U.S. patent application number 13/922729 was filed with the patent office on 2014-01-02 for intraocular lens with accommodation.
The applicant listed for this patent is Anew Optics, Inc.. Invention is credited to Robert E. Kellan, Paul Koch.
Application Number | 20140005782 13/922729 |
Document ID | / |
Family ID | 40799452 |
Filed Date | 2014-01-02 |
United States Patent
Application |
20140005782 |
Kind Code |
A1 |
Kellan; Robert E. ; et
al. |
January 2, 2014 |
Intraocular Lens with Accommodation
Abstract
An accommodating intraocular implant apparatus is disclosed for
implantation in the human eye. The apparatus includes an optic
portion having a periphery and an optic axis, said optic portion
lying substantially within an optic plane transverse to said optic
axis; at least one flexible haptic extending from a point on or
near the periphery of the optic portion; at least one flexible
haptic having a fixation anchor portion distal to the periphery of
the optic portion; and at least one flexible haptic having a
centering anchor portion. The fixation anchor portion and the
centering anchor portion are adapted to couple to a portion of the
eye.
Inventors: |
Kellan; Robert E.; (North
Andover, MA) ; Koch; Paul; (East Greenwich,
RI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Anew Optics, Inc. |
Bristol |
TN |
US |
|
|
Family ID: |
40799452 |
Appl. No.: |
13/922729 |
Filed: |
June 20, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11965263 |
Dec 27, 2007 |
8480734 |
|
|
13922729 |
|
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Current U.S.
Class: |
623/6.18 ;
623/6.46 |
Current CPC
Class: |
A61F 2220/0083 20130101;
A61F 2/1629 20130101; A61F 2002/1683 20130101; A61F 2220/0008
20130101; A61F 2/1624 20130101 |
Class at
Publication: |
623/6.18 ;
623/6.46 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
Claims
1. An accommodating intraocular implant apparatus for implantation
in the human eye, comprising: an optic portion having a periphery
and an optic axis, said optic portion lying substantially within an
optic plane transverse to said optic axis; at least one flexible
haptic extending from a point on or near the periphery of the optic
portion; at least one flexible haptic having a fixation anchor
portion distal to the periphery of the optic portion; and at least
one flexible haptic having a centering anchor portion distal to the
periphery of the optic portion, wherein the fixation anchor portion
and the centering anchor portion are adapted to couple to a portion
of the eye.
2. The apparatus of claim 1, wherein: the optic axis is adapted for
coaxial alignment with a vision axis of the eye; at least one
centering anchor portion is adapted to couple to the ciliary sulcus
of the eye; at least one fixation anchor portion is adapted to
couple to one of: a ciliary body, a ciliary muscle, or a ciliary
zonule of the eye; at least one flexible haptic is adapted to
connect the optic portion to the at least one centering anchor
portion to maintain the coaxial alignment of the optic axis with
the vision axis, and at least one haptic is configured to connect
the optic portion to the at least one fixation anchor portion and,
in response to ciliary muscle action in the eye, move the optic
portion along the vision axis to provide accommodation.
3. The apparatus of claim 1, wherein at least one flexible haptic
comprises at least one centering anchor portion and a least one
fixation anchor portion.
4. The apparatus of claim 3, wherein the at least one flexible
haptic comprises a first connecting portion extending from the
periphery of the optic portion to one of: the at least one fixation
anchor portion, the at least one centering anchor point.
5. The apparatus of claim 4, wherein the at least one flexible
haptic comprises a second connecting portion extending between at
least one fixation anchor portion and at least one centering anchor
portion.
6. The apparatus of claim 5, wherein the periphery of the optic
portion comprises a circumferential edge which lies substantially
in the optic plane, and the first connecting portion extends from
the circumferential edge to at least one fixation anchor portion at
an angle to the optic plane.
7. The apparatus of claim 6, wherein the first connecting portion
extends away from the optic plane on a side of the optic plane
adapted to face towards the posterior of the eye.
8. The apparatus of claim 6, wherein the at least one centering
anchor portion lies substantially within the optic plane.
9. The apparatus of claim 1, wherein at least one flexible haptic
comprises a closed loop type haptic extending from the periphery of
the optic portion.
10. The apparatus of claim 1, wherein at least one flexible haptic
comprises an open loop type haptic extending from the periphery of
the optic portion.
11. The apparatus of claim 1, wherein at least one flexible haptic
comprises a straight type haptic extending from the periphery of
the optic portion.
12. The apparatus of claim 1, wherein at least one flexible haptic
comprises a paddle type haptic extending from the periphery of the
optic portion.
13. The apparatus of claim 1, wherein at least one flexible haptic
comprises at least one fixation anchor portion, said anchor portion
extending from a surface of the at least one flexible haptic
adapted to face the anterior portion of the human eye.
14. The apparatus of claim 1, wherein at least one flexible haptic
comprises the at least one fixation anchor portion, said anchor
portion extending from a surface of the at least one flexible
haptic adapted to face the posterior portion of the human eye.
15. The apparatus of claim 1, comprising M centering anchoring
portions, where M is a positive integer: and N fixation anchor
portions, where N is a positive integer.
16. The apparatus of claim 15 where M is greater than 1 and N is
greater than 1.
17. The apparatus of claim 16 where N is greater than 3.
18. The apparatus of claim 17, where N is greater than 7.
19. The apparatus of claim 1, comprising multiple flexible haptics,
each of said multiple flexible haptics configured to connect at
least one centering anchor portion or at least one fixation anchor
portion to the periphery of the optic portion.
20. The apparatus of claim 1, wherein at least one flexible haptic
is integral with the optic portion.
21. The apparatus of claim 1, wherein the intraocular implant is
foldable.
22. The apparatus of claim 1, comprising a material selected from
the group consisting of: hydrogel, collagen, collamar, collagel,
acrylate polymers, methacrylate polymers, silicone polymers, and
composites thereof.
23. The apparatus of claim 1 comprising a first flexible haptic and
a second flexible haptic, each of said haptics including: a first
connecting portion extending between the periphery of the optic
portion and a first fixation anchor portion, a second connecting
portion extending between the first fixation anchor portion and a
centering anchor portion, a third connecting portion extending
between the centering anchor portion and a second fixation anchor
point; a fourth connecting portion extending between the second
fixation anchor portion and the periphery of the optic portion.
