Microneedle array patch

• US 20090118672A1
• Filed: 10/19/2007
• Published: 05/07/2009
• Est. Priority Date: 10/07/2002
• Status: Active Grant

• Current Assignee: Valeritas, LLC
• Original Assignee: Valeritas, LLC
• Inventors: Gonnelli, Robert R., McAllister, Devin V.
• Granted Patent: US 8,162,901 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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 delivery device for introducing a substance into or below the stratum corneum of a patient, comprising

a microneedle having a distal end and an interior channel that extends to the distal end,

a pin dimensioned for slidably extending into the interior channel and out the distal end, and an adhesive patch of the type capable of adhering to biological tissue.

2. A delivery device according to claim 1, wherein

the pin has an arcuate distal end for piercing biological tissue.

3. A delivery device according to claim 1, comprising

means for sliding the pin into and out of the interior channel.

4. A delivery device according to claim 1, further comprising

a reservoir for storing a fluid substance to be introduce into the biological tissue.

5. A delivery device according to claim 1, further comprising

a reservoir having a plurality of chambers.

6. A delivery device according to claim 1, further comprising

a pump for pumping a fluid through the interior channel.

7. A delivery device according to claim 6, further comprising a flow controller for controlling the rate at which fluid flows through the interior channel.

8. A delivery device according to claim 1, further comprising

a plug for insertion into a distal end of the channel to prevent tissue from entering the channel.

9. A delivery device according to claim 8, wherein the plug comprises a bioerodible material.

10. A delivery device according to claim 8, wherein the plug comprises a barb for gripping to biological tissue.

11. A delivery device according to claim 1, wherein the microneedle comprises an array of microneedles formed on a substrate.

12. A delivery device according to claim 1, wherein the pin comprises an array of pins fixed to a substrate and arranged to be co-axial with the interior channels of the array of microneedles.

13. A delivery device according to claim 12, further comprising a spring assembly for moving the springs axially within the interior channels.

14. A delivery device according to claim 1, further comprising a flange for coupling to the microneedle to an external device.

15. A delivery device according to claim 1, further comprising a pump for drawing a sample through the interior channel.

16. A transdermal patch, comprising at least one microneedle having an interior channel,

a removable plug disposed at a distal end of the interior channel, as

an adhesive patch for adhering at least one microneedle to biological tissue.

17. A method for introducing a substance into or below the stratum corneum of a patient, comprising

inserting into tissue of a patient a microneedle having a distal end and an interior channel that extends to the distal end, and

sliding a pin dimensioned into the interior channel and out the distal end.

18. A method according to claim 17, further comprising inserting a plurality of microneedles into the tissue of a patient.

19. A method according to claim 17, further comprising pumping a fluid through the microneedle.

20. A method according to claim 18, further comprising operating a syringe for pumping the fluid.