second and third recesses includes a concave surface. In one embodiment, the haptics further include an outer end, an inner end opposite the outer end, and a retention tab at the inner end. The optic-haptic interface can be positioned between the inner end and the outer end.

[0029] In one embodiment, the fastener is formed from a polymer or other suitable material. In one embodiment, the drug delivery component further comprises a drug delivery pad, and the one or more therapeutic agents are comprised in at least one of the drug delivery pad and the anchor portion. [Brief description of the drawings]

[0030] [Figure 1] 1 illustrates an environment for use of the intraocular drug delivery system of the present disclosure. [Diagram 2] 1 illustrates an environment for use of the intraocular drug delivery system of the present disclosure. [Figure 3A] 3A-3D show top views of an intraocular drug delivery system according to an embodiment of the present disclosure, respectively. [Figure 3B] 3A and 3B show top views of an intraocular drug delivery system according to an embodiment of the present disclosure, respectively. [Figure 3C] FIG. 3C shows a perspective view of the intraocular drug delivery system of FIG. 3B with a larger drug delivery component attached to an IOL assembly. [Figure 3D] FIG. 3C shows a bottom view of the intraocular drug delivery system of FIG. 3B with a larger drug delivery component attached to an IOL assembly. [Figure 4A] 4A shows a perspective view of an IOL assembly having an improved haptic configuration of the present disclosure; [Figure 4B] 4A and 4B show views of an IOL assembly according to an embodiment of the present disclosure. [Figure 4C] 4A-4C show diagrams of an IOL assembly according to an embodiment of the present disclosure. [Figure 4D] 4A and 4B show views of an IOL assembly according to an embodiment of the present disclosure. [Figure 5A] FIG. 1 shows a perspective view of a drug delivery component according to an embodiment of the present disclosure. [Figure 5B] FIG. 2 shows a bottom view of a drug delivery component according to an embodiment of the present disclosure. [Figure 5C] FIG. 2 shows a side view of a drug delivery component according to an embodiment of the present disclosure. [Figure 5D] 1 illustrates a top view of a fastener portion of a drug delivery component with the delivery pad removed from the view, according to an embodiment of the present disclosure. [Figure 6A] 6A and 6B show diagrams of an intraocular drug delivery system according to an embodiment of the present disclosure, in which Fig. 6A shows a top view of an exemplary intraocular drug delivery system and Fig. 6C and Fig. 6D show cross-sectional cuts. [Figure 6B] 6A and 6B show diagrams of an intraocular drug delivery system according to an embodiment of the present disclosure. [Figure 6C] 6A-6C are diagrams of an intraocular drug delivery system according to an embodiment of the present disclosure, and FIG. [Figure 6D] 6A and 6B show diagrams of an intraocular drug delivery system according to an embodiment of the present disclosure. FIG 6D is a partial cross-section of the system of FIG 6A as shown. [Figure 6E]6A-6D show diagrams of an intraocular drug delivery system according to an embodiment of the present disclosure: FIG 6E is a partial cross-section of the system in a plane parallel to the plane of the optic / lens; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] 1 and 2 show the placement and use of an intraocular drug delivery system within a patient's eye. Eye 1 includes a lens 2 (the eye's natural lens) and a lens capsule 3, an anterior chamber 4 containing a cornea 5 and an iris 6 as well as aqueous humor filling the space between the cornea and the iris, and a posterior chamber 7 between the iris and the lens capsule. The posterior chamber / vitreous 8 is the large space between the lens 2 and the retina 9. The natural lens 2 of eye 1 is characterized by an optical axis 10. (In the following description of intraocular drug delivery systems, the terms posterior and anterior are used in relation to the anatomy of the eye, with the cornea being anterior and the retina being posterior.) FIG. 2 shows the placement within the eye of an intraocular drug delivery system 20 including an ocular implant 12 and a drug delivery component 30 implanted within a subject's lens capsule (described in more detail herein). The lens capsule may include a natural lens, an artificial lens, or may not include a lens at all.

