WO2023139523A1 - Surgical systems and methods for treatment of glaucoma - Google Patents

Abstract

A penetration and flow device, comprising: a catheter with a port opening in a direction radial to a longitudinal axis of the catheter, a head coupled to an end of the microcatheter, a first baffle on the microcatheter, the first baffle located between the head and the port and extending radially, and a second baffle on the microcatheter, the first baffle located on the microcatheter opposite the first baffle, such that the port is between the first and second baffles, the second baffle extending radially.

Description

SURGICAL SYSTEMS AND METHODS FOR TREATMENT OF GLAUCOMA

FIELD OF THE INVENTION

The invention relates generally to systems, devices and methods for treatment of glaucoma. More specifically, the invention relates to surgical systems, devices and methods for improving intraocular pressure in the eye of a patient.

BACKGROUND

Glaucoma is a disease that affects over 60 million people worldwide, or about 1-2% of the population. The disease is typically characterized by an elevation in eye pressure (intraocular pressure) that causes pathological changes in the optic nerve which if left untreated can cause blindness. The increased intraocular pressure is generally caused by a resistance to drainage of aqueous humor or fluid from the eye.

Aqueous humor is a clear, colorless fluid that is continuously replenished by the ciliary body in the eye and then ultimately exits the eye through the trabecular meshwork. The trabecular meshwork extends circumferentially around the eye in the anterior chamber angle and feeds outwardly into a narrow circumferential passageway generally surrounding the exterior border of the trabecular meshwork (Schlemm’s canal). From Schlemm’s canal, aqueous humor empties into aqueous collector channels or veins positioned around and radially extending from Schlemm’s canal. Pressure within the eye is determined by a balance between the production of aqueous humor and its exit through the trabecular meshwork. Resistance to flow in the trabecular meshwork and/or Schlemm’s canal can cause decreased flow of aqueous humor out of the eye and increased intraocular pressure.

Treatments that reduce intraocular pressure can slow or stop progressive loss of vision associated with some forms of glaucoma and such treatments are currently the primary therapy for glaucoma. A number of treatment methods are currently used for reducing intraocular pressure to treat glaucoma including medication, laser therapies and various forms of surgery. Drug therapy includes topical ophthalmic drops or oral medications that either reduce the production or increase the outflow of aqueous humor. When medical and laser therapy fail, however, more invasive surgical therapy is typically used.

Surgical techniques for treating glaucoma generally involve improving aqueous humor outflow. Trabeculectomy, a procedure which is widely practiced, involves microsurgical dissection to mechanically create a new drainage pathway for aqueous humor to drain, by removing a portion of sclera and trabecular meshwork at the drainage angle. Trabeculectomy, however, carries risk of blockage of the surgically-created opening through scarring or other mechanisms and has been found to have limited long-term success. Furthermore, trabeculecomy surgery is associated with serious, potentially blinding complications.

Alternative surgical procedures to trabeculectomy include tube shunt surgeries, nonpenetrating trabeculectomy and viscocanalostomy. These procedures are invasive as they are “ab externo” (from the outside of the eye). Tube shunt surgeries involve significant extraocular and intraocular surgery with significant risk of surgical complications, as well as the long-term risk of failure from scarring. In the case of viscocanalostomy and nonpenetrating trabeculectomy, the procedures involve making a deep incision into the sclera and creating a scleral flap to expose Schlemm’s canal for cannulation and dilation. Due to the delicate nature of these ab-externo approaches, they are difficult to execute. Due to the invasiveness of such procedures and the difficulty of successfully accessing the small diameter of Schlemm’ s canal from the outside of the eye, “ab interno” techniques have been described for delivering ocular devices and compositions into Schlemm’s canal through the trabecular mesh work from the inside of the eye.

In glaucoma, trabecular meshwork (TM) resistance creates increased intraocular pressure. Newer glaucoma surgeries, call Microlnvasive Glaucoma Surgeries (MIGS) attempt to lower intraocular pressure (IOP) in a safer manner.

Current Microlnvasive Glaucoma Surgery (MIGS) techniques generally bypass the trabecular meshwork to reduce IOP.

SUMMARY

Embodiments of the invention include devices, systems and methods for treating glaucoma.

An embodiment of the disclosure includes a penetration and flow device, comprising: a catheter with a port opening in a direction radial to a longitudinal axis of the catheter, a head coupled to an end of the microcatheter, a first baffle on the microcatheter, the first baffle located between the head and the port and extending radially, and a second baffle on the microcatheter, the first baffle located on the microcatheter opposite the first baffle, such that the port is between the first and second baffles, the second baffle extending radially.

Another embodiment of the disclosure includes trabecular excision device for excising tissue of the trabecular meshwork of an eye of a patient, comprising: a longitudinally-extending body portion having a first end and a second end for insertion into the eye, and removing portion at the second end of the longitudinally-extending portion, the removing portion including barbs or other structure for contacting the tissue.

Another embodiment of the disclosure includes an implantable porous filament for implantation into a Schlemm’s canal of an eye of a patient, comprising: a flexible, filamentshaped body portion comprising a porous material defining multiple pores, each of the multiple pores sized to flow fluid through the body portion and to prevent flow of red blood cells through the body portion; a first end; and a second end opposite the first end.

Another embodiment of the disclosure includes an implantable filament for implantation into a Schlemm’s canal of an eye of a patient, comprising: a flexible, filamentshaped body portion comprising a substantially non-porous material and defining a plurality of longitudinal grooves extending along a length of the body portion; a first end; and a second end opposite the first end; wherein the body portion in cross-section forms an asymmetrical shape.

Another embodiment of the disclosure includes a device for treating glaucoma in an eye of a patient, comprising: a catheter configured to flow a fluid; a curved portion attached to an end of the catheter and configured to receive and direct the flow of fluid from the catheter into and around the Schlemm’s canal of the eye of a patient.

Another embodiment of the disclosure includes a fluid injection device for treating glaucoma in an eye of a patient, comprising: a hollow fluid-delivery tube including a first end and a second end; a curved distribution manifold connected to the second end of the fluiddelivery tube and configured to receive fluid from the fluid-delivery tube, the distribution manifold including a body portion having a first end with a first edge, a second end with a second edge, a top edge, a bottom edge and defining a channel for receiving and distributing the fluid from the fluid-delivery tube; wherein the body portion defines a circumferentially- extending gap between the top edge and the bottom edge for release of the fluid from the curved distribution manifold.

Another embodiment of the disclosure includes a method of treating glaucoma in an eye of a patient, comprising the steps of: making a paracentesis incision in the eye to access an anterior chamber of the eye; inserting a penetration and flow device having a hollow body portion defining a radially-opening port and having a lancer head, into a Schlemm’s canal of the eye from the anterior chamber; advancing the lancer head of the penetration and flow device along the Schlemm’s canal while injecting fluid through the port in the device into the Schlemm’s canal and collector channels of the Schlemm’s canal; cannulating the penetration and flow device 360° through the Schlemm’s canal; and retracting the penetration and flow device.

Another embodiment of the disclosure includes A method of treating glaucoma in an eye of a patient, comprising the steps of: excising a portion of a trabecular mesh network forming a Schlemm’s canal of the eye; inserting an injection device that includes a curved, open-channel manifold with a top edge and a bottom edge, the manifold connected to a fluiddelivery tube, into an anterior chamber of the eye; locating the top edge and bottom edge of the manifold in an area of the eye from which the trabecular mesh network portion was removed, such that the top edge and the bottom edge are pressed against a remaining portion of the Schlemm’s canal; causing pressurized fluid to flow through the fluid-delivery tube to the manifold and into the Schlemm’s canal and a plurality of collector channels corresponding to the Schlemm’s canal, thereby reducing resistance to drainage of fluid out of the anterior chamber.

BRIEF DESCRIPTION OF THE FIGURES

The drawings included in the present patent application are incorporated into, and form part of, the specification. They illustrate embodiments of the present disclosure and, along with the description, serve to explain the principles of the disclosure. The drawings are only illustrative of certain embodiments and do not limit the disclosure.

FIG. 1 is a MIGS system, according to an embodiment of the disclosure.

