SENSORS FOR CONTINUOUS ANALYTE MONITORING, AND RELATED METHODS

• US 20160089068A1
• Filed: 12/08/2015
• Published: 03/31/2016
• Est. Priority Date: 10/12/2012
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Blackwell, Jennifer, Bhm, Sebastian
• Granted Patent: US 9,844,328 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: B21G 1/003 Needles for special purposes, e.g. knitting, crochet, hat-pins
• CPC Class Codes: B21G 1/006 Special treatments of pins or needles, e.g. annealing, straightening
• CPC Class Codes: B21G 1/12 Securing, cleaning-off burrs, reconditioning polishing, grinding takes precedence over B21G1/02 - B21G1/10
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

Sensor devices including dissolvable tissue-piercing tips are provided. The sensor devices can be used in conjunction with dissolvable needles configured for inserting the sensor devices into a host. Hardening agents for strengthening membranes on sensor devices are also provided. Methods of using and fabricating sensor devices are also provided.

Claims

1-20. -20. (canceled)

21. A sensor device for measuring an analyte concentration in a host, comprising:

an in vivo portion configured for insertion under a host'"'"'s skin, wherein the in vivo portion comprises at least one electrode and a membrane covering at least a portion of the at least one electrode, wherein the in vivo portion is encapsulated in a biodegradable material that biodegrades following insertion into the host; and

an ex vivo portion configured to remain above the host'"'"'s skin surface after insertion of the in vivo portion, wherein the ex vivo portion is configured to receive direct pressure from a user for insertion of the in vivo portion of the sensor device, wherein the ex vivo portion comprises an adhesive configured to adhere the ex vivo portion to the host'"'"'s skin.

22. The sensor device of claim 21, wherein the biodegradable material dissolves within three hours after insertion into the host.

23. The sensor device of claim 21, wherein the biodegradable material provide increased column strength to the in vivo portion such that the in vivo portion can be inserted through the host'"'"'s skin without substantial buckling.

24. The sensor device of claim 21, wherein the in vivo portion has a length of from about 1 mm to about 7 mm.

25. The sensor device of claim 21, wherein the in vivo portion comprises a blunt tip.

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

27. 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.

28. The sensor device of claim 27, wherein the sensor electronics unit is configured to be located over a sensor insertion site.

29. The sensor device of claim 27, wherein the electrode is electrically connected to sensor electronics prior to insertion of the in vivo portion.

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

31. The sensor device of claim 21, wherein the in vivo portion is configured to be inserted without a removable needle.

32. 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.