U.S. patent application number 10/222209 was filed with the patent office on 2003-03-20 for shunt device and method for treating glaucoma.
Invention is credited to Ball, Stuart, Brown, Reay, Lynch, Mary G..
Application Number | 20030055372 10/222209 |
Document ID | / |
Family ID | 34657842 |
Filed Date | 2003-03-20 |
United States Patent
Application |
20030055372 |
Kind Code |
A1 |
Lynch, Mary G. ; et
al. |
March 20, 2003 |
Shunt device and method for treating glaucoma
Abstract
The present invention provides a shunt for the flow of aqueous
humor from the anterior chamber of the eye to Schlemm's canal. The
device comprises at least one lumen and optionally has at least one
anchor extending from the proximal portion within the anterior
chamber to assist in placement and anchoring of the device in the
correct anatomic position.
Inventors: |
Lynch, Mary G.; (Atlanta,
GA) ; Brown, Reay; (Atlanta, GA) ; Ball,
Stuart; (Mobile, AL) |
Correspondence
Address: |
William L. Warren
SUTHERLAND ASBILL & BRENNAN LLP
999 Peachtree Street NE
Atlanta
GA
30309-3996
US
|
Family ID: |
34657842 |
Appl. No.: |
10/222209 |
Filed: |
August 16, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60312799 |
Aug 16, 2001 |
|
|
|
Current U.S.
Class: |
604/8 ; 600/398;
604/294 |
Current CPC
Class: |
A61F 9/0017 20130101;
A61F 9/00781 20130101; A61F 2250/0067 20130101; A61M 25/0068
20130101; A61M 2210/0612 20130101; A61M 25/007 20130101 |
Class at
Publication: |
604/8 ; 604/294;
600/398 |
International
Class: |
A61M 005/00; A61M
035/00; A61B 003/16 |
Claims
We claim:
1. An aqueous humor shunt device to divert aqueous humor in an eye
from the anterior chamber into Schlemm's canal, the shunt device
comprising a distal portion having at least one terminal aspect
sized and shaped to be received circumferentially within a portion
of Schlemm's canal and a proximal portion having at least one
terminal aspect sized and shaped to be received within the anterior
chamber of the eye, wherein the distal portion has an outer
diameter of from about 0.1 mm to about 0.5 mm and a length of from
about 1 mm to 40 mm, wherein the device permits fluid communication
from the proximal portion in the anterior chamber to the distal
portion in Schlemm's canal.
2. The device of claim 1, wherein the outer diameter of the distal
portion is from about 0.23 mm to about 0.28 mm.
3. The device of claim 1, wherein the outer diameter of the distal
portion is from about 0.23 mm to about 0.26 mm.
4. The device of claim 1, wherein the length of the distal portion
is from about 1 mm to about 20 mm.
5. The device of claim 1, wherein the length of the distal portion
is from about 4 mm to about 7 mm.
6. The device of claim 1, wherein the length of the distal portion
is from about 6.0 mm.
7. The device of claim 1, wherein the length of the proximal
portion extends at least about 0.1 mm into the anterior
chamber.
8. The device of claim 1, wherein the proximal portion extends
about 0.1 mm to about 3 mm into the anterior chamber.
9. The device of claim 1, wherein the device is selectively coated
with a therapeutic agent.
10. The device of claim 9, wherein the device is selectively coated
with a tissue growth promoting agent.
11. The device of claim 9, wherein the terminal aspects are
selectively coated with a tissue growth inhibiting agent.
12. The device of claim 1, wherein the device permits a flow of
aqueous humor therethrough at a rate of about 2.5 microliters per
minute.
13. The device of claim 1, wherein the shunt device is a dual lumen
shunt.
14. The device of claim 13, wherein the dual lumen is bifurcated
for insertion into opposite directions within Schlemm's canal.
15. The device of claim 13, wherein the dual lumen anchors the
shunt.
16. The shunt of claim 13, wherein the dual lumen shunt is extruded
as a dual lumen tube and the individual lumens are partially
separated during manufacture.
17. The shunt of claim 13, wherein the dual lumen shunt is extruded
as a single lumen and two single lumens are partially attached
together during manufacture.
18. An aqueous humor shunt device to divert aqueous humor in an eye
from the anterior chamber into Schlemm's canal, the shunt device
comprising a distal portion having at least one terminal aspect
sized and shaped to be received circumferentially within a portion
of Schlemm's canal and a proximal portion having at least one
terminal aspect sized and shaped to be received within the anterior
chamber of the eye, wherein the device permits fluid communication
from the proximal portion in the anterior chamber to the distal
portion in Schlemm's canal, and wherein the proximal portion has an
anchor thereon to maintain the device in position when implanted in
tissues.
19. The device of claim 18, wherein the anchor extends
circumferentially around the proximal portion of the device.
20. The device of claim 18, wherein the anchor extends toward the
iris when implanted in the eye.
21. The device of claim 18, wherein the anchor extends away from
the iris when implanted in the eye.
22. The device of claim 18, wherein the anchor extends laterally
relative to the iris when implanted in the eye.
23. The device of claim 18, wherein the proximal portion has a
plurality of anchors.
24. The device of claim 18, wherein the anchor is inside the
anterior chamber when the device is implanted in the eye.
25. The device of claim 18, wherein the anchor is outside the
anterior chamber when the device is implanted in the eye.
26. The device of claim 18, wherein the shunt is anchored on a
shelf of corneo-scleral tissue created by a surgeon when the device
is implanted in the eye.
27. The device of claim 18, wherein the terminal aspect of the
proximal portion has an acute angle to facilitate passage into the
anterior chamber.
28. A method of implanting the anchored aqueous humor shunt device
of claim 1 or claim 18 to divert aqueous humor in an eye from the
anterior chamber into Schlemm's canal, comprising: a. creating a
conjunctival flap and a partial thickness scleral flap dissected
half-thickness into clear cornea; b. dissecting the flap anteriorly
to unroof the outer wall of Schlemm's canal; c. continuing the
dissection along a more shallow plane to create a corneo-scleral
shelf over the trabecular meshwork; d. inserting the device into
Schlemm's canal and the anterior chamber within the angle between
the iris and the cornea; and e. closing the scleral flap and
conjunctival wound.
29. The method of claim 28, wherein the device is further anchored
by the shelf.
30. The method of claim 28, wherein Schlemm's canal is injected
with a viscoelastic agent and/or a mitotic agent prior to insertion
of the device.
31. The method of claim 28, wherein the distal portion of the
device is inserted into Schlemm's canal before the posterior
portion is inserted into the anterior chamber.
32. The method of claim 28, wherein the distal portion of the
device is inserted into Schlemm's canal after the posterior portion
is inserted into the anterior chamber.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority filing benefit of U.S.
Serial No. 60/312,799 filed Aug. 16, 2001.
BACKGROUND OF THE INVENTION
[0002] 1. Field the Invention
[0003] The present invention is generally directed to a surgical
treatment for glaucoma, and relates more particularly to a device
and method for continuously decompressing elevated intraocular
pressure in eyes affected by glaucoma by diverting aqueous humor
from the anterior chamber of the eye into Schlemm's canal where
postoperative patency can be maintained with an indwelling shu
placed to connect the canal with the anterior chamber.
