Spiral Balloon Catheter Nested Design for Debris Removal
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Solution Overview
Problem
Existing balloon catheter systems for removing thrombi and particulate matter from blood vessels are traumatic to the vessel, inefficient in debris removal, and disrupt blood flow during inflation, with debris often escaping into the bloodstream.
Innovation Solution
A balloon catheter system featuring an inner compliant balloon that adopts a spiral conformation upon inflation, surrounded by a perforated outer non-compliant balloon, allowing for controlled aspiration and filtration of particulate matter while maintaining blood flow, with the inner balloon's spiral shape and outer balloon's pores facilitating the trapping and removal of debris.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a spiral balloon is inflated distally to the thrombus and pulled back to collect thrombotic material, then thrombus removal is achieved, but the procedure causes trauma to the blood vessel and blood flow is blocked during inflation
Solution Approach 1:
The patent employs a nested balloon configuration where an inner compliant spiral balloon is placed inside an outer non-compliant cylindrical balloon. The inner balloon engages the thrombus with its spiral conformation while the outer balloon provides structural support and maintains vessel patency. This nested arrangement allows the inner balloon to perform its thrombus-capturing function without fully occluding the vessel, as blood can flow through the space between the two balloons.
Solution Approach 2:
The patent applies different mechanical properties to different parts of the balloon system. The inner balloon is made compliant to allow it to conform to and engage the thrombus effectively, while the outer balloon is made non-compliant to maintain structural integrity and prevent over-expansion. This differentiation of local qualities enables each component to perform its specific function while minimizing overall vessel trauma.
2Reliability
If a spiral balloon is inflated to engage and collect thrombotic material, then debris trapping is improved, but some debris escapes into the bloodstream and is not removed
Solution Approach 1:
The nested balloon configuration creates a containment system where the inner spiral balloon captures thrombotic material within its spiral channels, while the outer non-compliant balloon acts as a containment shell. The space between the two balloons and the outer balloon's structure prevent captured debris from escaping into the bloodstream during the procedure.
3Reliability
If the balloon is inflated to completely seal the vessel for effective thrombus collection, then debris retention is improved, but blood flow through the vessel is blocked
Solution Approach 1:
The nested balloon system allows selective sealing - the inner balloon can engage and retain thrombus within its spiral structure while the outer balloon maintains a patent lumen for blood flow. Blood can circulate through the space between the inner and outer balloons, maintaining productivity while the inner balloon performs its retention function.
Data Source
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AI summary
The present invention provides a balloon catheter system comprising one or more conduits (10) to which are attached an inner compliant balloon (12) having a non-helical shape in its deflated state, said balloon being enclosed by an outer non-compliant or semi-compliant balloon (14), wherein the inner balloon is constructed such that upon inflation, said inner balloon is capable of adopting a spiral or helical conformation. The present invention also provides methods for using said balloon catheter system.