Eye stent and delivery system

Abstract

To provide an eye stent and a delivery system.SOLUTION: Some embodiments of the invention advantageously leverage expansion, dilation or by-pass of a Schlemm's canal using adjustable reversible self-expanding eye stents (SES) or eye tension rings (ETRs) of desired sizes to control and improve aqueous flow throughout a range of an uveolymphatic canal. As such, some embodiments include tension ring(s) or cylinders that are positioned either inside or outside the Schlemm's canal wall and is at least partially within the canal and / or is partially or fully anchored, attached, adhered, or otherwise held in place with respect to the wall or other locations within the canal and / or elsewhere in the canal.SELECTED DRAWING: Figure 26B

Description

Background Art

[0001] (Cross - reference to Related Applications) This application claims the benefit of U.S. Provisional No. 62 / 872,494, filed Jul. 10, 2019 (Attorney Docket No. 58141 - 703.101), U.S. Provisional No. 62 / 874,946, filed Jul. 16, 2019 (Attorney Docket No. 58141 - 703.102), and U.S. Provisional No. 62 / 945,160, filed Dec. 8, 2019 (Attorney Docket No. 58141 - 703.103), which are hereby incorporated by reference in their entireties.

[0002] (Background of the Invention) Glaucoma is the second leading cause of blindness worldwide, and millions of Americans lose their vision each year to degenerative diseases that cause this disorder. Glaucoma is a condition that results from an increase in intraocular pressure (IOP) due to various factors that irreversibly damage the optic nerve of the eye. Glaucoma tends to be hereditary and may have no symptoms leading up to it. There are an estimated 2 - 3 million patients in the United States with open - angle glaucoma, at a rate of about 1.9% of the U.S. population over 40 years old.

[0003] Reducing intraocular pressure (IOP) has been the optimal standard for treating glaucoma for over a century. However, little progress has been made in understanding how aqueous humor clearance works within the eye. Recent discoveries in lymphology have shown that the Schlemm's canal is essentially a lymphatic duct that is important in managing outflow and regulating IOP. Lymphedema is a condition that results from impaired flow in lymphatic vessels, and glaucoma is similar to "ocular lymphedema." As with other forms of lymphedema, swelling and increased pressure are common side effects from the accumulation of fluid with inadequate clearance.

[0004] Standard treatments for glaucoma include IOP-lowering eye drops, trabeculectomy, or other forms of surgical drainage devices that inject fluid into various locations (from internal to external). Moderate and severe glaucoma is often treated with a combined approach of surgical devices and eye drops. However, ineffective placement of devices, ineffective outflow, and poor compliance with eye drops make it difficult to address disease progression, especially since glaucoma is an asymptomatic disease.

[0005] Pharmacological approaches for treatment include the use of single agents, carbonic anhydrase inhibitors, prostaglandins themselves, beta blockers, alpha-2 agonists, etc., in prostaglandin (PG) monotherapy. Pharmacological approaches are of insufficient efficacy and are often used as short-term treatments. Compliance remains a major constraint for long-term efficacy and prevention of progression. In addition, side effects of pharmacological approaches include brow pain, miosis, flushing, and reduced night vision.

[0006] Conventional and recent surgical therapies include selective laser trabeculoplasty (SLT) and minimally invasive glaucoma surgery (MIGS). SLT is irreversible and requires ablation of the trabecular meshwork to create an outflow network. MIGS includes various devices that provide a flow channel for aqueous humor either outside the eye (externally) or inside the eye (internally). Internal devices typically reside within the trabecular meshwork, and external devices are typically transconjunctival / subconjunctival placements. Summary of the Invention Means for Solving the Problems

[0007] (Brief Summary of the Invention) In a first aspect, the present invention provides a device for maintaining the patency of the trabecular meshwork lymphatic region or Schlemm's canal within the eye, comprising an expansion member consisting of a single elongate element having a flexure configuration for radial expansion of the trabecular meshwork lymphatic region or Schlemm's canal within the eye. The expansion member in its flexure configuration has (i) sufficient radial strength to withstand the compressive stress exerted by the trabecular meshwork lymphatic region or Schlemm's canal within the eye, and (ii) sufficient void space within its structure to minimize occlusion of the collecting ducts within the trabecular meshwork lymphatic region or Schlemm's canal when the expansion member is implanted within the trabecular meshwork lymphatic region or Schlemm's canal within the eye.

[0008] The expansion member will typically "consist of" a single elongate element from another structure, but the device will typically include additional elements and features such as structures that are coupled or attached at one or both ends of the single elongate expansion member to assist in the operation or anchoring of the device within the trabecular meshwork region and / or Schlemm's canal. Such features may include, for example, tubular, helical, or other structures located at the proximal end of the single elongate element, configured to extend across the channel and into the anterior chamber to create a detour for fluid flow.

[0009] In certain embodiments, the single elongate element of the device of the present invention may comprise a preformed metal or polymer filament. Such filaments will typically comprise a solid core elongate wire, strand, fiber, or the like, but in some cases may comprise threads, cords, cables, or the like having multiple individual starts that are wound tightly enough or otherwise joined together to act as a single solid entity. In a specific example, the single elongate element may comprise a preformed metal wire such as a shape or thermally memory alloy wire. In a specific example, the single elongate element comprises a nitinol alloy wire.

[0010] The bending configuration of a single elongating element, when embedded therein, may comprise any one or combination of curves, loops, twists, bend angles, corners, kinks, arcs, or other non - linearities along the axial length of the single elongating element that define a volume - occupying virtual envelope that radially supports the uveal lymphatic region or the wall region of Schlemm's canal within the eye. This virtual envelope will typically be substantially cylindrical, but may have other shapes. In a specific embodiment, the single elongating element in its bending configuration is at least partially formed with a repeating number of spiral turns. In other embodiments, the single elongating element in its bending configuration is at least partially formed with repeating serpentine loops.

[0011] In specific instances, the single elongating element may preferably be curved along its length in its bending configuration when unconstrained, conforming to the shape of the uveal lymphatic region or Schlemm's canal within the eye. In other instances, at least one end of the single elongating element may often have a geometry different from that of the central region of the single elongating element, with both ends having a geometry different from the rest of the single elongating element. The geometry at the ends may differ only in dimensions, for example, a spiral with different wire diameters, spiral diameters, and / or pitches, or may differ in shape, for example, a loop that terminates at one or both ends of the single elongating element.

[0012] Exemplary preferred dimensions for a shape - memory helical wire embodiment of the single elongating element in its bending configuration are set forth in Table I. [Table 1]

[0013] In a further specific example, at least one end of a single elongating element is formed as or otherwise provided with a tubular structure or member such as a helix having a pitch closer and a diameter smaller than those of the central region. In many cases, both ends of a single elongating element are formed as a helix having a pitch closer and a diameter smaller than those of the central region. The closer pitch is typically in the range of 0.001 mm to 1 mm, usually 0.01 mm to 0.2 mm, preferably 0.05 mm to 0.15 mm, and the smaller diameter is in the range of 0.001 mm to 1 mm, usually 0.05 mm to 0.4 mm, preferably 0.1 mm to 0.3 mm.

[0014] In a further embodiment of the device for maintaining the viability of the present invention, the single elongating element may comprise any one or more of various features such as a radius of curvature selected to match that of the choroidal lymphatic vessels or Schlemm's canal of the eye. The single elongating element will also typically be polished via mechanical, chemical, or electrochemical means so as to improve finish and biocompatibility. The single elongating element may have at least one end formed as a loop. The single elongating element may have at least one end formed as a tightly wound coil. The single elongating element may have at least one feature at at least one of its ends configured to facilitate manipulation. The single elongating element may be at least partially biodegradable or bioresorbable. The single elongating element may comprise a drug eluting member formed on or embedded within its surface. The single elongating element may comprise a hydrophilic or hydrophobic coating to assist in the safety and efficacy of the intraocular device. The single elongating element may include a tortuous feature configured to permit aqueous humor flow between Schlemm's canal and the anterior chamber of the eye, and the tortuous feature may be located at the inlet, at the outlet, or along the length of the device.

[0015] In a second aspect, the present invention provides a method of treating glaucoma in a patient. The method typically includes implanting an expansion member, which consists of a single elongate element, into the patient's trabecular meshwork lymphatic vessels or Schlemm's canal. The single elongate element, when implanted, has (i) sufficient radial strength to withstand the compressive stress exerted by the trabecular meshwork lymphatic vessels or Schlemm's canal in the eye, and (ii) sufficient void space within its structure to minimize the occlusion of the collecting ducts within the trabecular meshwork lymphatic vessels or Schlemm's canal in the eye when the expansion member is implanted into the trabecular meshwork lymphatic vessels or Schlemm's canal in the eye, thereby opening the patient's trabecular meshwork lymphatic vessels or Schlemm's canal.

[0016] In specific embodiments of these methods of treating glaucoma of the present invention, the single elongate element typically has a bent configuration when implanted, and the term "bent" is defined as previously described. Alternatively, the method may further include introducing a delivery tube into the patient's trabecular meshwork lymphatic vessels or Schlemm's canal and releasing the expansion member from restraint such that the single elongate element expands radially in situ. In either case, the single elongate element typically comprises a preformed metal or polymer filament, but may also comprise any of the filaments described above.

[0017] In a preferred aspect of the method of the present invention, the single elongate element in its bent configuration is at least partially formed with repeated turns of a helix, or the single elongate element in its bent configuration is at least partially formed with repeated serpentine loops. Typically, the single elongate element is curved along its length in its bent configuration when there is no restraint to conform to the shape of the trabecular meshwork lymphatic vessels or Schlemm's canal in the eye. In many cases, at least one end of the single elongate element has a different geometry than the rest of the single elongate element, and frequently both ends of the single elongate element have a different geometry than that of the central region of the single elongate element.

