U.S. patent application number 11/329276 was filed with the patent office on 2006-05-25 for intraocular lens combinations.
Invention is credited to Daniel G. Brady, Robert E. Glick.
Application Number | 20060111776 11/329276 |
Document ID | / |
Family ID | 26830083 |
Filed Date | 2006-05-25 |
United States Patent
Application |
20060111776 |
Kind Code |
A1 |
Glick; Robert E. ; et
al. |
May 25, 2006 |
Intraocular lens combinations
Abstract
Intraocular lens combinations are provided which include an
axially movable primary intraocular lens (IOL) and a substantially
fixed compensating IOL. In certain embodiments, the compensating
IOL has no corrective power and serves only to inhibit or reduce
the risk of posterior capsular opacification (PCO). In other
embodiments, the primary IOL has higher corrective power than
required by the patient's prescription in order to amplify the
accommodation obtained from axial movement, and the compensating
IOL has negative corrective power to compensate for the excessive
diopter value of the primary IOL. In a preferred method, the
primary IOL is implanted in the capsular bag of an eye, and
centered about the optical axis. The compensating IOL is then
implanted in the capsular bag, sulcus, or anterior chamber and
axially aligned with the primary IOL. If desired, refractive
measurements may be made between insertion of the primary IOL and
insertion of the compensating IOL to improve refractive accuracy
and outcomes.
Inventors: |
Glick; Robert E.; (Lake
Forest, CA) ; Brady; Daniel G.; (San Juan Capistrano,
CA) |
Correspondence
Address: |
Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
CA
92705
US
|
Family ID: |
26830083 |
Appl. No.: |
11/329276 |
Filed: |
January 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10234801 |
Sep 4, 2002 |
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11329276 |
Jan 9, 2006 |
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09390380 |
Sep 3, 1999 |
6616692 |
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10234801 |
Sep 4, 2002 |
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60132085 |
Apr 30, 1999 |
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Current U.S.
Class: |
623/6.34 ;
623/6.37 |
Current CPC
Class: |
A61F 2/1629 20130101;
A61F 2250/0053 20130101; A61F 2002/1699 20150401; A61F 2/1648
20130101; A61F 2002/16901 20150401; A61F 2/1613 20130101; A61F 2/16
20130101; A61F 2002/009 20130101 |
Class at
Publication: |
623/006.34 ;
623/006.37 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
Claims
1. An intraocular lens combination configured for implantation into
the eye of a patient, the combination comprising: a primary
intraocular lens having a positive optical power and configured to
be disposed in the capsular bag of an eye, the primary intraocular
lens comprising a primary optic body curved about a first central
axis; and a compensating intraocular lens having a negative optical
power and configured to be disposed in the anterior chamber of the
eye, the compensating intraocular lens comprising a compensating
optic body curved about a second central axis and a fixation member
for securing the compensating optic body within the eye; and a
movement assembly adapted to cooperate with the eye to effect
accommodating movement of the primary intraocular lens in the eye
sufficient to produce an add power of about 1.75 to as high as 3.5
diopters.
2. The combination according to claim 1, wherein the primary
intraocular lens and the compensating intraocular lens are
configured to facilitate alignment of the first and second central
axes with an optical axis of the eye.
3. The combination according to claim 1, wherein: the primary optic
body has a first body diameter; and the compensating optic body has
a second body diameter substantially equal to the first body
diameter.
4. The combination according to claim 1, wherein: the patient has a
basic prescription for far vision correction; and the first optical
power combines with the negative optical power to provide a net
positive optical power corresponding to the patient's basic
prescription.
5. The combination according to claim 4, wherein: the patient has a
full add power prescription for near vision correction; the
movement assembly is adapted to cooperate with the eye to move the
primary optic body a distance corresponding to a diopter shift less
than what is required by the patient's full add power prescription;
and the first optical power is selected to amplify the diopter
shift sufficiently to obtain substantially full add power.
6. The combination according to claim 1, wherein: the patient has a
full add power prescription for near vision correction; the
movement assembly is adapted to cooperate with the eye to move the
primary optic body a distance corresponding to a diopter shift less
than what is required by the patient's full add power prescription;
and the first optical power is selected to amplify the diopter
shift sufficiently to obtain substantially full add power.
7. The combination according to claim 1, wherein the movement
assembly is adapted to move the primary optic body axially within
the eye.
8. The combination according to claim 7, wherein the movement
assembly is configured to provide at least about 0.5 mm of axial
movement.
9. The combination of claim 39, wherein the movement assembly is
configured to provide at least about 0.75 mm of axial movement.
10. The combination of claim 39, wherein the movement assembly is
configured to provide about 1 mm to about 1.2 mm of axial
movement.
11. The combination according to claim 1, wherein the compensating
optic body is located anteriorly of the primary optic body.
12. The combination according to claim 1, wherein the combination
is configured for implantation into an eye having a capsular bag,
and wherein the primary optic body is positioned in the capsular
bag.
13. The combination according to claim 12, wherein the fixation
member are configured to maintain the compensating optic body in a
substantially fixed axial position relative the capsular bag.
