Note: Descriptions are shown in the official language in which they were submitted.
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RETRACTABLE CAP ACTUATION FOR AN INTRAOCULAR LENS CARTRIDGE
TECHNICAL FIELD
[0001] The present disclosure generally relates to eye surgery and, more
particularly,
some embodiments may generally relate to systems, methods, and apparatuses for
removably
attaching a drive mechanism handpiece to an intraocular lens 000 cartridge
that folds the IOL
upon retraction of a cap.
BACKGROUND
[0002] The human eye can suffer a number of maladies causing mild
deterioration to
complete loss of vision. While contact lenses and eyeglasses can compensate
for some ailments,
ophthalmic surgery may be required for others. Generally, ophthalmic surgery
may be classified
into posterior segment procedures, such as vitreoretinal surgery, and anterior
segment procedures,
such as cataract surgery.
[0003] For cataract surgery, a surgical procedure may require incisions and
insertion of
tools within an eye to replace the clouded lens with an IOL. An insertion tool
can be used for
delivery of the IOL into the eye. By way of example, the insertion tool may
include a plunger for
forcing the IOL out of the nozzle of the insertion tool. In some instances,
the IOL may be pre-
loaded in the insertion tool. In other instances, a separate compartment may
be loaded into the
insertion tool. The plunger may engage the IOL to advance the IOL from the
compartment,
through a nozzle, and into the eye.
SUMMARY
[0004] In an exemplary embodiment, the present disclosure provides an
intraocular lens
(IOL) cartridge that folds the IOL upon retraction of a cap. The IOL cartridge
comprises a nozzle
and a compartment configured to receive an 10L. The nozzle is in fluid
communication with the
compartment. The IOL cartridge also includes a retractable cap configured to
be retracted from a
first position to a second position to manipulate the IOL for delivery and to
expose the nozzle. The
IOL cartridge may also include a plunger case that is in fluid communication
with the
compartment, wherein a plunger is movably disposed within the plunger case.
The IOL cartridge
may be configured such that when the retractable cap is in the first position,
the nozzle is positioned
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within the cap, and when the cap is in the second position, the nozzle is at
least partially exposed
outside of a distal end of the cap.
[0005] In another exemplary embodiment, the present disclosure provides an IOL
cartridge comprising a housing and a cap. The housing may comprise a
compartment configured
to receive an IOL. The cap may be adapted to at least partially surround the
compartment and be
configured to be retracted from a first position to a second position to
actuate a folding mechanism
of the housing to manipulate an IOL for delivery. The folding mechanism may
comprise a first set
of actuators, and the cap may comprise a first set of internal ramps
configured to actuate the first
set of actuators as the cap is retracted from the first position to the second
position. The first set
of actuators may include a pair of edge roller pivotably attached to the
housing and configured to
contact the first set of internal ramps. The folding mechanism may further
comprise a second set
of actuators, and the cap may further comprise a second set of internal ramps
configured to actuate
the second set of actuators as the cap is retracted from the first position to
the second position. The
second set of actuators may include a pair of compression arms pivotably
attached to the housing
and configured to contact the second set of internal ramps.
[0006] In another exemplary embodiment, the present disclosure provides a
method for
delivery of an IOL into an eye. The method comprises attaching an IOL
cartridge to a handpiece.
The IOL cartridge comprises a nozzle and a compartment comprising an IOL. The
nozzle is in
fluid communication with the compartment. The IOL cartridge also includes a
retractable cap that
covers the nozzle and the compartment. The IOL cartridge may also include a
plunger case that is
in fluid communication with the compartment, wherein a plunger is movably
disposed within the
plunger case. The method further includes retracting the retractable cap to
expose the nozzle and
fold the IOL.
[0007] It is to be understood that both the foregoing general description and
the following
detailed description are exemplary and explanatory in nature and are intended
to provide an
understanding of the present disclosure without limiting the scope of the
present disclosure. In that
regard, additional aspects, features, and advantages of the present disclosure
will be apparent to
one skilled in the art from the following detailed description.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0008] These drawings illustrate certain aspects of some of the embodiments of
the present
disclosure and should not be used to limit or define the disclosure.
