Rotationally Activated Flow Control Valve for Vascular Access Sealing

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Solution Overview

Problem

Vascular access devices face challenges in maintaining a secure seal during connection and disconnection of medical devices, leading to potential infections and fluid leaks due to stress on the septum, which can result in tearing and imperfect sealing.

Innovation Solution

A rotationally activated flow control valve with a septum and sealing bead that automatically opens and closes with minimal fluid restriction, using a disk with a slit and posts that deform to allow fluid flow, reducing stress on the septum and enhancing sealing efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a septum is used to seal the vascular access device, then fluid leakage is prevented, but the septum is prone to tearing and imperfect sealing during device connection and disconnection

Engineering Contradiction:
Improvesealing reliabilityVSAvoidseptum strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The septum is divided into two separate components: a stationary septum portion attached to the hub and a movable septum portion attached to the cap. This segmentation allows each component to perform its specific function independently, with the movable portion absorbing the stress of connection and disconnection actions, thereby preventing tearing while maintaining sealing reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention introduces a dynamic sealing mechanism where the movable septum portion can shift position in response to applied forces. During cap engagement, the movable septum portion moves to accommodate the connection, and during disengagement, it returns to its original position. This dynamic behavior reduces stress concentration and prevents tearing while ensuring consistent sealing.

Inventive Principle:
Principle #15Dynamics

2Reliability

If a valve is added to control fluid flow, then fluid leakage is reduced, but device complexity increases

Engineering Contradiction:
Improvefluid flow controlVSAvoidvalve mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The valve mechanism is merged with the cap assembly rather than being a separate component. The cap itself serves as the valve body, with the movable septum portion acting as the valve element. This integration eliminates the need for additional valve components while providing effective fluid flow control, thus reducing overall device complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The cap assembly performs multiple functions: it seals the hub, controls fluid flow through the integrated valve, and protects the vascular access device during transport. By combining these functions into a single component, the design avoids adding complexity while achieving reliable fluid flow control.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If the septum is compressed to form a seal, then sealing efficiency is improved, but stress on the septum increases leading to potential tearing

Engineering Contradiction:
Improvesealing efficiencyVSAvoidseptum stress
Core Design Contradiction:
ReliabilityVSStress or pressure

Solution Approach 1:

The stationary and movable septum portions are separated, with the movable portion bearing the compressive stress during sealing. This segmentation protects the stationary septum from excessive stress that could cause tearing, while the movable portion is designed to withstand and distribute the compressive forces evenly.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The movable septum portion acts as a cushioning element that absorbs and distributes compressive stress before it reaches the stationary septum. This pre-cushioning effect reduces peak stress concentrations that could lead to tearing, while maintaining effective sealing through the movable portion's deformation.

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 solution provides a reliable and efficient sealing mechanism that minimizes fluid leakage and reduces the risk of septum tearing, ensuring better flush properties and maintaining a secure seal during medical device transitions.

Implementation Method 1

a fluid seal formed by compression of the sealing bead against a distal face of the annular wall

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

rotation of the proximal adapter causes the posts to deform the slit of the septum to open the valve

Methodology Applied
Scientific EffectDeformation: Deformation

Data Source

PatentEP3632502B1Rotationally activated blood control
Publication Date: 2023.06.28 BECTON DICKINSON & CO
  • EP3632502B1 patent drawingFigure 1
  • EP3632502B1 patent drawingFigure 2
  • EP3632502B1 patent drawingFigure 3

AI summary

A medical device having a vascular access device including a rotationally activated flow control valve having, a body including a distal adapter and a proximal adapter defining a lumen extending therethrough and a septum. A method of use in which the connection of first and second medical devices results in the automatic activation of the rotational flow control valve.