Note: Descriptions are shown in the official language in which they were submitted.
W O 96/36377 CA 0 2 2 2 0 3 5 5 19 9 7 -11- 0 6 p~/Ug96/06774
INTRAOCULAR IMPLANT, DELIVERY DEVICE,
AND METHOD OF IMPLANTATION
FIELD OF THE INVHNTION
The invention relates generally to ophthalmic
implants for treatment of glaucoma, delivery devices for
implanting such implants, and to methods of implanting
such implants.
BACKGROUND OF THE INVENTION
Glaucoma is an eye condition characterized by
an increase in the intraocular pressure (IOP) of the eye
to an abnormal level. A normal eye maintains a proper
IOP by the circulation within the eye of aqueous humor --
aqueous humor is secreted from the ciliary body, passes
through the pupil into the anterior chamber of the
eyeball, and is filtered out of the eyeball via the
trabeculum and the Canal of Schlemm. With glaucoma, the
aqueous humor excretory pathway is blocked, the aqueous
humor cannot pass out of the eyeball at an adequate rate,
the IOP rises, the eyeball becomes harder, and the optic
nerve atrophies by the pressure applied on its fibers
leaving the retina. A characteristic optic neuropathy
develops, resulting in progressive death of the ganglion
cells in the retina, restriction of the visual field, and
eventual blindness. Advanced stages of the disease are
characterized also by significant pain.
Glaucoma treatment, if initiated early in the
course of the disease, can prevent further deterioration
and preserve most of the ocular functions. The goal of
glaucoma treatment is to reduce the IOP to a level which
is considered safe for a particular eye, but which is not
so low as to cause ocular malfunction or retinal
complications.
One type of glaucoma treatment is filtration
surgery, which provides an alternate route for aqueous
humor to exit the anterior chamber of the eyeball and
enter the sub-conjunctival space, thereby lowering the
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IOP. In full thickness operations a fistula is created
through the limbal sclera, connecting directly the
anterior chamber of the eyeball and the sub-conjunctival
space. Full thickness operations provide long-lasting
control of IOP; however, excessive loss of aqueous humor
from the eyeball during the early postoperative period
frequently leads to hypotony.
In guarded filtration surgery (trabeculectomy),
a fistula created through the limbal sclera is protected
by an overlying partial thickness sutured scleral flap.
The scleral flap provides additional resistance to
excessive loss of aqueous humor from the eyeball, thereby
reducing the risk of early postoperative hypotony.
However, trabeculectomy may result in higher eventual IOP
and increased risk of late failure of filtration,
compared with full thickness operations.
In accordance with one recently introduced
procedure, a full thickness filtering fistula may be
created by a holmium laser probe, with minimal surgically
induced trauma. After retrobulbar anesthesia, a
conjunctival incision (approximately 1 mm) is made about
12-15 mm posterior to the intended sclerostomy site, and
a laser probe is advanced through the sub-conjunctival
space to the limbus. Then, multiple laser pulses are
applied until a full thickness fistula is created. This
technique has sometimes resulted in early hypotony on
account of a difficulty in controlling the sclerostomy
size. In addition, early and late iris prolapse into the
sclerostomy has resulted in abrupt closure of the fistula
and eventual surgical failure. Further, despite its
relative simplicity, the technique still necessitates the
use of retrobulbar anesthesia to avoid pain caused by the
laser applications. The injection of anesthetic material
close to the already damaged optic nerve may sometimes
lead to further visual damage. A further disadvantage of
this procedure, as well as other types of glaucoma
filtration surgery, is the propensity of the fistula to
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be sealed by scarring.
Various attempts have been made to overcome the
problems of filtration surgery, for example, by using
ophthalmic implant devices. Typical ophthalmic implants
utilize drainage tubes so as to maintain the integrity of
the openings formed in the eyeball for the relief of the
IOP.
Typical ophthalmic implants suffer from several
disadvantages. For example, the implants typically
utilize a valve mechanism for regulating the flow of
aqueous humor from the eyeball; defects in and/or failure
of such valve mechanisms could lead to excessive loss of
aqueous humor from the eyeball and possible hypotony.