14. An intraocular lens combination configured for implantation
into the eye of a patient, the combination comprising: a primary
intraocular lens having a positive optical power and configured to
be disposed in the capsular bag of an eye, the primary intraocular
lens comprising a primary optic body curved about a first central
axis; and a compensating intraocular lens having a negative optical
power and configured to be disposed in the anterior chamber of the
eye, the compensating intraocular lens comprising a compensating
optic body curved about a second central axis and a fixation member
for securing the compensating optic body within the eye; and a
movement assembly adapted to cooperate with the eye to effect
accommodating movement of the primary intraocular lens in the eye,
the intraocular lens combination is configured to provide a full
add power prescription for near vision correction.
15. The combination according to claim 14, wherein the intraocular
lens combination configured to produce an add power of about 1.75
to as high as 3.5 diopters.
16. The combination according to claim 14, wherein the primary
intraocular lens and the compensating intraocular lens are
configured to facilitate alignment of the first and second central
axes with an optical axis of the eye.
17. An intraocular lens combination configured for implantation
into the eye of a patient, the combination comprising: a primary
intraocular lens having a positive optical power and configured to
be disposed in the capsular bag of an eye, the primary intraocular
lens comprising a primary optic body curved about a first central
axis; and a compensating intraocular lens having a negative optical
power and configured to be disposed in the anterior chamber of the
eye, the compensating intraocular lens comprising a compensating
optic body curved about a second central axis and a fixation member
for securing the compensating optic body within the eye; and a
movement assembly adapted to cooperate with the eye to effect
accommodating movement of the primary intraocular lens in the eye,
the intraocular lens combination configured to provide a diopter
shift in a range consistent with near vision prescription of a
typical presbyopic patient.
18. The combination according to claim 17, wherein the intraocular
lens combination is configured to provide a full add power
prescription for near vision correction.
19. The combination according to claim 17, wherein the intraocular
lens combination configured to produce an add power of about 1.75
to as high as 3.5 diopters.
20. The combination according to claim 17, wherein the primary
intraocular lens and the compensating intraocular lens are
configured to facilitate alignment of the first and second central
axes with an optical axis of the eye.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a Continuation-in-Part Application of
U.S. patent application Ser. No. 09/390,380, filed Sep. 3, 1999,
which claims the benefit of U.S. Provisional Application 60/132,085
filed Apr. 30, 1999. The disclosures of both the provisional
application and the non-provisional application are incorporated in
their entirety by reference herein.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to intraocular lens
combinations. More particularly, the invention relates to
intraocular lens combinations which are adapted to provide
substantial benefits, such as accommodating movement and/or
inhibition of posterior capsule opacification (PCO) in the eye.
[0003] The human eye includes an anterior chamber between the
cornea and iris, a posterior chamber including a capsular bag
containing a crystalline lens, a ciliary muscle, a vitreous chamber
behind the lens containing the vitreous humor, and a retina at the
rear of this chamber. The human eye has a natural accommodation
ability. The contraction and relaxation of the ciliary muscle
provides the eye with near, intermediate and distant vision. This
ciliary muscle action shapes the natural crystalline lens to the
appropriate optical configuration for focusing light rays entering
the eye on the retina.
[0004] After the natural crystalline lens is removed, for example,
because of cataract or other condition, a conventional, monofocal
IOL can be placed in the posterior chamber. Such a conventional IOL
has very limited, if any, accommodating ability. However, the
wearer of such an IOL continues to require the ability to view both
near and far (distant) objects. Corrective spectacles may be
employed as a useful solution. Recently, multifocal IOLs without
accommodating movement have been used to provide near/far vision
correction.
[0005] Attempts have been made to provide IOLs with accommodating
movement along the optical axis of the eye as an alternative to
shape changing. Examples of such attempts are set forth in Levy
U.S. Pat. No. 4,409,691, U.S. Pat. Nos. 5,674,282 and 5,496,366 to
Cumming, U.S. Pat. No. 6,176,878 to Gwon et al, U.S. Pat. No.
6,231,603 to Lang et al, and U.S. Pat. No. 6,406,494 to Laguette et
al. The disclosure of each of these patents is incorporated herein
by reference.
[0006] One problem that exists with such IOLs is that they often
cannot move sufficiently to obtain the desired accommodation. The
degree of accommodation has been closely related to the lens
prescription of the individual patient. In addition, the presence
of such lenses can result in cell growth from the capsular bag onto
the optics of such lenses. Such cell growth, often referred to as
posterior capsule opacification (PCO), can interfere with the
clarity of the optic to the detriment of the lens wearer's
vision.
[0007] It would be advantageous to provide IOLs adapted for
accommodating movement, which can preferably achieve an acceptable
amount of accommodation and/or a reduced risk of PCO.
SUMMARY OF THE INVENTION
[0008] New intraocular lens combinations (ILCs) have been
disclosed. The present ILCs provide distance, near and intermediate
vision through position, preferably axial position, changes in the
eye. The present combinations preferably enhance the degree of
accommodation achieved in spite of the movement and space
limitations within the eye. One advantage of the present ILCs is
the ability to standardize the prescription or optical power of the
moving or accommodating lens of the ILC. Thus, the required amount
of movement in the eye to achieve accommodation can be
substantially the same for all patients. This greatly facilitates
the design of the moving or accommodating lens. Further, with at
least certain of the present ILCs, inhibition of PCO is obtained.
