Note: Descriptions are shown in the official language in which they were submitted.
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LENS CAPSULE TENSION DEVICES
CROSS-REFERENCE TO RELATED APPLICATIONS
100011 The present application is a continuation-in-part of U.S.
Application No. 15/555,377
filed on September 1, 2017, which is a U.S. national stage entry under 35
U.S.C. 371 of
International Application No. PCT/U516/23830 filed on March 23, 2016, which
claims the
benefit of priority under 35 U.S.C. 119 of U.S. Application No. 62/142,554
filed on April 3,
2015, the disclosure of each of which is hereby incorporated by reference in
its entirety for all
purposes.
TECHNICAL FIELD
[00021 The present disclosure relates generally to the fields of medical
devices,
ophthalmology, and cataract surgery.
BACKGROUND
[0003] Capsular tension rings (CTRs) are used for stabilizing the capsular
bag in the eye.
They are fitted as implants into the intact capsular bag and, for example
after removal of the
natural lens of an eye, are used to support the capsular tissue. After removal
of the natural lens,
for example on account of pronounced opacity, it is necessary that the opened
capsular bag
remains substantially in its original shape and in this way facilitates the
implantation of an
artificial intraocular lens 0014 In cataract surgery, however, removal of the
natural lens may
result in damage to the zonular fiber tissue that secures the outside of the
capsular bag in the
region of its equator inside the eye. Removal of the natural lens and
replacement with a
substantially lower volume artificial lens also results in unpredictability of
positioning of the
artificial lens in the x-y-z planes. In order to avoid the associated
deformations of the capsular
bag or excessive stressing of the zonular fibers remaining undamaged, it is
known to implant a
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capsular equatorial ring of the aforementioned type in the opened capsular
bag. The capsular
equatorial ring remains within the capsular bag during the operation and
generally also after the
insertion of an intraocular lens, and it presses against the tissue
surrounding it in a ring shape.
BRIEF DESCRIPTION OF THE DRAWINGS
100041 The accompanying figures, which are incorporated into and form a
part of the
specification, illustrate embodiments of the subject technology and, together
with the description,
serve to explain the principles of the subject technology. The figures are
only for the purpose of
illustrating aspects of the subject technology and are not to be construed as
limiting.
100051 Figure 1 is a perspective view of a capsular tension ring, according
to some
embodiments.
100061 Figure 2 is an enlarged view of an end of a capsular tension ring,
according to some
embodiments.
10007] Figure 3 is an enlarged view of features on a capsular tension ring,
according to some
embodiments.
10008] Figure 4 is a perspective view of an outer section of a capsular
tension ring, according
to some embodiments.
100091 Figure 5 is a plan view of an outer section of a capsular tension
ring, according to
some embodiments.
[00101 Figure 6 is a plan view of a capsular tension ring, according to
some embodiments.
100111 Figure 7 is a plan view of a capsular tension ring, according to
some embodiments.
[00121 Figure 8 is an enlarged view of an end of a capsular tension ring,
according to some
embodiments.
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[0013] Figure 9 is a side view of a capsular tension ring, according to
some embodiments.
[0014] Figure 10 is a front view of a capsular tension ring, according to
some embodiments.
[0015] Figure 11 is an enlarged front view of a capsular tension ring,
according to some
embodiments.
[0016] Figure 12 is a plan view of an inner section of a capsular tension
ring, according to
some embodiments.
[0017] Figures 13A-13C are section views showing features of a capsular
tension ring,
according to some embodiments.
[00181 Figures 14A-14C are side views showing features of a capsular
tension ring,
according to some embodiments.
[00191 Figure 1 5 is a plan view of a capsular tension ring and an
intraocular lens in a relaxed
configuration, according to some embodiments.
[0020] Figure 16 is a plan view of a capsular tension ring and an
intraocular lens in a
compressed configuration, according to some embodiments.
[0021] Figure 17 is an enlarged view of a capsular tension ring mated with
a haptic of an
intraocular lens, according to some embodiments.
100221 Figure 18 is an enlarged view of an end of a capsular tension ring,
according to some
embodiments.
DETAILED DESCRIPTION
I. Definitions
[0023] To facilitate the understanding of the subject technology, a number
of terms are
defined below. Terms defined herein have meanings as commonly understood by a
person of
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ordinary skill in the areas relevant to the subject technology. Terms such as
"a", "an" and "the"
are not necessarily intended to refer to only a singular entity, but can
include the general class of
which a specific example may be used for illustration.
100241 As used herein, the term "features" is used throughout the
specification to describe
patterned features, including, but not limited to polygonal features,
polygonal grooves,
diagonally oriented grooves, helically oriented grooves, circular grooves,
intersecting grid
grooves, and concentric ring grooves.
[00251 As used herein, the term "micropatterning" or "micropattemed
features" preferably
refers to millimeter, micrometer, and/or nanometer scale surface modifications
including but not
limited to laser etching, chemical etching, photo-etching, photolithography,
machining,
stamping, deposition processes, mechanical drilling, molding, 3D printing,
Atomic Layer
Deposition or other means of modifying surfaces.
100261 As used herein, the term "overmolding" or "overmolded" is used
throughout the
specification to describe all molding and casting processes that can be used
to overmold an
underlying structure, such as the inner ring section of the device. In some
embodiments,
overmolding may be accomplished by an injection molding process that offers
improvements in
product resilience, structure, function and appearance. In some embodiments,
overmolding may
be accomplished by a casting process.
II. Description
[0027] Embodiments disclosed herein relate generally to the fields of
ophthalmology and
cataract surgery. More specifically, disclosed embodiments relate to a device
that is implanted in
the eye during cataract surgery and that can improve the optical functionality
of the eye.
Disclosed embodiments are in the field of medical devices and relate to
capsular tension rings
that are designed to be implanted in the capsular bag after removal of the
crystalline lens affected
by a cataract in association with an intraocular lens designed to replace the
crystalline lens. Some
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embodiments apply to stabilizing an implanted artificial lens from movement in
the x-y-z planes
and preventing undesired rotation.
[0028] According to some embodiments, a device comprises an open capsular
tension ring
comprising an inner ring surface and an outer ring surface, said inner and
outer ring surfaces
populated with a series of raised parallel polygon features, wherein each of
said polygon features
comprise at least one distinct edge. In some embodiments, at least one
distinct edge is a sharp
edge. In some embodiments, at least one distinct edge is a curved edge. In
some embodiments,
said ring further comprises a first end and a second end. In some embodiments,
said ring further
comprises a first arcuate arm extending from said first end. In some
embodiments, said ring
further comprises a second arcuate arm extending from said second end. In some
embodiments,
said first arcuate arm further comprises a first eyelet In some embodiments,
said second arcuate
arm further comprises a second eyelet. In some embodiments, said first and
second eyelets are
coplanar. In some embodiments, said first arcuate arm and said second arcuate
arm are coplanar.
In some embodiments, said features protrude from the inner and outer surfaces
of the ring
towards the center and away from the geometric center of the ring. In one
embodiment, said
features protrude from the inner and outer planes of the ring towards the
center and away from
the geometric center of the ring. In some embodiments, said outer surface
further comprises
vertical features. In some embodiments, said inner surface further comprises
vertical features. In
some embodiments, said outer surface further comprises horizontal features. In
some
embodiments, said inner surface further comprises horizontal features. In some
embodiments,
said features can be coupled with opposing features on an interfacing device
to stabilize said
interfacing device. In some embodiments, said interfacing device is an
intraocular lens implant
or lens haptic implant. In some embodiments, said stabilizing comprises
rotational resistance.
Some embodiments apply to stabilizing the artificial lens from movement in the
x-y-z planes. In
some embodiments, said features are etched. In some embodiments, said features
are
micropatterned features. In some embodiments, said features are configured as
interlocking
features. In some embodiments, said features are configured as docking and
receiving features.
