SENSORS FOR CONTINUOUS ANALYTE MONITORING, AND RELATED METHODS

• US 20140213866A1
• Filed: 04/10/2014
• Published: 07/31/2014
• Est. Priority Date: 10/12/2012
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Blackwell, Jennifer, Bohm, Sebastian, Estes, Michael J., Jackson, Jeff, Mitchell, Jason, Pryor, Jack, Rong, Daiting, Saint, Sean T., Simpson, Peter C., Sheth, Disha B., Wang, Shanger
• Application Number:
  US14/250,341
• Publication Number:
  US 20140213866A1
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 or resorptive
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles

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, the sensor device being configured for implantation in the host without use of an inserter, 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;

a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;

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

a retractable introducer sheath configured to cover at least a portion of the membrane during insertion of the sensor device.

2. The sensor device of claim 1, wherein a proximal end of the tissue piercing element has a diameter greater than a diameter of the sensor body.

3. The sensor device of claim 2, wherein a diameter of the introducer sheath is substantially equal to or less than the diameter of the proximal end of the tissue piercing element.

4. A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, 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; and

a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;

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

wherein the sensor body includes a cross-section that defines at least one trough that extends along a length of the sensor body.

5. The sensor device of claim 4, wherein the cross-section of the sensor body defines a plus sign with four evenly spaced troughs.

6. The sensor device of claim 4, wherein the cross-section of the sensor body defines a circle with a single trough.

7. The sensor device of claim 4, wherein the at least one electrode is located in the at least one trough.

8. The sensor device of claim 7, wherein the at least one electrode and the at least one membrane are flush with or recessed beneath an outer perimeter of the sensor body.

9. A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, 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;

a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host; 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;

wherein the sensor body includes a plurality of depressions.

10. The sensor device of claim 9, wherein the membrane is disposed within at least one of the depressions.

11. The sensor device of claim 10, wherein the membrane is flush with an outer surface of the sensor body, or recessed beneath the outer surface of the sensor body.

12. The sensor device of claim 9, wherein the depressions are randomly arranged.

13. A sensor device for measuring an analyte concentration in a host, the sensor device being configured for implantation in the host without use of an inserter, 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;

a piercing element at a distal end of the sensor unit, the piercing element being configured for piercing skin and/or tissue of the host;

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

a plurality of axially spaced depressions in the sensor body.

14. The sensor device of claim 13, wherein the membrane is disposed within the depressions.

15. The sensor device of claim 14, further comprising an outer layer of a material that is permeable to one or more selected analytes.