U.S. patent application number 12/720543 was filed with the patent office on 2010-07-29 for apparatus and method for surgical bypass of aqueous humor.
This patent application is currently assigned to ISCIENCE INTERVENTIONAL CORPORATION. Invention is credited to STANLEY R. CONSTON, ROBERT STAMPER, RONALD K. YAMAMOTO.
Application Number | 20100191103 12/720543 |
Document ID | / |
Family ID | 32030707 |
Filed Date | 2010-07-29 |
United States Patent
Application |
20100191103 |
Kind Code |
A1 |
STAMPER; ROBERT ; et
al. |
July 29, 2010 |
APPARATUS AND METHOD FOR SURGICAL BYPASS OF AQUEOUS HUMOR
Abstract
The invention provides minimally invasive microsurgical tools
and methods to form an aqueous humor shunt or bypass for the
treatment of glaucoma. The invention enables surgical creation of a
tissue tract (7) within the tissues of the eye to directly connect
a source of aqueous humor such as the anterior chamber (1), to an
ocular vein (4). The tissue tract (7) from the vein (4) may be
connected to any source of aqueous humor, including the anterior
chamber (1) ), an aqueous collector channel, Schlemm's canal (2),
or a drainage bleb. Since the aqueous humor passes directly into
the venous system, the normal drainage process for aqueous humor is
restored. Furthermore, the invention discloses devices and
materials that can be implanted in the tissue tract to maintain the
tissue space and fluid flow.
Inventors: |
STAMPER; ROBERT; (BERKELEY,
CA) ; CONSTON; STANLEY R.; (SAN CARLOS, CA) ;
YAMAMOTO; RONALD K.; (SAN FRANCISCO, CA) |
Correspondence
Address: |
Weaver Austin Villeneuve & Sampson LLP
P.O. BOX 70250
OAKLAND
CA
94612-0250
US
|
Assignee: |
ISCIENCE INTERVENTIONAL
CORPORATION
Menlo Park
CA
|
Family ID: |
32030707 |
Appl. No.: |
12/720543 |
Filed: |
March 9, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10528276 |
Sep 8, 2005 |
7699882 |
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PCT/US03/29488 |
Sep 17, 2003 |
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12720543 |
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60411668 |
Sep 17, 2002 |
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Current U.S.
Class: |
600/424 ;
606/108; 606/13; 606/45 |
Current CPC
Class: |
A61F 9/00781
20130101 |
Class at
Publication: |
600/424 ;
606/108; 606/13; 606/45 |
International
Class: |
A61F 9/007 20060101
A61F009/007; A61B 18/20 20060101 A61B018/20; A61B 18/18 20060101
A61B018/18; A61B 8/10 20060101 A61B008/10 |
Claims
1. An apparatus for creating a tract within the scleral tissues of
an eye comprising: an elongated body portion shaped to create said
tract wherein said tract forms a path for flow of aqueous humor
into an ocular vein.
2. The apparatus of claim 1 wherein said body portion comprises a
proximal end and distal end.
3. The apparatus of claim 2 wherein said body portion has an outer
diameter in the range of 50 to 500 microns.
4. The apparatus of claim 2 wherein said body portion comprises a
flexible microcannula.
5. The apparatus of claim 2 wherein said distal end comprises a
mechanical cutting tip.
6. The apparatus of claim 2 where in said distal end comprises an
energy source to ablate tissue.
7. The apparatus of claim 6 wherein said energy comprises laser
light, radio frequency energy, or thermal energy.
8. The apparatus of claim 2 where said distal end is visible by
medical imaging.
9. The apparatus of claim 8 wherein medical imaging comprises
ultrasound or optical coherence tomography.
10. The apparatus of claim 2 wherein said distal end comprises an
optical beacon visible under direct observation through scleral
tissues.
11. The apparatus of claim 2 wherein said body portion comprises an
outer sheath and an inner member.
