IOL with Drug Delivery Devices and Uninterrupted PCO Barrier Edge
20220104936 · 2022-04-07
Assignee
- SpyGlass Pharma, Inc. (Aliso Viejo, CA, US)
- The Regents Of The University Of Colorado, A Body Corporate (Denver, CO)
Inventors
- Craig Alan Cable, II (Aliso Viejo, CA, US)
- Glenn R. Sussman (Aliso Viejo, CA, US)
- James R. Dennewill (Aliso Viejo, CA, US)
- Malik Y. Kahook (Aliso Viejo, CA, US)
Cpc classification
A61F2002/1681
HUMAN NECESSITIES
International classification
Abstract
An ophthalmic implant including an IOL with haptics, and drug delivery devices secured to the haptics. The posterior-most extent of the drug delivery device is located anterior to the posterior edge or PCE barrier edge, of the IOL. In other configurations, the drug delivery devices are provided with PCO barrier edges.
Claims
1-23. (canceled)
24. An ophthalmic implant (11) comprising: an IOL assembly (12) comprising a lens (24), and a haptic (28), the IOL assembly characterized by an anterior surface and a posterior surface, and a circumferential side wall (24C), wherein the posterior surface joins the circumferential side wall in a sharply angular edge (24E), the sharply angular edge defining a plane (P) of the sharply angular edge; and a drug delivery device disposed on the haptic, the drug delivery device having a posterior surface (33P), and a circumferential side wall (33C), wherein the drug delivery device on the haptic does not disrupt formation of a PCO barrier.
25. The ophthalmic implant of claim 24, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is anteriorly displaced from the plane (P).
26. The ophthalmic implant of claim 25, wherein the posterior-most surface (30P) of the drug delivery device (30) is anteriorly displaced from the plane (P) by 0.1 to 1 millimeters.
27. The ophthalmic implant of claim 24, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is posteriorly displaced from the plane (P).
28. The ophthalmic implant of claim 24, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is co-planar with the plane (P).
29. The ophthalmic implant of claim 24, wherein the drug delivery device comprises a posterior panel (33) and an anterior panel (36) joined by a pair of posts (35), with an aperture (34) bounded by the posterior panel (33), anterior panel (36) and posts (35), and the haptic is disposed within the aperture to secure the drug delivery device to the haptic or the base of the haptic.
30. The ophthalmic implant of claim 29, wherein a portion of the circumferential side wall (33C) of the posterior panel (33) immediately abuts a portion of the side wall (24C) of the IOL (24).
31. The ophthalmic implant of claim 29, wherein the circumferential side wall (33C) of the posterior panel (33) is radially, outwardly displaced from the side wall (24C) of the IOL (24).
32. The ophthalmic implant of claim 24, wherein the drug delivery device comprises one or more therapeutic agents.
33. The ophthalmic implant of claim 32, wherein the one or more therapeutic agents comprises a beta blocker, an alpha agonist, a ROCK Inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic or cholinergic receptor activating agent, a prostaglandin analogue, a steroid, an aptamer, an antibody, a complement factor, an anti-oxidant, an anti-inflammatory agent, an anti-proliferative agents, an anti-mitotic agents, an antibiotic, or any combination thereof.
34. The ophthalmic implant of claim 32, wherein the one or more therapeutic agents comprises or consists of a prostaglandin analogue.
35. An ophthalmic implant (11) comprising: an IOL assembly (12) comprising a lens (24), and a haptic (28), the IOL assembly characterized by an anterior surface and a posterior surface, and a circumferential side wall (24C); the haptic (28) is joined to the lens via a haptic base (28B) having a shape and size configured for acceptance of a drug delivery device (30); and the drug delivery device (30) configured for disposition on the haptic (28), the drug delivery device (30) having an aperture (34) configured to accept the haptic base (28B), the aperture (34) being keyed to the shape and size of the haptic base (28B) in a configuration which inhibits rotation of the drug delivery device (30) about the haptic base (28B); such that, in an assembled configuration, the drug delivery device (30) is disposed on the haptic base (28B), with the haptic base (28B) occupying the aperture (34).
36. The ophthalmic implant of claim 35, wherein the drug delivery device (30) comprises a posterior panel (33) and an anterior panel (36) joined by a pair of posts (35), with an aperture (34) bounded by the posterior panel (33), anterior panel (36) and posts (35).
