Retrograde Septotomy Catheter for Aortic Dissection
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Solution Overview
Problem
Current catheter-based cutting devices for aortic dissections lack control over the site and length of septum cuts, often leading to complications such as sudden collapse of the true lumen and aneurysm development, especially in acute and chronic dissections, due to their mechanical actuator-dependent designs and inflexibility.
Innovation Solution
A catheter-based cutting device with a non-mechanically actuated cutting component, such as an RF electrode or ultrasonic blade, that cuts the septum in a retrograde manner, allowing for controlled septotomy by using guide wires to navigate and position the cutting component distally, thereby equalizing pressure between true and false lumens and facilitating the conversion of a double lumen into a single one.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a mechanical actuator-dependent cutting device is used, then the cutting function can be achieved, but the control over the site and length of septum cuts is lost, leading to complications
Solution Approach 1:
The patent replaces the mechanical actuator-dependent cutting system with a catheter-based system that uses RF energy or ultrasonic vibration to cut the septum. This substitution eliminates the need for complex mechanical actuators while providing precise control over the cutting site and length through the catheter's positioning capabilities and guide wire navigation.
Solution Approach 2:
The patent introduces guide wires as intermediaries to navigate and position the cutting device within the aorta. The guide wires enable precise control over the cutting site and length by allowing the operator to steer the catheter to the desired location before activating the cutting function, thereby resolving the control issue without requiring complex mechanical actuators.
2Productivity
If a fixed or movable blade cuts the septum in a proximal to distal direction, then the cutting function is achieved, but the true lumen may suddenly collapse with catastrophic consequences
Solution Approach 1:
The patent inverts the cutting direction from proximal to distal (conventional) to distal to proximal (retrograde). By cutting from the distal end toward the proximal end, the true lumen remains supported throughout the cutting process, preventing sudden collapse. This inversion of the cutting direction resolves the reliability issue while maintaining cutting efficiency through the use of RF or ultrasonic energy.
3Ease of operation
If a catheter with inner and outer tubular components is used, then the cutting function can be achieved, but the flexibility to navigate the bends of the arterial system is reduced
Solution Approach 1:
The patent employs flexible catheter construction with thin-walled tubular components that can navigate the bends of the arterial system. The catheter incorporates flexible materials and designs that allow it to conform to the tortuous anatomy of the aorta while maintaining the necessary structural integrity to deliver the cutting function. This flexibility resolves the navigation issue without requiring a complex coaxial system.
4Ease of operation
If a large assembly is introduced into the blood vessel, then the cutting function can be achieved, but the maneuverability within the blood vessel is reduced
Solution Approach 1:
The patent employs a nested design where the cutting component is housed within the catheter shaft. The cutting blade or electrode is contained within the catheter body and only exposed when needed at the target site. This nesting allows the device to be introduced through a small femoral artery puncture site while maintaining maneuverability within the blood vessel, resolving the contradiction between cutting capability and ease of operation.
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 solution enables safe and controlled septum cutting, preventing aneurysm development and malperfusion, while allowing for the insertion of a branched endograft, and provides increased flexibility to navigate the tortuous aorta, reducing the risk of catastrophic consequences during acute and chronic dissections.
Implementation Method 1
A catheter-based cutting device with a non-mechanically actuated cutting component, such as an RF electrode or ultrasonic blade
Implementation Method 2
A catheter-based cutting device with a non-mechanically actuated cutting component, such as an RF electrode or ultrasonic blade
Data Source
AI summary
Medical methods and devices for treating aortic dissections. A catheter-based cutting device permits cutting a septum of acute or chronic aortic dissections, in a retrograde manner. The catheter includes a base section having a central lumen therethrough and two flexible arms extending from a distal end thereof. The flexible arms can each have a guide wire channel therethrough. With distal ends of the two flexible arms separated, the two arms form a Y-shape with the base section. In one embodiment, with distal ends of the two flexible arms together, the two arms have a longitudinal profile, about a periphery thereof, identical to a longitudinal profile of the base section. A cutting component resides between the two arms. The cutting component can face distally outward between the two arms with the distal ends of the two flexible arms separated.