Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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SIZING A PHAKIC REFRACTIVE LENS
Field of the Inoention
This invention relates to an intraocular lens, in particular an intraocular
phakic
refractive lens, and a method of implanting a phakic refractive lens to
correct the eyesight
S of an eye.
The present invention is also directed to sizing a phakic refractive lens.
Specifically, the present invention is directed to a sized phakic refractive
lens and a
method of sizing a phakic refractive lens.
Background of the Im~ention
Major ocular components of an eye include a retina and cornea. The cornea
connects to the sclera at the limbus. An anterior segment of the eye is
divided into two
principle chambers by the iris and pupil. An anterior chamber is defined by
the space
between the cornea and the iris. A posterior chamber is defined by the space
between the
iris and vitreous.
A natural crystalline lens is located behind the pupil as defined by the iris.
The
natural crystalline lens is attached at its periphery by zonules. The eye is
deformable and
the zonule attachments allow the natural crystalline lens to deform to
different optical
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powers. In some cases, the natural crystalline lens does not properly deform
to achieve
a required focus or the length of the eyeball is such that an image does not
fall directly on
the retina. Spectacles or contact lenses are require to compensate for the
focus of the
natural lens or axial length of the eye. Recent technological developments
have provided
S a deformable and relatively permanent artificial intraocular lens that can
be implanted into
the eye to provide permanent vision correction. An intraocular lens has an
optical zone
portion, and generally made of flexible material suitable for optical use such
as silicone.
At least two general problems are associated with implantation of an
intraocular
lens. First, the implantation method requires a relatively large incision,
which can lead to
complications such as infection, retinal detachment and laceration of the
ocular tissue. A
second problem relates to the intraocular environment. Intraocular tissue is
extremely
delicate and sensitive. Any artificial body that is inserted into the eye must
be designed
with consideration of the body's interface with intraocular tissue on all
surfaces, not just
one surface as with an exterior, surface contact lens. Further, intraocular
tissue differs
from exterior eye tissue. At least one surface of exterior eye tissue is
exposed to the
hardening influence of an exterior environment, which at least to some extent
enures the
one surface to the effect of foreign bodies such as a surface contact lenses.
U.S. Patent Nos. 4,573,998 and 4,702,244 both to Mazzocco, disclose an
improved intraocular lens structure, method and instrumentation for
implantation through
a relatively small incision in ocular tissue. The disclosures ofthe 4,573,998
and 4,702,244
patents are incorporated herein by reference. The lens structure disclosed in
the
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4,573,990 and 4,702,244 patents comprises a deformable optical zone portion
having
prescribed memory characteristics. The lens can be deformed by compressing,
rolling,
folding, stretching or by a combination thereof to a small diameter for
insertion through
a small incision in the eye. The memory characteristics enable the lens to
return to an
original configuration with full size and fixed focal length after insertion.
The optical zone
portion of the lens is fabricated from a biologically inert material
possessing elasticity and
compression characteristics.
Co-pending parent applications, Serial Numbers 08/318,991 and 08/736,433 to
Feingold address a problem of shape of an intraocular lens with regard to the
intraocular
environment. The disclosure of this application is incorporated herein by
reference.
Feingold teaches a phakic refractive lens ("prl"), for example the IMPLANTABLE
CONTACT LENS (ICL) manufactured by STAAR Surgical AG of Switzerland, provided
with an outer radius of curvature between a lens body portion (base portion)
and a lens
portion (optic portion) that smoothly transitions therebetween. Specifically,
there exists
a transition in the outer radius of curvature of the lens between the lens
base portion and
the optic portion. It is important that the transition in the radius of
curvature between
these two portions or zones is such that there is a minimization of edge
formation so as
to prevent damage or wear to the back of the iris. A transition can be made
that has a
gradient of radius of curvature within very small dimensions. The transition
forms a
transition portion that defines an elliptically transcribed surface transition
from the surface
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of the optic portion to the surface of the base portion. Such an arrangement
works well
within the eye and does not appear to damage or wear the back of the iris.
Feingold also teaches that at least one groove can be provided in the outer
surface
of the phakic refractive lens. The groove is preferably in the arrangement of
a circular
groove located in the base portion and surrounding the optic portion. The
circular groove
allows for good ~;irculation of eye fluid to facilitate lubrication between
the phakic
refractive lens and the back of the iris. Other groove configurations can be
utilized.