In some embodiments, said features are magnetic. In some embodiments, said
features are
markings to identify clock hour relative to ocular surface features (helps
with implantation of the
IOL that corrects astigmatism). In some embodiments, said ring comprises
polymer and material
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content that allows for optical coherence topography imaging (allows for
anterior segment OCT
visualization and targeting). In some embodiments, the features that are
micropatterned also have
adhesive and/or cohesive qualities. In some embodiments, the inner and outer
surface of the ring
has adhesive and/or cohesive qualities without micropattems or etching. In
some embodiments,
said ring contains at least one medication. In some embodiments, said
medication is selected
from the group comprising anti-fibrotic agent, anti-inflammatory agent,
immunosuppressant
agent, anti-neoplastic agent, migration inhibitors, anti-proliferative agent,
rapamycin,
triamcinolone acetonide, everolimus, tacrolimus, paclitaxel, actinomycin,
azathioprine,
dexamethasone, cyclosporine, bevacizumab, an anti-VEGF agent, an anti-IL-1
agent,
canakinumab, an anti-IL-2 agent, viral vectors, beta blockers, alpha agonists,
muscarinic agents,
steroids, antibiotics, non-steroidal anti-inflammatory agents, prostaglandin
analogues, ROCK
inhibitors, nitric oxide, endothelia, matrixmetalloproteinase inhibitors,
CNPA, corticosteroids,
and/or antibody-based immunosuppresants. In some embodiments, said medication
is combined
with a silicone material. In some embodiments, said medication is combined
with a polymer. In
some embodiments, said polymer is selected from the group comprising
poly(lactic-co-glycolic
acid), polyethylene glycol, poly(lactic acid), poly(glycolic acid), poly(amido
ester), polyethylene
terephthalate, poly(caprolactone), poly(hydroxy butyrate), poly(butylene
succinate), poly(vinyl
alcohol), poly(hydroxybutyrate), poly(methyl aciylate), poly(methyl
methylmethacrylate),
poly(sebacic acid), carboxymethyl cellulose, ethyl cellulose, cellulose
acetate, polydioxanone, or
polymers from the categories: polyesters, polyanhydrides, polyamides,
polycyanoacrylates,
polyurethanes, polyorthoesters, silicones, acrylic polymers, cellulose
derivatives and/or
poloxamers. In some embodiments, medication may be slowly released from the
polymeric
material comprising the device. In some embodiments, said outer surface slowly
releases
medication.
100291 According to some embodiments, a method comprises: a) providing; i)
an insertion
device; and ii) a capsular tension ring comprising an inner ring surface and
an outer ring surface,
said inner and outer ring surfaces populated with a series of raised parallel
polygon features,
wherein each of said polygon features comprise at least one distinct edge, and
b) applying
outward pressure to an equatorial region of said capsular tension ring with
said insertion device
wherein said capsular tension ring is inserted into an ocular lens capsule.
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[0030] According to some embodiments, a method comprises: a) providing; i)
an insertion
device; and ii) a capsular tension ring comprising an inner ring surface and
an outer ring surface,
said inner and outer ring surfaces populated with a series of raised parallel
polygon features,
wherein each of said polygon features comprise at least one distinct edge; b)
loading of said
capsular tension ring into said insertion device; and c) inserting said
capsular tension ring into an
ocular lens capsule. In some embodiments, at least one distinct edge is a
sharp edge In some
embodiments, at least one distinct edge is a curved edge. In some embodiments,
said capsular
tension ring further comprises a central fixation element attached to said
insertion device. In
some embodiments, said central fixation element comprises two oppositely
extending arcuate
arms that engage along an equatorial region of said capsular tension ring.
Some embodiments
apply to stabilizing the artificial lens from movement in the x-y-z planes. In
some embodiments,
said features are micropattemed features. In some embodiments, said features
are configured as
interlocking features. In some embodiments, said features are configured as
docking and
receiving features. In some embodiments, said features are magnetic. In some
embodiments, said
features are markings to identify clock hour relative to ocular surface
features (helps with
implantation of the IOL, that corrects astigmatism). In some embodiments, said
ring comprises
polymer and material content that allows for optical coherence topography
imaging (allows for
anterior segment OCT visualization and targeting). In some embodiments, the
features that are
micropatterned also have adhesive and/or cohesive qualities. In some
embodiments, the inner
and outer surface of the ring has adhesive and/or cohesive qualities without
micropattems or
etching. In some embodiments, said ring contains at least one medication. In
some embodiments,
said medication is selected from the group comprising anti-fibrotic agent,
anti-inflammatory
agent, immunosuppressant agent, anti-neoplastic agent, migration inhibitors,
anti-proliferative
agent, rapamycin, triamcinolone acetonide, everolitnus, tacrolimus,
paclitaxel, actinomycin,
azathioprine, dexamethasone, cyclosporine, bevacizumab, an anti-VEOF agent, an
anti-IL-I
agent, canakinumab, an anti-IL-2 agent, viral vectors, beta blockers, alpha
agonists, muscarinic
agents, steroids, antibiotics, non-steroidal anti-inflammatory agents,
prostaglandin analogues,
ROCK inhibitors, nitric oxide, endothelin, matrixmetalloproteinase inhibitors,
CNPA,
corticosteroids, andior antibody-based immunosuppresants. In some embodiments,
said
medication is combined with a silicone material. In some embodiments, said
medication is
combined with a polymer. In some embodiments, wherein said polymer is selected
from the
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group comprising poly(lactic-co-glycolic acid), polyethylene glycol,
poly(lactic acid),
poly(glycolic acid), poly(amido ester), polyethylene terephthalate,
poly(caprolactone),
poly(hydroxy butyrate), poly(butylene succinate), polyvinyl alcohol),
poly(hydroxybutyrate),
poly(methyl acrylate), poly(methyl methylmethacrytate), poly(sebacic acid),
carboxymethyl
cellulose, ethyl cellulose, cellulose acetate, polydioxanone, or polymers from
the categories:
polyesters, polyanhydrides, potyam ides, polycyanoacrylates, polyurethanes,
polyorthoesters,
silicones, acrylic polymers, cellulose derivatives and/or poloxamers. In some
embodiments,
medication may be slowly released from the polymeric material comprising the
device. In some
embodiments, said outer section slowly releases medication.
[0031] According to some embodiments, a method comprises: a) providing: i)
a capsular
tension ring comprising an inner ring surface and an outer ring surface, said
inner and outer ring
surfaces populated with a series of raised parallel polygon features, wherein
each of said polygon
features comprise at least one distinct edge; and ii) an elongated fixation
element attached to said
capsular tension ring, said fixation element having a first end fixed to said
capsular tension ring
and a second free end; b) implanting said capsular tension ring in an ocular
capsular bag between
the posterior capsule and the annular anterior capsular flap with said
elongated fixation element.
In some embodiments, at least one distinct edge is a sharp edge. In some
embodiments, at least
one distinct edge is a curved edge. In some embodiments, said implanting
comprises positioning
said fixation element having a first end fixed to said capsular tension ring
and a second end
extending past an capsulorhexis edge and positioned anterior to said ocular
capsular bag with an
annular anterior capsular flap positioned therebetween. In some embodiments,
the method
further comprises the step of attaching said second free end of said fixation
element to an ocular
scleral wall, whereby said capsular tension ring generally stabilizes and
centralizes said capsular
bag in an ocular posterior chamber. Some embodiments apply to stabilizing the
artificial lens
from movement in the x-y-z planes. In some embodiments, said features are
micropatterned
features. In some embodiments, said features are configured as interlocking
features. In some
embodiments, said features are configured as docking and receiving features.
