Drug delivery devices and methods

• US 9,549,846 B2
• Filed: 07/27/2015
• Issued: 01/24/2017
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Novartis Ag
• Inventors: Clauson, Luke, Silvestrini, Thomas A., Ianchulev, Tsontcho, John, Steven
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/809,827
• Publication Number:
  US 20160022486A1
• Time in Patent Office: 547 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 47/30 Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2210/0606 Face
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

This disclosure relates generally to methods and devices for use in treating eye conditions with implantable drug delivery devices. One method includes introducing an implant into the suprachoroidal space, wherein the interior volume of the implant is plugged with a drug-release material comprising at least one active agent that elutes through at least one opening in the implant, wherein the drug-release material degrades from the interior volume of the implant over a period time.

Claims

1. A method of implanting an ocular implant for treating an ocular disorder of an eye, comprising:

forming a self-sealing incision in the cornea of the eye into the anterior chamber of the eye;

introducing an implant through the incision in an eye into the anterior chamber of the eye, the implant comprising;

a proximal end with at least one inflow port;

a distal end with at least one outflow port; and

an internal lumen extending through the implant between the at least one inflow port and at least one outflow port,

wherein the implant is mounted on an implantation instrument having a delivery wire extending through the internal lumen of the implant;

using the delivery wire to position the implant in the eye between a first and second tissue layer in fluid communication with the suprachoroidal space;

withdrawing the delivery wire from the internal lumen of the implant; and

injecting drug-release material through the delivery wire as the delivery wire is being withdrawn from the internal lumen of the implant filling the internal lumen of the implant with the drug-release material;

creating a lake of the drug-release material near the distal end of the implant; and

eluting an active agent from the drug-release material to treat the eye as the drug-release material degrades, wherein the space is maintained after the lake of drug-release material degrades.

2. The method of claim 1, further comprising preventing fluid flow through the internal lumen of the implant with the drug-release material.

3. The method of claim 2, wherein the drug-release material is configured to degrade over a period of time from the internal lumen of the implant.

4. The method of claim 3, wherein the period of time is selected from the group consisting of at least 12 hours, at least 24 hours, at least 3 days, at least 14 days, at least 30 days, at least 120 days, and at least one year.

5. The method of claim 3, further comprising creating a flow pathway through the internal lumen of the implant between the at least one inflow port and the at least one outflow port upon degradation of the drug-release material over the period of time.

6. The method of claim 5, further comprising positioning the distal end of the implant between a first and second tissue layer and into fluid communication with the suprachoroidal space.

7. The method of claim 6, further comprising releasing the implant from the delivery wire.

8. The method of claim 7, further comprising conducting aqueous humour through the flow pathway from the anterior chamber into the suprachoroidal space.

9. The method of claim 3, wherein the drug-release material is impregnated with at least one therapeutic agent.

10. The method of claim 9, wherein the at least one therapeutic agent is released over the period of time.

11. The method of claim 9, wherein the drug-release material comprises nanostructures facilitating zero order kinetic release of the at least one therapeutic agent.

12. The method of claim 1, wherein the drug-release material is a biodegradable polymer, including a poly(lactic-co-glycolic acid).

13. The method of claim 1, wherein injecting drug-release material through the delivery wire comprises injecting drug-release material through a bore in the delivery wire.