Sensors for continuous analyte monitoring, and related methods

• US 9,844,328 B2
• Filed: 12/08/2015
• Issued: 12/19/2017
• Est. Priority Date: 10/12/2012
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Blackwell, Jennifer, Bhm, Sebastian
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US14/962,972
• Publication Number:
  US 20160089068A1
• Time in Patent Office: 742 Days
• 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 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.