SENSORS FOR CONTINUOUS ANALYTE MONITORING, AND RELATED METHODS

• US 20150289788A1
• Filed: 04/10/2014
• Published: 10/15/2015
• Est. Priority Date: 04/10/2014
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Blackwell, Jennifer, Bohm, Sebastian, Estes, Michael J., Jackson, Jeff, Mitchell, Jason, Pryor, Jack, Rong, Daiting, Saint, Sean T., Sheth, Disha B., Wang, Shanger
• Application Number:
  US14/250,320
• Publication Number:
  US 20150289788A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

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; 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 comprises a stimulus-responsive material that changes at least one material property responsive to a stimulus.

2. The sensor device of claim 1, wherein the at least one material property is at least one of hardness, shape, permeability, relative hydrophilicity, modulus of elasticity, or conformation of polymer orientation.

3. The sensor device of claim 2, wherein the sensor body is hard ex vivo and soft in vivo.

4. The sensor device of claim 1, wherein the stimulus that induces the change in the at least one material property is at least one of temperature, hydration, radiation, electrical stimulus, or a magnetic field.

5. The sensor device of claim 1, wherein the sensor body is a polymer

6. The sensor device of claim 5, wherein the sensor body is polyurethane, polyester, polyamide, polyacrylate, or polyether, or copolymers thereof.

7. The sensor device of claim 1, wherein the stimulus-responsive material is a shape memory metal.

9. The sensor device of claim 1, wherein the sensor body defines a first shape prior to insertion into the host'"'"'s skin.

10. The sensor device of claim 9, wherein the sensor body defines a memorized shape, and the sensor body returns to the memorized shape after insertion into the host'"'"'s skin.

11. The sensor device of claim 10, wherein the first shape is curved or straight, and the memorized shape is curved or straight.

12. The sensor device of claim 10, wherein when the sensor body returns to the memorized shape stored spring energy is released from the sensor body.

13. The sensor device of claim 12, wherein the released spring energy creates a whipping action that facilitates piercing the host'"'"'s skin.

8. (canceled)

14. A method of making a sensor device configured for implantation in a host without use of an inserter, the method comprising:

forming a piercing tip on a sensor unit, the sensor unit including a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode;

wherein the membrane is applied to the sensor unit prior to forming the piercing tip on the sensor unit.

15. The method of claim 14, further comprising applying the membrane to the sensor unit.

16. The method of claim 14, wherein forming the piercing tip comprises forming an annular channel about a circumference of a wire that is coated with the membrane.

17. The method of claim 16, wherein the annular channel extends through the membrane and partially into the wire

18. The method of claim 16, further comprising applying tension to the coated wire.

19. The method of claim 18, wherein the tension induces strain in the wire proximate the annular channel, causing the wire to neck and fracture.

20. The method of claim 19, wherein the necking forms the piercing tip on the sensor body.

21. The method of claim 20, further comprising covering the piercing tip with a protective outer layer.