SENSORS FOR CONTINUOUS ANALYTE MONITORING, AND RELATED METHODS

• US 20140107450A1
• Filed: 02/28/2013
• Published: 04/17/2014
• Est. Priority Date: 10/12/2012
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Blackwell, Jennifer, Bohm, Sebastian
• Application Number:
  US13/780,808
• Publication Number:
  US 20140107450A1
• Time in Patent Office: Days
• US Class Current: 600/365
• 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. A sensor device for measuring an analyte concentration in a host, comprising:

a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode, the sensor body having a blunt tip;

a piercing element comprising a material configured to rapidly dissolve upon insertion into a host, the piercing element abutting the sensor tip and configured for piercing tissue; and

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

2. The sensor device of claim 1, wherein the piercing element is secured to the sensor tip.

3. The sensor device of claim 2, wherein the piercing element is adhered to the sensor tip.

4. The sensor device of claim 1, wherein the piercing element is not secured to the sensor tip, but is maintained in abutting contact therewith.

5. The sensor device of claim 4, wherein a sleeve surrounding the sensor tip and the piercing element maintains the abutting contact.

6. The sensor device of claim 1, wherein the piercing element comprises a coating that covers at least a portion of the sensor body including the sensor tip.

7. The sensor device of claim 6, wherein the coating comprises a sharp coating tip.

8. The sensor device of claim 1, wherein the material of the piercing element comprises a material configured to suppress wounding.

9. The sensor device of claim 1, wherein the material of the piercing element comprises a material configured to promote rapid wound healing.

10. The sensor device of claim 1, wherein the material of the piercing element comprises a material configured to induce osmotic pressure or oncotic pressure.

11. The sensor device of claim 1, wherein the material of the piercing element comprises one or more drugs.

12. The sensor device of claim 1, wherein the material of the piercing element comprises a vascular endothelial growth factor.

13. The sensor device of claim 1, wherein the material of the piercing element comprises at least one material selected from the group consisting of a salt, a metallic salt, a sugar, a synthetic polymer, polylactic acid, polyglycolic acid, and a polyphosphazene.

14. The sensor device of claim 1, wherein the material of the piercing element biodegrades or dissolves within a first day after insertion into the host.

15. The sensor device of claim 14, wherein the material of the piercing element biodegrades or dissolves within three hours after insertion into the host.

16. The sensor device of claim 1, wherein the piercing element does not extend past the sensor tip in the direction of the mounting unit, or extends only a nominal amount in said direction.

17. The sensor device of claim 1, wherein the piercing element extends past the sensor tip in the direction of the mounting unit, but stops short of the electrode.

18. The sensor device of claim 1, wherein the mounting unit comprises a guiding portion configured to guide insertion of the sensor unit through the host'"'"'s skin and to support a column strength of the sensor body such that the sensor unit is configured for insertion through the host'"'"'s skin without substantial buckling.

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

20. 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.

21. The sensor device of claim 20, wherein the at least one electrode is the support member.

22. The sensor device of claim 20, wherein the support member is configured to support at least a portion of the at least one electrode.

23. The sensor device of claim 20, wherein the support member is configured to substantially surround the at least one electrode.

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

25. The sensor device of claim 24, wherein the sensor electronics unit is configured to be located over a sensor insertion site.