U.S. patent application number 17/062909 was filed with the patent office on 2022-04-07 for iol with drug delivery devices and uninterrupted pco barrier edge.
This patent application is currently assigned to SpyGlass Pharma, Inc.. The applicant listed for this patent is The Regents of the University of Colorado, a body corporate, SpyGlass Pharma, Inc.. Invention is credited to Craig Alan Cable, II, James R. Dennewill, Malik Y. Kahook, Glenn R. Sussman.
Application Number | 20220104936 17/062909 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-07 |
United States Patent
Application |
20220104936 |
Kind Code |
A1 |
Cable, II; Craig Alan ; et
al. |
April 7, 2022 |
IOL with Drug Delivery Devices and Uninterrupted PCO Barrier
Edge
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.
Inventors: |
Cable, II; Craig Alan;
(Aliso Viejo, CA) ; Sussman; Glenn R.; (Aliso
Viejo, CA) ; Dennewill; James R.; (Aliso Viejo,
CA) ; Kahook; Malik Y.; (Aliso Viejo, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SpyGlass Pharma, Inc.
The Regents of the University of Colorado, a body
corporate |
Aliso Viejo
Denver |
CA
CO |
US
US |
|
|
Assignee: |
SpyGlass Pharma, Inc.
Aliso Viejo
CA
The Regents of the University of Colorado, a body
corporate
Denver
CO
|
Appl. No.: |
17/062909 |
Filed: |
October 5, 2020 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
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
FIELD OF THE INVENTIONS
[0001] The inventions described below relate to the field of
ophthalmic implants such as intraocular lenses.
BACKGROUND OF THE INVENTIONS
[0002] Intraocular lenses (IOL's) are artificial lenses for the eye
that can be implanted to replace the natural lens of a patient's
eye after the natural lens is removed. The natural lens might be
removed because it is affected by cataracts, and the IOL can be
implanted to provide clear vision and some degree of focusing to
the patient. An intraocular lens may also be implanted in a patient
without removing the natural lens (a phakic intraocular lens or
PIOL), to correct extreme near-sightedness or far-sightedness. It
is advantageous to administer some therapeutic agents to the eye,
coincident with implantation of the IOL, to alleviate various side
effects of the IOL or treat other conditions of the eye that might
coexist with the conditions that lead to cataracts. Side-effects
such as infection and inflammation, and conditions such as
glaucoma, can be treated with therapeutic agents that may be
incorporated into additional devices that may be secured to the
IOL. In addition to IOL's, ocular implants not including lenses may
be implanted to address various other conditions.
[0003] Posterior capsular opacification (PCO) is a condition that
affects some IOL implantations, and occurs due to migration of lens
epithelial cells into the region between the IOL and the posterior
portion of the lens capsule. As these lens epithelial cells
proliferate and differentiate in this region, the posterior portion
of the lens capsule becomes opaque. This can cause visual
impairment, sometimes referred to as a secondary cataract. This
effect may be limited by the structure of the IOL itself, such as
forming the IOL with a posterior surface and circumferential side
wall surface joined with a sharply angular edge (typically referred
to as a square edge). The posterior portion of the lens capsule
collapses onto the IOL, and fuses to the IOL, and the fused join
between the posterior portion of the lens capsule and the sharply
angular edge of the IOL serves as a barrier to lens epithelial
cells.
[0004] Previous patent applications, such as Kahook, et al.,
Ophthalmic Device For Drug Delivery, U.S. Pub. 2020/0022840 (Jan.
23, 2020) disclose various configurations of drug delivery devices
to be used in conjunction with IOL's. Others have proposed
placement of drug delivery devices on haptics. For those situations
in which placement of the drug delivery devices on the haptics is
preferred, we propose configurations that do not disrupt the square
edge needed to block migration of lens endothelial cells to the
back side of the IOL.
