U.S. patent application number 12/782639 was filed with the patent office on 2010-09-09 for accommodating intraocular lens.
Invention is credited to Victor C. Esch.
Application Number | 20100228346 12/782639 |
Document ID | / |
Family ID | 36228315 |
Filed Date | 2010-09-09 |
United States Patent
Application |
20100228346 |
Kind Code |
A1 |
Esch; Victor C. |
September 9, 2010 |
Accommodating Intraocular Lens
Abstract
An accommodating intraocular lens is provided that having
optical parameters that are altered in-situ using forces applied by
the ciliary muscles, in which a lens body carries an actuator
separating two fluid-filled chambers having either the same index
of diffraction or different indices of refraction, actuation of the
actuator changing the relative volumes of fluid within an optic
element of the lens and altering the optical power of the lens.
Inventors: |
Esch; Victor C.;
(Albuquerque, NM) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Family ID: |
36228315 |
Appl. No.: |
12/782639 |
Filed: |
May 18, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11844108 |
Aug 23, 2007 |
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12782639 |
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10971598 |
Oct 22, 2004 |
7261737 |
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11844108 |
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10734514 |
Dec 12, 2003 |
7122053 |
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10971598 |
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60433046 |
Dec 12, 2002 |
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Current U.S.
Class: |
623/6.37 |
Current CPC
Class: |
A61F 2002/1682 20150401;
A61F 2250/0053 20130101; A61F 2/1635 20130101; A61F 2/1648
20130101 |
Class at
Publication: |
623/6.37 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
Claims
1. An accommodating intraocular lens, comprising: an optic portion
comprising a first fluid chamber and a flexible layer partially
defining the first fluid chamber; a peripheral portion disposed
peripherally to the optic portion comprising a second fluid
chamber, wherein the first fluid chamber and the second fluid
chamber are in fluid communication; a fluid disposed within the
first and second fluid chambers; an annular element secured to the
flexible layer, wherein the peripheral portion is adapted to deform
in response to ciliary muscle movement to move the fluid from the
second fluid chamber to the first fluid chamber and deform the
flexible layer, thereby changing the power of the lens.
2. The lens of claim 1 wherein the annular element comprises a
plurality of apertures therein.
3. The lens of claim 1 wherein the annular element is adapted to
optimize the change in power of the lens by optimizing the
deformation of the flexible layer in response to fluid movement
from the second fluid chamber to the first fluid chamber.
4. The lens of claim 1 wherein the annular element is disposed
posterior to the flexible layer.
5. The lens of claim 1 wherein the annular element is disposed
anterior to the flexible layer.
6. The lens of claim 1 wherein the annular element defines a
central opening adapted to allow light to pass therethrough.
7. The lens of claim 1 wherein the annular element defines a
central opening therethrough, and wherein an optical axis of the
eye passes through the central opening.
8. The lens of claim 1 wherein the flexible layer is a first
flexible layer, the lens further comprising a second flexible
layer, and wherein the first flexible layer is an anterior flexible
layer and the second flexible layer is a posterior flexible
layer.
9. The lens of claim 1 wherein the annular element is adapted to
act as a fulcrum to deform the flexible layer in response to the
fluid movement.
10. The lens of claim 1 wherein the flexible layer is disposed
substantially perpendicular to an optical axis of the lens.
11. A method of providing an accommodative response in an eye,
comprising: providing an accommodative intraocular lens comprising
an optic portion comprising a first fluid chamber and a flexible
layer, a peripheral portion comprising a second fluid chamber,
wherein the first and second fluid chambers are in fluid
communication, a fluid disposed within the first and second
chambers, and an annular element; maintaining the annular element
secured to the flexible layer; implanting the accommodative
intraocular lens within the eye; and allowing the peripheral
portion to deform in response to ciliary muscle movement to move
fluid from the first fluid chamber to the second fluid chamber to
deform the flexible layer and change the power of the intraocular
lens.
12. The method of claim 11 wherein deforming the flexible layer
comprises preventing the portion of the flexible layer that is
secured to the annular element from deforming.
13. The method of claim 11 wherein the accommodating intraocular
lens comprises a second flexible layer, and wherein movement of
fluid from the first fluid chamber to the second fluid chamber
comprises deforming the second flexible layer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of pending U.S.
application Ser. No. 11/844,108, which is a continuation of U.S.
application Ser. No. 10/971,598, filed Oct. 22, 2004, now U.S. Pat.
No. 7,261,737; which application is a continuation-in-part of U.S.
application Ser. No. 10/734,514, filed Dec. 12, 2003, now U.S. Pat.
No. 7,122,053; and claims the benefit of priority from U.S.
Provisional Application No. 60/433,046, filed Dec. 12, 2002. These
applications are incorporated by reference as if fully set forth
herein.
FIELD OF THE INVENTION
[0002] The present invention relates to intraocular lenses ("IOLs")
having optical parameters that are changeable in-situ. More
particularly, the invention has applications in IOLs for in-capsule
implantation for cataract patients, wherein forces applied by the
ciliary muscles in the eye induce movement of fluid media within
the interior of the IOL, thereby altering an optical power of the
lens to provide accommodation.
BACKGROUND OF THE INVENTION
[0003] Cataracts are a major cause of blindness in the world and
the most prevalent ocular disease. Visual disability from cataracts
accounts for more than 8 million physician office visits per year.
When the disability from cataracts affects or alters an
individual's activities of daily living, surgical lens removal with
intraocular lens (IOL) implantation is the preferred method of
treating the functional limitations. In the United States, about
2.5 million cataract surgical procedures are performed annually,
making it the most common surgery for Americans over the age of 65.
