Methods for monitoring a physiological analyte

• US 6,299,578 B1
• Filed: 09/18/1997
• Issued: 10/09/2001
• Est. Priority Date: 12/28/1995
• 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, Potts, Russell Owen
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US08/933,025
• Time in Patent Office: 1,482 Days
• Field of Search: 600/309, 600/345-348, 600/363-366, 600/573, 600/584, 128/898-899
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A method for continual monitoring of a physiologic analyte in a subject includes steps of contacting the subject with a collection reservoir such that the analyte can move from the subject into the collection reservoir, the contents of the collection reservoir being in operative communication with a detector, collecting the analyte in the collection reservoir, using the detector to detect the analyte in the collection reservoir, and, once the analyte has been detected, rendering the analyte undetectable by the detector. Also, apparatus for continual monitoring of a physiologic analyte in a subject includes a collection reservoir for receiving the analyte from the subject, the contents of the collection reservoir being in operative relationship with a detector that detects the analyte in the reservoir, and means for rendering the analyte, once detected, undetectable by the reservoir.

Claims

1. A method for monitoring a physiologic analyte in a subject, comprising steps of:

(a) contacting the subject with a collection reservoir such that the analyte can move from the subject into said collection reservoir, the contents of the collection reservoir being in operative relationship with a detector,

(b) collecting the analyte in the collection reservoir,

(c) contacting the analyte with an enzyme that reacts with the analyte to produce a detectable chemical species, wherein the reaction of the analyte and the enzyme further results in conversion of the analyte to a reaction product that is not detected by the detector,

(d) using the detector to detect the detectable chemical species in the collection reservoir, and once the detectable chemical species has been detected, rendering the detectable chemical species undetectable by the detector,

repeating the steps (b), (c) and (d).

2. The method of claim 1, wherein the analyte is glucose and the enzyme is an enzyme that acts upon the glucose to substantially irreversibly produce a detectable chemical species and an undetectable reaction product.

3. A method for monitoring a physiologic analyte in a subject, the method comprising the steps of:

(a) contacting a skin surface of the subject with a collection reservoir such that the analyte can move from the subject into said collection reservoir, wherein contents of the collection reservoir are in operative relationship with a detector;

(b) collecting the analyte in the collection reservoir by applying energy to the skin surface of the subject;

(c) contacting the anlyte with an enzyme that reacts with the anlyte to produce a detectable species;

(d) using the detector to detect the detectable chemical species in the collection reservoir, and once the detectable chemical species has been detected, rendering the detectable chemical species undetectable by the detector thereby substantially climinating accumulation of detectable chemical species and analytes in the collection resevoir before repeating steps (b), (c) and (d); and

repeating the steps (b), (c), and (d).

4. The method of claim 3, wherein the analyte is glucose and the detectable chemical species is hydrogen peroxide.

5. The method of claim 3, wherein the enzyme is glucose oxidase and the collection reservoir contains an electrolyte.

6. The method of claim 3, wherein the energy applied is electrical energy.

7. The method of claim 6, wherein the electrical energy is iontophoretic current.

8. The method of claim 3, wherein the energy applied is ultrasound energy.

9. The method of claim 3, further comprising the step of applying to the skin surface a sweat inducing substance.

10. The method of claim 3, further comprising the step of applying to the skin surface a skin permeation enhancer.

11. A method for monitoring a physiologic analyte in a subject, wherein the method comprises the steps of:

(a) contacting a skin surface of the subject with a collection reservoir;

(b) collecting the analyte from the subject into the collection reservoir while the collection reservoir remains in contact with the skin surface of the subject by applying energy to the skin surface of the subject;

(c) discontinuing collection of the analyte by discontinuing the application of energy;

(d) reacting substantially all the collected analyte with an enzyme to produce a detectable chemical species wherein the reacting is carried out while the collection reservoir remains in contact with the skin surface of the subject;

(e) detecting the detectable chemical species in the collection reservoir by reacting the detectable chemical species with a sensor while the collection reservoir remains in contact with the skin surface of the subject, wherein said reacting renders the detectable chemical species subsequently undetectable;

(f) discontinuing detection after substantially all the detectable chemical species has been detected and rendered undetectable, thereby preventing significant accumulation of detectable chemical species in the collection reservoir; and

sequentially repeating steps (b), (c), (d), (e), and (f).

12. The method of claim 11, wherein the analyte is glucose and the detectable chemical species is hydrogen peroxide.

13. The method of claim 11, wherein the enzyme is glucose oxidase and the collection reservoir contains an electrolyte.

14. The method of claim 11, wherein the energy applied is electrical.

15. The method of claim 14, wherein the electrical energy is an iontophoretic current.

16. The method of claim 11, wherein the energy applied is ultrasound energy.

17. The method of claim 11, further comprising the step of applying to the skin surface a sweat inducing substance.

18. The method of claim 11, further comprising the step of applying to the skin surface a skin permeation enhancer.