[0032] Certain aspects of the present disclosure relate to an intraocular drug delivery system including an ocular implant and a drug delivery component connected in a configuration that stabilizes relative movement of the ocular implant and the drug delivery component. In one embodiment, the ocular implant 12 can be an intraocular lens (IOL) assembly that can include a central optic / lens 24 and one or more haptics 28 extending outwardly therefrom. The optic / lens 24 includes an anterior side 24A and a posterior side 24P. However, the disclosure is not so limited and the ocular implant can be any suitable ocular implant configured to include features that stabilize and retain the drug delivery components described herein.

[0033] The intraocular drug delivery system can include a drug delivery component configured to deliver various therapeutic agents to treat various conditions and disorders of the eye or other disorders that can be treated by the intraocular drug delivery system. In one embodiment, the drug delivery component can include one or more therapeutic agents to treat an ocular condition or disorder. In some embodiments, therapeutic agents useful for treating glaucoma can include, but are not limited to, brimonidine, latanoprost, timolol, pilocarpine, brinzolamide, and other therapeutic agents; for example, beta-blockers, alpha-agonists, ROCK inhibitors, adenosine receptor agonists, carbonic anhydrase inhibitors, adrenergic and cholinergic receptor activators, prostaglandin analogs, and combinations thereof. In other embodiments, therapeutic agents useful for treating wet macular degeneration glaucoma can include, but are not limited to, aflibercept, bevacizumab, pegaptanib, ranibizumab, steroids, aptamers, and combinations thereof. In yet other embodiments, therapeutic agents useful for the treatment of dry macular degeneration may include, but are not limited to, complement factors, antioxidants, anti-inflammatory agents, and combinations thereof. In other embodiments, therapeutic agents may be useful in the treatment of uveitis, such as methotrexate, antibodies, dexamethasone, triamcinolone, and other steroids. The therapeutic agent may also include one or more antiproliferative agents, antimitotic agents, anti-inflammatory agents, and other agents that inhibit or prevent lens epithelial cell migration, such as for treating posterior capsule opacification. In other embodiments, antibiotics such as fluoroquinolones, nonsteroidal agents such as ketorolac, and steroids such as prednisolone may be incorporated into the drug delivery component for postoperative management after cataract or other ocular surgery.

[0034] 3A and 3B show an exemplary intraocular drug delivery system 20 that can include an IOL assembly 22 and one or more drug delivery components 30. FIG. 3C and 3D show a perspective view of the front side of the system 20 of FIG. 3B and a bottom view of the rear side of the system 20 of FIG. 3B, respectively. In FIG. 3A, the system 20 includes a pair of relatively smaller drug delivery components 30. In FIGS. 3B-3D, the system 20 includes a pair of larger drug delivery components 30. The larger drug delivery components 30 can elute a therapeutic agent, for example, for a longer duration or at a higher rate, as compared to the smaller drug delivery components 30. The drug delivery components 30 can include different properties, for example, different elution rates, different therapeutic agents, among other aspects that can be modified. The present disclosure shows a relatively larger drug delivery component 30 as illustrated in FIG. 3B-3D. However, the present disclosure is not so limited, and the systems and methods described herein are also applicable to the relatively smaller drug delivery component 30 as illustrated in FIG. 3A.

[0035] The IOL assembly 22 of the system 20 includes a central optic / lens 24 and one or more haptics 28 extending outward from the plane or parallel planes of the optic / lens 24. As seen in the figure, the IOL assembly 22 includes a pair of haptics 28 extending outward from either side of the optic / lens 24. The optic / lens 24 can include an optic with vision correction or can simply be a scaffold to provide structural support. The drug delivery component 30 is configured for attachment (preferably releasable attachment) to the haptics 28 of the IOL assembly 22. The intraocular drug delivery system 20 includes an anterior side and a posterior side relative to the eye in which it is implanted. In other embodiments, the intraocular drug delivery system 20 can optionally include other devices, such as a capsular tension ring or a capsular scaffold, to hold the system in place during use.

