Ambulatory medicament pump with safe access control
Inventors
Rosinko, Michael J. • DAMIANO, Edward R. • Patel, Himanshu • EL-KHATIB, Firas H. • LeBourdais, Robert James
Assignees
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Publication Number
US-11688501-B2
Publication Date
2023-06-27
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 disclosure describes an ambulatory medicament pump and computer-implemented method that enable therapy change controls corresponding to a selected safe access level. The pump receives an access signal from an electronic access device and enables controls associated with a safe access level profile. Selecting a medicament therapy setting through the enabled controls modifies a control parameter used by a pump control algorithm to affect medicament therapy administration.
An electronic evaluation device receives subject evaluation data comprising therapy data corresponding to glycemic control and determines a safe access level and a validity period for associated therapy change controls. The evaluation device generates and transmits an access signal configured to cause the ambulatory medicament pump to enable the therapy change controls during the validity period. The system also provides password validation, safe access profiles, and encoding access data with validity values.
Additional ambulatory medicament pump functions include low-interruption software updating, secure direct cloud transfer of therapy data, automatic resumption after suspension, and alarm management. The disclosure further describes fault handling that preserves therapy during non-critical faults, glucose-control parameter refinement using therapy and sensor data, automated or user-confirmed delivery adjustments, and modular interfaces supporting sensor interoperability.
Claims Coverage
The independent claims are claims 1, 17, and 25, which cover three inventive features directed to pump-based enabling of access-level controls, processor-implemented enabling of therapy change controls, and evaluation-device determination of access levels.
Pump enables controls for a selected safe access level
Claim 1 covers an ambulatory medicament pump comprising a controller, data interface, memory storing safe access level profiles, and a processor that receives an access signal from an electronic access device to enable therapy change controls associated with a selected safe access level profile, wherein selecting a medicament therapy setting modifies a control parameter used by a pump control algorithm to affect medicament administration.
Computer-implemented enabling of therapy change controls
Claim 17 covers a computer-implemented method wherein a hardware processor of an ambulatory medicament pump receives an access signal from an electronic access device via a data interface and enables therapy change controls associated with a selected safe access level, such that selecting a medicament therapy setting modifies a control parameter used by a control algorithm to affect therapy administration.
Evaluation-based access level and validity period determination
Claim 25 covers an electronic evaluation device and computer-implemented method wherein subject evaluation data comprising therapy data corresponding to glycemic control is received, a safe access level and a validity period for therapy change controls are determined, and an access signal is generated and transmitted to cause the pump to enable the controls during the validity period.
The independent claims cover apparatus and method implementations for enabling pump therapy change controls corresponding to a selected safe access level, as well as an evaluation-device method for determining the access level and validity period from glycemic therapy data prior to transmitting an access signal.
Stated Advantages
Non-critical fault handling can preserve therapy when minimum operating parameters remain satisfied.
Documented Applications
Managing user access to therapy change controls of an ambulatory medicament pump providing medicament therapy to a subject.
Insulin therapy, selection among insulin therapy types, and automated blood glucose control intended to control a subject's glucose level.
Alarm monitoring, fault handling, and tracking carbohydrate-therapy equivalence in ambulatory medicament-device systems.
Transfer and secure management of therapy state data between medicament pumps and generation of backup therapy protocols.
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