Breath ketone detector

• US 8,871,521 B2
• Filed: 03/08/2012
• Issued: 10/28/2014
• Est. Priority Date: 03/08/2011
• Status: Active Grant

• Current Assignee: Akers Biosciences, Inc.
• Original Assignee: Akers Biosciences, Inc.
• Inventors: Akers, Raymond F. Jr.
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US13/415,624
• Publication Number:
  US 20120231548A1
• Time in Patent Office: 964 Days
• Field of Search: 436/128, 436/127, 422/430, 422/50
• US Class Current: 436/128
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0835 Ampoules
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 2800/02 Nutritional disorders
• CPC Class Codes: G01N 2800/18 Dental and oral disorders
• CPC Class Codes: G01N 33/18 Water
• CPC Class Codes: G01N 33/1826 Organic contamination in water
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10T 436/20 Oxygen containing
• CPC Class Codes: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing

Abstract

Ketoacidosis is an extreme and uncontrolled form of ketosis, which is a normal response to prolonged fasting. Embodiments of this invention test the ketone level of a patient by measuring the ketone bodies in breath condensation. Some embodiments include a device for medical testing comprising a hollow container, comprising powder mixture of sodium nitroferricyanide, ammonium sulfate and silica and a liquid including an ammonium hydroxide solution.

Claims

1. A device for medical testing for the presence of ketones in breath of a patient, comprising a hollow container, the hollow container containing:

a powder comprising

a powder reagent selected from the group consisting of sodium nitroferricyanide, dinitrophenyihydrazine, copper sulfate/potassium sodium tartrate, and combinations of any thereof; and

a powder component selected from the group consisting of sodium silicate, calcium sulfate, calcium chloride, montmorillonite clay, molecular sieves, phosphorous pentoxide, silica, cellulose, glass beads, poly(2,6-diphenylphenylene oxide polymer and combinations of any thereof; and

a liquid reagent solution comprising a strong base selected from the group consisting of an alkali hydroxide, an alkaline-earth metal hydroxide, and a combination of any thereof,

wherein the hollow container is configured such that the breath comes in contact with the powder after the patient blows into the hollow container, and the powder changes color upon exposure to the ketones and the liquid reagent solution.

2. The device of claim 1, wherein the powder further comprises ammonium sulfate.

3. The device of claim 2, wherein the powder further comprises a third powder component selected from the group consisting of glycine, lactose, disodium hydrogen phosphate, and combinations of any thereof.

4. The device of claim 1, wherein the powder comprises sodium nitroferricyanide in an amount of 0.36 mg to 36 mg, 20/50 grade silica in the amount of 10 mg to 1 g, and ammonium sulfate in an amount of 9.64 mg to 964 mg;

and the liquid reagent solution comprises ammonium hydroxide in an amount of 50 μ

L to 2000 μ

L of 15% to 30% aqueous solution.

5. The device of claim 1, wherein the powder is contained in a first ampoule, the liquid reagent solution is contained in a second ampoule, and the first and second ampoules are contained within the hollow container.

6. A method for testing for presence of ketones in breath of a patient using the device of claim 1, comprising:

exposing the powder to the breath of the patient;

contacting the powder with the liquid reagent solution to form a mixture; and

evaluating color of the mixture.

15. The device of claim 1, wherein the strong base is selected from the group consisting of ammonium hydroxide, lithium hydroxide, sodium hydroxide, potassium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, barium hydroxide, and combinations thereof.

7. A device for medical testing for the presence of ketones in breath of a patient, comprising a first ampoule and a second ampoule, wherein

the first and second ampoules are contained within a hollow container;

the first ampoule contains a powder comprising about 3.6 mg sodium nitroferricyanide, about 100 mg 20/50 grade silica, and about 96.4 mg ammonium sulfate; and

the second ampoule contains a liquid reagent solution comprising about 500 μ

L of about 22% ammonium hydroxide aqueous solution,

wherein the hollow container is configured such that the breath comes in contact with the powder after the patient blows into the hollow container, and the powder changes color upon exposure to the ketones and the liquid reagent solution.

8. A method for testing for presence of ketones in breath of a patient using the device of claim 7, comprising:

breaking the first ampoule;

exposing the powder to the breath by the patient blowing into the hollow container;

breaking the second ampoule;

contacting the powder with the liquid reagent solution to form a mixture; and

evaluating the color of the mixture.

9. A method for testing for presence of ketones in breath of a patient, comprising:

exposing a powder to the breath of the patient by the patient blowing into a hollow container containing the powder, wherein the powder comprises

a powder reagent selected from the group consisting of sodium nitroferricyanide, dinitrophenylhydrazine, copper sulfate/potassium sodium tartrate, and combinations of any thereof; and

a powder component selected from the group consisting of sodium silicate, calcium sulfate, calcium chloride, montmorillonite clay, molecular sieves, phosphorous pentoxide, silica, cellulose, glass beads, poly(2,6-diphenylphenylene oxide polymer and combinations of any thereof;

contacting the powder with a liquid reagent solution to form a mixture, wherein the liquid reagent comprises a strong base selected from the group consisting of an alkali hydroxide, an alkaline-earth metal hydroxide, and a combination of any thereof; and

evaluating color of the mixture.

10. The method of claim 9, wherein the powder is contained in a first ampoule, the liquid reagent solution is contained in a second ampoule, and wherein the first and second ampoules are contained within a hollow container.

11. The method of claim 10, further comprising:

breaking the first ampoule before exposing the powder to the breath, wherein exposing the powder to the breath comprises the patient blowing into the hollow container; and

breaking the second ampoule before contacting the powder with the liquid reagent solution.

12. The method of claim 9, wherein evaluating color of the mixture comprises comparing the color of the mixture to at least one reference color.

13. The method of claim 9, wherein the powder further comprises ammonium sulfate and silica.

14. The method of claim 13, wherein the powder comprises sodium nitroferricyanide in an amount of 0.36 mg to 36 mg, 20/50 grade silica in an amount of 10 mg to 1 g, and ammonium sulfate in an amount of 9.64 mg to 964 mg;

and the liquid reagent solution comprises ammonium hydroxide in an amount of 50 μ

L to 2000 μ

L of 15% to 30% aqueous solution.

16. The method of claim 9, wherein the strong base is selected from the group consisting of ammonium hydroxide, lithium hydroxide, sodium hydroxide, potassium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, barium hydroxide, and combinations thereof.