Chemical signal-impermeable mask

• US 6,141,573 A
• Filed: 08/04/1998
• Issued: 10/31/2000
• Est. Priority Date: 09/12/1995
• Status: Expired due to Term

• Current Assignee: Animas Technologies LLC (Johnson & Johnson)
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Kurnik, Ronald T., Tamada, Janet, Tierney, Michael
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/128,891
• Time in Patent Office: 819 Days
• Field of Search: 600/345-350, 600/362, 600/364, 600/365, 600/386, 600/382, 600/361, 600/300, 607/20, 607/309, 607/308
• US Class Current: 600/345
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

A chemical signal-impermeable mask is positioned in the electrolyte flow such that the mask is between a source of chemical signal and a working electrode which senses the chemical signal transported from the source (e.g., by diffusion). The configuration of the mask is such that the mask prevents substantially all chemical signal transport from the chemical signal source having a radial vector component relative to a plane of the mask and the catalytic face of the working electrode, thus allowing primarily only chemical signal transport that is substantially perpendicular to the place of the mask and the catalytic surface of the working electrode. By reducing or eliminating chemical signal radial transport toward the working electrode, the mask thus significantly reduces or eliminates edge effects. By substantially reducing edge effects created by radial transport of chemical signal, it is possible to obtain a more accurate measurement of the amount (e.g., concentration) of chemical signal that is transported from a given area of source material.

Claims

1. An assembly for use in a device for monitoring a chemical signal which diffuses through the skin of a subject, said assembly comprising:

(a) an ionically conductive material having first and second opposing faces, wherein said first face comprises a chemical signal target area and said second face comprises a skin contact surface area;

(b) a mask characterized by being substantially impermeable to a chemical signal, said mask having first and second opposing faces and an opening extending between said first and second faces, wherein the first face of the mask is positioned on the skin contact surface of the ionically conductive material and the opening in the mask is less than or substantially equal to said skin contact surface area; and

(c) a first release liner positioned over the first face of the ionically conductive material, wherein said first release liner is easily removed prior to use of the assembly.

2. The assembly of claim 1 further comprising a second release liner positioned over the second face of the mask, wherein said second release liner is easily removed prior to use of the assembly.

3. The assembly of claim 1, wherein the mask is attached to the ionically conductive material by chemical means.

4. The assembly of claim 3, wherein the mask is attached to the ionically conductive material by a chemical adhesive.

5. The assembly of claim 1, wherein the mask is positioned on the second face such that chemical signal transported through a plane of the mask, through the ionically conductive material, and toward the chemical signal target area is substantially only that signal which is transported in a direction substantially perpendicular to the chemical signal target area.

6. The mask of claim 1, wherein the first release liner includes a perforated cut therein which facilitates removal of the liner from the assembly.

7. The assembly of claim 1, wherein the opening in the mask constitutes an area which is in the range of 1% to 90% of an area encompassed by the entire mask plus opening.

8. The assembly of claim 1, wherein the ionically conductive material comprises a hydrogel.

9. The assembly of claim 1, wherein the ionically conductive material comprises a chemical signal-specific enzyme.

10. The assembly of claim 9, wherein the enzyme is glucose oxidase and the chemical signal is glucose.

11. The assembly of claim 1, wherein the first and second faces of the ionically conductive material are coplanar and each has a surface area in a range of from about 0.5 to about 10 cm² and the material has a thickness in a range of from about 5 mils to about 50 mils.

12. The assembly of claim 1, wherein the mask has a thickness in a range of from about 0.5 mils to about 10 mils.

13. The assembly of claim 1, wherein the mask has an adhesive coated on at least one of said first and second opposing faces.

14. The assembly of claim 13, wherein the adhesive is a pressure-sensitive adhesive.

15. The assembly of claim 1, wherein the mask is coated with a material which absorbs one or more compounds or ions which diffuse through the skin of said subject.

16. The assembly of claim 1, wherein the mask is comprised of a polymeric material.

17. The assembly of claim 1, wherein the mask is comprised of two or more layers of the same or different materials to provide a chemical signal-impermeable composition.