FIG. 2 is a representation of an embodiment of a Lancer Microcatheter surgical device of the disclosure.

FIG. 3 is a stylized front view of an implantable porous filter (IPF), according to an embodiment of the disclosure.

FIG. 4 is a cross-sectional view of the IPF of FIG. 3.

FIG. 5 is a cross-sectional view of the IPF of FIG. 3, according to another embodiment that includes grooves.

FIG. 6 is a stylized perspective view of a trabecular excision device (TED), according to an embodiment of the disclosure.

FIG. 7A is a perspective view of a retractable OVD injection device, according to an embodiment of the disclosure.

FIG. 7B is a top view of the OVD injection device of FIG. 7A without a carrier tube.

FIG. 7C is a bottom view of the OVD injection device of FIG. 7B without a carrier tube. FIG. 7D is a perspective view of the OVD injection device of FIG. 7B without a carrier tube.

FIG. 7E is another perspective view of the OVD injection device of FIG. 7B without a carrier tube.

FIG. 7F is a sectional view of a manifold of the OVD injection device of FIG. 7B, according to an embodiment.

FIG. 7G is a sectional view of a manifold of the OVD injection device of FIG. 7B with chamfered edges, according to another embodiment.

FIG. 7H is a perspective view of an end portion of a manifold with an end cap, according to an embodiment.

FIG. 71 is a perspective view of a portion of the OVD injection device of FIG. 7A in a retracted position.

FIG. 7J is a perspective view of a portion of the OVD injection device of FIG. 7A in a retracted position with the carrier tube removed.

FIG. 7K is a top view of a non-retractable OVD injection device, according to an embodiment.

FIG. 8 is a side view of a carrier tube of an OVD injection device, according to an embodiment of the disclosure.

FIG. 9 is a perspective view of an OVD injection device, according to another embodiment of the disclosure.

FIG. 10 is a side, cross-sectional view of an eye of a patient after removal of a portion of the trabecular meshwork and insertion of an IPF into Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 11 is a stylized front view of a portion of an eye of a patient after removal of a portion of the trabecular meshwork and insertion of an IPF with a connected TED into Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 12 is a stylized front view of a portion of an eye of a patient after removal of a portion of the trabecular mesh work and insertion of an IPF into Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 13 is a stylized front view of a portion of an eye of a patient after removal of a portion of the trabecular meshwork and insertion of a two-piece IPF, according to an embodiment of the disclosure. FIG. 14 is a stylized front view of an IPF in Schlemm’s canal of an eye, adjacent to a collector channels, and illustrating flow of aqueous through the IPF toward the collector channels, according to an embodiment of the disclosure.

FIG. 15 is a close-up view of a portion of FIG. 14 which includes a collector channel and adjacent IPF.

FIG. 16 is a stylized cross-sectional view of an embodiment of the IPF of FIG. 5 within Schlemm’s canal.

FIG. 17 is a stylized perspective view of an eye with an OVD injection device in place.

FIG. 18 is a stylized depiction of a portion of an OVD injection device inserted into Schlemm’s canal, with a curved manifold in contact with an outer wall of Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 19 is another stylized depiction of a portion of an OVD injection device inserted into Schlemm’s canal, with a curved portion in contact with an outer wall of Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 20 is stylized depiction of a portion of another embodiment of an OVD injection device having angled ends inserted into Schlemm’s canal, with a curved portion in contact with an outer wall of Schlemm’s canal, according to an embodiment of the disclosure.

FIG. 21 is a stylized depiction of a cross section of an eye with an OVD injection device positioned at Schlemm’s canal.

DETAILED DESCRIPTION

Unlike the present invention, known MIGS techniques and devices present a number of drawbacks. For example, known techniques and devices may bypass the resistance at the trabecular mesh work but only provide support for Schlemm’s canal for a small section — which in some cases is only approximately 1mm or 3-4 clock hours.

Viscocanaloplasty only offers temporary support to prevent the collapse of Schlemm’s canal. Once the ophthalmic viscosurgical device (OVD), which may be a viscoelastic agent or viscoelastic solution or fluid, leaves the eye, Schlemm’s canal may collapse

Some devices only incise the trabecular meshwork. This leaves behind two leaflets of TM that can potentially fibrose, rejoin and result in surgical failure.

In contrast, Microlnvasive Glaucoma Surgery (MIGS) systems, devices and methods of the disclosure can viscodilate the full 360 degrees of Schlemm’s canal and post-trabecular outflow system, excise 90-180 degrees of the trabecular mesh work with tissue sample analysis, viscodilate sections of the outflow system to supra-physiologic levels, and in embodiments, can leave a ring implant/depot for therapeutics that restores 360 degree full circumferential flow in Schlemm’s canal.

Referring to FIG. 1, in an embodiment, MIGS system 100 comprises Schlemm’s canal viscodilating Lancer Microcatheter with lancer tip (“Lancer Microcather”) 102, implantable porous filament (“IPF”) 104, trabecular excision device (TED) 106, and optional OVD injection device (“Glaucoma Ray Gun”) 108. As used herein, “OVD” (ophthalmic viscosurgical device) will be understood to be a viscoelastic agent, such as a solution or gel. MIGS system 100 may include all components 102, 104, 106, and 108 as depicted, or may include a combination of the various components that includes less than all four components.

Generally, and as will be described in detail further below, Lancer Microcatheter 102 offers improved OVD injection directly toward collector channels and the post-trabecular outflow system. IPF 104 is implantable into Schlemm’s canal for all or nearly all of the 360 degree circumference of the canal, and provides circumferential flow of aqueous around Schlemm’s canal. IPF 104 may also serve as a depot for slow-release therapeutics. Trabecular excision device (TED) 106 is configured to excise portions of the trabecular meshwork (TM), which may be a 90 to 180 degree excision, or less, leaving minimal leaflets behind. TED 106 also provides a topographically organized tissue sample for post-surgical histological / molecular analysis. Glaucoma Ray Gun 108 comprises a specialized OVD injector that forms a tight seal around the Schlemm’s canal and allows the injection of OVD into the collector channels at supraphysiologic pressures.

Referring specifically to FIG. 2, an embodiment of Lancer Microcatheter 102 is depicted adjacent to a portion of Schlemm’s canal 110. Schlemm’s canal is connected to, and in fluid communication with multiple collector channels 112, each with an opening 114 in a sidewall 115 with inside surface 117, of an eye 119 (see also FIG. 3). For the sake of illustration, only a portion of outer sidewall 115 of Schlemm’s canal 110 is depicted, and Lancer Microcatheter 102 is depicted as displaced from sidewall 115, though as described further below, microcatheter 102 in use would abut inside surface 117 and fit snugly within Schlemm’s canal 110.

In the depicted embodiment, Lancer Microcatheter 102 includes first end 116, second end 118, hollow catheter shaft 120, tip portion 122 and multiple baffles 124. Lancer Microcatheter 102 and its hollow catheter shaft 120 also defines at least one port 126.

First end 116 is an insertion end having tip portion 122 attached. Second end 118 may define opening 128, configured to couple to an OVD supply source and/or receive a flow of OVD 123 into hollow catheter shaft 120. Hollow catheter shaft 120 extends longitudinally and includes body portion 130 that defines channel 132, and exterior surface 133. Channel 132 extends from opening 128 at second end 118 along body portion 130 toward second end 116, extending to at least port 126, and in some embodiments, all the way to, and terminating at second end 116 and tip portion 122. As such, body portion 130 with its channel 132 is configured to receive a flow of OVD

123 from end 118 to port 126. Port 126 is defined in body portion 130 at body sidewall 131.

Tip portion 122 includes body portion 134 with first end 136 and second end 138. Body portion 134 may be tapered such that body portion 134 is wider at first end 136 and narrower at second end 138. In an embodiment, body portion 134 may be somewhat conical in shape.

In an embodiment, body portion 134 may comprise a polymeric material such as silicone or polypropylene. In an embodiment, body portion 134 may not define any internal cavities or channels, i.e., may be a solid piece, so as to be relatively stiff and inflexible. In other embodiments, body portion 134 may define some cavities, such as near first end 136, so as to give first end 136, the wide end, some flexibility.