37. The ophthalmic implant of claim 35, wherein the drug delivery device (30) comprises an anterior panel (36) with an anterior surface (36A) and an anterior surface edge (36E), and the anterior surface edge (36E) lies entirely in a plane (A) which is parallel to a major plane (B) of the IOL assembly.
38. The ophthalmic implant of claim 35, wherein the anterior surface (36A) is planar.
39. The ophthalmic implant of claim 35, wherein an anterior panel (36) is characterized by a circumferential dimension (40) and a radial dimension (41) and the circumferential dimension (40) is larger than the radial dimension (41).
40. The ophthalmic implant of claim 35, wherein the drug delivery device comprises one or more therapeutic agents.
41. The ophthalmic implant of claim 40, wherein the one or more therapeutic agents comprises a beta blocker, an alpha agonist, a ROCK Inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic or cholinergic receptor activating agent, a prostaglandin analogue, a steroid, an aptamer, an antibody, a complement factor, an anti-oxidant, an anti-inflammatory agent, an anti-proliferative agents, an anti-mitotic agents, an antibiotic, or any combination thereof.
42. The ophthalmic implant of claim 40, wherein the one or more therapeutic agents comprises or consists of a prostaglandin analogue.
43. An ophthalmic implant (11) comprising: an IOL assembly (12) comprising a lens (24), and a haptic (28), the IOL assembly characterized by an anterior surface and a posterior surface, and a circumferential side wall (24C); the haptic (28) is joined to the lens (12) via a haptic base (28B) having a shape and size configured for acceptance of a drug delivery device (30); and the drug delivery device (30) configured for disposition on the haptic, the drug delivery device (30) having an aperture (34) configured to accept the haptic base (28B), the aperture (34) being keyed to the shape and size of the haptic base (28B) in a configuration which inhibits rotation of the drug delivery device (30) about the haptic base (28B); such that, in an assembled configuration, the drug delivery device (30) is disposed on the haptic base (28B), with the haptic base (28B) occupying the aperture (34).
44. The ophthalmic implant of claim 43, wherein the drug delivery device (30) comprises a posterior panel (33) and an anterior panel (36) joined by a pair of posts (35), with an aperture (34) bounded by the posterior panel (33), anterior panel (36) and posts (35).
45. The ophthalmic implant of claim 43, wherein the drug delivery device (30) comprises an anterior panel (36) with an anterior surface (36A) and an anterior surface edge (36E), and the anterior surface edge (36E) lies entirely in a plane (A) which is parallel to a major plane (B) of the IOL assembly.
46. The ophthalmic implant of claim 43, wherein the anterior surface (36A) is planar.
47. The ophthalmic implant of claim 43, wherein an anterior panel (36) is characterized by a circumferential dimension (40) and a radial dimension (41) and the circumferential dimension (40) is larger than the radial dimension (41).
48. The ophthalmic implant of claim 43, wherein the drug delivery device comprises one or more therapeutic agents.
49. The ophthalmic implant of claim 48, wherein the one or more therapeutic agents comprises a beta blocker, an alpha agonist, a ROCK Inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic or cholinergic receptor activating agent, a prostaglandin analogue, a steroid, an aptamer, an antibody, a complement factor, an anti-oxidant, an anti-inflammatory agent, an anti-proliferative agents, an anti-mitotic agents, an antibiotic, or any combination thereof.
50. The ophthalmic implant of claim 48, wherein the one or more therapeutic agents comprises or consists of a prostaglandin analogue.
51. An ophthalmic implant (11) comprising: an IOL assembly (12) comprising a lens (24), and a haptic (28), the IOL assembly characterized by an anterior surface and a posterior surface, and a circumferential side wall (24C); the haptic (28) is joined to the lens via a haptic base (28B) having a shape and size configured for acceptance of a drug delivery device (30); the drug delivery device (30) configured for disposition on the haptic (28), the drug delivery device (30) having an aperture (34) configured to accept the haptic base (28B); and the haptic further comprising a first retaining structure, configured to inhibit outward migration of the drug delivery device (30) from the haptic base; wherein in an assembled configuration, the first retaining structure (37, 36, 39) obstructs the drug delivery device (30) and inhibits outward migration of the drug delivery device (30) from the haptic base (28B).
52. The ophthalmic implant of claim 51, wherein the first retaining structure comprises a detent or shoulder on the haptic, configured to inhibit with outward movement of the drug delivery device (30) along the haptic (28).
