IP Library › Granted Patent US 12,226,525
Granted Patent B2
US 12,226,525 · App. 17/133,980 · Granted Feb 18, 2025

Nasolacrimal drainage system implants for drug therapy

Inventors: Eugene de Juan, Jr. (San Francisco, CA); Stephen Boyd (Murrieta, CA); Cary J. Reich (Los Gatos, CA); Alan R. Rapacki (Redwood City, CA); Hanson S. Gifford (Woodside, CA); Mark Deem (Mountain View, CA)
A61K9/0051A61F9/0017A61F9/0026A61F9/00772A61F9/00781A61K9/00A61K9/0017A61K9/06A61K31/215A61K31/216A61K31/55A61K31/557A61K31/5575A61K31/573A61K47/34A61L31/16A61F2220/0008A61F2250/0067A61F2250/0087
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Quick Facts
Patent No.
US 12,226,525
App. No.
17/133,980
Granted
Feb 18, 2025
Kind
B2
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.

Claims (17)

1. A method for delivery of a therapeutic agent to an eye of a patient using a punctal plug, comprising:

positioning the punctal plug into a lacrimal punctum of an eye wherein the punctal plug comprises a plug body and a drug insert, wherein the drug insert comprises a drug core comprising a therapeutic agent and a polymer matrix, and wherein the plug body comprises silicone; and,

an impermeable sheath body partially covering the drug core, wherein the sheath body is configured to provide an exposed proximal end of the drug core in direct contact with tear fluid that releases the therapeutic agent to the eye; and,

delivering a dose of the therapeutic agent to the eye for a sustained treatment period, wherein the punctal plug remains in position for the sustained treatment period for at least of one week to 3 months.

2. The method of claim 1 , wherein the therapeutic agent comprises anti-glaucoma medications, antimicrobial agents, a corticosteroid, non-steroidal anti-inflammatories, a decongestant, an antihistamine, a cytokine inhibitor, a leucotriene inhibitor, an IgE inhibitor, an immunomodulator, a mast cell stabilizer, a cycloplegic, a lubricant or a surfactant.

3. The method of claim 1 , wherein the therapeutic agent is a corticosteroid.

4. The method of claim 1 , wherein the therapeutic agent is selected from a lubricant or a surfactant.

5. The method of claim 1 , wherein the therapeutic agent is selected from the group consisting of latanoporost, bimatoprost, timolol maleate, travoprost, cyclosporine and non-steroidal anti-inflammatories.

6. The method of claim 1 , wherein the therapeutic agent is cyclosporine.

7. The method of claim 1 , wherein the drug core of the punctal plug is further configured to deliver a bolus dose of the therapeutic agent.

8. The method of claim 1 , wherein the drug core of the punctal plug is further configured to deliver a burst dose of the therapeutic agent at a beginning of the treatment period.

9. The method of claim 1 , wherein the polymeric matrix comprises silicone, acrylate, polyethylene, polyurethane, polyester, polyglycolic acid (PGA), polylactic acid (PLA), poly(L-lactic acid) (PLLA), poly(L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) or combinations thereof.

10. The method of claim 1 , wherein the polymer matrix comprises polyurethane, polycaprolactone or polyethylene.

11. The method of claim 1 , wherein the drug core further comprises one or more additives to increase or decrease solubility of the therapeutic agent for controlled release of the therapeutic agent.

12. The method of claim 11 , wherein the one or more additives is selected from the group consisting of surfactants, tinuvin, salts and water.

13. The method of claim 1 , wherein a distal end of the drug core is sealed with a medical grade adhesive.

14. The method of claim 1 , wherein delivery of the therapeutic agent comprises pre and/or post-surgical treatments.

Continuity (11)
Continuation 16544884 · Aug 19, 2019
Continuation 16168554 · Oct 23, 2018
Continuation 15852619 · Dec 22, 2017
Continuation 15405991 · Jan 13, 2017
Continuation 14858555 · Sep 18, 2015
Continuation 14265071 · Apr 29, 2014
Continuation 13184690 · Jul 18, 2011
Continuation 11695545 · Apr 2, 2007
Provisional Application 60871864 · Dec 26, 2006
Provisional Application 60787775 · Mar 31, 2006
Related Publication 20210212941A1 · Jul 15, 2021
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