Methods of producing an assembly for use in a monitoring device

• US 6,370,410 B2
• Filed: 01/18/2001
• Issued: 04/09/2002
• 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:
  US09/764,550
• Publication Number:
  US 20010020125A1
• Time in Patent Office: 446 Days
• Field of Search: 600/345-350, 600/361, 600/362, 600/365, 600/307, 600/309, 600/382, 600/386, 600/395-397, 604/20
• 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. A method of producing an assembly for use in a monitoring device for monitoring a chemical signal present in a subject, said method comprising:

providing (a) an ionically conductive material comprising first and second faces, said first face comprising a chemical signal target area, the ionically conductive material comprising water and an electrolyte; and

(b) a mask characterized by being substantially impermeable to a chemical signal; and

positioning said mask on the second face of the ionically conductive material opposite the first 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 chemical signal transported in a direction substantially perpendicular to the chemical signal target area, thereby resulting in production of said assembly.

2. The method of claim 1, wherein the mask defines an opening through which chemical signal flows in a direction substantially perpendicular to the chemical signal target area.

3. The method of claim 2, 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.

4. The method of claim 2, wherein the chemical signal target area is substantially circular and the opening in the mask has a perimeter equal to or circumscribed within an outer perimeter of the circular chemical signal target area.

5. The method of claim 1, wherein the chemical signal target area is annular and the mask comprises a solid, circular piece, having an outer perimeter, said mask concentrically positioned with respect to the annular chemical signal target area such that the outer perimeter of the solid circular piece is circumscribed substantially within the annular chemical signal target area.

6. The method of claim 1, wherein the ionically conductive material comprises, (i) a hydrophilic compound which forms a gel in water, wherein the hydrophilic compound is present in an amount of about 4% or more by weight based on the total weight of the ionically conductive material, and (ii) a chloride salt.

7. The method of claim 6, wherein said ionically conductive material is a hydrogel.

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

9. The method of claim 8, wherein the enzyme is glucose oxidase and the chemical signal is glucose.

10. The method of claim 1, wherein the mask is coated with a material which absorbs one or more compounds or ions.

11. The method of claim 1, wherein the mask is comprised of a polymeric material.

12. The method 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.

13. The method 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 ionically conductive material has a thickness in a range of from about 5 mils to about 50 mils.

14. The method of claim 1, wherein the mask has a thickness in a range of about 0.5 mil to 10 mils and the ionically conductive material has a thickness in a range of about 10 mils to 50 mils.

15. The method of claim 1, further comprising providing (c) a working electrode having a catalytic surface, wherein the chemical signal target area is an area of the ionically conductive material face that contacts the catalytic surface of the working electrode during chemical signal monitoring said positioning further comprises positioning the catalytic surface such that is aligned with the chemical signal target area of the ionically conductive media.

16. The method of claim 15, wherein said working electrode comprises a catalytic surface comprised of a material selected from the group consisting of platinum, palladium, nickel, and oxides, dioxides and alloys thereof.

17. A method of producing an assembly for use in a monitoring device for monitoring glucose present in a subject, said method comprising:

providing (a) a hydrogel, comprising first and second faces, said first face comprising a chemical signal target area, the hydrogel comprising (i) a hydrophilic compound which forms a gel in water, wherein the hydrophilic compound is present in an amount of about 4% or more by weight based on the total weight of the hydrogel, (ii) a chloride salt, and (iii) glucose oxidase, (b) a mask characterized by being substantially impermeable to glucose, and (c) a working electrode having a catalytic surface, wherein the chemical signal target area is an area of the hydrogel face that contacts the catalytic surface of the working electrode during glucose monitoring; and

positioning (a) said mark on the second face of the ionically conductive material opposite the first face such that glucose transported through a plane of the mask, through the ionically conductive material, and toward the chemical signal target area is substantially only that glucose transported in a direction substantially perpendicular to the chemical signal target area, and (b) said catalytic surface that it is aligned with the chemical signal target area of the hydrogel, thereby resulting in production of said assembly.

18. The method of claim 17, wherein said working electrode comprises a catalytic surface comprised of a material selected from the group consisting of platinum, palladium, nickel, and oxides, dioxides and alloys thereof.

19. The method of claim 17, wherein the mask defines as opening through which chemical signal flows in a direction substantially perpendicular to the chemical signal target area.

20. The method of claim 19, wherein the opening in the mask constitutes an area which is in a range of 1% to 90% of an area encompassed by the entire mask plus opening.

21. The method of claim 19, wherein the chemical signal target area is substantially circular and the opening in the mask has a perimeter equal to or circumscribed within an outer perimeter of the circular chemical signal target area.