Microneedle with membrane

• US 20050137536A1
• Filed: 11/19/2004
• Published: 06/23/2005
• Est. Priority Date: 09/28/2001
• Status: Abandoned Application

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Application Number:
  US10/993,927
• Publication Number:
  US 20050137536A1
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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

Abstract

Membrane containing microneedles, microneedle arrays, and needles, and systems and methods relating to same are disclosed.

Claims

1. A microneedle device, comprising

a microneedle array, and

a membrane disposed thereon.

2. A microneedle device according to claim 1, wherein the membrane is an ion-selective material.

3. A microneedle device according to claim 2, wherein the ion-selective material selectively allows one or more desired analytes to pass therethrough while substantially blocking certain other analytes.

4. A microneedle device according to claim 3, wherein the desired analytes are selected from insulin, blood gas, calcium, and potassium.

5. A microneedle device according to claim 1, wherein the membrane is an ion transport membrane or an ion filter.

6. A microneedle device according to claim 1, wherein the membrane is disposed on the outside or inside of the microneedle array.

7. A microneedle device according to claim 1, wherein the membrane is partially disposed on the microneedle array.

8. A microneedle device according to claim 1, further comprising a layer having an electron transfer agent.

9. A microneedle device according to claim 1, wherein the electron transfer agent comprises an enzyme, or a functional derivative thereof.

10. A microneedle device according to claim 9, wherein the enzyme is selected from glucose oxidase (EC 1.1.3.4), lactose oxidase, galactose oxidase, enoate reductase, hydrogenase, choline dehydrogenase, alcohol dehydrogenase (EC 1.1.1.1), and glucose dehydrogenase.

11. A microneedle device according to claim 1, further comprising a sensor in electrical communication with the microneedle array.

12. A system for sample analysis, comprising

a microneedle having a membrane, and

a layer having an electron transfer agent disposed thereon, and

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

13. A system according to claim 12, 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.

14. A system according to claim 12, further comprising

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

15. A system according to claim 12, further comprising a dose control system for controlling as a function of a change in an electrical parameter a dose to deliver.

16. A system according to claim 12, for the comprising

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

17. A system according to claim 13, for the comprising

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

18. A patch comprising,

a substrate,

a plurality of microneedles formed on the substrate, and

a membrane disposed on the substrate.

19. A process for manufacturing a microneedle, comprising

forming a microneedle array substrate, and

forming a membrane on the substrate.

20. A process according to claim 19, further comprising disposing electron transfer agents on the substrate.