(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2002/0111608A1
`(43) Pub. Date:
`Aug. 15, 2002
`Baerveldt et al.
`
`US 2002O111608A1
`
`(54) MINIMALLY INVASIVE GLAUCOMA
`SURGICAL INSTRUMENT AND METHOD
`(76) Inventors: George Baerveldt, Monarch Beach, CA
`(US); Roy Chuck, Irvine, CA (US)
`Correspondence Address:
`KNOBBE MARTENS OLSON & BEAR LLP
`620 NEWPORT CENTER DRIVE
`SIXTEENTH FLOOR
`NEWPORT BEACH, CA 92660 (US)
`(21) Appl. No.:
`10/052,473
`(22) Filed:
`Jan. 18, 2002
`Related U.S. Application Data
`(60) Provisional application No. 60/263,617, filed on Jan.
`18, 2001.
`
`Publication Classification
`
`(51) Int. Cl." .......................... A61B 18/20; A61B 18/14;
`A61B 17/32
`
`(52) U.S. Cl. ................... 606/6; 606/15; 606/28; 606/41;
`606/49; 606/180
`
`(57)
`
`ABSTRACT
`
`Apparatuses and methods for the treatment of glaucoma are
`provided. The instrument uses either cauterization, a laser to
`ablate, Sonic or ultraSonic energy to emulsify, or mechanical
`cutting of a portion of the trabecular meshwork. The instru
`ment may also be provided with irrigation, aspiration, and a
`footplate. The footplate is used to enter Schlemm's canal,
`Serves as a guide, and also protects Schlemm'S canal.
`
`
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`25/2
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`Ex. 1015, p. 1 of 53
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`Ex. 1015, p. 2 of 53
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`Ex. 1015, p. 3 of 53
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`Ex. 1015, p. 4 of 53
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`Patent Application Publication Aug. 15, 2002. Sheet 4 of 37
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`Ex. 1015, p. 5 of 53
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`Ex. 1015, p. 21 of 53
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`Patent Application Publication Aug. 15, 2002. Sheet 23 of 37
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`Ex. 1015, p. 24 of 53
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`Patent Application Publication Aug. 15, 2002. Sheet 24 of 37
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`Ex. 1015, p. 25 of 53
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`Patent Application Publication Aug. 15, 2002. Sheet 25 of 37
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`Ex. 1015, p. 26 of 53
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`Ex. 1015, p. 27 of 53
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`Patent Application Publication Aug. 15, 2002 Sheet 27 of 37
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`Ex. 1015, p. 28 of 53
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`Ex. 1015, p. 29 of 53
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`Ex. 1015, p. 32 of 53
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`Ex. 1015, p. 35 of 53
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`US 2002/011 1608 A1
`
`Aug. 15, 2002
`
`MINIMALLY INVASIVE GLAUCOMA SURGICAL
`INSTRUMENT AND METHOD
`
`CROSS-REFERENCE TO THE RELATED
`APPLICATIONS
`0001. This application claims priority to U.S. Provisional
`Application Serial No. 60/263,617, filed Jan. 18, 2001, the
`disclosure of which is herein incorporated by reference in its
`entirety.
`
`BACKGROUND OF THE INVENTION
`0002) 1. Field of the Invention
`0003. The present invention relates to a new glaucoma
`Surgical instrument and method, and, in particular, removal
`of the trabecular meshwork by mechanical cautery, vapor
`ization or other tissue destruction means optionally coupled
`to an instrument with infusion, aspiration, and a footplate.
`0004 2. Description of the Related Art
`0005 Aqueous is a clear, colorless fluid that fills the
`anterior and posterior chambers of the eye. The aqueous is
`formed by the ciliary body in the eye and Supplies nutrients
`to the lens and cornea. In addition, the aqueous provides a
`continuous Stream into which Surrounding tissues can dis
`charge the waste products of metabolism.