First end 136 is configured to couple to hollow catheter shaft 120 at second end 116.

Second end 138 may be somewhat rounded, so as to be blunt, rather than pointed and sharp, so as to facilitate cannulation and advancement through Schlemm’s canal 110.

Lancer Microcatheter 102 may also include one or more baffles 124. In the embodiment depicted, Lancer Microcatheter 102 includes four baffles 124, namely, baffle 124a, 124b, 124c and 124d. In the depicted embodiment, two baffles are on each side of port 126, i.e., baffles 124c and 124d are on body portion 130 of hollow catheter shaft 120 near second side 140 of portion 126, and proximal to second end 116 of Lancer Microcatheter 102, and baffles 124a and 124b are on body portion 130 of hollow catheter shaft 120 second side 142 of portion 126, and distal to second end 116.

Each baffle 124 includes outer surface 144, first side 146 and second side 148. Outer surface 144 may include multiple longitudinally-extending grooves 150. In an embodiment, first and second sides 146 and 148 are flat. Each baffle 124 extends circumferentially around body portion 130 of hollow catheter shaft 120, extending radially from surface 133. In the depicted embodiment, baffles 124 are formed as a circular disc, with a central opening or hole filled by body portion 130. In other embodiments, each baffle 124 may form a toroid, rather than having flat sides.

Although four baffles 124 are depicted, Lancer Microcatheter 102 may include more or fewer baffles 124. In an embodiment, Lancer Microcatheter 102 may include only one baffle

124 on each side of port 126; in another embodiment, Lancer Microcatheter 102 may include three or more baffles 124 on each side of port 126. As will be explained further below, baffles 124 fit snugly within Schlemm’s canal, abutting, and effectively forming a seal with inside surface 117, so that OVD 123 flows out of port 140 and is directed into collector channel 112.

Referring to FIGS. 3-5, embodiments of IPF 104 are depicted. FIG. 3 is a front view of IPF 104, placed or formed into a circular or arcuate shape. FIG. 4 is a cross-sectional view of an embodiment of IPF 104, and FIG. 5 is a cross-sectional view of another embodiment of IPF 104. As described further below, IPR 104 is configured to be implanted into Schlemm’s canal, which is a part of the trabecular meshwork of the eye.

Referring specifically to FIGS. 3 and 4, IPF 104 includes body portion 150, outer surface 152, first end 154 and second end 156. IPF 104 may be comprised of a porous material defining multiple cavities or pores 158. Pores 158 may be sized to allow for the flow of aqueous and for relatively small diameter molecules, but not large enough for larger objects such as red blood cells. In an embodiment, IPF 104 comprises a hydrogel that allows the flow of aqueous through IPF 104 and also provides structural support to prevent the collapse of Schlemm’s canal. An advantage of the hydrogel material is that it may be biomechanically more compatible than other rigid materials such as nitinol and titanium, and may be better tolerated in the eye.

In this embodiment, in cross section, IPF 104 is circular, though as described with respect to FIG. 5, IPF 104 may define other shapes in cross section.

IPF 104 is generally flexible and relatively long and thin, so as to facilitate cannulation into Schlemm’s canal. As depicted, IPF 104 may comprise a single structure, i.e., a one-piece or one-portion structure, though in other embodiments, IPF 104 may comprise multiple, similar structures, such as two portions, as is depicted and described further below with respect to FIG. 13. A multi-portion IPF 104 may be easier to insert into Schlemm’s canal, as compared to one relatively long portion, as also described further below.

Referring specifically to FIG. 5, in another embodiment, IPF 104 in cross section defines multiple channels or grooves 160 to transport aqueous along the outer surface 152 of IPF 104. In this embodiment, IPF body portion 150 is asymmetrical in cross section, and includes first, relatively wide portion 162, as well as a plurality of relatively narrow portions 164, including portions 164a, 164b, 164c, 164d and 164e. Although the plurality of narrow portions 164 is depicted as five portions 164, in other embodiments, the number of narrow portions 164 may be more than five so as to increase IPF 104 surface area, or less than five, so as to decrease IPF 104 surface area. In this embodiment, as depicted, IPF 104 may not be porous, such that aqueous flows in grooves 160 and along outer surface 150. In other embodiments, IPF 104 may be porous, such that aqueous may flow within IPF 104 and also along outer surface 152 in grooves 160.

IPF 104, and in particular, a porous version of IPF 104, may be impregnated with slow- release therapeutics, serving as a large reservoir of medication that could potentially last years.

Referring to FIG. 6, an embodiment of trabecular excision device (TED) 106 is depicted. In this embodiment, TED 106 includes first end 170, second end 172, and body portion 173 between first end 170 and second end 172. In an embodiment, TED 106 comprises a relatively long filament- like structure. As described further below, TED 106 is partially cannulated into Schlemm’s canal, and is used to remove portions of the trabecular mesh work (TM).

First end 170 may comprise a grasping end, or an end for connection to another device for manipulating and controlling TED 106. In an embodiment, and as also described further below, fist end 170 may be connected to an end of IPF 104.

Second end 172 is configured to be inserted into the eye, and includes tip portion 174, top side 176 with top surface 178, first cutting edge 180 with barbs 182, and second cutting edge 184 with barbs 186. Tip portion 174, in an embodiment, may comprise a blunt or rounded end that facilitates insertion and movement through Schlemm’s canal. Top side 176 with top surface 178 extends longitudinally and in an embodiment may be planar as depicted. Top surface 178 may be textured as also depicted, so as to create a roughness that may be useful for gripping or pulling on portions of the TM.

First cutting edge 180 extends longitudinally away from tip portion 174 and includes a plurality of barbs or micro-hooks 182; second cutting edge 184 extends longitudinally away from tip portion 174 and includes a plurality of barbs or micro-hooks 186. In an embodiment, barbs 182 are substantially the same as barbs 186. First cutting edge 180 is opposite second cutting edge 184. In an embodiment, and as depicted, barbs 182 are distributed linearly along cutting edge 180, and equidistantly spaced apart. In an alternate embodiment, there are no spaces or gaps between barbs 182. Similarly, second cutting edge 184 is opposite first cutting edge 180. In an embodiment, and as depicted, barbs 186 are distributed linearly along cutting edge 184, and equidistantly spaced apart. In an alternate embodiment, there are no spaces or gaps between barbs 186.

Barbs 182 and 186 may each comprise a hook shape, and be relatively small, so as to be “micro-hooks.” Barbs 182 and 186 generally extend upward and away from their respective cutting edges 180 and 184, as well as top surface 178. In an embodiment, each barb 182 includes first edge 190, which may be curved in a direction from tip portion 184 toward first end 170, second edge 192, which may be straight, or curved in a direction similar to first edge 190, and tip 194. As will be described further below, barbs 182 and 186 are configured to contact the TM, hooking onto portions of the TM, such that portions of the TM can be removed by pulling on TED 106. The curvature of barbs 182, 186 allows for pushing TED 106 in a first- to-second end direction through Schlemm’s canal, while pulling back in the opposite direction will cause barbs 182, 186 to engage and penetrate tissue of the TM and Schlemm’s canal.

Referring to FIGS. 7A to 7F, a first, retractable embodiment of Glaucoma Ray Gun 108 (also referred to as an “injection device” or “OVD injection device”) is depicted in a first, protracted position. As described further below, Glaucoma Ray Gun 108 may be used instead of Lancer Microcatheter 102 for viscodilation of the TM outflow system, including collector channels, or may be used in conjunction with Lancer Microcatheter 102.

Referring specifically to FIGS. 7A to 7E, in an embodiment, Glaucoma Ray Gun 108 includes carrier tube 196, cannula or fluid-delivery tube 198 and curved sealing-and-OVD- distribution manifold or portion 200 (“curved portion” or “distribution manifold” or just “manifold” 200). As also described further below, Glaucoma Ray Gun 108 is used to create a seal with Schlemm’s canal and deliver pressurized OVD/fluid 123 to viscodilate the collector channels (also see FIGS. 17-21).

