Devices capable of fluid sample concentration for extended sensing of analytes

• US 10,506,968 B2
• Filed: 04/30/2018
• Issued: 12/17/2019
• Est. Priority Date: 10/23/2015
• Status: Expired due to Fees

• Current Assignee: Epicore Biosystems, Inc.
• Original Assignee: Eccrine Systems Inc.
• Inventors: Heikenfeld, Jason, Bertrand, Jacob A., Brothers, Michael, Jajack, Andrew
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/966,476
• Publication Number:
  US 20180289296A1
• Time in Patent Office: 596 Days
• Field of Search: None
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0016 based on measurement of electric currents, e.g. conductivity tests
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/5308 for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The disclosed invention provides a fluid sensing device and method capable of collecting a fluid sample, concentrating the sample with respect to one or more target analytes, and measuring the target analyte(s) in the concentrated sample. The invention is also capable of determining the change in molarity of the fluid sample with respect to the target analyte(s), as the sample is concentrated by the device. The invention further includes a method for using a fluid sensing device to concentrate a fluid sample with respect to one or more target analytes. The disclosed method further includes the ability to correlate the measured target analyte concentration to a physiological condition of a device wearer, or of a fluid source.

Claims

1. A sensing device configured to receive a fluid sample, the sensing device comprising:

one or more first analyte sensors for measuring a characteristic of a first analyte in the fluid sample;

a sample concentrator configured to generate a concentrated form of the fluid sample to increase a first molarity of the first analyte within the fluid sample to a second molarity, wherein the second molarity is at least two times higher than the first molarity, the sample concentrator comprising a membrane that is permeable to liquid and impervious to the first analyte, the membrane having a first surface adjacent to the fluid sample and a second surface opposite the fluid sample;

a collector for collecting the fluid sample from a body of a sensing device wearer;

a channel for transporting the fluid sample from the collector to the sample concentrator, to the one or more sensors, and away from the one or more sensors.

2. The sensing device of claim 1, further comprising:

one or more second analyte sensors for measuring a second analyte in the fluid sample, and wherein the sample concentrator is further configured to concentrate the fluid sample to increase a third molarity of the second analyte within the fluid sample to a fourth molarity, wherein the fourth molarity is at least two times higher than the third molarity, and wherein the membrane is further configured to be impervious to the second analyte.

3. The sensing device of claim 2, wherein a ratio of the first molarity to the second molarity is substantially equal to a ratio of the third molarity to the fourth molarity.

4. The sensing device of claim 1, wherein the sample concentrator further comprises:

a pump configured to draw water and/or fluid sample-abundant solutes through the membrane to concentrate the fluid sample relative to the first analyte.

5. The sensing device of claim 4, further comprising:

an osmolality sensor configured to measure a total osmolality of the pump.

6. The sensing device of claim 1, further comprising:

a flow-rate sensor for measuring a rate of movement of the fluid sample through the sensing device, wherein the rate of movement is measured at one of the following;

prior to the sample concentrator, or after the sample concentrator.

7. The sensing device of claim 1, the one or more first analyte sensors further comprising:

a primary sensor and a secondary sensor, wherein the primary sensor has a dynamic range configured for use on a first concentration of the first analyte, and the secondary sensor has a dynamic range configured for use on a second concentration of the first analyte, wherein the second concentration is greater than the first concentration.

8. The sensing device of claim 1, further comprising:

an osmolality sensor configured to measure a total osmolality of the fluid sample.

9. The sensing device of claim 1, wherein the sample concentrator further comprises:

a concentrator channel including one of;

an increasing density gradient within the concentrator channel that is oriented in a direction of fluid sample flow, a plurality of different densities within the concentrator channel that create a stepped increasing density gradient oriented in the direction of fluid sample flow, and a plurality of pores configured to interact with the first analyte as the fluid sample flows through the concentrator channel.

10. The sensing device of claim 1, further comprising:

one or more of;

a sweat stimulation component comprising a chemical capable of sweat generation and an iontophoresis electrode, or a reverse iontophoresis component configured to move the fluid sample into the device.