`0006 The aqueous produced in the ciliary process circu
`lates from the posterior chamber to the anterior chamber of
`the eye through the pupil and is absorbed through the
`trabecular meshwork, a plurality of crisscrossing collagen
`cords covered by endothelium. Once through the trabecular
`meshwork, the aqueous passes through Schlemm'S canal
`into collector channels that pass through the Scleral and
`empty into the episcleral venous circulation. The rate of
`production in a normal eye is typically 2.1 u/min. Intraocu
`lar preSSure in the eye is maintained by the formation and
`drainage of the aqueous. All the tissues within the corneo
`Scleral coat covering the eyeball are Subject to this pressure,
`which is higher than preSSure exerted on tissues at other
`locations in the body.
`0007 Glaucoma is a group of diseases characterized by
`progressive atrophy of the optic nerve head leading to visual
`field loss, and ultimately, blindness. Glaucoma is generally
`asSociated with elevated intraocular preSSure, which is an
`important risk factor for visual field loSS because it causes
`further damage to optic nerve fibers. Other causes of glau
`coma may be that the nerve is particularly Vulnerable to the
`preSSure due to poor local circulation, tissue weakness or
`abnormality of Structure. In a "normal’ eye, intraocular
`preSSure ranges from 10 to 21 mm mercury. In an eye with
`glaucoma, this pressure can rise to as much as 75 mm
`mercury.
`0008. There are several types of glaucoma, including
`open and closed angle glaucoma, which involve the abnor
`mal increase in intraocular preSSure, primarily by obstruc
`tion of the outflow of aqueous humor from the eye, or, leSS
`frequently, by over production of aqueous humor within the
`eye. The most prevalent type is primary open angle glau
`coma in which the aqueous humor has free access to the
`irridocorneal angle, but aqueous humor drainage is impaired
`through obstruction of the trabecular meshwork. In contrast,
`in closed angle glaucoma, the irridocorneal angle is closed
`
`by the peripheral iris. The angle block can usually be
`corrected by Surgery. LeSS prevalent types of glaucoma
`include Secondary glaucomas related to inflammation,
`trauma, and hemorrhage.
`0009 Aqueous humor is similar in electrolyte composi
`tion to plasma, but has a lower protein content. The aqueous
`humor keeps the eyeball inflated, Supplies the nutritional
`needs of the vascular lens and cornea and washes away
`metabolites and toxic substances within the eye. The bulk of
`aqueous humor formation is the product of active cellular
`Secretion by nonpigmented epithelial cells of the ciliary
`process from the active transport of Solute, probably Sodium,
`followed by the osmotic flow of water from the plasma. The
`nonpigmented epithelial cells of the ciliary proceSS are
`connected at their apical cell membranes by tight junctions.
`These cells participate in forming the blood/acqueous barrier
`through which blood-borne large molecules, including pro
`teins, do not pass.
`0010 Intraocular pressure (IOP) is a function of the
`difference between the rate at which acqueous humor enters
`and leaves the eye. Aqueous humor enters the posterior
`chamber by three means: 1) active Secretion by nonpig
`mented epithelial cells of the ciliary process; 2) ultrafiltra
`tion of blood plasma; and 3) diffusion. Newly formed
`aqueous humor flows from the posterior chamber around the
`lens and through the pupil into the anterior chamber; acque
`ous humor leaves the eye by 1) passive bulk flow at the
`irridocorneal angle by means of the uVeloscleral outflow, or
`by 2) active transportation through the trabecular meshwork,
`Specifically the juxta canalicar portion. Any change in 1), 2),
`or 3) will disturb aqueous humor dynamics and likely alter
`intraocular preSSure.
