SYSTEMS AND ASSOCIATED METHODS FOR MOUNTING DEVICES TO INTRAOcular LENS ASSEMBLY - Patent application

Abstract

Embodiments are disclosed relating to a system and method for securing a drug delivery component to an intraocular lens (IOL) assembly. The system generally includes a support base and a plunger. The support base includes a first portion configured to house the drug delivery component and a second portion configured to function as a plunger guide. The plunger can be inserted into the plunger guide such that the plunger is positioned to engage the drug delivery component and the IOL assembly during use. The plunger includes an elongated body and a tip, the tip including a ramp configured to mate with a fixation loop of the drug delivery component during use and a compartment configured to engage with a haptic of the IOL assembly during use.

Description

[Technical field]

[0001] The present disclosure relates to the field of intraocular drug delivery systems, and to systems and uses thereof for attaching drug delivery components to an intrafoveal lens assembly to create an intraocular drug delivery system. [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 intraocular 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 systems and methods described below provide a more efficient and / or robust approach for securing drug delivery components to an IOL. Summary of the Invention

[0005] Certain aspects of the present disclosure can include a system for securing one or more drug delivery components to an intraocular lens (IOL) assembly. According to these aspects, the drug delivery component can include a therapeutic agent-containing portion and a fixation loop coupled to the therapeutic agent-containing portion. In certain embodiments, the therapeutic agent-containing portion can be a drug-containing portion. According to these embodiments, the therapeutic agent-containing portion can be a pad, sponge, matrix, or other component capable of containing and dispersing one or more therapeutic agents. In still other embodiments, the therapeutic agent-containing portion can further include another agent to contain or store the therapeutic agent for distribution (e.g., a solid matrix, semi-solid matrix, gel, hydrogel, or other material capable of storing the therapeutic for long-term or short-term distribution). The IOL assembly can include at least one haptic. In certain aspects, the system can include a plunger and a support base. The plunger can include an elongated body and a tip. The support base can include at least a first portion and a second portion. The first portion can house the drug delivery component. The second portion can include a plunger guide configured to guide movement of the plunger relative to the support base. When the drug delivery component is positioned in the first portion, the plunger is configured to be guided in distal movement by the plunger guide such that the tip is received within the fixing loop of the drug delivery component to fix the drug delivery component in the first portion in a first state.

[0006] In certain embodiments, once the tip of the plunger is received within the fixation loop, additional distal movement of the plunger is configured to transition the fixation loop to a second state in which the fixation loop is expanded.

[0007] In certain embodiments, the tip of the plunger includes an upper surface and a ramp extending upwardly from the upper surface, the ramp configured to expand the fixation loop of the drug delivery component during distal movement to the second state.

[0008] In certain embodiments, the ramp includes a proximal surface and the tip of the plunger further includes a sidewall extending proximally from the proximal surface of the ramp, and the proximal surface of the ramp, the sidewall, and the upper surface of the tip of the plunger define a compartment for receiving therein a haptic of the IOL assembly through the fixation loop in the second state.

[0009] In certain embodiments, when the haptics of the IOL assembly are received within the compartment, proximal retraction of the plunger is configured to transition the fixation loop to a third state with the fixation loop contracted onto the haptics of the IOL assembly.

[0010] In certain embodiments, the first portion includes a recess configured in a size and shape to receive a therapeutic-agent-containing component of the drug delivery component therein. In certain embodiments, the first portion includes an IOL recess sized and shaped to receive an IOL assembly therein.

[0011] In certain embodiments, the plunger guide includes a passageway (or channel) for guiding the movement of the plunger. In certain embodiments, the system further includes a key lock configured to engage the plunger to prevent or stop movement within the plunger guide.

