U.S. patent application number 15/154841 was filed with the patent office on 2017-05-11 for intraocular lens insertion apparatus and lens case.
The applicant listed for this patent is ABBOTT MEDICAL OPTICS INC.. Invention is credited to Steven R. Anderson, Mark S. Cole, Nicholas E. Martin, Rod T. Peterson.
Application Number | 20170128196 15/154841 |
Document ID | / |
Family ID | 38107441 |
Filed Date | 2017-05-11 |
United States Patent
Application |
20170128196 |
Kind Code |
A1 |
Cole; Mark S. ; et
al. |
May 11, 2017 |
Intraocular Lens Insertion Apparatus and Lens Case
Abstract
A lens case for storing an intraocular lens contains a housing
for storing an intraocular lens and a support member configured to
support the intraocular lens. The support member includes a
plurality of jaws, the jaws having a closed configuration for
holding the intraocular lens and an open configuration for
releasing the intraocular lens. The lens case further comprises a
passage formed when the jaws are in the open configuration, the
passage including an opening in the lens case for transfer of the
intraocular lens into an intraocular lens inserter. The lens case
may further comprise an intraocular lens that is disposed between
the jaws, the intraocular lens comprising an optic and a haptic
coupled to the optic. The lens case may be configured to maintain
the haptic in either a first position in which a distal portion of
the haptic is disposed farther from the optic or a second position
in which the distal portion of the haptic is disposed closer to
optic. Preferably, the lens case is configured to provide the
second position during transfer of the intraocular lens into an
inserter and/or inserter cartridge.
Inventors: |
Cole; Mark S.; (Trabuco
Canyon, CA) ; Martin; Nicholas E.; (Irvine, CA)
; Anderson; Steven R.; (Rancho Santa Margarita, CA)
; Peterson; Rod T.; (Tustin Ranch, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT MEDICAL OPTICS INC. |
Santa Ana |
CA |
US |
|
|
Family ID: |
38107441 |
Appl. No.: |
15/154841 |
Filed: |
May 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11627931 |
Jan 26, 2007 |
9339374 |
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15154841 |
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11056501 |
Feb 11, 2005 |
8562674 |
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11627931 |
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60762918 |
Jan 26, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/1678 20130101;
A61F 2/1664 20130101; A61F 2/1662 20130101; A61F 2/1691
20130101 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
Claims
1. A lens case for storing an intraocular lens, comprising: a
housing for storing an intraocular lens; a support member
configured to support the intraocular lens, the support member
comprising a plurality of jaws, the jaws having a closed
configuration for holding the intraocular lens and an open
configuration for releasing the intraocular lens; and a passage
formed when the jaws are in the open configuration, the passage
including an opening in the lens case for transfer of the
intraocular lens into an intraocular lens inserter.
2. The lens case of claim 1, wherein the plurality of jaws comprise
a first jaw and a second jaw that move from the closed
configuration to the open configuration upon engagement between the
lens case and the inserter.
3. The lens case of claim 2, further comprising a locking mechanism
to maintain the jaws in the open configuration upon engagement
between the lens case and the inserter
4. The lens case of claim 3, wherein the locking mechanism
comprises a projection protruding from the first jaw having a
distal end, the distal end of the projection configured to engage a
portion of the second jaw when the first and second jaws are in the
open configuration.
5. The lens case of claim 1, wherein the first and second jaws have
a bias toward the closed configuration.
6. The lens case of claim 5, wherein the first jaw is pivotally
attached to a first arm and the second jaw is pivotally attached to
a second arm, the bias being produced by a spring force between the
first arm and the second arm.
7. The lens case of claim 5, wherein the first jaw has a first
proximal end and the second jaw has a second proximal end, the
first and second proximal ends being fixed relative to one another,
the first jaw and the second jaw being made of a resilient material
and disposed relative to one another so as to produce the bias.
8. The lens case of claim 1, wherein the plurality of jaws comprise
a top jaw, a bottom jaw, a right jaw, and a left jaw, at least one
of the top and bottom jaws or the left and right jaws move from the
closed configuration to the open configuration upon engagement
between the lens case and the inserter.
9. The lens case of claim 1, further comprising an intraocular lens
disposed between the jaws, the intraocular lens comprising an optic
configured to focus light onto the retina of the eye when placed
inside the eye and a haptic coupled to the optic for holding the
optic within the eye.
10. The lens case of claim 9, wherein the lens case is configured
to transfer the intraocular lens to inserter upon engagement of the
lens case and the inserter.
11. The lens case of claim 9, further comprising a triggering
device configured to transfer the intraocular lens into the
inserter upon engagement between the lens case and the
inserter.
12. The lens case of claim 11, wherein the triggering device is a
push member configured to be pushed during transfer of the
intraocular lens into the inserter.
13. The lens case of claim 11, wherein the triggering device is a
tab configured to be moved during transfer of the intraocular lens
into the inserter.
14. The lens case of claim 11, wherein the triggering device is a
cap configured to be moved during transfer of the intraocular lens
into the inserter.
15. The lens case of claim 9, wherein the lens case is configured
to maintain the haptic in either a first position in which a distal
portion of the haptic is disposed farther from the optic or a
second position in which the distal portion of the haptic is
disposed closer to optic, the lens case configured to provide the
second position during transfer of the intraocular lens into an
inserter.
16. The lens case of claim 15, wherein first position is a storage
position and the second position is a transfer position.
17. The lens case of claim 15, wherein the lens case is configured
to maintain the haptic in the second position during transfer of
the intraocular lens into the inserter.
18. The lens case of claim 15, wherein the lens case is configured
to automatically move the haptic from the first position to the
second position as the lens case engages the inserter.
19. The lens case of claim 15, wherein the distal portion of the
haptic is disposed either above or below at least a portion of the
optic when the haptic is in the second position.
20. The lens case of claim 15, wherein the first position is
configured to maintain the haptic in a lower stress condition for
storage of the intraocular lens and the second position is
configured to place the haptic in a higher stressed condition for
transferring the intraocular lens into the inserter.
21. The lens case of claim 15, further comprising a triggering
device configured to actuate movement of the haptic from the first
position to the second position.
22. The lens case of claim 21, wherein the triggering device is a
push member configured to be pushed in order to actuate movement of
the haptic from the first position to the second position.
23. The lens case of claim 21, wherein the triggering device is a
tab configured to be moved in order to actuate movement of the
haptic from the first position to the second position.
24. The lens case of claim 21, wherein the triggering device is a
cap configured to cover an opening of the lens case when the haptic
is in the first position.
25. The lens case of claim 15, wherein the plurality of jaws
comprises a top jaw and a bottom jaw.
26. The lens case of claim 25, wherein the top jaw comprises
folding means configured to move the haptic from the first position
to the second position.
27. The lens case of claim 26, wherein the folding means comprises
one or more pull line attached to the first jaw and configured to
be operably coupled to the first and second haptics so as to change
the intraocular lens from the first configuration to the second
configuration as the jaws are separated.
28. The lens case of claim 26, wherein the folding means comprises
a rotation device rotationally coupled to the intraocular lens, the
rotation device configured to rotate and to move the haptic from
the first position to the second position.
29. The lens case of claim 26, wherein the folding means comprises
an insert having first and second ends, at least one of the ends
attached to the top jaw and configured to operably engage the
haptic so as to move the haptic from the first position to the
second position.
30. A lens case for storing an intraocular lens, comprising: an
intraocular lens comprising an optic configured to focus light onto
the retina of an eye when placed inside the eye and a haptic
coupled to the optic for holding the optic within the eye; a
housing for storing the intraocular lens; a support member
configure to support the intraocular lens; and a shuttle configured
to move the haptic to a predetermined position relative to the
optic; a transfer mechanism configured to transfer the intraocular
lens and the shuttle together into an inserter.
31. An insertion system for delivering an intraocular lens into the
eye of a subject, comprising: a lens case comprising: a housing for
storing an intraocular lens; a support member configured to support
the intraocular lens, the support member comprising a plurality of
jaws, the jaws having a closed configuration for holding the
intraocular lens and an open configuration for releasing the
intraocular lens; and a passage formed when the jaws are in the
open configuration, the passage configured to allow transfer of the
intraocular lens into an inserter for placing the intraocular lens
into an eye of a subject; and an inserter comprising: a load
chamber configured to receive the intraocular lens from the lens
case; and an insertion tube coupled to the load chamber for
delivering the intraocular lens into an eye.
32. The insertion system of claim 31, further comprising an
intraocular lens disposed between the jaws, the intraocular lens
comprising an optic configured to focus light onto the retina of
the eye when placed inside the eye and a haptic coupled to the
optic for holding the optic within the eye.
33. The insertion system of claim 32, further comprising a shuttle
configured to move the haptic into a predetermined position
relative to the optic prior to or during transfer of the
intraocular lens from the load chamber.
34. The insertion system of claim 33, wherein the shuttle is
further configured to move together with the intraocular lens as
the intraocular lens is transferred into the insertion tube.
35. The insertion system of claim 33, wherein the shuttle is
configured to maintain the haptic in the predetermined position as
the intraocular lens moves into the insertion tube.
36. The insertion system of claim 31, wherein the inserter further
comprises: a nosepiece disposed at a distal end of the inserter,
the nose piece comprising a rotational axis substantially
perpendicular to the longitudinal axis and a load chamber with a
transfer interface for receiving an intraocular lens; the nosepiece
adapted to rotate approximately 180 degrees about the rotational
axis between a first orientation for loading the intraocular lens
and a second orientation for delivering the intraocular lens into
the eye of a subject.
37. The insertion system of claim 31, the inserter further
comprising an insertion tube having surface that is disposed at an
offset angle relative to an axis of travel of an insertion rod
axis, the offset angle being between about 1 degree and about 10
degrees.
38. A method of preparing an intraocular lens for delivery into the
eye of a subject, comprising: providing an inserter for delivering
an intraocular lens into the eye of a subject, the inserter
comprising a load chamber for receiving the intraocular lens;
providing a lens case, comprising: a housing for storing the
intraocular lens; and a support member configured to support the
intraocular lens, the support member comprising a plurality of
jaws, the jaws having a closed configuration for holding the
intraocular lens and an open configuration for releasing the
intraocular lens; engaging the lens case with the inserter; moving
the jaws to the open configuration; disengaging the lens case from
the inserter; and transferring the intraocular lens to the
inserter.