About 97 percent of cataract surgery patients receive intraocular
lens implants, with the annual costs for cataract surgery and
associated care in the United States being upwards of $4
billion.
[0004] A cataract is any opacity of a patient's lens, whether it is
a localized opacity or a diffuse general loss of transparency. To
be clinically significant, however, the cataract must cause a
significant reduction in visual acuity or a functional impairment.
A cataract occurs as a result of aging or secondary to hereditary
factors, trauma, inflammation, metabolic or nutritional disorders,
or radiation. Age-related cataract conditions are the most
common.
[0005] In treating a cataract, the surgeon removes the crystalline
lens matrix from the lens capsule and replaces it with an
intraocular lens ("IOL") implant. The typical IOL provides a
selected focal length that allows the patient to have fairly good
distance vision. Since the lens can no longer accommodate, however,
the patient typically needs glasses for reading.
[0006] More specifically, the imaging properties of the human eye
are facilitated by several optical interfaces. A healthy youthful
human eye has a total power of approximately 59 diopters, with the
anterior surface of the cornea (e.g. the exterior surface,
including the tear layer) providing about 48 diopters of power,
while the posterior surface provides about -4 diopters. The
crystalline lens, which is situated posterior of the pupil in a
transparent elastic capsule supported by the ciliary muscles,
provides about 15 diopters of power, and also performs the critical
function of focusing images upon the retina. This focusing ability,
referred to as "accommodation," enables imaging of objects at
various distances.
[0007] The power of the lens in a youthful eye can be adjusted from
15 diopters to about 29 diopters by adjusting the shape of the lens
from a moderately convex shape to a highly convex shape. The
mechanism generally accepted to cause this adjustment is that
ciliary muscles supporting the capsule (and the lens contained
therein), move between a relaxed state (corresponding to the
moderately convex shape) to a contracted state (corresponding to
the highly convex shape). Because the lens itself is composed of
viscous, gelatinous transparent fibers, arranged in an "onion-like"
layered structure, forces applied to the capsule by the ciliary
muscles cause the lens to change shape.
[0008] Isolated from the eye, the relaxed capsule and lens take on
a spherical shape. Within the eye, however, the capsule is
connected around its circumference by approximately 70 tiny
ligament fibers to the ciliary muscles, which in turn are attached
to an inner surface of the eyeball. The ciliary muscles that
support the lens and capsule therefore are believed to act in a
sphincter muscular mode. Accordingly, when the ciliary muscles are
relaxed, the capsule and lens are pulled about the circumference to
a larger diameter, thereby flattening the lens, whereas when the
ciliary muscles are contracted the lens and capsule relax somewhat
and assume a smaller diameter that approaches a more spherical
shape. This mechanism, called the "ciliary process" increases the
diopter power of the lens.
[0009] As noted above, the youthful eye has approximately 14
diopters of accommodation. As a person ages, the lens hardens and
becomes less elastic, so that by about age 45-50, accommodation is
reduced to about 2 diopters. At a later age the lens may be
considered to be non-accommodating, a condition know as
"presbyopia". Because the imaging distance is fixed, presbyopia
typically entails the need for bi-focals to facilitate near and far
vision.
[0010] Apart from age-related loss of accommodation ability, such
loss is innate to the placement of IOLs for the treatment of
cataracts. IOLs are generally single element lenses made from a
suitable polymer material, such as acrylics or silicones. After
placement, accommodation is no longer possible, although this
ability is typically already lost for persons receiving an IOL.
There is significant need to provide for accommodation in IOL
products so that IOL recipients will have accommodating
ability.
[0011] Although previously known workers in the field of
accommodating IOLs have made some progress, the relative complexity
of the methods and apparatus developed to date have prevented
widespread commercialization of such devices. Previously known
these devices have proved to complex to be practical to construct
or have achieved only limited success, due to the inability to
provide accommodation of more than 1-2 diopters.
[0012] U.S. Pat. No. 5,443,506 to Garabet describes an
accommodating fluid-filled lens wherein electrical potentials
generated by contraction of the ciliary muscles cause changes in
the index of refraction of fluid carried within a central optic
portion. U.S. Pat. No. 4,816,031 to Pfoff discloses an IOL with a
hard PMMA lens separated by a single chamber from a flexible thin
lens layer that uses microfluid pumps to vary a volume of fluid
between the PMMA lens portion and the thin layer portion and
provide accommodation. U.S. Pat. No. 4,932,966 to Christie et al.
discloses an intraocular lens comprising a thin flexible layer
sealed along its periphery to a support layer, wherein forces
applied to fluid reservoirs in the haptics vary a volume of fluid
between the plurality of layers to provide accommodation.
[0013] Although fluid-actuated mechanisms such as described in the
aforementioned patents have been investigated, accommodating lenses
currently nearing commercialization, such as developed by Eyeonics,
Inc. (formerly C&C Vision, Inc.) of Aliso Viejo, Calif., rely
ciliary muscle contraction of the IOL haptics to move the optic
towards or away from the retina to adjust the focus of the
device.
[0014] In view of the foregoing, it would be desirable to provide
apparatus and methods that restore appropriate optical focusing
power action to the human eye.
[0015] It further would be desirable to provide methods and
apparatus wherein a dynamic lens surface may be effectively
manipulated by the ciliary muscular mechanisms within the eye.
[0016] It still further would be desirable to provide methods and
apparatus that utilize pressure applied by the accommodating
muscular action to obtain mechanical deviation of an optical
surface of the IOL. In particular, it would be desirable to provide
an IOL in which muscular pressure may be applied through one or
more actuators to obtain a mechanical advantage.
SUMMARY OF THE INVENTION
[0017] In view of the foregoing, it is an object of the present
invention to provide apparatus and methods that restore appropriate
optical focusing power action to the human eye.