The implants also tend to clog over time, either from the
inside by tissue, such as the iris, being sucked into the
inlet, or from the outside by the proliferation of cells,
for example by scarring. Additionally, the typical
implant insertion operation is complicated, costly and
takes a long time.
United States Patent No. 3,788,327 to Donowitz
et al. shows a prior art implant utilizing a valve
mechanism for regulating the flow of aqueous humor from
the eyeball. As stated above, defects in and/or failure
of such a valve mechanism could lead to excessive loss of
aqueous humor from the eyeball and possible hypotony.
Additionally, both the inlet opening and the outlet
opening in the implant shown in United States Patent No.
3,788,327 may be susceptible to clogging -- the inlet
opening by the iris and the outlet opening by scarring.
Finally, implantation of an implant according to United
States Patent No. 3,788,327 may involve the separate
steps of first providing a tract for receiving the
implant and/or suturing the implant once it is in place,
which add time and possible complications to the
operation.
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SUMMARY OF THE INVENTION
It is an object of the invention to provide an
improved ophthalmic implant which may be implanted into
the eyeball for the treatment of glaucoma, a delivery
device for implanting such an implant, and an improved
method of implanting such an implant into the eyeball.
In one embodiment of an improved implant in
accordance with the invention, an intraocular implant is
provided to be implanted in the eyeball. The implant
includes a tube having an inlet end, an outlet end, and a
tube passage therebetween for permitting aqueous humor to
flow out of the eyeball, and a disk connected to the tube
at the outlet end of the tube. The tube passage may have
a cross-sectional area sufficiently small to inhibit the
flow of aqueous humor through the tube passage. The
cross-sectional area may be sufficiently small to prevent
flow when the IOP is below a threshold amount.
The disk, which is designed to be located
underneath the conjunctiva, may have an outer rim for
forming a reservoir having an enlarged cross-sectional
area relative to the cross-sectional area of the tube
passage. When aqueous humor flows through the tube
passage, a bleb of aqueous humor forms under the
conjunctiva so that the bleb and the elasticity of the
conjunctiva assist in regulating the flow of aqueous
-'' humor through the tube as a function of the IOP.
To prevent clogging of the implant, the tube at
its inlet end may be provided with a beveled surface
which faces away from the iris when the implant is
inserted. Additionally, one or more circumferential
holes may be provided along the tube for allowing aqueous
humor to flow into the tube passage even if the axial
inlet opening is blocked.
To prevent clogging at the outlet end, the disk
may have an outer rim as described above which raises the
conjunctiva away from the axial outlet
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of the tube passage to allow outflow. One or more inner
uprights (which may be in the form of an inner rim) may
also be provided on the disk for this purpose. Clogging
is further avoided by implanting the implant under the
conjunctiva at a distance away from an insertion slit in
the conjunctiva, such that healing of the slit does not
cause scar tissue to form in the area of the axial outlet
opening of the implant.
Implantation may be facilitated by further
features of the implant. For example, the implant may
have one or more retention projections (for example, in
the form of a spur or plate'). The retention projection
may be rigid, or it may be made of an elastic material
such that it is able to be flexed inward against the tube
during penetration through the sclera. Alternatively,
the retention projection may be designed to lie initially
relatively flat against the tube for easier penetration
through the sclera and to prevent tearing of the sclera,
with a mechanism for extending the retention projection
outwardly when the implant is implanted in the eyeball.
For example, the retention projection may be extended
outwardly by a separate expansion tool or may be
constructed of a shape memory material, such as PNiMA
or
nitinol, so that it is extended outwardly when subjected
. 25 to the heat of the eyeball. One or more retention
projections according to the invention are sufficient
to
reliably anchor the implant in the eyeball without the
need for sutures, saving time and costs.
Implantation may also be facilitated by the
provision of one or more markers on the implant visible
through the cornea upon passing through the sclera. For
example, a circumferential hole as described above may
serve as a marker; alternatively, the marker may be some
other suitable visible mechanism, such as a scratch or
colored mark on the tube. The visibility of the marker
lets the doctor know that the marker has passed through
the sclera, indicating that the implant is in place.
