Sensor inserter assembly
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte, such as blood glucose. An inserter having a retractable introducer is provided for subcutaneously implanting the sensor in a predictable and reliable fashion.
1. An assembly comprising:
an inserter device comprising:
an actuator button,
a sharp comprising a distal end configured to be inserted into a user,
a slidable shuttle,
a first spring,
a stem extending into an inner circumference of the first spring,
a second spring having a proximal end in contact with the slidable shuttle, and
a post extending into an inner circumference of the second spring;
a glucose sensor disposed within the inserter device, the glucose sensor comprising a distal end configured to be inserted into the user;
a mount releasably coupled with the inserter device, wherein the mount comprises an adhesive portion configured to adhere to skin of the user while the mount is coupled with the inserter device, and wherein a bottom surface of the mount is disposed within a distal plane; and
a liner removably attached to the adhesive portion of the mount, wherein the liner is configured to be removed from the adhesive portion before the adhesive portion is adhered to the skin of the user,
wherein the actuator button, when depressed, is configured to cause automatic advancement of the slidable shuttle, the sharp, and the glucose sensor by the first spring, such that the distal end of the sharp and the distal end of the glucose sensor advance through an opening in the mount and into the user,
wherein, before the actuator button is depressed, a portion of the stem is a first height from the distal plane and a portion of the post is a second height from the distal plane that is equal to the first height,
wherein a proximal end of the post comprises an opening,
wherein the distal end of the sharp is configured to automatically retract from within the user and into an interior space of the inserter device after the automatic advancement of the slidable shuttle, the sharp, and the glucose sensor,
wherein the mount is configured for positioning on the skin of the user prior to advancing the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount,
wherein the inserter device is configured to be removed from the mount while the distal end of the glucose sensor remains in the user,
wherein the second spring comprises a coiled spring, and
wherein the mount is further configured to receive an electronics component housing into the mount after the inserter device is removed from the mount.
2. The assembly of claim 1 , wherein the sharp and the glucose sensor are configured to automatically advance in a direction towards the skin of the user when the actuator button is depressed such that a proximal portion of the glucose sensor couples with the mount and the distal end of the glucose sensor is inserted into the user.
3. The assembly of claim 2 , wherein the second spring is configured to apply a force to automatically retract the slidable shuttle and the sharp in a direction away from the skin of the user.
4. The assembly of claim 3 , wherein the inserter device further comprises a lateral extension releasably engaged with a stop, and wherein the actuator button, when depressed, is further configured to release the lateral extension from the stop and cause a release of energy from the first spring, and
wherein, before the actuator button is depressed, a distal end of the lateral extension is a third height from the distal plane and the proximal end of the second spring is a fourth height from the distal plane that is greater than the third height.
5. The assembly of claim 4 , wherein the inserter device further comprises:
a housing coupled with the actuator button; and
a base coupled with the mount and the housing, the base comprising guides, wherein the slidable shuttle is configured to automatically advance along the guides of the base in a direction towards the skin of the user when the actuator button is depressed.
6. The assembly of claim 5 , wherein the glucose sensor is further configured to be electrically connected to electronics in the electronics component housing when the electronics component housing is received into the mount.
7. The assembly of claim 6 , wherein the mount further comprises a cavity for receiving the electronics component housing.
