Lacrimal implants and related methods

A method of providing a sustained drug release to an eye using a lacrimal implant comprising at least one drug insert, the method comprising:

• implanting the lacrimal implant in at least one lacrimal canaliculus, the lacrimal implant comprising;
• an implant body, comprising a first and second portions, the implant body non-linearly extending from a proximal end portion positionable within a vertical section of the lacrimal canaliculus to a distal end portion positionable within a horizontal section of the lacrimal canaliculus and having an intermediate portion therebetween, the proximal end of the first portion defining a longitudinal proximal axis and the distal end of the second portion defining a longitudinal distal axis, the first portion including a cavity;
• a drug insert disposed in the cavity, the drug insert including a polymeric matrix, a therapeutic agent dissolved or dispersed in the polymeric matrix, and an impermeable sheath body disposed over at least a portion of the polymeric matrix to define at least one insert exposed surface located at or near the proximal end of the first portion implant body;
• the intermediate portion partially extending in a first direction toward the proximal end portion, partially extending in a second direction toward the distal end portion, and partially extending in a third direction along the longitudinal distal axis, configured to bias against a portion of a lacrimal canaliculus ampulla wherein the third direction is perpendicular to the first direction of the intermediate portion, such that, when implanted in the lacrimal canaliculus, the implant body directionally biases laterally against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature;
• wherein the drug insert is configured to provide a sustained release of the therapeutic agent;
• and
• delivering the sustained release therapeutic agent over an extended period of at least one day to the eye, whereby a sustained drug release is provided to the eye.

A method of treating an ocular disorder by providing a sustained drug release to an eye using a lacrimal implant comprising at least one drug insert, the method comprising:

• implanting the lacrimal implant in a lacrimal canaliculus, wherein the lacrimal implant comprises;
• an implant body, comprising a first and second portions, the implant body non-linearly extending from a proximal end portion positionable within a vertical section of the lacrimal canaliculus to a distal end portion positionable within a horizontal section of the lacrimal canaliculus and having an intermediate portion therebetween, the proximal end of the first portion defining a longitudinal proximal axis and the distal end of the second portion defining a longitudinal distal axis, the first portion including a cavity;
• a drug insert disposed in the cavity, the drug insert including a polymeric matrix, a therapeutic agent dissolved or dispersed in the polymeric matrix, and an impermeable sheath body disposed over at least a portion of the polymeric matrix to define at least one insert exposed surface located at or near the proximal end of the first portion implant body;
• the intermediate portion partially extending in a first direction toward the proximal end portion, partially extending in a second direction toward the distal end portion, and partially extending in a third direction along the longitudinal distal axis, configured to bias against a portion of a lacrimal canaliculus ampulla wherein the third direction is perpendicular to the first direction of the intermediate portion, such that, when implanted in the lacrimal canaliculus, the implant body directionally biases laterally against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature;
• wherein the drug insert is configured to provide a sustained release of the therapeutic agent;
• and
• delivering the sustained release therapeutic agent over an extended period of at least one day to the eye, whereby the ocular disorder is treated.

The method of claim 28, wherein the therapeutic agent is selected from Timolol, betaxolol, levobunolol, atenolol, bimatoprost, travoprost, latanoprost, antimicrobial agents;

• antibiotic agents;
• antifungal agents;
• antiviral agents;
• anti-inflammatories;
• or non steroidal anti-inflammatories (NSAIDs).

A method of treating ocular, respiratory, inner ear, pulmonary, or inflammatory disorder using a lacrimal implant comprising at least one drug insert, the method comprising:

• implanting the lacrimal implant in a lacrimal canaliculus, wherein the lacrimal implant comprises;
• an implant body, comprising a first and second portions, the implant body non-linearly extending from a proximal end portion positionable within a vertical section of a lacrimal canaliculus to a distal end portion positionable within a horizontal section of the lacrimal canaliculus and having an intermediate portion therebetween, the proximal end of the first portion defining a longitudinal proximal axis and the distal end of the second portion defining a longitudinal distal axis, the first and/or second portion including a cavity;
• a drug insert disposed in the cavity, the drug insert including a polymeric matrix, a therapeutic agent dissolved or dispersed in the polymeric matrix, and an impermeable sheath body disposed over at least a portion of the polymeric matrix to define at least one insert exposed surface located at or near the proximal end of the first portion or the distal end of the second portion;
• the intermediate portion partially extending in a first direction toward the proximal end portion, partially extending in a second direction toward the distal end portion, and partially extending in a third direction along the longitudinal distal axis, configured to bias against a portion of a lacrimal canaliculus ampulla wherein the third direction is perpendicular to the first direction of the intermediate portion, such that, when implanted in the lacrimal canaliculus, the implant body directionally biases laterally against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature;
• wherein the drug insert is configured to provide a sustained release of the therapeutic agent;
• and
• delivering the therapeutic agent over an extended period of at least one day to an eye, nasal passage or inner ear whereby at least one of the ocular, respiratory, inner ear or inflammatory disorders is treated.