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WO2024182448A1 - Implants pour le traitement d'affections oculaires - Google Patents

Implants pour le traitement d'affections oculaires Download PDF

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Publication number
WO2024182448A1
WO2024182448A1 PCT/US2024/017558 US2024017558W WO2024182448A1 WO 2024182448 A1 WO2024182448 A1 WO 2024182448A1 US 2024017558 W US2024017558 W US 2024017558W WO 2024182448 A1 WO2024182448 A1 WO 2024182448A1
Authority
WO
WIPO (PCT)
Prior art keywords
shunt
implantable intraocular
filaments
bio
shunt body
Prior art date
Application number
PCT/US2024/017558
Other languages
English (en)
Inventor
Sam B. PARK
Reay Hugh BROWN
Original Assignee
Sight Sciences, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sight Sciences, Inc. filed Critical Sight Sciences, Inc.
Publication of WO2024182448A1 publication Critical patent/WO2024182448A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2401/00—Physical properties
    • D10B2401/12—Physical properties biodegradable
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/06—Vascular grafts; stents

Definitions

  • the present disclosure relates to ocular implants and their use for treating ocular conditions.
  • Glaucoma is a group of optic neuropathies associated with specific structural changes to the optic nerve ultimately leading to irreversible visual field loss. In many cases, this loss of vision is progressive and leads to blindness if untreated. According to the National Eye Institute at the United States National Institutes of Health, glaucoma is the leading cause of irreversible blindness worldwide. In 2020, approximately three million people in the United States carry a diagnosis of glaucoma. Worldwide, that number is 80 million people. By 2040, it is expected that over 110 million people will be living with this potentially blinding condition ("Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040", Ophthalmology 2014; 121 :2081-2090).
  • Glaucoma generally falls into two categories: open angle glaucoma and closed angle glaucoma.
  • Open angle glaucoma is approximately seven times more common than the closed angle form in both the U.S. and Europe (Quigley HA, Broman AT. Br. J. Ophthalmol. 2006; 90(3):262-267).
  • the course of both forms of the disease is, typically, a chronic and progressive loss of vision, leading to constriction of the visual field.
  • the ultimate result is permanent blindness. Because it is typically asymptomatic until the disease is significantly advanced, early diagnosis through regular eye exams and early treatment are critical.
  • Risk factors associated with glaucoma include family history, ethnic origin, and age. Having a first degree relative with glaucoma is associated with a significantly increased risk (Wolfs RC, Klaver CC, Ramrattan RS, van Duijn CM, Hofman A, de Jong PT. Arch Ophthalmol. 1998; 116(12): 1640-1645). Black and Hispanic individuals have increased prevalence of open angle glaucoma. Additionally, they are often diagnosed with more severe disease. Asian, Southeast Asian, Asian Indian, and Inuit individuals are more often diagnosed with closed angle glaucoma (see e.g., Varma R, Ying-Lai M, Francis BA, et al.; Los Angeles Latino Eye Study Group.
  • Closed angle glaucoma typically results from anatomic obstruction of the anterior chamber angle and its associated drainage channels.
  • the anatomic obstruction prevents aqueous humor from efficiently reaching the drainage channels thereby resulting in increased intraocular pressure.
  • Surgical iridectomy, laser iridotomy, or lensectomy are often considered more definitive surgical options versus more palliative medical therapy such as cholinergic drugs (e.g., pilocarpine eyedrops) to relive obstruction by pupil constriction.
  • Open angle glaucoma is much more common in the U.S., and it accounts for significantly more loss of vision that its closed counterpart. While the exact pathophysiology of OAG is not completely understood, it has been demonstrated that increased intraocular pressure (IOP) correlates with retinal ganglion cell death. There is a relationship between secretion of aqueous humor by the ciliary body and its egress from the eye via conventional trabecular meshwork pathways and the unconventional uveoscleral pathway. This relationship and any resultant imbalances determine IOP. It is felt that an increased resistance to outflow in the trabecular meshwork or more distal aqueous collector channels are associated with increased IOP in OAG.
  • IOP intraocular pressure
  • Increased IOP may cause mechanical stress on the lamina cribrosa, where retinal ganglion cell axons exit the eye to coalesce into the optic nerve.
  • lOP-induced stress at the lamina cribrosa can deform, damage, and interfere with the retinal axons leading to irreversible injury and vision loss. While such IOP associated damage typically occurs when the pressure is above the population average pressures, it can occur at lower or “normal” pressure depending on an individual’s vulnerability. Conversely, many people with higher-than-average IOP never develop glaucoma. A growing number of studies are identifying genomic loci associated with glaucoma susceptibility.
  • glaucoma may develop in patients with an intraocular pressure relatively high for their individual susceptibility (see e.g., Thorleifsson G, Walters GB, Hewitt AW, et al. Nat Genet. 2010;42(10):906-909; and Wiggs JL, Yaspan BL, Hauser MA, et al. PLoS Genet. 2012;8(4):el002654).
  • ganglion cell death does occur in glaucoma, characteristic changes in the optic nerve head and the nerve fiber layer become evident. This eventually is associated with characteristic visual field loss patterns.
  • Prompt referral to an eye care specialist is critical to treat the glaucoma and slow the progression of irreversible damage and subsequent loss of vision.
  • the primary goal of treatment is to slow progressive optic nerve damage in order to preserve vision and quality of life. Early diagnosis and intervention are critical given that visual loss is irreversible. Reduction of IOP with treatment combined with continuous diagnostic assessments of treatment efficacy are part of the mainstay of glaucoma care.
  • treatment is typically comprised of the least number of medications required to adequately reduce IOP.
  • Medications include drugs from the following families of compounds: prostaglandins, prostaglandin analogs, beta-adrenergic blockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, Rho-kinase (ROCK) inhibitors, and cholinergic drugs.
  • Trabeculectomy, valves, or shunts can be used to help control IOP.
  • MIGS minimally invasive glaucoma surgery
  • Various technologies are being employed to reduce IOP while reducing exposure to surgical risks posed by more invasive treatments like trabeculectomy or valve placement.
  • 2017. nearly 175,000 surgical procedures were performed.
  • MIGS procedures Ma AK, Lee JH, Warren JL, Teng CC. Clin Ophthalmol. 2020;14:2551-2560.
  • Drops can be cost prohibitive for patients, and patients can forget to regularly use them. Additionally, proper instillation into the conjunctival cul-de-sac may be more difficult, especially in the hands of the elderly or arthritic. Excessive instillation, such as instilling multiple drops, and subsequent wasting of medication is also an issue. However, even with proper instillation of the eyedrops, medication is wasted. For instance, a typical eyedrop may be 60-90 microliters, but the ocular surface can typically hold no more than 10 microliters. The therapeutic ingredients and the preservatives with which they are often combined can lead to ocular surface disease, discomfort, inflammation, dry eye, and reduced corneal sensitivity, all of which can irritate the eye and further reduce compliance. Multiple eyedrop medications can also lead to confusion and misuse of the medications. All of these factors combine to create problems with the mainstay of glaucoma therapy-drugs. However, medications do avoid a lot of the more serious complications that can occur with surgery.
  • shunts for draining aqueous humor utilize a lumen through which the aqueous humor flows.
  • the lumen may be present at the time of implantation, or the implant may expand upon implantation, creating the lumen in vivo.
  • shunting aqueous away from the anterior chamber is the most common surgical treatment (e.g., trabeculectomy) for glaucoma
  • a number of problems with existing shunts e.g., those with lumens
  • the implantation of such intraocular shunts can result in permanent scarring around the shunt in the subconjunctival space.
  • An implantable intraocular shunt for treating a condition of the eye, and their methods for use, are disclosed herein.
  • An implantable intraocular shunt may have a plurality of interconnected filaments forming a shunt body.
  • the body may have a delivery configuration and an implanted configuration.
  • a maximum height of the shunt body in the delivery configuration may be greater than the maximum height of the shunt body in the implanted configuration.
  • the shunt body may include a plurality of gaps between the plurality of filaments. In some variations, at least one gap of the plurality of gaps may have a parallelogram shape.
  • At least an internal surface of a filament of the plurality of filaments of an upper portion of the shunt body may be disposed in a gap of the plurality of gaps of a lower portion of the shunt body.
  • least one filament of the plurality of filaments may have a first diameter (DI) and at least one filament of the plurality of filaments may have a second diameter (D2).
  • DI first diameter
  • D2 second diameter
  • the at least one filament of the plurality of filaments with DI may be bio-erodible and the at least one filament of the plurality of filaments with D2 may be non- bio-erodible.
  • the plurality of filaments may be braided and/or woven, and the implantable intraocular shunt may include between 2 and 32 filaments. In some variations, the plurality of filaments may be braided and/or woven, and the implantable intraocular shunt may include between 6 and 16 filaments. Additionally, the implantable intraocular shunt may include 8 or 16 filaments. For example, the implantable intraocular shunt may have 8 filaments. Furthermore, the shunt body may include a weakened region. In some variations, the shunt body may be configured to reside at least partially within a suprachoroidal space of an eye.
  • the shunt body may include a proximal portion and a distal portion, and the proximal portion may be configured to reside at least partially within an anterior chamber of an eye.
  • the shunt body may be configured to transfer fluid along an external surface of the shunt body.
  • the shunt body may be configured to transfer fluid along only an external surface of the shunt body.
  • the shunt body may be configured to receive a portion of a delivery device.
  • the shunt body may be configured to transition from the delivery configuration to the implanted configuration upon release from a delivery device. Additionally, or alternatively, the shunt body may be configured to transition from the delivery configuration to the implanted configuration via contact with intraocular tissue.
  • At least one of the plurality of filaments may have a diameter (D).
  • the at least one gap may have a width dimension (“W”) between about D and about 15D. Further, the at least one gap may have a length dimension (“L”) between about D and about 15D.
  • the X dimension and/or the Y dimension may be about 4D.
  • the shunt body may lack a primary lumen in the implanted configuration. Additionally, the shunt body may have an upper portion with a thickness of about D to about 2D. The shunt body may have a lower portion with a thickness of about D to about 2D.
  • D may be between about 20 pm and about 300 pm. For example, D may be between about 40 pm and about 200 pm. As another example, D may be between about 60 pm and about 70 pm.
  • the implantable intraocular shunt may have a Pick Count (PC) associated with the plurality of filaments.
  • the PC may be between about 15 and about 50 picks per inch (PPI). Additionally, the PC may be between about 15 and about 20 PPI.
  • the shunt body may have a primary lumen between a proximal end and a distal end of the shunt body.
  • the primary lumen may have an elliptical cross-sectional shape.
  • the primary lumen may have a circular cross-sectional shape.
  • the primary lumen may have a pointed oval cross-sectional shape.
  • the shunt body may have a length of about 1 mm to about 20 mm.
  • the shunt body in the delivery configuration, may have a circular cross-sectional shape with a diameter of between about 100 pm and about 1100 pm.
  • the shunt body in the delivery configuration, may have an elliptical cross-sectional shape with a minor axis of between about 100 pm and about 600 pm, and a major axis of between about 100 pm and about 1100 pm.
  • the maximum height of the shunt body may be between about 100 pm and about 600 pm, and a width of the shunt body may be between about 100 pm and about 1100 pm.
  • the maximum height of the shunt body in the implanted configuration, may be between about 300 pm and about 500 pm, and a width of the shunt body may be between about 500 pm and about 1100 pm.
  • At least one filament of the plurality of filaments may include a bio-erodible material.
  • each filament of the plurality of filaments may include a bio-erodible material.
  • least one filament of the plurality of filaments may include a bio-erodible material and at least one filament of the plurality of filaments comprises a non-bio-erodible material.
  • the shunt body may include a proximal portion, a distal portion, and a central portion, and the proximal portion may include a bio-erodible material while one or more of the distal portion and the central portion may include a non-bio-erodible material.
  • the shunt body may include a proximal portion, a distal portion, and a central portion, and the distal portion may include a bio-erodible material while one or more of the proximal portion and the central portion may include a non-bio-erodible.
  • the bio-erodible material may include one or more of polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-lactide) (PGLA), polydioxanone (PDO), and polyglyconate.
  • the implantable intraocular shunt may include at least one rigid longitudinal strand running through at least a portion of the shunt body.
  • at least one rigid longitudinal strand may be bio-erodible and the plurality of filaments may be non-bio-erodible.
  • at least one rigid longitudinal strand and the plurality of filaments may be both bio-erodible.
  • at least one rigid longitudinal strand may have a first dissolution rate and at least one of the plurality of filaments may have a second dissolution rate. The first dissolution rate may be lower than or higher than the second dissolution rate.
  • the shunt body may further include a bio-erodible layer.
  • the bio-erodible layer may be disposed on one or both of an external surface and an internal surface of the shunt body.
  • the bio-erodible layer may be an adhesive layer, a bio glue, a viscoelastic material, or any combination thereof.
  • at least one filament of the plurality of filaments may include a bio-erodible material with a lower dissolution rate than a dissolution rate of the bio-erodible layer.
  • at least one filament of the plurality of filaments may have a bio-erodible material with a higher dissolution rate than a dissolution rate of the bio-erodible layer.
  • the shunt body may have a proximal end and a distal end. Additionally, the plurality of filaments may be joined at one or more of the proximal end and the distal end. The plurality of filaments may be joined by one or more of a bio-erodible collar, a non-bio-erodible collar, a bio-erodible adhesive, a non-bio-erodible adhesive, heat staking, laser welding, and mechanical fastening.
  • At least one filament of the plurality of filaments may have a lumen.
  • each filament of the plurality of filaments may have a lumen.
  • at least one filament of the plurality of filaments may include a fenestration configured to provide fluid contact between the lumen and an exterior surface of the shunt body.
  • Another implantable intraocular shunt may include a shunt body including a plurality of interconnected filaments.
  • the shunt body may have a round delivery configuration and a substantially flat implanted configuration. Additionally, the shunt body may be configured to transfer fluid along an external surface of the shunt body in the implanted configuration.
  • another implantable intraocular shunt may include a shunt body including a plurality of interconnected filaments.
  • the shunt body may have an upper portion, a lower portion, a proximal portion, a distal portion, an open configuration, and a collapsed configuration.
  • the upper portion and the lower portion may be curved in the open configuration and generally flat in the collapsed configuration. In the collapsed configuration, the upper and lower portions may form an upper layers and a lower layer, respectively.
  • another implantable intraocular shunt may include a shunt body including a plurality of interconnected filaments.
  • the shunt body may have an open configuration and a collapsed configuration. Additionally, the shunt body may be configured to receive a portion of a delivery device in the open configuration and may be configured to transfer fluid along an external surface of the shunt body in the collapsed configuration.
  • Yet another implantable intraocular shunt may include a plurality of interconnected filaments forming a shunt body having an upper portion and a lower portion.
  • the shunt body may have a delivery configuration and an implanted configuration.
  • an internal surface of the upper portion and an internal surface of the lower portion may be separated by a first maximum height.
  • at least a portion of the internal surface of the upper portion and at least a portion of the internal surface of the lower portion may be separated by no more than a second, smaller height.
  • at least a portion of the internal surface of the upper portion may contact at least a portion of the internal surface of the lower portion.
  • a method of treating a condition of an eye may include advancing an implantable intraocular shunt in a delivery configuration into the eye, positioning at least one end of the shunt within a suprachoroidal space of the eye, and releasing the implantable intraocular shunt from a delivery device with the portion disposed within the suprachoroidal space of the eye.
  • the shunt may be configured to collapse to an implanted configuration after release.
  • fluid may be directed away from anterior chamber to the suprachoroidal space along an external surface of the shunt in the implanted configuration.
  • the condition of the eye may be glaucoma.
  • the proximal end of the shunt may be positioned in an anterior chamber of an eye, and the distal end may be positioned in the suprachoroidal space of the eye.
  • another method of treating a condition of an eye may include advancing an implantable intraocular shunt disclosed herein in a delivery configuration into the eye, positioning at least one end of the shunt within a suprachoroidal space of the eye, and releasing the implantable intraocular shunt from a delivery device with the portion disposed within the suprachoroidal space of the eye.
  • the shunt may be configured to collapse to an implanted configuration after release.
  • fluid may be directed away from anterior chamber to the suprachoroidal space along an external surface of the shunt in the implanted configuration.
  • the condition of the eye may be glaucoma.
  • the proximal end of the shunt may be positioned in an anterior chamber of an eye, and the distal end may be positioned in the suprachoroidal space of the eye.
  • FIG. 1 shows a cross-sectional view of the anatomy of a normal human eye.
  • FIG. 2 shows a cross-sectional view of the anatomy of a human eye with an exemplary implant residing partially within a suprachoroidal space of the eye.
  • FIG. 3 A shows a top view of a schematic depiction of a single layer of an embodiment of a collapsible intraocular shunt with braided filaments.
  • FIG. 3B shows an embodiment of an intraocular shunt comprising a braided shunt body with eight filaments.