SUMMARY
[0005] The devices and methods described below provide for
placement of drug delivery devices on IOL haptics while preserving
a PCO barrier edge around the entire periphery of the back side of
the IOL. The configuration may be employed with IOL's and other
ophthalmic implants. The configuration allows implantation of an
IOL along with implantation of drug delivery devices to treat
various conditions affecting implant patients while maintaining a
PCO barrier which is effective around the entire periphery of the
IOL. The device includes an IOL assembly comprising a lens, and a
haptic. The IOL assembly is characterized by an anterior surface
and a posterior surface, and a circumferential side wall, wherein
the posterior surface joins the circumferential side wall in a
sharply angular edge, where the sharply angular edge defines a
plane of the sharply angular edge, and the sharply angular edge is
functional as a PCO barrier edge. The drug delivery devices are
disposed on the haptics, and are configured and disposed on the
haptic such that a posterior-most surface of each drug delivery
device is anteriorly displaced from the plane. With this
construction, the presence of the drug delivery devices on the
haptics do not disrupt formation of a PCO barrier between the sharp
edge and the posterior portion of the lens capsule.
[0006] In another configuration which preserves a PCO barrier edge,
the posterior-most extent of the drug delivery device may extend
posteriorly beyond the plane of the PCO barrier edge of the lens.
In this configuration, the drug delivery device is configured with
a posterior surface and a circumferential side wall adjacent the
posterior side wall, and, like the PCO barrier edge of the IOL
described above, the posterior surface of the drug delivery device
joins the circumferential side wall of the drug delivery device in
a sharply angular edge (also a posterior-lateral edge).
[0007] Additionally, other configurations of the drug delivery
device described below provide for stable positioning of the IOL
and drug delivery device within the capsular bag. The anterior
surface of the drug delivery device is configured such that forces
exerted on the drug delivery device by the capsular bag do not
promote tilting of the IOL relative to the equatorial plane of the
capsular bag, so that the optical axis of the IOL lens is not
angled relative to the optical axis of the eye. The posterior
surface may be a flat surface parallel to the plane of the IOL, or
a curved surface bounded by an edge which lies in a plane parallel
to the plane of the IOL.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIGS. 1 and 2 illustrate the environment of use of an
ophthalmic implant system for drug delivery.
[0009] FIG. 3 is a view of the IOL and drug delivery devices,
showing the posterior aspect of the device.
[0010] FIG. 4 is a view of the IOL and drug delivery devices,
showing the anterior aspect of the device.
[0011] FIG. 5 illustrates the intraocular lens and drug delivery
devices, illustrating the anterior offset of the haptics and drug
delivery devices.
[0012] FIG. 6 illustrates the sharply angular edge of the IOL.
[0013] FIGS. 7 and 8 illustrate an IOL and drug delivery device
combination in which the drug delivery device posterior is provided
with a PCO barrier edge distinct from the PCO barrier edge of the
IOL.
[0014] FIG. 9 shows the drug delivery device similar to that of
FIG. 8 with the addition of additional panels or blocks depending
from an anterior panel of the drug delivery device.
[0015] FIG. 10 illustrates a configuration in which the plane (D)
is posteriorly displaced from the plane (P) defined by the PCO
barrier edge 24E of the IOL.
[0016] FIG. 11 illustrates a configuration of the drug delivery
device and the haptic configured to avoid twisting of the drug
delivery device about the haptic.
[0017] FIGS. 12 and 13 illustrate a means of preventing outward
movement of the drug delivery device on the haptic, and features of
the drug delivery device which prevent or limit twisting of the
drug delivery device within the capsular bag.