`0011 Primary open angle glaucoma is caused by a block
`age in the trabecular meshwork. This leads to an increase in
`intraocular pressure. The major obstruction is at the juxta
`canalicular portion which is situated adjacent to Schlemm'S
`canal. In infants a goniotomy or a trabeculotomy can be
`performed. In goniotomy or trabeculotomy a Small needle or
`probe is introduced into Schlemm'S canal and the trabecular
`meshwork is mechanically disrupted into the anterior cham
`ber. Approximately 90-120 of trabecular meshwork can be
`disrupted. The anatomical difference between congenital
`glaucoma and adult glaucoma is that in congenital glaucoma
`the ciliary body muscle fibers insert into the trabecular
`meshwork and once disrupted the trabecular meshwork is
`pulled posteriorly allowing fluid to enter Schlemm's canal
`and to be removed through the normal collector channels
`that are present in the wall of Schlemm's canal. In adults the
`trabecular meshwork tears but remains intact and reattaches
`to the posterior scleral wall of Schlemm's canal blocking the
`collector channels.
`0012 Most treatments for glaucoma focus on reducing
`intraocular pressure. Treatment has involved administration
`of beta-blockerS Such as timolol to decrease acqueous humor
`production, adranergic agonists to lower intraocular preSSure
`or diuretics Such as acetazolamide to reduce acqueous pro
`duction, administration of miotic eyedropS. Such as pilo
`carpine to facilitate the outflow of aqueous humor, or
`prostaglandin analogs to increase uVeoScleral outflow. Acute
`forms of glaucoma may require peripheral iridectomy Sur
`gery to relieve pressure where drug therapy is ineffective and
`the patient's vision is at immediate risk. Other forms of
`
`Petitioner - New World Medical
`Ex. 1015, p. 39 of 53
`
`

`

`US 2002/011 1608 A1
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`Aug. 15, 2002
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`treatment have included physical or thermal destruction (
`“cyclodestruction”) of the ciliary body of the eye, com
`monly by Surgery or application of a laser beam, cryogenic
`fluid or high frequency ultrasound.
`0013 In guarded filtration surgery (trabeculectomy), a
`fistula created through the limbal Sclera is protected by an
`overlying partial thickness Sutured Scleral flap. The Scleral
`flap provides additional resistance to excessive loSS of
`aqueous humor from the eyeball, thereby reducing the risk
`of early postoperative hypotony.
`0.014.
`In accordance with one recently introduced proce
`dure, a full thickneSS filtering fistula may be created by a
`holmium laser probe, with minimal Surgically induced
`trauma. After retrobulbar anesthesia, a conjunctival incision
`(approximately 1 mm) is made about 12-15 mm posterior to
`the intended Sclerostomy Site, and a laser probe is advanced
`through the Sub-conjunctival Space to the limbus. Then,
`multiple laser pulses are applied until a full thickness fistula
`is created. This technique has Sometimes resulted in early
`hypotony on account of a difficulty in controlling the Scle
`rostomy size. In addition, early and late iris prolapse into the
`Sclerostomy has resulted in abrupt closure of the fistula and
`eventual Surgical failure. Further, despite its relative Sim
`plicity, the disadvantage of this procedure, as well as other
`types of glaucoma filtration Surgery, is the propensity of the
`fistula to be sealed by Scarring.
`0.015
`Various attempts have been made to overcome the
`problems of filtration Surgery, for example, by using oph
`thalmic implant instruments such as the Baerveldt Glaucoma
`Implant. Typical ophthalmic implants utilize drainage tubes
`So as to maintain the integrity of the openings formed in the
`eyeball for the relief of the IOP
`0016 Typical ophthalmic implants suffer from several
`disadvantages. For example, the implants may utilize a valve
`mechanism for regulating the flow of aqueous humor from
`the eyeball; defects in and/or failure of such valve mecha
`nisms could lead to excessive loss of aqueous humor from
`the eyeball and possible hypotony. The implants also tend to
`clog over time, either from the inside by tissue, Such as the
`iris, being Sucked into the inlet, or from the outside by the
`proliferation of cells, for example by Scarring. Additionally,
`the typical implant insertion operation is complicated, costly
`and takes a long time and is reserved for complicated
`glaucoma problems.
