U.S. patent application number 10/171354 was filed with the patent office on 2002-12-19 for injectable glaucoma device.
Invention is credited to Odrich, Steven A..
Application Number | 20020193725 10/171354 |
Document ID | / |
Family ID | 24037195 |
Filed Date | 2002-12-19 |
United States Patent
Application |
20020193725 |
Kind Code |
A1 |
Odrich, Steven A. |
December 19, 2002 |
Injectable glaucoma device
Abstract
A glaucoma device includes an aqueous tube shunt implant with a
foldable reservoir plate for injecting below the conjunctiva of a
patient's eye via a hollow cannula. The device has an internal
ostium with a flared lip at one end of a shaft having a flattened
wing extending to the sides. A foldable plate and reservoir are
provided at the at the other end of the shaft and connected to an
external ostium of the shaft. The flattened wing presents a flat
surface to the overlying conjunctiva and helps position the device
when used. The device is preferably made of silicone or acrylic so
that the entire implant is foldable and may be rolled up for
insertion via the cannula. Other improvements and a method for
implanting the device are disclosed as well.
Inventors: |
Odrich, Steven A.; (Bronx,
NY) |
Correspondence
Address: |
NOTARO AND MICHALOS
100 DUTCH HILL ROAD
SUITE 110
ORANGEBURG
NY
10962-2100
US
|
Family ID: |
24037195 |
Appl. No.: |
10/171354 |
Filed: |
June 13, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10171354 |
Jun 13, 2002 |
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09511979 |
Feb 24, 2000 |
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6471666 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61F 9/00781
20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A glaucoma device for implanting in the eye of a patient to
relieve intraocular pressure, the device comprising: a drainage
shaft; an internal ostium at one end of the drainage shaft, the
internal ostium having a flared lip; an external ostium adjacent
the second end of the drainage shaft on an upper side of the shaft;
a foldable plate connected to the second end of the drainage shaft;
and a pair of foldable wings extending from each of the left and
right sides of the drainage shaft.
2. A glaucoma device according to claim 1, wherein the foldable
wings and foldable reservoir plate are made of a biocompatible
material.
3. A glaucoma device according to claim 2, wherein the
biocompatible material is one of PMMA, a silicone and an
acrylic.
4. A glaucoma device according to claim 1, wherein the drainage
shaft has a diameter of about 350 microns and the internal ostium
has a diameter of about 500 microns.
5. A glaucoma device according to claim 1, further comprising a
longitudinal pigmented stripe on the drainage shaft.
6. A glaucoma device according to claim 5, wherein the pigmented
stripe is colored differently from tissues found in a human
eye.
7. A glaucoma device according to claim 5, wherein the drainage
shaft wall has a reduced thickness where the pigmented stripe is
located relative to the remainder of the drainage shaft wall.
8. A glaucoma device according to claim 1, further comprising a
ligature suture constrictably tied around the end of the drainage
shaft adjacent the external ostium.
9. A glaucoma device according to claim 2, wherein the plate and
wings are rolled to have a diameter which is about the same as a
shaft diameter of the drainage shaft.
10. A glaucoma shunt implantation kit comprising: a glaucoma shunt
having a drainage shaft, an internal ostium at one end of the
drainage shaft, the internal ostium having a flared lip, an
external ostium adjacent the second end of the drainage shaft on an
upper side of the shaft, a foldable plate connected to the second
end of the drainage shaft, a pair of foldable wings extending from
each of the left and right sides of the drainage shaft; and a
hollow cannula injector having means for pushing the glaucoma shunt
through the injector after the glaucoma shunt has been inserted
within the injector with the plate and wings folded to a diameter
less than an inner diameter of the injector.
11. A kit according to claim 10, wherein the cannula injector can
flex perpendicular to its longitudinal axis to facilitate
implantation of the glaucoma shunt.
12. A kit according to claim 10, wherein the glaucoma shunt is made
of a biocompatible material.
13. A kit according to claim 12, wherein the biocompantible
material is selected from the group consisting of PMMA, acrylic and
silicone.