53. The ophthalmic implant of claim 51, wherein the first retaining structure comprises a notch in the haptic base (28B); and the drug delivery device (30) comprises a second retaining feature comprising a post (35) configured to occupy the notch.
54. The ophthalmic implant of claim 51, wherein the drug delivery device (30) comprises a posterior panel (33) and an anterior panel (36) joined by a pair of posts (35), with an aperture (34) bounded by the posterior panel (33), anterior panel (36) and the posts (35); and the drug delivery device (30) is disposed over the haptic with one of the posts (35) disposed within the notch.
55. The ophthalmic implant of claim 51, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is anteriorly displaced from a plane (P).
56. The ophthalmic implant of claim 51, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is posteriorly displaced from a plane (P).
57. The ophthalmic implant of claim 51, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that a sharply angular edge (33E) of the drug delivery device (30) is co-planar with a plane (P).
58. The ophthalmic implant of claim 55, wherein the posterior-most surface (30P) of the drug delivery device (30) is anteriorly displaced from the plane (P) by 0.1 to 1 millimeters.
59. The ophthalmic implant of claim 51, wherein the drug delivery device comprises one or more therapeutic agents.
60. The ophthalmic implant of claim 59, wherein the one or more therapeutic agents comprises a beta blocker, an alpha agonist, a ROCK Inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic or cholinergic receptor activating agent, a prostaglandin analogue, a steroid, an aptamer, an antibody, a complement factor, an anti-oxidant, an anti-inflammatory agent, an anti-proliferative agents, an anti-mitotic agents, an antibiotic, or any combination thereof.
61. The ophthalmic implant of claim 59, wherein the one or more therapeutic agents comprises or consists of a prostaglandin analogue.
62. A method of treating an eye disease in a patient in need thereof, the method comprising: implanting an ophthalmic implant into a capsular bag of the eye of the patient, the ophthalmic implant comprising: an IOL assembly (12) comprising a lens (24), and a haptic (28), the IOL assembly characterized by an anterior surface and a posterior surface, and a circumferential side wall (24C), wherein the posterior surface joins the circumferential side wall in a sharply angular edge (24E), the sharply angular edge defining a plane (P) of the sharply angular edge; and a drug delivery device disposed on the haptic, the drug delivery device having a posterior surface (33P), and a circumferential side wall (33C), wherein the drug delivery device on the haptic does not disrupt formation of a PCO barrier.
63. The method of claim 62, wherein the drug delivery device (30) is configured and disposed on the haptic (28) such that the sharply angular edge (33E) of the drug delivery device (30) is anteriorly displaced from the plane (P).
64. The method of claim 63, wherein the posterior-most surface (30P) of the drug delivery device (30) is anteriorly displaced from the plane (P) by 0.1 to 1 millimeters.
65. The method of claim 63, further comprising allowing the capsular bag to approximate the IOL.
66. The method of claim 63, further comprising forming a PCO barrier between the posterior portion of the capsular bag and the sharply angular edge.
67. The method of claim 63, wherein the eye disease comprises glaucoma, wet macular degeneration, dry macular degeneration, uveitis, an infection or inflammation of the eye, or any combination thereof.
68. The method of claim 63, wherein the implanting comprises: folding or rolling the ophthalmic implant into a small diameter configuration into an injector; inserting the injector through a small slit between the cornea and sclera of the eye; and pushing the ophthalmic implant from the injector into a tissue of the eye.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0008]
[0009]
[0010]
[0011]
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
DETAILED DESCRIPTION OF THE INVENTIONS
[0018]
[0019]
[0020]
[0021]
[0022] As shown in
[0023] The drug delivery devices may be provided in many configurations. As illustrated in the figures, the drug delivery devices may be configured as a collar or sleeve with a through-hole, which can be slipped over the haptic and retained with a friction fit or detent arrangement. The drug delivery devices may comprise a polymer matrix with therapeutic agents embedded in the matrix, or it may be comprised of a therapeutic agent in an erodible form. The matrix preferably comprises silicone, though other suitable matrix material may be used. The entirety of the drug delivery device may comprise the matrix material loaded with therapeutic agent, or an erodible therapeutic agent, or the matrix material loaded with therapeutic agent, or an erodible therapeutic agent may be limited to portions of the drug delivery device, while the remaining portions are provided for structure.
