Scleral and conjuctival implants for drug therapy
Inventors
de Juan, Jr., Eugene • Boyd, Stephen • Reich, Cary • RAPACKI, ALAN • Gifford, Hanson S • Deem, Mark
Assignees
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Publication Number
US-9549852-B2
Publication Date
2017-01-24
Expiration Date
Abstract
An implant for insertion through a punctum and into a canalicular lumen of a patient. The implant includes a matrix of material, a therapeutic agent dispersed in the matrix of material, a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen and to allow the therapeutic agent to be released from a surface of the matrix of material to a tear film, and a retention structure configured to retain the implant within the canalicular lumen.
Core Innovation
The invention provides sustained ocular delivery using an implant placed between a sclera tissue layer and a conjunctiva tissue layer of an eye of a patient. The implant includes a therapeutic agent and a body of material that holds the therapeutic agent, and a retention structure is configured to retain the body of material between the sclera tissue layer and the conjunctiva tissue layer.
The implant is described as using a drug core that includes a matrix with dispersed therapeutic-agent inclusions. An impermeable sheath limits release such that the therapeutic agent is delivered at a proximal exposed surface that contacts tear and tear film fluid, and an occlusive element inhibits tear flow through the implant lumen while the exposed surface participates in therapeutic-agent delivery.
The retention structure is configured to anchor the implant in the canaliculus and/or punctum, including retention structures formed by struts, a coil, a cage, or expandable superelastic elements. Geometries for tuning delivery are described through variations in exposed surface area, including convex or concave surfaces, castellation, folds and channels, porous internal surfaces, and soft brush-like members.
Modular replacement of a drug core and/or sheath is described while retaining the expansion element. Therapeutic agents include glaucoma agents such as latanoprost, bimatoprost, and travoprost, and therapeutic-agent categories are described broadly for sustained dosing.
Claims Coverage
The claim coverage includes one independent claim describing an eye-delivery method and implant components, with six inventive features refined by dependent claims.
Placing an implant between sclera and conjunctiva with therapeutic agent, body of material, and retention structure
Placing an implant between a sclera tissue layer and a conjunctiva tissue layer of a patient, where the implant includes a therapeutic agent, a body of material that holds the therapeutic agent, and a retention structure configured to retain the body of material between the sclera tissue layer and the conjunctiva tissue layer.
Therapeutic agent held in a reservoir and/or matrix body of material
A body of material that holds the therapeutic agent in a reservoir and/or a matrix.
Polymer matrix body of material comprising selected polymer types
The body of material is a matrix comprising selected polymers chosen from a listed set of polymer materials and combinations.
Hydrogel matrix
The matrix comprises a hydrogel.
Sheath over a portion of the agent-holding body of material
The implant further comprises a sheath disposed over a portion of the body of material that holds the therapeutic agent.
Prostaglandin analogue selected from latanoprost, bimatoprost, and travoprost
The therapeutic agent is a prostaglandin analogue selected from the group consisting of latanoprost, bimatoprost, and travoprost.
The inventive features center on an ocular implant placed between sclera and conjunctiva, with the therapeutic agent held in a retained body of material and further specified by reservoir or matrix containment, polymer and hydrogel matrix types, a sheath, and prostaglandin analogue selection.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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