The present ILCs are relatively straightforward in construction,
can be implanted or inserted into the eye using systems and
procedures which are well known in the art and function effectively
with little or no additional treatments or medications being
required.
[0009] In one broad aspect of the present invention, intraocular
lens combinations (ILCs) comprise a first optic body, second optic
body and a movement assembly. The first optic body has a negative
or plano optical power and is adapted to be placed in a
substantially fixed position in a mammalian eye. In those cases
where the first optic body has a negative optical power, it is also
called the compensating optic body. The second optic body, also
called the primary optic body, has a higher optical power than the
first optic body. The movement assembly is coupled to the second
optic body and is adapted to cooperate with the eye, for example,
the zonules, ciliary muscle and capsular bag of the eye, to effect
accommodating movement of the second optic body in the eye.
[0010] Advantageously, the second optic body has a high plus
optical power to reduce the amount of movement, for example, axial
movement, in the eye needed to provide accommodation for
intermediate and near vision. The negative or minus optical power
of the first optic body compensates for the excess plus or positive
optical power in the first optic body. The use of such a
compensating lens, that is the first optic body having a negative
optical power, can allow for standardization of the optical power
correction in the second optic body. In other words, the optical
power of the second optic body, that is the primary or movable
optic body, can be approximately equal from optic body to optic
body, while the optical power of the first optic body, that is the
compensating or fixed optic body, is adjusted from optic body to
optic body to meet the specific vision correction needs
(prescription) of each individual patient. Consequently, the
required amount of movement of the second optic body in the eye can
be approximately the same for all patients.
[0011] The present ILCs provide accommodation, preferably an
acceptable degree of accommodation, in spite of movement and space
limitations in the eye. For example, the maximum theoretical amount
of axial movement for a simple disc lens having an overall diameter
of 11 millimeters (mm) and an optic diameter of 5 mm that undergoes
1 mm of compression in its diameter is about 1.65 mm. The amount of
axial movement required for a plus 15 diopter optic to provide 2.5
diopters of additional power in the spectacle plane is about 2.6
mm. However, a plus 30 diopter optic requires only 1.2 mm of axial
movement to provide 2.5 diopters of additional power in the
spectacle plane. Thus, by increasing the plus power of the second
optic, which is adapted for accommodating movement, a reduced
amount of movement is needed to achieve higher or enhanced degrees
of accommodation. The first or fixed optic preferably has a minus
power to compensate for the excess plus power in the second
optic.
[0012] The present ILCs preferably include first and second optics
with optical powers which provide a net plus optical power. To
illustrate, assume that the patient requires a plus 15 diopter
correction. The first optic body is provided with a minus 15
diopter optical power and the second optic body with a plus 30
diopter optical power. The net optical power of this ILC is
approximately the sum of minus 15 diopters and plus 30 diopters or
plus 15 diopters, the desired prescription for the patient in
question. The powers of the first and second optics are only
approximately additive since the net power of the combination also
depends on other factors including, but not limited to, the
separation of the two optics, the magnitude of the power of each
individual optic body and its location in the eye and the like
factors. Also, by adjusting the optical power of the first optic
body, the net optical power of the ILC can be adjusted or
controlled even though the optical power of the second optic body
is standardized or remains the same, for example, at a plus 30
diopter optical power. By standardizing the optical power of the
second optic body, the amount of movement in the eye required to
obtain a given level of accommodation is substantially the same,
and preferably well within the space limitations in the eye, from
patient to patient.
[0013] In one very useful embodiment, the movement assembly
comprises a member including a proximal end region coupled to the
second optic body and a distal end region extending away from the
second optic body and adapted to contact a capsular bag of the eye.
Such movement assembly may completely circumscribe the second optic
body or may be such as to only partially circumscribe the second
optic body.
[0014] The second optic body preferably is adapted to be positioned
in the capsular bag of the eye.
[0015] The first optic body may be coupled to a fixation member, or
a plurality of fixation members, adapted to assist in fixating the
first optic body in the eye. Each fixation member preferably has a
distal end portion extending away from the first optic body. In one
embodiment, the distal end portion of the fixation member is
adapted to be located in the capsular bag of the eye. Alternately,
the distal end portion of the fixation member may be located in
contact with a sulcus of the eye. As a further alternate, the
distal end portion of the fixation member may be adapted to be
located in an anterior chamber of the eye.
[0016] The first optic body may be located posterior in the eye
relative to the second optic body or anterior in the eye relative
to the second optic body. In a useful embodiment, the first optic
body is adapted to be positioned in contact with the posterior wall
of the capsular bag of the eye. This positioning of the first optic
body provides for effective compensation of the plus or positive
vision correction power of the second optic body. In addition, by
having the first optic body in contact with the posterior wall of
the capsular bag, cell growth from the capsular bag onto the ILC,
and in particular onto the first and second optics of the ILC, is
reduced. This, in turn, reduces the risk of or inhibits posterior
capsule opacification (PCO).
[0017] In one embodiment, the fixation member or members and the
movement assembly are secured together, preferably permanently
secured together. Thus, when inserting the ILC into the eye, a
single combined structure can be inserted. This reduces the need to
position the first and second optics relative to each other. Put
another way, this feature allows the surgeon to very effectively
and conveniently position the ILC in the eye with reduced surgical
trauma to the patient.