12. The apparatus of claim 11 wherein said inner member is
removable during use from said outer sheath.
13. The apparatus of claim 1 which additionally comprises a space
maintaining material placeable within said tract.
14. The apparatus of claim 13 wherein said space maintaining
material comprises hyaluronic acid.
15. The apparatus of claim 13 wherein said space maintaining
material comprises a cellular proliferation inhibitor.
16. The apparatus of claim 15, wherein said cellular proliferation
inhibitor comprises methotrexate, paclitaxel, or sirolimus.
17. The apparatus of claim 13, wherein said space maintaining
material comprises an anti-thrombotic agent.
18. The apparatus of claim 17 wherein said anti-thrombotic agent
comprises heparin or tissue plasminogen activator.
19. The apparatus of claim 13 wherein said material comprises a
stent device.
20. The apparatus of claim 19 wherein said device comprises
hyaluronic acid.
21. The apparatus of claim 19 wherein said device comprises a
nickel titanium alloy.
22. The apparatus of claim 19 wherein said device is changeable in
situ from a first configuration to a second configuration.
23-30. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority of U.S. Provisional Patent
Application No. 60/411,668 (Attorney Docket No. ISC1P003P), filed
17 Sep. 2002, which application is incorporated herein by reference
in its entirety for all purposes.
BACKGROUND OF THE INVENTION
[0002] Glaucoma is a disease condition of the eye in which
increased intraocular pressure (IOP) is created by dysfunction in
the drainage mechanism for the aqueous humor. Aqueous humor is
produced within the eye in the ciliary body and flows within the
anterior region of the eye. The aqueous humor normally flows
through a network of tissues at the interior angle of the anterior
chamber, named the trabecular meshwork and subsequently into a
circular drainage space named Schlemm's canal. The aqueous humor
continues its drainage path into collector channels and finally
into aqueous veins to enter the venous system.
[0003] Typically in open angle glaucoma, the pathway for aqueous
humor becomes narrowed or occluded, increasing IOP and resulting in
gradual nerve damage and loss of vision. Such conditions are
usually treated by topical drugs in the form of eye drops, but may
result in surgical treatment if drug treatment becomes ineffective
or if patient compliance is an issue. Traditional glaucoma surgery,
such as trabeculotomy or trabeculectomy, involves dissection of the
eye and the forming of new holes through the trabecular meshwork
portion of the drainage pathway. The fluid is channeled to a
reservoir formed under the conjunctiva known as a bleb. While blebs
are effective in removing the aqueous humor, bleb complications
present the highest incidence of post-surgical complications due to
irritation and infection.
[0004] A new class of surgical procedures aims to approach
treatment of the ocular drainage system from the scleral tissues
without penetrating the interior chamber of the eye. These
procedures are termed "non-penetrating" surgery and involve careful
surgical dissection of the scleral tissues to access the tissues
involved with ocular drainage. Deep sclerectomy is a form of this
type of procedure in which a portion of intrascleral tissue is
removed nearly to Descemet's membrane to allow significant aqueous
flow from the anterior chamber to a bleb. Viscocanalostomy is
another non-penetrating procedure, which increases the flow of
aqueous humor form the anterior chamber into a surgically created
intrascleral lake. Although non-penetrating procedures present
fewer direct complications than traditional surgeries, most of the
procedures still require the surgical dissection of ocular tissues
and a high level of surgical skill.
[0005] Various approaches and devices for glaucoma surgery
involving the rerouting of aqueous humor have been described in the
art. One approach involves the shunting of aqueous humor through a
tube in the anterior chamber into a reservoir implanted on the
surface of the eye. See Mendez U.S. Pat. No. 4,428,746, White U.S.
Pat. No. 4,554,918, Molteno U.S. Pat. No. 4,750,901, Ahmed U.S.