[0018] In further examples of the methods herein, the radius of curvature of a single extension element matches that of the scleral lymphatic vessels or Schlemm's canal of the eye. The radius of curvature of the single extension element may be selected to cause an inward or outward warp of the scleral lymphatic vessels or Schlemm's canal of the eye. The ends of the single extension element may be positioned to crush Schlemm's canal and allow flow between Schlemm's canal and the trabecular meshwork.

[0019] The methods herein may further comprise additional aspects such as eluting a drug from a single extension element. The single extension element may comprise a hydrophilic or hydrophobic coating to assist in the safety and efficacy of the intraocular device. The single extension element may be positioned within the anterior chamber to provide aqueous humor flow at the inlet, at the outlet, along the length of the device, within or outside the tube, or into or from the anterior chamber of the eye. The single extension element may be implanted using fluorescence or image-guided surgery to avoid occlusion of the collecting ducts within the scleral lymphatic vessels or Schlemm's canal of the eye. The single extension element may be implanted with the assistance of an expandable member consisting of a balloon or suction.

[0020] Further specific aspects of the methods herein include customizing a single extension element based on the preoperative intraocular pressure (IOP) and the desired adjustment or reduction of the intraocular pressure (IOP). The single extension element may be capable of delivering energy to transform the shape of the device or the shape of the surrounding tissue.

[0021] The methods of this specification further comprise various delivery options. A single elongating element may be delivered using a tool comprising a device channel that comprises an outer sheath and an inner member, the device being configured to be disposed between the inner member and the outer sheath, the delivery tool comprising a locking member configured to reversibly lock the device within the device channel. The single elongating element may be delivered using access from an angle outside the eye into the interior of the anterior chamber or into the subconjunctival or limbal or scleral regions of the eye. The single elongating element may be delivered with the aid of staining or visualization so as to access the eye's ducts in a minimally invasive manner. The single elongating element may be delivered using a delivery tool having a pressurization system for controlling the delivery of the device into the eye. The single elongating element may be delivered using a delivery tool assisted by a visualization scope or imaging. The single elongating element may be delivered using a delivery tool attached to a syringe. The single elongating element may be delivered using a delivery tool having temperature control for manipulating the physical state of the device before, during, and after delivery. The single elongating element may be delivered using a delivery tool that incorporates a slider or plunger or that can be controlled using a twist or axial contact board or contact roller. The single elongating element may be delivered using a delivery tool that can also provide an incision required to access the choroidal lymphatic duct or duct. The single elongating element may be delivered using a delivery tool that provides an expansion channel and can reduce friction in the delivery of the device. The single elongating element may be delivered using a delivery tool that pre-tightens or winds up the device. The single elongating element may be delivered using a delivery tool powered by a piezoelectric or vibrating motor. The single elongating element may be delivered using a delivery tool that utilizes a guide wire and can deliver, position, reposition, or retract the device.

[0022] In some embodiments, the single elongating element may at least partially consist of a polymeric material selected from the group consisting of polyvinylidene fluoride, polyvinylidene difluoride (PVDF), polyvinylpyrrolidone (PVP), polyurethane, polyethylene glycol (PEG), polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA), polymethyl methacrylate (PMMA), polyacrylate, polyamide, polyimide, polyester, silicone, carbon composite materials, and equivalents. Such materials may be used in substantially pure form or as mixtures or composites with other materials.

[0023] In some embodiments, the single elongating element may at least partially consist of at least one metal or alloy selected from the group consisting of titanium, stainless steel, cobalt-chromium alloy, gold, platinum, silver, iridium, tantalum, tungsten, aluminum, vanadium, and equivalents.

[0024] Some embodiments of the present invention are directed to minimally invasive systems and methods for treating glaucoma by utilizing one, two, or more adjustable shape memory tube tension rings (or stents) configured to be placed within the lumen of the trabecular meshwork or Schlemm's canal. The tension ring typically, but not exclusively, exerts a radially outward mechanical force on the tube in a non-penetrating manner to restore patency of the tube and improve aqueous humor flow therethrough. The ring can include a proximal end, a distal end, a coiled section having a plurality of turns therebetween, and proximal and distal eyelets for ease of manipulation, transfer, or retraction using a separate insertion or retrieval device. The coiled section has a variable outer diameter along its length. The ring can be made from shape memory alloys (SMA), stainless steel, flexible metals such as titanium, and flexible polymers including shape memory polymers (SMP), silicone, polyvinylidene difluoride (PVDF), polymethyl methacrylate (PMMA), polypropylene (PP), polyethersulfone (PES), polylactic acid (PLA), polyglycolic acid (PGA), as well as small diameter shape memory wires or tubes (e.g., about 5 - 30 μm wire diameter and 150 - 500 μm device outer diameter) such as adjustable biodegradable polymers, drug eluting shape memory alloys (such as nitinol).

[0025] Some embodiments of the present invention advantageously utilize the expansion of the trabecular meshwork lymphatic ducts or Schlemm's canal using an adjustable and reversible self-expanding eye stent (SES) or eye tension ring (ETR) of a desired size within the eye to control and improve fluid flow throughout the extent of the canal. Accordingly, some embodiments include an adjustable tension ring or cylinder that is at least partially positioned within the canal and / or is partially or fully tethered, attached, adhered, or otherwise held in a fixed position relative to the canal opening or other locations within the canal and / or other portions within the trabecular meshwork. The expansion of the canal can be configured to vary in different zones within Schlemm's canal independently and based on patient-specific needs. In some embodiments, the tension ring may be one, two, three, four, five, six separate rings of various sizes. In some embodiments, the system can be configured to control the aqueous humor flow rate through the canal. In some embodiments, the ring can be substituted by a cylinder, including some with fixed elements. The adjustable reversible eye tension ring can be configured in some embodiments to conform to the range of a specific patient in terms of canal dimensions.

[0026] In some embodiments, the adjustable and reversible self-expanding eye stent (SES) or eye tension ring (ETR) can include one, two, or more than two fixed elements. The fixed elements can facilitate the fixation of the SES to the canal wall. In some embodiments, the SES may include protrusions or indentations to stabilize and / or fix the SES at the wall. The fixed elements can also include, for example, sub-elements for tethering the SES to the wall, such as grooves, teeth, ridges, or a serrated pattern. In some embodiments, two or more of the same or different fixed elements can be used in combination.

[0027] In some embodiments, the SES can include one or more features, such as grooves or loops, to enable easy capture and removal of the SES when needed.

[0028] Also, what is disclosed herein are various materials for SES, including shape memory alloys (SMA), stainless steel, flexible metals such as titanium, which are embedded through a small incision and can bounce back to their original configuration without damage, and flexible polymers including shape memory polymers (SMP), silicone, polyvinylidene difluoride (PVDF), polymethyl methacrylate (PMMA), polypropylene (PP), polyethersulfone (PES), polylactic acid (PLA), polyglycolic acid (PGA), as well as adjustable biodegradable polymers. In some embodiments, the SES material may include a coating to prevent degradation and encapsulation. The coating can be essentially hydrophobic or hydrophilic, such as silicone or polytetrafluoroethylene, or other lubricating coatings. In some embodiments, the SES may include a drug-eluting coating on the surface or within the substrate / bulk to further promote eye healing.

[0029] In some embodiments, what is disclosed is a method of surgically implanting SES. The delivery system may contain a cannula for making an incision into the channel and a trigger mechanism for deploying the SES with each click or turn. The SES can be pre-loaded for various sizes in a cartridge that can be attached to the delivery system. The advantage of such a technique is to accurately position the SES and deploy it within the appropriate zone within the tube. The SES can, in some cases, be implanted via an installation tool that allows for the use of operating features that can also be used to easily relocate or retract it. The SES can be implanted alone or in combination with other SES in some embodiments.

[0030] The SES can be customized for a specific patient, including age, race, demographics, constitution, tube dimensions, anatomical differences, and other factors specific to the patient. The SES can also be customized based on the patient's baseline IOP or desired IOP reduction by selecting the length and width of the SES and expanding, and thus controlling, the aqueous humor outflow. Due to the unique features of the SES device and delivery technique, the device can offer several advantages, including maximum expansion of the tube with the presence of material within the tube, non-obstruction of the lymphatic drainage / collecting ducts for sufficient drainage, nano / micro incisional surgery with minimal material interaction with tissue, and full reversibility.

[0031] In some embodiments, the device can include any combination of the following features, or others as disclosed herein.

[0032] An adjustable self-expanding eye stent (SES) or eye tension ring (ETR) embodiment that is stored and loaded within a delivery system, and once deployed, the stored embodiment springs open, assumes a shape with its shape memory, forms one or more tension or torsion rings that are inside or outside the tube wall and larger than the tube diameter, and will provide separation between the pre-compressed tubes of the Schlemm's canal or the trabecular meshwork lymphatic ducts of any animal. One or more embodiments with various sizes can be deployed within the pre-compressed tubes at various locations. The embodiment can be a combination of a smaller diameter at the ends (to anchor and prevent movement) and a larger diameter in the center, or the same SES can contain these variations.

[0033] SES made from circular / rectangular / square polymers or metal or alloy wires / tubes. The wire tube OD can be from 0.0005 inches to 0.10 inches. Non-circular wire embodiments can be from 0.0005 inches to 0.10 inches × 0.0005 inches to 0.10 inches.

[0034] An SES shaped to conform to the radius or arc of the perimeter of the globe or trabecular meshwork pathway. In some embodiments, the shape may not exert a warp or constriction on the tube. In some other embodiments, the shape may have an inward warp of the tube.