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Implantation of an implant may be performed by
use of a delivery device in accordance with the
invention, comprising a handle and a rodlike instrument,
for example a needle or probe, for carrying the implant
for insertion into the eyeball. The delivery device has
a tip for insertion into the tube passage of the implant
and a suitable retention mechanism for preventing the
implant from moving up the delivery device during
implantation. The retention mechanism may also be
constructed to prevent the implant from rotating during
implantation to insure proper orientation of the implant
in the eyeball. The delivery device may additionally
have a suitable expansion~tool for extending one or more
retention projections of the implant outwardly once the
projection or projections have penetrated through the
sclera.
In one embodiment of an improved method of
implanting an implant according to the invention, a small
Slit is c_!tit i n a pnrtinn ~nf the~~ n j a nWiva w hit.' h
normally lies at a distance away from the intended
implantation site. As the implant itself is very small,
the slit also may be very small, for example about 2 mm
in length or less. The small size of the slit as well as
its positioning at a distance away from the implantation
site, for example about 10 mm, helps prevent
contamination of the sclerostomy site and reduces the
risk of infection.
The implant is placed through the slit,
directed to the implantation site, and inserted into the
sclera at the implantation site. The sclera may be
pierced either by a needle-like tip of the tube of the
implant formed by a beveled surface at the inlet end of
the tube as described above or by the tip of a needle of
the delivery device which carries the implant. Thus, the
implant may be inserted directly into the eyeball without
the need for any separate piercing step, resulting in
cost and time savings.
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An intraocular implant, delivery device, and
method of implantation according to the invention provide
the advantages of a full thickness fistula, while
avoiding the limitations of the standard trabeculectomy.
An implant according to the invention may be very small
and implantable without surgery. No surgery room or
hospitalization is necessary, thereby reducing costs.
Implantation is minimally invasive, simple and quick,
requiring only local anesthesia. Retrobulbar anaesthesia
is not necessary, and thus iatrogenic damage to the optic
nerve is avoided. There is no need to perform an
iridectomy, and thus aqueous flow is maintained, lens
nourishment is unaffected, .and the likelihood of
cataracts developing as a result of the procedure is
reduced.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic cross-sectional view of a first
embodiment of an intraocular implant according
to the invention, shown inserted in an eyeball;
Figure 2 is an enlarged perspective view of the
intraoc~ular implant of Figure l;
Figure 3 is a view similar to Figure 2, with part of the
intraocular implant cut away to show a
sectional view thereof;
Figure 4 is an enlarged perspective view of a disk
portion of the intraocular implant of Figure 1;
Figures 5 through 7 illustrate the action of the
conjunctiva during operation of the intraocular
implant of Figure 1, with Figure 5 showing a
stage of the operation without a bleb formed,
Figure 6 showing formation of a bleb, and
Figure 7 showing further formation of the bleb;
Figures 8 through 10 illustrate a delivery device and
insertion of the intraocular implant of Figure
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1 into an eyeball, with Figure 8 showing the
delivery device and implant before insertion,
Figure 9 showing the delivery device and
implant being placed through a slit in the
conjunctiva, and Figure 10 showing the implant
after insertion with the delivery device
withdrawn;
Figure 11 is an enlarged perspective view of a second
embodiment of an intraocular implant according
to the invention, with part of the intraocular
implant cut away to show a sectional view
thereof ;
r""~~ Figure 12 is a top view of the intraocular implant of
Figure 11, showing a disk portion of the
implant;
Figure 13 illustrates a delivery device and insertion of
the intraocular implant of Figure 11 into an
eyeball;
Figure 14 is a schematic cross-sectional view of the
intraocular implant of Figure 11, shown
inserted in an eyeball; and
-- Figures 15 and 16 illustrate a third embodiment of an
intraocular implant according to the invention, with
Figure 15 showing the implant prior to attachment
of a retention plate and Figure 16 showing the
implant after attachment of the retention plate.
DETAILED DESCRIPTION OF THE DRAWINGS
Figure 1 illustrates an intraocular implant 30,
constructed in accordance with an embodiment of the
invention, implanted in an eyeball 10. The implant 30
comprises a needle-like tube 32 and a disk 34. The plane
of the disk 34 forms an angle with the tube 32 that
corresponds to the angle between the surface of the
sclera 12 and the axis of insertion of the implant 30.
