Ambulatory Pump Input Lockout for Inadvertent Activation

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Solution Overview

Problem

Ambulatory medical devices, such as insulin infusion pumps, are prone to unintended or inadvertent activation, which can lead to dangerous and deleterious consequences due to untimely or unexpected insulin delivery.

Innovation Solution

The device operates in an active mode that receives user input through an input interface and transitions to a safe mode if the input is detected in an out-of-bounds region, requiring a predetermined activation input to resume normal operation, such as a timed pattern or sequence of button presses, to prevent accidental activation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the device operates in active mode with simplified input recognition, then ease of operation is improved, but reliability deteriorates due to increased risk of inadvertent activation

Engineering Contradiction:
Improveease of operationVSAvoidreliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device performs preliminary validation of user inputs by checking whether touches occur within defined valid regions of the touchscreen before executing commands. This preliminary action prevents inadvertent activations while maintaining ease of operation for legitimate inputs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary validation layer between the touchscreen input and the device processor. This intermediary checks the position and validity of each touch input, acting as a mediator that blocks unintended commands while allowing intended ones to pass through to the processor.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the device uses a touchscreen interface with large input areas, then ease of operation is improved, but reliability worsens due to increased out-of-bounds input errors

Engineering Contradiction:
Improveease of operationVSAvoidreliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies local quality by defining specific valid regions on the touchscreen where inputs are accepted, rather than treating the entire screen as a uniform input area. This allows certain zones to be designated as input-receptive while others serve as protective buffers against inadvertent activation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The touchscreen interface is segmented into multiple regions: valid input regions where touches are processed and invalid regions where touches are ignored. This segmentation maintains ease of operation within valid zones while preventing errors from touches in boundary or invalid areas.

Inventive Principle:
Principle #1Segmentation

3Reliability

If the device requires complex activation sequences, then reliability is improved by preventing accidental activation, but ease of operation deteriorates

Engineering Contradiction:
ImprovereliabilityVSAvoidease of operation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent requires only partial confirmation for activation - specifically, verification that the touch occurs within a valid region. This partial action approach provides sufficient reliability improvement without requiring excessive confirmation steps that would burden the user.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentUS12548654B2Preventing inadvertent changes in ambulatory medical devices
Publication Date: 2026.02.10 TANDEM DIABETES CARE INC
  • US12548654B2 patent drawing
  • US12548654B2 patent drawing
  • US12548654B2 patent drawing

AI summary

A portable medical device is operated in an active mode in which the device receives a user input at an input interface and provides the received user input to a processor of the device. The active mode is terminated and the device is operated in a safe mode, in which the received user input is not provided to the processor and/or one or more device function is disabled, in response to determining that the received user input was received in an out of bounds region of the input interface. The safe mode is terminated in response to receiving a predetermined user input comprising an activation input.