14. A kit according to claim 10, wherein the inner diameter of the
injector is between 500 and 700 microns.
15. A method of implanting a glaucoma shunt in a patient's eye,
comprising: providing a glaucoma shunt having a drainage shaft, an
internal ostium at one end of the drainage shaft, the internal
ostium having a flared lip, an external ostium adjacent the second
end of the drainage shaft on an upper side of the shaft, a foldable
plate connected to the second end of the drainage shaft, a pair of
foldable wings extending from each of the left and right sides of
the drainage shaft; folding the glaucoma shunt to fit within a
hollow cannula injector; providing an implant opening in the
patient's eye; inserting the cannula injector with the glaucoma
shunt through the implant opening; injecting the glaucoma shunt
below a conjunctiva of the patient's eye; positioning the glaucoma
shunt with the internal ostium inside the patient's eye and the
wings and plate unfolded; removing the cannula injector; and
closing the implant opening.
16. A method according to claim 15, wherein providing the implant
opening comprises performing a laser sclerostomy on a patient's eye
to create the implant opening.
17. A method according to claim 16, wherein the glaucoma shunt
further comprises a longitudinal pigmented stripe on the drainage
shaft, the method further comprising using a laser, after injecting
and positioning the glaucoma shunt, to make fenestrations in the
drainage shaft where the pigmented stripe is located.
18. A method according to claim 16, further comprising tightening a
ligature suture around the drainage shaft to to constrict the
initial flow of aqueous through the glaucoma shunt.
19. A method according to claim 15, wherein providing the implant
opening comprises using the site of a previous trabeculectomy as
the implant opening.
20. A method according to claim 19, wherein the glaucoma shunt
further comprises a longitudinal pigmented stripe on the drainage
shaft, the method further comprising using a laser, after injecting
and positioning the glaucoma shunt, to make fenestrations in the
drainage shaft where the pigmented stripe is located.
21. A method according to claim 16, further comprising tightening a
ligature suture around the drainage shaft to to constrict the
initial flow of aqueous through the glaucoma shunt.
Description
FIELD AND BACKGROUND OF THE INVENTION
[0001] The present invention relates generally to the field of
glaucoma treatment devices and in particular to a new and useful
implantable glaucoma shunt for relieving internal pressure in a
patient's eye. The new glaucoma shunt has a foldable plate and
reservoir which permit the shunt to be injected into a patient's
eye using a cannula.
[0002] Implantable glaucoma shunts are known which require more
extensive surgery or require the shunt to be sutured into place on
the patient's eye. Other shunts are simply cylinders which are
injected nearly perpendicularly into the patient's eye and held by
frictional fit by eye tissue.
[0003] U.S. Pat. No. 5,127,901 teaches an ophthalmic implant for
draining aqueous humor from the anterior chamber of the eye having
a transcleral conduit having an inlet opening at one end thereof
for communicating with the anterior chamber of an eye, and an
outlet opening at an opposite end of the conduit for draining fluid
from the anterior chamber. An elongated arch shaped subconjunctival
channel is connected to the conduit and has an inlet opening into
the channel for communicating with the outlet opening of the
conduit, the channel having an outlet openings for discharging
fluid from the conduit, subconjunctivally over the sclera of the
eye. A one-way flow resisting valve is provided in the conduit for
allowing a flow of fluid to pass under resistance and in only one
direction from the inlet to the outlet of the conduit, whereby
pressure in the anterior chamber is relieved while avoiding
excessive outflow of fluid from the anterior chamber.
[0004] The shunt of U.S. Pat. No. 5,127,901 is not foldable,
however and must still be implanted into a patient's eye using
surgical cutting techniques.
[0005] Other glaucoma shunts include U.S. Pat. No. 5,743,868, for
example, which discloses a cylindrical drainage tube which can be
injected through the surface of a patient's cornea. The tube is
formed from a hollow rigid cylinder surrounding a porous core
layer. The device is simply pushed into place using a plunger
implant mechanism and positioned so that the exterior end is
substantially flush with the surface of the cornea. The device
lacks any wings or means for securing the device underneath the
conjunctiva or sclera.
