Ambulatory medicament pump with safe access control
Inventors
Rosinko, Michael J. • DAMIANO, Edward R. • Patel, Himanshu • EL-KHATIB, Firas H. • LeBourdais, Robert James
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11610661-B2
Publication Date
2023-03-21
Expiration Date
Abstract
Systems and methods are disclosed herein for managing access to therapy controls of an ambulatory medicament pump that provides therapy to a subject using safe access levels associated with the therapy controls. The therapy change controls may enable modification of the corresponding therapy control parameters. The disclosed systems and methods can determine the eligibility of a subject receiving therapy from the ambulatory medicament pump or a user of the ambulatory medicament pump, for a safe access level and provide access to the corresponding therapy change controls. The ambulatory medicament pump may provide access to the therapy change controls upon receiving an access signal. In some cases, the ambulatory medicament pump may receive a time-based passcode and provide access to the therapy change controls upon receiving a matching passcode from the user.
Core Innovation
The system provides access-controlled changes to therapy settings for an ambulatory medicament pump and glucose level control system. The ambulatory medicament pump receives a request to access therapy change controls associated with a safe access level and communicates with an electronic passcode device. When a user passcode attempt matches the device-specific passcode, the pump enables the therapy change controls affecting medicament administration.
The glucose level control system receives and validates an access code comprising safe access level data and a unique identifier. Responsive to validation, the system enables a second glucose level therapy control configuration that differs from a first configuration. This enabled configuration modifies or enables modification of execution of a control algorithm generating a dose control signal for the ambulatory medicament pump.
The modular architecture further supports passcode-gated interfaces, insulin or glucagon mode selection, sensor-based alarm management, and therapy suspension. The system also generates configuration codes from tracked therapy data to adjust control parameters, initialize replacement devices, and facilitate data transfer across sensors and user devices. Because introductory sections are not present, the background problem being solved is not explicitly described in patent.
Claims Coverage
The three independent claims are claim 1, claim 12, and claim 21, identifying three inventive features across system and method implementations.
Passcode-gated therapy change controls
Claim 1 recites an ambulatory medicament pump receiving a request to access therapy change controls associated with a safe access level, sending a passcode request comprising a device identifier to an electronic passcode device, receiving a user passcode attempt, and enabling the controls when the user passcode attempt matches the device passcode.
Access-code-enabled glucose therapy configuration system
Claim 12 recites a glucose level control system that receives and validates an access code comprising safe access level data and a unique identifier, and enables a second glucose level therapy control configuration different from a first configuration to modify or enable modification of execution of a control algorithm generating a dose control signal for an ambulatory medicament pump.
Access-code-enabled glucose therapy configuration method
Claim 21 recites a method of receiving and validating an access code comprising safe access level data and a unique identifier, and enabling a different glucose level therapy control configuration that modifies or enables modification of execution of a control algorithm generating a dose control signal for an ambulatory medicament pump.
The independent claims cover passcode-gated access to pump therapy change controls and access-code validation to enable an alternative glucose level therapy control configuration modifying control algorithm execution.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Safe-access control for modifying therapy change controls on an ambulatory medicament pump providing medicament infusion to a subject.
Enabling an alternative glucose level therapy control configuration modifying execution of a control algorithm generating pump dose control signals.
Generating configuration codes from tracked therapy data to set glucose-control parameters, transfer configurations, or initialize replacement medicament pumps.
Automated glucose level control implementations providing insulin or glucagon mode selection, therapy suspension controls, and backup therapy protocol generation.
Application-version downloading, installation, deferral of updates until therapy delivery is safe, and fault recovery in medicament delivery systems.
Interoperating across glucose sensors and medicament pumps in a modular blood glucose control system using device-specific encoding and decoding profiles.
Glucose management workflows including sensor-based alarm management, carbohydrate-dose recommendations, and automated parameter refinement using glycemic metrics.
Interested in licensing this patent?