[0035] An SES with shallow or variable pits across the length of the SES. The pitch of the helical SES can vary from 0.00005 inches to 0.10 inches. In some embodiments, a tighter pitch can be on either the proximal end, or the distal end, or both. In some embodiments, a wider pitch can be on either the proximal end, or the distal end, or both.

[0036] An SES with rigidity that allows it to be linearly pushed into the Schlemm's canal without losing its integrity / deforming.

[0037] An SES with open distal and proximal ends. In some embodiments, the SES may have one or more coils that are welded together to form a closed loop at any one or more points or ends along the length of the SES. In some other embodiments, the SES pitch at the distal end, proximal end, or both ends is shallow such that the coil loops back on itself to form a closed loop. In some other embodiments, one or both of the proximal end or distal end of the SES are welded to a preceding or succeeding coil to complete the loop.

[0038] An SES where one or both ends of the SES are tightly wound such that the Schlemm's canal is crushed by the tightly wound coil, thereby allowing flow between the Schlemm's canal and the trabecular meshwork through and along the length of one or more tightly wound portions.

[0039] An SES consisting of various perforations and extensions for anchoring to the tube wall.

[0040] A SES with multiple perforations or features to enable rapid exchange, repositioning, or removal.

[0041] A SES designed and selected based on patient-specific IOP through preoperative measurements.

[0042] A SES designed with irregularities on the peripheral circumference, including protrusions, depressions, etc. to enable better anchoring and prevention of movement.

[0043] A SES implanted with the same surgical technique as positioning another SES within the patient's Schlemm's canal.

[0044] A SES designed to vary the sweep from 10 to 360 degrees. Additionally, the SES may have multiple continuous or discontinuous sweeps from 1 to 10.

[0045] A SES used in multiple with various dimensions within a tube to control the shape of expansion, the amount and direction of flow.

[0046] A SES that can be customized for a specific patient or animal, including factors such as age, race, demographics, genetic predisposition, tube dimensions, Schlemm's canal dimensions, intraocular pressure (IOP) measurements, anatomical differences in the eye, and other factors specific to the patient or animal.

[0047] A SES that is a tension ring that can be customized to contract and / or extend in response to adjusting the operating characteristics of the SES for safe and easy transfer, repositioning, or removal.

[0048] An adjustable self-expanding eye stent (SES) or eye tension ring (ETR) embodiment that is stored and loaded within a delivery system, such that once deployed, the stored embodiment springs open, assumes a shape with its shape memory, forms one or more tension or torsion rings that are on the inner or outer side of the tube wall and larger than the tube diameter, and will provide separation between pre-compressed tubes of the Schlemm's canal within the body of any animal. A balloon catheter or incisional cannula may be deployed prior to deployment of the SES to enable dilation of the Schlemm's canal and to enable easy deployment of the SES.

[0049] An SES having a sharp leading edge or cannula such that the SES can puncture the tube wall, tether it, and remain in an expanded state from the outer side of the tube wall.

[0050] An SES having operating features such that the SES is tethered to the inner side of the tube wall to enable subsequent manipulation of the SES.

[0051] An SES that can be delivered in a contracted (or smaller) state by using external energy (electrical, mechanical, thermal, RF, light, etc.) to manipulate the temperature of the SES.

[0052] An adjustable self-expanding eye stent (SES) or eye tension ring (ETR) embodiment that can be manipulated by an insertion tool such that its temperature can be externally controlled through an energy source (electrical, mechanical, thermal, RF, light, etc.) to modify (contract or expand) the shape of the SES and make the insertion or retrieval procedure both minimally invasive, responsive, and easy to manipulate / handle.

[0053] An SES made of extruded metal or plastic tubing such that the SES is in a stored state and once the SES is deployed to a desired location, the SES assumes a shape with its shape memory and configuration.

[0054] An SES consisting of extruded metal or plastic tubes, on which measurement markers are printed so that the extruded metal or plastic tubes serve as reference points in SES deployment.

[0055] An SES with a cannula and / or balloon at the distal end that can facilitate the opening of the Schlemm's canal and the tethering from the tube incision / aperture to accurately deploy and position the SES.

[0056] An SES that allows the user to feel incrementally advancing towards the distal shaft as induced by the delivery device. The deployment mechanism can be carried from the handle of the device. The deployment mechanism can be made to be measured based on a pre-determined measurement location where the advancement is pre-determined.

[0057] A stapler-type device where the SES is stored in a cartridge containing a pre-determined count such as 1 to 6 SES, and a single SES is individually dispensed from the cartridge via a trigger mechanism from the handle of the SES delivery system.

[0058] An SES delivery system having SES pre-loaded in a plurality of cartridges, enabling the deployment of all SES in a single procedure and minimizing the time required.

[0059] An SES delivery system that is manually or mechanically driven through a pusher catheter shaft / tubes, i.e., is a staple or is electromechanically delivered to a desired location and / or is energy-driven, i.e., can be either a radio frequency or an electronic signal.

[0060] An SES that can have features such as loops, hooks, or eyelets to enable easy capture using an SES recovery system that can allow the SES to be compressed and drawn into the system when repositioning or removal is desired.

[0061] The SES can be withdrawn by compressing or refolding the embodiment back into a linear or figure-eight shape, and can either be fully withdrawn or repositioned.

[0062] (31.) The SES can be withdrawn by capturing the operating characteristics of the SES and rewinding it onto a track / guide.

[0063] The SES can be withdrawn by capturing the operating characteristics and using external energy to manipulate the temperature of the SES to contract the SES.

[0064] An SES delivery system and an SES recovery system having a polymer coating, including fluoropolymers and silicones, etc. The coating may also be used to seal and prevent coagulation, residue accumulation, or degradation over time.

[0065] The SES can be deployed using tools and / or mechanisms for holding both segments of the SES aligned with the axis of the SES. The SES is then repositioned by pivoting the SES perpendicular to the deployment axis.

[0066] An SES with customized dimensions based on the biometrics of the Schlemm's canal space. The Schlemm's canal may be measured or imaged as a preoperative scan using various qualitative or quantitative measurement tools to determine a customized fit of the SES size required for the specific needs of the patient. Biometric measurements, including Schlemm's canal dimensions, Schlemm's canal angle, cross-sectional area (CSA), may be used to determine and customize the SES design to fit the specific physiological and anatomical needs of the patient.

[0067] An SES with customized dimensions based on intraocular pressure readings and eye biometrics. The IOP can be used to determine a customized fit of the SES size required for the specific needs of the patient or for the required reduction of IOP.

[0068] As the patient ages and as the ducts and Schlemm's canal undergo physiological changes, the SES may be replaced (with other sizes or tensile strengths) to adapt to the changing needs.

[0069] A device for maintaining the patency of the intraocular uveoscleral lymphatic region or Schlemm's canal, comprising a self-expanding shape memory member having a proximal end, a distal end, and a passage therebetween configured to facilitate the flow of body fluid therebetween, the shape memory member further comprising a plurality of partial or complete loops between the proximal end and the distal end, the shape memory member comprising a central portion and a lateral portion, the central portion having a first diameter, the lateral portion having a second diameter, the first diameter not being equal to the second diameter, and the shape memory member further comprising a first radially compressed configuration convertible to a second radially expanded configuration.

[0070] Such a device, wherein the first diameter is greater than the second diameter.

[0071] Such a device, wherein the first diameter is smaller than the second diameter.

[0072] Such a device, wherein the central portion has a generally constant first diameter throughout the entire length of the central portion. Such a device.

[0073] Such a device, wherein the lateral portion has a generally constant second diameter throughout the entire length of the central portion. Such a device.

[0074] Such a device, wherein non-adjacent loops of the device are only interconnected via directly adjacent loops.

[0075] Such a device, wherein the shape memory member has a diameter of from about 0.0005 inches to about 0.050 inches.

[0076] A device in which the shape memory member has a non-circular cross-section, the cross-section has a major axis and a minor axis, and the minor axis dimension is from about 0.0005 inches to about 0.050 inches.

[0077] A device in which the radius of curvature of the device matches that of the grapevine lymphatic vessels within the sphere.

[0078] A device in which the radius of curvature of the device can have an inward or outward bend of the tube.

[0079] A device in which the proximal end of the device can have a pitch dimension from 0.0005 inches to about 0.050 inches.

[0080] A device in which the distal end of the device can have a pitch dimension from 0.0005 inches to about 0.050 inches.

[0081] A device in which the body of the device can have a pitch dimension from 0.0005 inches to about 0.050 inches.

[0082] A device in which the proximal and / or distal ends of the device can have a smaller pitch compared to the body.

[0083] A device in which the proximal and / or distal ends of the device can have coils that terminate in the same plane where the closed loop ends.

[0084] A device in which the proximal and / or distal ends of the device can be polished via mechanical, chemical, or electrochemical methods.

[0085] A device in which the proximal and / or distal ends of the device can be welded to preceding or subsequent coils to complete the loop.

[0086] The Schlemm's canal is crushed by a tightly wound coil, whereby one or both ends of the device are tightly wound so as to allow flow between the Schlemm's canal and the trabecular meshwork through the tightly wound coil and along the length of one or more tightly wound portions. Such a device.

[0087] Such a device further comprising one or more operating features proximate to at least one of the proximal and distal ends.

[0088] Such a device, wherein one or more operating features are selected from the group consisting of an inlet, a hook, and a loop.

[0089] Such a device, wherein one or more operating features are selected from the group consisting of an inlet, a hook, and a loop.

[0090] Such a device, wherein the operating feature is used for mooring into a tube.

