US2021236731A1PendingUtilityA1

Operating multi-modal medicine delivery systems

Assignee: BIGFOOT BIOMEDICAL INCPriority: Jan 5, 2016Filed: Apr 21, 2021Published: Aug 5, 2021
Est. expiryJan 5, 2036(~9.4 yrs left)· nominal 20-yr term from priority
A61M 2230/201A61M 2230/005A61M 2205/702A61M 2205/6009A61M 2205/52A61M 2205/502A61M 2205/3584A61M 2205/3561A61M 2205/3553A61M 2205/3306A61M 5/1723A61M 5/1452A61M 5/14276A61M 5/14244A61M 5/1407G16H 20/17
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Claims

Abstract

A multi-modal medicine delivery system in which some embodiments can be configured to control dispensation of medicine according to any of a plurality of delivery modes, such as by closed-loop delivery modes and open-loop delivery modes, and according to a secondary feedback loop to determine user-specific settings related to dosage delivery.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method, comprising:
 obtaining analyte sensor data about a user of a medication delivery system;   operating a medication delivery system according to a first delivery mode, the first delivery mode allowing at least some control of delivery of medication to the user without user supervision; and   changing a mode of the medication delivery system according to a second delivery mode responsive to detecting an absence or presence of a signal for communicating the analyte sensor data about the user, the second delivery mode disallowing control of delivery of medication to the user without user supervision.   
     
     
         2 . The method of  claim 1 , further comprising obtaining, while the medication delivery system is operating according to first delivery mode, (i) analyte sensor data and (ii) one or more of medicine delivery data and food intake data. 
     
     
         3 . The method of  claim 2 , further comprising responsive to the obtained (i) analyte sensor data and (ii) the one or more of the medicine delivery data and the food intake data, determining user-specific dosage parameters that influence amounts of the medications to deliver to the user according to the first delivery mode. 
     
     
         4 . The method of  claim 3 , further comprising, while the medication delivery system is operating according to and without exiting the second delivery mode, performing the following:
 obtaining (i) additional analyte sensor data and (ii) additional medicine delivery data;   determining one or more updates to the user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional medicine delivery data; and   delivering the medication to the user according to the second delivery mode and responsive to the updates to the user-specific dosage parameters.   
     
     
         5 . The method of  claim 4 , further comprising determining the amount of the medication to deliver to the user according to the first delivery mode via a primary feedback loop that utilizes the analyte sensor data and the user-specific dosage parameters. 
     
     
         6 . The method of  claim 4 , wherein the analyte sensor data indicates a blood analyte level for the user at one or more specific times. 
     
     
         7 . The method of  claim 4 , wherein the medicine delivery data identifies amounts and times at which the medication was previously delivered to the user. 
     
     
         8 . The method of  claim 4 , wherein the food intake data identifies amounts and times at which one or more foods were consumed by the user. 
     
     
         9 . The method of  claim 4 , further comprising determining the one or more updates to the user-specific dosage parameters via a secondary feedback loop. 
     
     
         10 . The method of  claim 4 , wherein the medication delivery system comprises a portable insulin infusion pump system, the analyte sensor data comprises data describing blood glucose readings, and the medicine delivery data identifies insulin dosages delivered to the user from the portable insulin infusion pump system. 
     
     
         11 . The method of  claim 4 , wherein the additional updates to the user-specific dosage parameters are determined based at least partially on both (i) analyte sensor data and medicine delivery data generated during the first delivery mode and (ii) additional analyte sensor data and additional medicine delivery data generated during the second delivery mode. 
     
     
         12 . The method of  claim 4 , further comprising:
 detecting a transition trigger event comprising the detection of the absence or the presence of the signal for communicating the analyte sensor data about the user; and   responsive to the transition trigger event, switching from the first delivery mode to the second delivery mode.   
     
     
         13 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting the transition trigger event automatically without user input. 
     
     
         14 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting that communication with the analyte sensor has been lost or initiated. 
     
     
         15 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting an expiration of a period of time for operating the medication delivery system according to the first delivery mode. 
     
     
         16 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting that one or more calibrations for one or more components of the medication delivery system has failed to be completed after a threshold period of time. 
     
     
         17 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting a scheduled transition in a time-based schedule for a patient using the medication delivery system. 
     
     
         18 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting one or more components of the medication delivery system failing one or more safety checks. 
     
     
         19 . The method of  claim 12 , wherein detecting the transition trigger event comprises detecting a user input at the medication delivery system. 
     
     
         20 . The method of  claim 19 , wherein the signal for communicating the analyst sensor data about the user comprises a control signal. 
     
     
         21 . The method of  claim 20 , wherein the control signal comprises one or more of a wireless signal or a power signal. 
     
     
         22 . A multi-modal insulin delivery system, comprising:
 an insulin delivery device configured to deliver insulin to a user of the multi-modal insulin delivery system;   a controller associated with the insulin delivery device and comprising:
 at least one processor; and 
 at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the controller to: 
 while operating according to and without exiting a first delivery mode of delivering insulin, performing the following:
 obtaining (i) analyte sensor data and (ii) one or more of insulin delivery data and food intake data; 
 responsive to the obtained the (i) analyte sensor data and (ii) the one or more of the insulin delivery data and the food intake data, determining user-specific dosage parameters that influence insulin delivery within the first delivery mode; and 
 determining a schedule of basal dosages of insulin based at least partially on the determined user-specific dosage parameters; 
 
 switching to a second delivery mode and delivering insulin to the user according to the second delivery mode and according to the determined schedule of basal dosages of the insulin, and 
 while the multi-modal insulin delivery system is operating according to and without exiting the second delivery mode, performing the following:
 obtaining additional analyte sensor data and additional insulin delivery data; 
 determining one or more updates to the user-specific dosage parameters based on (i) the additional analyte sensor data and (ii) the additional insulin delivery data; and 
 delivering insulin to the user according to the second delivery mode and responsive to the updates to the user-specific dosage parameters. 
 
   
     
     
         23 . The system of  claim 22 , wherein the user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate. 
     
     
         24 . A method of delivering insulin, comprising:
 obtaining, while delivering insulin to a user according to a first delivery mode, (i) analyte sensor data and (ii) one or more of insulin delivery data and food intake data associated with the user;   determining usage-specific dosage parameters based at least partially on the (i) analyte sensor data and (ii) the one or more of the insulin delivery data and the food intake data, the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the first delivery mode;   switching to a second delivery mode and delivering insulin to the user based at least partially on the determined usage-specific dosage parameters; and   obtaining, while delivering insulin to the user according to the second delivery mode, (i) additional analyte sensor data and (ii) additional insulin delivery data;   determining one or more updates to the user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, the updates to the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the second delivery mode; and   delivering insulin to the user according to the second delivery mode and responsive to the updates to the user-specific dosage parameters.   
     
     
         25 . The method of  claim 24 , wherein the user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate.

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