Microneedle array patch

• US 8,162,901 B2
• Filed: 10/19/2007
• Issued: 04/24/2012
• Est. Priority Date: 10/07/2002
• Status: Expired due to Fees

• Current Assignee: Valeritas, LLC
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R., McAllister, Devin V.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US11/975,717
• Publication Number:
  US 20090118672A1
• Time in Patent Office: 1,649 Days
• Field of Search: 604 46- 47, 604/180, 604/151, 604/181, 604186-187, 604/191, 604236-238, 604/246
• US Class Current: 604/246
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Microneedle devices for transport of molecules, including drugs and biological molecules, across tissue, are provided. The microneedle devices permit drug delivery or removal of body fluids at clinically relevant rates across skin or other tissue barriers, with minimal or no damage, pain, or irritation to the tissue. Microneedles can be formed of biodegradable or non-biodegradable polymeric materials or metals. In a preferred embodiment, a microneedle device includes a plugging element comprising a platform including a plurality of microneedle plugs for preventing skin or other tissue barriers from entering the hollow microneedles. In another preferred embodiment, a microneedle device includes a plurality of bioerodible elements for temporarily plugging the hollow microneedles, thereby preventing skin or other tissue barriers from entering the hollow microneedles.

Claims

1. A microneedle device comprising:

one or more microneedles capable of penetrating the stratum corneum, each of said microneedles comprising an interior channel and a proximal end and a distal end; and

a plugging element for plugging one or more of said one or more microneedles, where said plugging element is disposed within the interior channel of one or more of said one or more microneedles;

wherein the plugging element is configured to be removed from the interior channel of the one or more of said one or more microneedles to allow delivery of material across a biological barrier, and wherein the one or more of said one or more microneedles are configured to deliver material only when the plugging element is removed from the interior channel.

2. A microneedle device according to claim 1, further comprising a substrate to which the proximal end of each of said one or more microneedles is affixed.

3. A microneedle device according to claim 2, wherein said plugging element is affixed to said substrate.

4. A microneedle device according to claim 1, wherein said plugging element has a pointed distal end for piercing biological tissue.

5. A microneedle device according to claim 1, further comprising an adhesive.

6. A microneedle device according to claim 1, wherein said one or more microneedles has a perpendicular cross section and said cross section is circular, polygonal, or oblong.

7. A microneedle device according to claim 1, wherein the device comprises microneedles of different lengths.

8. A microneedle device according to claim 1, wherein the device comprises microneedles having interior channels of different diameters.

9. A microneedle device according to claim 1, wherein the device comprises microneedles of different cross-sectional shapes.

10. A microneedle device according to claim 1, further comprising a reservoir in fluid communication with one or more of said one or more microneedles.

11. A microneedle device according to claim 1, further comprising multiple chambers in which material to be delivered is stored.

12. A microneedle device according to claim 1, further comprising one or more elements selected from the group consisting of one or more pumps, one or more sensors, one or more valves, one or more actuators, and one or more microprocessors.

13. A microneedle device according to claim 1, wherein the plugging element mimics the cross-sectional shape of one or more of said one or more microneedles.

14. A microneedle device according to claim 1, wherein the plugging element is configured to remain attached to the microneedle device when it is removed from the interior channel of the one or more of said one or more microneedles.

15. A microneedle device according to claim 1, wherein the plugging element is configured to detach from the microneedle device when it is removed from the interior channel of the one or more of said one or more microneedles.