[0091] Such a device, wherein the shape memory member comprises a biodegradable polymer with controlled absorption into the eye.

[0092] Such a device, wherein the shape memory member comprises a drug eluting member coated on the surface or embedded in the bulk for controlled release into the eye.

[0093] Such a device, wherein the shape memory member comprises a hydrophobic coating.

[0094] Such a device, wherein the shape memory member comprises a hydrophilic coating.

[0095] Such a device, having a sharp edge, wherein the proximal end is configured to pierce the tube wall, moor within the tube wall itself, and hold it in an expanded state from the outside of the tube wall.

[0096] Such a device with surface irregularities, where the shape memory member is configured to facilitate mooring and / or prevention of movement.

[0097] Such a device where the surface irregularities comprise one or more of ridges, rough surfaces, pores, and depressions.

[0098] Such a device comprising from about 1 to about 100 partial or complete loops.

[0099] Such a device where the device has a meandering and / or expanding feature at an inlet or outlet, or along the length of the device, into or out of a tube in the anterior chamber.

[0100] Such a device where the device has a meandering feature into the anterior chamber for aqueous humor flow at an inlet or outlet, or along the length of the device, into or out of a tube in the anterior chamber.

[0101] Such a device where the device has an extended diameter at an inlet or outlet, or along the length of the device, into or out of a tube in the anterior chamber, at a section where a meandering and / or expanding feature is desired.

[0102] Such a device where the device can be implanted using fluorescence or image guidance so as to avoid occlusion of the collecting ducts within the tube.

[0103] Such a device where the device can be a wire that self-expands within the tube and is shaped into various configurations to maintain patency.

[0104] Such a device where the device can have specific dimensions in outer diameter, pitch, wire diameter, and shape so as to adapt to the required tensile force that may be needed within the tube.

[0105] Such a device assisted by finite element modeling for a selected patient population group.

[0106] Such a device, wherein the device has a polymer sheath along the length of the device in a continuous or discontinuous manner.

[0107] A delivery system comprising such a device, an outer sheath, an inner member, and a delivery tool having a device channel, wherein the device is configured to be disposed between the inner member and the outer sheath, and the delivery tool comprises a locking member configured to reversibly lock the device within the device channel.

[0108] Such a delivery system, wherein delivery can be accessed from an angle outside the eye, inside the anterior chamber, or in the subconjunctival region or limbal region or scleral region.

[0109] Such a delivery system, assisted by staining or visualization to access the duct in a minimally invasive manner.

[0110] Such a delivery system, wherein the delivery tool comprises a scope or visualization.

[0111] Such a delivery system, wherein the delivery tool has a pressurization system for controlling the delivery of the device.

[0112] Such a delivery system, wherein the delivery tool is attached to a syringe.

[0113] Such a delivery system, wherein the delivery tool has temperature control for manipulating the state of the device before, during, and after delivery.

[0114] Such a delivery system, wherein the inner, outer members, and the device can be controlled using a slider or plunger.

[0115] Such a delivery system, wherein the inner, outer members, and the device can be controlled using a twist or an axial contact board.

[0116] Such a delivery system in which the inner and outer members and the device can be controlled using torsion or axial contact rollers.

[0117] Such a delivery system in which the member can provide an incision required to enter the trabecular meshwork lymphatic duct or tube.

[0118] Such a delivery system that can have an uncoiling channel for reducing friction in the delivery of the device.

[0119] Such a delivery system that can pre-tighten or wind up the device.

[0120] Such a delivery system that can be powered by a piezoelectric or vibrating motor.

[0121] Such a delivery system that can use a guide wire to deliver the device.

[0122] Such a delivery system that can use a guide wire to reposition or retract the device.

[0123] A method of treating glaucoma in a patient, comprising: using an expandable member to expand the trabecular meshwork lymphatic duct or Schlemm's canal in the patient; radially expanding at least one device comprising a shape memory member with a plurality of windings within the Schlemm's canal to expand the diameter of the Schlemm's canal, wherein the at least one device comprises a larger diameter portion and a smaller diameter portion, and the larger diameter portion provides a radial force on the Schlemm's canal sufficient to maintain the patency of the Schlemm's canal; and unlocking the operating features of the at least one device from the delivery tool.

[0124] Such a method in which the expandable member comprises a balloon.

[0125] Such a method comprising radially expanding a plurality of devices.

[0126] A method in which a plurality of devices are sequentially expanded radially.

[0127] A method in which a plurality of devices have various sizes and / or shapes.

[0128] Such a method further comprising removing the delivery tool from the Schlemm's canal.

[0129] The delivery tool comprises a scope having a device channel, an outer sheath, and an inner member, and the device is arranged in a radially compressed configuration between the inner member and the outer sheath during delivery. Such a method.

[0130] Such a method further comprising axially moving the outer sheath relative to the device to enable the device to expand radially.

[0131] Following radially expanding at least one device within the Schlemm's canal, less than about 25% of the total surface area of the device is exposed to the aqueous humor within the Schlemm's canal. Such a method.

[0132] Such a method in which the shape memory member has a maximum diameter of less than about 0.050 inches.

[0133] Such a method in which the device, once implanted, does not axially extend outside the Schlemm's canal.

[0134] Such a method further comprising delivering energy to at least one device to size and / or transform the device.

[0135] Such a method in which at least one device is custom-generated based on the biometrics of the patient's Schlemm's canal.

[0136] Such a method in which at least one device is custom-generated based on measured patient parameters selected from one or more of a preoperative image, Schlemm's canal dimensions, Schlemm's canal cross-sectional area, and Schlemm's canal perimeter.

[0137] Such a method in which at least one device is custom-generated based on a measured patient preoperative intraocular pressure (IOP) and a desired adjustment of the IOP.

[0138] A method of treating glaucoma in a patient, comprising using an expandable member to expand or bypass the trabecular meshwork or Schlemm's canal in the patient, and radially expanding at least one device comprising a shape memory member with a plurality of windings within or across Schlemm's canal to provide a bypass and / or expansion into the diameter of Schlemm's canal, wherein the at least one device comprises a larger continuous diameter portion and a smaller diameter portion, and the larger diameter portion provides a radial force against Schlemm's canal sufficient to maintain the patency of Schlemm's canal.

[0139] Such a method in which the device has bypass and / or expansion features at an inlet or outlet, or along the length of the device, into / out of Schlemm's canal from / to the anterior chamber.

[0140] Such a method in which the device has bypass features at an inlet or outlet, or along the length of the device, into / out of Schlemm's canal from / to the anterior chamber at a wound and / or incision.

[0141] Such a method in which the device has bypass features at an inlet or outlet, or along the length of the device, along the same peripheral surface of Schlemm's canal away from the anterior chamber at a wound and / or incision.

[0142] The Schlemm's canal is crushed by a tightly wound coil, such that one or both ends of the device are tightly wound so as to allow flow between the Schlemm's canal and the trabecular meshwork through the tightly wound coil and / or along the length of one or more tightly wound portions.

[0143] One or more wound portions, such that one or both ends of the device project into the trabecular meshwork through the wall of the tube, so as to allow flow between the tube and the trabecular meshwork through the tightly wound coil and / or along the length of one or more tightly wound portions.

[0144] Such that the device has a polymeric sheath along the length of the device in a continuous or discontinuous fashion.

[0145] Delivering an effector tool in proximity to the Schlemm's canal and a pre-embedded device resident within the lumen of the Schlemm's canal, the pre-embedded device comprising one or more shape memory members with a plurality of windings, the windings forming a tube with a variable inner diameter, the device maintaining the patency of the lumen of the Schlemm's canal, contacting the operating characteristics of the pre-embedded device with the effector tool, locking at least one operating characteristic of the device, and removing or repositioning the device, a method of repositioning or removing a device for treating glaucoma in a patient.

[0146] Such method further comprising delivering energy from the effector to the operating characteristic to change the size and / or shape of the device.

[0147] Such that the operating characteristic comprises a hook, a loop, a magnet, or a threaded feature.