`0.017. There are many problems, however, in effectively
`treating glaucoma with long term medicinal or Surgical
`therapies. One problem is the difficulty in devising means to
`generate pharmacologically effective intraocular concentra
`tions and to prevent extraocular side effects elicited by a
`Systemic administration. Many drugs are administered topi
`cally or locally. The amount of a drug that gets into the eye
`is, however, only a Small percentage of the topically applied
`dose because the tissueS of the eye are protected from Such
`Substances by numerous mechanisms, including tear turn
`over, blinking, conjunctival absorption into Systemic circu
`lation, and a highly Selective corneal barrier.
`0.018
`Pharmacological treatment is prohibitively expen
`Sive to a large majority of glaucoma patients. In addition,
`many people afflicted with the disease live in remote or
`undeveloped areas where the drugs are not readily acces
`sible. The drugs used in the treatment often have undesirable
`
`Side effects and many of the long-term effects resulting from
`prolonged use are not yet known. Twenty-five percent of
`patients do not use their medications correctly.
`0019 Glaucoma is a progressively worsening disease, so
`that a filtration operation for control of intraocular preSSure
`may become necessary. Present Surgical techniques to lower
`intraocular pressure, when medication fails to decrease fluid
`flow into the eye or to increase fluid outflow, include
`procedures that permit fluid to drain from within the eye to
`extraocular sites by creating a fluid passageway between the
`anterior chamber of the eye and the potential Supra-Scleral/
`Sub-Tenon's Space, or, alternatively, into or through the
`Canal of Schlemm (see, e.g., U.S. Pat. No. 4,846,172). The
`most common operations for glaucoma are glaucoma filter
`ing operations, particularly trabeculectomy. These opera
`tions involve creation of a fistula between the Subconjunc
`tival Space and the anterior chamber. This fistula can be
`made by creating a hole at the limbuS by either cutting out
`a portion of the limbal tissues with either a scalpel blade or
`by burning with a cautery through the Subconjunctival Space
`into the anterior chamber. Fluid then filters through the
`fistula and is absorbed by episcleral and conjunctival. In
`order for the Surgery to be effective, the fistula must remain
`Substantially unobstructed. These drainage or filtering pro
`cedures, however, often fail by virtue of closure of the
`passageway resulting from the healing of the very wound
`created for gaining access to the Surgical Site. Failures most
`frequently result from Scarring at the site of the incisions in
`the conjunctiva and the Tenon's capsule. The Surgery fails
`immediately in at least 15% of patients, and long term in a
`much higher percentage. Presently, this consequence of
`trabeculectomy, closure of the passageway, is treated with 5
`fluorouracil and Mitomycin C, which apparently prevent
`closure by inhibiting cellular proliferation. These drugs,
`however, are highly toxic and have undesirable Side effects,
`including Scleral melting, hypotony, leaks, and late infec
`tions.
`0020. Other Surgical procedures have been developed in
`an effort to treat Victims of glaucoma. An iridectomy,
`removal of a portion of the iris, is often used in angle-closure
`glaucoma wherein there is an occlusion of the trabecular
`meshwork by iris contact. Removal of a piece of the iris then
`gives the aqueous free passage from the posterior to the
`anterior chambers in the eye. The tissue of the eye can grow
`back to the pre-operative condition, thereby necessitating
`the need for further treatment.
`0021. In view of the limited effectiveness of treatment
`options, there is, therefore, a need to develop more effective
`treatments for glaucoma.
`
`SUMMARY OF THE INVENTION
`0022. The present invention is a surgical instrument and
`minimally invasive Surgical method to remove at least a
`portion of the trabecular meshwork of the eye, providing for
`aqueous drainage in the treatment of glaucoma.