Pat. Nos. 5,071,408, 5,411,473, 5,616,118, 5,681,275, 5,785,674,
6,261,256, Baerveldt, et al. U.S. Pat. Nos. 5,178,604, 5,397,300,
5,558,629, 6,050,970, Speckman U.S. Pat. No. 5,338,291, Memmen U.S.
Pat. No. 5,370,607, Jacob U.S. Pat. No. 5,882,327, Odrich U.S. Pat.
No. 6,41,666. A similar approach is to shunt the aqueous humor
through a tube placed in the anterior chamber into a bleb on the
surface of the eye. See Worst U.S. Pat. No. 5,180,362, Suson U.S.
Pat. No. 6,508,779, Wilcox WO 02/32343.
[0006] Another approach described in the art is the shunting of
aqueous humor from the anterior chamber to the tear film of the
eye. See Ungerleider U.S. Pat. Nos. 4,936,825; 5,372,577; Wandel
U.S. Pat. No. 5,807,302; Brown U.S. Pat. No. 6,595,945.
[0007] Another approach described in the art is placing a shunt for
aqueous humor through the trabecular meshwork to connect the
anterior chamber and Schlemm's canal. See Lynch et al. U.S. Pat.
No. 6,450,984, Hill U.S. Pat. No. 6,533,768, WO 01/78656, and
Gharib et al. US 2002 0165478.
SUMMARY OF THE INVENTION
[0008] The invention provides an apparatus for creating a tract
within the scleral tissues of an eye comprising an elongated body
portion shaped to create a tract which forms a path for flow of
aqueous humor into an ocular vein. The elongated body portion has a
proximal end and a distal end. The distal end may comprise a
mechanically cutting tip or an energy source to ablate tissue. The
distal end may be visible by medical imaging methods such as ultra
sound, or optical coherence topography or visible under direct
observation by an optical beacon at the tip. The apparatus may
additionally accommodate a space-maintaining material for placement
within the tract, such as hyaluronic acid or a cell proliferation
inhibitor. These space-maintaining materials may also comprise a
stent device made of hyaluronic acid, nickel, titanium alloy or
other material.
[0009] The invention also provides a method for creating a path for
flow of aqueous humor of the eye into an ocular vein
comprising;
[0010] a. inserting an apparatus to form a tissue opening into an
ocular vein on the anterior portion of the eye;
[0011] b. directing the apparatus to create a tract from the vein
to a source of aqueous humor,
[0012] c. removing the apparatus;
[0013] d. closing the tissue opening while retaining flow through
the tract between the vein and the source.
[0014] In another embodiment of the method the path is created
by
[0015] a. inserting the apparatus through a tissue opening in the
eye into a source of aqueous humor;
[0016] b. directing the apparatus to create a tract from the source
into an ocular vein;
[0017] c. removing the apparatus while retaining flow through the
tract between the vein and the source; and
[0018] d. optionally closing the tissue opening.
[0019] The source of aqueous humor typically will comprise the
anterior chamber, Schlemm's canal, the collector channel or a
bleb.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1. Sectional view of the anterior portion of the human
eye.
[0021] FIG. 2. Cross-sectional view of the drainage system in the
human eye.
[0022] FIG. 3. Cross-sectional view of the drainage system in the
human eye showing a microsurgical tool and tissue tract from an
episcleral vein to the anterior chamber.
[0023] FIG. 4. Cross-sectional view of the drainage system in the
human eye showing tissue tract from an episcleral vein to Schlemm's
canal.
[0024] FIG. 5. Cross-sectional view of the of an embodiment of the
invention comprising a microcannula assembly.
[0025] FIG. 6. View of an embodiment of a microcannula assembly
incorporating fiber optic core for transmission of energy from a
source.
[0026] FIG. 7A. View of an embodiment of the invention comprising
tube-stent devices.
[0027] FIG. 7B. View of a stent device comprising alternating
filament loops.
[0028] FIG. 8A. Sectional view of the anterior portion of the human
eye showing bypass implant comprising shape memory material
incorporating a reduced diameter segment to maintain flow control
at a minimum level.