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The implant 30 is inserted in the sclera 12 of the
eyeball 10, in the limbal area 14 adjacent to the cornea
16, and protrudes into the anterior chamber 20 adjacent
the iris 22. The implant 30 is inserted so that the disk
34 is placed on a surface of the sclera 12 underneath the
conjunctiva 18. The implant 30 may be
.--,.,
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placed above or below the Tenon's capsule (not shown).
It will be appreciated by persons of ordinary skill in
the art that the exact location for inserting the implant
30 is not restricted to that shown, and may be any other
suitable position, such as behind the iris 22.
Figure 2 shows an enlarged perspective view of
the implant 30 of Figure 1, and Figure 3 shows a similar
view, with part of the implant 30 cut away. The tube 32,
which may take the form of a modified standard
retrobulbar tip, has an ir~let end 40, an outlet end 50,
and a tube passage 38 extending therebetween, with the
tube passage 38 having an axial inlet 41 and an axial
outlet 51. The disk 34 is connected to the tube 32 at
its outlet end 50. The entire implant is very small; for
example the tube 32 may have a length of about 2 mm and a
width of about 0.5 mm, and the disk 34 may have a
diameter of about 1 mm and a thickness of less than 0.1
mm.
The tube passage 38 has a cross-sectional area
sufficiently small to inhibit the flow of aqueous humor
through the tube passage. In one embodiment, for
example, the cylindrical tube passage 38 has a diameter
of about 300 micrometers. By using a specified internal
cross-sectional area for the tube passage, excessive loss '
of aqueous humor from the eyeball is prevented.
When the IOP is above a threshold amount, for
--- example about 5mm Hg, aqueous humor drains from the
anterior chamber 20 of the eyeball 10 through the axial
inlet 41 and one or more circumferential holes 42,
through the tube passage 38, and into the space under the
conjunctiva 18. The circumferential holes 42 may take
any suitable form; for example, they may be in the form
of circular openings whose combined cross-sectional area
is equal to the
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cross-sectional area of the tube passage 38. The
circumferential holes 42 prevent the tube passage 38 from
becoming clogged at its inlet end because, even if the
iris 22 obstructs the axial inlet 41, aqueous humor can
still pass through the circumferential holes 42. In the
event the axial inlet 41 is obstructed, the
circumferential holes 42 also serve to cause a back
Yres~Lire in th° f'"l~,o paj°~,~~o ~Q t-.-, ~~,,~, -the aX1-al
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v.uarc .~ca c m.v unc.a.
41. The circumferential holes 42 serve the additional
purpose of insuring a proper insertion depth of the
implant 30, as the upper hole is visible during
implantation after penetration through the sclera and
thus can be used as a marker. To serve this function,
any other suitable marker (such as a scratch or colored
mark) may be used.
The inlet end 40 of the tube 32 has a needle-
like tip formed by a beveled surface 36, angled sharply
for easy insertion into the eyeball. The beveled surface
36 increases the area of the axial inlet 41 to enlarge
the entrance to the tube passage 38. The beveled surface
36 is designed to face away from the iris 22 to reduce
the possibility of obstruction of the axial inlet 41.
Because the disk 34 is designed to rest against the
sclera 14 and the beveled surface 36 is designed to face
away from the iris 22, the beveled surface 36 lies in a
plane which is angled opposite to the plane in which the
.- disk 34 lies.
The tube 32 may have one or more retention
projections in the form of one or more spurs 52 provided
integrally with it for retaining the implant 30 in the
eyeball 10 after insertion. Alternatively, the retention
spur 52 may be made as a separate part connected to the
tube 32 by, for example, welding or brazing. The
retention spur 52 may be rigid, or it may be flexible
such that it bends toward the tube 32 during penetration
of the sclera and springs outward to its original shape
after passing through the sclera. Alternatively, the
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retention spur 52 may be designed for plastic deformation
by a separate expansion tool (for example, a balloon)
once it is in the eyeball 10, or the retention spur 52
may be constructed of a shape memory material, such as
PMMA or nitinol, such that the spur is flat against the
tube when cool but expands to its final shape when
subjected to the heat of the eyeball 10.
