MULTI-RESERVOIR DEVICE AND METHOD FOR TRANSDERMAL SENSING

• US 20090234214A1
• Filed: 05/26/2009
• Published: 09/17/2009
• Est. Priority Date: 07/30/2004
• Status: Abandoned Application

• Current Assignee: MicroCHIPS Inc.
• Original Assignee: MicroCHIPS Inc.
• Inventors: Herman, Stephen J., Santini, John T. JR., Staples, Mark A.
• Application Number:
  US12/471,973
• Publication Number:
  US 20090234214A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61F 2013/00642 soluble, e.g. in water
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

Devices and methods are provided for transdermal diagnostic sensing, alone or in combination with transdermal drug delivery. The device includes a substrate having a plurality of discrete reservoirs, each reservoir having at least one opening; contents disposed in the reservoirs, the contents of each reservoir including a diagnostic agent or a sensor for measuring an analyte; at least one discrete reservoir cap which cover said at least one opening; control means for disintegrating or permeabilizing the reservoir cap; means for transporting an analyte from the skin to said sensors and/or for transporting said diagnostic agent to the skin following release of said diagnostic agents from said reservoir; and means for securing the device to the skin of a patient.

Claims

1. A device for sensing an analyte in a human or other animal comprising:

a substrate having a plurality of discrete reservoirs, each reservoir having at least one opening;

contents disposed in the reservoirs, the contents of each reservoir comprising a diagnostic agent or a sensor for measuring an analyte;

at least one discrete reservoir cap which cover said at least one opening;

control means for disintegrating or permeabilizing the reservoir cap;

means for transporting an analyte from the skin to said sensors and/or for transporting said diagnostic agent to the skin following release of said diagnostic agents from said reservoir; and

means for securing the device to the skin of a patient.

2. The device of claim 1, wherein the reservoir cap is formed of an electrically conductive material and the circuitry comprises an electrical input lead connected to said reservoir cap, an electrical output lead connected to said reservoir cap, wherein the reservoir cap is ruptured by application of an electrical current through the reservoir cap via the input lead and output lead.

3. The device of claim 1, wherein the reservoir cap comprises a metal film.

4. The device of claim 1, wherein the means for transporting comprises a transport medium disposed between the reservoir caps and the skin.

5. The device of claim 4, wherein the transport medium comprises a permeable body through which the one or more diagnostic agents released from the reservoirs can diffuse.

6. The device of claim 4, wherein the transport medium comprises a reservoir containing a liquid, gel, or semi-solid permeation material.

7. The device of claim 1, wherein the means for transporting comprises a flexible or rigid member having media-filled holes with spacing corresponding to reservoir membrane openings.

8. The device of claim 6, wherein the transport medium reservoir comprises a single pool of a biocompatible transport fluid into which the one or more diagnostic agents are diluted prior to delivery to the skin.

9. The device of claim 6, wherein the transport medium reservoir comprises individual channels for delivery of the one or more diagnostic agents with no or minimal dilution prior to delivery to the skin.

10. The device of claim 1, further comprising a housing which contains the substrate and control means.

11. The device of claim 1, comprising a removably attachable electronics portion which comprises a power source and at least a portion of the control means.

12. The device of claim 1, wherein the means for transporting comprises a plurality of microneedles.

13. The device of claim 1, wherein the means for transporting comprises one or more chemical penetration enhancers.

14. The device of claim 1, wherein the means for transporting comprises an ultrasound generator.

15. The device of claim 1, wherein the means for transporting comprises means for effecting iontophoresis, electroosmosis, or electroporation.

16. The device of claim 1, wherein the means for transporting comprises a heating element.

17. The device of claim 1, wherein the reservoirs are microreservoirs.

18. The device of claim 1, wherein the means for securing comprises a pressure sensitive adhesive, an adhesive layer which is permeable to the one or more diagnostic agents, or a combination thereof.

19. The device of claim 1, wherein the diagnostic agent comprises a Small Molecule Metabolite Reporter.

20. The device of claim 1, wherein the sensor can measure the epidermal skin or blood glucose level in a patient.