[0018] The fixation member and movement assembly may be secured,
for example, fused, together at the distal end portion of the
fixation member and the distal end region of the movement
assembly.
[0019] In an alternate embodiment, there is no connection between
the fixation member or members of the compensating lens and the
movement assembly of the primary lens. That is, the compensating
lens and primary lens are completely separate from and independent
of one another, enabling them to be implanted consecutively, rather
than simultaneously. This allows the lenses to be inserted through
a smaller incision than would be possible with a combined
structure. In the case of separate lenses, however, special care
must be taken to axially align the two lenses in order to avoid
decentration issues.
[0020] In another broad aspect of the present invention, ILCs are
provided which comprise a first optic body having a posterior
surface adapted to be positioned in contact with a posterior wall
of the capsular bag of the eye; a second optic body adapted to
focus light toward a retina of the eye; and a movement assembly
coupled to the second optic body and adapted to cooperate with the
eye to effect accommodating movement of the second optic body in
the eye. The first optic body has a substantially plano optical
power or a negative optical power. These ILCs are particularly
adapted to inhibit PCO.
[0021] The first optic body of these combinations preferably is
adapted to be placed in a substantially fixed position in the eye.
The posterior surface of the first optic body advantageously is
configured to substantially conform to a major portion, that is, at
least about 50%, of the posterior wall of the capsular bag of the
eye in which the combination is placed. More preferably, the
posterior surface of the first optic body is configured to
substantially conform to substantially all of the posterior wall of
the capsular bag. Such configuration of the first optic body is
very useful in inhibiting cell growth from the eye onto the first
and second optics and in inhibiting PCO.
[0022] In one embodiment, the first optic body, which contacts the
posterior wall of the capsular, has a substantially plano optical
power and the second optic body has a far vision correction power.
In an alternate embodiment, the first optic body has a negative
optical power and the second optic body has a positive optical
power, more preferably, so that the optical powers of the first and
second optics provide a net plus optical power in the eye in which
the combination is placed. In this latter embodiment, the second,
or primary, optic body is preferably placed in the capsular bag,
while the first, or compensating, optic body, may be placed in the
bag, the sulcus or the anterior chamber, or attached to the
iris.
[0023] In a very useful embodiment, the first optic body includes
an anterior surface and at least one projection extending
anteriorly from this anterior surface. The at least one projection
is positioned to limit the posterior movement of the second optic
body in the eye. Thus, the movement of the second optic body is
effectively controlled to substantially maintain the configuration
of the combination and/or to substantially maintain an advantageous
spacing between the first and second optics.
[0024] The movement assembly may be structured and functions
similarly to movement assembly of the previously described
ILCs.
[0025] The first optic body may have a fixation member or members
coupled thereto. The fixation member or members are adapted to
assist in fixating the first optic body in the eye, that is in
contact with the posterior wall of the capsular bag of the eye. In
one embodiment, the first optic body itself is configured and/or
structured so that no fixation member or members are needed to
maintain the first optic body in contact with the posterior wall of
the capsular bag of the eye. The first optic body and the movement
assembly of these ILCs may be secured together.
[0026] In general, the first and second optics of the present ILCs
may be made of any suitable materials. Preferably, the first and
second optics are made of polymeric materials. More preferably, the
first and second optics and the movement assembly, and the fixation
member(s), if any, are deformable for insertion through a small
incision in the eye.
[0027] The present movement assemblies are sufficiently flexible to
facilitate movement of the second optic body in the eye upon being
acted upon by the eye. In one very useful embodiment, the movement
assembly includes a hinge assembly, preferably adapted and
positioned to facilitate the accommodating movement of the second
optic body.
[0028] In those embodiments in which the first optic body has a
substantially plano optic body power, the second optic body
preferably has a far vision correction power, more preferably such
a power for infinity, in the unaccommodated state.
[0029] In a further broad aspect of the present invention, methods
for inserting an ILC in an eye are provided. Such methods comprise
providing an ILC in accordance with the present invention, as
described herein. The ILC is placed into the eye, for example, in
the capsular bag of the eye or partly in the capsular bag of the
eye, using equipment and techniques which are conventional and well
known in the art. The ILC is placed in a rest position in the eye,
for example, a position so that the eye, and in particular the
ciliary muscle and zonules of the eye, effectively cooperate with
the movement assembly to move the second optic body of the ILC
anteriorly in the eye from the rest position to provide for
positive accommodation. No treatments or medications, for example,
to paralyze the ciliary muscle, to facilitate fibrosis or otherwise
influence the position of the ILC in the eye, are required.
[0030] In one embodiment, the primary and compensating lenses are
connected by the fixation member or members and the movement
assembly, and are thus simultaneously implanted in the eye. In
another embodiment, the primary lens is implanted first and
centered about the optical axis. The the compensating lens is then
inserted anteriorly of the primary lens and optically aligned with
the primary lens. This latter embodiment may require a smaller
incision than that required for the unitary combination of the
former embodiment. In addition, this embodiment allows for
refractive measurements to be made after the primary lens has been
implanted, so that any new refractive errors that may have been
introduced as a result of the surgery itself can be taken into
account, and a more accurate prescription for the compensating lens
can be obtained.