Description
RELATED APPLICATION
[0001] The present application claims priority to and is a
divisional of U.S. application Ser. No. 11/627,931, filed Jan. 26,
2007, which is a continuation-in-part of and claims priority to
U.S. application Ser. No. 11/056,501, filed Feb. 11, 2005 and to
provisional application No. 60/762,918, under 35 U.S.C
.sctn.119(e), which was filed on Jan. 26, 2006, the entire contents
of which are hereby incorporated by reference in their entirety for
all purposes as if fully set forth herein.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] The present invention relates to devices, systems, and
methods for delivering an intraocular lens into an eye. More
particularly, the invention relates to devices, systems, and
methods in which the intraocular lens is loaded from the front end
of the device.
[0004] Description of the Related Art
[0005] Intraocular lenses (IOLs) may be implanted in the eye of a
subject to replace the natural crystalline lens or to otherwise
modify the vision of an eye containing either the natural lens or
another IOL. IOLs commonly include an optic and one or more
flexible fixation members or haptics extending from the optic to
secure and center the optic within the eye. When the IOL replaces
the natural lens, the natural lens must first be removed, for
instance, using a phacoemulsification system. The IOL is then
generally implanted using an insertion apparatus or device that
rolls, folds, or otherwise configures the lens for delivery through
a small incision in the eye in a way that reduces trauma and
expedites post-surgery healing.
[0006] Inserters for delivering IOLs into the eye generally employ
a cartridge having a hollow insertion tube or cannula through which
the folded IOL is passed using a pushrod. The inserter may be
designed for reuse, in which case the inserter components are
usually made of some type of metal alloy. Alternatively, disposable
inserters may be used that are made of less expensive materials,
such as plastics, and that remain in a sterile package until ready
for use. The pushrod and insertion tube may be designed to
advantageously provide the surgeon precise control of the IOL as it
is placed inside the eye, for example as disclosed in U.S. Pat. No.
6,093,193, herein incorporated by reference.
[0007] One problem encountered with existing inserters is
difficulty in loading the IOL into the inserter. The IOL is
typically manually moved from a sterile environment to an inserter
or associated cartridge using forceps or tweezers. Manual transfer
of the IOL presents difficulties in maintaining both sterility of
the IOL and the correct orientation of the IOL within the cartridge
or inserter. Improper orientation of the IOL can result in
inadequate surgeon control and even damage to the IOL during
delivery into the eye.
[0008] These problems may be mitigated by preloading the IOL at the
manufacturer into a cartridge or container that is designed to
attach directly to the inserter during transfer of the IOL. The
cartridge or container may be attached to the inserter either at
the manufacturer or by the user just prior to surgery. In either
case, the IOL is generally not stored directly in the inserter,
since it is desirable to maintain the IOL in an unstressed state
during storage in order to prevent deformation of the optic
element. Thus, some type of transfer process is still generally
necessary for loading the IOL into the inserter.
[0009] Prior to transferring the IOL into the inserter, the IOL
stored in an unstressed state inside some type of storage case.
During loading, the storage case is typically attached above or to
one side of a load chamber that is in line with a pushrod used
during insertion of the IOL into an eye. As the IOL is loaded into
the load chamber, various means and mechanisms known in the art may
be used to manipulate the IOL from an unstressed storage state to a
state more suitable for delivery of the IOL into the eye of a
subject or patient. In transferring the IOL from the holding
chamber, the IOL is thus moved along an axis that is normal to the
longitudinal axis of travel of the inserter pushrod. Such designs
require relatively complex mechanisms to move IOL along two
substantially orthogonal axes (i.e., the transfer axis and the
longitudinal axis of the inserter pushrod). Another potential
problem with such loading configurations is that the mechanisms for
transferring the IOL may fail to provide adequate visibility of the
IOL within the inserter. Inadequate visibility of the IOL makes it
more difficult to provide adequate lubrication and ensure proper
orientation and of the IOL.
[0010] It would be advantageous to provide devices, systems, and
methods to better facilitate the transfer of IOLs into an inserter
and/or placement of IOLs into the eye of a subject during an ocular
surgery.
SUMMARY OF THE INVENTION
[0011] The present invention relates to devices, systems, and
methods for delivering an intraocular lens into the eye of a
subject or patient that addresses at least some of the problems
discussed above. Using embodiments of the invention, an intraocular
lens may be transferred from a storage case to an inserter
handpiece and/or inserter cartridge in preparation for placement
into the eye of the subject. In certain embodiments, portions of
the intraocular lens, such as the optic or haptics, may be
manipulated during transfer into the inserter handpiece from a
configuration that is more suitable for storage of the intraocular
lens to a configuration that is more suitable for insertion into
the eye.
[0012] One aspect of the present invention involves a lens case for
storing an intraocular lens. The lens case comprises a housing for
storing an intraocular lens and a support member configured to
support the intraocular lens. The support member comprises a
plurality of jaws, the jaws having a closed configuration for
holding the intraocular lens and an open configuration for
releasing the intraocular lens. The lens case further comprises a
passage formed when the jaws are in the open configuration, the
passage including an opening in the lens case for transfer of the
intraocular lens into an intraocular lens inserter or inserter
cartridge for placing the intraocular lens into an eye of a
subject. The lens case may further comprise an intraocular lens
that is disposed between the jaws, the intraocular lens comprising
an optic and a haptic coupled to the optic. The lens case may be
configured to maintain the haptic in either a first position in
which a distal portion of the haptic is disposed farther from the
optic or a second position in which the distal portion of the
haptic is disposed closer to optic. Preferably, the lens case is
configured to provide the second position during transfer of the
intraocular lens into an inserter and/or inserter cartridge.
[0013] In another aspect of the invention, the above lens case is
part of an insertion system for delivering an intraocular lens into
the eye of a subject. The insertion system further comprises an
inserter configured for receiving the intraocular lens from the
lens case and for placing the intraocular lens into the eye of the
subject. The inserter comprises a load chamber configured to
receive the intraocular lens from the lens case and an insertion
tube coupled to the load chamber for delivering the intraocular
lens into an eye. The inserter may further comprise a nosepiece or
cartridge disposed at a distal end of the inserter, the nosepiece
comprising a rotational axis substantially perpendicular to the
longitudinal axis and a load chamber with a transfer interface for
receiving an intraocular lens. The nosepiece may be adapted to
rotate approximately 180 degrees about the rotational axis between
a first orientation for loading the intraocular lens and a second
orientation for delivering the intraocular lens into the eye of a
subject.
[0014] In yet another aspect of the invention, a lens case for
storing an intraocular lens comprises an intraocular lens including
an optic and a haptic coupled thereto, a housing for storing the
intraocular lens, a support member configure to support the
intraocular lens, and a transfer mechanism. The lens case may
further comprise a shuttle that is configured to move with the
intraocular lens so as to carry and/or support the intraocular lens
during transfer from the lens case to an inserter or cartridge that
is used to place the intraocular lens into the eye of a subject. In
some embodiments, the shuttle is replaced by or supplemented by a
haptic manipulator or haptic folder that is configured to move the
haptic to a predetermined position relative to the optic, for
example, during transfer of the lens from the lens case to the
inserter.
[0015] In still another aspect of the present invention, a method
of preparing an intraocular lens for delivery into the eye of a
subject comprises providing an inserter for delivering an
intraocular lens into the eye of a subject, the inserter comprising
a load chamber for receiving the intraocular lens. The method also
comprises providing a lens case according to an embodiment of the
invention that includes a plurality of jaws for holding an
intraocular lens. The method additionally comprises engaging the
lens case with the inserter and moving the jaws from a closed
configuration to an open configuration. The method further
comprises disengaging the lens case from the inserter and
transferring the intraocular lens to the inserter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the present invention will be better
understood from the following detailed description when read in
conjunction with the accompanying drawings. Such embodiments, which
are for illustrative purposes only, depict the novel and
non-obvious aspects of the invention. The drawings include the
following figures, with like numerals generally indicating like
parts:
[0017] FIG. 1 is a side view of an insertion system according to an
embodiment of the invention showing a lens case and an inserter
with a nosepiece disposed in a load position.
[0018] FIG. 2 is a top view of a nosepiece of the inserter
illustrated in FIG. 1.
[0019] FIG. 3 is an end view of the inserter illustrated in FIG.
1.
[0020] FIG. 4 is a side view of the inserter illustrated in FIG. 1
showing the nosepiece disposed in an intermediate position.
[0021] FIG. 5 is a side view of the inserter illustrated in FIG. 1
showing the nosepiece disposed in a delivery position.
[0022] FIG. 6 is a perspective view of an inserter according to an
embodiment of the invention showing an intraocular lens disposed
for insertion into the eye of a subject.
[0023] FIG. 7 is a top view of a container according to an
embodiment of the invention for holding an insertion system that
includes an inserter and a lens case.
[0024] FIG. 8 illustrates a surgical system according to the
present invention for performing an ocular surgery.
[0025] FIG. 9 is a block diagram illustrating a method according to
an embodiment of the present invention for delivering an
intraocular lens into eye of a subject.
[0026] FIG. 10 is a top view of the insertion system shown in FIG.
1 illustrating engagement of the lens case with the nosepiece.
[0027] FIG. 11 is a top view of the insertion system shown in FIG.
1 illustrating disengagement of the lens case from the
nosepiece.
[0028] FIG. 12 is a block diagram illustrating a method according
to an embodiment of the present invention for packaging and
providing an insertion system to a user for delivery of an
intraocular lens into the eye of a subject.
[0029] FIG. 13a is a top view of a lens case according to
embodiments of the invention for holding an intraocular lens.
[0030] FIG. 13b is a side view of the lens case in FIG. 13a showing
a pair of jaws in a closed configuration.
[0031] FIG. 13c is a side view of the lens case in FIG. 13a showing
a pair of jaws in an open configuration.
[0032] FIG. 13d is a perspective view of the components of lens
case in FIG. 13a.
[0033] FIG. 14a is another embodiment of a lens case according to
the invention showing a pair of jaws in a closed configuration.
[0034] FIG. 14b is a side view of another embodiment of a lens case
according to the invention showing a pair of jaws in an open
configuration.
[0035] FIG. 15 is a perspective view of the components of the lens
case in FIG. 14a.
[0036] FIGS. 16a and 16b are top views of another embodiment of a
lens case according to the invention showing means for moving at
least one haptic.
[0037] FIG. 16c is a side view of the lens case shown in FIGS. 16a
and 16b.
