Microneedles, microneedle arrays, and systems and methods relating to same

• US 20030135167A1
• Filed: 09/19/2002
• Published: 07/17/2003
• Est. Priority Date: 09/19/2001
• Status: Active Grant

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Granted Patent: US 8,361,037 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• 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; and, optionally, a reservoir for delivery of drugs or collection of analyte, as well as pump(s), sensor(s), and/or microprocessor(s) to control the interaction of the foregoing.

Claims

1. A microneedle device, comprising

a first layer formed into the shape of a microneedle and comprising a material suitable for piercing tissue,

a second layer disposed above the first layer, and capable of acting as an electrical insulator, and

a third layer disposed above the second layer and capable of conducting and electrical charge.

4. A microneedle according to claim 1, wherein the second layer comprises an electrically insulating material.

5. A microneedle according to claim 4, wherein the insulating material is selected from the group consisting of silicon, glass, plastic, air ceramic, oxidized silicon and mylar.

6. A microneedle according to claim 1, wherein the third layer comprises a metal.

7. A microneedle according to claim 6, wherein the metal is selected from the group consisting of copper, silver, tungsten, titanium, gold, platinum, palladium, nickel and [titanium].

8. A microneedle according to claim 1, wherein at least one of the second and third layers comprise material deposited on to the first layer.

9. A microneedle according to claim 1, wherein at least one of the layers comprise layers formed of a doped material.

10. A microneedle according to claim 1, wherein at least one of the layers comprise a layer formed of sputtered material.

11. A microneedle according to claim 1, wherein at least one of the first and second layers is discontinuous.

12. A microneedle according to claim 1, further comprising

a layer having an election transfer agent.

13. A microneedle according to claim 1, wherein the election transfer agent comprises an enzyme.

2. A microneedle according to claims, wherein the first layer comprises a metal material.

3. A microneedle according to claim 2, wherein the metal material selected from the group consisting of copper, silver, tungsten, titanium, gold, platinum, palladium, nickel and [titanium].

14. A system for sample analysis, comprising

a microneedle having

a first metal layer formed

as a needle,

a second insulating layer disposed above the first layer, and

a third metal layer disposed above the second layer and having an election transfer agent disposed thereon, and

a sensor coupled to the third metal layer and capable of detecting a change in an electrical parameter.

15. A system according to claim 14, wherein the sensor is selected from the group consisting of a resistor, a hall effect device, a capacitor, an inductor, a thermsistor, and a differential amplifier.

16. A system according to claim 14, further comprising

a delivery mechanism for delivering a medicant through the microneedle in response to a detected change in an electrical parameter.

17. A system according to claim 14, further comprising a dose control system for controlling as a function of a change in an electrical parameter a dose to deliver.

18. A system according to claim 14, for the comprising

a visual display for generating a visual indication of a detected change in an electrical parameter.

19. A system according to claim 14, for the comprising

an audio indicator for generating an audio signal to indicate a detected change in an electrical parameter.

20. A patch comprising,

a substrate, and

a plurality of microneedles formed on the substrate wherein at least one of the microneedles comprises at least three layers.

21. A process for manufacturing a microneedle, comprising

forming a first layer of material in the shape of a microneedle, and

forming a second layer of material on the first layer.

22. A process according to claim 21, further comprising

forming on the second layer a third layer of material.

23. A process according to claim 21, further comprising disposing election transfer agents on at least one layer.