In some
embodiments, said features are magnetic. In some embodiments, said features
are markings to
identify clock hour relative to ocular surface features (helps with
implantation of the IOL that
corrects astigmatism). In some embodiments, said ring comprises polymer and
material content
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that allows for optical coherence topography imaging (allows for anterior
segment OCT
visualization and targeting). In some embodiments, said ring contains at least
one medication. In
some embodiments, said medication is selected from the group comprising anti-
fibrotic agent,
anti-inflammatory agent, immunosuppressant agent, anti-neoplastic agent,
migration inhibitors,
anti-proliferative agent, rapamycin, triamcinolone acetonide, everolimus,
tacrolimus, paclitaxel,
actinomycin, azathioprine, dexamethasone, cyclosporine, bevacizumab, an anti-
VEGF agent, an
anti-IL-1 agent, canakinumab, an anti-IL-2 agent, viral vectors, beta
blockers, alpha agonists,
muscarinic agents, steroids, antibiotics, non-steroidal anti-inflammatory
agents, prostaglandin
analogues, ROCK inhibitors, nitric oxide, endothelin, matrixmetalloproteinase
inhibitors, CNPA,
corticosteroids, and/or antibody-based immunosuppresants. In some embodiments,
said
medication is combined with a silicone material. In some embodiments, said
medication is
combined with a polymer. In some embodiments, wherein said polymer is selected
from the
group comprising poly(lactic-co-glycolic acid), polyethylene glycol,
poly(lactic acid),
poly(glycolic acid), poly(amido ester), polyethylene terephthalate,
poly(caprolactone),
poly(hydroxy butyrate), poly(butylene succinate), poly(vinyl alcohol),
poly(hydroxybutyrate),
poly(methyl acrylate), poly(methyl methylmethacrylate), poly(sebacic acid),
carboxymethyl
cellulose, ethyl cellulose, cellulose acetate, polydioxanone, or polymers from
the categories:
polyesters, polyanhydrides, polyamides, polycyanoaaylates, polyurethanes,
polyorthoesters,
silicones, acrylic polymers, cellulose derivatives andlor poloxamers. In some
embodiments,
medication may be slowly released from the polymeric material comprising the
device. In some
embodiments, said outer section slowly releases medication.
100321 According to some embodiments, a capsular tension ring for insertion
into an ocular
lens capsule to apply outward pressure in the area of the equatorial region
comprises an inner
ring section and an outer ring section, said inner ring section having: a
central fixation element;
two arcuate arms extending generally oppositely from the fixation element,
said arms forming an
arc to engage along the equatorial region of the capsule, said fixation
element and arms being
constructed; and outer section enveloping said inner ring section. In some
embodiments, said
outer section having: a vertical profile of at least 1.0 millimeters and
horizontal profile of at least
150 micrometers. In some embodiments, the capsular tension ring further
comprises an inner
ring surface and an outer ring surface, said inner and outer ring surfaces
populated with a series
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of raised parallel polygon features, wherein each of said polygon features
comprise at least one
distinct edge. In some embodiments, at least one distinct edge is a sharp
edge. In some
embodiments, at least one distinct edge is a curved edge. In some embodiments,
said central
fixation element is configured to be received by an insertion device. In some
embodiments, said
capsular tension ring arm is arranged relatively to be loaded into the
insertion device by pulling
on the central fixation element and thereby draw the arms into the insertion
device together,
followed by discharge of the arcuate arms together from the device into the
capsule. In some
embodiments, said fixation element and the aims are coplanar. In some
embodiments, said ring
further includes a stem section between the fixation element and the arms. In
some embodiments,
said arms are coplanar and the fixation element is offset out of the plane of
the arms when
deployed in a capsule. In some embodiments, said fixation element is an
eyelet. In some
embodiments, said fixation element is a groove formed between adjacent ends of
the arms. In
some embodiments, said inner section is made from nitinol. In some
embodiments, said outer
section is made from polymer materials that allows for absorption or
incorporation of drugs for
slow release. In some embodiments, said outer section is overmolded upon said
inner section. In
some embodiments, said outer section has a distinct sharp edge. In some
embodiments, said
outer section has vertical features. In some embodiments, said outer section
vertical features
comprise outer ring surface vertical features. In some embodiments, said outer
section vertical
features comprise inner ring surface vertical features. in some embodiments,
said ring provides
rotational stability to the subsequently implanted intraocular lens. Some
embodiments apply to
stabilizing the artificial lens from movement in the x-y-z planes. In some
embodiments, said
features are produced by etching. In some embodiments, said features are
micropatterned
features. In some embodiments, said features are configured as interlocking
features. In some
embodiments, said features are configured as docking and receiving features.
In some
embodiments, said features are magnetic. In some embodiments, said features
are markings to
identify dock hour relative to ocular surface features (helps with
implantation of the IOL that
corrects astigmatism. In some embodiments, said ring comprises polymer and
material content
that allows for optical coherence topography imaging (allows for anterior
segment OCT
visualization and targeting). In some embodiments, said ring contains at least
one medication. In
some embodiments, said medication is selected from the group comprising and-
fibrotic agent,
anti-inflammatory agent, immunosuppressant agent, anti-neoplastic agent,
migration inhibitors,
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anti-proliferative agent, rapamycin, triamcinolone acetonide, everolimus,
tacrolimus, paclitaxel,
actinomycin, azathioprine, dexamethasone, cyclosporine, bevacizumab, an anti-
VEGF agent, an
anti-IL-I agent, canakinumab, an anti-IL-2 agent, viral vectors, beta
blockers, alpha agonists,
muscarinic agents, steroids, antibiotics, non-steroidal anti-inflammatory
agents, prostaglandin
analogues, ROCK inhibitors, nitric oxide, endothelin, matrixmetalloproteinase
inhibitors, CNPA,
corticosteroids, and/or antibody-based immunosuppressants. In some
embodiments, said
medication is combined with a silicone material. In some embodiments, said
medication is
combined with a polymer. In some embodiments, said polymer is selected from
the group
comprising poly(lactic-co-glycolic acid), polyethylene glycol, poly(lactic
acid), poly(glycolic
acid), poly(amido ester), polyethylene terephthalate, poly(caprolactone),
poly(hydroxy butyrate),
poly(butylene succinate), polyvinyl alcohol), poly(hydroxybutyrate),
poly(methyl acrylate),
poly(methyl methylmethacrylate), poly(sebacic acid), carboxymethyl cellulose,
ethyl cellulose,
cellulose acetate, polydioxanone, or polymers from the categories: polyesters,
polyanhydrides,
polyamides, polycyanoacrylates, polyurethanes, polyorthoesters, silicones,
acrylic polymers,
cellulose derivatives and/or poloxamers. In some embodiments, medication may
be slowly
released from the polymeric material comprising the device. In some
embodiments, said outer
section slowly releases medication.
10033] According to some embodiments, a device for restoring and
maintaining the natural
tension and anatomy of a lens capsule post-surgically in an eye of a subject
comprises: an open
capsular tension ring structure having a shape configured to circumferentially
fit within a post-
surgical lens capsule of the eye. Some embodiments apply to stabilizing the
artificial lens from
movement in the x-y-z planes. In some embodiments, the capsular tension ring
structure may
have a shape formed to circumferentially contact an inner surface of the lens
capsule. In addition,
the shape of the capsular tension ring structure is substantially that of a
natural lens peripheral
shape. Furthermore, natural elasticity of the lens capsule may
circumferentially anchor the open
capsular tension ring structure continuously to an internal capsular surface.
In some
embodiments, the device is secured in place by the raised features of the
outer ring surface or
outer ring surface of the outer section of the ring. Further still the open
capsular tension ring
structure may comprise an elastic material, such as silicone, acrylic or other
materials used for
the production of foldable IOLs or materials effective as drug delivery
vehicles.
