Transcutaneous analyte sensor

• US 10,835,161 B2
• Filed: 02/12/2016
• Issued: 11/17/2020
• 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.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US15/042,967
• Publication Number:
  US 20160157766A1
• Time in Patent Office: 1,740 Days
• Field of Search: 600309, 600345-366
• 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 device for measuring an analyte concentration, the device comprising:

a sensor having a substantially circular cross section, the sensor configured to be inserted into a host, wherein the sensor comprises;

an in vivo portion, the in vivo portion forms a tissue piercing element at a distal end of the in vivo portion, the tissue piercing element configured to pierce a skin of the host,

at least one electrode, and

a biodegradable material surrounding at least a portion of the sensor, wherein the biodegradable material degrades after insertion into the host;

a membrane covering at least a portion of the at least one electrode, wherein the biodegradable material is configured to protect the membrane from damage during insertion of the sensor;

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

a spring configured to insert the sensor into the host, the spring urging the sensor toward the skin of the host; and

a retainer configured to hold the spring in a tensioned state and release the spring when the retainer is removed, causing the spring to move toward the skin of the host.

2. The device of claim 1, 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.

3. The device of claim 2, 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.

4. The device of claim 3, wherein the spring is pre-loaded prior to sensor insertion.

5. The device of claim 4, further comprising a retainer feature configured to maintain the spring in a tensioned state prior to sensor insertion.

6. The device of claim 3, wherein the spring is further configured to guide the sensor during sensor insertion.

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

8. The device of claim 1, wherein the sensor electronics are operatively and detachably connected to the sensor.

9. The device of claim 1, wherein the sensor electronics are configured to be located over a sensor insertion site.

10. The device of claim 1, 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.

11. The device of claim 1, further comprising a skin tensioner configured to stretch the skin surface to create an increase in tension at a point of sensor insertion.

12. The device of claim 11, wherein the skin tensioner has a shape that permits a skin to conform to a contour of the skin tensioner.

13. The device of claim 11, wherein the skin tensioner is configured to define an area of higher tension zone for sensor insertion.

14. The device of claim 11, wherein the skin tensioner comprises a circular cross-section.

15. The device of claim 11, wherein the skin tensioner is configured to displace skin outwards to increase tension at point of insertion.

16. The device of claim 11, wherein the skin tensioner is a component of the on-skin unit.

17. The device of claim 16, wherein the on-skin unit is configured to remain affixed to the skin.

18. The device of claim 11, wherein the skin tensioner comprises at least one of silicone, polyurethane, or neoprene.

19. The device of claim 11, wherein the skin tensioner is configured to conform to the contour of the skin surface.