Apparatus and Methods for Drug Delivery Using Microneedles

• US 20150209180A1
• Filed: 08/27/2013
• Published: 07/30/2015
• Est. Priority Date: 08/27/2012
• Status: Abandoned Application

• Current Assignee: Clearside Biomedical, Inc., Emory University, Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Clearside Biomedical, Inc.
• Inventors: Prausnitz, Mark R., Edelhauser, Henry F., Zarnitsyn, Vladimir G., Patel, Samirkumar R., Grossniklaus, Hans
• Application Number:
  US14/424,685
• Publication Number:
  US 20150209180A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration

Abstract

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5.

Claims

1. An apparatus, comprising:

a microneedle having a distal end portion and a proximal end portion, and defining a lumen, the proximal end portion configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge, the proximal end portion including a base surface configured to contact a surface of a target tissue,

the distal end portion including a beveled surface, the beveled surface defining a first bevel angle and a second bevel angle different than the first bevel angle.

2. The apparatus of claim 1, wherein the first bevel angle is less than the second bevel angle.

3. The apparatus of claim 1, wherein the first bevel angle is less than 20 degrees and the second bevel angle is greater than the first bevel angle.

4. The apparatus of claim 1, wherein:

the first bevel angle is a tip angle; and

the second bevel angle is an inside angle.

5. The apparatus of claim 1, wherein a ratio of a bevel height to a bevel width is less than about 2.5.

6. The apparatus of claim 1, wherein the first bevel angle is less than about 18 degrees.

7. The apparatus of claim 1, wherein the first bevel angle is less than about 12 degrees.

8. The apparatus of claim 1, wherein the second bevel angle is greater than about 45 degrees.

9. The apparatus of claim 1, wherein at least a portion of the bevel surface is curved.

10. The apparatus of claim 1, wherein:

a bevel height is less than about 500 μ

m; and

a bevel width is less than about 320 μ

m.

11. The apparatus of claim 1, wherein an outer diameter of the microneedle is substantially constant and an inner diameter of the microneedle is about 120 μ

m or less.

12. An apparatus, comprising:

a microneedle having a distal end portion and a proximal end portion, and defining a lumen, the proximal end portion configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge, the proximal end portion including a base surface configured to contact a surface of a target tissue,

the distal end portion including a beveled surface, the beveled surface defining a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5.

13. The apparatus of claim 12, wherein the microneedle is rigid and is 30 gauge or smaller.

14. The apparatus of claim 12, wherein an outer diameter of a shaft portion of the microneedle is substantially constant and an inner diameter of the microneedle is about 120 μ

m or less.

15. The apparatus of claim 12, wherein the tip angle is less than about 18 degrees.

16. The apparatus of claim 12, wherein the ratio of the bevel height to the bevel width less than about 2.2.

17. The apparatus of claim 12, wherein at least a portion of the bevel surface is curved.

18. The apparatus of claim 12, wherein the beveled surface defines an inside angle of greater than 30 degrees.

19. The apparatus of claim 12, wherein the bevel height is less than about 500 μ

m.

20. The apparatus of claim 12, further comprising:

the cartridge coupled to the proximal end portion of the microneedle, the cartridge configured to contain at least one of a VEGF, a VEGF inhibitor, or a combination thereof.

21. The apparatus of claim 12, wherein the base surface substantially circumscribes a shaft portion of the microneedle.

22. The apparatus of claim 12, wherein the base surface is substantially normal to a center line of the lumen of the microneedle.

23. A method, comprising:

inserting a microneedle into an eye such that a distal edge defined by a beveled surface of the microneedle does extend through the choroid of the eye, the beveled surface defining a tip angle of less than about 20 degrees, the beveled surface having a height such that an opening defined by the beveled surface is within at least one of a suprachoroidal space or a lower portion of the sclera; and

conveying a substance from a cartridge coupled to a proximal end portion of the microneedle into the suprachoroidal space via the opening defined by the beveled surface.

24. The method of claim 23, wherein the inserting includes inserting the microneedle via a target location of the surface of the eye, a center line of the microneedle defining an angle with a plane tangent to the target location of between 80 and 100 degrees.

25. The method of claim 23, wherein, the inserting includes inserting the microneedle substantially normal to a target surface of the eye.

26. The method of claim 23, wherein the inserting is independent of an angular orientation about a center line of the microneedle.

27. The method of claim 23, wherein the inserting includes inserting the microneedle such that a base of the microneedle contacts a target surface of the eye.

28. The method of claim 23, wherein the conveying includes defining, at least in part, the suprachoroidal space.

29. The method of claim 23, wherein the substance is at least one of a VEGF, a VEGF inhibitor, or a combination thereof.