[0148] Such that the operating characteristic comprises a hook, a loop, a magnet, or a threaded feature. The present invention provides, for example, the following. (Item 1) A device for maintaining the patency of the uveoscleral lymphatic region or Schlemm's canal in the eye, the device comprising an expansion member consisting of a single elongate element having a flexure configuration for radial expansion of the uveoscleral lymphatic region or Schlemm's canal in the eye, the expansion member in its flexure configuration having (i) sufficient radial strength to withstand the compressive stress exerted by the uveoscleral lymphatic region or Schlemm's canal in the eye and (ii) sufficient void space within its structure to minimize occlusion of the collecting ducts in the uveoscleral lymphatic region or Schlemm's canal in the eye when the expansion member is implanted in the uveoscleral lymphatic region or Schlemm's canal in the eye, a device. (Item 2) The device for maintaining patency according to item 1, wherein the single elongate element comprises a preformed metal or polymer filament. (Item 3) The device for maintaining patency according to item 2, wherein the single elongate element comprises a preformed metal wire. (Item 4) The device for maintaining patency according to item 3, wherein the single elongate element comprises a shape or thermo-memory alloy wire. (Item 5) The device for maintaining patency according to item 4, wherein the single elongate element comprises a nickel-titanium alloy wire. (Item 6) The device for maintaining patency according to any one of items 1-5, wherein the single elongate element in its flexure configuration is at least partially formed with repeated spiral turns. (Item 7) The device for maintaining patency according to any one of items 1-5, wherein the single elongate element in its flexure configuration is at least partially formed with repeated serpentine loops. (Item 8) The device for maintaining patency according to any one of items 1-7, wherein the single elongating element is curved along its length in its bent configuration when there is no constraint to conform to the shape of the uveoscleral lymphatic region or the Schlemm's canal in the eye. (Item 9) The device for maintaining patency according to any one of items 1-8, wherein at least one end of the single elongating element has a geometry different from that of the rest of the single elongating element. (Item 10) The device for maintaining patency according to any one of items 1-8, wherein both ends of the single elongating element have a geometry different from that of the central region of the single elongating element. (Item 11) The device for maintaining patency according to item 1, wherein the single elongating element is a shape memory alloy wire formed in a cylindrical helix, having a diameter in the range of 0.001 mm to 1 mm, a pitch between continuous turns in the range of 0.001 mm to 10 mm, and a central region with a diameter in the range of 0.001 mm to 10 mm when unconstrained. (Item 12) The device for maintaining patency according to any one of items 1-11, wherein at least one end of the single elongating element is formed in a helix and has a pitch tighter and a diameter smaller than that of the central region. (Item 13) The device for maintaining patency according to item 12, wherein both ends of the single elongating element are formed in a helix and have a pitch tighter and a diameter smaller than that of the central region. (Item 14) The device for maintaining patency according to item 12 or 13, wherein the tighter pitch is in the range of 0.001 mm to 1 mm and the smaller diameter is in the range of 0.001 mm to 1 mm. (Item 15) The device for maintaining patency according to item 1, wherein the single elongating element is selected to match the radius of curvature of the uveoscleral lymphatic or Schlemm's canal of the eye and has a radius of curvature. (Item 16) The single elongating element is a device for maintaining the patency according to item 1, which is polished via mechanical, chemical, or electrochemical methods so as to improve finish and biocompatibility. (Item 17) The single elongating element is a device for maintaining the patency according to item 1, which has at least one end formed into a loop. (Item 18) The single elongating element is a device for maintaining the patency according to item 1, which has at least one end formed as a tightly wound coil. (Item 19) The single elongating element is a device for maintaining the patency according to item 1, which has at least one feature at its at least one end configured to facilitate manipulation. (Item 20) The single elongating element is a device for maintaining the patency according to item 1, which is at least partially biodegradable or bioresorbable. (Item 21) The single elongating element is a device for maintaining the patency according to item 1, which comprises a drug eluting member formed on or embedded in its surface. (Item 22) The single elongating element is a device for maintaining the patency according to item 1, which comprises a hydrophilic or hydrophobic coating for assisting the safety and effectiveness of the device in the eye. (Item 23) The single elongating element is a device for maintaining the patency according to item 1, which comprises tortuous features configured to permit aqueous humor flow between Schlemm's canal and the anterior chamber of the eye. (Item 24) The tortuous features are a device for maintaining the patency according to item 23, which are located at an inlet, an outlet, or along the length of the device. (Item 25) A method for treating glaucoma in a patient, Comprising implanting an extension member consisting of a single extension element into the patient's uveal lymphatic vessel or Schlemm's canal, The single extension element has (i) sufficient radial strength to withstand the compressive stress exerted by the uveal lymphatic vessel region or Schlemm's canal in the eye, and (ii) sufficient void space within its structure to minimize occlusion of the collecting ducts in the uveal lymphatic vessel region or Schlemm's canal in the eye when the extension member is implanted into the uveal lymphatic vessel region or Schlemm's canal in the eye, a method of opening the patient's uveal lymphatic vessel or Schlemm's canal. (Item 26) The single extension element has a bent configuration when implanted, the method of treating glaucoma according to item 25. (Item 27) The method of treating glaucoma according to item 25, further comprising introducing a delivery tube into the patient's uveal lymphatic vessel or Schlemm's canal and releasing the extension member from restraint so that the single extension element expands radially in situ. (Item 28) The single extension element comprises a preformed metal or polymer filament, the method of treating glaucoma according to any one of items 25-27. (Item 29) The single extension element comprises a preformed metal wire, the method of treating glaucoma according to item 28. (Item 30) The single extension element comprises a shape or heat memory alloy wire, the method of treating glaucoma according to item 29. (Item 31) The single extension element comprises a nickel-titanium alloy wire, the method of treating glaucoma according to item 30. (Item 32) The single extension element in its bent configuration is at least partially formed with repeated spiral turns, the method of treating glaucoma according to any one of items 25-31. (Item 33) The method for treating glaucoma according to any one of items 25-31, wherein the single elongating element in the bent configuration is at least partially formed with repeated serpentine loops. (Item 34) The method for treating glaucoma according to any one of items 25-33, wherein the single elongating element is curvilinear along its length in the bent configuration when there is no constraint for conforming to the shape of the uveoscleral lymphatic region or the Schlemm's canal in the eye. (Item 35) The method for treating glaucoma according to any one of items 25-34, wherein at least one end of the single elongating element has a geometric shape different from the rest of the single elongating element. (Item 36) The method for treating glaucoma according to any one of items 25-34, wherein both ends of the single elongating element have a geometric shape different from that of the central region of the single elongating element. (Item 37) The method for treating glaucoma according to any one of items 25-35, wherein the single elongating element is a shape memory alloy wire formed in a cylindrical helix, having a diameter in the range of 0.001 mm to 1 mm, a pitch between continuous turns in the range of 0.001 mm to 10 mm, and a central region with a diameter in the range of 0.001 mm to 10 mm when unconstrained. (Item 38) The method for treating glaucoma according to any one of items 25-37, wherein at least one end of the single elongating element is formed in a helix and has a pitch closer and a diameter smaller than that of the central region. (Item 39) The method for treating glaucoma according to any one of items 25-37, wherein both ends of the single elongating element are formed in a helix and have a pitch closer and a diameter smaller than that of the central region. (Item 40) The method for treating glaucoma according to item 38 or 39, wherein the closer pitch is in the range of 0.001 mm to 1 mm, and the smaller diameter is in the range of 0.001 mm to 1 mm. (Item 41) The method for treating glaucoma according to any one of items 25-40, wherein the radius of curvature of the single extension element matches that of the trabecular meshwork lymphatic vessel or Schlemm's canal of the eye. (Item 42) The method for treating glaucoma according to any one of items 25-41, wherein the radius of curvature of the single extension element is selected to cause an inward or outward warp of the trabecular meshwork lymphatic vessel or Schlemm's canal of the eye. (Item 43) The method for treating glaucoma according to any one of items 25-42, wherein the end of the single extension element is positioned to crush Schlemm's canal and enable fluid flow between Schlemm's canal and the trabecular meshwork. (Item 44) The method for treating glaucoma according to any one of items 25-43, further comprising eluting a drug from the single extension element. (Item 45) The method for treating glaucoma according to any one of items 25-44, wherein the single extension element is provided with a hydrophilic or hydrophobic coating to assist in the safety and effectiveness of the device within the eye. (Item 46) The method for treating glaucoma according to any one of items 25-45, wherein the single extension element is positioned within the anterior chamber to provide aqueous humor flow at the inlet, at the outlet, along the length of the device, into or out of the tube, or into or from the anterior chamber of the eye. (Item 47) The method for treating glaucoma according to any one of items 25-46, wherein the single extension element is implanted using fluorescence or image-guided surgery so as to avoid occlusion of the collecting ducts within the trabecular meshwork lymphatic vessel or Schlemm's canal of the eye. (Item 48) The method for treating glaucoma according to any one of items 25-47, wherein the single extension element is an expandable member comprising a balloon or is implanted with the assistance of suction. (Item 49) The single elongating element is a method for treating glaucoma according to any one of items 25-48, which is customized based on the preoperative intraocular pressure IOP and the desired adjustment or reduction of the intraocular pressure IOP. (Item 50) The single elongating element is a method for treating glaucoma according to any one of items 25-49, which is capable of delivering energy for transforming the shape of the device or the shape of the surrounding tissue. (Item 51) The single elongating element includes an outer sheath and an inner member, is provided with a device channel, is delivered using a tool, the device is configured to be disposed between the inner member and the outer sheath, and the delivery tool is provided with a locking member configured to reversibly lock the device within the device channel. The method for treating glaucoma according to any one of items 25-50. (Item 52) The single elongating element is a method for treating glaucoma according to any one of items 25-50, which is delivered using access from the inner side of the anterior chamber or from the outer angle of the eye from the subconjunctival region or limbal region or scleral region of the eye. (Item 53) The single elongating element is a method for treating glaucoma according to any one of items 25-52, which is delivered with the assistance of staining or visualization so as to access the eye's duct in a minimally invasive manner. (Item 54) The single elongating element is a method for treating glaucoma according to any one of items 25-53, which is delivered using a delivery tool having a pressurization system for controlling the delivery of the device into the eye. (Item 55) The single elongating element is a method for treating glaucoma according to any one of items 25-50, which is delivered using a delivery tool assisted by a visualization scope or imaging. (Item 56) The single elongating element is a method for treating glaucoma according to any one of items 25-50, which is delivered using a delivery tool attached to a syringe. (Item 57) The method for treating glaucoma according to any one of items 25 - 50, wherein the single elongating element is delivered using a delivery tool having temperature control for manipulating the physical state of the device before, during, and after delivery. (Item 58) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool that incorporates a slider or plunger or can be controlled using a twisting or axial contact board or contact roller. (Item 59) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool and can also provide an incision required to enter the trabecular meshwork lymphatic duct or tube. (Item 60) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool, provides an expansion channel, and can reduce friction in the delivery of the device. (Item 61) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool that pre - tightens or winds up the device. (Item 62) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool and can be powered by a piezoelectric or vibrating motor. (Item 63) The method for treating glaucoma according to item 25, wherein the single elongating element is delivered using a delivery tool that utilizes a guide wire and can deliver, position, reposition, or retract the device. (Item 64) The device for maintaining the patency according to item 1, wherein the single extension element is at least partially formed of a polymeric material selected from the group consisting of polyvinylidene fluoride, polyvinylidene difluoride (PVDF), polyvinylpyrrolidone (PVP), polyurethane, polyethylene glycol (PEG), polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA), polymethyl methacrylate (PMMA), polyacrylate, polyamide, polyimide, polyester, silicone, and carbon composite materials. (Item 65) The device for maintaining the patency according to item 1, wherein the single extension element is at least partially formed of a metal or metal alloy selected from the group consisting of titanium, stainless steel, cobalt-chromium alloy, gold, platinum, silver, iridium, tantalum, tungsten, aluminum, and vanadium.