[0038] FIG. 17a is a top view of another embodiment of a lens case
according to the invention showing a cap for moving at least one
haptic.
[0039] FIG. 17b is a side of the lens case shown in FIG. 17a.
[0040] FIG. 18a is a top view and a side top view of another
embodiment of a lens case according to the invention showing means
for rotating an intraocular lens.
[0041] FIG. 18b is a top view and a side top view of the lens case
shown in FIG. 18a showing the haptics of an intraocular lens
wrapped about the rotating means.
[0042] FIG. 19 is a side view of another embodiment of a lens case
according to the invention showing a chord configured to move the
haptics of an intraocular lens.
[0043] FIG. 20 is a side view of another embodiment of a lens case
according to the invention showing two chords configured to move
the haptics of an intraocular lens.
[0044] FIG. 21 is a side view of another embodiment of a lens case
according to the invention showing a finger configured to move the
haptics of an intraocular lens.
[0045] FIG. 22 is a top view of another embodiment of a lens case
according to the invention comprising a haptic folder or
manipulator configured to move the haptics of an intraocular lens
relative to the optic thereof.
[0046] FIG. 23a is a top view of an intraocular lens for use in the
lens case illustrated in FIG. 22.
[0047] FIGS. 23b, 23c, and 23d are various views and embodiments of
a haptic folder illustrated in FIG. 22.
[0048] FIGS. 24a, 24b, and 24c are top views of the haptic folder
or manipulator shown in FIG. 23a showing interaction with an
intraocular lens.
[0049] FIGS. 25a, 25b, and 25c are top views of the haptic folder
or manipulator shown in FIG. 23a showing interaction with an
intraocular lens inside an inserter.
[0050] FIG. 26 is an end view of another embodiment of an inserter
according to the invention showing a rib for holding the haptics of
an intraocular lens.
[0051] FIG. 27 is a view of another embodiment of an inserter
according to the invention showing a sloped insertion tube.
[0052] FIG. 28 is a flow chart of a method according to the
invention for preparing an intraocular lens for delivery into the
eye of a subject.
[0053] FIGS. 29a, 29b, 29c, and 29d are side views showing use of
the lens cartridge shown in FIG. 13a-13d.
[0054] FIG. 30 is a flow chart of another method according to the
invention for preparing an intraocular lens for delivery into the
eye of a subject.
[0055] FIGS. 31a, 31b, 31c and 31d are side views showing use of
the lens cartridge shown in FIG. 15.
DETAILED DESCRIPTION OF THE DRAWINGS
[0056] Referring to FIGS. 1-6, in certain embodiments, an insertion
system 10 for delivering an intraocular lens 11 into the eye of a
subject comprises an inserter 14 for delivering the intraocular
lens 11 and a lens case 18 for holding the intraocular lens 11
prior to delivery into the eye by the inserter 14. The intraocular
lens 11 comprises an optic 12 that is configured, in conjunction
with the cornea of the eye and/or an additional IOL, to focus light
onto the retina of eye. The intraocular lens 11 may further
comprise one or more fixation members or haptics 13 configured to
hold and/or center the optic 12 within the eye. The inserter 14
comprises handpiece 20 having a longitudinal axis CH, a proximal
end 24, and a distal end 28. The inserter 14 further comprises a
cartridge or nosepiece 30 disposed at the distal end 28 of the
inserter 14. The nosepiece 30 has a rotational axis CR that is
substantially perpendicular to the longitudinal axis CH and a load
chamber 34 with a transfer interface 36 for receiving the
intraocular lens 11. The lens case 18 has a transfer port 40 for
delivering, moving, or transferring the intraocular lens 11 from
the lens case 18 and into the load chamber 34.
[0057] The nosepiece 30 is adapted to move or rotate between a
first position 41 suitable for loading or transferring the
intraocular lens 11 (illustrated in FIG. 1) and a second position
42 suitable for delivering the intraocular lens 11 into the eye
(illustrated in FIG. 5). For example, the nosepiece 30 may be
adapted to rotate approximately 180 degrees about the rotational
axis CR between the first position 41 and the second position 42
(compare FIGS. 1, 4, and 5). In certain embodiments, the nosepiece
30 may be adapted for placement in intermediate positions between
the first and second positions 41, 42 and/or beyond the first
position 41 or the second position 42. For example, an intermediate
position between the first and second positions 41, 42 might be
utilized for insertion of a viscoelastic or other substance either
before and/or after loading of the intraocular lens 11 into the
nosepiece 30.
[0058] Prior to use by a practitioner, the intraocular lens 11 is
preferably disposed inside the lens case 18. The lens case 18 may
be used to secure and protect the intraocular lens 11 during
shipment from the manufacturer and for storage of the intraocular
lens 11 over an extended period of time, for example, over a period
of at least about six months, one year, or even over a period of at
least 2 years to at least 4 years. The lens case 18 preferably
maintains the intraocular lens 11 in a non-stress or low-stress
condition in order to prevent permanent deformation of the optic 12
that could result in undesirable optical effects or aberrations
after placement inside an eye. The interior of the lens case 18 may
be filled or partially filled with a substances such as a liquid or
gel; for example, a viscoelastic material or OVD. Such substances
may be supplied prior to shipment by the manufacturer and/or by a
practitioner prior to transfer between the lens case 18 and the
inserter 14 (or associated lens cartridge). The viscoelastic
material may be used, for example, to protect or preserve the
intraocular lens 11 or to maintain the intraocular lens 11 in
non-stress or low stress condition.
[0059] In certain embodiments, the interior of the lens case 18 is
filled or partially filled with a balanced salt solution (BSS) or
similar fluid. In other embodiments, the interior of the lens case
18 is filled or partially filled with a viscoelastic or OVD in
combination with a BSS or similar fluid. The use of a BSS, alone or
in combination with OVD's, may favorably reduce friction. For
example, the use of a BSS may be used to increase lubricity between
the intraocular lens 11 and the internal walls of the inserter 14
(e.g., the insertion tube wall of the inserter cartridge). In
addition, a BSS, alone or in combination with OVD's, may be used to
reduce tackiness of the haptics 13, especially in the case where
the intraocular lens 11 is a one-piece intraocular lens in which
the optic and haptics are integrally fabricated from a single
material. In other embodiments, a combination of OVD's, with or
without a BSS, may be used to reduce friction or tackiness.
[0060] The lens case 18 may be disposable and made of plastic
material suited for storage and protection of the intraocular lens
11. Alternatively, at least portions of the lens case 18 be
reusable, in which case the at least portions may be made of a
metal material or some other material that may be used to increase
the strength, durability, or function of the lens case 18.
[0061] The inserter 14 may be constructed for delivery of any of
the various types of intraocular lenses known in the art. For
example, the intraocular lens 11 may be a foldable lens made of at
least one of the materials commonly used for resiliently deformable
or foldable optics, such as silicone polymeric materials, acrylic
polymeric materials, hydrogel-forting polymeric materials, such as
polyhydroxyethylmethacrylate, polyphosphazenes, polyurethanes, and
mixtures thereof and the like. In one embodiment, the inserter 14
is used with an intraocular lens 11 having an optical zone that is
made of SENSAR.RTM. brand of acrylic. Other advanced formulations
of silicone, acrylic, or mixtures thereof are also anticipated.
Selection parameters for suitable lens materials are well known to
those of skill in the art. See, for example, David J. Apple, et
al., Intraocular Lenses: Evolution, Design, Complications, and
Pathology, (1989) William & Wilkins. The lens material
preferably has a refractive index allowing a relatively thin, and
preferably flexible optic section, for example, having a center
thickness in the range of about 150 microns to about 1000 microns,
depending on the material and the optical power of the intraocular
lens 11. At least portions of the intraocular lens 11, for example
one or more haptics or fixation members, may be constructed of a
more rigid material including such polymeric materials as
polypropylene, polymethylmethacrylate PMMA, polycarbonates,
polyamides, polyimides, polyacrylates, 2-hydroxymethylmethacrylate,
poly (vinylidene fluoride), polytetrafluoroethylene and the like;
and metals such as stainless steel, platinum, titanium, tantalum,
shape-memory alloys, e.g., nitinol, and the like.
[0062] Additionally, the inserter 14 may be configured to deliver
intraocular lenses having either a single focus or producing two or
more foci using refraction, diffraction, or some combination
thereof. The inserter 14 may also be used to deliver an
accommodating intraocular lens or system of lenses, either together
or separately. The inserter 14 may be configured to deliver the
intraocular lens 11 into the capsular bag of the eye or into some
other portion of the eye, such as the anterior chamber of the eye.
The inserter 14 may be used to deliver the intraocular lens 11 into
either a phakic or aphakic eye. Additionally, the inserter 14 may
be used to deliver the intraocular lens 11 into the eye of a
subject already having an intraocular lens located either in the
capsular bag or otherwise located within or on the eye.
[0063] The transfer port 40 of lens case 18 may be used during
transfer of the intraocular lens 11 and configured to couple the
transfer interface 36 of load chamber 34. The transfer port 40 may
further comprise a cover (discussed below) for sealing the interior
of the lens case 18. The cover may be manually removed just prior
to transfer of the intraocular lens 11 into the load chamber 34.
Alternatively, the cover may be constructed to automatically move
out of the way to allow transfer of the intraocular lens 11 when
the lens case 18 engages the nosepiece 30.
[0064] As illustrated in FIG. 2, the nosepiece 30 further comprises
a delivery channel 43 for delivering the intraocular lens 11 into
the eye, the delivery channel 43 having a delivery port 44 with a
cross-sectional area that is preferably less than a cross-sectional
area of the load chamber 34. Unless otherwise indicated, the term
"cross-sectional area," as used herein, means the area of a
referenced element in a plane that is perpendicular to the
longitudinal axis CH of the handpiece 20. The delivery channel 43
comprises a tapered portion 46 extending from the load chamber 34
and is substantially disposed along the longitudinal axis CH when
the nosepiece 30 is disposed in the first position 41 and when the
nosepiece 30 is disposed in the second position 42. The tapered
portion 46 may be used to compress and form the intraocular lens 11
into an elongated and/or compressed configuration suitable for
delivery into the eye through the delivery port 44.
