Stabilization Wire for Catheter Access in Tortuous Arteries
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current percutaneous intervention systems face challenges in accessing and stabilizing the sheath, embolic protection device (EPD), and stent delivery system within the tortuous arterial system, particularly in type III hostile aortic arches, leading to potential injuries and complications such as cerebral embolism or stroke.
Innovation Solution
A percutaneous intervention system is proposed, utilizing a bifurcated catheter with a procedural lumen and a stabilization lumen, along with a stabilization wire and snare mechanism, to provide end-to-end tension stabilization and secure the procedural catheter during stenting procedures in tortuous arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guide catheter and guide wire are used to access the carotid artery through a type III aortic arch, then the procedural catheter can be delivered to the treatment site, but the guide catheter becomes unstable and may flip out into the aortic arch during stent delivery
Solution Approach 1:
A stabilization wire is introduced as an intermediary element that connects the guide catheter to a stable anchor point in the aortic arch or descending aorta. This wire acts as a mediator to prevent the guide catheter from flipping out during stent delivery, resolving the instability issue while maintaining access capability.
Solution Approach 2:
The stabilization wire is deployed before stent delivery to pre-establish stability of the guide catheter system. By securing the catheter in place beforehand, the system prevents potential flipping movements during subsequent stent delivery operations.
2Ease of operation
If stiff wires and catheters are used to navigate the tortuous arterial system, then access to the carotid artery is achieved, but injuries to the arterial walls occur such as dissections and trauma
Solution Approach 1:
The system transitions from using stiff wires to a stabilization wire with optimized mechanical properties. The stabilization wire has sufficient rigidity to provide stability but maintains flexibility to navigate tortuous vessels without causing arterial wall injuries. This parameter optimization resolves the contradiction between navigability and tissue safety.
3Reliability
If the sheath, EPD, and stent delivery system are stabilized using conventional methods, then the procedure can be performed, but uncontrolled collapse of these devices in the ascending aorta causes cerebral embolism or stroke
Solution Approach 1:
The stabilization wire serves as an intermediary support structure that prevents uncontrolled collapse of the sheath, EPD, and stent delivery system. By maintaining proper positioning and stability of these devices in the ascending aorta, the wire prevents them from dragging over the carotid stenosis and causing cerebral embolism or stroke.
4Ease of operation
If guide wires are dragged over the tortuous arterial regions during insertion and removal, then access is established, but cutting into the arterial walls occurs causing dissections and trauma
Solution Approach 1:
The guide wire is replaced with a stabilization wire engineered with optimized mechanical properties including appropriate flexibility, surface characteristics, and radial strength. These parameter changes enable the wire to navigate tortuous vessels during insertion and removal without cutting into or dissecting the arterial walls, while still providing necessary stabilization functionality.
Data Source
Figure 1
Figure 2~3
Figure 4~5
AI summary
Tortuosity of vessels at or leading to the site of minimally invasive procedures is a problem for conducting such procedures as they increase the difficulty to guide the procedural catheters through tortuous vessels. Methods and apparatus for stabilization of the sheaths and catheters during access, procedures, and withdrawal in these tortuous vessels are disclosed. The apparatus and method for improving access include application of a pull component to the stabilized procedural catheter using a stabilization catheter/wire in addition to a push component from the percutaneous access to make the access easier while enabling use of more flexible catheters and softer wires. These methods and devices address the problems of trauma to the vessels during access, procedure and removal of catheters and wires, improve pushability of softer catheters and wires, and also substantially reduce substantially the procedure time.