Further, Feingold teaches that a passageway can be provided in the phakic
refractive lens between posterior and anterior surfaces to equalize
intraocular pressure
against the lens surfaces to allow equalization of pressure between anterior
and posterior
eye chambers. The passageway is provided in a variety of different forms. The
passageway can be in the form of a groove in the anterior surface and a groove
in the
posterior surface that connect to form a continuous channel or the passageway
can be
provided in the form of a hole through the thickness dimension of the phakic
refractive
lens at one or more locations.
Feingold also provides one or more through holes in the iris to place the
anterior
chamber and posterior chamber in fluid communication to allow equalization of
pressure
therebetween. This prevents the phakic refractive lens from being sucked into
tight
contact with the back of the iris to cause damage and wear to the back of the
iris. The
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tight contact effect is due to a differential pressure between the posterior
and anterior eye
chambers. The through holes eliminate the differential pressure between the
chambers.
Figure 25 is a partial side sectional view of a human eye showing a location
of an
implanted phakic refractive lens. The lens is located in the posterior chamber
and can be
fixed in the chamber by a peripheral body member (haptic), which extends
beyond the
optic portion of the lens. The body member accomplishes fixation by contacting
the
peripheral tissues of the eye posterior to the iris in the area of the ciliary
sulcus. The
posterior surface of the lens intimately contacts the convex anterior surface
of the lens.
One problem with this arrangement is that the intimate contact between
surfaces
of the implanted lens and the natural crystalline lens can cause cataracts. It
is desirable
to place the phakic refractive lens in a position with respect to the natural
lens that
minimizes contact between surfaces of the implanted lens and the natural
crystalline lens
to reduce the risk of cataracts. Heretofore however, it has been believed
necessary to
intimately contact the two surfaces in order to achieve proper refractive
correction. The
present invention is based in part on a finding that proper refractive
correction can be
achieved and at the same time, development of cataracts can be avoided by
implanting a
phakic refractive lens so as to form a spacing between the posterior surface
of the phakic
refractive lens and the anterior surface of the natural crystalline lens.
The concept of a deformable phakic refractive lens was invented by Dr. Thomas
R. Mazzocco. In U.S. Patent No. 4,702,244 to Thomas R. Mazzocco, Fig. 60 shows
a
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deformable phakic refractive lens positioned in the posterior chamber between
the natural
crystalline lens and the iris.
STAAR Surgical AG of Switzerland has been developing a refractive phakic lens
and refers to their phakic refractive lens under the trademark IMPLANTABLE
CONTACT LENS or ICL. STAAR Surgical AG has been conducting significant
clinical
studies on the IMPLANTABLE CONTACT LENS, which studies indicate that the
IIVVIPLANTABLE CONTACT LENS is effective for refractive correction of the
human
eye. The IIVVIPLANTABLE CONTACT LENS has also been utilized as a phakic/pseudo-
phakic lens in which the natural crystalline lens has been replaced with an
intraocular lens
and then further corrected with a phakic refractive lens such as the
IMPLANTABLE
CONTACT LENS.
Summary of the Invention
A first object of the invention is to provide an improved intraocular lens in
the
form of an phakic refractive lens and improved method of implanting the phakic
refractive
1 S lens.
A second object is to provide a phakic refractive lens that forms a spacing
with the
natural crystalline lens of the eye when the phakic refractive lens is
implanted into the eye.
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A third object is to provide a phakic refractive lens that cooperates with the
natural
crystalline lens to correct eyesight.
A fourth cbject of the present invention is to provide a phakic refractive
lens that
remains comfortably fitted into the eye over extended periods of time.
A fifth object of the present invention is to provide an improved method of
implantation of a phakic refractive lens.
These and other objects of the present invention are described in detail in
the
description of the invention taken in conjunction with the drawings.
The invemi~n relates to a method of implanting an intraocular phakic
refractive
lens into an eye having a natural crystalline lens and pupil. The method
comprises steps
of providing a phakic refractive lens and inserting the phakic refractive lens
into a
posterior chamber of the eye into a position anterior to and in a vicinity of
the natural
crystalline lens in the location of the pupil to provide a spacing between the
phakic
refractive lens and the natural crystalline lens.
The invention also relates to a phakic refractive lens implanted in a
posterior
chamber of an eye in a vicinity of the natural crystalline lens. The phakic
refractive lens
comprises a shape predetermined with respect to a shape of the natural
crystalline lens to
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form a spacing between a posterior surface of the phakic refractive lens and
an anterior
surface of the natural crystalline lens.
The invention also relates to a phakic refractive lens for implanting in the
vicinity
of a natural crystalline lens of an eye. The phakic refractive lens comprises
a shape that
is predetermined with respect to a shape of the natural crystalline lens to
form a spacing
between a posterior surface of the phakic refractive lens and an anterior
surface of the
natural crystalline lens when the phakic refractive lens is implanted into the
eye.
