System and method for switching between medicament delivery control algorithms
Inventors
Ulrich, Thomas R. • Kogler, Keith P.
Assignees
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Publication Number
US-12161842-B2
Publication Date
2024-12-10
Expiration Date
Abstract
Disclosed herein are systems and methods for safely switching between medicament delivery control algorithms for control of an ambulatory infusion pump or other medical device. Infusion pumps and/or remote control devices may be capable of operating different algorithms for delivery of medicament and provided herein are mechanisms for safely transitioning between algorithms.
Core Innovation
The invention relates to an ambulatory infusion pump system configured to deliver medicament to a patient while supporting switching between medicament delivery control algorithms. A processor determines medicament delivery commands according to a first medicament delivery control algorithm and determines that the medicament delivery commands transition to being determined by a second medicament delivery control algorithm. During the transition, the system activates a temporary supervisory algorithm configured to review and selectively prevent or enable the medicament delivery commands determined according to the second medicament delivery control algorithm for a transition period of time, and then deactivates the temporary supervisory algorithm upon expiration of the transition period of time.
The invention maintains continuity of therapy by using a current state file that represents therapy state information for the transition. The pump monitors and stores monitored pump parameters while delivering medicament according to the first medicament delivery algorithm in a current state file in memory, establishes a connection with a second medicament delivery algorithm for replacing the first medicament delivery algorithm, transfers the current state file from memory for use by the second medicament delivery algorithm, and enables medicament to be delivered according to the second medicament delivery algorithm after transferring the current state file.
To support safe transitions without double or missed dosing, the invention uses supervisory predictive low glucose suspend (PLGS) during a transition period. A temporary supervisory algorithm selectively negates or allows delivery commands based on CGM trends and prediction of crossing a low-glucose threshold, and is deactivated after the transition period. If the remote connection or commands are lost, the system automatically reverts to a default on-board algorithm, thereby continuing medicament delivery under a default medicament delivery control algorithm.
Claims Coverage
The document contains two independent claims. Across these claims, the core coverage includes algorithm transition with a temporary supervisory algorithm, and algorithm replacement using transfer of a current state file containing monitored pump parameters.
Temporary supervision during algorithm transition
Activate a temporary supervisory algorithm configured to review and selectively prevent or enable the medicament delivery commands determined according to the second medicament delivery control algorithm for a transition period of time following the transition; and deactivate the temporary supervisory algorithm upon expiration of the transition period of time.
Current state file transfer for algorithm replacement
Store the monitored pump parameters while medicament is delivered according to the first medicament delivery algorithm in a current state file in the memory; establish a connection with a second medicament delivery algorithm for replacing the first medicament delivery algorithm for determining medicament to be delivered to the patient with the ambulatory infusion pump; transfer the current state file from memory for use by the second medicament delivery algorithm; and enable medicament to be delivered according to the second medicament delivery algorithm after transferring the current state file.
Overall, the independent claims cover transitioning between first and second medicament delivery control algorithms with a temporary supervisory algorithm that selectively prevents or enables second-algorithm commands for a transition period, and replacing the first delivery algorithm with a second delivery algorithm by storing monitored pump parameters in a current state file and transferring that current state file for use by the second algorithm.
Stated Advantages
Enables therapy decisions without double/missed dosing during transitions.
Supports bumpless transitions by negating or allowing delivery commands during a transition period.
Automatically reverts to a default on-board algorithm when remote connection or commands are lost.
Documented Applications
Ambulatory infusion pump therapy operation using safe switching between medicament delivery control algorithms, including operation with a remote or alternate algorithm and supervisory predictive low glucose suspend (PLGS) during an algorithm transition.
Remote control device-based connection to a second medicament delivery algorithm with transfer of a current state file so medicament delivery continues under the second algorithm.
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