[0031] Preferably, the first and second optics and the movement
assembly are deformed prior to being placed into the eye. Once the
ILC is placed in the eye, and after a normal period of recovery
from the surgical procedure, the ILC, in combination with the eye,
provides the mammal or human wearing the ILC with effective
accommodation, preferably with reduced risk of PCO. In the
unaccommodated state, the ILC preferably provides the mammal or
human wearing the ILC with far vision correction.
[0032] Any and all features described herein and combinations of
such features are included within the scope of the present
invention provided that the features of any such combination are
not mutually inconsistent.
[0033] Further aspects and advantages of the present invention are
set forth in the following detailed description and claims,
particularly when considered in conjunction with the accompanying
drawings in which like parts bear like reference numerals.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] FIG. 1 is a front plan view of an ILC in accordance with the
present invention.
[0035] FIG. 2 is a cross-sectional view taken generally along line
2-2 of FIG. 1.
[0036] FIG. 3 is a cross-sectional view of an additional ILC in
accordance with the present invention.
[0037] FIG. 4 is a fragmentary sectional view of an eye in which an
alternate ILC in accordance with the present invention has been
implanted.
[0038] FIG. 5 is a fragmentary sectional view, similar to FIG. 4,
in which the compensating optic body of the ILC is implanted in the
anterior chamber of the eye.
[0039] FIG. 6 is a front plan view of an intraocular lens useful in
an ILC in accordance with the present invention.
[0040] FIG. 7 is a fragmentary sectional view, similar to FIGS. 4
and 5, in which the compensating optic body of the ILC is implanted
in the capsular bag of the eye.
DETAILED DESCRIPTION OF THE DRAWINGS
[0041] Referring now to FIGS. 1 and 2, an ILC according to the
present invention, shown generally at 10, includes a first optic
body 12, a second optic body 14, a disc type fixation member 16 and
a disc type movement assembly 18.
[0042] The first optic body 12 has substantially plano optical
power and is adapted to be held in a fixed position, for example,
at least partially by the fixation member 16. When the ILC 10 is
positioned in a human eye, the posterior surface 20 of first optic
body 12 is in contact with the inner posterior wall of the capsular
bag of the eye. This positioning of optic body 12 is very effective
in reducing or inhibiting endothelial cell growth from the capsular
bag onto the first optic body 12. In effect, the positioning of the
first optic body 12 against the posterior surface of the capsular
bag inhibits or reduce the risk of PCO.
[0043] The second optic body 14 includes a distance vision
correction power. The movement assembly 18 extends radially
outwardly from second optic body 14 and fully circumscribes the
second optic body 14. Movement assembly 18 has a proximal end
region 22 which is coupled to the second optic body 14 at first
optic body periphery 24.
[0044] Movement assembly 18 extends radially outwardly to a distal
end region 26 including a peripheral zone 28.
[0045] Fixation member 16 includes a distal end portion 30
including a peripheral area 32. The movement assembly 18 and
fixation member 16 are fused together at the peripheral zone 28 and
peripheral area 32. Thus, the entire ILC 10 is a single unitary
structure. The first optic body 12 and fixation member 16 can be
manufactured separately from second optic body 14 and movement
assembly 18 and, after such separate manufacture, the fixation
member and movement assembly can be fused together. Alternately,
the entire ILC 10 can be manufactured together. Also, if desired,
the first optic body 12 and fixation member 16 can be inserted into
the eye separately from the second optic body 14 and movement
assembly 18. Thus, ILC 10 can comprise a plurality of separate
components.
[0046] Movement assembly 18 extends outwardly from second optic
body 14 sufficiently so that the distal end region 26, and in
particular the peripheral zone 28 of the distal end region, is in
contact with the inner peripheral wall of the posterior capsular
bag when the ILC 10 is implanted in the eye.
[0047] As best seen in FIG. 2, when ILC 10 is at rest, the second
optic body 14 is positioned vaulted anteriorly relative to the
distal end region 26 of movement assembly 18. In other words, the
anterior surface 34 of second optic body 14 is anterior of the
anterior surface 36 of movement assembly 18 at distal end region 26
and/or the posterior surface 38 of the second optic body 14 is
anterior of the posterior surface 40 of the movement assembly at
the distal end region.
[0048] The first and second optics 12 and 14 may be constructed of
rigid biocompatible materials, such as polymethyl methacrylate
(PMMA), or flexible, deformable materials, such as silicone
polymeric materials, acrylic polymeric materials, hydrogel
polymeric materials, and the like, which enable the optics 12 and
14 to be rolled or folded for insertion through a small incision
into the eye. Although the first and second optics 12 and 14 as
shown are refractive lens bodies, the present ILCs can include at
least one diffractive lens body, and such embodiment is included
within the scope of the present invention.
[0049] As noted previously, first optic body 12 has a substantially
plano or zero optical power. Second optic body 14 is prescribed for
the wearer of ILC 10 with a baseline or far (distance) diopter
power for infinity. Thus, the wearer of ILC 10 is provided with the
vision correction power of second optic body 14 with little or no
contribution from the first optic body 12.
