Infusion Set Strain Relief for Diabetic Catheter Kinking

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Solution Overview

Problem

Infusion sets for diabetic patients face issues such as catheter kinking, irritation, and interference from tubing, leading to delayed or interrupted insulin delivery, which can be exacerbated by movement or external forces affecting the infusion site.

Innovation Solution

The introduction of a strain relief system integrated into the infusion set, including adhesive layers, flexible materials, and Piezo pump devices, which provide 360-degree rotation and absorb movement, reducing micro-motion and tunneling, and incorporating features like oil-impregnated plungers and expanded tubing reservoirs for improved stability and delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a soft Teflon-based catheter is used to infuse insulin under the skin, then irritation at the insertion site is reduced, but the catheter is prone to kinking which can delay or interrupt insulin delivery

Engineering Contradiction:

Improveinsertion site irritationVSAvoidinsulin delivery continuity

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The catheter is constructed from composite materials combining Teflon (PTFE) with reinforcing elements or structural modifications that prevent kinking while maintaining the low-irritation properties of Teflon. This allows the catheter to retain its biocompatibility while gaining mechanical rigidity to prevent collapse or deformation during infusion.

Inventive Principle:

Principle #40Composite materials

2Strength

If a steel infusion needle is used to infuse insulin under the skin, then insertion strength is sufficient, but the needle may irritate the insertion site if moved

Engineering Contradiction:

Improveinsertion strengthVSAvoidinsertion site irritation

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The steel needle is completely removed from the final infusion configuration. Instead, a Teflon-based catheter is used for actual insulin infusion, which is softer and causes less irritation. The needle is only used temporarily during the insertion process and then discarded, separating the insertion function from the infusion function.

Inventive Principle:

Principle #2Taking out (Extraction)

3Ease of operation

If tubing is used to connect the medicament supply to the infusion set, then delivery is enabled, but the tubing can be subject to interference and adversely affect the infusion set

Engineering Contradiction:

Improvemedicament deliveryVSAvoidinfusion set performance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The tubing is integrated with the infusion set components rather than being a separate external element. The strain relief features are incorporated directly into the hub or base of the infusion set, merging the tubing connection and strain relief functions into a unified structure that eliminates interference points.

Inventive Principle:

Principle #5Merging (Combining)

4Stability of the object's composition

If the infusion set is secured to the skin with adhesive, then stability is improved, but movement or external forces can still affect the infusion site

Engineering Contradiction:

Improveinfusion set stabilityVSAvoidmicro-motion and tunneling

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

Strain relief features are incorporated into the infusion set design to absorb and cushion external forces before they can reach the catheter insertion site. These features act as a protective buffer that prevents movement and tunneling by dissipating mechanical stress away from the vulnerable insertion point.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 strain relief system extends the life of infusion sets by minimizing catheter movement, reducing leakage and irritation, and ensuring consistent insulin delivery, while the Piezo pump enhances insertion and reduces skin tenting, improving overall infusion system performance.

Implementation Method 1

The hub or base has an adhesive which retains the base of the set on the skin surface during use

Methodology Applied

Scientific EffectAdhesion: Adhesive

Implementation Method 2

strain relief system integrated into the infusion set, including adhesive layers, flexible materials, and Piezo pump devices, which provide 360-degree rotation and absorb movement

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 3

Piezo pump devices

Methodology Applied

Scientific EffectPiezoelectric effect: Piezoelectric Effect

Data Source

PatentEP2673025B1Improvements in infusion systems

Publication Date: 2025.01.08 BECTON DICKINSON & CO

Figure 1A~1C
Figure 2A~2B
Figure 3A~3C

AI summary

An infusion system comprises an infusion set (30) with one or more advanced features including tube set strain relief (10), infusion pumps having heat exchange abilities and two-direction pumping abilities (100), Piezo pump devices (200), reservoirs (220, 240) made from expanded tubing, and oil impregnated pump plungers (302). An exemplary strain relief (10) includes an adhesive layer (12) such as pressure sensitive adhesive (PSA) secured to a base (14). The base (14) rotatably receives a pin (18) of a tube holder (16). The pin (18) is captured within an opening (22) of the base (14) to allow 360 degree rotation of the tube holder (16).