[0036] The outer extent of the haptics 28 is long enough to impinge on the capsular bag of the subject's eye when the system 20 is implanted, while the radially outer extent of the drug delivery component 30 is preferably shorter than the radially outer extent of the haptics 28 so as to avoid the drug delivery component 30 impinging on the capsular bag at the equatorial region of the capsular bag of the subject's eye when placed on the implanted IOL assembly 22. As shown, FIG. 3A shows an embodiment in which the drug delivery component 30 is configured to dimensionally correspond to the size and shape of the optic-haptic junction area, and FIGS. 3B-3D show an embodiment in which the drug delivery component 30 is configured to be dimensionally larger than the optic-haptic junction area. However, the present disclosure is not so limited and the drug delivery component 30 may be sized to be formed in any manner suitable for the intended use, such as ¼ of the circumference of the optic, ⅓ of the circumference of the optic, ½ of the circumference of the optic, etc.

[0037] 4A-4D show an exemplary IOL assembly 22 of the present disclosure. As shown in FIGS. 4A and 4B, each of the haptics 28 includes features for retaining and stabilizing a drug delivery component (not shown) when coupled to the IOL assembly 22. To that end, each of the haptics 28 includes a retention tab 40 and a gusset 44, which together form a waist or incut 52 for retaining and stabilizing a fixation portion (not shown) of the drug delivery component when the fixation loop is received in the waist 52 (fixation portion 50 of the drug delivery component 30 shown received on the waist 52 of the IOL assembly 22 in FIG. 3D). The waist 52 defines a narrow portion that widens toward the optic / lens 24 and also widens toward the gusset 44 and retention tab 40. In this manner, the drug delivery component is retained in the waist 52 to inhibit movement away from the waist 52 and to inhibit rotation of the drug delivery component relative to the IOL assembly 22.

[0038] 4A-4B, the haptic has an outer free end 41 and an inner free end 45, both of which are free (i.e., not bonded to a structure). The outer free end 41 terminates in a rounded protrusion or tip. The inner free end 45 also terminates in a rounded protrusion or tip that defines a retention tab 40, which overhangs a waist 52. The haptic 28 is connected to the optic / lens 24 at a point or portion between the two ends 41, 45 along the longitudinal length of the haptic 28. In other words, the haptic 28 is not connected to the optic / lens 24 at the end 41, 45 of the haptic 28, instead the ends 41, 45 are free and the haptic 28 is connected to the optic / lens 24 at a point or portion between the ends 41, 45. The haptics 28 are connected to the optic / lens 24 at an optic-haptic or lens-haptic junction 48 via radially extending members or connection tabs 49 (hereafter referred to as "radially extending members") of the haptics 28. The radially extending members 49 are proximate the inner free end 45 that defines the retention tab 40. The radially extending members 49 extend from an arc or portion of the edge 25 of the optic / lens 24. The radially extending members 49 are defined by a pair of surfaces, the first surface 43 and the second surface 42, that define a waist 52. The radially extending members 49 and the optic-haptic junction 48 of the haptics 28 are illustrated in FIG. 4C with cross-hatching, generally referring to the location or position where the haptics 28 join the optic / lens 24.

[0039] 4A-4B, opposite the first surface 43 formed by the retention tab 40, the haptic 28 includes a curved notch or gusset 44 having a second surface 42 that facilitates bending and curving of the haptic 28 during use. More specifically, the gusset 44 defines a relatively narrow cross-sectional area 51 of the haptic 28 that allows for curving of the haptic 28 between the ends 41, 45. In addition to being defined between the second surface 42 and the first surface 43 of the haptic 28, a waist 52 is also defined between the front surface 46 and the rear surface 47 (shown in FIGS. 4C-4D). In some embodiments, the first surface 43 of the retention tab 40 includes a radial or concave surface, and the second surface 42 of the retention tab 40 at the gusset 44 includes a radial or concave surface to provide a curved or concave inner portion at the optic-haptic junction 48 of the haptic 28 relative to the lens 24. A front surface 46 of the haptic 28 between the retention tab 40 and the gusset 44 can interact with at least a portion of a drug delivery component (not shown) to stabilize its orientation during use. In some embodiments, the front surface 46 can be sized and shaped to match the size and shape of the drug delivery component (e.g., can interact with the entire drug delivery component or substantially the entire drug delivery component).