[0012] In certain embodiments, the system further comprises a drug delivery component. Aspects of the present disclosure may include a method for securing a drug delivery component to an intraocular lens (IOL) assembly. The drug delivery component may include a therapeutic agent-containing component and a fixation loop coupled to the therapeutic agent-containing component. The IOL assembly may include a haptic. The method may include the following steps: providing a system including a support base and a plunger, the plunger including a tip. The support base may include a first portion and a second portion. The first portion may house the drug delivery component. The second portion may include a plunger guide configured to guide movement of the plunger relative to the support base. The method may further include inserting the drug delivery component back side up in the first portion of the support base such that the fixation loop of the drug delivery component is exposed. The method may further include advancing a tip of the plunger through the fixation loop of the drug delivery component to expand the fixation loop. The method may further include routing a haptic of the IOL assembly through the fixation loop of the drug delivery component. The method can further include retracting the tip of the plunger through the fixation loop of the drug delivery component to retract the fixation loop onto the haptic.

[0013] In certain embodiments, the method can further include positioning the IOL assembly posterior side up within the support base. In certain embodiments, routing a haptic of the IOL assembly through a fixation loop of the drug delivery component may further include at least one of using forceps, grasping the haptic, and routing a first end of the haptic through the fixation loop of the drug delivery component.

[0014] In certain embodiments, the method can further include pulling the first end of the haptic until the second end of the haptic seats against a ramp on the tip of the plunger.

[0015] Certain aspects of the present disclosure may include a system for securing a drug delivery component to an intraocular lens (IOL) assembly. The drug delivery component may include a therapeutic agent-containing component and a fixation loop coupled to the therapeutic agent-containing component. The IOL assembly may include one haptic or two or more haptics. The system may further include a support base and a plunger. The support base may include a plunger guide and a recess, the recess being configured to be sized and shaped to receive the therapeutic agent-containing component of the drug delivery component therein in a posterior-up orientation. The plunger guide may guide movement of the plunger relative to the support base along an axis that intersects with the recess. When the therapeutic agent-containing component is received within the recess, the plunger is configured to be guided in a distal movement by the plunger guide such that a tip of the plunger is received within the fixation loop of the drug delivery component.

[0016] In certain embodiments, the tip of the plunger includes a ramp and a sidewall extending proximally from the ramp. In other embodiments, a compartment is formed by the proximal surface of the ramp and the inner surface of the sidewall, the compartment being sized and shaped to receive a portion of the haptic therein.

[0017] In certain embodiments, in the back-side up orientation, the fastening loops are exposed. In certain embodiments, once the tip of the plunger is received within the fixation loop of the drug delivery component, additional distal movement of the plunger is configured to expand the fixation loop to receive the haptics of the IOL assembly therethrough.

[0018] In certain embodiments, the system may include a drug delivery component according to the disclosure herein. In other embodiments, it is contemplated that the kit may include any or all of the components disclosed for the systems described herein. In some embodiments, the kit may include some or all of the components of the disclosed systems, and optionally, one or more instruction guides. In one embodiment, the IOL may be provided separately from the systems disclosed herein. In other embodiments, the IOL is provided in a kit that includes the systems disclosed herein. [Brief description of the drawings]