[0004] 2. Background Art
[0005] Glaucoma is a significant public health problem, because
glaucoma is a major cause of blindness. The blindness that results
from glaucoma involves both central and peripheral vision and has a
major impact on an individual's ability to lead and independent
life.
[0006] Glaucoma is an optic neuropathy (a disorder of the optic
nerve) that usually occurs in the setting of an elevated
intraocular pressure. The pressure within the eye increases and
this is associated with changes in the appearance ("cupping") and
function ("blind spots" in the visual field) of the optic nerve. If
the pressure remains high enough for a long enough period of time,
total vision loss occurs. High pressure develops in an eye because
of an internal fluid imbalance.
[0007] The eye is a hollow structure that contains a clear fluid
called "aqueous humor." Aqueous humor is formed in the posterior
chamber of the eye by the ciliary body at rate of about 2.5
microliters per minute. The fluid, which is made at a fairly
constant rate, then passes around the lens, through the pupillary
opening in the iris and into the anterior chamber of the eye. Once
in the anterior chamber, the fluid drains out of the eye through
two different routes. In the "uveoscleral" route, the fluid
percolates between muscle fibers of the ciliary body. This route
accounts for approximately ten percent of the aqueous outflow in
humans. The primary pathway for aqueous outflow in humans is
through the "canalicular" route that involves the trabecular
meshwork and Schlemm's canal.
[0008] The trabecular meshwork and Schlemm's canal are located at
the junction between the iris and the sclera. This junction or
corner is called "the angle." The trabecular meshwork is a
wedge-shaped structure that runs around the circumference of the
eye. It is composed of collagen beams arranged in a
three-dimensional sieve-like structure. The beams are lined with a
monolayer of cells called trabecular cells. The spaces between the
collagen beams are filled with an extracellular substance that is
produced by the trabecular cells. These cells also produce enzymes
that degrade the extracellular material. Schlemm's canal is
adjacent to the trabecular meshwork. The outer wall of the
trabecular meshwork coincides with the inner wall of Schlemm's
canal. Schlemm's canal is a tube-like structure that runs around
the circumference of the cornea. In human adults, Schlemm's Canal
is believed to be divided by septa into a series of autonomous,
dead-end canals.
[0009] The aqueous fluid travels through the spaces between the
trabecular beams, across the inner wall of Schlemm's canal into the
canal, through a series of about 25 collecting channels that drain
from Schlemm's canal and into the episcleral venous system. In a
normal situation, aqueous production is equal to aqueous outflow
and intraocular pressure remains fairly constant in the 15 to 21
mmHg range. In glaucoma, the resistance through the canalicular
outflow system is abnormally high.
[0010] In primary open angle glaucoma, which is the most common
form of glaucoma, the abnormal resistance is believed to be along
the outer aspect of trabecular meshwork and the inner wall of
Schlemm's canal. It is believed that an abnormal metabolism of the
trabecular cells leads to an excessive build up of extracellular
materials or a build up of abnormally "stiff" materials in this
area. Primary open angle glaucoma accounts for approximately
eighty-five percent of all glaucoma. Other forms of glaucoma (such
as angle closure glaucoma and secondary glaucomas) also involve
decreased outflow through the canalicular pathway but the increased
resistance is from other causes such as mechanical blockage,
inflammatory debris, cellular blockage, etc.
[0011] With the increased resistance, the aqueous fluid builds up
because it cannot exit fast enough. As the fluid builds up, the
intraocular pressure (IOP) within the eye increases. The increased
IOP compresses the axons in the optic nerve and also may compromise
the vascular supply to the optic nerve. The optic nerve carries
vision from the eye to the brain. Some optic nerves seem more
susceptible to IOP than other eyes. While research is investigating
ways to protect the nerve from an elevated pressure, the only
therapeutic approach currently available in glaucoma is to reduce
the intraocular pressure.
[0012] The clinical treatment of glaucoma is approached in a
step-wise fashion. Medication often is the first treatment option.
Administered either topically or orally, these medications work to
either reduce aqueous production or they act to increase outflow.
Currently available medications have many serious side effects
including: congestive heart failure, respiratory distress,
hypertension, depression, renal stones, aplastic anemia, sexual
dysfunction and death. Compliance with medication is a major
problem, with estimates that over half of glaucoma patients do not
follow their correct dosing schedules.
[0013] When medication fails to adequately reduce the pressure,
laser trabeculoplasty often is performed. In laser trabeculoplasty,
thermal energy from a laser is applied to a number of noncontiguous
spots in the trabecular meshwork. It is believed that the laser
energy stimulates the metabolism of the trabecular cells in some
way, and changes the extracellular material in the trabecular
meshwork. In approximately eighty percent of patients, aqueous
outflow is enhanced and IOP decreases. However, the effect often is
not long lasting and fifty percent of patients develop an elevated
pressure within five years. The laser surgery is not usually
repeatable. In addition, laser trabeculoplasty is not an effective
treatment for primary open angle glaucoma in patients less than
fifty years of age, nor is it effective for angle closure glaucoma
and many secondary glaucomas. If laser trabeculoplasty does not
reduce the pressure enough, then filtering surgery is performed.
With filtering surgery, a hole is made in the sclera and angle
region. This hole allows the aqueous fluid to leave the eye through
an alternate route.
[0014] The most commonly performed filtering procedure is a
trabeculectomy. In a trabeculectomy, a posterior incision is made
in the conjunctiva, the transparent tissue that covers the sclera.
The conjunctiva is rolled forward, exposing the sclera at the
limbus. A partial thickness scleral flap is made and dissected
half-thickness into the cornea. The anterior chamber is entered
beneath the scleral flap and a section of deep sclera and
trabecular meshwork is excised. The scleral flap is loosely sewn
back into place. The conjunctival incision is tightly closed.
Post-operatively, the aqueous fluid passes through the hole,
beneath the scleral flap and collects in an elevated space beneath
the conjunctiva. The fluid then is either absorbed through blood
vessels in the conjunctiva or traverses across the conjunctiva into
the tear film.
[0015] Trabeculectomy is associated with many problems. Fibroblasts
that are present in the episelera proliferate and migrate and can
scar down the scleral flap. Failure from scarring may occur,
particularly in children and young adults. Of eyes that have an
initially successful trabeculectomy, eighty percent will fail from
scarring within three to five years after surgery. To minimize
fibrosis, surgeons now are applying antifibrotic agents such as
mitomycin C (MMC) and 5-fluorouracil (5-FU) to the scleral flap at
the time of surgery. The use of these agents has increased the
success rate of trabeculectomy but also has increased the
prevalence of hypotony. Hypotony is a problem that develops when
aqueous flows out of the eye too fast. The eye pressure drops too
low (usually less than 6.0 mmHg); the structure of the eye
collapses and vision decreases.
[0016] Trabeculectomy creates a pathway for aqueous fluid to escape
to the surface of the eye. At the same time, it creates a pathway
for bacteria that normally live on the surface of the eye and
eyelids to get into the eye. If this happens, an internal eye
infection can occur called endophthalmitis. Endophthalmitis often
leads to permanent and profound visual loss. Endophthalmitis can
occur anytime after trabeculectomy. The risk increases with the
thin blebs that develop after MMC and 5-FU. Another factor that
contributes to infection is the placement of a bleb. Eyes that have
trabeculectomy performed inferiorly have about five times the risk
of eye infection than eyes that have a superior bleb. Therefore,
initial trabeculectomy is performed superiorly under the eyelid, in
either the nasal or temporal quadrant.
