Analyte sensor and apparatus for insertion of the sensor
An apparatus for insertion of a medical device in the skin of a subject is provided.
1. An insertion assembly, comprising:
(a) an on-body unit, comprising:
a housing comprising a top surface and a bottom surface,
wherein the top surface of the housing comprises a first opening having a first maximum width, and a second opening having a second maximum width less than the first maximum width,
wherein the bottom surface of the housing comprises an opening of the bottom surface, and
wherein a longitudinal axis extends through the first opening of the top surface and the opening of the bottom surface;
a glucose sensor; and
sensor electronics disposed within the housing and coupled with the glucose sensor, wherein the sensor electronics comprise a processor, a power source, an analog interface, a data storage unit, and wireless communication circuitry configured to communicate data indicative of a glucose level according to a Bluetooth communication protocol; and
(b) an inserter, comprising:
a proximal end, a distal end, and an interior; and
a sharp extending through the first opening of the top surface and the opening of the bottom surface along the longitudinal axis,
wherein the on-body unit and the sharp are entirely disposed in the interior of the inserter,
wherein at least a portion of the glucose sensor is disposed in the sharp,
wherein the inserter is configured to advance the on-body unit and the sharp from a first position to a second position such that the sharp pierces skin of a user and the housing of the on-body unit is secured to the skin of the user in the second position,
wherein the distal end of the inserter is configured to be positioned on the skin of the user before advancement of the on-body unit and the sharp, and
wherein the inserter is further configured to automatically retract the sharp from within the user and leave a part of the glucose sensor in the skin of the user.
2. The insertion assembly of claim 1 , wherein the on-body unit further comprises a side wall of the housing, wherein the side wall is located between the top surface and the bottom surface.
3. The insertion assembly of claim 2 , wherein the side wall comprises a first portion and a second portion, wherein the first portion of the side wall is orthogonal to the bottom surface of the housing, and wherein the second portion of the side wall defines a non-orthogonal angle relative to the top surface of the housing.
4. The insertion assembly of claim 1 , further comprising an adhesive portion configured to secure the housing of the on-body unit to the skin of the user.
5. The insertion assembly of claim 4 , wherein the adhesive portion is further configured to extend outwardly beyond the bottom surface of the housing of the on-body unit along the skin in all directions when the housing of the on-body unit is secured to the skin of the user.
6. The insertion assembly of claim 4 , wherein the adhesive portion is disposed on the bottom surface of the housing of the on-body unit before advancement of the on-body unit and the sharp.
7. The insertion assembly of claim 1 , wherein the sensor electronics are in a sleep mode or an idle mode when the on-body unit is in the first position.
8. The insertion assembly of claim 1 , wherein the sensor electronics are configured to be activated when the on-body unit is at or near the second position.
9. The insertion assembly of claim 1 , wherein the processor of the sensor electronics is coupled with the power source, the analog interface, the data storage unit, and the wireless communication circuitry.
10. The insertion assembly of claim 1 , wherein the sensor electronics further comprise a leakage detection circuit, an antenna, or a serial communication section.
11. The insertion assembly of claim 1 , wherein the wireless communication circuitry of the sensor electronics is configured to establish a Bluetooth communication link with a mobile telephone device and transmit the data indicative of the glucose level to the mobile telephone device.
12. The insertion assembly of claim 1 , wherein the sensor electronics further comprise an opening of the sensor electronics, and wherein the sharp extends through the opening of the sensor electronics.
13. The insertion assembly of claim 1 , wherein the proximal end of the inserter comprises an inserter handle, wherein the distal end of the inserter comprises an inserter base, and wherein the inserter handle is configured to move in a downward direction toward the skin of the user relative to the inserter base in response to an application of force on the inserter handle.
14. The insertion assembly of claim 13 , wherein the inserter base is configured to remain stationary relative to the skin of the user in response to the application of force on the inserter handle.
15. The insertion assembly of claim 13 , wherein the inserter is further configured to advance the on-body unit and the sharp from the first position to the second position after the application of force on the inserter handle.
16. The insertion assembly of claim 1 , further comprising a cap removably attached to a distal portion of the inserter.
17. The insertion assembly of claim 16 , wherein the cap is removably attached to the distal portion of the inserter by a plurality of threads.
18. The insertion assembly of claim 16 , wherein the cap includes a first interior space, and wherein a section of the glucose sensor and a section of the sharp are housed within the first interior space, and wherein the first interior space comprises a sterile environment.
19. The insertion assembly of claim 18 , wherein the cap comprises an upwardly extending boss including a second interior space, wherein the upwardly extending boss extends into the first interior space, wherein the section of the glucose sensor and the section of the sharp are partially disposed within the second interior space of the upwardly extending boss, and wherein the upwardly extending boss comprises a cylindrical shape and is disposed on an interior surface of the cap.
20. The insertion assembly of claim 1 , wherein a maximum height of the sensor electronics disposed within the housing of the on-body unit relative to the bottom surface of the housing is between 3 millimeters and 25 millimeters.
21. The insertion assembly of claim 1 , wherein a height profile of the housing of the on-body unit is less than or equal to approximately 10 millimeters.
22. The insertion assembly of claim 1 , wherein the inserter is configured to retract the sharp entirely within the interior of the inserter.
23. The insertion assembly of claim 1 , further comprising a sensor hub,
wherein the glucose sensor comprises a distal sensor portion and a proximal sensor portion,
wherein the distal sensor portion is configured to sense a glucose level of the user,
wherein the proximal sensor portion is engaged with the sensor hub, and
wherein the distal sensor portion is substantially orthogonal to the proximal sensor portion.
24. The insertion assembly of claim 1 , wherein the glucose sensor is a wire sensor.
25. The insertion assembly of claim 1 , wherein the glucose sensor includes a sensing layer comprising an enzyme configured to convert glucose to hydrogen peroxide, and wherein the sensor electronics are configured to generate the data indicative of the glucose level based on a sensed level of the hydrogen peroxide.
26. The insertion assembly of claim 1 , wherein the distal end of the inserter defines a plane, and wherein the bottom surface of the on-body unit housing is parallel to the plane when the on-body unit is in the first position.
27. The insertion assembly of claim 1 , wherein the on-body unit and the sharp are configured to advance in a linear direction when advancing from the first position to the second position.
28. The insertion assembly of claim 1 , wherein a distance between the housing when the on-body unit is in the first position and the housing when the on-body unit is in the second position is greater than a maximum height of the housing.
29. The insertion assembly of claim 1 , wherein the sharp extends through the first opening of the top surface and the opening of the bottom surface along the longitudinal axis when the on-body unit is in the first position.
30. The insertion assembly of claim 1 , wherein the sharp is configured to pierce the skin of the user at an angle substantially perpendicular to the skin of the user.