LAA Conduit for Flow Stagnation in Atrial Fibrillation

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Solution Overview

Problem

Existing methods to prevent flow stagnation in the left atrial appendage (LAA) are inadequate, particularly in cases of atrial fibrillation, as they either occlude the LAA, which is undesirable due to risks and anatomical variations, or simply remodel/dilate, which does not effectively address the issue of reduced blood flow and potential clot formation.

Innovation Solution

A prosthetic conduit is implanted to direct blood flow from the pulmonary vein into the LAA, using a radially collapsible and expandable tubular body with an inlet portion anchored in the pulmonary vein or LAA, directing blood flow to minimize stagnation and thrombus formation by leveraging pressure differentials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If occlusion of the LAA is performed to prevent flow stagnation, then clot formation risk is reduced, but the LAA loses its compliance chamber function and hormone source capability

Engineering Contradiction:

Improveclot formation preventionVSAvoidLAA compliance chamber function

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device segments the LAA into two functional zones: an occluded portion (distal to the implant site) that prevents clot formation, and a patent portion (proximal to the implant site) that maintains compliance chamber function and hormone secretion. The implant creates a partition within the LAA rather than complete occlusion.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implant provides localized occlusion only at the distal portion of the LAA where clot formation occurs, while leaving the proximal portion patent to maintain physiological functions. This localized approach preserves regional functionality while addressing the specific problem of clot formation.

Inventive Principle:

Principle #3Local quality

2Stability of the object's composition

If occlusion devices are mounted to tissue surrounding the LAA to secure them, then device stability is improved, but the risk of rupture and pericardial effusion increases due to thin surrounding tissue

Engineering Contradiction:

Improvedevice stabilityVSAvoidrupture and pericardial effusion risk

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The implant is nested within the LAA lumen itself rather than being mounted to external tissue. The device fits inside the anatomical structure, using the LAA's own walls for support and stability, thereby avoiding the need to anchor to thin surrounding tissue.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The implant acts as an intermediary structure within the LAA that provides device stability through its own structural integrity and interaction with blood flow, rather than relying on anchoring to surrounding tissue. The device's design allows it to stabilize itself within the LAA without compromising adjacent structures.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Shape

If simple remodeling or dilation of the LAA is performed, then anatomical structure is improved, but flow stagnation persists due to lack of atrial contraction in atrial fibrillation

Engineering Contradiction:

ImproveLAA anatomical structureVSAvoidblood flow velocity

Core Design Contradiction:

ShapeVSSpeed

Solution Approach 1:

The implant extracts or removes the stagnant blood from the distal LAA by creating an occlusion that redirects flow. This eliminates the stagnant portion where clots form, addressing the flow velocity problem without requiring changes to atrial contraction mechanics.

Inventive Principle:

Principle #2Taking out (Extraction)

4Adaptability or versatility

If the LAA geometry varies from person to person as noted, then anatomical adaptability is required, but occlusion of the oval-shaped ostium with an implant becomes difficult

Engineering Contradiction:

Improveanatomical adaptabilityVSAvoidocclusion device implantation difficulty

Core Design Contradiction:

Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The implant is designed with dynamic characteristics that allow it to adapt to varying LAA geometries. The device can conform to different anatomical configurations while maintaining its occlusion function, making it easier to implant across diverse patient populations.

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 conduit increases blood flow through the LAA, reducing the risk of clot formation and stroke by enhancing flow velocity and volume, thereby protecting against flow stagnation and thrombus formation in patients with atrial fibrillation.

Implementation Method 1

directing a flow of blood from the pulmonary vein through a lumen of the conduit and outwardly through an outlet portion of the conduit... leveraging pressure differentials

Methodology Applied

Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentUS10206799B2Device and method for increasing flow through the left atrial appendage

Publication Date: 2019.02.19 EDWARDS LIFESCIENCES CORP

AI summary

Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.