Sensors for continuous analyte monitoring, and related methods

Patent metadata

Field	Value
Publication number	US-10932709-B2
Application number	US-201514964433-A
Country	US
Kind code	B2
Filing date	Dec 9, 2015
Priority date	Oct 12, 2012
Publication date	Mar 2, 2021
Grant date	Mar 2, 2021

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.

First claim

What is claimed is:

1. 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 a sensor body, at least one electrode, a membrane covering at least a portion of the at least one electrode, wherein the sensor body comprises a hydration-responsive material, such that the sensor body changes from a straight configuration to a curved configuration in response to hydration, wherein the sensor body is more rigid in the straight configuration than in the curved configuration, wherein the in vivo portion is configured to be inserted without a removable needle, wherein the in vivo portion further comprises a retractable sheath at least partially surrounding the membrane and providing the sensor body with additional column strength to prevent buckling of the sensor body during insertion through the skin, wherein the retractable sheath is configured to withdraw from the skin after insertion; 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 connected to the in vivo portion for insertion of the in vivo portion of the sensor device with a force applied to the ex vivo portion, wherein the ex vivo portion comprises an adhesive configured to adhere the ex vivo portion to the host's skin.

2. The sensor device of claim 1 , wherein, in response to hydration, the hydration-responsive material changes at least one of hardness, shape, or modulus of elasticity.

3. The sensor device of claim 1 , wherein the sensor body is hard ex vivo and soft in vivo.

4. The sensor device of claim 1 , wherein the sensor body comprises a polymer.

5. The sensor device of claim 1 , wherein the sensor body comprises polyurethane, polyester, polyamide, polyacrylate, or polyether.

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

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

8. The sensor device of claim 1 , wherein the ex vivo portion comprises a sensor electronics unit operatively and detachably connected to the sensor body.

9. The sensor device of claim 8 , wherein the sensor electronics unit is configured to be located over a sensor insertion site.

10. The sensor device of claim 8 , wherein the electrode is electrically connected to sensor electronics prior to insertion of the in vivo portion.

11. The sensor device of claim 1 , 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.

12. The sensor device of claim 1 , wherein the in vivo portion further comprises a piercing element located at a distal end of the sensor body and configured to pierce the skin for insertion of the in vivo portion, and
wherein the retractable sheath has a diameter equal to or less than a diameter of a proximal end of the piercing element.

Assignees

• Dexcom Inc

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

Classifications

• A61B5/14503 Primary

  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 title

• A61B5/6848

  Needles · CPC title

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/4839

  combined with drug delivery · CPC title