[0065] Referring to FIG. 3, the interface 36 of the nosepiece 30
may comprise an aperture 48 that is preferably substantially
centered about the longitudinal axis CH and distally located
relative to the delivery channel 43 when the nosepiece 30 is in the
first position 41. The interface 36 may alternatively or
additionally comprise other elements or means, such as a cover, for
providing protection of the intraocular lens 11 and/or for
providing transfer of the intraocular lens 11 to the inserter
14.
[0066] Referring again to FIG. 1, the inserter 14 preferably
comprises a pushrod 50 with a tip 52 that is preferably attached at
the proximal end 24 of the handpiece 20. With the inserter 14 in
the second position 42, the tip 52 of the pushrod 50 traverses
substantially along the longitudinal axis CH and may be used to
advance the intraocular lens 11 down the nosepiece 30 and into the
eye. The handpiece 20 of the inserter 14 directs the tip 52 of the
pushrod 50 along the longitudinal axis CH towards the distal end 28
and into the load chamber 34, where the tip 52 engages the
intraocular lens 11 during delivery of the intraocular lens 11.
[0067] In certain embodiments, the pushrod 50 may be configured to
traverse through the nosepiece 30 when the nosepiece 30 is in the
first position. In such embodiments, for example, the tip 52 may be
used to control one or more of the haptics of the intraocular lens
11 during transfer from the lens case 18. The pushrod 50 may also
be used to help maintain the nosepiece 30 in the first position 41,
as illustrated in FIG. 1.
[0068] The tip 52 of the pushrod 50 may engage the intraocular lens
11 using any of the devices or methods known in the art. For
example, the tip 52 of the pushrod 50 may either push against an
edge portion of the intraocular lens 11. Alternatively, the tip 52
of the pushrod 50 may engage an inner portion of the intraocular
lens 50 in order to more evenly distribute the pushing force over a
greater area of the lens surface. In other embodiments, the tip 52
of the pushrod 50 does not directly contact the intraocular lens
11, but instead engages an intermediate device or substance, such
as a viscoelastic, that distributes pressure across the intraocular
lens 11 that causes it to proceed through the nosepiece 30 and into
the eye.
[0069] The inserter 14 is adapted to receive the intraocular lens
11 from the lens case 18 and to deliver the intraocular lens 11
into the eye, for example, after the natural lens has been removed.
The inserter 14 and its various components may be made of any of
the materials common in the art such as plastic or metal. Plastic
materials are preferable if the inserter 14 is made for one-time
use or a limited number of uses before disposing of the inserter
14. Metal materials are preferable if the inserter is constructed
for reuse, where the inserter 14 is sterilized prior to each use
using either heat and/or sterilizing agents such as alcohol.
[0070] In the illustrated embodiment, a longitudinal axis CN of the
nosepiece 30 is substantially centered within the handpiece 20. The
term "substantially centered," as used here, means that a small
amount of translational or rotational offset may be present in
certain embodiments when the nosepiece 30 is in at least one of the
first and second positions 41, 42. For instance, a small amount of
translational or rotational offset may be used to provide a
predetermined amount of transverse force between the tip 52 of the
pushrod 50 and at least some portion of the nosepiece 30, as
describe in further detail below herein. In some embodiments, the
longitudinal axis CN is offset from the longitudinal axis CH of the
handpiece 20, for example, to provide a desired position of the
intraocular lens 11 relative to the tip of the pushrod 50.
[0071] The nosepiece 30 may be coupled to the handpiece 20 using
devices and means known to those of skill in the art. In certain
embodiments, the nosepiece 30 is lockably coupled to the handpiece
20 when the nosepiece 30 is in the first position 41, the second
position 42, and/or one or more intermediate positions. The means
or devices used to lock the nosepiece 30 in the first and/or second
positions 41, 42 preferably provide a locking force of sufficient
magnitude to substantially prevent the nosepiece 30 from moving
during loading of the intraocular lens 11 into the nosepiece 30
and/or delivery of the intraocular lens 11 into the eye.
Preferably, the magnitude of the locking force is low enough to
allow relatively easy manipulation of the nosepiece 30 between the
first and second positions 41, 42. Alternatively, the nosepiece 30
may be locked in the first and/or second positions using a lock
mechanism or device (e.g., a pin or spring latch) that may be
released or disengaged when manipulating the nosepiece 30 between
the first and second positions 41, 42. In one embodiment, the
nosepiece 30 is locked in the first position 41 by either pressing
the tip 52 of the pushrod 50 against the delivery port 44 of the
nosepiece 30 or by at least partially traversing the pushrod 50
through the delivery channel 43 of the nosepiece 30.
[0072] In certain embodiments, the longitudinal axis CN of the
nosepiece 30 is substantially coaxial with the longitudinal axis CH
of the handpiece 20 when the nosepiece 30 is in either the first
position 41 or the second position 42. The term "substantially
coaxial" as used herein means that the axes CH and CN are coaxial
or that there is an offset angle between the axes CH and CN when
the nosepiece 30 is in at least one of the first position 41 and
the second position 42. In other embodiments, the axes CH and CN
are offset from one another. In yet other embodiments, there is an
offset angle between the axes CH and CN in either a clockwise or
counter-clockwise direction when the nosepiece 30 is in the first
and/or second positions 41, 42 (e.g., FIG. 27). In such
embodiments, the offset angle is preferably less than about 10
degrees, more preferably less than about 5 degrees, and even more
preferably less than about 2 degree. In one embodiment, an offset
angle exist between the axes CH and CN when the nosepiece 30 is in
the second position 42 such that the pushrod 50 produces a
transverse force on at least some portion of the nosepiece 30, such
as the delivery channel 43, as the pushrod 50 advances along the
longitudinal axis CH. This transverse force may be advantageously
used to prevent the tip 52 of the pushrod from moving on top of a
portion of the intraocular lens 11 during delivery into the eye. In
other embodiments,
[0073] The nosepiece 30 may further comprise an outer surface 57
that substantially surrounds the load chamber 34 and the delivery
channel 43. Preferably, the outer surface 57 is generally tapered
from one end of the nosepiece 30 (e.g., near the transfer interface
36) having a relatively large cross-section, to an opposite end
(e.g., near the delivery port 44) having a relatively small
cross-section. The relatively small cross-section allows, among
other things, the nosepiece 30 to be inserted into a relatively
small incision in the eye, while the relatively large cross-section
allows the intraocular lens 11 to be loaded into the load chamber
34 of the nosepiece 30 in a substantially uncompressed state. The
outer surface 57 of the nosepiece 30 may further comprise a top
face 58 and a bottom face 60 containing one or more openings 62.
The openings 62 may be in the form of an aperture, notch, or some
other type of void for providing at least partial access to the
load chamber 34 and/or the delivery channel 43. For example,
referring to FIGS. 1 and 2, the bottom face 60 is disposed below
the load chamber 34 and comprises an aperture 64 that is
rectangular in shape. The aperture 64 may, of course, take other
shapes such as circle or a slit. As illustrated in FIG. 2, the top
face 58 is disposed above the load chamber 34 and comprises an
elongated notch 66. In other embodiments, for example as illustrate
in FIG. 6, the elongated notches 66 are disposed on both the top
and bottom faces 58, 60. In still other embodiments, there is only
one opening 62 on either the top face 58 or the bottom face 60.
Alternatively, one or more openings may be disposed at locations
other than or in addition to the top and bottom faces 58, 60, for
instance, on the sides of the outer surface between the top and
bottom faces 58, 60.
[0074] The openings 62 may be used to visually inspect the insides
of load chamber 34 prior to, during, or after transfer of the
intraocular lens 11 into the nosepiece 30. The opening 62 may also
be used to introduce one or more substances, for example a
viscoelastic, into the load chamber 34 or some other portion of the
nosepiece 30. Such substances may be introduced into the load
chamber 34 from the transfer interface 36 of the load chamber 34
and visually inspected via the opening 62. The opening 62 may also
be used as an overflow port through which excess amounts of
injected substances exit the load chamber 34. Other uses of the
opening 62 are consistent with embodiments of the inserter 14 or
the insertion system 10. For instance one or more openings 62 may
be configured to receive inspection instruments or tools for
manipulating or otherwise preparing the intraocular lens 11 for
delivery through the delivery channel 43 and into the eye. The
opening 62 may also be used to aid in alignment of inserter 14
components with lens case 18 components when the nosepiece 30 is in
either the first or second positions 41, 42.
[0075] Referring to FIG. 7, in certain embodiments, the insertion
system 10 further comprises a package or container 70 for holding
the inserter 14 and the lens case 18. For example, the container 70
may be in the form of a shrink-wrap package 70 illustrated in FIG.
7 and comprising top and bottom sheets of material that envelop the
inserter 14 and the lens case 18. The inserter 14 and the lens case
18 are preferably placed inside the container 70 in a sterile
environment and sealed in a manner that maintains the sterility of
the inserter 14 and the lens case 18 until they are ready for use.
Alternatively, the inserter 14 and the lens case 18 may be
sterilized after being enclosed inside the container 70. In other
embodiments, the lens case 18 and the inserter 14 are packaged in
separate containers, for example, to reduce inventory costs. In
such embodiments, the individual containers may be placed together
by the manufacturer, distributor, or user in a larger container or
package, for example, for shipping or storage. In some embodiments,
an inserter is packaged in one type of container for shipment with
one or more lens cases 18 containing intraocular lenses having, for
instance, differing Diopter powers, differing spherical aberration,
or some other optical or mechanical characteristic.
[0076] The container 70 may be made of plastic, metal, or any other
suitable material suitable for sealing the inserter 14 and the lens
case 18 and providing a sterile environment during storage.
Combinations of such material are also possible. For example, the
bottom sheet of the shrink-wrap package 70 may be made of a metal
foil, while the top sheet is made of a transparent plastic material
that is bondable to the metal foil, thus allowing visible
inspection of the inserter 14 and the lens case 18 while inside the
container 70. The container 70 may take other configurations,
besides that illustrated in FIG. 7, for example a cardboard
box.