  • FIG. 4A shows a cross-sectional view of an embodiment of an intraocular shunt with an elliptical shunt body in a delivery configuration.
  • FIG. 4B shows a cross-sectional view of an embodiment of a circular shunt body in a delivery configuration.
  • FIG. 4C shows a cross- sectional view of an embodiment of a pointed oval shunt body with a pre-formed crush plane in a delivery configuration.
  • FIG. 4D shows a cross-sectional view of an embodiment of a shunt body with two lumens, in a delivery configuration.
  • FIG. 4E shows a cross-sectional view of the shunt body of FIG. 4D, in an implanted configuration.
  • FIG. 4F shows a cross-sectional view of an embodiment of a shunt body with three lumens, in a delivery configuration.
  • FIG. 4G shows a cross-sectional view of the shunt body of FIG. 4F, in an implanted configuration.
  • FIG. 4H shows a cross-sectional view of an embodiment of a shunt body with four lumens, in a delivery configuration.
  • FIG. 41 shows a cross-sectional view of the shunt body of FIG. 4H, in an implanted configuration.
  • FIG. 5 A shows a cross-sectional view of an embodiment of a pointed oval shunt body, with height and width dimensions indicated.
  • FIG. 5B shows an embodiment of a braided shunt body comprising eight filaments with a length dimension indicated.
  • FIG. 5C shows a perspective view of an embodiment of a braided shunt body comprising eight filaments.
  • FIG. 6A shows braided filaments of a shunt body.
  • FIG. 6B is a schematic depiction of a braided shunt body with a plurality of gaps.
  • FIG. 7A and FIG. 7B depict a side view and a perspective view, respectively, of a portion of a braided shunt body in an implanted configuration.
  • FIG. 7C shows a cross-sectional view of an embodiment of a braided shunt body with layer thickness indicated.
  • FIG. 8A shows a side view of an embodiment of a braided shunt body in an implanted configuration.
  • FIG. 8D shows a cross-sectional view of the braided shunt body of FIG. 8 A in an implanted configuration.
  • FIG. 8B shows a top view of an embodiment of a portion of a single layer of a braided shunt body in an implanted configuration.
  • FIG. 8C shows a perspective view of an embodiment of a braided shunt body in an implanted configuration.
  • FIG. 9A shows a side view of an embodiment of a braided shunt body comprising 16 filaments in a delivery configuration.
  • FIG. 9B shows a top view of the braided shunt body of FIG. 9A comprising 16 filaments in a delivery configuration.
  • FIG. 9C shows a perspective view of the braided shunt body of FIG. 9A comprising 16 filaments in a delivery configuration.
  • FIG. 9D shows a cross-sectional view of the braided shunt body of FIG. 9D comprising 16 filaments in a delivery configuration.
  • FIG. 10A shows a generalized depiction of a single layer of a shunt body comprising two types of filaments (e.g., bio-erodible, non-bio-erodible).
  • FIG. 10B shows an embodiment of a braided shunt body with eight filaments comprising two types of filaments in a delivery configuration.
  • FIG. 10C shows a perspective view of the braided shunt body of FIG. 10B with eight filaments comprising two types of filaments in a delivery configuration.
  • FIG. 11 A shows a generalized depiction of a single layer of a shunt body with two different regions comprising different types of filaments (e.g., bio-erodible, non-bio-erodible).
  • FIG. 10A shows a generalized depiction of a single layer of a shunt body comprising two types of filaments (e.g., bio-erodible, non-bio-erodible).
  • FIG. 1 IB shows an embodiment of a shunt body, with two different regions comprising different types of filaments, in a delivery configuration.
  • FIG. 11C shows a perspective view of the shunt body of FIG. 1 IB with eight filaments, with two different regions comprising different types of filaments, in a delivery configuration.
  • FIG. 12A shows a top view of an embodiment of a shunt body with longitudinal strands within the weave of filaments, in a delivery configuration.
  • FIG. 12B shows a perspective view of the shunt body of FIG. 12 A with longitudinal strands within the weave of filaments, in a delivery configuration.
  • FIG. 13 A shows an embodiment of a shunt body in a delivery configuration, where the braided filaments are covered in an encasing material.
  • FIG. 13B shows a perspective view of the shunt body of FIG. 13 A in a delivery configuration, wherein the braided filaments are covered in an encasing material.
  • FIG. 14A shows an embodiment of a shunt body in a delivery configuration, where individual filaments are joined at discrete points at the proximal and distal ends of the shunt body.
  • FIG. 14B shows a perspective view of the shunt body of FIG. 14A in a delivery configuration, where individual filaments are joined at discrete points at the proximal and distal ends of the shunt body.
  • FIG. 15A shows an embodiment of a shunt body in a delivery configuration, where the distal and proximal ends are capped with a collar.
  • FIG. 15B shows a perspective view of the shunt body of FIG. 15A in a delivery configuration, where the distal and proximal ends are capped with a collar.
  • FIG. 16A shows an embodiment of a shunt body with an internal liner.
  • FIG. 16B shows a perspective view of the shunt body of FIG. 16A with an internal liner.
  • FIG. 17A shows an embodiment of a shunt body with a braided configuration, comprising 16 filaments, in a delivery configuration.
  • FIG. 17B shows a cross-sectional view of the shunt body of FIG. 17A in a delivery configuration.
  • FIG. 17C shows a generalized view of a braided structure, with a plurality of gaps, of a shunt body.
  • FIG. 17D shows a perspective view of the shunt body of FIG. 17A in a delivery configuration.
  • FIG. 18A and FIG. 18B show an embodiment of a shunt body with a number of fenestrations.
  • FIG. 18C shows another embodiment of shunt body with a number of fenestrations.
  • FIG. 19A and FIG. 19B show two embodiments of shunt bodies comprising bundles of braided tubes.
  • FIG. 20A and FIG. 20B show two embodiments of flat shunt bodies with lumens and channels, respectively.
  • FIG. 21 A shows an embodiment of a flat shunt body in a delivery configuration.
  • FIG. 21B shows the flat shunt body of FIG. 21 A in an implantation configuration.
  • FIG. 22 and FIG. 23 show two embodiments of implant bodies with lumens and channels, respectively.
  • FIG. 24 shows an embodiment of an implant body comprising braided wicking filaments.
  • FIG. 25 shows an embodiment of a non-braided implant body comprising a sponge material.
  • FIG. 26 shows an exemplary implant body labeled with 3 -dimensional axes for describing planes along which a weakened region lies.
  • FIG. 27A, FIG. 27B, and FIG. 27C show exemplary fluid pathways along exemplary implants.
  • implantable intraocular devices e.g., shunts
  • methods for treating ocular conditions of the eye e.g., the devices described herein are intended to be implanted in the eye (e.g., within the suprachoroidal space of the eye) while minimizing or eliminating cyclodialysis and scarring.
  • the devices are generally configured to have a delivery configuration (e.g., expanded, lengthened, un-collapsed, uncompressed) before and during implantation into the eye, and an implanted configuration (e.g., flattened, shortened, collapsed, compressed) after implantation.
  • one or more tissues surrounding the device may naturally apply pressure to the device, which may transition, or assist in transitioning, the device to its implanted configuration.
  • fluid may flow away from part of the eye (e.g., anterior chamber) along one or more parts of the device (e.g., a filament) to be absorbed through the vasculature of the eye (e.g., within the sclera, choroidal vasculature) while minimally disrupting the surrounding tissue.
  • the devices may be wholly or partly constructed of a bio-erodible material, such that, over time, the devices may safely dissolve, allowing the tissues surrounding the implant location to close and heal.
  • the devices may be wholly or partly constructed of a bio-erodible material, such that, over time, the devices may safely dissolve, allowing a gap in the tissues to stay open permanently or semi-permanently.
  • FIG. 1 shows a stylized partial cross-sectional view of the anatomy of a normal human eye.
  • the eye can be conceptualized as a fluid filled sphere. Anteriorly, it is bounded by the cornea (100), a three-layered clear tissue that allows entry of light, and functions like a protective window allowing for entry of light into the eye.
  • the periphery of the cornea (100) is known as the corneal limbus (“limbus”) (102) which defines the junction with the sclera (104).
  • the limbus (102) contains stem cells for the ocular surface, contains numerous aqueous outflow pathways, and is highly vascularized.
  • the sclera (104) is the opaque, tough, protective, outer layer of the eye. Like the cornea it is essentially avascular. Overlying the sclera (104) is the conjunctiva (106), the thin, clear tissue that overlies the sclera (104) and the inside of the eyelids. By contributing mucus and tears, it helps lubricate the ocular surface. In addition, it is vascularized, and it helps contribute to ocular immune responses. The space below the conjunctiva is the subconjunctival space (122).
  • iris Posterior to the cornea, is the iris (108), or the colored part of the eye. It is an annular structure which can adjust its aperture (pupil) to regulate the amount of light entering the eye. Bright light causes constriction of the pupil thereby limiting exposure to excessive light or resulting glare. Under dim lighting, the pupil opens to capture more of the available light.
  • the anterior chamber angle (110) which is filled with aqueous humor, resides between the iris and cornea. At its periphery, there is the anterior chamber angle (110), where aqueous drains out of the eye through the trabecular meshwork and Schlemm’s canal.
  • the lens (112) Behind the iris (108) is the lens (112).
  • the normal lens is transparent, and it focuses light on the retina to create a clear image. With age or disease, the lens (112) may cloud, and this is known as cataract.
  • the lens (112) is suspended in the eye by fibers known as lens zonules. One end of the zonules attach around the equator of the lens (112). The other end of the zonules attaches to the ciliary body (114). Contraction and relaxation of the ciliary body alter load on the zonules thereby resulting in increased curving of the lens or flattening of the lens (112). This is the primary mechanism our eyes use for focusing.
  • the ciliary body (114) not only contains muscles that apply load to the zonules, but it is also responsible for secreting aqueous humor which travels through the ciliary sulcus (116), the peripheral part of the posterior chamber. Implants or devices residing in the ciliary sulcus or peripheral posterior chamber avoid the visual axis and thus do not interfere with vision. Aqueous humor flows into the ciliary sulcus and posterior chamber into the pupil and ultimately into the anterior chamber (110). Research has also shown that aqueous humor currents can also drive fluid and substances through the vitreous and through the retina. In other words, the currents are bidirectional.
  • the posterior chamber is the space in the eye behind the iris and in front of the lens.
  • the ciliary sulcus (116) is the space between the front of the ciliary body (114) and the posterior surface of the iris. This part of the posterior chamber is typically 12 mm in diameter.
  • the vitreous humor (118) is the gelatinous substance filling the central cavity of the eye. Its volume is approximately 4-4.5 mL. It is bounded by the retina peripherally and posteriorly. Anteriorly, it is bounded by Berger’s space, which separates the vitreous cavity from the lens centrally and by the canal of Petit, also known as spatia zonularis, which separates it from the lens peripherally.
  • the retina is the photosensitive nerve layer lining the back of the eye. In humans, the retina has ten layers, with the outermost, or closest to the sclera (104), being the retinal pigment epithelium. This layer has been implicated in macular degeneration.
  • the choroid (120) is a high flow, low resistance vascular layer that nourishes and oxygenates the outer two thirds of the retina. It has also been implicated in macular degeneration. Sitting between the choroid (120) and the sclera is the suprachoroidal space.
  • the macula is a region of the retina that accounts for high contrast, crisp vision. It is the functional center of the retina and gives humans their central vision. For example, the ability to read or recognize faces clearly is dependent on the macula. Macular degeneration affects this area, and thus can have devastating impact on vision.
  • the optic nerve is the coalescence of approximately 1 million retinal axons carrying visual information from the eye to vision centers in the brain.
  • the devices described herein may be implantable intraocular shunts configured to provide one or more (e.g., a plurality, two or more, three or more, etc.) drainage pathways from a first location or part of the eye to a second location or part of the eye.
  • the shunts may be configured to each provide one or more drainage pathways from the anterior chamber of an eye to a suprachoroidal space in order to lower intraocular pressure.
  • FIG. 2 is another stylized depiction of a normal human eye with an exemplary implantable intraocular shunt (206).
  • the anterior chamber (200) is shown as bounded on its anterior surface by the cornea (202).
  • the cornea (202) is connected on its periphery to the sclera (204).
  • Schlemm’s canal (208) extends 360 degrees circumferentially around the trabecular meshwork.
  • At the apex formed between the iris (210) and sclera (204) is the anterior chamber angle (212).
  • the suprachoroidal space (214) lies between the sclera (204) and the choroid (216).
  • an intraocular shunt (206) is depicted with a distal end residing within the suprachoroidal space (214) with a proximal end residing in the anterior chamber (200).
  • the implantable intraocular shunts described herein may comprise a shunt body with a delivery configuration (e.g., expanded, lengthened, uncollapsed, uncompressed) that, for instance, allows a medical professional to easily handle the shunt and to assist in targeting the desired implantation site in an eye.
  • a delivery configuration e.g., expanded, lengthened, uncollapsed, uncompressed
  • the shunt body may transition to an implanted configuration (e.g., flattened, shortened, collapsed, compressed), which has a relatively small profile compared to current conventional shunts, and may lack a primary lumen to allow for controlled flow of all or a majority of the aqueous humor.
  • an implanted configuration e.g., flattened, shortened, collapsed, compressed
  • the intraocular shunts described herein may comprise a shunt body with a maximum height in the delivery configuration that is greater than a maximum height of the shunt body in the implanted configuration.
  • shunt bodies of the implantable intraocular shunts described herein may have a first delivery configuration for advancement to and placement within the eye, and a second, different, implanted configuration, in which the shunt body is configured to transfer fluid along the shunt body.
  • shunt bodies may be implanted in the eye while in the delivery configuration, after which the shunt may transition to the implanted configuration, by, for example, collapsing.
  • shunts described herein may remain in the implanted configuration during use, in which they may transfer fluid along one or more surfaces (e.g., an external surface of the shunt body, an external surface of one or more filaments of a shunt body) of the shunt body.
  • shunt bodies described herein may be configured to primarily transfer fluid along an external surface of the shunt body.
  • the shunt bodies may be configured to transfer fluid along only an external surface of the shunt body.
  • An external surface of the shunt body may be, for instance, an outward-facing surface of the shunt body (e.g., a surface facing tissue as opposed to facing another portion of the shunt body in the delivery configuration, a surface along an outer perimeter of the shunt body in the delivery configuration), such as, an external, outward-facing surface of one or more of a plurality of filaments of the shunt body (e.g., a tissue-facing surface of one or more filaments, a surface of a filament along an outer perimeter of the shunt body).
  • an outward-facing surface of the shunt body e.g., a surface facing tissue as opposed to facing another portion of the shunt body in the delivery configuration, a surface along an outer perimeter of the shunt body in the delivery configuration
  • an external, outward-facing surface of one or more of a plurality of filaments of the shunt body e.g., a tissue-facing surface of one or more filaments, a surface of a filament along an
  • a shunt body may be configured to transfer fluid along an internal surface of the shunt body (e.g., an inward-facing surface of one or more of a plurality of filaments, a surface facing another portion of the shunt body in the delivery configuration, a surface along an inner perimeter of the shunt body in a delivery configuration).
  • a shunt body may be additionally or alternatively configured to allow for fluid to flow within the shunt body, such as, between one or more filaments (e.g., within interstitial spaces of the shunt body formed between the filaments).
  • FIG. 27A shows a perspective view of a braided filament shunt body (2700A) in an implanted configuration comprising a plurality of filaments (2702A).
  • fluid (2704A) flows from one end of the implant (e.g., at a cyclodialysis, 2708A) in paths (2706A) along external surfaces and/or within interstitial spaces of the shunt body (2700A).
  • FIG. 27B shows a side view of an exemplary braided filament shunt body (2700B) in an implanted configuration comprising a plurality of filaments (2702B).
  • Fluid (2704B) may move from one end of the implant (e.g., at a cyclodialysis, 2708B) in paths (2706B) along external surfaces and/or within interstitial spaces of the shunt body (2700B).
  • FIG. 27C shows another view of an exemplary shunt body (2700C) in an implanted configuration comprising a plurality of filaments (2702C). Fluid (2704C) flows from one end of the implant in paths (2706C) along external surfaces and/or within interstitial spaces of the shunt body (2700C).
  • the simulated fluid pathways are not limited to those shown in their respective figures and may originate at any point along the cross-sectional area of the shunt body.
  • the paths are the thin lines denoting various fluid flow pathways.
  • the shunt bodies described herein may be configured to transition between a first delivery configuration and a second implanted configuration, and in some embodiments, may be configured to collapse and/or deform from the delivery configuration to the implanted configuration, thereby changing one or more dimensions (e.g., height, width) of the shunt bodies.
  • the maximum height and/or maximum width of the shunt body may be different between a delivery configuration and an implanted configuration. For instance, the maximum height may be greater in the delivery configuration than in the implanted configuration. The maximum width may be the same or greater in the implanted configuration than in the delivery configuration.
