Systems and methods for measuring sodium concentration in saliva

• US 20060121548A1
• Filed: 11/08/2005
• Published: 06/08/2006
• Est. Priority Date: 11/09/2004
• Status: Abandoned Application

• Current Assignee: Remote Clinical Solutions, Inc.
• Original Assignee: Remote Clinical Solutions, Inc.
• Inventors: Hwang, Charles G., Robbins, David J.
• Application Number:
  US11/270,194
• Publication Number:
  US 20060121548A1
• Time in Patent Office: Days
• US Class Current: 435/18
• CPC Class Codes: C12Q 1/34 involving hydrolase
• CPC Class Codes: G01N 2333/924 acting on glycosyl compounds (3.2)
• CPC Class Codes: G01N 2800/04 Endocrine or metabolic disorders
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

Systems and methods for measuring saliva sodium concentration using a chromatographic reaction enable rapid-results, low-cost diagnosis of various medical conditions in an outpatient setting. In one embodiment, measured patient saliva sodium concentration is used by the patient or the patient'"'"'s healthcare provider to guide medical decision making. In another embodiment, measured patient saliva sodium concentration is processed to mechanically adjust the concentration of sodium in an aqueous solution to be delivered to the patient for oral administration. In yet another embodiment, a closed loop system measures saliva sodium concentration and uses any of a number of different types of feedback control systems to monitor and control the fluid and/or electrolyte state of the patient.

Claims

1. A measurement system comprising:

a sample collector adapted to collect a saliva sample;

a measurement device comprising a chromatography chamber and a chromatography buffer;

a solid phase chromatography medium, said medium having a labeling system which produces a visible label in the presence of sodium, and

wherein the sample collector is configured to deliver collected sample to the chromatography medium.

2. A measurement system as in claim 1, wherein the sample collector comprises an absorptive material selected from the group consisting of a bite-size sponge, a pad, a swab, or filter paper.

3. A measurement system as in claim 1, wherein the sample collector absorbs patient saliva as a result of a patient-initiated action such as licking, sucking, or applying saliva to the sample collector.

4. A measurement system as in claim 1, wherein the sample collector absorbs a dosed amount of saliva, thereby creating a dosed saliva sample.

5. A measurement system as in claim 4, wherein said dosed amount of saliva is subsequently expressed from the sample collector by squeezing or plunging or wringing or some other mechanical means.

6. A measurement system as in claim 1, wherein the sample collector absorbs a non-dosed amount of saliva.

7. A measurement system as in claim 6, wherein a portion of said non-dosed amount of saliva is subsequently removed by a secondary device, which squeezes or plunges or wrings a dosed amount of saliva from the sample collector, thereby creating a dosed saliva sample.

8. A measurement system as in claim 1, wherein the user is alerted visually when the sample collector has collected the minimum amount of saliva necessary to complete the measurement.

9. A measurement system as in claim 1, wherein the container is most often, but not necessarily, made of plastic, glass, aluminum, stainless steel, rubber, or some combination thereof.

10. A measurement system as in claim 1, wherein the container comprises a cup, tube, bladder, or box.

11. A measurement system as in claim 1, wherein the container is formed integrally with the sample collector.

12. A measurement system as in claim 1, wherein the container is reasonably attached to the sample collector.

13. A measurement system as in claim 1, wherein the container is reasonably detached from the sample collector.

14. A measurement system as in claim 1, wherein the container holds one or more chromatography chambers.

15. A measurement system as in claim 1, wherein the chromatography chamber(s) store a single dose, or a plurality of doses, of a chromatography buffer.

16. A measurement system as in claim 1, wherein a dose of the chromatography buffer is released from the chromatography chamber(s) for contact with the dosed saliva sample.

17. A measurement system as in claim 1, wherein a dose, or a plurality of doses, of the chromatography buffer are released from the chromatography chamber(s) for contact with one, or multiple, controls.

18. A measurement system as in claim 1, wherein the buffer is separated from the dosed saliva sample via a foil cover or other mechanical barrier.