24. The apparatus of claim 23, wherein the periphery of the optic
portion comprises a circumferential edge which lies substantially
in the optic plane, and the first and fourth connecting portions
extend from the circumferential edge at an angle to the optic
plane.
25. The apparatus of claim 24, wherein the first and fourth
connecting portion extend away from the optic plane on a side of
the optic plane adapted to face towards the posterior of the eye
when the intraocular implant is implanted.
26. The apparatus of claim 1, wherein the at least one fixation
anchor portion comprises one of: a serrated portion, a wedge shaped
portion, a cylindrical portion, multiple connected wedge shaped
portions, multiple connected cylindrical portions, a bar shaped
portion.
27. A method for correcting vision in a human eye comprising:
implanting an accommodating intraocular implant in the eye, said
intraocular implant including: an optic portion having a periphery
and an optic axis, said optic portion lying substantially within an
optic plane transverse to said optic axis; at least one flexible
haptic extending from a point on or near the periphery of the optic
portion; at least one flexible haptic having a fixation anchor
portion distal to the periphery of the optic portion; and at least
one flexible haptic having a centering anchor portion, wherein the
fixation anchor portion and the centering anchor portion are
adapted to couple to a portion of the eye.
28. The method of claim 27, wherein the implanting comprises:
coupling at least one centering anchor portion to the ciliary
sulcus of the eye; coupling at least one fixation anchor portion to
one of: a ciliary body, a ciliary muscle, a ciliary zonule of the
eye.
29. The method of claim 28, wherein the implanting further
comprises: making an incision in the eye; folding the accommodating
intraocular implant into a folded state small enough to pass
through said incision; passing the accommodating intraocular
implant through the incision to a desired position within the eye;
unfolding the accommodating intraocular implant to an unfolded
state suitable for coupling to the eye.
30. The method of claim 29, further comprising removing the natural
crystalline lens of the eye.
Description
BACKGROUND
[0001] The present disclosure relates to implantable intraocular
lenses.
[0002] Implantation of artificial lenses into the human eye has
been a standard technique for many years, both to replace the
natural crystalline lens (aphakic eye) and to supplement and
correct refractive errors of the natural lens (phakic eye).
However, accommodation provided by such replacement lenses is
minimal or non-existent.
[0003] The crystalline lens is a transparent structure that focuses
light in the human eye. Opacification of the lens known as cataract
formation is a common cause of poor vision in the elderly, and can
be corrected surgically.
[0004] Modern cataract surgery is performed by manual extracapsular
cataract extraction, or by phacoemulsification. In both operations
an opening is made in the anterior capsule to allow removal of the
lens. The capsular bag remnant, however, is left in situ to provide
support for an intraocular lens implant which is inserted following
removal of the cataract, to replace the focusing power of the
natural crystalline lens.
[0005] It is known to provide an intraocular lens implant which
typically comprises a central focusing element, known as an optic,
and peripheral support structure, known as a haptic. The optic and
the haptic of the intraocular lens may be manufactured from
transparent rigid plastics material such as polymethyl
methacrylate, or from flexible plastics material such as silicone
or hydrogel. Intraocular lens implants manufactured from flexible
material are typically preferable to those made of rigid material
because the lens may be folded to allow insertion through a small
incision in the sclera or outercoat of the eye and is then required
to unfold to its original dimension.
[0006] The optic and haptic of the intraocular lens may be
manufactured from the same material as a single piece unit or the
haptic may be attached to the optic by a variety of mechanisms.
There may be one or a plurality of haptics attached to the optic,
although the most common configuration includes an optic with two
outwardly extending haptics. The purpose of the haptic or haptics
is to provide optimal centration of the optic as well as a means of
fixation of the implant within the eye (e.g. within a capsular bag
remnant of the original lens following cataract or lens
extraction). It is preferable that the haptics conform to the
periphery of the capsular bag to provide a larger surface area of
contact between the intraocular lens implant and the capsular bag
and to ensure centration of the optic.
[0007] It is also possible to implant a lens in front of the
anterior capsule behind the iris with the haptics resting in the
region between the root of the iris and ciliary processes, known as
the ciliary sulcus.
[0008] Intraocular lenses may also be inserted in phakic eyes to
correct refractive errors, such as myopia or hyperopia, in front of
the crystalline lens behind the iris with the haptic providing
support in the ciliary sulcus. Furthermore, as an alternative site
of implantation in phakic eyes, intraocular lenses may be inserted
in front of the iris in the anterior chamber with the haptics
resting in the angle of the anterior chamber.
[0009] An example of a conventional intraocular lens 100 in
accordance with the prior art shown in FIG. 1 comprises a central
optic 101, and two haptics 102 connected to the central optic 101.
As shown in FIG. 2, the conventional intraocular lens 100 is
mounted in the capsular bag 200 of a human eye with the central
optic 101 coaxially aligned with a vision axis A of the eye.
However, an anterior chamber distance (ACD) is fixed (i.e., the
lens 100 does not accommodate), the central optic 101 is not
movable along the vision axis A of the eye, and the refractive
power of the lens cannot be adjusted. As shown in FIG. 3, the
conventional intraocular lens 100 can also be mounted in the
ciliary sulcus 300 of the human eye when the capsular bag 200 is
not complete. The two haptics 102 of the conventional intraocular
lens 100 are settled on the ciliary sulcus 300. However, the
anterior chamber distance (ACD) is fixed, and the refractive power
thereof cannot be adjusted.
[0010] Intraocular lenses differ with respect to their
accommodation capability, and their placement in the eye.
Accommodation is the ability of an intraocular lens to accommodate,
which is to focus the eye for near and distant vision. Natural
accommodation in a normal human eye involves shaping of the natural
crystalline lens by automatic contraction and relaxation of the
ciliary muscle of the eye by the brain to focus the eye at
different distances. Ciliary muscle relaxation shapes the natural
lens for distant vision. Ciliary muscle contraction shapes the
natural lens for near vision.
