Surgical Instruments for Anterior Goniotomy

Abstract

A surgical instrument (40, 40A) for performing a goniotomy includes a hand grip (44, 44A) having an elongated configuration with a proximal end and a distal end. The instrument (40, 40A) includes a tip (52, 52A) connected to the distal end (48, 48A) of the hand grip (44, 44A), the tip (52, 52A) having a cutting means for creating trabecular cleavage surfaces that result in the remaining trabecular leaflets being just below Schwaller's line of the eye to improve drainage of aqueous humor from the eye. In one form, the cutting means includes a pair of angled arcuate cutting surfaces (70, 70A) that join to define an arcuate cutting edge (74, 74A).

Description

[Technical field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 63 / 341,485, filed May 13, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to microsurgical instruments for performing ophthalmic procedures for the treatment of eye diseases such as glaucoma, and more particularly to surgical instruments for facilitating anterior goniotomy procedures. [Background technology]

[0003] Goniotomy was first described as a surgical procedure to treat congenital and developmental glaucoma caused by developmental abnormalities in the trabecular outflow system. As a result of this abnormality, the trabecular meshwork itself becomes thicker, and these changes lead to increased intraocular pressure that can damage the internal structures of the eye, including the optic nerve, leading to the development of glaucoma. Later, goniotomy was found to reduce intraocular pressure in adults.

[0004] The purpose of goniotomy is to selectively cut abnormal trabecular tissue to improve the flow of aqueous humor from the eye, which in turn reduces intraocular pressure (IOP). Lowering IOP helps stabilize the enlargement of the cornea and the dilation and extension of the eye that often occurs in congenital / developmental glaucoma. Importantly, as aqueous outflow is improved, damage to the optic nerve can be halted and reversed. The patient's vision can improve after surgery. In adults, goniotomy cuts diseased outflow tissue, similar to its effect of reducing outflow resistance in childhood glaucoma.

[0005] Goniotomy can restore normal drainage of aqueous humor from the eye by severing segments of the trabecular meshwork, thus allowing the aqueous humor to drain through the open area where the strip of trabecular meshwork has been severed. Goniotomy and several prior art instruments that can be used to perform such procedures are described in U.S. Patent No. 6,979,328, which is incorporated herein by reference in its entirety.

[0006] Currently, there remains a need in the art for the development of improved, easy to use, inexpensive, minimally invasive instruments that can be used to perform goniotomy or other similar procedures to reduce intraocular pressure. Summary of the Invention

[0007] In accordance with one broad aspect of the present invention, a microsurgical instrument is disclosed that is specifically configured to facilitate performing an anterior goniotomy for the treatment of glaucoma, the instrument including a specially configured tip that facilitates the creation of a specific unique cleavage plane just below Schwalbe's line to improve drainage of aqueous humor from the eye.

[0008] In one preferred form of the invention, the instrument includes a hand grip having an elongated configuration with a proximal end and a distal end, the instrument includes a tip connected to the distal end of the hand grip, the tip having cutting means for forming a trabecular cleavage plane just below Schwalbe's line.

[0009] In one preferred form of the invention, the tip includes a base extending from a distal end of the hand grip portion and extending along a base axis. The tip includes an intermediate portion extending from the base along an intermediate portion axis transverse to the base axis. The tip further includes a distal portion extending from the intermediate portion along a distal portion axis transverse to the intermediate portion axis. The distal portion includes a cutting means.

[0010] In yet another aspect of the invention, the cutting means has the form of a pair of beveled arcuate cutting surfaces that join to define an arcuate cutting edge. Preferably, the arcuate cutting edge defines an edge axis that is at an angle of about 30 degrees to about 50 degrees relative to a plane containing the distal and medial piece axes. More preferably, the edge axis is at an angle of about 40 degrees relative to a plane containing the distal and medial piece axes.

[0011] In accordance with one preferred form of the invention, the distal end of the tip includes a blunt surface located opposite (forward relative to the hand grip) the cutting means.

[0012] In accordance with another preferred aspect of the invention, the base axis extends generally parallel to the hand grip axis and the intermediate section axis forms an angle with respect to the base axis of between about 130 degrees and about 160 degrees.

[0013] According to another preferred embodiment of the invention, the cutting means faces rearwardly towards the hand grip.

[0014] In yet another form of the invention, the distal portion of the tip includes a blunt surface opposite the cutting means, the cutting means being disposed closer to the hand grip than the blunt surface.

[0015] In another form of the invention, the cutting means has an angled configuration defining a semi-circular arcuate cutting edge.

[0016] In another form of the invention, the hand grip includes (i) a reservoir for containing irrigation fluid, or (ii) a connection for communicating with an external irrigation fluid source.

[0017] In accordance with one broad aspect of the invention, a method of using a surgical instrument to treat the trabecular meshwork of an eye is disclosed. The method includes a first step of obtaining a surgical instrument of the invention having at least a hand grip of an elongated configuration with a proximal end and a distal end. The instrument includes a tip connected to the distal end of the hand grip. The tip has a cutting means for forming a cleavage plane just below (posteriorly along the optical axis) the Schwalbe line of the eye. The method includes the further step of grasping the hand grip and bringing the cutting means into contact with the trabecular meshwork at or below the Schwalbe line. The method includes the further step of dissecting the trabecular meshwork anteriorly such that the tissue separates to various degrees from the Schwalbe line.

[0018] In one form of the invention, the cutting means of the instrument is an elliptical, flat, beveled surface terminating in a distal arcuate cutting edge.

[0019] In another form of the invention, the cutting means of the instrument is a conical surface terminating in a sharp distal cutting edge. Preferably, the sharp cutting edge or tip is at an angle of about 40 degrees to the axis of the distal portion of the tip.

[0020] In another form of the invention, the cutting means of the instrument has a tapered configuration defining a surface that converges and terminates in a blunt, rounded distal edge.

[0021] In accordance with yet another aspect of the invention, the cutting means has a tapered configuration defining a concave surface terminating in a spatula-shaped distal edge.

[0022] In one broad form of the invention, the instrument may include an internal passageway terminating in at least one irrigation port to direct the flow of irrigation fluid generally out of the distal end of the instrument.

[0023] In another aspect of the invention, the distal segment axis of the instrument is at an angle of between about 90 degrees and about 140 degrees relative to the medial segment axis, more preferably at an angle of about 120 degrees. [Brief description of the drawings]

