Intraocular drug delivery platform

Abstract

To provide an intraocular drug delivery platform for use with an intraocular lens assembly.SOLUTION: There is provided an intraocular drug delivery platform for use with an intraocular lens assembly. The platform includes a ring, haptics to maintain the ring in position in the capsular bag, compartments on the anterior surface of the ring for accommodating a drug-eluting matrix or other drug mass, and a skirt extending posteriorly from the posterior surface of the ring to constrain movement, including lateral or inferior / superior movement, of the intraocular lens relative to the ring.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The inventions described below relate to the field of intraocular drug delivery platforms. [Background technology]

[0002] Intraocular lenses may be used in conjunction with drug delivery devices. In previous applications, such as U.S. Patent Application Publication No. 2019 / 0129997, filed July 19, 2019, the inventors disclosed various modular embodiments of intraocular lenses (IOLs) and drug delivery devices arranged in various ways on the IOLs. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Application Serial No. 16 / 516,356 Summary of the Invention [Problem to be solved by the invention]

[0004] The devices and methods described below provide a more convenient means for adding drug delivery platforms to modular IOLs, and drug delivery platforms. [Means for solving the problem]

[0005] The devices and methods described below provide for the placement of a drug delivery platform with an IOL, configured to limit or inhibit relative movement of the IOL and drug delivery platform and enable the replacement of a drug-eluting mass placed within a compartment of the drug delivery platform. The drug delivery platform includes a ring with one or more compartments or other means for releasably retaining a drug-eluting mass or other solid drug mass (which may erode, slowly disintegrate, or dissolve in the eye) on the anterior side of the ring. The drug delivery platform also includes a skirt extending rearward from the posterior surface. The skirt is configured to partially or completely surround the opening and have an inner diameter sized to retain the IOL lens within its walls or between its sections. The inner diameter of the skirt is preferably larger than the intraocular lens and the opening of the intraocular lens assembly. The skirt extends around the intraocular lens and is configured to inhibit the platform from moving toward the visual axis and obstructing the patient's field of vision. The skirt is configured to restrict movement, including lateral or up-and-down movement, of the intraocular lens relative to the ring. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 1 shows the environment in which an intraocular drug delivery system is used. [Figure 2] FIG. 2 illustrates the environment in which the intraocular drug delivery system is used. [Figure 3] FIG. 3 illustrates a drug delivery platform configured for use with an intraocular lens assembly. [Figure 4] FIG. 4 is a rear view of the drug delivery platform of FIG. [Figure 5] FIG. 5 is a rear view of the combined drug delivery platform and intraocular lens assembly. DETAILED DESCRIPTION OF THE INVENTION

[0007] 1 and 2 illustrate 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, and an anterior chamber 4, which includes a cornea 5, an iris 6, aqueous humor that fills the space between the cornea and the iris, and a ciliary sulcus (posterior chamber) 7 between the iris and the lens capsule. The posterior chamber / vitreous body 8 is the large space between the lens and the retina 9. The eye's natural lens 2 is characterized by an optical axis 10 (in the following description of drug delivery platforms and associated intraocular lens assemblies, the terms posterior and anterior are used with reference to the anatomy of the eye, with the cornea being anterior and the retina being posterior).

[0008] FIG. 2 illustrates the placement of a drug delivery platform 11 within the eye along with an intraocular lens assembly 12. In this example, the drug delivery platform 11 is provided in the form of a ring and is implanted in the lens capsule along with the intraocular lens assembly 12. As shown in FIG. 2, the drug delivery platform is intended for use with the intraocular lens assembly 12, although it can also be placed alone. As shown in FIG. 2, the drug delivery platform is positioned anterior to the intraocular lens assembly 12 (in front of the intraocular lens assembly 12) and is attached to the intraocular lens with a retaining rim or skirt that extends posteriorly (with respect to the anatomy of the eye). The drug delivery platform can also be positioned below the iris and above the lens capsule. The lens capsule may contain a natural lens, an artificial lens, or no lens at all.

[0009] Figure 3 is a front view of the drug delivery platform of Figure 2 configured for use with an intraocular lens assembly. The drug delivery platform includes a ring 14, which is preferably flat like a washer and preferably a complete ring with no gaps, continuous around the entire 360° circumference of the ring, having an anterior surface 14A and a posterior surface 14P (shown in Figure 4) and a central opening 15. On the anterior surface, the drug delivery platform includes one or more compartments 16 configured to hold a drug-eluting mass 17. While there may be only one compartment and no more, two or more compartments disposed around the periphery of the ring are preferred. The drug-eluting mass may be provided in the form of a block, plate, wafer, cylindrical, or spherical pellet, configured to fit securely within a compartment having an interior space shaped to receive the mass.

