Sensor inserter assembly

Abstract

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 - 15 . (canceled) 
     
     
         16 . An assembly comprising:
 an inserter device comprising:
 an actuator button, 
 a sharp comprising a distal end configured to be inserted into a user, 
 a first spring, 
 a stem extending into an inner circumference of the first spring, 
 a second spring, and 
 a post extending into an inner circumference of the second spring; 
   a glucose sensor disposed within an interior of the inserter device, the glucose sensor comprising a distal end configured to be inserted into the user; and   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,   wherein the actuator button, when depressed, is configured to cause a release of energy from the first spring, wherein the release of energy from the first spring causes advancement of the distal end of the sharp and the distal end of the glucose sensor in a direction towards the skin of the user 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 the post comprises and open proximal end,   wherein, after the advancement of the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount and into the user, the distal end of the sharp is further configured to automatically retract from within the user and into the interior of the inserter device,   wherein the mount is configured for positioning on the skin of the user prior to the actuator button being depressed,   wherein the inserter device is configured to be removed from the mount while the distal end of the glucose sensor remains in the user, 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.   
     
     
         17 . The assembly of  claim 16 , wherein the assembly further comprises 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, and wherein the liner comprises a pull tab. 
     
     
         18 . The assembly of  claim 17 , wherein the inserter device further comprises a slidable shuttle,
 wherein the slidable shuttle is coupled with the sharp, and   wherein the second spring comprises a coiled spring having a proximal end in contact with the slidable shuttle.   
     
     
         19 . The assembly of  claim 18 , wherein the release of energy from the first spring further causes advancement of the slidable shuttle in a direction towards the skin of the user. 
     
     
         20 . The assembly of  claim 19 , wherein a proximal portion of the glucose sensor is configured to couple with the mount, and
 wherein the glucose sensor is configured to be in electrical communication with electronics in the electronics component housing when the electronics component housing is received into the mount.   
     
     
         21 . The assembly of  claim 19 , wherein the second spring is configured to apply a force to retract the slidable shuttle and the sharp in a direction away from the skin of the user without user interaction after the actuator button is depressed,
 wherein the stem is disposed entirely within the interior of the inserter device before the actuator button is depressed, and   wherein the first spring comprises a coiled spring or a wound spring.   
     
     
         22 . The assembly of  claim 16 , 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. 
     
     
         23 . The assembly of  claim 22 , 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. 
     
     
         24 . The assembly of  claim 18 , wherein the inserter device further comprises a first longitudinally extending member parallel to an insertion axis and a second longitudinally extending member parallel to the insertion axis,
 wherein the first longitudinally extending member surrounds a first portion of an outer circumference of the second spring,   wherein the second longitudinally extending member surrounds a second portion of the outer circumference of the second spring,   wherein the first longitudinally extending member has a first length, and   wherein the second longitudinally extending member has a second length that is equal to the first length.   
     
     
         25 . The assembly of  claim 16 , wherein the stem comprises an open distal end, and wherein, before the actuator button is depressed, the open proximal end of the post is a third height from the distal plane and the open distal end of the stem is a fourth height from the distal plane that is less than the third height. 
     
     
         26 . 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 coupled with the sharp, 
 a first spring, 
 a stem extending into an inner circumference of the first spring. 
 a second spring comprising a coiled 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 an interior of 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, and wherein the liner comprises a pull tab,   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 advancement of the slidable shuttle, the sharp, and the glucose sensor in a direction towards the skin of the user 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 the post comprises an open proximal end,   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 inserter device further comprises a housing coupled with the actuator button, and wherein the stem is in a same position relative to the housing before the actuator button is depressed and when the distal end of the sharp and the distal end of the glucose sensor advance into the user,   wherein, after the advancement of the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount and into the user, the distal end of the sharp is further configured to automatically retract from within the user,   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, 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.   
     
     
         27 . The assembly of  claim 26 , wherein the stem comprises an open distal end. 
     
     
         28 . The assembly of  claim 27 , wherein the post further comprises a first length, and wherein the stem further comprises a second length that is less than the first length. 
     
