Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
2000-01-12
2002-11-12
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C623S006560, C623S006590
Reexamination Certificate
active
06478821
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to intraocular lenses (IOLs) and in particular to IOLs that reduce or even eliminate irritation of the ciliary band or angle and the sulcus in the eye and reduce the incidence of pupillary block, and, if a natural crystalline lens is present, to reduce the risk of cataract formation.
IOLs are commonly used to modify vision. For example, IOLs are used to replace the natural lens of the eye when warranted by medical conditions. A common practice is to implant an IOL in a region of the eye known as the capsular bag or posterior bag or capsule. However, in this practice, a potential risk exists that cells from the eye may grow in front of and/or in back of the optical portion of the IOL. Such cell growth tends to block the optical portion of the IOL and impair vision.
IOLs may be implanted in regions of the eye other than in the capsular bag. Anterior chamber IOLs (AIOLs) and posterior chamber IOLs (PIOLs) are known in the prior art. These prior art IOLs are designed such that a portion of the haptics of the IOLs are located against the angle or ciliary band of the eye for the AIOLs or against the sulcus of the eye for the PIOLs.
A disadvantage of the prior art AIOLs is the risk that the fixation members or haptics of the AIOLs may irritate the ciliary band. A disadvantage of the PIOLs is the risk that the optic of the PIOLs may irritate the natural crystalline lens, if such lens is present, and possibly result in cataract formation.
Referring now to Prior Art
FIG. 1
, a posterior/anterior chamber intraocular lens (“PACL”)
10
combines the advantage of an optic
12
positioned in the anterior chamber
14
of an eye
16
and haptics
18
that position the lens resting in the sulcus
20
. The PACL
10
reduces the opportunity of irritation to the angle or ciliary band
22
and the natural lens
24
. Such PACLs are disclosed in U.S. patent application Ser. No. 09/166,328 filed Oct. 5, 1998, which is commonly assigned with the present application and is incorporated herein in its entirety by reference.
The eye
16
is comprised of a cornea
26
shown to the left and an iris
28
shown in the middle of the eye. It is to be understood that the cornea
26
is at the front of the eye
16
. The iris
28
divides the eye
16
into the anterior chamber
14
at the front of the eye and the posterior chamber
30
in the back of the eye. The iris
28
also defines the pupil
32
, which is the opening in the middle of the iris. In front of the iris
28
is the sclera spur
34
. The sclera spur
34
and the iris
28
delimit the ciliary band
22
. Behind the iris
28
is the ciliary process
36
, from which extends the ciliary muscle
38
. The ciliary muscle
38
supports the natural crystalline lens
24
of the eye
16
. The iris
28
and the ciliary process
36
define the sulcus
20
.
The haptics
18
of the PACL
10
are two opposing elongated fixation members that extend from the optic
12
. The optic
12
defines an optical axis
50
that extends through the center
52
of the optic. The haptics
18
have a proximal segment
54
attached to the optic
12
, an intermediate segment
56
, and terminates in a distal segment
58
. The optic
12
and the proximal segment
54
are located in the eye anterior chamber
14
. The haptic distal segment
58
rests against the sulcus
20
.
The intermediate segment
56
of the haptic
18
extends through a hole
60
in the periphery of the iris
28
. The intermediate segment
56
is substantially parallel to the optical axis
50
. The holes
60
may be formed by an iridectomy, or be naturally occurring openings in the iris
28
. The holes
60
have an additional benefit of improving fluid flow between the anterior chamber
14
and the posterior chamber
30
. Other details of the PACL
10
are disclosed in the above-incorporated U.S. Patent Application.
Recently developed AIOLs for insertion in eyes which contain the natural crystalline lens (“phakic” eyes) include the Nuvita™ MA-20 lens, which has a four-point haptic for fixation in the angle, and is made of rigid polymethyl methacrylate (PMMA). Another AIOL used in phakic eyes is known as the Artisan™ lens and is disclosed in Worst U.S. Pat. No. 5,192,319, which is incorporated in its entirety herein by reference. This AIOL is fixated on the iris by “pinching” the iris tissue. Made of rigid PMMA, the Artisan™ lens is difficult to implant due to the delicacy of the iris tissue. Worst U.S. Pat. No. 4,215,440, which is incorporated in its entirety herein by reference, discloses another iris-fixated AIOL, which uses one or more fixation members, each having a pair of pincer arms that pinch an anterior surface of the iris. This AIOL detachably attaches the IOL to the iris such that the optic is positioned in the iris opening and has many of the same disadvantages as does the Artisan™ lens. Suzuki U.S. Pat. No. 5,628,796, which is incorporated in its entirety herein by reference, discloses an AIOL with fixation arms or support legs that are inserted in and through fine bores or apertures made by incision in a peripheral site of the iris.
Disadvantages associated with these IOLs for phakic implantation include a requirement for large incisions in the cornea for non-foldable IOLs and potential for damage and inflammation to delicate tissue from rigid haptics. Also involved are one or more of the complications which include corneal endothelial cell loss due to mechanical abrasion against the cornea, inflammation, pupil ovalization, problems with aqueous flow in the iridio-corneal angle, and implant decentration.
There continues to be a need for new IOLs.
SUMMARY OF THE INVENTION
New iris fixated intraocular lenses (IFIOLS) have been discovered. The present IFIOLs are relatively easy and straightforward to implant in the eye and effectively fixate to the iris of the eye. The present IFIOLs are adapted to be firmly fixated to the iris, for example, so as to prevent accidental dislodgement. These IFIOLs can be sized and structured so as not to interfere with the zonules and sulcus angle of the eye, and with the natural lens of the eye, if such natural lens is present.
The iris to which the present IFIOL is fixated has a side and a hole, for example, a iridectomy hole or opening, extending from the iris side and through the iris. In one broad aspect, the present IFIOLs comprise an optic and at least one fixation member or haptic. The fixation member is joined to the optic and includes a distal segment including a through-iris portion adapted to extend through the iris hole and an anchor portion. The anchor portion has or is adapted to have an anchor structure positioned to be disposed proximate to the iris side so as to be effective in fixating the IFIOL to the iris.
In one aspect of the invention, the optic is adapted to be disposed in the anterior chamber while the anchor portion is adapted to be disposed in the posterior chamber or the anterior chamber, preferably in the posterior chamber.
The anchor portion may have the anchor structure prior to the intraocular lens being placed in the eye or the anchor portion may be adapted to form the anchor structure after the intraocular lens is placed in the eye.
In one embodiment, the anchor portion adapted to form the anchor structure after insertion or placement in the eye may be comprised of hydrophilic material adapted to absorb aqueous fluid and form the anchor structure in the eye. The hydrophilic material used may be any suitable such material, for example, a material suitable for use in the eye. Examples of useful hydrophilic materials include, but are not limited to, acid-treated polymers, base-treated polymers, hydrogel-forming polymeric materials and the like and mixtures and combinations thereof.
In another embodiment of the invention, the anchor portion adapted to form the anchor structure after insertion in the eye may be comprised of an elastic memory material adapted to form the anchor structure in the eye. Any suitable elastic memory material may be employed, provided that such material is useful in the
Laguette Stephen W.
Weinschenk, III Joseph I.
Advanced Medical Optics, Inc.
Gluck Peter Jon
Uxa, Jr. Frank J.
Willse David H.
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