[0029] FIG. 8B. Sectional view of the anterior portion of the human
eye showing laser energy being applied externally to increase the
diameter of the shape memory bypass implant.
[0030] FIG. 9. Cross-sectional view of microcannula assembly
incorporating a detachable tube stent as the distal sheath of the
assembly.
[0031] FIG. 10A. Sectional view of the anterior portion of the
human eye showing detachable tube stent assembly creating tract
from an episcleral vein to the anterior chamber.
[0032] FIG. 10B. Sectional view of the anterior portion of the
human eye showing tube stent in place after removal of the cannula
assembly.
DESCRIPTION OF INVENTION
[0033] The present invention to provide minimally invasive
microsurgical tools and methods, which enable surgical creation of
a tissue tract within the tissues of the eye to directly connect a
source of aqueous humor such as the anterior chamber, to an ocular
vein, thereby forming a shunt or bypass for aqueous humor. The
aqueous veins, into which aqueous humor normally drains, are good
candidates for this procedure, however the invention is not limited
to these specific vessels. Furthermore, the tissue tract from the
vein may be connected to any source of aqueous humor, including the
anterior chamber, an aqueous collector channel, Schlemm's canal, or
a drainage bleb. Since the aqueous humor passes directly into the
venous system, the normal drainage process for aqueous humor is
restored. The tools and methods effectively bypass the small
anatomical structures of the drainage system, such as the
trabecular meshwork, Schlemm's canal and the collector channels,
which have been identified with the mechanism of glaucoma.
Furthermore, the invention describes devices and materials that can
be implanted in the tract to maintain the tissue space and fluid
flow post operatively.
[0034] The invention comprises tools, materials and related methods
to surgically create a bypass for aqueous humor. FIG. 1 shows a
sectional view of the anterior portion of the human eye for
reference. The invention involves the steps of: firstly,
identifying a candidate vein 4 on or within the eye of a living
subject; secondly, inserting one or more tools into the eye to
create a tissue tract in the sclera 3, that connects the vein to a
source of aqueous humor such as the anterior chamber of the eye 1,
or Schlemm's canal 2; thirdly, optionally inserting an implant or
material to maintain the tract opening and fluid flow, and; lastly,
closing the surgical access site as required. The tools and
materials comprise the apparatus to create a tissue tract within
scleral tissues of the eye such that the tract acts as a fluid path
for aqueous humor to the vein.
[0035] A magnified cross-sectional view of the drainage system of
the human eye is shown in FIG. 2 for reference. An episcleral vein
4 is identified suitable for creating the bypass. Candidate vessels
can be found close to the surface of the eye, such as but not
limited to, conjunctiva veins, anterior ciliary veins, and
episcleral veins. Surface vessels can be directly visualized and
accessed while subconjunctival vessels may require a small incision
in the conjunctiva for access. Subsurface vessels such as collector
channels 5 and aqueous veins 6 can be identified by high-resolution
medical imaging methods such as high frequency ultrasound (HFU) or
optical coherence topography (OCT). The use of medical imaging is
preferred in that veins which are in the most surgically desired
location, can be selected. Vessels which are angled toward the
anterior chamber 1, or Schlemm's canal 2, and having appropriate
dimensions and minimal tortuosity, can be identified as candidates
for bypass. The use of an ultrasound or optical contrast agent,
either delivered directly to the candidate vein or systemically to
the subject, will facilitate vein identification. Doppler imaging
can be used to assist identification of candidate blood vessels.
Pressure changes applied to the anterior chamber will also
facilitate vein identification and selection by distinguishing
vessels with the most direct connection to the aqueous drainage
system. In some situations the blood/aqueous interface can be seen
in episcleral veins. Changes in pressure in the chamber will cause
this interface to move forward and backward within the vein.