[0017] In addition to scarring, hypotony and infection, there are
other complications of trabeculectomy. The bleb can tear and lead
to profound hypotony. The bleb can be irritating and can disrupt
the normal tear film, leading to blurred vision. Patients with
blebs generally cannot wear contact lenses. All of the
complications from trabeculectomy stem from the fact that fluid is
being diverted from inside the eye to the external surface of the
eye.
[0018] When trabeculectomy doesn't successfully lower the eye
pressure, the next surgical step often is an aqueous shunt device.
An aqueous diversion device of the prior art is a silicone tube
that is attached at one end to a plastic (polypropylene or other
synthetic) plate. With an aqueous shunt device, an incision is made
in the conjunctiva, exposing the sclera. The plastic plate is sewn
to the surface of the eye posteriorly, usually over the equator. A
full thickness hole is made into the eye at the limbus, usually
with a needle. The tube is inserted into the eye through this hole.
The external portion of the tube is covered with either donor
sclera or pericardium. The conjunctiva is replaced and the incision
is closed tightly.
[0019] With prior art aqueous diversion devices, aqueous drains out
of the eye through the silicone tube to the surface of the eye.
Deeper orbital tissues then absorb the fluid. The outside end of
the tube is protected from fibroblasts and scarring by the plastic
plate. Many complications are associated with aqueous shunt
devices. A thickened wall of scar tissue that develops around the
plastic plate offers some resistance to outflow and in many eyes
limits the reduction in eye pressure. In some eyes, hypotony
develops because the flow through the tube is not restricted. Many
physicians tie an absorbable suture around the tube and wait for
the suture to dissolve post-operatively at which time enough scar
tissue has hopefully formed around the plate. Some devices contain
a pressure-sensitive valve within the tube, although these valves
may not function properly. The surgery involves operating in the
posterior orbit and many patients develop an eye muscle imbalance
and double vision post-operatively. With prior art aqueous shunt
devices, a pathway is created for bacteria to get into the eye and
endophthalmitis can potentially occur.
[0020] The prior art includes a number of such aqueous shunt
devices, such as U.S. Pat. No. 4,936,825 (providing a tubular shunt
from the anterior chamber to the corneal surface for the treatment
of glaucoma), U.S. Pat. No. 5,127,901 (directed to a transscleral
shunt from the anterior chamber to the subconjunctival space), U.S.
Pat. No. 5,180,362 (teaching a helical steel implant that is placed
to provide drainage from the anterior chamber to the
subconjunctival space), and U.S. Pat. No. 5,433,701 (generally
teaching shunting from the anterior chamber to the scleral or
conjunctival spaces).
[0021] In addition to the prior art aqueous shunt devices described
above, other prior art devices for glaucoma surgery have used
setons, or other porous, wick-like components to divert and convey
excess aqueous from the anterior chamber to the exterior ocular
surface. Examples include U.S. Pat. Nos. 4,634,418 and 4,787,885
(teaching the surgical treatment of glaucoma using an implant that
consists of a triangular seton (wick)), and U.S. Pat. No.
4,946,436, (teaching the use of a porous device to shunt anterior
chamber to subscleral space). These patents do not teach placement
in Schlemm's canal.
[0022] Some prior art references for glaucoma management have been
directed at Schlemm's canal, but these have not involved the
placement of long-term, indwelling shunts. U.S. Pat. No. 5,360,399
teaches the temporary placement of a plastic or steel tube with
preformed curvature in Schlemm's canal with injection of a viscous
material through the tube to hydraulically expand and hydrodissect
the trabecular meshwork. The tube is removed from the canal
following injection. Because the tube is directed outwardly from
the eye for injection access, the intersection of the outflow
element with the preformed curved element within Schlemm's canal is
at about a 90 degree angle relative to the plane of the curvature,
and 180 degrees away from the anterior chamber. Therefore, at no
time does any portion of the '399 device communicate with the
anterior chamber. Furthermore, relative to that portion within
Schlemm's canal, this tube has a larger diameter injection cuff
element, which serves as an adapter for irrigation. Therefore, this
device is not adapted for shunting aqueous between the anterior
chamber and Schlemm's canal.
[0023] Most of the problems that have developed with current
glaucoma treatment devices and procedures have occurred because
aqueous fluid is drained from inside of the eye to the surface of
the eye. A need exists, then, for a more physiologic system to
enhance the drainage of aqueous fluid from the anterior chamber
into Schlemm's canal. In the vast majority of glaucoma patients,
the resistance problem lies between Schlemm's canal and the
anterior chamber. The canal itself, the collecting channels and the
episcleral venous system all are intact. Enhancing aqueous flow
directly into Schlemm's canal would minimize the scarring that
usually occurs with external filtration procedure since the
internal angle region is populated with a single line of
nonproliferating trabecular cells. Enhancing aqueous flow directly
into Schlemm's canal would minimize hypotony since the canal is
part of the normal outflow system and is biologically engineered to
handle the normal volume of aqueous humor. Enhancing aqueous flow
directly into Schlemm's canal would eliminate complications such as
endophthalmitis and leaks.
SUMMARY OF THE INVENTION
[0024] The present invention is directed to a novel shunt and an
associated surgical method for the treatment of glaucoma in which
the shunt is placed to divert aqueous humor from the anterior
chamber of the eye into Schlemm's canal. The present invention
therefore facilitates the normal physiologic pathway for drainage
of aqueous humor from the anterior chamber, rather than shunting to
the sclera or another anatomic site as is done in most prior art
shunt devices. The present invention is further directed to
providing a permanent, indwelling shunt to provide increased egress
of aqueous humor from the anterior chamber to Schlemm's canal for
glaucoma management.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1A is an illustration showing an overhead perspective
view of one embodiment of the present invention, in which the
inventive shunt is comprised of tubular elements extending
bi-directionally within Schlemm's canal.
[0026] FIG. 1B is an overhead view of the embodiment of the present
invention shown in FIG. 1A, with phantom lines detailing the
internal communication between the lumens of the tubular elements
comprising the inventive device.
[0027] FIG. 1C is an illustration showing an overhead perspective
view of one embodiment of the present invention, in which the
inventive shunt is comprised of mesh tubular elements extending
bi-directionally within Schlemm's canal.
[0028] FIG. 1D is an illustration showing an overhead perspective
view of one embodiment of the present invention, in which the
inventive shunt is comprised of solid, porous elements extending
bi-directionally within Schlemm's canal.
[0029] FIG. 1E is an overhead perspective view of another
embodiment of the present invention, with phantom lines detailing
the internal communication between the two proximal lumens and the
single distal lumen of the inventive device.
[0030] FIG. 2 is an illustration showing another embodiment of the
present invention, in which the inventive shunt is comprised of
perforated tubular elements and with an angulated terminal aspect
of the proximal portion.