Sizing A Phakic Refractioe Lens
A first object of the present invention is to provide an improved phakic
refractive
lens.
A second object of the present invention is to provide a sized phakic
refractive
lens.
A third object of the present invention is to provide a sized phakic
refractive lens
to custom fit the actual dimensions of an eye.
A fourth abject of the present invention is to provide a phakic refractive
lens
custom designed and sized to fit an eye.
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A fifth object of the present invention is to provide a phakic refractive lens
custom
designed to fit to the inner dimensions of the inner structure of ari eye.
A sixth object of the present invention is directed to a method of sizing a
phakic
refractive lens for an eye.
A seventh object ofthe present invention is directed to a method of sizing a
phakic
refractive lens for an eye previously measured.
The present invention is directed to a sized phakic refractive lens and a
method of
sizing a phakic refractive lens.
The phakic refractive lens according to the present invention is a sized
phakic
refractive lens. Specifically, the structure of the eye is carefully measured
to determine
its shape, conformation and size dimensions of the inner structure of the eye,
and
subsequently a custom phakic refractive lens is designed based on this
information and
then implanted in the eye.
The eye is measured by any suitable technique for providing details of the
shape,
confirmation and/or size dimensions of the inner structure of the eye.
Specifically, the
phakic refractive lens known as the IMPLANTABLE CONTACT LENS ("ICL") is
designed to fit in the posterior chamber between the natural crystalline lens
and the iris,
and vaults over at least a center portion of the natural crystalline lens. The
edges of the
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IIUVIPLANTABLE CONTACT LENS along its major axis are located on the zonules
and/or located in the ciliary sulcus. Thus, accurate measurement of the
location of the
shape, conformation, and size dimensions of the zonules and/or sulcus is
important with
respect to sizing the length and width dimensions of the IMPLANTABLE CONTACT
LENS along its major and minor axes. Further, the actual detailed shape of the
zonules
and/or sulcus must be determined along one or more axis in the eye along which
the major
axis of the intraocular contact lens will be aligned, since the zonule-to-
zonule and/or
sulcus-to-sulcus dimensions can change at different angles of orientation
within each eye
of a patient. Further, it is not uncommon that the dimensions from eye-to-eye
of a
particular patient vary (i.e. different in dimensions at the same angle of
orientation in each
eye). Thus, the shape, confirmation and/or size dimensions of each eye of a
patient
typically are different, and must be precisely and accurately measured to
properly design
and size an IMPLANTABLE CONTACT LENS for the particular patient's eye.
In the application of an IMPLANTABLE CONTACT LENS, the length of the
major axis, length of the minor axis, degree of vaulting defined by the angle
between the
center plane of the lens portion and a average plane of a haptic portion,
dimensions of the
lens portion, dimensions of the haptic portion, shape of the haptics, shape of
the edges,
shape and size of the footpads, and other important design parameters of the
IIVVIPLANTABLE CONTACT LENS are all specified based on the shape, confirmation
and size prescription of a patient's particular eyes after precisely and
accurately measuring
the particular eye. Further, the distance and location of each footpad
designed to contact
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with the zonules and/or sulcus must be precisely and accurately be specified
for proper
and comfortable fit of the implantable contact lens in the eye.
One preferred method of measuring the eye for designing and sizing an
implantable
contact lens is by measuring the exterior white-to-white measurements of the
eye
S , particularly along an axis ofthe eye along which the major axis ofthe
implantable contact
lens will be aligned once implanted. The white-to-white measurement can also
be made
at other angles of orientation of the eye (e.g. along diagonal axis of the
footpads of the
implantable contact lens) to properly design and shape the implantable contact
lens forthe
particular eye. Based on the white-to-white measurements of the eye, this
information is
fed into a formula or algorithm to provide the exact design parameters of the
implantable
contact lens to provide proper design and sizing of the implantable contact
lens.
Another preferred method of measuring an eye involves use of ultrasonic
radiation
for measuring the exact shape, confirmation and size dimensions of the inner
structures
of the eyes. For example, the exact shape and location of the zonules and/or
sulcus can
be determined using ultrasonic radiation to detect these structures within the
eye. The
ultrasonic radiation, emission and detection is based on emitting ultrasonic
waves into the
eye with some of the ultrasonic waves reflecting at the interface between the
inner
structure ofthe eye and the fluid medium within the eye, which provides a
reflected image
detectable to create a precise and accurate visual depiction of the shape,
confirmation and
size dimensions of the inner structure of the eye. The ultrasonic apparatus
can scan the
entire eye or portions thereofto carefully map the shape, confirmation and
size dimensions
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ofthe inner structure of the eye (e.g. natural crystalline lens, capsular bag,
zonules, sulcus,
iris, pupil, sclera and other structure involved with the surgical placement
of an
11VIPLANTABLE CONTACT LENS).