[0011] Most non-accommodating implanted lenses have single focus
optics which focus the eye at a certain fixed distance only and
require the wearing of eye glasses to change the focus. Other
non-accommodating lenses have multifocal optics which image both
near and distant objects on the retina of the eye and provide both
near vision and distant vision sight without eyeglasses. Multifocal
intraocular lenses, however, suffer from the disadvantage that each
bifocal image represents only about 40% of the available light and
the remaining 20% of the light is lost in scatter.
[0012] What is still desired is a new and improved intraocular lens
implant wherein the coaxial position of the central optic along the
vision axis may be changed by control of the user and accommodate
automatically. Preferably, the new and improved intraocular lens
implant will utilize the ciliary muscle action and to effect
accommodation movement of the lens optic along the vision axis of
the eye between a distant vision position to a near vision
position.
SUMMARY
[0013] The inventors have realized that an intraocular implant
device may provide accommodation. For example, an implant may
include an optic portion, e.g. a lens, positioned along a vision
axis of the eye. At least one centering anchor portion of the
implant is received by the ciliary sulcus of the eye, and at least
one fixation anchor portion is received by the ciliary body,
ciliary muscle, or zonules. One or more haptics connect the
centering and fixation anchor portions to the optic portion. The
fixation anchor portions move in response to the natural action
(i.e. contraction or relaxation) of the ciliary body/muscle. This
motion is transferred by one or more haptics to the optic portion,
moving it along the vision axis, and thereby providing
accommodation. During this action, the centering anchor portions
received by the sulcus remain substantially stationary, and
operate, along with one or more haptics to maintain the alignment
of the optic portion with the vision axis.
[0014] In one aspect, disclosed is an accommodating intraocular
implant apparatus for implantation in the human eye, which
includes: an optic portion having a periphery and an optic axis,
the optic portion lying substantially within an optic plane
transverse to the optic axis; at least one flexible haptic
extending from a point on or near the periphery of the optic
portion; at least one flexible haptic having a fixation anchor
portion distal to the periphery of the optic portion; and at least
one flexible haptic having a centering anchor portion. The fixation
anchor portion and the centering anchor portion are adapted to
couple to a portion of the eye.
[0015] In some embodiments, the optic axis is adapted for coaxial
alignment with a vision axis of the eye. In some embodiments, at
least one centering anchor portion is adapted to couple to the
ciliary sulcus of the eye; at least one fixation anchor portion is
adapted to couple to one of: a ciliary body, a ciliary muscle, or a
ciliary zonule of the eye; at least one flexible haptic is adapted
to connect the optic portion to the at least one centering anchor
portion to maintain the coaxial alignment of the optic axis with
the vision axis, and at least one haptic is configured to connect
the optic portion to the at least one fixation anchor portion and,
in response to ciliary muscle action in the eye, move the optic
portion along the vision axis to provide accommodation.
[0016] In some embodiments, at least one flexible haptic includes
at least one centering anchor portion and a least one fixation
anchor portion. In some embodiments, the at least one flexible
haptic includes a first connecting portion extending from the
periphery of the optic portion to one of: the at least one fixation
anchor portion and the at least one centering anchor point. The at
least one flexible haptic may include a second connecting portion
extending between the at least one fixation anchor portion and the
at least one centering anchor portion. In some such embodiments,
the periphery of the optic portion includes a circumferential edge
which lies substantially in the optic plane, and the first
connecting portion extends from the circumferential edge to the at
least one fixation anchor portion at an angle to the optic plane.
In some embodiments, the first connecting portion extends away from
the optic plane on a side of the optic plane adapted to face
towards the posterior of the eye. In some embodiments, the at least
one centering anchor portion lies substantially within the optic
plane.
[0017] In some embodiments, at least one flexible haptic includes a
closed loop type haptic extending from the periphery of the optic
portion, an open loop type haptic extending from the periphery of
the optic portion, a straight type haptic extending from the
periphery of the optic portion, or a includes a paddle type haptic
extending from the periphery of the optic portion.
[0018] In some embodiments, at least one flexible haptic includes
at least one fixation anchor portion, the anchor portion extending
from a surface of the at least one flexible haptic adapted to face
the anterior portion of the human eye.
[0019] In some embodiments, at least one haptic includes the at
least one fixation anchor portion, the anchor portion extending
from a surface of the at least one flexible haptic adapted to face
the posterior portion of the human eye.
[0020] In some embodiments, the apparatus includes M centering
anchoring portions, where M is a positive integer, and N fixation
anchor portions, where N is a positive integer. For example, in
some embodiments, M is greater than 1 and N is greater than 1.
[0021] In some embodiments, N is greater than 3. In some
embodiments, N is greater than 7.
[0022] Some embodiments include multiple flexible haptics, each of
the multiple flexible haptics configured to connect at least one
centering anchor portion or at least one fixation anchor portion to
the periphery of the optic portion.
[0023] In some embodiments, at least one flexible haptic is
integral with the optic portion.
[0024] In some embodiments, the intraocular implant is
foldable.
[0025] In some embodiments, the implant includes a material
selected from the group consisting of: hydrogel, collagen,
collamar, collagel, acrylate polymers, methacrylate polymers,
silicone polymers, and composites thereof.
[0026] Some embodiments include a first flexible haptic and a
second flexible haptic, each of the haptics including: a first
connecting portion extending between the periphery of the optic
portion and a first fixation anchor portion, a second connecting
portion extending between the first fixation anchor portion and a
centering anchor portion, a third connecting portion extending
between the centering anchor portion and a second fixation anchor
point; a fourth connecting portion extending between the second
fixation anchor portion and the periphery of the optic portion. In
some embodiments, the periphery of the optic portion includes a
circumferential edge which lies substantially in the optic plane,
and the first and fourth connecting portions extend from the
circumferential edge to at an angle to the optic plane. In some
embodiments, the first and fourth connecting portion extend away
from the optic plane on a side of the optic plane adapted to face
towards the posterior of the eye when the intraocular implant is
implanted.
[0027] In some embodiments, the at least one fixation anchor
portion includes one of: a serrated portion, a wedge shaped
portion, a cylindrical portion, multiple connected wedge shaped
portions, multiple connected cylindrical portions, a bar shaped
portion.
