Transcutaneous analyte sensors, applicators therefor, and associated methods

• US 10,595,900 B2
• Filed: 10/20/2016
• Issued: 03/24/2020
• Est. Priority Date: 10/21/2015
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Schoonmaker, Ryan Everett, Blackwell, Jennifer, Davis, Christopher M., DeRenzy, David, Gobrecht, Eric, Halac, Jason, Hughes, Jonathan, Hurst, Kathleen Suzanne, Koplin, Randall Scott, Lieu, Phong, Neuser, Kyle, Newhouse, Todd Andrew, Pryor, Jack, Simpson, Peter C., Brown Wells, Maria Noel, England, Justen Deering, Mah, Stefanie Lynn, Barbod, Leonard Darius, Allen, Jillian K., Estes, Michael J., Pupa, Philip Thomas, Goldsmith, Timothy Joseph, Keller, Kyle Tinnell
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US15/298,721
• Publication Number:
  US 20170112531A1
• Time in Patent Office: 1,251 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 2017/0023 disposable
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• 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

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 activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing. Systems and methods according to present principles allow for such steps to occur without significant loss of spring force, and without deleterious effects such as seal slingshotting.

Claims

1. An applicator for applying an on-skin sensor assembly to skin of a host, the applicator comprising:

an applicator housing operatively coupled to a disposable housing, the disposable housing being configured to receive an electronics unit, the electronics unit being configured to generate analyte information based on a signal from a sensor;

an insertion assembly comprising an insertion member, the insertion member being configured to insert the sensor into the skin of the host;

a resistance member releasably coupled to the insertion assembly, wherein the resistance member comprises an elastomer;

a first drive assembly containing a first amount of stored energy, the first drive member being configured to drive the insertion member in a distal direction to an inserted position; and

a second drive assembly containing a second amount of stored energy, the second drive member being configured to drive the insertion member in a proximal direction,

wherein the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly.

2. The applicator of claim 1, wherein the first drive assembly is configured to drive the insertion member in the proximal direction after the insertion member reaches the inserted position.

3. The applicator of claim 1, wherein the second amount of stored energy is sufficient to drive the insertion member in a proximal direction to a retracted position.

4. The applicator of claim 1, wherein the resistance member is frictionally engaged with the insertion assembly.

5. The applicator of claim 1, wherein the resistance member is slidably coupled with the insertion assembly.

6. The applicator of claim 1, wherein the insertion member comprises a needle.

7. The applicator of claim 1, wherein the insertion assembly comprises a cannula.

8. The applicator of claim 7, wherein the insertion member is configured to travel through the cannula as the insertion member moves distally.

9. The applicator of claim 1, wherein at least one of the first drive assembly and the second drive assembly is configured to convert rotational motion into linear motion.

10. The applicator of claim 1, wherein the second amount of stored energy is greater than the first amount of stored energy.

11. The applicator of claim 1, wherein the resistance member is a seal.

12. An applicator for applying an on-skin sensor assembly to skin of a host, the applicator comprising:

an applicator housing operatively coupled to a disposable housing, the disposable housing being configured to receive an electronics unit, the electronics unit being configured to generate analyte information based on a signal from a sensor;

an insertion assembly comprising an insertion member, the insertion member being configured to insert the sensor into the skin of the host;

a resistance member releasably coupled to the insertion assembly, wherein the resistance member comprises a seal;

a first drive assembly containing a first amount of stored energy, the first drive member being configured to drive the insertion member in a distal direction to an inserted position; and

a second drive assembly containing a second amount of stored energy, the second drive member being configured to drive the insertion member in a proximal direction,

wherein the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly.

13. The applicator of claim 12, wherein the first drive assembly is configured to drive the insertion member in the proximal direction after the insertion member reaches the inserted position.

14. The applicator of claim 12, wherein the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly and drive the insertion member in a proximal direction to a retracted position.

15. The applicator of claim 12, wherein the resistance member is frictionally engaged with the insertion assembly.

16. The applicator of claim 12, wherein the resistance member is slidably coupled with the insertion assembly.

17. The applicator of claim 12, wherein the resistance member comprises an elastomer.

18. The applicator of claim 12, wherein the insertion member comprises a needle.

19. The applicator of claim 12, wherein the insertion assembly comprises a cannula.

20. The applicator of claim 19, wherein the insertion member is configured to travel through the cannula as the insertion member moves distally.

21. The applicator of claim 12, wherein the second amount of stored energy is greater than the first amount of stored energy.

22. An applicator for applying an on-skin sensor assembly to skin of a host, the applicator comprising:

an applicator housing operatively coupled to a disposable housing, the disposable housing being configured to receive an electronics unit, the electronics unit being configured to generate analyte information based on a signal from a sensor;

an insertion assembly comprising an insertion member, the insertion member being configured to insert the sensor into the skin of the host;

a resistance member releasably coupled to the insertion assembly, wherein the resistance member comprises a polymer;

a first drive assembly containing a first amount of stored energy, the first drive member being configured to drive the insertion member in a distal direction to an inserted position;

a second drive assembly containing a second amount of stored energy, the second drive member being configured to drive the insertion member in a proximal direction, and

a trigger configured to activate the first drive assembly, wherein the trigger comprises an electromechanical element configured to be activated by a signal received from a transmitter,

wherein the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly.

23. The applicator of claim 22, wherein the first drive assembly is configured to drive the insertion member in the proximal direction after the insertion member reaches the inserted position.

24. The applicator of claim 22, wherein the second amount of stored energy is sufficient to drive the insertion member in a proximal direction to a retracted position.

25. The applicator of claim 24, wherein the resistance member is frictionally engaged with the insertion assembly.

26. The applicator of claim 24, wherein the resistance member is slidably coupled with the insertion assembly.

27. The applicator of claim 22, wherein the resistance member comprises is a seal.

28. The applicator of claim 22, wherein the trigger comprises a smartphone running an insertion application.

29. The applicator of claim 22, further comprising a safety lock configured to prevent operation of the trigger.