[0024] In the accompanying drawings which form part of this specification, like numerals are used to refer to like parts. [Figure 1] FIG. 1 is a left side view of a first embodiment of a surgical instrument according to the present invention. [Diagram 2] FIG. 2 is a top view of the device of FIG. 1. [Diagram 3] FIG. 2 is an isometric view from above and to the right of the device of FIG. 1. [Figure 4] FIG. 4 is an enlarged isometric view of the operative distal tip of the instrument of FIG. [Diagram 5] FIG. 2 is a greatly enlarged, partial left side view of the distal tip of the instrument shown in FIG. 1. [Figure 6] FIG. 2 is a greatly enlarged, partial top view of the distal tip of the instrument shown in FIG. 1. [Figure 7] FIG. 2 is a left side view of a second embodiment of a surgical instrument in accordance with the present invention. [Figure 8] FIG. 8 is a top view of the device of FIG. [Figure 9] FIG. 8 is an isometric view from above and to the right of the device of FIG. 7. [Figure 10] FIG. 8 is an enlarged isometric view of a distal portion of the instrument of FIG. [Figure 11] FIG. 8 is a greatly enlarged, partial left side view of the distal tip of the instrument shown in FIG. [Figure 12] FIG. 8 is a greatly enlarged, partial plan view of the distal tip of the instrument shown in FIG. [Figure 12A] FIG. 13 is a greatly enlarged, fragmentary plan view of a distal portion of a variation of the second embodiment of a surgical instrument according to the present invention. [Figure 12B] FIG. 12B is an enlarged top isometric view of the distal portion of the device shown in FIG. 12A. [Figure 13A] FIG. 12A is an optical coherence tomography image of an eye after surgery using a device according to the present invention, showing the formation of trabecular leaflets or flaps one month after surgery. [Figure 13B] FIG. 12B is an optical coherence tomography image of an eye after surgery using a device according to the present invention, showing the formation of trabecular leaflets or flaps 12 months after surgery. [Figure 13C]FIG. 12C is an optical coherence tomography image of an eye after surgery using a device according to the present invention, showing the formation of trabecular leaflets or flaps 27 months after surgery. [Figure 13D] FIG. 12D is another optical coherence tomography image of an eye after surgery using an instrument according to the present invention, showing the classic formation of a trabecular leaflet or flap. [Figure 14] FIG. 13 is a partial front view of a third embodiment of a surgical instrument in accordance with the present invention, wherein the instrument is configured as a left tilt instrument. [Figure 15] FIG. 15 is an enlarged isometric view of the operative distal tip of the instrument of FIG. [Figure 16] FIG. 15 is a greatly enlarged partial front view of the operative distal tip of the instrument of FIG. [Figure 17] FIG. 13 is a partial isometric view of a fourth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument. [Figure 18] FIG. 18 is a greatly enlarged, partial isometric view of the operative distal tip of the instrument of FIG. 17. [Figure 19] FIG. 13 is a partial isometric view of a fifth embodiment of a surgical instrument in accordance with the present invention, the instrument configured as a left tilt instrument. [Figure 20] FIG. 20 is a partial front view of the device of FIG. 19. [Figure 21] FIG. 20 is a partial left side view of the device of FIG. 19. [Figure 22] FIG. 20 is a greatly enlarged, partial isometric view of the operative distal tip of the instrument of FIG. 19. [Figure 23] FIG. 13 is a partial isometric view of a sixth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument. [Figure 24] FIG. 24 is a greatly enlarged, partial right side view of the device of FIG. 23. [Diagram 25] FIG. 24 is a greatly enlarged partial front view of the device of FIG. 23. [Figure 26] FIG. 13 is a partial front view of a seventh embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument and with only the tip visible. [Figure 27] FIG. 27 is a partial right side view of the device of FIG. 26. [Figure 28] FIG. 13 is a partial front view of an eighth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a left-tilting instrument with only the tip visible; [Figure 29] FIG. 29 is a partial isometric view from the front left of the device of FIG. 28. [Diagram 30] FIG. 13 is a partial front view of a ninth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument and with only the tip visible. [Diagram 31] FIG. 31 is a partial isometric view from the right front of the device of FIG. 30. [Diagram 32] FIG. 15 is a partial front view of a tenth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a left-tilting instrument with only the tip visible; [Diagram 33] FIG. 33 is a partial isometric view from the front left of the device of FIG. 32. [Diagram 34] FIG. 15 is a partial front view of an eleventh embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument and with only the tip visible. [Diagram 35] FIG. 35 is a partial isometric view from the right front of the device of FIG. 34. [Diagram 36] FIG. 23 is a partial front view of a twelfth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a left-tilting instrument with only the tip visible; [Figure 37] FIG. 37 is a partial isometric view from the front left side of the device of FIG. 36. [Figure 38] FIG. 23 is a partial front view of a thirteenth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a right-tilt instrument and with only the tip visible. [Figure 39] FIG. 23 is a partial front view of a fourteenth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only the tip visible; [Diagram 40] FIG. 23 is a partial isometric view of a fifteenth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible; [Diagram 41] FIG. 41 is another partial isometric view of the device of FIG. [Diagram 42] FIG. 41 is another partial isometric view of the device of FIG. 40 showing the interior of the device. [Diagram 43] FIG. 41 is a left side view of the device of FIG. [Diagram 44] FIG. 23 is a partial isometric view from below of a sixteenth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Diagram 45] FIG. 45 is a right side view of the device of FIG. 44 showing the interior of the device. [Figure 46] FIG. 23 is a partial isometric view from below of a seventeenth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Figure 47] FIG. 47 is a partial top view of the device of FIG. 46. [Figure 48] FIG. 23 is a partial rear view of an eighteenth embodiment of a surgical instrument in accordance with the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible; [Figure 49] FIG. 49 is an isometric view from below of the device of FIG. 48. [Figure 50] FIG. 23 is a partial isometric view from the left side of a nineteenth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Figure 51] FIG. 51 is a partial left side view of the device of FIG. 50. [Figure 52] FIG. 23 is a partial isometric view from below of a twentieth embodiment of a surgical instrument in accordance with the present invention, where the instrument is configured as a left tilt instrument with only a portion of the tip visible; [Diagram 53] FIG. 53 is another isometric view from below of the device of FIG. 52. [Figure 54] FIG. 21 is a partial isometric view from the right side of a twenty-first embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible. [Figure 55] FIG. 55 is another isometric view from the right side of the device of FIG. 54. [Figure 56] FIG. 22 is a partial rear isometric view of a twenty-second embodiment of a surgical instrument according to the present invention, the instrument configured as a left tilt instrument with only a portion of the tip visible; [Figure 57] FIG. 57 is another isometric view from the front of the device of FIG. 56. [Figure 58] FIG. 23 is a partial rear isometric view of a twenty-third embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Figure 59] FIG. 59 is another isometric view from the left side of the device of FIG. 58. [Figure 60] FIG. 24 is a partial isometric view from below of a twenty-fourth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Figure 61] FIG. 61 is another isometric view from the right side of the device of FIG. 60. [Figure 62] FIG. 25 is a partial rear view of a twenty-fifth embodiment of a surgical instrument according to the present invention, the instrument configured as a left tilt instrument with only a portion of the tip visible. [Figure 63] FIG. 63 is an isometric view from the right side of the device of FIG. 62. [Figure 64] FIG. 26 is a partial isometric view of a twenty-sixth embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible; [Figure 65] FIG. 65 is a left side view of the device of FIG. [Figure 66] FIG. 27 is a partial isometric view from below of a twenty-seventh embodiment of a surgical instrument according to the present invention, the instrument being configured as a left tilt instrument with only a portion of the tip visible; [Figure 67] FIG. 28 is a partial isometric view of a twenty-eighth embodiment of a surgical instrument according to the present invention, the instrument configured as a left tilt instrument with only a portion of the tip visible. [Figure 68] FIG. 29 is a partial rear view of a twenty-ninth embodiment of a surgical instrument in accordance with the present invention, the instrument configured as a left tilt instrument with only a portion of the tip visible; [Figure 69] FIG. 30 is a greatly enlarged, partial isometric view of a 30th embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible; [Figure 70] FIG. 23 is a greatly enlarged, partial isometric view of a thirty-first embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left-tilt instrument and where only a portion of the tip is visible. [Figure 71]FIG. 71 is a greatly enlarged, partial isometric view of the device of FIG. 70, showing the internal features of the device. [Figure 72] FIG. 71 is a greatly enlarged, partial right side view of the device of FIG. 70. [Figure 72] FIG. 72 is a greatly enlarged, partial right side view of the device of FIG. 70, showing the internal features of the device. [Figure 74] FIG. 23 is a greatly enlarged partial left side view of a thirty-second embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left tilt instrument and where only a portion of the tip is visible. [Figure 75] FIG. 75 is a greatly enlarged, partial right side view of the device of FIG. 74. [Figure 76] FIG. 75 is an enlarged, fragmentary, isometric top view of the device of FIG. [Figure 77] FIG. 23 is a greatly enlarged partial rear view of a thirty-third embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left tilt instrument and where only a portion of the tip is visible. [Figure 78] FIG. 78 is a greatly enlarged partial rear view of the device of FIG. 77, showing the internal features of the device. [Figure 79] FIG. 1 is a top isometric view of a first illustrative embodiment of the present invention coupled with an irrigation hand grip or hand piece. [Figure 80] FIG. 23 is a greatly enlarged, partial isometric view from above of a thirty-fourth embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left-tilt instrument and where only a portion of the tip is visible. [Figure 81] FIG. 81 is a partial top view of a portion of the device shown in FIG. 80. [Figure 82] FIG. 23 is a greatly enlarged, partial isometric view from above of a thirty-fifth embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left-tilt instrument and where only a portion of the tip is visible; [Figure 83] FIG. 83 is a fragmentary isometric view from above of a portion of the device shown in FIG. [Figure 84]FIG. 23 is a greatly enlarged, partial isometric view from above of a thirty-sixth embodiment of a surgical instrument according to the present invention, where the instrument is configured as a left-tilt instrument and where only a portion of the tip is visible; [Figure 85] FIG. 85 is a fragmentary isometric view from above of a portion of the device shown in FIG. [Figure 84] FIG. 23 is a greatly enlarged, partial isometric view from above of a thirty-seventh embodiment of a surgical instrument according to the present invention, the instrument being configured as a left-tilting instrument with only a portion of the tip visible; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] With reference to FIGS. 1-6, in accordance with a first exemplary embodiment of the present invention, the present goniotomy surgical instrument 40 includes a handpiece or hand grip 44 for being grasped by a user of the instrument 40. The grip 44 has an elongated configuration including a proximal end 46 and a distal end 48, and defines a hand grip axis 50 extending between the proximal end 46 and the distal end 48. FIGS. 1-6 show a first variation of the instrument 40 for use as a right-tilted instrument. FIGS. 7-12 show a left-tilted variation of the instrument 40A, which will be described in more detail below. It is further contemplated that this embodiment of the instrument 40 may also be configured as a straight instrument without an angle. Each of these variations of the instruments 40 and 40A are configured to contact a particular angle, arc, or portion of the trabecular meshwork of the patient's eye, as will be discussed in more detail below. The hand grip 44 may preferably have either a rounded or flat configuration and is serrated to facilitate gripping. Additionally, hand grip 44 may be a cannula hub or fitting with means for attachment to a larger machine, irrigation system, or commercially available irrigation handpiece (e.g., threads, snap-fit ​​connection, luer lock connection, friction fit, lock, etc.) Numbered features of the embodiments of instruments 40 and 40A shown and described herein are generally designated with numbers where such features are similar in structure and function.

[0026] Referring now to FIG. 4 , the instrument 40 includes a tip 52 that extends directly from the distal end 48 of the hand grip 44 or indirectly from the distal end 48 of the hand grip 44 via one or more straight or angled shank portions, depending on the right, left, or straight designed use of the instrument 40.

[0027] In the illustrated first preferred embodiment of the instrument 40, the tip 52 includes a base 54 that extends from the distal end 48 of the hand grip 44 and defines a base axis 56 passing through its geometric center. The base axis 56 is substantially parallel to and coincident with the central axis 50 of the hand grip 44. The tip 52 further includes an intermediate portion 58 that extends from the base 54 along an intermediate portion axis 60 that is transverse or angled to the base axis 56. Preferably, the intermediate portion axis 60 is at an angle of about 130 degrees to about 160 degrees, more preferably about 145 degrees, relative to the base axis 56. The tip 52 includes a distal portion 64 that extends from the intermediate portion 58 along a distal portion axis 66 that is transverse to the intermediate portion axis 60. Preferably, the distal portion axis 66 is at an angle of about 90 degrees to about 140 degrees, more preferably about 120 degrees, relative to the intermediate portion axis 60. Distal portion 64 includes cutting means for creating trabecular leaflets at or just slightly posterior or inferior to Schwalbe's line of the eye. The inventors have found that increasing the angle between axis 66 and axis 60 to between about 90 degrees and about 120 degrees significantly improves the user's ability to perform the surgical procedure to create the leaflets.