[0031] FIG. 3A is an illustration showing a perspective of another
embodiment of the present invention in which the inventive shunt is
comprised of elements that are partially tubular and partially open
in their configuration.
[0032] FIG. 3B is an illustration showing a top view of the
embodiment of the present invention in FIG. 3A, with phantom lines
detailing the internal communication of the device.
[0033] FIG. 3C is an illustration showing a side view from the
proximal end of the embodiment of the present invention in FIG.
3A.
[0034] FIG. 3D is an illustration showing a perspective of another
embodiment of the present invention in which the inventive shunt is
comprised of elements that are partially open and trough-like in
their configuration.
[0035] FIG. 4 is an illustration showing another embodiment of the
present invention, in which the inventive shunt is comprised of
distal elements having wicking extensions at their terminal ends,
and in which the proximal portion has a sealed, blunted tip with a
portal continuous with the lumen of the proximal portion, oriented
to face away from the iris when the device is implanted in
Schlemm's canal.
[0036] FIG. 5A is an illustration showing another embodiment of the
inventive shunt in which a portion of the device enters Schlemm's
canal in only one direction and shunts fluid in a non-linear path
from the anterior chamber.
[0037] FIG. 5B is an illustration showing an alternative embodiment
of the inventive shunt in which the entire shunt is placed within
Schlemm's canal but contains a fenestration to maintain fluid
egress of aqueous humor from the anterior chamber to Schlemm's
canal.
[0038] FIG. 5C is an illustration showing a side view of one
embodiment of the present invention, in which the inventive shunt
is comprised of tubular elements, with a proximal portion extending
towards the anterior chamber that is shorter relative to the distal
portions which extend bi-directionally within Schlemm's canal.
[0039] FIG. 5D is an illustration showing an alternative embodiment
of the inventive shunt comprised of a partially open trough-like
element which is placed within Schlemm's canal but contains a
portal to maintain fluid egress of aqueous humor from the anterior
chamber to Schlemm's canal.
[0040] FIG. 5E is an illustration showing an alternative embodiment
of the inventive shunt comprised of a solid, but porous wick-like
element which is placed within Schlemm's canal
[0041] FIG. 6A is an illustration showing certain anatomic details
of the human eye.
[0042] FIG. 6B is a cross-sectional illustration showing the
anatomic relationships of the surgical placement of an exemplary
embodiment of the present invention.
[0043] FIG. 6C is a cross-sectional illustration showing the
anatomic relationships of the surgical placement of another
exemplary embodiment of the present invention in which the proximal
portion has an angulated terminal aspect with a sealed, blunted tip
with a portal continuous with the lumen of the proximal portion,
oriented to face away from the iris when the device is implanted in
Schlemm's canal.
[0044] FIG. 7A is a cross-sectional illustration showing the
anatomic relationships of the surgical placement of an exemplary
embodiment of the present invention showing the proximal portion of
the device and a barb-shaped anchor extending toward the iris.
[0045] FIG. 7B is a cross-sectional illustration showing the
anatomic relationships of the surgical placement of another
exemplary embodiment of the present invention showing the proximal
portion of the device having an annular or circumferential anchor
thereon.
[0046] FIG. 8A shows one embodiment of the device having a
bi-directional distal portion and an anchor on the proximal portion
extending circumferentially thereon.
[0047] FIG. 8B shows another embodiment of the device having a
bi-directional distal portion and an anchor on the proximal portion
extending medially toward the location of the iris when
implanted.
[0048] FIG. 8C shows another embodiment of the device having a
bi-directional distal portion and an anchor on the proximal portion
extending laterally on each side of the device when implanted.
[0049] FIG. 9 shows another embodiment having a bi-directional
distal portion and an anchor on the proximal portion extending
circumferentially thereon in a barbed or cone shape to facilitate
introduction into the anterior chamber and to inhibit removal
therefrom.
[0050] FIG. 10 shows another embodiment having a tapered proximal
portion with screw threads.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The present invention provides an aqueous humor shunt device
to divert aqueous humor in the eye from the anterior chamber into
Schlemm's canal, in which the shunt device comprises a distal
portion having at least one terminal aspect sized and shaped to be
circumferentially received within a portion of Schlemm's canal, and
a proximal portion having at least one terminal aspect sized and
shaped to be received within the anterior chamber of the eye,
wherein the device permits fluid communication between the proximal
portion in the anterior chamber to the distal portion in Schlemm's
canal. Fluid communication can be facilitated by an aqueous humor
directing channel in either the proximal or distal portions, as
described below. Fluid communication can also be facilitated by a
wicking function of a solid proximal or distal portions of the
device, for example.
[0052] The present invention also provides embodiments of an
inventive shunt comprising a body of biocompatible material of a
size and shape adapted to be at least partially circumferentially
received within a portion of Schlemm's canal to divert aqueous
humor from the anterior chamber of the human eye to and within
Schlemm's canal, and wherein the body facilitates the passage of
aqueous humor from the anterior chamber into Schlemm's canal. This
embodiment of the device of the present invention can be produced
without the proximal portion of the previous embodiment extending
into the anterior chamber. An aqueous humor directing channel can
facilitate the passage of aqueous humor from the anterior chamber
into Schlemm's canal. Fluid communication can also be facilitated
by a wicking function of a solid body portion, for example.
[0053] The invention contemplates many different configurations for
an aqueous humor directing channel, provided that each assists in
channeling aqueous humor from the anterior chamber to Schlemm's
canal, such as by providing a lumen, trough, wick or capillary
action. For example, the aqueous humor directing channel can be a
fully enclosed lumen, a partially enclosed lumen, or a trough-like
channel that is at least partially open. The invention contemplates
that a solid monofilament or braided polymer, such as Proline.RTM.
(polypropylene), can be inserted into Schlemm's canal to provide a
wicking or stenting function to facilitate the passage of aqueous
humor from the anterior chamber to Schlemm's canal. Such a wicking
or stenting extension can also be grooved or fluted along any
portion of the length thereof, so as to be multi-angular or
star-shaped in cross-section. The devices of the present invention
can be constructed of a solid, matrix, mesh, fenestrated, or porous
material, or combinations thereof.
[0054] Traditional glaucoma teaching states that Schlemm's canal in
an adult is divided by septa into separate canals, rendering the
complete passage of a suture impossible. Preliminary studies on
adult human eye bank eyes have shown that Schlemm's canal is,
indeed, patent. A suture can be passed through the entire
circumference of the canal. It has not been heretofore determined
that Schlemm's canal is patent throughout its circumference in
normal adult individuals, as opposed to being divided by septae
into multiple dead end canals. The invention utilizes this
knowledge to access Schlemm's canal and to create and maintain the
natural physiologic egress of aqueous humor from the anterior
chamber to Schlemm's canal and to the collecting channels.
[0055] The present invention also provides methods of use of the
shunt devices. One embodiment of the present invention is directed
to a surgical method to divert aqueous humor from the anterior
chamber of the eye into Schlemm's canal with a device that is
implanted to extend from within the anterior chamber to Schlemm's
canal. The portion of the device extending into Schlemm's canal can
be fashioned from a flexible material, such as silicone, capable of
being received within a portion of the radius, curvature, and
diameter of Schlemm's canal. The external diameter of the proximal
portion can be about 0.1 mm to 0.5 mm, or about 0.3 mm. Preliminary
studies indicate a preferred diameter for the proximal portion to
be about 0.23 mm to about 0.28 m, or preferably about 0.23 mm to
about 0.26 mm. All or parts of the device may be solid, porous,
tubular, trough-like, fenestrated, or pre-curved.