Brief Description of the Drawings

[0149]

Figure 1

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Figure 3A

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Figure 7A

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Figure 11

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Figure 12

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Figure 13

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Figure 14

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Figure 15

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Figure 16A

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Figure 16B

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Figure 25A

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Figure 25B

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Figure 26B

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Figure 26C

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Figure 26D

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Figure 27

[0187] (Detailed Description of the Invention) Several factors affect the onset and progression of glaucoma as discussed in the previous section. The important regions where aqueous humor drainage occurs are within the trabecular meshwork lymphatic ducts or Schlemm's canal. When this region is blocked or constricted, it produces a cascade effect of inflammation, including edema or an increase in intraocular pressure. Expanding and / or creating a detour flow for the trabecular meshwork lymphatic ducts or Schlemm's canal enables continuous regulated clearance of aqueous humor, which restores the lymphatic function of the eye and thus regulates intraocular pressure.

[0188] Disclosed herein are adjustable self-expanding eye stent (SES) or reversible eye tension ring (ETR) embodiments that can be configured to adjust the diameter and opening of Schlemm's canal. The SES can include various generally prosthetic devices that include a tubular member configured to maintain or improve the patency of at least a portion of a trabecular meshwork lymphatic duct such as Schlemm's canal 400. In some embodiments, the device can improve the patency of Schlemm's canal rather than other trabecular meshwork regions.

[0189] Disclosed herein is a method for deploying a prosthetic device using expandable members such as balloon techniques, expandable devices (e.g., a movable cage with struts), etc., to a fixed tube, or an adjustable self-expanding eye stent (SES), or a reversible eye tension ring (ETR) 401. In some embodiments, the leading edge of the delivery device for the SES or cannula can create an entry incision 402 such that the SES 401 can be delivered in a folded state. Once inside the tube 400, the SES 401 can be fully deployed and extend in situ as shown in FIG. 4A. The SES 401 may contain one or more operating features 403 so that it can be used to adjust, reposition, and retrieve from and within the choroid lymphatic vessels. In some embodiments, the deployment of the SES 401 can be controlled by a spring-loaded plunger or a threaded screw-type tool. Some embodiments of the SES 401 can be deployed into a balloon-expandable tube to tether or expand and keep the tube away from crushing. In some embodiments, multiple SESs 401 can be deployed at various locations within the tube 400 to enable adjustment of flow through controlled expansion along the length of the tube and / or diversion of fluid within the tube.

[0190] Disclosed herein are the operating features 403 contained within a device such as the SES 401. In some embodiments, the SES 401 can include one, two, or a number of operating features 403 such as returns, grooves, or loops to enable easy tethering, capture, re-alignment, repositioning, and removal of the SES 401 when needed. The operating features can be axially or externally located, on the inner or outer side of the tube wall, and can be through or non-through type with respect to the tube wall. One major aspect of the operating features within the SES in some embodiments is to enable control for reversibility of the procedure.

[0191] Disclosed herein are various methods of removing a prosthetic device, including SES401, when reversibility or repositioning is desired. In some embodiments, a minimally invasive retrieval device can be deployed by containing a retrieval wire with features that couple to the operative feature 403 within SES401, as shown in FIG. 4B. In some embodiments, the operative feature 403 can be coupled via a hook-loop, hook-hook, or loop-hook configuration. In some embodiments, one or both of the retrieval or operative features 403 can include complementary magnets, grippers, adhesives, suction mechanisms, and equivalents, including, for example, a movable jaw. In some embodiments, the retrieval device may wind SES401 into a track or threaded feature within the device. Insertion into 403, tethering / connection, and removal of SES401 may all, in some cases, be performed by external control of the device (outside the body).

[0192] Disclosed herein are embodiments of prosthetic devices such as wire-form SES401 with one or more operative features 403 at the proximal or distal end of the SES. FIG. 4B illustrates various views of such embodiments. The operative features can be, for example, eyelets 403 that extend radially inwards or outwards in other embodiments, or other features as disclosed elsewhere in this specification.

[0193] Disclosed herein are embodiments of suture devices such as a flat or angled ribbon form SES 401 with one or more operative features 403 at the proximal or distal end of the SES. For example, the structure can be substantially helical with a plurality of revolutions as shown, with a flat cross-section such as oval or rectangular, for example. FIGS. 5A-5C illustrate various views of an embodiment of SES 401 where the tension ring 404 is continuous along the length of the SES 401 but the diameter varies. In other embodiments, either or both of the central or lateral portions can have a progressive or stepped variable diameter. Operative features 403 such as eyelets or others disclosed herein can be attached, connected, or integrally formed at one or both ends of the device or elsewhere and can be made of the same or different materials than the remainder of the device itself. In some embodiments, the extended length and / or number of revolutions of the central portion of larger diameter is about 50%, 60%, 70%, 80%, 90%, or more or less than that of the extended length and / or number of revolutions of the device as a whole.

[0194] Disclosed herein is a method for deploying a prosthetic device such as an adjustable reversible self-expanding eye stent (SES) or an eye tension ring (ETR) within the Schlemm's canal. In some embodiments, the leading edge or other portion of the SES 401 can be inserted using an insertion device between the Schlemm's canals. In some embodiments, depending on partial or complete insertion, the SES 401 snaps into place and assumes a radially expanded configuration, and due to the shape memory properties of the SES 401 material, can keep the Schlemm's canal in a widely open state. In some embodiments, multiple SES 401s of similar or various diameters can be deployed within the Schlemm's canal depending on the biological structure. Some embodiments can include a range, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, or more devices, or, for example, any two of the foregoing values such as 1 - 10 devices or 2 - 8 devices. Each device can be installed directly adjacent to each other, for example, in contact with each other, overlapping with each other, or spaced apart, not in direct contact with each other, or in combinations thereof. Additionally, some embodiments can have one, two, or more relatively large diameter tension rings 404 within the SES 401 relative to other rings of the SES, which can be centered or positioned elsewhere depending on the anchoring requirements within the Schlemm's canal. In other embodiments, multiple such SES 401s can be deployed within the tube. In some embodiments, one large SES can be deployed covering the entire length or perimeter of the Schlemm's canal with similar or various diameters along its length as shown in FIGS. 5A or 5B.

[0195] Disclosed herein is an embodiment of a prosthetic device including an SES 401 that can connect an eye tension ring 404 via a connection anchor or support structure 600 for stability as shown in FIGS. 6A and 6B. In some embodiments, there can be some of the eye tension rings 404 connected in a similar continuous or discrete manner.

[0196] Disclosed herein are embodiments of a prosthetic device that include a SES401 that is a discontinuous independent tension ring 404 with an operating feature 403 (which can be positioned either outside or inside the tube 400). In some embodiments, these SES401s may be inserted one at a time or several traversing various locations within the tube 400.

[0197] Disclosed herein are embodiments of a prosthetic device that include a SES401 that has a variable pitch and length. The SES401 may have a detour and / or expansion feature 800 for adjusting the detour of aqueous humor through the tube and / or the detour and / or fluid across the tube and within the tube. This feature 800 may be at the entrance of the tube wall as shown in FIG. 8C, which may also serve to moor the SES401 within the tube, along with ease of operation to reposition the SES401 device within the tube or retrieve it away from the tube.

[0198] Disclosed herein are embodiments of a suture device that include a SES401 having variable pitch and length, as shown in FIGS. 9A - 9D. The SES401 may have a plurality of tortuous and / or dilation features 800 and 900 for regulating the flow of aqueous humor through the tube and / or the diversion of fluid within and across the tube. These features 800 or 900 may be at each end of the SES device 401 or may be continuous along the length of the device 401. These features as shown in FIGS. 9A - 9D may also serve to tether the SES401 within the tube, along with facilitating the manipulation to reposition the SES401 device within the tube or retrieve it away from the tube, as shown in FIG. 9E. Additionally, these features may have various inner diameters 901, similar to a tube or channel for controlling the entry and exit of fluid across and within the tube. Additionally, the entry access or tortuous features 800 or 900 may be at several locations (two, three, four, five, etc.) along the length of the tube and may be fully enclosed within the tube, or may partially or fully cross the tube and be enclosed within the anterior chamber.

[0199] Disclosed herein are embodiments of a suture device that include a SES401 having variable pitch across its free length, as shown in FIGS. 10A - 10F. Variations in the pitch of the helical coil of the SES401 may be utilized to adjust and customize the expansion, tortuosity, tethering, and manipulation of the SES401 and to regulate aqueous humor flow and IOP.

[0200] Disclosed herein are embodiments of a suture device that include a SES401 having variable pitch, diameter, and shape across its free length, as shown in FIGS. 11A - 11J. Variations in the pitch and diameter of the helical coil along the free length of the SES401 may be utilized to adjust and customize the expansion, tortuosity, tethering, and manipulation of the SES401 and to regulate aqueous humor flow and IOP.