[0077] Referring to FIG. 8, in certain embodiments, a surgical
system 80 for performing an ocular surgery comprises a
phacoemulsification system 82 having a surgical handpiece 84 for
removing the natural lens of an eye and an electronic controller 88
for controlling the fluidics of surgical handpiece 84 and/or the
phacoemulsification power into the surgical handpiece 84. The
system 80 further comprises at least one inserter, such as the
inserter 14, and at least one lens case, such as the lens case 18,
wherein the lens case 18 preferably has an intraocular lens
enclosed therein. The system 80 may include a plurality of lens
cases, such as the lens case 18, and/or inserters, such as the
inserter 14. Alternatively, the system 80 may include a plurality
of containers 70, each containing at least one inserter 14 and at
least one lens case 18, preferably containing an intraocular lens
therein. Such configurations allow a practitioner to perform
multiple surgeries. In certain embodiments, the controller 88
controls the delivery of electrical power into a transducer, such
as a piezo-electric driver, that is part of the surgical handpiece
84. In such embodiments, the piezo-electric driver changes size in
accordance with changes in the electrical voltage and/or current
provided by the controller 88. The controller 88 may also be used
to control and/or monitor the irrigation fluid entering the eye
and/or the aspiration used to remove fluid from the eye.
[0078] Referring to FIG. 9, in certain embodiments, a method 100
for delivering the intraocular lens 11 into the eye of a subject
comprises an operational block 110, which comprises providing the
insertion system 10, including the inserter 14 and the lens case
18. The method 100 further comprises an operational block 120,
which comprises disposing the nosepiece 30 in the first position
41, with the delivery channel 43 being disposed along the
longitudinal axis CH. The method 100 also comprises an operational
block 130, which comprises engaging the lens case 18 to the
nosepiece 30 such that the transfer port 40 of the lens case 18
operably connected to the transfer interface 36 of the load chamber
34. The method 100 further comprises an operational block 140,
which comprises transferring the intraocular lens 11 from the lens
case 18 into the load chamber 34. The method 100 additionally
comprises an operational block 150, which comprises disengaging the
lens case 18 from the nosepiece 30. The method 100 also comprises
an operational block 160, which comprises moving the nosepiece 30
to the second position 42, which is suitable for delivering the
intraocular lens 11 into the eye of a subject. The method 100
optionally comprise an operational block 170, which comprises
optionally removing a natural lens from the eye of a subject. The
method 100 also comprises an operational block 180, which comprises
delivering the intraocular lens 11 into the eye of a subject.
[0079] In operational block 110, the insertion system 10 may be
packaged in a container such as the container 70 illustrated in
FIG. 7. Preferably, the intraocular lens 11 is preloaded in the
lens case 18 by the manufacturer such that the intraocular lens 11
is in a sterile, unstressed environment.
[0080] In operational block 120, the nosepiece 30 is oriented in
the first position 41, as illustrated in FIG. 1. By disposing the
nosepiece 30 in this position, the load chamber 34 and the transfer
interface 36 are distally located from the remaining portions of
the inserter 14 and are thus readily accessible for transfer of the
intraocular lens 11 from the lens case 18.
[0081] Referring to FIG. 10, in operational block 130, lens case 18
is engaged with the nosepiece 30. During engagement, the lens case
18 may at least partially surround the load chamber 34 of the
nosepiece 30 such that the transfer interface 36 of the load
chamber 34 is aligned and/or coupled to the transfer port 40 of the
lens case 18. The engagement may be secured by means for at least
partially locking the lens case 18 and the nosepiece 30 together,
for example through the use of detents or spring loading. In
certain embodiments, the load chamber 34 at least partially engages
the nosepiece 30 prior to use by a practitioner and/or before
shipment by the manufacturer or distributor. In such embodiments,
the lens case 18 may be more fully engaged with the nosepiece 30 at
operational block 130 of the method 100 or, alternatively, the
operational block 130 becomes unnecessary altogether.
[0082] In operational block 140, the intraocular lens 11 is
transferred from the lens case 18 and into the load chamber 34 of
the nosepiece 30 in preparation for delivery of the intraocular
lens 11 into the eye of a subject. This operation may be totally
distinct from the engagement of the lens case 18 with the nosepiece
30 (operational block 130) or may occur simultaneously with the
lens case 18 is engaged with the nosepiece 30. In certain
embodiments, the tip 52 of the pushrod 50 may be used to manipulate
one or more haptics 13a, 13b of the intraocular lens 11 either
during transfer of the intraocular lens 11 from the lens case 18 to
the load chamber 34 and/or subsequent to the delivery of the
intraocular lens 11 into the load chamber 34.
[0083] Referring to FIG. 11, in operational block 150, the lens
case 18 is disengaged or separated from the nosepiece 30. After
disengagement, the lens case 18 may be disposed of or prepared for
receiving a new lens in the same or a subsequent surgery. Structure
and/or means may be provided for maintaining the intraocular lens
11 within the load chamber 34 of the nosepiece 30 upon
disengagement of the load chamber 34 from the nosepiece 30. For
instance, the load chamber 34 may contain one or more catches,
hooks, or similar structures for engaging one or more haptics 13a,
13b of the intraocular lens 11 as it moves into the load chamber
34. For example, FIGS. 10 and 11 illustrate a catch 71 that engages
the haptic 13a of the intraocular lens 11. During the loading of
the intraocular lens 11 into the load chamber 34, the leading edge
of the haptic 13a advances past the catch 71 in a way that prevents
or impedes the intraocular lens 11 from sliding back towards the
aperture 48 of the load chamber 34. In certain embodiments, the
catch 71 may be part of the distal tip 52 of the pushrod 50.
[0084] Referring again to FIGS. 4 and 5, in operational block 160,
the nosepiece 30 is moved to the second position is preparation for
delivery of the intraocular lens into the eye of a subject. As
illustrated in FIG. 4, moving the nosepiece 30 to the second
position 42 preferably comprises rotating the nosepiece 30 about
the rotational axis CR to the second position 42, as illustrated in
FIG. 5. As seen in FIG. 4, the nosepiece 30 is preferably rotated
in a direction such that load chamber 34 and the intraocular lens
11 are disposed above the longitudinal axis CH of the handpiece 20
during rotation from the first position 41 to the second position
42. Alternatively, rotation in the opposite direction may also be
used to rotate the nosepiece 30 from the first position 41 to the
second position 42. In certain embodiments, the nosepiece 30
rotates between the first position 41 and the second position 42
about the rotational axis CR by approximately 180 degrees. In other
embodiments, the nosepiece 30 rotates greater or less than 180
degrees, preferably in the range of about 170 degrees or less to
about 190 degrees or more, more preferably about 175 degrees to
about 185 degrees, and even more preferably between about 178
degrees and about 182 degrees.
[0085] In certain embodiments, the nosepiece 30 moves or rotates
between the first position 41 and the second position 42 in an
automated or semi-automated fashion. For example, the handpiece 20
may be configured such that nosepiece 30 rotates from the first
position 41 to the second position 42 as the pushrod 50 traverses
the longitudinal axis CH of the handpiece 20. This may be
accomplished, for instance, by using a spring, cam, and/or linkage
mechanism that is engaged by the pushrod 50 as is nears the
nosepiece 30.
[0086] Referring again to FIG. 5, in certain embodiments, moving or
rotating the nosepiece 30 from the first position 41 to the second
position 42 transversely displaces at least a portion of the haptic
13b from the pushrod 50. For instance, by rotating the nosepiece 30
in the direction indicated in FIG. 4, the haptic 13b may be
disposed above the pushrod 50 as the nosepiece 30 arrives at the
second position 42 and is pushed in an upward direction by the
pushrod 50. By disposing the haptic 13b above the pushrod 50, the
intraocular lens 11 is advantageously positioned so that the haptic
13b is not deformed or damaged by the pushrod 50 as the pushrod 50
advances the intraocular lens 11 down the delivery channel 43 for
delivery into the eye. This geometry between the pushrod 50 and the
haptic 13b is accomplished simply by moving the nosepiece 30 from
the first position 41 to the second position 42, with little or no
additional manipulation of the haptic 13b by a practitioner, such
as a surgeon or assisting nurse. Alternatively, the tip 52 of the
pushrod 50 may be moved proximally along the longitudinal axis CH
or otherwise adjusted to obtain a predetermined geometric
relationship between the intraocular lens 11 and the tip 52 of the
pushrod 50. For example, the tip 52 of the pushrod 50 may initially
be disposed along a portion of the optic body of the intraocular
lens 11 when the nosepiece 30 is rotated from the first position 41
to the second position 42. Subsequently, the tip 52 of the pushrod
50 may then be retracted slightly such that the tip 52 engages or
is disposed along the edge of the optic body of the intraocular
lens 11.
[0087] In the illustrated embodiment, the rotational axis CR of the
nosepiece 30 is generally perpendicular to the longitudinal axis CH
of the handpiece 20 and intersects, or substantially intersects,
the longitudinal axis CH of the handpiece 20. Alternatively, the
rotational axis CR may be displaced above or below the longitudinal
axis CH (not shown). For example, the rotational axis may be
disposed below the longitudinal axis CH by an amount selected to
locate the optic 12 of the intraocular lens 11 at a predetermined
vertical height relative to the tip 52 of the pushrod 50 and/or the
tip of the haptic 13b.
[0088] In certain embodiments, the nosepiece 30 may be configured
to be movable between the first position 41 and the second position
42 in a manner that combines both rotation and translation of the
nosepiece 30. For example, the nosepiece 30 may be rotated from the
first position 41 by approximately 180 degrees and then pushed back
distally along the longitudinal axis CH of the handpiece 20. The
translation motion may be used, for instance, to secure the
nosepiece 30 against the body of the handpiece 20 in preparation
for delivery of the intraocular lens 11. Other combinations of
rotation and/or translation may be use for moving the nosepiece 30
between the first position 41 and the second position 42.
[0089] In operational block 170, the natural lens may be removed,
for instance using the phacoemulsification system 82. In such
instances, the surgical handpiece 84 is used to remove the natural
lens of the eye and is under the control of the electronic
controller 88, which may be used to control the fluidics of the
surgical handpiece 84 and/or the power into the surgical handpiece
84. In certain embodiments, the controller 88 is used to adjust the
fluidics of the surgical handpiece 84 and/or power into the
surgical handpiece 84 in accordance to system conditions. The
amount of power into the surgical handpiece 84 and/or the fluidics
of the surgical handpiece 84 may be changed due to the presence of
an occlusion in an aspiration line, for example, as disclosed in
U.S. Pat. No. 5,700,240, herein incorporated by reference. The
removal of the natural lens may be performed before, during, or
after the other operational blocks of the method 100. For instance,
a nurse or assistant may perform operational blocks 110 through 160
while a surgeon is performing operational block 170. In certain
embodiments, the natural lens is not removed or has been removed
during a previous surgery and the method 100 would not include the
operational block 170. For instance, the intraocular lens 11 may be
phakic intraocular lens (e.g., an intraocular lens that is
delivered into an eye still containing the natural lens) or a lens
that is used to supplement another intraocular lens placed into the
eye during a previous surgery.