[0019] [Figure 1A] 1A shows exemplary IOL assemblies and drug delivery components that can be used in connection with the systems and methods of the present disclosure, with FIG. 1A showing two intraocular drug delivery systems, each including a drug delivery component attached to the haptics of an IOL assembly. [Figure 1B] 1A-1C illustrate exemplary IOL assemblies and drug delivery components that may be used in connection with the systems and methods of the present disclosure. FIG. 1B illustrates an exemplary drug delivery component. [Figure 1C] 1A-1C illustrate exemplary IOL assemblies and drug delivery components that may be used in connection with the systems and methods of the present disclosure. FIG. 1C illustrates an exemplary IOL assembly. [Figure 2A] 1A-1D show two perspective views of a system for attaching a drug delivery component to an IOL assembly according to an embodiment of the present disclosure. [Figure 2B] 1A-1D show two perspective views of a system for attaching a drug delivery component to an IOL assembly according to an embodiment of the present disclosure. [Figure 2C] 2C shows an exploded perspective view of the system of FIG. 2A and FIG. 2B according to an embodiment of the present disclosure. [Figure 3A] 3A illustrates an exemplary plunger according to an embodiment of the present disclosure, with FIG. 3A showing a top view of the plunger. [Figure 3B]3A and 3B show an exemplary plunger according to an embodiment of the present disclosure; FIG. 3B shows a perspective side view of the plunger; [Figure 3C] 3A-3C show enlarged partial views of the plunger tip according to an embodiment of the present disclosure, with FIG. 3C showing a front perspective view. [Figure 3D] 3A-3D show enlarged partial views of a plunger tip according to an embodiment of the present disclosure, with FIG. 3D showing a side perspective view. [Figure 4A] 1 shows a perspective view of a support base or tray of a system for mounting a drug delivery component of an IOL assembly according to an embodiment of the present disclosure. [Figure 4B] 1 shows a top view of a support base or tray of a system for mounting a drug delivery component of an IOL assembly according to an embodiment of the present disclosure. [Figure 5A] 1 shows a perspective view of a key for a system for attaching a drug delivery component of an IOL assembly according to an embodiment of the present disclosure. [Figure 5B] 1 shows a front view of a key for a system for attaching a drug delivery component of an IOL assembly according to an embodiment of the present disclosure. [Figure 6A] FIG. 2 illustrates a perspective view of a key and a plunger positioned away from each other according to an embodiment of the present disclosure. [Figure 6B] FIG. 2 illustrates a perspective view of a key coupled to a plunger according to an embodiment of the present disclosure. [Figure 7A] 1 illustrates a close-up view of a portion of the system of the present disclosure showing the plunger engaged with the drug delivery component, according to an embodiment of the present disclosure. [Figure 7B] FIG. 13 illustrates an enlarged partial view of the system of the present disclosure showing the haptics of the IOL assembly engaged with the plunger and inserted through a fixed portion of the drug delivery component, attaching the drug delivery component to the haptics of the IOL assembly, according to an embodiment of the present disclosure. [Figure 8] 1 is a flowchart illustrating an exemplary method of attaching a drug delivery component of an IOL assembly, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] SUMMARY The present disclosure relates to a system for attaching or securing a drug delivery component to an intraocular lens (IOL) assembly, and related methods of use. For context, FIGS. 1A-1C show an exemplary intraocular drug delivery system 20 that can be assembled using the systems and methods of the present disclosure. Such an intraocular drug delivery system 20 can include an IOL assembly 22 and one or more drug delivery components 30. The IOL assembly 22 includes a central optic / lens 24 and one or more haptics 28 extending outward from a plane or parallel plane of the optic / lens 24. The optic / lens 24 can include an optic with vision correction or can be a scaffold to provide structural support. The drug delivery components 30 are configured to be attached to the haptics 28 of the IOL assembly 22. In certain embodiments, the attachment is releasable. In other embodiments, the attachment is not releasable. The intraocular drug delivery system 20 includes an anterior surface and a posterior surface relative to a subject's eye when implanted. In some embodiments, the intraocular drug delivery system 20 can optionally include other devices, such as a capsular expansion ring or a capsular scaffold, to hold the system in place during use.

[0021] 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 to avoid the drug delivery component 30 impinging on the capsular bag of the subject's eye at the equatorial region of the capsular bag when placed on the implanted IOL assembly 22. In certain embodiments, the drug delivery component 30 can be configured to dimensionally correspond to the size and shape of the optic-haptic junction area. In other embodiments, the drug delivery component 30 is configured to be dimensionally larger than the optic-haptic junction area. However, the disclosure is not so limited and the drug delivery component 30 can be sized to be shaped in any manner suitable for the intended use, for example, a quarter of the circumference of the optic, a third of the circumference of the optic, a half of the circumference of the optic, etc.

[0022] FIG. 1A shows two intraocular drug delivery systems 20. On the left side, the system 20 includes a pair of larger drug delivery components 30. On the right side, the system 20 includes a pair of smaller drug delivery components 30. The larger drug delivery components 30 can elute therapeutic agents for a longer duration or at a higher rate, for example, compared to the smaller drug delivery components 30. The drug delivery components 30 can also include different properties, such as different elution rates, different therapeutic agents, and other aspects that can be modified. The present disclosure shows a relatively large drug delivery component 30 shown on the left side of FIG. 1A. However, the present disclosure is not so limited, and the systems and methods described herein are also applicable to the relatively small drug delivery component 30 shown on the right side of FIG. 1A.

