Ambulatory Infusion Pump Step Therapy With Adjustable Rate Ramping

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Solution Overview

Problem

Conventional ambulatory infusion pumps are cumbersome to set up and program for therapies requiring step-wise delivery profiles, such as IVIG, due to complex spreadsheet-based systems that lack customization options during infusion.

Innovation Solution

An ambulatory infusion pump with a graphical user interface (GUI) that allows users to input parameters for a step delivery function, including initial rate, plateau rate, step duration, rate increment, and total infusion volume, with a processor calculating infusion duration and automatically adjusting delivery rates based on user input.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional spreadsheet-based profiles are used for step therapy delivery, then the infusion pump can deliver complex step-wise delivery profiles, but the setup and programming becomes complicated and time-consuming

Engineering Contradiction:
Improvestep therapy delivery capabilityVSAvoidsetup and programming complexity
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent transforms the complex spreadsheet-based profile system into a simplified parameter-based configuration system. Instead of requiring users to work with complex spreadsheets, the system accepts simple parameters (initial rate, plateau rate, step duration, rate increment, total infusion volume) and automatically generates the step therapy delivery profile. This parameter change approach resolves the contradiction by maintaining adaptability for complex therapies while dramatically improving ease of operation.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional fixed spreadsheet profiles are used, then the infusion profile is predetermined, but the profile cannot be adjusted or customized during infusion to accommodate patient needs

Engineering Contradiction:
Improvepredetermined infusion profileVSAvoidreal-time customization capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic adjustability in the infusion system. The step therapy delivery profile is no longer fixed but can be modified in real-time based on patient tolerance and clinical needs. Users can adjust parameters such as step duration, rate increment, and plateau rate during the infusion process. This dynamic approach resolves the contradiction by maintaining reliable predetermined profiles while adding real-time customization capability.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If conventional pumps require manual calculation of infusion duration, then the system is simpler, but the process becomes time-consuming and prone to errors

Engineering Contradiction:
Improvesystem structureVSAvoidinfusion duration calculation time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The patent implements automatic calculation of infusion duration based on the parameters provided by the user. The system self-calculates the infusion duration using the formula: infusion duration = (total infusion volume - (initial rate × step duration × number of steps)) / plateau rate, and adds this automatically to the profile. This self-service approach resolves the contradiction by maintaining simple system structure while eliminating time-consuming manual calculations and reducing errors.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP4035708A1Advanced step therapy delivery for an ambulatory infusion pump and system
Publication Date: 2022.08.03 ICU MEDICAL INC
  • EP4035708A1 patent drawingFigure 1a~1b
  • EP4035708A1 patent drawingFigure 2
  • EP4035708A1 patent drawingFigure 3~4

AI summary

Embodiments relate to systems, methods and devices for delivering a drug or other therapy to a patient with an ambulatory infusion pump configured to provide a series of tolerance-building steps leading up to a plateau delivery rate. The plateau delivery rate is maintained until the prescribed amount of drug or therapy fluid is delivered to the patient. Embodiments of the invention include providing the patient or other user with a mechanism to decrease, or step down, the therapy delivery rate if a tolerance was not achieved at a lower rate, and providing notifications prior to a step up in a dosage delivery rate.