The preferred method of mapping the eye including determining the shape,
confirmation and size dimensions of the inner structure of the eye can be
accomplished by
using one or more beams of ultrasonic radiation generated by an ultrasonic
transducer
positioned outside the eye. The one or more beams can scan an sweep the entire
inner
structure of the eye to provide a reflected image that is captured on a
detector. The
detected image can be displayed on a cathode ray tube (CRT), which can be
scaled to
precisely and accurately measure the shape, confirmation and size dimensions
ofthe inner
structure of the eye.
Brief Description of the Figures
Figure 1 is a cross-sectional view of a positive intraocular phakic refractive
lens,
as indicated in Figure 3.
Figure 2 is a cross-sectional view of the phakic refractive lens in Figure l,
as
indicated in Figure 3.
Figure 3 is a top planar view of the positive phakic refractive lens as shown
in
Figures 1 and 2.
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Figure 4 is a cross-sectional view of another embodiment of a positive phakic
refractive lens as indicated in Figure 6.
Figure 5 is a cross-sectional view of the positive phakic refractive lens
shown in
Figure 4, as indicated in Figure 6.
Figure 6 is a top planar view of the positive phakic refractive lens as shown
in
Figures 4 and S.
Figure 7 is a table of examples of positive phakic refractive lenses directed
to the
two embodiments shown in Figures 5-10.
Figure 8 is a cross-sectional view of a negative phakic refractive lens
according
to the present invention, as indicated in Figure 10.
Figure 9 is a cross-sectional view of the negative phakic refractive lens
shown in
Figure 8, as indicated in Figure 10.
Figure 10 is a top planar view of the negative phakic refractive lens shown in
Figures 8 and 9.
Figure 11 is another embodiment of a negative phakic refractive lens according
to
the present invention, as indicated in Figure 12.
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Figure 12 is a cross-sectional view of the phakic refractive lens shown in
Figure
11, as indicated in Figure 13.
Figure 13 is a top planar view of the negative phakic refractive lens shown in
Figures 11 and 12.
Figure 14 is a table of examples of negative phakic refractive lenses directed
to the
two embodiments shown in Figure 8-13.
Figure 1 S is a top planar view of another embodiment of a positive phakic
refractive lens according to the present invention.
Figure 16 is a cross-sectional view of the positive phakic refractive lens, as
indicated in Figure 15.
Figure 17 is a partial detailed cross-sectional view of a portion of the
positive
phakic refractive lens shown in Figures 15 and 16, illustrating the detailed
curvature
thereof.
Figure 18 is a table indicating the detailed curvature as an example of the
embodiment of the positive phakic refractive lens shown in Figures 15-17.
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Figure 19 s another embodiment of a negative phakic refractive lens according
to
the present invention.
Figure 20 is a top planar view of another negative phakic refractive lens
according
to the present invention with a circular groove in the lens body portion
thereof.
Figure 21 is a cross-sectional view of the negative phakic refractive lens, as
indicated in Figure 20.
Figure 22 is a cross-sectional view of an eye having an phakic refractive lens
according to the present invention implanted therein.
Figure 23 is a cross-sectional view the eye with a prior art phakic refractive
lens
implanted therein.
Figure 24 is a cross-sectional view of another embodiment of a phakic
refractive
lens.
Figure 25 is a partial side sectional view of a human eye with a phakic
refractive
lens illustrating a lens implant of the prior art.
Figures 2(i-28 are partial side sectional views of a human eye with phakic
refractive lenses illustrating lens implants according to the present
invention.
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Figure 29 is a detailed perspective view of an eye.
Figure 30 is a detailed cross-sectional view of an eye containing an
aVIPLANTABLE CONTACT LENS type of phakic refractive lens.
Detailed Description of the Preferred Enzbodiments
S The intraocular phakic refractive lens ("prl") according to the present
invention
can be provided with a concave posterior face that is shaped substantially
complementary
to the convex shape of the anterior surface of the natural crystalline lens.
