Analyte monitoring device and methods

• US 10,285,632 B2
• Filed: 07/25/2017
• Issued: 05/14/2019
• Est. Priority Date: 04/16/2010
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Feldman, Benjamin J., Liu, Zenghe, Cho, Hyun, Rush, Benjamin M.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US15/659,480
• Publication Number:
  US 20170319110A1
• Time in Patent Office: 658 Days
• Field of Search: 600345-366, 600309
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Claims

1. An apparatus for determining analyte concentration, comprising:

an analyte sensor configured to have a portion in fluid contact with an interstitial fluid under a skin layer, the analyte sensor including a working electrode and a counter electrode; and

an on-body electronics unit electrically coupled to the analyte sensor and comprising a housing with a plurality of electrical contacts, a first resistor-capacitor (RC) pair coupled between a first node and a second node, and a second RC pair coupled in series with the first RC pair between the second node and a third node,

wherein;

a first electrical contact of the plurality of electrical contacts of the on-body electronics unit is coupled to the first node, a second electrical contact of the plurality of electrical contacts of the on-body electronics unit is coupled to the second node, and a third electrical contact of the plurality of electrical contacts of the on-body electronics unit is coupled to the third node, and

the first node is coupled to the working electrode and the third node is coupled to the counter electrode such that a first voltage between the first electrical contact and the second electrical contact of the on-body electronics unit represents a real-time current analyte concentration level, a second voltage between the second electrical contact and the third electrical contact of the on-body electronics unit represents an average analyte concentration level over a period of time, and a difference between the first voltage and the second voltage represents a real-time trending of the analyte concentration level.

2. The apparatus of claim 1, wherein the first electrical contact, the second electrical contact, and the third electrical contact are concentrically positioned on the housing of the on-body electronics unit.

3. The apparatus of claim 2, wherein the second electrical contact is located in approximately a center of the first electrical contact and the third electrical contact.

4. The apparatus of claim 2, wherein the first electrical contact is located between the third electrical contact and the second electrical contact.

5. The apparatus of claim 2, wherein the third electrical contact has a greater radius than the first electrical contact.

6. The apparatus of claim 1, wherein the analyte sensor is a self-powered sensor.

7. The apparatus of claim 1, wherein the analyte sensor is a glucose sensor.

8. The apparatus of claim 1, wherein the on-body electronics unit includes one or more data processing components to perform one or more of filter, encode, store, or analyze one or more signals from the analyte sensor.

9. The apparatus of claim 8, wherein the one or more data processing components determines trend information based on an analyte concentration monitored by the analyte sensor.

10. The apparatus of claim 1, wherein the on-body electronics unit further comprises a temperature sensor configured to measure a body temperature near the analyte sensor, and the on-body electronics unit is configured to perform one or more of output the measured body temperature or calibrate measurement readings in association with an analyte concentration monitored by the analyte sensor.

11. A method of determining analyte concentration, comprising:

generating a first voltage between a working electrode and a counter electrode of an analyte sensor, the analyte sensor being configured to have a portion in fluid contact with an interstitial fluid under a skin layer; and

dividing the generated first voltage in an on-body electronics unit electrically coupled to the analyte sensor, the first voltage being divided between a first node, a second node, and a third node of the on-body electronics unit, the on-body electronics unit comprising a housing with a plurality of electrical contacts, a first resistor-capacitor (RC) pair coupled between the first node and the second node, and a second RC pair coupled in series with the first RC pair between the second node and the third node, the plurality of electrical contacts including a first electrical contact, a second electrical contact, and a third electrical contact;

providing a second voltage between the first electrical contact and the second electrical contact, the first electrical contact being coupled to the first node, the second electrical contact being coupled to the second node;

providing a third voltage between the second electrical contact and the third electrical contact, the third electrical contact being coupled to the third node,

wherein the first node is coupled to the working electrode and the third node is coupled to the counter electrode such that the second voltage between the first electrical contact and the second electrical contact of the on-body electronics unit represents a real-time current analyte concentration level, the third voltage between the second electrical contact and the third electrical contact of the on-body electronics unit represents an average analyte concentration level over a period of time, and a difference between the second voltage and the third voltage represents a real-time trending of the analyte concentration level.

12. The method of claim 11, wherein the first electrical contact, the second electrical contact, and the third electrical contact are concentrically positioned on the housing of the on-body electronics unit.

13. The method of claim 12, wherein the second electrical contact is located in approximately a center of the first electrical contact and the third electrical contact.

14. The method of claim 12, wherein the first electrical contact is located between the third electrical contact and the second electrical contact.

15. The method of claim 12, wherein the third electrical contact has a greater radius than the first electrical contact.

16. The method of claim 11, wherein the analyte sensor is a self-powered sensor.

17. The method of claim 11, wherein the analyte sensor is a glucose sensor.

18. The method of claim 11, wherein the on-body electronics unit includes one or more data processing components to perform one or more of filter, encode, store, or analyze one or more signals from the analyte sensor.

19. The method of claim 18, wherein the one or more data processing components determines trend information based on an analyte concentration monitored by the analyte sensor.

20. The method of claim 11, wherein the on-body electronics unit further comprises a temperature sensor configured to measure a body temperature near the analyte sensor, and the on-body electronics unit is configured to perform one of more of output the measured body temperature or calibrate measurement readings in association with an analyte concentration monitored by the analyte sensor.