[0201] Disclosed herein are embodiments of a prosthetic device that include a hook, or C-loop, or ring, or eyelet, or the like having a unique shape for positioning, deploying, mooring, removing, recovering, and generally manipulating the SES401. These features may enable the SES401 to adjust and customize the expansion, detour, mooring, and manipulation of the SES401, and to adjust the aqueous humor flow and IOP.

[0202] Disclosed herein are embodiments of a prosthetic device that include the SES401 having a polymeric sheath across the SES401. In some embodiments, as shown in FIGS. 13A and 13B, the sheath may cross the coils of the SES401 or extend continuously throughout the entire length of the SES in various zones inside the inlet, outlet, center, or length of the SES401. This sheath may enable adjustment and customization of the expansion, detour, mooring, and manipulation of the SES401, and may adjust the aqueous humor flow and IOP. The polymeric sheath may be made from various degradable and non-degradable polymers, including polytetrafluoroethylene (PTFE), silicone, lubricants, degradable polymers, hydrophobic polymers, hydrophilic polymers, hybrid polymers, and the like. The polymeric sheath may be continuous or discontinuous across the length and diameter of the SES401. The polymeric sheath may be coated over the base metal, alloy, polymeric coil that makes up the SES401 using casting, molding, spray coating, dip coating, or other techniques.

[0203] Disclosed herein are embodiments of a prosthetic device that, in some cases, include the SES401 that can form a double helix or feedback pattern as shown in FIG. 14, with two discrete ends distally and a continuous loop end proximally without a free end. In some embodiments, there are two operating features 403 shown in a state where both are within the entry plane on the distal end of the device 401, but some embodiments may include, for example, only one, or three, four, or more operating features.

[0204] What is disclosed herein are embodiments of a method of using preoperative measurements of intraocular pressure (IOP) to customize a device, e.g., SES diameter, length, and pitch, for specific requirements of IOP reduction. Yan et al (2016 - Schlemm’s Canal and Trabecular Meshwork in Eyes with Primary Open Angle Glaucoma: A Comparative Study Using High-Frequency Ultrasound Biomicroscopy, PLOS One, 11 (1) https: / / doi.org / 10.1371 / journal.pone.0145824) have demonstrated the correlation of Schlemm’s canal diameter to IOP. FIG. 15 shows an example of determining and customizing the SES401 design to fit the desired outflow and thus the desired IOP reduction for a specific patient. The aqueous humor outflow in the uveoscleral lymphatic vessels can be directly correlated to the extent of dilation of this conduit. One or more customized devices can then be manufactured and then implanted, for example, in a separate procedure. However, the sizing procedure and the implantation procedure can be combined in a single procedure in other embodiments.

[0205] Disclosed herein are embodiments of a prosthetic device that includes an SES401 configured to be delivered in a minimally invasive manner and retain an intended shape in situ. In some embodiments, the SES may be circular in shape with a plurality of sweeps (rotations). In some variants, the SES401 may have a total of 2 to 30 sweeps (or rotations), an overall or partial sweep such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, or 30 sweeps, or a range including any two of the foregoing values. In some embodiments, the pitch (separation between each ring) may be from about 0.0001 inches to about 0.1 inches, such as about 0.0001 inches, 0.0005 inches, 0.001 inches, 0.002 inches, 0.003 inches, 0.005 inches, 0.01 inches, 0.05 inches, 0.1 inches, or a range including any two of the foregoing values. Disclosed herein are embodiments that partially or completely cover, for example, at least about, about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or about less than that, or a range including any two of the foregoing values, of the axial length of the Schlemm's canal. The illustrations shown herein also demonstrate an operating feature 901 that enables ease of operation, transfer, and retraction using a separate retrieval device. In some embodiments, the implanted SES will not extend axially into any other trabecular meshwork region. In some embodiments, the implanted SES extends axially into one or more of the trabecular meshwork or the trabecular meshwork region.

[0206] Disclosed herein are embodiments of a prosthetic device that includes a SES401 delivered in a minimally invasive form and retaining the intended shape in situ. In some embodiments, the SES may be circular in shape with multiple sweeps (rotations). In some variants, the SES401 may have a total of 2 to 30 sweeps (or rotations), either in whole or in part. In some embodiments, the pitch (the separation between each ring) can be from 0.0001 inches to 0.1 inches. Disclosed herein are embodiments that either partially or fully cover the Schlemm's canal. The illustrations shown herein also demonstrate an operating feature 403 that enables ease of operation, transfer, and retraction using a separate retrieval device. In some embodiments, the central portion of the SES may have the largest diameter for better anchoring within the Schlemm's canal and preventing movement within the Schlemm's canal, with a diameter that gradually decreases from the central portion to one or both ends.

[0207] In some embodiments, the larger diameter portion of the prosthetic device can have an average or maximum diameter that is about or at least about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, 100%, or more than that, or a range including any two of the foregoing values, relative to the average or maximum diameter of the smaller diameter portion.

[0208] Disclosed herein are embodiments of a method that uses preoperative measurements of trabecular meshwork characteristics such as diameter, length, tension, modulus of elasticity, etc. to customize the SES401 device and cross a channel or tube to appropriately provide tension and thus patency, and ultimately provide the required IOP reduction. Finite element analysis (FEA) and modeling may be used to determine the patient anatomical dimensions of the SES device 401, including features such as coil diameter, overall tube / device diameter, pitch, pitch variance, inlet and outlet dimensions, etc.

[0209] In some embodiments, the SES device 401 may be directly implanted into the trabecular meshwork lymphatic vessels and may be slid. FIG. 16A illustrates a variant of the SES device made from a shape memory alloy and a polymeric material. FIGS. 16B and 16C show the SES device 401 in situ within the trabecular lymphatic duct 400 that appropriately expands the duct / catheter. The variant shown in FIG. 16A may be utilized according to the required expansion of the duct / catheter.

[0210] In some embodiments, the SES device 401 may be delivered into the trabecular meshwork / schlemm's canal from within the anterior chamber 1703, or from the outer angle of the eye within the subconjunctival region, or the limbal region 1702, or the scleral region 1704. FIG. 17 illustrates a cross-sectional view of the eye with indications for various locations of insertion that are considered as possibilities for the SES device to access the trabecular meshwork / schlemm's canal. One location shown is from the inner angle 1703 of the anterior chamber of the eye. Other locations outside the eye, such as the limbal region 1702 or the sclera 1704, may be used to make an incision and access the trabecular lymphatic duct 400 directly below or beneath the scleral tissue. The access may be made easier by selective coloring or staining of the duct. Such access may provide an added benefit in terms of delivery safety and ease. In addition, the corneal region may also be used as a location for the first incision.

[0211] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving prosthetic devices such as the minimally invasive SES401. The temperature of the SES401 can be controlled externally through an energy source (electricity, mechanical, thermal, RF, ultrasonic, etc.) by an insertion tool such that the temperature can be manipulated (e.g., increased or decreased) to modify (shrink or expand) the shape of the SES401 and make the insertion or retrieval procedure both minimally invasive, responsive, and easy to manipulate / handle. In some embodiments, the device can be repositioned by applying torque (e.g., twisting) to the device rather than axially pushing or pulling the device in a proximal or distal direction at least initially.

[0212] Disclosed in FIGS. 18A - 18C are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving prosthetic devices such as the minimally invasive SES401. In some embodiments, the delivery device 1800 may contain an outer cannula 1801 for accessing the choroid lymphatic vessel 400. The outer cannula 1801 may be made of a metal, alloy, ceramic, or polymeric material so as to access the vessel. In some embodiments, the outer cannula 1801 may have a sharp leading edge for providing an incision for accessing the conduit 400. In some embodiments, the outer cannula 1801 may house an inner cannula 1802 or the SES device 401. In some embodiments, the inner cannula 1802 may house the SES device and the inner cannula may be made of a metal, alloy, ceramic, or polymeric material. FIG. 18 thus illustrates a variant of the SES delivery device 1800 containing an outer cannula 1801 that houses an inner cannula 1802 that houses the SES device 401. Sliders 1803 and 1804 for moving the cannulas and the device are highlighted. The radii of the outer cannula 1801 and the inner cannula 1802 match those of the eye and the conduit 400 and may allow for validity in pivoting and advancing.

[0213] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving implant devices such as the minimally invasive SES401. In some embodiments, the delivery device 2000 may contain an outer cannula 1801 for accessing the choroid lymphatic vessel 400.

[0214] Figures 19A-19C illustrate a variant of the in situ SES delivery device 2000 that accesses the choroid lymphatic vessel 400 using the outer cannula 1801 and delivers the SES device 401 using the inner cannula 1802. An SES device for delivering the SES device 401 from the inner cannula 1802 is also shown.

[0215] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving implant devices such as the minimally invasive SES401. In some embodiments, the delivery device 2000 may contain an outer cannula 1801 for accessing the choroidal lymphatic vessel 400. FIG. 20 illustrates a variant of the SES delivery device 2000 that utilizes a positive pressure system 2001 to control the advancement, deployment, and retraction of the SES device 401. In some embodiments, the delivery device 2000 may contain a plunger 2002 for controlling (increasing or decreasing the pressure) within the sealed chamber 2001 and for controlling the movement of the SES device 401 along cannulas 1802 and 1801 into the choroidal lymphatic vessel 400. In some embodiments, the delivery device 2000 may contain a channel with a reducing perimeter, such as a cone 2004, for compressing the SES device 401 to a smaller diameter within the inner 1802 or outer 1801 cannula or both. In some embodiments, the delivery device 2000 may contain a sealed region 2005 (metal, alloy, ceramic, polymer, silicone, foam, etc.) for providing a highly efficient conversion of the pressure differential from the chamber 2001 to the linear movement of the SES device 401. In some embodiments, the chamber 2001 may be filled with a liquid, gas, or air so as to generate a pressure control device. The device may also be powered by an external energy source. In some embodiments, the delivery system 2000 may be provided as a unit for meshing with an existing syringe or delivery device for ease of use.