The phakic
refractive lens is adapted to provide a face to face relationship with the
anterior surface
of the natural crystalline lens. However, as hereinafter described, at least a
part of the
posterior surface ofthe phakic refractive lens is separated from the anterior
surface ofthe
natural crystalline lens to form a spacing between the phakic refractive lens
and the natural
crystalline lens. The spacing is formed at a location between the phakic
refractive lens and
the pupil of the eye.
An embodiment of a positive phakic refractive lens according to the present
invention is shown in Figures 1-3.
The phakic refractive lens 10 is defined by an oval-shaped lens body portion
12
defined by major axis diameter DM and minor axis diameter Dm, and radius R2,
and a
circular shaped lew; portion 14 having a diameter Do.
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The lens portion 14 has a thickness Tc and the lens body portion 12 has an
edge
thickness Te, as shown in Figure 1. Further, the lens portion 14 has a
curvature SRfr, and
the lens body portion 12 has an outer curvature SRo and an inner curvature
SRi.
Another embodiment of a positive phakic refractive lens according to the
present
invention as shown in Figures 4-6.
The phakic refractive lens 20 is defined by an oval-shaped lens body portion
22
defined by major axis diameter DM and minor axis diameter Dm, and a radius R2,
and a
circular shaped lens portion 24 having a diameter Do.
The lens portion 24 has a thickness Tc and the lens body portion 22 has an
edge
thickness Te, as shown in Figure 4. Further, the lens portion 24 has a
curvature SRfr and
the lens body portion 22 has an outer curvature SRfr2 (SRo) and an inner
curvature SRi.
Specific examples of the positive phakic refractive lens are given in the
table in
Figure 7. In these examples, T = 0.05 ~ 0.02mm, Sro = 9.4 t 0.1, SRi = 9.8, DM
= 10.5
t0.lmm,Dm=6~0.3mmandR2~0.1.
An embodiment of a negative phakic refractive lens according to the present
invention as shown in Figures 8-10.
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The phakic refractive lens 30 is defined by an oval-shaped lens body portion
32
defined by major axis diameter DM and minor axis diameter Dm, and having a
radius R2,
and a circular shaped lens portion 34 having a diameter Do.
The lens portion 34 has a thickness Tc and the lens body portion 32 has an
edge
thickness Te, as shown in Figure 8. Further, the lens portion 34 has a
curvature SRfr and
the lens body portion 32 has an outer curvature SRo and an inner curvature
SRi.
Another embodiment of a negative phakic refractive lens according to the
present
invention as shown in Figures 11-13.
The phakic refractive lens 40 is defined by an oval-shaped lens body portion
42
defined by major axis diameter DM and minor axis diameter Dm, and having a
radius R2,
and a circular shaped lens portion 44 having a diameter Do.
The lens portion 44 has a thickness Tc and the lens body portion 42 has an
edge
thickness Te, as shown in Figure 11. Further, the lens portion 44 has a
curvature SRfr and
the lens body portion 42 has an outer curvature SRfr2 (SRo) and an inner
curvature SRi.
Specific examples of the positive intraocular refractive lens are given in the
table
in Figure 14. In these examples, T = 0.05 t 0.02mm, Sro = 9.4 ~ 0.1, SRi =
9.8, DM =
10.5 ~ O.lmm, Dm = 6 t 0.3mm and R2 ~ 0.1. When the value of Rfr reaches
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100,000mm, as shown in Figure 14, the anterior surface of the optic portion of
the lens
is essentially planar, as it appears in Figure 11.
A further embodiment of a positive intraocular refractive lens 50 is shown in
Figures 15-17.
The phakic refractive lens 50 is defined by an oval-shaped lens body portion
52
defined by major axis diameter DM and minor axis diameter Dm, and radius R2,
and a
circular shaped lens portion 54 having a diameter Do. The lens portion 54 has
a thickness
Tc and the lens body portion 52 has an edge thickness Te, as shown in Figure
16.
The detailed curvature of the phakic refractive lens is shown in Figure 17. An
example of this particular lens is given in the table in Figure 18 with the
designations Rl-
R8 corresponding to Figure 17.
A further embodiment of a negative phakic refractive lens 60 is shown in
Figure
19. The advantage of this embodiment is that a small gap exists between the
phakic
refractive lens center and the natural lens allowing for flow ofbody fluids,
and to minimize
friction which could potentially cause mechanical damage and cataracts in the
eye.
An even further embodiment of a negative phakic refractive lens 70 is shown in
Figure 20.
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The phaki;; refractive lens 70 is defined by an oval-shaped lens body portion
72
defined by major a.tis diameter DM and minor axis diameter Dm, and a circular
shaped
lens portion 74 having a diameter Do. The lens portion 74 has a thickness Tc
and the lens
body portion 72 has an edge thickness Te, as shown in Figure 21.