In an embodiment, carrier tube 196 includes body portion 202 defining channel 204, first end 206 and second end 208. In an embodiment, channel 204 extends from first end 206 to second end 208, and is configured to receive cannula 198. In an embodiment, carrier tube 196 may be a cannula made from hypodermic tubing (17 SX) that would fit a 2.2mm incision and that is configured to be used to receive and deploy cannula of fluid delivery tube 198.

Cannula 198 is a hollow tube, which in an embodiment is comprised of a nitinol material, configured to receive and flow OVD or fluid 123, and extends transversely from manifold 200 to at least end 206 of body portion 204. In other relatively rigid embodiments, cannula 198 may comprise other materials, such as stainless steel or a rigid polymer. Cannula 198 defines channel 210 with an opening 212 adjacent to manifold 200. In an embodiment, cannula 198 has an outside diameter than is approximately the same as, or smaller than, an inside diameter of body portion 202 (diameter of channel 204), so that cannula 198 may be slidably moved within channel 204 of carrier tube 196 (if used), including in a lengthwise direction, or rotational direction.

In an embodiment, cannula 198 has an outside diameter (OD) in the range of 0.4mm to 0.8 mm; in another embodiment, the OD is in the range of 0.5mm to 0.7mm; in another embodiment, the OD is approximately 0.6mm. In an embodiment, cannula 198 has an outside diameter (OD) in the range of 0.4mm to 0.8 mm; in another embodiment, the OD is in the range of 0.5mm to 0.7mm; in another embodiment, the OD is approximately 0.6mm. Outside diameters in these ranges not only facilitate insertion into the eye, but also are close in size to Schlemm’s canal, thereby facilitating sufficient sealing for pressurizing the canal.

In an embodiment, an inside diameter (ID) of cannula 198 is in a range of 0.4mm to 0.6mm. In an embodiment, the ID is approximately 0.5mm.

In an embodiment, a length of cannula 198 is in a range of 30mm to 50mm; in one such embodiment, a length of cannula 198 is in a range of 35mm to 45mm; in an embodiment, a length of cannula 198 is approximately 39mm.

Central axis C extends along the length of cannula 198.

In an embodiment, and as depicted, manifold 200 includes body portion 214, first end 216, second end 218. Body potion 214 includes inside surface 220, first lengthwise edge 222, second lengthwise edge 224, first end edge 226, second end edge 228, top edge 229 and bottom edge 231. Body portion 214 defines opening 230, which in an embodiment, is aligned with opening 212 of cannula 198. Body portion 214 with inside surface 220 defines groove or channel 232 extending lengthwise from first end edge 226 to second end edge 228, and widthwise from first lengthwise edge 222 to second lengthwise edge 224.

Manifold 200 and its body portion 214 defines or forms an arcuate shape along its length from first end 216 to second end 218 to create a firm seal with Schlemm’s canal and to direct OVD / fluid 123 to viscodilate Schlemm’s canal and in particular, collector channels 112. In an embodiment, a radius of curvature of manifold 200 is defined to match a radius of curvature of Schlemm’s canal. In an embodiment, a radius of curvature is in a range of 6mm to 10mm; in another embodiment, a radius of curvature is approximately 8mm. In an embodiment, an arc length of manifold 200 is in a range of 8mm to 12mm; in an embodiment, an arc length of manifold 200 is approximately 9mm.

Referring also to FIGS. 7F and 7G, in an embodiment, curved portion 200 in cross section at end edges 226 and 228, is also arcuate, and in an embodiment, and as depicted, forms a “C” shape or “U” shape, though other shapes in cross section are contemplated. In an embodiment, surface 220 and each edge 226 and 228 forms a semi-circle, though in other embodiments surface 220 and edges 226, 228 may extend more than or less than 180 degrees when viewed in cross section. Channel 232 is an “open” channel in the sense that body portion 214 includes an outer circumferentially-extending gap between top edge 229 and bottom edge 231 for allowing flow of the fluid received from fluid-deliver tube or cannula 198. Referring specifically to FIG. 7G, in an embodiment, top edge 229 and bottom edge 231 may be chamfered, rather than forming square edges as depicted in FIG. 7H. Chamfered edges can facilitate better sealing with Schlemm’s canal, and in some cases, easier insertion into the eye.

Referring to both FIGS. 7E, 7F and 7G, manifold-edge axis ME extends between top edge 229 and bottom edge 231. Central axis C of cannula 198 forms an angle a with manifoldedge axis ME, such that manifold 200 is canted or slightly rotated with respect to cannula 198. In an embodiment, angle a may be in a range of 20° to 40°; in an embodiment, angle a may be in a range of 25° to 35°; in one such embodiment, angle a is approximately 30°. As will become more evident based on FIG. 21 as described below, having an angle a that is greater than zero will facilitate good sealing with Schlemm’s canal and cause a cannula end opposite manifold 200 to be directed posteriorly toward an outer surface of the eye.

Eye axis E lies in a plane of the eye that is generally parallel to a plane at the pupil, as depicted and described further below with respect to FIG. 21. In an embodiment, and as depicted and described further below, when positioned in the eye, axis ME forms an angle P with eye axis E.

Referring to FIG. 7H, a portion of end 218 of manifold 200 is depicted having optional end cap 233. Although not depicted, opposite end 216 may also include an end cap 233. When present, end caps 233 may help with sealing against Schlemm’s canal, improving canal pressure.

Referring to FIGS. 7A, 71 and 7J, and as described above, in an embodiment, OVD injection device 108 is a retractable device, and manifold 200 may comprise a flexible material, that will retain its curved shape, but also be pliable enough to be deformed and withdrawn into channel 204 of carrier tube 196, such that manifold 200 may be deployed during surgery, as described further below. Manifold 200 is securely coupled to cannula 198 so that movement of cannula 198 translates to movement of manifold 200.

Referring specifically to FIG. 7A, injection device 108 is depicted in an extended or non-retracted configuration. In this non-retracted configuration, manifold 200 is entirely outside of carrier tube 196, as is a portion of cannula 198. This extended configuration is a use configuration, wherein manifold 200 is out of carrier tube 196 and fully extended or unfolded and ready for contact with Schlemm’s canal.

In contrast, and referring to FIGS. 71 and 7J, manifold 200 is in a folded configuration, and partially (as depicted) or fully inserted into channel 204 of carrier tube 196. FIG. 71 depicts manifold 200 in a folded configuration and partially inserted into channel 204; FIG. 7J depicts manifolde 200 in a folded configuration, without depicted carrier tube 196, for the sake of illustration.

Manifold 200 is bent about a folding or bending point, which may be a center point, such that first half 335 and second half 337 of manifold 200 extend substantially parallel to one another. First end 216 and second end 218 are adjacent to, and in some embodiments, may be in contact with one another. First portion 231 a of bottom edge 231 is adj acent to second portion 231b of bottom edge 231, and in some embodiments, may be in contact with one another.

When cannula 198 is pushed through carrier tube 196, resilient manifold 200 is pushed out of, or released from, carrier tube 196. Upon release, manifold 200, which is made from a resilient material, retakes its unfolded shape, which is depicted in FIG. 7A.

Referring to FIG. 7k, in an alternate embodiment, OVD injection device 108 is not retractable, but rather, retains a relatively fixed shape. In such an embodiment, injection device 108 does not include carrier tube 196, and manifold 200 comprises a relatively rigid material, such as metal, such as stainless steel or another metal, a polymer, and so on. In the non-retractable embodiment of FIG. 7K, in addition to manifold 200 and cannula 198, the device also includes a connecting plenum 337 which connects cannula 198 to manifold 200. In an embodiment, connecting plenum 337 may be partially hollow, forming a cavity or plenum to receive OVD from cannula 198 and provide it to manifold 200.

Referring to FIGS. 8 and 9, another embodiment of Glaucoma Ray Gun 108 is depicted. In this embodiment, Glaucoma Ray Gun 108 includes carrier tube 196, cannula 198 and manifold 200, but in this embodiment, manifold 200 is integrally formed from an end portion of cannula 198. In an embodiment, cannula 198 may comprise a nitinol tube.

Referring specifically to FIG. 8, cannula 198 initially defines a pair of opposing cutouts or slots 240 at second end 208 of carrier tube 196. Slots 240 extend lengthwise from second end 241 in a direction toward first end 243. Due to the addition of slots 240, second end 241 includes first portion 242 and second opposite portion 244. Slots 240 may be formed as a wire EDM (Electrical Discharge Machining) cutout.