  • the delivery configuration and the implanted configuration are the same (e.g., the shunt body does not change shape upon implantation).
  • the maximum height and/or the maximum width of the shunt body in the implanted configuration may between about 50 pm and about 1100 pm.
  • the maximum height and/or the maximum width of the shunt body may independently be about 50 pm and about 1100 pm, about 50 pm and about 1000 pm, about 50 pm and about 900 pm, about 50 pm and about 800 pm, about 50 pm and about 700 pm, about 50 pm and about 600 pm, about 50 pm and about 500 pm, about 50 pm and about 400 pm, about 50 pm and about 300 pm, about 50 pm and about 200 pm, about 50 pm and about 100 pm, about 100 pm and about 1100 pm, about 100 pm and about 1000 pm, about 100 pm and about 900 pm, about 100 pm and about 800 pm, about 100 pm and about 700 pm, about 100 pm and about 600 pm, about 100 pm and about 500 pm, about 100 pm and about 400 pm, about 100 pm and about 300 pm, about 100 pm and about 200 pm, about 200 pm and about 1100 pm, about 200 pm and about 1000 pm, about 200 pm and about 1000 pm, about 200 pm and about
  • the maximum height and/or maximum width may be independently about 50 pm, 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 350 pm, 400 pm, 450 pm, 500 pm, 550 pm, 600 pm, 650 pm, 700 pm, 750 pm, 800 pm, 850 pm, 900 pm, 950 pm, 1000 pm, 1050 pm, or 1100 pm.
  • the maximum height and/or the maximum width of the shunt body in the delivery configuration may be between about 50 pm and about 1100 pm.
  • the maximum height and/or the maximum width of the shunt body are independently about 50 pm and about 1100 pm, about 50 pm and about 1000 pm, about 50 pm and about 900 pm, about 50 pm and about 800 pm, about 50 pm and about 700 pm, about 50 pm and about 600 pm, about 50 pm and about 500 pm, about 50 pm and about 400 pm, about 50 pm and about 300 pm, about 50 pm and about 200 pm, about 50 pm and about 100 pm, about 100 pm and about 1100 pm, about 100 pm and about 1000 pm, about 100 pm and about 900 pm, about 100 pm and about 800 pm, about 100 pm and about 700 pm, about 100 pm and about 600 pm, about 100 pm and about 500 pm, about 100 pm and about 400 pm, about 100 pm and about 300 pm, about 100 pm and about 200 pm, about 200 pm and about 1100 pm, about 200 pm and about 1000 pm, about 200 pm and
  • the maximum height and/or maximum width may independently be about 50 pm, 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 350 pm, 400 pm, 450 pm, 500 pm, 550 pm, 600 pm, 650 pm, 700 pm, 750 pm, 800 pm, 850 pm, 900 pm, 950 pm, 1000 pm, 1050 pm, or 1100 pm.
  • a shunt body may be configured to collapse, deform, bend, or otherwise change in size and/or shape between the delivery configuration and the implanted configuration.
  • the shunt body may be configured (e.g., by virtue of the filamentbased design and based on one or more of number, size, material, of the filaments) to collapse or fold along a plane (e.g., a crush plane) when transitioning from the delivery configuration to the implanted configuration.
  • a first portion (e.g., upper portion, first side portion) of the shunt body may contact a second portion (e.g., lower portion, second side portion) of the shunt body (e.g., below the crush plane, on second, opposite side of crush plane).
  • a second portion e.g., lower portion, second side portion
  • an internal surface of an upper portion of the shunt body may contact an internal surface of a lower portion of the shunt body.
  • portions of the shunt body spaced apart from one another, or not otherwise in contact with one another, in the delivery configuration may be closer to, and in some instances, touching or in contact with one another, in the implanted configuration.
  • a shunt body in either the delivery configuration or implanted configuration, may have a proximal end and a distal end.
  • the length of the shunt body from the proximal end to the distal end may be any length suitable for implantation in a human eye and transferring of fluid between two locations in the human eye (e.g., in a suprachoroidal space).
  • the shunt body may have a length of between about 1 mm and about 20 mm.
  • the shunt bodies described herein may have a length of between about 1 mm and about 20 mm, about 1 mm and about 15 mm, about 1 mm and about 10 mm, between about 1 mm and about 10 mm, about 1 mm and about 9 mm, about mm and about 8 mm, about 1 mm and about 7 mm, about 1 mm and about 6 mm, about mm and about 5 mm, about 1 mm and about 4 mm, about 1 mm and about 3 mm, about 1 mm and about 2 mm, about 2 mm and about 20 mm, about 2 mm and about 15 mm about 2 mm and about 10 mm, about 2 mm and about 9 mm, about 2 mm and about 8 mm, about 2 mm and about 7 mm, about 2 mm and about 6 mm, about 2 mm and about 5 mm, about 2 mm and about 4 mm, about 2 mm and about 3 mm, about 3 mm and about 20 mm, about 2 mm and about 15 mm, about
  • the length is about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, or greater than 20 mm.
  • the implantable intraocular shunts described herein may comprise a plurality of interconnected filaments, forming a shunt body.
  • the interconnected filaments may be arranged in any way suitable to form a generally tubular shunt body that may be collapsed to take on a reduced profile in an implanted state (e.g., planar, flat, or sheet-like configuration).
  • the shunt body may have a central lumen in the delivery configuration, which may be partially or fully eliminated in the implanted configuration.
  • the shunt body may not have a primary lumen for fluid transfer in the implanted configuration.
  • the shunt body may retain a primary lumen in the implanted configuration.
  • either lumen may have any suitable shape, including, for example, circular, ovular, pointed ovular, and the like.
  • the filaments may be interconnected in a number of ways, including, but not limited to, being knitted (e.g., a single filament looped continuously to form an interconnected body), woven (e.g., two or more filaments where at least one longitudinal filament serves as the warp filament and at least one transverse filament serves as the weft filament), and/or braided (e.g., three or more filaments interlaced with one another at any angle).
  • a shunt body may comprise filaments interconnected in two or more different ways (e.g., woven and braided). While some variations of any of the disclosed shunt bodies are depicted in a knitted configuration, and some variations are depicted in a braided configuration, it should be understood that the filaments may be interconnected in any fashion.
  • the interconnected filaments may be arranged such that in the delivery and/or implanted configurations there is more than one lumen.
  • a shunt body may have 2, 3, 4, 5, 6, or greater than 6 lumens.
  • two or more lumens may have the same or similar cross-sectional shape, or two or more different cross sectional shapes.
  • an implantable intraocular shunt may have two or more lumens in a delivery configuration, and may lack one or more lumens in an implanted configuration.
  • the shunt body may be configured to collapse, deform, bend, or otherwise change in size and/or shape between the delivery configuration and the implanted configuration in a predetermined manner and/or in a predetermined region or area of the shunt body.
  • the shunt body may comprise one or more weakened portions or regions along a length of the shunt body that may provide for preferential bending of the shunt body in that region, such that the shunt body may be configured to collapse in a predetermined manner (e.g., along a predetermined crush plane) when transitioning from the delivery configuration to the implanted configuration.
  • Such weakened regions may be along any suitable portion of the shunt body, such as, along one or more (e.g., two opposing) sides of a shunt body.
  • the weakened regions may be positioned 180 degrees from one another.
  • a weakened region may be continuous, e.g., form a continuous line along a side of the shunt body where filaments are present) and/or discontinuous (e.g., form a discontinuous line along a side of the shunt body where only a portion of the filaments along the line are weakened).
  • a crush plane may be formed transverse (e.g., orthogonal) to a major axis of the shunt body, such that the crush plane is formed along the minor axis.
  • a crush plane may be centrally located (e.g., may be a plane formed along a central lateral axis of the shunt body), where equal parts of the shunt body are on either side of the crush plane.
  • a crush plane may be offset from the central lateral axis.
  • a crush plane may be any of an XY, an XZ, or a ZY plane.
  • FIG. 26 shows an embodiment of an exemplary shunt body (2600) with an XYZ coordinate axis.
  • a crush plane may be along an XY plane of a shunt body. In some embodiments, a crush plane may be along an XZ plane of a shunt body. In some embodiments, a crush plane may be along a ZY plane of a shunt body.
  • the weakened region may be formed during manufacturing of the shunt body (e.g., while on a mandrel, over which the plurality of filaments is woven, knitted, or braided, after removal from the mandrel), using, for example, mechanical strain, thermal deformation, or the like. Weakened portions may be formed by any reasonable means.
  • the weakened portions may be formed by one or more of yielding the material by deformation, heat forming the filament material to a set shape over a mandrel, mechanically removing material to create a more flexible region than the rest of the shunt body, etching a portion of the shunt body, and cutting or ablating filaments.
  • the weakened region in the presently described implantable intraocular shunts may assist in the structural conversion of the shunt body from the delivery configuration to the implanted configuration (e.g., encourage collapse in vivo) and/or may assist in transitioning the shunt body from a delivery configuration to an implanted configuration in a predetermined and/or controlled manner.
  • An implantable intraocular shunt may comprise any number of filaments suitable for being interconnected by knitting, weaving, braiding, and the like.
  • an implantable intraocular shunt may comprise a plurality of filaments (e.g., between 2 and 32 filaments).
  • an implantable intraocular shunt may comprise between 2 and 32, 2 and 28, 2 and 24, 2 and 20, 2 and 16, 2 and 12, 2 and 8, 2 and 4, 4 and 32, 4 and 28, 4 and 24, 4 and 20, 4 and 16, 4 and 12, 4 and 8, 8 and 32, 8 and 28, 8 and 24, 8 and 20, 8 and 16, 8 and 12, 12 and 32, 12 and 28, 12 and 24, 12 and 20, 12 and 16, 16 and 32, 16 and 28, 16 and 24, 16 and 20, 20 and 32, 20 and 28, 20 and 24, 24 and 32, 24 and 28, or 28 and 32 filaments.
  • an implantable intraocular shunt may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 or 32 filaments.
  • an implantable intraocular shunt comprises greater than 32 filaments.
  • a filament may have a circular cross-sectional geometry.
  • a filament may have a non-circular cross-sectional geometry.
  • a single filament may be intertwined, thus forming a plurality of filaments. For instance, a single filament may be looped into a plurality of filaments.
  • At least one filament with a circular cross-section, including all filaments may have a diameter (“D”).
  • at least one filament with a noncircular cross section, including all filaments may have a major axis and a minor axis.
  • each filament of the plurality of filaments forming the shunt body may have the same diameter or major and/or minor axes, while in other instances, the plurality of filaments may be formed from filaments with two or more diameters or major and/or minor axes.
  • At least one filament of the plurality of filaments has a first diameter (DI) or major and/or minor axes and at least one filament of the plurality of filaments has a second diameter (D2) or major and/or minor axes.
  • a plurality of filaments may comprise filaments with at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 different diameters (D2-D32) or major and/or minor axes.
  • a plurality of filaments may comprise filaments with between 2 and 32, 2 and 28, 2 and 24, 2 and 20, 2 and 16, 2 and 12, 2 and 8, 2 and 4, 4 and 32, 4 and 28, 4 and 24, 4 and 20, 4 and 16, 4 and 12, 4 and 8, 8 and 32, 8 and 28, 8 and 24, 8 and 20, 8 and 16, 8 and 12, 12 and 32, 12 and 28, 12 and 24, 12 and 20, 12 and 16, 16 and 32, 16 and 28, 16 and 24, 16 and 20, 20 and 32, 20 and 28, 20 and 24, 24 and 32, 24 and 28, or 28 and 32 different diameters (D2-D32) or major and/or minor axes.
  • D2-D32 diameters
  • a first set of filaments may have the same first diameter or major and/or minor axes
  • a second set of filaments may have the same second, different diameter (i.e., the first diameter and second diameter are different) or different major and/or minor axes.
  • the shunt bodies described herein may have any number of sets of filaments with different diameters or major/and minor axes, including for example, one set (e.g., all filaments of the same diameter), two sets, three sets, four sets, five sets, six sets, seven sets, eight sets, nine sets or more.
  • Each of the plurality of filaments may have any diameter suitable for forming an intraocular shunt.
  • at least one of the filaments of the plurality of filaments described herein may have a diameter that is less than about 25 pm.
  • the diameter of at least one of the filaments may be between about 20 pm and about 300 pm, about 20 pm and about 275 pm, about 20 pm and about 250 pm, about 20 pm and about 225 pm, about 20 pm and about 200 pm, about 20 pm and about 175 pm, about 20 pm and about 150 pm, about 20 pm and about 125 pm, about 20 pm and about 100 pm, about 20 pm and about 75 pm, about 20 pm and about 50 pm, about 20 pm and about 25 pm, about 25 pm and about 300 pm, about 25 pm and about 275 pm, about 25 pm and about 250 pm, about 25 pm and about 225 pm, about 25 pm and about 200 pm, about 25 pm and about 175 pm, about 25 pm and about 150 pm, about 25 pm and about 125 pm, about 25 pm and about 100 pm, about 25 pm and about 75 pm, about 25 pm and about 50 pm, about 50 pm and about 300 pm, about 50 pm and about 275 pm, about 50 pm and about 250 pm, about 50 pm and about 225 pm, about 50 pm and about 200 pm, about 50 pm and about 175
  • the diameter of at least one of the filaments may be about 20 pm, 25 pm, 30 pm, 35 pm, 40 pm, 45 pm, 50 pm, 55 pm, 60 pm, 65 pm, 70 pm, 75 pm, 80 pm, 85 pm, 90 pm, 95 pm, 100 pm, 105 pm, 110 pm, 115 pm, 120 pm, 125 pm, 130 pm, 135 pm, 140 pm, 145 pm, 150 pm, 155 pm, 160 pm, 165 pm, 170 pm, 175 pm, 180 pm, 185 pm, 190 pm, 195 pm, 200 pm, 205 pm, 210 pm, 215 pm, 220 pm, 225 pm, 230 pm, 235 pm, 240 pm, 245 pm, 250 pm, or greater.
  • Individual filaments may also have any non-circular cross-sectional geometry.
  • Filaments of any of the implantable intraocular shunts described herein may comprise, in part or in whole, a variety of materials suitable for use in a human subject, such as one or more biocompatible polymers or plastics or polymer composites.
  • biocompatible polymers include poly(lactic-co-glycolic acid) (PLGA), poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(glycolide-co-lactide) (PGLA), polydioxanone (PDO), L-lactic acid, D-lactic acid, polyglycolic acid (PGA), poly-epsilon-caprolactone (PCL), high density polyethylene (HDPE), poly(styrene-block-isobutylene-block-styrene) (SIBS), polyurethane, polycarbonate, polypropylene, polymethylmethacrylate (PMMA), polybutylmethacrylate, polyesters, polytetrafluoroethylene (PTFE), silicone, acrylic polymers, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl chloride, ethyl vinyl acetate, collagen, collagen derivatives, flexible fused silica, polyolefins, NYLON®
  • the filaments may be fully or partially bio-erodible (e.g., biodegradable), and may, for instance, comprise poly(D,L-lactide), poly(D,L-lactide-co- glycolide), poly(D,L-lactide)acid, and polyethylene glycol 3350.
  • One or more bio-erodible filaments or portions of the shunt bodies described herein may have one or more dissolution period (e.g., the time period over which it takes for the filament or portion to fully erode in an eye).
  • the dissolution period is at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 30, 36, 48, 60, or 72 months (including all values and sub-ranges therein).
  • the shunt body is configured to erode in between about 1 month and about 3 months, about 2 months and about 4 months, about 1 month and about 6 months, about 6 months and about 9 months, about 6 months and about 12 months, about 12 months and about 18 months, about 12 months and about 24 months, about 24 months and about 36 months, about 12 months to about 72 months or about 1 month to about 72 months after implantation.
  • the period of time is from between about 0 months and 1 month, between about 0 months and about 2 months, between about 0 months and about 3 months, between about 0 months and about 4 months, between about 0 months and about 5 months, between about 0 months and about 6 months, between about 0 months and about 7 months, between about 0 months and about 8 months, between about 0 months and about 9 months, between about 0 months and about 10 months, between about 0 months and about 11 months, between about 0 months and about 12 months, between about 1 month and about 2 months, between about 1 month and about 3 months, between about 1 month and about 4 months, between about 1 month and about 5 months, between about 1 month and about 6 months, between about 1 month and about 7 months, between about 1 month and about 8 months, between about 1 month and about 9 months, between about 1 month and about 10 months, between about 1 month and about 11 months, between about 1 month and about 12 months, between about 2 months and about 3 months, between about 2 months and about 4 months, between about 2 months and about 5 months, between about
  • the dissolution period is at least about 1 year, 2 years, 3 years, 4 years, 5 years, 10 years, 15 years, 20 years or between about 1 year and about 5 years, about 1 year and about 10 years, about 5 years and about 10 years, about 5 years and about 15 years, about 10 years and about 20 years, about 5 years and about 20 years, or about 1 year and about 20 years.
