Tack for intraocular drug delivery and method for inserting and removing same

• US 5,466,233 A
• Filed: 04/25/1994
• Issued: 11/14/1995
• Est. Priority Date: 04/25/1994
• Status: Expired due to Term

• Current Assignee: AMO Development LLC (Johnson & Johnson)
• Original Assignee: Escalon Ophthalmics Incorporated
• Inventors: Weiner, Alan L., Johnson, Sterling, Sinnett, Kevin
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/232,895
• Time in Patent Office: 568 Days
• Field of Search: 604/294, 604/890.1, 604/46, 604/892.1, 604/11
• US Class Current: 604/890.1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

A tack for intraocular drug delivery and a method for insertion and removal of an intraocular device for sustained release of a drug are provided. The tack comprises a post, an anchoring region and a head. The post is for being positioned within the vitreous region of the eye. The post has a first end and a second end, and includes a drug to be administered. The anchoring region is affixed to the second end of the post, and includes a width measured perpendicularly to a longitudinal axis of the tack which varies to provide the anchoring region with a configuration to anchor the tack within at least one of a sclera, a retina and a choroid. The head extends radially outwardly from the anchoring region such that upon insertion of the anchoring region and post within the eye, the head remains external to the eye and abuts a scleral surface of the eye. Other embodiments include a tack comprising a post, a central portion, a head and a suture hole through the head for anchoring the head to the sclera. Alternatively the tack comprises a post having a first portion of liquid drug, a hollow central portion filled with a second portion of liquid drug in fluid communication with the post and a head with an opening which allows for injection of subsequent doses of liquid drug through the head into the central portion.

Claims

1. A tack for intraocular drug delivery, comprising:

(a) a post including a drug to be administered, the post having a first end and a second end, the first end for being positioned within a vitreous region of an eye, the post having a length measured parallel to a longitudinal axis of the tack, the length being determined according to a dosage of the drug to be administered and such that obstruction of vision through a lens of the eye is minimized;

(b) an anchoring region affixed to the second end of the post, the anchoring region including a width measured perpendicularly to the longitudinal axis of the tack, said width varying to provide the anchoring region with a configuration which anchors the tack within at least one of a sclera, a retina and a choroid; and

(c) a head extending radially outwardly from the anchoring region such that upon insertion of the anchoring region and post within the eye, the head remains external to the eye and abuts a scleral surface of the eye.

2. The tack according to claim 1, wherein the anchoring region is divided into a first portion and a second portion, the first portion of the anchoring region having a first width measured perpendicularly to a longitudinal axis of the tack and the second portion of the anchoring region having a second width such that the first width varies to create a first concave section in the first portion of the anchoring region and to secure the first portion within the choroid and the retina and the second width varies to create a second concave section in the second portion of the anchoring region and to secure the second portion within the sclera.

3. The tack according to claim 1, wherein the post is generally conical in shape, the first end of the post having a point to facilitate puncturing of the tack in the eye.

4. The tack according to claim 1, wherein the post is solid and comprises a drug dispersed in a nonerodible polymeric matrix such that the drug is delivered to the eye by diffusing through the post.

5. The tack according to claim 1, wherein the post is solid and comprises a drug dispersed in an erodible polymeric matrix such that the drug is delivered to the eye by dissolution of the post.

6. The tack according to claim 1, wherein the post comprises a membrane which is at least semi-permeable forming a hollow chamber, the chamber being filled with a liquid drug to be delivered to the eye which passes through the membrane.

7. The tack according to claim 1, wherein the post comprises a solid core which is constructed of a drug, the core being surrounded by a membrane which is at least semi-permeable such that the drug is delivered to the eye by dissolution and diffusion.

8. The tack according to claim 1, wherein the head is flexible.

9. The tack according to claim 8, wherein the head is generally convex and has a generally circular perimeter.

10. The tack according to claim 9, wherein the head is curved to complement a curvature of the eye at a point where the head abuts the eye.

11. A tack for intraocular drug delivery, comprising:

(a) a post including a drug to be administered, the post having a first end and a second end, the first end for being positioned within a vitreous region of an eye, the post having a length measured parallel to a longitudinal axis of the tack, the length being determined according to a dosage of the drug to be administered and such that obstruction of vision through a lens of the eye is minimized;

(b) a central portion affixed to the second end of the post, the central portion for being positioned within at least one of a retina, a choroid and a sclera;

(c) a head extending radially outwardly from the central portion such that upon insertion of the central portion and post within the eye, the head remains external to the eye and abuts a scleral surface of the eye; and

(d) a suture hole extending through the head for receiving a suture to anchor the head to the sclera.