[0023] FIG. 1B illustrates an exemplary drug delivery component 30 of the present disclosure. The drug delivery component 30 can include a therapeutic agent, which can include the entirety or a portion of a drug delivery pad 70 (such as an internal drug delivery pad, gel, or drug eluting matrix). The drug delivery component 30 can include a drug delivery pad 70 that can elute the therapeutic agent from a drug depot, or dissolve or biodegrade over time to release the therapeutic agent, or can be formulated in any other suitable drug delivery configuration known in the art for delivering the therapeutic agent. The drug delivery component 30 can further include a fixed portion 50 attached to the rear side of the drug delivery pad 70. The drug delivery component 30 including the drug delivery pad 70 can be referred to as a therapeutic agent-containing portion, a drug-containing portion, or a drug portion. The therapeutic agent-containing portion referred to above can be a pad, sponge, matrix, or other component that can contain, store, and / or disperse one or more therapeutic agents. The fixation portion 50 (also referred to as a fixation loop) may include structures 55 such as posts that extend vertically from the rear side of the drug delivery pad 70 and are connected by a horizontally extending band 60 to form an opening 65 (e.g., a slot, hole, or compartment). The opening 65 is configured to receive the haptics 28 of the IOL assembly 22 such that the haptics 28 can pass through the opening 65. The fixation portion 50 may generally function as a drug delivery component 30 retention loop and may be formed from any suitable material for the intended use. The fixation loop 50 may be flexible so that it stretches or expands to allow the haptics 28 of the IOL assembly 22 to be received through the loop 50. And, once expanded and placed in place on the optic-haptic junction, the fixation loop 50 may contract on the optic-haptic junction. As a non-limiting example, the fixation portion 50 may be formed from an FDA approved polymer for ophthalmic use that is compatible with the intended therapeutic agent, e.g., medical grade silicone. Furthermore, the anchoring portion 50 may be attached to the drug delivery pad by any method known in the art suitable for such purpose, such as, for example, medical grade adhesive, thermal bonding, or the like.

[0024] 1C, the haptics 28 of the IOL assembly 22 can be configured with features for retaining and stabilizing the drug delivery component 30 relative to the IOL assembly 22. To that end, the haptics 28 include retention tabs 40 and gussets 44 that together form a waisted or notched portion 52 for retaining and stabilizing the fixation portion 50 of the drug delivery component 30 when a fixation loop 50 is received within the waisted portion 52. The waisted portion 52 defines a narrow portion that widens toward the optic / lens 24 and also widens toward the gussets 44 and retention tabs 40. In this manner, the drug delivery component 30 is retained in the waisted portion 52.

[0025] 1C, the retention tab 40 at the optics or first end of the haptic 28 has an outer surface 43 and an inner surface 42 at the optics-haptic junction 48. Opposite the outer surface 43 formed by the retention tab 40, the haptic 28 includes a curved notch or gusset 44 having an inner surface 42 that facilitates bending and flexing of the haptic 28 during use. A waisted portion 52 is defined between the inner surface 42 and the outer surface 43 of the haptic 28. In some embodiments, the outer surface 43 of the retention tab 40 includes a radial surface, and the inner surface 42 of the retention tab at the gusset 44 includes a radial surface to provide a curved inner portion at the junction of the haptic 28 to the lens 24. Between the retention tab 40 and the gusset 44, the front surface of the haptic 28 provides an upper surface 46 that can engage at least a portion of the drug delivery component 30 to stabilize its orientation during use. In some embodiments, the upper surface 46 can be sized and shaped to match the size and shape of the drug delivery component 30 (e.g., to engage with the entirety or substantially the entirety of the drug delivery component 30).