The disk 34, shown enlarged in Figure 4,
comprises a base 44, an outer rim 46, and a plurality of
inner uprights 48. The areas between the uprights 48
consitute passageways 56 for transverse flow of aqueous
humor. The base 44 and outer rim 46 define a reservoir
54 such that, in operation, the aqueous humor flows out
of the axial outlet 51 of the tube passage 38, between
the uprights 48, and into the reservoir 54. The
passageways 56 may be considered as part of the reservoir
54. The enlarged cross-sectional area of the reservoir
54 as compared to the cross-sectional area of the tube
passage 38 provides a larger area for absorption of the
aqueous humor by the conjunctiva 18 and also acts in
conjunction with the elasticity of the conjunctiva 18 to
assist in regulating the flow of aqueous humor through
the implant 30 as a function of the IOP.
Figures 5 through 7 illustrate the action of
the conjunctiva 18 during operation of the implant 30,
in
which it can be seen that the aqueous humor which flows
.-- - out of the tube passage forms a "bleb" 24 below the
conjunctiva 18. It will be appreciated by persons having
ordinary skill in the art that a higher IOP results in
a
higher flow rate through the implant 30, and a greater
force of the aqueous humor on the conjunctiva 18.
In addition to defining the reservoir 54, the
outer rim 46 of the disk 34 serves the additional purpose
of raising the conjunctiva 18 away from the axial outlet
51 to prevent clogging of the tube passage 38. The inner
uprights 48 also serve this purpose.
The shape of the disk 34 may be, but is not
limited to, an ellipse, and it will be appreciated by
persons having ordinary skill in the art that it may
conform to any shape which allows the implant to fit
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under the conjunctiva 18 and which regulates the IOP.
The size and/or shape of the disk 34 and/or the angle
between the disk 34 and the tube 32 can also be changed
in order to use different implants for different persons'
eyes.
Figures 8 through 10 illustrate a delivery
device 60 and a method of inserting the intraocular
implant 30 into an eyeball. The implant 30 is first
attached to the delivery device 60, having a handle 62
and a suitable rodlike instrument 64 such as a needle or
probe. The rodlike instrument 64 has a tip 70 for
penetrating a tube passage of the implant 30 and a
retention mechanism for preventing the implant from
moving up the delivery device during implantation, for
example in the form of an abutment surface 68 having an
angle generally corresponding to that of the disk 34.
This configuration also prevents rotation of the implant
30 on the delivery device 60, thereby insuring proper
orientation of the implant in the eyeball. The retention
mechanism may also include one or more projections for
extending inside the outer rim and/or between the inner
uprights on the disk 34. In an alternative embodiment,
the retention mechanism may be the tip of the rodlike
instrument, constructed to engage the inside of the tube
passage of the implant with a friction fit, thereby
preventing the implant from moving up the delivery device
during implantation.
A delivery device 60 in which the rodlike
instrument is a needle 65 is illustrated in Figure 9. In
that illustrated embodiment, the delivery device 60 is
similar to a standard medical syringe having a housing
and a needle 65 with a bore 67. The front tip 69 of the
needle 65 is configured as an abutment surface having an
angle generally corresponding to that of the disk 34.
The bore 67 of the needle 65 has a tip in the form of a
plug 71 which is configured to have a cross-sectional
shape corresponding to that of the tube passage
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38. The implant 30 is placed over the plug 71, with the
end of the plug 71 projecting into the tube passage 38,
and with the front tip 69 of the needle 65 abutting
against the disk 34. The plug 71 blocks the tube passage
38 during implantation.
To insert the implant 30 into the eyeball 10, a
small slit 26 is cut in a portion of the conjunctiva 18
which normally lies at a distance away from a portion 28
of the conjunctiva 18 which normally covers the intended
implantation site: A small slit distanced away from the
implantation site, for example a 1-2 mm slit about 5-15
mm away from the implantation site, reduces the
possibility of aqueous humor flowing out of the
conjunctiva through the slit, reduces the possibility of
infection, reduces the possibility of scarring over the
axial outlet of the implant, and facilitates closing and
healing.