[0028] In another aspect, a method for correcting vision in a human
eye is disclosed including implanting an accommodating intraocular
implant in the eye. The intraocular implant being of any of the
types described above. In some embodiments, the implanting
includes: coupling at least one centering anchor portion to the
ciliary sulcus of the eye; coupling at least one fixation anchor
portion to one of: a ciliary body, a ciliary muscle, a ciliary
zonule of the eye.
[0029] In some embodiments, the implanting further includes: making
an incision in the eye; folding the accommodating intraocular
implant into a folded state small enough to pass through the
incision; passing the accommodating intraocular implant through the
incision to a desired position within the eye; and unfolding the
accommodating intraocular implant to an unfolded state suitable for
coupling to the eye. Some embodiments further include removing the
natural crystalline lens of the eye.
[0030] Embodiments may include any of the above described features
alone or in combination.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a front elevation view of a conventional
intraocular lens in accordance with the prior art;
[0032] FIG. 2 is a side elevation view of the intraocular lens of
FIG. 1 shown mounted in a capsular bag of a human eye and coaxially
aligned with an imaginary vision axis of the eye;
[0033] FIG. 3 is a side elevation view of the intraocular lens of
FIG. 1 shown mounted in a ciliary sulcus of a human eye and
coaxially aligned with an imaginary vision axis of the eye;
[0034] FIG. 4 is a front view of an exemplary intraocular implant
10;
[0035] FIG. 5 is a side section view of intraocular implant 10;
[0036] FIG. 6a is a side view of implant 10 positioned within an
aphakic human eye;
[0037] FIG. 6b is a side view of implant 10 positioned within an
aphakic human eye showing accommodation in response to ciliary
muscle relaxation;
[0038] FIG. 7a shows a front view of implant 10;
[0039] FIG. 7b shows a cross section of implant 10;
[0040] FIG. 7c shows a front view of implant 10;
[0041] FIG. 7d shows a cross section of implant 10;
[0042] FIG. 7e shows a front view of implant 10;
[0043] FIG. 7f shows a cross section of implant 10;
[0044] FIG. 7g shows a front view of implant 10;
[0045] FIG. 7h shows a cross section of implant 10;
[0046] FIG. 7i shows a front view of implant 10;
[0047] FIG. 7j shows a cross section of implant 10;
[0048] FIG. 8a shows a front view of implant 10;
[0049] FIG. 8b shows a side elevation of implant 10;
[0050] FIG. 9 shows a side view of implant 10 positioned within an
aphakic human eye;
[0051] FIG. 10 shows a front view of implant 10 with an exemplary
haptic configuration.
[0052] FIG. 11 shows a front view of implant 10 with an exemplary
haptic configuration.
[0053] FIG. 12a shows a front view of implant 10 with an exemplary
haptic configuration.
[0054] FIG. 12b shows a front view of implant 10 with an exemplary
haptic configuration similar to that given in FIG. 12a.
[0055] FIG. 13a shows a front view of implant 10 with an exemplary
haptic configuration.
[0056] FIG. 13b shows a front view of implant 10 with an exemplary
haptic configuration similar to that given in FIG. 13a.
[0057] FIG. 14a shows a front view of implant 10 with an exemplary
haptic configuration.
[0058] FIG. 14b shows a front view of implant 10 with an exemplary
haptic configuration similar to that given in FIG. 14a.
[0059] FIG. 15 shows a front view of implant 10 with an exemplary
haptic configuration.
[0060] FIG. 16a shows a front view of implant 10 with an exemplary
haptic configuration.
[0061] FIG. 16b shows a front view of implant 10 with an exemplary
haptic configuration similar to that given in FIG. 16a.
[0062] FIG. 17 shows cross sections of various exemplary anchor
portions for implant 10.
[0063] FIG. 18 shows a side elevation of an exemplary embodiment of
implant 10 featuring a plano-convex type optic portion 12.
[0064] Like reference numerals and labels refer to like elements
throughout the figures.
DETAILED DESCRIPTION
[0065] In the eye, the natural lens of the eye separates the
aqueous humor from the vitreous body. The iris separates the region
between the cornea or anterior of the eye and the lens into an
anterior chamber and a posterior chamber. The natural crystalline
lens is contained in a membrane known as the capsule or capsular
bag. When the natural lens is removed from the eye, the capsule may
also be removed (intracapsular excision), or the anterior portion
of the capsule may be removed with the natural crystalline lens,
leaving the posterior portion of the capsule intact (extracapsular
extraction), often leaving small folds or flaps from the anterior
portion of the capsule. In an intraocular implant, an artificial
lens may be inserted in the anterior chamber, the posterior
chamber, or the capsular sac.
[0066] FIGS. 4 through 7j through show an exemplary embodiment of
an accommodating intraocular implant 10 according to the present
disclosure for implantation in the human eye. Throughout the
figures, the orientation with respect to the eye is shown relative
to vision axis A, which appears in side views as a dotted arrow
pointing toward the anterior (front) portion of the eye. The axis A
appears in front views as a black dot, indicating that the anterior
facing point of the arrow would pierce through the page toward the
reader in the front view. In each figure showing a front view, an
orientation is assumed where the top of patient's head would be
towards the top of the figure ("twelve o'clock"), while the
patient's feet would be toward the bottom of the figure ("six
o'clock").
[0067] Referring to FIG. 4, implant 10 includes an optic portion 12
adapted for coaxial alignment with the vision axis A of the human
eye. Two centering anchor portions 14 are received by the ciliary
sulcus 15 of the eye. Four fixation anchor portions 16 are received
by the ciliary body/muscle 18 of the eye, (e.g., in the zonules
positioned closely to the ciliary body). The anchor points are
connected to the periphery (e.g. circumferential edge) 22 of optic
portion 12 by two haptics 20. Each haptic 20 forms a closed loop
(e.g. as shown with a distorted "C" or "U" shape) with the optic
portion 12, and connects two fixation anchor portions 16 and one
centering anchor portion 14 to the optic portion 12.