DETAILED DESCRIPTION OF THE INVENTIONS
[0018] FIGS. 1 and 2 illustrate placement and use of an IOL (or
other ophthalmic implant system) in the eye of a patient. The eye 1
includes a lens 2 (the natural lens of the eye) and lens capsular
bag 3, and the anterior chamber 4 which includes the cornea 5 and
iris 6 and aqueous humour filling the space between the cornea and
the iris, and a posterior chamber 7 between the iris and the
capsular bag. The posterior cavity/vitreous body 8 is the large
space between the lens and the retina 9. The natural lens 2 of the
eye is characterized by an optical axis 10. The capsular bag is
characterized by an equatorial plane 13, which is generally
perpendicular to the optical axis. (In the following description of
the ophthalmic implant and/or intraocular lens system, the terms
posterior and anterior will be used in relation to the anatomy of
the eye, in which the cornea is anterior and the retina is
posterior.)
[0019] FIG. 2 illustrates a placement of the IOL system (or other
ophthalmic implant system) 11 in the eye including the intraocular
lens assembly 12 and drug delivery device 30 which is implanted in
the capsular bag in conjunction with the intraocular lens assembly
12. As shown in FIG. 2, and in more detail in FIGS. 3 through 5,
the drug delivery device 30 is disposed on the haptics 28. The
intraocular lens assembly 12 includes a lens 24 and one or more
haptics 28, and one or more drug delivery devices 30. The
intraocular lens assembly 12 is characterized by an anterior
surface 24A and a posterior surface 24P and a circumferential side
wall surface 24C. Other ophthalmic implants such as a capsular
tension ring, or a capsular scaffold for holding the drug delivery
devices in place may take the place of the IOL. The haptics may be
any form of haptic, such as C-loops or J-loops.
[0020] FIG. 3 is a view of the IOL 12 and drug delivery devices 30,
showing the posterior aspect of the device, including the posterior
surface 24P of the lens 24, and the sharply angular
posterior-lateral edge 24E of the IOL, which may be the edge of the
lens proper, or the edge of a frame surrounding the lens. The joint
31 between the haptic and the lens is preferably displaced/offset
anteriorly from the sharp edge, to retain the PCO edge entirely
around the periphery of the posterior side of the lens. (Typically,
the lens and haptics will be integrally formed, and this "joint"
refers to the transition between the lens and the haptic.) A drug
delivery device 30 is disposed on one or both haptics 28
(preferably both), secured in any suitable manner, such as a
friction fit of the tubular (rectangular or cylindrical) drug
delivery device slipped over the haptic. The drug delivery device
is characterized by a posterior surface 30P, facing posteriorly
just as the posterior surface 24P of the lens does. The posterior
surface 30P is also displaced/offset anteriorly from the
posterior-lateral edge 24E, to avoid disruption of the fusion of
the posterior capsule 3 to the posterior-lateral edge 24E. For
completeness, FIG. 4 is a view of the IOL and drug delivery
devices, showing the anterior aspect of the device, including the
anterior surface 24A of the lens 24, each haptic 28, and the drug
delivery devices 30 secured to the haptics. The front edge of the
IOL, at which point the anterior surface 24A meets the
circumferential side wall surface of the IOL, may be a sharply
angular edge comparable to the edge 24E on the posterior side of
the IOL, or may be rounded or configured to obtain desired optical
characteristics.
[0021] FIG. 5 illustrates the intraocular lens assembly 12,
including the lens 24, one or more haptics 28, and one or more drug
delivery devices 30. As shown in FIG. 5, the sharp edge 24E between
the posterior surface 24P of the IOL and circumferential side wall
surface 24C is an edge that circumscribes the lens 24 (preferably
entirely circumscribes the lens), and establishes a plane (P) in
which the sharp edge lies. The posterior-most extent of the drug
delivery devices and optionally, the joint between the haptic and
the lens is displaced anteriorly from this plane, not extending
posteriorly to the plane (P) established by the sharp posterior
edge of the IOL. In FIG. 6, the plane of the sharp posterior edge
is marked as plane (P). The posterior extent of the drug delivery
devices attached to the haptics is limited (and, optionally, the
haptic joint), for example, by an offset represented by plane D.