[0050] The fixation member 16 and movement assembly 18, as shown,
are integral (unitary) with and circumscribe the first and second
optics 12 and 14, respectively. Alternately, fixation member 16
and/or movement assembly 18 can be mechanically or otherwise
physically coupled to first optic body 12 and second optic body 14,
respectively. Also, the fixation member 16 and/or movement assembly
18 may only partially circumscribe first and second optics 12 and
14, respectively, and such embodiments are included within the
scope of the present invention. The fixation member 16 and movement
assembly 18 may be constructed from the same or different
biocompatible materials as first and second optics 12 and 14, and
preferably are made of polymeric materials, such as polypropylene
silicone polymeric materials, acrylic polymeric materials, and the
like. Movement assembly 18 has sufficient strength and rigidity to
be effective to transfer the force from the ciliary muscle of the
eye so that the second optic body 14 is movable axially in the eye
to effect accommodation.
[0051] Movement member 18 includes a region of reduced thickness 41
located at the proximal end region 22. This area of reduced
thickness, which completely circumscribes the second optic body 14,
acts as a hinge to provide additional flexibility to the movement
member 18 to extenuate or amplify the accommodating movement of
second optic body 14 in response to the action of the ciliary
muscle and zonules.
[0052] The fixation member 16 and movement assembly 18 preferably
are deformable, in much the same manner as first and second optics
12 and 14 are deformable, to facilitate passing ILC 10 through a
small incision into the eye. The material or materials of
construction from which fixation member 16 and movement assembly 18
are made are chosen to provide such members with the desired
mechanical properties, e.g., strength and/or deformability, to meet
the needs of the particular application involved.
[0053] The ILC 10 can be inserted into the capsular bag of a
mammalian eye using conventional equipment and techniques, for
example, after the natural crystalline lens of the eye is removed,
such as by using a phacoemulsification technique. The ILC 10
preferably is rolled or folded prior to insertion into the eye, and
is inserted through a small incision into the eye and is located in
the capsular bag of the eye.
[0054] The ILC 10 in the eye is located in a position in the
capsular bag so that the posterior surface 20 of first optic body
12 is maintained in contact with the inner posterior wall of the
capsular bag. As noted previously, positioning the first optic body
12 in contact with the posterior wall of the capsular bag reduces
the risk of or inhibits cell growth from the capsular bag onto the
first optic body 12 which, in turn, reduces or inhibits PCO. The
ciliary muscle and zonules of the eye provide force sufficient to
move axially second optic body 14 sufficiently to provide
accommodation to the wearer of ILC 10.
[0055] The ILC 10 should be sized to facilitate the movement of the
second optic body 14 in response to the action of the ciliary
muscle and zonules of the eye in which the ILC is placed.
[0056] If the ILC 10 is too large, the ciliary muscle and zonules
will be inhibited from effectively contracting/relaxing so that the
amount of accommodating movement will be unduly restricted. Of
course, if the ILC 10 is too small, the second optic body 14 will
be ineffective to focus light on the retina of the eye, may cause
glare and/or the movement member may not cooperate with the eye to
effect the desired amount of accommodating movement. If the ILC 10
is to be included in an adult human eye, the first and second
optics 12 and 14 preferably have diameters in the range of about
3.5 mm to about 7 mm, more preferably in the range of about 5 mm to
about 6 mm. The ILC 10 preferably has an overall maximum diameter,
with the movement assembly 18 in the unflexed or rest state, in the
range of about 8 mm to about 11 mm or about 12 mm.
[0057] The present ILC 10 has the ability, in cooperation with the
eye, to move the second optic body 14 both posteriorly and
anteriorly in the eye, to provide for both distance focus and near
focus, respectively. This movement of ILC 10 advantageously occurs
in response to action of the ciliary muscle and zonules, which
action is substantially similar to that which effects accommodation
in an eye having a natural crystalline lens. Thus, the ciliary
muscle and zonules require little, if any, retraining to function
in accordance with the present invention. The movement member 18,
as described herein, preferably is effective to facilitate or even
enhance or extenuate the axial movement of the second optic body 14
caused by the action of the ciliary muscle and zonules to provide
increased degree of accommodation.
[0058] FIG. 3 illustrates an additional ILC, shown generally at
110, in accordance with the present invention. Except as expressly
described herein, ILC 110 is structured and functions similar to
ILC 10. Components of ILC 110 which correspond to components of ILC
10 are indicated by the same reference numeral increased by
100.
[0059] One primary difference between ILC 110 and ILC 10 relates to
the substitution of a posterior lens structure 40 for the first
optic body 12 and fixation member 16. Lens structure 40 includes a
posterior face 42 which is configured to come in contact with and
substantially conform to the inner posterior surface of the
capsular bag of the eye in which the ILC 110 is to be placed. Thus,
the surface 42 which extends around the peripheral area 44 and
across the center region 46 of the lens structure 40 is adapted to
come in contact with and substantially conform to the inner
posterior wall of the capsular bag. Moreover, the lens structure 40
is adapted to remain in contact with this inner posterior wall of
the capsular bag and to be fixed in the eye. This configuration has
been found to be very effective in inhibiting cell growth from the
eye onto the ILC 110. The anterior surface 48 of lens structure 40
is configured to provide the lens structure with a substantially
plano or zero optical power. Second optic body 114 is prescribed
for the wearer of ILC 110 with a baseline or distance or far
(distance) dioptic power for infinity. Thus, the wearer of ILC 110
is provided with a vision correction power of second optic body 114
with little or no contribution from the lens structure 40.