[0028] 13A-13D, a series of optical coherence tomography images of an eye 100 operated on by an instrument 40 are shown. Directions referred to herein are generally taken relative to the optical axis 110 (or a line parallel thereto) of such eye 100, with the anterior direction being axially upward in FIGS. 13A-13D away from the optic portion or lens of the eye, and the posterior direction being axially downward in FIGS. 13A-13D toward the optic portion of the eye. FIGS. 13A-13D show the cornea 120, iris 130, and opening of Schlemm's canal 140 of the eye 100. The inventors have found that the instrument 40 disclosed herein is advantageously configured to safely and efficiently incise the trabecular tissue just below Schwalbe's line to allow the separated trabecular meshwork or tissue 150 to fall in a posterior direction from the cornea 120 toward the iris 130. Trabecular leaflets or flaps 150 extending at an angle or arc around the optical axis 110 can improve flow through Schlemm's canal 140 to lower intraocular pressure and reduce medication required by glaucoma patients. FIG. 13A shows eye 100 one month after surgery using the device 40 of the present invention, FIG. 13B shows the same eye 100 12 months after surgery, and FIG. 13C shows the same eye 100 27 months after surgery. FIG. 13D shows a typical appearance of the trabecular vent in eye 100 after iVent surgery according to the present invention. The acute angle of the trabecular corneal angle is typical for the postoperative appearance of vents created using the techniques of the present invention. The appearance of this trabecular vent angle is distinctly different from the appearance of the angle after other forms of goniotomy, GATT, OMNI, etc.

[0029] 5 and 6, the preferred cutting means of the instrument 40 has the form of a pair of beveled arcuate cutting surfaces 70 which join to define an arcuate cutting edge 74. The cutting surfaces 70 are preferably semicircular and define a bevel which terminates rearwardly to face the hand grip 44 of the instrument 40 when grasped by a user. As seen in FIG. 5, the instrument 40 defines a plane 68 which includes the intermediate tip 58 of the tip 52 and the axes 60 and 66 of the distal portion 64. The arcuate cutting edge 74 defines a central edge axis 80 which is at an angle of about 30-50 degrees, more preferably about 40 degrees, relative to the plane 68. At the most distal end of the distal portion 64 relative to the hand grip 44 is a blunt surface 78 opposite the arcuate cutting edge 74. The blunt surface 78 is the furthest portion of the tip 52 away from the hand grip 44.

[0030] With reference to FIG. 5, the distal portion 64 of the tip 52 preferably has a width of about 0.1 mm.

[0031] With reference to FIG. 6, the distal portion 64 of the tip 52 preferably has a working blade length along the distal portion axis 66 of about 0.30 mm, and a blade width perpendicular to the axis 66 of about 0.15 mm.

[0032] The inventors of the present invention believe that the embodiments of the instruments discussed herein may advantageously allow the surgeon to improve flow through the outflow tissue by uncoupling the trabecular meshwork from Schwalbe's lines while preserving the valve-like function inherent to the outflow system. The instruments herein may reduce the cost of glaucoma procedures compared to existing surgical instruments having expensive hand pieces and may improve surgical outcomes by reducing the time of procedures compared to surgeries performed with prior art devices. The instruments disclosed herein may be easier for the surgeon to use, less expensive than prior art devices on the market, and / or may reduce or eliminate post-operative visits by the patient to the surgeon.

[0033] The present invention facilitates the creation of unique incisions into the trabecular tissue compared to all other currently known methods for opening the trabecular meshwork, including but not limited to Kahook Dual Blade, OMNI 360 Surgical System, iStent inject, Hydraus, GATT, Hemi-GATT and Tanito Goniotomy. The advantages of the present invention include precise and selective opening of the anterior most surface of the trabecular meshwork, essentially just posterior to Schwalbe's line. This selective opening of the trabecular meshwork allows for cutting of the trabecular meshwork tissue with minimal disruption of the existing intracanalicular valve system. The cut trabecular meshwork is separated from Schwalbe's line but remains attached to the scleral ring. Depending on the elasticity of the leaflets as well as other factors including gravity and post-operative healing, the leaflets remain open to various degrees. This selective anterior cutting of the trabecular meshwork protects against the destruction of microscopic support structures at the angle and theoretically preserves the pump / valve function within Schlemm's canal.

[0034] An additional benefit of this procedure is that it minimizes damage and preserves the valve system, unlike the Kahook Dual Blade, iTrack, Omni 360, GATT prior art, Tanito, Espaillat, trabeculotomy, or Avic procedures. The minimal disruption of the microscopic support structures within Schlemm's canal in the present invention minimizes the possibility of blood backflow due to low intraocular pressure (assuming the valve structures remain essentially intact). In addition, since there is no device or instrument that rubs along or disrupts the posterior wall of Schlemm's canal, the device further minimizes the risk of disrupting any of the endothelial lining of Schlemm's canal, any associated vascularized tissue, and microscopic intracanalicular structures such as valves and microtubules. Also, depending on the degree of glaucoma disease and valve dysfunction, the specific cleavage planes created in the anterior trabecular meshwork can allow for the stretching of the intracanalicular valve system with improved function. Furthermore, the unique design of the device allows for the maintenance of the anterior chamber.

[0035] The inventors have named the unique method of the present invention Interventional Valve Enhanced Trabeculotomy or "iVent." iVent makes a precise cut at the anterior surface of the trabecular meshwork. When creating this cleavage plane, care is taken to avoid intracanalicular structures and valves. A vent is created by specifically cutting the anterior trabecular meshwork.

[0036] With traction, by simply dissecting the trabecular meshwork, the anterior attachment is released and the posterior aspect of the trabecular meshwork is shifted away from its anterior insertion into the corneal / endoscleral wall. Displacement of the anterior trabecular meshwork from its insertion site allows for traction on the intracanalicular structures and enhancement of canalicular valve function. By strengthening the pump / valve mechanism, IOP is lowered through improvement of the traditional outflow pathway. This mechanism of enhancement is particularly unique to the iVent.

[0037] iVent differs from other anterior segment angle surgeries because it avoids the destruction of intracanalicular structures. The enhancement of conventional outflow pathways may be considered similar to that seen after procedures such as selective laser trabeculoplasty or SLT, which has the potential to further enhance or rejuvenate the outflow pathways of the eye. The cellular stimulation generated by iVent further improves the pumping mechanism of the intracanalicular valve. In addition, because the trabecular meshwork is cut and not incised and removed (as in other types of angle surgery), iVent is less disruptive and results in a lower degree of acute intraocular inflammation. Schwalbe's lines harbor a significant population of unique cells with stem cell properties, as shown in (1) Raviola, G. Schwalbe's line's cells: a new cell type in the trabecular meshwork of Macaca mulatta. Invest Ophthalmol Vis Sci. m1982:22:45-56 and (2) Braunger BM, Ademoglu B, Koschade SE, at al., Identification of adult stem cells in Schwalbe's line region of the primate eye. IOVS 2014;55:7499-7507, both of which are incorporated herein by reference in their entirety. These adult stem cells, known as Schwalbe's follicles, may compensate for the loss of trabecular meshwork cells associated with glaucoma. These cells can be directly stimulated by iVent to provide a population of multipotent stem cells that can differentiate into outflow cells that enhance outflow physiology. Cytokine release and other factors associated with favorable wound healing from iVent treatment likely stimulate these stem cells to provide a cell population to improve outflow.

[0038] Importantly, the iVent does not involve the implantation of a foreign body and therefore there is no concern of stent or object displacement. With the present invention there is no concern of erosion or failure as with implants. Given the lack of an implant and the minimal trauma of the technique, the iVent is minimally traumatic to the corneal endothelial cells.

[0039] It is currently believed that the iVent is less disruptive to the trabecular meshwork as a result of which there is a lower risk of abnormal wound healing compared to the other prior art techniques mentioned above. The iVent further does not remove the valves and channels of the trabecular meshwork and does not occlude or block such channels.

[0040] The iVENT procedure has been found by the inventors to reduce intraocular pressure to low intraocular pressure when the patient is on one medication or off medication (i.e., medication drop). The results we are seeing with iVENT appear to be distinctly different than the results we have seen with KDB, trabeculotomy, OMNI, cyclosacral and sciatic or other angle-based procedures. These prior art mentioned procedures tend to have more modest IOP reductions, resulting in post-operative IOP in the mid-teens range with the patient on one or two medications. The fact that we are seeing significantly lower intraocular pressures after iVENT procedure speaks to the novel and unique nature of this procedure and how it specifically enhances the patient's natural outflow pathways by improving the function of the intracanalicular pump / valve mechanism.

[0041] It will be appreciated that the devices disclosed herein may be formed in a variety of sizes for small incision or conventional glaucoma surgery.

[0042] In one currently preferred method of use, the instrument 40 may be configured for use in dissecting the nasal or temporal angle of the right and / or left eye. The instrument 40 may be inserted through an incision in the cornea of ​​the operative eye. The arc of the trabecular meshwork at Schwalbe's line (or a minimum of posterior thereto) is then engaged by the cutting means of the instrument to generate a unique cleavage plane. The trabecular meshwork descends posteriorly toward the iris. An angle prism may be used to view the trabecular meshwork as it is engaged by the instrument 40. Irrigation fluid may be optionally applied in reflux bursts or jet pulses by the user of the instrument 40, as needed.

[0043] Cutting of the anterior trabecular meshwork is accomplished by making an incision just below or at the Schwalbe line. Based on the particular clinical case, the surgeon may selectively incise 1-5 clock hours. Additionally, the surgeon may choose to incise one area, leave an island of trabecular meshwork untreated, and then incise a subsequent area to maximize canal opening but minimize tissue disruption. This technique creates a unique anterior cut plane that allows the trabecular shelves or tissue to remain open, which has the advantage of minimizing disruption of microscopic structures within the canal. In fact, a small corneal incision can be made in the nasal quadrant to treat a 180 degree temporal angle, thus creating a 360 degree iVent.

[0044] The design of the present instrument allows for precise alignment to Schwalbe's line without the difficult positioning maneuvers to make the incision at 6 o'clock (when seated at the side of the patient's head). This is easily done with an instrument designed to be symmetrical. If the surgeon were to sit on the opposite side, he or she could potentially access the lateral 6 clock hours and theoretically treat 360 degrees if desired; although this approach is not the primary intent of this instrument, the inventors have adopted it in certain circumstances.

