System, method and apparatus with multiple reservoirs for in situ calibration of implantable sensors

• US 9,949,673 B2
• Filed: 07/21/2015
• Issued: 04/24/2018
• Est. Priority Date: 08/26/2014
• Status: Active Grant

• Current Assignee: Maxim Integrated Products, Inc. (Analog Devices, Inc.)
• Original Assignee: Maxim Integrated Products, Inc. (Analog Devices, Inc.)
• Inventors: Di Cristina, John F.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US14/805,330
• Publication Number:
  US 20160058343A1
• Time in Patent Office: 1,008 Days
• Field of Search: 600309, 600310, 600316, 600322, 600345, 600347, 600365, 600372
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

A subcutaneous sensor system includes a sensor, a plurality of reservoirs, a plurality of pumps, a mixer provided with a plurality of mixer inlets and a mixer outlet, and a controller having an input coupled to the sensor output and a plurality of control outputs coupled to the plurality of pumps and the mixer. In certain embodiments, the system further includes an enclosure for the reservoirs, the pumps, the mixer and the controller, e.g. in the form of a skin patch or in the form of an implantable enclosure. In certain embodiments, the sensor is external to the enclosure and implanted beneath the skin tissue.

Claims

1. A subcutaneous sensor system with multiple reservoirs for calibrating solutions comprising:

a sensor having a sensor output;

a plurality of reservoirs provided with a corresponding plurality of reservoir outlets, wherein there are N reservoirs and N reservoir outlets;

a plurality of pumps provided with a corresponding plurality of pump inlets and a corresponding plurality of pump outlets, wherein the plurality of pump inlets are coupled to the plurality of reservoir outlets, wherein there are N pumps, N pump inlets and N pump outlets, wherein the N pump inlets are coupled to the N reservoir outlets, and wherein a first reservoir of the plurality of reservoirs contains a first calibration solution and a second reservoir of the plurality of reservoirs contains a second calibration solution different from the first calibration solution;

a mixing valve provided with a plurality of mixing valve inlets and a mixing valve outlet, wherein the plurality of mixing valve inlets comprise N mixing valve inlets that are coupled to the N pump outlets and wherein the first calibration solution and the second calibration solution are mixed in the mixing valve to provide a third calibration solution that is intermediate to the first calibration solution and the second calibration solution; and

a controller having an input coupled to the sensor output and a plurality of control outputs coupled to the plurality of pumps and the mixing valve, wherein the plurality of control outlets include N control outlets coupled to the N pumps, whereby the controller can controls the plurality of pumps and the mixing valve to provide a plurality of different calibration solutions at the mixing valve outlet.

2. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 1 further comprising an enclosure for the reservoirs, the pumps, the mixing valve and the controller.

3. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 2 wherein the enclosure comprises a skin patch.

4. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 2 wherein the enclosure is implanted beneath skin tissue.

5. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 2 wherein the sensor is external to the enclosure and is implanted beneath skin tissue.

6. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 1 wherein the controller comprises a microcontroller unit (MCU).

7. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 6 wherein the MCU includes digital memory.

8. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 6 wherein the controller further comprises a sensor analog front end (AFE) coupling the MCU to the sensor.

9. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 8 wherein the sensor is coupled to the AFE with a conductor.

10. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 9 wherein the conductor is at least partially enclosed within a tube connected to the mixer outlet.

11. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 6 wherein the controller further includes a data interface coupled to the MCU.

12. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 6 wherein the controller further includes an auto-calculation (Autocal) controller coupling the MCU to the plurality of pumps and to the mixing valve.

13. A subcutaneous sensor system with multiple reservoirs for calibration solutions as recited in claim 1 wherein the first calibration solution is chosen to be proximate a first end of a linear operating region of the sensor and the second calibration solution is chosen to be proximate a second end of the linear operating region of the sensor.

14. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 1 further comprising a third reservoir for a cleaning solution.

15. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 1 wherein the mixing valve is one of a plurality of mixing valves.

16. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 1 wherein the controller comprises an integrated circuit.

17. A subcutaneous sensor system with multiple reservoirs for calibrating solutions comprising:

an enclosure;

a tube having a first end disposed within the enclosure and a second end disposed outside of the enclosure;

a sensor disposed proximate to the second end of the tube and having a sensor output;

a conductor at least partially enclosed within the tube and having a first end and a second end, the first end being coupled to the sensor output;

a plurality of reservoirs disposed within the enclosure and provided with a corresponding plurality of reservoir outlets, wherein there are N reservoirs and N reservoir outlets, wherein a first reservoir of the plurality of reservoirs contains a first calibration solution and a second reservoir of the plurality of reservoirs contains a second calibration solution different from the first calibration solution;

a plurality of pumps disposed within the enclosure and provided with a corresponding plurality of pump inlets and a corresponding plurality of pump outlets, wherein the plurality of pump inlets are coupled to the plurality of reservoir outlets, wherein there are N pumps, N pump inlets and N pump outlets, wherein the N pump inlets are coupled to the N reservoir outlets;

a mixing valve disposed within the enclosure and provided with a plurality of mixing valve inlets and a single mixing valve outlet coupled to the first end of the tube, wherein the plurality of mixing valve inlets comprise N mixing valve inlets that are coupled to the N pump outlets, and wherein the first calibration solution and the second calibration solution are mixed in the mixing valve to provide a third calibration solution that is intermediate to the first calibration solution and the second calibration solution; and

a microcontroller unit (MCU) disposed within the enclosure and having an input coupled to the second end of the conductor and a plurality of control outputs coupled to the plurality of pumps and the mixing valve, wherein the plurality of control outlets include N control outlets coupled to the N pumps.

18. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 17 wherein the enclosure comprises a skin patch.

19. A subcutaneous sensor system with multiple reservoirs for calibrating solutions as recited in claim 17 wherein the enclosure is adapted to be implanted beneath skin tissue.