Furthermore, pressure changes can result in a change of the
apparent vein diameter, which can be directly observed.
[0036] Cross-sectional views of the drainage system of the human
eye with a surgically created tissue tract are shown in FIGS. 3 and
4 for reference. The use of HFU or OCT imaging is desired to
determine the optimal placement of the tissue tract 7, from the
candidate vein to the anterior chamber 1, or if desired, to a
collector channel, Schlemm's canal 2, or an existing bleb. When
forming a connection 9 of a vein to the anterior chamber, any
region of the anterior chamber in proximity to the vein may be used
including the area at the anterior segment angle and the
corneal-scleral junction. The surgeon may use imaging techniques to
pre-plan the route of the surgery and to verify locations,
direction and placement of the microsurgical tool 8, during the
procedure. The method may comprise first access to a vein 4, and
then creating a tract 7, toward and into a source of aqueous humor
such as the anterior chamber 1. Alternatively, the method may
comprise access from the anterior chamber first, and then through
the subsurface tissues to a vein. The advantage of such a method is
that the tissue penetration may be accomplished through clear
cornea, starting 180.degree. from the bypass point and transversing
through the anterior chamber. The microsurgical tool is placed at
the correct site for penetration of the tissues through to the
candidate vein. Small, clear corneal incisions are self-sealing and
therefore do not require closure mechanisms. If the initial
penetration of the tool into the eye is elsewhere, then the entry
inscision may need to be closed after removal of the tool.
[0037] The microsurgical tool may comprise an elongated tool, such
as a microcannula, with a tip at one end which is directed into a
vein. This may be a mechanically cutting tip such as a solid or
hollow trocar-like member capable of creating a tunneled tract of
controlled diameter through scleral tissues. In another embodiment,
the tool may comprise a hollow tube with a sharpened distal edge
used to core out a tissue tract. The removal of tissue may promote
the subsequent stability of the tract and aid placement of an
implant device into the channel. Referring to FIG. 5, the tool may
comprise an outer sheath 11 and inner member, with the outer sheath
disposed axially about the inner member. The inner member may
comprise a trocar 10, solid rod, hollow rod or cylinder, needle,
wire or optical fiber. The inner member may be designed to allow
exchange during use to allow specific functions to be brought to
the tip of the tool once it is located in tissue. The microcannula
may be handled at its proximal end by a suitable accommodating
mechanism such as luer fitting 12.
[0038] Referring to FIG. 6, an optical fiber inner member may be
used to carry visible light to the tip of the fiber 13, which may
be disposed to reside at the tip of the sheath and hence may be
used for direct visualization of the location of the tool through
scleral tissues. In the case of an opaque outer sheath material, a
cutout section or window near the distal tip of the sheath may be
provided to visualize the optical fiber tip. The optical fiber may
be fabricated from glass, fused silica, or plastic that is
optically transparent to the wavelength of light used for
visualization. The described optical beacon can provide an adjunct
method of tracking the creation of the tract, aiding HFU or OCT
imaging. Alternately, the optical fiber may be used to carry energy
for tissue ablation such as laser energy, in order to create the
tract. The tip may also accommodate transmission of radio frequency
or thermal energy to ablate or coagulate tissue. The fiber optic
line 14 is connected to energy source 15.
[0039] The microsurgical tool is sized appropriate for access
through small vessels and to create controlled diameter tissue
tracts. Diameters from 50-500 microns are useful, and in particular
diameters from 50-200 microns are preferred. Outer diameter of a
sheath member may correspond to these ranges and may comprise a
wall thickness between 10 and 100 microns. The microsurgical tool
can comprise a flexible microcannula to allow the distal tip to be
advanced within the vein toward a source of aqueous humor such as
the anterior chamber. The microsurgical tool may be fabricated from
structural materials such as metals including steel, titanium, and
nickel-titanium alloys, structural polymers including polyimide,
polyethylene, polyamide, polypropylene, polystyrene,
polymethylmethacrylate, polytetrafluoroethylene, and polysulfone.
