Linked Vascular Valve Frames for Axial Stability Under Cyclic Pressure

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Solution Overview

Problem

Current therapies for venous insufficiency, such as vein stripping and laser treatments, are destructive and fail to effectively restore venous flow and valvular competence due to positional instability in the vessel, exacerbated by hydrostatic cyclic pressure loading.

Innovation Solution

Prosthetic vascular valves with a frame design featuring a high aspect ratio and shape-memory material that maintains axial orientation and vessel wall contact under dynamic loading, utilizing a frame with stabilizing structures and a membrane that adjusts to vessel dimensions, ensuring consistent operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If prosthetic vascular valves are implanted in veins subjected to hydrostatic cyclic pressure loading, then venous flow can be restored, but positional instability occurs causing loss of axial orientation and valve effectiveness

Engineering Contradiction:

Improvevalvular functionVSAvoidaxial orientation

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The frame is divided into multiple discrete segments or struts rather than a continuous structure. These segmented elements can independently adjust to pressure loading while maintaining overall axial alignment, preventing the valve from rotating or migrating under hydrostatic cyclic pressure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The frame incorporates dynamic elements that can adapt their configuration in response to pressure changes. The frame structure flexes and deforms elastically under hydrostatic pressure to maintain contact with the vessel wall while preserving axial orientation, allowing the valve to remain effective throughout the cardiac cycle.

Inventive Principle:

Principle #15Dynamics

2Stability of the object's composition

If frame structure is made rigid to maintain axial orientation, then positional stability improves, but adaptability to vessel wall contact under dynamic loading decreases

Engineering Contradiction:

Improveaxial orientationVSAvoidvessel wall contact

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The frame utilizes flexible, thin-walled tubular structures that can deform elastically under pressure. These flexible frame elements maintain axial orientation through their geometric design while adapting their shape to maintain contact with the pulsating vessel wall throughout the cardiac cycle.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The frame material or structure changes its mechanical parameters (such as flexibility or stiffness) in response to pressure loading. This allows the frame to be sufficiently rigid to maintain axial orientation while becoming more compliant under dynamic loading to ensure continuous vessel wall contact.

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If frame aspect ratio is increased to improve axial stability, then axial orientation is maintained, but device complexity increases

Engineering Contradiction:

Improveaxial alignmentVSAvoidframe structure

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The high aspect ratio frame structure serves multiple functions simultaneously: it provides axial stability, maintains vessel wall contact, and anchors the valve in position. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in overall device complexity despite the elevated aspect ratio.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 prosthetic vascular valves provide stable venous flow and valvular function by maintaining axial alignment and contact with the vessel wall, effectively addressing venous insufficiency and other circulatory issues, including those caused by elevated central vein pressures.

Implementation Method 1

a frame with stabilizing structures and a membrane that adjusts to vessel dimensions, ensuring consistent operation

Methodology Applied

Scientific EffectShape-memory material: Shape Memory Alloy

Implementation Method 2

maintains axial orientation and vessel wall contact under dynamic loading

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS12485027B2Prosthetic vascular valves having linked frame segments

Publication Date: 2025.12.02 INCUBAR LLC

AI summary

A device for implantation in the vasculature of a patient includes a first frame segment and a second frame segment. The first frame segment includes a first frame and a first membrane attached to the first frame. The second frame segment is linked by a linkage to the first frame segment. The second frame segment includes a second frame and a second membrane attached to the second frame.