METHODS, SYSTEM AND DEVICES FOR ANALYZING A BIOLOGICAL FLUID SAMPLE FOLLOWING ION EXCHANGE

• US 20110076776A1
• Filed: 05/20/2009
• Published: 03/31/2011
• Est. Priority Date: 05/20/2008
• Status: Active Grant

• Current Assignee: Cantimer, Inc.
• Original Assignee: Cantimer, Inc.
• Inventors: Dickerman-Stewart, Aaron, Stewart, Ray F.
• Granted Patent: US 8,426,207 B2
• Time in Patent Office: Days
• US Class Current: 436/71
• CPC Class Codes: B01J 39/04 Processes using organic exchangers
• CPC Class Codes: B01J 45/00 Ion-exchange in which a complex or a chelate is formed; Use of material as complex or chelate forming ion-exchangers; Treatment of material for improving the complex or chelate forming ion-exchange properties ion-exchange chromatography processes B01D15/36
• CPC Class Codes: G01N 1/4044 by chemical techniques; Digestion; Chemical decomposition
• CPC Class Codes: G01N 33/545 Synthetic resin
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/17 Nitrogen containing
• CPC Class Codes: Y10T 436/171538 Urea or blood urea nitrogen
• CPC Class Codes: Y10T 436/201666 Carboxylic acid

Abstract

Devices, methods and systems effective to evaluate a physical or chemical property of an ion exchange resin-treated biological fluid sample are provided.

Claims

1. A method for measuring a physical or chemical property of a biological fluid collected from a subject, comprising

a. treating a biological fluid sample with an ion exchange material;

b. contacting the ion exchange material-treated biological fluid sample with a sensor comprising a hydrogel responsive by a change in a physical or chemical property to the biological fluid sample;

c. evaluating a change in said physical or chemical property of said hydrogel in response to contact with said ion exchange material-treated biological fluid sample; and

d. correlating the change in said hydrogel sensor with a physical or chemical property of said biological fluid sample.

2. The method according to claim 1, wherein said biological fluid is selected from the group consisting of saliva, whole blood, plasma, serum, tear fluid, lymph, synovial fluid, urine, sputum, semen, vaginal lavage, bone marrow and cerebrospinal cord fluid.

3. The method according to claim 2, wherein said biological fluid is saliva.

4. The method according to claim 1, wherein the change in said physical or chemical property of said hydrogel is a change in volume, a change in optical density, a change in refractive index or a change in AC conductivity.

5. The method according to claim 1, wherein said hydrogel is a cross-linked hydrogel having a net negative charge.

6. The method according to claim 5, wherein said hydrogel is a cross-linked hydrogel comprised of a hydroxyalkyl acrylate, a hydroxyalkyl methacrylate, a vinyl ether, or a vinyl pyrrolidone.

7. The method according to claim 1, wherein said hydrogel comprises an anionic moiety selected from a carboxylate group, a sulfate group, a sulfonate group and a phosphate group.

8. The method according to claim 1, wherein said ion exchange material is a cation exchange resin.

9. The method according to claim 1, wherein said ion exchange material is a chelating resin.

10. The method according to claim 9, wherein said chelating resin comprises an iminodiacetic acid functionality.

11. The method according to claim 1, wherein said ion exchange material is selected from the group consisting of a water insoluble polymeric cation exchange resin, EDTA, oxalic acid, citric acid and a water soluble polyacrylate.

12. The method according to claim 1, wherein said treatment is effective to remove Ca²⁺ from the saliva.

13. The method according to claim 1, wherein the physical or chemical property of said biological fluid sample is a physical property selected from the group consisting of absorption at a given wavelength, density, electric conductivity, pH, osmolality, osmolarity, thermal transfer, viscosity, dielectric constant, refractive index and light scattering.