[0024] In use, the IOL assembly of
[0025]
[0026] The sharply angular edge 33E of the posterior panel 33 preferably extends entirely around the posterior panel and side wall of the posterior panel. The sharply angular edge 33E of the posterior panel 33, and the circumferential side wall 33C may immediately abut the circumferential side wall 24C of the IOL, or the sharply angular edge 33E of the posterior panel 33, and the circumferential side wall 33C may be spaced from the circumferential side wall 24C, leaving a small radial gap between the PCO barrier edge of the IOL and the PCO barrier edge of the posterior panel 33, such that the circumferential side wall 33C of the posterior panel 33 is radially, outwardly displaced from the side wall 24C of the IOL 24.
[0027] If the plane (D) is coplanar with the plane (P), and the posterior panel directly abuts the IOL side wall, the area of the posterior panel directly abutting the IOL side wall may be provided with an edge that is not sharply angular, and the PCO barrier edge and remaining edge of the posterior panel will provide a sharply angular edge around entire periphery of the combined IOL and drug delivery device.
[0028]
[0029] In use, the IOL assembly and drug delivery device configurations of
[0030] This may be accomplished by securing the drug delivery device 30 on the haptic 28 such that the sharply angular edge 33E of the drug delivery device 30 is anteriorly displaced from the plane (P), such that the sharply angular edge 33E of the drug delivery device 30 is posteriorly displaced from the plane (P), or such that the sharply angular edge 33E of the drug delivery device 30 is co-planar with the plane (P).
[0031] Various configurations of the drug delivery device may be employed to ensure that the IOL assembly 11, once implanted, remains in the preferred anterior/posterior position within the capsular bag, and remains in the desired orientation with the plane of the lens 24 perpendicular to the optical axis 10 of the eye, and, correspondingly, coplanar with the equatorial plane of the capsular bag, or in a plane parallel to the equatorial plane of the capsular bag.
[0032] Means for preventing radially outward movement of the drug delivery device on the haptic may also be employed. As shown in
[0033]
[0034]
[0035] The IOL may be implanted by folding or rolling it into a small diameter configuration in an injector, inserting the injector through a small slit between the cornea and sclera, and pushing the IOL from the injector. Upon ejection from the injector, the IOL unfurls within the capsular bag and the haptics open and expand to the extent permitted by the confines of the capsular bag. The capsular bag will eventually collapse upon the IOL, and the posterior portion of the capsule will approximate the surfaces of the IOL, and in particular the sharp edge 24E. The tight join between the capsule and the sharp edge inhibits migration of lens epithelial cells to the region between the posterior portion of the capsule and the posterior surface of the IOL. The drug delivery device may be secured to the haptic upon manufacture, or it may be secured by the surgeon immediately before implantation, immediately after implantation, or long after implantation (for example as a replacement for an original drug delivery device which has been depleted).
[0036] In each embodiment described, the drug delivery device can be configured to deliver various therapeutic agents to treat various conditions. Brimonidine, latanoprost, timolol, pilocarpine, brinzolamide and other drugs in the general categories of beta blockers, alpha agonists, ROCK Inhibitors, adenosine receptor agonists, carbonic anhydrase inhibitors, adrenergic and cholinergic receptor activating agents, and prostaglandin analogues may be incorporated into the drug delivery devices to treat glaucoma. Aflibercept, bevacizumab, pegaptanib, ranibizumab, steroids, and aptamers may be incorporated into the drug delivery devices to treat wet macular degeneration. Complement factors, anti-oxidants and anti-inflammatory agents may be incorporated into the drug delivery devices to treat dry macular degeneration. Methotrexate, antibodies, dexamethasone, triamcinolone, and other steroid agents may be incorporated into the drug delivery devices to treat uveitis. Anti-proliferative agents, anti-mitotic agents, anti-inflammatory agents, and other medications that would inhibit the spread of lens epithelial cells may be incorporated into the drug delivery devices to treat posterior capsular opacification. Antibiotics such as fluoroquinolones, non-steroidal agents such as ketorolacs, and steroids such as prednisolones may be incorporated into the drug delivery devices for post-op management after cataract surgery to treat infection and inflammation.
[0037] While the configurations described above are described in the context of intraocular lens, each configuration may be employed with various other forms of ocular implants intended for implantation in the capsular bag, including capsular tension rings and capsular scaffolds.
[0038] While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. The 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 the various beneficial features may be employed in embodiments alone or in combination with each other. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.