[0018] It is a further object of this invention to provide methods
and apparatus wherein a dynamic lens surface may be effectively
manipulated by the ciliary muscular mechanisms within the eye.
[0019] It is another object of the present invention to provide
methods and apparatus that utilize pressure applied by the
accommodating muscular action to obtain mechanical deviation of an
optical surface of the IOL.
[0020] It is a further object of this invention to provide methods
and apparatus for applying muscular pressure, through one or more
actuators, to obtain a mechanical advantage in altering the optical
parameters of one of more surfaces of the IOL.
[0021] These and other objects of the present invention are
accomplished by providing a lens in which force exerted on a fluid
reservoir by the ciliary process is applied to a movable optical
surface through an actuator whose area is the same as or smaller
than the area of the optical surface. In this manner, the optical
surface is made to move through a deflection that is more
pronounced than would be otherwise possible. In addition, the force
exerted by the ciliary process upon the outer surface of the IOL
may be oriented in a direction optimal for the motion of the
optical surface.
[0022] In accordance with the principles of the invention, a lens
is provided comprising an optic element forming a housing and
having an actuator that divides the housing into first and second
fluid chambers. The first and second fluid chambers are filled with
first and second fluids, respectively, having either the same index
of defraction or different indices of refraction. The optical
parameters of the lens are altered by varying the amounts of first
and second fluids in the first and second chambers. In a first
embodiment the actuator comprises a flexible transparent layer
operated on directly by movement of fluid from a reservoir; in a
second embodiment the actuator comprises one or more extensible
cells that act to deflect a flexible transparent layer.
[0023] In accordance with another aspect of the invention, a
reservoir containing one of the first or second fluids is disposed
in a haptic of the IOL, so that forces applied to the haptic by the
ciliary process are transmitted via the fluid to deform the
flexible layer. In alternative embodiments the reservoirs may be
located in a non-optic portion of the lens and actuated by
compressive or torsional forces applied by the ciliary muscles
through the haptics.
[0024] Alternatively, or in addition, fulcrum points may be
disposed within the optic element to facilitate deflection of the
flexible layer, thereby providing a multiplying effect of the
forces applied by the ciliary process.
[0025] Methods of using the lens of the present invention also are
provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Further features of the invention, its nature and various
advantages will be more apparent from the accompanying drawings and
the following detailed description of the preferred embodiments, in
which:
[0027] FIG. 1 is a sectional side view of a human eye;
[0028] FIGS. 2A and 2B are, respectively, detailed sectional side
views of the lens and supporting structures of FIG. 1 illustrating
relaxed and contracted states of the ciliary muscles;
[0029] FIGS. 3A and 3B are, respectively, an exploded perspective
and side sectional view taken along line 3B-3B of an exemplary
embodiment of an accommodating intraocular lens constructed in
accordance with the principles of the present invention;
[0030] FIGS. 4A and 4B are, respectively, an exploded perspective
and side sectional view taken along line 4B-4B of an alternative
embodiment of an accommodating intraocular lens of the present
invention;
[0031] FIG. 5 is a side sectional view of an alternative embodiment
of the accommodating IOL similar to that of FIGS. 4A and 4B,
depicting the use of an annular fulcrum;
[0032] FIGS. 6A and 6B are, respectively, an exploded perspective
and side sectional view taken along line 6B-6B of another
alternative embodiment of an accommodating intraocular lens of the
present invention;
[0033] FIGS. 7A-7C are schematic views of illustrating the use of
fulcrum points to facilitate deflection of an optical surface in
accordance with the principles of the present invention;
[0034] FIG. 8 is a side-sectional view of another illustrative
embodiment in which inflow and outflow pathways connect the optic
element to a fluid reservoir;
[0035] FIGS. 9A and 9B are, respectively, a plan view, partly in
section, and a side-sectional view of another embodiment of the
lens of the present invention in which the reservoir is designed to
equalize forces applied by the ciliary muscles;
[0036] FIGS. 10A and 10B are, respectively, an exploded perspective
view and a side-sectional view of another alternative embodiment of
the lens of the present invention; and
[0037] FIG. 11 is a plan view of an alternative haptic arrangement
for a lens of type shown in FIG. 10.
DETAILED DESCRIPTION OF THE INVENTION
[0038] The present invention is directed to an in-situ
accommodating intraocular lens system. In accordance with the
principles of the present invention, methods and apparatus are
provided wherein a lens has an optic element comprising a substrate
and an actuator that divides the interior of the housing into two
or more fluid-filled chambers. The fluids filling the chambers may
have the same or different indices of refraction. The optical power
of the lens is altered by changing the relative amounts of fluids
in the chambers, thereby changing the curvature of one of the
chambers and the refractive path of light passing through the optic
element.
[0039] Referring to FIGS. 1 and 2, the structure and operation of a
human eye are first described as context for the present invention.
Eye 10 includes cornea 11 pupil 12, ciliary muscles 13, ligament
fibers 14, capsule 15, lens 16 and retina 17. Natural lens 16 is
composed of viscous, gelatinous transparent fibers, arranged in an
"onion-like" layered structure, and is disposed in transparent
elastic capsule 15. Capsule 15 is joined by ligament fibers 14
around its circumference to ciliary muscles 13, which are in turn
attached to the inner surface of eye 10.
