Analyte sensor devices, connections, and methods
Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.
1. An on-body device, comprising:
(1) a glucose sensor assembly comprising:
a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor; and
a distal tail section comprising a distal portion of the glucose sensor configured to be positioned under a skin surface and in contact with a bodily fluid of a subject;
(2) a housing comprising:
a top portion;
a base portion configured to be adhered to the skin surface of the subject by an adhesive patch;
a first space defined by the top portion and the base portion; and
a plurality of grooves, wherein at least a portion of each groove of the plurality of grooves is disposed on a periphery of the base portion; and
(3) sensor electronics positioned within the first space, the sensor electronics comprising a processor, a battery, and a printed circuit board,
wherein the base portion of the housing comprises a recess in a bottom exterior surface, the recess comprising a distal-facing opening, wherein the recess defines a second space different from the first space, and wherein the recess is configured to receive the connector support via the distal-facing opening, and
wherein the connector support of the glucose sensor assembly is disposed in the recess such that the glucose sensor is electrically coupled with the sensor electronics by the connector support.
2. The on-body device of claim 1 , wherein the housing further comprises a side wall, wherein the top portion of the housing comprises a top exterior surface, and wherein the side wall is located between the top exterior surface of the top portion of the housing and the bottom exterior surface of the base portion of the housing.
3. The on-body device of claim 2 , wherein the housing further comprises a plurality of engagement recesses circumferentially disposed thereon.
4. The on-body device of claim 3 , wherein the sensor electronics further comprise a wireless communications facility, and wherein the wireless communications facility is configured to communicate data indicative of a glucose level to a receiver unit.
5. The on-body device of claim 4 , wherein the recess is configured to receive the connector support via the distal-facing opening while the sensor electronics are in the first space.
6. The on-body device of claim 5 , wherein the top portion of the housing comprises a first aperture, wherein the printed circuit board comprises a second aperture, and wherein a longitudinal insertion axis extends through the first aperture and the second aperture.
7. The on-body device of claim 5 , wherein the connector support is electrically coupled with the sensor electronics via an interface that is external to the first space, and wherein the interface is disposed within the recess.
8. The on-body device of claim 5 , wherein the glucose sensor assembly further comprises a bent section between the proximal section and the distal tail section, wherein the proximal section and the distal tail section are approximately perpendicular to each other.
9. The on-body device of claim 5 , wherein each engagement recess of the plurality of engagement recesses comprises a concave portion.
10. The on-body device of claim 5 , wherein each engagement recess of the plurality of engagement recesses is disposed on the side wall of the housing.
11. The on-body device of claim 5 , wherein the side wall comprises a first portion and a second portion, wherein the first portion of the side wall is substantially orthogonal to the bottom exterior surface of the base portion of the housing, and wherein the second portion of the side wall is non-orthogonal to the top exterior surface of the top portion of the housing.
12. The on-body device of claim 5 , wherein the connector support comprises a planar surface.
13. The on-body device of claim 5 , further comprising an elastomeric sealing member disposed within the recess.
14. The on-body device of claim 13 , wherein the elastomeric sealing member is in contact with the connector support.
15. The on-body device of claim 5 , wherein the adhesive patch is coupled with the base portion, and wherein the adhesive patch comprises a window aligned with the distal-facing opening.
16. The on-body device of claim 5 , wherein the sensor electronics further comprise a first set of mating features coupled with a second set of mating features of the glucose sensor assembly.
17. The on-body device of claim 5 , wherein the recess of the base portion further comprises a first set of mating features coupled with a second set of mating features of the glucose sensor assembly.
18. The on-body device of claim 5 , wherein the distal-facing opening comprises a polygonal cross-sectional area, and wherein a shape of the connector support of the glucose sensor assembly corresponds with the polygonal cross-sectional area of the distal-facing opening.
