Infusion Pump Safety Sequence Keypad for Real-Time Validation

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Solution Overview

Problem

Infusion pumps do not provide real-time feedback on the validity of user input during programming, leading to potential errors in treatment parameter settings due to incorrect selection of context parameters.

Innovation Solution

A safety sequence keypad that provides context cues to the user after each keypress, analyzing input in real-time to ensure that entered values are within valid treatment parameter ranges, indicated by soft and hard limits defined by the drug library.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the pump waits until the user completes entering and submits an entered value to provide feedback, then the system complexity is reduced, but the reliability decreases because errors are not detected in real-time

Engineering Contradiction:
Improveaccuracy of treatment parameter entryVSAvoidcomplexity of feedback mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs preliminary validation of the entered value against the valid range defined by soft and hard limits before the user submits the value. The keypad sequence monitor continuously monitors the sequence value as the user enters it, and provides feedback about validity in real-time, allowing the user to correct errors before final submission.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements real-time feedback by displaying context cues that indicate whether the current sequence value is within the valid treatment parameter range. The feedback includes visual indicators showing if the value is below the lower soft limit, above the upper soft limit, or within the valid range, allowing the user to adjust the entry immediately.

Inventive Principle:
Principle #23Feedback

2Reliability

If the pump provides real-time feedback after each keypress, then the reliability improves by preventing errors, but the device complexity increases due to continuous monitoring requirements

Engineering Contradiction:
Improveprevention of incorrect therapy deliveryVSAvoidcomplexity of sequence monitoring system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system prepares the valid range (lower and upper soft limits, lower and upper hard limits) in advance from the drug library based on selected context parameters. This preliminary preparation allows for efficient real-time comparison without requiring complex calculations during the entry process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The keypad sequence monitor provides continuous real-time feedback by comparing the current sequence value with the pre-established valid range. The system displays context cues that immediately indicate whether the entered value is valid or invalid, and if invalid, what context parameter changes would make it valid.

Inventive Principle:
Principle #23Feedback

3Loss of time

If the pump indicates validity only after submission, then the ease of operation is maintained with simple input processing, but the loss of time increases due to delayed error detection

Engineering Contradiction:
Improvetime to detect and correct entry errorsVSAvoidsimplicity of data entry process
Core Design Contradiction:
Loss of timeVSEase of operation

Solution Approach 1:

The system performs the validation check in advance during the data entry process itself, rather than waiting until after submission. The keypad sequence monitor continuously checks the sequence value against the valid range as the user enters each digit, detecting errors before the user completes the entry and submits.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides immediate feedback about the validity of the entered value during the data entry process. Context cues are displayed in real-time to indicate whether the current sequence value is within the valid treatment parameter range, allowing the user to correct errors immediately without delaying the overall process.

Inventive Principle:
Principle #23Feedback

4Adaptability or versatility

If the pump provides context cues for updated context parameters, then the adaptability improves by guiding users to correct settings, but the device complexity increases due to additional processing requirements

Engineering Contradiction:
Improveability to guide users to valid settingsVSAvoidcomplexity of context parameter processing
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system provides feedback not only about the validity of the entered value but also about which context parameter changes would make the value valid. The keypad sequence monitor identifies and displays context cues indicating the specific context parameter (e.g., drug selection, concentration, clinical care area) that, if changed, would result in the entered value becoming within the valid range.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically adjusts the valid range based on changes in context parameters. When the user selects different context parameters (drug, concentration, clinical care area), the system retrieves the corresponding soft and hard limits from the drug library and updates the valid treatment parameter range, providing guidance on how parameter changes affect validity.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4070180B1Infusion pump with safety sequence keypad
Publication Date: 2025.09.17 ICU MEDICAL INC
  • EP4070180B1 patent drawingFigure 1
  • EP4070180B1 patent drawingFigure 2
  • EP4070180B1 patent drawingFigure 3A

AI summary

An infusion pump is configured to provide one or more context cues to a user while the user programs the infusion pump to deliver an infusion therapy. In some embodiments, the infusion pump includes a display configured to display a keypad and to receive input from a user, a processor in communication with the display, and a memory in communication with the processor. The memory stores instructions that cause a keypad sequence monitor to receive context parameters, the context parameters corresponding to a drug selection, a drug concentration selection, or a clinical care area in which the drug is to be infused. The keypad sequence monitor accesses a drug library using the context parameter to determine a valid parameter range corresponding to a range of values between lower and upper soft limit values stored in the drug library. The keypad sequence monitor is further configured to receive an treatment parameter value from the user and display one or more context cues upon determining that the received treatment parameter value is outside of a valid treatment parameter range, but would be within a valid treatment parameter range if one of the context parameters were changed.