Microneedle drug delivery device

• US 6,611,707 B1
• Filed: 12/02/1999
• Issued: 08/26/2003
• Est. Priority Date: 06/04/1999
• Status: Expired due to Term

• Current Assignee: Valeritas, LLC
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Gujral, Inder-Jeet, Prausnitz, Mark R., Allen, Mark G.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/452,979
• Time in Patent Office: 1,363 Days
• Field of Search: 424/424, 424/449, 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
• US Class Current: 604/21
• 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. A device 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, and

at least one reservoir which is in connection with the base ends of at least one of the microneedles, either integrally or separably until the moment of use,

wherein the volume or amount of material to be transported can selectively be altered.

2. The device of claim 1 wherein the reservoir is formed of a material which is deformable.

3. The device of claim 2 wherein the reservoir is elastic.

4. The device of claim 1 wherein the reservoir further comprises a therapeutic, prophylactic, or diagnostic agent.

5. The device of claim 4 wherein the agent is selected from the group consisting of peptides, proteins, carbohydrates, nucleic acid molecules, lipids, organic molecules, biologically active inorganic molecules, and combinations thereof.

6. The device of claim 1 wherein the diameter of the microneedles is between about 1 μ

m and about 100 μ

m.

7. The device of claim 1 wherein the length of the microneedles is between about 100 μ

m and 1 mm.

8. The device of claim 1 wherein the microneedles are adapted to provide an insertion depth of less than about 100 to 150 μ

m.

9. The device of claim 1 comprising a three dimensional array of microneedles.

10. The device of claim 1 further comprising an adhesive material for securing the device during delivery.

11. The device of claim 1 wherein at least the microneedles are manufactured for single use as a disposable reagent.

12. The device of claim 1 wherein the device further comprises means for stopping delivery.

13. The device of claim 1 wherein the substrate is formed of a flexible material.

14. The device of claim 1 in a packaging that protects the device from damage and/or contamination.

15. The device of claim 1 further comprising a removable liner that covers the microneedle tips and that can be used to protect and/or seal access to or from the microneedles.

16. The device of claim 1 wherein the device comprises rate control means, which can be used to regulate the rate or extent at which materials flow through the microneedles.

17. The device of claim 16 wherein the rate control means is a membrane at one end of the microneedles through which agent or fluid must pass.

18. The device of claim 16 wherein the rate control means is a material positioned within the hollow pathway of the microneedles.

19. The device of claim 1 comprising multiple microneedle arrays in combination with means for accessing one or more arrays at a time.

20. The device of claim 1 comprising means for preventing undesired contact with or use of the microneedles.

21. The device of claim 20 wherein the means is packaging that covers the microneedles.

22. The device of claim 20 wherein the means is packaging that shears off the microneedles, or tips thereof, after use.

23. The device of claim 20 wherein the means are materials which are delivered into the hollow pathways to seal the microneedles.

25. The device of claim 6, wherein microneedles have an outer diameter between 10 and 100 microns.

24. A kit of parts for delivering a therapeutic, prophylactic or diagnostic agent across or into tissue comprising:

(a) one or more microneedle devices which comprise a plurality of hollow microneedles comprising a metal, a substrate to the microneedles are attached or integrated, and at least one reservoir which is selectably in communication with the microneedles, wherein at least one of the reservoirs contains the therapeutic, prophylactic or diagnostic agent to be delivered; and

(b) a triggering device which is adapted to activate delivery of the agent from reservoir through the microneedles of one of the devices at a time.