[0060] Alternately, second optic body 114 has a high plus power,
for example, plus 30 diopters. The lens structure 40, and in
particular the region of the lens structure, defined by the
anterior surface 48, which extends substantially across the entire
field of vision of the wearer of ILC 110, has a minus vision
correction power which is controlled to provide the correction
prescription for use in the eye in which the ILC 110 is placed. For
example, if this eye requires a plus 15 diopter power, the lens
structure 40 has a vision correction power of approximately minus
15 diopters so that the net vision correction power of the
combination of lens structure 40 and second optic body 114, is plus
15 diopters.
[0061] The lens structure can be made from materials described
previously with regard to first optic body 12 and fixation member
16.
[0062] One additional feature of lens structure 40 relates to the
anteriorly extending projections 50 which extend from the base
element 52 of lens structure 40. The number of these projections 50
can range from 2 to about 6 or more. Alternately, a continuous
annulus projecting anteriorly can be provided. The purpose of the
projections 50 or the continuous annulus is to limit the posterior
movement of the second optic body 114 and movement assembly 118.
This limitation in the movement provides an additional degree of
control of the ILC 110, and prevent a collapse of the ILC 110 and
maintains an advantageous degree of separation between second optic
body 114 and anterior surface 48 of lens structure 40.
[0063] FIG. 4 illustrates the use of an alternate ILC in accordance
with the present invention. This ILC, shown generally at 60
includes a compensating IOL 61 comprising a first, or compensating,
optic body 62, and a primary IOL 63 comprising a second, or
primary, optic body 64 and a movement assembly 66. The compensating
optic body 62 is coupled to a fixation member 68 which includes a
distal end portion 70 in contact with the periphery 72 of the
sulcus 73 of eye 74. Fixation member 68 is a disk fixation member
which completely circumscribes the compensating optic body 62.
However, it should be noted that the disc fixation member 68 can be
replaced by two or more filament fixation members or plate fixation
members or other types of fixation members, many of which are
conventional and well known in the art. Movement assembly 66 is
coupled to the primary optic body 64 and completely circumscribes
the primary optic body. The primary optic body 64 is located in the
capsular bag 76 of eye 74 and is vaulted anteriorly to some extent
to enhance accommodating movement of the primary optic body.
[0064] The primary optic body 64 has a plus power higher than the
power required by the basic prescription of a presbyopic patient.
For instance for a patient requiring plus 15 diopters of far vision
correction, primary optic body 64 might have a corrective power of
plus 30 diopters. The compensating optic body 62 is a negative or
minus lens having a minus vision correction power which is
controlled to provide the correct prescription for use in eye 74.
For the patient described above, the compensating optic body 62 has
a vision correction power of approximately minus 15 diopters so
that the net vision correction power of the combination of
compensating optic body 62 and primary optic body 64 equals the
patient's basic prescription of plus 15 diopters. The compensating
optic body 62, fixation member 68, primary optic body 64 and
movement assembly 66 can be made from materials described
previously with regard to the first optic body 12, fixation member
16, second optic body 14 and movement assembly 18,
respectively.
[0065] The compensating optic body 62 is shown here as a meniscus
style optic body; that is, the anterior surface of the optic body
is convex and the posterior surface is concave. However, other
negative diopter configurations could also be used, such as
plano/concave or biconcave. In addition, one or both of the
surfaces of the compensating optic body 62 could be multifocal or
aspheric to allow for additional accommodation.
[0066] In the configuration shown in FIG. 4, the fixation member 68
is in contact with the periphery 72 of the sulcus 73 of the eye 74.
This is a relatively durable component of the eye and is effective
to support the fixation member 68 in maintaining the compensating
optic body 62 in a fixed position.
[0067] The movement assembly 66 cooperates with the ciliary muscle
78 and zonules 80 of eye 74 to move the second optic body 64
axially along optical axis 82 of the eye. The amount of axial
movement achieved will vary from patient to patient depending on
such parameters as capsular bag dimensions. However, the movement
should be at least about 0.5 mm, and more preferably, at least
about 0.75 mm. In a very useful embodiment, the accommodation
assembly should allow about 1 mm to about 1.2 mm of movement. With
a primary optic body 64 having a corrective power of plus 30
diopters, this amount of movement will be amplified to create an
additional add power, or diopter shift, of about 1.75 to about 2.5,
or possibly as high as 3.5 diopters. A diopter shift in this range
is consistent with the near vision, or add, prescription of a
"typical" presbyopic patient.
[0068] FIG. 5 illustrates another ILC, shown generally at 360, in
accordance with the present invention. Except as expressly
described herein, ILC 360 is structured and functions similarly to
ILC 60. Components of ILC 360 which correspond to components of ILC
60 are identified by the same reference numeral increased by
300.
[0069] One primary difference between ILC 360 and ILC 60 relates to
the positioning of compensating optic body 362. Specifically,
compensating IOL 361 is located in anterior chamber 90 of eye 374.
Fixation member 368 is coupled to the compensating optic body 362
and extends outwardly and comes in contact with the angle 92 of eye
374. The arrangement of compensating optic body 362 and fixation
member 368 is such that the compensating optic body is maintained
in a substantially stationary position in the anterior chamber 90
of eye 374. The primary optic body 364 is adapted to be moved
axially along optical axis 382 of eye 374 by the ciliary muscle 378
and zonules 380 acting on the movement assembly 366.