The important feature ofthis embodiment is the circular groove G provided in
the
lens body portion 72 surrounding the lens portion 74. The circular groove G
allows for
circulation offluid inside the eye. Further, the groove G can be used for lens
manipulation
during surgery, and facilitates the equalization of intraocular pressure.
An embodiment of an phakic refractive lens 80 having a lens body portion 82
and
lens portion 84, is shown in Figs. 22 and 23. In this embodiment, an air
passageway 86
(e.g. hole) is provided in the center optical axis of the lens portion 84 for
equalizing the
pressure between the anterior surface 88 and posterior surface 90 of the
phakic refractive
lens 80. This air passageway 8G allows for equalization of pressure between
the anterior
chamber and posterior chamber of the eye. Otherwise, a significant suction or
negative
pressure can occur on the anterior surface of the phakic refractive lens
sucking the back
of the iris into contact therewith and causing damage or wear to the iris.
The phakic refractive lens 80 is provided with a pair of indents 92, as shown
in
Figs. 22 to 24, for allowing the phakic refractive lens 80 to be manipulated
under the iris
during the implantation operation. The indents 92 are significantly better
than through
holes for purposes of manipulation, since the bottoms of the indents prevent
penetration
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of a manipulating tool through the lens and inadvertently into contact with
the natural lens
that would cause an immediate cataract of the natural lens.
Figure 25 illustrates a lens implantation according to the prior art. Figure
25
shows a natural eye 100 with posterior chamber 102 and natural crystalline
lens 104 with
S anterior surface 106. A phakic refractive lens 108 is shown implanted into
the posterior
chamber 102 into a position at the pupil 98 wherein the posterior surface 110
of lens 108
is in intimate contact with the anterior surface lOG of natural crystalline
lens 104.
In one embodiment, a dimension of the eye is determined and the phakic
refractive
lens is provided according to the eye dimension so that the phakic refractive
lens forms
a spacing when inserted into the posterior chamber. For example, the arc of
radius of
curvature of the natural crystalline lens can be determined by methodology
known in the
art. The arc of radius of curvature of the phakic refractive lens is then
determined
according to the arc of radius of curvature of the natural crystalline lens.
If a phakic
refractive lens is provided that has an arc of radius of curvature less than
the arc of
curvature of the natural crystalline lens, the implanted phakic refractive
lens will form a
spacing with the anterior surface of the natural crystalline lens. In another
embodiment,
the arc from a location on the ciliary body of the natural crystalline lens
over an arc of
radius of curvature of the natural crystalline lens to another location on the
ciliary body
of the natural crystalline lens is determined. If the phakic refractive lens
is provided with
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a posterior surface having an arc greater than the determined arc, the
implanted phakic
refractive lens will form a spacing with the anterior surface of the natural
crystalline lens.
A phakic refractive lens according to any of Figures 1-24 can be implanted in
a
natural eye by the method of the present invention. The artificial intraocular
phakic
refractive lens is inserted into a posterior chamber of the eye to a position
anterior to and
in a vicinity of the natural crystalline lens to provide a spacing between the
phakic
refractive lens and the natural crystalline lens as shown in Figures 26-28.
Preferably the
spacing is a separation between the posterior surface of the phakic refractive
lens and the
anterior surface of the natural crystalline lens of between SOpm and 150pm.
Figure 26 illustrates one embodiment wherein the phakic refractive lens 102
rests
at its periphery edge 104 at zonule attachment IOG. In this embodiment, the
radius of
curvature of the arc of the posterior surface 108 of the phakic refractive
lens 102 is less
than the radius of curvature of the arc of the anterior surface 110 of the
crystalline lens
112 and the arch of the arc of the phakic refractive lens 102 forms a vaulted
relationship
over the crystalline lens surface 110 at the location of the pupil 98 to form
the spacing 114
of the invention. The spacing 114 is located between phakic refractive lens
102 and the
pupil 98. As shown in Figure 26, the phakic refractive lens 102 does not
contact either
the natural crystalline lens 112 or the iris, at any point on the lens 112 or
the iris.