[0068] FIG. 5 shows a side view of implant 10. Optic portion 12 has
a circumferential edge 22 which lies substantially within optic
plane O. As shown, centering anchor points 14 also lie within optic
plane O. Note, however, in some embodiments the centering anchor
points may be in an angled position (i.e. anterior or posterior to)
optic plane O. Fixation anchor portions 16 are located posterior to
optic plane O. Each haptic 20 extends at an angle to optic plane O
from circumferential edge 22 to a first fixation anchor portion 20.
The haptic 20 continues on, angling toward the anterior of the eye
to connect to a centering anchor portion 16 located in the optic
plane O. From centering anchor portion 16, the haptic 20 continues,
angling towards the posterior of the eye to connect to a second
fixation anchor portion (not shown in the side view) located
posterior to optic plane O. Finally, from the second fixation
portion 16, the haptic 20 extends back to circumferential edge 22
of optic portion 12, completing a closed loop.
[0069] FIGS. 6a and 6b show a side view of implant 10 positioned
within the posterior chamber 23 outside of capsular bag remnant 24
of aphakic human eye 26. Fixation anchor portions 16 extend from
the sides of haptics 20 facing the anterior of the eye 26 and are
received by the zonules 28 of the ciliary body/muscle 18. Centering
anchor portions 14 are received by the ciliary sulcus 15.
[0070] In FIG. 6b, the ciliary muscle 18 has contracted to provide
accommodation. The muscle action moves the zonules 28 and attached
fixation anchor portions 16 inward as indicated by the small
arrows. Haptics 20 transfer this motion to optic portion 12, moving
it forward along vision axis toward anterior chamber 25, as
indicated by the small arrows. The motion of optic portion 12
adjusts the optical properties of the eye (e.g. refractive power)
thereby providing accommodation. Similarly, relaxation of ciliary
body/muscle 18 will move optic portion 12 towards the posterior of
eye 26. Accordingly, accommodation between near vision and far
vision is provided using natural muscular action.
[0071] During the muscle action and accommodation motion of optic
portion 12, centering anchor portions 16 anchored in the sulcus
remain substantially stationary. Haptics 20 connect the
substantially fixed centering anchor portions to optic portion 12,
and thereby act to maintain the coaxial alignment of optic portion
12 with vision axis A. Accordingly, accommodation is provided while
maintaining good centration (e.g. coaxial alignment along vision
axis A) of optic portion 12 of implant 10.
[0072] FIGS. 7a, 7c, 7e, 7g, and 7i show front views of implant 10;
FIGS. 7b, 7d, 7f, 7h, and 7j show accompanying side view cross
sections of implant 10. The orientations of the sections are
indicated in the figures by thick black lines through the
respective front views. FIG. 7b shows a cross section through the
centering anchor portions 14. As shown, the centering anchor
portions 14 are in the same plane as edge 22 of optic portion 12.
As noted above, however, in some embodiments, the position of the
centering anchor portions may be angled, e.g., by a few
degrees.
[0073] FIG. 7d shows a cross section of implant 10 intersecting
haptics 20 at portions along the haptic loop midway between a
fixation anchor portion 16 and a centering anchor portion 14. At
this point the haptics 20 are posterior to optic portion 12, as
fixation anchor portions 16 are posterior to and the accompanying
centering anchor portions 14, which, as noted above, in the same
plane as the optic portion 12.
[0074] FIG. 7f shows a cross section of implant 10 through the
haptics 20 along the portions of the haptics 20 extending from edge
22 of optic portion 12 to fixation anchor portions 16. As noted
above, these portions of the haptics 20 angle posterior to the
optic portion 12. Fixation anchor portions 16 are formed as angled
tips of the haptic.
[0075] FIG. 7h shows a cross section of implant 10 through a
portion 32 of a first haptic 20 connecting a centering anchor
portion 14 and a fixation anchor portion 16, and through a portion
34 of a second haptic 20 extending from edge 22 of optic portion to
fixation anchor portion 16. Portion 32 of the first haptic 20
angles towards the anterior to connect to the centering anchor
portion 14 located in the plane of the optic portion 12. Portion 34
of the second haptic 20 angles towards the posterior to connect to
fixation anchor portion 16. Again, the fixation anchor portion 16
is shown formed as an angled tip of haptic 20.
[0076] FIG. 7j shows a cross section of implant 10 through the
fixation anchor portions 16. Fixation anchor portions 16 are shown
formed as angled tips of haptics 20, with a serrated surface on the
posterior sides of the haptics 20 at the tips for gripping the
zonules 28 of the ciliary body/muscle 18.
[0077] FIG. 8a shows a front view of implant 10; FIG. 8b shows an
accompanying side elevation of implant 10 viewed from the direction
indicated by the broad arrow. Again, the portion of the haptics 20
extending from edge 22 to fixation anchor portions 16 angle
posterior to the optic. The portions connecting the fixation anchor
portions 16 to the centering anchor portions 14 come anterior until
they are roughly in the plane of optic portion 12, where the
haptics 20 extend out to reach past the ciliary body/muscle 18 to
the sulcus 15.
[0078] Although on exemplary embodiment is shown above, it is to be
understood that various modifications and alternative embodiments
are within the scope of this disclosure. For example, as shown in
FIGS. 5a and 5b, implant 10 is positioned outside of capsular bag
24. However, in some embodiments, the implant may be positioned
inside of the bag 24. FIG. 9 shows a modification of implant 10 in
which fixation anchoring portions 16 are located on the sides of
the haptics 20 facing the posterior of the eye.
[0079] FIGS. 10 through 16b show embodiments of implant 10
featuring various haptic configurations. For example, FIG. 10 shows
a front view of an embodiment of implant 10 featuring two centering
anchor portions 14 received by the sulcus 15 and four fixation
anchor portions 16 received by the ciliary body muscle 18 (or
zonules 28, not shown). Each of the anchor portions 14, 16 is
connected to optic portion 12 by a corresponding closed loop haptic
20. The haptics 20 corresponding to centering anchor portions 14
extend out to the sulcus 15, and may lie in the plane of optic
portion 12, or be angled by, for example, a few degrees to the
anterior or posterior. The haptics 20 corresponding to fixation
anchor portions 16 extend posterior at an angle to the plane of
optic portion 12 toward the ciliary body 18. As in the embodiment
above, muscle action of the ciliary body 18 is transferred by the
fixation anchor portions 16 and corresponding haptics 20 to move
optic portion 12 along vision axis A, thereby providing
accommodation. During accommodation, centering anchor portions
remain substantially fixed within the sulcus 15, and corresponding
haptics 20 hold optic portion 12 in coaxial alignment with vision
axis A.
