LAA Occlusion via Nested Balloon Segmentation

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Solution Overview

Problem

Current methods for occluding the left atrial appendage (LAA) to prevent strokes in atrial fibrillation patients are inadequate due to incomplete closure, risk of bleeding, and puckering of the LAA ostium, particularly in elderly patients, with existing devices like the WATCHMAN and LARIAT systems experiencing gaps and trauma-related complications.

Innovation Solution

The use of an epicardial approach with multiple inflatable balloons and electromagnetic or magnetic forces to achieve a complete occlusion of the LAA ostium without puckering, employing a closure device with a suture looped around semi-rigid tubes and biocompatible coatings for enhanced sealing and safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing occlusion devices (WATCHMAN, LARIAT) are used to close the LAA, then stroke prevention is achieved, but incomplete closure and gaps remain, leading to persistent bleeding risk

Engineering Contradiction:

Improveclosure completenessVSAvoidbleeding risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The closure device is divided into multiple separate elements: a first element that occludes the LAA ostium and a second element that occludes the LAA body. This segmentation allows each element to be optimized for its specific function and ensures complete closure by addressing different portions of the LAA independently, eliminating gaps that would persist with a single-device approach.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent employs a nested structure where the second occlusion element (for the LAA body) is delivered through and positioned within the first occlusion element (at the ostium). This nested delivery system ensures proper positioning of both elements and allows the smaller distal element to be accurately placed within the LAA body while the proximal element seals the ostium, achieving complete closure without gaps.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If conventional occlusion methods are applied, then LAA closure is attempted, but puckering of the LAA ostium occurs, particularly in elderly patients

Engineering Contradiction:

Improveclosure stabilityVSAvoidostium morphology

Core Design Contradiction:

ReliabilityVSShape

Solution Approach 1:

The invention applies different occlusion strategies to different local regions of the LAA. The first element is specifically designed to occlude the ostium with a shape and size matched to the local anatomy, while the second element addresses the body of the LAA. This localized approach prevents puckering by ensuring the ostium is occluded without excessive compression or distortion of the surrounding tissue, which is particularly important in elderly patients with more fragile vasculature.

Inventive Principle:

Principle #3Local quality

3Reliability

If existing devices are deployed to occlude LAA, then stroke prevention is achieved, but trauma and bleeding complications occur during deployment

Engineering Contradiction:

Improvestroke prevention efficacyVSAvoidprocedure-related trauma

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent introduces a delivery system that acts as an intermediary between the operator and the occlusion devices. The catheter-based delivery system with controlled deployment mechanisms allows the occlusion elements to be positioned and released with precision, minimizing trauma during deployment. The system enables gradual expansion and positioning of the occlusion elements, reducing the risk of sudden tissue damage and bleeding complications while ensuring effective stroke prevention.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

This method ensures a reliable and safe complete occlusion of the LAA, reducing the risk of bleeding and trauma, while maintaining hemostasis and preventing embolic strokes by effectively sealing the LAA ostium without the complications associated with existing technologies.

Implementation Method 1

The use of an epicardial approach with multiple inflatable balloons and electromagnetic or magnetic forces to achieve a complete occlusion of the LAA ostium without puckering

Methodology Applied

Scientific EffectElectromagnetic force: Electromagnetic Induction

Implementation Method 2

The use of an epicardial approach with multiple inflatable balloons and electromagnetic or magnetic forces to achieve a complete occlusion of the LAA ostium without puckering

Methodology Applied

Scientific EffectInflation pressure: Pressure Increase

Data Source

PatentUS10952736B2Methods and systems for preventing bleeding from the left atrial appendage

Publication Date: 2021.03.23 KRISHNAN SUBRAMANIAM CHITOOR

AI summary

The disclosure presents methods and systems for applying a suction force to a surface of a left atrial appendage (LAA) with a tube attached to an exterior surface of an inflatable balloon. The disclosure also presents methods and systems for inflating a first inflatable balloon within a cavity of a left atrial appendage (LAA). A method may include applying a suction force with at least one tube coupled to the first inflatable balloon to attract the first inflatable balloon to an interior surface of the LAA or to a second inflatable balloon. A method may include puncturing, using a tissue-penetrating tip, a target surface of the LAA.