Gas pressure actuated microneedle arrays, and systems and methods relating to same

• US 8,920,375 B2
• Filed: 09/23/2002
• Issued: 12/30/2014
• Est. Priority Date: 09/21/2001
• Status: Expired due to Fees

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US10/252,739
• Publication Number:
  US 20030135158A1
• Time in Patent Office: 4,481 Days
• Field of Search: 604/93.01, 604/131, 604/133, 604/264, 604/246, 604/247, 604140-141, 604145-146, 604/245, 604 20- 22
• US Class Current: 604/141
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The microneedle devices disclosed herein in some embodiments include a substrate; one or more microneedles; a reservoir for delivery of drugs; a gas source, and, optionally, pump(s), sensor(s), and/or microprocessor(s) to control the interaction of the foregoing.

Claims

1. A microneedle device, comprising:

a substrate,

a microneedle array attached to or integrally formed on a base of the substrate,

a fluid reservoir,

a gas source, and

a flexible layer which allows one or more substances from the fluid reservoir and gas from the gas source to pass therethrough,

wherein said fluid reservoir is disposed between said gas source and said flexible layer and wherein activation of the gas source causes gas to flow into the fluid reservoir and forces a substance from the fluid reservoir, through the flexible layer, and through the microneedles of the microneedle array.

2. The device of claim 1, wherein the fluid reservoir contains a fluid.

3. The device of claim 2, wherein the fluid includes a therapeutic agent.

4. The device of claim 3, wherein the therapeutic agent is selected from vaccines, chemotherapy agents, pain relief agents, dialysis-related agents, blood thinning agents, and compounds that can be targeted to carry compounds that can kill cancer cells.

5. The device of claim 3, wherein the therapeutic agent is selected from proteins, enzymes, polysaccharides, polynucleotide molecules, and synthetic organic and inorganic compounds.

6. The device of claim 3, wherein the therapeutic agent is selected from anti-infectives, hormones, growth regulators, drugs regulating cardiac action or blood flow, and drugs for pain control.

7. The device of claim 3, wherein the therapeutic agent is selected from insulin, heparin, morphine, interferon, EPO, tumor vaccines, and infectious disease vaccines.

8. The device of claim 3, wherein the therapeutic agent is insulin.

9. The device of claim 1, wherein the flexible layer is resilient or elastic.

10. The device of claim 1, wherein the flexible layer has slits.

11. The device of claim 1, wherein the flexible layer has one-way valves.

12. The device of claim 1, wherein the flexible layer is semi-permeable.

13. The device of claim 1, wherein the flexible layer substantially prevents one or more substances from passing therethrough.

14. The device of claim 1, wherein the flexible layer is a material selected from the group consisting of a rubber, a polymer, a plastic, a metal, and a composite.

15. The device of claim 1, wherein the device is skin patch.

16. The device of claim 1, further comprising a chamber disposed between said flexible layer and said substrate.

19. The device of claim 1, wherein the microneedle array comprises hollow microneedles.

20. The device of claim 1, wherein the microneedle array comprises porous microneedles.

17. A method for delivering a drug through a microneedle device, comprising

providing a substrate,

providing a microneedle array attached to or integrally formed on a base of the substrate,

providing a gas source,

providing a fluid reservoir comprising drug to be delivered,

providing a flexible layer which allows drug from the fluid reservoir and gas from the gas source to pass therethrough, wherein the reservoir is disposed between the gas source and the flexible layer, and wherein activation of the gas source causes gas to flow into the fluid reservoir and forces drug from the fluid reservoir, through the flexible layer, and through the microneedle array, and

activating the gas source to deliver drug.

18. The method of claim 17, further comprising providing a chamber disposed between said flexible layer and said substrate.

21. The method of claim 17, wherein the microneedle array comprises hollow microneedles.

22. The method of claim 17, wherein the microneedle array comprises porous microneedles.