[0056] One embodiment of the present invention is illustrated in
FIG. 1A, in which the shunt device 100 is shown in a side view. The
shunt device 100 of this embodiment is comprised of two portions, a
proximal portion 10 which joins a distal portion 25. The proximal
portion 10 and distal portion 25 shown create an enclosed tubular
channeling structure. The total length of the distal portion 25 may
be between about 1.0 mm to 40 mm, preferably about 4 mm to 6 mm.
The same embodiment of the present invention is illustrated with
phantom lines showing the internal fluid communication path in FIG.
1B. The lumen or channeling space defined by the walls of the
proximal portion 10 and the distal portion(s) 25 are continuous at
their junction at the distal portion portal 20.
[0057] An alternate embodiment of the present invention is shown in
FIG. 1C, in which the shunt device 100 is comprised of two luminal
mesh elements, with a proximal portion 10 which joins a distal
portion 25. Yet another embodiment of the present invention is
shown in FIG. 1D, in which the shunt device 100 is comprised of two
solid, porous elements which may provide wick-like fluid
communication therethrough, with a proximal portion 10 which joins
a distal portion 25.
[0058] An alternate embodiment of the present invention is shown in
FIG. 1E, in which the shunt device 100 is comprised of a proximal
portion 10 having two lumens therein terminating in proximal
portion portals 18. The distal portion 25 shaped and sized to be
received within Schlemm's canal extends in either direction having
separate lumens traversing therethrough from each of the distal
portion portals 20.
[0059] Other examples of embodiments of the present invention are
shown in FIGS. 2-5D. FIG. 2 shows an embodiment of the inventive
shunt in which the device 100 is tubular and fenestrated (15, 30)
in its configuration, with an acute (<90) angle of junction
between the proximal portion 10 and the plane defined by the distal
portion 25. Such fenestrations (15, 30) may be placed along any
portion of the device 100 to facilitate the passage of fluid
therethrough, but are particularly directed towards the collecting
channels of the eye. FIG. 2 further shows an alternate embodiment
of the present invention in which the terminal aspect 16 of the
proximal portion is angulated toward the iris 40 with respect to
the main axis of the proximal portion 10, with the portal 18 of the
proximal portion directed toward from the iris 40. In alternate
embodiments as shown in FIG. 6C, the portal 18 of the proximal
portion 16 is directed away from the iris 40.
[0060] FIG. 3A shows an embodiment of the inventive shunt in which
a portion of the channeling device is enclosed and tubular in
configuration at the junction of the proximal portion 10 and the
distal portion 25, but where the distal portion 10 is a trough-like
channel. The distal portion portal 20 is also shown. The invention
contemplates that any portion of the device 100 can be
semi-tubular, open and trough-like, or a wick-like extension.
Tubular channels can be round, ovoid, or any other enclosed
geometry. Preferably the non-tubular trough-like aspects are
oriented posteriorly on the outer wall of the canal to facilitate
aqueous humor drainage to the collecting channels of the eye, as
shown in FIG. 3A.
[0061] FIG. 3B shows an overhead view of the embodiment of the
inventive shunt of FIG. 3A, further detailing the relationship
among the proximal portion 10 and the distal portion 25. The
aqueous humor directing channel is shown in dashed lines. FIG. 3C
shows a proximal view of the embodiment of the inventive shunt of
FIG. 3A, further detailing the relationship among the proximal
portion 10 and the distal portion 25.
[0062] FIG. 3D shows another embodiment of the inventive shunt in
which the structure of the device 100 comprises an aqueous humor
directing channel that is both open and curved in a continuous
trough-like configuration along the proximal portion 10 and the
distal portion 25. The distal portion portal 20 is also an open
trough-like channel.
[0063] FIG. 4 shows another embodiment of the inventive shunt with
the addition of aqueous humor-wicking extensions 32 which are
either continuous with, or attached to the terminal aspects of the
distal portion 25. The wicking extensions 32 can be fashioned from
a monofilament or braided polymer, such as proline, and preferably
have a length of about 1.0 mm to about 16.0 mm. Furthermore, the
proximal portion 10 is curved with a sealed, blunted tip 16 and
contains a portal 18 in fluid communication with the lumen of the
proximal portion and oriented to face away from the iris when the
shunt device 100 is implanted in its intended anatomic position.
The shunt device 100 can also help to maintain the patency of
Schlemm's canal in a stenting fashion.
[0064] FIG. 5A shows another embodiment of the inventive shunt in
which the proximal portion 10 joins a single, curved distal portion
25 in a "V-shaped," tubular configuration. The embodiment shown in
FIG. 5A can also have a portal (not shown) in the distal portion 25
adjacent to the junction with the proximal portion 10 in order to
facilitate bi-directional flow of fluid within the canal.
Fenestrations and non-tubular, trough-like terminal openings are
contemplated in all embodiments of the invention, and these
fenestrations and openings may be round, ovoid, or other shapes as
needed for optimum aqueous humor channeling function within the
anatomic spaces involved.
[0065] FIG. 5B shows another embodiment of the inventive shunt in
which the body or device 100 comprises only a single, curved distal
portion 25 which contains a distal portion portal 20 oriented
towards the anterior chamber to allow egress of aqueous humor from
the anterior chamber to Schlemm's canal. The body of this device
can have a length of about 1.0 mm to about 40 mm, preferably about
6 mm. The external diameter of the device (or the distal portions
of the device) can be about 0.1 mm to about 0.5 mm, preferably
about 0.2 mm to about 0.3 mm, preferably about 0.23 mm to about
0.28 m or about 0.26 mm.
[0066] FIG. 5C shows another embodiment of the inventive shunt in
which the device 100 comprises a bi-directional tubular distal
portion 25 which is intersected by a proximal portion 10 which is
short in length relative to the distal portion 25 and is directed
towards the anterior chamber.
[0067] FIG. 5D shows still another embodiment of the inventive
shunt in which the device 100 comprises a bi-directional,
trough-like, curved distal portion 25 for insertion into Schlemm's
canal, which contains a distal portion portal 20 oriented to allow
egress of aqueous humor from the anterior chamber, wherein the
trough-like distal portion 25 is oriented to open toward the
collecting channels to facilitate the egress of aqueous humor.
[0068] FIG. 5E shows another embodiment of the inventive shunt in
which the device 100 comprises a bi-directional, solid distal
portion 25 for insertion into Schlemm's canal to facilitate the
egress of aqueous humor from the canal to the collecting channels
in a wicking capacity. The solid distal portion 25 can be porous or
non-porous.
[0069] As the inventive device is an implant, it can be fabricated
from a material that will be compatible with the tissues and fluids
with which it is in contact. The device may be constructed of
biodegradable or non-biodegradable materials. It is preferable that
the device not be absorbed, corroded, or otherwise structurally
compromised during its in situ tenure. Moreover, it is equally
important that the eye tissues and the aqueous remain
non-detrimentally affected by the presence of the implanted device.