[0216] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving prosthetic devices such as the minimally invasive SES401. In some embodiments, the delivery device 2000 may contain an outer cannula 1801 for accessing the choroid lymphatic vessel 400. FIG. 21 illustrates a variant of the SES delivery device 2000 that utilizes a positive pressure system to control the advancement, deployment, and retraction of the SES device 401. In some embodiments, the delivery device 2000 may contain a sealed region 2105 (such as metal, alloy, ceramic, polymer, silicone, foam, etc.) for providing a highly efficient conversion of the pressure difference from the chamber 2101 to the linear movement of the SES device 401. In some embodiments, the chamber 2101 may be filled with liquid, gas, or air to generate a pressure control device. The device may also be powered by an external energy source. In some embodiments, the device 2000 may have a plunger or slider 2102 for controlling the delivery.

[0217] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving prosthetic devices such as the minimally invasive SES401. In some embodiments, the delivery device may utilize various contact boards 2201 (or plates or feather boards) that can contact the SES device 401 at a point, area, or plane such that the device can be incrementally advanced or retracted in any direction. In some embodiments, these contact boards 2201 may be made of metal, alloy, ceramic, polymer, or silicone material. FIGS. 22A and 22B illustrate representative sketches of settings such as for controlling the movement of the SES device 401.

[0218] Disclosed herein are embodiments of methods for advancing, delivering, positioning, repositioning, and / or retrieving implant devices such as the minimally invasive SES401. In some embodiments, the SES401 device may have a guidewire 2301 that can direct the SES401 device into the tube 400. In some embodiments, the guidewire 2301 may be selectively attached to the SES device 401 using an engagement portion 2302 by external control through a trigger or movement. In some embodiments, the guidewire 2301 may expand the SES device 401 to a smaller outer diameter and enable easier movement within the tube 400 or within the inner or outer cannula of the delivery system therein. In some embodiments, the guidewire 2301 may be used to be removed from or attached to the SES device 401 using an engagement portion 2302 that can be externally controlled trigger movement. FIGS. 23A and 23B illustrate variants of the SES delivery device 2300 that utilize a 2302 guidewire that can be selectively attached / removed from the SES device and control the advancement, deployment, and retraction of the SES device 401.

[0219] Disclosed herein are variants of the wire form SES device 401 that can be developed in a non-helical form with a partial or semi-circular sweep. In some other embodiments, the wire form SES device 401 may have a sweep that is either a complete or partial turn for proper stent placement in the longitudinal section of the tube 400. FIGS. 24A-24C contain illustrations and examples of some such embodiments.

[0220] Disclosed herein are embodiments of an SES device 401. FIG. 25A illustrates a curvilinear electropolished SES device with a variable pitch and a finished closed loop end along the length of the device. In some embodiments, the radius of curvature of the SES device may be designed to exactly match the curvature of the circumference of the grape membrane lymphatic vessels within the globe. In some embodiments, the radius of curvature may also be designed to provide a certain amount of tension or additional dilation to improve drainage through the collecting ducts. FIGS. 25B and 25C illustrate closer views of the proximal and distal ends, respectively. In some embodiments, the proximal end 2501 and / or distal end 2502 of the SES may have a tighter pitch 2503 compared to the body 2504 of the device, allowing for a smoother progression across the channel during delivery and, in addition, acting as a detour into the eye chamber for improved fluid circulation and drainage. In some embodiments, the body of the SES may have a wider pitch 2504 and maintain an equilibrium of the minimum amount of material required to keep the grape membrane lymphatic vessels in an expanded state for aqueous humor survival. In some embodiments, the SES may be processed via polishing methods such as mechanical, chemical, electrochemical polishing methods, etc. to improve the surface finish and, in addition, improve the biocompatibility of the surface. In some embodiments, the ends of the SES may be welded using a laser, heat, microwave, or other energy source to form a closed loop 2505 or other desired shape for ease of progression and safer implantation.

[0221] What is disclosed herein is a variant of an in situ SES device. FIG. 26A illustrates a variant of a curvilinear electropolished SES device 401 in situ within the choroidal lymphatic vessel 400. The narrow gauge wire of device 401 is prevented from crossing the perimeter of the tube 400 and blocking the collecting duct 2603. In some embodiments, the SES device 401 may have a uniform pitch across the length of the device. In some other embodiments, such as those shown in FIG. 26A, the SES device 401 may have a tightly wound pitch towards the two ends 2601 and 2604 and a wider pitch towards the body 2602. The wider pitch 2602 on the body can provide proper patency of the fluid within the channel without blocking any of the collecting ducts. The tightly wound ends can provide a complete or partial diversion of fluid from the anterior chamber into the channel to assist with fluid flow, clearance, and intraocular pressure. In some embodiments (such as those shown in FIG. 26B), the SES device 401 resides in situ within the choroidal lymphatic vessel 400 and may expand the tube while the proximal end 2601 extends into the anterior chamber across the channel at the wound 2605 such that the proximal end creates a diversion for fluid flow. In similar embodiments, the wound 2605 and the proximal end 2601 can provide an uninterrupted aqueous humor flow and clearance into the expanded choroidal lymphatic vessel 400 and reduce intraocular pressure. In some embodiments, such diversions may be provided at both ends of the device. In some embodiments (such as those shown in FIG. 26C), the SES device 401 resides in situ within the choroidal lymphatic vessel 400 and may expand the tube, while the proximal end 2601 extends along the same plane as the channel and creates a crushed wound opening 2605 and diversion for fluid flow. In some embodiments, such diversions may be provided at both ends of the device. FIG. 26D contains a perspective close-up view of a proximal end diversion variant where the tightly wound proximal and / or distal ends 2061 can be seen residing outside of the tube 400 with access into the tube 400 at the wound 2605. The wider body of the narrow gauge wire 2602 is shown not to block the collecting duct 2603.

[0222] What is disclosed herein is a variant for deploying an SES device. FIG. 27 illustrates a variant of a slide insertion type device for deploying an SES and a detailed exploded view of such a delivery system. In some embodiments, the SES delivery system may use a sliding action delivery system. In some embodiments, the delivery device may comprise a body 2707 and positioning screws 2704, 2705 for controlling the position of an outer or inner cannula 2701. In some embodiments, a plunger made from a wire or braided wire 2702 may be used to deploy, deliver, or retrieve the SES device. In some embodiments, the plunger 2702 may be controlled using a sliding wire 2703 that can be controlled using a slider 2706 nested within the inserter body 2707.

[0223] What is disclosed herein is an embodiment of a method for delivering a suturing device such as an SES401. In some embodiments, fluid pressure with a sealed area may be used to deliver the device. In some other embodiments, a feather board or collet advancement device may be used to deliver the device such that horizontal compression can lead to vertical movement or vice versa. In some other embodiments, the shape memory setting of the SES device 401 may be employed to deliver a device that is a wire and cause it to self-expand in its original position within a tube 400. In some other embodiments, the delivery device may have an uncoiler channel for improving the vector and reducing friction in the delivery of the SES device 401. In some other embodiments, the SES device 401 may be pre-tightened or wound up and delivered in this state, and may relax, extend, or expand in its original position within the tube 400. In some embodiments, a twist or axial roller may be used to deliver the SES device 400 within the cannula of the delivery device in its original position within the tube 400. In some embodiments, piezoelectric vibration and vibration using a micromotor may be used to deliver the SES device.

[0224] What is disclosed herein are embodiments of a method of using preoperative measurements of Schlemm's canal physiology to customize a device, e.g., a SES, for specific requirements. Imaging techniques such as optical microscopy, ultrasound, fluoroscopy, near-infrared imaging, CT scan, CSA (cross-sectional area), diameter measurement, etc. can be utilized in pre-treatment techniques to determine and customize the SES401 design to fit the specific physiological and anatomical needs of the patient. One or more customized devices can then be manufactured and then implanted, for example, in a separate procedure. However, sizing and implantation procedures can be combined in a single procedure in other embodiments.

[0225] It is contemplated that various combinations or sub - combinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the present inventions. Further, the disclosure herein of any specific feature, aspect, method, property, characteristic, quality, attribute, element, or equivalent related to an embodiment can be used in all other embodiments described herein. Thus, it should be understood that the various features and aspects of the disclosed embodiments can be combined with each other or substituted for each other to form various aspects of the disclosed invention. Accordingly, it is intended that the scope of the present invention disclosed herein should not be limited by the specific disclosed embodiments described above. Further, the present invention may be subject to various modifications and alternative forms, and specific examples thereof are shown in the drawings and described in detail herein. However, the present invention is not limited to the specific forms or methods disclosed, but on the contrary, the present invention encompasses all modifications, equivalents, and alternatives that fall within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner, but they can also include any third - party instructions of those actions, either explicitly or implicitly. For example, an action such as "inserting an SES proximate to the distal end of the Schlemm's canal" includes "instructing to insert an SES proximate to the distal end of the Schlemm's canal". The scope disclosed herein also encompasses any and all overlaps, sub - ranges, and combinations thereof. Terms such as "maximum", "at least", "above", "below", "between", and equivalents include the recited numbers. Numbers preceded by terms such as "approximately", "about", and "substantially" as used herein include the recited numbers and still represent an amount close to the described amount that performs the desired function or achieves the desired result.For example, the terms “about,” “approximate,” and “substantially” can refer to amounts that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the quantity being described.

Claims

[Claim 1] The invention described in this specification.

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