Left Atrial Balloon Modulating Pressure for Heart Failure
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Solution Overview
Problem
Current treatments for Heart Failure with preserved Ejection Fraction (HFpEF) are inadequate, as they fail to effectively address the underlying atrial dysfunction and stiffness, leading to pulmonary congestion and right-sided heart failure, especially in patients with Atrial Fibrillation, due to the inability to restore complete left atrial functionality.
Innovation Solution
A system comprising a pressurizing element, such as a balloon, positioned in the left atrium, controlled by circuitry to modulate pressure during different phases of the cardiac cycle, increasing relative volume during diastole and reducing it during systole to enhance diastolic filling of the left ventricle, and optionally including a second pressurizing element in the pulmonary artery to coordinate pressure modifications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a pressurizing element is used to increase left atrial pressure during systole, then left ventricular filling is improved, but device complexity increases
Solution Approach 1:
The cardiac cycle is segmented into distinct phases (diastole and systole), with the pressurizing element performing different functions in each phase: increasing volume during diastole to reduce filling pressure, and decreasing volume during systole to increase pressure differential for ventricular filling. This temporal segmentation allows a single device to address multiple hemodynamic requirements.
Solution Approach 2:
The pressurizing element dynamically changes its volume based on the phase of the cardiac cycle, transitioning between expanded and contracted states. This dynamic behavior allows the device to adapt to the changing hemodynamic requirements of the heart, providing pressure support when needed while minimizing interference with natural cardiac function.
2Stress or pressure
If left atrial pressure is increased during systole, then pressure differential is improved, but energy consumption increases
Solution Approach 1:
The pressurizing element operates periodically, synchronizing its volume changes with the natural rhythm of the cardiac cycle. By activating only during specific phases (increasing volume during diastole, decreasing volume during systole) and remaining inactive during other phases, the device minimizes energy consumption while maintaining effective pressure differential when physiologically beneficial.
Solution Approach 2:
The system uses feedback from cardiac cycle detection to timing the pressurizing element's operation. The control circuitry monitors cardiac activity and triggers volume changes at optimal moments in the cardiac cycle, ensuring that energy is expended only when it will produce the desired hemodynamic effect of increasing pressure differential during systole.
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 approach reduces pulmonary congestion, improves left ventricular filling, and enhances cardiac output by restoring atrial compliance and functionality, effectively addressing the challenges faced in HFpEF and Atrial Fibrillation.
Implementation Method 1
The walls of the Left Atrium (LA) become stiffer and less compliant leading to a reduction in Left Atrial reservoir strain (expansion during filling) and active strain (compression during emptying)
Implementation Method 2
the increase in the left atrial pressure during atrial systole increases a pressure differential between the left atrium and a left ventricle that improves diastolic filling of the left ventricle
Data Source
AI summary
A system for treating atrial dysfunction, including heart failure and/or atrial fibrillation, that includes one or more pressurizing elements and control circuitry. The one or more pressurizing elements can comprise one or more balloons and can be configured to be positioned in the left atrium, and optionally the pulmonary artery, of a patient's heart. The one or more pressurizing elements can be coupled to one or more positioning structures that can be configured to position the one or more pressurizing elements in the left atrium, and optionally the pulmonary artery. The control circuitry can be configured to operate the one or more pressurizing elements to decrease or increase pressure and/or volume in the left atrium, and optionally the pulmonary artery, in accordance with different phases of the cardiac cycle. The control circuitry can be further configured to operate the one or more pressurizing elements to generate coordinated pressure modifications in the left atrium, and optionally the pulmonary artery.