19. The on-body device of claim 5 , wherein the housing comprises a single integral unit.
20. The on-body device of claim 19 , wherein the top portion and the base portion form a single over-molded unit comprising a thermoplastic material, and wherein the single over-molded unit seals the sensor electronics within the first space.
21. The on-body device of claim 5 , wherein the top portion and the base portion are coupled by a snap-fit mechanism such that the sensor electronics are sealed within the first space.
22. The on-body device of claim 5 , wherein the top portion and the base portion are welded together such that the sensor electronics are sealed within the first space.
23. The on-body device of claim 5 , wherein the top portion and the base portion are adhered together such that the sensor electronics are sealed within the first space.
24. An assembly comprising:
an applicator comprising a sharp;
an on-body device comprising:
(1) a glucose sensor assembly comprising:
a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor; and
a distal tail section comprising a distal portion of the glucose sensor configured to be positioned under a skin surface and in contact with a bodily fluid of a subject;
(2) a housing comprising:
a top portion comprising a top exterior surface and an aperture;
a base portion configured to be adhered to the skin surface of the subject by an adhesive patch;
a side wall;
a plurality of engagement recesses circumferentially disposed on the housing; and
a first space defined by the top portion and the base portion; and
(3) sensor electronics positioned within the first space, the sensor electronics comprising a processor, a battery, and a printed circuit board,
wherein the base portion of the housing comprises a recess in a bottom exterior surface, the recess comprising a distal-facing opening, wherein the recess defines a second space different from the first space, and wherein the recess is configured to receive the connector support via the distal-facing opening,
wherein the connector support of the glucose sensor assembly is disposed in the recess such that the glucose sensor is electrically coupled with the sensor electronics by the connector support,
wherein the on-body device and the sharp are entirely disposed within an interior of the applicator,
wherein the applicator is configured to advance the on-body device and the sharp from a first position to a second position such that a distal end of the sharp pierces the skin surface of the subject and the base portion of the housing is adhered to the skin surface of the subject,
wherein the applicator is further configured to automatically retract the distal end of the sharp from within the subject to within the interior of the applicator,
wherein the plurality of engagement recesses is detachably engaged to the applicator when the on-body device is in the first position, and
wherein the side wall of the housing is located between the top exterior surface of the top portion of the housing and the bottom exterior surface of the base portion of the housing.
25. The assembly of claim 24 , wherein the sharp extends through the aperture of the top portion of the housing when the on-body device is in the first position, and
wherein the sensor electronics further comprise a wireless communications facility, and wherein the wireless communications facility is configured to communicate data indicative of a glucose level to a receiver unit.
26. The assembly of claim 25 , wherein the recess is configured to receive the connector support via the distal-facing opening while the sensor electronics are in the first space,
wherein the connector support is electrically coupled with the sensor electronics via an interface that is external to the first space, and wherein the interface is disposed within the recess,
wherein the glucose sensor assembly further comprises a bent section between the proximal section and the distal tail section, wherein the proximal section and the distal tail section are approximately perpendicular to each other when the on-body device is in the first position, and
wherein each engagement recess of the plurality of engagement recesses is disposed on the side wall of the housing.
27. The assembly of claim 26 , wherein the aperture of the top portion of the housing is a first aperture, wherein the printed circuit board comprises a second aperture, and wherein the sharp extends through the second aperture when the on-body device is in the first position.
28. The assembly of claim 26 , wherein the distal-facing opening comprises a polygonal cross-sectional area, and wherein a shape of the connector support of the glucose sensor assembly corresponds with the polygonal cross-sectional area of the distal-facing opening.
29. The assembly of claim 25 , wherein the side wall of the housing comprises a first portion and a second portion, wherein the first portion of the side wall is substantially orthogonal to the bottom exterior surface of the base portion of the housing, and wherein the second portion of the side wall is non-orthogonal to the top exterior surface of the top portion of the housing.
30. The assembly of claim 24 , wherein the housing further comprises a plurality of grooves, wherein at least a portion of each groove of the plurality of grooves is disposed on a periphery of the base portion.