  • “about 0 months” refers to the time of approximate implantation of one implantable intraocular shunt or plurality of implantable intraocular shunts.
  • One or more new implanted intraocular shunts may be delivered to one or more locations of the eye when one or more implanted intraocular shunts degrade within the eye.
  • one or more new shunts may replace one or more partially or fully degraded shunts every month, every 2 months, every 3 months, every 6 months, every 12 months, every 18 months, every 2 years, every 3 years, or more, or at any interval therein.
  • the shunt bodies described herein may comprise multiple filaments with different dissolution properties.
  • at least one of filament of the plurality of filaments may comprise a bio-erodible material.
  • at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 filaments of the plurality of filaments may comprise a bio- erodible material.
  • each filament of the plurality of filaments may comprises a bio-erodible material.
  • At least one filament of the plurality of filaments comprises a bio-erodible material and at least one filament of the plurality of filaments comprises a non-bio-erodible material.
  • at least one of the filaments may comprise a bio-erodible material, and at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 of the filaments comprises a non-bio-erodible material. Any combination of bio-erodible and non-bio-erodible filaments are suitable for the implantable intraocular shunts of this disclosure.
  • the shunt bodies described herein may comprise a plurality of filaments, and each filament may have the same or a different material relative to the other filaments.
  • each of the filaments of the plurality of filaments may be made of the same material.
  • the plurality of filaments may comprise at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 different materials.
  • a single filament may comprise more than one material.
  • each filament independently comprises one material. Any of the materials described above are suitable for such combinations.
  • the shunt bodies described herein may comprise one or more gaps or openings formed between two or more individual filaments of the plurality of filaments.
  • the interconnection e.g., weave, braid, knit
  • the shunt body may comprise a plurality of gaps, and the gaps may have one or more of a variety of shapes.
  • At least one gap of the plurality of gaps may have a parallelogram shape (e.g., square-shaped, rectangular-shaped, rhombus-shaped), while in other embodiments, at least one gap of the plurality of gaps may have a round, circular, oval, or non-circular shape.
  • the at least one gap may have a gap width (“W”) and a gap length (“L”).
  • the gap width and gap length for two or more of the gaps (including all of the gaps) may be the same, or the gap width and gap length for two or more of the gaps (including all of the gaps, two or more sets of gaps) may be different.
  • each gap in the shunt body has the same length.
  • each gap in the shunt body has the same width. In some embodiments, each gap in the shunt body has the same length and the same width. In some embodiments. In some embodiments, one set of gaps in the shunt body has the same length, and one or more sets of gaps have a different length or lengths. In some embodiments, one set of gaps in the shunt body has the same width, and one or more sets of gaps have a different width or widths.
  • FIG. 6A depicts a close-up of a perspective view of loosely braided filaments (604A) of a shunt body, with a plurality of gaps (602A).
  • FIG. 6B depicts a close-up of a perspective view of a generalized depiction of a braided shunt body with a plurality of filaments (604B) forming a plurality of gaps (602B).
  • the gaps (602B) are shown to have length (608B) and width (61 OB) dimensions.
  • Individual filaments have a diameter (606B), although it should be understood that individual filaments in a given shunt body may have the same or, independently, different diameters, as described in detail previously.
  • the physical and mechanical properties of the implantable intraocular shunts described herein can be tuned by altering at least one or more of the number of filaments, the density of the filaments (e.g., loose weave, tight weave), and the gap dimensions.
  • the gap width of at least one gap may be between about D and about 15D, about D and about 14D, about D and about 13D, about D and about 12D, about D and about 1 ID, about D and about 10D, about D and about 9D, about D and about 8D, about D and about 7D, about D and about 6D, about D and about 5D, about D and about 4D, about D and about 3D, about D and about 2D, about 2D and about 10D, about 2D and about 9D, about 2D and about 8D, about 2D and about 7D, about 2D and about 6D, about 2D and about 5D, about 2D and about 4D, about 2D and about 3D, about 3D and about 10D, about 3D and about 9D, about 3D and about 8D, about 3D and about 7D, about 3D and about 6D, about 3D and about 5D, about 3D and about 4D, about 2D and about 3D, about 3D and about 10D, about 3D and about 9D, about
  • the gap width of at least one gap may be about D, ID, 2D, 3D, 4D, 5D, 6D, 7D, 8D, 9D, 10D, 11D, 12D, 13D, 14D, 15D, or greater than 15D.
  • the gap length of at least one gap may be “L” between about D and about 15D.
  • the gap length of at least one gap may be between about D and about 15D, about D and about 14D, about D and about 13D, about D and about 12D, about D and about 1 ID, about D and about 10D, about D and about 9D, about D and about 8D, about D and about 7D, about D and about 6D, about D and about 5D, about D and about 4D, about D and about 3D, about D and about 2D, about 2D and about 10D, about 2D and about 9D, about 2D and about 8D, about 2D and about 7D, about 2D and about 6D, about 2D and about 5D, about 2D and about 4D, about 2D and about 3D, about 3D and about 10D, about 3D and about 9D, about 3D and about 8D, about 3D and about 7D, about 3D and about 8D, about 3D and about 10D, about 3D and about 9D, about 3
  • the gap length of at least one gap may be about D, ID, 2D, 3D, 4D, 5D, 6D, 7D, 8D, 9D, 10D, 1 ID, 12D, 13D, 14D, 15D, or greater than 15D.
  • the gap width and gap length for at least one gap may be roughly equal.
  • the gap width and the gap length for at least one gap may both be about D, ID, 2D, 3D, 4D, 5D, 6D, 7D, 8D, 9D, 10D, 11D, 12D, 13D, 14D, 15D, or greater than 15D.
  • FIG. 3 A depicts a generalized, top view of an implant body comprising braided (300A) filaments (302A) forming a plurality of gaps (306B).
  • the implant body comprises a plurality of contact points (304A), which are formed at each location where a filament contacts another filament.
  • FIG. 3B depicts a top view of an exemplary shunt body (300B), with a plurality of gaps (306B) and contact points (304B).
  • PC Pick Count
  • Pick count is defined as the number of filaments rotating in one direction in one cycle length of the shunt body divided by the cycle length (typically defined as picks/inch, or PPI).
  • the shunt bodies described herein may, for instance, have a PC of between about 5 and about 50.
  • the PC may be between about 5 and about 50, about 5 and about 45, about 5 and about 40, about 5 and about 35, about 5 and about 30, about 5 and about 25, about 5 and about 20, about 5 and about 15, about 5 and about 10, about 10 and about 50, about 10 and about 45, about 10 and about 40, about 10 and about 35, about 10 and about 30, about 10 and about 25, about 10 and about 20, about 10 and about 15, between about 15 and about 50, about 15 and about 45, about 15 and about 40, about 15 and about 35, about 15 and about 30, about 15 and about 25, about 15 and about 20, between about 20 and about 50, about 20 and about 45, about 20 and about 40, about 20 and about 35, about 20 and about 30, about 20 and about 25, between about 25 and about 50, about 25 and about 45, about 25 and about 40, about 25 and about 35, about 25 and about 30, between about 30 and about 50, about 30 and about 45, about 30 and about 40, about 30 and about 35, between about 35 and about 50, about 35 and about 45, about 35 and about 40, between about 40,
  • the PC may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.
  • the proximal end may be the end of a proximal portion of the shunt body
  • the distal end may be the end of a distal portion of the shunt body.
  • the proximal and/or distal portions of the shunt body may be configured to reside at least partially within a first location in an eye, while the other of those two portions is configured to reside at least partially in another location of the eye.
  • the proximal and/or distal portions of the shunt body may be configured to reside at least partially within an anterior chamber of an eye, while the other of those two portions is configured to reside at least partially in another part of the eye (e.g., the suprachoroidal space).
  • an implantable intraocular device described herein may comprise a shunt body comprising a plurality of interconnected filaments, wherein the shunt body has a round delivery configuration and a substantially flat implanted configuration.
  • the shunt body is configured to transfer fluid along an external surface of the shunt body in the implanted configuration.
  • a round delivery configuration may be similar to that shown in FIG. 17D, with a cross-sectional shape like that shown in FIG. 17B.
  • an implantable intraocular device described herein may comprise a shunt body comprising a plurality of interconnected filaments, wherein the shunt body comprises an upper portion, a lower portion, a proximal portion, a distal portion, an open configuration, and a collapsed configuration.
  • the upper portion and the lower portion are curved in the open configuration and generally flat in the collapsed configuration.
  • the upper and lower portions form an upper layer and a lower layer, respectively.
  • an implanted configuration has a generally collapsed configuration compared to the delivery configuration.
  • an implantable intraocular shunt comprises a plurality of interconnected filaments forming a shunt body comprising an upper portion and a lower portion, wherein the shunt body has a delivery configuration and an implanted configuration.
  • an internal surface of the upper portion and an internal surface of the lower portion are separated by a first maximum height
  • at least a portion of the internal surface of the upper portion and at least a portion of the internal surface of the lower portion are separated by no more than a second, smaller height.
  • at least a portion of the internal surface of the upper portion contacts at least a portion of the internal surface of the lower portion.
  • an implantable intraocular shunt described herein comprises a shunt body comprising a plurality of interconnected filaments, wherein the shunt body has an open configuration and a collapsed configuration.
  • the shunt body is configured to receive a portion of a delivery device in the open configuration and is configured to transfer fluid along an external surface of the shunt body in the collapsed configuration.
  • at least an internal surface of a filament of the plurality of filaments of an upper portion of the shunt body is disposed in a gap of the plurality of gaps of a lower portion of the shunt body.
  • the shunt bodies may be configured to extend into the anterior chamber by about 50 pm, 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 350 pm, 400 pm, 450 pm, 500 pm, 550 pm, 600 pm, 650 pm, 700 pm, 750 pm, 800 pm, 850 pm, 900 pm, 950 pm, or 1000 pm.
  • a shunt body may comprise a primary lumen between a proximal end and a distal end of the shunt body.
  • a primary lumen may have any cross-sectional geometry (e.g., elliptical, pointed oval, square, trapezoid, triangle).
  • the primary lumen may have an elliptical or pointed oval cross-sectional shape.
  • the major and/or minor axes may each be about 50 pm to about 2000 pm.
  • the major and/or minor axes may each be about 50 pm to about 1100 pm, about 50 pm to about 1000 pm, about 50 pm to about 900 pm, about 50 pm to about 800 pm, about 50 pm to about 700 pm, about 50 pm to about 600 pm, about 50 pm to about 500 pm, about 50 pm to about 400 pm, about 50 pm to about 300 pm, about 50 pm to about 200 pm, about 50 pm to about 100 pm, about 100 pm to about 2000 pm, about 100 pm to about 1100 pm, about 100 pm to about 1000 pm, about 100 pm to about 900 pm, about 100 pm to about 800 pm, about 100 pm to about 700 pm, about 100 pm to about 600 pm, about 100 pm to about 500 pm, about 100 pm to about 400 pm, about 100 pm to about 300 pm, about 100 pm to about 200 pm, about 200 pm to about 2000 pm, about 200 pm to about 1100 pm, about 200 pm to about 1000 pm, about 200 pm to about 900 pm, about 200 pm to about 800 pm, about 200 pm to about 700 pm, about 200 pm to about 1000 pm, about 200 pm to
  • the major and/or minor axes are independently about 50 pm, 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 350 pm, 400 pm, 450 pm, 500 pm, 550 pm, 600 pm, 650 pm, 700 pm, 750 pm, 800 pm, 850 pm, 900 pm, 950 pm, 1000 pm, 1050 pm, 1100 pm, about 1200 pm, about 1300 pm, about 1400 pm, about 1500 pm, about 1600 pm, about 1700 pm, about 1800 pm, about 1900 pm, about 2000 pm, or greater than about 2000 pm.
  • the primary lumen of a shunt body may have a circular (including roughly circular) cross-sectional shape.
  • the primary lumen may have a diameter of between about 50 pm to about 1100 pm.
  • the diameter may be about 50 pm to about 1100 pm, about 50 pm to about 1000 pm, about 50 pm to about 900 pm, about 50 pm to about 800 pm, about 50 pm to about 700 pm, about 50 pm to about 600 pm, about 50 pm to about 500 pm, about 50 pm to about 400 pm, about 50 pm to about 300 pm, about 50 pm to about 200 pm, about 50 pm to about 100 pm, about 100 pm to about 2000 pm, about 100 pm to about 1100 pm, about 100 pm to about 1000 pm, about 100 pm to about 900 pm, about 100 pm to about 800 pm, about 100 pm to about 700 pm, about 100 pm to about 600 pm, about 100 pm to about 500 pm, about 100 pm to about 400 pm, about 100 pm to about 300 pm, about 100 pm to about 200 pm, about 200 pm to about
  • the diameter may be about 50 pm, 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 350 pm, 400 pm, 450 pm, 500 pm, 550 pm, 600 pm, 650 pm, 700 pm, 750 pm, 800 pm, 850 pm, 900 pm, 950 pm, 1000 pm, 1050 pm, 1100 pm, about 1200 pm, about 1300 pm, about 1400 pm, about 1500 pm, about 1600 pm, about 1700 pm, about 1800 pm, about 1900 pm, about 2000 pm, or greater than about 2000 gm
  • FIGS. 4A-4C Exemplary, non-limiting, examples of cross sections of the shunt bodies described herein are shown in FIGS. 4A-4C.
  • FIG. 4A depicts a shunt body (400A) comprising a primary lumen (410A) with an elliptical cross-sectional shape having major (402A) and minor (404A) axes.
  • a circular cross-sectional shape (400B) of the shunt bodies described herein comprises a primary lumen (410B), and is defined by a diameter (406B).
  • FIG. 4C shows a pointed oval cross-sectional shape, which comprises a primary lumen (410C) and a crush plane (408C).
  • a crush plane may be formed through the central major axis (e.g., intersects a plane formed through the central minor axis).
  • any shunt body e.g., 400A, 400B, 400C
  • any cross-sectional shape may have a crush plane.
  • FIGS. 4D-4I Additional examples of cross sections of the shunt bodies described herein are shown in FIGS. 4D-4I.
  • FIG. 4D depicts a cross section of a shunt body (400D) comprising a plurality of interconnected filaments (412D), and having two primary lumens (410D).
  • FIG. 4F depicts a cross section of a shunt body (400F) comprising a plurality of interconnected filaments (412F), and having three primary lumens (410D).
  • FIG. 4H depicts a cross section of a shunt body (400H) comprising a plurality of interconnected filaments (412H), and having four primary lumens (41 OH), and a crush plane (408H).
  • FIG. 41 depict a cross section of the shunt bodies of FIG. 4D, 4F, and 4H, respectively, in a delivery configuration.
  • any shunt body e.g., 400D, 400F, 400H
  • any cross-sectional shape may optionally have a crush plane.
  • FIGS. 5A-5C An exemplary shunt body is shown in FIGS. 5A-5C.
  • a shunt body may have, for example, a PC between 2 and 25 PPI.
  • FIG. 5 A shows a cross section of a pointed oval shunt body (500A), having a major axis (502A) and minor axis (504A), as well as a crush plane (506A).
  • FIG. 5B depicts braided shunt body (500B) comprising eight filaments. Also shown are a plurality of gaps (51 OB) and a length dimension of the shunt body (508B).
  • FIG. 5C show a perspective view of braided shunt body comprising 8 filaments.
  • the shunt bodies described herein may have one or more layers formed by the interconnected filaments.
  • the shunt bodies may comprise an upper portion and a lower portion.
  • the upper and lower portions may comprise, for example, the collective filaments (e.g., woven, braided, knitted) above and below a plane traversing the shunt body (e.g., an XY plane, an XZ plane, a ZY plane), respectively.
  • a shunt body may have a cross-sectional shape in a configuration (e.g., delivery, implanted) that has a plane (e.g., a crush plane), and the upper and lower portions may describe the part of the shunt body that lies above and below the plane, respectively.
  • FIG. 7A shows a top view of one potion (e.g., upper, lower) of an exemplary shunt body.
  • FIG. 7B shows an exemplary shunt body in an implanted configuration, where the upper and lower portions are in contact with one another.
  • FIG. 7B shows a cross-sectional view of an exemplary shunt body (700C) with an upper and lower portion (e.g., layer) with a thickness shown by 704C.
  • the thickness of a portion (e.g., one or more layers) of the shunt body may be determined by at least the diameter of the plurality of filaments and the method of interconnection between those filaments.
  • layer may refer to the portion above and/or below a plane, as described previously.
  • An exemplary layer (704C) is shown in FIG. 7.
  • the implantable intraocular shunts described herein may have a maximum height and/or width for a given configuration (e.g., delivery, implanted). Put another way, the maximum height for a given configuration is the distance between an outer surface of one portion and the other surface of another portion (e.g., the distance between an outer surface of an upper portion and the outer surface of a lower portion).