[0040] As shown in FIG. 4C, which is a rear view of the IOL assembly 22, the optic-haptic junction 48 and the radially extending members 49 are shown with cross-hatching. The radially extending members 49 that define the optic-haptic junction 48 connect the haptic 28 to the optic / lens 24 along the length of the haptic 28 between the terminal ends 41, 45 of the haptic 28. As shown in FIG. 4D, which shows an enlarged cross-sectional view of the IOL assembly 22, the rear surface 47 of the radially extending members 49 includes a relief cut 84 to provide additional stability to the drug delivery component during use and / or to maintain the PCO barrier. The relief cut 84 is defined by a pair of chamfered edges 85 and a concave surface 86 that lies in a plane that is further forward than the optic / lens 24. More specifically, as seen in FIG. 4D, the concave surface 86 is further forward than the edge 88 that surrounds the optic / lens 24. In one embodiment, the concave surface 86 and the front surface 46 may be generally parallel to one another.

[0041] As can be seen from Figures 4A and 4B, among other things, the waist 52 of the haptic 28 is defined by a pair of depressions having concave surfaces 42, 43 at the haptic-optical junction 48. The concave surfaces 42, 43 are in the plane of the optic / lens 24. In addition, the haptic 28 includes a relief cut 84 that defines a depression on the posterior surface 47, as seen in Figure 4D. Thus, at the optic-haptic junction 48, the haptic 28 defines a depression on the periphery of the haptic 28 for receiving a drug delivery component thereon. It should be noted that the anterior surface 46 of the haptic can include a depression or relief cut, as seen in Figure 4D. In one embodiment, the haptic 28 can include a depression on its entire periphery.

[0042] 5A-5C show an exemplary drug delivery component 30 of an intraocular drug delivery system. The drug delivery component 30 can include a therapeutic agent, which can include the entirety or a portion of the drug delivery pad 70 (such as an internal drug delivery pad, gel, or drug eluting matrix). The drug delivery pad 70 can elute one or more therapeutic agents from a drug depot, dissolve or biodegrade over time to release the therapeutic agent, or be formulated in any other suitable drug delivery configuration known in the art. The drug delivery component 30 can further include a fastener 50 attached to the rear side of the drug delivery pad 70. The fastener 50 can include structures 55, such as posts, extending vertically from the rear side of the drug delivery pad 70 and connected by a horizontally extending band 60 to form an opening 65 (e.g., a slot, aperture, or compartment). The fastener 50 can generally function as a drug delivery component 30 retention loop and can be formed from any suitable material for the intended use. As a non-limiting example, the fixation portion 50 can be formed from an FDA approved polymer for ophthalmic use that is compatible with the intended therapeutic agent, such as medical grade silicone. Furthermore, the fixation portion 50 can be attached to the drug delivery pad 70 by any method known in the art suitable for such purposes, such as medical grade adhesives, thermal bonding, etc. Although the drug delivery component 30 is described as including a drug delivery pad 70 that can include one or more therapeutic agents, the entire drug delivery component 30, including the drug delivery pad 70 and the fixation portion 50, can include a therapeutic agent dispersed throughout. The drug delivery pad 70 and the fixation portion 50 can include the same or different therapeutic agents therein.

[0043] The fixation portion 50 (i.e., the retention loop) or a portion thereof may be flexible to allow it to expand beyond the haptics (not shown) and then contract over the waist of the IOL assembly (not shown). In one embodiment, the band 60 may be flexible to expand and contract. In one embodiment, the band 60 and the struts 55 may be flexible to expand and contract. In one embodiment, the band 60, the struts 55, and the drug delivery pad 70 may be flexible to expand and contract. FIGS. 5A-5C show the drug delivery component 30 in an unexpanded state as it may exist prior to being coupled with an IOL assembly. FIGS. 6B-6D show the drug delivery component 30 with the band 60 slightly expanded to extend beyond the posterior relief cut of the IOL assembly.

[0044] 5A-5C, aperture 65 is sized and shaped to receive the haptics of the IOL assembly therein such that the haptics can pass through aperture 65. As best seen in FIG. 5C, aperture 65 generally defines a rectangular cross-section formed by posterior surface 72 of drug delivery pad 70, inner surface 56 of post 55, and inner surface 62 of band 60. The surfaces defining aperture 65 generally conform to or correspond to the shape of the waist of the haptics.