[0009] FIG. 1 illustrates a top perspective view of an insertion tool
including an IOL
cartridge with a retractable cap in an initial non-retracted position, in
accordance with some
embodiments of the present disclosure;
[0010] FIG. 2 illustrates a cutaway top perspective view of the IOL cartridge,
in
accordance with some embodiments of the present disclosure;
[0011] FIG. 3 illustrates a cutaway top view of the IOL cartridge, in
accordance with some
embodiments of the present disclosure;
[0012] FIG. 4 illustrates a cutaway top view of the IOL cartridge with the
retractable cap
in an initial non-retracted position, in accordance with some embodiments of
the present
disclosure;
[0013] FIG. 5 illustrates a cutaway side view of the IOL cartridge with the
retractable cap
in the initial non-retracted position, in accordance with some embodiments of
the present
disclosure;
[0014] FIG. 6 illustrates a top perspective view of the insertion tool
including the IOL
cartridge with the retractable cap in a retracted position, in accordance with
some embodiments of
the present disclosure;
[0015] FIG. 7 illustrates a cutaway top view of an IOL cartridge with the
retractable cap
in a retracted position, in accordance with some embodiments of the present
disclosure;
[0016] FIG. 8 illustrates a cutaway side view of the IOL cartridge with the
retractable cap
in the retracted position, in accordance with some embodiments of the present
disclosure;
[0017] FIG. 9 illustrates a side cross-sectional view of an IOL cartridge
removably
attached to a handpiece; and
[00181 FIGS. 10A and 10B illustrate implantation of an IOL in accordance with
some
embodiments of the present disclosure.
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DETAILED DESCRIPTION
[0019] For the purposes of promoting an understanding of the principles of the
present
disclosure, reference will now be made to the implementations illustrated in
the drawings and
specific language will be used to describe them. It will nevertheless be
understood that no
limitation of the scope of the disclosure may be intended. Any alterations and
further modifications
to the described devices, instruments, methods, and any further application of
the principles of the
present disclosure are fully contemplated as would normally occur to one
skilled in the art to which
the disclosure relates. In particular, it may be fully contemplated that the
features, components,
and/or steps described with reference to one or more implementations may be
combined with the
features, components, and/or steps described with reference to other
implementations of the
present disclosure. For simplicity, in some instances the same reference
numbers are used
throughout the drawings to refer to the same or like parts.
[0020] Embodiments of the present disclosure provide an intraocular lens
cartridge ("IOL
cartridge") that folds the IOL upon retraction of a cap. The cap may initially
cover, in a non-
retracted position, a nozzle of the IOL cartridge to protect the nozzle from
any damage during
storage and/or shipping. Retracting the cap exposes the nozzle and also
actuates a folding
mechanism of the IOL cartridge to fold the IOL for delivery into an eye. The
IOL cartridge may
be a preloaded cartridge that is preloaded with the IOL. The IOL cartridge may
be part of a modular
delivery system that includes a universal interface for removable attachment
to various handpieces
that include different types of drive mechanisms.
[0021] Particular embodiments of the present disclosure allow
interchangeability between
different handpieces such as disposable and reusable handpieces, and the IOL
cartridge. The
disposable handpieces may include manual drive mechanisms (e.g., manually
actuated via pushing
or screwing, and/or manually actuated via a fluid or a resilient member such
as a spring) that are
not electrically powered. The reusable handpieces may include the manual drive
mechanisms as
well as electrically powered drive mechanisms (e.g., stator windings). It
should be noted that these
types of handpieces are examples and that other types of handpieces or drive
mechanisms may be
utilized in accordance with particular embodiments of the present disclosure.
[0022] Particular embodiments of the present disclosure allow assembling of
the handpiece
to the IOL cartridge, delivering the IOL, and disengaging the handpiece from
the used IOL
cartridge, if needed. The universal interface allows the different types of
handpieces to be easily
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paired to and utilized with the IOL cartridge for IOL implantation. A
handpiece may be secured to
the IOL cartridge by sliding an end of the handpiece over the plunger case of
the IOL cartridge to
form an insertion tool. Once the insertion tool is formed, the IOL may be
delivered into an eye.