[0006] A plunger device for implanting cylindrical glaucoma drains
is taught by U.S. Pat. No. 5,893,837. The device is placed at the
end of the plunger for insertion through eye tissue. The glaucoma
devices inserted using the plunger do not have wings or reservoir
flaps.
[0007] U.S. Pat. No. 5,752,928 teaches a glaucoma device having a
reservoir plate made of a flexible material, such as silicone
rubber. The device is implanted through an incision in the eye
followed by suturing the incision.
[0008] U.S. Pat. No. 5,178,604 is for a glaucoma implant having a
flexible elastomeric plate. The plate is curved to conform to the
curvature of a person's eye. The plate is inserted through an
incision into a position beneath the portion of the eye known as
Tenon's capsule and over the sclera. The plate is sutured to the
sclera. The plate can be folded to permit a smaller incision in the
eye. A preferred material for the plate is silicone elastomer. The
Baerveldt '604 patent does not teach injecting the device into
place and no provision is made for securing the device without
sutures until after tissue has grown around the device.
[0009] A continuation-in-part patent, U.S. Pat. No. 5,397,300,
discloses a similar device. The glaucoma device in U.S. Pat. No.
5,397,300 also has a flexible plate. The plate has at least one
through hole to permit the growth of scar tissue to assist holding
the plate in position following suturing during the implant
procedure.
[0010] A laser is taught for use in making the incision for
implanting a glaucoma device in U.S. Pat. No. 5,626,558. The device
has a plate connected to the exterior end of a tube forming the
body of the device. The plate may be sutured to the sclera to hold
the device in place after insertion.
[0011] U.S. Pat. No. 5,370,607 teaches an implant device having a
pair of wings extending from a reservoir around the body of a
person's eye. The device is inserted through an incision and
sutured into place. A tab positioned between the reservoir and the
drainage tube in the center of the reservoir between the wings is
used to suture the device in place. The wings are used to stabilize
the placement of the device underneath the ocular muscles.
[0012] U.S. Pat. No. 4,554,918 shows a glaucoma device having a
reservoir with a flat attachment plate having holes therethrough
for receiving sutures or permitting tissue ingrowth. The plate is
preferably made of silicone rubber, polymethyl methacrylate polymer
or other similar polymers, among other compositions. A pair of flat
rectangular fins extending from the sides of the tube are used to
secure the device to the sclera beneath a small flap.
[0013] The prior glaucoma shunt devices are either simple tubes or
ports injected directly through the eye, rather than implanted
below the conjunctiva, or require tissue cutting, extensive tissue
manipulation and suturing to successfully implant the device below
the conjunctiva.
SUMMARY OF THE INVENTION
[0014] It is an object of the present invention to provide a
glaucoma shunt which can be implanted in a patient's eye using
minimally invasive surgery techniques.
[0015] It is a further object of the invention to provide an
implantable glaucoma device which does not require sutures to hold
the device in position once the device has been implanted in a
patient's eye.
[0016] Accordingly, a new glaucoma device is provided comprising a
foldable aqueous tube shunt implant for injecting below the
conjunctiva of a patient's eye via a hollow cannula. The device is
used to drain aqueous humor from the anterior chamber of a person's
eye to help control glaucoma and intraocular pressure.
[0017] The device has an internal ostium with a flared lip at one
end of a shaft having a flattened wing extending to the sides. A
foldable plate and reservoir are provided at the other end of the
shaft and connected to an external ostium of the shaft. The
flattened wing presents a flat surface to the overlying conjunctiva
and helps position the device when used.
[0018] The device is preferably made of silicone or acrylic so that
the entire implant is foldable and may be rolled up for insertion
via the cannula.
[0019] Since the entire implant device may be folded and injected
into place within a person's eye, the implant can be implanted
using a cannula following laser sclerostomy in a minimally invasive
procedure and without incisional surgery. Sutures are not needed to
hold the implant in place once it has been injected into position.