Referring also to FIG. 9, first portion 242 is bent away from body portion 245 in a first direction, and second portion 242 is bent away from body portion 245 in a second direction, generally opposite to the first direction. Together, first bent or curved portion 242 with second bent or curved portion 244 form manifold 200. Opening 230 is located centrally in manifold 200 and is integral to channel 210 of cannula 198.

During manufacture, a heat set fixture may be used to form the two curved portions 242 and 244 into the depicted banana peel shape that has been rotated upwards and outwards. Although not depicted, embodiments of OVD injection device or Ray Gun 108 may also include one or more devices in fluid and/or mechanical connection with end 199, which is the end opposite manifold 200. Such devices may include a fluid pump and/or controller for controlling fluid flow and fluid pressure. A pressure and flow controller may be in the form of a handpiece that is operable by the hand of a surgeon. In one such embodiment, the pressure and flow controller may include a trigger grip for control. In an embodiment, the controller may be capable of receiving or coupling to a source of OVD fluid, including an OVD cartridge.

Referring again to FIGS. 1-2, Microlnvasive Glaucoma Surgery (MIGS) system 100 with its components Lancer Microcatheter 102, implantable porous filament (IPF) 104, trabecular excision device (TED) 106 and Glaucoma Ray Gun 108 may be used to perform various microinvasive glaucoma surgeries or procedures. In an embodiment, MIGS system 100 is used to perform the following steps of a microinvasive glaucoma surgical procedure as follows, which will also be described in further detail below with respect to FIGS. 10-21: Step 250: Two paracentesis incisions lmm-1.5mm are made on the left and / or the right with respect to the surgeon. The two paracentesis incision are that the surgeon may treat either the superior or inferior 180 degrees of Schlemm’s canal.

Step 252: The anterior chamber of the eye 119 is filled with OVD 123.

Step 254: Under gonioscopy, a 1mm goniotomy is created with a 25G hypodermic needle. Step 256: Lancer Microcatheter 102 with lancer tip 122 is inserted into Schlemm’s canal 110 ab interno (from the anterior chamber).

Step 258: Lancer Microcatheter 102 is advanced along Schlemm’s canal 110 while injecting OVD 123 to treat the post-TM outflow system, including its collector channels.

Step 260: Lancer Microcatheter 102 is cannulated 360 degrees.

Step 262: Lancer Microcatheter 102 is retracted. As it is retracted, it may serve as a guide to direct IPF 104 and/or TED 106 into Schlemm’s canal 110. In other embodiments, IPF 104 may be independently cannulated into Schlemm’s canal 110.

Step 264: TED 106 is cannulated into part of Schlemm’s canal 110 via the goniotomy site. With a ripcord maneuver, 90-180 degrees of the trabecular meshwork is excised.

Step 266: IPF 104 is cannulated into Schlemm’s canal 110.

With respect to Steps 256-262, and referring to FIG. 2, Lancer Microcatheter 102 is inserted into Schlemm’s canal 110 from the anterior chamber at Step 256. Blunt lancer tip 122 pushes through, and to a certain extent may expand Schlemm’s canal as Lancer Microcatheter 102 is advanced as part of Step 258. The bluntness of tip 138 may prevent damage to Schlemm’s canal. Port 126 is aligned with an opening 114 of a collector channel 112. Pressurized OVD 123 flows through channel 132 of Lancer Microcatheter 102, out port 126, and into and through collector channel 112. Baffles 148 are located on one side of channel 112, while baffles 150 are located on another side of collector channel 112. Since baffles 148 and 150 obstruct Schlemm’s canal on either side of the collector channel 112, pressure in the area of channel 112 is maintained, and OVD 123 is efficiently and effectively directed into collector channel 112. Maintaining pressure and directing OVD 123 to a particular collector channel 112 can be especially useful in the event that tracers are being combined with the OVD 123 to map and/or treat the post-trabecular outflow system.

As OVD 123 or another therapeutic is injected, the collector channel 112 and corresponding post-trabecular outflow system is viscodilated/treated.

It will be understood that various devices and supply sources for providing OVD 123 may be connected to fit to end 128 of Lancer Microcatheter 102 so as to deliver a pressurized flow of OVD 123 into Lancer Microcatheter 102.

After viscodilating or treating a first collector channel 112, a position of Lancer Microcatheter 102 is moved, so as to align port 126 with a second collector channel 112, so that OVD flows into the second collector channel 112, thusly viscodilating the second collector channel 112 and corresponding post-trabecular outflow system.

Lancer Microcatheter 102 is subsequently moved through Schlemm’s canal 110, injecting OVD 123 at the various collector channels 112 in communication with Schlemm’s canal 110. In an embodiment, Lancer Microcatheter 102 is cannulated through Schlemm’s canal 360 degrees, as indicated in Step 260. Viscodilation may be accomplished as Lancer Microcatheter 102 is advance or pushed through Schlemm’s canal 110, or as Lancer Microcatheter 102 is withdrawn from Schlemm’s canal 110, or in some embodiments viscodilation and flow of OVD 123 may occur while both advancing and withdrawing Lancer Microcatheter 102.

In an embodiment, Lancer Microcatheter 102 may act as a guide wire to ensure proper placement of IPF 104.

Microcatheter 102 with is unique tip portion 122, and use thereof as described above, provides a number of advantages. First, Lancer Microcatheter 102 effectively directs OVD 123 toward the post-trabecular outflow system, including collector channels 112. Second, there is only minimal reflux of OVD 123 to unwanted locations, such as, for example, the interior chamber of the eye. Third, since lancer tip portion 122 is the widest part of the cannula, this minimizes resistance to advancement of the trailing body portion 134 and baffles 148, 150 through Schlemm’s canal 110. Fourth, Lancer Microcatheter 102 facilitates the injection of OVD 123 and/or tracers and/or therapeutics.

At Step 262, Lancer Microcatheter 102 is retracted.

With respect to Step 264, and referring to FIGS. 6, 10 and 11, TED 106 is partially cannulated into Schlemm’s canal for about 90-120 degrees. FIG. 10 is a simplified cross- sectional view of a human eye, depicting Schlemm’s canal 110, anterior chamber 111, iris 113, lens 151 and sclera 153. FIG. 11 is a cross-sectional view looking into eye 119, depicting the placement of TED 106 in Schlemm’s canal 110 that is defined by outer wall 115 of Schlemm’s canal and “inner wall” 117 of Schlemm’s canal. The “inner wall” 117 is also comprised of portions of the trabecular meshwork or TM. In the embodiment depicted, a portion of the TM has been removed through the use of TED 106, forming opening or gap 272, such that Schlemm’s canal 110 is in direct fluid communication with anterior chamber 111 and its aqueous therein. In the embodiment depicted, TED 106 is connected to IPF 104 at linkage 270.

As described above with respect to FIG. 6, TED 106 has a specialized, textured surface, which may include micro-hooks or barbs 182 and 186. When this textured surface contacts the trabecular meshwork, it is very adherent to the trabecular meshwork. When a ripcord maneuver is performed, it can excise about 90 degrees of TM. By using TED 106 on Schlemm’s canal 110 in both a clockwise and counterclockwise fashion, one can excise up to 180 degrees of trabecular meshwork.

In the embodiment where TED 106 includes two cutting edges 180 and 184, as depicted in FIG. 6, the amount of force needed to excise the trabecular meshwork is minimized and tissue / cellular detail for histological analysis is preserved. The use of TED 106 also ensures a topographically organized trabecular meshwork, allowing comparison of trabecular meshwork excised from the superior 180 degrees versus the inferior 180 degrees.

In an embodiment, and as depicted in FIG. 11, in an embodiment, TED 106 is detachably linked to IPF 104 at linkage 270 in a manner that allows TED 106 to be detached from IPF 104 so that performing the ripcord maneuver detaches TED 106 from the IPF 104 at linkage 270. IPF 104 thus acts as a guide wire to prevent TED 106 from false passaging and inadvertently damaging collateral structures.