The implant 30, by delivery device 60, is
passed through the slit 26, under the conjunctiva 18, to
the implantation site in the sclera 14. Figure 9 shows
the advancement of the implant only schematically; it
will be appreciated that in practice the implant is
directed from the slit to the implantation site generally
along the surface of the sclera, such that the
longitudinal axis of the implant is generally parallel
to
the surface of the sclera. Upon reaching the
__ implantation site, the implant is tilted for penetration
into the sclera. The acute angle of the needle-like tip
formed by the beveled surface 36 of the implant 30
ensures that the implant 30 enters the sclera 14 easily.
The needle-like tip penetrates through the sclera 14 into
the anterior chamber 20 of the eyeball 10, while the disk
34 is pushed up against the sclera 14.
When the implant 30 is in place, as shown in
Figure 10, the retention spur (or spurs) 52 anchors the
implant 30 in the eyeball 10 and prevents the implant 30
from sliding out as the delivery device 60 is withdrawn.
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The retention spur 52 also prevents the implant 30 from
slipping out once in place.
It will be appreciated by persons having
ordinary skill in the art that the insertion of the
implant is not restricted to the method described above,
and it may be inserted by any of several methods known
in
the art. The delivery device may comprise an 'internal'
or 'external' needle. A straight or twisted guide wire,
known in the art, may also be used to guide the delivery
device to its precise position. To ease insertion, the
delivery device may be vibrated, or a lubricant, such
as
medical paste or gel, can be spread onto the delivery
device. Additionally, after implantation of the implant
a suitable fibrosis inhibiting compound (e. g. SFU,
mitomycin) may be applied to the implantation site.
w Figures 11 shows an alternative embodiment of an
intraocular implant 130 constructed in accordance with
the invention. The implant 130 comprises a tube 132
attached to an elliptical disk 134. The tube 132 has an
inlet end 140, an outlet end 150, and a tube passage 138,
with the tube passage 138 having an axial inlet 141, an
axial outlet 151, and circumferential holes 142 to drain
the aqueous humor from the anterior chamber 20 of the
eyeball 10 into the space under the conjunctiva 18.
The distal end 152 of the tube 132 has a
partially conical shape. A plurality of retention
projections in the form of retention flanges 158 are
formed on the outer circumference of the tube 132,
approximately parallel to the disk 134, to act as anchors
to retain the implant 130 in the eyeball.
As shown in the enlarged view in Figure 12, the
disk 134 comprises an elliptical base 144, an outer rim
146, and an inner upright curved to form an inner rim
148, defining therebetween a reservoir 154. A plurality
of "U"-shaped passageways 156 are formed in the inner
rim
148 for allowing aqueous humor to flow from the
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axial outlet 151 into the reservoir 154. The outer rim
146 and the inner rim 148 prevent the conjunctiva 18 from
clogging the axial outlet 151.
As shown in Figure 12, the disk 134 is
elliptical in shape. The longer axis of the disk 134 is
approximately twice the diameter of the tube 132, and the
disk 134 is eccentrically displaced relative to the tube
i~2 . T he eiiiptical--5hcipe- and--piace~TieWt--of -t he--visit i3 4
allows a wide anchoring area for the implant 130 and
maximizes the outlet drainage area on the longer axis of
the ellipse. The shorter axis of the ellipse enables the
implant 130 to fit within the narrow space under the
conjunctiva 18.
Figure 13 illustrates a delivery device 160 and
a method of inserting the intraocular implant 130 into
an
eyeball. The implant 130 is slidably fixed over a needle
164 of the delivery device 160, which, similar to a
standard medical syringe, has needle 164 attached to a
housing 162. The tip 174 of needle 164, which passes
through the implant 130, is acutely angled so that the
tip 174 is generally in line with the angle of the lower
part of the implant 130.
A front surface of the delivery device 160 is
formed as an abutment surface angled to match the angle
of the disk 134 and further comprises an indent 172 to
hold the implant 130 in place during implantation. The
..~' shape of the delivery device 160 and the angled surface
of the disk 134 prevent the implant 130 from rotating
during implantation.