[0045] The inventors believe that the concept that the ocular outflow system is a passive filter is outdated. Indeed, Dr. Jorge A. Alvarado has found that severe changes occur in the cellular components and throughout the trabecular meshwork during primary open-angle glaucoma and aging. The authors demonstrate that trabecular meshwork endothelial cells regulate aqueous humor outflow by actively releasing enzymes and cytokines that increase transendothelial flow upon binding to Schlemm's canal endothelial cells, thereby promoting aqueous humor outflow. Trabecular meshwork endothelial cells secrete these factors in response to stimuli such as mechanical stretch, laser irradiation, and pro-inflammatory cytokines.

[0046] The present inventors believe that the devices and methods of the present invention are highly effective and may provide longer lasting results.

[0047] It is believed that dissecting the trabecular meshwork just posterior to the location of Schwalbe's line allows for the creation of a unique trabecular flap, unlike others created by prior art instruments. Although this flap is hinged posteriorly at the scleral spur, the opening angle of the flap below Schwalbe is intended to preserve and possibly strengthen intracanalicular structures (i.e., valves, tubules, etc.). These structures are destroyed when prior art sutures, filaments, or catheters are passed through Schlemm's canal, or when the trabecular shelf is parallel to the iris. However, when a specially designed spatula that is angled, tilted, and curved is used to create selective and precise anterior dissections in the trabecular meshwork, these intracanalicular structures are preserved and protected. In fact, it is very likely that the trabecular meshwork flap that is released when inserted most anteriorly will provide some tension or stretch to the intracanalicular valves, the valvular disease named by the inventors, potentially enhancing their function.

[0048] 7-12, another embodiment of the instrument of the present invention is shown and designated as 40A. The numbered features of instrument 40A are generally designated with the letter suffix "A" and are similar to the features of the previously described illustrated embodiment of instrument 40 sharing the same numbers (without the letter suffix "A"). Instrument 40A operates in the same manner as described in detail above and has the same basic features as hand grip 44A having a tip 52A including a base 54A that extends from a distal end 48A of hand grip 44A and defines a base axis 56A through its geometric center. Base axis 56A is substantially parallel to and coincident with central axis 50A of hand grip 44A. Tip 52A further includes an intermediate portion 58A extending from base 54A along an intermediate portion axis 60A that is transverse to or angled from base axis 56A. Preferably, the intermediate section axis 60A is at an angle of about 130 degrees to 160 degrees relative to the base axis 56A, and more preferably at an angle of about 145 degrees. It is further contemplated that this embodiment may be configured as a straight instrument with no angle.

[0049] The tip 52A includes a distal portion 64A extending from the intermediate portion 58A along a distal portion axis 66A that is transverse to the intermediate portion axis 56A. Preferably, the distal portion axis 66A is at an angle between about 90 degrees and about 140 degrees, more preferably about 120 degrees, relative to the intermediate portion axis 60A. The distal portion 64A includes cutting means for preparing the remaining trabecular leaflets at or just posterior to the Schwalbe line of the eye.

[0050] The embodiment of the instrument 40A differs from the first embodiment of the instrument 40 described above in that the distal portion 64A is configured as a left leaning instrument relative to the hand grip 44A and the remainder of the tip 52A.

[0051] 12A and 12B, a variation of the second illustrated embodiment of the instrument of the present invention is illustrated and designated as 40A'. The numbered features of instrument 40A' are generally designated with the suffix "A'" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the suffix letter "A'"). Instrument 40A' operates in the same manner as described in detail above and has the same basic features of a hand grip with a tip including a base that extends from a distal end of the hand grip and defines a base axis passing through its geometric center. The base axis is substantially parallel to and coincident with the central axis of the hand grip. The tip further includes an intermediate portion 58A' that extends from the base along an intermediate portion axis 60A' that is transverse or at an angle to the base axis. Preferably, the intermediate portion axis 60A' is at an angle of about 130 degrees to about 160 degrees to the base axis, more preferably at an angle of about 145 degrees.

[0052] The tip 52A' includes a terminal portion 64A' that extends from the intermediate portion 58A' along a terminal portion axis 66A' that transverses the intermediate portion axis 56A'. The terminal portion 64A' includes cutting means for creating the remaining trabecular leaflets at or just posterior to Schwalbe's line of the eye.

[0053] This embodiment of instrument 40A' differs from the second embodiment of instrument 40A described above in that the distal portion axis 66A' is angled at approximately 120 degrees relative to the intermediate portion axis 60A'. The inventors have found that increasing this angle significantly improves the ability of various users to create the aforementioned leaflets in a left-tilt instrument (as shown), a right-tilt instrument (e.g., as shown in the embodiment of instrument 40 in Figures 1-6), or a straight, non-angled instrument in which the distal portion of the instrument extends in a plane that includes the central axis of the hand grip.

[0054] Arcuate cutting edge 74A' is angled from about 30 degrees to about 50 degrees from a plane containing axes 60A' and 66A', and more preferably at about 40 degrees from the plane.

[0055] 14-16 and 17-18, additional embodiments of the instruments of the present invention are illustrated and designated as 40B (left tilt instrument) and 40C (right tilt instrument), respectively. It is further contemplated that these embodiments may be configured as straight instruments that are not angled. The numbered features of instruments 40B and 40C are generally designated with a letter suffix "B" or "C" and are similar to the features of the previously illustrated embodiment of instrument 40 that share the same numbers (without the letter suffix "B" or "C"). Instruments 40B, 40C operate in the same manner as described in detail above and have the same basic features of hand grips 44B, 44C with tips 52B, 52C including bases 54B, 54C that extend from distal ends 48B, 48C of hand grips 44B, 44C and define base axes 56B, 56C through their geometric centers. The base axis 56B, 56C is substantially parallel to and coincident with the central axis 50B, 50C of the hand grip 44B, 44C. The tip 52B, 52C further includes an intermediate portion 58B, 58C extending from the base 54B, 54C along an intermediate portion axis 60B, 60C that is transverse to or angled with the base axis 56B, 56C. Preferably, the intermediate portion axis 60B, 60C is at an angle of between about 130 degrees and 160 degrees relative to the base axis 56B, 56C, and more preferably at an angle of about 145 degrees.

[0056] The tips 52B, 52C include terminal portions 64B, 64C extending from the intermediate portions 58B, 58C along terminal portion axes 66B, 66C that are transverse to the intermediate portion axes 56B, 56C. Preferably, the terminal portion axes 66B, 66C are at an angle between about 90 degrees and about 140 degrees, more preferably about 120 degrees, relative to the intermediate portion axes 60B, 60C. The terminal portions 64B, 64C include cutting means for creating trabecular leaflets at or just posterior to Schwalbe's line of the eye.

[0057] The embodiment of instruments 40B, 40C differs from the first embodiment of instrument 40 described above in that the end portions 64B, 64C are configured with elliptical, angled surfaces 70B, 70C that are at an angle of approximately 45 degrees relative to the axes 66B, 66C and face rearwardly toward the handles 44B, 44C when the instruments 40B, 40C are grasped by a user. The angled surfaces 70B, 70C define blunt, rounded distal edges 74B, 74C.

[0058] 19-22 and 23-25, additional embodiments of the instruments of the present invention are shown and are designated as 40D (left tilt instrument) and 40E (right tilt instrument), respectively. It is further contemplated that these embodiments may be configured as straight instruments that are not angled. The numbered features of instruments 40D and 40E are generally designated with a letter suffix "D" or "E" and are similar to the features of the previously illustrated embodiment of instrument 40 that share the same numbers (without the letter suffix "D" or "E"). Instruments 40D, 40E operate in the same manner as described in detail above and have the same basic features of hand grips 44D, 44E with tips 52D, 52E including bases 54D, 54E that extend from distal ends 48D, 48E of hand grips 44D, 44E and define base axes 56D, 56E through their geometric centers. The base axis 56D, 56E is substantially parallel to and coincident with the central axis 50D, 50E of the hand grip 44D, 44E. The tip 52D, 52E further includes an intermediate portion 58D, 58E extending from the base 54D, 54E along an intermediate portion axis 60D, 60E that is transverse or angled relative to the base axis 56D, 56E. Preferably, the intermediate portion axis 60D, 60E is at an angle of between about 130 degrees and 160 degrees, more preferably about 145 degrees, relative to the base axis 56D, 56E.

[0059] The tips 52D, 52E include terminal portions 64D, 64E extending from the intermediate portions 58D, 58E along terminal portion axes 66D, 66E that are transverse to the intermediate portion axes 56D, 56E. Preferably, the terminal portion axes 66D, 66E are at an angle between about 90 degrees and about 140 degrees, more preferably about 120 degrees, relative to the intermediate portion axes 60D, 60E. The terminal portions 64DB, 64E include cutting means for creating trabecular leaflets at or just posterior to Schwalbe's line of the eye.

[0060] Importantly, the embodiment of the instrument 40D, 40E differs from the above-described first embodiment of the instrument 40 in that the distal end portions 64D, 64E are configured with a tapered configuration defining a pair of opposing trapezoidal faces 70D, 70E and a pair of opposing triangular faces 71D, 71E that meet and terminate in blunt, rounded distal edges 74D, 74E that are at an angle of approximately 45 degrees relative to the axis 66E, 66E. The edges between the faces 70D, 70E, 71D, 71E are sharpened to form leaflets, while the edges 74D, 74E are blunted to enhance safety.

[0061] 26-27 and 28-29, additional embodiments of the instruments of the present invention are shown and are designated as 40F (right tilt instrument) and 40G (left tilt instrument), respectively. It is further contemplated that these embodiments may be configured as straight instruments, not angled. The numbered features of instruments 40F and 40G are generally designated with a letter suffix "F" or "G" and are similar to the features of the previously illustrated embodiment of instrument 40 sharing the same numbers (without the letter suffix "F" or "G"). Instruments 40F, 40G operate in the same manner as described in detail above.

[0062] Importantly, the embodiment of instrument 40F, 40G differs from the above-described first embodiment of instrument 40 in that the distal portion 64F, 64G is configured with a tapered spatula configuration defining a concave surface 70F, 70G and a pair of opposing concave edges 71F, 71G that join and terminate in blunt rounded distal edges 74F, 74G that are angled at approximately 40 degrees relative to the axis 66F, 66G. The edges between the surfaces 70F, 70G, 71F, 71G are sharpened to form the leaflets, while the edges 74F, 74G are blunted to enhance safety.