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[00341 According to some embodiments, a method for restoring natural
tension and anatomy
of a Jens capsule post-surgically in an eye of a subject comprises the steps
of anchoring the
device, such as with the eyelets on each end of the device, circumferentially
to an internal
surface of the lens capsule of the post-surgical eye; and providing tension to
an equatorial area of
the lens capsule via the capsular tension ring structure comprising the device
whereby the
capsular tension ring structure directs tension inwardly towards the center of
the lens capsule
such that an equatorial diameter of the lens capsule is decreased, thereby
restoring natural
tension and anatomy to the lens capsule. In some embodiments, the vertical
features on the
outside surface of the device anchor the capsular tension ring structure in
place and prevents
undesired rotation of the ring or any device attached to said ring. In some
embodiments, the
variable horizontal width of the raised features prevents rotation and
provides an anchoring
feature. In some embodiments, the variable vertical height of the outer
section prevents rotation
and provides an anchoring feature.
[0035] According to some embodiments, a method for restoring natural
tension and anatomy
of a lens capsule post-surgically in an eye of a subject comprises the steps
of inserting the open
capsular tension ring device, as described supra, circumferentially into an
internal surface of the
lens capsule of the post-surgical eye wherein the raised features articulate
into a space around the
lens capsule, said raised features disposed proximately to an equatorial area
of the lens capsule
whereby the natural tension and anatomy of the lens capsule in the eye is
restored. Some
embodiments apply to stabilizing the artificial lens from movement in the x-y-
z planes.
III. Use of the Device
[0036] Generally, the following indications may exist for implanting a
capsular tension ring
in the capsular bag; local absence of zonular fibers, or damaged zonular
fibers, guarantee of
consistent operating conditions, luxation of an IOL, desired extension or
spreading of the
capsular bag, stabilization of the capsular bag after removal of the lens in
cases of high myopia,
zonulolysis, pseudoexfoliation, Marchesani syndrome, and simplified
implantation of foldable
intraocular lenses. Some embodiments have the additional aspects of
stabilizing a connected
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intraocular lens in the x-y-z dimension and also inhibiting PCO by providing a
distinct upper and
lower edge to the device for prevention of central migration of epithelial
cells in the lens bag.
[0037] Moreover, according to some embodiments, the implantation of the
capsular tension
ring affords one or more of the following advantages: circular spreading of
the capsular bag,
consistent operating conditions, prevention of secondary cataract, inhibition
of capsular bag
shrinkage, minimizing or avoidance of capsular bag folds, reduced clouding of
the anterior
capsule margin and thus better fundus visualization, e.g. in patients with
problems affecting the
retina.
[0038] Among other things, provided herein are devices, systems and methods
for restoring
natural capsular tension and anatomy post-surgically in the lens capsule of an
eye. The capsular
tension ring can be implemented as an open capsular tension ring device that
is anchorable in the
lens capsule of the eye after lens extraction, such as during cataract
surgery. The open capsular
tension ring device can anchor to the peripheral part of the internal capsular
surface, or can be
anchored by the natural capsular structure of the lens capsule. The outer
section of the open
capsular tension ring device may comprise an elastic material and/or may be a
material effective
for delivery of a drug, pharmaceutical or other therapeutic compound as is
known in the art. The
inner section of the open capsular tension ring device may comprise a stiff
central open ring. In
some embodiments, said inner section comprises a plastic or metal material,
such as nitinol. For
example, the outer section of the open capsular tension ring device may
comprise a plastic,
silicone, acrylic, or other material useful for the production of a flexible
intraocular lens. The
device may be coupled to an appropriate opto-mechanical mechanism to perform
accommodation.
[0039] The device may be coupled with an ophthalmic lens system, such as an
intraocular
lens with mounting structures. The device may be designed, formed or
configured to receive an
intraocular lens while anchored to the lens capsule. Optionally the
intraocular lens may add to or
solely provide the inwardly directed tension to reduce the capsular equatorial
diameter upon
incorporation into the tensioning device. Thus, some embodiments also provide
a method of
restoring capsular tension to a post-surgical eye via implantation of the
device or ophthalmic lens
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system into the post-surgical lens capsule and to stabilize an implanted
artificial lens from
movement in the x-y-z planes.
[0040] The described aspects, structures, or characteristics of the subject
technology may be
combined in any suitable manner in one or more embodiments. In the following
description,
numerous specific details are recited to provide a thorough understanding of
embodiments of the
subject technology. One skilled in the relevant art may recognize, however,
that the subject
technology may be practiced without one or more of the specific details, or
with other methods,
components, materials, and so forth. In other instances, well-known
structures, materials, or
operations are not shown or described in detail to avoid obscuring aspects of
the subject
technology.
[0041] Other objects, advantages, and novel features, and further scope of
applicability of the
present technology will be set forth in part in the detailed description to
follow, taken in
conjunction with the accompanying drawings, and in part will become apparent
to those skilled
in the art upon examination of the following, or may be learned by practice of
the technology.
The objects and advantages of the subject technology may be realized and
attained by means of
the instrumentalities and combinations particularly pointed out in the
appended claims.
IV. Device Description
[0042] Embodiments disclosed herein comprise a CTR. CTRs are generally used
in cataract
surgery. Cataract surgery can involve removing a cataractous lens and
implanting an artificial
lens implant for vision correction. The lens bag that receives the IOL implant
can be
compromised due to laxity of supporting fibers (called zonules) and may
require support with a
tensioning ring that is inserted prior to insertion of the IOL. Capsular
tension rings are these
tensioning rings.
[0043] According to some embodiments, the CTR can have a larger vertical
(e.g., 1.5
millimeters) and horizontal (e.g., 500 micrometers) body profile. This may,
for example, address
the poor ability of current devices to place the capsular bag on stretch to
provide for more
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predictable positioning of the IOL implant and the inability to separate the
anterior and posterior
capsule which results in posterior capsular pacification (PC0) and anterior
capsular
opacification (ACO) and subsequent IOL decentration.
[0044] According to some embodiments, the CTR can be manufactured from
polymer
materials (e.g., silicone or other) that allow for absorption or incorporation
of drugs for slow
release compared to CTRs that are made of poly(methyl methacrylate) (PMMA).
[0045] According to some embodiments, the CTR can have a distinct edge
design that allows
for prevention of PCO. In some embodiments, said distinct edge is sharp or
curved. In some
embodiments, the vertical features on the sides are ¨200 micrometers wide and
200 micrometers
in between each features. In some embodiments, said features are produced by
etching.
[0046] According to some embodiments, the CTR can have one or more eyelets
at one or
more ends of the CTR, which can, for example, permit anchoring or fixation of
the CTR device.
According to some embodiments, the eyelet(s) can be radially overlapped by the
outer section of
the device. This can, for example, facilitate insertion of the CTR into a CTR
injector device, or
increase an ease of insertion of the CTR into the CTR injector device, by
reducing a tendency of
portions of the CTR such as the outer section to catch on components of the
CTR injector device
upon loading of the CTR into the injector device.
[0047] According to some embodiments, the CTR may be designed having an
inner surface
and outer surface, either or both of which can be populated with polygons
having multiple
surface features. In some embodiments, said features are micropatterned
features. In some
embodiments, these features function to provide to the capsular bag with
enhanced stability (anti-
rotation ability). In some embodiments, the surface features may be designed
to receive IOL
haptics and act as a rotational braking system to prevent or otherwise reduce
undesired post-
operative clockwise or counterclockwise rotation of an implanted lens. This
may lead to the
success of "toric" lenses that are designed to correct vision (astigmatism)
with different powers
in different lens meridians. As they exist today, these lenses rotate
significantly and can lead to
suboptimal vision correction. A rotational braking system on a CTR would allow
for enhanced
vision restoration and stability of astigmatism correction over the long-term.
According to some
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embodiments, the features of the rotational braking system may additionally
permit bi-directional
rotation of the IOL device (in both clockwise and counter-clockwise
directions) upon application
of an external force during a surgical implantation procedure. This can, for
example, allow for
precise rotational positioning of a toric lens by a surgeon.