[0080] FIG. 11 shows a front view of an embodiment of implant 10
featuring two centering anchor portions 14 received by the sulcus
15 and four fixation anchor portions 16 received by the ciliary
body 18. As in the embodiment shown in FIG. 10, each of the
fixation anchor portions 16 is connected to optic portion 12 by a
corresponding open loop haptic 20. However, centering anchor
portions 14 are each connected to optic portion 12 with open loop
haptic 30 (e.g. a haptic with a curved portion which extends from
and curves back towards, but does not reattach to optic portion
12). Again, the fixation anchor portions 16 and corresponding
haptics 20 transfer ciliary muscle motion to provide accommodation,
while centering anchor portions 14 and corresponding haptics 30
maintain the desired alignment of optic portion 12.
[0081] FIG. 12a shows a front view of an embodiment of implant 10
featuring two centering anchor portions 14 received by the sulcus
15 and two fixation anchor portions 16 received by the ciliary body
18. The centering anchor portions 14 are connected to optic portion
12 with open loop type haptics 30 extending in opposing directions
from the circumferential edge 22 of optic portion 12. Similarly,
the fixation anchor portions 16 are connected to optic portion 12
with open loop type haptics 30, each open loped haptic 30 extending
in from the circumferential edge 22 in substantially the same
direction as a corresponding closed loop haptic 20.
[0082] FIG. 12b shows a front view of an embodiment of implant 10
similar to that shown in FIG. 12a , but with the position of
centering anchor portions 14 and corresponding open loop haptics 30
rotated by about 90 degrees relative to fixation anchor portions 16
and corresponding close looped haptics 20 (i.e. fixation anchor
portions 16 are located at roughly twelve o'clock and six o'clock
in the plane of optic portion 12, while centering anchor portions
14 are located at roughly three o'clock and nine o'clock). It is to
be understood that, in various embodiments, the relative position
of these components may form any arbitrary angle.
[0083] FIG. 13a shows a front view of an embodiment of implant 10
featuring two centering anchor portions 14 received by the sulcus
15 and four fixation anchor portions 16 received by the ciliary
body 18. The centering anchor portions 14 are connected to optic
portion 12 by open loop type haptics 30 extending from
circumferential edge 22. The fixation anchor portions 16 are each
connected to optic portion 12 with corresponding straight type
haptic 40 (i.e. a haptic extending in a substantially straight line
from optic portion to the fixation anchor portion). In some
embodiments, one or more of the straight type haptics 40 may extend
to the posterior at an angle to the plane of optic portion 12. As
shown in FIG. 13a the centering anchor portions 14 are located at
roughly three and nine o'clock in the plane of optic portion 12.
FIG. 13b shows an embodiment where the centering anchor portions 14
and corresponding open loop type haptics 30 have been rotated by
about 90 degrees, such that the centering anchor portions 14 are
located at roughly twelve and six o'clock.
[0084] FIG. 14a shows a front view of an embodiment of implant 10
featuring two centering anchor portions 14 received by the sulcus
15 and four fixation anchor portions 16 received by the ciliary
body 18. Each of two closed loop type haptics 20 extend from
circumferential edge 22 to the ciliary body 18 and connect a pair
of the fixation anchor portions 16 to optic portion 12. The
centering anchor portions 14 are connected to optic portion 12 by
open loop type haptics 30 extending from circumferential edge 22 to
the sulcus 15. As shown in FIG. 14a the centering anchor portions
14 are located at roughly three and nine o'clock. FIG. 14b shows an
embodiment where the centering anchor portions 14 and corresponding
open loop type haptics 30 have been rotated by about 90 degrees,
such that the centering anchor portions 14 are located at roughly
twelve and six o'clock.
[0085] FIG. 15 shows a front view of an embodiment of implant 10
featuring six centering anchor portions 14 received by the sulcus
15 and eight fixation anchor portions 16 received by the ciliary
body 18. Each centering anchor portion 14 is connected to optic
portion 12 by a closed loop type haptic 20 extending from
circumferential edge 22 out to the sulcus 15. Each of the fixation
anchor portions 16 is connected to optic portion 12 by a closed
loop type haptic 20 extending from circumferential edge 22 to
ciliary body 16.
[0086] FIG. 16a shows a front view of an embodiment of implant 10
featuring two centering anchor portions 14 received by the sulcus
15 and eight fixation anchor portions 16 received by the ciliary
body 18. Each fixation anchor portions 16 is connected to optic
portion 12 by a closed loop type haptic 20 extending from
circumferential edge 22 to ciliary body 16. The centering anchor
portions 14 are connected to optic portion 12 by open loop type
haptics 30 extending from circumferential edge 22 to the sulcus 15.
FIG. 16b shows a front view illustrating alternative placement of
the embodiment of implant 10 shown in FIG. 16a, where the
orientation of implant 10 has been rotated 90 degrees with respect
to the eye.
[0087] Although several examples of haptic systems are presented
above, it is to be understood that other suitable configurations
may be used. Any number of haptics may be used. Each haptic may
connect optic portion 12 to one or more of the centering anchor
portions 14 or the fixation anchor portions 16. The connected
anchor portions may be integral with the haptic. As shown above,
the haptics may be of the open loop type, closed loop type, or
straight type. In some embodiments the haptic may be of the paddle
type, i.e. solid element (without a central aperture) bounded by a
curved, e.g., C-shaped or U-shaped, peripheral edge. The haptics
may extend from one or more positions on the periphery of optic
portion 12.