8. The assembly of claim 7 , wherein the glucose sensor is received within the sharp.
9. An assembly comprising:
an inserter device comprising:
an actuator button,
a safety mechanism configured to impede the actuator button,
a sharp comprising a distal end configured to be inserted into a user,
a slidable shuttle,
a first spring,
a stem extending into an inner circumference of the first spring,
a second spring having a proximal end in contact with the slidable shuttle, and
a post extending into an inner circumference of the second spring;
a glucose sensor disposed within the inserter device, the glucose sensor comprising a distal end configured to be inserted into the user;
a mount releasably coupled with the inserter device, wherein the mount comprises an adhesive portion configured to adhere to skin of the user while the mount is coupled with the inserter device, and wherein the adhesive portion extends outwardly beyond a bottom portion of the mount in all directions, and wherein a bottom surface of the mount is disposed within a distal plane; and
a liner removably attached to the adhesive portion of the mount, wherein the liner is configured to be removed from the adhesive portion before the adhesive portion is adhered to the skin of the user,
wherein the safety mechanism comprises a safety barrier, and wherein the safety barrier is configured to be removed from the inserter device before the actuator button is depressed,
wherein the actuator button, when depressed, is configured to cause automatic advancement of the slidable shuttle, the sharp, and the glucose sensor by the first spring, such that the distal end of the sharp and the distal end of the glucose sensor advance through an opening in the mount and into the user,
wherein, before the actuator button is depressed, a portion of the stem is a first height from the distal plane and a portion of the post is a second height from the distal plane that is equal to the first height,
wherein a proximal end of the post comprises an opening,
wherein the distal end of the sharp is configured to automatically retract from within the user and into an interior space of the inserter device after the automatic advancement of the slidable shuttle, the sharp, and the glucose sensor,
wherein the mount is configured for positioning on the skin of the user prior to advancing the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount,
wherein the inserter device is configured to be removed from the mount while the distal end of the glucose sensor remains in the user,
wherein the second spring comprises a coiled spring, and
wherein the mount is further configured to receive an electronics component housing into the mount after the inserter device is removed from the mount.
10. The assembly of claim 9 , wherein the sharp and the glucose sensor are configured to automatically advance in a direction towards the skin of the user when the actuator button is depressed such that a proximal portion of the glucose sensor couples with the mount and the distal end of the glucose sensor is inserted into the user.
11. The assembly of claim 10 , wherein the first spring is a coiled spring or a wound spring.
12. The assembly of claim 11 , wherein the first spring is a wound spring.
13. The assembly of claim 10 , wherein the mount further comprises a positioning structure configured to facilitate positioning of the glucose sensor.
14. The assembly of claim 10 , wherein the inserter device is configured to transcutaneously position at least a portion of the glucose sensor at an angle of insertion between 15 and 60 degrees relative to the skin of the user.
15. The assembly of claim 14 , wherein the inserter device is configured to transcutaneously position at least a portion of the glucose sensor at an angle of insertion between 30 and 45 degrees relative to the skin of the user.
16. The assembly of claim 15 , wherein the inserter device is configured to transcutaneously position at least a portion of the glucose sensor at an angle of insertion of 45 degrees relative to the skin of the user.
17. The assembly of claim 10 , wherein the inserter device further comprises a lateral extension releasably engaged with a stop, and wherein the actuator button, when depressed, is further configured to release the lateral extension from the stop and cause a release of energy from the first spring, and
wherein, before the actuator button is depressed, a distal end of the lateral extension is a third height from the distal plane and the proximal end of the second spring is a fourth height from the distal plane that is greater than the third height.
18. The assembly of claim 17 , wherein the second spring is configured to apply a force to automatically retract the slidable shuttle and the sharp in a direction away from the skin of the user.
19. The assembly of claim 9 , wherein the inserter device further comprises:
a housing coupled with the actuator button; and
a base coupled with the mount and the housing, the base comprising guides, wherein the slidable shuttle is configured to automatically advance along the guides of the base in a direction towards the skin of the user when the actuator button is depressed.
20. The assembly of claim 9 , wherein the glucose sensor is further configured to be electrically connected to electronics in the electronics component housing when the electronics component housing is received into the mount.
21. The assembly of claim 20 , wherein the mount further comprises a cavity for receiving the electronics component housing.
