Nested Balloon Catheter for Controlled Embolization
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Solution Overview
Problem
Current balloon catheters used for tumor embolization in the liver face challenges such as rapid embolization of distal capillaries, high intra-tumor pressure, reflux of blood and embolic agents, and poor distribution of embolic agents due to high volume flow from the hepatic artery, leading to uncontrollable delivery and procedural variability.
Innovation Solution
A balloon catheter design where the balloon is positioned below the surface of the catheter, allowing for a low profile and rapid inflation/deflation, with a strong bonding mechanism to maintain the balloon's position during procedures, even with viscous solutions, and a flexible distal portion to navigate tortuous vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon is bonded to the external surface of a catheter, then the balloon can be securely positioned for embolization, but the catheter diameter increases preventing access into small vessels
Solution Approach 1:
The balloon is nested within a pocket formed by the catheter body, allowing it to be stored in a retracted position during navigation. When deployed, the balloon expands outward from the catheter surface. This nesting approach allows secure balloon positioning without permanently increasing the catheter's external diameter, enabling access to small vessels while maintaining reliable balloon deployment capability.
2Productivity
If high volume flow is used from the hepatic artery, then embolization agents can be delivered rapidly, but distal capillaries become occluded prematurely causing reflux and poor distribution
Solution Approach 1:
The embolization procedure uses periodic action by inflating the balloon in stages rather than continuous high-flow delivery. The balloon is inflated to occlude the vessel, embolic agents are delivered during occlusion when flow is controlled, then the balloon is deflated to allow blood flow resumption. This periodic occlusion-delivery cycle prevents premature distal capillary occlusion and reflux while maintaining efficient agent delivery and ensuring uniform distribution throughout the tumor vasculature.
Data Source
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Figure 3~4C
Figure 5A~5B
AI summary
A balloon catheter assembly is provided with an outer catheter, an inner catheter, an outer adapter, a balloon and a support sheath, and is configured such that the balloon resides entirely within a predetermined volume having an outer diameter substantially equal to or less than the outside diameter of the distal end of the outer catheter when the balloon is in a deflated configuration. Methods of using and steering the catheter assemblies are also provided.