The offset is sufficient to avoid disruption of the fusion of the
posterior portion of the capsule with the sharp angular edge 24E,
and may be 0.1 to 1.0 mm. The sharply angular edge 24E may be any
edge configured to function as a PCO barrier edge, and may be
characterized by, for example, and inside angle .alpha. of
80-100.degree., and a corner radius 32 of less than 500 um, and
preferably less than 60 um. This is illustrated in FIG. 6.
[0022] As shown in FIG. 5, the natural lens capsule 3 (shown in
phantom) has collapsed onto the IOL, and, along the line at which
the capsule meets the sharp edge 24E, and this forms an effective
barrier against migration of the lens endothelial cells from the
anterior chamber into the space posterior to the IOL, between the
IOL posterior surface and the capsule posterior surface.
[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 FIGS. 3 through 6 with the drug
delivery device configured and disposed on the haptic such that a
posterior-most surface of the drug delivery device will be
anteriorly displaced from the plane (P) once installed so that the
presence of the drug delivery device on the haptic does not disrupt
formation of a PCO barrier with the PCO barrier edge of the IOL
lens when implanted within a capsular bag of an eye of the patient;
and thereafter the capsular bag will approximate the IOL, and form
a PCO barrier between the posterior portion of the capsular bag and
the sharply angular edge uninterrupted by the posterior of the drug
delivery device.
[0025] FIGS. 7 and 8 illustrate an IOL 12 and drug delivery device
30 assembled, in which the drug delivery device posterior is
provided with a PCO barrier edge distinct from the PCO barrier edge
of the IOL. As shown in FIG. 7, the IOL system 11 includes the IOL
12 with haptics 28 extending from the lens 24. The drug delivery
device 30 is disposed on the haptic, and, in this configuration,
includes a posterior panel 33 with a posterior surface 33P which
may or may not extend posteriorly beyond the plane (P) of the PCO
barrier edge (shown in FIGS. 5 and 6), and an oblong aperture 34
which accommodates a portion of the haptic nearest the rim of the
IOL lens which is oblong and mated to the oblong aperture. Two
posts 35 extend anteriorly from the posterior panel 33 to join with
an anterior panel 36 which is disposed on the anterior side of the
haptic 28, forming the aperture 34 which is bounded by the
posterior panel 33, anterior panel 36 and posts 35. As appears from
FIG. 8, the posterior surface 33P of posterior panel 33 of the drug
delivery device is joined to the side wall 33C of the posterior
panel with a sharply angular edge 33E. This sharply angular edge
may be similar to that of the sharply angular edge of the IOL,
formed at the junction of the posterior surface 33P and the
circumferential side wall 33C of the posterior side wall. The
sharply angular edge 33E of the posterior panel may define a plane
(D) which may be posterior to, or anterior to, or co-planar with,
the plane (P) defined by the PCO barrier edge 24E of the IOL. Thus,
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),
posteriorly displaced from the plane (P), or co-planar with the
plane (P). FIG. 10 illustrates a configuration in which the plane
(D) is posteriorly displaced from the plane (P) defined by the PCO
barrier edge 24E of the IOL.
[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] FIG. 8 shows the drug delivery device 30 of FIG. 7 in
isolation, showing the aperture 34, posts 35 and posterior panel 33
and the anterior panel 36. FIG. 9 shows the drug delivery device 30
similar to that of FIG. 8 showing the apertures 34, posts 35 and
posterior panel 33 and the anterior panel 36, with the addition of
additional side panels or blocks 37. The side panels may extend
posteriorly from the anterior panel, or they may be fixed to the
posts. The portion of this drug delivery device which comprises a
matrix material loaded with therapeutic agent, or an erodible
therapeutic agent may include one or more, or all, of the anterior
panel, posts, posterior panel or side panel(s).