[0040] Isolated from the eye, the relaxed capsule and lens takes on
a spherical shape. However, as described hereinabove, when
suspended within the eye by ligament fibers 14, capsule 15 moves
between a moderately convex shape (when the ciliary muscles are
relaxed) to a highly convex shape (when the ciliary muscles are
contracted). As depicted in FIG. 2A, when ciliary muscles 13 relax,
capsule 15 and lens 16 are pulled about the circumference, thereby
flattening the lens. As depicted in FIG. 2B, when ciliary muscles
13 contract, capsule 15 and lens 16 relax somewhat, thus allowing
the lens and capsule to assume a more spherical shape, and thus
increasing the diopter power of the lens.
[0041] As discussed hereinabove, accommodating lenses currently
nearing commercialization, such as the Crystalens device under
development by Eyeonics, Inc., Aliso Viejo, Calif., typically
involve converting diametral movements of the ciliary muscle into
forward and backward movement of the optic portion of the IOL
relative to the retina. This approach is thought to be required
because, following extraction of a cataract-effected lens, the
capsular bag is very loose, and the ligament fibers that couple the
capsule to the ciliary muscles are no longer in tension. Devices
such as the Crystalens thus do not employ the natural accommodation
mechanisms described above, but instead rely directly on radially
inward compressive forces applied by the ciliary muscle to the
haptics of the IOL.
[0042] In accordance with principles of the present invention,
radially compressive forces applied to the haptics of the IOL are
employed to provide accommodation by deflecting a flexible
transparent layer that separates two fluids preferably having
different indices of refraction. This deflection causes a variation
in the optical path of light passing through the lens, thus
altering its optical parameters.
[0043] Referring now to FIGS. 3A and 3B, a first illustrative
embodiment of an accommodating IOL of the present invention is
described. IOL 20 preferably comprises substrate 21, flexible layer
22 and anterior element 23, which may be assembled in a sandwiched
configuration, depicted in FIG. 3B.
[0044] Substrate 21 preferably comprises a sturdy transparent
polymer and includes posterior lens 24, haptics 25, lower chamber
26, reservoirs 27, passageways 28 and relief chambers 29. Lower
chamber 26 communicates with reservoirs 27 disposed on the ends of
haptics 25 via passageways 28. Lower chamber 26, reservoirs 27 and
passageways 28 are filled with transparent fluid 30, such as
silicone. The outwardly directed surfaces of haptics 25 preferably
comprise a resilient elastic material that permits force applied to
those surfaces by the ciliary muscles to cause fluid to move from
reservoirs 27 through passageways 28 into lower chamber 26.
[0045] Anterior element 23 preferably comprises a rigid transparent
material, and includes anterior lens 31, and relief reservoirs 32.
The interior surface of anterior element 23 is convex and forms
upper chamber 33, which accommodates upward motion of flexible
transparent layer 22, as described hereinbelow. Relief reservoirs
32 are disposed in alignment with relief chambers 29 in substrate
21, outside the optical path of anterior lens 31. Upper chamber 33
communicates with relief reservoirs 32 via passageways 34, and is
filled with transparent fluid 35, such as silicone. Preferably,
transparent fluid 30 in lower chamber 26 has a different index of
refraction than transparent fluid 35 in upper chamber 33.
[0046] Flexible transparent layer 22 divides upper chamber 33 of
anterior element 23 from lower chamber 26 of substrate 21 and acts
as an actuator in redistributing the relative volumes of fluid in
the upper and lower chambers. Ends 36 of flexible transparent layer
also separate relief reservoirs 32 in anterior element 23 from
relief chambers 29 in substrate 21. Because relief chambers 29 are
empty, they permit excess fluid entering the relief reservoirs 32
to cause the layer to reversibly bulge into the relief chambers
when flexible transparent layer is deflected upward.
[0047] When assembled as shown in FIG. 3B and implanted into the
empty capsule of a cataract patient, compressive forces applied by
the ciliary muscles cause fluid 30 to move from reservoirs 27 into
lower chamber 26, thereby causing flexible transparent layer 22 to
deflect upward, as shown in dotted line. Upward motion of layer 22
causes excess fluid in upper chamber 33 to move through passageways
34 into relief reservoirs. Because relief chambers 29 in substrate
21 are not fluid-filled, they permit layer 22 to bulge downward
into the relief chambers.
[0048] In accordance with the principles of the present invention,
movement of layer 22, and the accompanying displacement of a volume
of fluid 35 with a volume of fluid 30 of a different index of
fraction, changes the optical parameters of the lens, thereby
moving the focus of the lens from near to far or vice-versa.
Posterior lens 24 also provides optical power, and also optical
index dispersion so as to optimize aberration characteristics,
including wave aberration of all order, or chromatic
aberration.
[0049] When the ciliary muscles relax, layer 22 resiliently
contracts to its original position, forcing excess fluid 30 from
lower chamber back into reservoirs 27 via passageways. In addition,
as the pressure in upper chamber 33 is reduced, fluid 35 passes out
of relief reservoirs 32 via passageways 34 and into upper chamber
33, thereby relieving bulging of layer 22 into relief chambers
29.
[0050] Referring now to FIGS. 4A and 4B, another illustrative
embodiment of an accommodating IOL of the present invention
constructed in accordance with the principles of the present
invention is described. IOL 40 is similar in construction to IOL 20
of FIG. 3, but has two interfaces to alter the power of the lens
responsive to fluid movement. More specifically, IOL 40 comprises
substrate 41, flexible layer 42, anterior element 43, flexible
layer 44 and posterior element 45. All of these components are
assembled in a sandwiched configuration, as depicted in FIG.
4B.
[0051] Substrate 41 preferably comprises a sturdy transparent
polymer and includes haptics 46, central chamber 47, reservoirs 48,
passageways 49 and relief chambers 50 formed in each of upper
surface 51 and lower surface 52. Central chamber 47 communicates
with reservoirs 48 disposed on the ends of haptics 46 via
passageways 49. Central chamber 47, reservoirs 48 and passageways
49 are filled with transparent fluid 54, such as silicone. The
outwardly directed surfaces of haptics 46 preferably comprise a
resilient elastic material that permits force applied to those
surfaces by the ciliary muscles to cause fluid to move from
reservoirs 48 through passageways 49 into central chamber 47.
