External Valve Perfusion Balloon for Aortic Valvuloplasty Flow Control
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Solution Overview
Problem
Medical procedures involving balloon inflation in body vessels, such as Balloon Aortic Valvuloplasty, temporarily disable heart valves, causing disruptions in blood flow due to undesirable backflow, necessitating a solution to regulate fluid flow during these procedures.
Innovation Solution
An inflatable perfusion balloon with an external valve system that controls fluid flow by selectively covering and uncovering entrance passages, utilizing a tubular, flapped, or spiral design to mimic the function of a disabled valve, allowing for enhanced flow regulation during inflation.
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 intended function, but the heart valve is temporarily disabled causing disruptions in blood flow and undesirable back flow
Solution Approach 1:
The balloon is divided into multiple separate compartments or cells that can be independently controlled. This segmentation allows different portions of the balloon to serve different functions - some areas can be inflated to create space while other areas maintain patency for blood flow, preventing complete valve disability and reducing backflow disruptions
Solution Approach 2:
A valve mechanism is introduced as an intermediary component between the balloon and the blood flow path. This valve can selectively open or close to regulate blood flow during balloon inflation, preventing undesirable backflow while maintaining forward flow when needed, thus resolving the conflict between balloon function and blood flow continuity
2Ease of operation
If a traditional valve mechanism is integrated within the balloon, then flow control is achieved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The valve mechanism is extracted from the interior of the balloon and positioned externally. This external placement simplifies the internal balloon structure, making it easier to manufacture while maintaining the flow control function. The external valve can be a simpler component that interfaces with the balloon rather than being integrated within its complex three-dimensional structure
Solution Approach 2:
The external valve is designed to perform multiple functions: it can regulate blood flow during balloon inflation, prevent backflow, and potentially control deflation as well. This multi-functionality reduces the need for additional separate components, simplifying the overall device while maintaining comprehensive flow control capability
3Stability of the object's composition
If the balloon includes a non-compliant shell for structural support, then the balloon maintains its shape, but the manufacturing process becomes more difficult
Solution Approach 1:
The non-compliant shell is pre-formed or pre-assembled as a separate component before being integrated with the balloon. This preliminary preparation allows for standardized manufacturing of the rigid structural element, which can then be attached to the flexible balloon using simplified assembly processes rather than requiring complex integrated manufacturing
Solution Approach 2:
The design utilizes a thin-film flexible balloon interior combined with an external non-compliant shell structure. This separation allows the flexible portion to be manufactured using conventional balloon techniques while the rigid shell can be manufactured separately using appropriate rigid material processes, then assembled together, simplifying both manufacturing steps
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 external valve system effectively regulates fluid flow during balloon inflation, preventing backflow and facilitating easier manufacturing, particularly with a non-compliant shell, by allowing controlled fluid passage and blocking, thus maintaining blood flow during medical procedures.
Implementation Method 1
A valve is associated with the balloon for controlling the fluid flow within the passage. The valve is for selectively covering the entrances to the passage to control the flow of fluid therein.
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. The apparatus includes an inflatable perfusion balloon including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon including a plurality of cells in a single cross section and a covering for at least partially covering the cells. A valve associated with the balloon controls the fluid flow within the passage, the valve being arranged external to the passage. The valve may form a tubular extension of the covering, or may be separate from the covering, and may comprise flaps. A spiral covering may also form the valve.