The lip on the inner ostium holds the device in place.
[0020] The various features of novelty which characterize the
invention are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages and
specific objects attained by its uses, reference is made to the
accompanying drawings and descriptive matter in which a preferred
embodiment of the invention is illustrated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] In the drawings:
[0022] FIG. 1 is a top plan view of the glaucoma device of the
invention;
[0023] FIG. 2 is a partial sectional side elevational view of the
glaucoma device implanted into a patient's eye;
[0024] FIG. 3 is a sectional side elevational view of the glaucoma
device inside an implantation cannula; and
[0025] FIG. 4 is a top plan view of a further embodiment of the
glaucoma device of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] Referring now to the drawings, in which like reference
numerals are used to refer to the same or similar elements, FIG. 1
shows the glaucoma device 10 of the invention having internal
ostium 20 with a flared lip 25 at the end of a drainage shaft 30.
The flared lip 25 tapers from the internal ostium 20 to the shaft
30, so that the diameter of the internal ostium 20 is greater than
that of the shaft 30.
[0027] Foldable wings 40 are formed on the sides of the drainage
shaft 30. An external ostium 50 is provided at the other end of the
shaft 30 on the upper side of the shaft. A foldable plate 60 is
attached to the end of shaft 30 opposite the internal ostium 20.
The plate 60 has openings 70 in the top surface.
[0028] FIG. 2 shows the glaucoma device 10 implanted in a patient's
eye 100. The device 10 is positioned underneath the conjunctiva 120
and rests on the patient's sclera 130. The internal ostium 20 is
inserted through the inner edge of the cornea 110 adjacent the
pupil 150 and sclera 130. The lens 140 of the patient's eye 100 is
shown for reference.
[0029] As seen in the drawing, the glaucoma device 10 is positioned
with the internal ostium 20 extending inside the eyeball, while the
external ostium 50 and plate 60 are outside the eyeball. Higher
pressure liquid inside the patient's eye 100 can naturally drain
through the glaucoma shunt device 10 via the ostiums 20, 50 and
shaft 30 to outside the eye. Thus, internal eye, or intraocular,
pressure is relieved by the presence of the glaucoma shunt device
10 of the invention.
[0030] The foldable wings 40 help to position the device 10 by
providing a flat surface for the overlying conjunctiva 120 to rest
upon. The wings 40 should be oriented facing toward the conjunctiva
120 to maximize their benefit. The plate 60 acts as a foreign
object inside the patient's eye which causes tissue to grow around
the plate 60 over a period of time. The tissue growth assists in
holding the device 10 in place over an extended period of time.
[0031] The entire glaucoma device 10 is made of a foldable
biocompatible material. Suitable biocompatible materials include
poly methylmethacrylate (PMMA), silicone or acrylic. The materials
used to make the plate 60 may be rolled up to a cylinder roughly
having the same size diameter as the drainage shaft 30. Similarly,
the wings 40 may be folded up around the sides of the drainage
shaft 30.
[0032] Preferably, the diameter of the drainage shaft 30 is about
350 microns and the device 10 is about 12 mm long. The diameter of
the internal ostium 20 is preferably about 500 microns. The wings
40 are between 1 and 2 mm across when unfolded.
[0033] FIG. 3 displays the glaucoma device 10 rolled up inside a
cannula injector 200 having a plunger 210 and insertion opening
220. The reservoir plate 60 is rolled up to fit within the cannula
shaft 205. The plunger 210 can be activated using any known method
for pushing objects with plungers, such as by a simple mechanical
handle of a type commonly found on syringes. In a preferred
embodiment of the cannula injector 200, the cannula shaft 205 can
flex perpendicularly to the longitudinal axis, as shown by arrows
F, but does not compress along the longitudinal axis. The flexion
assists the implantation of the glaucoma device 10 in a patient's
eye.
[0034] The cannula injector 200 can be used to implant the glaucoma
device 10 after a laser has been used to make an opening in the
patient's eye, such as by laser sclerostomy (ab externo or ab
interno). Alternatively, the device 10 can be inserted through an
opening in the eye created by a prior trabeculectomy.