14. The method according to claim 13, wherein said physical property is osmolality.

15. The method according to claim 1, wherein said physical or chemical property of said biological fluid sample is a chemical property selected from the group consisting of the concentration of glucose, creatinine, urea, cortisol, total protein, total electrolytes, estrogen, progesterone, testosterone, a cation, e.g., sodium (Na⁺);

calcium (Ca²⁺);

potassium (K⁺), or magnesium (Mg²⁺);

an anion, e.g., chloride (Cl⁻

);

fluoride (Fl);

bromide (Br);

sulfate (SO₄²⁻

);

nitrate (NO₃⁻

);

carbonate (CO₃²⁻

); and

bicarbonate (HCO₃⁻

).

16. The method according to claim 1, wherein said evaluating comprises monitoring said hydrogel for a decrease in volume to detect a saliva osmolality.

17. The method according to claim 1, wherein said evaluating comprises monitoring the hydrogel for an increase in hydrogel volume to detect saliva osmolality.

18. A hydrogel sensor system for measuring a physical or chemical property of a biological fluid sample, comprising:

a cartridge for collecting and treating a biological fluid sample, said cartridge comprising a vessel defining an interior space having side walls, a bottom and a openable lid, said vessel containing an ion exchange material, wherein said vessel traps said biological fluid sample for mixing with said ion exchange material and is adapted for attachment to a device comprising a hydrogel sensor effective to measure a physical or chemical property of said biological fluid.

19. A hydrogel sensor system for measuring a physical or chemical property of a biological fluid sample, comprising:

a disposable cartridge for collecting and treating said biological fluid sample, comprising a vessel defining an interior space having side walls, a bottom and an openable lid, said vessel containing an ion exchange material and adapted to receive a biological fluid sample, said vessel having an aperture that is selectively opened or closed such that in the closed position the vessel retains the biological fluid sample and in the opened position the vessel allows the biological fluid sample to leave the vessel, wherein said cartridge is adapted for attachment to a device comprising a hydrogel sensor effective to measure a physical or chemical property of said biological fluid.

22. A device for collecting a biological fluid sample from a subject and measuring a physical or chemical property of said fluid, comprising:

(a) a movable microcantilever sensor having a known resistance corresponding to an initial position of the tip of said microcantilever;

(b) a hydrogel secured to a rigid substance and positioned against said microcantilever, wherein the change in a physical property of said hydrogel deflects said microcantilever resulting in a change in resistance;

(c) a hydrogel sensor system according to any one of claims 19-21 adapted to place a ion exchange medium-treated biological fluid sample in contact with said hydrogel; and

(d) a signaling component which creates a detectable signal in response to movement of the microcantilever.

23. The device according to claim 22, wherein said sensor is disposable.

20. A hydrogel sensor system for measuring a physical or chemical property of a biological fluid sample having a disposable cartridge for collecting and treating a biological fluid sample, said disposable cartridge comprising:

(a) a first compartment for collecting and storing said biological fluid sample defining an interior space having side walls, a bottom and a openable lid;

(b) a second compartment containing an ion exchange material and adapted to receive said biological fluid sample from said first compartment, wherein said biological fluid sample and said ion exchange material are combined in said second compartment to yield a ion exchange medium-treated sample; and

(c) a third compartment for storage and sampling of said ion exchange medium-treated sample, said third compartment having an aperture, selectively openable such that in the closed position the ion exchange medium-treated sample is retained in said third compartment and wherein in the opened position the ion exchange medium-treated sample may be transferred from said cartridge to a device comprising a hydrogel sensor effective to measure a physical or chemical property of said biological fluid.

21. A hydrogel sensor system for measuring a physical or chemical property of a biological fluid sample, having a disposable cartridge for collecting and treating a biological fluid sample, said disposable cartridge comprising:

a collection vessel having a first portion with a capillary channel adapted to receive a fluid sample therein, a second proportion comprising a chamber housing a ion exchange medium, wherein a septum between said first and second portions is penetrated by movement of a plunger having a mechanism for penetrating the septum wherein the contents of the ion exchange medium-containing chamber and the capillary channel are mixed, wherein said cartridge is adapted for attachment to a device for measuring a physical or chemical property of said biological fluid.