Polymer membranes for continuous analyte sensors

Patent metadata

Field	Value
Publication number	US-11730407-B2
Application number	US-202217583057-A
Country	US
Kind code	B2
Filing date	Jan 24, 2022
Priority date	Mar 28, 2008
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

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.

First claim

What is claimed is:

1. A sensor for measurement of an analyte, the sensor comprising:
an in vivo portion configured to be inserted within a body of a host, the in vivo portion comprising:
an electrode configured to measure a signal associated with an analyte concentration in the host; and
a membrane located over at least a portion of the electrode, wherein the membrane comprises an enzyme; and

an ex vivo portion configured to remain outside of the body of the host,
wherein the sensor is configured to be calibrated based on a correlation between an in vivo sensor sensitivity and an in vitro sensor sensitivity;
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of between 7% to 10% over a sensor session of anywhere between 1 to 30 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 between 8% to 9.5% 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 is disposed over a planar surface.

5. The sensor of claim 1 , wherein the in vivo sensitivity and the in vitro sensitivity have a ratio from about 1-to-1.5 to about 1-to-10.

6. The sensor of claim 1 , wherein the in vivo sensitivity and the in vitro sensitivity have a ratio from about 1-to-0.1 to about 1-to-0.7.

7. The sensor of claim 1 , wherein the correlation between the in vivo sensor sensitivity and the in vitro sensor sensitivity is due at least in part to consistent sensor manufacturing.

8. The sensor of claim 1 , wherein the membrane is configured to control a flux of the analyte therethrough.

9. A sensor for measurement of an analyte, the sensor comprising:
an in vivo portion configured to be inserted within a body of a host, the in vivo portion comprising:
an electrode configured to measure a signal associated with an analyte concentration in the host and
a membrane located over at least a portion of the electrode, wherein the membrane comprises an enzyme; and

an ex vivo portion configured to remain outside of the body of the host,
wherein the sensor is configured to be calibrated based on a correlation between an in vivo sensor sensitivity and an in vitro sensor sensitivity;
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of between 5% to 15% over a sensor session of anywhere between 1 to 30 days, and
wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 80 mg/dL, a second level of accuracy corresponding to a second mean absolute relative difference, the mean absolute relative difference being less than the second mean absolute relative difference.

10. A sensor for measurement of an analyte, the sensor comprising:
an electrode configured to measure a signal associated with an analyte concentration in a host;
an enzyme domain; and
a membrane in contact with the enzyme domain, wherein the membrane is located over at least a portion of the electrode, and wherein the membrane configured to reduce a flux of one or more interferents from reaching the enzyme domain,
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of between 7% to 10% over a sensor session of between 1 to 30 days, and
wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

11. The sensor of claim 10 , wherein the membrane is in contact with the electrode.

12. The sensor of claim 10 , wherein the membrane is configured to control a flux of the analyte therethrough.

13. The sensor of claim 10 , further comprising a potentiostat connected with the electrode and wherein the reducing the flux of one or more interferents from reaching the enzyme domain is due to application of a predetermined electrical potential to the electrode by the potentiostat.

14. The sensor of claim 10 , wherein the mean absolute relative difference is between 8% to 9.5% over the sensor session.

15. The sensor of claim 10 , wherein the enzyme domain comprises an enzyme configured to react with the analyte.

16. The sensor of claim 10 , wherein the membrane is disposed over a planar surface.

17. A sensor for measurement of an analyte, the sensor comprising:
an electrode configured to measure a signal associated with an analyte concentration in a host
an enzyme domain; and
a membrane in contact with the enzyme domain, wherein the membrane is located over at least a portion of the electrode, and wherein the membrane configured to reduce a flux of one or more interferents from reaching the enzyme domain,
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of between 5% to 15% over a sensor session of between 1 to 30 days, and
wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood
wherein the sensor is configured to provide, at analyte concentrations of from 40 mg/dL to 80 mg/dL, a second level of accuracy corresponding to a second mean absolute relative difference, the mean absolute relative difference being less than the second mean absolute relative difference.

Assignees

• Dexcom Inc

Inventors

• Boock Robert
• Rixman Swinney Monica
• Zhang Huashi
• Estes Michael J
• Lawrence Kristina

Classifications

• G06T12/10

  Image preprocessing, e.g. calibration, positioning of sources or scatter correction · CPC title

• G01N2015/016

  White blood cells · CPC title

• A61B5/14865 Primary

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• A61B5/1468

  using chemical or electrochemical methods, e.g. by polarographic means · CPC title

• A61B5/1473

  invasive, e.g. introduced into the body by a catheter · CPC title