However, in an alternate different embodiment, TED 106 is a stand-alone device, not attached or linked to IPF 104, and which may be used independently to excise portions of the trabecular meshwork.

TED 106 with the histological trabecular mesh work tissue sample are removed from the anterior chamber and can be submitted for laboratory analysis. Excision of TM in a topographically organized fashion - for research and biomolecular analysis and precision phenotyping of patient’s disease is another advantage of TED 106. Further, use of TED 106 to accomplish complete excision of TM minimizes leaflets that can fibrose and cause surgical failure.

TED 106 and related methods of use described herein provide a number of advantages over known systems, devices and methods. For example, TED 106 with body portion 173 is flexible, and in an embodiment, does not include a rigid shaft as may be used in some microsurgical procedures. Known devices for removing TM have a rigid shaft where the pivot point to trace Schlemm’s canal should be in the center of the pupil, on the visual axis. However, since such known rigid-shaft devices are accessed from a temporal incision, the effective surgical pivot point does not line up with the visual axis, resulting in suboptimal surgical ergonomics. The suboptimal surgical ergonomics may result in damage to the junctions between Schlemm’s canal 110 and collector channels 112, which may increase the postoperative IOP. TED 106 with its flexible design is self-guiding once it is inserted into Schlemm’s canal. Other known devices remove tissue in a strip, which can subsequently be distorted with surgical handling. This may introduce histological artifact and may reduce the value of molecular analysis of the sample. In contrast, TED 106 supports the removed TM sample and maintains the topographical organization. TED 106 more effectively removes the TM, and leaves minimal leaflets of TM behind that can proliferate and fibrose to result in surgical failure.

With respect to Step 266, and referring to FIG. 12, IPF 104 is cannulated into part of Schlemm’s canal 110. FIG. 12 is a front view of IPF 104 inserted into Schlemm’s canal 110, between outer wall 115 and inner wall / TM 117. TM 117, prior to removal, extends circumferentially 360 degrees around anterior chamber 111, and defining an inner boundary of Schlemm’s canal 110. As depicted, approximately 90 degrees of trabecular meshwork 117 has been removed, as indicted by the double-headed arrow, using TED 106 (also see FIG. 11), forming gap 272 in TM 117, and leaving approximately 270 degrees intact. It will be understood that more or less of TM 117 may be removed. For example, 90 to 180 degrees of TM 117 may be removed, leaving 180 to 270 of TM 117 intact.

Because the majority of TM 117 is left intact, IPF 104 is retained with Schlemm’s canal 110.

Referring to FIG. 13, in an embodiment, IPF 104 may comprise two main portions, 104a and 104b, rather than the single structure of FIG. 12. Having a two part IPF 104 may provide an advantage with respect to implantation. In this two-part embodiment, each portion 104a and 104b is separately cannulated into Schlemm’s canal 110. This results in less surgical manipulation as compared to cannulating a single filament IPF 104 360 degrees about Schlemm’s canal 110.

Referring to FIG. 14, a one-piece IPF 104 is depicted after insertion into Schlemm’s canal 110. Multiple collector channels 112 are in fluid communication with Schlemm’s canal 110, which are both in fluid communication with aqueous humor within anterior chamber 111. Fluid flow of aqueous humor from anterior chamber 111 into Schlemm’s canal 110 and into individual collector channels 112 is depicted by directional arrows.

Implanted IPF 104 provides complete 360 degree circumferential flow of aqueous humor around Schlemm’ s canal 110. Thus aqueous humor entering Schlemm’ s canal 110 from the site of TM excision, gap 272, can travel 180 degrees to drain to the high flow collector channels 112.

Referring also to FIG. 15, a close-up view of a portion of IPF 104 in Schlemm’s canal 110, and adjacent to a collector channel 112 is depicted. Because IPF 104 is porous with multiple pores 158, IPF 104 allows for the flow of aqueous, and small diameter molecules through IPF 104, but excludes larger objects such as red blood cells. In an embodiment, pores 158 are smaller than the diameter of red blood cells. This allows aqueous humor to exit the eye, as indicated by the arrow indicating a flow of aqueous from anterior chamber 111 through IPF 104 and towards and into collector channel 112, which is the desired effect. Blood reflux from collector channels 112 into the eye, which can result in the complication of hyphema, is prevented or minimized (as indicated by the downward arrow and X).

Referring to FIG. 16, the embodiment of IPF 104 of FIG. 5 is depicted in cross-section in Schlemm’s canal 110. In this embodiment, first, wide portion 162, is positioned adjacent to, and facing, an opening of collector channel 112. Unlike the opposite side of IPF 104 of this embodiment, first, wide portion 162 does not define grooves 160. As such, IPF 104 protects against blood reflux. At the same time, narrow portions 164 define grooves or channels therebetween, allowing circumferential flow around 360 degrees of Schlemm’s canal.

Implantation of embodiments of IPF 104 combine the efficacy of 360 goniotomy procedures in lowering IOP with an improved safety profile of segmental goniontomy (60-270 degrees) to prevent hypotony, blood reflux, hyphema, and excessive inflammation.

In some embodiments, IPF 104 is impregnated with slow-release therapeutics, providing a relatively large reservoir of medication, which potentially could last years. IPF 104 may be replaced over time after the medication is depleted. IPF 104 provides a number of advantages. For example, IPF 104 supports Schlemm’s canal over 360 degrees. As such, IPF is able to access all collector channels, thereby providing maximal outflow. Compared to known drug reservoirs, IPF 104 has a much larger volume and is able to hold much more therapeutics. IPF 104 is not close to the endothelium so there is a reduced risk of endothelial decompensation. IPF 104 also prevents blood reflux from collector channels, and the flexible nature of IPF 104 reduces the risk of it false passaging compared to the stiffer alternatives.

Referring again to FIGS. 1 and 7 A, MIGS system 100 may also include Glaucoma Ray Gun or injection device 108 for viscodilating collector channels 112. Glaucoma Ray Gun 108 may be used to viscodilate collector channels 112, rather than using Lancer Microcatheter 102 for viscodilation. Alternatively, Glaucoma Ray Gun 108 may be used after use of Lancer Microcatheter 102 for further or enhanced viscodilation of collector channels 112.

Referring also to FIGS. 17-21, an embodiment of Glaucoma Ray Gun 108 positioned at Schlemm’s canal 110 is depicted. As described briefly above with respect to FIG. 7A, manifold 200 may initially be entirely, or substantially, within channel 204 of carrier tube 196, when a retractable embodiment of device 108 is used. During MIGS surgery, end 208 of carrier tube 196 is positioned adjacent to the eye 119. Cannula 198 is deployed through an incision in the eye, and manifold 200 is released from carrier tube 196 and into Schlemm’s canal 110. In embodiments, wherein OVD injection device 108 is a non-retractable device, such as that described above with respect to FIG. 7K, carrier tube 1976 is not used, and manifold 200 with cannula 198 is inserted through the incision in the eye.

A retractable embodiment of device 108 has the advantage that a smaller incision may be made in the eye for insertion of device 108.

Manifold 200 is then positioned in or at Schlemm’s canal 110, such that inside surface 220 faces an inside surface of outer wall 115 of Schlemm’s canal 110. First and second lengthwise edges 222 and 224 may be in contact with the inside surface of Schlemm’s canal 110. First and second end edges 226 and 228, in an embodiment, may also contact the inside surface of Schlemm’s canal 110. As such, manifold 200 of Glaucoma Ray Gun 108 forms a seal with Schlemm’s canal 110. Because the radius of curvature of manifold 200 is substantially the same as the radius of curvature of Schlemm’s canal 110, in an embodiment, a firm seal with the inside surface of the outer wall of Schlemm’s canal 110 is possible.

In some embodiments, end edges 226 and 228 may not contact the tissue of Schlemm’s canal 110, or may only partially seal with Schlemm’s canal 110. In the embodiment of Glaucoma Ray Gun 108 ends of manifold 200 are angled so as to ensure better sealing with Schlemm’s canal 110.

As depicted in FIG. 21, eye 119 in cross section, with OVD injection device or Ray Gun 108 positioned against Schlemm’s canal 110 is depicted. In this depiction, an end portion of manifold 200 is also in cross section.