A number of materials are available to meet the engineering and
medical specifications for the shunts. In the exemplary embodiments
of the present invention, the shunt device 100 is constructed of a
biologically inert, flexible material such as silicone or similar
polymers. Alternate materials might include, but are not limited
to, thin-walled Teflon.RTM., polypropylene, other polymers or
plastics, metals, or some combination of these materials. The shunt
device 100 may be constructed as either porous or solid in
alternate embodiments. The material can contain a therapeutic agent
deliverable to the adjacent tissues.
[0070] In the embodiments shown in FIGS. 1-4, the proximal portion
10 joins the distal portion(s) 25 at an angle sufficient to allow
the placement of the proximal portion 15 within the anterior
chamber of the eye when the distal portion 25 is oriented in the
plane of Schlemm's canal. The proximal portion 10 is preferably of
sufficient length, about 0.1 to about 3.0 mm or about 2.0 mm, to
extend from its junction with the distal portion 25 in Schlemm's
canal towards the adjacent space of the anterior chamber. While
many geometries can be used for channeling aqueous humor, the
diameter or width of the proximal portion 10 can be sized to yield
an internal diameter of between about 0.1 and about 0.5 mm,
preferably about 0.2 mm to about 0.3 mm for a tubular or curved
shunt, or a comparable maximal width for a shunt with a
multiangular configuration. In other embodiments, the proximal
portion is a non-luminal, non-trough-like wicking extension that
provides an aqueous humor directing channel along the length
thereof.
[0071] Because the nature of the iris 40 is such that it tends to
comprise a plurality of rather flaccid fimbriae of tissue, it is
desirable to avoid said fimbriae from being drawn into the lumen of
an implant, thus occluding the shunt device. Therefore, the
proximal portion 10 may contain a plurality of fenestrations to
allow fluid ingress, arranged to prevent occlusion by the adjacent
iris. Alternately, the proximal portion 10 may comprise only a
proximal portion portal 18 in the form of a fenestration oriented
anteriorly to provide continuous fluid egress between the anterior
chamber of the eye and the directing channel of the shunt. Said
fenestrations may be any functional size, and circular or
non-circular in various embodiments of the present invention. In
addition, a porous structural material can assist in channeling
aqueous humor, while minimizing the potential for intake of
fimbriae.
[0072] Furthermore, the proximal portion 10 may be positioned
sufficiently remote from the iris 40 to prevent interference
therewith, such as by traversing a more anterior aspect of the
trabecular meshwork into the peripheral corneal tissue. In yet
another possible embodiment, as shown in FIG. 6C, the device 100
may comprise a proximal portion 10 in which the terminal aspect of
said proximal portion 10 is curved or angled toward the iris 40,
and with a blunted, sealed tip 16 and a portal 18 oriented
anteriorly to face away from the underlying iris 40. Such a
configuration would tend to decrease the possibility of occlusion
of the shunt device by the iris 40.
[0073] The device 100 may contain one or more unidirectional valves
to prevent backflow into the anterior chamber from Schlemm's canal.
The internal lumen for an enclosed portion of the device or the
internal channel defined by the edges of an open portion of the
device communicates directly with the inner lumen or channel of the
distal portion at the proximal portion portal 20.
[0074] The distal portion 25 may have a pre-formed curve to
approximate the 6.0 mm radius of Schlemm's canal in a human eye.
Such a pre-formed curvature is not required when flexible material
is used to construct the shunt device 100. The distal portion 25
may be of sufficient length to extend from the junction with the
proximal portion 10 through any length of the entire circumference
of Schlemm's canal. Embodiments having a distal portion 25 that
extends in either direction within Schlemm's canal can extend in
each direction about 1.0 mm to 20 mm, or about 3.0 mm. to permit
circumferential placement through Schlemm's canal. The diameter or
width of the distal portion 25 can be sized to yield an outer
diameter of between about 0.1 and 0.5 mm, or about 0.3 mm, for a
tubular or curved shunt, or a comparable maximal width for a shunt
with a multiangular configuration. The distal portion 25 may
contain a plurality of fenestrations to allow fluid egress,
arranged to prevent occlusion by the adjacent walls of Schlemm's
canal. In other embodiments, the distal portion is a non-luminal,
non-trough-like wicking extension that provides an aqueous humor
directing channel along the length thereof.
[0075] In the exemplary embodiments of the present invention, the
shunt device may be either bi-directional, with the distal portion
of the implant intersecting with the proximal portion in a
"T-shaped" junction as shown in FIGS. 1A-1E, 2, 3A-3D, 4 and 5C, or
uni-directional, with a "V-shaped" junction of the proximal and
distal shunt portions, as shown in FIG. 5A. A bi-directional shunt
device can have a distal portion that is threaded into opposing
directions within Schlemm's canal. In the case of the
uni-directional shunt, only the distal shunt portion is placed
within Schlemm's canal. In these exemplary embodiments, "non-linear
fluid communication" means that at least some portion of the shunt
through which fluid passes is not in a straight line. Examples of
non-linear shunts are the above described bi-directional "T"
shapes, and the unidirectional "V" shapes, or shunts having two
channel openings which are not in straight alignment with each
other when implanted.
[0076] The surgical anatomy relevant to the present invention is
illustrated in FIG. 6A. Generally, FIG. 6A shows the anterior
chamber 35, Schlemm's canal 30, the iris 40, cornea 45, trabecular
meshwork 50, collecting channels 55, episcleral veins 60, pupil 65,
and lens 70. FIG. 6B illustrates the surgical placement of the
exemplary embodiment of the present invention, with the relevant
anatomic relationships. It should be noted that the inventive
device is designed so that placement of the distal portion 25
within Schlemm's canal 30 results in an orientation of the proximal
portion 10 within the anterior chamber 35 within the angle defined
by the iris 40 and the inner surface of the cornea 45. Therefore,
if the plane defined by Schlemm's canal is defined as zero degrees,
the proximal portion 10 can extend therefrom at an angle of between
about +60 degrees towards the cornea 45 or -30 degrees toward the
iris 40, more preferably in the range of 0 to +45 degrees. This
range may vary in individuals having a slightly different location
of Schlemm's canal 30 relative to the limbal angle of the anterior
chamber 35.
[0077] In yet another embodiment of the present invention not
shown, the shunt device 100 is configured with one distal portion
25 which is tubular to provide a shunting functionality and a
plurality of proximal portions 10 which provide an anchoring
function to stabilize the overall implant device, in addition to
providing fluid communication from the anterior chamber to
Schlemm's Canal.
[0078] Therefore, the invention provides an aqueous humor shunt
device to divert aqueous humor in an eye from the anterior chamber
into Schlemm's canal, the shunt device comprising a distal portion
having at least one terminal aspect sized and shaped to be received
circumferentially within a portion of Schlemm's canal and a
proximal portion having at least one terminal aspect sized and
shaped to be received within the anterior chamber of the eye,
wherein the proximal portion has an anchor extending therefrom to
maintain the position of the terminal aspect of the proximal
portion within the anterior chamber of the eye, wherein device
permits fluid communication from the proximal portion in the
anterior chamber to the distal portion in Schlemm's canal. In
alternative embodiments, such an anchor can extend from distal
portions of the device to assist in stabilization of the implant
within Schlemm's canal.
