Variable Aortic Occlusion Balloon for Counterpulsation

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Solution Overview

Problem

Current aortic valve replacement procedures face challenges in controlling hemodynamic forces and stabilizing tools due to incomplete occlusion of the aorta, which affects both antegrade and retrograde blood flow, necessitating a system that can adjust occlusion levels during different cardiac cycle phases and procedure stages.

Innovation Solution

A variable occlusion device positioned in the ascending aorta above the Sinus of Valsalva, which expands during diastole to limit regurgitation and contracts during systole to maximize antegrade flow, using inflatable elements like balloons to control the degree of occlusion synchronously with the cardiac cycle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the aorta is occluded to limit aortic regurgitation during valve replacement procedures, then aortic regurgitation is reduced, but forward blood flow patency through the aorta is compromised

Engineering Contradiction:
Improveaortic regurgitationVSAvoidforward blood flow
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The balloon occlusion device transitions from a static fixed-balloon design to a dynamic counterpulsating system that alternates between inflation and deflation phases synchronized with the cardiac cycle. The balloons are inflated during diastole to limit retrograde flow and deflated during systole to maximize antegrade flow, creating a dynamic adaptation that resolves the contradiction between limiting regurgitation and maintaining forward flow patency.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system implements periodic counterpulsation by synchronizing balloon inflation and deflation with the cardiac cycle phases. Balloons are inflated during diastole to prevent retrograde flow and deflated during systole to allow forward flow, creating a periodic action pattern that alternates between these two states. This periodic modulation resolves the contradiction by applying occlusion only when needed (during diastole) and removing it when forward flow is required (during systole).

Inventive Principle:
Principle #19Periodic action

2Object-affected harmful factors

If fixed partial occlusion is used to control regurgitation, then aortic regurgitation is limited, but the degree of occlusion cannot be adjusted during different procedure stages

Engineering Contradiction:
Improveaortic regurgitationVSAvoidadjustability of occlusion degree
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The system replaces the fixed, static balloon occlusion with a dynamic counterpulsating mechanism that can adapt its occlusion degree in real-time. The balloons are controlled to inflate and deflate in synchronization with the cardiac cycle, allowing the degree of occlusion to be dynamically adjusted between maximum (fully inflated during diastole) and minimum (deflated during systole). This dynamic capability provides the adaptability needed for different procedure stages while maintaining effective regurgitation control.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the occlusion parameter dynamically by controlling the inflation and deflation of balloons during different phases of the cardiac cycle. During diastole, the balloons are inflated to a specific volume to achieve the desired degree of occlusion for limiting regurgitation. During systole, the balloons are deflated to reduce occlusion and maximize forward flow. This parameter change strategy allows continuous adjustment of occlusion degree to match procedural needs.

Inventive Principle:
Principle #35Parameter changes

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 solution allows for optimized coronary perfusion and reduced aortic regurgitation during valve replacement procedures by adjusting occlusion levels, enhancing procedural stability and safety by minimizing interference with blood flow.

Implementation Method 1

The balloon structure includes six identical cylindrical balloons disposed coaxially and symmetrically about the body of the catheter

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS10881412B2Method and system for balloon counterpulsation during aortic valve replacement
Publication Date: 2021.01.05 HOCOR CARDIOVASCULAR TECHNOLOGIES LLC
  • US10881412B2 patent drawing
  • US10881412B2 patent drawing
  • US10881412B2 patent drawing

AI summary

Methods and systems for regulating aortic regurgitation during aortic valve replacement or repair procedures utilize a temporary aortic valve (TAV) catheter and a controller. The temporary aortic valve catheter has an expandable occlusion device which can partially occlude the aortic lumen during ventricular diastole with a lesser occlusion during ventricular systole. Exemplary balloon structures include multiple, independently inflatable balloons which are inflated in synchrony with the cardiac cycle by the controller. By controlling aortic regurgitation, the repair or replacement protocols can be conducted with less interference from blood flow.