[0048] According to some embodiments, the CTR may contain features to help
guide
positioning of a secondary device, such as an IOL haptic. In some embodiments,
said features are
structural features on the surface of the ring. In some embodiments, said
features are configured
as interlocking features. In some embodiments, said features are configured as
docking and
receiving features. In some embodiments the receiving/docking features are
married to
receiving/docking features on an IOL or IOL haptic. In some embodiments, said
features are
micropatterned features. In some embodiments, said features are magnetic.
[0049] According to some embodiments, the CTR can have markings to identify
clock hour
(rotational position) relative to ocular surface features (e.g., to help with
implantation of the IOL
that corrects astigmatism).
[0050] According to some embodiments, the CTR can have polymer and material
content
that allows for optical coherence topography (OCT) imaging (e.g., to allow for
anterior segment
OCT visualization and targeting).
[0051] According to some embodiments, the CTR can be coated with secondary
materials to
slow exit of drug that is incorporated into body of CTR. In some embodiments,
the drug is
incorporated into the outer section of the device.
[0052] Figures 1- 8 show a capsular tension ring 1 and components
associated with such a
ring, in accordance with some embodiments.
[0053] With reference to, for example, Figure 1, the capsular tension ring
1 can be
implemented as an open capsular tension ring that is generally C-shaped. The
capsular tension
ring 1 has an outer surface 2 and an inner surface 3. The outer surface 2 and
inner surface 3 are
each annular surfaces or ring surfaces that extend about a central axis 38
which forms a
geometric center of the ring. The outer surface 2 extends along an outer
circumference and
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corresponds to an outer radius 40 of the capsular tension ring 1. The inner
surface 3 extends
along an inner circumference and corresponds to an inner radius 41 of the
capsular tension ring
[0054] The capsular tension ring 1 has features 4 on both the outer surface
2 and the inner
surface 3. The features 4 are arranged circumferentially along the outer
surface 2 and inner
surface 3. Although features 4 are shown arranged on both the outer surface 2
and inner surface
3, implementations are contemplated in which the capsular tension ring 1 has
such features on
only the outer surface 2 or inner surface 3.
[0055] With continued reference to, for example, Figure 1, the capsular
tension ring 1 has a
first end 7 and second end 8 each with an eyelet 11. In this particular
embodiment, the ring also
has an inner section 18 and an outer section 17. In some embodiments, the
inner section 18 is
made from a wire and the outer section 17 is made from a material molded or
deposited over the
inner section 18 wire. The features 4 are formed at least in part on the
surface or surfaces of the
outer section 17. The inner section 18 has a generally annular or arcuate
portion 42 extending
from the first end 7 to the second end 8 with a curved configuration about
central axis 38. The
capsular tension ring 1 is symmetrical with two arcuate arms, a first arcuate
arm 9 and a second
arcuate arm 10.
[0056] Figure 2 shows a close up of one of the ends of the capsular tension
ring 1. Vertical
features 13 extend in an axial direction along the direction of central axis
38 and may vary in
width in the axial direction, indicated by the arrow. Alternatively, they may
have constant width
in some embodiments. Horizontal features 14 extend in a circumferential
direction along a
circumference of the capsular tension ring 1 (e.g., outer or inner
circumference) and are also
indicated with the arrows.
[0057] The features 4 are shown in Figure 2 as raised parallel polygon
features forming a
series of ridges 43 and valleys 44. The polygon features are referred to as
parallel in that each
polygon feature can be parallel to its adjacent polygon features, thereby
forming a series of
parallel ridges and valleys. In the illustrated example, the polygon features
extend substantially
straight in the axial direction (direction along central axis 38), although
they can alternatively be
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angled with respect to the central axis 38 (e.g., similar to the teeth of a
helical gear), or have
curved geometries in the axial direction (e.g., similar to the teeth of a
screw gear). In curved
geometry implementations, the polygon features may extend along parallel
curves to each other,
for example.
[0058] Figure 3 shows a close up of features 4 implemented as raised
parallel polygon
features. In some embodiments, the raised parallel polygon features have a
sharp edge 5, and in
some embodiments, the features have a curved edge 6. In some embodiments, the
capsular
tension ring 1 can include both sharp edges 5 and curved edges 6.
[0059] As seen in Figure 3, for example, a ridge 43 having a sharp edge 5
can have opposing
sides 47 that extend substantially parallel to each other in a radial
direction, and a ridge 43
having a curved edge 6 can have opposing sides 47 that converge towards each
other in a radial
direction. For ridges 43 having curved edge 6 that protrude radially outward
from the outer
surface 2, the opposing sides 47 can converge towards each other in a
direction away from the
central axis 38. For ridges 43 having curved edge 6 that protrude radially
inward from the inner
surface 3, the opposing sides 47 can converge towards each other in a
direction towards from the
central axis 38.
[0060] Figure 4 shows a view of the outer section 17 of the capsular
tension ring 1. This
figure shows the variability of the vertical features 13. The height may vary
in addition to the
variability of the horizontal features 14. In some embodiments, the outer
section 17 is comprised
of polygonal sections, which may vary in vertical, horizontal, or both
vertical and horizontal
widths. As seen in Figure 4, the variability can result in wavy upper and/or
lower borders. It is
also contemplated that any one or more of the forgoing aspects can be made
constant as opposed
to varying. For example, Figure 1 shows the outer section 17 implemented with
substantially
constant vertical width resulting in substantially flat upper and lower
borders. The vertical
dimension in this case can alternatively be referred to as the axial direction
as it extends along
the direction of central axis 38 or the axis of the ring.
[0061] Figure 5 shows an overhead view of the outer section 17 of the
capsular tension ring
1. Figure 6 shows an underside view of the outer section 17 of the capsular
tension ring 1 with
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the ends of the inner section 18 emerging from the ends of the outer section
17. Eyelets 11 are
disposed at the ends of the inner wire section 18 and emerge from the ends of
the outer section
17 so that they are exposed outside of the outer section 17.
[0062] Figure 6 also shows an example of how features 4 can be arranged
circumferentially
along the inner surface 3 and/or outer surface 2, so that the features 4 can
have a pattern such as
a ridge and valley pattern or other repeating structure that repeats in the
circumferential direction
39 about central axis 38. As seen in Figure 6, the features 4 can include
protrusions (e.g., ridges
or raised polygon structures) on the inner surface 3 that protrude radially
inward from inner
surface 3, or toward central axis 38 in radial direction 30. As seen in Figure
6, the features 4 can
include protrusions (e.g., ridges or raised polygon structures) on the outer
surface 2 that protrude
radially outward from outer surface 2, or away from central axis 38 in radial
direction 30.
[0063] According to some embodiments, a solid angle 46 subtended from the
central axis 38
by an adjacent pair 45 of features 4 such as an adjacent pair of ridges can
provide a stepwise
rotational positioning system for an intraocular lens or other interfacing
device to slide along the
inner surface 3 upon application of external force to the interfacing device
(e.g., by a surgeon).
For example, upon application of the external force, the interfacing device
may be able to
stepwise click into place as it slides from ridge to ridge, while in the
absence of the external
force, the ridges can resist rotation of the interfacing device to provide a
rotational braking
system. The solid angle 46 can vary depending the implementation, and factors
such as
manufacturing processes, construction of the features 4, or desired rotational
precision for the
interfacing device. According to some embodiments, for example, the solid
angle 46 can be less
than 10 degrees. According to some embodiments, for example, the solid angle
46 can be less
than 5 degrees. According to some embodiments, for example, the solid angle 46
can be less
than 3 degrees. According to some embodiments, for example, the solid angle 46
can be
between 10 degrees and 0.5 degrees. According to some embodiments, for
example, the solid
angle 46 can be between 5 degrees and 0.5 degrees. According to some
embodiments, for
example, the solid angle 46 can be between 3 degrees and 0.5 degrees. It is
also contemplated
that the solid angle can be outside of these ranges, for example.