[0026] 2A-2C, the system 200 of the present disclosure generally includes a support base or tray 202 and a plunger 204. The system 200 may optionally include a plunger stop / lock pin or key 206 to hold the plunger 204 in place prior to use, if desired. In certain embodiments, the support base 202 includes a first portion 210 that forms a slot, groove, recess, or other depression 220 that is sized and shaped to accommodate or receive the drug delivery component 30 in a back-side up orientation to expose the fixation loop 50. The first portion 210 may also include a slot, groove, recess, or other depression 222 that is sized and shaped to accommodate or receive the IOL assembly (not shown in FIGS. 2A-2C) in a back-side up orientation. The IOL assembly may be placed within the recess 222 to present the correct orientation of the IOL for coupling the IOL assembly to the drug delivery component 30. In other embodiments, instead of the recess 222, the first portion 210 may include a protrusion configured to receive the IOL assembly and to provide a correct orientation of the IOL. The support base 202 also includes a second portion including a plunger guide 212 into which the plunger 204 is inserted along an axis that intersects with the recess 220 for the drug delivery component 30. In this manner, the plunger 204 is positioned to engage with the drug delivery component 30 and the IOL assembly (not shown) during use. In some embodiments, the plunger 204 may be guided by the plunger guide 212 in distal movement (i.e., toward the recess 220) and in proximal movement (i.e., away from the recess 220). In distal movement, the plunger 204 may extend through the fixation loop 50 of the drug delivery component 30 shown in FIGS. 2A and 2B. In this state, the tip of the plunger 204 may be positioned under the tab 224 to prevent the plunger 204 from moving off the surface of the support base 202. The plunger guide 212 may be a passageway that receives the plunger 204 along a linear path or axis.

[0027] As shown in Figures 2A and 2B, the key 206 is insertable into an opening in the plunger guide 212. As described below, the key 206 includes a mechanism that engages the plunger 204 and the plunger guide 212 to prevent distal and proximal movement of the plunger 204. Figures 2A and 2B show the system 200 in a state where the key 206 has locked the plunger 204 in place relative to the support base 202. In this state, the system 200 is suitable for packaging and shipping.

[0028] 3A and 3B, the plunger 204 includes an elongated body 302 and a tip 304 at a distal end thereof. The plunger tip 304 includes a ramp 306 configured to engage a fixation loop of a drug delivery component (not shown in FIGS. 3A and 3B) during use, and a compartment 308 configured to engage a haptic of an IOL assembly (not shown) during use. FIGS. 3C and 3D show enlarged partial views of the tip 304 including the ramp 306 and the compartment 308.

[0029] 3A-3D, the plunger tip 304 includes a generally flat top surface 310. The plunger tip 304 includes a pair of generally parallel side edges 312 extending proximally from a distal-most point. Each of the pair of side edges 312 includes an angled section 314 that extends outwardly such that the width of the plunger tip 304 is wider. As can be seen, one of the angled sections 314 extends outwardly in a distal direction more than the other angled section 314. The ramp 306 is defined on a portion of the top surface 310 of the plunger tip 304. That is, the width of the ramp 306 does not extend across the entire width of the top surface 310. Stated another way, there is an open space or gap where the top surface 310 continues past the ramp 306 on one side thereof. The proximal side of the ramp 306, including the proximal surface 316, is generally flat. A thin sidewall 318 extends proximally from one of the side edges 312. The thin sidewall 318 widens as it extends proximally, arching toward the opposite side edge 312. A compartment 308 is defined between the proximal face 316, the sidewall 318, and a top surface 310 of the plunger tip 304. The compartment 308 is coextensive with the open space or gap where the top surface 310 continues past the ramp 306.

[0030] Proximal to the plunger tip 304, the plunger 204 includes a generally cylindrical shaft 320. The shaft 320 includes a pair of notches 322 that extend downwardly through opposing portions of the cylindrical shaft 320. The pair of notches 322 are sized and shaped to engage with the key 206. At the proximal end of the plunger 204 are an alignment structure 324 and an engagement structure 326 that are sized and shaped to be engaged by a user (e.g., the thumb).

[0031] 4A and 4B show perspective and top views, respectively, of the support base 202. As seen in the figures, the support base 202 includes a first portion 210 forming a slot, groove, recess, or other indentation 220 configured in a size and shape to accommodate or receive a drug delivery component (not shown in FIGS. 4A and 4B) in a back-side-up orientation to expose the fixation loop. Adjacent to the drug delivery component recess 220 is a recess 222 for receiving an IOL assembly (not shown). As shown in the figures, the recess 222 for the IOL assembly does not intersect with the drug delivery component recess 220. The recess 222 is oriented as a guide that a user can use when coupling the drug delivery component to the haptics of the IOL assembly. For example, a user can place the IOL assembly in the recess 222 to indicate the correct orientation of the IOL before coupling the IOL assembly to the drug delivery component. The first portion 210 has a tab 224 for engaging with a plunger tip of a plunger (not shown).