Manifold 200 is fully inserted into anterior chamber 111 of eye 119, as is a portion of cannula 198, through incision I. Manifold 200 with surface 220 is opposite a collector channel 112. Top edge 229 and bottom edge 231 of manifold 200 are adjacent to and in contact with Schlemm’s canal 110, such that manifold axis ME, which extends between the two edges, is substantially parallel to the contacted tissue of Schlemm’s canal 110. Eye axis E extends transversely to Schlemm’s canal, and in a plane that extends across the anterior chamber from one side of Schlemm’s canal to the other side.

The wall of tissue forming Schlemm’s canal 110 forms angle P with eye axis E and the plane across anterior chamber 111 that includes Schlemm’s canal 110. In an embodiment, when properly placed and sealing with Schlemm’s canal, manifold axis ME also forms approximately the same angle with eye axis E.

Cannula 198 and its central axis C forms an angle y with eye axis E. In an embodiment, angle y may be in a range of 5° to 15°; in an embodiment, angle a may be in a range of 8° to 12°; in one such embodiment, angle a is approximately 10°.

After making contact with Schlemm’s canal 110, pressurized OVD/fluid may be injected through cannula 198 and into Schlemm’s canal 110. As described above, Glaucoma Ray Gun 108, in an embodiment, includes an OVD control device in fluid communication with cannula 198 so as to control and/or measure injection pressure and volume. OVD/fluid is directed circumferentially about Schlemm’s canal 110 by manifold 200, pressurizing areas of Schlemm’s canal 110 and directing OVD/fluid into collector channels 112, thereby viscodilating collector channels 112. In an embodiment, and in part depending on the arc length of manifold 200, Glaucoma Ray Gun 108 can provide direct viscodilation to approximately up to 180 degrees of the Schlemm’s canal. This allows for hyperdilation of collector channels 112 and reduced postop IGP’s in the low teens and high single digits. Further, the injection of OVD prevents the anterior chamber from collapsing and clears blood reflux during the procedure.

Glaucoma Ray Gun 108 can also be used to simultaneously inject multiple fluids. In an embodiment, Glaucoma Ray Gun 108 is used to inject a first OVD/tracer into the collector channels, e.g., trypan/OVD, and a second, different OVD to maintain the anterior chamber. After viscodilation, OVD is evacuated and the incisions are sealed.

Referring also to FIG. 20, another embodiment of Glaucoma Ray Gun 108 is depicted positioned at Schlemm’s canal 110. This embodiment of Glaucoma Ray Gun 108 is substantially the same as device 108 depicted and described with respect to FIGS. 7A-7J. However, in this embodiment, ends 216 and 218 of manifold 200 are tapered or angled, such that Glaucoma Ray Gun 108 forms a tighter seal at ends 216 and 218. The improved sealing allows for increased OVD/fluid pressure in Schlemm’s canal 110 and collector channels 112.

As compared to Lancer Microcatheter 102, the use of Glaucoma Ray Gun 108 provides viscodilation of collector channels 112 at a higher pressure than Lancer Microcatheter 102 is able to provide. This allows maximal dilation of collector channels 112 for up to 180 degrees of Schlemm’s canal 110. Use of TED 106 or another TM-excising device is necessary to remove a section of TM to allow access for Glaucoma Ray Gun 108 and to fit manifold 200 adjacent to Schlemm’s canal 110, so as to viscodilate collector channels 112.

Glaucoma Ray Gun 108 provides a number of advantages over other devices as well. For example, Glaucoma Ray Gun 108 facilitates direct venoplasty with an OVD cannula without the cannula creating a tight seal on the outer wall of Schlemm’s canal 110. Further, as compared to known devices, the unique design of Glaucoma Ray Gun 108 produces a much tighter seal on the outer wall of Schlemm’s canal, which causes more effective viscodilation of collector channels.

In certain MIGS procedures, Glaucoma Ray Gun 108 may be used instead of Lancer Microcatheter 102 to viscodilate collector channels 112, and before implanting IPF 104. In other embodiments of MIGS procedures, Glaucoma Ray Gun 108 may be used for viscodilation of collector channels 112 so as to decrease IOP, but without subsequent IPF 104 implantation.

Referring again to FIG. 1, MIGS system 100 is a system that works together as a whole to provide the best surgical result possible with the maximum amount of safety. Lancer Microcatheter 102 with its lancer tip Lancer Microcatheter, and/or Glaucoma Ray Gun 108, provides 360 degrees of viscodilation of and treatment of all the collector channels in 360 degrees. Therefore, MIGS system 100 will be effective in patients regardless of where the dominance of their outflow system is, for example, nasal vs temporal outflow dominance. Without the use of trabecular excision device (TED) 106, post IOP would not be as low, and without IPF 104, there would be an increased risk for postop hyphema. TED 106 removes up to 180 degrees of the trabecular meshwork. This overcomes the site of most resistance to outflow. Since TED 106 is removable, it also provides a TM tissue sample for histological / molecular analysis and precision medicine.

Implantable porous filament (IPF) 104 ensures long term IOP control and surgical success because it supports Schlemm’s canal and prevents the collapse of Schlemm’s canal. This ensures 360-degree circumferential flow. The porous design allow aqueous to leave the anterior chamber but prevents blood reflux from entering into the anterior chamber. In an embodiment, IPF 104 excludes molecules the size of approximately 27 picograms, which is the weight of red blood cells. Without Eancer Microcatheter 102 and IPF 104, there would not be 360 circumferential flow so that aqueous humor could not easily flow from the area of excised TM to the rest of the collector channels 112 180 degrees away.

All of the features disclosed in this specification (including the references incorporated by reference, including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including references incorporated by reference, any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any incorporated by reference references, any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed The above references in all sections of this application are herein incorporated by references in their entirety for all purposes.

Although specific examples have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement calculated to achieve the same purpose could be substituted for the specific examples shown. This application is intended to cover adaptations or variations of the present subject matter. Therefore, it is intended that the invention be defined by the attached claims and their legal equivalents, as well as the following illustrative aspects. The above described aspects embodiments of the invention are merely descriptive of its principles and are not to be considered limiting. Further modifications of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention.

Claims

What is claimed is:

1. A penetration and flow device for treating glaucoma, comprising: a catheter with a port opening in a direction radial to a longitudinal axis of the catheter, a head coupled to an end of the microcatheter, a first baffle on the microcatheter, the first baffle located between the head and the port and extending radially, and a second baffle on the microcatheter, the first baffle located on the microcatheter opposite the first baffle, such that the port is between the first and second baffles, the second baffle extending radially.

2. The penetration and flow device of claim 1, wherein the head includes a lancer tip.

3. The penetration and flow device of claim 1, wherein the catheter is a microcatheter.

4. The penetration and flow device of claim 1, further comprising a third baffle adjacent the first baffle, the third baffle located between the first baffle and the head, and a fourth baffle adjacent the second baffle.

5. The penetration and flow device of claim 1, further comprising another port.

6. The penetration and flow device of claim 1 , wherein the head includes a tapered tip portion.

7. The penetration and flow device of claim 6, wherein the head forms a conical shape.

8. The penetration and flow device of claim 6, wherein the head includes a rounded tip.

9. The penetration and flow device of claim 1, wherein the head defines at least one cavity.

10. The penetration and flow device of claim 1 , wherein each of the first and second baffles forms a disc shape having an outside diameter that is greater than an outside diameter of the catheter.

11. The penetration and flow device of claim 10, wherein the disc shape is a circular shape.

12. The penetration and flow device of claim 1, wherein at least one of the first and second baffle includes longitudinally-extending grooves.

13. A trabecular excision device for excising tissue of the trabecular meshwork of an eye of a patient, comprising: a longitudinally-extending body portion having a first end and a second end for insertion into the eye, and a removing portion at the second end of the longitudinally-extending portion, the removing portion including barbs or other structure for contacting the tissue.

14. The trabecular excision device of claim 13, wherein the longitudinally extending body portion forms a filament-like structure.

15. The trabecular excision device of claim 13, wherein the first end of the longitudinally-extending body portion is configured to be grasped by a user.