[0079] The multiple proximal portions or the anchor extension(s)
from the distal or proximal portion (collectively referred to as
the "anchor") in the various embodiments described below and
apparent to those of skill in the art in view of the present
disclosure, provide multiple improvements for the shunt device. The
anchor facilitates implantation and proper placement of the device,
as the proximal portion can be advanced into the anterior chamber
and then pulled back into place until it contacts the edge of the
anterior chamber. As further described below, a shelf may be
created by the surgical procedure for implantation that is designed
to capture the anchor. This permits the surgeon to determine how
much of the proximal portion is left extending into the anterior
chamber. The anchor feature also allows the surgical alternative of
first implanting the proximal portion into the anterior chamber,
and then placing the distal portion(s) into Schlemm's canal. The
anchor also serves to anchor the shunt device in the desired
location within the anterior chamber and Schlemm's canal with
minimal shifting during normal use.
[0080] The anchor can be fabricated by a simple thickening of the
material of construction of the shunt, e.g. silicon, at the desired
site on the proximal portion, or can be made of another material
attached thereto. Additionally, the anchor can be fabricated by
removal of excess material. The anchor can extend from the proximal
portion in virtually any functional shape, such as in a rounded or
barbed fashion. FIG. 7A is a cross-sectional illustration showing
the anatomic relationships of the surgical placement of an
exemplary embodiment of the present invention showing the proximal
portion 10 of the device and a barb-shaped anchor 80 extending
toward the iris. FIG. 7B is a cross-sectional illustration showing
the anatomic relationships of the surgical placement of another
exemplary embodiment of the present invention showing the proximal
portion 10 of the device having an annular or circumferential
anchor 80 thereon.
[0081] Therefore, the anchor can extend circumferentially around
the proximal portion, or only in one or more directions therefrom.
FIG. 8A shows one embodiment of the device having a bi-directional
distal portion 25 and an anchor 80 on the proximal portion 10
extending circumferentially thereon. FIG. 8B shows another
embodiment of the device having a bi-directional distal portion 25
and an anchor 80 on the proximal portion 10 extending medially
toward the location of the iris when implanted. FIG. 8C shows
another embodiment of the device having a bi-directional distal
portion 25 and an anchor 80 on the proximal portion 10 extending
laterally on each side of the device when implanted. The invention
contemplates many other configurations of the anchor, including a
plurality of teeth extending from the proximal portion.
[0082] The device may also be provided with an anchor for placement
adjacent the exterior surface of the anterior chamber to assist in
surgical placement and securing the device, with or without a
corresponding anchor adjacent the interior surface of the anterior
chamber. Thus, a potential configuration to stabilize the implant
is a device having anchors for positioning inside the anterior
chamber and inside Schlemm's canal to secure the device about the
trabecular meshwork between the anterior chamber and Schlemm's
canal.
[0083] It is understood that the anchor can extend in any direction
in any shape and size which facilitates implantation or anchoring
of the device. For example, FIG. 9 shows another embodiment having
a bi-directional distal portion 25 and an anchor 80 on the proximal
portion 10 extending circumferentially thereon in a barbed or cone
shape to facilitate introduction into the anterior chamber and to
inhibit removal therefrom. Furthermore, the end of the proximal
portion can be cut at an angle, rather than blunted or square cut,
in order to facilitate introduction through the wall of the
anterior chamber. The angled shape of the tip of the proximal
portion allows the proximal portal to have a larger surface area to
facilitate the flow of aqueous. The device should be at least
capable of permitting the flow of aqueous humor at the estimated
normal production rate of about 2.5 microliters per minute.
[0084] FIG. 10 shows yet another embodiment of the device in which
the proximal end comprises a larger single proximal lumen 10 which
branches to form a pair of distal lumens 25 for insertion into
Schlemm's canal. The proximal end is preferably tapered and
contains screw threads 80 such that the device can be screwed into
the anterior chamber and anchored therein by means of the threads
and the distal ends inserted in Schlemm's canal. This embodiment
would, in some instances, simplify insertion by eliminating the
need to make an incision into the anterior chamber.
[0085] The anchor, as well as optionally the remainder of the
device, can be constructed on a textured, grooved or porous
material in order to facilitate the growth of cells, such as
fibroblasts, to stabilize the implant from movement. Preferably,
the extreme tips of the proximal and distal ends of the device are
produced to avoid the attraction of new tissues, such as
fibroblasts, which may grow at the surgical site and impede the
flow of aqueous therethrough. Therefore, the proximal portion of
the device can be produced to extend beyond the entrance into the
anterior chamber by 0.1 to 3 mm, or preferably about 0.5 mm. As
discussed above, the angled tip of the proximal portal will create
a range of lengths along the proximal portion extending into the
anterior chamber.
[0086] The distal portion(s) should similarly extend beyond the
site of surgery and subsequent fibroblast proliferation. Therefore,
the distal portion(s) can have a length of approximately 4 mm to 6
mm, again taking into consideration variability for angled
extremities. The single or dual lumen shunt devices of the present
invention can be manufactured by conventional molding or extrusion
techniques. In the case of extrusion production, single lumens can
be subsequently partially joined together to form dual lumen
devices, or the individual lumens of a co-extruded dual lumen
devices can be partially separated to define distal portions
extendable in separate directions. It is preferable that such
devices be constructed such that they will not kink when wrapped
around a 0.25 mm object.
[0087] Optionally, the device may also include one or more visible
markings on the device to assist in proper placement in the
anterior chamber or Schlemm's canal. Markings on the distal ends
could be used to confirm the distal ends are properly inserted in
Schlemm's canal and markings on the proximal end would avoid over
or under insertion into the anterior chamber.
[0088] Optionally, the device may be selectively coated or
permeated with therapeutic agents as desired. For example, where
ingrowth is desired for stability, certain growth factors may be
present, whereas at the terminal portals where obstructions are to
be avoided, certain antifibrotic agents may be present, such as
5-fluourouracil or mitomycin. The device may be more generally
provided with coatings that are antibiotic, anti-inflammatory, or
carboxylic anhydrase inhibitors. Agents that facilitate the
degradation of collagen within the trabecular meshwork can also be
employed.
[0089] The present invention provides methods for the implantation
and use of the shunt devices. The surgical procedure necessary to
insert the device requires an approach through a conjunctival flap.
A partial thickness scleral flap is then created and dissected
half-thickness into clear cornea. The posterior aspect of Schlemm's
canal is identified and the canal is entered posteriorly. Schlemm's
canal and/or the anterior chamber may be expanded and lubricated by
injection of a viscoelastic and/or a mitotic agent. Suitable
viscoelastic compositions and devices and methods for their
injection into the eye are disclosed in U.S. Pat. No. 5,360,399
which is incorporated herein by reference. When using viscoelastic
compositions as part of the present invention care should be taken
to avoid over-expanding and rupturing Schlemm's canal. The proximal
portion of the shunt is then inserted through the inner wall of
Schlemm's canal and trabecular meshwork into the anterior chamber
within the angle between the iris and the cornea. In some cases, as
incision may be needed from Schlemm's canal through the trabecular
meshwork into the anterior chamber to facilitate passage of the
proximal portion therethrough. One arm of the distal portion of the
shunt device is grasped and threaded into Schlemm's canal. In a
similar fashion, the other arm of the distal portion of the shunt
device (when present) is inserted into Schlemm's canal in the
opposing direction from the first. The scleral flap and
conjunctival wound are closed in a conventional manner.