[0032] The plunger guide 212 includes a passageway from the proximal end of the support base 202 that is sized to receive the plunger therein in a single orientation. A proximal opening 226 of the support base 202 includes an elongated section 228 that is sized and shaped to fit into the alignment structure of the plunger in an orientation that aligns the ramp on the plunger tip in an upward position. In this orientation, a notch on the plunger is aligned with an opening 230 in the plunger guide 212 so that a key (not shown) can be inserted into the opening 230 and secured to the plunger at the notch. As shown, the distal end of the plunger guide 212 includes an arcuate surface that terminates in an angled corner 232. The angled corner 232 is sized and shaped to engage the haptics of the IOL assembly and support the IOL assembly in place when the plunger is retracted (moved proximally) to retract the fixation loops of the drug delivery component onto the haptics.

[0033] 5A and 5B show perspective and front views, respectively, of a key 206 of a system for mounting a drug delivery component of an IOL assembly. As shown, the key 206 includes an engagement structure 502 in the form of a tab or plate at a proximal end. At approximately the midpoint of the key 206 is a guard 504 extending outwardly from the engagement structure 502. Extending distally from the guard 504 are a pair of fingers 506 sized and shaped to be received around the shaft of a plunger in a notch (not shown in FIGS. 5A and 5B). The engagement structure 502 extends downwardly from the guard 504 on two sides and terminates in a pair of ends 508 that engage with a plunger guide.

[0034] 6A and 6B show perspective views of the key 206 and plunger 204 positioned away from one another, and the key 206 coupled to the plunger 204, respectively. As shown, the fingers 506 of the key 206 may snap or be positioned around the elongated body 302 of the plunger 204 in the notches 322 of the shaft 320. When coupled thereto, the plunger 204 is prevented from moving distally and proximally relative to the support base (not shown in FIGS. 6A and 6B) because the key 206 contacts a plunger guide (not shown).

[0035] FIG. 7A shows a close-up partial view of the system 200 showing the plunger 204 engaged with the drug delivery component 30. In a particular embodiment, the plunger tip 304 is received through the locking loop 50 of the drug delivery component 30 inserted into the recess 220 of the first portion 210 of the support base 202 in a back-side-up orientation exposing the locking loop 50. The plunger tip 304 is also received under the tab 224. In this state, suitable for packaging and shipping, a key (not shown in FIG. 7A) can be inserted into the opening of the plunger guide 212 or the plunger 204 can be oriented in the correct position to receive the key. In this state, the parallel side edges 312 and the substantially flat top surface 310 of the plunger tip 304 are positioned through the locking loop 50.

[0036] FIG. 7B shows a close-up partial view of the system 200 showing the haptics 28 of the IOL assembly 22 engaged with the plunger 204 and inserted through the fixation loop 50 of the drug delivery component 30 to attach the drug delivery component 30 to the haptics 28 of the IOL assembly 22. FIG. 7B shows the plunger 204 advanced or moved distally from its previous position in FIG. 7A. To do so, a key (not shown in FIG. 7B) must be removed from its engagement with the plunger 204. Distal advancement of the plunger 204 from the state shown in FIG. 7A expands the fixation loop 50 by wedging the ramp 306 under it. With sufficient distal advancement, the thin sidewall 318 expands the fixation loop 50 upwards and opens onto the compartment 308, allowing the haptics 28 to be delivered through the fixation loop 50.

[0037] As shown in FIG. 7B, the retention tab 40 of the haptic 28 abuts the proximal surface 316 of the ramp 306. Opposite the retention tab 40, the free end of the haptic 28 faces the angled corner 232 such that retraction of the plunger 204 causes the free end of the haptic 28 to contact the angled corner 232 of the plunger guide 212, preventing the haptic 28 from moving in the proximal direction. As the plunger 204 moves proximally from the position shown in FIG. 7B, the fixation loop 50 slides along the side wall 318 and down the ramp 306, which causes the fixation loop 50 (which is flexible) to contract. The free end of the haptic 28 contacts the angled corner 232 and the retention tab 40 continues to be moved proximally because it is in contact with the proximal surface 316 of the ramp 306. Thus, haptic 28 is forced to rotate at least slightly clockwise when fixation loop 50 is contracted onto the waist of haptic 28 .

