DIAGNOSTIC DEVICE AND METHOD FOR SENSING HYDRATION STATE OF A MAMMALIAN SUBJECT

• US 20120289863A1
• Filed: 07/03/2012
• Published: 11/15/2012
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: HydraDx, Inc.
• Original Assignee: HydraDx, Inc.
• Inventors: Goldstein, Andrew S., Bellizzi, Frank
• Granted Patent: US 8,611,992 B2
• Time in Patent Office: Days
• 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 2562/029 Humidity sensors
• CPC Class Codes: A61B 5/4277 saliva secretion
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence

Abstract

Timed sensing of collection of saliva in a liquid collection element of predetermined volumetric capacity may be used to determine salivary secretion rate, as may be indicative of state of euhydration or dehydration. Sensing of salivary flow rate may be further augmented by sensing concentration of at least one analyte in saliva (e.g., with an immunochromatographic assay performed in a lateral flow device) in order to determine a state of euhydration or dehydration. Production of saliva may be stimulated, and collected saliva may be analyzed to generate an analyte detection signal that indicative of presence and/or correlative of concentration of at least one analyte in the collected saliva to sense a state of euhydration or dehydration.

Claims

1. An apparatus for sensing a state of euhydration, state of dehydration, or salivary secretion rate of a mammalian subject, the apparatus comprising:

a liquid collection element comprising a hydrophilic, porous medium or fibrous medium arranged for placement in fluid communication with oral mucosa of a mammalian subject;

a plurality of electrical contacts arranged to detect saturation of portions of the liquid collection element;

a microprocessor arranged to receive signals indicative of closure of a plurality of electrical circuits including the plurality of electrical contacts, and to identify a state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject based at least in part on signals received from the plurality of electrical circuits; and

a signaling element in communication with the microprocessor and arranged to generate an output signal indicative of state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject.

2. An apparatus according to claim 1, comprising a substrate arranged to support or engage the liquid collection element, wherein the plurality of electrical contacts are arranged on or over the substrate.

3. An apparatus according to claim 1, wherein the plurality of electrical contacts is arranged between the substrate and the liquid collection element, and the plurality of electrical contacts is arranged to detect saliva absorbed by or migrated through the liquid collection element.

4. An apparatus according to claim 1, wherein various circuits of the plurality of electrical circuits are arranged to be closed upon exposure to saliva transmitted through different portions of the liquid collection element.

5. An apparatus according to claim 1, wherein the plurality of contacts includes a plurality of contact pairs arranged to be closed in sequence upon migration of saliva through different portions of the liquid collection element.

6. An apparatus according to claim 1, wherein the microprocessor is arranged to identify a state of state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject based at least in part on a time period within which closure of various electrical circuits of the plurality of electrical circuits is completed.

7. An apparatus according to claim 1, comprising a removable cover arranged over at least a portion of the liquid collection element.

8. An apparatus according to claim 1, wherein the signaling element comprises a display.

9. An apparatus according to claim 1, wherein the signaling element comprises an audible signal output element.

10. An apparatus according to claim 1, comprising a sampling portion and a monitoring portion, wherein the liquid collection element is arranged in the sampling portion, wherein each of the microprocessor and the signaling element is arranged in the monitoring portion, and wherein the sampling portion is operatively connected to the monitoring portion via at least one of an electrical communication cable, an electrical connector, and a wireless communication element.

11. A method utilizing the apparatus of claim 1 for sensing a state of euhydration, state of dehydration, or salivary secretion rate of a mammalian subject.

12. A method according to claim 11, further comprising use of the output signal to diagnose a disease state of the mammalian subject.

13. A method according to claim 12, wherein the disease state includes hyposalivation as a symptom thereof.

14. A method according to claim 11, further comprising use of the output signal to detect a side effect of drug interaction with the mammalian subject.

15. A method according to claim 14, wherein use of the output signal to detect a side effect of drug interaction comprises comparison of the output signal or information derived therefrom with at least one reference value or reference value range correlative of the side effect of drug interaction.

16. A method according to claim 11, further comprising performing an assay utilizing saliva collected with the liquid collection element to generate a quantitative or qualitative output signal based on concentration of at least one analyte in the saliva.

17. A method according to claim 16, wherein the assay comprises an immunochromatographic assay.

18. A method for sensing a state of euhydration or dehydration of a mammalian subject, the method comprising:

placing at least a portion of a liquid collection element comprising a hydrophilic porous medium or fibrous medium in contact with oral mucosa of the mammalian subject;

detecting presence of saliva at first, second, and third positions along or adjacent to the liquid collection element with respect to time while the at least a portion of the liquid collection element is in contact with oral mucosa of the mammalian subject to close a plurality of electrical circuits; and

generating an output signal indicative of state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject based at least in part on the sensing of closure of the plurality of electrical circuits with respect to a period of time.

19. An apparatus for sensing a state of euhydration, state of dehydration, or salivary secretion rate of a mammalian subject, the apparatus comprising:

a liquid collection element arranged for placement in fluid communication with oral mucosa of a mammalian subject;

a substrate arranged to support or engage the liquid collection element, with the substrate having arranged thereon a plurality of electrical contacts including (a) electrical contacts arranged to close a first electrical circuit upon exposure to saliva when the liquid collection element is placed in fluid communication with oral mucosa of the mammalian subject, and (b) electrical contacts arranged to close at least a second electrical circuit upon exposure to saliva transported though at least a portion of the liquid collection element;

a microprocessor arranged to receive signals indicative of closure of the first electrical circuit and closure of the at least a second electrical circuit, and to identify a state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject based at least in part on signals received from the first electrical circuit and the at least a second electrical circuit; and

a signaling element in communication with the microprocessor and arranged to generate an output signal indicative of state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject.

20. An apparatus according to claim 19, wherein the microprocessor is arranged to identify a state of state of euhydration, state of dehydration, or salivary secretion rate of the mammalian subject based at least in part on a time period within which closure of the first electrical circuit is completed and closure of at least a second electrical circuit is completed.