Microneedle drug delivery device

• US 7,226,439 B2
• Filed: 06/04/2003
• Issued: 06/05/2007
• 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: Prausnitz, Mark R., Allen, Mark G., Gujral, Inder-Jeet
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/454,973
• Publication Number:
  US 20030208167A1
• Time in Patent Office: 1,462 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: 604/506
• 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 method for delivering an agent into a biological barrier, comprising providing a device having:

a plurality of hollow microneedles having a base end and a tip, with at least one hollow pathway disposed between the base end and the tip,

a substrate to which the base ends of the microneedles are attached, and

at least one reservoir containing the agent to be delivered and being in fluidic connection with the base ends of at least one of the microneedles,

selectively altering the volume of the reservoir, and

inserting at least one of the microneedles into the biological barrier to deliver an agent through the microneedles and into the biological barrier.

2. The method of claim 1 further comprising reducing the volume of the agent in the reservoir by driving the agent through at least one of the microneedles.

3. The method of claim 1 wherein the biological barrier is tissue.

4. The method of claim 1 further comprising providing a reservoir formed of a material which is deformable.

5. The method of claim 1 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 method of claim 1 further comprising providing a plunger for compressing the reservoir.

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

8. The method of claim 1 further comprising adapting the substrate for removably connecting to a standard or Luer-lock syringe.

9. The method of claim 1 further comprising fracturing a barrier interposed between the reservoir and the substrate.

10. The method of claim 1 further comprising monitoring feedback to indicate that delivery has been initiated or completed.

11. The method of claim 1 further comprising mixing the agent with particles capable of blocking the hollow pathway and thereby preventing delivery of the agent.

12. The method of claim 1 further comprising providing an osmotic pump to move agent.

13. The method of claim 1 comprising providing multiple reservoirs.

14. The method of claim 13 wherein the reservoirs are in communication with each other.

15. The method of claim 13 wherein one or more reservoirs contain a solid formulation and one or more reservoirs contains a liquid carrier for the solid formulation.

16. The method of claim 1 further comprising regulating the rate at which the agent flows through the microneedles.

17. The method of claim 16 whereby regulating comprises disposing a membrane within the hollow pathway for controlling the rate at which the agent follows through the hollow pathway.

18. The method of claim 1 further comprising providing multiple microneedle arrays and means for accessing one or more arrays at a time.