Medical devices and methods

Abstract

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user. The in vivo analyte sensor is coupled to an electronics unit holding a memory with instruction to cause processing circuitry to initiate a predetermined time period that is longer than a predetermined life of the sensor, during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device, and at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature.

What is claimed is: 
     
         1 . A glucose monitoring system, comprising:
 an eletrochemical transcutaneous glucose sensor comprising:
 a proximal portion electrically coupled to an on-body electronics unit, wherein the proximal portion is configured to extend above a skin surface of a user after insertion of a distal portion of the sensor; and 
 the distal portion configured to be inserted perpendicular to the skin surface using an insertion device, such that at least a portion of the distal portion is in contact with the user's interstitial fluid; 
   wherein the electronics unit:
 is attached to an adhesive layer that is configured to attach to the skin surface; 
 is less than or equal to 5 mm in its maximum thickness; 
 is less than or equal to 30 mm in its maximum diameter; 
 is pre-loaded during a manufacturing process into the insertion device; 
 and comprises:
 an RF transceiver configured to wirelessly transmit data from the electronics unit to one or more handheld display devices and to wirelessly receive data from one or more of the display devices; and 
 one or more non-transitory computer-readable mediums comprising instructions which, when executed by processing circuitry, are configured to cause the processing circuitry to:
 initiate a predetermined time period that is longer than a predetermined life of the sensor; 
 during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device; and 
 at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature; and 
 
 
   
       wherein the insertion device comprises a cap that is rotatably coupled to a housing of the insertion device and retains the sensor within the housing prior to insertion. 
     
     
         2 . The glucose monitoring system of  claim 1 , wherein one or more of the features comprises operation of the electronics unit. 
     
     
         3 . The glucose monitoring system of  claim 1 , wherein the transmitted data comprises the glucose levels and one or more of the features comprises the display of one or more of the glucose levels on one or more of the display devices. 
     
     
         4 . The glucose monitoring system of  claim 1 , wherein the predetermined time period and the predetermined life of the sensor are initiated by use of an insertion device. 
     
     
         5 . The glucose monitoring system of  claim 1 , wherein the predetermined time period and the predetermined life of the sensor are initiated by positioning the distal portion of the sensor under the skin surface and in fluid contact with the user's interstitial fluid. 
     
     
         6 . The glucose monitoring system of  claim 1 , wherein the expiration of the predetermined time period is determined based at least in part on the number of signals converted to respective corresponding glucose levels. 
     
     
         7 . The glucose monitoring system of  claim 1 , wherein the predetermined life of the sensor is 10 or 14 days. 
     
     
         8 . A method comprising:
 initiating a predetermined time period that is longer than a predetermined life of an electrochemical transcutaneous glucose sensor, wherein the sensor comprises a proximal portion and a distal portion, wherein the proximal portion is electrically coupled to an on-body electronics unit configured to be placed on a skin surface of a user and is configured to extend above a skin surface of a user after insertion of a distal portion of the sensor, and wherein the distal portion is configured to be inserted perpendicular to the skin surface using an insertion device, such that at least a portion of the distal portion is in contact with the user's interstitial fluid;   converting, during the predetermined time period, signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device;   disabling, deactivating, or ceasing use of, at the expiration of the predetermined time period, one or more feature.   
     
     
         9 . The method of  claim 8 , wherein one or more of the features comprises operation of the electronics unit. 
     
     
         10 . The method of  claim 8 , wherein one or more of the features comprises displaying one or more of the glucose levels on one or more display devices. 
     
     
         11 . The method of  claim 8 , wherein the predetermined time period and the predetermined life of the sensor are initiated by use of an insertion device. 
     
     
         12 . The method of  claim 8 , wherein the predetermined time period and the predetermined life of the sensor are initiated by positioning the distal portion of the sensor under the skin surface and in fluid contact with the user's interstitial fluid. 
     
     
         13 . The method of  claim 8 , wherein the expiration of the predetermined time period is determined based at least in part on the number of signals converted to respective corresponding glucose levels. 
     
     
         14 . The method of  claim 8 , wherein the predetermined life of the sensor is 10 or 14 days. 
     
     
         15 . A glucose monitoring system, comprising:
 one or more non-transitory computer-readable mediums comprising instructions which, when executed by processing circuitry, are configured to cause the processing circuitry to:
 initiate a predetermined time period that is longer than a predetermined life of an electrochemical transcutaneous glucose sensor, wherein:
 the sensor comprises:
 a proximal portion electrically coupled to an on-body electronics unit, wherein the proximal portion is configured to extend above a skin surface of a user after insertion of a distal portion of the sensor; and 
 the distal portion configured to be inserted perpendicular to the skin surface using an insertion device, such that at least a portion of the distal portion is in contact with the user's interstitial fluid,; and 
 
 the electronics unit:
 is attached to an adhesive layer that is configured to attach to the skin surface; 
 is less than or equal to 5 mm in its maximum thickness; 
 is less than or equal to 30 mm in its maximum diameter; 
 is pre-loaded during a manufacturing process into the insertion device; and 
 comprises an RF transceiver configured to wirelessly transmit data from the electronics unit to one or more handheld display devices and to wirelessly receive data from one or more of the display devices; and 
 
 the insertion device comprises a cap that is rotatably coupled to a housing of the insertion device and retains the sensor within the housing prior to insertion; and 
 
 during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device; and 
 at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature. 
   
     
     
         16 . The glucose monitoring system of  claim 15 , wherein one or more of the features comprises operation of the electronics unit. 
     
     
         17 . The glucose monitoring system of  claim 15 , wherein the transmitted data comprises the glucose levels and one or more of the features comprises the display of one or more of the glucose levels on one or more of the display devices. 
     
     
         18 . The glucose monitoring system of  claim 15 , wherein the predetermined time period and the predetermined life of the sensor are initiated by use of an insertion device. 
     
     
         19 . The glucose monitoring system of  claim 15 , wherein the predetermined time period and the predetermined life of the sensor are initiated by positioning the distal portion of the sensor under the skin surface and in fluid contact with the user's interstitial fluid. 
     
     
         20 . The glucose monitoring system of  claim 15 , wherein the expiration of the predetermined time period is determined based at least in part on the number of signals converted to respective corresponding glucose levels. 
     
     
         21 . The glucose monitoring system of  claim 15 , wherein the predetermined life of the sensor is 10 or 14 days.