[0063] 30-31 and 32-33, additional embodiments of the instruments of the present invention are shown and designated as 40H (right-tilt instrument) and 40I (left-tilt instrument), respectively. The numbered features of instruments 40H and 40I are generally designated with a letter suffix "H" or "I" and are similar to the features of the previously described illustrated embodiments of instrument 40 sharing the same numbers (without the letter suffix "H" or "I"). It is further contemplated that these embodiments may be configured as straight instruments that are not angled. Instruments 40H, 40I operate in the same manner as described in detail above with respect to instrument 40. The embodiments of instruments 40H, 40I differ from the previously described embodiments of instruments 40B and 40C in that the end portions 64H, 64I are configured with inclined surfaces 70H, 70I that are at an angle of approximately 30 degrees relative to the axes 66H, 66I.

[0064] 34-35 and 36-37, additional embodiments of the instruments of the present invention are shown and are designated as 40J (right tilt instrument) and 40K (left tilt instrument), respectively. It is further contemplated that this embodiment may be configured as a straight instrument without an angle. The numbered features of instruments 40J and 40K are generally designated with a letter suffix "J" or "K" and are similar to the features of the previously described illustrated embodiment of instrument 40 that share the same numbers (without the letter suffix "J" or "K"). Instruments 40J, 40K operate in the same manner as described in detail above with respect to instrument 40. The embodiment of instruments 40J, 40K differs from the previously described embodiments of instruments 40B and 40C in that the end portions 64J, 64K are configured with inclined surfaces 70J, 70K that are at an angle of approximately 60 degrees relative to the axes 66J, 66K.

[0065] 38 and 39, additional embodiments of the instruments of the present invention are shown and are designated as 40L (right tilt instrument) and 40M (left tilt instrument), respectively. The numbered features of instruments 40L and 40M are generally designated with a letter suffix "L" or "M" and are similar to the features of the previously described illustrated embodiment of instrument 40 that share the same numbers (without the letter suffix "L" or "M"). Instruments 40L, 40M operate in a similar manner as described in detail above with respect to instrument 40.

[0066] Importantly, the embodiment of the instrument 40L, 40M differs from the first embodiment of the instrument 40 described above in that the end portions 64L, 64M are configured with tapered conical surfaces 70L, 70M that terminate in sharpened distal ends 74L, 74M that are angled at approximately 40 degrees relative to the axes 66L, 66M. The distal ends 74L, 74M are sharpened to create leaflets within the trabecular meshwork.

[0067] In general, the instruments shown and described herein may include one or more through passages that communicate with an irrigation fluid source (located in a reservoir within the handgrip or located in an external pressurized container or machine and connected to the handgrip through tubing). With reference to FIG. 79, the handgrip 44 may include a pressure switch 45, bellows, or other means to facilitate selective application of irrigation fluid from a reservoir or irrigation fluid source to a target surgical site or location at the distal working end of the instrument proximate the cutting means. Such a handgrip having a reservoir and pressure switch is disclosed in WO 2023 / 018568 to Nallakrishnan, which is incorporated herein by reference in its entirety. Alternatively, irrigation fluid may be provided through a sleeve or tube located around a portion of the instrument. It will be appreciated that many commercially available irrigation handpieces or systems are available and the instrument may be adapted to function with such handpieces or systems.

[0068] In another broad form of the invention, the embodiments of the instruments disclosed herein can be attached or otherwise coupled to a movable hand grip portion in the form of a handpiece to aid in the performance of a surgical procedure. The handpiece may be, for example, a longitudinally vibrating phacoemulsification handpiece, a torsionally vibrating phacoemulsification handpiece, an elliptically vibrating phacoemulsification handpiece, a phacoemulsification handpiece configured for three-dimensional vibratory motion, a vitrectomy handpiece, a piezoelectric handpiece, an ultrasonic handpiece, a solenoid valve handpiece, a pneumatic handpiece, or a battery-powered handpiece. Other vibrating handpieces may be used with the instruments disclosed herein.

[0069] The handpiece may be developed for the treatment of open angle glaucoma, particularly in the paracanalicular space (JCS), including, but not limited to, or based on vibration, pulsating, oscillating, guillotine, piezo, radio frequency (RF), and combination therapies including neodymium doped yttrium aluminum garnet (Nd:YAG) laser platforms and specially designed tips and / or laser probes. The handpiece may be a cautery or cryosurgery handpiece.

[0070] The proximal end or portion of the instrument, when incorporated into the handpiece, does not itself function as a hand grip, but may be removably or non-removably coupled to the handpiece by mating threads, luer lock, pressure fit, snap fit, etc.

[0071] 40-43, an embodiment of a cannulated instrument of the present invention is illustrated and designated as 40N. While only a left-tilted instrument 40N is illustrated, it is understood that a right-tilted instrument 40N, and a non-angled or straight instrument 40N, opposite the speculum, are contemplated. The numbered features of instrument 40N are generally designated with the letter "N" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40B and 40C which share the same numbers (without the letter "N" suffix). Instrument 40N operates in a similar manner as described in detail above with respect to instrument 40.

[0072] Importantly, embodiment 40N of instrument 40N differs from instruments 40B and 40C described above in that instrument 40N is configured with an internal passageway 76N that terminates in an irrigation port 75N disposed in inclined surface 70N. Irrigation port 75N is configured to direct the flow of irrigation fluid generally along axis 66N.

[0073] 44 and 45, a further embodiment of the cannulated instrument of the present invention is shown and designated as 40O. While only a left tilt instrument 40O is illustrated, it is understood that a right tilt instrument 40O, and a non-angled or straight instrument 40O, opposite the speculum, are contemplated. The numbered features of instrument 40O are generally designated with the letter "O" suffix and are similar to the features of the previously illustrated embodiments of instruments 40B and 40C which share the same numbers (without the letter "O" suffix). Instrument 40O operates in a similar manner as described in detail above with respect to instrument 40.

[0074] Importantly, embodiment of instrument 40O differs from instruments 40B and 40C described above in that instrument 40O is configured with an internal passageway 76O terminating in a pair of irrigation ports 75O located within intermediate portion 58O and distal portion 64O. Irrigation ports 75O are configured to direct a first flow of irrigation fluid generally along axis 60O of intermediate portion 58O and a second flow of irrigation fluid in a direction perpendicular or orthogonal to axes 60O and 66O, respectively, of instrument 40O.

[0075] 46 and 47, a further embodiment of the cannulated instrument of the present invention is shown and designated as 40P. While only a left-tilted instrument 40P is illustrated, it is understood that a right-tilted instrument 40P, and a non-angled or straight instrument 40P, opposite the speculum, are contemplated. The numbered features of instrument 40P are generally designated with a letter "P" suffix and are similar to the features of the previously illustrated embodiments of instruments 40B and 40C which share the same numbers (without the letter "P" suffix). Instrument 40P operates in a similar manner as described in detail above with respect to instrument 40.

[0076] Importantly, embodiment of instrument 40P differs from instruments 40B and 40C described above in that instrument 40P is configured with an internal passageway 76P that terminates in a pair of opposing irrigation ports 75P located within intermediate portion 58P. Irrigation ports 75P are configured to direct the flow of irrigation fluid generally along axis 60P of tip distal portion 64P.

[0077] 48 and 49, a further embodiment of the cannulated instrument of the present invention is illustrated and designated as 40Q. While only a left tilt instrument 40Q is illustrated, it is understood that a right tilt instrument 40Q, and a non-angled or straight instrument 40Q, opposite the speculum, are contemplated. The numbered features of instrument 40Q are generally designated with the letter "Q" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40B and 40C which share the same numbers (without the letter "Q" suffix). Instrument 40Q operates in a similar manner as described in detail above with respect to instrument 40.

[0078] Importantly, embodiment of instrument 40Q differs from instruments 40B and 40C described above in that instrument 40Q is configured to have an internal passageway that terminates in a single irrigation port 75Q located at the bend between intermediate portion 58Q and distal portion 64Q. Irrigation port 75Q is configured to direct the flow of irrigation fluid generally along tip axis 60Q.

[0079] 50 and 51, an embodiment of a cannulated instrument of the present invention is illustrated and designated as 40R. While only a left-tilted instrument 40R is illustrated, it is understood that a right-tilted instrument 40R, and a non-angled or straight instrument 40R, opposite the speculum, are contemplated. The numbered features of instrument 40R are generally designated with the letter "R" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40D and 40E which share the same numbers (without the letter "R" suffix). Instrument 40R operates in a similar manner as described in detail above with respect to instrument 40.

[0080] Importantly, the embodiment of the instrument 40R differs from the instruments 40D and 40E described above in that the instrument 40R is configured with an internal passageway that terminates in a single irrigation port 75R located in the distal end portion 64R adjacent the cutting means. The irrigation port 75R is configured to direct the flow of irrigation fluid generally along the axis 66R of the distal end portion 64R.

[0081] 52 and 53, an embodiment of a cannulated instrument of the present invention is illustrated and designated as 40S. While only a left-tilted instrument 40S is illustrated, it is understood that a right-tilted instrument 40S, and a non-angled or straight instrument 40S, opposite the speculum, are contemplated. The numbered features of instrument 40S are generally designated with the letter "S" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40D and 40E which share the same numbers (without the letter "S" suffix). Instrument 40ES operates in a similar manner as described in detail above with respect to instrument 40.

[0082] Importantly, embodiment of instrument 40S differs from instruments 40D and 40E described above in that instrument 40S is configured with an internal passageway that terminates in a pair of irrigation ports 75S located in intermediate portion 58S and distal portion 64S. Irrigation ports 75S are configured to direct a first flow of irrigation fluid generally along axis 60S of intermediate portion 58S and a second flow of irrigation fluid in a direction orthogonal or perpendicular to axes 60S and 66S, respectively, of instrument 40S.

