Method for monitoring glucose level

• US 5,056,521 A
• Filed: 06/29/1989
• Issued: 10/15/1991
• Est. Priority Date: 06/29/1989
• Status: Expired due to Fees

• Current Assignee: Health Craft International, Inc.
• Original Assignee: Health Craft International, Inc.
• Inventors: Booher, Jon, Parsons, J. Stuart
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Pfaffle, K. M.
• Application Number:
  US07/374,535
• Time in Patent Office: 838 Days
• Field of Search: 128/635, 128/741, 128/760, 128/787, 128/898, 204/153.12, 204/403, 324/692, 324/713, 324/724
• US Class Current: 600/347
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A sample of oral fluid is collected by an absorbent nonreactive collecting swab brought into contact with a favorable surface in the oral cavity. The fluid is interstitial transudate selectively collected from the vestibule region of the oral cavity at the junction of the superior labial mucous membrane and the superior gingivae between the upper canine teeth. The collecting swab is an open cell foam material with a fine (e.g., 0.3 mm diameter) cell size. The collecting swab is placed in a cylindrical concentrator and the fluid sample is squeezed through a small hole in the concentrator by pushing a plunger into the concentrator and squeezing the fluid from the collecting swab into a monitoring instrument located off site. A common electronic circuit in the instrument generates an electrical glucose representative readout for oral fluid or whole blood. A sheet of graph paper has rectangular coordinates one of which represents glucose level and the other which represents time of day. The first coordinate of the graph paper is mounted on a flat surface adjacent to a linear glucose level display. The user can record readings on the linear display by simply projecting such readings laterally on the graph to the applicable time of day and placing a mark on the graph. In the instrument, an enzyme electrode receives the sample from the concentrator. The electrode has a membrane that is wetted by a buffer solution when not in use.

Claims

1. A method for monitoring glucose comprising the steps of:

placing a nonreactive absorbent collecting swab in contact with a surface of the oral cavity of a patient to collect thereon a sample of glucose level indicative oral fluid;

removing the collecting swab from the oral cavity;

transferring the sample from the collecting swab to an enzyme electrode off site of the patient;

sensing an electric current produced by the enzyme electrode in response to the sample and displaying the sensed electric current to indicate glucose level.

2. The method of claim 1, in which the collecting swab is placed in contact with a surface of the oral cavity at the junction of the superior labial mucous membrane and the superior gingivae between the upper canine teeth.

3. The method of claim 1, in which the collecting swab is an open cell foam material with a cell size in the order of 0.3 mm in diameter.

4. The method of claim 3, in which the collecting swab is secured to a piston that rides in a cylinder open at one end and having a small hole at the other end, the transferring step comprising pushing the piston against the other end of the cylinder to squeeze the sample through the small hole.

5. A method for monitoring glucose comprising the steps of:

applying to an enzyme electrode a sample of glucose level indicative oral fluid taken from a surface of the oral cavity of a patient at the junction of the superior labial mucous membrane and the superior gingivae between the upper canine teeth;

sensing the electric current produced by the enzyme electrode in response to the sample; and

displaying the sensed electric current to indicate glucose level.