12. The tack according to claim 11, wherein the central portion has a constant width, the width being measured perpendicularly to the longitudinal axis of the tack.

13. The tack according to claim 11, wherein the post is generally conical in shape, the first end of the post having a point to facilitate puncturing of the tack in the eye.

14. The tack according to claim 11, wherein the post is solid and comprises a drug dispersed in a nonerodible polymeric matrix such that the drug is delivered to the eye by diffusing through the post.

15. The tack according to claim 11, wherein the post is solid and comprises a drug dispersed in an erodible polymeric matrix such that the drug is delivered to the eye by dissolution of the post.

16. The tack according to claim 11, wherein the post comprises a membrane which is at least semi-permeable forming a hollow chamber, the chamber being filled with a liquid drug to be delivered to the eye which passes through the membrane.

17. The tack according to claim 11, wherein the post comprises a solid core which is constructed of a drug, the core being surrounded by a membrane which is at least semi-permeable such that the drug is delivered by osmosis.

18. The tack according to claim 11, wherein the head is flexible.

19. The tack according to claim 18, wherein the head is generally convex and has a generally circular perimeter.

20. The tack according to claim 19, wherein the head is curved to complement a curvature of the eye at a point where the head abuts the eye.

21. A tack for intraocular drug delivery, comprising:

(a) a post including a membrane which is at least semi-permeable forming a hollow void, the void being filled with a first portion of a liquid drug to be administered, the post having a first end and a second end, the first end for being positioned within a vitreous region of an eye, the post having a length measured parallel to a longitudinal axis of the tack, the length being determined according to a dosage of the drug to be administered and such that obstruction of vision through a lens of the eye is minimized;

(b) a hollow central portion affixed to the second end of the post and being filled with a second portion of the liquid drug to be administered, the hollow central portion being in fluid communication with the void, the central portion for being positioned within at least one of a retina, a choroid and a sclera of the eye; and

(c) a head extending radially outwardly from the central portion such that upon insertion of the central portion and the post within the eye, the head remains external to the eye and abuts a scleral surface of the eye, the head having an opening in fluid communication with the hollow central portion for injection of subsequent doses of the liquid drug.

22. The tack according to claim 21, further comprising a removable cap covering the opening in the head.

23. The tack according to claim 21, further comprising an injection port within the opening.

24. The tack according to claim 23, further comprising a removable sterile cover in communication with the injection port.

25. The tack according to claim 21, wherein the central portion has a width measured perpendicularly to a longitudinal axis of the tack, said width varying to provide the central portion with a configuration which anchors the tack within at least one of a sclera, a retina and a choroid.

26. The tack according to claim 21, wherein the head is flexible.

27. The tack according to claim 21, further comprising a suture hole extending through the head for receiving a suture to anchor the head to the sclera.

28. The tack according to claim 21, wherein the head is generally convex and has a generally circular perimeter.

29. The tack according to claim 27, wherein the head is curved to complement a curvature of the eye at a point where the head abuts the eye.

30. A method for insertion and removal of an intraocular device for providing sustained release of a drug, comprising the steps of:

(a) separating a portion of a conjunctival membrane of an eye from a portion of scleral tissue underlying the portion of the conjunctival membrane;

(b) making an incision through the portion of scleral tissue into a vitreous region of the eye such that an opening for insertion of the device is created;

(c) inserting the device into the opening such that a first portion of the device is situated in the vitreous region and a second portion of the device is positioned external to the portion of scleral tissue;

(d) reattaching the portion of the conjunctival membrane to the portion of the scleral tissue underlying the portion of the conjunctival membrane;

(e) maintaining the first portion of the device in the vitreous region until the first portion of the device has delivered a predetermined dosage of the drug into the vitreous region;

(f) separating the portion of the conjunctival membrane from the portion of scleral tissue underlying the portion of the conjunctival membrane;

(g) removing the device from the eye; and

(h) reattaching the portion of the conjunctival membrane over the opening in the portion of scleral tissue.

31. The method according to claim 30, further comprising the step of closing the opening in the portion of scleral tissue with a suture material after removing the device.

32. The method according to claim 30, wherein in step (a) the portion of conjunctival membrane is separated from the eye proximate to a ciliary pars plana of the eye.

33. The method according to claim 30, wherein in step (b) the incision made is a full thickness incision.

34. The method according to claim 30, wherein in step (c) the device is inserted by a syringe.

35. The method according to claim 30, further comprising the step of suturing the second portion of the device remaining external to the portion of scleral tissue to the portion of scleral tissue.

36. The method according to claim 30, wherein in step (e) the first portion of the device is maintained in the vitreous region for at least 3 days.