Ambulatory Insulin Pump Bolus Override With Staged Confirmation
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Solution Overview
Problem
Existing insulin pumps have rigid maximum bolus limits that do not account for individual user needs, potentially preventing necessary medicament delivery and causing safety issues due to accidental overdoses.
Innovation Solution
An ambulatory infusion pump with a maximum bolus override feature that alerts users when a requested dose exceeds the limit, requiring confirmation before delivering a first portion, followed by reminders for a second portion, allowing flexibility while ensuring safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a maximum bolus limit is set to prevent accidental overdoses, then safety is improved, but flexibility to accommodate individual user needs deteriorates
Solution Approach 1:
The system dynamically adjusts the bolus limit based on user confirmation state. Initially, a strict maximum limit is enforced for safety. When a user requests a bolus exceeding this limit, the system transitions to a dynamic state where the limit can be overridden through a multi-step confirmation process, allowing the delivered bolus amount to dynamically adapt to actual user needs while maintaining safety through controlled flexibility.
Solution Approach 2:
The system changes the parameter of maximum bolus amount from a fixed value to a variable that can be temporarily increased through user confirmation. The processor modifies the effective bolus limit parameter based on user input, allowing it to scale from the programmed maximum to higher amounts when medically necessary, thus resolving the contradiction between fixed safety limits and flexible adaptability.
2Adaptability or versatility
If a high maximum bolus limit is set to accommodate all users, then flexibility is improved, but risk of accidental overdose increases
Solution Approach 1:
The bolus delivery process is segmented into multiple confirmation stages. Instead of a single high-limit override, the system divides the override process into sequential steps: initial limit exceeded warning, first confirmation request, second confirmation request, and final delivery. This segmentation creates multiple safety checkpoints that prevent accidental overdoses while still allowing flexible high-dose delivery when genuinely needed.
Solution Approach 2:
The system performs preliminary actions by warning the user before bolus delivery and requiring advance confirmations. The processor issues warnings about limit exceedance and requires user confirmation before delivering boluses above the maximum limit, preparing the user for the high-dose delivery in advance and preventing accidental overdoses through proactive safety measures.
3Device complexity
If a uniform maximum bolus limit is applied to all users, then device simplicity is maintained, but individualized treatment needs cannot be met
Solution Approach 1:
The system enables self-service by allowing each user to individually override the maximum bolus limit through a simple confirmation process on their own device. Instead of requiring complex individualized programming by healthcare providers, users can autonomously adjust their bolus limits based on their specific treatment needs, maintaining device simplicity while enabling individualized treatment through user-initiated overrides.
Data Source
AI summary
An ambulatory infusion pump can include a maximum bolus override procedure. When a bolus amount greater than a maximum bolus amount is requested, the pump can provide an alert indicating that the amount requested exceeds the maximum bolus amount. If the user confirms the request in response to the alert, the bolus amount can be delivered to the user. The amount delivered in response to the confirmation can be a first portion of the bolus amount. A reminder can then be provided that a second portion of the bolus amount that is a remaining portion of the requested bolus amount was also requested. If a second confirmation is received in response to the alert, the second portion of the bolus amount can also delivered to the user.