[0090] In operational block 180, the intraocular lens 11 is
delivered into the eye by advancing the lens down the delivery
channel 43 using the pushrod 50 until the lens passes through the
delivery port 44 and into the eye. The tip 52 of the pushrod 50 may
have any of the various configurations used in the art or
incorporate an innovative configuration designed to provide a
predetermined advantage. In certain embodiments, the tip 52 of the
pushrod 50 may be made of a relatively soft material and/or be
disposed to engage a portion of the intraocular lens 11, for
example a fold in the body of the intraocular lens. In other
embodiments, the tip 52 of the pushrod 50 may be made of a
relatively hard material and/or be disposed to engage an edge or
peripheral portion of the intraocular lens 11. The specific
characteristics of the pushrod 50 and the tip 52 may be selected
depending on the type of intraocular lens being delivered, for
example, depending or whether the intraocular lens 11 is made of
silicone based material or a relatively stiffer material such as an
acrylic based material. Other parameters of the intraocular lens 11
may also be used in determining the specific characteristics of the
pushrod 50 and the tip 52.
[0091] During delivery of the intraocular lens 11 into the eye, the
pushrod 50 is preferably substantially disposed along the
longitudinal axis CH. In certain embodiments, the tip 52 and/or the
pushrod 50 may be configured to provide a biasing force against at
least a portion of the delivery channel 43 during delivery of the
intraocular lens 11. Such a biasing force may be used to prevent
the tip 52 of the pushrod 50 from moving onto the intraocular lens
11, for example, when the intraocular lens 11 is made of an acrylic
material and/or the tip 52 is made of a relatively hard material.
In certain embodiments, at least a portion of the pushrod 50, for
example the tip 52 of the pushrod 50, may be offset asymmetrically
from the longitudinal axis CH. In other embodiments, at least a
portion of the pushrod 50 may have an offset angle relative to the
longitudinal axis CH. In yet other embodiments, a portion of the
inserter 14, for example the delivery channel 43, may have an
offset angle relatively to at least one of the longitudinal axis CH
and a longitudinal axis along which the tip 52 of the pushrod 50
travels.
[0092] The method 100 may additionally comprise introducing one or
more substances, for example a viscoelastic, into at least a
portion of the nosepiece 30 and/or the lens case 18. The substance
may be introduced at any time or at various times during the method
100, for example through one or more of the openings 62 or through
the transfer interface 36 of the load chamber 34.
[0093] Referring to FIG. 12, in certain embodiments, a method 200
for packaging and delivering the insertion system 10 to a user
comprises an operational block 210, which comprises providing the
inserter 14. The method 200 further comprises an operational block
220, which comprises providing the lens case 18. The method 200
also comprises an optional operational block 230, which comprises
optionally enclosing the intraocular lens 11 inside the lens case
18. The method 200 additionally comprises an operational block 240,
which comprises enclosing the inserter 14 and lens case 18 within
the container 70. The method 200 further comprises an optional
operational block 250, which comprises optionally storing the
container 70. The method 200 further includes an operational block
260, which comprises shipping the container 70.
[0094] In operational block 230, the lens case 18 preferably
contains an intraocular lens, for example the intraocular lens 11,
prior to packaging inside the container 70. Preferably, the
intraocular lens 11 is disposed inside the lens case 18 prior to
shipment by the manufacturer or distributor, so as to
advantageously maintain the intraocular lens 11 in a sterile
environment until ready for use by a practitioner or their
assistant. The intraocular lens 11 may be maintained in a low
stress or essentially stress free state inside the lens case 18,
allowing the intraocular lens 11 to be stored over long periods of
time without unwanted permanent deformation that could reduce
visual acuity or perception inside the eye.
[0095] In operational block 240, the inserter 14 and the lens case
18 are enclosed in the container 70, as illustrated in FIG. 7 and
described in greater detail above herein. The inserter 14 and the
lens case 18 are preferably packaged such that they are separate
from one another; however, other configurations are possible. For
example, the inserter 14 and the lens case 18 may be placed
adjacent to one another and sealed so as to provide a container 70
that is relatively small. Also, the lens case 18 and the nosepiece
30 may be coupled together prior to shipment to a practitioner and
placed and/or sealed inside the container 70.
[0096] In operational block 250, the container 70 is stored till
ready for shipment, distribution, or use. In operational block 260,
the container 70 is shipped by the manufacturer or distributor
either individually, as a part of a set of containers 70, or as
part of the phacoemulsification system 80. In certain embodiments,
several lens cases 18, each containing a different intraocular lens
11, may be packaged, stored, and/or shipped together to a customer
or storage location. Each container 70 may contain an intraocular
lens 18 having the same optical power as other containers 70.
Alternatively, each container 70 may have a predetermined optical
power that is different from other containers 70.
[0097] Referring to FIGS. 13a-d, in some embodiments a lens case
300, for storing an intraocular lens 301, comprises a housing 302
and a support member 304. The housing 302 is configured for holding
the intraocular lens 301 until it is ready to be transferred to the
inserter 14 or another inserter configured to engage the lens case
300. The intraocular lens 301 comprises one or more haptics 308
connected to an optic 310. The support member 304 is configured to
support the intraocular lens 301 and comprises a plurality of jaws
312, for example the top jaw 312a and the bottom jaw 312b
illustrated in FIG. 13b. The jaws 312 have a closed configuration
for confining and/or holding the intraocular lens 11, for example
as illustrated in FIG. 13b. The jaws 312 also have an open
configuration for releasing the intraocular lens 301 that is
suitable for transferring the intraocular lens 301 into the
inserter 14, for example, as illustrated in FIG. 13c. The lens case
300 is configured for transferring the intraocular lens 301 into
the inserter 14 upon or during the process of engagement and/or
subsequent disengagement between the lens case 300 and the inserter
14.
[0098] The housing 302 generally encloses the intraocular lens 301
and preferably maintains the intraocular lens 301 in a sterile
environment until it is ready to be transferred to the inserter 14.
The housing may be made of a plastic, metal, or any other material
suitable for a surgical environment. The lens case housing 302 and
the lens case 300 have a proximal end 314 and a distal end 315. An
opening 316 through which the intraocular lens 301 is transferred
is disposed on the distal end 315. The housing 302 may have
additional openings or windows, for example, for insertion of a
viscoelastic or other material, for attachment of other components
such as a pusher mechanism, or to provide visibility of intraocular
lens 301 and/or support member 304. In some embodiments, the
housing 302 and/or the rest of the lens case 300 is disposable. In
other embodiments, all or part of the lens case 300 and/or the
housing 302 are reusable. In such embodiments, the lens case 300 is
configured to allow placement of an intraocular lens into the
housing 302 by a user (e.g., a nurse, surgeon, or supplier) and is
preferably autoclavable.
[0099] The support member 304 and/or the jaws 312 are generally
configured to be biased toward a closed configuration, as
illustrated, for example, in FIG. 13b. In the closed configuration,
the intraocular lens 301 is preferably secured or held so as to
prevent damage, for example, during storage, shipping, and/or
handling prior to use. The jaws 312 may be configured such that
portions of opposing jaws (e.g., portions of top jaw 312a and
bottom jaw 312b) are touching and/or pressed against one another
when disposed in the closed configuration. In such embodiments, the
optic 310 and/or the haptics 312 may be disposed within voids
provided between mating faces of opposing jaws 312 when in the
closed configuration.
[0100] The bias may be over come, for example when the intraocular
lens 301 is to be transferred into the inserter 14, so that the
jaws 312 are in an open configuration, for example as illustrated
in FIG. 13c. In certain embodiments, the lens case 300 further
comprises means for holding or maintaining the jaws 312 in the open
configuration once the bias has been overcome. For example,
referring to FIG. 3c, the support member 304 may comprise a locking
mechanism 317 that maintains the jaws in the open configuration
upon engagement between the lens case and the inserter. The locking
mechanism may comprise a projection 318a protruding from the top
jaw 312a having a distal end that is configured to engage a portion
318b of the bottom jaw 312b when the jaws 312a, b are in the open
configuration. Variation on this approach, as well as other
devices, principles, and mechanisms, may additionally or
alternatively be used to provide the holding means. For example the
jaws 312 and/or other portions of the support member may be
configured to form magnets that attract more strongly to one
another as the jaws 312 move from the closed configuration to the
open configuration.
[0101] FIG. 13b illustrates one method of providing a predetermined
bias for maintaining the jaws 312 in the closed configuration. In
such embodiments, the top jaw 312a is pivotally attached to a first
arm 319a and the bottom jaw 312b is pivotally attached to a second
arm 319b, the bias being produced by a force, for example a spring
force, between the arms 319a, b. The bias is produces by a spring
320 that tends to push the arms 319a, 319b away from one another.
Pivots 322a, 322b are disposed such that the force pushing the arms
319a, 319b apart also tends to push jaws 312a, b together to
produce the desired biasing of the jaws 312 toward the closed
configuration. The use of spring 320 is illustrative only and other
devices, configurations, and methods of producing the bias toward
the closed configuration of the jaws 312 are anticipated. For
example, in another embodiment illustrated in FIG. 14a, a top jaw
312a' has a first proximal end 324a and a bottom jaw 312b' has a
second proximal end 324b, the first and second proximal ends 324a,
b being fixed relative to one another by attachment to a fixed
structure 328. The top jaw 312a' and the bottom jaw 312b' are made
of a resilient material and are disposed relative to one another so
as to produce a bias toward a closed configuration. The jaws 312'
may be moved to an open configuration by overcoming the bias force,
as illustrated in FIG. 14b.
[0102] Referring to FIG. 15, in certain embodiments, a lens case
300'' comprises four jaws 312'', for examples top jaw 312a'',
bottom jaw 312b'', right jaw 312c'' (as seen from a distal end
315''), and left jaw 312d''. The additional jaws 312'', as compared
to the two jaws 312 for lens case 300, may be used to provide
additional stability and/or protection of the intraocular lens 11.
