Continuous analyte monitoring system

• US 9,814,389 B2
• Filed: 12/23/2014
• Issued: 11/14/2017
• Est. Priority Date: 12/31/2013
• Status: Active Grant

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Inventors: DeHennis, Andrew
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/580,289
• Publication Number:
  US 20150182115A1
• Time in Patent Office: 1,057 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 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 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

An improved analyte monitoring system having a sensor and a transceiver with improved communication and/or user interface capabilities. The transceiver may communicate with and power the sensor. The transceiver may receive one or more analyte measurements from the sensor and may calculate one or more analyte concentrations based on the received analyte measurements. The transceiver may generate analyte concentration trends, alerts, and/or alarms based on the calculated analyte concentrations. The system may also include a display device, which may be, for example, a smartphone and may be used to display analyte measurements received from the transceiver. The display device may execute a mobile medical application. The system may include a data management system, which may be web-based.

Claims

1. A system for detecting an amount or concentration of an analyte in vivo within a living organism, the system comprising:

(A) an analyte sensor comprising;

(A1) an analyte indicator configured to exhibit a detectable property based on the amount or concentration of the analyte in proximity to the analyte indicator;

(A2) sensor elements configured to generate a data signal based on the detectable property exhibited by the analyte indicator; and

(A3) a transceiver interface device configured to receive a power signal and generate power for powering the sensor elements and to convey data signals generated by the sensor elements;

(B) a transceiver comprising;

(B1) a sensor interface device configured to convey the power signal to the transceiver interface device of the analyte sensor and to receive data signals conveyed by the transceiver interface device of the analyte sensor;

(B2) a processor configured to;

calculate analyte concentrations based on the received data signals,

calculate analyte concentration trends based on the calculated analyte concentrations,

generate alerts or alarms based on the calculated analyte concentrations and the calculated analyte concentration trends, and

perform an analyte concentration calibration based on one or more user-entered calibration points; and

(B3) a display interface device configured to convey the calculated analyte concentrations and the calculated analyte concentration trends to a display device and receive the one or more user-entered calibration points from the display device, wherein the display interface comprises a wireless communication circuit configured to wirelessly convey the calculated analyte concentrations, the calculated analyte concentration trends, and the generated alerts or alarms to the display device; and

(C) a display device configured to receive the analyte concentrations and the calculated analyte concentration trends conveyed by the display interface device of the transceiver, to display the received analyte concentrations and the calculated analyte concentration trends, and to facilitate user entry of the calibration points.

2. The system of claim 1, wherein the analyte sensor is an implantable sensor.

3. The system of claim 1, wherein the display device is a smartphone.

4. The system of claim 1, wherein the wireless communication circuit employs a wireless communication standard to wirelessly convey the calculated analyte concentrations.

5. The system of claim 4, wherein the wireless communication standard is a Bluetooth standard.

6. The system of claim 1, wherein the transceiver does not display the calculated analyte concentrations.

7. The system of claim 1, wherein the display device is configured to upload the received analyte concentrations to a web-based data management system.

8. The system of claim 7, further comprising the web-based data management system.

9. The system of claim 1, wherein the analyte sensor further comprises a sensor housing, and the sensor elements and transceiver interface device are contained within the sensor housing.

10. The system of claim 1, wherein the detectable property is an optical property.

11. The system of claim 1, wherein the sensor elements comprise a light source and a photodetector.

12. The system of claim 1, wherein the analyte is glucose.

13. The system of claim 1, wherein the transceiver interface device of the analyte sensor is an antenna configured to wirelessly receive the power signal from the transceiver and to wirelessly convey the data signals generated by the sensor elements, and the sensor interface device of the transceiver is an antenna configured to wirelessly convey the power signal to the antenna of the analyte sensor and to receive the data signals from the antenna of the analyte sensor.

14. The system of claim 13, wherein the antennas of the analyte sensor and transceiver are inductive elements.

15. The system of claim 1, wherein the sensor interface device of the transceiver and the transceiver interface device of the analyte sensor are a wire connected through a transdermal needle tip.

16. The system of claim 1, wherein the transceiver is external.

17. The system of claim 1, wherein the transceiver is internal.

18. The system of claim 1, wherein the transceiver does display the calculated analyte concentrations.

19. The system of claim 18, wherein the transceiver displays the calculated analyte concentrations via an LCD or LED.

20. A system for detecting an amount or concentration of an analyte in vivo within a living organism, the system comprising:

(A) an analyte sensor comprising;

(A1) an analyte indicator configured to exhibit a detectable property based on the amount or concentration of the analyte in proximity to the analyte indicator;

(A2) sensor elements configured to generate a data signal based on the detectable property exhibited by the analyte indicator; and

(A3) a transceiver interface device configured to receive a power signal and generate power for powering the sensor elements and to convey data signals generated by the sensor elements;

(B) a transceiver comprising;

(B1) a sensor interface device configured to convey the power signal to the transceiver interface device of the analyte sensor and to receive data signals conveyed by the transceiver interface device of the analyte sensor; and

(B2) a display interface device configured to convey the received data signals to a display device; and

(C) a display device configured to;

receive the data signals conveyed by the display interface device of the transceiver,

calculate analyte concentrations based on the received data signals,

calculate analyte concentration trends based on the calculated analyte concentrations,

generate alerts or alarms based on the calculated analyte concentrations and the calculated analyte concentration trends,

display the calculated analyte concentrations and the calculated analyte concentration trends,

perform an analyte concentration calibration based on one or more user-entered calibration points, and

facilitate user entry of the calibration points.

21. The system of claim 20, wherein the display device is a smartphone.

22. The system of claim 20, wherein the display device is configured to upload the calculated analyte concentrations to a web-based data management system.

23. The system of claim 22, further comprising the web-based data management system.