IVUS Re-Entry Catheter for Precise True Lumen Access
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Solution Overview
Problem
Current devices for re-entering the true lumen during percutaneous coronary interventions (PCI) for chronic total occlusions (CTO) are challenging due to reliance on angiographic guidance, which is imprecise and can cause vessel damage, and existing devices are stiff, difficult to deliver, and unsuitable for smaller vascular beds, leading to high failure rates and complications.
Innovation Solution
The use of an intravascular ultrasound (IVUS) guided catheter with an ultrasound beam to visualize and direct a re-entry wire into the desired area of the plaque, ensuring safe and accurate re-entry into the true lumen, reducing the risk of perforation and dissection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If angiographic guidance is used for re-entry, then the procedure can be performed with standard equipment, but the guidance is imprecise and can cause vessel damage
Solution Approach 1:
The patent replaces angiographic guidance (mechanical/fluoroscopic system) with intravascular ultrasound (IVUS) guidance (acoustic system). The IVUS catheter with ultrasound transducer provides real-time imaging of the vessel wall and lumen, enabling precise visualization of the re-entry point and true lumen location without the limitations of angiography, thereby improving measurement precision and reducing vessel damage risk
Solution Approach 2:
The patent introduces an intermediary imaging system (IVUS) between the operator and the target site. The ultrasound transducer acts as an intermediary that provides real-time feedback about the catheter position, vessel wall characteristics, and true lumen location, allowing the operator to navigate and perform re-entry with enhanced precision and safety
2Adaptability or versatility
If existing re-entry devices are used, then the procedure can be performed, but the devices are stiff, difficult to deliver, and unsuitable for smaller vascular beds
Solution Approach 1:
The patent employs a dynamic catheter design where the distal portion can be selectively shaped or configured during the procedure. The catheter can transition from a flexible delivery state to a more rigid working state when needed, allowing easy delivery through tortuous and small vessels while maintaining the ability to perform precise re-entry operations
Solution Approach 2:
The patent utilizes changes in catheter parameters (such as flexibility, diameter, or shape) to adapt to different vascular conditions. The catheter can be designed with variable stiffness along its length or can change its configuration during delivery and deployment, enabling it to navigate smaller vascular beds effectively while remaining easy to deliver
3Measurement precision
If IVUS guided catheter is used, then real-time visualization and precise re-entry are achieved, but the device complexity increases
Solution Approach 1:
The patent merges the ultrasound transducer, catheter structure, and re-entry functionality into a single integrated device. The IVUS catheter combines imaging capabilities with the re-entry mechanism, allowing real-time visualization and precise re-entry to be achieved through one device rather than multiple separate components, thereby managing complexity through integration
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
Enhances the success rate and safety of treating CTOs by providing real-time visualization, allowing for precise re-entry into the true lumen, thereby reducing complications such as vessel perforation and dissection.
Implementation Method 1
The catheter includes an ultrasound transducer for emitting an ultrasound beam at an angle to form an ultrasound image that guides the re-entry wire
Data Source
AI summary
A catheter for facilitating re-entry of a re-entry wire into a true lumen or into any desired region of a blood vessel may have an elongate shaft with a first lumen. A distal port and a first proximal port are fluidly coupled with the first lumen. A wire re-entry port is adjacent the distal end of the elongate shaft. The wire re-entry port has a re-entry axis. An ultrasound transducer on the catheter is configured to produce an image the blood vessel, and has a central axis that allows visualization of the re-entry wire as it exits the re-entry port and re-enters the true lumen. This allows the operator to ensure that the re-entry wire re-enters the true lumen in a desired location and does not damage the vessel.