In certain embodiments, additional jaws 312'' may be used to
provide enhanced performance during delivery of the intraocular
lens 301 to the inserter 14. The lens case 300'' also comprises a
triggering device 330''. The triggering device 330'' may be
configured to be a push member that is used deliver or aid in the
delivery of the intraocular lens 301 into the inserter 14 by
pushing the intraocular lens 301 towards the distal end 315'' of
the lens case 300''. In certain embodiments, the triggering device
330'' may additionally or alternatively be configured to perform
other functions, for example to move or hold one or more of the
haptics 308 in a preferred position or configuration, as discussed
in greater detail below. In some embodiments, the triggering device
330'' may be a tab that is pulled, rotated, twisted, or otherwise
moved to provide a predetermined action. In yet other embodiments,
the triggering device 330'' may be a cap that is used to perform a
predetermined function while simultaneously providing an opening in
the lens case 300''. For example, the cap 330'' may be disposed at
the distal end 315'' of the lens case 300'' in order to
simultaneously provide an opening for the delivery of the
intraocular lens 301 and move one or more haptics 315 to a
predetermined position or configuration.
[0103] In some instances, it is desirable to control the location
of the haptics of an intraocular lens during loading of the
intraocular lens into the inserter and/or as the intraocular lens
is compress during injection into an eye. This may become
especially desirable in the case of so called one-piece IOLs in
which the haptics are typically made of softer, less rigid
materials that may become twisted or poorly positioned when the IOL
is compressed during insertion. This can be particularly
problematic with a trailing haptic, which is more likely to come
into contact with the inserter tip and can, therefore, become
damaged or torn by the inserter. In such situations, it may be
desirable to place at least the trailing haptic above or below the
optic of the IOL so that it does not come into contact with the
inserter tip during insertion into the eye.
[0104] Referring to FIGS. 16a-16c, in certain embodiments, the lens
case 300 is configured to place and maintain a distal portion 332
of at least one of the haptics 308 either or above or below the
optic 310. In the illustrated embodiment, the intraocular lens 301
comprise a leading haptic 308a and a trailing haptic 308b. The lens
case 300 is used to place and maintain the distal portion 332 of
the haptic 308 in either a first position (e.g., a storage
position) in which the distal portion 332 of the haptic 308 is
disposed farther from the optic 310, as illustrated in FIG. 16a, or
a second position (e.g., a delivery position) in which the distal
portion 332 of the haptic 308 is disposed closer to optic, as
illustrated in FIG. 16b. Preferably, the storage position leaves
the intraocular lens 301 in an unstressed or low stress condition
so that the lens 310 does not become deformed during long storage
periods in the lens case 300, which can result in degradation of
the optical performance of the intraocular lens 11. Prior to
insertion, the haptic 308 and/or the optic 310 are temporary placed
in a higher stress condition in order prevent the haptic 308 from
becoming damaged during insertion into the eye. The lens case 300
is generally configured to move the distal portion 332 of the
haptic 308 to the delivery position during or in preparation for
transfer of the intraocular lens 301 into the inserter 14. Thus,
lens case 300 is able to automatically move the haptic 308 from the
storage position to the delivery position either as the lens case
300 engages the inserter 14 or just prior to engagement by using
means such as those discussed herein.
[0105] In the currently illustrated embodiment, the support member
304 of the lens case 300 comprises a pair of gripper pins 334 and a
pair of folding pins 338. The pins 334, 338 may be used help
rotationally stabilize the intraocular lens 301 and may be
configured to retract when the intraocular lens 301 is ready to be
transferred to the inserter 14. The folding pins may act as pivot
points around which the haptics 308 rotate as they are moved from
the storage position to the delivery position shown in FIGS. 16a
and 16b, respectively. The support member 304 further comprises one
or more actuating pins or arms 340 that are moved to place the
distal portion 332 of the haptic 308 closer to or over the optic
310 of the intraocular lens 11.
[0106] In some embodiments, as illustrated in FIGS. 16b and 16c,
the distal portions 332 of both the leading and trailing haptics
308a, b are disposed over the outer portions of the optic 310.
Alternatively, only the distal portion 332 of the leading haptic
308a or of the trailing haptic 308b are disposed over the optic
310. In other embodiments, the distal portion 332 of only one of
the haptics 308 is initially placed over or near the optic 310 in
preparation for transfer of the intraocular lens 301 to the
inserter 14, while the distal portion 332 of the remaining haptic
308 is disposed over or near the optic 310 during or after the
transfer of the intraocular lens 11. The distal portion 332 or some
other portion of at least one of the haptics 308 may be place near,
above, or below the optic 310. The portion of the haptic 308 may be
disposed at the periphery of the optic 310 of the intraocular lens
301 or closer to the center of the optic 310. Other locations of
portions of the haptic 308 are consistent with embodiments of the
invention in which the haptic 308 is favorably positioned to
protect the haptic during transfer to the inserter 14 and/or during
insertion into the eye of a subject.
[0107] Actuation of the movement of one or more of the haptics 308
may be provided by engagement and/or disengagement between the lens
case 300 and the inserter 14. Alternatively or additionally, the
lens case 300 may comprise a triggering device or means that is
used to actuate movement of a portion of one or more of the haptics
308 from the initial storage position to the final delivery
position. For example, FIGS. 17a and 17b illustrate an embodiment
in which a lens case 300a comprises a support member 304a and a cap
or cover 342 that is disposed at a distal end 315a of the lens case
300a. The cap 342 is configured to cover an opening of a housing
(not shown) and is connected by a tether 344 or some other means to
an actuating arm 340a. When the intraocular lens 301 is ready to be
transferred, the cap 342 is removed so as to expose the opening and
move the actuating arm 340a so as to place one or more of the
haptic 308 to a predetermined location or orientation. FIG. 17b
illustrates the two positions of the actuating arm 340a (i.e.,
before and after removal of the cap 342). Alternatively, the
triggering device may be something other than the cap 342, for
example a tab or push member or other device that is engaged by a
user to initiate movement of the haptics from a storage position to
a delivery position.
[0108] Referring to FIGS. 18a and 18b, which each show top and side
views of a lens case 300b, a cap 342b may be used to actuate
positioning of the haptics 308 by coupling the cap 342' to rotation
device 348 to which the actuating arms 340' are attached. In this
embodiment, the rotation device 348 is held in an initial position
by the cap 342' in which the haptics 308 are in a predetermined
low-stress configuration. When the cap 342' is removed, the
rotation device 348 is allowed to rotate to a final biased position
(e.g., delivery position) in which the actuating arms 340' rotate
the entire intraocular lens 301 so as to wrap both the leading and
trailing haptics 308 about the optic 310.
[0109] Referring to FIG. 19, in some embodiments, movement of one
or more of the haptics 308 to a delivery position, in which the
haptics 308 are more favorably disposed for insertion into the eye,
may be accomplished as a lens case 300c engages the inserter 14. A
lens case 300c comprises upper and lower jaws 350a, 350b and a
thread, cord, or foil 352. The two ends of the thread, cord, or
foil 352 are attached to the upper jaw 350a and are wrapped around
one or more of the haptics 308 so that when the jaws 350 are
separated, the foil 352 moves the one or more haptics into a
delivery position in preparation for insertion into an eye. In some
embodiments, as illustrated in FIG. 20, a lens case 300d comprises
one or more threads, cords, or foils 352' that are attached at one
end to an upper jaw 350a'. The other end of the threads, cords, or
foils 352' are wrapped around or otherwise engaged with one or more
of the haptics 308 of the intraocular lens 11. Similar to the
previous embodiment, when the upper and lower jaws 350a', 350b' are
separated, the threads, cords, or foils 352' move the one or more
haptics into a delivery position suitable for insertion of the
intraocular lens 301 into an eye.
[0110] Referring to FIG. 21, in some embodiments, a lens case 300e
comprises a protruding finger 360 attached to a distal end 315e of
a housing and/or support member 361 of the lens case 300e. A distal
end 362 of the finger 360 is configured to engage one or more of
the haptics 308 of the intraocular lens 11, so as to move the one
or more haptics 308 into a delivery position suitable for insertion
of the intraocular lens 301 into an eye. Actuation of the finger
360 may be initiated by engagement of the distal end 315e with the
inserter 14 or some other object configured for that purpose.
[0111] Referring to FIGS. 22 and 23a-d, in certain embodiments, a
lens case 400 for storing an intraocular lens 401 comprises a
housing 402, a support member 404, a proximal end 403, a distal end
404, and an opening 405 disposed at the distal end 404 and
configured to engage an inserter such as the inserter 14. The
intraocular lens 401 comprises an optic 410a attached to leading
haptic 408a and a trailing haptic 408b. The trailing haptic
includes a distal end 409. The lens case 400 also comprises a
haptic manipulator or haptic folder 411 that is configured to
engage and manipulate at least one of the haptics 408a, 408b. The
haptic folder 411 may comprise one or more detents 412 or similar
such structures that are configured to engage mating indentations
in the lens case 400 or a component disposed therein. The detents
412 may be configured to generally provided resistance to motion of
the haptic folder 411 within the lens case 400 and/or to fix or
hold the haptic folder 411 at a predetermined location within the
lens case 400 during the process of transferring of the intraocular
lens 401 into an inserter and/or inserter cartridge. The haptic
folder is generally configured to engage at least one of the haptic
408a, b and/or to hold, carry, and/or push the intraocular lens
401. In the illustrated embodiment, engagement of the distal
portion 409 of the trailing haptic 408b is provided by a protrusion
or finger 413.
[0112] Referring to FIGS. 23c and 23d, in some embodiments haptic
folder 411 is a shuttle 411' that is configured to be transferred
along with the intraocular lens 401 from the lens case 400 to an
inserter or cartridge. For example, the shuttle 411' includes a
through hole 422 that is disposed longitudinally along the shuttle
411 and sized so as to allow the push rod of an inserter to pass
therethrough, thus allowing the pushrod tip access to the
intraocular lens 401 when the intraocular lens 401 and the shuttle
411' are disposed within the inserter.
[0113] Referring to FIGS. 24a and 24b, in some embodiments the
haptic folder 411 is configured to engage and move the haptic 408b
to a predetermined position or configuration relative to the optic
410. In the illustrated embodiment, the predetermined position
configuration comprises the distal portion 409 of the haptic 408b
being positioned over the periphery of the optic 410; however,
other locations and configurations of the haptic 408b are possible,
as discussed above in relation to the haptics 308. The
predetermined position may be any position or configuration of the
haptic 408b suitable for preparing the intraocular lens 401 for
insertion into an eye using an inserter such as the inserter 14.