`0023) A preferred embodiment of the present invention
`involves inserting a Surgical instrument through a Small
`corneal incision transcamerally under direct visualization to
`ablate the trabecular meshwork. The instrument may include
`a foot plate, Such that the instrument can penetrate the
`trabecular meshwork into Schlemm's canal. The footplate
`may also act as a protective device for the endothelial cells
`
`Petitioner - New World Medical
`Ex. 1015, p. 40 of 53
`
`

`

`US 2002/011 1608 A1
`
`Aug. 15, 2002
`
`and collector channels lining the Scleral wall of Schlemm's
`canal. The instrument may also comprise an infusion System
`and aspiration System. Infusion maintains and deepens the
`anterior chamber So that easy access of the angle of the eye
`is obtained to the trabecular meshwork and Schlemm's
`canal. Infusion also allows fluid to flow out to the collector
`channels whilst the Surgery is being performed, thus keeping
`the Surgical Site blood free. Aspiration is designed to remove
`ablated tissue, gas and bubble formation, and all intraocular
`debris generated. The aspiration may be directly linked to
`either a cutting mechanism, Such as a guillotine cutting
`machine, laser probe, a piezo-electric crystal producing
`Sonic or ultraSonic energy, or cautery element. These
`modalities are capable of Substantially complete tissue
`removal by mechanical means, cautery, vaporization, or
`other tissue destruction techniques.
`0024. The Surgical instrument is used to perform a
`goniectomy procedure, by removing a portion of the trabe
`cular meshwork consisting of the pigmented trabecular
`meshwork, allowing free access of aqueous from the anterior
`chamber through to the Scleral portion of Schlemm's canal
`that contains the endothelial cells and most importantly the
`collector channels that lead back to the episcleral venous
`System.
`In another embodiment, a Schlemmectomy Surgi
`0.025
`cal procedure, Similar to a trabeculotomy, a Schlemmectomy
`probe is inserted into Schlemm's canal under direct visual
`ization through a Scleral incision, Such that the Surface of the
`instrument faces the trabecular meshwork and the tissue
`comprising the pigmented and a portion of the nonpig
`mented trabecular meshwork facing into Schlemm's canal is
`removed by a cautery element, radio-frequency electrode, or
`an ultrasound transducer formed from a piezo-electric crys
`tal.
`0026. This instrument is advantageous because it com
`bines existing procedures with new technology, providing a
`Simple Solution for glaucoma treatment.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0.027
`FIG. 1 is a cross sectional schematic diagram of a
`human eye.
`0028 FIG. 2 is a cross sectional schematic diagram
`which shows aqueous flow into and through the anterior
`chamber in a human eye.
`0029 FIGS. 3a-d shows diagrammatically the progres
`Sion of the deformation of the lamina cribrosa in glaucoma.
`0030 FIGS. 4a-c show diagrammatically the steps of
`performing a goniectomy.
`0.031
`FIGS. 5a-d show diagrammatically the steps of
`performing a trabeculodialysis.
`0.032 FIGS. 6a-e show diagrammatically the steps of a
`trabeculotomy procedure using a probe of a preferred
`embodiment.
`0.033
`FIG. 7 is a perspective view which shows agoniec
`tomy cautery probe of a preferred embodiment.
`0034 FIG. 8 is a cross-sectional schematic diagram
`which shows the goniectomy cautery probe of FIG. 7.
`
`0035 FIG. 9 is a cross sectional schematic diagram
`which shows another embodiment of the goniectomy cau
`tery probe of FIG. 7.
`0036 FIG. 10a is a detailed view which shows the probe
`tip of the goniectomy cautery probe of FIG. 7.
`0037 FIG. 10b is a cross-sectional schematic diagram
`which shows the probe tip of the goniectomy cautery probe
`of FIG 7.
`0038 FIG.11a is a detailed view which shows the probe
`tip of the goniectomy cautery probe of FIG. 7.
`0039 FIG. 11b is a cross-sectional schematic diagram
`which shows the probe tip of the goniectomy cautery probe
`of FIG 7.
`0040 FIG.12a is a detailed view which shows the probe
`tip of the goniectomy cautery probe of FIG. 7.
`0041
`FIG. 12b is a cross-sectional schematic diagram
`which shows the probe tip of the goniectomy cautery probe
`of FIG 7.
`0042 FIG. 13 is a perspective view which shows a
`goniectomy cautery probe of a preferred embodiment.