  • the thickness of a portion may vary across the layer of interconnected filaments. In some embodiments, the thickness may be an average thickness across the entire layer of interconnected filaments in a given portion of a shunt body. In some embodiments, the thickness may be about D to about 2D (D being previously defined). In some embodiments, the thickness may be about D to about 2D, about D to about 1.75D, about D to about 1.5D, about D to about 1.25D, about 1.25D to about 2D, about 1.25D to about 1.75D, about 1.25D to about 1.5D, about 1.5D to about 2D, about 1.5D to about 1.75D, or about 1.75D to about 2D. In some embodiments, the thickness is consistent between each portion of a shunt body.
  • an upper portion has a different thickness than a lower portion.
  • shape of a portion e.g., an upper portion, a lower portion
  • the shape of a portion may be generally planar or flat when the shunt body is in an implanted configuration.
  • portions of a shunt body in an implanted configuration may have less of a curvature (e.g., larger radius of curvature) than those same portions of the shunt body in a delivery configuration.
  • FIGS. 8A-8D depict different views of an exemplary intraocular shunt in a fully collapsed configuration (e.g., an implanted configuration).
  • FIG. 8A depicts a side view of a shunt body (800A) in an implanted configuration, wherein a number of contact points (e.g., 802 A) can be seen
  • FIG. 8B depicts a top view of the shunt body (800 A) of FIG. 8 A, showing a plurality of gaps (e.g., 802B) and a plurality of contact points (e.g., 804B).
  • FIG. 8A depicts a side view of a shunt body (800A) in an implanted configuration, wherein a number of contact points (e.g., 802 A) can be seen
  • FIG. 8B depicts a top view of the shunt body (800 A) of FIG. 8 A, showing a plurality of gaps (e.g., 802B) and a plurality
  • FIG. 8C is an alternative view of an exemplary shunt body in an implanted configuration (800C) comprising 16 filaments, again showing gaps (802C) and contact points (804B).
  • FIG. 8D shows the cross-section of the same exemplary shunt body (800D) with an upper portion (806D) and a lower portion (808D) in contact with one another.
  • FIGS. 9A-9D depict an embodiment of a shunt body comprising a lumen with a pointed oval cross-sectional shape in the delivery configuration and a pre-formed crush plane to facilitate transitioning of the shunt body from the delivery configuration to the implanted configuration after implantation of the intraocular shunt.
  • FIG. 9A shows a side view of the shunt body (900A) comprising 16 filaments and a plurality of gaps (902A) and contact points (904A), while FIG. 9B depicts a top view of the shunt body (900A) depicted in FIG. 9A, also depicting the plurality of gaps (e.g., 902A) and contact points (e.g., 904A).
  • FIG. 9A shows a side view of the shunt body (900A) comprising 16 filaments and a plurality of gaps (902A) and contact points (904A)
  • FIG. 9B depicts a top view of the shunt body (900A) depicted in FIG.
  • FIG. 9C is a perspective view of the shunt body (900A) in a delivery configuration (900C), again showing gaps (902C).
  • FIG. 9D depicts a cross-sectional view of the shunt body (900A) with an upper portion and a lower portion above and below a crush plane (906D), respectively.
  • a primary lumen (908D) is shown bounded by the upper portion (910D) and lower portion (912D).
  • the shunt body may be collapsed (e.g., along the crush plane), such that the upper portion and the lower portion of the shunt body contact one another. In other words, at least one surface of each of the upper and lower portions (on either side of the crush plane) contact one another.
  • FIG. 10A shows a generalized, top view of a braided filament shunt body (1000A) comprising a first type of filament (1002A; e.g., a first material or a bio-erodible filament with a first erosion rate) and a second type of filament (1004A; e.g., a second material, a non-bio- erodible filament, or a bio-erodible filament with a second erosion rate), and a plurality of gaps (1006A) and contact points (1008A).
  • 10B depicts an exemplary shunt body (1000B) comprising a first type of filament (1002B; e.g., a first material or a bio-erodible filament with a first erosion rate) and a second type of filament (1004B; e.g., a second material, a non-bio- erodible filament, or a bio-erodible filament with a second erosion rate), and a plurality of gaps (1006B) and contact points (1008B).
  • a first type of filament (1002B; e.g., a first material or a bio-erodible filament with a first erosion rate
  • a second type of filament 1004B
  • 10C is a perspective view of an exemplary shunt body (1000C) comprising a first type of filament (1002C; e.g., a first material or a bio-erodible filament with a first erosion rate) and a second type of filament (1004C; e.g., a second material, a non-bio-erodible filament, or a bio-erodible filament with a second erosion rate), and a plurality of gaps (1006C) and contact points (1008C).
  • a first type of filament (1002C; e.g., a first material or a bio-erodible filament with a first erosion rate
  • a second type of filament 1004C
  • a plurality of gaps (1006C) and contact points (1008C
  • a shunt body may comprise a proximal portion, a distal portion, and a central portion.
  • Each of the proximal portion, distal portion, and central portion may comprise the same or different materials.
  • the proximal portion, distal portion, and central portion may comprise filaments with the same or different diameters.
  • the distal portion may comprise a bio-erodible material, and one or more of the proximal portion and the central portion may comprise a non-bio-erodible material.
  • the proximal portion may comprise a bio-erodible material, and one or more of the distal portion and the central portion may comprise a non-bio-erodible material.
  • FIGS. 11 A-l 1C depict an embodiment of an implantable intraocular shunt.
  • 11 A shows a generalized, top view of a braided filament shunt body (1100A) comprising a distal portion comprising a first type of filament (1102A; e.g., a first material or a bio-erodible filament with a first erosion rate) and another portion (e.g., central, proximal) comprising a second type of filament (1104A; e.g., a second material, a non-bio-erodible filament, or a bio- erodible filament with a second erosion rate), and a plurality of gaps (1008A) and contact points (1106A).
  • 1 IB is a rendering of an exemplary shunt body (1100B) comprising a distal portion comprising a first type of filament (1102B; e.g., a first material or a bio-erodible filament with a first erosion rate) and another portion (e.g., central, proximal) comprising a second type of filament (1104B; e.g., a second material, a non-bio-erodible filament, or a bio-erodible filament with a second erosion rate), and a plurality of gaps (1108B) and contact points (1108B).
  • 11C is a perspective view of an exemplary shunt body (1100C) comprising a distal portion comprising a first type of filament (1102C; e.g., a first material or a bio-erodible filament with a first erosion rate) and another portion (e.g., central, proximal) comprising a second type of filament (1104C; e.g., a second material, a non-bio-erodible filament, or a bio-erodible filament with a second erosion rate), and a plurality of gaps (1106C) and contact points (1108C).
  • a first type of filament (1102C
  • a first material or a bio-erodible filament with a first erosion rate e.g., a first material or a bio-erodible filament with a first erosion rate
  • another portion e.g., central, proximal
  • a second type of filament e.g., a second material, a non-bio-erodible filament, or a
  • a plurality of filaments of the shunt bodies described herein may comprise two or more filaments of different diameters (e.g., D1-D32, or more).
  • the at least one filament of the plurality of filaments with DI is bio-erodible and the at least one filament of the plurality of filaments with D2 is non-bio-erodible.
  • Filaments of diameters D1-D32 may individually be bio-erodible or non-bio-erodible.
  • the implantable intraocular shunts described herein may also comprise one or more rigid longitudinal strands within the shunt body.
  • the implantable intraocular shunts may comprise at least one rigid longitudinal strand running through at least a portion of the body.
  • a longitudinal strand may run the entire length of the shunt body.
  • a longitudinal strand may also run the length of a portion the shunt body.
  • One or more longitudinal strands (which may be straight and/or rigid) may have one or more lengths.
  • the longitudinal strands described herein may, for instance, serve as a stiff support for the implantable intraocular shunt to prevent buckling during insertion.
  • one or more of the longitudinal strands is bio- erodible.
  • At least one rigid longitudinal strand is bio-erodible and the plurality of filaments are non-bio-erodible. In some embodiments, at least one rigid longitudinal strand and the plurality of filaments are both bio-erodible. In some embodiments, at least one rigid longitudinal strand has a first erosion rate and at least one of the plurality of filaments has as second erosion rate. For instance, in some embodiments, one or more of the bio-erodible longitudinal strands may have a higher erosion rate than the plurality of filaments of the shunt body. In this way, the longitudinal strands may rapidly dissolve after implantation, while the shunt body remains and dissolves with a lower erosion rate.
  • one or more of the bio-erodible longitudinal strands may have a lower erosion rate than the remainder of the shunt body.
  • the first erosion rate is lower (slower) than the second erosion rate, and in some embodiments, the first erosion rate is higher (faster) than the second erosion rate.
  • the longitudinal strands may provide support to the tissues at the implant site.
  • FIG. 12A depicts a shunt body (1200A) with rigid longitudinal strands (1204A) within a plurality of filaments (1202 A), as well as contact points (1206 A) and gaps (1208 A).
  • FIG. 12B shows a perspective view of a shunt body (1200B) with 8 filaments (1202B), with longitudinal strands (1204B) running the length of the shunt body (1200B). Also shown are contact points (1206B) and a plurality of gaps (1208B).
  • the filaments of the intraocular shunt may be encased or otherwise covered with an encasing material. Utilizing an encasing material may provide additional structural support to the implantable intraocular shunts described.
  • the encasing material may comprise a bio-erodible material.
  • the encasing material may comprise a layer of material, such as, for example, a layer of bio-erodible material (i.e., a bio-erodible layer).
  • the bio-erodible layer may be disposed on an external surface (e.g., outer circumference) of the shunt body.
  • the bio-erodible layer may be disposed on an internal surface (e.g., internal circumference of a shunt body when in the delivery configuration) of the shunt body. In some embodiments, the bio-erodible layer may be disposed on an internal and external surface of the shunt body. The bio-erodible layer may be formed on all or a portion of any of the aforementioned surfaces.
  • a bio-erodible layer and a plurality of filaments of a shunt body may have the same or different erosion rates. In some embodiments, the plurality of filaments, or at least one of the plurality of filaments, may comprise a bio-erodible material with a lower erosion rate than an erosion rate of the bio-erodible layer.
  • At least one filament of the plurality of filaments may comprise a bio-erodible material with a higher erosion rate than an erosion rate of the bio-erodible layer.
  • the bio-erodible layer completely encases the braided filaments.
  • FIGS. 13A and 13B show an exemplary shunt body (1300A) comprising 8 filaments (1302A) and a plurality of contact points (1304A) and gaps (1308A), encased in bio-erodible layer (1310A), with a lumen (1306A) running through the shunt body.
  • 13B provides a perspective view of an exemplary shunt body (13006) comprising 8 filaments (1302B) and a plurality of contact points (1304B) and gaps (1308B), encased in a bio- erodible layer (1310B), with a lumen (1306B) running through the shunt body.
  • a casing material may comprise an adhesive layer, a bio glue, a viscoelastic material, or any combination thereof
  • a plurality of filaments of the shunt bodies described herein may be joined to maintain shape or provide localized stiffness. For instance, two or more strands may be joined at a contact point and/or at the proximal and/or distal ends of a shunt body. In some embodiments, the plurality of filaments may be joined at one or more of the proximal end and the distal end. A plurality of filaments may be joined in a number of ways, including, but not limited to, a bio- erodible collar, a non-bio-erodible collar, a bio-erodible adhesive, a non-bio-erodible adhesive, heat staking, laser welding, mechanical fastening, or any combination thereof.
  • Coupled fibers may be joined at one or more ends of the shunt body or at a localized section of fibers along the length of the shunt body.
  • FIG. 14A shows a shunt body (1400A) in a delivery configuration, where individual filaments (1402 A) are joined at discrete points (1404 A) at the proximal and distal ends of the shunt body.
  • the shunt body also has gaps (1408A), and contact points (1406 A) at which the filaments may or may not be joined.
  • FIG. 14A shows a shunt body (1400A) in a delivery configuration, where individual filaments (1402 A) are joined at discrete points (1404 A) at the proximal and distal ends of the shunt body.
  • the shunt body also has gaps (1408A), and contact points (1406 A) at which the filaments may or may not be joined.
  • FIG. 14B shows a perspective view of a shunt body (1400B) in a delivery configuration, where individual filaments (1402B) are joined at discrete points (1404B) at the proximal and distal ends of the shunt body.
  • the shunt body also has gaps (1408B), and contact points (1406B) at which the filaments may or may not be joined.
  • FIG. 15A shows a shunt body (1500A) in a delivery configuration, where individual filaments (1502A) are joined by collars (1504A) at the proximal and distal ends of the shunt body.
  • the shunt body also has gaps (1508A), and contact points (1506A) at which the filaments may or may not be joined.
  • FIG. 14B shows a perspective view of a shunt body (1500B) in a delivery configuration, where individual filaments (1502B) are joined by collars (1504B) at the proximal and distal ends of the shunt body.
  • the shunt body also has gaps
  • Such end collars may be applied to one or both ends and may be externally or internally attached to the shunt body (1500B).
  • a shunt body may be supported by an internal liner.
  • Such internal liners may comprise a bio-erodible, a non-bio-erodible material, or a combination thereof.
  • the internal liner may span a portion of the shunt body or the full length of the shunt body.
  • the liner is tubular.
  • the liner may contain fenestrations or holes facilitating internal-to-extemal communication.
  • the shunt liner may be comprised of any suitable material, including an adhesive layer, a bio glue, a viscoelastic material, or a polymer layer.
  • an internal liner, and a plurality of filaments of a shunt body may have the same or different erosion rates.
  • the plurality of filaments, or at least one of the plurality of filaments comprises a bio-erodible material with a lower erosion rate than an erosion rate of the internal liner.
  • at least one filament of the plurality of filaments comprises a bio- erodible material with a higher erosion rate than an erosion rate of the internal liner.
  • FIG. 16A and 16B show an exemplary shunt body (1600A) comprising 8 filaments (1602A) and a plurality of contact points (1606A) and gaps (1608A), with an internal liner (1604A) running the length of the shunt body (1600A).
  • FIG. 16B provides a perspective view of an exemplary shunt body (1600B) comprising 8 filaments (1602B) and a plurality of contact points (161 OB) and gaps (1608B), with an internal liner (1604B) running the length of the shunt body (1600B), the internal liner comprising a lumen (1612B).
  • the shunt bodies described herein may be formed of tightly braided (and/or woven, knitted) filaments.
  • a tightly braided shunt body comprises 8 or more, or 16 or more filaments.
  • a tightly braided shunt body comprises a plurality of gaps, wherein a width dimension “W” is between about D and about 3D, and wherein a length dimension “L” is between about D and 3D.
  • FIG. 17A depicts a top view of an exemplary shunt body (1700A) comprising 16 filaments (1702A), with a plurality of gaps (1704A) and contact points (1714A).
  • FIG. 6B shows a cross-sectional shape of an exemplary tightly braided shunt body (1700B) comprising 16 filaments (1702B), with a cross- sectional diameter (1706B).
  • FIG. 17C shows a close perspective of a generalized depiction of a tightly braided shunt body (1700C) with a plurality of filaments (1702C) forming a plurality of gaps (1704C) and contact points (1714C).
  • the gaps (1704C) are shown to have length (1710C) and width (1712C) dimensions.
  • FIG. 17D shows a perspective view of a tightly braided shunt body (1700D) in a delivery configuration comprising a plurality of filaments (1702D), and with a cross-sectional diameter (1716D).
  • the delivery configuration of the shunt body (1700D) comprises a primary lumen (1706D) running the length of the shunt body (1700D).
  • the implantable intraocular shunts described herein may comprise different, braided or non-braided (e.g., non-woven, non-knitted) forms.
  • a shunt body comprises a lattice structure in a tubular configuration.
  • FIG. 18A depicts an exemplary side-view of a rigid shunt body (1800A), in which a plurality of gaps (1804A) has been cut, forming a fluid connection between an outside surface of the shunt body and a primary lumen (1802A).
  • the primary lumen (1802A) of the shunt body (1800A) may be in fluid communication with an external surface of the shunt body via the plurality of gaps (1804A).
  • FIG. 18B shows a perspective view of a shunt body in a delivery configuration (1800B), in which a plurality of gaps (1804A) has been cut, forming a fluid connection between an outside surface of the shunt body and a primary lumen (1802A), and with a cross-sectional diameter (1806B).
  • FIG. 18C depicts a different exemplary shunt body (1800C) with a plurality of gaps (1802C) and a cross-sectional diameter (1806C).
  • such shunt bodies may comprise a crush plane to encourage collapse of the shunt body from a delivery configuration to an implanted configuration.
  • Implantable intraocular shunts described herein may also have shunt bodies comprising a plurality of interconnected tubes (e.g., filaments with internal lumens). Such tubes may be braided, woven, or twisted, and may have cross-sectional shapes as described previously. Such tubes may be mechanically joined with, for example, glue, welding, encapsulation with a substrate, and the like.
  • tubes e.g., filaments with internal lumens.