16. The trabecular excision device of claim 13, wherein the first end of the longitudinally-extending body portion is configured to be connected to an implantable porous filament (IPF).

17. The trabecular excision device of claim 13, wherein the second end includes a tip portion that forms a rounded end.

18. The trabecular excision device of claim 17, wherein the removing portion includes a top side with a top surface, and the barbs project radially from the top surface.

19. The trabecular excision device of claim 18, wherein the barbs comprise two parallel rows of barbs.

20. The trabecular excision device of claim 18, wherein the top surface forms an uneven texture configured for gripping tissue of the eye.

21. The trabecular excision device of claim 13, wherein each barb is curved in a direction from the second end to the first end along a leading edge.

22. The trabecular excision device of claim 13, wherein the removing portion includes a first cutting edge the comprises a row of the barbs aligned linearly in a direction from the second end to the first end.

23. The trabecular excision device of claim 22, further comprising a second cutting edge opposite the first cutting edge and aligned in parallel with the first cutting edge.

24. The trabecular excision device of claim 23, wherein the barbs are distributed equidistantly with a space between each barb.

25. The trabecular excision device of claim 13, wherein the barbs are distributed equidistantly with a space between each barb.

26. An implantable porous filament for implantation into a Schlemm’s canal of an eye of a patient, comprising: a flexible, filament-shaped body portion comprising a porous material defining multiple pores, each of the multiple pores sized to flow fluid through the body portion and to prevent flow of red blood cells through the body portion; a first end; and a second end opposite the first end.

27. The implantable porous filament of claim 26, wherein the body portion comprises a hydrogel.

28. The implantable porous filament of claim 26, wherein the body portion as viewed in cross section is substantially circular in circumference.

29. The implantable porous filament of claim 26, , wherein the body portion as viewed in cross section is asymmetrical.

30. The implantable porous filament of claim 26, wherein the body portion comprises a single structure.

31. The implantable porous filament of claim 26, wherein the body portion comprises two structures.

32. The implantable porous filament of claim 26, wherein the second end is configured to connect to a trabecular excision device.

33. The implantable porous filament of claim 26, further comprising therapeutic drugs impregnated into the body portion.

34. The implantable porous filament of claim 26, wherein the body portion defines a plurality of longitudinal grooves extending along a length of the body portion.

35. An implantable filament for implantation into a Schlemm’s canal of an eye of a patient, comprising: a flexible, filament-shaped body portion comprising a substantially non-porous material and defining a plurality of longitudinal grooves extending along a length of the body portion; a first end; and a second end opposite the first end; wherein the body portion in cross-section forms an asymmetrical shape.

36. The implantable porous filament of claim 35, wherein the body portion comprises a single structure.

37. The implantable porous filament of claim 35, wherein the body portion comprises two structures.

38. The implantable porous filament of claim 35, wherein the second end is configured to connect to a trabecular excision device.

39. The implantable porous filament of claim 35, further comprising therapeutic drugs impregnated into the body portion.

40. A device for treating glaucoma in an eye of a patient, comprising: a catheter configured to flow a fluid; a curved portion attached to an end of the catheter and configured to receive and direct the flow of fluid from the catheter into and around the Schlemm’s canal of the eye of a patient.

41. A fluid injection device for treating glaucoma in an eye of a patient, comprising: a hollow fluid-delivery tube including a first end and a second end; a curved distribution manifold connected to the second end of the fluid-delivery tube and configured to receive fluid from the fluid-delivery tube, the distribution manifold including a body portion having a first end with a first edge, a second end with a second edge, a top edge, a bottom edge and defining a channel for receiving and distributing the fluid from the fluid-delivery tube; wherein the body portion defines a circumferentially-extending gap between the top edge and the bottom edge for release of the fluid from the curved distribution manifold.

42. The fluid injection device of claim 41, wherein the first edge and the second edge each form a C shape.

43. The fluid injection device of claim 41, wherein the first edge and the second edge each form a semi-circle.

44. The fluid injection device of claim 41, wherein the top and bottom edges are chamfered edges.

45. The fluid injection device of claim 41 , wherein the body portion defines a radius of curvature that is in a range of 6mm to 10mm.

46. The fluid injection device of claim 45, wherein an arc length of the body portion is in a range of 8mm to 12mm.

47. The fluid injection device of claim 41 , wherein an arc length of the body portion is in a range of 8mm to 12mm.

48. The fluid injection device of claim 41, wherein a lengthwise central axis of the fluid-delivery tube forms a non-zero angle with an axis extending between the top edge and the bottom edge.

49. The fluid injection device of claim 48, wherein the non-zero angle is in a range of 20° to 40°.

50. The fluid injection device of claim 49, wherein the non-zero angle is substantially 30°.

51. The fluid injection device of claim 41, further comprising a carrier tube configured to receive a portion of the fluid-delivery tube and a portion of the curved distribution manifold.

52. The fluid injection device of claim 51 , wherein the curved distribution manifold comprises a flexible material, and the distribution manifold is configured to fold about a folding point.

53. The fluid injection device of claim 52, wherein the folding point is a center point of the curved distribution manifold.

54. The fluid injection device of claim 52, wherein the flexible material comprises a polymer material.

55. The fluid injection device of claim 41, further comprising a fluid pressure and flow controller connected to the first end of the fluid-delivery tube.

56. The fluid injection device of claim 54, wherein the fluid pressure and flow controller comprises a hand-held device.

57. The fluid injection device of claim 56, wherein the hand-held device includes a trigger mechanism for fluid pressure and flow control.

58. The fluid injection device of claim 55, wherein the fluid pressure and flow controller comprises a fluid pump.

59. A method of treating glaucoma in an eye of a patient, comprising the steps of: making a paracentesis incision in the eye to access an anterior chamber of the eye; inserting a penetration and flow device having a hollow body portion defining a radially-opening port and having a lancer head, into a Schlemm’s canal of the eye from the anterior chamber; advancing the lancer head of the penetration and flow device along the Schlemm’s canal while injecting fluid through the port in the device into the Schlemm’s canal and collector channels of the Schlemm’s canal; cannulating the penetration and flow device 360° through the Schlemm’s canal; and retracting the penetration and flow device.

60. The method of claim 59, further comprising connecting an implantable porous filament to the penetration and flow device, and wherein retracting the penetration and flow device causes the connected implantable porous filament to be cannulated into the Schlemm’s canal.

61. The method of claim 59, further comprising inserting an implantable porous filament into Schlemm’s canal after injecting fluid into the Schlemm’s canal and collector channels.

62. The method of claim 59, further comprising excising a portion of Schlemm’s canal prior to inserting the implantable porous filament.

63. The method of claim 62, wherein excising a portion of Schlemm’s canal comprises excising portions of a trabecular mesh network forming a portion of Schlemm’s canal.

64. The method of claim 63, wherein excising a portion of Schlemm’s canal includes inserting in a first direction a trabecular excision device (TED) into a portion of Schlemm’s canal, then moving the TED in a second direction opposite to the first direction, causing the TED to contact and retain a portion of the trabecular mesh network.

65. A method of treating glaucoma in an eye of a patient, comprising the steps of: excising a portion of a trabecular mesh network forming a Schlemm’s canal of the eye; inserting an injection device that includes a curved, open-channel manifold with a top edge and a bottom edge, the manifold connected to a fluid-delivery tube, into an anterior chamber of the eye; locating the top edge and bottom edge of the manifold in an area of the eye from which the trabecular mesh network portion was removed, such that the top edge and the bottom edge are pressed against a remaining portion of the Schlemms’ canal; causing pressurized fluid to flow through the fluid-delivery tube to the manifold and into the Schlemm’s canal and a plurality of collector channels corresponding to the Schlemm’s canal, thereby reducing resistance to drainage of fluid out of the anterior chamber.

66. The method of claim 65, further comprising inserting an implantable porous filament into Schlemm’s canal.

67. The method of claim 65, further comprising connecting the fluid-delivery tube to a pressure and flow controller.

68. The method of claim 67, further comprising controlling the pressure and flow of the fluid using a trigger mechanism of the pressure and flow controller.

69. A system including the devices of claim 1, 13 and 26