Nasolacrimal drainage system 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-10383817-B2
Publication Date
2019-08-20
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 relates to a drug insert configured for placement within a channel of a punctal plug. The drug insert includes a drug core that comprises a therapeutic agent admixed with a polymer matrix comprising a non-bioabsorbable polymer, and the drug core is partially covered by an impermeable sheath body.
The impermeable sheath body is configured to provide an exposed proximal end of the drug core for direct contact with tear fluid. When the drug insert is disposed within a channel of the punctal plug and the punctal plug is inserted into a lacrimal canaliculus of a subject, the tear fluid releases the therapeutic agent to the eye. The drug insert further includes a sealant covering a distal end of the drug insert.
The overall approach is directed to delivering ophthalmic therapeutics through nasolacrimal drainage-system structures using a sheath-exposed drug-core geometry for tear-fluid contact. The use of a non-bioabsorbable polymer matrix, together with an impermeable sheath, is presented as part of the mechanism to control release from the drug core during sustained use.
Claims Coverage
The partial content provides one independent claim and multiple dependent refinements. The independent claim defines the overall drug-insert structure and placement in a punctal plug channel for tear-fluid-mediated delivery, with additional inventive feature refinements recited in the dependent claims.
Drug core with therapeutic agent in a non-bioabsorbable polymer matrix
A drug core comprising a therapeutic agent admixed with a polymer matrix comprising a non-bioabsorbable polymer.
Impermeable sheath exposing a proximal drug-core end to tear fluid
An impermeable sheath body partially covering the drug core, configured to provide an exposed proximal end of the drug core in direct contact with tear fluid to release therapeutic agent to the eye when disposed within a punctal plug channel inserted into a lacrimal canaliculus.
Distal-end sealant on the drug insert
A sealant covering a distal end of the drug insert.
Polymer-matrix materials selected from a specified material list
The polymer matrix comprises one or more selected materials from a specified list of polymers, proteins, metals/alloys, and other biocompatible substances.
Therapeutic-agent selection from ophthalmic drug classes
The therapeutic agent includes one or more ophthalmic medication classes comprising anti-glaucoma medications and multiple anti-inflammatory, anti-allergy, and immunomodulatory agents, together with lubricant/surfactant components.
Therapeutic-agent selection including named compounds and categories
The therapeutic agent is selected from a group including latanoprost, bimatoprost, timolol maleate, travoprost, cyclosporine, and non-steroidal anti-inflammatories.
Medical-grade adhesive sealant
The sealant is a medical-grade adhesive.
Sustained delivery for at least one week
A drug insert configured to deliver a therapeutic agent to a patient’s eye for at least one week.
Across the independent and dependent claims, the core inventive coverage centers on a non-bioabsorbable-polymer drug core, an impermeable sheath that exposes the proximal end to tear fluid within a punctal plug channel, and a distal-end sealant. Dependent claims further narrow the polymer-matrix material options, therapeutic-agent categories and named agents, specify the sealant as a medical-grade adhesive, and add a delivery-time constraint of at least one week.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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