[0052] Anterior element 43 preferably comprises a rigid transparent
material, and includes anterior lens 55, and relief reservoirs 56.
The interior surface of anterior element 43 is convex and forms
upper chamber 57, which accommodates upward motion of flexible
transparent layer 42, as described hereinbelow. Relief reservoirs
56 are disposed in alignment with relief chambers 50 in substrate
41, outside the optical path of anterior lens 43. Upper chamber 57
communicates with relief reservoirs 56 via passageways 58, and is
filled with transparent fluid 59, such as silicone. Preferably,
transparent fluid 54 in central chamber 47 has a different index of
refraction than transparent fluid 59 in upper chamber 57.
[0053] Posterior element 45 is similar in construction to anterior
element 43, and preferably comprises a rigid transparent material.
Posterior element 45 includes posterior lens 60 and relief
reservoirs 61. The interior surface of posterior element 45 is
convex upward and forms lower chamber 62, which accommodates
downward motion of flexible transparent layer 44. Relief reservoirs
61 are disposed in alignment with relief chambers formed in the
lower surface of substrate 41, outside the optical path of
posterior lens 45. Lower chamber 62 communicates with relief
reservoirs 61 via passageways 64, and is filled with transparent
fluid 65, which may be the same as fluid 59 in upper chamber 57.
Preferably, transparent fluid 54 in central chamber 47 has a
different index of refraction than transparent fluid 65 in lower
chamber 62.
[0054] Flexible transparent layer 42 separates upper chamber 57 of
anterior element 43 from central chamber 47 of substrate 41, while
flexible transparent layer 44 separates lower chamber 62 from
central chamber 47. As described below, layers 42 and 44 act as
actuators for altering the relative volumes of fluids in the
chambers, and thus the optical power of the lens. The ends of
flexible transparent layer 42 separate relief reservoirs 56 in
anterior element 43 from relief chambers 50 in the upper surface of
substrate 41. Likewise, the ends of flexible transparent layer 44
separate relief reservoirs 61 in posterior element 45 from the
relief chambers in the lower surface of substrate 41. Because the
relief chambers are empty, they permit excess fluid entering the
relief reservoirs 56 and 61 to cause layers 42 and 44 to reversibly
bulge into the relief chambers when flexible transparent layers 42
and 44 are deflected outward from central chamber 47.
[0055] When assembled as shown in FIG. 4B and implanted into the
empty capsule of a cataract patient, compressive forces applied by
the ciliary muscles cause fluid 54 to move from reservoirs 48 into
central chamber 47, thereby causing flexible transparent layers 42
and 44 to deflect outward. Upward motion of layer 42 and downward
motion of layer 44 causes excess fluid in upper and lower chambers
57 and 62 into the respective relief reservoirs 56 and 61. Because
the corresponding relief chambers in substrate 41 are not
fluid-filled, they permit layers 42 and 44 to bulge into the relief
chambers. Movement of layers 42 and 44, and the accompanying
displacement of volumes of fluid 59 and 65 with volumes of fluid 54
of a different index of fraction, changes the optical parameters of
the lens, thereby moving the focus of the lens from near to far or
vice-versa.
[0056] When the ciliary muscles relax, each of layers 42 and 44
resiliently contracts to its original position, forcing excess
fluid from central chamber 47 back into reservoirs 49. In addition,
as pressure in upper and lower chambers 57 and 62 is reduced,
fluids 59 and 65 return from relief reservoirs 56 and 61 into the
upper and lower chambers, respectively.
[0057] Referring now to FIG. 5, an alternative embodiment of an
accommodating IOL of the invention, similar in design to the
embodiment of FIG. 4 is described. IOL 70 comprises substrate 71,
flexible layers 72 and 73, and anterior and posterior elements 74
and 75, assembled in a sandwiched configuration.
[0058] Substrate 71 is similar in construction to substrate 41 of
FIG. 4, and comprises haptics 76, central chamber 77, reservoirs
78, passageways 79 and relief chambers formed in each of its upper
and lower surfaces, arranged as described for the embodiment of
FIG. 4. With this arrangement, force applied to the outer surfaces
of haptics 76 by the ciliary muscles cause fluid to move from
reservoirs 78 through passageways 79 into central chamber 77.
[0059] Anterior element 74 preferably comprises a rigid transparent
material, and anterior lens 81, relief reservoirs (arranged as in
the embodiment of FIG. 4), and annular fulcrum 82. The interior
surface of anterior element 74 is convex and forms fluid-filled
upper chamber 83, which accommodates upward motion of flexible
layer 72, as described hereinbelow. Relief reservoirs are disposed
in alignment with relief chambers in substrate 71, outside the
optical path of anterior lens 74, and act to relieve excess
pressure in the upper chamber when flexible layer 72 deflects
upward. As described for the embodiment of FIG. 4, upper chamber 83
contains a fluid having a different index of refraction than the
fluid in central chamber 77. Posterior element 75 is similar in
construction to anterior element 74, and preferably also includes
annular fulcrum 84 disposed in fluid-filled lower chamber 85.
[0060] Flexible transparent layer 72 separates upper chamber 83 of
anterior element 74 from central chamber 77 of substrate 41, while
flexible transparent layer 73 separates lower chamber 85 from
central chamber 77. Layers 72 and 73 preferably comprise a
resilient flexible material that flexes against annular fulcrums 82
and 84 when fluid is moved into central chamber 77 by forces
applied to reservoirs 78.
