TRANSCUTANEOUS ANALYTE SENSORS, APPLICATORS THEREFOR, AND ASSOCIATED METHODS

• US 20130267813A1
• Filed: 03/14/2013
• Published: 10/10/2013
• Est. Priority Date: 04/04/2012
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Pryor, Jack, Bohm, Sebastian, DeRenzy, David, Halac, Jason, Kline, Daniel S., Lieu, Phong, Livingston, Adam J., Masterson, Steve, Neale, Paul V., Simpson, Peter C., Ubach, Antonio Joao
• Granted Patent: US 9,615,779 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Some embodiments contemplate engagement of the transmitter with the housing after release of the applicator.

Claims

1. A method of applying an on-skin sensor assembly to a host, wherein the on-skin sensor assembly comprises a housing secured to the applicator, wherein the housing is configured to receive an electronics unit, comprising:

attaching an applicator to a skin of a host, the applicator comprising a sensor insertion mechanism, a trigger, and a base;

inserting the electronics unit into the housing, wherein the electronics unit is configured to generate analyte information based on a signal from a sensor;

activating the trigger, thereby causing the sensor insertion mechanism to insert a sensor into the host, to secure the electronics unit to the housing such that the sensor electrically contacts the electronics unit, and to cause the housing to detach from the base; and

removing the applicator from the skin of the host, whereby an on-skin sensor assembly comprising the housing, the electronics unit, and the inserted sensor remains on the skin of the host.

2. The method of claim 1, wherein attaching the applicator to the skin of the host occurs before the electronics unit is inserted into the housing.

3. The method of claim 1, wherein attaching the applicator to the skin of the host occurs after the electronics unit is inserted into the housing.

4. The method of claim 1, further comprising, before applying the applicator, removing a door from the applicator covering a port configured for receiving the electronics unit when the electronics unit is inserted into the housing.

5. The method of claim 1, further comprising providing a removable liner covering an adhesive patch, wherein the adhesive patch is attached to the housing and radially extends from the housing, and wherein the adhesive patch comprises an adhesive configured to attach the base to the host.

6. The method of claim 5, further comprising providing a package configured to contain the base, the housing, the sensor insertion mechanism, and the trigger, wherein the package comprises the removable liner covering the adhesive patch.

7. The method of claim 6, wherein the package further comprises a cover, wherein the cover is a component of the applicator.

8. The method of claim 6, wherein the package further comprises a removable door, wherein the removable door covers a port configured for receiving the electronics unit.

9. The method of claim 6, wherein the removable liner comprises instructions printed thereon for using the applicator.

10. The method of claim 6, wherein multiple applicators are provided in the package.

11. The method of claim 1, wherein the applicator comprises a removable liner covering an adhesive patch, wherein the adhesive patch is attached to the housing, wherein the adhesive patch comprises an adhesive configured to attach the base to the host, wherein removing the applicator from the package exposes the adhesive, and wherein attaching the applicator causes the adhesive to attach the housing to the host.

12. A method of applying an on-skin sensor assembly to a host, comprising:

attaching an applicator to a skin of a host, the applicator comprising a sensor insertion mechanism, a trigger, and a base;

a housing secured to the applicator, wherein the housing is configured to receive an electronics unit;

activating the trigger, thereby causing the sensor insertion mechanism to insert a sensor into the host and to cause the housing to detach from the base;

removing the applicator from the skin of the host, whereby the housing and the inserted sensor remain on the skin of the host; and

inserting the electronics unit into the housing, wherein the electronics unit is configured to generate analyte information based on a signal from the sensor, and wherein the electronics unit is secured to the housing such that the sensor electrically contacts the electronics unit, whereby an on-skin sensor assembly comprising the housing, the electronics unit, and the inserted sensor is obtained.

13. The method of claim 12, wherein the housing is configured to receive the electronics unit in a partially seated configuration, and wherein the trigger is configured, in response to being activated, to cause the sensor insertion mechanism to insert the sensor into the host and to fully seat the electronics unit to the housing such that the sensor electrically contacts the electronics unit.

14. The method of claim 13, wherein the partially seated configuration is provided by a lock configured to limit an extent to which the electronics unit can be inserted into the housing prior to sensor insertion.

15. The method of claim 14, wherein the trigger is further configured to release the electronics unit from the lock after sensor insertion, wherein in response to the electronics unit being released from the lock, the electronics unit is configured to be secured to the housing such that the sensor electrically connects to one or more contacts on the electronics unit.

16. The method of claim 15, wherein a time between the sensor insertion into the host and the electronics unit securing the sensor is less than about 1 s.

17. The method of claim 12, wherein the base is configured to draw the electronics unit into the housing.

18. The method of claim 12, wherein the sensor assembly is configured to provide one or more tactile, auditory, or visual indications that the electronics unit has been inserted into the housing in the partially seated configuration.

19. The method of claim 12, wherein the sensor assembly further comprises a trigger lock configured to prevent activation of the trigger.

20. The method of claim 19, wherein the trigger is configured to be released from the trigger lock in response to at least partial insertion of the electronics unit into the housing.

21. The method of claim 12, wherein the housing is configured to adhere to a host'"'"'s skin, wherein, in use, the sensor is configured to extend through the housing and into the host'"'"'s skin;

and wherein the electronics unit is configured to operably connect to the sensor and generate analyte information based on a signal from the sensor when the electronics unit is secured within the housing, wherein operable connection of the electronics unit to the sensor comprises pressing the sensor against one or more electrical contacts of the electronics unit, and wherein the sensor is configured to be held in the assembly with a retention force.

22. The method of claim 21, wherein the sensor is configured such that connection of the electronics unit to the sensor causes the sensor to bend, whereby the sensor is configured to conform to the shape of the one or more electrical contacts.

23. The method of claim 21, wherein the retention force is at least about 0.1 pounds when subjected to a standard pull test or a standard push test.

24. The method of claim 12, wherein the electronics unit is inserted into the housing after the applicator is removed from the skin of the host.