Modular Infusion Set Segmentation for Powered Components

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Solution Overview

Problem

Infusion systems for administering medicaments, particularly for diabetic therapy, face challenges in maintaining small size, low cost, and safety while avoiding adverse interference between medicament administration and glucose level monitoring, especially due to the need for a single-lumen infusion cannula that is not disclosed in prior art.

Innovation Solution

An infusion set with a single-lumen cannula for subcutaneous medicament delivery, integrated with an on-board energy source and optional functional components like stimulators and delivery supervisory installations, allowing autonomous operation without external power, and separate from the monitoring system to maintain a small skin contact surface and low weight.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Weight of moving object

If an infusion set is made small and lightweight for skin attachment, then it can be worn directly on the skin with remote pump, but it cannot integrate electrically powered functional components without increasing size and weight

Engineering Contradiction:
Improveinfusion set weightVSAvoidfunctional component integration
Core Design Contradiction:
Weight of moving objectVSAdaptability or versatility

Solution Approach 1:

The infusion set is divided into a disposable part (infusion cannula, adhesive patch) and a reusable part (housing with energy source and functional components). This segmentation allows the reusable part to contain electrically powered components while the disposable part remains small and simple for skin attachment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The infusion set employs a disposable part that is replaced regularly (every 2-3 days in diabetic therapy) to maintain sterility, while the expensive reusable part with energy source and functional components is reused. This allows integration of powered components without increasing the cost and size of the disposable portion.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Reliability

If multiple functional components are integrated into the infusion set, then medicament administration is improved, but the skin contact surface area increases

Engineering Contradiction:
Improvemedicament administration effectivenessVSAvoidskin contact surface
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

Functional components (stimulator, sensor, alarm) are integrated into the reusable housing portion that does not contact the skin, while only the minimal necessary infusion cannula and adhesive patch contact the skin. This segmentation maintains small skin contact area while providing enhanced functionality.

Inventive Principle:
Principle #1Segmentation

3Extent of automation

If an on-board energy source is integrated into the infusion set, then functional components can operate autonomously, but manufacturing cost increases

Engineering Contradiction:
Improvefunctional component autonomyVSAvoidinfusion set cost
Core Design Contradiction:
Extent of automationVSEase of manufacture

Solution Approach 1:

The energy source is placed in the reusable part of the infusion set, which is expensive and reused multiple times. The disposable part remains simple and inexpensive to manufacture and replace. This distribution of costs makes the overall system more economically viable while maintaining autonomy.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Device complexity

If a single-lumen infusion cannula is used, then device complexity is reduced, but it cannot support both infusion and monitoring functions simultaneously

Engineering Contradiction:
Improvecannula structureVSAvoidinfusion and monitoring capability
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The infusion function is provided by a simple single-lumen cannula in the disposable part, while monitoring and other functional capabilities are provided by separate components in the reusable housing. This segmentation allows each component to be optimized independently - the cannula remains simple while the system gains versatility.

Inventive Principle:
Principle #1Segmentation

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The infusion set effectively administers medicaments with improved tissue stimulation and flow supervision, reducing pain perception and maintaining system autonomy and cost-effectiveness, while allowing separate monitoring of health parameters without interference.

Implementation Method 1

a stimulator for electrically stimulating body tissue to improve the resorption kinetics of the medicament

Methodology Applied
Scientific EffectElectrical stimulation:

Implementation Method 2

a heating element for heating body tissue to improve the resorption kinetics of the medicament

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 3

an acoustic transducer for vibrating body tissue to improve the resorption kinetics of the medicament

Methodology Applied
Scientific EffectVibration: Vibration

Data Source

PatentEP2353628B1Modular infusion set with an integrated electrically powered functional component
Publication Date: 2021.02.17 F HOFFMANN LA ROCHE & CO AG
  • EP2353628B1 patent drawingFigure 1~3
  • EP2353628B1 patent drawingFigure 4~5
  • EP2353628B1 patent drawingFigure 6~8

AI summary

Infusion set for administering a medicament delivered by an infusion pump (30) which can be carried separately from the infusion set, a) the infusion set comprising a disposable part (1), a reusable part (2), and an electrically powered functional component (7, 8), b) the disposable part (1) comprising: b1) an adhesive underside for attachment at an infusion site on a person's skin, b2) a single lumen infusion cannula (11) which projects from the underside and is the only skin piercing or penetrating element of the infusion set, b3) a first connector (15) for fluidically connecting the cannula to the infusion pump, b4) and a second connector (16), c) and the reusable part (2) comprising: c1) an energy source (21) for electrically powering the functional component (7, 8), c2) and a third connector (26) mating with the second connector (16) of the disposable part (1) to interconnect the disposable part (1) and the reusable part (2), d) wherein the reusable part (2) is in the interconnected state fluidically isolated from the disposable part (1); e) and wherein the disposable part (1) comprises a feeding line (4) fluidically connecting an upstream end of the first connector (15) with a downstream end of the cannula (11) to feed and deliver the medicament via the disposable part (1) and bypass the reusable part (2).