[0083] 54 and 55, an embodiment of the cannulated instrument of the present invention is illustrated and designated as 40T. While only a left-tilted instrument 40T is illustrated, it is understood that a right-tilted instrument 40T, and a non-angled or straight instrument 40T, opposite the speculum, are contemplated. The numbered features of instrument 40T are generally designated with a letter "T" suffix and are similar to the features of the previously illustrated embodiments of instruments 40D and 40E which share the same numbers (without the letter "T" suffix). Instrument 40T operates in a similar manner as described in detail above with respect to instrument 40.

[0084] Importantly, embodiment of instrument 40T differs from instruments 40D and 40E described above in that instrument 40T is configured with an internal passageway (not visible in FIGS. 54 and 55) that terminates in a pair of opposing irrigation ports 75T located in intermediate portion 58T. Irrigation ports 75T are configured to direct the flow of irrigation fluid generally along a direction perpendicular to axes 60T and 66T.

[0085] 56 and 57, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40U. While only a left-tilt instrument 40U is illustrated, it is understood that a right-tilt instrument 40U, and a non-angled or straight instrument 40U, opposite the speculum, are contemplated. The numbered features of instrument 40U are generally designated with the letter "U" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40D and 40E which share the same numbers (without the letter "U" suffix). Instrument 40U operates in a similar manner as described in detail above with respect to instrument 40.

[0086] Importantly, embodiment of instrument 40U differs from instruments 40D and 40E described above in that instrument 40U is configured with an internal passageway (not visible in FIGS. 56 and 55) that terminates in a single irrigation port 75U located at the bend between distal portion 64U and intermediate portion 58U. Irrigation port 75U is configured to direct the flow of irrigation fluid generally along axis 60U of intermediate portion 58U.

[0087] 58 and 59, another embodiment of the cannulated instrument of the present invention is illustrated and designated 40V. While only a left-tilt instrument 40V is illustrated, it is understood that a right-tilt instrument 40V, and a non-angled or straight instrument 40V, opposite the speculum, are contemplated. The numbered features of instrument 40V are generally designated with the letter "V" suffix and are similar to the features of the previously illustrated embodiments of instruments 40F and 40G which share the same numbers (without the letter "V" suffix). Instrument 40V operates in a similar manner as described in detail above with respect to instrument 40.

[0088] The embodiment of instrument 40V differs from instruments 40F and 40G described above in that instrument 40V is configured with an internal passageway (not visible in FIGS. 58 and 59) that terminates in a single irrigation port 75V located within a concave surface 70V in distal portion 64V. Irrigation port 75V is configured to direct the flow of irrigation fluid generally along axis 66V of distal portion 64V.

[0089] 60 and 61, another embodiment of the cannulated instrument of the present invention is illustrated and designated 40W. While only a left-tilt instrument 40W is illustrated, it is understood that a right-tilt instrument 40W, and a non-angled or straight instrument 40W, opposite the speculum, are contemplated. The numbered features of instrument 40W are generally designated with the letter "W" suffix and are similar to the features of the previously illustrated embodiments of instruments 40F and 40G which share the same numbers (without the letter "W" suffix). Instrument 40W operates in a similar manner as described in detail above with respect to instrument 40.

[0090] The embodiment of instrument 40W differs from instruments 40F and 40G described above in that instrument 40W is configured with an internal passageway (not visible in FIGS. 60 and 61) that terminates in a pair of irrigation ports 75W located at an intermediate portion 58W of the instrument tip. Irrigation ports 75W are configured to direct a first flow of irrigation fluid generally along axis 60W and a second flow of irrigation fluid generally along a direction perpendicular or orthogonal to axes 66W and 60W, respectively.

[0091] 62 and 63, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40X. While only a left-tilt instrument 40X is illustrated, it is understood that a right-tilt instrument 40X, and a non-angled or straight instrument 40X, opposite the mirror, are contemplated. The numbered features of instrument 40X are generally designated with a letter "X" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40F and 40G which share the same numbers (without the letter "X" suffix). Instrument 40X operates in a similar manner as described in detail above with respect to instrument 40.

[0092] The embodiment of instrument 40X differs from instruments 40F and 40G described above in that instrument 40X is configured with an internal passageway (not visible in FIGS. 62 and 63) that terminates in a single irrigation port 75X located in the instrument tip intermediate portion 58X. Irrigation port 75X is configured to direct the flow of irrigation fluid generally along the axis of intermediate portion 58X.

[0093] 64 and 65, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40Y. While only a left tilt instrument 40Y is illustrated, it is understood that a right tilt instrument 40Y, and a non-angled or straight instrument 40Y, opposite the speculum, are contemplated. The numbered features of instrument 40Y are generally designated with the letter "Y" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40L and 40M which share the same numbers (without the letter "Y" suffix). Instrument 40Y operates in a similar manner as described in detail above with respect to instrument 40.

[0094] The embodiment of the instrument 40Y differs from the instruments 40L and 40M described above in that the instrument 40Y is configured with an internal passageway 76Y that terminates in a single irrigation port 75Y located at the distal end portion 64Y of the instrument tip. The irrigation port 75Y is configured to direct the flow of irrigation fluid generally along the axis 66Y of the distal end portion 64Y.

[0095] 66, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40Z. While only a left-tilt instrument 40Z is illustrated, it is understood that a right-tilt instrument 40Z, and a non-angled or straight instrument 40Z, opposite the speculum, are contemplated. The numbered features of instrument 40Z are generally designated with a letter "Z" suffix and are similar to the features of the previously described illustrated embodiments of instruments 40L and 40M which share the same numbers (without the letter "Z" suffix). Instrument 40Z operates in a similar manner as described in detail above with respect to instrument 40.

[0096] The embodiment of instrument 40Z differs from instruments 40L and 40M described above in that instrument 40Z is configured with an internal passageway (not visible in FIG. 66) that terminates in a pair of irrigation ports 75Z located in an intermediate portion 58Z of the instrument tip. Irrigation ports 75Z are configured to direct a first flow of irrigation fluid generally along axis 60Z of intermediate portion 58Z and a second flow of fluid in a direction perpendicular to axes 66Z and 60Z.

[0097] 67, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40AA. While only a left-tilt instrument 40AA is illustrated, it is understood that a right-tilt instrument 40AA, and a non-angled or straight instrument 40AA, opposite the speculum, are contemplated. The numbered features of instrument 40AA are generally designated with the letter suffix "AA" and are similar to the features of the previously described illustrated embodiments of instruments 40L and 40M which share the same numbers (without the letter suffix "AA"). Instrument 40AA operates in a similar manner as described in detail above with respect to instrument 40.

[0098] The embodiment of instrument 40AA differs from instruments 40L and 40M described above in that instrument 40AA is configured with an internal passageway (not visible in FIG. 67) that terminates in a pair of opposing irrigation ports 75AA located at an intermediate portion 58AA of the instrument tip. The irrigation ports 75AA are configured to direct opposing flows of irrigation fluid generally perpendicular to axis 60AA.

[0099] 68, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40BB. While only a left tilt instrument 40BB is illustrated, it is understood that a right tilt instrument 40BB, and a non-angled or straight instrument 40BB, on the opposite side of the mirror, are contemplated. The numbered features of instrument 40BB are generally designated with the letter suffix "BB" and are similar to the features of the previously described illustrated embodiments of instruments 40L and 40M which share the same numbers (without the letter suffix "BB"). Instrument 40BB operates in a similar manner as described in detail above with respect to instrument 40.

[0100] The embodiment of instrument 40BB differs from instruments 40L and 40M described above in that instrument 40BB is configured with an internal passageway (not visible in FIG. 68) that terminates in a single irrigation port 75BB located at the instrument tip intermediate portion 58BB. Irrigation port 75BB is configured to direct the flow of irrigation fluid generally along an axis defined by the intermediate portion.

[0101] 69, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40CC. While only a left-tilted instrument 40CC is illustrated, it is understood that a right-tilted instrument 40CC, and a non-angled or straight instrument 40CC, opposite the speculum, are contemplated. The numbered features of instrument 40CC are generally designated with the letter suffix "CC" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "CC"). Instrument 40CC operates in a similar manner as described in detail above with respect to instrument 40A.

[0102] The embodiment of the instrument 40CC differs from the instrument 40A described above in that the instrument 40CC is configured with an internal passageway 76CC that terminates in a single irrigation port 75CC located at the distal portion 64CC of the instrument tip 52CC. The irrigation port 75CC is configured to direct the flow of irrigation fluid generally along a central axis defined by the distal portion 64CC.

[0103] 70-73, another embodiment of the cannulated instrument of the present invention is shown and designated as 40DD. While only a left-tilted instrument 40DD is illustrated, it is understood that a right-tilted instrument 40DD, and a non-angled or straight instrument 40DD on the opposite side of the mirror, are contemplated. The numbered features of instrument 40DD are generally designated with the letter suffix "DD" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "DD"). Instrument 40DD operates in a similar manner as described in detail above with respect to instrument 40A.

[0104] The embodiment of instrument 40DD differs from instrument 40A described above in that instrument 40DD is configured with a first irrigation port 75DD located at a distal portion 64DD of instrument tip 52DD and an internal flow passage 76DD terminating in a second irrigation port 75DD located at an intermediate portion 58DD of tip 52DD. The first irrigation port 75DD is configured to direct the flow of irrigation fluid generally along a central axis 60DD defined by intermediate portion 58DD, and the second irrigation port 75DD is configured to direct the flow of irrigation fluid downwardly generally perpendicular to each of central axes 60DD and 66DD.

[0105] 74-76, another embodiment of the cannulated instrument of the present invention is shown and designated as 40EE. While only a left-tilt instrument 40EE is illustrated, it is understood that a specular, right-tilt instrument 40EE, and a non-angled or straight instrument 40EE are contemplated. The numbered features of instrument 40EE are generally designated with the letter suffix "EE" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "EE"). Instrument 40EE operates in a similar manner as described in detail above with respect to instrument 40A.

