# US 8,034,105 B2 · Ophthalmic implant for treatment of glaucoma > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,034,105 B2 - Document ID: US8034105B2 - Status: Granted - Kind: B2 - Application number: 11/305,306 - Filed: 2005-12-16 - Published: 2006-08-31 - Granted: 2011-10-11 - Earliest claimed: 2004-12-16 - Assignees: iScience Interventional Corporation - Inventors: Robert Stegmann; Stanley R. Conston; David J. Kupiecki; John McKenzie; Candice D. Pinson; Ronald K. Yamamoto - Web page: https://patentgrep.com/patent/US8034105B2 ## CPC - A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)} - 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 (dental prosthetics A61C) ## Abstract A method is provided for increasing the outflow of fluid through Schlemm's canal that is useful for treatment of glaucoma. The implant is placed in Schlemm's canal by use of a flexible delivery instrument attached to the implant. The instrument and implant are positioned within the canal, the implant is released and the distal and proximal ends of the implant are connected to apply sufficient axial tensioning force on the inner wall of the canal to increase fluid permeability. In another embodiment a delivery instrument attached to the implant is positioned in the canal securing one of the distal or proximal ends of the implant within the canal. The implant provides sufficient axial tensioning force on the inner wall of the canal to increase fluid permeability of the inner wall of the canal. The other of the distal or proximal ends may be secured to maintain the tensioning force on the inner wall of the canal. ## Claims ### Claim 1 A method for increasing the aqueous outflow of fluid through Schlemm's canal in the eye comprising the steps of a) positioning in Schlemm's canal a delivery tool comprising an implant, said implant comprising an elongated element with distal and proximal ends positionable within said canal so as to provide a radially inward force to the inner wall of said canal to thereby increase fluid permeability of the inner wall of said canal; and a flexible delivery device attached to said implant; b) releasing said implant from said flexible delivery device; and c) connecting said distal and proximal ends of said implant to each other to apply sufficient tensioning force along the longitudinal axis of said implant to impart a radially inward force on the inner wall of said canal to increase fluid permeability of the inner wall of said canal. ### Claim 2 (depends on 1) A method according to claim 1 comprising the step of withdrawing said delivery device from Schlemm's canal subsequent to releasing said implant in said canal. ### Claim 3 (depends on 1) A method according to claim 1 wherein said implant is provided with sufficient mechanical stiffness to impart said radially inward force to said inner wall upon placement within said canal. ### Claim 4 (depends on 1) A method according to claim 1 wherein said elongated element comprises a helical filament. ### Claim 5 (depends on 1) A method according to claim 1 wherein said implant comprises at least two of said elongated elements twisted together in a helical manner. ### Claim 6 (depends on 1) A method according to claim 1 wherein said implant comprises at least two of said elongated elements fixed in a parallel manner. ### Claim 7 (depends on 1) A method according to claim 1 wherein said elongated element comprises a serpentine filament having a circular cross-sectional aspect. ### Claim 8 (depends on 1) A method according to claim 1 wherein said elongated element comprises a serpentine filament having an ovoid cross-sectional aspect. ### Claim 9 (depends on 7, 8) A method according to claim 7 or 8 wherein said filament comprises a series of loops. ### Claim 10 (depends on 1) A method according to claim 1 wherein said elongated element comprises first regions of a first cross-sectional dimension interspaced with second regions of a second cross-sectional dimension wherein said first cross-sectional dimension is larger than said second cross-sectional dimension. ### Claim 11 (depends on 10) A method according to claim 10 wherein said first regions comprise beads. ### Claim 12 (depends on 10) A method according to claim 10 wherein said first regions comprise cylindrical segments. ### Claim 13 (depends on 10) A method according to claim 10 wherein said first regions freely rotate relative to said second regions. ### Claim 14 (depends on 1) A method according to claim 1 wherein said elongated element comprises filament loops connected to an axial element. ### Claim 15 (depends on 1) A method according to claim 1 wherein said elongated element comprises filament loops connected at alternating ends. ### Claim 16 (depends on 1) A method according to claim 1 wherein said elongated element is provided with a shape comprises multiple angular bends resembling a saw-tooth profile to promote flow of aqueous humor from the inner wall of said canal to the collector channels on the outer wall of said canal. ### Claim 17 (depends on 1) A method according to claim 1 wherein said elongated element is provided with a shape comprises repeating semicircular profiles to promote flow of aqueous humor from the inner wall of said canal to the collector channels on the outer wall of said canal. ### Claim 18 (depends on 1) A method according to claim 1 wherein said elongated element is provided with a shape comprising a helical filament to promote flow of aqueous humor from the inner wall of said canal to the collector channels on the outer wall of said canal. ### Claim 19 (depends on 1) A method according to claim 1 wherein said elongated element is provided with a shape comprising a tube with internal channels to promote flow of aqueous humor from the inner wall of said canal to the collector channels on the outer wall of said canal. ### Claim 20 (depends on 1) A method according to claim 1 wherein said implant is provided with an expanded tip to dilate said canal. ### Claim 21 (depends on 1) A method according to claim 1 wherein said implant comprises a metal. ### Claim 22 (depends on 1) A method according to claim 1 wherein said implant comprises a