[0010] The mass may be inserted into the compartment before or after implantation. The compartment is configured to retain the mass with a friction fit or other releasable attachment means relative to the mass, allowing it to be inserted, removed, and replaced using a tool inserted through the cornea or a slit formed between the cornea and the sclera while the platform is in place within the eye. The compartment has an open side, as shown, which may be at the inner edge of the ring, the outer edge of the ring, or a radial edge that allows for insertion and removal of the mass. The compartment provides a convenient means for releasably securing the mass to the ring, allowing it to be easily attached, removed, and / or replaced without the use of specialized tools other than a simple grasper or hook. Other releasable attachment means may be used to secure the mass or other replaceable drug matrix to the drug delivery platform 11, such as a snap ring attachment including a corresponding annular detent on the annular matrix and drug delivery platform, or a snap-fit ​​detent disposed within a recess on the ring that interfaces with a corresponding detent-receiving recess on the mass.

[0011] The drug delivery platform may also include haptics 18, which are outwardly biased filaments configured to abut the lens equator inside the lens capsule 3 (where the drug delivery platform is to be implanted within the capsule) and to hold the ring centered within the lens capsule 3 and aligned with the optical axis of the eye.

[0012] FIG. 4 is a posterior view of the drug delivery platform of FIG. 3 . This view shows the posterior surface 14P of the ring 14, the central opening 15, and the platform haptics 18. An intraocular lens retention structure, such as an annular skirt 19, extends rearward from the posterior surface 14P and partially or completely surrounds the opening. The skirt is configured to inhibit migration of the drug delivery platform into the optic of the intraocular lens with which it is used (or, correspondingly, to retain the lens component of an intraocular lens assembly within the skirt). The skirt need not extend a full 360° around the opening but may be interrupted by gaps. Alternatively, the skirt may be divided into several sections, each of which partially surrounds the opening and is positioned in the opening to secure the ring on the lens relative to the plane of the lens, the ring, or the ring-lens assembly. The skirt defines a second opening having an inner diameter slightly larger than the opening and the intraocular lens so that the lens fits within the skirt, while the opening in the ring is slightly smaller than the lens, thereby inhibiting or limiting movement of the lens to a position anterior to the ring. The inner diameter of the second opening in the skirt may be configured to allow slight lateral and / or vertical movement of the lens within the skirt.

[0013] FIG. 5 is a posterior view of the coupled drug delivery platform and intraocular lens assembly 12 as it is positioned during implantation within the eye. The intraocular lens assembly includes the intraocular lens 20 itself and, typically, a pair of lens haptics 21. The lens haptics, like the platform haptics, are outwardly biased filaments configured to abut against the lens equator inside the lens capsule to center the lens within the capsule and align it with the optical axis of the eye. As shown in FIG. 5, the lens 20 is constrained within the inner boundary of the skirt, thereby aligning it along a common anterior-posterior axis with the ring 14 of the platform 13. While the lens has some freedom of anterior-posterior movement relative to the ring, the haptics function to maintain both components in parallel planes close to the equatorial plane of the lens capsule 3, or coplanar, so that both components are preferably centered about the optical axis 10 of the eye when implanted in the lens capsule.

[0014] The mass 17 is sized and dimensioned for insertion into the compartment and retained therein by a friction fit. The mass can comprise a matrix infused or impregnated with a therapeutic agent. Suitable matrix materials include silicone, hydrogel, PLGA, PVA, PLA, biodegradable or biodegradable polymers, non-degradable medical-grade or other polymers, or non-polymeric diffusion barriers. Suitable therapeutic agents include bimatoprost and other prostaglandin analogs, beta-blockers, alpha-agonists, carbonic anhydrase inhibitors, and Rho kinase inhibitors. Crystalline bimatoprost embedded in silicone is currently suitable for the long-term treatment of glaucoma. Other therapeutic agents can be used for the long-term treatment of macular degeneration, vascular disorders, corneal dystrophies, corneal degeneration, genetic diseases, myopia, refractive errors, presbyopia, uveitis, edema, postoperative inflammation, or other ocular or periocular disorders.

[0015] The mass 17 is preferably sized and dimensioned to be inserted into the compartment and retained therein by a friction fit (or any other suitable releasable attachment structure). The mass, the compartment, or both may include semi-permeable membranes to control the diffusion or elution of the therapeutic agent from the mass. The compartments may also be perforated with openings sized to control the exposure of the mass to the surrounding tissue, thereby allowing for control of the elution rate of the therapeutic agent from the mass.

