Flushable Catheter Assembly Septum Activator

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Solution Overview

Problem

Current infusion therapies face complications due to regions of stagnant fluid flow in vascular access devices and extravascular systems, leading to trapped blood, air bubbles, and medications, which can cause infections, tissue damage, and unintended effects.

Innovation Solution

A flushable peripheral IV catheter assembly with a septum and septum activator that allows selective activation of fluid flow, preventing stagnant flow regions by using a flexible or semi-flexible septum with air vent channels and flow deflectors to ensure controlled flashback and proper fluid dynamics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a septum is used to prevent fluid flow through the catheter adapter, then blood exposure is prevented, but fluid flow activation becomes complex

Engineering Contradiction:
Improveblood exposureVSAvoidfluid flow activation
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

A valve mechanism with a valve member is introduced as an intermediary between the septum and the fluid flow path. The valve member can be selectively positioned to either block or permit fluid flow through the catheter adapter, simplifying the activation process while maintaining blood protection during insertion

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The function of controlling fluid flow is extracted from the septum itself and assigned to a separate valve mechanism. This allows the septum to focus on its primary function of preventing blood exposure during insertion, while the valve mechanism handles fluid flow activation independently

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If manual occlusion of the vein is performed to prevent blood exposure, then blood exposure is reduced, but the operation becomes difficult and time-consuming

Engineering Contradiction:
Improveblood exposureVSAvoidcatheter adapter coupling
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The valve mechanism is pre-configured in a closed position before catheter insertion. This preliminary state automatically prevents blood exposure during the coupling operation, eliminating the need for manual occlusion. The valve remains in this protective state until fluid flow is intentionally activated

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the catheter adapter is attached to IV tubing before catheter placement, then blood exposure is prevented, but flashback is prevented and fluid flow control is lost

Engineering Contradiction:
Improveblood exposureVSAvoidflashback verification
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The valve mechanism transitions from a static closed state during insertion to a dynamically controllable state after placement. The valve can be selectively opened to permit flashback verification and controlled fluid flow, while maintaining protection during the critical insertion phase

Inventive Principle:
Principle #15Dynamics

4Stability of the object's composition

If regions of stagnant fluid flow exist in the vascular access device, then valve mechanism conformation is maintained, but trapped blood and air bubbles cause infections and complications

Engineering Contradiction:
Improvevalve mechanism conformationVSAvoidtrapped blood and air bubbles
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The valve mechanism is designed to maintain continuous fluid flow through the catheter adapter when activated, preventing stagnant regions. The flow path is configured to ensure that fluid continuously moves through all areas of the valve mechanism, eliminating dead zones where blood or air bubbles could become trapped

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The valve mechanism incorporates specific structural features in critical areas to prevent stagnation. The conformation of the valve member and surrounding structures is optimized to guide fluid flow continuously through all regions, ensuring no localized stagnant zones exist when the valve is open

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3308825B1Systems and methods for providing a flushable catheter assembly
Publication Date: 2020.04.01 BECTON DICKINSON & CO
  • EP3308825B1 patent drawingFigure 1~3
  • EP3308825B1 patent drawingFigure 4
  • EP3308825B1 patent drawingFigure 5A

AI summary

A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit "flashback" of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.