TRANSCUTANEOUS ANALYTE SENSOR

• US 20110077490A1
• Filed: 09/29/2010
• Published: 03/31/2011
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Bohm, Sebastian, Boock, Robert, Brauker, James H., Simpson, Peter C., Neale, Paul V.
• Granted Patent: US 9,357,951 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

A transcutaneous sensor device configured for continuously measuring analyte concentrations in a host is provided. In some embodiments, the transcutaneous sensor device 100 comprises an in vivo portion 160 configured for insertion under the skin 180 of the host and an ex vivo portion 170 configured to remain above the surface of the skin 180 of the host after sensor insertion of the in vivo portion. The in vivo portion may comprise a tissue piercing element 110 configured for piercing the skin 180 of the host and a sensor body 120 comprising a material or support member 130 that provides sufficient column strength to allow the sensor body to be pushable in a host tissue without substantial buckling. The ex vivo portion 170 may be configured to comprise (or operably connect to) a sensor electronics unit and may comprise a mounting unit 150. Also described here are various configurations of the sensor body and the tissue piercing element that may be used to protect the membrane of the sensor body.

Claims

1. A sensor device for measuring an analyte concentration, the sensor device comprising:

a sensor unit comprising an in vivo portion having a tissue piercing element and a sensor body, the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode; and

a mounting unit configured to support the sensor device on an exterior surface of a host'"'"'s skin.

2. The sensor device of claim 1, wherein the mounting unit comprises a guiding portion configured to guide insertion of the in vivo portion of the sensor unit through the host'"'"'s skin and to support a column strength of the sensor unit such that the in vivo portion is capable of being inserted through the host'"'"'s skin without substantial buckling;

and wherein the guiding portion is configured to remain ex vivo during insertion of the in vivo portion of the sensor unit.

3. The sensor device of claim 2, wherein the tissue piercing element, with the support of the guiding portion, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling.

4. The sensor device of claim 1, wherein the tissue piercing element is configured to protect the membrane from damage during insertion of the in vivo portion of the sensor unit.

5. The sensor device of claim 1, wherein a largest dimension of a cross section transverse to a longitudinal axis of the tissue piercing element is greater than a largest dimension of a cross section transverse to a longitudinal axis of the sensor body.

6. The sensor device of claim 1, wherein the at least one electrode comprises a working electrode and a reference electrode.

7. The sensor device of claim 1, wherein the sensor body further comprises a support member configured to protect the membrane from damage during insertion of the sensor unit.

8. The sensor device of claim 7, wherein the at least one electrode is a support member.

9. The sensor device of claim 7, wherein the support member, with the support of a guiding member of the mounting unit, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling.

10. The sensor device of claim 7, wherein the support member is configured to support at least a portion of the at least one electrode.

11. The sensor device of claim 7, wherein the support member is configured to substantially surround the at least one electrode.

12. The sensor device of claim 1, wherein the mounting unit comprises a sensor electronics unit operatively and detachably connected to the sensor body.

13. The sensor device of claim 12, wherein the sensor electronics unit is configured to be located over a sensor insertion site.

14. A sensor array for measuring an analyte concentration, the sensor array comprising:

a laminate comprising an adhesive layer configured for adhering the laminate to a host'"'"'s skin; and

a plurality of sensor devices each attached to the laminate and each configured for insertion through the skin at a different insertion site, wherein each sensor device comprises a sensor unit and a mounting unit configured to support the sensor device on an exterior surface of the host'"'"'s skin, the sensor unit comprising an in vivo portion having a tissue piercing element and a sensor body, the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode.

15. The sensor array of claim 14, wherein the laminate comprises sensor electronics operatively connected to the sensor devices.

16. The sensor array of claim 14, wherein the plurality of sensor devices are configured to provide parallel measurements of analyte concentration.

17. The sensor array of claim 14, wherein the plurality of sensor devices comprises a first sensor device and a second sensor device, wherein the first sensor device is configured to measure analyte concentration at a first range of analyte concentrations and the second sensor device is configured to measure analyte concentration at a second range of analyte concentrations, wherein the first range is different from the second range.

18. The sensor array of claim 14, wherein the plurality of sensor devices comprises a first sensor device and a second sensor device, wherein the first sensor device comprises a first sensor body configured to reside in a host tissue at a first depth, wherein the second sensor device comprises a second sensor body configured to reside in the host tissue at a second depth, and wherein the first depth is different from the second depth.