[0016] In use, the drug delivery platform can be used in a method for intraocular delivery of a therapeutic agent into a patient's eye after or in conjunction with implantation of an intraocular lens. A surgeon inserts the above-described intraocular drug delivery platform (13) into a patient's eye and positions the intraocular drug delivery platform (13) anterior to the intraocular lens (in front of the intraocular lens), thereby positioning the intraocular lens within the patient's eye so that the posterior surface of the ring faces the anterior surface of the intraocular lens and the intraocular lens is positioned within the skirt. (Alternatively, the surgeon may position the intraocular drug delivery platform (13) posterior to the intraocular lens assembly, such that the anterior surface of the ring faces the posterior surface of the intraocular lens and the intraocular lens is positioned within the skirt. In this case, the intraocular drug delivery platform (13) may be manufactured with a skirt extending forward from the anterior surface of the ring.) If the drug delivery platform initially includes an empty compartment and is inserted into the eye with the compartment empty, after the intraocular drug delivery platform is positioned in the patient's eye, the surgeon inserts a first drug-eluting mass into the patient's eye and secures the first drug-eluting mass to the ring with the releasable attachment means. If the releasable attachment means includes a compartment (16) located on its front surface and the compartment has an opening for receiving and removing a mass from the compartment, the surgeon inserts the first drug-eluting mass (sized and dimensioned to fit within the compartment) and secures the first drug-eluting mass to the ring by inserting the first drug-eluting mass into the compartment. The surgeon may then remove the first drug-eluting mass from the ring and secure a second drug-eluting mass to the ring while the drug delivery platform is in place in the patient's eye. The surgeon may replace the mass when most or all of the therapeutic agent has eluted and the mass is exhausted, or may replace the mass with a second mass containing a second therapeutic agent that is different from the first therapeutic agent in the first mass (if the mass is biodegradable, the surgeon may simply insert a new mass once it has completely degraded or eroded).

[0017] If the drug delivery platform initially includes a compartment for holding a drug-eluting mass and is inserted into the eye with the compartment filled with one or more first masses, the surgeon may leave the drug delivery platform and masses in the patient's eye for an extended period of time after the intraocular drug delivery platform is placed in the patient's eye. Once the masses are depleted, the surgeon may remove the first drug-eluting mass from the ring and secure a second drug-eluting mass to the ring while the drug delivery platform remains in the patient's eye. Once most or all of the therapeutic agent has eluted and the first mass is depleted, the surgeon may replace the mass with a second mass containing a second therapeutic agent different from the first therapeutic agent in the first mass (if the mass is biodegradable, the surgeon may simply insert a new mass once it has completely degraded or eroded). If the releasable attachment means includes a compartment (16) located on the front surface and the compartment has an opening for receiving and removing the mass from the compartment, the surgeon inserts a second drug-eluting mass (sized and dimensioned for a friction fit within the compartment) and secures the second drug-eluting mass to the ring by inserting the second drug-eluting mass into the compartment.

[0018] The effect of the releasable attachment means can occur with or without the effect of the lens retention structure, and the effect of the lens retention structure can occur with or without the effect of the releasable attachment means. For example, for phakic patients (patients with an intact natural lens), the drug delivery platform may be provided without a lens retention skirt. The drug delivery platform may be implanted in the ciliary sulcus with platform haptics engaging the ciliary sulcus anterior to the (intact) lens capsule. For pseudophakic patients (patients who have previously had an intraocular lens implanted), the drug delivery platform may be implanted in the ciliary sulcus with the platform haptics engaging the ciliary sulcus anterior to the (intact) lens capsule. In embodiments of methods for implanting a device in the ciliary sulcus for phakic and pseudophakic patients, the drug delivery platform may include haptics configured to abut the periphery of the ciliary sulcus. For aphakic patients (patients without any lenses), the drug delivery platform may be implanted in a corresponding position with haptics configured to abut the periphery of the ciliary sulcus, or with haptics configured to abut the capsular bag, with or without a skirt.