After the IOL implantation, the IOL cartridge can be easily detached from the
handpiece (e.g., a
reusable handpiece) by pulling the handpiece from the IOL cartridge.
[0023] FIG. 1 illustrates a top perspective view of an insertion tool 10
including an IOL
cartridge 12 with a retractable cap ("cap") 14 in an initial non-retracted
position, in accordance
with some embodiments of the present disclosure. In the illustrated
embodiment, the cap 14 may
be movably disposed over an interior housing 16 of the IOL cartridge 12. The
interior housing 16
may house a compartment 18. An IOL 26 may be disposed within the compartment
18.
[0024] The IOL 26 may be any suitable intraocular lens. The IOL 26 may include
a lens
portion 28 and haptic extensions 30. The haptic extensions 30 may be side
struts (or other suitable
extensions) extending from the lens portion 28 that may stabilize the IOL 26
when it may be
disposed within the patient's eye. It should be understood that the IOL 26
shown in FIG 1 is merely
exemplary and that techniques disclosed herein may be used with any suitable
IOL. For example,
a modular IOL (not shown) that includes a lens portion disposable in a base
with haptic extensions
can also be used.
[0025] The insertion tool 10 may also include a handpiece 29 that is removably
attached
to the IOL cartridge 12 which may include a plunger case 31. The plunger case
31 may be a rigid,
hollow, and tubular member that may be inserted into a handpiece 29. The
plunger case 31 may
be secured to the handpiece 29 via a flexible clip 38. The flexible clip 38
may extend from the
plunger case 31 through an aperture 39 of the handpiece 29. It should be noted
that various
handpieces may be used with different types of IOL cartridges. The handpiece
29 may include an
electrically powered or a non-electrically powered drive mechanism that may
include a push rod
33 extending along a length of the handpiece 29. The push rod 33 may be
movably disposed within
the handpiece 29 and may be manually actuated via a rotatable knob 35, which
may cooperate with
a fluid or a resilient member such as a spring 37 or another actuation
mechanism.
[0026] While the cap 14 is in the non-retracted position, the IOL 26 may be in
an unfolded
state, for example. A tip 19 of the cap 14 may include an aperture 17 to
expose a nozzle (not
shown) as the cap 14 is retracted, in a direction indicated by a directional
arrow 23. In general, for
the purposes of discussing and describing the various components and features
of the handpiece
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29 and the IOL cartridge 12, reference to a proximal end or direction may
refer to a direction more
towards an end of the handpiece 29 comprising the rotatable knob 35, according
to the directional
arrow 23. Likewise, reference to a distal end or direction may refer to a
direction more towards
an end of the IOL cartridge 12 comprising the tip 19, according to a
directional arrow 27.
[0027] FIG. 2 is a cutaway top perspective view of the IOL cartridge 12 of
FIG. 2 while
the cap 14 (shown on FIG. 1) is in the non-retracted position, in accordance
with particular
embodiments of the present disclosure. In the illustrated embodiment, the cap
14 is not depicted
to allow viewing of internal components beneath the cap 14 of the IOL
cartridge 12.
[0028] The interior housing 16 may include the compartment 18. The compartment
18
may include one or more mechanisms or actuators for engaging with the IOL 26
in order to fold,
splay, straighten, or otherwise manipulate the IOL 26. For example, a folding
mechanism may
include edge rollers 42 pivotably attached to the interior housing 16. The
interior housing 16 may
also include compression arms 44 that are also pivotably disposed within the
interior housing 16
via pins 46 which extend vertically through the compression arms 44 into the
housing 16 to allow
rotation (e.g., in a lateral direction) of the compression arms 44. The
compression arms 44 may
include projections 48 that may extend upward to contact internal ramps (not
shown) of the cap
14. The IOL 26 may be disposed at a center of the interior housing 16 within
the compartment 18
and between the compression arms 44 and the edge rollers 42. The IOL 26 may be
preloaded and
held in place within grooves 45 of the edge rollers 42. The edge rollers 42,
upon actuation (i.e.,
retraction of the cap 14), rotate inward and downward (e.g., vertical
rotation) to fold the IOL 26.
