Aortic Occlusion Balloon Assembly for Low-Profile REBOA Control
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Solution Overview
Problem
Existing REBOA devices have large profiles, require tracking over an endovascular wire, and lack adjustable occlusion capabilities, posing challenges in insertion, bleeding risks, and limited control over blood flow, especially in emergency settings.
Innovation Solution
A low-profile occlusion device with an atraumatic J-tip and self-similar balloon envelope that allows for smooth inflation and deflation, adjustable occlusion, and safe overinflation, compatible with a 4 French introducer sheath, featuring a peel-off J-tip straightener and elastomeric construction for ease of use and control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional REBOA devices are used with larger profiles, then they can be inserted via larger introducer sheaths, but this increases bleeding risks and insertion complications
Solution Approach 1:
The occlusion balloon is constructed from a thin, flexible elastomeric material that can be collapsed into a compact configuration for insertion through small introducer sheaths (4-7 French), then expanded to provide effective occlusion. This flexible shell approach allows the device to have a small insertion profile while maintaining full functional capability when deployed.
Solution Approach 2:
The catheter system employs a nested configuration where the occlusion balloon is collapsed within the catheter shaft during insertion, similar to nested dolls. The balloon envelope is contained within the catheter body, allowing the entire assembly to pass through small introducer sheaths before deployment at the target site.
2Ease of operation
If conventional devices require tracking over an endovascular wire, then positioning can be guided, but this increases procedure complexity and training requirements
Solution Approach 1:
The invention extracts the endovascular wire component from the procedure by providing self-contained radiopaque markers directly on the catheter body. These markers allow direct visualization and positioning of the catheter without requiring tracking over a separate guidewire, simplifying the overall procedure and reducing steps.
Solution Approach 2:
The catheter incorporates radiopaque markers that appear under fluoroscopic imaging, allowing visual tracking and positioning similar to color changes in visible light. These markers enable the operator to see the catheter position and guide placement without needing additional wire-based tracking systems.
3Reliability
If the balloon is inflated to full occlusion, then blood flow is completely blocked, but this increases risk of balloon or vessel rupture
Solution Approach 1:
The occlusion balloon is designed with dynamic inflation capabilities, allowing the operator to adjust the inflation volume to achieve the desired level of occlusion. The balloon can be partially inflated to provide gradient occlusion or fully inflated when complete blockage is needed, with the ability to quickly deflate if complications arise. This dynamic control optimizes occlusion effectiveness while minimizing the risk of vessel rupture.
Solution Approach 2:
The device allows for partial occlusion by inflating the balloon to less than full capacity when complete blood flow blockage is not required. This partial action approach provides sufficient occlusion for many clinical scenarios while significantly reducing the pressure and force exerted on the vessel wall, thereby minimizing the risk of rupture or barotrauma.
4Reliability
If the balloon envelope changes shape during inflation, then it can expand to occlude the vessel, but this creates turbulent flow during deflation
Solution Approach 1:
The occlusion balloon is designed with a spheroidal or rounded geometry that maintains a consistent curved shape during both inflation and deflation. This spherical configuration allows the balloon to expand uniformly to occlude the vessel while collapsing smoothly and symmetrically during deflation, minimizing turbulence and promoting laminar blood flow restoration. The curved surface area distribution ensures gradual flow transition rather than abrupt changes.
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 device reduces insertion complications, minimizes bleeding risks, and provides controlled blood flow adjustments, enhancing safety and utility in emergency and clinical settings by maintaining a consistent shape during inflation and deflation, and allowing overinflation without vessel rupture.
Implementation Method 1
a single elastomeric molded balloon that envelopes a portion of the elongate shaft and its central wire
Implementation Method 2
inflation fluid for expanding the balloon envelope may be injected, via a syringe or other mechanism
Data Source
AI summary
An occlusion assembly for occluding the aorta of a patient is presented. The occlusion assembly includes an elongate shaft of two separate extrusions to which an elastomeric balloon envelope is bonded to an end of each. A support wire extends through the elongates shaft and the balloon envelope. At the proximal end of the shaft the proximal end of the support wire is secured to a proximal hub to give the entire assembly sufficient stiffness to be advanced into the vasculature of the patient. The balloon envelope is pre-molded to have a reverse teardrop or “ice cream cone” like shape and will maintain that general shape throughout inflation to the fully inflated state. If the balloon envelope is over inflated, the balloon envelope will advance distally and proximally (lengthening) along the support wire without damage to the surrounding vessel.