[0061] In the embodiment of FIG. 5, annular fulcrum 82
illustratively comprises an annular ring extending inward from the
interior surface of anterior element 74 to contact flexible layer
72, and may include apertures to permit transparent fluid contained
in upper chamber 83 to move freely within the chamber. Annular
fulcrum 84 disposed in lower chamber 85 comprises a corresponding
structure that contacts flexible layer 73. Fulcrums 82 and 84 fix
the surfaces of layers 72 and 73 to optimize the efficiency and
effectiveness of changing the optical power of layers 72 and 73
using the available flow of fluid.
[0062] As will be appreciated, the mechanical advantage obtained by
fulcrums 82 and 84, and the degree of deflection imposed upon
layers 72 and 73 is dependent upon the distance of the fulcrum
contact point from the optical axis of the lens. In addition, while
illustratively described as annular rings, fulcrums 82 and 84 may
comprise other suitable shapes, such as discrete pegs or cones.
[0063] Operation of the embodiment of FIG. 5 is similar to that of
the embodiment of FIG. 4, except that fulcrums 82 and 84 control
deflection of layers 72 and 73. When implanted into the empty
capsule of a cataract patient, compressive forces applied by the
ciliary muscles cause fluid to move from reservoirs 78 into central
chamber 77, thereby causing layers 72 and 73 to deflect
outward.
[0064] Because outward motion of layers 72 and 73 is fixed by the
points of contact with fulcrums 82 and 84, layers 72 and 73 may
assume different deflection patterns (illustrated in dotted line in
FIG. 5) than for the unconstrained layers in the embodiment of FIG.
4. Deflection of layers 72 and 73, and the accompanying
displacement of volumes of fluid in upper and lower chambers 83 and
85 with corresponding volumes of fluid of a different index of
fraction in central chamber 77, changes the optical parameters of
the lens, thereby moving the focus of the lens from near to far or
vice-versa.
[0065] When the ciliary muscles relax, each of layers 72 and 73
returns to its original position, thereby forcing excess fluid from
central chamber 77 back into reservoirs 78. In addition, as
pressure in upper and lower chambers 83 and 85 is reduced, fluid
returns from the relief reservoirs into the upper and lower
chambers respectively, as described for the lens of FIG. 4.
[0066] Referring now to FIGS. 6A and 6B, another alternative
embodiment of an accommodating IOL of the present invention is
described, in which a flexible layer is deflected using extensible
cells that have a smaller area than the layer itself. IOL 90
comprises substrate 91, actuator element 92, flexible layer 93 and
anterior element 94, which may be assembled in a sandwiched
configuration, FIG. 6B.
[0067] Substrate 91 preferably comprises a sturdy transparent
polymer and includes posterior lens 95, haptics 96, lower chamber
97, reservoirs 98, passageways 99 and lower relief reservoirs 100.
Lower chamber 97 communicates with reservoirs 98 disposed on the
ends of haptics 96 via passageways 99. Lower chamber 97, reservoirs
98, passageways 99 and lower relief reservoirs 100 are filled with
transparent fluid 101. The outwardly directed surfaces of haptics
96 comprise a resilient elastic material that permits force applied
to those surfaces by the ciliary muscles to cause fluid to move
from reservoirs 98 through passageways 99 into lower chamber
99.
[0068] Actuator element 92 comprises disk-shaped member 102 having
a plurality of cells 103 extending upwardly from its upper surface.
Each cell 103 illustratively comprises an annular sidewall 104 and
top 105. The relative thicknesses of member 102 and sidewalls 104
and tops 105 are selected so that when pressurized fluid is
introduced into lower chamber 97, tops 105 of cells 103 extend
axially upward. Illustratively, cells 103 are arranged in a ring at
a predetermined radius from the optical axis of lens 90, although
more or fewer cells 103 may be employed, and then location selected
to enhance deflection of layer 93, as described hereinbelow.
[0069] Anterior element 94 preferably comprises a rigid transparent
material, and includes anterior lens 106, and upper relief
reservoirs 107. The interior surface of anterior element 94 is
convex and forms upper chamber 108, which accommodates upward
motion of flexible layer 93, as described hereinbelow. Upper relief
reservoirs 107 are disposed in alignment with lower relief chambers
100 in substrate 91, outside the optical path of anterior lens 94.
Upper chamber 108 communicates with upper relief reservoirs 107 via
passageways 109, and is filled with transparent fluid 110.
[0070] Flexible layer 93 is affixed around its circumference to
substrate 91 and is disposed in contact with tops 105 of cells 103.
Transparent fluid 111 is contained within space 112 between the
upper surface of actuator element 92 and lower surface of layer 93.
Lower relief reservoirs 100 communicate with space 112 via
passageways 113 disposed in substrate 91. A portion of layer 93
divides upper relief reservoirs 107 from lower relief reservoirs
100, for purposes to be described hereinafter. Fluid 111 disposed
in space 112 preferably has the same index of refraction as fluid
101 in lower chamber 97, and a different index of refraction than
fluid 110 contained in upper chamber 108.
[0071] When assembled as shown in FIG. 6B and implanted into the
empty capsule of a cataract patient, compressive forces applied by
the ciliary muscles cause fluid 101 to move from reservoirs 98 into
lower chamber 97, thereby causing tops 105 of cells 103 to extend
axially upward. Upward movement of tops 105 of cells 103 in turn
causes layer 93 to deflect upward and displace fluid 110 in upper
chamber 108. Fluid displaced from upper chamber 108 flows into
upper relief reservoirs 107 via passageways 109.
