Sub-tenon drug delivery

• US 6,413,245 B1
• Filed: 10/04/2000
• Issued: 07/02/2002
• Est. Priority Date: 10/21/1999
• Status: Expired due to Term

• Current Assignee: Novartis Ag
• Original Assignee: Alcon Universal Ltd.
• Inventors: Marsh, David Allen, York, Billie M., Dahlin, David C., Struble, Craig B., Clark, Abbot F., Yaacobi, Yoseph
• Primary Examiner(s): Huson, Gregory
• Assistant Examiner(s): Prunner, Kathleen J.
• Application Number:
  US09/677,656
• Time in Patent Office: 636 Days
• Field of Search: 604/264, 604/272, 604/48, 604/506, 604/521
• US Class Current: 604/264
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

Disclosed is a method and apparatus for delivering a drug formulation to a human eye. The method includes the steps of inserting the apparatus below the Tenon'"'"'s capsule and above the sclera at a point posterior to the limbus of the eye and injecting the drug formulation to form a drug depot on an outer surface of the sclera. The apparatus includes a cannula having a distal portion, a proximal portion, and a bend separating the distal portion and the proximal portion. The distal portion has a radius of curvature substantially equal to a radius of curvature of the globe of the eye. A tangent of the distal portion at the bend is disposed at an angle no more than about 56 degrees with respect to the proximal portion.

Claims

1. A cannula, comprising:

a distal portion having a radius of curvature substantially equal to a radius of curvature of a globe of a human eye;

a proximal portion; and

a bend separating said distal portion and said proximal portion,

wherein a tangent of said distal portion at said bend is disposed at an angle of no more than about 56 degrees with respect to said proximal portion.

2. The cannula of claim 1 wherein said distal portion comprises an arc length of about 15 mm to about 18 mm.

3. The cannula of claim 1 further comprising:

a hub coupled to said proximal portion for removably coupling to a syringe; and

a hollow bore disposed axially within said distal portion and said proximal portion.

4. The cannula of claim 3 wherein said distal portion has a plurality of orifices, each of said orifices communicating with said hollow bore.

5. The cannula of claim 3 wherein said bend is adopted to prevent said syringe from interfering with a patient'"'"'s face, bridge of the nose, and eyebrows when said distal portion is inserted into said eye.

6. The cannula of claim 1 wherein said distal portion comprises an interior side and a tip having an orifice on said interior side.

7. The cannula of claim 1 wherein said distal portion has a radius of curvature substantially equal to a radius of curvature of a sclera of said eye.

8. The cannula of claim 1 wherein said radius of curvature of said distal portion is about 11.5 mm to about 14 mm.

9. The cannula of claim 1 wherein said distal portion is made of plastic.

10. The cannula of claim 1 wherein said distal portion comprises a tip and an orifice proximate said tip, and wherein a part of said distal portion proximate said tip is made of plastic, and a remainder of said distal portion is made from metal.

11. The cannula of claim 1 wherein said angle is about 56 degrees.

12. The cannula of claim 1 wherein said distal portion comprises a tip having an olive shape.

13. The cannula of claim 1 wherein said distal portion comprises:

a tip; and

a fiber optic light source disposed at said tip.

14. The cannula of claim 1 wherein said distal portion, said proximal portion, and said bend comprise a first lumen, and further comprising:

a second lumen having a geometry substantially similar to said first lumen and disposed adjacent said first lumen.

15. The cannula of claim 14 wherein said first lumen and second lumen are not in communication.

16. The cannula of claim 14 further comprising a tip, and wherein said first lumen and said second lumen are in communication proximate said tip.

17. The cannula of claim 1 wherein said distal portion and said proximal portion are formed of 19 gauge needle stock.

18. A method of delivering a drug to a human eye, comprising the steps of:

inserting a cannula below a Tenon'"'"'s capsule and above a sclera of said human eye at a point posterior to a limbus of said eye, said cannula comprising;

a distal portion having a radius of curvature substantially equal to a radius of curvature of a globe of said human eye;

a proximal portion; and

a bend separating said distal portion and said proximal portion,

wherein a tangent of said distal portion at said bend is disposed at an angle of no more than about 56 degrees with respect to said proximal portion;

injecting a drug formulation through said cannula to form a drug depot on an outer surface of said sclera.

19. The method of claim 18 wherein said distal portion of said cannula comprises a tip, and further comprising the step of disposing said tip proximate a macula of said eye.

20. The method of claim 18 wherein said drug formulation comprises a suspension.

21. The method of claim 20 wherein said suspension comp rises a bioerodable polymer.

22. The method of claim 20 wherein said suspension comprises a non-bioerodable polymer.

23. The method of claim 18 wherein said drug formulation comprises an emulsion.

24. The method of claim 18 wherein said drug formulation comprises an ointment.

25. The method of claim 18 wherein said drug formulation forming solution comprises a gel.

26. The method of claim 18 wherein said distal portion has a radius of curvature substantially equal to a radius of curvature of a sclera of said eye.

27. The method of claim 18 wherein said inserting step comprises inserting said cannula into a superior temporal quadrant of said eye.

28. The method of claim 18 wherein said inserting step comprises inserting said cannula into an inferior temporal quadrant of said eye.

29. The method of claim 18 wherein said drug formulation comprises a pharmaceutically active agent selected from the group consisting of 4,9(11)-Pregnadien-17α

,21-diol-3,20-dione and 4,9(11)-Pregnadien-17α

,21-diol-3,20-dione-21-acetate.

30. The method of claim 18 wherein said drug formulation comprises eliprodil.

31. The method of claim 18 wherein said drug formulation comprises nepafenac.

32. A method of delivering a drug to a human eye, comprising the steps of:

inserting a cannula below a Tenon'"'"'s capsule and above a sclera of said human eye at a point posterior to a limbus of said eye, said cannula having a distal portion having a radius of curvature substantially equal to a radius of curvature of a globe of said eye; and

injecting a drug formulation through said cannula to form a drug depot on an outer surface of said sclera, said drug formulation comprising a pharmaceutically active agent selected from the group consisting of 4,9(11)-Pregnadien-17α

,21-diol-3,20-dione and 4,9(11)-Pregnadien-17α

,21-diol-3,20-dione-21-acetate.

33. The method of claim 32 wherein said injecting step comprises forming said drug depot on said outer surface of said sclera generally above a macula of said eye.

34. The method of claim 32 further comprising disposing a tip of said distal portion proximate said macula of said eye.

35. A cannula, comprising:

a hub for removably coupling to a syringe;

a proximal portion; and

a distal portion having a tip, an orifice proximate said tip, and a radius of curvature substantially equal to a radius of curvature of a globe of a human eye, wherein a part of said distal portion proximate said tip is made of plastic.

36. The cannula of claim 35 wherein a remainder of said distal portion is formed of metal.