Method and apparatus for non-invasive analysis of saliva

• US 7,993,283 B1
• Filed: 03/04/2009
• Issued: 08/09/2011
• Est. Priority Date: 07/23/2007
• Status: Expired due to Fees

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: Altschul, Randice Lisa
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/380,939
• Time in Patent Office: 888 Days
• Field of Search: 600/573, 600/580, 600/582, 600/584, 422 56- 58, 422/61, 435/287.7, 435/287.8, 435/287.9, 435/805, 435/810, 435/969, 435/970, 435/975, 436 63- 71, 436/808, 436/810, 436/823, 206/305, 206/459.1, 206/459.5, 206/804, 206/820, 206/828
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit

Abstract

A method and apparatus for non-invasive analysis of saliva includes a user friendly lolli-pop like apparatus that is self contained and provides the user with a method to obtain saliva by sucking or licking on the pop head, the saliva activates a color change reaction on the apparatus that results in a color visual response that can be compared to a color coded alphanumeric gauge for analysis in monitoring health conditions and concerns.

Claims

1. An apparatus for conducting a non-invasive analysis of saliva to determine the presence and the level of a certain constituent carried by the saliva, the apparatus comprising:

a flat card-like device having a flat configuration resembling a relatively thin card, the device including a base;

a visible gauge on the base, the visible gauge including an interpretation site and visible regions of different colors displayed upon the base adjacent the interpretation site;

a lolli-pop-like structure including a stem integrated with the base and a head integrated with the stem, the stem including a finger-grip, and the head including a receptor for the reception of a saliva sample;

the receptor being constructed of a material having a saliva-absorbing texture;

the stem being selectively pivoted by a user out of the flat configuration for placement at a first position wherein the head is spaced away from the base for placement of the head in juxtaposition with the user'"'"'s mouth to facilitate reception of the saliva sample in the receptor, and wherein the stem extends away from the base to expose the finger-grip for gripping by the user, and is pivoted subsequently to a second position wherein the stem is retracted toward the base and the head is inserted into the flat configuration to place the receptor of the head at the interpretation site, confined in juxtaposition with the visible gauge; and

a reagent carried by one of the head at the receptor and the base at the interpretation site, the reagent being capable of changing color in response to exposure to the certain constituent, such that upon placement of the stem in the first position, the finger-grip is available for gripping by the user, with the receptor exposed for receiving the saliva sample, and upon subsequent placement of the stem in the second position, the receptor is juxtaposed with the interpretation site, confined within the base, so that any change in color of the reagent in response to exposure of the reagent to the saliva sample will be visibly registered in side-by-side contiguity with the regions of different colors of the visible gauge for enabling a direct visual comparison of the change in color of the reagent with a corresponding color of a visible region of the visible gauge, thereby providing a directly readable indication of the presence and the level of the certain constituent in the saliva sample.

2. The apparatus of claim 1 wherein the analysis of the saliva sample is for a level of glucose concentration, and the reagent consists essentially of glucose oxidase and peroxidase, a buffer, a mixture of tetramethylbenzidine and syringaldazine, and non-reactive ingredients.

3. The apparatus of claim 1 wherein the analysis of the saliva sample is for a level of alcohol, and the reagent consists essentially of alcohol oxidase and peroxidase, a buffer, a stabilizer, tetratmethylbenzidine, and at least one of the group consisting of algin, methyl benzothiazolinone hydrazone hydrochloride, and dimethylaminobenzoic acid.

4. The apparatus of claim 1 wherein the analysis of the saliva sample is for a level of keto, and the reagent consists essentially of diaphorase, sodium nitroprusside, a buffer and at least one of the group consisting of nitroprusside and diazonium salt.

5. The apparatus of claim 1 wherein the analysis of the saliva sample is for the presence of a drug, and the reagent consists essentially of an ion exchange resin, at least one of the group consisting of dinitrophenyl and aryl hydrazine, and a stain selected from the group consisting of Dragendorff and ninhydrin.