Several tools with different material composition and design may be
used sequentially in the surgical procedure. For example, one tool
may be used to access the vessel and exchanged with a tool to
create the scleral tissue tract. Alternatively, different types of
inner members such as for cutting or light conduction may be used
interchangeably within an outer sheath.
[0040] The tool will accommodate features for orientation of the
tract identified and controlled by the clinical practitioner. The
use of medical imaging to coordinate or verify the position and
orientation of the tract aids accuracy and precision of tract
placement. Tools which are in the field of view of the imaging
system allow for identification of the tool's position while
minimizing the creation of artifacts into the image. Selection of
tool material and/or the use of contrast markers can provide the
desired imaging properties for the tools.
[0041] The tract created may optionally be filled with a material
to help maintain the patency and fluid flow of the tract. Such
materials may comprise an anti-fibrotic material, anti-thrombotic
agent, space maintaining material, tube-like stent or similar
device to assure that the drainage tract remains patent.
Anti-fibrotic materials such as hyaluronic acid and cellular
proliferation inhibitors such as methotrexate, sirolimus, and
paclitaxel, may be applied or released from a device within the
tract. Anti-thrombotic agents such as heparin and tissue
plasminogen activator may also be applied or released from a device
within the tract. Such materials may be in the form of
microspheres, microparticles, microfibers, open-or closed-cell
matrices, foams, gels and tubes, which may be designed to change
their configuration in-situ after implantation. The materials may
comprise degradable materials such as hyaluronic acid, collagen ,
glycosoaminoglycans and degradable synthetic polymers. The
materials may also comprise non-degradable materials with
biocompatibility suitable for implant use including metals such as
steel, titanium, and nickel-titanium alloys, and polymers such as
polytetrafluoroethylene, polymethylmethacrylate, polyimide,
polyethylene, polypropylene and polysulfone.
[0042] A tubular stent-like device may be placed within the tract
to enlarge the tract diameter or provide stabilization through
mechanical means. Referring to FIG. 7a, there are examples shown of
a simple tube 16 and a fenestrated tube 17. The outer sheath of the
microsurgical tool may comprise a tube-stent, and can be left
behind after the tool core is removed. Referring to FIG. 9, there
is shown such a microcannula assembly comprising a trocar tip core
10, the detachable stent 22, driving cannula 23, and handle 24. The
tube-stent may be pre-sized based on pre-surgical imaging or may be
designed to be cut to size prior to or after implantation. The
venous end of the tube-stent may be implanted to reside in the vein
or further advanced to reside in a collector channel. The
tube-stent may reside in the entire tissue tract between the vein
and the aqueous humor source, or a portion of the tract. Several
discrete tube-stents may also be used in stabilizing the tissue
tract.
[0043] The diameter of the tube-stent may be designed to allow
expansion in-situ, for example, by hydraulic pressure or thermal
energy, or through the use of shape memory materials for
construction of the tube-stent. Referring to FIG. 8b, a laser 20 is
used to increase the diameter of a shape memory implant 21. For
long-term stability, preferred are tube-stents designed to be
conformable to the tissue tract and that do not create mechanical
loads on the tissue other than for dilation of the tract.
