US2021001038A1PendingUtilityA1

Drug delivery device

Assignee: TANDEM DIABETES CARE INCPriority: Dec 26, 2013Filed: Sep 17, 2020Published: Jan 7, 2021
Est. expiryDec 26, 2033(~7.4 yrs left)· nominal 20-yr term from priority
G08C 2201/93A61M 2205/52G16H 20/17A61M 2205/3592G16H 40/40G16H 40/67A61M 2205/3576A61M 2230/201A61M 5/14244A61M 2205/50A61M 2205/12A61M 2205/3584G08C 17/02A61M 2205/502
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Claims

Abstract

A system and method provide for enhanced reliability and safety of programming and/or operating a medical device, such as an infusion pump.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . A method of providing closed loop therapy to a patient with an ambulatory infusion pump system, comprising:
 storing at least one acceptable operation parameter for closed loop delivery of medicament with an ambulatory infusion pump, the at least one acceptable operation parameter related to a timing of automatic delivery of a bolus of medicament;   receiving glucose level data of a user from a continuous glucose monitor system;   comparing the glucose level data of the user to a high glucose threshold;   determining, based on the comparison of the glucose level data of the user to the target glucose level, that an automatic bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold;   determining whether automatic delivery of the bolus delivery of medicament is permissible based on the at least one acceptable operation parameter related to a timing of automatic delivery of a bolus of medicament; and   preventing an ambulatory infusion pump from automatically delivering the bolus delivery of medicament if it is determined that the bolus delivery of medicament is not permissible based on the at least one acceptable operation parameter related to a timing of delivery of a bolus of medicament.   
     
     
         22 . The method of  claim 21 , further comprising enabling the ambulatory infusion pump to deliver the bolus delivery of medicament if it is determined that the bolus delivery of medicament is permissible based on the at least one acceptable operation parameter related to a timing of delivery of a bolus of medicament. 
     
     
         23 . The method of  claim 21 , wherein the device that determines that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold is a remote control device of the ambulatory infusion pump system. 
     
     
         24 . The method of  claim 21 , wherein the device that determines that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold to a target glucose level is the ambulatory infusion pump. 
     
     
         25 . The method of  claim 21 , further comprising modifying an ongoing delivery of medicament to the user based on the comparison of the glucose level data. 
     
     
         26 . The method of  claim 25 , wherein modifying the ongoing delivery of medicament includes modifying a basal rate of medicament. 
     
     
         27 . The method of  claim 21 , further comprising preventing the ambulatory infusion pump from delivering the bolus delivery of medicament if it is determined that an amount of the bolus delivery of medicament is not below a maximum permissible value. 
     
     
         28 . The method of  claim 21 , further comprising preventing the ambulatory infusion pump from delivering the bolus delivery of medicament if it is determined that an amount of the bolus delivery of medicament is not within an acceptable range. 
     
     
         29 . The method of  claim 21 , wherein determining that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold includes calculating an amount of medicament that would lower the user's glucose level to a target glucose level. 
     
     
         30 . A method of providing closed loop therapy to a patient with an ambulatory infusion pump system, comprising:
 receiving glucose level data of a user from a continuous glucose monitor system;   comparing the glucose level data of the user to a high glucose threshold;   determining, based on the comparison of the glucose level data of the user to the target glucose level, that an automatic bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold;   determining whether the automatic bolus delivery of medicament would be delivered an acceptable amount of time after a previous bolus delivery; and   preventing an ambulatory infusion pump from automatically delivering the bolus delivery of medicament if it is determined that the bolus delivery of medicament would not be delivered an acceptable amount of time after the previous bolus delivery.   
     
     
         31 . The method of  claim 30 , further comprising enabling the ambulatory infusion pump to deliver the bolus delivery of medicament if it is determined that the bolus delivery of medicament would be delivered an acceptable amount of time after the previous bolus delivery. 
     
     
         32 . The method of  claim 30 , wherein the device that determines that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold is a remote control device of the closed loop therapy system. 
     
     
         33 . The method of  claim 30 , wherein the device that determines that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold is the ambulatory infusion pump. 
     
     
         34 . The method of  claim 30 , further comprising modifying an ongoing delivery of medicament to the user based on the comparison of the glucose level data. 
     
     
         35 . The method of  claim 34 , wherein modifying the ongoing delivery of medicament includes modifying a basal rate of medicament. 
     
     
         36 . The method of  claim 30 , further comprising preventing the ambulatory infusion pump from delivering the bolus delivery of medicament if it is determined that an amount of the bolus delivery of medicament is not below a maximum permissible value. 
     
     
         37 . The method of  claim 30 , further comprising preventing the ambulatory infusion pump from delivering the bolus delivery of medicament if it is determined that an amount of the bolus delivery of medicament is not within an acceptable range. 
     
     
         38 . The method of  claim 30 , wherein determining that the bolus delivery of medicament is needed to lower the user's glucose level below the high glucose threshold includes calculating an amount of medicament that would lower the user's glucose level to a target glucose level.

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