Simultaneously, upon actuation, the compression arms 44 laterally rotate
inward to compress the
haptic extensions 30. Once compressed and folded, the IOL 26 is ready for
delivery into an eye.
The IOL cartridge 12 may also include a nozzle 50 that is in fluid
communication with the
compartment 18. The IOL 26 may be delivered through the nozzle 50.
[0029] FIG. 3 is a cutaway top view of the IOL cartridge 12 of HG. 2 in the
non-retracted
position, in accordance with particular embodiments of the present disclosure.
In the illustrated
embodiment, the cap 14 (shown on FIG. 1) is not depicted to allow viewing of
internal components
beneath the cap 14 of the IOL cartridge 12. Pins 43 extend from the edge
rollers 42 into the interior
housing 16, thereby enabling rotation of the edge rollers 42, upon retraction
of the cap 14. Upon
depression, the cap 14 may axially move along lateral portions 47 that extend
longitudinally along
an exterior 49 of the interior housing 16. As previously noted, retraction of
the cap 14 causes
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rotation of the edge rollers 42 and the compression arms 44, thereby folding
and compressing the
IOL 26 for delivery through the nozzle 50.
[0030] FIG. 4 illustrates a cutaway top view of an IOL cartridge 12 with a cap
14 in the
non-retracted position, in accordance with particular embodiments of the
present disclosure. The
cap 14 is in the initial non-retracted position to provide protective coverage
for the nozzle 50 and
to maintain the IOL 26 (shown on FIG. 1) in a non-folded state during storing
and/or shipping of
the IOL cartridge 12_
[0031] The plunger case 31 may extend from an end of the IOL cartridge 12 that
is opposite
to the nozzle 50, as illustrated. The cap 14 may include internal ramps 52
that are aligned with the
projections 48 of the compression arms 44. The internal ramps 52 may extend
inward from lateral
portions 53 of the cap 14. The internal ramps 52 may be configured to guide
the projections 48
along the internal ramps 52, as the cap 14 is retracted (indicated by the
directional arrow 23). The
compression arms 44 may rotate inward (e.g., lateral rotation) as the cap 14
is advanced and the
projections 48 move along the internal ramps 52, thereby compressing the
haptic extensions 30
(e.g., shown on FIG. 1).
[0032] FIG. 5 illustrates a cutaway side view of the IOL cartridge 12 with the
cap 14 in the
non-retracted position, in accordance with particular embodiments of the
present disclosure.
Although not illustrated, an opposite side of the cap 14 is configured
similarly to the side that is
depicted. The cap 14 is in the initial non-retracted position. The cap 14 may
include an internal
ramp 54 that is aligned with a lower portion 56 of the edge roller 42. The
internal ramp 54 may
extend upward and may be configured to receive and lift or raise the lower
portion 56 of the edge
roller 42, as the cap 14 is retracted (indicated by the arrow 23). As the
lower portion 56 of the edge
roller 42 is contacted by the internal ramp 54, the lower portion 56 may be
pushed upward due to
the inclined surface of the internal ramp 54, as the cap 14 is further
retracted or moved in the
direction indicated by the arrow 23. As the lower portion 56 of the edge
roller 42 is raised, the
edge roller 42 may rotate vertically to fold the IOL 26 (shown on FIG. 1).
Therefore, as the cap 14
is retracted (indicated by the arrow 23), both internal ramps 54 (one on
either side of the cap 14)
may contact the lower portions 56 of the edge rollers 42 and vertically rotate
the edge rollers 42,
thereby folding the IOL 26.
[0033] FIG. 6 illustrates a top perspective view of the insertion tool 10
including the IOL
cartridge 12 with the cap 14 in a retracted position, in accordance with some
embodiments of the
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present disclosure. While the cap 14 is in the retracted position, the IOL 26
(not shown) is in a
folded and compressed state. In the illustrated embodiment, the cap 14 has
been retracted such that
the nozzle 50 has passed through the aperture 17 of the cap 14, thereby
exposing the nozzle 50.
Upon depression of the push rod 33 the IOL 26 may be advanced from the IOL
cartridge 12.
