Pulmonary Artery Flow Restrictor With Nitinol Anti-Migration Frame

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Solution Overview

Problem

Current devices for pulmonary artery flow restriction, such as the Medtronic MVP, are prone to migration and do not adequately restrict pulmonary flow, posing risks due to their design for peripheral embolization rather than intended use, and surgical pulmonary banding carries high morbidity and mortality.

Innovation Solution

A pulmonary artery flow restrictor device composed of a smart memory alloy (SMA) wire frame with a thermoplastic layer and a screw mechanism coil, designed for precise placement and retrieval, featuring anti-migration geometry and controlled blood flow through a central aperture, utilizing nitinol for stability and biocompatibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the Medtronic MVP device is modified for use as a flow restrictor, then peripheral embolization function is achieved, but the device migrates off position and collapses

Engineering Contradiction:

Improveflow restrictor functionVSAvoiddevice stability

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The device is divided into distinct functional segments: a flow restrictor portion with central aperture for blood flow control, a mesh portion for structural support and anchoring, and a delivery system portion. This segmentation allows each component to be optimized for its specific function while working together to achieve stable placement and reliable flow restriction.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device combines multiple materials with complementary properties: nitinol (a shape memory alloy) provides superelasticity and shape memory for stable positioning, while the mesh structure provides mechanical support. This composite construction resolves the contradiction by using materials specifically suited for flow restriction and stability rather than adapting a peripheral embolization device.

Inventive Principle:

Principle #40Composite materials

2Productivity

If surgical pulmonary banding is performed, then pulmonary artery flow is restricted, but morbidity and mortality increase

Engineering Contradiction:

Improveflow restriction effectivenessVSAvoidmorbidity and mortality

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical surgical banding system with an endovascular device system. Instead of requiring open thoracic surgery and mechanical banding of the pulmonary artery, the device is delivered via a catheter through the vascular system, achieving the same flow restriction function through a minimally invasive approach that eliminates surgical morbidity and mortality risks.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The device introduces an intermediary endovascular platform between the surgical approach and the flow restriction function. By delivering the flow restrictor through the vascular system rather than requiring direct surgical access, the intermediary delivery system enables the procedure to be performed with minimal invasive techniques, thereby reducing harmful factors while maintaining flow restriction effectiveness.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If a percutaneous implanted intraluminal device is created, then pulmonary artery flow is minimized, but device migration occurs

Engineering Contradiction:

Improvepulmonary flow minimizationVSAvoiddevice positioning stability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The device incorporates dynamic properties through the use of nitinol, a shape memory alloy that exhibits superelasticity and shape memory. These dynamic characteristics allow the device to adapt to physiological conditions, maintain stable positioning through elastic recovery, and resist migration forces while effectively minimizing pulmonary artery flow.

Inventive Principle:

Principle #15Dynamics

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 provides stable, controlled pulmonary flow restriction, minimizing migration and turbulence, suitable for pediatric and adult patients, and can be delivered and retrieved via a minimally invasive procedure, offering a safer alternative to surgical methods.

Implementation Method 1

The device comprises a smart memory alloy (SMA) wire frame partially covered with a thermoplastic layer

Methodology Applied

Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

a thermoplastic layer covering the proximal end of the SMA wire frame... configured to direct blood flow through the at least one central aperture and prevent blood flow through the SMA wire frame

Methodology Applied

Scientific EffectPhysical containment: Physical Containment

Data Source

PatentUS20250325270A1Pulmonary artery flow restrictor

Publication Date: 2025.10.23 REGENTS OF THE UNIVERSITY OF MINNESOTA

AI summary

The invention provides an endovascular device for use in restricting blood flow through the pulmonary artery. The device comprises a smart memory alloy wire frame partially covered with a thermoplastic layer. The device further comprises a screw mechanism coil coupled to the wire frame and/or thermoplastic layer and configured to allow delivery and retrieval of the device.