[0019] The drug delivery platform itself, including only the ring, only the skirt, or both the ring and the skirt, may contain a drug-eluting mass or other solid drug mass (which may erode, slowly disintegrate, or dissolve in the eye) or may be configured without a separate drug-eluting mass (17). In this configuration, the drug delivery platform has all the features of the drug delivery platform of FIGS. 3 and 4, including the ring 14 having an anterior surface 14A and a posterior surface 14P and a central opening 15, and optionally includes a compartment 16 configured to hold the drug-eluting mass 17, platform haptics 18, and an annular skirt 19 extending rearward from the posterior surface 14P and partially or completely surrounding the opening. The compartment 17 may be omitted or retained for use with a drug-eluting mass containing a therapeutic agent. The platform may contain a first therapeutic agent, and the drug-eluting mass in the compartment may contain a second therapeutic agent different from the first therapeutic agent.

[0020] The benefits of a lens retention structure can be achieved without the benefits of a releasable attachment means. For example, a method for intraocular delivery of an IOL into a patient includes inserting a ring (14) having an anterior surface (14A) and a posterior surface (14P) and a central opening (15), with a skirt (19) extending posteriorly from the posterior surface (14P), the skirt having an inner diameter larger than both the intraocular lens (20) of the intraocular lens assembly and the opening (15), the skirt (19) partially or completely surrounding the opening (15) configured to retain the intraocular lens assembly (12). The ring can be configured as a centering device for the IOL or as a carrier for a pinhole device or second lens for correcting astigmatism, refractive error, or multifocality.

[0021] While preferred embodiments of the apparatus and method have been described in relation to the environment in which they were developed, they are merely illustrative of the principles of the present invention. Various elements of the embodiments may be combined with each other to obtain the benefits of those elements or classes, 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 present invention and the scope of the appended claims.

Claims

1. An intraocular drug delivery platform (13) for use with an intraocular lens assembly (12), comprising: a ring (14) having a front surface (14A), a rear surface (14P), and a central opening (15); a drug-eluting or other solid drug mass (17) containing a therapeutic agent configured to be placed on said front surface (14A), and releasable attachment means (16) for releasably securing said mass to said front surface (14A); a skirt (19) extending rearward from said rear face (14P), said skirt partially or completely surrounding said opening (15); Equipped with The skirt (19) has an inner diameter larger than both the intraocular lens (20) of the intraocular lens assembly and the opening (15) and is configured to hold the intraocular lens assembly (12). Intraocular drug delivery platform (13).

2. An intraocular drug delivery platform (13) for use with an intraocular lens assembly (12), comprising: a ring (14) having a front surface (14A), a rear surface (14P), and a central opening (15); a drug-eluting or other solid drug mass (17) containing a therapeutic agent configured to be placed on said front surface (14A), and releasable attachment means (16) for releasably securing said mass to said front surface (14A); a skirt (19) extending rearward from said rear face (14P), said skirt partially or completely surrounding said opening (15); Equipped with The skirt (19) has an inner diameter larger than both the intraocular lens (20) of the intraocular lens assembly and the opening (15), and is configured to extend around the intraocular lens to inhibit movement of the platform toward the visual axis. Intraocular drug delivery platform (13).

3. the attachment means having a compartment (16) disposed on the front surface and the drug-eluting mass (17) disposed with the compartment (16); the compartment has an opening for receiving and removing the mass from the compartment; said mass (17) being sized and dimensioned to friction fit within said compartment (16); 10. The apparatus of claim 1.

4. the attachment means having a compartment (16) disposed on the front surface and the drug-eluting mass (17) disposed with the compartment (16); the compartment has an opening for receiving and removing the mass from the compartment; said mass (17) being sized and dimensioned to friction fit within said compartment (16); 3. The apparatus of claim 2.

5. the drug-eluting mass (17) comprising a therapeutic agent embedded within a matrix; 10. The apparatus of claim 1.

6. the drug-eluting mass (17) comprising a therapeutic agent embedded within a matrix; 3. The apparatus of claim 2.

7. the therapeutic agent comprises bimatoprost; 10. The apparatus of claim 1.

8. the therapeutic agent comprises bimatoprost in a crystalline form; 10. The apparatus of claim 1.

9. the therapeutic agent comprises bimatoprost or other prostaglandin analogs, beta-blockers, alpha-agonists, carbonic anhydrase inhibitors, or Rho-kinase inhibitors; 10. The apparatus of claim 1.

10. the therapeutic agent comprises bimatoprost or other prostaglandin analogs, beta-blockers, alpha-agonists, carbonic anhydrase inhibitors, or Rho-kinase inhibitors; 3. The apparatus of claim 2.

