OCULAR INSERT APPARATUS AND METHODS

• US 20130144128A1
• Filed: 09/14/2012
• Published: 06/06/2013
• Est. Priority Date: 06/01/2010
• Status: Active Grant

• Current Assignee: ForSight VISION5, Inc. (Abbvie Incorporated)
• Original Assignee: Eugene De Juan, Jr., Macfarlane K. Angela
• Inventors: de Juan, Eugene Jr., Alster, Yair, Reich, Cary J., MacFarlane, K. Angela, Chang, Janelle, Alejandro, Jose D., Sutton, Douglas, Boyd, Stephen, Sierra, David
• Granted Patent: US 8,939,948 B2
• Time in Patent Office: Days
• US Class Current: 600/236
• 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, and

a second structure supported by, and disposed along at least a portion of, the first structure, the second structure presenting a softer, cushioning surface to the eye than the first structure, the second structure comprising the at least one therapeutic agent;

wherein the apparatus comprises a first shape prior to placement in the eye and a second shape when placed and wherein the first structure is configured to retain substantially the second shape when placed for a time on the eye.

2. The apparatus of claim 1, wherein the resistance to deflection is configured to shape the conjunctiva with the insert so as to receive the insert.

3. The apparatus of claim 1, wherein the insert 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.

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

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

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

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

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

9. The apparatus of claim 6, wherein the retention structure is adapted to move within conjunctival sacs and remain on eyes of a population continuously for at least about one month.

10. The apparatus of claim 6, wherein the 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.

11. The apparatus of claim 6, 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.

12. The apparatus of claim 6, wherein the one or more folds of the conjunctiva comprise a plurality of folds of the bulbar conjunctiva and wherein the retention structure comprises a cross-sectional dimension so as to fit within the one or more of the plurality of folds of the bulbar conjunctiva and move with the eye when the eye rotates.

13. The apparatus of claim 12, wherein the one or more folds of the bulbar conjunctiva are located between a limbus of the eye and a formix of the eye.

14. The apparatus of claim 12, wherein the retention structure extends along an elongate arcuate path with the cross-sectional dimension so as to fit within the one or more folds of the bulbar conjunctiva.

15. The apparatus of claim 14, wherein the one or more folds of the bulbar conjunctiva comprise a plurality of folds of the bulbar conjunctiva and wherein each of the plurality of folds of the bulbar conjunctiva comprises an invagination corresponding to an invagination depth and wherein the cross-sectional dimension corresponds to the invagination depth such that the elongate retention structure extends along the invagination.

16. The apparatus of claim 6, wherein the one or more folds of the conjunctiva comprise palpebral folds of the conjunctiva and wherein the retention structure comprises a cross-sectional dimension so as to fit within the one or more folds of the palpebral conjunctiva and move with the eye when the eye rotates.

17. The apparatus of claim 6, wherein the one or more folds of the bulbar conjunctiva comprise folds of a sac of the conjunctiva of the eye.

18. The apparatus of claim 6, wherein the retention structure comprises a ring sized to fit the eye.

19. The apparatus of claim 6, wherein the retention structure comprises a ring having a diameter sized to fit the eye.

20. The apparatus of claim 6, wherein the retention structure comprises a hoop having a hoop strength to resist deflection when placed on the eye.

21-113. -113. (canceled)