Mechanical features of the tube-stent such as tissue interfacing
porosity may be incorporated to aid retention. Tube-like stents may
be comprised of permanent or biodegradable materials. Suitable
materials include metals such as steel, titanium and nickel
titanium alloys, and biocompatible polymers such as hyaluronic
acid, collagen, glycosoaminoglycans, polylactic acid, polyglycolic
acid, polytetrafluoroethylene, polymethylmethacrylate, polyimide,
polyethylene, polypropylene and polysulfone
[0044] Furthermore, the tube-stent device can also have a design to
provide a controlled amount of flow restriction that would limit
retrograde flow of blood. Devices with different flow resistance
may be fabricated and chosen for optimization of aqueous flow by
the practitioner. Referring to FIG. 8a, a shape memory stent
incorporating a reduced diameter segment 19 connects the anterior
chamber 2 with an episcleral vein 4 via entry point 9. A valve may
be incorporated into the tube stent to limit retrograde flow or to
set a threshold pressure for flow. In another embodiment, the flow
characteristics of the tube-stent may be varied after the procedure
upon examination of the patient's IOP. Various energy sources such
as laser light, RF or microwave may be directed at a portion of the
implant to dilate or contract discrete segments to control flow. A
photoreactive polymer or a pre-stressed polymer similar to heat
shrink tubing may be employed to perform this function.
[0045] In a similar embodiment, the stent-like device may comprise
a series of filaments or wires. Referring to FIG. 7b, the device
may be formed as a woven tube or a series of filament loops 18. The
filament loops may be attached to each other in an alternating, or
"zigzag" pattern, or may be attached to a linear member along one
axis. The loops may be disposed at an angle to the axis, and be
sufficiently flexible to maintain the tract opening without
creating undue stress upon the surrounding tissues. Such an
embodiment allows for the stent device to conform to changes in
diameter or direction of the tract.
[0046] The invention also provides methods to surgically create an
aqueous bypass in the eye. The following methods are provided as
explanatory and do not constitute the entire scope of methods which
may be used in conjunction with the microsurgical tools described
herein. Referring to FIGS. 10a and 10b, in a first example, the
surgeon will visually identify a candidate vein 4 on or about the
surface of the eye. Using high resolution imaging techniques, a
pathway from a target point along the axis of the vein to the
desired endpoint, such as the anterior chamber 2, is mapped. A
surgical tool comprising a handle 24, tube stent sheath 22, and
trocar is used. The trocar has a distal point configured to pierce
the tissues. The tube-stent will be of correct length to connect
the chamber and vein. The vein is cannulated with the tool at the
target point, and the tool oriented in the angle and direction that
was plotted from the imaging session. The tool is advanced along
the pathway until the tip is seen penetrating the anterior chamber
at entry point 9, preferably above the iris. The trocar inner
member and the tool are removed, leaving the tube-stent 22 behind.
Alternatively, a syringe containing an antifibrotic hydrogel can be
attached to the proximal end of the sheath. The hydrogel is applied
into the tract at the same time that the tool, including the
sheath, is being withdrawn, to aid in maintaining the tract. The
access site is then sealed by any requisite surgical method.
[0047] In another example, an episcleral vein is located by
visualization through a surgical microscope. A target point is
designated along the vein, at a distal point of sufficient diameter
to accept the incoming microsurgical tool. An entry point is
determined along the corneal limbus approximately 180.degree. away
from the candidate vein. A gonio lens is used to visually inspect
the anterior angle at the bypass site to choose a target entry
point to connect to the vein. The microsurgical tool in this
instance comprises a fiber optic inner member with a trocar like
distal tip and an outer member comprising a tube-stent of the
correct length to connect the chamber and vein. The tool is
advanced through the clear cornea at the entry point and advanced
across the anterior chamber to the tissue entry point. The tool is
then advanced through the tissues guided toward the candidate vein
by visualization of the beacon tip of the tool. The tool is
advanced until the distal tip enters the vein and then continued
until a sufficient portion of the tube stent distal end is within
the vessel to maintain flow. If sized correctly, the proximal end
of the tube stent will now reside just within the anterior chamber.
The tool is withdrawn, leaving the tube stent behind. The entry
point may be surgically closed or allowed to self-seal.
[0048] The procedure may also be performed on more than one venous
site per eye as may be required to provide adequate drainage. In
practice, the procedure may be performed on one site, and the
patient's IOP monitored post-surgically. If more pressure reduction
is required, then a subsequent procedure may be performed at
another target site. Multiple drainage paths can thereby be
created.
* * * * *