[0045] The cross-sectional shape of the struts 55 of the fixation portion 50 of the drug delivery component is shown in FIG. 5D, which is a top view of the fixation portion 50 with the delivery pad removed from the view. As can be seen, the opening 65 is generally rectangular in cross-section and sized to receive the haptic therethrough, while the outer portions of the struts 55 are sized and shaped to interact with the gussets and retention tabs of the haptics (not shown), respectively, to inhibit movement of the drug delivery component relative to the IOL assembly (not shown). The left strut 55 is oval or pill shaped, sized to interact with the gussets, and generally oriented at an angle AN between the axis AXf of the fixation portion 50 and the axis AXp of the strut 55. In one embodiment, the angle AN can be about 125 degrees. In one embodiment, the angle AN can be about 90 degrees to about 135 degrees.

[0046] FIG. 6A shows a top view of the intraocular drug delivery system 20 with the section cuts of FIG. 6C and FIG. 6D shown thereon. Similar to FIG. 6A, FIG. 6E shows a partial cross-section of the system 20 in a plane parallel to the plane of the optic / lens 24. In FIG. 6A, the drug delivery pad 70 is depicted as transparent to view the posts 55 relative to the retention tabs 40 and gussets 44 of the haptics 28, whereas in FIG. 6E, the drug delivery pad has been removed from the view through the cross-section. In both views, the angled or "inner" posts 55a are held between the gusset 44 and the edge 25 of the optic / lens 24 as they transition to the gusset 44, whereas the "outer" posts 55o are held between the retention tabs 40 and the edge 25 of the optic / lens 24. Cooperation of the retention and stabilization features of the ocular implant and the fixation of the drug delivery component results in an intraocular drug delivery system in a configuration that stabilizes the relative movement of the ocular implant and the drug delivery component.

[0047] 6B shows a side view of the drug delivery component 30 fitted onto the haptic 28 of the IOL assembly 22 of an embodiment of the present disclosure, with the inner or concave portion of the retention tab 40 extending around the post 55o and at least a portion of the posterior surface 72 of the drug delivery pad 70 positioned on the anterior surface 46 of the haptic 28 to provide stabilization of the position and orientation of the drug delivery component 30 relative to the IOL assembly 22. The band 60 of the fixation portion 50 is in an elongated state and extends beyond the relief cut 84 on the posterior surface 47.

[0048] FIG 6C is a partial cross-sectional view of the system 20 taken along the cut line shown in FIG 6A. In particular, FIG 6C is a partial cross-sectional view of the system 20 taken along the cut line of the upper left portion of the system 20 in FIG 6A. FIG 6C shows a side cross-sectional view of the drug delivery component 30 fitted onto the haptic 28 of the IOL assembly 22 of an embodiment of the present disclosure, with the bottom surface 57 of the post 55o positioned within the retention tab 40 being higher or more anterior (plane PL shown by dashed line) than the bottom 53 of the retention tab 40 providing further stabilization of the drug delivery component 30 and / or maintaining the PCO barrier. The contour of the fixation portion 50 of the drug delivery component 30 relative to the retention and stabilization features of the ocular implant further provides stabilization of the relative movement of the ocular implant and the drug delivery component 30.

[0049] FIG. 6D is a partial cross-sectional image of the system 20 along the cut line shown in FIG. 6A. FIG. 6D also shows a cross-sectional view of the drug delivery component 30 fitted onto the radially extending members 49 of the haptics 28 of the IOL assembly 22 of an embodiment of the present disclosure, showing the relative positioning of the fixation portion 50 and the retention and stabilization features of the ocular implant. The cross-section cuts through both struts 55o, 55a, the band 60, and the radially extending members 49 at the optic-haptic junction 48. The horizontal band 60 extends downwardly around the radially extending members 49 of the haptics 28 to secure the drug delivery component 30 to the IOL assembly 22. The bottom of the horizontal band 60 is above the posterior capsule opacification (PCO) barrier at the optic-haptic junction (the PCO barrier is illustrated by the dashed line DL1). The bottoms 53 of the posts 55o, 55a are higher (in the plane indicated by dashed line DL2) than the bottoms 61 of the retention tabs 40. Translation or movement, including rotation, of the drug delivery component 30 relative to the haptics 28 is at least partially constrained by the generally rectangular cross-sectional shape of the radially extending members 49 and the corresponding shape of the fastening portions 50 of the drug delivery component 30.