22. The assembly of claim 21 , wherein the glucose sensor is received within the sharp.
23. The assembly of claim 9 , wherein the assembly is a part of a glucose monitoring kit, wherein the glucose monitoring kit further comprises the electronics component housing, wherein the electronics component housing contains electronics, wherein the electronics are configured to be electrically coupled with the glucose sensor, and wherein the electronics comprise a transmitter, a power supply, and a data storage unit.
24. The assembly of claim 9 , wherein the assembly is a part of a glucose monitoring kit, wherein the glucose monitoring kit further comprises a display device configured to display a glucose level of the user.
25. The assembly of claim 9 , wherein the inserter device is packaged in a cocked state and wherein the inserter device is further configured to be removed from a packaging before the adhesive portion of the mount is adhered to the skin of the user.
26. The assembly of claim 9 , wherein the slidable shuttle is configured to automatically advance at an average speed of at least one meter per second.
27. An assembly comprising:
an inserter device comprising:
an actuator button,
a safety mechanism configured to impede the actuator button,
a sharp comprising a distal end configured to be inserted into a user,
a slidable shuttle,
a first spring,
a stem extending into an inner circumference of the first spring,
a second spring having a proximal end in contact with the slidable shuttle,
a post extending into an inner circumference of the second spring, and
a lateral extension releasably engaged with a stop;
a glucose sensor disposed within the inserter device, the glucose sensor comprising a distal end configured to be inserted into the user;
a mount releasably coupled with the inserter device, wherein the mount comprises an adhesive portion configured to adhere to skin of the user while the mount is coupled with the inserter device, and wherein a bottom surface of the mount is disposed within a distal plane; and
a liner removably attached to the adhesive portion of the mount, wherein the liner is configured to be removed from the adhesive portion before the adhesive portion is adhered to the skin of the user,
wherein the safety mechanism comprises a safety barrier, and wherein the safety barrier is configured to be removed from the inserter device before the actuator button is depressed,
wherein the actuator button, when depressed, is configured to release the lateral extension from the stop and cause a release of energy from the first spring, wherein the release of energy from the first spring causes automatic advancement of the slidable shuttle, the sharp, and the glucose sensor such that the distal end of the sharp and the distal end of the glucose sensor advance through an opening in the mount and into the user,
wherein, before the actuator button is depressed, a portion of the stem is a first height from the distal plane and a portion of the post is a second height from the distal plane that is equal to the first height,
wherein a proximal end of the post comprises an opening,
wherein, before the actuator button is depressed, a distal end of the lateral extension is a third height from the distal plane and the proximal end of the second spring is a fourth height from the distal plane that is greater than the third height,
wherein the distal end of the sharp is configured to automatically retract from within the user and into an interior space of the inserter device after the automatic advancement of the slidable shuttle, the sharp, and the glucose sensor,
wherein the mount is configured for positioning on the skin of the user prior to advancing the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount,
wherein the inserter device is configured to be removed from the mount while the distal end of the glucose sensor remains in the user,
wherein the second spring comprises a coiled spring, and
wherein the mount is further configured to receive an electronics component housing into the mount after the inserter device is removed from the mount.
28. The assembly of claim 27 , wherein the first spring is a wound spring,
wherein the adhesive portion extends outwardly beyond a bottom portion of the mount in all directions,
wherein the sharp and the glucose sensor are configured to automatically advance in a direction towards the skin of the user when the actuator button is depressed such that a proximal portion of the glucose sensor couples with the mount and the distal end of the glucose sensor is inserted into the user,
wherein the second spring is configured to apply a force to automatically retract the slidable shuttle and the sharp in a direction away from the skin of the user, and
wherein the glucose sensor is further configured to be electrically connected to electronics in the electronics component housing when the electronics component housing is received into the mount.
29. The assembly of claim 28 , wherein the inserter device further comprises:
a housing coupled with the actuator button; and
a base coupled with the mount and the housing, the base comprising guides, wherein the slidable shuttle is configured to automatically advance along the guides of the base in a direction towards the skin of the user when the actuator button is depressed.