IP Library › Granted Patent US 11,147,483
Granted Patent B2
US 11,147,483 · App. 16/177,269 · Granted Oct 19, 2021

Polymer membranes for continuous analyte sensors

Inventors: Robert J. Boock (Carlsbad, CA); Monica A. Rixman (Medford, MA); Huashi Zhang (San Diego, CA); Michael J. Estes (Poway, CA); Kristina Lawrence (Escondido, CA)
Assignee: DexCom, Inc.
A61B5/14865A61B5/1468A61B5/1473A61B5/1486A61B5/14532A61B5/14546C12Q1/006G01N27/40A61B5/7203B33Y70/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,147,483
App. No.
16/177,269
Granted
Oct 19, 2021
Kind
B2
Abstract

Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Claims (37)

1. A sensor for continuous measurement of an analyte concentration, the sensor comprising:

an electrode configured to continuously measure a signal associated with the analyte concentration in a host; and

a membrane located over the electrode, wherein the membrane comprises:

a first domain comprising an enzyme; and

a second domain located over the first domain, wherein the second domain is configured to reduce a flux of the analyte therethrough;

wherein the sensor is configured to provide, at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of no more than 10% over a sensor session of at least 10 days, and wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

2. The sensor of claim 1 , wherein the mean absolute relative difference is no more than about 7% over the sensor session.

3. The sensor of claim 1 , wherein the enzyme is configured to react with the analyte.

4. The sensor of claim 1 , wherein the membrane comprises a copolymer comprising a fluorocarbon segment.

5. The sensor of claim 1 , wherein the membrane comprises a copolymer comprising a silicone segment.

6. The sensor of claim 1 , wherein the membrane comprises a polycarbonate segment.

7. The sensor of claim 1 , wherein the electrode is in contact with the first domain.

8. The sensor of claim 1 , wherein the electrode is configured to measure hydrogen peroxide.

9. The sensor of claim 1 , wherein the membrane is disposed over a planar surface.

10. The sensor of claim 1 , wherein the sensor is configured to be calibrated based on a correlation between an in vivo sensor sensitivity and an in vitro sensor sensitivity.

11. The sensor of claim 1 , wherein the sensor is configured to be calibrated based on a ratio between an in vivo sensitivity and an in vitro sensitivity, wherein the ratio is from about 1 to 1.5 to about 1 to 10.

12. The sensor of claim 1 , wherein the sensor is configured to be calibrated based on a ratio between an in vivo sensitivity and an in vitro sensitivity, wherein the ratio is from about 1 to 0.1 to about 1 to 0.7.

13. A system for continuous measurement of an analyte concentration, the system comprising:

a sensor comprising:

a sensing region configured to continuously produce sensor data associated with the analyte concentration in a host; and

a membrane located over the sensing region, wherein the membrane comprises:

a first domain comprising an enzyme; and

a second domain disposed over the first domain, wherein the second domain is configured to reduce a flux of the analyte therethrough;

a processor configured to process continuous sensor data; and

a user interface configured to display information associated with the continuous sensor data;

wherein the sensor is configured to provide, at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of no more than about 10% over a sensor session of at least 10 days, and wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

14. The system of claim 13 , wherein the mean absolute relative difference is no more than about 7% over the sensor session.

15. The system of claim 13 , wherein the enzyme is configured to react with the analyte.

16. The system of claim 13 , wherein the membrane comprises a copolymer comprising a fluorocarbon segment.

17. The system of claim 13 , wherein the membrane comprises a copolymer comprising a silicone segment.

18. The system of claim 13 , wherein the membrane comprises a polycarbonate segment.

19. The system of claim 13 , wherein the sensing region is in contact with the first domain.

20. The system of claim 13 , wherein the sensing region is configured to measure hydrogen peroxide.

21. The system of claim 13 , wherein the membrane is disposed over a planar surface.

22. The system of claim 13 , wherein the sensor is configured to be calibrated based on a correlation between an in vivo sensor sensitivity and an in vitro sensor sensitivity.

23. The system of claim 13 , wherein the sensor is configured to be calibrated based on a ratio between an in vivo sensitivity and an in vitro sensitivity, wherein the ratio is from about 1 to 1.5 to about 1 to 10.

24. The system of claim 13 , wherein the sensor is configured to be calibrated based on a ratio between an in vivo sensitivity and an in vitro sensitivity, wherein the ratio is from about 1 to 0.1 to about 1 to 0.7.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2021
From: BOOCK, ROBERT; RIXMAN, MONICA A.; ZHANG, HUASHI; ESTES, MICHAEL J.; LAWRENCE, KRISTINA
To: DEXCOM, INC.
Reel/Frame 056384/0066 →
Continuity (8)
Continuation 15611692 · Jun 1, 2017
Continuation 14742137 · Jun 17, 2015
Continuation 14517663 · Oct 17, 2014
Continuation 14058154 · Oct 18, 2013
Continuation 12718299 · Mar 5, 2010
Continuation In Part 12413231 · Mar 27, 2009
Provisional Application 61040594 · Mar 28, 2008
Related Publication 20190069826A1 · Mar 7, 2019
Cited By (1)
US 12,507,921