Sensors for continuous analyte monitoring, and related methods

Patent metadata

Field	Value
Publication number	US-9844328-B2
Application number	US-201514962972-A
Country	US
Kind code	B2
Filing date	Dec 8, 2015
Priority date	Oct 12, 2012
Publication date	Dec 19, 2017
Grant date	Dec 19, 2017

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 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 sensor, a bioactive agent, a biodegradable material, a hardening agent, and a membrane, wherein the hardening agent is integrated into the membrane, wherein the membrane covers at least a portion of the at least one sensor, wherein the hardening agent increases a column strength of the sensor, wherein the biodegradable material encapsulates at least a portion of the sensor, wherein the biodegradable material is configured to biodegrade following insertion into the host, wherein the biodegradable material is formed of a material that provides the sensor with sufficient column strength to prevent sensor buckling during insertion of the in vivo portion, wherein the biodegradable material has a Rockwell Hardness of 25 D to 65 D, wherein the at least one sensor lacks a column strength necessary to be inserted alone through the host's skin without buckling, wherein the bioactive agent is configured to suppress wounding; 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 pressure from a user to cause 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.

2. The sensor device of claim 1 , wherein the biodegradable material dissolves within three hours after insertion into the host.

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

4. The sensor device of claim 1 , wherein the sensor in vivo portion comprises a blunt tip.

5. The sensor device of claim 1 , wherein the sensor comprises a working electrode and a reference electrode.

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

7. The sensor device of claim 6 , wherein the sensor electronics unit is configured to be located over a sensor insertion site.

8. The sensor device of claim 6 , wherein the sensor is electrically connected to sensor electronics prior to insertion of the in vivo portion.

9. The sensor device of claim 1 , wherein the in vivo portion is configured to be inserted without a removable needle configured to pierce the host's skin during insertion of the in vivo portion.

10. 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.

11. The sensor device of claim 1 , wherein the hardening agent is configured to increase promotes adhesion of the membrane to the sensor.

12. The sensor device of claim 11 , wherein the hardening agent promotes resistance to peeling of the membrane from the sensor during sensor insertion.

Assignees

• Dexcom Inc

Inventors

• Simpson Peter C
• Blackwell Jennifer
• Böhm Sebastian

Classifications

• A61B2017/00004

  (bio)absorbable, (bio)resorbable or resorptive · CPC title

• A61B5/14532

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

• A61B5/14865

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• A61B17/3468

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

• 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