  • Such tubes may be braided, woven, or twisted, and may have cross-sectional shapes as described previously.
  • Such tubes may be mechanically joined with, for example, glue, welding, encapsulation with a substrate, and the like.
  • Individual tubes may have fenestrations (or holes) of various shapes (e.g., circular, square, ovular, rectangular, triangular, diamond, and the like) and sizes (e.g., 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, or 125 pm, or less than 10 pm, greater than 125 pm, or any intermediate value therein) to encourage fluid transfer.
  • FIGs. 19A and 19B show two exemplary shunt bodies comprising interconnected tube.
  • FIG. 19A shows a shunt body (1900A) comprising a plurality of tubes (1902A), each with an internal lumen (1904A), wherein the shunt body (1900A) is defined by a length (1908A) and a width (1906A).
  • FIG. 19B shows a similar shunt body (1900B) comprising a plurality of tubes (1902B), each with an internal lumen (1906B), and where one or more of the plurality of tubes has a plurality of fenestrations (191 OB).
  • Implantable intraocular shunts described herein may comprise a generally flat (e.g., planar) shunt body comprising lumens and/or channels to conduct fluid from a first end of the shunt body to a second end of the shunt body.
  • FIG. 20A shows such a shunt body (2000A) having a thickness (2002 A), a width (2004A), and a length (2006A), with a plurality of lumens (2008A) disposed within the shunt body (2000A).
  • a plurality of lumens might comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 or more lumens.
  • a plurality of channels might comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 or more channels.
  • such flat shunt bodies may a single configuration that is used during both delivery and while implanted.
  • intraocular shunts comprising flat shunt bodies may not have different delivery and implantation configurations, and may instead have one configuration that serves as both a delivery and an implanted configuration.
  • Such shunt bodies may be extruded, laser etched, or micromolded.
  • the channels or lumens disposed within the shunt bodies may vary in dimension and shape, and may have any suitable shape, such as, for example, roughly rectangular, rounded (e.g., circular, ovular), or triangular cross-sectional shapes.
  • a shunt body has a round or folded delivery configuration and a flat implanted configuration.
  • FIG. 21 A shows an exemplary flat shunt body in a delivery configuration (2100A) with a primary lumen (2104), a plurality of triangular open channels or grooves (2106A), and a height dimension (2102A). While depicted as triangular, an open channel or groove may have any suitable shape (e.g., square, rectangular, circular, semi-circular, elliptical).
  • Such shunt bodies are configured to convert to an implanted configuration in vivo, such as the one shown in FIG. 2 IB.
  • a shunt body (2100B) has a generally planar shape with a height dimension (2108B) and a width dimension (2110B), and comprising a plurality of triangular channels (2106B).
  • the delivery configuration of such implants may make the shunt body more easily deployed using conventional delivery devices.
  • the shunt bodies have the same advantages as discussed previously.
  • the shunt body may be configured to interface with a portion of a delivery device.
  • such implants comprise any of the materials described herein, such as, for example, a bio-erodible material.
  • the shunt bodies have a closure mechanism (e.g., joints, glue joints, latches) that prevent the delivery configuration from opening prior to implantation.
  • the intraocular shunts described herein may comprise solid shunt bodies comprising a plurality of enclosed or open lumens or channels. Such implants may be extruded, laser etched, or micro-molded.
  • the channels or lumens may vary in dimension and shape, and may have a rectangular, semi-circular, rounded (e.g., circular, ovular, etc.), or triangular shape.
  • the channels or lumens comprise a bio-erodible material that degrades at a higher erosion rate than the bio-erodible material of the rest of the shunt body.
  • FIG. 22 shows a cylindrical shunt body (2200) with a width (2202) and a plurality of lumens (2204) running through the shunt body (2200).
  • FIG. 23 depicts a cylindrical shunt body (2300), with a width (2306) and a length (2308), in which a plurality of semi-circular channels (2310) within the external surface of the shunt body (2300).
  • Additional shunt bodies may comprise a wicking material that may be either bio- erodible or non-bio-erodible.
  • FIG. 24 shows an exemplary shunt body (2400) with a width (2404) and a length (2406), comprising a plurality of bundled filaments (2402) that comprise a wicking material.
  • FIG. 25 depicts a cylindrical shunt body (2500) with a cross- sectional diameter (2508), comprising a wicking material (e.g., sponge, felt).
  • a wicking material e.g., sponge, felt.
  • Such implants may be configured to have a circular, square, rectangular, triangular, or oval cross-sectional geometry.
  • the wicking material may be pre-compressed for easier storage of the shunt body before implantation and/or to minimize initial cyclodialysis.
  • Such shunt bodies may have a crush plane to encourage collapse in vivo, as described previously.
  • One advantage of such shunts is that there are no lumens or channels to get clogged or pinched, thus avoiding the blockage of fluid flow after implantation.
  • a shunt body described herein may generally be configured to receive a portion of a delivery device.
  • the shunt bodies may be configured to transition from the delivery configuration to the implanted configuration upon release from a delivery device.
  • a shunt body is configured to transition from the delivery configuration to the implanted configuration via contact with intraocular tissue.
  • such methods may comprise advancing an implantable intraocular shunt in a delivery configuration into the eye and transitioning the implantable intraocular shut to an implanted configuration.
  • the methods described herein comprise positioning at least one end of the shunt within a structure of the eye.
  • structures of the eye include suprachoroidal space, sub-retinal space, sub-conjunctiva, retrobulbar space, intrascleral space, Sub-Tenon’s space, and conjunctiva.
  • the proximal end of the shunt may be positioned in a first location of an eye, and the distal end is positioned in a second location of any eye.
  • the proximal end of the shunt may be positioned in an anterior chamber of an eye, and the distal end may be positioned in the suprachoroidal space of the eye.
  • the distal end of the shunt may be positioned in the sub conjunctiva or the retrobulbar space.
  • the distal end of the shunt may be positioned in the sub conjunctiva or the retrobulbar space and the proximal end may be positioned in the anterior chamber.
  • the methods described herein may comprise releasing the implantable intraocular shunt from a delivery device. In some embodiments, the methods comprise releasing the implantable intraocular shunt from a delivery device with the portion disposed within the structure of the eye. In some embodiments, the structure of the eye is the suprachoroidal space. In some embodiments, the shunt is configured to collapse to an implanted configuration after release. It should be understood that the shunts disclosed herein may configured to reside partially or fully within any part of the eye (e.g., posterior chamber, behind the lens) [0128] As described previously, the implantable intraocular shunts disclosed herein may be configured to direct fluid from one structure of the eye to another structure or location within the eye.
  • fluid may be directed away from the anterior chamber to another structure in the eye primarily along an external surface (e.g., along an outer external surface of at least one of a plurality of filaments) of the shunt in the implanted configuration.
  • a minority of the fluid may be directed away from the anterior chamber to another structure in the eye along an internal surface (e.g., internal surface of at least one of a plurality of filaments) of the shunt in the implanted configuration.
  • a majority of the fluid is directed away from the anterior chamber to the suprachoroidal space along an external surface of the shunt in the implanted configuration. After fluid is directed away from an initial structure of the eye (e.g., anterior chamber), the fluid may be absorbed into the vasculature of the eye.
  • the methods described herein are intended to treat conditions of the eye, such as glaucoma.
  • the eye Prior to administering the implantable intraocular shunt, the eye may be anesthetized, and one or more antiseptics may be applied to the eye to prepare it for the implantation procedure.
  • Anesthesia may include one or a combination of the following types of anesthesia: topical, subconjunctival, sub-Tenon’s, peribulbar, and retrobulbar.
  • an eyelid speculum may be applied to expose the ocular surface and prevent the eyelids from closing. In some instances, it may be advantageous to dilate the pupil.
  • the procedure may also be performed at a slit lamp with the patient seated upright, or it may be performed at a microscope with the patient supine.
  • the implant may be advanced and/or positioned using loupes, a gonioprism, a slit lamp, or a surgical microscope.
  • the procedure may be done in an operating room, although, advantageously, the methods described herein are suitable for being performed at a doctor’s office or in a minor procedure room.
  • the implantable intraocular shunt must be advanced through an external tissue (e.g., sclera, conjunctiva, cornea, limbus) to reach the desired or target location or position within the eye.
  • methods may comprise advancing the implantable intraocular shunt through the sclera or cornea, such as, for example, using a delivery device containing or otherwise supporting the implants.
  • methods may comprise puncturing a tissue of the eye (e.g., sclera, cornea) with a needle or cannula, such as a needle or cannula of a delivery device, and advancing a distal end of the needle or cannula carrying the implantable intraocular shunt therein to a desired implant location, such as directly within a mural tissue, in the posterior chamber, in the anterior chamber, in the subconjunctival space, or in the vitreous.
  • a tissue of the eye e.g., sclera, cornea
  • a needle or cannula such as a needle or cannula of a delivery device
  • a delivery device may further comprise a pusher (e.g., a pusher rod, guidewire) slidably disposed within a lumen of the needle or cannula, and advancing the implantable intraocular shunt may comprise pushing or otherwise delivering at least one implant by moving (e.g., advancing) the pusher relative to the cannula or needle.
  • methods may comprise creating an intramural tunnel or channel separately from, and prior to, advancing the implantable intraocular shunt to the target location.
  • the tunnel or channel may be created with an instrument such as a needle or a femtosecond laser.
  • the channel or tunnel may be created using the implantable intraocular shunt delivery device prior to, or during, advancement of the implant to the desired location.
  • the implantable intraocular shunt may be positioned within the mural tissue directly, or within a tunnel or channel, and additionally or alternatively may also comprise operating an actuator of the delivery device to release the implant from the delivery device.
  • the actuator may comprise, for instance, a button, a knob, or a slider, a lever, and/or a wheel.
  • the actuator may, for instance, control a pusher in contact with or releasably coupled to the implantable intraocular shunt.
  • a guidewire may contact a portion of the implantable intraocular shunt, and the implantable intraocular shunt may be advanced from a cannula and/or positioned using the guidewire. After delivering the implantable intraocular shunt to the target location with the guidewire, the implantable intraocular shunt may be released from the guidewire and/or the guidewire may be withdrawn, leaving the implantable intraocular shunt in place.
  • one or more actuators may be coupled to a handle of the delivery device.
  • advancing the implantable intraocular shunt may involve advancing a portion of a delivery device through a sclera of the eye.
  • advancing the implantable intraocular shunt may involve advancing a portion of a delivery device through a cornea or limbus of the eye
  • the implantable intraocular shunt may be disposed within the delivery device.
  • the implantable intraocular shunt may be disposed within a cannula of the delivery device, and at least a distal end of the cannula may be advanced through a sclera of the eye.
  • a portion of the delivery device (e.g., the cannula) and/or implantable intraocular shunt may be visualized during advancement and/or positioning using loupes, a slit lamp, gonioprism, a surgical microscope, or any combination thereof. Additionally, or alternatively, a implantable intraocular shunt may be implanted in a structure of the eye (e.g., suprachoroidal space) gonioscopically.
  • the methods described herein may comprise delivering a plurality (e.g., two, three, four, or more) of implantable intraocular shunt to the eye.
  • the implantable intraocular shunt may be delivered simultaneously or sequentially, and may reside in the eye simultaneously and/or sequentially (e.g., the implants may all be implanted for the same period of time, for different, overlapping periods of time, or for different non-overlapping periods of time).
  • any number of implantable intraocular shunts may comprise the same shunt body or may comprise different shunt bodies.
  • the implantable intraocular shunts described herein may be at least partly bio-erodible.
  • one or more new implants e.g., replacement implants
  • a new implantable intraocular shunts may replace a partially or fully degraded implant every month, every 2 months, every 3 months, every 6 months, every 12 months, every 18 months, every 2 years, every 3 years, or more, or at any interval therein.
  • Embodiment 1-1 An implantable intraocular shunt comprising a plurality of interconnected filaments forming a shunt body, wherein the body has a delivery configuration and an implanted configuration, and wherein a maximum height of the shunt body in the delivery configuration is greater than the maximum height of the shunt body in the implanted configuration.
  • Embodiment 1-2 The implantable intraocular shunt of embodiment I- 1, wherein the shunt body comprises a plurality of gaps between the plurality of filaments.
  • Embodiment 1-3 The implantable intraocular shunt of embodiment 1-2, wherein at least one gap of the plurality of gaps has a parallelogram shape.
  • Embodiment 1-4 The implantable intraocular shunt of any one of embodiments 1-1 to 1-4, wherein at least one of the plurality of filaments has a diameter (D).
  • Embodiment 1-5 The implantable intraocular shunt of any one of embodiments 1-2 to 1-4, wherein the at least one gap has a width dimension (“W”) between about D and about 15D.
  • Embodiment 1-6 The implantable intraocular shunt of any one of embodiments 1-3 to 1-5, wherein the at least one gap has a length dimension (“L”) between about D and about 15D.
  • Embodiment 1-7 The implantable intraocular shunt of any one of embodiments 1-5 to 1-6, wherein the W dimension and/or the L dimension is about 4D.
  • Embodiment 1-8 The implantable intraocular shunt of any one of embodiments 1-1 to 1-7, wherein the implant has a Pick Count (PC) associated with the plurality of filaments.
  • PC Pick Count
  • Embodiment 1-9 The implantable intraocular shunt of embodiment 1-8, wherein the PC is between about 15 and about 50 picks per inch (PPI).
  • Embodiment I- 10 The implantable intraocular shunt of embodiment 1-9, wherein the PC is between about 15 and about 20 PPI.
  • Embodiment 1-11 The implantable intraocular shunt of any one of embodiments 1-1 to 1-10, wherein in the delivery configuration, the shunt body comprises a primary lumen between a proximal end and a distal end of the shunt body.
  • Embodiment 1-12 The implantable intraocular shunt of embodiment 1-11, wherein the primary lumen has an elliptical cross-sectional shape.
  • Embodiment 1-13 The implantable intraocular shunt of embodiment 1-11, wherein the primary lumen has a circular cross-sectional shape.
  • Embodiment 1-14 The implantable intraocular shunt of embodiment 1-11, wherein the primary lumen has a pointed oval cross-sectional shape.
  • Embodiment 1-15 The implantable intraocular shunt of any one of embodiments 1-1 to 1-14, wherein the shunt body lacks a primary lumen in the implanted configuration.
  • Embodiment 1-16 The implantable intraocular shunt of any one of embodiments 1-1 to 1-15, wherein the shunt body comprises an upper portion with a thickness of about D to about 2D.
  • Embodiment 1-17 The implantable intraocular shunt of any one of embodiments 1-1 to 1-16, wherein the shunt body comprises a lower portion with a thickness of about D to about 2D.
  • Embodiment 1-18 The implantable intraocular shunt of any one of embodiments 1-4 to 1-17, wherein D is between about 20 pm and about 300 pm.
  • Embodiment 1-19 The implantable intraocular shunt of any one of embodiments 1-4 to 1-18, wherein D is between about 40 pm and about 200 pm.
  • Embodiment 1-20 The implantable intraocular shunt of any one of embodiments 1-4 to 1-19, wherein D is between about 60 pm and about 70 pm.
  • Embodiment 1-21 The implantable intraocular shunt of any one of embodiments 1-1 to 1-20, wherein the shunt body has a length of about 1 mm to about 2 mm.
  • Embodiment 1-22 The implantable intraocular shunt of any one of embodiments 1-1 to 1-21, wherein, in the delivery configuration, the shunt body has a circular cross-sectional shape with a diameter of between about 100 pm and about 1100 pm.
  • Embodiment 1-2 The implantable intraocular shunt of any one of embodiments 1-1 to 1-22, wherein, in the delivery configuration, the shunt body has an elliptical cross-sectional shape with a minor axis of between about 100 pm and about 600 pm, and a major axis of between about 100 pm and about 1100 pm.
  • Embodiment 1-24 The implantable intraocular shunt of any one of embodiments 1-1 to 1-23, wherein, in the implanted configuration, the maximum height of the shunt body is between about 100 pm and about 600 pm, and a width of the shunt body is between about 100 pm and about 1100 pm.
  • Embodiment 1-25 The implantable intraocular shunt of any one of embodiments 1-1 to 1-24, wherein, in the implanted configuration, the maximum height of the shunt body is between about 300 pm and about 500 pm, and a width of the shunt body is between about 500 pm and about 1100 pm.
  • Embodiment 1-26 The implantable intraocular shunt of any one of embodiments 1-1 to 1-25, wherein at least one filament of the plurality of filaments comprises a bio-erodible material
  • Embodiment 1-27 The implantable intraocular shunt of any one of embodiments 1-1 to 1-26, wherein each filament of the plurality of filaments comprises a bio-erodible material.
  • Embodiment 1-28 The implantable intraocular shunt of any one of embodiments 1-1 to 1-27, wherein at least one filament of the plurality of filaments comprises a bio-erodible material and at least one filament of the plurality of filaments comprises a non-bio-erodible material.