[0088] FIG. 17 shows cross sectional shapes suitable for use as
centering anchor portions 14 to be received in the sulcus 15 or
fixation anchor portions to be received in the ciliary body/muscle
18 or zonules 28. The cross sectional shapes include a cylinder 50,
rectangle 52, wedge 54, modified wedge 55, multiple connected
cylinders 56, 58, multiple wedges 60, multiple modified wedges 61,
etc. The anchor portion may include a serrated surface 62,
scalloped surface 64, etc. The anchor portion may include a
relatively thin surface 66 with one or more relatively large
protrusions 68 shaped as, for example, wedges, cylinders, modified
wedges, etc. The anchor portion may include a relatively thick
surface 70 with one or more relatively small protrusions 72 shaped
as, for example, wedges, cylinders, modified wedges, etc. In
various embodiments, any other configuration which can be received
by the relevant portion of the eye may be used.
[0089] Referring to FIG. 18, in various embodiments, optic portion
12 comprises an anterior optical surface 84 and posterior optical
surface 86. The combination of surface 84 and surface 86 may result
in the optic being substantially planar, convex, plano-convex
(illustrated in FIG. 18) and concave, bi-convex, concave-convex, or
other known form. The diameter of optic portion 12 can vary as
needed to accommodate the angle-to-angle measurement of the eye and
curvature of the eye. In typical applications, the overall length
of implant 10 (optic and haptics) to be inserted into an individual
patient's eye is determined by adding a 1 mm white-to-white
measurement of the patient's eye. In one embodiment, optic portion
12 has a 6 mm optical zone.
[0090] Optic portion 12 may be ground to the required diopter
measurements necessary for vision correction. Optic portion 12 may
form a lens, and the lens may be a negative or positive meniscus
lens and may include correction for astigmatism. Depending on the
refractive index of the material used, and the required vision
correction, optic portion 2 may have the same thickness at central
portion 87 and circumferential edge 22, or central portion 87 may
be thinner than circumferential edge 22. In one embodiment, the
thickness of optic 12 is 1 mm.
[0091] In some embodiments, implant 10 is designed to be foldable
to facilitate insertion through small incisions, e.g., 3 mm in
length or less. The device can be folded in the optic body, at any
point in the flexible haptics, at the junction points between the
optic body and the flexible haptics, or all of the above. The
device can be folded with single or multiple folds along any
direction.
[0092] Implant 10 can be usefully implanted into the eye as either
a refractive phakic intraocular lens assembly or an aphakic
intraocular lens assembly. Phakic intraocular lens implantation is
becoming more popular because of their good refractive and visual
results and because they are relatively easy to implant in most
cases (Zaldivar & Rocha, 36 Int. Ophthalmol. Clin. 107-111
(1996); Neuhann et al., 14 J. Refract. Surg. 272-279 (1998); Rosen
& Gore, 24 J. Cataract Refract. Surg. 596-606 (1998); Sanders
et al., 24 J. Cataract Refract. Surg. 607-611 (1998)). The
implantation can be performed by an ordinarily skilled
ophthalmologist. Little surgical injury occurs to the ocular
tissues during such implantation. When the surgical quality is not
compromised, the results are highly predictable, immediate, and
lasting.
[0093] For typical applications, suitable materials for implant 10
are solid, flexible, foldable optical, non-biodegradable materials
such as hydrogel, collamer, collagel (hydrogel-collagen blends)
acrylic polymers, polymethylmethacrylate (PMMA) and silicone
polymers. The implant 10 may also be made of a composite of
materials, i.e. where the flexible haptics are fabricated from one
material and optic portion 12 from another material, for example,
acrylic optics and hydrogel haptics. Where the lens assembly is
used in the aphakic eye, flexible, but less foldable, materials may
be preferred. For example, for the aphakic eye, the implant 10 may
be made of all PMMA or a composite of PMMA optics and prolene
haptics.
[0094] The implantation of implant 10 can generally be performed as
provided by (Singh, eMedicine Ophthalmology (2000)
http://www.emedicine.com/oph/topic662.htm).
[0095] First, the administration of local antibiotic drops is
begun. A useful antibiotic is Tobramycin 0.3%, 1 drop, 6 times a
day. Then, the pupil of the eye is contracted with 1% pilocarpine
drops, administered for example at 15-minute intervals, starting 45
minutes before surgery. Drops (such as NSAID drops) are
administered 2 times before surgery to minimize inflammation.
[0096] General anesthesia can be performed on the patient, but
local anesthesia is preferred. For local anesthesia, 2% lidocaine
with 7.5 U/ml hyaluronidase can be given 10 minutes before surgery.
Orbital compression is applied to make the eye soft and to reduce
orbital pressure.
[0097] For preparation of the surgical field, the periorbital skin
of the patient is painted with iodine, then 5% povidine is applied.
5% povidine is also applied two-three times to the lid margin and
the conjunctival fornices. Then, the eye is washed with saline.
[0098] An eye speculum is used for exposure of the surgical field.
Upper and lower lid sutures, as well as superior rectus sutures can
be applied in place of the speculum. (A sutureless procedure can
also be used.) Adhesive plastic, applied to the surface of the
eyelids, is used to pull the eyelashes.
[0099] For making small intraoperative incisions, a side port (for
example, 0.6 mm) is made in the anterior chamber. This injection is
started at the opposite limbus. As the aqueous fluid drains, it is
replaced, for example, with a viscoelastic agent. The depth of the
anterior chamber is not reduced at any time.
[0100] In one embodiment, for implantation of the implant 10 into
the eye, two side ports are made to introduce the instruments that
are used to fix the iris to the haptics. The width of the incision
depends on the diameter of the intraocular lens assembly of the
invention (being, for example, 4-5 mm). The incision may be made at
the limbus or in the clear cornea. If a pocket section is made,
wound closure (see, below) can be made without sutures. The
intraocular lens assembly of the invention can then be introduced
in the pre-crystalline space with angled-suture forceps the lens is
positioned, for example, behind the iris on a horizontal axis with
a cyclodialysis spatula. The intraocular lens assembly of the
invention is then manipulated to center the optic on the pupil.