[0050] As mentioned above, FIG. 6E shows a partial cross-section of the system 20 in a plane parallel to the plane of the optic / lens 24. In particular, the drug delivery pad of the drug delivery component (not shown) has been removed through the cross-section to show only the fixation portion 50 including the struts 55o, 55a. As can be seen, the outer struts 55o are bounded by the retention tab 40 and the edge 25 of the optic / lens 24, and the angled struts 55a are bounded by the gusset 44 and the edge 25 of the optic / lens 24. Thus, rotation of the fixation portion 50 (i.e., clockwise, counterclockwise in the view of FIG. 6E) is inhibited. Also, because the waist 52 of the radially extending member 49 is narrower than the relatively wider portion of the edge 25 extending outward from the retention tab 40 and gusset 44 on one side and the optic / lens 24 side, the fixation portion 50 of the drug delivery component is stabilized and maintained in position at the waist 52. Thus, in order for the drug delivery component to be removed from its position over the waist portion 52 of the radially extending member 49 , the fastening portion 50 must be stretched significantly beyond the retention tab 40 .

[0051] In one embodiment, the drug delivery component can include a first and a second drug delivery component and can be configured to allow placement of the second drug delivery component within the first drug delivery component. Placement of the second drug delivery component within the first drug delivery component can be accomplished at the time of manufacture of the drug delivery component, perioperatively immediately prior to or immediately after implantation, intraoperatively, or in the same procedure in which the IOL assembly is implanted. The first and / or second drug delivery components are subject to wear and, when worn, can be removed and replaced in a procedure that can be accomplished well after the surgery in which the IOL assembly is initially inserted.

[0052] The intraocular drug delivery system can be introduced into a patient's eye through a small incision at the edge of the cornea and into the patient's capsular bag. For initial placement of the intraocular drug delivery system, the drug delivery component can be secured to the IOL assembly before both are inserted into the eye, and the assembled system can be folded, passed through the incision, and then released into the capsular bag or ciliary sulcus. Alternatively, for initial placement of the intraocular drug delivery system, the drug delivery component can be secured to the IOL assembly after insertion of the IOL into the eye by first inserting the IOL through the incision, releasing it into the capsular bag or ciliary sulcus, then inserting the drug delivery component through the incision, and manipulating the drug delivery component to slide the fixation portion over the haptics, thereby securing the drug delivery component to the haptics and the IOL assembly.

[0053] In one embodiment, if the originally implanted drug delivery component is worn out by either elution or bioerosion, a subsequent surgical procedure can be performed in which the surgeon removes the original drug delivery component, makes another incision at the corneal border, and uses a gripping tool to insert and secure a new drug delivery component to the haptic and IOL assembly. Removal of the original drug delivery component and replacement with a new drug delivery component can be performed, for example, after the original drug delivery component is gone or worn out, or whenever it is desired to replace the original drug delivery component with a new drug delivery component that contains a supplemented or different therapeutic agent, and can be performed after the incision made to implant the original drug delivery component has healed and therefore a new incision needs to be made. During the surgical procedure, if necessary, the surgeon can insert a gripping tool to remove the original drug delivery component from the haptic and IOL assembly and remove it from the eye, insert a new drug delivery component, and use the gripping tool to manipulate the new drug delivery component to slide over the haptics and thereby secure it to the IOL assembly.

[0054] While preferred embodiments of the apparatus and methods have been described with reference to the environment in which they were developed, they are merely illustrative of the principles of the invention. Elements of the various embodiments may be incorporated into each of the other species to obtain the benefits of those elements in combination with such other species, and various beneficial features may be used in the embodiments alone or in combination with each other. Other embodiments and configurations may be devised without departing from the spirit of the invention and the scope of the appended claims.

Claims

1. 1. A stabilized intraocular drug delivery system configured for implantation into an eye of a subject, comprising: an intraocular lens (IOL) assembly and a drug delivery component; the IOL assembly includes a lens and a haptic extending outwardly from the lens, the haptic configured to engage the drug delivery component, the haptic including an outer end, an inner end opposite the outer end, a retention tab at the inner end, and a connection tab positioned between the outer end and the inner end and adjacent the lens; the drug delivery component includes a therapeutic agent and a fixation portion having an opening sized and dimensioned to receive the haptic and fix the drug delivery component to the IOL assembly; An intraocular drug delivery system, wherein the fixing portion of the drug delivery component is configured to be fixed to the connection tab of the haptic so that the retention tab restrains movement of the drug delivery component relative to the IOL assembly.