  • Embodiment 1-2 The implantable intraocular shunt of any one of embodiments 1-1 to 1-28, wherein the shunt body comprises a proximal portion, a distal portion, and a central portion, and wherein the proximal portion comprises a bio-erodible material, and one or more of the distal portion and the central portion comprises a non-bio-erodible material.
  • Embodiment 1-30 Embodiment 1-30.
  • the implantable intraocular shunt of any one of embodiments 1-1 to 1-29 wherein the shunt body comprises a proximal portion, a distal portion, and a central portion, and wherein the distal portion comprises a bio-erodible material, and one or more of the proximal portion and the central portion comprises a non-bio-erodible.
  • Embodiment 1-3 The implantable intraocular shunt of any one of embodiments 1-27 to 1-30, wherein the bio-erodible material comprises one or more of polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-lactide) (PGLA), polydioxanone (PDO), and polyglyconate.
  • PLA polylactic acid
  • PLGA poly(lactic-co-glycolic acid)
  • PGLA poly(glycolide-co-lactide)
  • PDO polydioxanone
  • polyglyconate polyglyconate
  • Embodiment 1-32 The implantable intraocular shunt of any one of embodiments 1-2 to 1-31, wherein, in the implanted configuration, at least an internal surface of a filament of the plurality of filaments of an upper portion of the shunt body is disposed in a gap of the plurality of gaps of a lower portion of the shunt body.
  • Embodiment 1-33 The implantable intraocular shunt of any one of embodiments 1-1 to 1-32, wherein at least one filament of the plurality of filaments has a first diameter (DI) and at least one filament of the plurality of filaments has a second diameter (D2).
  • DI first diameter
  • D2 second diameter
  • Embodiment 1-34 The implantable intraocular shunt of embodiment 1-33, wherein the at least one filament of the plurality of filaments with DI is bio-erodible and the at least one filament of the plurality of filaments with D2 is non-bio-erodible.
  • Embodiment 1-35 The implantable intraocular shunt of any one of embodiments 1-1 to 1-34, wherein the implantable intraocular shunt comprises at least one rigid longitudinal strand running through at least a portion of the shunt body.
  • Embodiment 1-36 The implantable intraocular shunt of embodiment 1-35, wherein the at least one rigid longitudinal strand is bio-erodible and the plurality of filaments are non-bio- erodible.
  • Embodiment 1-37 The implantable intraocular shunt of embodiment 1-35, wherein each of the at least one rigid longitudinal strand and the plurality of filaments is both bio- erodible.
  • Embodiment 1-38 The implantable intraocular shunt of embodiment 1-37, wherein the at least one rigid longitudinal strand has a first dissolution rate and at least one of the plurality of filaments has a second dissolution rate.
  • Embodiment 1-39 The implantable intraocular shunt of embodiment 1-38, wherein the first dissolution rate is lower than the second dissolution rate.
  • Embodiment 1-40 The implantable intraocular shunt of embodiment 1-38, wherein the first dissolution rate is higher than the second dissolution rate.
  • Embodiment 1-4 The implantable intraocular shunt of any one of embodiments 1-1 to 1-40, wherein the shunt body further comprises a bio-erodible layer.
  • Embodiment 1-42 The implantable intraocular shunt of embodiment 1-41, wherein the bio-erodible layer is disposed on an external surface of the shunt body.
  • Embodiment 1-43 The implantable intraocular shunt of embodiment 1-41, wherein the bio-erodible layer is disposed on an internal surface of the shunt body.
  • Embodiment 1-44 The implantable intraocular shunt of any one of embodiments 1-41 to 1-43, wherein the bio-erodible layer is an adhesive layer, a bio glue, a viscoelastic material, or any combination thereof.
  • Embodiment 1-45 The implantable intraocular shunt of any one of embodiments 1-41 to 1-44, wherein at least one filament of the plurality of filaments comprises a bio-erodible material with a lower dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-46 The implantable intraocular shunt of any one of embodiments 1-41 to 1-45, wherein at least one filament of the plurality of filaments comprises a bio-erodible material with a higher dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-47 The implantable intraocular shunt of any one of embodiments 1-1 to 1-46, wherein the shunt body has a proximal end and a distal end, and wherein the plurality of filaments is joined at one or more of the proximal end and the distal end.
  • Embodiment 1-48 The implantable intraocular shunt of embodiment 1-47, wherein the plurality of filaments is joined by one or more of a bio-erodible collar, a non-bio-erodible collar, a bio-erodible adhesive, a non-bio-erodible adhesive, heat staking, laser welding, and mechanical fastening.
  • Embodiment 1-49 The implantable intraocular shunt of any one of embodiments 1-1 to 1-48, wherein the plurality of filaments is braided and/or woven wherein the implantable intraocular shunt comprises between 2 and 32 filaments.
  • Embodiment 1-50 The implantable intraocular shunt of any one of embodiments 1-1 to 1-49, wherein the plurality of filaments is braided and/or woven wherein the implantable intraocular shunt comprises between 6 and 16 filaments.
  • Embodiment 1-51 The implantable intraocular shunt of any one of embodiments 1-1 to 1-50, wherein the implantable intraocular shunt comprises 8 or 16 filaments.
  • Embodiment 1-52 The implantable intraocular shunt of any one of embodiments 1-1 to 1-51, wherein said implantable intraocular shunt comprises 8 filaments.
  • Embodiment 1-53 The implantable intraocular shunt of any one of embodiments 1-1 to 1-52, wherein at least one filament of the plurality of filaments comprises a lumen.
  • Embodiment 1-54 The implantable intraocular shunt of any one of embodiments 1-1 to 1-53, wherein each filament of the plurality of filaments comprises a lumen.
  • Embodiment 1-55 The implantable intraocular shunt of embodiment 1-53 or 1-54, wherein at least one filament of the plurality of filaments comprises a fenestration configured to provide fluid contact between the lumen and an exterior surface of the shunt body.
  • Embodiment 1-56 The implantable intraocular shunt of any one of embodiments 1-1 to 1-55, wherein the shunt body comprises a weakened region.
  • Embodiment 1-57 The implantable intraocular shunt of any one of embodiments 1-1 to 1-56, wherein the shunt body is configured to reside at least partially within a suprachoroidal space of an eye.
  • Embodiment 1-58 The implantable intraocular shunt of any one of embodiments 1-1 to 1-57, wherein the shunt body comprises a proximal portion and a distal portion, and wherein the proximal portion is configured to reside at least partially within an anterior chamber of an eye.
  • Embodiment 1-59 The implantable intraocular shunt of any one of embodiments 1-1 to 1-58, wherein the shunt body is configured to transfer fluid along an external surface of the shunt body.
  • Embodiment 1-60 The implantable intraocular shunt of any one of embodiments 1-1 to 1-59, wherein the shunt body is configured to transfer fluid along only an external surface of the shunt body.
  • Embodiment 1-61 The implantable intraocular shunt of any one of embodiments 1-1 to 1-60, wherein, in the delivery configuration, the shunt body is configured to receive a portion of a delivery device.
  • Embodiment 1-62 The implantable intraocular shunt of any one of embodiments 1-1 to 1-61, wherein the shunt body is configured to transition from the delivery configuration to the implanted configuration upon release from a delivery device.
  • Embodiment 1-63 The implantable intraocular shunt of any one of embodiments 1-1 to 1-62, wherein the shunt body is configured to transition from the delivery configuration to the implanted configuration via contact with intraocular tissue.
  • Embodiment 1-64 An implantable intraocular shunt comprising: a shunt body comprising a plurality of interconnected filaments, wherein the shunt body has a round delivery configuration and a substantially flat implanted configuration, and wherein the shunt body is configured to transfer fluid along an external surface of the shunt body in the implanted configuration.
  • Embodiment 1-65 The implantable intraocular shunt of embodiment 1-64, wherein the shunt body comprises a plurality of gaps between the plurality of interconnected filaments.
  • Embodiment 1-66 The implantable intraocular shunt of embodiment 1-65, wherein at least one gap of the plurality of gaps has a parallelogram shape.
  • Embodiment 1-67 The implantable intraocular shunt of any one of embodiments 1-64 to 1-66, wherein at least one of the plurality of interconnected filaments has a diameter (D).
  • Embodiment 1-68 The implantable intraocular shunt of any one of embodiments 1-65 to 1-67, wherein the at least one gap has a width dimension (“W”) between about D and about 15D.
  • W width dimension
  • Embodiment 1-69 The implantable intraocular shunt of any one of embodiments 1-66 to 1-68, wherein the at least one gap has a length dimension (“L”) between about D and about 15D.
  • Embodiment 1-70 The implantable intraocular shunt of any one of embodiments 1-68 to 1-69, wherein the W dimension and/or the L dimension is about 4D.
  • Embodiment 1-71 The implantable intraocular shunt of any one of embodiments 1-64 to 1-70, wherein the implant has a Pick Count (PC) associated with the plurality of interconnected filaments.
  • PC Pick Count
  • Embodiment 1-72 The implantable intraocular shunt of embodiment 1-71, wherein the PC is between about 15 and about 50 picks per inch (PPI).
  • PC picks per inch
  • Embodiment 1-73 The implantable intraocular shunt of embodiment 1-71 or 1-72, wherein the PC is between about 15 and about 20 PPI.
  • Embodiment 1-74 The implantable intraocular shunt of any one of embodiments 1-64 to 1-73, wherein in the delivery configuration, the shunt body comprises a primary lumen between a proximal end and a distal end of the shunt body.
  • Embodiment 1-75 The implantable intraocular shunt of any one of embodiments 1-64 to 1-74, wherein the shunt body lacks a primary lumen in the implanted configuration.
  • Embodiment 1-76 The implantable intraocular shunt of any one of embodiments 1-64 to 1-78, wherein the shunt body comprises an upper portion with a thickness of about D to about 2D.
  • Embodiment 1-77 The implantable intraocular shunt of any one of embodiments 1-64 to 1-76, wherein the shunt body comprises a lower portion with a thickness of about D to about 2D.
  • Embodiment 1-78 The implantable intraocular shunt of any one of embodiments 1-67 to 1-77, wherein D is between about 20 pm and about 300 pm.
  • Embodiment 1-79 The implantable intraocular shunt of any one of embodiments 1-66 to 1-78, wherein D is between about 40 pm and about 200 pm.
  • Embodiment 1-80 The implantable intraocular shunt of any one of embodiments 1-66 to 1-79, wherein D is between about 60 pm and about 70 pm.
  • Embodiment 1-81 The implantable intraocular shunt of any one of embodiments 1-64 to 1-80, wherein the shunt body has a length of about 1 mm to about 20 mm.
  • Embodiment 1-82 The implantable intraocular shunt of any one of embodiments 1-64 to 1-81, wherein, in the delivery configuration, the shunt body has a circular cross-sectional shape with a diameter of between about 100 pm and about 1100 pm.
  • Embodiment 1-83 The implantable intraocular shunt of any one of embodiments 1-64 to 1-82, wherein, in the implanted configuration, the maximum height of the shunt body is between about 100 pm and about 600 pm, and a width of the shunt body is between about 100 pm and about 1100 pm.
  • Embodiment 1-84 The implantable intraocular shunt of any one of embodiments 1-64 to 1-83, wherein, in the implanted configuration, the maximum height of the shunt body is between about 300 pm and about 500 pm, and a width of the shunt body is between about 500 pm and about 1100 pm.
  • Embodiment 1-85 The implantable intraocular shunt of any one of embodiments 1-64 to 1-84, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material.
  • Embodiment 1-86 The implantable intraocular shunt of any one of embodiments 1-64 to 1-85, wherein each filament of the plurality of interconnected filaments comprises a bio- erodible material.
  • Embodiment 1-87 The implantable intraocular shunt of any one of embodiments 1-64 to 1-86, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material and at least one filament of the plurality of interconnected filaments comprises a non-bio-erodible material.
  • Embodiment 1-88 The implantable intraocular shunt of any one of embodiments 1-64 to 1-87, wherein the shunt body comprises a proximal portion, a distal portion, and a central portion, and wherein the proximal portion comprises a bio-erodible material, and one or more of the distal portion and the central portion comprises a non-bio-erodible material.
  • Embodiment 1-89 The implantable intraocular shunt of any one of embodiments 1-64 to 1-88, wherein the shunt body comprises a proximal portion, a distal portion, and a central portion, and wherein the distal portion comprises a bio-erodible material, and one or more of the proximal portion and the central portion comprises a non-bio-erodible.
  • Embodiment 1-90 The implantable intraocular shunt of any one of embodiments 1-85 to 1-89, wherein the bio-erodible material comprises one or more of polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-lactide) (PGLA), polydioxanone (PDO), and polyglyconate.
  • PLA polylactic acid
  • PLGA poly(lactic-co-glycolic acid)
  • PGLA poly(glycolide-co-lactide)
  • PDO polydioxanone
  • polyglyconate polyglyconate
  • Embodiment 1-91 The implantable intraocular shunt of any one of embodiments 1-65 to 1-90, wherein, in the implanted configuration, at least an internal surface of a filament of the plurality of interconnected filaments of an upper portion of the shunt body is disposed in a gap of the plurality of gaps of a lower portion of the shunt body.
  • Embodiment 1-92 The implantable intraocular shunt of any one of embodiments 1-64 to 1-91, wherein at least one filament of the plurality of interconnected filaments has a first diameter (DI) and at least one filament of the plurality of interconnected filaments has a second diameter (D2).
  • DI first diameter
  • D2 second diameter
  • Embodiment 1-93 The implantable intraocular shunt of embodiment 1-92, wherein the at least one filament of the plurality of interconnected filaments with DI is bio-erodible and the at least one filament of the plurality of interconnected filaments with D2 is non-bio-erodible.
  • Embodiment 1-94 The implantable intraocular shunt of any one of embodiments 1-64 to 1-93, wherein the implantable intraocular shunt comprises at least one rigid longitudinal strand running through at least a portion of the shunt body.
  • Embodiment 1-95 The implantable intraocular shunt of embodiment 1-94, wherein the at least one rigid longitudinal strand is bio-erodible and the plurality of interconnected filaments are non-bio-erodible.
  • Embodiment 1-96 The implantable intraocular shunt of embodiment 1-94, wherein each of the at least one rigid longitudinal strand and the plurality of filaments is both bio- erodible.
  • Embodiment 1-97 The implantable intraocular shunt of embodiment 1-94, wherein the at least one rigid longitudinal strand has a first dissolution rate and at least one of the plurality of interconnected filaments has a second dissolution rate.
  • Embodiment 1-98 The implantable intraocular shunt of embodiment 1-97, wherein the first dissolution rate is lower than the second dissolution rate.
  • Embodiment 1-99 The implantable intraocular shunt of embodiment 1-97, wherein the first dissolution rate is higher than the second dissolution rate.
  • Embodiment I- 100 The implantable intraocular shunt of any one of embodiments 1-64 to 1-99, wherein the shunt body further comprises a bio-erodible layer.
  • Embodiment 1-101 The implantable intraocular shunt of embodiment I- 100, wherein the bio-erodible layer is disposed on an external surface of the shunt body.
  • Embodiment 1-102 The implantable intraocular shunt of embodiment I- 100, wherein the bio-erodible layer is disposed on an internal surface of the shunt body.
  • Embodiment 1-103 The implantable intraocular shunt of any one of embodiments I- 100 to 1-102, wherein the bio-erodible layer is an adhesive layer, a bio glue, a viscoelastic material, or any combination thereof.
  • Embodiment 1-104 The implantable intraocular shunt of any one of embodiments I- 100 to 1-103, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material with a lower dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-105 The implantable intraocular shunt of any one of embodiments I- 100 to 1-103, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material with a higher dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-106 The implantable intraocular shunt of any one of embodiments 1-64 to 1-105, wherein the shunt body has a proximal end and a distal end, and wherein the plurality of interconnected filaments is joined at one or more of the proximal end and the distal end.
  • Embodiment 1-107 The implantable intraocular shunt of embodiment 1-106, wherein the plurality of interconnected filaments is joined by one or more of a bio-erodible collar, a non- bio-erodible collar, a bio-erodible adhesive, a non-bio-erodible adhesive, heat staking, laser welding, and mechanical fastening.
  • Embodiment 1-108 The implantable intraocular shunt of any one of embodiments 1-64 to 1-107, wherein the plurality of interconnected filaments is braided and/or woven, and wherein the implantable intraocular shunt comprises between 2 and 32 filaments.
  • Embodiment 1-109 The implantable intraocular shunt of any one of embodiments 1-64 to 1-108, wherein the plurality of filaments is braided and/or woven, and wherein the implantable intraocular shunt comprises between 6 and 16 filaments.
  • Embodiment 1-110 The implantable intraocular shunt of any one of embodiments 1-64 to 1-109, wherein the implantable intraocular shunt comprises 8 or 16 filaments.
