Intra-Aortic Balloon Framing to Prevent Retrograde Flow
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Solution Overview
Problem
Existing intra-aortic balloon (IAB) assist devices suffer from inefficiencies in pressure augmentation due to energy loss through shock waves, absorption by the aorta, distance from the heart, and retrograde flow, limiting their effectiveness in non-cardiac pathologies and increasing clinical risks.
Innovation Solution
A system combining an expandable frame with a unidirectional flow control valve to prevent retrograde flow and position the pumping balloon centrally, allowing larger balloon volumes and smaller catheter sizes, while maintaining efficient pressure augmentation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If a large balloon volume is used to achieve desired pressure augmentation, then pressure augmentation effect is improved, but catheter diameter increases causing arterial trauma and femoral circulation compromise
Solution Approach 1:
The aorta is divided into multiple compartments using expandable frames with valve members that create separate flow zones. This segmentation allows the pumping balloon to generate pressure augmentation in a localized compartment without requiring a large balloon volume, thereby avoiding femoral artery trauma while achieving effective pressure support in specific vascular territories.
Solution Approach 2:
Pressure augmentation is applied locally to specific vascular compartments rather than uniformly throughout the entire aorta. The expandable frames with valve members create localized high-pressure zones that can be targeted to specific organs or vascular beds, achieving effective pressure support with a smaller balloon volume and thus avoiding the need for large catheter diameters.
2Productivity
If a large balloon volume is used to achieve sufficient blood flow to brain and organs, then perfusion is improved, but risk of amputation increases due to femoral blood flow compromise
Solution Approach 1:
The circulatory system is segmented into multiple compartments using expandable frames with valve members. This allows blood flow augmentation to be directed selectively to specific organs (brain, kidneys, etc.) through controlled compartmentalization, achieving sufficient perfusion without requiring a large balloon volume that would compromise femoral circulation.
Solution Approach 2:
The system changes the spatial distribution parameters of pressure and flow by creating multiple discrete high-pressure compartments rather than a single large-volume balloon. This parameter change allows effective organ perfusion with a smaller overall balloon volume, thereby avoiding femoral artery trauma and reducing amputation risk.
3Productivity
If IAB is placed in the Aortic arch to improve flow, then circulatory assist is improved, but severe whipping trauma occurs upon inflation
Solution Approach 1:
The aortic arch is divided into multiple small compartments using expandable frames with valve members. Instead of inflating a single large balloon that causes whipping trauma, the system creates multiple small localized pressure zones that provide circulatory assist without the mechanical trauma associated with large-volume balloon inflation in the curved aortic arch.
Solution Approach 2:
Pressure augmentation is applied locally to specific segments of the aorta rather than using a large balloon in the aortic arch. This local quality approach provides effective circulatory assist while avoiding the whipping trauma that occurs when a large balloon is inflated in the curved arch geometry.
4Stress or pressure
If a bigger balloon catheter is used to achieve large balloon volumes, then pressure augmentation is improved, but arterial trauma and femoral circulation compromise increase
Solution Approach 1:
The pressure augmentation function is segmented into multiple small compartments created by expandable frames with valve members. This segmentation allows the use of a small-diameter catheter to deliver a pumping balloon that creates multiple localized high-pressure zones, achieving effective aortic pressure augmentation without requiring a large catheter diameter that would cause arterial trauma.
Solution Approach 2:
Pressure augmentation is achieved through local quality changes in multiple discrete vascular compartments rather than through a single large-volume balloon. This approach allows the use of a small catheter diameter while still achieving effective pressure support through the cumulative effect of multiple localized pressure zones.
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 system achieves improved circulatory compartmentalization and pressure augmentation with reduced clinical risks, enabling application in various circulatory systems, including arterial, venous, lymphatic, and cerebrospinal circulations.
Implementation Method 1
combining the expandable frame portion with a unidirectional flow control or check valve which prevents flow from the downstream circulation towards the balloon
Implementation Method 2
The expandable frame can be any shape adapted to conform to the general shape of the aorta or any other body channel, and serves to space the pumping balloon from the wall of the aorta or body channel
Implementation Method 3
During diastole, whilst the aortic valve is closed and the LV is receiving blood for the next cardiac cycle, the balloon inflates within the aorta. The previously blood-filled aortic space is abruptly occupied by the inflated balloon, which raises the pressure in the aorta and ejects blood towards all directions
Implementation Method 4
During systole, deflation of the balloon creates an empty space within the aorta which 'vacuums' blood out of the Left Ventricle (LV). Drawing blood from the LV assists the effort of the failing heart to pump out blood
Implementation Method 5
The elastic properties of the aorta, which absorbs a substantial portion of the pulse wave energy generated by the balloon
Implementation Method 6
The initially transverse direction of the inflated balloon's expansion pulse wave, which creates energy loss through a shock wave exerted on the aorta, prior to generating an effective axial pulse wave
Data Source
Figure 1a~1b
Figure 1c~1d
Figure 1e~1f
AI summary
A circulatory assist apparatus comprising: an inflatable pumping balloon having a proximal end joined to an elongated balloon catheter, the balloon catheter having a distal end joined to the pumping balloon and a proximal end, separated from the distal end by a length sufficient to extend from within a circulatory lumen to the outside of a patient's body, for receiving positive and negative pressure pulses from a pump to inflate and deflate the pumping balloon; and a radially expandable frame, mounted on one of a segment extending distally from the pumping balloon, the balloon catheter, and a sleeve tube surrounding the balloon catheter. The expandable frame is manipulable to expand within the circulatory lumen, and functions to space apart the inflatable balloon from the circulatory lumen, having a first diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by said manipulation.