Saliva-monitoring biosensor electrical toothbrush

Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Means for analyzing liquid or solid sample

Reexamination Certificate

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C422S051000, C422S051000, C422S082010, C422S082020, C422S082050, C600S573000, C600S582000, C600S584000, C600S309000

Reexamination Certificate

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06623698

ABSTRACT:

BACKGROUND OF THE INVENTION
There is a growing need for a home diagnostic system for monitoring various personal physical health conditions and for the early detection of health problems. Such systems are typically used to determine fertility periods, pregnancy, labor onset, alcohol levels, glucose levels of diabetic persons and indicators that signal a need for comprehensive HIV testing. Home diagnostics systems are desirable because they are convenient to use and reduce health care costs.
(1) Field of the Invention
The present invention relates to saliva-monitoring oral devices including saliva-monitoring electrical toothbrushes.
(2) Related Art
Several patents describe various systems for collecting and diagnosing the contents of saliva. Some of the prior art diagnostic purposes and collection and testing procedures are summarized below.
Fertility, Pregnancy and Labor Onset Tests
U.S. Pat. No. 3,968,011 by Manautou et al. shows the use of optical density curves of saliva samples to indicate pregnancy. Such curves have a first peak and a smaller second peak in daily measurements; however, the second peak is eliminated when pregnancy occurs. In application, a paper test strip impregnated with a peroxidase and guaiac shows a color change when wet with saliva during the fertile period. The change is caused by the presence of peroxide in the saliva. The test strip is costly and may not be reused. U.S. Pat. No. 4,385,125 by Preti et al. monitors saliva for the concentration of certain long-chain alcohols, particularly dodecanol, for detecting ovulation. The dodecanol content of saliva remains at a relatively constant level throughout the menstrual cycle, but exhibits a single peak at the time of ovulation. Because the method is complicated, it is more suitable for laboratory tests than home use. Several commercially available hand held devices predict ovulation based on a measured peak in electrical resistance corresponding to sodium and potassium electrolyte levels which are reflective of hormone changes that occur several days before ovulation. The measured data on the changes of electrolytes in saliva may be inconsistent since an oral sensor probe is placed on the tongue where the thickness of the saliva layer may vary. While there are disadvantages associated with all of the above methods, each method demonstrates the feasibility of using an optical sensor or a conductivity sensor for measuring signals derived from a saliva sample to predict an ovulation period or pregnancy.
U.S. Pat. No. 5,480,776 by Dullien discloses a method for detecting the onset of labor by analyzing a body fluid, such as saliva, for estriol hormone concentration. The method correlates the estriol concentration with a standard value and relates the rate of increase of the concentration as an indicator of the onset of labor. A preferred assay utilizes an enzyme-labeled component in a competitive binding assay for estriol. In a typical assay, antibody is attached to a solid surface such as a porous reagent strip. The antibody-coated solid surface is then contacted simultaneously with a sample and with a competitive binding compound. After reaction, if sufficient estriol is present in the sample, then no enzyme is present to produce a color change (positive result). Otherwise, a change of color indicates the absence of estriol in the sample (negative result). This method is most effective when the rate of increase of estriol hormone is monitored on a daily or regular basis.
Alcohol Tests
Saliva may also be used to test blood alcohol level. Ethyl alcohol is a component of the blood that perfuses the salivary glands. The ethanol content of saliva has been determined through measurements to be about 9% higher than capillary blood alcohol content. However, U.S. Pat. No. 5,968,746 to Schneider et al. indicates a high correlation coefficient (r=97) between ethanol concentrations in simultaneously drawn blood and saliva samples. The test unit described in the patent uses a vacuum-packed ampoule containing dried enzyme, a solution swellable plug and a suitable colorimetric reagent. Since the test is activated by breaking the ampoule, it is not re-useable and the test is not suitable for home use. The test strip method of U.S. Pat. No. 4,786,596 to Adams, uses alcohol oxidase, peroxidase and a hydrogen donor indicator such as tetraalkalbengidine in a carrier matrix supported on the strip. The alcohol oxidase functions as a catalyst to convert any ethanol present along with ambient oxygen to acetaldehyde and hydrogen peroxide. The peroxidase functions as a catalyst to induce a color change in the hydrogen donor indicator and converts the hydrogen peroxide to water. Because this method requires the use of a color chart to visually identify the alcohol concentration, it is subject to interpretation errors. The test procedure does, however, confirm the effectiveness of testing alcohol concentration by using saliva.
Blood Glucose Tests
Efforts have been made to develop a noninvasive monitoring procedure for blood glucose using a saliva sample instead of drawing a test blood sample from a finger. U.S. Pat. No. 6,102,872 by Doneen et al. discloses that glucose concentration of oral fluid is approximately 0.5% to 1.0% of the contemporaneous blood concentration. The patent details the correlation between measured oral glucose level and the concentration of blood glucose. The patentee uses a small pore size membrane having sodium citrate mixed with citric acid for stimulating saliva secretion and collecting filtered saliva. The filtered saliva is in contact with a colorimetric glucose film. The film contains the enzymes glucose oxidase and horseradish peroxidase, and a combination of dyes and accessory reagents, such as buffers and stabilizers, for producing a colored spot or line with color intensity proportional to the glucose concentration in the saliva sample. In application, reflectance measurements by a spectrophotometer are converted into an estimated blood glucose value with the use of a computational chip in a monitor.
U.S. Pat. No. 5,500,374 by Wenzhi uses a UV detector and electrostatic ion chromatography to produce a chromatogram from a saliva sample. Diagnosis for diabetes mellitus is based on the presence or absence of a chromato-peak of the diabetes mellitus-specific component. Since the saliva sample is required to be injected into a stationary phase in a separation column, the method is not suitable for home use. In U.S. Pat. No. 4,105,522 to Friedenberg et al., the concentration level of glucose in saliva is determined by oxidizing a test sample with an oxidizing agent and measuring the electrical potential (in millivolts) of a primary cell in which the residual oxidizing solution is the electrolyte. U.S. Pat. No. 5,264,103 by Hoshioka, U.S. Pat. No. 5,997,817 by Crismore et al. and U.S. Pat. No. 6,004,441 by Fuziwara et al. use a dry reagent layer of specific chemical compositions and a biosensor of a special electrode arrangement for testing glucose concentration. The dry reagent layer is dissolved in a blood sample. The biosensor is not renewable, i.e. it can not be regenerated for subsequent use.
HIV Tests
Saliva is also used to test for HIV indicators. Advantages of using saliva samples instead of blood test samples are avoidance of costly handling and reduction in health risks to workers. While HIV is not known to be transmitted in saliva, it is present in saliva. A published research article, “The Diagnostic Uses of Saliva,” J. Oral Pathol. and Medicine, 19:119-125 (1990), suggests that saliva be used as a source for screening for anti-HIV antibodies. Furthermore, a commercial anti-HIV assay kit has been developed for the purpose of detecting anti-HIV antibodies in saliva. In U.S. Pat. No. 5,695,930 by Weinstein et al., a HIV test kit method for detecting anti-HIV-I antibodies in saliva is described. To enable confidentiality and convenience of frequent testing, the patent discloses an inexpensive assay kit for anti-HIV antibodies in saliva that can be personally performed at home without the

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