  • Embodiment 1-111 The implantable intraocular shunt of any one of embodiments 1-64 to 1-110, wherein the implantable intraocular shunt comprises 8 filaments.
  • Embodiment 1-112. The implantable intraocular shunt of any one of embodiments 1-64 to 1-111, wherein at least one filament of the plurality of interconnected filaments comprises a lumen.
  • Embodiment 1-113 The implantable intraocular shunt of any one of embodiments 1-64 to 1-112, wherein each filament of the plurality of interconnected filaments comprises a lumen.
  • Embodiment 1-114 The implantable intraocular shunt of embodiment 1-112 or 1-113, wherein at least one filament of the plurality of interconnected filaments comprises a fenestration configured to provide fluid contact between the lumen and an exterior surface of the shunt body.
  • Embodiment 1-115 The implantable intraocular shunt of any one of embodiments 1-64 to 1-114, wherein the shunt body comprises a weakened region.
  • Embodiment 1-116 The implantable intraocular shunt of any one of embodiments 1-64 to 1-115, wherein the shunt body is configured to reside at least partially within a suprachoroidal space of an eye.
  • Embodiment 1-117 The implantable intraocular shunt of any one of embodiments 1-64 to 1-116, wherein the shunt body comprises a proximal portion and a distal portion, and wherein the proximal portion is configured to reside at least partially within an anterior chamber of an eye.
  • Embodiment 1-118 The implantable intraocular shunt of any one of embodiments 1-64 to 1-117, wherein the shunt body is configured to transfer fluid along only an external surface of the shunt body.
  • Embodiment 1-119 The implantable intraocular shunt of any one of embodiments 1-64 to 1-118, wherein, in the delivery configuration, the shunt body is configured to receive a portion of a delivery device.
  • Embodiment 1-120 The implantable intraocular shunt of any one of embodiments 1-64 to 1-119, wherein the shunt body is configured to transition from the delivery configuration to the implanted configuration upon release from a delivery device.
  • Embodiment 1-121 The implantable intraocular shunt of any one of embodiments 1-64 to 1-120, wherein the shunt body is configured to transition from the delivery configuration to the implanted configuration via contact with intraocular tissue.
  • Embodiment 1-122 An implantable intraocular shunt comprising: a shunt body comprising a plurality of interconnected filaments, wherein the shunt body comprises an upper portion, a lower portion, a proximal portion, a distal portion, an open configuration, and a collapsed configuration, and wherein the upper portion and the lower portion are curved in the open configuration and generally flat in the collapsed configuration, and wherein, in the collapsed configuration, the upper and lower portions form an upper layer and a lower layer, respectively.
  • Embodiment 1-123 An implantable intraocular shunt comprising: a shunt body comprising a plurality of interconnected filaments, wherein the shunt body has an open configuration and a collapsed configuration, and wherein the shunt body is configured to receive a portion of a delivery device in the open configuration and is configured to transfer fluid along an external surface of the shunt body in the collapsed configuration.
  • Embodiment 1-124 An implantable intraocular shunt comprising a plurality of interconnected filaments forming a shunt body comprising an upper portion and a lower portion, wherein the shunt body has a delivery configuration and an implanted configuration, wherein in the delivery configuration, an internal surface of the upper portion and an internal surface of the lower portion are separated by a first maximum height, and in the implanted configuration, at least a portion of the internal surface of the upper portion and at least a portion of the internal surface of the lower portion are separated by no more than a second, smaller height.
  • Embodiment 1-125 The implantable intraocular shunt of any one of embodiments I- 122 to 1-124, wherein the shunt body comprises a plurality of gaps between the plurality of interconnected filaments.
  • Embodiment 1-126 The implantable intraocular shunt of embodiment 1-125, wherein at least one gap of the plurality of gaps has a parallelogram shape.
  • Embodiment 1-127 The implantable intraocular shunt of any one of embodiments I- 122 to 1-126, wherein at least one of the plurality of interconnected filaments has a diameter (D).
  • Embodiment 1-128 The implantable intraocular shunt of any one of embodiments I-
  • the at least one gap has a width dimension (“W”) between about D and about 15D.
  • Embodiment 1-129 The implantable intraocular shunt of any one of embodiments I-
  • the at least one gap has a length dimension (“L”) between about D and about 15D.
  • Embodiment 1-130 The implantable intraocular shunt of embodiment 1-128 or 1-129, wherein the W dimension and/or the L dimension is about 4D.
  • Embodiment 1-131 The implantable intraocular shunt of any one of embodiments I- 122 to 1-130, wherein the implantable intraocular shunt has a Pick Count (PC) associated with the plurality of interconnected filaments.
  • PC Pick Count
  • Embodiment 1-132 The implantable intraocular shunt of embodiment 1-131, wherein the PC is between about 15 and about 50 picks per inch (PPI).
  • PC picks per inch
  • Embodiment 1-133 The implantable intraocular shunt of embodiment 1-131 or 1-132, wherein the PC is between about 15 and about 20 PPI.
  • Embodiment 1-134 The implantable intraocular shunt of any one of embodiments I- 127 to 1-133, wherein D is between about 20 pm and about 300 pm.
  • Embodiment 1-135. The implantable intraocular shunt of any one of embodiments I- 127 to 1-134, wherein D is between about 40 pm and about 200 pm.
  • Embodiment 1-136 The implantable intraocular shunt of any one of embodiments I- 127 to 1-135, wherein D is between about 60 pm and about 70 pm.
  • Embodiment 1-137 The implantable intraocular shunt of any one of embodiments I- 122 to 1-124, wherein the shunt body has a length of about 1 mm to about 20 mm.
  • Embodiment 1-138 The implantable intraocular shunt of any one of embodiments I- 122 to 1-138, wherein, in the delivery configuration or open configuration, the shunt body has a circular cross-sectional shape with a diameter of between about 100 pm and about 1100 pm.
  • Embodiment 1-139 The implantable intraocular shunt of any one of embodiments 1-64 to 1-138, wherein, in the implanted configuration or the collapsed configuration, the maximum height of the shunt body is between about 100 pm and about 600 pm, and a width of the shunt body is between about 100 pm and about 1100 pm.
  • Embodiment 1-140 The implantable intraocular shunt of any one of embodiments I- 124 to 1-139, wherein, in the implanted configuration, the first maximum height of the shunt body is between about 300 pm and about 500 pm, and a width of the shunt body is between about 500 pm and about 1100 pm.
  • Embodiment 1-141 The implantable intraocular shunt of any one of embodiments I- 122 to 1-140, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material.
  • Embodiment 1-142 The implantable intraocular shunt of any one of embodiments I- 122 to 1-141, wherein each filament of the plurality of interconnected filaments comprises a bio- erodible material.
  • Embodiment 1-143 The implantable intraocular shunt of any one of embodiments I- 122 to 1-142, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material and at least one filament of the plurality of interconnected filaments comprises a non-bio-erodible material.
  • Embodiment 1-144 The implantable intraocular shunt of any one of embodiments I- 141 to 1-143, wherein the bio-erodible material comprises one or more of polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-lactide) (PGLA), polydioxanone (PDO), and polyglyconate.
  • PLA polylactic acid
  • PLGA poly(lactic-co-glycolic acid)
  • PGLA poly(glycolide-co-lactide)
  • PDO polydioxanone
  • polyglyconate polyglyconate
  • Embodiment 1-145 The implantable intraocular shunt of any one of embodiments I- 122 to 1-144, wherein at least one filament of the plurality of interconnected filaments has a first diameter (DI) and at least one filament of the plurality of interconnected filaments has a second diameter (D2).
  • DI first diameter
  • D2 second diameter
  • Embodiment 1-146 The implantable intraocular shunt of embodiment 1-145, wherein the at least one filament of the plurality of interconnected filaments with DI is bio-erodible and the at least one filament of the plurality of interconnected filaments with D2 is non-bio-erodible.
  • Embodiment 1-147 The implantable intraocular shunt of any one of embodiments I- 122 to 1-146, wherein the implantable intraocular shunt comprises at least one rigid longitudinal strand running through at least a portion of the shunt body.
  • Embodiment 1-148 The implantable intraocular shunt of embodiment 1-147, wherein the at least one rigid longitudinal strand is bio-erodible and the plurality of interconnected filaments are non-bio-erodible.
  • Embodiment 1-149 The implantable intraocular shunt of embodiment 1-147, wherein each of the at least one rigid longitudinal strand and the plurality of filaments is both bio- erodible.
  • Embodiment 1-150 The implantable intraocular shunt of embodiment 1-147, wherein the at least one rigid longitudinal strand has a first dissolution rate and at least one of the plurality of interconnected filaments has a second dissolution rate.
  • Embodiment 1-151 The implantable intraocular shunt of embodiment 1-150, wherein the first dissolution rate is lower than the second dissolution rate.
  • Embodiment 1-152 The implantable intraocular shunt of embodiment 1-150, wherein the first dissolution rate is higher than the second dissolution rate.
  • Embodiment 1-153 The implantable intraocular shunt of any one of embodiments I- 122 to 1-153, wherein the shunt body further comprises a bio-erodible layer.
  • Embodiment 1-154 The implantable intraocular shunt of embodiment 1-153, wherein the bio-erodible layer is disposed on an external surface of the shunt body.
  • Embodiment 1-155 The implantable intraocular shunt of embodiment 1-153, wherein the bio-erodible layer is disposed on an internal surface of the shunt body.
  • Embodiment 1-156 The implantable intraocular shunt of any one of embodiments I- 153 to 1-155, wherein the bio-erodible layer is an adhesive layer, a bio glue, a viscoelastic material, or any combination thereof.
  • Embodiment 1-157 The implantable intraocular shunt of any one of embodiments I- 153 to 1-156, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material with a lower dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-158 The implantable intraocular shunt of any one of embodiments I- 153 to 1-156, wherein at least one filament of the plurality of interconnected filaments comprises a bio-erodible material with a higher dissolution rate than a dissolution rate of the bio-erodible layer.
  • Embodiment 1-159 The implantable intraocular shunt of any one of embodiments I- 122 to 1-158, wherein the shunt body has a proximal end and a distal end, and wherein the plurality of interconnected filaments is joined at one or more of the proximal end and the distal end.
  • Embodiment 1-160 The implantable intraocular shunt of embodiment 1-159, wherein the plurality of interconnected filaments is joined by one or more of a bio-erodible collar, a non- bio-erodible collar, a bio-erodible adhesive, a non-bio-erodible adhesive, heat staking, laser welding, and mechanical fastening.
  • Embodiment 1-161 The implantable intraocular shunt of any one of embodiments I- 122 to 1-160, wherein the plurality of interconnected filaments is braided and/or woven wherein the implantable intraocular shunt comprises between 2 and 32 filaments.
  • Embodiment 1-162 The implantable intraocular shunt of any one of embodiments I- 122 to 1-161, wherein the plurality of filaments is braided and/or woven wherein the implantable intraocular shunt comprises between 6 and 16 filaments.
  • Embodiment 1-163 The implantable intraocular shunt of any one of embodiments I- 122 to 1-162, wherein the implantable intraocular shunt comprises 8 or 16 filaments.
  • Embodiment 1-164 The implantable intraocular shunt of any one of embodiments I- 122 to 1-163, wherein said implantable intraocular shunt comprises 8 filaments.
  • Embodiment 1-165 The implantable intraocular shunt of any one of embodiments I- 122 to 1-164, wherein at least one filament of the plurality of interconnected filaments comprises a lumen.
  • Embodiment 1-166 The implantable intraocular shunt of any one of embodiments I- 122 to 1-166, wherein each filament of the plurality of interconnected filaments comprises a lumen.
  • Embodiment 1-167 The implantable intraocular shunt of embodiment 1-165 or 1-166, wherein at least one filament of the plurality of interconnected filaments comprises a fenestration configured to provide fluid contact between the lumen and an exterior surface of the shunt body.
  • Embodiment 1-168 The implantable intraocular shunt of any one of embodiments I- 122 to 1-167, wherein the shunt body comprises a weakened region.
  • Embodiment 1-169 The implantable intraocular shunt of any one of embodiments I- 122 to 1-169, wherein the shunt body is configured to reside at least partially within a suprachoroidal space of an eye.
  • Embodiment 1-170 The implantable intraocular shunt of any one of embodiments I- 122 to 1-169, wherein the shunt body comprises a proximal portion and a distal portion, and wherein the proximal portion is configured to reside at least partially within an anterior chamber of an eye.
  • Embodiment 1-171 The implantable intraocular shunt of any one of embodiments I- 122 to 1-170, wherein the shunt body is configured to transfer fluid along only an external surface of the shunt body.
  • Embodiment 1-172 The implantable intraocular shunt of any one of embodiments I- 122 to 1-171, wherein, in the delivery configuration, the shunt body is configured to receive a portion of a delivery device.
  • Embodiment 1-173 The implantable intraocular shunt of any one of embodiments I- 122 to 1-172, wherein the shunt body is configured to transition from the delivery configuration or the open configuration to the implanted configuration or the closed configuration upon release from a delivery device.
  • Embodiment 1-174 The implantable intraocular shunt of any one of embodiments I- 122 to 1-173, wherein the shunt body is configured to transition from the delivery configuration or the open configuration to the implanted configuration or the closed configuration via contact with intraocular tissue.
  • Embodiment 1-175. The implantable intraocular shunt of embodiment 1-67, wherein in the implanted configuration, at least a portion of the internal surface of the upper portion contacts at least a portion of the internal surface of the lower portion.
  • Embodiment 1-176 A method of treating a condition of an eye comprising: advancing an implantable intraocular shunt in a delivery configuration into the eye; positioning at least one end of the shunt within a suprachoroidal space of the eye; and releasing the implantable intraocular shunt from a delivery device with the portion disposed within the suprachoroidal space of the eye, wherein shunt is configured to collapse to an implanted configuration after release.
  • Embodiment 1-177 The method of embodiment 1-176, wherein fluid is directed away from anterior chamber to the suprachoroidal space along an external surface of the shunt in the implanted configuration.
  • Embodiment 1-178 The method of embodiment 1-176 or 1-177, wherein the condition of the eye is glaucoma.
  • Embodiment 1-179 The method of any one of embodiments 1-176 to 1-178, wherein the proximal end of the shunt is positioned in an anterior chamber of an eye, and the distal end is positioned in the suprachoroidal space of the eye.
  • Embodiment 1-180 A method of treating a condition of an eye comprising: advancing the implantable intraocular shunt of any one of embodiments 1-1 to 1-175 in a delivery configuration into the eye; positioning at least one end of the shunt within a suprachoroidal space of the eye; and releasing the implantable intraocular shunt from a delivery device with the portion disposed within the suprachoroidal space of the eye, wherein shunt is configured to collapse to an implanted configuration after release.
  • Embodiment 1-181. The method of embodiment 1-180, wherein fluid is directed away from anterior chamber to the suprachoroidal space along an external surface of the shunt in the implanted configuration.
  • Embodiment 1-182 The method of embodiment 1-180 or 1-181, wherein the condition of the eye is glaucoma. [0321] Embodiment 1-183. The method of any one of embodiments 1-180 to 1-182, wherein the proximal end of the shunt is positioned in an anterior chamber of an eye, and the distal end is positioned in the suprachoroidal space of the eye.

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Abstract

L'invention concerne des dispositifs intraoculaires implantables (par exemple, des shunts) et des procédés de traitement d'affections oculaires de l'œil. De manière générale, les dispositifs décrits ici sont destinés à être implantés dans l'œil dans une configuration de pose et à résider dans l'œil dans une configuration implantée. Un dispositif peut être un shunt intraoculaire implantable ayant une pluralité de filaments interconnectés formant un corps de shunt. Le corps de shunt peut avoir une configuration de pose et une configuration implantée, et une hauteur maximale du corps de shunt dans la configuration de pose peut être supérieure à la hauteur maximale du corps de shunt dans la configuration implantée.
PCT/US2024/017558 2023-02-27 2024-02-27 Implants pour le traitement d'affections oculaires WO2024182448A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8585753B2 (en) * 2006-03-04 2013-11-19 John James Scanlon Fibrillated biodegradable prosthesis
US10568762B2 (en) * 1999-04-26 2020-02-25 Glaukos Corporation Stent for treating ocular disorders
US10828195B2 (en) * 2006-11-10 2020-11-10 Glaukos Corporation Uveoscleral shunt and methods for implanting same
US20210128357A1 (en) * 2006-01-17 2021-05-06 Alcon Inc. Glaucoma treatment device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10568762B2 (en) * 1999-04-26 2020-02-25 Glaukos Corporation Stent for treating ocular disorders
US20210128357A1 (en) * 2006-01-17 2021-05-06 Alcon Inc. Glaucoma treatment device
US8585753B2 (en) * 2006-03-04 2013-11-19 John James Scanlon Fibrillated biodegradable prosthesis
US10828195B2 (en) * 2006-11-10 2020-11-10 Glaukos Corporation Uveoscleral shunt and methods for implanting same

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