Any of the devices or means used with the various embodiments of
the lens case 300 discussed herein (e.g., those illustrated in
FIGS. 16-22) may be used, for example, to actuate the shuttle 411
to move the haptic 408.
[0114] With further referenced to FIG. 24c, the lens case 400 or a
fixed surfaced disposed therein may comprise one or more
indentations 423 for receiving the detents 412 of the haptic folder
411 when the haptic folder 411 arrives at a predetermined location
within the lens case 400. The lens holder is generally configured
so that once the trailing haptic is in the predetermined
configuration, the detent 412 and the indentations 423 engage one
another to prevent or impede further motion of the haptic folder
411 within the lens case 400 (e.g., to prevent the haptic folder
from staying with the intraocular lens 401 after disengagement
between the lens case 400 and the inerter or cartridge receiving
the intraocular lens 401.
[0115] Referring to FIGS. 25a-c, in certain embodiments, the lens
case 400 is part of an insertion system comprising the lens case
400, an inserter 430, and the shuttle 411'. The inserter 430 may
comprise a receiving, loading, or holding chamber 432, a tapered
transition section 434, an insertion tube 438, and a pushrod 440.
In one embodiment, the inerter 430 is the handpiece 20 and the
holding chamber 432 is the nosepiece 30. In some embodiments, the
pushrod may have an enlarged distal tip 442 and/or be made of a
softer material. The lens case 400 may be configured to transfer
both the intraocular lens 401 and the shuttle 411' together into
the inserter 430 (e.g., as in FIG. 25a). In this manner, the
shuttle 411' functions both to move the haptic 408b to the
predetermined position and to maintain the haptic 408b in that
position as the intraocular lens 401 moves from the receiving
chamber 432 into the transition section 434 and toward the
insertion tube 438. Alternatively, the shuttle 411' may be replace
with a haptic folder that does not stay with the intraocular lens
401 after transfer (e.g., the haptic folder 411 illustrated in
FIGS. 24a-c).
[0116] As illustrate in FIG. 25b, the distal tip 442 of the pushrod
440 may be sized slightly larger than the diameter of the
through-hole 422 of the shuttle 411'. In this manner, the tip 442
of the pushrod 440 does not initially contact the intraocular lens
440 as it is moved toward the insertion tube 438. Other
configurations and means may also be used to prevent the initial
contact between tip 442 and the intraocular lens 401, such as
biasing the tip 442 toward one side of the through hole 422.
[0117] Referring to FIG. 26, in certain embodiments, a rib or plug
444 may be used in place of or in conjunction with the shuttle 411'
(e.g., when using the haptic folder 411) in order to hold the
haptic 408b in the predetermined position after the intraocular
lens 401 has been transferred to the inserter 430. The rib 444 may
be part of the inserter 430, such as the loading chamber 432, and
hingedly or otherwise mounted thereon. Once the intraocular lens
401 (and optionally the shuttle 411') is in place in the load
chamber 432, the rib 444 is moved into position to hold the haptic
408b in position. Alternatively, the rib 444 may be biased toward
its final position and be temporarily displaced slightly as the
intraocular lens 401 and/or the shuttle 411' are moved into place
inside the receiving chamber.
[0118] Referring to FIG. 27, in some embodiments, the insertion
tube 438 of the inserter 430 may be configured to have a slight
angle .theta. relative to the direction of travel of the pushrod
440. This configuration may be used to help prevent the tip 442
from riding up into the intraocular lens 401 or at least reduce the
amount by which the tip 442 rides up into the intraocular lens 401.
This may be beneficial, since this type of engagement of the tip
442 with the intraocular lens 401 may damage or even tear the
intraocular lens 401. In some embodiments, for example when the tip
442 is made of a relatively soft material, some engagement of the
tip 442 may be desirable. The angle .theta. may be selected to
control the amount of engagement of tip 442 with a surface of the
intraocular lens 401 as it moves into and through the insertion
tube 438.
[0119] Referring to FIGS. 28 and 29, a method 500 of preparing
transferring an intraocular lens from a lens case to an inserter,
in preparation for delivery of the lens into the eye of a subject,
comprises an operational block 502, which comprises providing the
inserter 14 for delivering the intraocular lens 401 into the eye of
a subject. The method 500 also comprises an operational block 504,
which comprises providing the lens case 300. The method 500 further
comprises an operational block 506, which comprises engaging the
lens case 300 with the inserter so as to allow transfer of the
intraocular lens from the lens case 300 to the inserter. The method
500 additionally comprises an operational block 508, which
comprises moving the jaws 312 to an open configuration upon
engagement between the lens case and the inserter. The method 500
also comprises an operational block 510, which comprises
transferring or pushing the intraocular lens 401 to the inserter 14
by pushing the lens case 300 toward the inserter 14. The method 500
also comprises an operational block 512 that comprises disengaging
the lens case from the inserter.
[0120] The method 500 may be used, when applicable, in whole or in
part with any lens case in accordance with embodiments of the
invention, for example the lens cases 300', 300'', 300a-e, and 400.
The method may also be used with other inserters, such as the
inserter 430. Use of the method 500 with the lens case 300 and the
inserter 14 is at least partially illustrated in FIGS. 29a-d. In
FIG. 29a, the lens case 300 is aligned with the transfer interface
36 of the load chamber 34. In FIG. 29b, the lens case 300 is
advanced towards the inserter 14 until the transfer interface 36
begins to engage an opening in the distal end of the lens case 300.
In certain embodiments, a cover (not shown) is disposed over an
opening in the distal end of the lens case 300 for protection and
the cover is removed at the beginning of, or just prior to, the
transfer process. Alternatively, the cover may be configured to be
removed, punctured, or otherwise opened through engagement of the
lens case 300 and the inserter 14. As the lens case 300 and the
inserter 14 engage, mating portions on each device (not clearly
shown) encourage the upper and lower jaws 312 to begin to open in
order to release the intraocular lens 401 for delivery into the
inserter 14. In certain embodiments, the leading and/or trailing
haptics 308a, b are also moved into a delivery position. In other
embodiments, the positioning of the haptics 308 is carried out
before the engagement between the lens case 300 and the inserter
14, for example as discussed above herein. Referring to FIG. 29c,
the lens case 300 is fully engaged and the jaws 312 are fully
separated so that the intraocular lens may be deposited inside the
load chamber 34. In some embodiments, the locking mechanism 317 is
provided to maintain the jaws 312 in the open configuration.
Referring to FIG. 29d, the lens case 300 is disengaged, leaving the
intraocular lens 401 inside the loading chamber 34. Thus, the lens
case 300 is configured to deliver the intraocular lens 401 to
inserter 14 upon disengagement between the lens case 300 and the
inserter 14.
[0121] Referring to FIGS. 30 and 31, a method 550 is illustrated
for transferring an intraocular lens from a lens case to an
inserter in preparation for delivering the intraocular lens into
the eye of a subject. The method 550 is similar to the method 500,
except that transfer of the intraocular lens is accomplished by
actively operating a triggering device rather than relying on the
action of pushing the lens case towards the inserter. Accordingly,
the method 500 comprises an operational block 552, which comprises
providing the inserter 14 for delivering the intraocular lens 401
into the eye of a subject. The method 550 also comprises an
operational block 554, which comprises providing the lens case
300''. The method 550 further comprises an operational block 556,
which comprises engaging the lens case 300'' with the inserter so
as to allow transfer of the intraocular lens from the lens case
300'' to the inserter. The method 550 additionally comprises an
operational block 558, which comprises moving the jaws 312 to an
open configuration upon engagement between the lens case and the
inserter. The method 550 also comprises an operational block 560,
which comprises transferring or pushing the intraocular lens 401 to
the inserter 14 by operating the triggering device 330''. The
method 550 also comprises an operational block 562 that comprises
disengaging the lens case from the inserter.
[0122] The method 550 may be used, when applicable, in whole or in
part with any lens case in accordance with embodiments of the
invention, for example the lens cases 300, 300', 300a-e, and 400.
The method 550 may also be used with other inserters, such as the
inserters 430. FIGS. 31 a-d at least partially illustrate use of
the one method 550. For each figure, a top view of the lens case
300'' and a distal portion of the inserter 14 is shown on top,
while a side view of each of these elements is shown directly
below. In FIG. 31a, the lens case 300'', which contains the
intraocular lens 11, is aligned with the transfer interface 36 of
the load chamber 34. In FIG. 31b, the lens case 300'' is advanced
towards the inserter 14 until the transfer interface 36 begins to
engage an opening in the distal end of the lens case 300''. In
certain embodiments, a cover (not shown) is disposed over an
opening over the distal end of the lens case 300'' for protection,
where the cover may be removed at the beginning of, or just prior
to, the transfer process of the intraocular lens 11. Alternatively,
the cover may be configured to be removed, punctured, or opened
through engagement of the lens case 300'' and the inserter 14. As
the lens case 300'' and the inserter 14 engage, mating portions on
each device (not clearly shown) cause the jaws 312a'', 312b'',
312c'', and 312d'' to open in order to release the intraocular lens
11 for delivery into the inserter 14. In certain embodiments, the
leading and/or trailing haptics 308a, b are also moved into a
delivery position during the process. Referring to FIG. 31c, the
lens case 300'' is fully engaged with the inserter 14 and the jaws
312 are fully separated. At this point, the triggering devices
330'' may be fully pushed or otherwise manipulated or engaged to
advance the intraocular lens 11 into the load chamber 34 of the
inserter 14. In some embodiments, a locking mechanism is provided
to maintain the jaws 312 in the open configuration. Referring to
FIG. 31d, the lens case 300'' is disengaged, leaving the
intraocular lens 11 inside the loading chamber 34. Thus, the lens
case 300'' is configured to deliver the intraocular lens 11 to
inserter 14 upon disengagement between the lens case 300'' and the
inserter 14.
[0123] The above presents a description of the best mode
contemplated of carrying out the present invention, and of the
manner and process of making and using it, in such full, clear,
concise, and exact terms as to enable any person skilled in the art
to which it pertains to make and use this invention. This invention
is, however, susceptible to modifications and alternate
constructions from that described above which are fully equivalent.
Consequently, it is not the intention to limit this invention to
the particular embodiments disclosed. On the contrary, the
intention is to cover modifications and alternate constructions
coming within the spirit and scope of the invention as generally
expressed by the following claims, which particularly point out and
distinctly claim the subject matter of the invention.
* * * * *