In another embodiment shown in Figure 27, the phakic refractive lens 122
includes
a body portion 124 that positions the optic portion 126 of the lens in its
vaulted
22
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WO 01/30273 PCT/US00/41252
relationship anterior to the natural crystalline lens 128 at the location of
pupil 98. A
vaulted phakic refractive lens describes a phakic refractive lens having a
concave posterior
surface 132 that is arched to form a spacing 134 between the posterior surface
132 of the
phakic refractive lens 122 and the anterior surface 136 of natural crystalline
lens 128
S when the phakic refractive lens 122 is implanted and seated in an eye. The
vaulted arch
is formed as a result of an elongated body portion 124 that is seated to
extend from zonule
attachment 138 at lens periphery 140 so as to form the arched structure
separated by a
spacing 134 from the natural lens anterior surface 13G.
In still another embodiment shown in Figure 28, the phakic refractive lens 152
comprises an optic; portion 154 and a body portion 15G. The radius of the arc
of posterior
surface 158 of the optic portion is smaller than the radius of the arc of the
posterior
surface 160 of the body portion 15G so that the respective arcs meet at an
angle. The
smaller radius of the arc of the optic portion 154 forms the vaulted
relationship with the
anterior surface lfi2 of the crystalline lens 164 in the location of the pupil
98 to form
spacing 166. In this embodiment, the radius of the arc of the lens body 156
can be the
same as the radius of the arc of the anterior surface 162 of the crystalline
lens 164 so that
the posterior surface 160 of the lens body portion 15G resides on the surface
of the
anterior surface 1t2 ofthe crystalline lens 1G4 in a face to face
relationship. The alternate
relationship is shown in Figure 27 where the radius of the arc of the body
portion 124 can
be less than the radius of the arc of the anterior lens surface 136 so that
the spacing 134
of the invention is formed by a combination of the vaulted optic portion and a
cavity
between the body portion and the crystalline lens 128.
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WO 01/30273 PCT/US00/41252
The phakic refractive lens of the present invention can be deformable in
accordance with the lenses of the Mazzocco patents so that the lens can be
implanted
through a small incision made in the ocular tissue. These phakic refractive
lenses have
prescribed memory characteristics. The phakic refractive lenses can be
deformed by
compressing, rolling, folding, stretching or the like or by a combination
thereof, to a
diameter of 80% or less of the cross-sectional diameter of the optic. The
prescribed
memory characteristics permit the lenses to restore to their original
configuration, full size
and fixed focal length after insertion into the eye.
Preferably, the phakic refractive lens body of the present invention can be a
silicon
material or more preferably a collagenous acrylic reaction copolymer that is
biologically
compatible with tissue of the natural eye. These materials are known in the
art as
represented by U.S. Patent 5,104,957 to Kelman e1 al. The collagenous acrylic
reaction
copolymers are particularly advantageous. The acrylic collagen polymer lens is
permeable
to both gases and nutrients. The lens has significant water content and
permits free
1 S perfusion of nutrients that are required by the eye. Further while
applicants do not intend
to be bound by the following explanation, it is believed that an acrylic
collagen polymer
phakic refractive lens permits a permeation of ocular fluid through the lens
body and into
the spacing formed between the implanted phakic refractive lens body posterior
surface
and the natural crystalline lens anterior surface. A reaction may take place
within the
spacing. At any rate, it is known that an interphase zone is formed in the
spacing. The
interphase zone enhances wearing comfort of the implanted phakic refractive
lens.
Additionally the interphase provides a transition between the natural
crystalline lens and
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implanted phakic refractive lens that permits adjustment of light transmission
properties
of the phakic refractive lens to light transmission properties of the natural
crystalline lens
so as to provide accurate vision .
Other modifications of the present invention will occur to those skilled in
the art
S subsequent to a review of the present application. For example, the arch
that forms the
spacing can be a result of an elongated haptic lens portion that is seated so
as to extend
from a zonule attachment at the lens periphery so as to form an ached
structure separated
from the natural crystalline lens anterior surface. In this application, a
haptic portion is
a portion of an intraocular lens that extends from the zonule attachment at
the lens
periphery. The haptic portion may coincide with the base portion or the haptic
may be
considered only a part of a larger base portion that extends with the
transition portion and
optic portion to form the vault over the natural crystalline lens.
These modifications and equivalents thereof are intended to be included within
the
scope of this invention.
Sizing Phakic Refractive Lens
Figure 29 shows a detailed perspective view of an eye. The white-to-white
measurement Dww is shown in Figure 29 being measured along the y-axis. The
same
measurement can be made at continuous or incremental angles A around the
entire 180
degrees to fully map the white-to-white dimension. This information can then
be utilized
CA 02401862 2002-08-30
WO 01/30273 PCT/US00/41252
in a formula or algorithm to compute the size of the phakic refractive lens
for proper
sizing within the eye. Specifically, the white-to-white measurement is
somewhat
mathematically related to the dimensions of the inner structure of the eye
including the
dimensions ofthe zonules-to-zonules and/or sulcus-to-sulcus measurements.
