TRANSCUTANEOUS ANALYTE SENSOR

• US 20160157766A1
• Filed: 02/12/2016
• Published: 06/09/2016
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Boock, Robert J., Bohm, Sebastian, Brauker, James H., Neale, Paul V.
• Granted Patent: US 10,835,161 B2
• Time in Patent Office: Days
• 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

1-18. -18. (canceled)

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

a sensor configured to be inserted into a host, wherein the sensor comprises an in vivo portion, wherein the sensor comprises at least one electrode, wherein the sensor further comprises a membrane covering at least a portion of the at least one electrode;

an on-skin unit configured to support the sensor on an exterior surface of a host'"'"'s skin, wherein the on-skin unit comprises sensor electronics; and

a skin tensioner configured to stretch the skin surface to create an increase in tension at a point of sensor insertion.

20. The device of claim 19, wherein the on-skin unit comprises a guiding portion configured to guide insertion of the in vivo portion of the sensor through the host'"'"'s skin and to support a column strength of the sensor 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.

21. The device of claim 20, wherein the sensor, with the support of the guiding portion, is capable of withstanding an axial load greater than about 1 Newton without substantial buckling.

22. The device of claim 19, wherein the at least one electrode comprises a working electrode and a reference electrode.

23. The device of claim 19, wherein the sensor comprises a sensor body configured to protect the membrane from damage during insertion of the sensor.

24. The device of claim 19, wherein sensor electronics unit are operatively and detachably connected to the sensor.

25. The device of claim 19, wherein the sensor electronics unit is configured to be located over a sensor insertion site.

26. The device of claim 19, wherein the membrane is configured to be located between the at least one electrode and surrounding tissue after insertion of the in vivo portion of the sensor.

27. The device of claim 19, wherein the skin tensioner has a shape that permits a skin to conform to a contour of the sink tensioner.

28. The device of claim 19, wherein the skin tensioner is configured to define an area of higher tension zone for sensor insertion

29. The device of claim 19, wherein the skin tensioner comprises a circular cross-section.

30. The device of claim 19, wherein the skin tensioner is configured to displace skin outwards to increase tension at point of insertion.

31. The device of claim 19, wherein the skin tensioner is a component of the on-skin unit.