Ocular insert apparatus and methods

• US 8,939,948 B2
• Filed: 09/14/2012
• Issued: 01/27/2015
• Est. Priority Date: 06/01/2010
• Status: Active Grant

• Current Assignee: ForSight VISION5, Inc. (Abbvie Incorporated)
• Original Assignee: ForSight VISION5, Inc. (Abbvie Incorporated)
• Inventors: de Juan, Eugene Jr., Alster, Yair, Reich, Cary J., MacFarlane, K. Angela, Chang, Janelle, Boyd, Stephen, Sierra, David, Alejandro, Jose D., Sutton, Douglas, Gould, Alexander J.
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/618,052
• Publication Number:
  US 20130144128A1
• Time in Patent Office: 865 Days
• Field of Search: 604294-302
• US Class Current: 604/294
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

A comfortable insert comprises a retention structure sized for placement under the eyelids and along at least a portion of conjunctival sac of the upper and lower lids of the eye. The retention structure resists deflection when placed in the conjunctival sac of the eye and to guide the insert along the sac when the eye moves. The retention structure can be configured in many ways to provide the resistance to deflection and may comprise a hoop strength so as to urge the retention structure outward and inhibit movement of the retention structure toward the cornea. The insert may move rotationally with deflection along the conjunctival sac, and may comprise a retention structure having a cross sectional dimension sized to fit within folds of the conjunctiva. The insert may comprise a release mechanism and therapeutic agent to release therapeutic amounts of the therapeutic agent for an extended time.

Claims

1. An apparatus to treat an eye of a patient, the eye having a conjunctiva, the apparatus comprising:

a first, substantially ring-like structure adapted to be positioned onto an anterior surface of, and outside an optical zone of, the eye at least partially underneath at least one of the upper and lower eyelids, the first structure comprising at least one retention structure configured to guide the apparatus along a conjunctival sac when the eye moves; and

a second structure supported by at least a portion of at least one retention structure disposed through the second structure, wherein the second structure is formed of a material softer than the first structure thereby presenting a softer, cushioning surface available to contact the eye, and wherein the second structure comprises at least one therapeutic agent disposed on or dispersed into the material of the second structure;

wherein the apparatus has a first shape prior to placement onto the eye and, the apparatus conforms in situ to a second shape when placed for a period of time, and wherein, after being removed from the eye, the first structure is configured to retain substantially the second shape.

2. The apparatus of claim 1, wherein the apparatus comprises an amount of resistance to form one or more of a fold, a pocket, or deformation of the conjunctiva so as to receive and retain the insert.

3. The apparatus of claim 1, wherein the apparatus comprises a hoop having a hoop strength to resist deflection when placed on the eye.

4. The apparatus of claim 1, wherein the apparatus comprises a reversibly deflectable hoop having a circumference sized to fit the eye.

5. The apparatus of claim 1, wherein the at least one retention structure is sized to be received within one or more folds of the conjunctiva to hold the at least one retention structure on the eye for an extended time.

6. The apparatus of claim 5, wherein the at least one retention structure is adapted to move within the conjunctival sac and remain on the eye continuously for at least about one week.

7. The apparatus of claim 5, wherein the at least one retention structure is adapted to move within the conjunctival sac and remain on the eye continuously for at least about one month.

8. The apparatus of claim 5, wherein the at least one retention structure is adapted to move within conjunctival sacs and remain on eyes of a population continuously for at least about one month.

9. The apparatus of claim 5, wherein the at least one retention structure is adapted to move within the conjunctival sac without attaching to the eye and remain on the eye continuously for at least about one month.

10. The apparatus of claim 5, wherein the one or more folds of the conjunctiva comprise a plurality of folds extending along a bulbar conjunctiva of the eye and a plurality of folds extending along a palpebral conjunctiva of the eye.

11. The apparatus of claim 5, wherein the at least one retention structure comprises a hoop having a hoop strength to resist deflection when placed on the eye.

12. The apparatus of claim 1, wherein the second structure comprises a soft material disposed along at least a portion of the first structure at locations corresponding to one or more of a lacrimal gland or a caruncle when the apparatus is positioned on the eye.

13. The apparatus of claim 12, wherein the at least one retention structure is shaped with an inward extension to inhibit irritation of the lacrimal gland.

14. The apparatus of claim 12, wherein the at least one retention structure is shaped with an inward extension to inhibit contact with the caruncle of the eye.

15. The apparatus of claim 12, wherein the retention structure is shaped with a first inward extension to inhibit irritation of the lacrimal gland and a second inward extension to inhibit contact with the caruncle of the eye.

16. An apparatus adapted to be positioned onto an anterior surface of an eye outside an optical zone of the eye at least partially underneath at least one of the upper and lower eyelids to treat the eye, the apparatus comprising:

a support structure comprising at least one therapeutic agent disposed on or dispersed into a material of the support structure; and

a retention structure at least a portion of which is disposed through the support structure,

wherein the material of the support structure is softer than the retention structure thereby presenting a softer surface available to contact the eye, and

wherein the retention structure provides a resistance to deflection of the apparatus such that the apparatus has a first shape prior to placement onto the eye, conforms in situ to a second shape when placed on the eye for a period of time, and after being removed from the eye retains substantially the second shape.

17. The apparatus of claim 16, wherein the resistance to deflection comprises a self-loading resistance to deflection and provides a self-loading deflection angle within a range from about 0 degrees to about 70 degrees.

18. The apparatus of claim 16, wherein the retention structure is an annular, ring-like structure and the at least a portion of the retention structure disposed through the support structure comprises 75, 80, 80, 180, 270, or 360 degrees of the annular retention structure.

19. The apparatus of claim 18, wherein the retention structure is a suture formed of polypropylene or nylon.

20. The apparatus of claim 19, wherein the material of the support structure comprises a silicone matrix.