Prosthetic Valve Baffle Structure for Hemodynamic Flow Control

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Solution Overview

Problem

Transcatheter prosthetic heart valves often fail to replicate the natural hemodynamics of native valves, leading to complications such as turbulent or stagnant flow, which can result in thrombus formation and affect blood flow profiles.

Innovation Solution

A prosthetic valve design incorporating a stent frame and a baffle structure that modifies blood flow to eliminate or reduce turbulent and stagnant regions, promoting laminar or near-laminar flow by using a vortical or laminar flow baffle to mimic the natural velocity profile of native valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional prosthetic valve structure is used, then the valve can be implanted with simple construction, but it fails to replicate natural hemodynamics causing turbulent or stagnant flow

Engineering Contradiction:

Improvehemodynamic performanceVSAvoidvalve structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The valve structure is segmented into multiple functional components: a valve body with leaflets for flow control, a stent frame for structural support, and a baffle structure for flow direction control. This segmentation allows each component to be optimized for its specific function while collectively achieving natural hemodynamics without excessive overall complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A baffle structure is introduced as an intermediary component between the valve body and the outflow tract. This baffle acts as a mediator that redirects blood flow to follow the natural curvature of the left ventricular outflow tract, eliminating turbulent flow patterns without requiring complex valve leaflet designs.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If the valve structure is simplified for easier manufacture, then manufacturing cost and complexity are reduced, but turbulent flow regions increase leading to thrombus formation

Engineering Contradiction:

Improvevalve construction simplicityVSAvoidturbulent flow and thrombus risk

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The flow control function is extracted from the valve leaflets and transferred to a separate baffle structure. This allows the valve leaflets to maintain a simple, conventional design for ease of manufacture while the baffle structure independently handles the flow direction control to prevent turbulence and thrombus formation.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The baffle structure converts the potentially harmful effect of flow separation and turbulence into beneficial vortex flow patterns. By strategically positioning the baffle, the design intentionally creates controlled vortices that follow the natural outflow tract curvature, transforming a harmful flow pattern into a beneficial one that prevents thrombus while maintaining simple valve construction.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If the baffle structure is added to improve flow patterns, then laminar flow is promoted and thrombus risk is reduced, but device complexity increases

Engineering Contradiction:

Improvethrombus resistanceVSAvoidvalve component count

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The baffle structure serves multiple functions simultaneously: it directs blood flow along the outflow tract curvature, creates beneficial vortex patterns, prevents flow stagnation, and reduces turbulence. This multi-functionality achieves thrombus resistance without requiring multiple separate components, thereby limiting the increase in device complexity.

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 baffle structure reduces the likelihood of thrombus formation and improves blood flow profiles by encouraging laminar flow, enhancing the functional performance of the prosthetic valve and mimicking the natural flow patterns of healthy valves.

Implementation Method 1

the baffle structure is configured and located to encourage laminar or near-laminar flow... manipulate a natural profile of blood flow exiting the valve structure to eliminate or reduce turbulent and/or stagnant regions

Methodology Applied

Scientific EffectVortical flow: Vortex Ring

Implementation Method 2

encourage laminar or near-laminar flow... eliminate or reduce turbulent and/or stagnant regions

Methodology Applied

Scientific EffectLaminar flow: Laminar Flow

Data Source

PatentEP3399947B1Prosthetic valve with flow director

Publication Date: 2024.12.25 MEDTRONIC VASCULAR INC

Figure 1A~1C
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AI summary

A prosthetic valve comprising a stent frame, a valve structure, and a baffle structure. The stent frame defines a lumen. The valve structure is disposed within the lumen, and defines an inflow side and an outflow side. An outflow track is established within the lumen downstream of the outflow side and along which fluid flow from the valve structure progresses. The baffle structure is connected to the stent frame downstream of the outflow side. In some embodiments, the baffle structure directs blood flow into designated areas to encourage laminar flow and eliminate or reduce turbulence.