`0043 FIG. 14 is a perspective view which shows a
`goniectomy cautery probe of a preferred embodiment.
`0044 FIG. 15a is a detailed view which shows the probe
`tip of the goniectomy cautery probe of FIG. 13.
`004.5
`FIG. 15b is a cross-sectional schematic diagram
`which shows the probe tip of the goniectomy cautery probe
`of FIG. 13.
`0046 FIG. 16a is a detailed view which shows the probe
`tip of the cautery probe of FIG. 14.
`0047 FIG. 16b is a cross-sectional schematic diagram
`which shows the probe tip of the cautery probe of FIG. 14.
`0048 FIG. 17 shows a schematic of a circuit diagram of
`a preferred embodiment of a goniectomy probe.
`0049 FIG. 18 is a perspective view which shows a
`goniectomy probe.
`0050 FIG. 19 is a cross-sectional schematic diagram
`which shows an embodiment of the probe of FIG. 18.
`0051
`FIG. 20 is a cross-sectional schematic diagram
`which shows an embodiment of the probe of FIG. 18.
`0052 FIG. 21 is a cross-sectional schematic diagram
`which shows an embodiment of the probe of FIG. 18.
`0053 FIG. 22 is a cross-sectional schematic diagram
`which shows an embodiment of the probe of FIG. 18.
`0054 FIG. 23 is a cross-sectional schematic diagram
`which shows an embodiment of the probe of FIG. 18.
`0055 FIG. 24a is a perspective view which shows a
`preferred embodiment of a laser goniectomy probe.
`0056 FIG. 24b is a perspective view which shows a
`preferred embodiment of a laser goniectomy probe.
`0057 FIG. 25 is a cross sectional schematic diagram of
`the laser goniectomy probe of FIG. 24a.
`0058 FIG. 26 is a cross sectional schematic diagram of
`the laser goniectomy probe of FIG. 24b.
`
`Petitioner - New World Medical
`Ex. 1015, p. 41 of 53
`
`

`

`US 2002/011 1608 A1
`
`Aug. 15, 2002
`
`0059 FIG. 27 is a cross sectional schematic diagram of
`the laser goniectomy probe of FIG. 24b.
`0060 FIG. 28 is a perspective view which shows a
`Schlemmectomy probe of a preferred embodiment.
`0061 FIGS. 29a-c are detailed views which show the
`probe tip of the probe of FIG. 28.
`0062 FIG. 30 is a perspective view of an alternative
`preferred embodiment of the probe of FIG. 28.
`0063 FIGS.31 a, b, c are detailed views of the probe tip
`of FIG. 30.
`0064 FIGS. 32a, b are detailed views which show the
`probe tip of the probe of FIG. 30.
`0065 FIG. 33a is a detailed view which shows the probe
`tip of the probe of FIG. 30.
`0.066
`FIG. 33b is a cross-sectional schematic diagram
`which shows the probe tip of the probe of FIG. 30.
`0067 FIG.34a is a detailed view which shows the probe
`tip of the probe of FIG. 30.
`0068 FIG. 34b is a cross-sectional schematic diagram
`which shows the probe tip of the probe of FIG. 30.
`0069 FIG.35a is a detailed view which shows the probe
`tip of the probe of FIG. 30.
`0070 FIG. 35b is a cross-sectional schematic diagram
`which shows the probe tip of the probe of FIG. 30.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`0071 Referring to FIG. 1, relevant structures of the eye
`will be briefly described, so as to provide background for the
`anatomical terms used herein. Certain anatomical details,
`well known to those skilled in the art, have been omitted for
`clarity and convenence.