[0106] The embodiment of instrument 40EE differs from instrument 40A described above in that instrument 40EE is configured with an internal flow passage 76EE that terminates in a pair of opposing irrigation ports 75EE located in the intermediate portion 58EE of the instrument tip 52EE, directing the flow of irrigation fluid generally parallel to a central axis 66EE (left and right) defined by the terminal portion 58EE.

[0107] 77 and 78, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40FF. While only a left-tilt instrument 40FF is illustrated, it is understood that a right-tilt instrument 40FF, and a non-angled or straight instrument 40FF, on the opposite side of the mirror, are contemplated. The numbered features of instrument 40FF are generally designated with the letter suffix "FF" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "FF"). Instrument 40FF operates in a similar manner as described in detail above with respect to instrument 40A.

[0108] The embodiment of the instrument 40FF differs from the instrument 40A described above in that the instrument 40FF is configured with an internal flow path 76FF terminating in a single irrigation port 75FF located at the junction of the intermediate portion 58FF and the distal portion 64FF of the instrument tip 52FF, directing the flow of irrigation fluid approximately parallel to a central axis (from the plane of the drawings of Figures 77 and 78 defined by the intermediate portion 58FF).

[0109] 80 and 81, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40GG. While only a left-tilt instrument 40GG is illustrated, it is understood that a right-tilt instrument 40GG, and a non-angled or straight instrument 40GG, opposite the speculum, are contemplated. The numbered features of instrument 40GG are generally designated with the letter suffix "GG" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "GG"). Instrument 40GG operates in a similar manner as described in detail above with respect to instrument 40A.

[0110] The embodiment of instrument 40GG differs from instrument 40A described above in that instrument 40GG is configured with an internal flow path terminating in a pair of opposing irrigation ports 75GG located just proximal to the junction of intermediate portion 58GG and distal portion 64GG of instrument tip 52GG, directing the flow of irrigation fluid approximately perpendicular or perpendicular (outside of a plane containing said axes) to central axes 66GG and 60GG.

[0111] 82 and 83, another embodiment of the cannulated instrument of the present invention is illustrated and designated as 40HH. While only a left-tilted instrument 40HH is illustrated, it is understood that a right-tilted instrument 40HH, and a non-angled or straight instrument 40HH, opposite the speculum, are contemplated. The numbered features of instrument 40HH are generally designated with the letter suffix "HH" and are similar to the features of the previously described illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "HH"). Instrument 40HH operates in a similar manner as described in detail above with respect to instrument 40A.

[0112] The embodiment of instrument 40HH differs from instrument 40A described above in that instrument 40HH is configured with a pair of opposing irrigation ports 75HH located in the distal portion 64HH of instrument tip 52HH that direct the flow of irrigation fluid approximately perpendicular or perpendicular to central axes 66HH and 60HH (outside of the plane containing said axes), and an internal flow path terminating in a third irrigation port 75HH located in the intermediate portion 58HH just proximal to the junction of the intermediate portion 58HH and the distal portion 64HH that directs the flow of irrigation fluid approximately laterally and approximately perpendicular or perpendicular to central axis 60HH and in a plane containing axes 66HH and 60HH.

[0113] 84 and 85, two additional embodiments of the cannulated instruments of the present invention are shown and designated as 40II and 40JJ, respectively. While only left-tilted instruments 40II and 40JJ are illustrated, it will be understood that right-tilted instruments on the opposite side of the mirror, and non-angled or straight instruments are contemplated herein. The numbered features of instruments 40II and 40JJ are generally designated with a letter suffix "II" or "JJ" and are similar to the features of the previously illustrated embodiment of instrument 40A sharing the same numbers (without the letter suffix "II" or "JJ"). Instruments 40II and 40JJ operate in a similar manner as described in detail above with respect to instrument 40A.

[0114] The embodiments of instruments 40II and 40JJ differ from instrument 40A described above in that instruments 40II and 40JJ are configured with an internal flow passage that terminates in a single irrigation port 75II and 75JJ located at the junction between intermediate portions 58II and 58JJ and terminal portions 64II and 64JJ for directing the flow of irrigation fluid generally transverse to central axes 66II and 66JJ and 60II and 60JJ, respectively. Irrigation port 75II is circular and irrigation port 75JJ is elliptical.

[0115] Various modifications and alterations to this invention will become apparent to those skilled in the art without departing from the scope and spirit of the invention. Exemplary embodiments and examples are provided by way of example only and are not intended to limit the broadest scope of the invention.

Claims

1. 1. A goniotomy surgical instrument comprising: a hand grip having an elongated configuration and having a proximal end and a distal end; a tip connected to the distal end of the hand grip, the tip having cutting means for creating trabecular leaflets at Schwalbe's line of the eye.

2. The tip is a base extending from the distal end of the hand grip portion and extending along a base axis; an intermediate portion extending from the base along an intermediate portion axis transverse to the base axis; 2. The goniotomy surgical instrument of claim 1, further comprising a distal portion extending from said intermediate portion along a distal portion axis transverse to said intermediate portion axis, said distal portion including said cutting means.

3. The goniotomy surgical instrument of claim 1 , wherein said cutting means is a pair of beveled arcuate cutting surfaces that join to define an arcuate cutting edge.

4. The goniotomy surgical instrument of claim 3 , wherein the arcuate cutting edge defines an edge axis that is angled from about 30 degrees to about 60 degrees relative to a plane containing the distal portion axis and the intermediate portion axis.

5. The goniotomy surgical instrument of claim 4 , wherein said edge axis is at an angle of approximately 40 degrees relative to said plane containing said distal portion axis and said intermediate portion axis.

6. The goniotomy surgical instrument of claim 2 , wherein said distal portion of said tip includes an opposite facing blunt surface compared to said cutting means.

7. The goniotomy surgical instrument of claim 2, wherein the distal section axis is at an angle of about 90 degrees to about 140 degrees relative to the intermediate section axis.

8. The goniotomy surgical instrument of claim 7 , wherein said distal section axis is at an angle of approximately 120 degrees relative to said intermediate section axis.

9. The goniotomy surgical instrument of claim 2 , wherein the base axis extends parallel to a hand grip axis and the intermediate section axis is at an angle of about 130 degrees to about 160 degrees relative to the base axis.

10. The goniotomy surgical instrument of claim 1 , wherein said cutting means faces said hand grip.

11. 3. The goniotomy surgical instrument of claim 2, wherein said distal portion of said tip includes an opposite facing blunt surface compared to said cutting means, said cutting means being disposed closer to said hand grip than said blunt surface.

12. The goniotomy surgical instrument of claim 1 , wherein said cutting means has an angled configuration defining a semicircular, arcuate cutting edge.

13. The goniotomy surgical instrument of claim 1 , wherein said cutting means is an elliptical flat beveled surface terminating in a distal arcuate cutting edge.

14. The goniotomy surgical instrument of claim 1 , wherein said cutting means is a conical surface terminating in a distal sharp cutting edge.

15. The goniotomy surgical instrument of claim 1 , wherein said cutting means has a tapered configuration defining a surface terminating in a blunt rounded distal edge.

16. The goniotomy surgical instrument of claim 1 , wherein said cutting means has a tapered configuration defining a concave surface terminating in a spatula-shaped distal edge.

17. The goniotomy surgical instrument of claim 1 , further comprising an internal passageway terminating in at least one irrigation port for generally directing a flow of irrigation fluid from the instrument.

18. 10. The goniotomy surgical instrument of claim 1, wherein the hand grip includes a reservoir for containing irrigation fluid stored therein, and means for selectively applying the irrigation fluid from the reservoir to a surgical site.

19. The goniotomy surgical instrument of claim 1 , wherein the hand grip includes a connection for receiving a flow of irrigation fluid received from an external irrigation fluid source.

20. 1. A method of using a goniotomy surgical instrument to treat the trabecular meshwork of the eye, the method comprising: Obtaining a goniotomy surgical instrument according to claim 1; grasping the hand grip on the cutting means to contact the trabecular meshwork of the eye just below Schwalbe's line; and cutting the leaflets of the trabecular meshwork.

21. 1. A goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ), a hand grip (44, 44A) having an elongated configuration and having a proximal end (46, 46A) and a distal end (48, 48A); and a tip (52, 52A, 52A', 52B, 52C, 52D, 52E, 52F, 52G, 52H, 52I, 52J, 52K, 52L, 52M, 52N, 52O, 52P, 52Q, 52R, 52S, 52T, 52U, 52V, 52W, 52X, 52Y, 52Z, 52AA, 52BB, 52CC, 52DD, 52EE, 52FF, 52GG, 52HH, 52II, 52JJ) connected to the distal end (48, 48A) of the hand grip (44, 44A); 52. A goniotomy surgical instrument, the tip (52, 52A, 52A', 52B, 52C, 52D, 52E, 52F, 52G, 52H, 52I, 52J, 52K, 52L, 52M, 52N, 52O, 52P, 52Q, 52R, 52S, 52T, 52U, 52V, 52W, 52X, 52Y, 52Z, 52AA, 52BB, 52CC, 52DD, 52EE, 52FF, 52GG, 52HH, 52II, 52JJ) having cutting means for forming trabecular leaflets at Schwalbe's lines in the eye.

