Bifurcated Sheath Catheter Stabilization in Tortuous Aortic Arches
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Solution Overview
Problem
Stenting procedures in carotid arteries, particularly in type III hostile aortic arches, face challenges due to tortuous anatomy, leading to injuries from uncontrolled collapse of sheaths and devices, which can result in cerebral embolism or stroke, and require stabilization to prevent trauma to arterial walls.
Innovation Solution
A bifurcated sheath catheter system with a procedural lumen and a stabilization lumen, utilizing a stabilizer such as a modified Fogarty balloon or micro-anchor, is used to stabilize the sheath and procedural catheter during carotid artery interventions, providing frictional contact or pin fixation within secondary vessels to maintain stability and prevent trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guide catheter and guide wire are used to access carotid arteries in type III hostile aortic arches, then access to the arterial system can be achieved, but uncontrolled collapse of the sheath and device occurs leading to trauma to arterial walls and risk of cerebral embolism
Solution Approach 1:
A stabilizer wire is introduced as an intermediary element that extends from the guide catheter into a secondary vessel (such as the subclavian or innominate artery). This stabilizer wire acts as a mediator that provides structural support to the guide catheter, preventing uncontrolled collapse and reducing trauma to the arterial walls during stenting procedures in tortuous aortic arches.
Solution Approach 2:
The stabilizer wire is positioned and secured in the secondary vessel before the stenting procedure is completed. By establishing this preliminary stabilization mechanism, the system prevents harmful collapse and trauma during subsequent device manipulation and stent deployment, rather than reacting to problems after they occur.
2Reliability
If the sheath and procedural catheter are stabilized using frictional contact or pin fixation in secondary vessels, then stability and prevention of trauma is improved, but device complexity increases
Solution Approach 1:
The guide catheter system is segmented into functional components: a main guide catheter for accessing the carotid artery, a separate stabilizer wire for providing structural support, and a bifurcated configuration that allows the stabilizer to extend into a secondary vessel while the main catheter performs the procedural function. This segmentation allows each component to be optimized for its specific purpose.
Solution Approach 2:
The bifurcated sheath catheter system is designed to perform multiple functions: the main lumen accommodates the procedural catheter for stenting, while the secondary lumen accommodates the stabilizer wire that provides structural support. This multi-functional design integrates stabilization and procedural access into a single device platform.
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 bifurcated sheath catheter system effectively reduces injuries to arterial walls by stabilizing the sheath and procedural catheter, enhancing the safety and success of stenting procedures in complex aortic arches, thereby minimizing the risk of cerebral embolism and improving blood flow normalization.
Implementation Method 1
providing frictional contact or pin fixation within secondary vessels to maintain stability
Implementation Method 2
utilizing a stabilizer such as a modified Fogarty balloon or micro-anchor
Data Source
AI summary
For percutaneous minimally-invasive intervention in vessels originating from other tortuous vessels, such as the tortuous aortic arch, guide wires/catheters are used to enable procedural catheters to access the vessels where an interventional procedure is needed. Two new methods for fixing a stabilization wire/catheter and providing the needed tension and stabilization without a second percutaneous access are disclosed (1) using a micro-anchor and pin and (2) using a modified Fogarty Balloon. These methods are also usable for access to and treatment of peripheral embolisms in tortuous vessels as well as renal and other visceral interventions.