`0072. As shown in FIG. 1, the cornea 103 is a thin,
`transparent membrane which is part of the outer eye and lies
`in front of the iris 104. The cornea 103 merges into the sclera
`102 at a juncture referred to as the limbus 108. A layer of
`tissue called bulbar conjunctiva 106 covers the exterior of
`the sclera 102. The bulbar conjunctiva 106 is thinnest
`anteriorly at the limbus 108 where it becomes a thin epi
`thelial layer which continues over the cornea 103 to the
`corneal epithelium. As the bulbar conjunctiva 106 extends
`posteriorly, it becomes more Substantial with greater
`amounts of fibrous tissue. The bulbar conjunctiva 106
`descends over Tenon's capsule approximately 3 mm from
`the limbus 108. Tenon's capsule is thicker and more sub
`Stantial encapsulatory tissue which covers the remaining
`portion of the eyeball. The Subconjunctival and Sub-Tenon's
`capsule Space become one when these two tissues meet,
`approximately 3 mm from the limbus. The ciliary body or
`ciliary process 110 is part of the uveal tract. It begins at the
`limbus 108 and extends along the interior of the sclera 102.
`The choroid 112 is the vascular membrane which extends
`along the retina back towards the optic nerve. The anterior
`chamber 114 of the eye is the space between the cornea 103
`and a crystalline lens 116 of the eye. The crystalline lens of
`the eye is situated between the iris 104 and the vitreous body
`120 and is enclosed in a transparent membrane called a lens
`capsule 122. The anterior chamber 114 is filled with aqueous
`
`humor 118. The trabecular meshwork 121 removes excess
`acqueous humor 118 from the anterior chamber 114 through
`Schlemm'S canal 124 into collector channels which merge
`with blood-carrying veins to take the aqueous humor 118
`away from the eye.
`0073. As shown in FIG. 2, the flow of aqueous 118 is
`from the posterior chamber, through the pupil, into the
`anterior chamber 114.
`0074 FIGS. 3a-d show longitudinal sections through the
`optic nerve head, illustrating the progressive deepening of
`the cup 302 in the nerve head from normal to advanced
`glaucoma. FIG. 3a shows a normal nerve and FIG. 3d
`shows an effected nerve in advanced glaucoma. AS the cup
`302 deepens and the lamina cribrosa 306 becomes more
`curved, axons 304 passing through the lamina 306 are
`Subject to kinking and preSSure as they make their way
`through the lamina 306.
`0075) Goniotomy
`0.076 FIGS. 4a-c show the steps for performing a
`goniotomy procedure. AS Shown in FIG. 4a, locking forceps
`406 are typically used to grasp the inferior and Superior
`rectus muscles. Agoniotomy lens 408 is positioned on the
`eye. Agoniotomy knife 400 is inserted from the temporal
`aspect beneath the goniotomy lens and Viewed through a
`microScope. The cornea is irrigated with balanced Salt
`Solution. The Surgeon positions the goniotomy lens 408 on
`the cornea, holding the lens 408 with an angled, toothed
`forceps 406 placed into the two dimples at the top of the lens
`408.
`0077. The surgeon places the goniotomy knife 400 into
`and through the cornea 1.0 mm anterior to the limbus,
`maintaining the knife 400 parallel to the plane of the iris
`(FIG. 4b). Slight rotation of the knife 400 facilitates smooth
`penetration into the anterior chamber without a Sudden break
`through the cornea. The Surgeon continues to gently apply
`preSSure and rotate the goniotomy knife 400, directing it
`acroSS the chamber, parallel to the plane of the iris, until
`reaching the trabecular meshwork in the opposite angle.
`0078. The Surgeon visualizes the trabecular meshwork
`under direct microScopy and engages the Superficial layers
`of the meshwork at the midpoint of the trabecular band. The
`incision is typically made 100 to 120, as designated by Cin
`FIG. 4b, circumferentially, first incising clockwise 5020 to
`60°, then counterclockwise for 50 to 60.
`0079. As the tissue is incised, a white line can be seen and
`the iris usually drops posteriorly. An assistant facilitates
`incision by rotating the eye in the opposite direction of the
`action of the blade (FIG. 4c).
`0080. The surgeon completes the goniotomy incision and
`promptly withdraws the blade. If aqueous escapes from the
`wound and the chamb