Microneedle drug delivery device

• US 8,257,324 B2
• Filed: 05/21/2007
• Issued: 09/04/2012
• Est. Priority Date: 06/04/1999
• Status: Expired due to Term

• Current Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Prausnitz, Mark R., Allen, Mark G., Gujral, Inder-Jeet
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US11/805,096
• Publication Number:
  US 20070225676A1
• Time in Patent Office: 1,933 Days
• Field of Search: 604/191, 604/186, 604/20, 604/22, 604/35, 604/46, 604/181, 604/183, 604/239, 604/261, 604/272, 604/890.1, 6048911-8921, 604/246, 424/424, 424/449
• US Class Current: 604/272
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Simple microneedle devices for delivery of drugs across or into biological tissue are provided, which permit drug delivery at clinically relevant rates across or into skin or other tissue barriers, with minimal or no damage, pain, or irritation to the tissue. The devices include a substrate to which a plurality of hollow microneedles are attached or integrated, and at least one reservoir, containing the drug, selectably in communication with the microneedles, wherein the volume or amount of drug to be delivered can be selectively altered. The reservoir can be formed of a deformable, preferably elastic, material. The device typically includes a means, such as a plunger, for compressing the reservoir to drive the drug from the reservoir through the microneedles, In one embodiment, the reservoir is a syringe or pump connected to the substrate.

Claims

1. An apparatus for transport of a material across or into a biological barrier, comprising:

a plurality of hollow microneedles each having a base end and a tip, with at least one hollow pathway disposed at or between the base end and the tip, wherein the microneedles comprise a metal;

a substrate to which the base ends of the microneedles are attached or integrated;

at least one reservoir in which the material is disposed and which is in connection with the base end of at least one of the microneedles, either integrally or separably;

a sealing mechanism interposed between the at least one reservoir and the substrate, wherein the sealing mechanism comprises a fracturable barrier; and

a device that expels the material in the reservoir into the base end of at least one of the microneedles,

wherein the biological barrier comprises living tissue.

2. The device of claim 1, wherein the reservoir comprises a syringe secured to the substrate, and wherein the device that expels the material comprises a plunger connected to a top surface of the reservoir.

3. The apparatus of claim 2, further comprising a spring engaged with the plunger.

4. The apparatus of claim 2, further comprising an attachment mechanism that secures the syringe to the apparatus.

5. The apparatus of claim 1, wherein the substrate is adapted to removably connect to a standard or Luer-lock syringe.

6. The apparatus of claim 1, further comprising a sealing mechanism that is secured to the tips of the microneedles.

7. The apparatus of claim 1, further comprising means for providing feedback to indicate that delivery of the material from the reservoir has been initiated or completed.

8. The apparatus of claim 1, wherein the device that expels the material from the reservoir comprises an osmotic pump.

9. The apparatus of claim 1, wherein the plurality of microneedles are disposed at an angle other than perpendicular to the substrate.

10. The apparatus of claim 1, wherein the at least one reservoir comprises multiple reservoirs.

11. The apparatus of claim 10, wherein the multiple reservoirs can be connected to or are in communication with each other.

12. The apparatus of claim 10, wherein the multiple reservoirs comprise a first reservoir and a second reservoir, wherein the first reservoir contains a solid formulation and the second reservoir contains a liquid carrier for the solid formulation.

13. The apparatus of claim 10, wherein the volume or amount of material to be transported can selectively be altered.

14. The apparatus of claim 1, wherein the fracturable barrier comprises a thin foil.

15. The apparatus of claim 1, wherein the fracturable barrier comprises a polymer.

16. The apparatus of claim 1, wherein the fracturable barrier comprises a laminate film.

17. The apparatus of claim 1, wherein the fracturable barrier comprises a biodegradable polymer.

18. The apparatus of claim 1, further comprising means for providing feedback to indicate that the microneedles have penetrated the biological barrier.

19. The apparatus of claim 18, wherein the means for providing feedback comprises a measurement of a change in pH at the biological barrier.

20. The apparatus of claim 18, wherein the means for providing feedback comprises a change in color of an electrical device.

21. The apparatus of claim 20, wherein the electrical device comprises a light emitting diode.

22. The apparatus of claim 20, wherein the electrical device comprises a liquid crystal display.

23. The apparatus of claim 18, wherein the means for providing feedback comprises a measurement of a change in electrical resistance at the biological barrier.