22. The tip (52, 52A, 52A', 52B, 52C, 52D, 52E, 52F, 52G, 52H, 52I, 52J, 52K, 52L, 52M, 52N, 52O, 52P, 52Q, 52R, 52S, 52T, 52U, 52V, 52W, 52X, 52Y, 52Z, 52AA, 52BB, 52CC, 52DD, 52EE, 52FF, 52GG, 52HH, 52II, 52JJ) Extending from a distal end (48, 48A) of said hand grip portion (44, 44A) and extending along a proximal axis (56, 56A, 56B, 56C, 56D, 56E, 56F, 56G, 56H, 56I, 56J, 56K, 56L, 56M, 56N, 56Q, 56U, 56V, 56X, 56BB, 56FF) A base portion (54, 54A, 54B, 54C, 54D, 54E, 54F, 54G, 54H, 54I, 54J, 54K, 54L, 54M, 54N, 54O, 54P, 54Q, 54R, 54S, 54T, 54U, 54V, 54W, 54X, 54Y, 54Z, 54AA, 54BB, 54FF) From the base (54, 54A, 54B, 54C, 54D, 54E, 54F, 54G, 54H, 54I, 54J, 54K, 54L, 54M, 54N, 54O, 54P, 54Q, 54R, 54S, 54T, 54U, 54V, 54W, 54X, 54Y, 54Z, 54AA, 54BB, 54FF, 54GG, 54HH, 54II, 54JJ), Intermediate portions (60, 60A, 60A', 60B, 60C, 60D, 60E, 60F, 56G, 56H, 56I, 56J, 56K, 56L, 56M, 56N, 56Q, 56U, 56V, 56X, 56BB, 56FF, 56GG, 56HH, 56II, 56JJ) extending across the base axis (56, 56A, 56B, 56C, 56D, 56E, 56F, 56G, 56H, 56I, 56J, 56K, 56L, 56M, 56N, 56Q, 56U, 56V, 56X, 56BB, 56FF, 56GG, 56HH, 56II, 56JJ) 0F, 60G, 60H, 60I, 60J, 60K, 60L, 60M, 60N, 60O, 60P, 60Q, 60R, 60S, 60T, 60U, 60V, 60W, 60X, 60Y, 60Z, 60AA, 60BB, 60CC, 60DD, 60EE, 60GG, 60HH, 60II, 60JJ) intermediate portions (58, 58A, 58 A', 58B, 58C, 58D, 58E, 58F, 58G, 58H, 58I, 58J, 58K, 58L, 58M, 58N, 58O, 58P, 58Q, 58R, 58S, 58T, 58U, 58V, 58W, 58X, 58Y, 58Z, 58AA, 58BB, 58CC, 58DD, 58EE, 58GG, 58HH, 58II, 58JJ), From the intermediate portion (58, 58A, 58A', 58B, 58C, 58D, 58E, 58F, 58G, 58H, 58I, 58J, 58K, 58L, 58M, 58N, 58O, 58P, 58Q, 58R, 58S, 58T, 58U, 58V, 58W, 58X, 58Y, 58Z, 58AA, 58BB, 58CC, 58DD, 58EE, 58GG, 58HH, 58II, 58JJ), the intermediate portion shaft (60, 60A, 60A', 60B, 60C, 60D, 60E, 60F, 60G, 60H, 60I, 60J, 60K, 60L, 60M, 60N, 60O, 60P, 60Q , 60R, 60S, 60T, 60U, 60V, 60W, 60X, 60Y, 60Z, 60AA, 60BB, 60CC, 60DD, 60EE, 60GG, 60HH, 60II, 60JJ) across the end segment axis (66, 66A, 66A', 66B, 66C, 66D, 66E, 66F, 66G, 66H, 66I, 66J, 66K, 66L, 66M, 66N, 66O, 66P, 66Q, 66R, 66S, 66T, 66U, 66V, 66W, 66X, 66Y, 66Z, 66AA, 66BB, 66DD, 66EE, 66FF, 66GG, 66HH, 66II, 66JJ). a terminal portion (64, 64A, 64A', 64B, 64C, 64D, 64E, 64F, 64G, 64H, 64I, 64J, 64K, 64L, 64M, 64N, 64O, 64P, 64Q, 64R, 64S, 64T, 64U, 64V, 64W, 64X, 64Y, 64Z, 64AA, 64BB, 64CC, 64DD, 64EE, 64FF, 64GG, 64HH, 64II, 64JJ) extending along 22. The goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 64AA, 64BB, 64CC, 64DD, 64EE, 64FF, 64GG, 64HH, 64II, 64JJ) of claim 21 further comprising a distal end portion comprising said cutting means.40AA、40BB、40CC、40DD、40EE、40FF、40GG、40HH、40II、40JJ)。、

23. 23. The goniotomy surgical instrument (40, 40A, 40A', 40GG, 40HH, 40II, 40JJ) of claim 21 or 22, wherein the cutting means is a pair of beveled arcuate cutting surfaces (70, 70A, 70A', 70GG, 70HH, 70II, 70JJ) joining to define arcuate cutting edges (74, 74A, 74A', 74GG, 74HH, 74II, 74JJ).

24. 24. The goniotomy surgical instrument of claim 23, wherein said arcuate cutting edge (74, 74A, 74A', 74GG, 74HH, 74II, 74JJ) defines an edge axis (80, 80A) that is angled from about 30 degrees to about 60 degrees with respect to a plane (68, 68A) that contains said terminal portion axis (66, 66A, 66A', 66GG, 66HH, 66II, 66JJ) and said intermediate portion axis (60, 60A, 60A', 60GG, 60HH, 60II, 60JJ).

25. 25. The goniotomy surgical instrument (40, 40A, 40A', 40GG, 40HH, 40II, 40JJ) of claim 24, wherein the edge axis (80, 80A) is at an angle of approximately 40 degrees with respect to the plane (68, 68A) containing the end portion axis (66, 66A, 66A', 66GG, 66HH, 66II, 66JJ) and the intermediate portion axis (60, 60A, 60A').

26. The goniotomy surgical instrument (40, 40A, 40A', 40GG, 40HH, 40II, 40JJ) according to any one of claims 21 to 25, wherein the distal portion (64, 64A, 64A', 64GG, 64HH, 64II, 64JJ) of the tip (52, 52A, 52A', 52GG, 52HH, 52II, 52JJ) comprises a blunt surface (78, 78A, 78A', 78GG, 78HH, 78II, 78JJ) facing away compared to the cutting means.

27. 23. The goniotomy surgical instrument of claim 22, wherein said end portion axis (66, 66A, 66A') is at an angle of about 90 degrees to about 140 degrees relative to said intermediate portion axis (60, 60A, 60A').

28. 28. The goniotomy surgical instrument (40, 40A, 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF) of claim 27, wherein said end portion axis (66, 66A, 66A') is at an angle of approximately 120 degrees relative to said intermediate portion axis (60, 60A, 60A').

29. 23. The goniotomy surgical instrument of claim 22, wherein said base axis (56, 56A) extends parallel to a hand grip axis (50, 50A) and said intermediate section axis (60, 60A, 60A') is at an angle of about 130 to about 160 degrees relative to said base axis (56, 56A).

30. The goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF) of any one of claims 21 to 29, wherein the cutting means faces the hand grip (44, 44A).

31. 31. The goniotomy surgical instrument (40, 40A, 40A', 40GG, 40HH, 40II, 40JJ) of any one of claims 21 to 30, wherein the distal portion (64, 64A, 64A', 64GG, 64HH, 64II, 64JJ) of the tip (52, 52A, 52A', 52GG, 52HH, 52II, 52JJ) includes a blunt surface (78, 78A, 78A', 78GG, 78HH, 78II, 78JJ) facing the cutting means, the cutting means being positioned closer to the hand grip (44, 44A) than the blunt surface (78, 78A, 78A', 78GG, 78HH, 78II, 78JJ).

32. The goniotomy surgical instrument (40, 40A, 40A', 40GG, 40HH, 40II, 40JJ) according to any one of claims 21 to 31, wherein said cutting means has an angled configuration defining a semi-circular arcuate cutting edge (74, 74A, 74A', 74GG, 74HH, 74II, 74JJ).

33. The goniotomy surgical instrument (40B, 40C, 40H, 40I, 40J, 40K) according to any one of claims 21 to 32, wherein the cutting means is an elliptical flat beveled surface (70B, 70C, 70H, 70I, 70J, 70K) terminating in a distal arcuate cutting edge (74B, 74C, 74H, 74I, 74J, 74K).

34. The goniotomy surgical instrument (40L, 40M) according to any one of claims 21 to 33, wherein said cutting means is a conical surface (70L, 70M) terminating in a distal sharp cutting edge (74L, 74M).

35. The goniotomy surgical instrument (40L, 40M) according to any one of claims 21 to 34, wherein said cutting means has a tapered configuration defining faces (70D, 70E, 71D, 71E) terminating in blunt, rounded distal edges (74D, 74E).

36. The goniotomy surgical instrument (40F, 40G) according to any one of claims 21 to 35, wherein said cutting means has a tapered configuration defining a concave surface (70F, 70G) terminating in a spatula-shaped distal edge (74F, 74G).

37. terminating in at least one irrigation port (75N, 75O, 75P, 75Q, 75R, 75S, 75T, 75U, 75V, 75W, 75X, 75Y, 75Z, 75AA, 75BB, 75CC, 75DD, 75EE, 75FF, 75GG, 75HH, 75II, 75JJ) and receiving irrigation fluid from said instrument (40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ); 37. The goniotomy surgical instrument (40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ) of any one of claims 21 to 36, further comprising an internal passageway (76N, 76O, 76P, 76Q, 76R, 76S, 76T, 76U, 76V, 76W, 76X, 76Y, 76Z, 76AA, 76BB, 76CC, 76DD, 76EE, 76FF) generally directing the flow of

38. 38. The goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ) of any one of claims 21 to 37, wherein the hand grip (44, 44A) includes a reservoir for containing irrigation fluid stored therein and means for selectively applying the irrigation fluid from the reservoir to a surgical site.

39. The goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ) of any one of claims 21 to 38, wherein the hand grip (44, 44A) includes a connection for receiving a flow of irrigation fluid received from an external irrigation fluid source.

40. 1. A method of using a goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ) to treat the trabecular meshwork of an eye, comprising: - obtaining a goniotomy surgical instrument (40, 40A, 40A', 40B, 40C, 40D, 40E, 40F, 40G, 40H, 40I, 40J, 40K, 40L, 40M, 40N, 40O, 40P, 40Q, 40R, 40S, 40T, 40U, 40V, 40W, 40X, 40Y, 40Z, 40AA, 40BB, 40CC, 40DD, 40EE, 40FF, 40GG, 40HH, 40II, 40JJ) according to any one of claims 21 to 39; gripping said hand grip (44, 44A) on said cutting means to contact said trabecular meshwork of the eye just below Schwalbe's line; and cutting the leaflets of the trabecular meshwork.

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