Medicament pumps and control systems for managing glucose control therapy data of a subject
Inventors
DAMIANO, Edward R. • EL-KHATIB, Firas H. • Patel, Himanshu • Rosinko, Michael J. • LeBourdais, Robert James
Assignees
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Publication Number
US-11610662-B2
Publication Date
2023-03-21
Expiration Date
Abstract
Glucose control systems are disclosed. An ambulatory medicament pump that is configured to wirelessly transmit one or more of a plurality of glucose control parameters and glucose control therapy data to a second ambulatory medicament pump is disclosed. A control system for transferring historical pump data from a first ambulatory medicament pump to a second ambulatory medicament pump is also disclosed. The control system can receive the historical pump data from a first ambulatory medicament pump, determine that at least one of a plurality of pairing conditions is satisfied to connect the data interface to the second ambulatory medicament pump, transmit, via the data interface, a pairing signal to the second ambulatory medicament pump, and transmit at least one of the therapy data associated with the delivery of the glucose control therapy or the glucose control parameter.
Core Innovation
The invention features an ambulatory medicament pump and a glucose level control system that determine glucose control therapy data and generate glucose control parameters. When at least one specified pairing condition is satisfied, the pump or system wirelessly transmits the therapy data and control parameters to a second pump or system. The therapy data includes an amount of insulin on board, a time of delivery, or delivery information, while the control parameters include subject-related, glucose, pharmacokinetic, and medicament-delivery information.
The pairing conditions triggering wireless transmission include scheduled events, meal announcements, replacement or readiness indications, alert threshold conditions, insufficient medicament, and requests from a remote electronic device. In addition, the glucose level control system generates a dose output for administration of medicament to a subject. The system also supports manual-dose reporting, adaptive refinement of glucose-control parameters, and modular interfaces for interoperability among devices.
The medical device further provides safety-evaluated, time-limited access codes for changing therapy configurations, passcode controls, and automatic resumption of suspended therapy. Severity-ranked alarm and non-critical fault management preserve therapy when minimum operating parameters remain satisfied. Furthermore, software updates are installed or activated with minimal therapy interruption, and therapy data is transferable directly to a cloud computing system or utilized for backup protocols.
Claims Coverage
The claims identify three independent claims covering three inventive features: an ambulatory medicament pump, a method performed by a first ambulatory medicament pump, and a glucose level control system.
Ambulatory medicament pump wireless transmission
Independent claim 1 covers an ambulatory medicament pump comprising a pump controller, a wireless data interface, memory, and a hardware processor that determines glucose control therapy data, generates glucose control parameters, and wirelessly transmits the data and parameters to a second ambulatory medicament pump in response to at least one satisfied pairing condition.
Method for transmitting glucose control data between pumps
Independent claim 15 covers a method performed by a hardware processor of a first ambulatory medicament pump comprising determining glucose control therapy data, generating glucose control parameters, determining that at least one pairing condition is satisfied, and wirelessly transmitting the parameters and therapy data to a second ambulatory medicament pump.
Glucose level control system dose generation and conditional transfer
Independent claim 27 covers a glucose level control system comprising a wireless data interface, memory storing an application configured to generate a dose output for medicament administration, and a hardware processor that determines glucose control therapy data, generates glucose control parameters, and wirelessly transmits them to a second glucose level control system upon satisfaction of at least one pairing condition.
Together, the three independent claims cover a pump apparatus, a pump-to-pump transfer method, and a glucose level control system. Each claim ties the wireless transmission of glucose control parameters and therapy data to the satisfaction of at least one specified pairing condition, with the system claim additionally covering dose output generation.
Stated Advantages
Software updates can be installed or activated with minimal therapy interruption.
Therapy can be preserved when minimum operating conditions remain satisfied.
The described features support improved glycemic control.
Documented Applications
Transfer of glucose control therapy history and parameters between ambulatory medicament pumps or glucose level control systems upon satisfaction of a pairing condition, including pump replacement, scheduled events, meal announcements, malfunctions, or low medicament.
Use of a glucose level control system to generate a dose output for medicament administration and wirelessly transmit glucose control parameters and therapy data to a second glucose level control system or remote electronic device.
Manual-dose reporting to an automated glucose control system to account for insulin or glucagon on board.
Initializing replacement systems using configuration codes generated from therapy history, and managing access to therapy-setting changes through validated passcodes.
Supporting interoperability among pumps, glucose sensors, and remote devices through modular interfaces.
Changing glucose-therapy configurations on an ambulatory medical device using safety-evaluated, time-limited access codes and passcode-based setting controls.
Installing or activating application updates for an ambulatory medical device, with fallback to verified or safe application versions.
Transferring therapy data to a cloud computing system, providing remote therapy reports, and sending alerts when an alert threshold condition is met.
Managing suspended therapy, alarms, and non-critical faults, including automatic therapy resumption and preserving therapy when minimum operating conditions remain satisfied.
Personalized nutrition, therapy management, and backup care during pump unavailability using backup injection or pump protocols generated from logged insulin therapy.
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