[0090] The following procedure may be followed for the insertion of
a bi-directional shunt within Schlemm's canal, in particular to
insert an anchored shunt as disclosed onto a surgically prepared
tissue shelf:
[0091] Obtain general or local anesthesia. Preferably with either a
retrobulbar or peribulbar injection of an anesthetic agent
(lidocaine, bupivacaine, etc.).
[0092] Scrub the periocular region with a surgically acceptable
antiseptic such as povodine solution. Place a lid speculum.
[0093] Make a fornix-based conjunctival incision at the limbus.
Ensure hemostasis with either bipolar cautery or diathermy.
[0094] Make a 3-4 mm.times.3-4 mm scleral flap, extending to a
depth within approximately 100 of the choroid.
[0095] Dissect the flap anteriorly to unroof the outer wall of
Schlemm's canal.
[0096] Continue the dissection along a more shallow plane to create
a corneo-scleral shelf over the trabecular meshwork. At surgeon's
discretion, place a stay suture through the scleral flap to hold it
in position.
[0097] At surgeon's discretion, dilate the opening to Schlemm's
canal on both sides of the flap using a viscocanalostomy cannula
and a viscoelastic agent (e.g., hyaluronate or
hyaluronate/chondroitin sulfate).
[0098] Make a paracentesis at the limbus distal to the surgical
site.
[0099] At surgeon's discretion, inject a viscoelastic agent and a
miotic (carbachol or acetylcholine) into the anterior chamber to
deepen the area.
[0100] Remove the GMP Shunt from its case. Insert the distal
portions of the shunt into the canal on both sides.
[0101] Enter the anterior chamber along the corneo-scleral shelf
using a keratome blade or a 21 gauge needle.
[0102] Insert the proximal portion of the tube into the anterior
chamber. Close the scleral flap with interrupted 10-0 nylon
sutures. Initially, place one suture at the base and one each along
the two sides. Bury the suture knots.
[0103] Deepen the anterior chamber with balanced salt solution
through the paracentesis.
[0104] Test the scleral flap with a cellulose sponge. If there is
leakage, place additional 10-0 nylon sutures to achieve a
watertight closure.
[0105] Close the conunctiva with appropriately sized absorbable
sutures.
[0106] Dress the eye with subconjunctival and/or topical
broad-spectrum antibiotic and corticosteroid.
[0107] Place a protective shield over the eye and tape the shield
in place.
[0108] Results of Preclinical Study in Animal Eyes
[0109] Study Device
[0110] A study in 16 swine was performed using a shunt device
comprising two (2) 7 mm length, 0.125 mm inner diameter and 0.250
mm outer diameter silicone (65 A durometer) tubes bonded together
with silicone adhesive over a 1.0 mm length at the proximal end,
creating a Y shape. The device was implanted in one eye of each
animal and the non-implanted eye served as a control.
[0111] Surgical Procedure
[0112] For each animal, the periocular area of the study eye was
prepped (eyelash trimming and betadine). The animal was then
anesthesized using isofluorane. Under sterile conditions, a lid
speculum was used to open the eyelids. An operating microscope was
swung into place. A peripheral corneal bridle suture was placed to
rotate the eye and expose the superior nasal limbus. A fornix-based
conjunctival incision was made in the sclera and hemostasis ensured
with bipolar cautery. A partial-thickness triangular scleral flap
that measured 4.times.4 mm was made at the limbus and dissected
anteriorly into clear cornea. A second, deeper flap was created at
the base of the first flap, and dissected anteriorly to unroof the
porcine equivalent of Schlemm's canal. The plane of the deeper flap
then was angled anteriorly to create a corneoscleral shelf. A
viscoelastic agent (hyaluronate and chondroitin sulfate) was
instilled into the Schlemm's canal-like space on either side using
a viscocanalostomy cannula. The distal aspects of the
bi-directional glaucoma shunt were inserted into the canal on
either side of the unroofing site. The anterior chamber was entered
through the corneoscleral shelf and a viscoelastic agent instilled
into the anterior chamber. The proximal (radial) portion of the
shunt was inserted into the anterior chamber through the
corneoscleral shelf. The scleral flaps were tightly closed with
10-0 nylon sutures and the knots buried. The conjunctiva was closed
with absorbable suture. The bridle suture was removed.
Subconjuctival garamycin and decadron were instilled interiorly.
The eye was dressed with tobramycin-decadron ointment. The animal
was allowed to awaken and returned to the boarding area.
[0113] In each case, the surgical endpoints were achieved. The
Schlemm's canal-like space was accurately located and unroofed in
16 of 16 eyes and the device was successfully implanted without
complication. Neither ocular structures nor the device were damaged
during implantation. The surgical site was adequately closed
without difficulty. During the procedure there was no observable
touching between the device and the corneal endothelium, no
collapse of the anterior chamber, no anterior chamber bleeding
requiring washout, no tearing of the iris, and no touching between
the device and the iris. All animals tolerated the surgery and
anesthesia well.
[0114] Clinical Observations
[0115] All animals tolerated the implant procedure well. No animal
demonstrated post-operative pain or discomfort as evidenced by
rubbing, decreased eating or sleeping. No sight-threatening
complications occurred due to implanting the device. Specifically,
there was no chronic inflammatory reaction to the device, erosion
of surrounding tissues, choroidal detachment or hemorrhage, retinal
detachment, or infection.
[0116] The swine included in this study were normal animals without
glaucoma. At baseline, the average intraocular pressures of the
right and left eyes were equivalent. At 3 months post-operatively,
the intraocular pressure in the study eye with the device was 14%
lower than the contralateral (control) eye (n=16 animals).
[0117] It was unanticipated that IOP would drop in the study eyes
since these eyes did not have glaucoma and therefore did not have
an area of abnormal resistance to bypass. Nevertheless, the device
resulted in a lower pressure even in these normal eyes. No eye had
hypotony or ocular hypertension. Thus, in this interim phase of the
study, the potential for pressure lowering of the device in a
non-glaucomatous animal model was demonstrated.
[0118] Demonstration of in Vivo Fluid Flow
[0119] At 3 months, two devices were explanted from two eyes for
pressure-flow testing. In these eyes, a fornix-based conjunctival
incision was made over the scleral flap. The scleral flap was
gently loosened from the surrounding tissue and dissected forward
to unroof the Schlemm's canal-like space. The device was identified
within the space and the distal portions of the device were removed
from the space, leaving the proximal portion within the anterior
chamber. At this point, aqueous fluid was observed to flow through
the shunt from the anterior chamber out of the distal tubes,
demonstrating in vivo flow through the device.
[0120] While the above-described embodiments are exemplary, the
invention contemplates a wide variety of shapes and configurations
of the shunt to provide fluid communication between the anterior
chamber and Schlemm's canal. The abovedescribed embodiments are,
therefore, not intended to be limiting to the scope of the claims
and equivalents thereof.
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