[0038] The systems of the present disclosure can be made in any suitable manner known in the art. As non-limiting examples, the systems can be made using 3D printing, machine tools, or molded from plastic. Any material suitable for use in connection with ophthalmic surgery performance can be used. Furthermore, the support base and the plunger can be made from the same material or from different materials. The systems can be made for one-time single use or for repeated use (e.g., they can be disposable or can be made to be cleaned and sterilized between uses). As non-limiting examples, the systems can be made from FDA approved and / or USP compliant polymers, such as Class VI polypropylene (PP-P5M6K-080), or made from FDA approved metals or metal alloys, such as stainless steel (SS316L). However, the present disclosure is not so limited.

[0039] In certain embodiments, the drug delivery component can be attached or secured to the IOL assembly utilizing the system of the present disclosure in any suitable manner. By way of example, a method 800 of attaching a drug delivery component to an IOL assembly is provided in the flow chart of FIG. 8. In step 802, a user can insert the drug delivery component back side up into a first portion of a support base configured to accommodate the drug delivery component such that the fixation loop of the drug delivery component is exposed (see, for example, FIG. 7A). In step 804, a user can remove a pin (if present) that stops / locks the plunger. This can be done with one hand while holding the support base with the other hand. In step 806, a plunger can be advanced through the plunger guide and through the fixation loop of the drug delivery component. One hand of the user can hold the support base and the user can actuate (push / insert) the plunger with the other hand to advance the plunger through the fixation loop of the drug delivery component until an initial resistance stop point is reached (see FIG. 7A). In step 808, the user can then remove the IOL assembly from the separate packaging and place the IOL assembly posterior side up into the support base. In step 810, the haptics are fed through the fixation loop. This step may include using forceps or other suitable tools (e.g., Catalyst Surgical's Fechtner Ring Forceps or equivalent) to gently grasp the leading haptic and feed the haptic through the fixation loop of the drug delivery component until the forceps can no longer feed the haptic through the fixation loop. At this point, at least a portion of the haptic has been fed through the fixation loop, thereby allowing the user to pull the tip of the haptic from the other side of the fixation loop. Then, using the forceps, the user can gently grasp the tip of the haptic that was fed through the fixation loop and pull the remaining section of the haptic through the fixation loop until the end of the haptic that seats against the slope of the plunger tip thereby securing the drug delivery component to the IOL assembly (see FIG. 7B).In step 812, the user can then retract the plunger proximally, contracting the fixation loop onto the waist of the haptic. In step 814, the IOL assembly with the drug delivery component attached thereto can be removed from the plunger (e.g., slid off the elongated body) by retracting the plunger proximally through the plunger guide. These steps can be repeated as necessary to secure additional drug delivery components to any remaining haptics of the IOL assembly.

[0040] While preferred embodiments of the apparatus and method 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 varieties to obtain the benefits of those elements in combination with such other varieties, 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 system for securing a drug delivery component to an intraocular lens (IOL) assembly, the drug delivery component including a therapeutic agent-containing portion and a fixation loop coupled to the therapeutic agent-containing portion, the IOL assembly including a haptic, the system comprising: a plunger and a support base, the plunger including an elongated body and a tip, the support base including a first portion and a second portion, the first portion configured to house the drug delivery component, and the second portion including a plunger guide configured to guide movement of the plunger relative to the support base; The system is configured such that when the drug delivery component is positioned in the first portion, the plunger is guided in a distal movement by the plunger guide such that the tip is received within the fixing loop of the drug delivery component to fix the drug delivery component to the first portion in a first state.

2. 2. The system of claim 1, wherein once the tip of the plunger is received within the fixation loop, additional distal movement of the plunger is configured to transition the fixation loop to a second state in which the fixation loop is expanded.