[0034] FIG. 7 illustrates a cutaway top view of the IOL cartridge 12 with the
cap 14 in the
retracted position, in accordance with particular embodiments of the present
disclosure. In the
illustrated embodiment, the cap 14 is in the retracted position to expose the
nozzle 50. In this
retracted position, the internal ramps 52 have been advanced and the
projections 48 of the
compression arms 44 have moved along the internal ramps 52 to flat portions 51
of the cap 14.
The flat portions 51 are adjacent to apexes 55 of the internal ramps 52. The
projections 48 are
locked in place within recesses 57 that may be positioned in center portions
58 of the cap 14. The
recesses 57 are adjacent to the flat portions 51 and the apexes 55, while the
cap 14 is in the retracted
position. In this retracted position, the compression arms 44 are laterally
rotated inward and the
haptic extensions 30 (shown on FIG. 1) are compressed.
[0035] FIG. 8 illustrates a cutaway side view of the IOL cartridge 12 with the
cap 14 in a
retracted position, in accordance with particular embodiments of the present
disclosure. As
previously noted, the opposite side of the cap 14 may be configured similarly
to the side that is
illustrated. In the illustrated embodiment, the cap 14 is in the retracted
position and the IOL 26
(not shown) is in a folded state. The internal ramp 54 has been advanced and
the lower portion 56
of the edge roller 42 has been vertically raised and rotated and is positioned
on a flat portion 60 of
the cap 14 that may be adjacent to an apex 62 of the internal ramp 54. Upon
advancement of the
internal ramps 54 of the cap 14, the lower portions 56 of the edge rollers 42
are vertically rotated
and positioned on the flat portions 60, and the IOL 26 is in a folded state.
[0036] FIG. 9 illustrates a side cross-sectional view of the insertion tool 10
that includes
the IOL cartridge 12 removably attached to the handpiece 29 in accordance with
particular
embodiments of the present disclosure. In the illustrated embodiment, the cap
14 is retracted and
the nozzle 50 is exposed. An interior portion 73 of the cap 14 is exposed to
the compartment 18.
The plunger case 31 may be disposed within a housing 69 of the handpiece 29
and secured therein
via the flexible clip 38 (shown on FIG. 1). The plunger case 31 is in fluid
communication with the
compartment 18. A plunger 72 may be movably disposed within the plunger case
31. The plunger
72 may be an elongated rigid member extending lengthwise within the plunger
case 31. The push
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rod 33 of the handpiece 29 may be actuated to advance the plunger 72 forward
to deliver the IOL
26, in the folded and compressed state, from the compartment 18 through a
passage 74 and the
nozzle 50, and into a patient's eye. The passage 74 may extend from the
compartment 18 and
through the nozzle 50. After delivery of the IOL 26, the nozzle 50 may be
removed from the
patient's eye, and the handpiece 29 may be pulled from the IOL cartridge 12 to
disengage the IOL
cartridge 12 from the handpiece 29. The flexible clip 38 (shown on FIG. 1) may
be depressed to
unlock the IOL cartridge 12 from the handpiece 29. The used IOL cartridge 12
may then be
disposed.
[0037] With reference to FIGS. 1-9, an exemplary technique for assembling the
IOL
cartridge 12 (e.g., shown on FIG. 1) to a handpiece (e.g., the handpiece 29
shown on FIG. 1) to
form the insertion tool 10 (e.g., shown on FIG. 1) in accordance with
particular embodiments of
the present disclosure is described as follows.
[0038] First, the plunger case 31 of the IOL cartridge 12 with the cap 14 in a
non-retracted
position (e.g., see FIG. 1) may be inserted into the handpiece 29 (e.g., see
FIG. 1) thereby securing
(e.g., via the flexible clip 38 shown on FIG. 1) the IOL cartridge 12 to the
handpiece 29 to form
the insertion tool 10. Then, the cap 14 may be retracted to expose the nozzle
50 (e.g., see FIG. 6).
