Orienting Catheter with Occlusion Balloon for CTO Re-entry
Solution Overview
Problem
Chronic total occlusions in blood vessels pose a significant challenge as they obstruct blood flow, leading to severe conditions such as peripheral artery disease and coronary artery disease, often resulting in limb amputation and high mortality rates due to the inability to establish a viable blood flow path around the occlusion.
Innovation Solution
The use of a system comprising an orienting catheter and an occlusion catheter with a balloon to isolate a target volume, reduce pressure, and facilitate the re-entry of a re-entry device into the distal lumen segment, allowing for the establishment of a blood flow path between proximal and distal segments of a blood vessel obstructed by a chronic total occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon is inflated to occlude the blood vessel lumen and isolate a target volume, then the isolation effectiveness is improved, but the device complexity increases
Solution Approach 1:
The system is divided into distinct functional modules: an orienting catheter with orienting element for navigation, an occlusion catheter with balloon for isolation, and a re-entry device for creating the bypass path. Each component performs a specific function, allowing the complex overall task to be achieved through coordinated simpler parts.
Solution Approach 2:
The balloon acts as an intermediary device that temporarily occludes the blood vessel lumen to create an isolated target volume. This intermediary structure enables the subsequent deployment of the re-entry device by providing a controlled environment, and is later deflated and removed after serving its purpose.
2Ease of operation
If aspiration is used to reduce pressure inside the target volume, then the re-entry device deployment is facilitated, but the device complexity increases
Solution Approach 1:
The occlusion catheter is designed with multi-functionality, incorporating both the balloon for occlusion and the aspiration lumen for pressure reduction. This universal device performs multiple functions that would otherwise require separate components, thereby facilitating re-entry device deployment without proportionally increasing overall system complexity.
3Measurement precision
If an orienting catheter with tracking element is used to navigate through the blood vessel, then the positioning precision is improved, but the device complexity increases
Solution Approach 1:
The tracking element is advanced along the orienting catheter shaft, with the tracking element being nested within or alongside the catheter structure. This nested arrangement allows the tracking element to follow the catheter's path through the blood vessel, providing positioning information without requiring the tracking element to be a completely separate external system.
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
This method effectively creates a blood flow path around occlusions, improving vascular access and reducing the risk of complications associated with chronic total occlusions, thereby enhancing treatment outcomes for patients with PAD and CAD.
Implementation Method 1
The occlusion catheter defines an inflation lumen disposed in fluid communication with an interior of the balloon so that the balloon can be selectively inflated by injecting an inflation fluid through the inflation lumen
Implementation Method 2
The occlusion catheter defines an aspiration lumen disposed in fluid communication with a distal port positioned so that fluid can be withdrawn from the target volume and into the aspiration lumen
Data Source
AI summary
A system and method for treating a blood vessel that is at least partially obstructed by an occlusion which divides the lumen into a proximal lumen segment and a distal lumen segment. The system includes an orienting catheter having an orientation element positionable in an intrawall space of the vessel and an occlusion catheter having an occlusion balloon inflatable in the proximal lumen segment so as to isolate a target volume including the intrawall space. The pressure inside the target volume is reduced to a pressure below the pressure of the distal lumen segment so that the intima presses against the orienting element of the orienting catheter. A distal end of a reentry device may be advanced from the orienting catheter through the intima and into the distal lumen segment.