[0029] In use, the IOL assembly and drug delivery device
configurations of FIGS. 7, 8 and 9 may be implanted within the
capsular bag of an eye of the patient, and the capsular bag may
then approximate the IOL, and form a PCO barrier between the
posterior portion of the capsular bag and the sharply angular edge
of the IOL and form a PCO barrier between the capsular bag and the
sharply angular edge of the posterior panel. The drug delivery
device 30 will be secured on the haptic 28 such that 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, or
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, leaving a radial gap between the PCO barrier edge of the
IOL and the PCO barrier edge of the posterior panel 33.
[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. FIG. 11 illustrates a configuration of the drug
delivery device 30 and the haptic 28. To avoid twisting of the drug
delivery device about the haptic, the aperture through the drug
delivery device (between the posterior panel and the anterior panel
and connecting posts) is keyed to the shape of the base of the
haptic, in any suitable manner and any suitable means, to inhibit
or prevent rotation of the drug delivery device about the base of
the haptic. In FIG. 11, this is accomplished with a haptic base 28B
having a square or rectangular cross section, and a drug delivery
device having a matching square or rectangular aperture sized to
accommodate the haptic base. Thus, the drug delivery device is
configured for disposition on the haptic, and the aperture is
configured to accept the haptic base, and the aperture is
correspondingly keyed to the shape and size of the haptic base in a
configuration which inhibits rotation of the drug delivery device
about the haptic base. In the assembled configuration, the drug
delivery device is disposed on the haptic base, with the haptic
base occupying the aperture. Any other configuration, in which the
aperture is keyed to the haptic base, may be employed, such as an
elliptical haptic base paired with an elliptical aperture, or a
hexagonal haptic base paired with a hexagonal aperture in the drug
delivery device. Thus, various means for preventing twisting of the
drug delivery device about the haptic or haptic base may be
employed.
[0032] Means for preventing radially outward movement of the drug
delivery device on the haptic may also be employed. As shown in
FIG. 11 for example, the haptic may include a detent ridge 38
protruding from the haptic, with an optional corresponding detent
accepting groove on the interior of the drug delivery device
aperture. The drug delivery device may, once in place over the
haptic base, impinge or abut the detent, thus preventing movement
of the drug delivery device over the haptic. FIGS. 12 and 13
illustrate an embodiment of the haptic and drug delivery device, in
which the haptic has a notch 39 disposed on the side of the haptic
base 28B. The notch combined with a configuration of the post of
the drug delivery device which fits within the notch provides an
interference fit between the drug delivery device and the haptic.
Once the drug delivery device is stretched over the haptic base, a
post of the drug delivery device will fit within the notch, and the
interference fit between the notch and the post will prevent
outward migration of the drug delivery device.
[0033] FIGS. 12 and 13 illustrate another means of preventing
outward movement, which includes a shoulder 40 rising anteriorly
from the haptic, combined with a shoulder on the anterior panel or
plate of the drug delivery device. Once the drug delivery device is
stretched over the haptic base, the drug delivery device will
impinge on the shoulder and interfere with the shoulder and will
prevent outward migration of the drug delivery device.
[0034] FIG. 13 also illustrates features of the drug delivery
device which prevent or limit twisting of the drug delivery device
with the capsular bag. The anterior panels are configured to limit
the potential for twisting of the IOL relative the equator, or the
plane established by the equator, of the capsular bag. Referring to
FIG. 13, the anterior panel 36 has planar anterior surface 36A in
which the entire edge 36E lies in a plane A, or a curved anterior
surface in which the entire edge 36E lies in a plane A, and this
planar surface or edge plane is disposed in a plane A which is
parallel to the major plane of the IOL lens B, and, when properly
implanted, the equatorial plane of the capsular bag (item 13 in
FIG. 1). The anterior panel may have a large lateral or
circumferential dimension 41 compared to the radial dimension 42
(FIG. 11) and the anterior surface of the anterior panel is
preferably flat, and aligned in a plane parallel to the plane of
the IOL. With this configuration, collapse of the capsular bag upon
the IOL and the drug delivery device will be unlikely to exert
forces on the IOL and drug delivery device which may twist or tilt
the IOL within the capsular bag.
[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.
* * * * *