Glucose detector and method

• US 6,102,872 A
• Filed: 05/04/1998
• Issued: 08/15/2000
• Est. Priority Date: 11/03/1997
• Status: Expired due to Term

• Current Assignee: PBI Technology, Inc.
• Original Assignee: Pacific Biometrics, Inc.
• Inventors: Harris, Holden H., Doneen, Byron A., Warnick, G. Russell
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/072,115
• Time in Patent Office: 834 Days
• Field of Search: 600/345, 600/347, 600/349, 600/365, 600/573, 600/580, 600/582, 600/584, 128/898, 422/50, 422/56, 422/58, 422/61, 435/14
• US Class Current: 600/582
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A non-invasive glucose monitoring device includes a mechanism for stimulating salivary glands secretion of saliva into oral fluid prior to collecting a sample of the oral fluid. A mechanism is provided for detecting the amount of glucose in the sample, a mechanism also being provided for quantitating blood glucose level based on the amount of glucose detected. A method of non-invasively monitoring glucose includes the steps of stimulating salivary glands secretion of saliva into oral fluid, collecting a sample of the oral fluid, detecting an amount of glucose in the sample, and then quantitating the blood glucose level based on the amount of glucose detected.

Claims

1. A noninvasive glucose monitoring device comprising:

a housing comprising an outer membrane, an inner membrane, and a collection means for collecting a sample of the oral fluid;

a stimulation means for stimulating salivary gland secretion of saliva into oral fluid, wherein said stimulation means is in said housing;

detection means operatively connected to said collection means for detecting an amount of glucose in the sample; and

quantitation means operatively connected to said detection means for quantitating blood glucose level based on the amount of glucose detected.

2. The noninvasive glucose monitoring device of claim 1 wherein said housing comprises a means of injection for dispensing said stimulation means therefrom and collection of oral fluid therein.

3. The noninvasive glucose monitoring device of claim 1 wherein said inner membrane is a dialysis membrane.

4. The noninvasive glucose monitoring device of claim 1 wherein said outer membrane is a filtering surface container defining an enclosed chamber.

5. The noninvasive glucose monitoring device of claim 1 wherein said housing contains osmotic means for drawing the oral fluid into said housing.

6. The noninvasive glucose monitoring device of claim 5, wherein said stimulating means stimulates salivary gland secretion and draws the oral fluid into said housing.

7. The noninvasive glucose monitoring device of claim 6, wherein said stimulating means is citric acid.

8. The noninvasive glucose monitoring device of claim 1 further comprises a support strip, comprising a first end and a second end, wherein said housing is mounted to said first end, said strip supporting said detection means and quantitation means therein and fluid transfer means for transferring oral fluid from said housing to said detection means and quantitation means.

9. The noninvasive glucose monitoring device of claim 8, wherein said housing further comprises a sealed membrane container and a piercing means for piercing an opening in said container to release the sample into said transfer means.

10. A noninvasive glucose monitoring device comprising:

oral fluid collection means for collecting a sample of oral fluid comprising an inner membrane and an outer membrane, and

blood glucose determining means for determining blood glucose level from the sample of oral fluid, wherein said determining means is operatively connected to said collection means.

11. A noninvasive fluid collection device comprising:

oral fluid collection means for collecting a sample of oral fluid comprising an inner membrane and an outer membrane;

a blood glucose determining means for determining blood glucose levels from the sample of oral fluid, wherein said determining means is operatively connected to said collection means; and

saliva stimulating means for stimulating salivary gland secretion of glucose.

12. A noninvasive collection device comprising oral fluid collection means for collecting a sample of oral fluid comprising an inner membrane and an outer membrane, oral fluid dilution means for diluting the oral fluid to increase the rate of uptake of the oral fluid into said collection means and a blood glucose determining means for determining blood glucose levels from the sample of oral fluid, wherein said determining means is operatively connected to said collection means.

13. A method of monitoring blood glucose by:

stimulating salivary gland secretion of saliva into oral fluid;

collecting a sample of the oral fluid using a glucose monitoring device comprising an inner membrane and an outer membrane and a blood glucose determining means for determining blood glucose levels from the sample of oral fluid, wherein said determining means is operatively connected to said collection means;

determining an amount of glucose in the sample; and

quantitating a blood glucose level based on the amount of glucose detected.

14. The method of monitoring blood glucose of claim 13, wherein said collecting step is further defined as using a physical force to drive oral fluid through a filtering surface into a sample receptacle.

15. The method of monitoring blood glucose of claim 14, wherein the sample receptacle is a sealed, puncturable container.

16. The method of claim 15, wherein said method further comprises the further step of puncturing an opening in the receptacle to release the oral fluid collected therein, whereby a readable signal on a support strip indicative of the blood glucose level is produced.

17. The method of claim 14, wherein said physical force is an osmotic gradient, wherein said physical force osmotically drives the oral fluid into said sample receptacle.

18. A method of noninvasively monitoring blood glucose levels by collecting a sample of oral fluid using a glucose monitoring device comprising an inner membrane and an outer membrane and a blood glucose determining means operatively connected to a collection means for determining blood glucose levels from the sample of oral fluid and determining a blood glucose level therefrom.

19. A method of noninvasively collecting oral fluid by collecting a sample of oral fluid using a glucose monitoring device comprising an inner membrane and an outer membrane and a blood glucose determining means operatively connected to a collection means for determining blood glucose levels from the sample of oral fluid while stimulating saliva secretion.

20. A method of noninvasively collecting oral fluid by first diluting oral fluid to increase oral fluid uptake in a collection device and then collecting a sample of the oral fluid using a glucose monitoring device comprising an inner membrane and an outer membrane and a blood glucose determining means operatively connected to a collection means for determining blood glucose levels from the sample of oral fluid.