Lacrimal implants and related methods

Inventors

Rapacki, Alan R. • Rubinchik, Valery • Kjellbotn, Charles Richard

Assignees

Mati Therapeutics Inc

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Publication Number

US-10238535-B2

Patent

Publication Date

2019-03-26

Expiration Date


Abstract

Lacrimal implants and related methods providing secure, wedgable retention within a lacrimal punctum and associated canaliculus of an eye are disclosed. The lacrimal implants can comprise an implant body configured for at least partial insertion through the lacrimal punctum and into the canaliculus. The implant body can include first and second portions, and can extend from a proximal end of the first portion defining a longitudinal proximal axis to a distal end of the second portion defining a longitudinal distal axis. The implant body can be configured such that, when implanted using an integral dilator, an angled intersection exists between the proximal and distal axes. In this way, at least a portion of the implant body can be biased against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, thereby retaining an implanted position of the lacrimal implant using anatomical structures.

Core Innovation

The invention relates to a lacrimal implant for insertion into a lacrimal canaliculus, having an implant body with first and second portions and an intermediate portion extending in multiple directions. The proximal end of the first portion defines a longitudinal proximal axis and the distal end of the second portion defines a longitudinal distal axis. When implanted, the implant body directionally biases laterally against a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, including biasing against a portion of a lacrimal canaliculus ampulla.

A cavity is formed in the first portion and includes a drug insert disposed in the cavity. The drug insert includes a polymeric matrix with a therapeutic agent dissolved or dispersed in the polymeric matrix, and an impermeable sheath 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 implant body. The drug insert is configured to provide sustained therapeutic agent release to an eye.

The implant further includes a graspable projection extending from the proximal end of the first portion and including an inward-extending retaining lip. The retaining lip overhangs a cavity to secure the drug insert within the cavity and overhangs a proximal surface of the drug insert when fully seated, thereby securing the insert position. In addition, the implant body inhibits fluid flow into and through the lacrimal canaliculus, and the implant body is configured so an angled intersection exists between the proximal axis and the distal axis for biasing at least a portion of the implant body against tissue at or more distal to a canalicular curvature.

Claims Coverage

The provided excerpt contains three independent claims. Across these independent claims, the coverage focuses on a non-linear lacrimal implant geometry that creates an angled intersection between proximal and distal axes to bias against canalicular curvature, together with an internal drug insert having a matrix and impermeable sheath for sustained release, and a graspable projection with an inward retaining lip that secures the insert position, with an additional fluid-flow inhibiting limitation in one independent claim.

Non-linear lacrimal implant with proximal and distal axes for lateral biasing at canalicular curvature

An 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, the proximal end defining a longitudinal proximal axis and the distal end defining a longitudinal distal axis, configured such that the implant body directionally biases laterally against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, including bias against a portion of a lacrimal canaliculus ampulla, and wherein an angled intersection exists between the proximal axis and the distal axis for biasing.

Drug insert disposed in a cavity with polymeric matrix, impermeable sheath, and exposed surface for sustained therapeutic release

A cavity in the first portion containing a drug insert that includes a polymeric matrix with a therapeutic agent dissolved or dispersed in the polymeric matrix, and an impermeable sheath 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, the drug insert providing sustained therapeutic agent release to an eye.

Inward-extending retaining lip on a graspable projection to secure the drug insert position

A graspable projection extending at least partially from the proximal end of the first portion, the graspable projection including an inward-extending retaining lip that overhangs a cavity to secure the drug insert within the cavity, wherein the inward-extending retaining lip overhangs a proximal surface of the drug insert when fully seated in the cavity thereby securing a position of the insert.

Retention element on the proximal end of the second portion to bias against lacrimal canaliculus ampulla

A proximal end of the second portion comprises a retention element configured to bias against a portion of a lacrimal canaliculus ampulla.

Fluid flow inhibition through the lacrimal canaliculus

The implant body inhibits fluid flow into and through the lacrimal canaliculus.

Ovoid graspable projection

An ovoid graspable projection extending at least partially from the proximal end of the first portion, including an inward-extending retaining lip overhanging a cavity to secure the drug insert within the first portion.

The independent claim set is directed to lacrimal implants that combine a non-linear implant geometry creating an angled intersection between proximal and distal axes to bias against tissue at or distal to a canalicular curvature, a drug insert in a proximal cavity having a matrix and impermeable sheath with an exposed surface for sustained therapeutic agent release to an eye, and a graspable projection with an inward retaining lip that secures the drug insert position, with retention-element biasing against the lacrimal canaliculus ampulla and, in one independent claim, inhibition of fluid flow into and through the lacrimal canaliculus.

Stated Advantages

Improves retention by biasing laterally against a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, including bias against the lacrimal canaliculus ampulla.

Inhibits fluid flow into and through the lacrimal canaliculus.

Provides sustained therapeutic agent release to an eye via the drug insert with matrix and impermeable sheath.

Provides secured positioning of the drug insert using an inward-extending retaining lip overhanging the cavity.

Documented Applications

Delivering a sustained therapeutic agent to an eye using a lacrimal implant insertable into a lacrimal canaliculus.

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