[0072] Simultaneously, because lower relief reservoirs 100
communicate with space 112, fluid 111 is drawn from lower relief
reservoirs as layer 93 is deflected upward by cells 103.
Consequently, the portions of layer 93 that divide upper relief
reservoirs 107 from lower relief reservoirs 100 serve as diaphragms
that permit fluid to be simultaneously displaced into one reservoir
and withdrawn from the other. This enables fluids 110 and 111 to
pass freely in and out of the optical space in order to balance
relative volumes of fluid, the total volume of fluids 110 and 111
remaining constant.
[0073] In accordance with the principles of the present invention,
movement of layer 93, and the accompanying displacement of volumes
of fluid 110 in upper chamber 108 with a corresponding volume of
fluid 111 of a different index of fraction in space 112, changes
the optical parameters of the lens, thereby moving the focus of the
lens from near to far or vice-versa. Posterior lens 95, which in
this case comprises a solid material, also provides additional
optical power. Posterior lens 95 also may provide optical index
dispersion so as to optimize aberration characteristics, including
wave aberration of all order, or chromatic aberration.
[0074] When the ciliary muscles relax, tops 105 of cells 103
contract, and layer 93 resiliently contracts to its original
position. This in turn forces excess fluid 111 in space 112 back
into lower relief reservoirs 100. In addition, as the pressure in
upper chamber 108 is reduced, fluid 110 is drawn out of upper
relief reservoirs 107 and into upper chamber 108.
[0075] In the embodiment of FIG. 6, fluid 101 is forced into cell
103 by ciliary forces acting on the surface of reservoir 98, so
that the actuator works in a direction parallel to the optical axis
of the lens. As will be appreciated, actuator element 92 must be
index matched to fluid 101, which moves with cells 103, as well as
fluid 111 that surrounds cells 103 in space 112. Also in the
embodiment of FIG. 6, posterior lens 95 is formed from the same
material as substrate 91. Alternatively, posterior lens 95 may
comprise a different material than substrate 91, having a shape and
optical parameters chosen to optimize the optical performance of
the lens system.
[0076] In accordance with another aspect of the present invention,
cells 103 of the embodiment of FIG. 6 act not only to deflect layer
93, but also serve as fulcrum contact points, in a manner analogous
to the annular fulcrum 82 of the embodiment of FIG. 5.
[0077] Referring now to FIGS. 7A-7C, the effect of location of the
fulcrum, whether a solid point of contact (as in FIG. 5) or point
of contact of a cell (as in FIG. 6) is further described.
Generally, fixation within the optical zone of surface 120
(corresponding to the layer or flexible layers of the various
embodiments described hereinabove), may be accomplished in several
fashions depending on the effect and efficiency required of the
fluid forces provided by the fluid being moved into the chamber or
cell by the forces acting on the reservoirs in the IOL haptics.
[0078] If it is desired that surface 120 assume a flatter
configuration 120' that provides less optical focusing power (shown
in dotted line in FIG. 7A), then fixation at fulcrum point 121
would be desired. If, on the other hand, it is desired that surface
120 provide more power when the ciliary muscles contract
(corresponding to highly convex configuration 120'', shown in
dotted line in FIG. 7B), then fixation at fulcrum points 122 would
be desirable.
[0079] As a further alternative, to obtain most efficient use of
fluid power, e.g., to obtain maximal change in optical power for a
given movement of surface 120 (corresponding to surface
configuration 120''' in FIG. 7C), some fixation at some
intermediate fulcrum point 123 may be desired. Fulcrum point 123
also may be selected so as to minimize the change in the volumes of
the total fluid within the optical zone, thereby obviating the need
for relief reservoirs to absorb excess fluid volumes. In this
latter case, deflection of the flexible layer causes sufficient
redistribution of the fluids within the first and second chambers
to alter the power of the lens.
[0080] It additionally should be understood that by selecting the
indices of refraction of the solid and liquid materials used in the
lens of the present invention, it may be possible for a positive
surface (i.e., convex surface) to act as a negative lens, and
vice-versa.
[0081] The dynamic response of the eye is relatively fast, but is
not beyond the ability of fluids to move in the dimensions of
interests, on the order of 5 mm or less. It may, however, be
required that the fluid motion be managed in some manner so as to
avoid fatiguing the ciliary muscles.
[0082] Referring now to FIG. 8, an exemplary arrangement is
described for controlling fluid flows into and out of a cell, such
as cell 103 of the embodiment of FIG. 6. IOL 130 is constructed
similarly to IOL 90 of FIG. 6, and is designated with like-primed
numbers. IOL 130 differs, however, in that instead of having single
passageway 99 connecting reservoir 98 to lower chamber 97, as in
FIG. 6, separate inflow channel 131 and outflow channel 132 are
provided, each controlled by a one-way valve, such as flap valves
133 and 134. In addition, inflow channel 131 may have a smaller or
larger cross-sectional area than outflow channel 132.
Alternatively, inflow and outflow channels 131 and 132 may have the
same flow area, but with more or fewer inflow channels than outflow
channels.
[0083] With respect to FIGS. 9A and 9B, a further alternative
embodiment of the lens of the present invention is described.
Whereas the previously described lens embodiments illustratively
employ two haptics, each with its own reservoir, IOL 140 comprises
single haptic 141 that surrounds the optic element. Haptic 141
contains reservoir 142 that is coupled by channels 143 to manifold
144. Manifold 144 serves to equalize pressures applied to the
haptic by the ciliary muscles, and equalize the resulting fluid
flows through passageways 145 to chamber 146 and thus cell 147.
Cell 147 in turn controls deflection of layer 148, as in the
above-described embodiment of FIG. 6. As described for the
preceding embodiments, all surfaces and fluids are appropriately
index matched.
