Toroid Balloon Assemblies With Perfusion Lumen for Heart Valve Procedures
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Solution Overview
Problem
Existing balloon-based heart valve procedures risk blocking or restricting blood flow, potentially leading to serious injury or death, and require rapid pacing, which poses additional risks and complications.
Innovation Solution
A balloon assembly comprising a series of toroid balloons with a perfusion lumen that allows blood flow when inflated, featuring a flexible valve to regulate flow direction and prevent backflow, enabling procedures without rapid pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a balloon member is expanded within a native heart valve to increase opening size, then blood flow through the valve is improved, but blood flow is blocked or restricted in the passageway which can lead to serious injury or death
Solution Approach 1:
The balloon assembly is divided into multiple toroid balloons arranged in series, each contributing to the overall expansion while maintaining a central perfusion lumen. This segmentation allows the balloon to achieve sufficient expansion force to open the valve while preserving a continuous pathway for blood flow through the center
Solution Approach 2:
The perfusion lumen acts as an intermediary pathway that allows blood to flow through the balloon assembly during inflation. This mediator structure enables the balloon to remain inflated long enough to perform the valve procedure without completely blocking blood flow, eliminating the need for rapid pacing
2Object-affected harmful factors
If a balloon member is inflated for only a brief period to avoid blood occlusion, then the risk of injury is reduced, but the procedure time is constrained and requires rapid pacing
Solution Approach 1:
The perfusion lumen maintains continuous blood flow through the balloon assembly during the entire inflation period. This continuous perfusion allows the procedure to be performed at a normal, controlled pace without the need for rapid pacing, as blood flow is never completely interrupted
Solution Approach 2:
The balloon assembly is designed with the perfusion lumen built-in from the beginning, allowing blood flow to be maintained throughout the procedure. This preliminary design feature eliminates the need for emergency rapid pacing protocols that would otherwise be required to manage blood occlusion risks
3Productivity
If a balloon member is expanded to deploy an artificial heart valve, then the valve is successfully implanted, but positioning is complicated by pressure buildup in the left ventricle
Solution Approach 1:
The perfusion lumen serves as a pressure relief intermediary that allows blood to flow through the balloon assembly during inflation. This prevents pressure buildup in the left ventricle that would otherwise complicate valve positioning, enabling more controlled and accurate implantation
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
Enables blood perfusion during heart valve procedures, reducing the risk of adverse effects from prolonged blood occlusion and eliminating the need for rapid pacing, allowing for safer and more controlled interventions.
Implementation Method 1
each toroid balloon in configured to transition between a deflated state and an inflated state
Implementation Method 2
featuring a flexible valve to regulate flow direction and prevent backflow
Data Source
AI summary
The present disclosure relates to balloon assemblies designed to permit blood flow through a central perfusion channel, at least when blood flows in a proximally-oriented direction. Such a balloon assembly can include one or more toroid balloons, each defining a cavity that can be independently fed by one or more inflation tubes coupled thereto to inflate the balloon. When the toroid balloons are inflated within a patient lumen or a prosthetic device, such as a prosthetic heart valve, blood is allowed to flow through the perfusion lumen. A balloon assembly can further include a flexible valve configured to regulate blood flow when the balloon assembly is inflated, to allow proximally directed flow through a channel formed in a flexible funnel thereof, and prevent backflow in the opposite direction.