Magnetically Guided Re-Entry Catheter for Chronic Arterial Occlusions
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Solution Overview
Problem
Chronic total occlusions in coronary and peripheral arteries pose significant challenges in PCI procedures, with high failure rates and limited access to advanced revascularization methods, leading to increased morbidity and mortality due to conditions like angina, heart failure, and limb ischemia.
Innovation Solution
A magnetically guided re-entry catheter system using a ferromagnetic guidewire and a magnetically affixed catheter to facilitate precise re-entry into the true lumen, assisted by electrocautery for tissue cutting, enhancing the reliability and safety of crossing chronic total occlusions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional wire crossing techniques are used to cross chronic total occlusions, then the procedure can be performed with standard equipment, but the success rate is low (40-63% failure rate)
Solution Approach 1:
The patent replaces conventional mechanical wire-crossing techniques with a magnetic field-based system. A magnet is positioned in the subintimal space and uses magnetic attraction to pull a ferromagnetic guidewire through the occlusion, substituting mechanical force with magnetic force to achieve wire crossing with higher success rates
Solution Approach 2:
The patent changes the physical parameters of the guidewire by incorporating ferromagnetic materials (such as iron oxide particles or ferromagnetic alloys) into the guidewire structure. This parameter change enables the guidewire to respond to magnetic fields, transforming it from a passive mechanical element to an actively controllable component that can be guided by magnetic attraction forces
2Reliability
If advanced re-entry and retrograde chronic total occlusion PCI techniques are used, then crossing success may improve, but the procedures are complicated and time consuming
Solution Approach 1:
The patent replaces complex mechanical manipulation techniques with a magnetic field-based guidance system. The magnet-guidewire magnetic attraction system provides direct control over wire positioning, eliminating the need for time-consuming mechanical trial-and-error maneuvers and reducing procedural complexity while maintaining high crossing success rates
3Ease of operation
If subintimal balloon inflation is used to disrupt tissue planes for wire re-entry, then wire re-entry can be achieved, but re-entry fails in about 30% of CART cases
Solution Approach 1:
The patent substitutes the mechanical balloon-inflation method with a magnetic field-based wire guidance system. Instead of relying on balloon-induced tissue disruption, the ferromagnetic guidewire is directly attracted to and guided by the magnet through the subintimal space, providing more reliable and controlled wire re-entry without the failures associated with mechanical disruption methods
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 system improves the precision, speed, and safety of re-entering the true lumen, increasing procedural success and reducing complications in PCI procedures for chronic total occlusions.
Implementation Method 1
The magnet force of the magnet can draw the second guidewire to the magnet when the second guidewire is in range of the magnet
Implementation Method 2
assisted by electrocautery for tissue cutting
Data Source
AI summary
The present disclosure is a magnetically guided re-entry catheter system and method configured to direct subintimal crossing and re-entry into the artery true lumen of a guidewire during treatment of arterial chronic total occlusions. A magnet is affixed to a catheter, and the catheter is directed through the artery containing the chronic total occlusion via a guidewire. A second, ferromagnetic guidewire is directed through the artery to the opposite side of the chronic total occlusion, before crossing out of the true lumen into the subintimal. The magnetic attraction between the second guidewire and the magnet directs re-entry of the second guidewire into the true lumen once the second guidewire has passed the chronic total occlusion.