As the cap 14 is retracted (e.g., see FIGS. 7 and 8), the IOL 26 may be folded
and compressed
(e.g., see FIGS. 7 and 8). As previously mentioned, in additional or
alternative embodiments, in
addition to or instead of folding the IOL 26, the cap 14 and internal housing
16 of the IOL cartridge
12 may be configured such that retraction of the cap 14 causes one or more
portions of the IOL
26, such as the haptic extensions 30,10 be straightened or splayed. Upon
actuation of the push rod
33 (e.g., see FIG. 1), the plunger 72 advances forward to deliver the IOL 26
from the compartment
18 through the nozzle 50 (e.g., see FIG. 9).
[0039] To disassemble the insertion tool 10 after delivery of the IOL 26, the
IOL cartridge
12 may be pulled out from the handpiece 29 thereby sliding the plunger case 31
out from the
handpiece 29 to form a separate IOL cartridge 26 and a separate handpiece 29.
[0040] FIGS. 10A and 10B illustrate an exemplary technique for implantation of
the IOL
26 into an eye 76 of a patient in accordance with particular embodiments of
the present disclosure.
FIG. 10A illustrates an incision 80 that may be made in the eye 76 by a
surgeon. For example, the
incision 80 may be made through the sclera of the eye 76. The incision 80 may
be a suitable width
or length. Without limitation, the suitable width and/or length may be less
than 3 millimeters, and
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in some instances may be less than 2 millimeters. After the incision 80 is
made, the nozzle 50 of
the insertion tool 10 may be inserted through the incision 80 into an interior
portion of the eye 76.
The insertion tool 10 may be actuated to dispense the IOL 26 into a capsular
bag 88 of the eye 76,
as shown on FIG. 1013.
[0041] The IOL 26 may be delivered in a folded (or rolled configuration) and
allowed to
unfurl after ejection from the insertion tool 10. Upon dispensation, the IOL
26 should unfurl and
settle within the capsular bag 88 of the eye 76, as shown on FIG. 10B. The
haptic extensions 30
may be manipulated, for example, to engage an equator of the capsular bag 88.
The haptic
extensions 30 may engage the capsular bag 88 to secure the IOL 26 in the
capsular bag 88.
[0042] Use of the methods and systems described herein may provide numerous
benefits
and advantages over other IOL delivery systems. For example, folding or other
manipulation of
the IOL may be streamlined. The integrated functionality of the folding or
other manipulation of
the IOL 26 with the retraction of the cap 14 of the IOL cartridge 12 may
ensure that the IOL
insertion tool 10 is used correctly and may guard against potential user
errors. For example, in
order to expose the nozzle 50 of the IOL cartridge 12, the cap 14 must first
be retracted, thus
causing the IOL 26 to be folded and put into a proper configuration for
delivery. This integrated
functionality of the retractable cap 14 may thus ensure that a proper sequence
of steps for
preparing, configuring, and delivering an IOL are followed, and therefore may
guard against
premature delivery or ejection of the IOL 26 prior to proper folding or other
configuring.
[0043] Additionally, the interchangeable utilization between different drive
mechanisms
and the preloaded IOL cartridge offers a simplified and uniform process for
pairing drive
mechanisms to preloaded IOL cartridges. Thus, a variety of handpieces
employing different types
of drive mechanisms may be used with each of numerous different types of IOL
cartridges, and
therefore different types of IOLs. For example, a user may readily select
between multiple types
of drive mechanisms he or she wishes to use depending on the type of IOL
and/or the type of IOL
cartridge. Additionally, while one user may prefer to use a first type of
drive mechanism handpiece
for a given IOL cartridge, a different user may have the option of using a
second type of drive
mechanism handpiece for the same given type of IOL cartridge. Importantly, by
allowing for a
common, or standard interface for securing the handpieces to the IOL
cartridges, the user
experience of securing a handpiece to an IOL cartridge may be substantially
the same, regardless
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of the type of drive mechanism or type of IOL cartridge, and thus IOL, being
used, which may
also increase ease-of-use for an operator as well as streamline IOL delivery
procedures.
[0044] It is believed that the operation and construction of the present
disclosure will be
apparent from the foregoing description. While the apparatus and methods shown
or described
above have been characterized as being preferred, various changes and
modifications may be made
therein without departing from the spirit and scope of the disclosure as
defined in the following
claims.
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