[0035] A much smaller opening can be used to implant the glaucoma
device 10 of the invention, compared to a non-folding implant,
since the device 10 is inserted using cannula injector 200. The
opening has only to be sufficiently large to permit the cannula
opening 220 to pass through. The cannula injector 200 preferably
has a diameter of between 500-700 microns and is made to permit
flexibility perpendicular to the longitudinal axis, but not
compression of the longitudinal axis. The device 10 is inserted and
unfolded beneath the conjunctiva 120 of the patient's eye. The
internal ostium 20 and flared lip 25 are positioned through the
side of the eyeball. The flared lip 25 and plate 60 hold the device
in place in conjunction with the wings 40, so that no suturing is
needed.
[0036] Since the laser sclerostomy and implant injection can both
be done in a doctor's office, the device 10 provides a new level of
convenience and simplicity heretofore unknown in glaucoma
treatment. When a prior trabeculectomy opening is used, the
procedure is further simplified by the elimination of the need for
laser. A patient no longer has to visit the hospital or endure a
lengthy procedure to have a glaucoma shunt implanted. The recovery
time is much shorter, since even when a laser is used, the laser
creates a much smaller opening through the eye of the patient, and
no suturing is needed to secure the device 10 in place in the
patient's eye 100.
[0037] The device 10 permits the in-office conversion of previous
failed non-implant filtration surgery to successful tube shunt
mediated filtration. The glaucoma device 10 allows patients whose
trabeculectomies have failed to undergo an in-office implantation
using the old, failed trabeculectomy site to re-establish the flow
of aqueous out of the eye. Thus, additional incisional surgery in a
hospital operating room is not required when the device 10 of the
invention is used.
[0038] In a further embodiment of the glaucoma device 10 shown in
FIG. 4, a pigmented stripe 90 is provided longitudinally down one
side of the drainage shaft 30. The stripe 90 is colored to be
distinguishable from the tissue in which the device 10 is going to
be implanted as described above. Preferably, the stripe 90 is
colored differently from the eye tissues surrounding where the
device 10 will be implanted.
[0039] Once the device 10 has been implanted, a laser having an
appropriately tuned frequency is used to make one or more
fenestrations or holes through the wall of drainage shaft 30 where
the stripe 90 is located. The pigment of the stripe 90 and the
frequency of the laser should be selected so that the laser will
pass through the tissues surrounding the implant device 10 and
cause the least amount of damage possible. The number of holes
created in the striped portion 90 of the drainage shaft 30 wall
will affect the flow rate of aqueous through the device 10 from the
patient's eye.
[0040] In a preferred version of the device 10 having the pigmented
stripe 90, the drainage shaft 30 wall thickness in the area of the
stripe 90 is reduced from that of the remainder of the drainage
shaft 30. The laser can more easily be used to perforate the wall
of the drainage shaft 30 where the stripe 90 is provided.
[0041] In yet another embodiment of the device 10, a ligature
suture 95 is provided around an end of the tube adjacent the
external ostium 50. The ligature suture 95 is tied around the end
in a manner which permits the ligature suture 95 to be tightened
once the device 10 has been implanted. The ligature suture 95 is
used to constrict the flow of aqueous through the device 10 when it
is initially placed in the patient's eye. It is well known that the
initial depressurization of the eye during this type of glaucoma
treatment procedure results in much increased liquid flow than
after a period of time has passed. By initially constricting the
flow of aqueous through the device 10 using the ligature suture 95,
the patient's eye is prevented from being excessively
depressurized. A ligature suture 95 is used since it will dissolve
after a short period of time, such as 10-20 days, and once the
suture 95 is dissolved, normal fluid flow through the device 10 is
allowed.
[0042] While a specific embodiment of the invention has been shown
and described in detail to illustrate the application of the
principles of the invention, it will be understood that the
invention may be embodied otherwise without departing from such
principles.
* * * * *