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[0064] Figure 7 shows an overhead view of the outer section 17 of the
capsular tension ring 1
with the ends of the inner section 18 emerging from the ends of the outer
section 17. Eyelets 11
at the ends of the inner wire section 18 emerge from the ends of the outer
section 17 from the
eyelet holes 12, encircled next to B and shown in greater detail in Figure 8
and 11. In this
embodiment, the inner section 18 has been overmolded to form an outer section
17. Figure 7
also shows examples of dimensions that can be employed in the capsular tension
ring 1.
[0065] Figure 8 shows a detailed view of the end of the capsular tension
ring 1. In this
particular example, there is a 0.20 millimeter horizontal width at the bottom
19 of the raised
parallel polygonal features. This value is equivalent to the width of valleys
in the circumferential
direction 39. The raised polygonal features (which can have curved 6 and sharp
edges 5) have a
width 20 of 0.31 millimeter distance. This value is equivalent to the width of
ridges in the
circumferential direction 39. In this example, the outer section 17 has a
width of 0.30
millimeters at the thinnest section 21 and 0.50 millimeters at the greatest
width 22. These values
are equivalent to the thickness of the outer section 17 in the radial
direction 30. It will be
appreciated that these are just some examples of dimensions that can be
employed in the capsular
tension ring 1, and it is contemplated that numerous other dimensions can be
employed.
[0066] Figure 9 shows a side view of the vertical features 13 of the outer
section 17 and
outer surface 2 of the capsular tension ring 1. The smallest vertical height
23 of the outer section
vertical features has a width of 1.0 millimeter. The largest vertical height
24 of the outer section
vertical features has a width of 1.5 millimeters. These values are equivalent
to the thickness of
the outer section 17 along a direction of the axis 38. It will be appreciated
that these are just
some examples of dimensions that can be employed in the capsular tension ring
1, and it is
contemplated that numerous other dimensions can be employed, including
constant vertical
heights or thickness in the axial direction.
[0067] Figure 10 shows a side view of the vertical features 13 of the outer
section 17 and
inner surface 3 of the capsular tension ring 1. The first end 7 and second end
8 are visible with
the eyelet holes 12 at the ends. A detailed view of the second end 8 is shown
encircled in detail
C, see Figure 11.
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[0068] As seen in Figure 11, for example, each of the eyelets 11 can emerge
from an eyelet
hole 12. Figure 11 shows a detailed view of the second end 8. In this
embodiment, the end has a
vertical height (or axial thickness) of 1.50 millimeters. The eyelet hole 12
is shown equidistantly
in the end of the ring.
[0069] Figure 12 shows an example of the inner section 18 with eyelets 11
and without outer
section 17. This example is a nitinol inner wire section. The nitinol inner
wire section has an
annular or arcuate portion 42 connecting the eyelets 11 at opposing ends of
the inner section wire
section.
[0070] Figures 13A-13C show examples of features 4 that can be employed on
the capsular
tension ring 1 on the inner surface 3 and/or outer surface 2. These figures
are a schematic
representation of a cross section of the features 4 taken along a plane that
intersects the outer
section 17 in a direction perpendicular to the central axis 38.
[0071] Figure 13A is a schematic representation of the features 4 shown in
Figures 1-3,
which include ridges 43 and valleys 44 having sharp edge 5. As seen in Figure
13A, the
opposing sides 47 can extend parallel to each other and be sloped at an angle
54 of
approximately 90 degrees. The ridges 43 have a generally rectangular profile.
[0072] Figure 13B is a schematic representation of another example of the
features 4. In this
example, the features 4 have a generally trapezoidal profile. The features 4
include ridges 43 and
valleys 44 in which opposing sides 47 of each ridge converge towards each
other, and in which
the opposing sides are sloped at an angle less than 90 degrees.
[0073] Figure 13C is a schematic representation of another example of the
features 4. In this
example, the features 4 have a generally curved profile. The features 4
include ridges 43 and
valleys 44 in which opposing sides 47 of each ridge converge towards each
other, and in which
the opposing sides are sloped at an angle less than 90 degrees.
[0074] In each of the examples shown in Figures 13A-13C, each of the
features 4 are shown
as radially symmetric. In particular, the ridges 43 are symmetric about a
radial line segment 52
that extends from the central axis 38 through the ridges 43 and bisects the
ridges 43 (central axis
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38 not shown in this figure). According to some embodiments, radially
symmetric arrangements
such as those shown in Figures 13A-13C can permit bi-directional rotational of
an interfacing
device such as an intraocular lens or haptic of an intraocular lens as the
interfacing device slides
along the ridges 43 in either rotational direction (e.g., clockwise or
counterclockwise) with
substantially equal levels of resistance in either direction.
[0075] In each of the examples shown in Figures 13A-13C, each of the
features 4 are also
shown with a slope angle 54 with respect to the surface from which that
feature protrudes.
According to some embodiments, this slope angle 54 can determine a degree of
rotational
resistance to rotation of an interfacing device as the interfacing device
slides along the features.
In this case, a greater angle can provide greater rotational resistance while
a lesser angle can
provide lesser rotational resistance. In these illustrated examples, the
rectangular ridges shown
in Figure 13A have the greatest slope angle 54 at an angle of approximately 90
degrees and can
provide the greatest rotational resistance out of these examples, followed by
the trapezoidal
ridges shown in Figure 13B which have a slope angle 54 of less than 90
degrees, followed by the
curved ridges shown in Figure 13C which have the lowest slope angle 54 and can
provide the
least amount of rotational resistance out of these examples. It is
contemplated that a variety of
slope angles 54 can be suitably used in various implementations. According to
some
embodiments, the slope angle can be between 30 degrees and 100 degrees. It is
also
contemplated that bi-directional rotation of the interfacing device can be
achieved in some cases
without a radially symmetric arrangement, for example, if the slope angle 54
for the two
opposing sides 47 differ from one another but are both less than 90 degrees.
100761 In each of the examples shown in Figures 13A-13C, the ridges 43
shown also form
adjacent pairs of ridges that can be spaced apart from each other at a pitch
53. This pitch 53 can
determine the angle subtended 46 from the central axis 38 by the adjacent pair
or by an arc
extending between the adjacent pair of ridges. According to some embodiments,
the pitch 53
can determine a rotational precision for step wise rotation of the interfacing
device as it slides
along the ridges. Accordingly, the pitch 53 can be selected to correspond to
any of the subtended
angles described herein.
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[0077] Figures 14A-14C show further examples of features 4, according to
some
embodiments. Figures 14A-14C show the features from a side view, e.g., when
the features 4
are viewed in a direction normal to the inner surface 3 (for features
protruding from the inner
surface) or the outer surface 2 (for features protruding from the outer
surface). Figures 14A-14C
each show examples in which the features 4 are implemented as parallel polygon
features
arranged as a pattern of parallel ridges (black lines) and valleys (white
spaces between black
lines). As seen for example in Figure 14A, the ridges can be arranged to
extend substantially
straight in the axial direction and substantially parallel to central axis 38.
As seen for example in
Figure 14B, the ridges can be arranged to extend at an angle in the axial
direction and at a non-
zero angled to central axis 38 (e.g., similar to the teeth of a helical gear).
As seen for example in
Figure 14C, the ridges can be arranged to with curved geometry with a series
of parallel curves
(e.g., similar to the teeth of a screw gear). Any one of these arrangements
shown in Figures
14A-14C can be configured in accordance with any one of the arrangements shown
in Figures
13A-13C, for example.
[0078] It will be appreciated that the shapes and arrangements shown in
Figures 13-14 are
just some examples that can be employed in the capsular tension ring 1, and it
is contemplated
that numerous other shapes, arrangements, and dimensions can be employed.
Further, while the
above examples explain some exemplary considerations or technical effects that
can be achieved
by the various parameters, it is contemplated that other principles of
operation or effects can be
utilized in the capsular tension ring 1 without being tied to these particular
principles.
