Perfusion Balloon Selective Valve Flow Control
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Solution Overview
Problem
Current perfusion balloons used in medical procedures, such as Balloon Aortic Valvuloplasty, temporarily disable heart valves, causing disruptions in blood flow due to inflation, which can lead to undesirable backflow.
Innovation Solution
A selectively actuatable perfusion balloon with an inflatable valve that allows for controlled fluid flow, featuring a spherical balloon with internal passages and a movable valve that can obstruct or allow flow, supported by a catheter shaft with lumens for inflation and guidewire tubes, enabling regulation of fluid flow during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the balloon is inflated to create space inside the body, then the balloon can perform its function, but the heart valve is temporarily disabled causing disruptions in blood flow
Solution Approach 1:
The balloon is divided into multiple segments or zones: a main inflation portion for creating space and a separate perfusion channel with valve integration for maintaining blood flow. This segmentation allows the balloon to simultaneously achieve expansion for its primary function while preserving continuous perfusion through the integrated valve mechanism.
Solution Approach 2:
The perfusion valve and control mechanisms are nested within the balloon structure itself. The valve is integrated into the balloon wall or positioned within the inflation lumen, allowing the smaller functional components to be contained within the larger balloon structure. This nesting enables the valve to regulate flow through the inflated balloon without requiring external control systems.
2Productivity
If the balloon is inflated to disable the heart valve for the procedure, then the procedure can be performed, but undesirable back flow occurs
Solution Approach 1:
The perfusion valve is designed as a dynamic component that can actively adjust its opening and closing based on flow direction and pressure gradients. The valve responds to changing hemodynamic conditions during the procedure, opening to allow forward flow and closing to prevent backflow, thereby dynamically adapting to maintain unidirectional perfusion throughout the procedure.
Solution Approach 2:
The system converts the necessary valve disability caused by balloon inflation into a beneficial controlled environment. By intentionally disabling the native valve and replacing its function with a controlled perfusion system, the harmful uncontrolled backflow is transformed into a beneficial controlled unidirectional flow that can be precisely regulated to support the procedure while protecting against complications.
3Device complexity
If a traditional balloon is used without selective flow control, then the structure is simple, but flow regulation is not possible
Solution Approach 1:
The balloon is designed with multiple functions integrated into a single device: the main balloon provides expansion for the procedure, while the integrated perfusion valve provides flow regulation, and the control mechanism provides selective actuation. This multi-functionality allows the single device to perform both structural support and active flow management without requiring separate independent systems.
Solution Approach 2:
A control mechanism serves as an intermediary between the operator and the perfusion valve. This intermediary component, which may be a control balloon, wire, or external actuation system, translates operator input into precise valve actuation. The intermediary enables sophisticated flow control capabilities while maintaining a relatively simple overall device structure that can be delivered and manipulated through standard catheter techniques.
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 solution allows for selective regulation of fluid flow, mimicking natural valve function and minimizing disruptions during medical procedures, ensuring continued blood perfusion while the heart valve is temporarily disabled.
Implementation Method 1
an inflatable valve that may be used to selectively block the passage
Implementation Method 2
controlling the fluid flow through the perfusion balloon when inflated
Data Source
AI summary
An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid includes a first inflatable balloon, such a perfusion balloon with a plurality of cells in a single cross-section of the balloon for permitting the fluid flow in the vessel. An inflatable valve, which may take the form of a second inflatable balloon, may be provided for controlling the fluid, flow through the first balloon when inflated. Through selective movement of the second balloon when inflated via the flow rhythms created by the beating heart, a one way valve results that can be used to mimic the natural flow created by the valve under treatment.