2. The intraocular drug delivery system of claim 1 , wherein the drug delivery component further comprises a drug delivery pad containing one or more therapeutic agents, and the fixation portion is adjacent to the drug delivery pad.

3. The intraocular drug delivery system of claim 2, wherein the fixing portion of the drug delivery component includes a pair of structures and a band, the pair of structures extending from the drug delivery pad, and the pair of structures connected by the band to form the opening.

4. The intraocular drug delivery system of claim 3 , wherein when the drug delivery component is secured to the connection tab of the haptic, one of the pair of structures interfaces with the retention tab, a first surface of the connection tab, and a first portion of the lens.

5. 5. The intraocular drug delivery system of claim 1, wherein the connection tab includes a first surface adjacent the retention tab and a second surface opposite the first surface, the second surface adjacent a portion of the haptic; An intraocular drug delivery system, wherein the haptic further includes a gusset formed in the portion of the haptic, the gusset configured to interact with at least a portion of the drug delivery component to inhibit movement of the drug delivery component relative to the IOL assembly.

6. The intraocular drug delivery system of claim 5 , wherein the portion of the drug delivery component includes one of a pair of structures of the fixation portion.

7. The intraocular drug delivery system of claim 1 , wherein the opening in the fixing portion of the drug delivery component defines a generally rectangular cross-section.

8. 2. The intraocular drug delivery system of claim 1, wherein the connection tab includes a first surface adjacent the retention tab and a second surface opposite the first surface, the second surface adjacent a portion of the haptic, the first and second surfaces being curved and defining a waist.

9. The intraocular drug delivery system of claim 1 , wherein the waist portion is the narrowest portion of the connection tab.

10. The intraocular drug delivery system of claim 1 , wherein the retention tab extends from the connection tab.

11. The stabilized intraocular drug delivery system of claim 1 , wherein the stabilized intraocular drug delivery system is sized and shaped to be implanted in the lens capsule or ciliary sulcus of the subject's eye.

12. 1. A stabilized intraocular drug delivery system configured for implantation into an eye of a subject, comprising: an intraocular lens (IOL) assembly and a drug delivery component; the IOL assembly includes a lens and a haptic extending outwardly from the lens, the haptic configured to engage the drug delivery component, the haptic including an outer end, an inner end opposite the outer end, and a connection tab positioned between the outer end and the inner end and adjacent the lens; the drug delivery component includes a drug delivery pad and a fixation portion coupled to the drug delivery pad, the drug delivery pad including one or more therapeutic agents, the fixation portion includes first and second structures extending from the drug delivery pad, a band coupled to the first and second structures, and an opening formed between the drug delivery pad, the first and second structures, and the band, the opening being sized and dimensioned to receive the haptic and fix the drug delivery component to the IOL assembly, the first and second structures being different shapes from one another, An intraocular drug delivery system, wherein the fixing portion of the drug delivery component is configured to be fixed to the connection tab of the haptic to restrict movement of the drug delivery component relative to the IOL assembly.

13. The intraocular drug delivery system of claim 12 , wherein the inner ends of the haptics are free and overhang the connection tabs.

14. The intraocular drug delivery system of claim 13, wherein the inner end of the haptic includes a retention tab extending from the connection tab, the retention tab including a curved surface for interacting with one of the first and second structures of the fixing portion of the drug delivery component.

15. The intraocular drug delivery system of claim 12 , wherein an axis extends from the first structure through the band to the second structure, the first structure including a body angled relative to the axis.

16. The intraocular drug delivery system of claim 15 , wherein the body of the first structure is elliptical.

17. The intraocular drug delivery system of claim 12 , wherein the opening of the fixation portion is approximately rectangular in cross section.

18. The intraocular drug delivery system of claim 12 , wherein the fixation portion is formed from a polymer.

19. The intraocular drug delivery system of claim 12, wherein the inner end of the haptic includes a retention tab extending from the connection tab, the connection tab including a first surface adjacent the retention tab and a second surface opposite the first surface, the second surface adjacent a portion of the haptic, the first and second surfaces being curved and defining a waist.

