System, method and apparatus for sensor insertion

• US 10,376,213 B2
• Filed: 06/30/2009
• Issued: 08/13/2019
• Est. Priority Date: 06/30/2009
• Status: Active Grant

• Current Assignee: Konamite Limited
• Original Assignee: WaveForm Technologies, Inc. (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Bruce, Robert, Kreitlow, David, Federiuk, Isaac, Polcin, Ryan, Slomski, Dennis, Ward, Eric, Resch, Mihai
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): Catina, Michael A
• Application Number:
  US12/495,238
• Publication Number:
  US 20100331642A1
• Time in Patent Office: 3,696 Days
• Field of Search: 600345
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive

Abstract

Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.

Claims

1. A sensor insertion tool for inserting a sensor through intact skin without a cannula or trocar, comprising:

a channel guide assembly, comprising

a channel guide, and

a channel guide cover, wherein the channel guide and the channel guide cover together form a channel guide assembly channel;

a motive force assembly to store and release energy, comprising

a motive force member,

a hammer channel separate from and non-contiguous with the channel guide assembly channel, and having a curved portion,

a hammer extending through the channel guide cover into the channel guide assembly channel, and

a hammer pin coupled to and extending transverse from the hammer, the hammer pin configured to extend from the hammer into the hammer channel and move along the curved portion of the hammer channel to guide the hammer to strike a sensor subassembly positioned within the channel guide assembly channel;

a cocking assembly coupled to the motive force assembly to load energy into the motive force assembly; and

a trigger assembly having a trigger member coupled to the motive force assembly to release stored energy in response to actuation of the trigger member.

2. The sensor insertion tool of claim 1, wherein the sensor insertion tool is disposable.

3. The sensor insertion tool of claim 1, wherein the channel guide assembly is permanently coupled to the motive force assembly.

11. The sensor insertion tool of claim 1, wherein the channel guide assembly comprises:

an elongated housing to reversibly mechanically lock in contact with the sensor subassembly and having a vertically protruding interior region and an aperture; and

a channel defined by the vertically protruding interior region of the housing, the channel providing a passage through the channel guide assembly, said channel to accommodate the sensor subassembly.

12. The sensor insertion tool of claim 11, wherein the channel guide assembly reversibly mechanically locks to the sensor subassembly prior to sensor insertion.

13. The sensor insertion tool of claim 12, wherein the channel guide assembly is releasable from the sensor subassembly by actuation of a release member of the channel guide or the sensor insertion tool.

14. The sensor insertion tool of claim 11, wherein the elongated housing comprises a release element that unlocks the analyte sensor assembly from the channel guide assembly.

4. A sensor insertion tool for inserting a sensor through intact skin without a cannula or trocar, comprising:

a motive force assembly comprising

a motive force member,

a curved track,

a hammer, and

a hammer pin coupled to and extending transverse from the hammer into the curved track, the hammer pin configured to move along a curved portion of the curved track to guide the hammer to strike a sensor subassembly within a channel guide assembly channel separate from and non-contiguous with the curved track, the channel guide assembly comprising a channel guide, and a channel guide cover that together form the channel guide assembly channel;

a cocking assembly coupled to the motive force assembly to load energy into the motive force assembly;

a trigger assembly coupled to the motive force assembly to release the energy in response to actuation of the trigger assembly; and

a retention element that couples the sensor subassembly to the channel guide assembly.

5. The sensor insertion tool of claim 4, wherein the motive force member comprises one or more springs.

6. The sensor insertion tool of claim 4, further comprising a release member to engage a component of the channel guide assembly to retain the sensor subassembly, the actuation of the release member adapted to cause an uncoupling of the sensor subassembly from the channel guide assembly.

7. The sensor insertion tool of claim 4, further comprising an elongated housing.

8. The sensor insertion tool of claim 4, further including the channel guide assembly.

9. The sensor insertion tool of claim 8, wherein the channel guide assembly is permanently coupled to a component of the sensor insertion tool.

10. The sensor assembly insertion tool of claim 4, wherein the sensor assembly insertion tool is a single use device.

15. The sensor insertion tool of claim 7, wherein the elongated housing comprises a cocking indicator.