biocompatible polymer. ### Claim 23 (depends on 1) A method according to claim 1 wherein said implant comprises a biologically active agent. ### Claim 24 (depends on 23) A method according to claim 23 wherein said biologically active agent is selected from the group consisting of an anti-thrombogenic agent, anti-microbial agent, anti-inflammatory agent, anti-fibrotic agent, anti-cell proliferative agent and anti-adhesion agent. ### Claim 25 (depends on 24) A method according to claim 24 wherein said biologically active agent is selected from the group consisting of heparin, tissue plasminogen activator, a steroid, an antimicrobial agent, hyaluronic acid, rapamycin, paclitaxol, 5-fluorouracil, mitomycin and methotrexate. ### Claim 26 (depends on 1) A method according to claim 1 wherein said tensioning force along the longitudinal axis is in the range of about 0.027 to 0.292 grams force per mm arc length of said canal. ### Claim 27 (depends on 26) A method according to claim 26 wherein said tensioning force along the longitudinal axis is in the range of about 0.159 to 0.265 grams force per mm arc length of said canal. ### Claim 28 (depends on 1) A method according to claim 1 wherein said inward force causes distension of said canal. ### Claim 29 (depends on 1) A method according to claim 1 wherein said implant comprises a filament of sufficient length to be placed entirely along the circumference of Schlemm's canal. ### Claim 30 (depends on 29) A method according to claim 29 wherein said implant comprises a non-elastic filament. ### Claim 31 (depends on 29) A method according to claim 29 wherein said filament does not have a lumen. ### Claim 32 (depends on 1) A method according to claim 1 wherein said ends of said implant are attached through a securing element. ### Claim 33 (depends on 32) A method according to claim 32 wherein said securing element is attached to a tensioning element providing said tensioning force. ### Claim 34 A method for increasing the aqueous outflow of fluid through Schlemm's canal in the eye comprising the steps of a) positioning in Schlemm's canal a delivery tool comprising an implant, said implant comprising an elongated element with distal and proximal ends positionable within said canal so as to provide a radially inward force to the inner wall of said canal; to thereby increase fluid permeability of the inner wall of said canal; and a flexible delivery device attached to said implant; b) releasing said implant from said flexible delivery device in said canal; c) securing one of said distal or proximal ends within said canal; d) adjusting the longitudinal tension of said implant to provide sufficient tensioning force along the longitudinal axis of said implant to impart a radially inward force on the inner wall of said canal to increase fluid permeability of the inner wall of said canal; e) securing the other of said distal or proximal ends within said canal to maintain said tensioning force on the inner wall of said canal. ### Claim 35 (depends on 34) A method according to claim 34 comprising the step of withdrawing said delivery device from Schlemm's canal subsequent to securing said implant in said canal. ### Claim 36 (depends on 34) A method according to claim 34 wherein said axial tensioning force is provided to said implant through a securing element at said one or both of said ends, said securing element attachable to a tensioning element providing said tensioning force. ### Claim 37 (depends on 36) A method according to claim 36 wherein said tensioning element comprises a spring. ### Claim 38 (depends on 36) A method according to claim 36 wherein said tensioning element is accommodated in a protecting housing. ### Claim 39 (depends on 36) A method according to claim 36 wherein said tensioning element comprises a crimping element for securing said implant in a tensioned position. ### Claim 40 (depends on 36) A method according to claim 36 wherein said securing element comprises a ring. ### Claim 41 (depends on 36) A method according to claim 36 wherein said tensioning element comprises a spring. ### Claim 42 (depends on 36) A method according to claim 36 wherein said tensioning element comprises an elastic element providing 4 to 6 grams force per mm change in length. ### Claim 43 (depends on 36) A method according to claim 36 wherein said securing element comprises a clamp. ### Claim 44 (depends on 36) A method according to claim 36 wherein said securing element allows adjustment of the length of said implant. ### Claim 45 (depends on 34) A method according to claim 34 wherein said ends are connected with a tensioning force in the range of about 1 to 11 grams. ### Claim 46 (depends on 45) A method according to claim 45 wherein said ends are connected with a tensioning force in the range of about 6 to 10 grams. ### Claim 47 (depends on 34) A method according to claim 34 wherein said inward force causes distension of said canal. ### Claim 48 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a cannula. ### Claim 49 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a guidewire. ### Claim 50 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device provides 360° circumferential cannulation of Schlemm's canal. ### Claim 51 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device further comprises a mechanical element for attachment of said implant. ### Claim 52 (depends on 51) A method according to claim 51 wherein said mechanical element comprises a hole, slot, or an area of increased diameter at a tip of said flexible delivery device. ### Claim 53 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a guidance element for locating said device during placement and advancement within Schlemm's canal. ### Claim 54 (depends on 53) A method according to claim 53 wherein said guidance element comprises a fiber optic beacon. ### Claim 55 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a lumen for injection of viscous materials. ### Claim 56 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a lubricious coating. ### Claim 57 (depends on 1, 34) A method according to claim 1 or 34 wherein said flexible delivery device comprises a rounded tip.