The delivery device 160 shown in Figure 13 is
used in a manner similar to that described above with
reference to Figures 8 through 10. In this embodiment,
however, the acute angle of the needle tip 174 pierces
the sclera. The angled inlet end of the implant device
130 follows the needle tip 174 through the sclera 14,
into the anterior chamber 20 of the eyeball. As shown in
Figure 14, the retention flanges 158 anchor the implant
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130 in position and prevent the implant 130 from sliding
out as the delivery device 160 is withdrawn. The
anchorage of the retention flanges 158 also prevents the
implant 130 from slipping out on~~e in place.
Figures 15 and 16 illu;atrate a third embodiment
of an intraocular implant according to the invention.
This embodiment is similar to that shown in Figures 1
through 10, with the exception that a separately attached
retention projection in the form of a retention plate 252
is used for anchoring instead of the retention spur 52.
The retention plate is inserted :into a groove 253 in the
tube of the implant 230 and may he fastened by any
suitable means, for example by wE:lding in the case of an
implant 230 constructed of stain:Less steel.
An intraocular implant constructed in
accordance with the invention ma~r be manufactured
entirely from or covered with amr suitable material such
as stainless steel, silicon, gold, nitinol, Teflon~~
tantalum, PMMA, or any other suit:able plastic or other
material. The implant may also be coated with heparin or
any other suitable biology active. compound.
Manufacture of an intraocular implant in
accordance with the invention mar be carried out
according to the following proce:~s. The tube may be
formed from the tip of a standard stainless steel
hypodermic needle. Using an EDM machine, small holes are
drilled proximate the tip of the needle to form the
circumferential holes. At a distance from the tip
corresponding to the desired lenctth of the tube, the
needle is cut at the appropriate angle to correspond to
the desired angle of the disk. The side of the needle is
then undercut to form a projection which can be later
bent outwardly to form the spur.
The disk may be chemically etched from a
stainless steel sheet according to the following process.
A pattern of the disk is drawn or.. a computer aided design
(CAD) system and plotted on a transparent film using a
16
CA 02220355 1997-11-06 ,~eT/US 9 6 / 0 6 ? 7 4
tt'EAIUS 2 8 JUL'97
laser plotter. Plottings are made of both the upper side
and the lower side of the disk. The plotting for the
upper side, for example, includes the outer rim and the
inner uprights; the plotting for the lower side, for
example, includes the base of tae disk.
A layer of photoresist is adhered to both
surfaces of the stainless steel sheet. The photoresist
is then exposed to UV light through the film on which the
plottings are made. The areas of the sheet which are
blocked by the plottings are not exposed. The
photoresist which has been exposed to UV light is then
chemically removed.
Using an etching chemical, the stainless steel
sheet is then etched, so that the chemical eats away the
,.,--.1 15 areas of the sheet from which the photoresist has been
removed. The etching is time-controlled such that the
chemical takes away material only to a predetermined
depth.
By use of a plotting for the upper side which
includes the outer rim and the uprights, the chemical on
the upper surface of the sheet takes away material on the
outside of the disk, in the reservoir including between
the uprights, and in the center of the disk which is to
receive the tube. Because the etching is time-
controlled, the chemical acting on the top of the sheet
takes away material only part way through the thickness
..--' of the sheet. By use of a plotting for the lower side ,
which includes the base of the disk, the chemical on the
lower surface of the sheet takes away material on the
outside of the disk and in the center of the disk which
is to receive the tube. The chemical acting on the
bottom of the sheet takes away material part way through
the thickness of the sheet. Because of action from both
the top and the bottom, the material on the outside of
the disk and in the center of the disk which is to
receive the tube is completely taken away by the etching
process through the entire thickness of the sheet. A
17 _ ___.
A~hENflED SH'E~T
W 0 96136377 CA 0 2 2 2 0 3 5 5 19 9 7 -11- 0 6 p~~g96/06774
small projection may be left on the outside of the disk
during the etching process to prevent the disk from being
dislodged from the sheet.
It will be appreciated by persons having
ordinary skill in the art that variations on this
manufacturing process and other manufacturing processes
are possible. For example, an implant made of plastic
may be manufactured by a suitable molding operation.
As will also be appreciated by persons having
ordinary skill in the art, the various embodiments of
intraocular implants, delivery devices, and methods for
implantation described hereinabove are given by way of
example only. Various changes, modifications and
variations may be applied to the described embodiments
without departing from the scope of the invention,
defined by the appended claims.
18