During implantation of implant into the anterior chamber, the lens
is centered and fixed so that it does not slip out of position. The
lens can be positioned between the cornea and the iris, but
avoiding contact with either to prevent corneal damage,
proliferation of corneal epithelium on the anterior surface of the
lens causing opacification, or iris. If the lens is not positioned
properly with respect to the pupil, too much light may be admitted
to the retina, causing serious vision difficulties. The haptics
generally lodge as described above. Also, the anterior chamber of
the eye is filled with the aqueous humor, a fluid secreted by the
ciliary process, passing from the posterior chamber to the anterior
chamber through the pupil, and from the angle of the anterior
chamber it passes into the spaces of Fontana to the pectinate villi
through which it is filtered into the venous canal of Schlemm. The
implanted lens is positioned so the flow of fluid is not
blocked.
[0101] After implant 10 is implanted, the viscoelastic material (if
previously introduced into the eye chambers) is removed from the
anterior and posterior chambers of the eye with an aspiration
syringe (such as a 24-gauge cannula). Implant 10 is fixed and
centered by the haptics of the lens as described in the examples
above. The anterior chamber is washed thoroughly with saline. The
pupil is contracted with intraocular acetylcholine 1%, carbachol
0.01%, or pilocarpine 0.5% solution. The incision is closed by
hydrating the corneal incisions. A suture rarely is needed.
[0102] In another embodiment, for implantation of implant 10, the
main incision is made at the ventral area of the eye (at the "top"
of the eye, at "12 o'clock"). The width is preferably equal to the
size of the optic, which may be 4-5 mm. Side incisions are made,
approximately 1 mm wide. Implant 10 is inserted then vertically.
Implant 10 rotated inside the viscoelastic-filled anterior chamber;
the haptics are placed horizontally as in the examples provided
above.
[0103] In some embodiments, fixating implant 10 may be a bimanual
procedure. Implant 10 may be implanted using special tools to
compress the haptics, such as forceps or cannulae, or may rely on
microhooks to manipulate the optic through a hole in the surface of
the optic (see discussion in U.S. Pat. No. 6,142,999). A
vertically-holding lens forceps, which enters the anterior chamber
through the main incision, centers the optic on the pupil and holds
it steadily. A thin forceps is introduced from the side incision
and grasps the iris close to the claw, allowing manipulation of the
iris, and/or fixation of one or more of the haptics, for example,
in the configurations described above. Both instruments are
withdrawn, and the surgeon changes hands for holding each tool. The
anterior chamber of the eye is again deepened with viscoelastic
material, and the lens-fixation instruments are reintroduced. A
second haptic-fixation maneuver may then be performed through the
incision on the opposite side. Accordingly, implant 10 may be
centered and fixated using the techniques described above,
providing accommodation for the patient.
[0104] A peripheral iridectomy can then be performed. Then, the
introduced viscoelastic material (if any) is aspirated through the
three incisions. The anterior chamber is gently irrigated and
inflated with air to remove all viscoelastic material.
[0105] For closure of the incision line, the apposition of the
sides of the incision may be achieved by one or two superficial
sutures. Alternatively, a large air bubble may be left inside the
anterior chamber to effect an apposition. If the limbal incision
was made without a pocket, then a closure of the incision line
should be performed using sutures.
[0106] At the end of the surgery, 20 mg of gentamycin and 2 mg of
dexamethasone are subconjunctivally injected. A sterile pad and a
protective shield are applied.
[0107] In some embodiments, the intraocular lens assembly of the
invention can be located in the posterior chamber of the eye, using
methods known to those of skill in the ophthalmic art.
[0108] Aphakic implantation is also usefully provided for by
implant 10. As noted above, the lens assembly can be surgically
implanted outside or inside of the evacuated capsular bag of the
lens of an eye. When implanted inside the capsular bag (for
example, through the anterior capsule opening in the bag), implant
10 may be placed in a position such that optic portion 12 is
aligned with the opening defined by the anterior capsular remnant.
Implant 10 may be centered and fixated using the techniques
described above, providing accommodation for the patient.
[0109] Advantageously, in some embodiments post-operative
atropinization of the optic ciliary muscle is not required for
implant 10 (when implanted either as a refractive phakic
intraocular lens or an aphakic intraocular lens) to achieve
accommodation. During surgery, especially for implantation of
aphakic intraocular lenses, the ciliary muscle of the eye had
previously and typically been paralyzed with a ciliary muscle
relaxant to place the muscle in its relaxed state. Ciliary muscle
relaxants include anticholinergics such as atropine, scopolamine,
homatropine, cyclopentolate and tropicamide. Atropine is preferred.
Proprietary preparations of atropine include Isopto Atropine (eye
drops); Minims Atropine Sulphate (single-dose eye drops); Min-I-Jet
Atropine (injection); Actonorm Powder (combined with antacids and
peppermint oil); Atropine-1; Atropine-Care; Atropisol; Isopto
Atropine; Ocu-tropine; Atropair; Atropine Sulfate S.O.P.; Atrosulf;
1-Tropine; Isopto Atropine; and Ocu-Tropine. Prior to this
invention (i.e., while implanting intraocular lenses not having the
advantages of the foldable intraocular lens assembly of the
invention), the patient's eye would be atropinized following
surgery, to allow for accommodation of the lens of the implanted
aphakic intraocular lens assembly to the eye (see discussion, U.S.
Pat. No. 6,051,024). Following surgery, the ciliary muscle relaxant
(such as atropine) would be periodically introduced throughout a
post-operative fibrosis and healing period (such as two to three
weeks) to maintain the ciliary muscle in its relaxed state until
fibrosis was complete. This drug-induced relaxation of the ciliary
muscle prevented contraction of the ciliary muscle and immobilized
the capsular bag. Thus, the implanted intraocular lens optic fixed
during fibrosis in its distant vision position within the eye
relative to the retina (accommodation). The implanted lens pressed
backward against and thereby forwardly stretched the elastic
posterior capsule of the capsular bag. By contrast, because of the
haptic design of the intraocular lens assembly of the invention,
the lens can, when fixated and centered using the techniques
described above, provide accommodation for the patient without the
administration of post-operative atropine.
[0110] It will be apparent to those skilled in the art that other
changes and modifications can be made in the above-described
invention and methods for making and using the same, without
departing from the scope of the invention herein, and it is
intended that all matter contained in the above description shall
be interpreted in an illustrative and not in a limiting sense.
* * * * *
References