TRANSCUTANEOUS ANALYTE SENSOR

• US 20160095542A1
• Filed: 12/14/2015
• Published: 04/07/2016
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Boock, Robert J., Bhm, Sebastian, Brauker, James H., Neale, Paul V.
• Granted Patent: US 10,667,733 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

1-20. -20. (canceled)

21. A direct-press insertion sensor device for measuring an analyte concentration, the device comprising:

an in vivo portion configured to be inserted through a skin of a host, the in vivo portion comprising at least one electrode and a membrane covering at least a portion of the at least one electrode; and

an ex vivo portion configured to support the sensor device on a surface of the skin of the host, the ex vivo portion comprising;

an upper surface comprising a flexible material configured to receive direct pressure from a user for insertion of the in vivo portion of the sensor device; and

a lower surface comprising an adhesive configured to adhere the ex vivo portion to the host'"'"'s skin.

22. The sensor device of claim 21, wherein the in vivo portion is configured to be inserted through the host'"'"'s skin without substantial buckling.

23. The sensor device of claim 21, wherein the in vivo portion is configured to withstand an axial load greater than about 1 Newton without substantial buckling.

24. The sensor device of claim 21, wherein the at least one electrode comprises a working electrode and a reference electrode.

25. The sensor device of claim 21, wherein the ex vivo portion comprises a sensor electronics unit operatively and detachably connected to the in vivo portion.

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

27. The sensor device of claim 21, wherein the upper surface comprises an elastomeric material.

28. The sensor device of claim 21, wherein the in vivo portion has a substantially circular or oval shape.

29. The sensor device of claim 21, wherein the ex vivo portion has a domed shape prior to sensor insertion.

30. The sensor device of claim 21, wherein the direct pressure is from a thumb or finger of a user.

31. The sensor device of claim 21, wherein the upper surface is configured to remain in a collapsed state after the insertion of the in vivo portion.

32. The sensor device of claim 21, wherein the in vivo portion comprises a sensor body and a tissue piercing element.

33. The sensor device of claim 21, wherein the ex vivo portion comprises a guiding portion configured to provide guidance and support to the in vivo portion as the in vivo portion is inserted through the skin of the host.

34. The sensor device of claim 21, wherein the ex vivo portion comprises a lock to prevent withdrawal of the in vivo portion after insertion.

35. The sensor device of claim 21, wherein the ex vivo portion comprises a self-containing sterile field, wherein prior to sensor insertion the in vivo portion is hidden inside the self-containing field skin and cannot be seen.