20. The intraocular drug delivery system of claim 19 , wherein the waist portion is the narrowest portion of the connection tab.

21. The intraocular drug delivery system of claim 12 , wherein at least one of the drug delivery pad and the fixation portion contains a therapeutic agent therein.

22. 22. The intraocular drug delivery system of claim 1, wherein the stabilized intraocular drug delivery system is sized and shaped to be implanted in the lens capsule or ciliary sulcus of the subject's eye.

23. 1. A stabilized intraocular drug delivery system configured for implantation into an eye of a subject, comprising: an intraocular lens (IOL) assembly and a drug delivery component; the IOL assembly includes a haptic and an optic, the haptic extending outwardly from the optic at an optic-haptic junction, the haptic including a pair of recesses defining a waist at the optic-haptic junction; An intraocular drug delivery system, wherein the drug delivery component includes a therapeutic agent and a fixation portion having an opening sized and dimensioned to receive the haptic and fix the drug delivery component to the IOL assembly, the fixation portion of the drug delivery component being configured to be fixed to the waist portion of the haptic to inhibit movement of the drug delivery component relative to the IOL assembly.

24. 24. The intraocular drug delivery system of claim 23, wherein the pair of depressions are positioned on opposing surfaces.

25. The intraocular drug delivery system of claim 23 , wherein each of the pair of recesses comprises a concave surface.

26. The intraocular drug delivery system of claim 23, wherein the haptic further includes an outer end, an inner end opposite the outer end, and a retention tab at the inner end, and the optical portion-haptic joint is positioned between the inner end and the outer end.

27. 27. The intraocular drug delivery system of claim 26, wherein the retention tab extends from the waist portion to define one of the pair of recesses.

28. 24. The intraocular drug delivery system of claim 23, wherein the haptic includes a rear surface, a front surface opposite the rear surface, a first side end, and a second side end opposite the first side end, the first and second side ends extending between the rear surface and the front surface, a first recess of the pair of recesses defined on the first side end, and a second recess of the pair of recesses defined on the second side end.

29. The intraocular drug delivery system of claim 23 , wherein the fixation portion is formed from a polymer.

30. 24. The intraocular drug delivery system of claim 23, wherein the drug delivery component further comprises a drug delivery pad, and the therapeutic agent is contained in at least one of the drug delivery pad and the fixation portion.

31. 1. A stabilized intraocular drug delivery system configured for implantation into an eye of a subject, comprising: an intraocular lens (IOL) assembly and a drug delivery component; the IOL assembly includes an optic and a haptic extending outwardly from the optic at an optic-haptic junction, the haptic including an anterior surface, a posterior surface opposite the anterior surface, and a first depression on the posterior surface or on the anterior surface at the optic-haptic junction; An intraocular drug delivery system, wherein the drug delivery component includes a therapeutic agent and a fixation portion having an opening sized and shaped to receive the haptic, and the fixation portion of the drug delivery component is configured to be fixed to the haptic at the first recess of the optical portion-haptic junction to inhibit movement of the drug delivery component relative to the IOL assembly.

32. The intraocular drug delivery system of claim 31 , wherein the first depression is on the posterior surface and the haptic further comprises a second depression on the anterior surface.

33. The intraocular drug delivery system of claim 31, wherein the haptic further includes a first side end extending between the front and rear surfaces and a second side end opposite the first side end and extending between the front and rear surfaces, the first side end including a second recess at the optic-haptic junction and the second side end including a third recess at the optic-haptic junction.

34. The intraocular drug delivery system of claim 33 , wherein each of the second and third recesses comprises a concave surface.

35. The intraocular drug delivery system of claim 31, wherein the haptic further includes an outer end, an inner end opposite the outer end, and a retention tab at the inner end, and the optical portion-haptic junction is positioned between the inner end and the outer end.

36. The intraocular drug delivery system of claim 31 , wherein the fixation portion is formed from a polymer.

37. 32. The intraocular drug delivery system of claim 31, wherein the drug delivery component further comprises a drug delivery pad, and the therapeutic agent is contained in at least one of the drug delivery pad and the fixation portion.

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