Specifically,
there is a correlation between the white-to-white measurement and the zonule-
to-zonule
dimensions and/or sulcus-to-sulcus measurements. This is a fast and easy
method for
sizing a phakic refractive lens. However, it is preferable to be able to
actually map with
high precision and accuracy the inner structure of the eye involved with the
placement of
a phakic refractive lens into the eye.
A detail cross-sectional view of the eye is shown in Figure 30. The natural
crystalline lens 200 is enclosed within the capsular bag 202. The capsular bag
202 is
supported within the eye by zonules 204. The zonules 204 surround the entire
periphery
of the capsular bag 202 and operate like a sphincter. The zonules 204 are
connected to
the congentiva 206, which is a muscular portion of the eye. The iris 208 is
located in front
ofthe natural crystalline lens 200 and the pupil 210 is defined by an opening
through the
iris 208. The base of the iris 208 connects with the congentiva 206 and
defines an annular
recess referred to as the sulcus 212.
In the embodiments shown in Figure 30, a IMPLANTABLE CONTACT LENS
214 type of phaki~ refractive lens is positioned between the natural
crystalline lens 200
and the iris 208. It is to be noted that the IMPLANTABLE CONTACT LENS 214
substantially vaults over the entire natural crystalline lens 200 and rests on
the zonules
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WO 01/30273 PCT/US00/41252
204. Specifically. a space 21 G is provided between the anterior surface of
the capsular
202 covering the anterior portion of the natural crystalline lens 200 and the
posterior
surface of the IMPLANTABLE CONTACT LENS 214.
Typically, this space 21G is filled with nourishing eye fluid which continues
to
circulate and be replenished to maintain the health of the capsular bag 202
and natural
crystalline lens 200. The IMPLANTABLE CONTACT LENS 214 is defined by a lens
portion 214x, and a haptic portion 214b. The haptic portion 214b is provided
with four
(4) spaced apart footpads 214c resting or in contact with the zonules 204. The
footpads
214c support the remaining portions of the IMPLANTABLE CONTACT LENS 214 up
and away from the surface of the natural crystalline lens 202, or otherwise
allows the lens
to vault over the natural crystalline lens 202 so as to prevent any
substantial contact with
the natural crystalline lens 202.
Various important dimensions of the eye to be measured for proper sizing of
the
IMPLANTABLE CONTACT LENS 214 is shown in Figure 30. The length ofthe natural
1 S crystalline lens 200 is defined by the dimension D,. The dimension Du
defines the inner
dimension of the location where the zonules connect to the natural crystalline
lens 200.
The dimension Dzi is less than the dimension D,, since the zonules 204 connect
somewhat
inwardly from an outer edge of the natural crystalline lens 200. The dimension
DZO defines
the outer dimension ofthe zonules at or near where the zonules connect to the
congentiva
206. The dimension DS defines the outer dimension of the sulcus 212. The
dimensions
Zil and Z,2 define the length of the zonules on the left side and right side,
respectively, of
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WO 01/30273 PCT/US00/41252
the natural crystalline lens 200. The dimension Z" and the dimension Z,~ can
vary with
respect to each other and also vary around the entire circumference of the
natural
crystalline lens 200. The dimensions S" and S,Z define the depth of the sulcus
212. These
are the macroscopic dimensions of the eye of interest in sizing the
implantable contact lens
214. However, the dimensions of substructure including the width of the point
of
connections of the outer portion of the zonules to the congentiva 206 may be
of interest
for accurate and precise positioning of the IMPLANTABLE CONTACT LENS 214
within the eye.
In the event that the IMPLANTABLE CONTACT LENS 214 is oversized for the
particular eye in which it has been implanted, the IMPLANTABLE CONTACT LENS
214 may vault too much and force the anterior surface of the implantable
contact lens 214
into the posterior chamber of the iris 208 potentially causing rubbing and/or
damage to
a back portion of the iris (e.g. rubbing off pigment located on posterior side
of iris 208).
Further, overvaulting of the implantable contact lens 214 may cutoff natural
fluid flow
from the sulcus 212 where eye fluid is generated and then circulated towards
the pupil 210
into the anterior chamber causing a surgically induced glaucoma in the
patient's eye. In
the event that the implantable contact lens is undersized, it may cause
undesirable contact
with the natural crystalline 220 inducing a cataract due to rubbing
therebetween. Thus,
proper sizing of the IMPLANTABLE CONTACT LENS 214 is important.
28