[0079] Figure 15 shows an ophthalmic system including capsular tension ring
1 arranged
around an interfacing device such as an intraocular lens 26. As seen in Figure
15, the intraocular
lens 26 have a central optic 28 (also referred to herein as an "optical
element"), such as a toric or
other type of artificial lens, and one or more haptics 27 (also referred to
herein as "haptic
elements") extending radially outwardly from the central optic 28 and attached
or coupled to the
central optic 28 to provide structural support. In this particular example,
the haptics 27 are
implemented as a pair of arms in which each arm spirals outwardly from the
central optic 28,
although it is contemplated that any other suitable haptics may be used.
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[0080] The haptic(s) 27 are configured to mate with the annular inner
surface 3 of the
capsular tension ring 1. For example, the haptic(s) can each include one or
more mating features
29 on an outer surface thereof. The mating features 29 on the haptic(s) 27 can
be configured to
interleave with or interact with features 4 of the capsular tension ring 1,
and can include any
complementary features to the features 4 of the capsular tension ring 1.
According to some
embodiments, the mating features 29 can include protrusions, ridges and
valleys, and raised
polygon features, or raised parallel polygon features that are configured to
slidingly engage with
corresponding features 4 of the capsular tension ring 1.
[0081] Figure 15 shows the capsular tension ring 1 in a relaxed
configuration around the
intraocular lens 26 such that the intraocular lens is not fully secured or
engaged with the capsular
tension ring 1. Figure 16 shows the capsular tension ring 1 in a compressed
configuration such
that the mating features 29 on the haptic(s) 27 are engaged with and
interleaved with the features
4 of the capsular tension ring, and such that the intraocular lens 26 is
secured substantially
coaxially within the ring. According to some embodiments, the mating features
29 of the haptic
27 can be slidingly engaged with the features 4 of the capsular tension ring 1
when in an engaged
configuration like that shown in Figure 16. The features can resist undesired
rotation of the
intraocular lens in the absence of any external force, while permitting bi-
directional rotation
about the central axis (e.g., clockwise and counterclockwise) upon application
of external force
to the intraocular lens 26. This can be accomplished using, for example,
radially symmetric
features such as those described above, or any other suitable features that
allow for such sliding
engagement.
100821 Figure 17 shows an enlarged view of mating between features 4 of the
capsular
tension ring 1 and mating features 29 of the haptic 27. As seen for example in
Figure 17, the
mating features 29 of the haptic 27 do not necessarily need to mate with the
features of the ring
with 1:1 correspondence. In this example, the mating features 29 have a pitch
that is about twice
the pitch of the features 4 of the ring, such that the features 4 of the ring
mate with the mating
features of the haptic with 2:1 correspondence. It is contemplated that a
variety of relative
pitches and mating correspondences may be used in various implementations. For
example,
according to some embodiments the mating features of the haptic can have a
pitch that is
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substantially equal to the pitch of the features on the ring so that the
features of the ring mate
with the mating features of the haptic with 1:1 correspondence. According to
some
embodiments, the mating features of the haptic can have a pitch that is
approximately double the
pitch of the features on the ring so that the features of the ring mate with
the mating features of
the haptic with 2:1 correspondence. According to some embodiments, the mating
features of the
haptic can have a pitch that is approximately triple the pitch of the features
on the ring so that the
features of the ring mate with the mating features of the haptic with 3:1
correspondence. It is
also contemplated that other arrangements may be used.
[0083] Figure 18 shows an end of capsular tension ring 1, according to some
embodiments.
As seen in Figure 18, the capsular tension ring 1 can include outer section 17
and an eyelet 11
extending from the outer section 17 so that it is exposed. The eyelet 11 can
be attached to or be a
part of inner section 18, which can be enveloped or covered by the outer
section 17. As seen in
Figure 18, the outer section 17 can radially overlap with the eyelet 11, i.e.,
overlap with the
eyelet 11 in the radial direction 30. In this case, a radial line segment
originating from the
central axis 38 and drawing radially outward through the outer section 17 will
also intersect with
the eyelet 11. This contrasts with the eyelets 11 shown in Figure 1, for
example, where the
eyelets 11 and the outer section 17 do no radially overlap. According to some
embodiments,
such a radially overlapping arrangement may be useful to, for example,
facilitate assembly or
loading of the capsular tension ring 1 into an inserter device by reducing a
tendency of the outer
section to catch onto components of the inserter device as it is drawn in. In
this example, the
radially overlapping arrangement is achieved by having the eyelet 11 extend
radially inwardly
from the outer section 17 such that a portion of the outer section is radially
outside of the inner
section. It is contemplated that the capsular tension ring 1 can otherwise
include any one or
more of the aspects described above, including, for example, a wire inner
section and an
overmolded outer material section, for example.
4. Device Implantation
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[0084] Some embodiments relate to a capsular tension ring for insertion
into an ocular lens
capsule to apply outward pressure in the area of the equatorial region, the
capsular tension ring
comprising an inner section 18 and an outer ring section 17, said inner
section 18 having: a
central fixation element; two arcuate arms (9 and 10) extending generally
oppositely from the
fixation element, said arms forming an arc to engage along the equatorial
region of the capsule,
said fixation element and arms being constructed; and outer section 17
enveloping said inner
section 18. In some embodiments, said outer section 17 has: a vertical profile
of at least 1.0
millimeters and horizontal profile of at least 150 micrometers. In some
embodiments, said
central fixation element adapted to be received by an insertion device 25% In
some embodiments,
said capsular tension ring arms (9 and 10) are arranged relatively to be
loaded into the insertion
device 24 by pulling on the central fixation element and thereby draw the arms
into the insertion
device 24. together, followed by discharge of the arcuate arms (9 and 10)
together from the
device into the capsule. In some embodiments, said fixation element and the
arms are coplanar.
In some embodiments, said ring further includes a stem section between the
fixation element and
the arms. In some embodiments, said arms are coplanar and the fixation element
is offset out of
the plane of the arms when deployed in a capsule. In some embodiments, said
fixation element is
an eyelet. In some embodiments, said fixation element is a groove formed
between adjacent ends
of the arms. In some embodiments, said inner section is made from nitinol. In
some
embodiments, said outer section is made from polymer materials that allows for
absorption or
incorporation of drugs for slow release. In some embodiments, said outer
section 17 is
overmolded upon said inner section. In some embodiments, said outer section
has at least one
distinct edge. In some embodiments, said distinct edge comprises a sharp edge
5. In some
embodiments, said outer section has at least one curved edge 6. In some
embodiments, said outer
section has vertical features 13. In some embodiments, said outer section
vertical features
comprise outer ring surface vertical features. In some embodiments, said outer
section vertical
features comprises inner ring surface vertical features 13. In some
embodiments, said ring
provides rotational stability to the subsequently implanted intraocular lens.
In some
embodiments, said features are produced by etching. In some embodiments, the
device is folded
inside the capsular sac in a plane oblique or transverse to the general plane
of the ocular lens
capsule before it is released, thereby enabling the device to take up its
place in the equatorial
region without risk of lesion of the sac or of tearing of the zonules, thanks
to the damping effect
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of the flexible material junction, which reduces the impact of the segment
with the tissue of the
capsular sac.
[0085] The diameter of the capsular tension ring may be selected so that,
once implanted, it
is slightly compressed against the equatorial region of the capsular sac. This
compression has the
effect of closing the capsular tension ring by moving its ends toward each
other, the first end 7
passing outside the second end 8 and thus forming a very small step at the
overlap of the ends 7
and 8. The resulting discontinuity is minimized by the small thickness and the
inherent flexibility
of the first end 7, which tends to be crushed radially between the end 8 and
the capsular tissue at
the level of the equator. Afterwards, in the post-operative period, the
capsular sac may shrink, by
about 0.5 mm to 1.5 mm in diameter, the consequence of which is to increase
the overlapping
length.
