Orthogonally redundant sensor systems and methods

Patent metadata

Field	Value
Publication number	US-11229384-B2
Application number	US-201816203951-A
Country	US
Kind code	B2
Filing date	Nov 29, 2018
Priority date	Sep 6, 2011
Publication date	Jan 25, 2022
Grant date	Jan 25, 2022

Abstract

A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values. The sensors' distal portions may be inserted into a user's body via a single delivery needle and may be co-located inside the user's body.

First claim

What is claimed is:

1. A continuous glucose monitoring system comprising:
an orthogonally redundant glucose sensor, comprising:
an optical glucose sensor including a light guide on a first substrate and having a proximal portion that is configured to be disposed externally to a body of a user and a distal portion configured for internal placement in the user's body, the optical glucose sensor having a first failure mode; and
a non-optical glucose sensor including at least one electrode on a second substrate and having a proximal portion that is configured to be disposed externally to the user's body and a distal portion configured for internal placement in the user's body, the non-optical glucose sensor having a second failure mode, wherein the first substrate and the second substrate are integrated into an integrated flex circuit, and wherein the light guide is disposed in an interior of the integrated flex circuit and the at least one electrode is disposed on an external surface of the integrated flex circuit;

a hand-held monitor having a display; and
an external transmitter having a housing that houses the proximal portion of the optical glucose sensor and the proximal portion of the non-optical glucose sensor, wherein the transmitter includes instrumentation configured to receive an optical signal from the optical sensor and a non-optical signal from the non-optical sensor and configured to convert each of said optical and non-optical signals to respective glucose values, and wherein the transmitter is configured to wirelessly transmit said respective glucose values.

2. The system of claim 1 , wherein the light guide includes a proximal portion that is configured to be disposed externally to the user's body and said distal portion that is configured for internal placement in the user's body.

3. The system of claim 2 , wherein the proximal portion of the optical fiber is optically coupled to an assay interrogating system.

4. The system of claim 3 , wherein the assay interrogating system is an optoelectronic interrogating system.

5. The system of claim 3 , wherein the interrogating system is a stacked planar integrated optical system (SPIOS).

6. The system of claim 2 , wherein the optical fiber has a circular cross-section having a diameter of between 200 μm and 500 μm.

7. The system of claim 2 , further including a glucose-permeable membrane, wherein the membrane has a closed end, a hollow interior, and an open end that is coupled to the optical fiber's distal portion.

8. The system of claim 7 , wherein the optical glucose sensor includes an assay having a glucose receptor, a glucose analog, and a first fluorophore.

9. The system of claim 8 , wherein the assay is housed in an assay compartment defined within the membrane's hollow interior and between the optical fiber's distal portion and the membrane's closed end.

10. The system of claim 9 , wherein the assay compartment is placed within tissue of the user.

11. The system of claim 10 , wherein the membrane is biodegradable.

12. The system of claim 8 , wherein the first fluorophore is water soluble.

13. The system of claim 1 , wherein the respective distal portions of the optical sensor and the non-optical sensor are co-located within the user's body.

14. The system of claim 1 , wherein the hand-held monitor includes an integrated blood glucose meter, and the transmitter wirelessly transmits said respective glucose values to the hand-held monitor.

15. The system of claim 14 , further including an insulin pump, wherein the transmitter wirelessly communicates with the insulin pump.

16. The system of claim 15 , wherein said glucose monitoring system is a closed-loop system.

17. The system of claim 1 , further including an insertion device including an insertion needle configured to simultaneously insert said optical glucose sensor and said non-optical glucose sensor into the user's body.

18. The system of claim 1 , wherein the non-optical glucose sensor is an electrochemical glucose sensor.

19. The system of claim 18 , wherein the electrochemical glucose sensor includes a plurality of electrodes.

20. The system of claim 1 , further comprising an insertion device including an insertion needle, wherein the integrated flex circuit is configured to be carried inside said needle for simultaneous insertion of said optical glucose sensor and said non-optical glucose sensor into the user's body.

Assignees

• Medtronic Minimed Inc

Inventors

• Shah Rajiv
• Kristensen Jesper Svenning
• Wolfe Katherine T
• Aasmul Soren
• Bansal Anubhuti

Classifications

• A61B5/6849

  in combination with a needle set · CPC title

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• G01N2021/7786

  Fluorescence · CPC title

• G01N21/6408

  with measurement of decay time, time resolved fluorescence · CPC title

• G01N2021/6484

  Optical fibres · CPC title