11. An intraocular drug delivery platform (13) for use with an intraocular lens assembly (12), comprising: a ring (14) having a front surface (14A), a rear surface (14P), and a central opening (15); a skirt (19) extending rearward from said rear face (14P), said skirt partially or completely surrounding said opening (15); Equipped with the skirt (19) has an inner diameter larger than both the intraocular lens (20) of the intraocular lens assembly and the opening (15) and is configured to hold the intraocular lens assembly (12); The ring (14) or the skirt (19), or both the ring and the skirt, contain a drug-eluting mass or other solid drug mass containing a therapeutic agent. Intraocular drug delivery platform (13).

12. the therapeutic agent comprises bimatoprost; 12. The apparatus of claim 11.

13. the therapeutic agent comprises bimatoprost in a crystalline form; 12. The apparatus of claim 11.

14. the therapeutic agent comprises bimatoprost or other prostaglandin analogs, beta-blockers, alpha-agonists, carbonic anhydrase inhibitors, or Rho-kinase inhibitors; 12. The apparatus of claim 11.

15. 1. A method for intraocular delivery of a therapeutic agent into an eye of a patient, comprising: Inserting the intraocular drug delivery platform (13) of claim 1 into the patient's lens capsule or ciliary sulcus; placing the intraocular drug delivery platform (13) in front of the intraocular lens (20) placed in the patient's eye such that the posterior surface of the ring (14P) faces the anterior surface (20A) of the intraocular lens, such that the intraocular lens is placed within the skirt (19); With the intraocular drug delivery platform (13) positioned within the patient's eye, inserting a first drug-eluting mass (17) into the patient's eye and securing the first drug-eluting mass (17) to the ring (14) with the releasable attachment means (16); A method comprising:

16. said releasable attachment means including a compartment (16) located on said front surface (14A); the compartment has an opening for receiving and removing the first drug eluting mass from the compartment; the first drug-eluting mass is sized and dimensioned to frictionally fit within the compartment; the step of securing the first drug eluting mass to the ring comprises inserting the first drug eluting mass into the compartment.

16. The method of claim 15.

17. after securing the first drug eluting mass to the ring, removing the first drug eluting mass from the ring and securing a second drug eluting mass to the ring while the drug delivery platform is indwelling in the eye of the patient.

16. The method of claim 15.

18. the first drug-eluting mass is biodegradable or biodegradable; the method further comprising, after securing the first drug eluting mass to the ring, securing a second drug eluting mass to the ring after the first drug eluting mass has degraded or eroded while the drug delivery platform is in the eye of the patient.

16. The method of claim 15.

19. 1. A method for intraocular delivery of a therapeutic agent into an eye of a patient, comprising: Inserting an intraocular drug delivery platform (13) into the patient's lens capsule or ciliary sulcus, the intraocular drug delivery platform (13) comprising: a ring (14) having a front surface (14A), a rear surface (14P), and a central opening (15); releasable attachment means (16) for releasably securing the first drug-eluting mass and the second drug-eluting mass to said front surface (14A); the first drug-eluting mass is secured to the releasable attachment means before or after the drug delivery platform is implanted in the eye of the patient; inserting one of the first drug-eluting mass (17) or the second drug-eluting mass into the patient's eye with the intraocular drug delivery platform (13) positioned within the patient's eye, and securing the first drug-eluting mass (17) or the second drug-eluting mass to the ring (14) by the releasable attachment means (16); method.

20. said releasable attachment means including a compartment (16) located on said front surface (14A); the compartment has openings for receiving and removing the first and second drug eluting masses from the compartment; the first and second drug eluting masses are sized and dimensioned to friction fit within the compartments; the step of securing the first and second drug eluting masses to the ring comprises inserting the first drug eluting mass into the compartment; and, when the first drug eluting mass is consumed, inserting the second drug eluting mass into the compartment.

20. The method of claim 19.

21. 1. A method for intraocular delivery of a therapeutic agent into an eye of a patient, comprising: Inserting an intraocular drug delivery platform (13) into the patient's lens capsule or ciliary sulcus, the intraocular drug delivery platform (13) comprising: a ring (14) having a front surface (14A), a rear surface (14P), and a central opening (15); a skirt (19) extending rearward from said rear face (14P), said skirt partially or completely surrounding said opening (15); Equipped with the skirt (19) has an inner diameter larger than both the intraocular lens (20) of the intraocular lens assembly and the opening (15) and is configured to hold the intraocular lens assembly (12); placing the intraocular drug delivery platform (13) in front of the intraocular lens (20) placed in the patient's eye such that the posterior surface of the ring (14P) faces the anterior surface (20A) of the intraocular lens, such that the intraocular lens is placed within the skirt (19); method.

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