[0086] After implanting the capsular tension ring, the surgeon may position
an intraocular
lens 26 inside the ring. The haptic elements 27 can be C-shaped, J-shaped or
flat, with or without
an aperture, and there can be two or three of them, for example. Each is in
contact with or bears
against the cylindrical interior surface of the main portion of the annular
body. Some intraocular
lens 26 have three haptic elements 27 with a large aperture extending from the
periphery of the
optic 28 and forming an assembly with the capsular tension ring 1. The ring 1
therefore
advantageously serves also to center and locate the intraocular lens 26 in the
capsular sac. The
axial width of the interior surface may provide a good bearing surface for the
haptic elements of
the intraocular implant.
[0087] A ring of the above kind has the advantage of maintaining its
diameter despite
shrinkage of the capsular sac. The raised features, vertical and horizontal
features, and in some
cases at least one sharp edge provide an excellent barrier to cellular
migration. The inner section
18 comprises rigid material and the overmolded outer section 17 has said
features.
[0088] In one embodiment, implanting the ring 1 may be followed by
implanting the
intraocular lens 26 in accordance with the standard practice using forceps or
an injector. The
haptic elements 27 of the intraocular lens are in contact with or bear against
the annular interior
surface of the main portion of the ring.
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[0089] According to some embodiments, a method of treatment can involve,
implanting a
capsular tension ring in an eye, the capsular tension ring comprising an inner
surface having a
plurality of features. The method can further involve rotating a haptic
element of an intraocular
lens along the plurality of features in a first rotational direction. The
method can further involve
rotating the haptic element of the intraocular lens along the plurality of
features in a second
rotational direction opposite to the first rotational direction. According to
some embodiments,
the rotation in the first and second directions can be performed during an
implantation procedure
to rotationally position, for example, a toric intraocular lens with respect
to the eye. According to
some embodiments, the method can further involve further rotating the
intraocular lens with
respect to the eye in a subsequent procedure (e.g., after an initial post-
operative period). This
may be useful to, for example, prevent or mitigate tissue ingrowth into the
haptics of the
intraocular lens.
[0090] Some embodiments of the capsular tension ring may be impregnated
beforehand with
an anti-proliferation product. Some embodiments of the capsular tension ring
may have
micropatterned anti-proliferation surfaces as described in U.S. Patent
Application No.
14/396,941, the disclosure of which is hereby incorporated by reference in its
entirety for all
purposes. The teachings of the present disclosure are not limited to the
embodiments described
or to the preferred materials, but to the contrary encompass all variants of
structures,
configurations and materials that are compatible with the subject matter of
the present disclosure.
[0091] The present disclosure contemplates embodiments comprising devices
and methods
for stabilization of an ocular lens capsule and preventing artificial
intraocular lens implant
rotation post cataract surgery, are well adapted to attain the ends and
advantages mentioned as
well as those that are inherent therein. The particular embodiments disclosed
above are
illustrative only, as the teachings of present disclosure may be modified and
practiced in
different but equivalent manners apparent to those skilled in the art having
the benefit of the
present disclosure. It is therefore evident that the particular illustrative
embodiments disclosed
herein may be altered or modified and all such variations are considered
within the scope and
spirit of the present disclosure. Although the subject technology has been
described with
reference to these particular embodiments, other embodiments can achieve the
same results. The
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entire disclosures of all applications, patents, and publications cited above,
and of the
corresponding application are hereby incorporated by reference.
[0092] The foregoing description is provided to enable a person skilled in
the art to practice
the various configurations described herein. While the subject technology has
been particularly
described with reference to the various figures and configurations, it should
be understood that
these are for illustration purposes only and should not be taken as limiting
the scope of the
subject technology.
[0093] There may be many other ways to implement the subject technology.
Various
functions and elements described herein may be partitioned differently from
those shown without
departing from the scope of the subject technology. Various modifications to
these
configurations will be readily apparent to those skilled in the art, and
generic principles defined
herein may be applied to other configurations. Thus, many changes and
modifications may be
made to the subject technology, by one having ordinary skill in the art,
without departing from
the scope of the subject technology.
[0094] It is understood that the specific order or hierarchy of steps in
the processes disclosed
is an illustration of exemplary approaches. Based upon design preferences, it
is understood that
the specific order or hierarchy of steps in the processes may be rearranged.
Some of the steps
may be performed simultaneously. Any accompanying method claims present
elements of the
various steps in a sample order, and are not meant to be limited to the
specific order or hierarchy
presented.
[0095] A phrase such as "an aspect" does not imply that such aspect is
essential to the
subject technology or that such aspect applies to all configurations of the
subject technology. A
disclosure relating to an aspect may apply to all configurations, or one or
more
configurations. An aspect may provide one or more examples of the disclosure.
A phrase such
as "an aspect" may refer to one or more aspects and vice versa. A phrase such
as "an
embodiment" does not imply that such embodiment is essential to the subject
technology or that
such embodiment applies to all configurations of the subject technology. A
disclosure relating to
an embodiment may apply to all embodiments, or one or more embodiments. An
embodiment
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may provide one or more examples of the disclosure. A phrase such "an
embodiment" may refer
to one or more embodiments and vice versa. A phrase such as "a configuration"
does not imply
that such configuration is essential to the subject technology or that such
configuration applies to
all configurations of the subject technology. A disclosure relating to a
configuration may apply
to all configurations, or one or more configurations. A configuration may
provide one or more
examples of the disclosure. A phrase such as "a configuration" may refer to
one or more
configurations and vice versa.
100961 As used herein, the phrase "at least one of' preceding a series of
items, with the term
"and" or "or" to separate any of the items, modifies the list as a whole,
rather than each member
of the list (i.e., each item). The phrase "at least one of' does not require
selection of at least one
of each item listed; rather, the phrase allows a meaning that includes at
least one of any one of
the items, and/or at least one of any combination of the items, and/or at
least one of each of the
items. By way of example, the phrases "at least one of A, B, and C" or "at
least one of A, B, or
C" each refer to only A, only B, or only C; any combination of A, B, and C;
and/or at least one
of each of A, B, and C.
[0097] Terms such as "top," "bottom," "front," "rear" and the like as used
in this disclosure
should be understood as referring to an arbitrary frame of reference, rather
than to the ordinary
gravitational frame of reference. Thus, a top surface, a bottom surface, a
front surface, and a rear
surface may extend upwardly, downwardly, diagonally, or horizontally in a
gravitational frame
of reference.
[0098] Furthermore, to the extent that the term "include," "have," or the
like is used in the
description or the claims, such term is intended to be inclusive in a manner
similar to the term
"comprise" as "comprise" is interpreted when employed as a transitional word
in a claim.
[0099] The word "exemplary" is used herein to mean "serving as an example,
instance, or
illustration." Any embodiment described herein as "exemplary" is not
necessarily to be
construed as preferred or advantageous over other embodiments.
[01001 A reference to an element in the singular is not intended to mean
"one and only one"
unless specifically stated, but rather "one or more." Pronouns in the
masculine (e.g., his) include
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the feminine and neuter gender (e.g., her and its) and vice versa. The term
"some" refers to one
or more. Underlined and/or italicized headings and subheadings are used for
convenience only,
do not limit the subject technology, and are not referred to in connection
with the interpretation
of the description of the subject technology. All structural and functional
equivalents to the
elements of the various configurations described throughout this disclosure
that are known or
later come to be known to those of ordinary skill in the art are expressly
incorporated herein by
reference and intended to be encompassed by the subject technology. Moreover,
nothing
disclosed herein is intended to be dedicated to the public regardless of
whether such disclosure is
explicitly recited in the above description.
[0101] While certain aspects and embodiments of the subject technology have
been
described, these have been presented by way of example only, and are not
intended to limit the
scope of the subject technology. Indeed, the novel methods and systems
described herein may
be embodied in a variety of other forms without departing from the spirit
thereof. The
accompanying claims and their equivalents are intended to cover such forms or
modifications as
would fall within the scope and spirit of the subject technology.
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