Implantable Access Device Valve Assembly Actuation

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Solution Overview

Problem

Existing subcutaneously implanted vascular access ports face issues with needle penetration damaging the septum, limited fluid flow rates, and difficulty in clearing thrombosis due to perpendicular needle insertion and 90° bend in the fluid flow path, leading to complications like hemolysis and thrombus formation.

Innovation Solution

An implantable access device with a valve assembly that changes its operating condition from unactuated to actuated by a needle, featuring a spring element to constrain the valve in the unactuated state and radially expand to allow fluid flow, reducing the risk of damage and facilitating easy cleaning, with a flexible tubing passageway and a needle receptacle to prevent penetration damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a needle is inserted percutaneously into a vessel for repeated access, then simple and inexpensive access is provided, but vessel thrombosis, stenosis, pseudo-aneurism formation, and infections occur

Engineering Contradiction:
Improvesimplicity and cost of access methodVSAvoidvessel integrity and infection risk
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The access system is divided into separate components: a percutaneous needle for initial access, a subcutaneous port chamber for fluid infusion, and a catheter for vessel access. This segmentation allows the needle to be removed after initial access, eliminating repeated punctures while maintaining simple access through the skin.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A subcutaneous port chamber serves as an intermediary device between the percutaneous needle and the intravascular catheter. The port chamber with its self-sealing septum allows fluid transfer without requiring repeated needle insertions into the vessel, reducing thrombosis and infection risks while maintaining simple access.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If transcutaneous catheters are used to avoid repeated needle insertion, then vessel access stability is improved, but infections at the skin penetration point occur

Engineering Contradiction:
Improvevessel access stabilityVSAvoidinfection risk at skin penetration point
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system separates the skin penetration function (needle through septum) from the vessel access function (catheter in vessel). The subcutaneous port chamber acts as an isolated intermediate chamber that can be accessed through the skin without creating a continuous open pathway to the vessel, reducing infection risk while maintaining stable access.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The percutaneous needle is designed as a temporary, disposable component used only for initial access and fluid transfer to the port chamber. After transferring fluid, the needle is removed and discarded, eliminating the need for repeated skin punctures and reducing cumulative infection risk while maintaining simple access methodology.

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

3Device complexity

If a 90° bend is included in the fluid flow path from perpendicular needle to subcutaneous catheter, then compact port design is achieved, but hemolysis occurs due to damage to blood

Engineering Contradiction:
Improveport chamber compactnessVSAvoidhemolysis and blood damage
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The fluid flow path is redirected from a perpendicular arrangement (90° bend) to a collinear arrangement (180° angle) by changing the dimensional orientation of the catheter relative to the port chamber. The catheter exits the port chamber in the opposite direction of needle insertion, creating a straight-line flow path that eliminates turbulent 90° bends while maintaining compact port design through optimized component layout.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 device ensures safe and efficient fluid flow with reduced risk of valve damage, supports high flow rates, and simplifies thrombosis clearance, minimizing complications such as hemolysis and thrombus formation, while being easy to manufacture and use.

Implementation Method 1

at least one spring element to constrain the at least one valve assembly into the first, unactuated operating condition

Methodology Applied
Scientific EffectElastic force: Elasticity

Implementation Method 2

the at least one valve assembly in the first, unactuated operating condition is longitudinally elongated and radially compressed in such a way to prevent a fluid flow through the at least one passageway and that the at least one valve assembly in the second, actuated operating condition is longitudinally compressed and radially elongated in such a way to permit a fluid flow through the at least one passageway

Methodology Applied
Scientific EffectRadial expansion and longitudinal compression: Deformation

Data Source

PatentEP3381501B1Implantable access device for accessing the vascular system of a human or animal body
Publication Date: 2024.05.29 PFM MEDICAL AG
  • EP3381501B1 patent drawingFigure 1~2
  • EP3381501B1 patent drawingFigure 3~4
  • EP3381501B1 patent drawingFigure 5a~5c

AI summary

The invention relates to an implantable access device (1) for accessing the vascular system of a human or animal body (2), particularly subcutaneously implantable access port, comprising: at least one inlet opening (4), at least one outlet opening (5) and at least one passageway (6) between the at least one inlet opening (4) and the at least one outlet opening (5), further comprising at least one valve assembly (7) in the at least one passageway (6), which in a first, unactuated operating condition prevents a fluid flow through the at least one passageway (6) and in a second, actuated operating condition permits a fluid flow through the at least one passageway (6), which is characterized in that the at least one valve assembly (7) in the first, unactuated operating condition is longitudinally elongated and radially compressed in such a way to prevent a fluid flow through the at least one passageway (6) and that the at least one valve assembly (7) in the second, actuated operating condition is longitudinally compressed and radially elongated in such a way to permit a fluid flow through the at least one passageway (6).