6. The apparatus of claim 1 wherein the analysis of the saliva sample is for determining pregnancy, and the reagent consists essentially of a buffer and a phenyl derivative of N-acetyl-beta-D-glucosamine resulting from reaction to the presence of N-acetyl-beta-D-glucosaminidase at acid pH to yield phenol with a specific color alkaline pH.

7. The apparatus of claim 1 including a plurality of lolli-pop-like structures integrated with the base.

8. The apparatus of claim 1 wherein the lolli-pop-like structure is die-cut within the base and is bent out of and back into the base for use, and the gauge includes alphanumeric characters to enable calibration of the results of a particular saliva sample analysis.

9. The apparatus of claim 1 wherein the material of the receptor is an absorbent sponge like material.

10. The apparatus of claim 1 wherein the reagent is carried by the receptor.

11. The apparatus of claim 1 wherein the reagent is carried by the base at the interpretation site.

12. A method for conducting a non-invasive analysis of saliva to determine the presence and the level of a certain constituent carried by the saliva, the method comprising:

providing a flat card-like device having a flat configuration resembling a relatively thin card, the device including a base;

providing a visible gauge on the base, the visible gauge including an interpretation site and visible regions of different colors displayed upon the base adjacent the interpretation site;

providing a lolli-pop-like structure including a stem integrated with the base and a head integrated with the stem, the stem including a finger-grip, and the head including a receptor for the reception of a saliva sample, the receptor being constructed of a material having a saliva-absorbing texture;

pivoting the stem out of the flat configuration to a first position wherein the head is spaced away from the base to locate the head in juxtaposition with a user'"'"'s mouth for facilitating reception of the saliva sample in the receptor, and wherein the stem extends away from the base to expose the finger-grip for gripping by the user;

subsequently pivoting the stem to a second position wherein the stem is retracted toward the base and the head is inserted into the flat configuration to place the receptor of the head at the interpretation site, confined in juxtaposition with the visible gauge; and

providing a reagent carried by one of the head at the receptor and the base at the interpretation site, the reagent being capable of changing color in response to exposure to the certain constituent, such that upon placement of the stem in the first position, the finger-grip is available for gripping by the user, with the receptor exposed for receiving the saliva sample, and upon subsequent placement of the stem in the second position, the receptor is juxtaposed with the interpretation site, confined within the base, so that any change in color of the reagent in response to exposure of the reagent to the saliva sample is visibly registered in side-by-side contiguity with the regions of different colors of the visible gauge for enabling a direct visual comparison of the change in color of the reagent with a corresponding color of a visible region of the visible gauge, thereby providing a directly readable indication of the presence and the level of the certain constituent in the saliva sample.

13. The method of claim 12 wherein the analysis of the saliva sample is for a level of glucose concentration, and the reagent consists essentially of glucose oxidase and peroxidase, a buffer, a mixture of tetramethylbenzidine and syringaldazine, and non-reactive ingredients.

14. The method of claim 12 wherein the analysis of the saliva sample is for a level of alcohol, and the reagent consists essentially of alcohol oxidase and peroxidase, a buffer, a stabilizer, tetratmethylbenzidine, and at least one of the group consisting of algin, methyl benzothiazolinone hydrazone hydrochloride, and dimethylaminobenzoic acid.

15. The method of claim 12 wherein the analysis of the saliva sample is for a level of keto, and the reagent consists essentially of diaphorase, sodium nitroprusside, a buffer and at least one of the group consisting of nitroprusside and diazonium salt.

16. The method of claim 12 wherein the analysis of the saliva sample is for the presence of a drug, and the reagent consists essentially of an ion exchange resin, at least one of the group consisting of dinitrophenyl and aryl hydrazine, and a stain selected from the group consisting of Dragendorff and ninhydrin.

17. The method of claim 12 wherein the analysis of the saliva sample is for determining pregnancy, and the reagent consists essentially of a buffer and a phenyl derivative of N-acetyl-beta-D-glucosamine resulting from reaction to the presence of N-acetyl-beta-D-glucosaminidase at acid pH to yield phenol with a specific color alkaline pH.

18. The method of claim 12 wherein the reagent is provided carried by the head at the receptor.

19. The method of claim 12 wherein the reagent is provided carried by the base at the interpretation site.