     
         29 . The assembly of  claim 28 , wherein, before the actuator button is depressed, the open proximal end of the post is a fifth height from the distal plane and the open distal end of the stem is a sixth height from the distal plane that is less than the fifth height. 
     
     
         30 . The assembly of  claim 29 , wherein the inserter device further comprises a safety mechanism configured to impede the actuator button, wherein the safety mechanism comprises a safety barrier, wherein the safety barrier extends across a top surface of the actuator button, wherein the safety barrier comprises a grippable portion that extends outwardly in a direction away from the top surface of the actuator button, and wherein the safety barrier is configured to be removed from the inserter device before the actuator button is depressed. 
     
     
         31 . The assembly of  claim 26 , wherein the first spring comprises a coiled spring or a wound spring, and wherein a proximal portion of the glucose sensor is configured to couple with the mount. 
     
     
         32 . The assembly of  claim 26 , wherein the second spring is configured to apply a force to retract the slidable shuttle and the sharp in a direction away from the skin of the user. 
     
     
         33 . The assembly of  claim 26 , wherein the inserter device further comprises a first longitudinally extending member parallel to an insertion axis and a second longitudinally extending member parallel to the insertion axis,
 wherein the first longitudinally extending member surrounds a first portion of an outer circumference of the second spring,   wherein the second longitudinally extending member surrounds a second portion of the outer circumference of the second spring,   wherein the first longitudinally extending member has a first length, and   wherein the second longitudinally extending member has a second length that is equal to the first length.   
     
     
         34 . The assembly of  claim 26 , 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. 
     
     
         35 . 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 comprising a coiled 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 an interior of 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, 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, and wherein the liner comprises a pull tab,   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 advancement of the slidable shuttle, the sharp, and the glucose sensor in a direction towards the skin of the user 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 the post comprises an open proximal end,   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, after the advancement of the distal end of the sharp and the distal end of the glucose sensor through the opening in the mount and into the user, the distal end of the sharp is further configured to automatically retract from within the user and into the interior of the inserter device,   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, 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.   
     
     
         36 . The assembly of  claim 35 , wherein the post further comprises a first length, and wherein the stem comprises a second length that is less than the first length. 
     
     
         37 . The assembly of  claim 36 , wherein the stem is disposed entirely within the interior of the inserter device before the actuator button is depressed. 
     
     
         38 . The assembly of  claim 37 , wherein the stem further comprises an open distal end. 
     
     
         39 . The assembly of  claim 38 , wherein the safety barrier extends across a top surface of the actuator button, and wherein the safety barrier comprises a grippable portion that extends outwardly in a direction away from the top surface of the actuator button. 
     
     
         40 . The assembly of  claim 39 , wherein the housing of the inserter device is coupled with the actuator button, and wherein the stem is in a same position relative to the housing before the actuator button is depressed and when the distal end of the sharp and the distal end of the glucose sensor advance into the user. 
     
     
         41 . The assembly of  claim 40 , wherein, before the actuator button is depressed, the open proximal end of the post is a fifth height from the distal plane and the open distal end of the stem is a sixth height from the distal plane that is less than the fifth height. 
     
     
         42 . The assembly of  claim 41 , wherein the inserter device further comprises a first longitudinally extending member parallel to an insertion axis and a second longitudinally extending member parallel to the insertion axis,
 wherein the first longitudinally extending member surrounds a first portion of an outer circumference of the second spring,   wherein the second longitudinally extending member surrounds a second portion of the outer circumference of the second spring,   wherein the first longitudinally extending member has a first length, and   wherein the second longitudinally extending member has a second length that is equal to the first length.   
     
     
         43 . The assembly of  claim 41 , wherein the mount further comprises a positioning structure configured to facilitate positioning of the glucose sensor, and 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. 
     
     
         44 . The assembly of  claim 38 , wherein the second spring is configured to apply a force to retract the slidable shuttle and the sharp in a direction away from the skin of the user without user interaction after the actuator button is depressed. 
     
     
         45 . The assembly of  claim 38 , wherein the first spring comprises a coiled spring or a wound spring,
 wherein the glucose sensor is received within the sharp, and   wherein a proximal portion of the glucose sensor is configured to couple with the mount.