19. A measurement system as in claim 16, wherein the release mechanism comprises piercing a foil cover or other pierceable member of the chromatography chamber;

mechanically or electronically moving or removing a physical barrier between the buffer and the dosed saliva sample or controls;

turning a dial;

transforming the state of the physical barrier between the buffer and the dosed saliva sample or controls, for example, from solid to liquid;

or pushing or pulling a lever or button.

20. A measurement system as in claim 1, wherein the chromatography buffer comprises a sodium-free, aqueous component, such as buffered DDI water or saliva matrix.

21. A measurement system as in claim 1, wherein the chromatography buffer includes a colorimetric substrate for beta-galactosidase.

22. A measurement system as in claim 1, wherein the chromatography buffer includes stabilizers, said stabilizers serving to preserve the enzymatic activity, and/or stabilize the buffer, and/or preserve the calorimetric substrate.

23. A measurement system as in claim 22, wherein the stabilizers comprise microcrystalline cellulose.

24. A measurement system as in claim 22, wherein the stabilizers comprise glycerol, said glycerol serving to stabilize the buffer and/or to prevent freezing.

25. A measurement system as in claim 1, wherein a solid phase chromatography medium contains immobilized beta-galactosidase.

26. A measurement system as in claim 1, wherein the solid phase chromatography medium contains constant or varying concentrations of the immobilized enzyme.

27. A measurement system as in claim 1, wherein the solid phase chromatography medium comprises Whatman paper, silica gel on a nitrocellulose backing, agarose gel, or other filter paper.

28. A measurement system as in claim 1, wherein the chromatography medium includes a colorimetric substrate for beta-galactosidase.

29. A measurement system as in claim 21, wherein the colorimetric substrate comprises X-Gal, ONPG, or other calorimetric substrates.

30. A measurement system as in claim 1, wherein the means for measuring saliva sodium concentration via a chromatographic reaction comprise combining a dosed saliva sample with a chromatography buffer, said combination providing the chromatographic impetus along the length of a solid phase chromatography medium.

31. A measurement system as in claim 1, wherein the means for measuring saliva sodium concentration via a chromatographic reaction comprise the binding of sodium ions in the dosed saliva sample with beta-galactosidase, said binding producing a colorimetric reaction via a colorimetric substrate for the enzyme.

32. A measurement system as in claim 1, wherein the means for measuring saliva sodium concentration via a chromatographic reaction comprise observing the distance along the length of the chromatography medium required to deplete the dosed saliva sample of sodium ions, said distance measured by physical markers, said markers calibrated according to the sodium concentration of the dosed saliva sample.

33. A measurement system as in claim 32, wherein the calibration of saliva sodium concentration may take a numerical form corresponding to standard saliva or plasma sodium concentrations (e.g. sodium concentration of 135 mEq/L), a numerical form which does not correspond to standard sodium concentrations (e.g. level 1, 2, 3), a qualitative form (e.g. high, normal, low), or a combination thereof.

34. The measurement system of claim 1, wherein the means for measuring saliva sodium concentration via a chromatographic reaction comprise one or more controls.

35. The measurement system of claim 1, wherein patient saliva sodium concentration data is wirelessly transmitted to the receiving system of a diagnostic, monitoring, or data processing device.

36. The measurement system of claim 35, wherein said wirelessly transmitted patient data is electronically processed and used to generate commands for a fluid and/or electrolyte delivery system.

37. A method for determining a level of dehydration in the patient, wherein the level of dehydration is based upon measured saliva sodium concentration.

38. A method for rehydrating a patient, said method comprising:

determining a level of dehydration in the patient; and

preparing a rehydration fluid by combining an amount of sodium with an aqueous component, wherein the amount of sodium is selected based on the determined level of dehydration.

39. A method as in claim 38, wherein the level of dehydration is based upon measured saliva sodium concentration.

40. A method as in claim 38, wherein the rehydration fluid is prepared by mechanically releasing a calibrated amount of sodium into an aqueous component in a drinking vessel.

41. A rehydration system comprising:

a measurement device which analyzes a patient sample to determine a level of rehydration; and

a drinking device which combines an aqueous component and an amount of an electrolyte selected based on the measured level of dehydration.