Chemical signal-impermeable mask

• US 5,735,273 A
• Filed: 09/12/1995
• Issued: 04/07/1998
• 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): Bahr, Jennifer
• Assistant Examiner(s): Huang, Stephen
• Application Number:
  US08/527,061
• Time in Patent Office: 938 Days
• Field of Search: 128/637-644, 602/20, 602/304-308
• 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 monitoring device for monitoring a chemical signal, the chemical signal being a compound which diffuses through the skin of a subject, the assembly comprising:

a) an ionically conductive material having a first face having 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, the mask being positioned on a second face of the ionically conductive material opposite the first material 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.

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

3. The assembly of claim 2, wherein 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.

4. The assembly of claim 2, wherein the opening in the mask has a perimeter equal to or circumscribed within an outer perimeter of the target area.

5. The assembly of claim 1, wherein the mask is solid and the target area is annular.

6. The assembly of claim 1, wherein the ionically conductive material comprises:

i) a hydrophilic compound which forms a gel in water, which compound is present in an amount of about 4% or more by weight based on the weight of the ionically conductive material;

ii) a hydrogel comprising about 95% or less water; and

iii) a chloride containing salt.

7. The assembly of claim 1, wherein the ionically conductive material comprises glucose oxidase and the chemical signal is glucose.

8. 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.

9. The patch assembly 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.

10. A sensor assembly for use with a chemical signal monitoring device, comprising;

a sensor housing having a top portion and a bottom portion, the bottom portion defining a bottom portion opening

a chemical signal impermeable mask positioned between the top portion and the bottom portion, the mask having a surface area greater than or equal to the surface area of the bottom portion opening, and defining a mask opening, the mask being positioned so that the mask opening and the bottom portion opening are aligned; and

a working electrode positioned in the top portion of the sensor housing;

wherein prior to use of the device a hydrogel is inserted between the sensor housing bottom portion and top portion such that when the sensor assembly is closed, the top portion is positioned directly over the bottom portion such that a first hydrogel face contacts the mask, and the working electrode is in contact with a second hydrogel face opposite the first hydrogel face, the working electrode being positioned directly opposite the bottom portion opening, wherein chemical signal transported through a plane of the mask, through the hydrogel and toward the working electrode is substantially only that chemical signal transported in a direction substantially perpendicular to the working electrode.

11. The sensor assembly of claim 10, wherein the hydrogel comprises glucose oxidase, the mask is impermeable to glucose, and the working electrode comprises platinum.

12. The sensor assembly of claim 10, wherein the surface area of each the first and second hydrogel faces is in a range of about 0.5 cm² to 10 cm².

13. The sensor assembly of claim 10, wherein the mask has a thickness in a range of about 0.5 mils to 10 mils.

14. The sensor assembly of claim 10, wherein the hydrogel has a thickness in a range of about 10 mils to 50 mils.

15. The sensor assembly of claim 10, wherein the assembly has a total thickness in a range of about 5 mils to 50 mils.

16. An assembly for use in monitoring a chemical signal, comprising:

(a) an ionically conductive material comprised of water, electrolyte and an enzyme;

(b) a working electrode having a catalytic surface comprised of a material selected from the group consisting of platinum, palladium, nickel, and oxides, dioxides and alloys thereof, the catalytic surface contacting a first face of the ionically conductive material; and

(c) a chemical signal impermeable mask positioned on a second face of the ionically conductive material (a) opposite the first ionically conductive material face and opposite the catalytic surface of the electrode (b), the mask having an outer perimeter which is equal to or extends beyond an outer perimeter of the working electrode (b) and having an opening therein which has a perimeter which is equal to or circumscribed within the outer perimeter of the working electrode, wherein chemical signal transported through a plane of the mask, through the ionically conductive material, and toward the catalytic surface of the electrode is substantially only that chemical signal transported in a direction substantially perpendicular to the catalytic surface of the electrode.

17. The assembly of claim 16, wherein the material (a), electrode (b), and mask (c) are such that the mask blocks substantially all chemical signal flowing to the catalytic surface which is not flowing in a direction substantially perpendicular to the catalytic surface and allows substantially all chemical signal to flow to the catalytic surface which is flowing to that surface in a substantially perpendicular path.

18. The assembly of claim 16, wherein the first and second faces of the ionically conductive material each have a geometric surface area in a range of about 0.5 cm² to 10 cm² and the material has a thickness in range of about 5 to about 50 mils, further wherein the working electrode (b) has a catalytic surface with a geometric surface area in a range of about 0.25 to about 5.0 cm², and still further wherein the mask (c) has a thickness in a range of about 0.5 mil to about 10 mils.

19. An assembly for use in a monitoring device for monitoring a chemical signal, comprising:

a) an ionically conductive material;

b) a mask characterized by being impermeable to the chemical signal, the mask being positioned between ionically conductive material and a source of chemical signal; and

c) a working electrode which measures chemical signal transported from the source of chemical signal

wherein the mask is concentric to the working electrode and further wherein the chemical signal that passes through a plane of the mask is that chemical signal that is transported from the source to the catalytic surface in a manner which is substantially perpendicular to the catalytic surface.

20. The patch assembly of claim 19, wherein the ionically conductive material is a hydrogel having an enzyme therein and the catalytic surface is comprised of a material selected from the group consisting of platinum, palladium, nickel, oxides thereof, dioxides thereof and alloys thereof.