Analyte sensor subassembly and methods and apparatuses for inserting an analyte sensor associated with same

• US 8,483,792 B2
• Filed: 03/17/2009
• Issued: 07/09/2013
• Est. Priority Date: 03/17/2008
• Status: Active Grant

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation
• Inventors: Slomski, Dennis, Bruce, Robert, Fortuna, Jon, Kreitlow, David B.
• Primary Examiner(s): Hopkins, Christine D
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/405,985
• Publication Number:
  US 20090234212A1
• Time in Patent Office: 1,575 Days
• Field of Search: 600302-308, 600345-371, 600481-507, 600529-545, 606/129
• US Class Current: 600/345
• 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 5/6849 in combination with a needle set

Abstract

Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Claims

1. An analyte sensor subassembly, comprising:

a housing;

an analyte sensor fixed to and extending from a first side of the housing, the analyte sensor having an anode and a cathode;

a first electrical connector having at a first end a first electrical contact coupled to the anode of the analyte sensor and at a second end a second electrical contact extending from the first side of the housing for electrical coupling to an analyte sensor assembly;

a second electrical connector having at a first end a third electrical contact coupled to the cathode of the analyte sensor and at a second end a fourth electrical contact extending from the first side of the housing for electrical coupling to the analyte sensor assembly; and

a striking surface on a second side of the housing, opposite the first side, for receiving a motive force to insert the analyte sensor into skin of an individual and electrically couple the second and fourth electrical contacts to the analyte sensor assembly.

2. The analyte sensor subassembly of claim 1, further comprising an encapsulant at least partially filling an interior cavity of the housing.

3. The analyte sensor subassembly of claim 2, further comprising a gasket coupled to the housing and at least partially sealing the interior cavity of the housing.

4. The analyte sensor subassembly of claim 1, wherein the housing comprises a non-circular cross-section.

5. The analyte sensor subassembly of claim 1, wherein the housing comprises a keel, wherein the keel has a channel at least partially containing the analyte sensor.

6. The analyte sensor subassembly of claim 1, wherein the analyte sensor is flexible.

7. The analyte sensor subassembly of claim 1, wherein the electrical contacts coupled to the anode and the cathode comprise semicircular cups.

8. The analyte sensor subassembly of claim 1, wherein the second and fourth electrical contacts comprise spring member contacts.

9. A sensor subassembly channel guide, comprising:

an elongated tubular housing to mate with an analyte sensor assembly and having an interior region, an exterior surface, a first opening at a first end that is configured to receive a motive force from a motive force device to drive an analyte sensor subassembly, and a second opening at a second end that permits passage of the analyte sensor subassembly; and

a channel located in the interior region of the housing providing a passage for the analyte sensor subassembly to pass through the sensor subassembly channel guide, said channel configured to mate with the analyte sensor subassembly.

10. The channel guide of claim 9, wherein the channel has a non-circular cross-section to align the analyte sensor subassembly.

11. The channel guide of claim 9, wherein the housing is further configured to mate with a separate motive force device.

12. The channel guide of claim 9, further comprising at least one protrusion extending from an interior surface of the channel, wherein the at least one protrusion is configured to retain the analyte sensor subassembly in a fixed position in the channel prior to application of a sufficient force.

13. The channel guide of claim 9, further comprising at least one protrusion extending from an interior surface of the channel, wherein the at least one protrusion is configured to align the analyte sensor subassembly for insertion of a sensor associated with the analyte sensor subassembly into skin of an individual.

14. A sensor insertion tool for inserting an analyte sensor into skin, comprising:

a housing having a curved track, wherein the housing mates with an analyte sensor channel guide having a curved channel;

a plunger coupled to a spring, wherein the plunger travels in or along the curved track when the spring is actuated to push an analyte sensor subassembly along a curved path within the curved channel; and

a cocking mechanism coupled to the plunger to load energy in the spring prior to inserting the analyte sensor into skin.

15. The sensor insertion tool of claim 14, further comprising a release mechanism to release the cocking mechanism and the plunger to allow the plunger to travel in or along the curved track and strike the analyte sensor or analyte sensor subassembly.

16. The sensor insertion tool of claim 14, wherein said spring is a tension or torsion spring.

17. A method of inserting an analyte sensor into skin, comprising:

providing a channel guide at least partially containing an analyte sensor subassembly, the analyte sensor subassembly having an analyte sensor and electrical contact members, the channel guide removably coupled to an analyte sensor assembly on an individual'"'"'s skin and including a first opening at a first end and a second opening at a second end, the sensor assembly having electrical contacts configured to correspond to the electrical contact members of the analyte sensor subassembly;

coupling a motive force device to the channel guide; and

activating the motive force device to provide a motive force to the analyte sensor subassembly, through the first opening in the channel guide, to move the analyte sensor subassembly through the channel guide such that the analyte sensor at least partially exits the channel guide through the second opening and at least partially enters the skin, wherein the electrical contact members of the analyte sensor subassembly are thereby brought into electrical contact with the corresponding electrical contacts of the sensor assembly.

18. An analyte sensor assembly, comprising:

a first sensor assembly having a circuit board and one or more electrical contacts coupled to the circuit board;

a second sensor assembly for releasable and mechanical coupling to the first sensor assembly; and

a sensor subassembly having an analyte sensor, a housing, and one or more electrical contact members extending from the housing for electrically coupling the analyte sensor to the one or more electrical contacts on the first sensor assembly, the sensor subassembly configured to mechanically engage with the second sensor assembly during use and only after the analyte sensor has been at least partially inserted into skin of an individual.

19. The analyte sensor assembly of claim 18, further comprising a gasket coupled to the sensor subassembly to provide a seal between the sensor subassembly and the second sensor assembly after insertion of the analyte sensor.

20. The analyte sensor assembly of claim 18, further comprising a gasket coupled to the second sensor assembly to provide a seal between the first and second sensor assembly when the first and second sensor assembly are coupled together.

21. The analyte sensor assembly of claim 18, wherein the second sensor assembly further comprises a recess to engage with the sensor subassembly during and after insertion of the analyte sensor.

22. The analyte sensor assembly of claim 21, further comprising one or more retainer clips disposed in the recess to restrict retraction of the sensor subassembly from engagement with the second sensor assembly.

23. The analyte sensor assembly of claim 21, further comprising one or more ribs disposed in the recess to align the sensor subassembly during and after insertion of the analyte sensor.

24. The analyte sensor assembly of claim 18, wherein the one or more electrical contact members of the sensor subassembly are configured to electrically couple with the one or more electrical contacts of the first sensor assembly only after the analyte sensor has been at least partially inserted into the skin.