[0070] Still another embodiment of an ILC according to the present
invention is shown in FIG. 7, indicated generally at 560. Except as
expressly described herein, ILC 560 is structured and functions
similarly to ILC 60. Components of ILC 560 which correspond to
components of ILC 60 are identified by the same reference numeral
increased by 500.
[0071] Again, ILC 560 differs from ILC 60 primarily in the location
of the compensating IOL 561, which is located in the capsular bag
76 with the primary optic body 564, rather than in the sulcus or
anterior chamber. In this configuration, the compensating optic
body 562 would not be truly stationary since the capsular bag 76
itself typically moves about 0.4 mm during accommodation. However,
axial movement of the compensating optic body 562 relative the
capsular bag 76 can be limited by appropriate design of the
fixation member or members 568. Controlling other factors such as
material selection, length, width and angulation of the fixation
member or members 58 relative the compensating optic body 562 can
limit the overall axial movement of the compensating optic body 562
to less than 0.5 mm which, for the purposes of this invention, can
be regarded as "substantially fixed."
[0072] A preferred method of implanting an ILC will now be
discussed. The method is equally effective for the embodiments of
FIGS. 5, 6, and 7, but for purposes of illustration will be
discussed specifically with reference to FIG. 7.
[0073] Initially, the primary IOL 563 is inserted through an
incision in the patient's cornea and positioned in the capsular bag
76 using conventional techniques. Preferably, the incision is less
than 4 mm in length. If the primary optic body 564 and movement
assembly 566 are unitary as illlustrated, they are inserted
simultaneously. However, it is also possible to implant an
independent movement assembly 566 first, and then insert the
primary optic body in the movement assembly 566.
[0074] After the primary IOL 563 is placed in the capsular bag 76,
a measurement is taken to determine the location of the primary
optic body 564 relative to the optical axis 82. If desired,
refractive measurements may also be made at this time to accurately
determine an appropriate prescription for the compensating IOL
561.
[0075] If the original incision is still open, the compensating IOL
561 is inserted through the same incsion using conventional
techniques. If the incision has closed, a new one, preferably also
measuring less than 4 mm, is made before insertion. A keratoscope
or similar instrument is then used to guide the surgeon in
positioning the fixation member or members 568 such that
compensating optic body 562 and the primary optic body 564 are
axially aligned with the optical axis 82 and one another. If
necessary, the primary optic body 564 may also be repositioned at
this time.
[0076] Alignment of the two optic bodies 562 and 564 is a crucial
aspect of this invention, since any decentration of images will be
amplified by the high diopter power of the primary optic body 564.
Visual confirmation of alignment can be facilitated by providing
the compensating optic body 562 with a diameter D.sub.CB equal to
the diameter D.sub.PB of the primary optic body 564.
[0077] In addition, the ILC 560 can be made less sensitive to
decentration by increasing the diameter of the optic zone, that is
the portion of the optic body which has corrective power, in one or
both of the IOLs 561 and 563. For instance, while the optic zones
of prior art IOLs typically have a diameter in the range of about
3.5 mm to about 7 mm, the diameters of the optic zones D.sub.PZ and
D.sub.CZ in IOLS 561 and 563, respectively, should be in the high
end of that range or even higher, i.e. preferably from 5 mm to 8
mm. Even more preferably, at least one of the optic zone diameters
D.sub.PZ or D.sub.CZ should be in the range of about 6.5 mm to
about 8 mm. Although, as mentioned previously, the diameters
D.sub.PB and D.sub.CB of the optic bodies 562 and 564 are
preferably equal, the diameters D.sub.PZ and D.sub.CZ of the optic
zones need not be.
[0078] Another factor influencing centration is the flexibility of
fixation member or members 568. Preferably the member or members
568 are sufficiently flexible to allow the surgeon to reposition
them as needed during the implantation process, but stiff enough to
remain in a substantially fixed axial and radial position once
implanted.
[0079] FIG. 6 illustrates a still further embodiment of an
intraocular lens in accordance with the present invention. This
intraocular lens, shown generally at 400 includes an optic body 401
and four (4) equally spaced apart movement members 403. Each of the
movement members 403 includes a distal region 405 and a proximal
region 407 which is coupled to the optic body 401. A hinge, for
example, a linear hinge, such as a reduced thickness area 409, is
located near the proximal end 407 of each of the movement members
403. A linear hinge is particularly advantageous to achieve
enhanced, or even substantially maximum theoretical, axial
movement.
[0080] The IOL 400 can be used in place of the various second
optic/movement assembly subcombinations noted above. One
distinction between IOL 400 and these other subcombinations is the
use of four (4) individual movement members 403 which do not
totally circumscribe the optic body 401 relative to the movement
assemblies noted previously which fully circumscribe the second
optics. It should be noted that the movement assemblies of the
present ILCs can have other configurations, for example, which are
effective to facilitate or even enhance the movement of the second
optics.
[0081] While this invention has been described with respect to
various specific examples and embodiments, it is to be understood
that the invention is not limited thereto and that it can be
variously practiced within the scope of the following claims.
* * * * *