3. 3. The system of claim 1 or 2, wherein the tip of the plunger includes an upper surface and a sloped portion extending upwardly from the upper surface, the sloped portion configured to expand the fixation loop of the drug delivery component during distal movement to the second state.

4. 4. The system of claim 3, wherein the ramp includes a proximal surface, the tip of the plunger further includes a sidewall extending proximally from the proximal surface of the ramp, and the proximal surface of the ramp, the sidewall, and the top surface of the tip of the plunger define a compartment for receiving the haptics of the IOL assembly through and into the fixation loop in the second state.

5. A system as described in any one of claims 1 to 4, wherein when the haptics of the IOL assembly are received within the compartment, proximal retraction of the plunger is configured to transition the fixation loop to a third state with the fixation loop contracted onto the haptics of the IOL assembly.

6. The system of claim 1 , wherein the first portion includes a recess configured and sized to receive therein the therapeutic-agent-containing portion of the drug delivery component.

7. The system of claim 1 , wherein the first portion includes an IOL recess sized and shaped to receive the IOL assembly therein.

8. The system of claim 1 , wherein the plunger guide includes a passageway for guiding movement of the plunger.

9. The system of claim 1 further comprising a key lock configured to engage the plunger to prevent movement within the plunger guide.

10. The system of claim 1 further comprising the drug delivery component.

11. 1. A method for securing a drug delivery component to an intraocular lens (IOL) assembly, the drug delivery component including a therapeutic agent-containing portion and a fixation loop coupled to the therapeutic agent-containing portion, the IOL assembly including a haptic, the method comprising: providing a system including a plunger and a support base, the plunger including a tip, the support base including a first portion and a second portion, the first portion configured to house the drug delivery component, and the second portion including a plunger guide configured to guide movement of the plunger relative to the support base; inserting the drug delivery component backside up in the first portion of the support base such that a fixing loop of the drug delivery component is exposed; advancing the tip of the plunger through the fixation loop of the drug delivery component to expand the fixation loop; routing the haptics of the IOL assembly through the fixation loop of the drug delivery component; retracting the tip of the plunger through the fixation loop of the drug delivery component to retract the fixation loop onto the haptic. The method includes:

12. The method of claim 11 , further comprising positioning the IOL assembly posterior side up within the support base.

13. The method of claim 11 or 12, wherein routing the haptic of the IOL assembly through a fixation loop of the drug delivery component includes using forceps, grasping the haptic, and routing a first end of the haptic through a fixation loop of the drug delivery component.

14. The method of claim 13 , further comprising pulling the first end of the haptic until a second end of the haptic seats against a ramp on the tip of the plunger.

15. 1. A system for securing a drug delivery component to an intraocular lens (IOL) assembly, the drug delivery component including a therapeutic agent-containing portion and a fixation loop coupled to the therapeutic agent-containing portion, the IOL assembly including a haptic, the system comprising: a support base and a plunger, the support base including a plunger guide and a recess, the recess configured to be sized and shaped to receive the therapeutic-agent-containing portion of the drug delivery component therein in a rear-side up orientation, and the plunger guide configured to guide movement of the plunger relative to the support base along an axis that intersects the recess; When the therapeutic agent-containing portion is received within the recess, the plunger is configured to be guided in distal movement by the plunger guide such that a tip of the plunger is received within the fixed loop of the drug delivery component.

16. The system of claim 15 , wherein the tip of the plunger includes a ramp and a sidewall extending proximally from the ramp.

17. The system of claim 16 , wherein a compartment is formed by a proximal surface of the ramp and an inner surface of the sidewall, the compartment being sized and shaped to receive a portion of the haptic therein.

18. The system of claim 15 , wherein in the back-side-up orientation, the fastening loop is exposed.

19. The system of claim 15, wherein when the tip of the plunger is received within the fixation loop of the drug delivery component, additional distal movement of the plunger is configured to expand the fixation loop to receive the haptics of the IOL assembly therethrough.

20. The system of claim 15 further comprising the drug delivery component.

21. 21. A kit comprising the system of any one of claims 1 to 10 or 15 to 20 and at least one container.

22. 22. The system of claim 21 further comprising an instruction guide.

23. 23. The system of claim 21 or 22, wherein the kit does not include an IOL.

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