# US 11,110,001 B2 · Expandable drug delivery devices and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,001 B2 - Document ID: US11110001B2 - Status: Granted - Kind: B2 - Application number: 16/671,749 - Filed: 2019-11-01 - Published: 2020-02-27 - Granted: 2021-09-07 - Earliest claimed: 2014-11-10 - Assignees: ForSight Vision4, Inc. - Applicants: ForSight Vision4, Inc. - Inventors: Bradley G. Bachelder; Randolph E. Campbell; Darren G. Doud; Signe R. Erickson; Kevin W. Sacherman - Web page: https://patentgrep.com/patent/US11110001B2 ## CPC - A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts} - A61K 9/0051: {Ocular inserts or implants} - A61P 27/02: Ophthalmic agents - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2210/0061: swellable - A61F 2250/001: for adjusting a diameter - A61F 2250/0068: the pharmaceutical product being in a reservoir - A61F 2250/0069: Sealing means - 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) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion. ## Claims ### Claim 1 A drug delivery device configured to be at least partially implanted in an eye, the device comprising: a retention structure positioned near a proximal end region of the device; a porous drug release element positioned in fluid communication with an outlet of the device; an elongated core element having a longitudinal axis; and a reservoir formed of a non-compliant material positioned around the elongated core element, the reservoir having a volume configured to contain one or more therapeutic agents and to be in fluid communication with the outlet through the porous drug release element, wherein the device is configured to be at least partially inserted into the eye, and wherein the reservoir is configured to enlarge in a non-distensible manner from an insertion configuration having a first three-dimensional shape to a deployed configuration having a second three-dimensional shape, such that the second three-dimensional shape is eccentrically positioned relative to the longitudinal axis of the elongated core element. ### Claim 2 (depends on 1) The device of claim 1, wherein a first portion of the volume of the reservoir in the deployed configuration unfolds away from the lens of the eye and is greater than a remaining portion of the volume. ### Claim 3 (depends on 2) The device of claim 2, wherein the first portion and the remaining portion each remain outside the visual axis of the eye. ### Claim 4 (depends on 1) The device of claim 1, wherein a proximal end of the reservoir is separated a distance from one or more internal tissue surfaces surrounding a penetration site of the eye when in the deployed configuration. ### Claim 5 (depends on 1) The device of claim 1, wherein the elongated core element extends from the proximal end region of the device to a distal end region of the device. ### Claim 6 (depends on 5) The device of claim 5, wherein the drug release element is coupled to the elongated core element near the distal end region of the device and the retention structure is coupled to the elongated core element near the proximal end region of the device. ### Claim 7 (depends on 5) The device of claim 5, wherein the elongated core element comprises an inner lumen and one or more openings extending through a wall of the elongated core element, wherein the inner lumen of the elongated core element is in fluid communication with the reservoir volume through the one or more openings. ### Claim 8 (depends on 7) The device of claim 7, wherein the elongated core element comprises a cylindrical geometry and further comprises a flow director to direct flow through the one more openings. ### Claim 9 (depends on 8) The device of claim 8, wherein the flow director comprises a first cylindrical region coupled to a second cylindrical region by a funnel shaped region, wherein the first cylindrical region has a larger cross-sectional diameter than the second cylindrical region. ### Claim 10 (depends on 5) The device of claim 5, wherein the retention structure comprises a proximal flange element configured to extend outside a sclera of the eye and a neck, the neck having a proximal region configured to extend through a penetration site in the sclera of the eye and a distal extension extending inside the vitreal cavity of the eye. ### Claim 11 (depends on 10) The device of claim 10, wherein the distal extension of the neck surrounds a portion of the elongated core element near the proximal end of the device providing stabilization of the neck to maintain a position of the reservoir. ### Claim 12 (depends on 11) The device of claim 11, wherein the distal extension of the neck prevents contact between the reservoir and internal surfaces of the eye adjacent the penetration site. ### Claim 13 (depends on 11) The device of claim 11, wherein an upper surface of the proximal flange element indicates orientation of the reservoir in the deployed configuration and a direction of eccentricity of the second three-dimensional shape. ### Claim 14 (depends on 13) The device of claim 13, wherein the upper surface indicates orientation due to a shape of the flange element or a mark on the upper surface of the flange element visible to a user from outside the eye. ### Claim 15 A drug delivery device, the device comprising: a proximal end region of the device comprising a retention structure; and a distal end region of the device configured to be at least partially implanted into an eye, the distal end region comprising: a porous drug release element positioned in fluid communication with an outlet of the device; an elongated core element; and a reservoir positioned around the elongated core element, the reservoir having a volume configured to contain one or more therapeutic agents and to be in fluid communication with the outlet through the porous drug release element, wherein the reservoir is configured to enlarge from an insertion configuration to a deployed configuration, wherein after at least partial implantation in the eye along an axis of insertion, a wall of the reservoir is configured to unfold asymmetrically relative to the elongated core element towards the deployed configuration. ### Claim 16 (depends on 15) The device of claim 15, further comprising a flow director positioned within a lumen of the elongated core element, the flow director configured to facilitate filling of the reservoir volume. ### Claim 17 (depends on 16) The device of claim 16, wherein the flow director comprises a first cylindrical region coupled to a second cylindrical region by a funnel-shaped region to direct flow through one or more openings in the elongated core element, wherein the first cylindrical region has a larger cross-sectional diameter than the second cylindrical region. ### Claim 18 (depends on 15) The device of claim 15, wherein the wall of the reservoir configured to unfold asymmetrically formed a major portion of the reservoir relative to the elongated core element and a minor portion relative to the elongated core element. ### Claim 19 (depends on 18) The device of claim 18, wherein after expansion of the reservoir into the deployed configuration inside the eye, the major portion is directed away from anterior tissue of a vitreal cavity of the eye. ### Claim 20 (depends on 15) The device of claim 15, wherein the retention structure comprises a proximal flange element configured to extend outside a sclera of the eye and a neck, the neck having a proximal region configured to extend through a penetration site in the sclera of the eye and a distal extension extending inside the sclera of the eye. ### Claim 21 (depends on 20) The device of claim 20, wherein the distal extension of the neck surrounds a portion of the elongated core element near the proximal end of the device providing stabilization of the neck to maintain a position of the reservoir. ### Claim 22 (depends on 21) The device of claim 21, wherein the distal extension of the neck prevents contact between the reservoir and internal surfaces of the eye adjacent the penetration site.