[0084] Referring now to FIGS. 10A and 10B, a further alternative
embodiment of an accommodating lens constructed in accordance with
the principles of the present invention is described. IOL 150
comprises substrate 151, actuator element 152 and anterior element
153, which may be assembled in a sandwiched configuration, FIG.
10B.
[0085] Substrate 151 preferably comprises a sturdy transparent
polymer and includes posterior lens 154, haptics 155, lower chamber
156, reservoirs 157 and passageways 158. Lower chamber 156
communicates with reservoirs 157 via passageways 158, and lower
chamber 156, reservoirs 157 and passageways 158 are filled with
transparent fluid 159. Haptics 155 have ends 160 that are slidably
disposed in reservoirs 157 and serve as plungers that permit
compressive force applied to the haptics by the ciliary muscles to
cause fluid to move from reservoirs 157 through passageways 156 and
into lower chamber 156. Haptics 155 may include coil springs 161 or
other suitable means to bias the haptics to an extended position
that maintains engagement of the outer surfaces of the haptics with
the capsule and/or ciliary muscles.
[0086] Actuator element 152 comprises disk-shaped member 162 having
a plurality of cells 163 extending upwardly from its upper surface.
Each cell 163 illustratively comprises annular sidewall 164 and top
165. The relative thicknesses of member 162 and sidewalls 164 and
tops 165 are selected so that tops 165 are relatively more flexible
than the other portions of actuator element 152. Accordingly, when
pressurized fluid is introduced into lower chamber 156, tops 165 of
cells 163 extend axially upward. Illustratively, cells 163 are
arranged in a ring at a predetermined radius from the optical axis
of lens 150, although more or fewer cells 163 may be employed, and
their location selected to enhance deflection of the flexible layer
of anterior element 153, as described hereinbelow.
[0087] Anterior element 153 comprises flexible transparent layer
166 that forms the anterior lens of IOL 150, and support ring 167.
Flexible transparent layer 166 assumes a convex shape when it
contacts tops 165 of cells 163, and forms upper chamber 168.
Because flexible transparent layer 166 can move outward when
deflected by cells 163, relief reservoirs as in the embodiment of
FIG. 6, may be omitted. Upper chamber 168 is filled with
transparent fluid 169 having an index of refraction the same as
fluid 159 disposed in lower chamber 156 and the interior of cells
163, and preferably the same index of refraction as the material of
transparent layer 166. Layer 166 may have a cross-sectional
thickness profile, or stiffness profile, that provides for optimal
deformation when forces from cells 163 are applied, so that good
optical performance may be obtained throughout the deflection
range.
[0088] When assembled as shown in FIG. 10B and implanted into the
empty capsule of a cataract patient, compressive forces applied by
the ciliary muscles cause fluid 159 to move from reservoirs 157
into lower chamber 156, thereby causing tops 165 of cells 163 to
extend axially upward. Upward movement of tops 165 of cells 163 in
turn causes flexible layer 166 of the anterior element to deflect
upward and redistribute fluid 169 contained in upper chamber
168.
[0089] In accordance with the principles of the present invention,
movement of flexible layer 166, and the accompanying redistribution
of fluid 169 in upper chamber 168, with a corresponding increase in
the volume of fluid 159 in cells 163, changes the optical
parameters of the lens, thereby moving the focus of the lens from
near to far or vice-versa. Posterior lens 154, which in this case
comprises a solid material, also provides additional optical power,
and also may provide optical index dispersion so as to optimize
aberration characteristics.
[0090] When the ciliary muscles relax, coil springs 161 drive
haptics 155 radially outward, thereby drawing fluid from within
cells 163 into reservoirs 157. This in turn permits tops 165 of
cells 163 to contract, and flexible layer 166 resiliently contracts
to its original position. As for the previous embodiments, fluid is
forced into the cells by ciliary forces acting on the reservoirs
through the haptics, so that the actuator works in a direction
parallel to the optical axis of the lens. In addition, cells 163 of
the embodiment of FIG. 10 act not only to deflect flexible layer
166, but also serve as fulcrum contact points.
[0091] Referring to FIG. 11, another alternative embodiment of the
accommodating IOL of the present invention is described. IOL 170 is
similar in construction to IOL 150 of FIG. 10, and includes
substrate 171, actuator element 172 and anterior element 173.
Substrate 171 includes reservoirs 174 that are coupled to lower
chamber (disposed beneath actuator element 172) via passageways
175. The lower chamber is fluidly coupled to the interior of cells
176 as described above with respect to FIG. 10B. Anterior element
173 includes flexible transparent layer 177 disposed in contact
with the tops of cells 176, and is coupled to substrate 171 via
support ring 178.
[0092] Haptics 179 are affixed to substrate 171 so that lever
portions 180 of the haptics contact flexible walls of reservoirs
174. Haptics 179 are configured to engage the capsule, so that
contraction of the ciliary muscles applies a torsional force on
lever portions of the haptics. This force manifests as a
compression of reservoirs 174, which in turn causes fluid to move
from reservoirs 174 through the lower chamber and into the
interiors of cells 176. The tops of cells 176 then extend upwardly,
causing flexible transparent layer 177 to deflect. As described for
the preceding embodiment of FIG. 10, deflection of layer 177
permits redistribution of fluid within the lens, thus altering the
optical power of the lens. When the ciliary muscles relax, lever
portions 180 reduce the force applied to reservoirs 174, and the
lens returns to its unstressed condition
[0093] While preferred illustrative embodiments of the invention
are described above, it will be apparent to one skilled in the art
that various changes and modifications may be made therein without
departing from the invention. The appended claims are intended to
cover all such changes and modifications that fall within the true
spirit and scope of the invention.
* * * * *