Aortic Septotomy Jaw-and-Cutter Assembly for Stable Stent Landing
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Solution Overview
Problem
Current endovascular devices for treating chronic type B aortic dissection are unreliable and risky due to the thickness of the aortic dissection flap, leading to challenges in creating optimized landing zones for stent-grafts, and existing laser-based systems are technically demanding and prone to malpositioning.
Innovation Solution
An endovascular aortic septotomy device with a distal head assembly and bi-directional cutting mechanism, featuring jaw members and a cutting member shielded during deployment, to safely and reproducibly cut the aortic dissection flap, creating a better attachment site for stent-grafts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current endovascular devices are used to cut the aortic dissection flap, then the procedure can be performed, but the reliability is poor and the risk of aortic rupture is high due to the thickness of the flap
Solution Approach 1:
The cutting member is divided into multiple segments or sections that can independently engage the aortic dissection flap. This segmentation allows the cutting action to be distributed across multiple contact points, reducing the risk of uncontrolled tearing or rupture while maintaining effective cutting through the thick flap tissue.
Solution Approach 2:
A shield or protective element is introduced as an intermediary between the cutting member and the aortic wall. This shield guides the cutting action, prevents lateral deviation that could cause rupture, and provides a controlled path for the cutting member through the thick dissection flap, thereby improving reliability and reducing harmful effects.
2Reliability
If laser-based septotomy devices are used, then cutting capability is provided, but the device complexity increases and malpositioning occurs
Solution Approach 1:
The patent replaces complex laser-based mechanical systems with a simpler mechanically-actuated cutting member. The cutting member is directly driven by mechanical actuation mechanisms within the delivery catheter, eliminating the need for complex laser delivery systems, fiber optic alignment mechanisms, and associated control systems, thereby reducing device complexity while maintaining cutting capability.
3Ease of operation
If the cutting member is exposed during deployment, then cutting can be performed, but the risk of unintended cutting and aortic rupture increases
Solution Approach 1:
The cutting member is pre-positioned within a protective shield or sheath during delivery and deployment. The shield is only retracted or moved aside at the precise moment when cutting is intended, allowing the cutting member to remain protected during navigation and deployment. This preliminary protective action prevents unintended cutting while maintaining ease of operation when cutting is required.
Solution Approach 2:
A movable shield or protective element serves as an intermediary that controls the exposure of the cutting member. This shield can be dynamically positioned to expose the cutting member only when needed for cutting the dissection flap, while providing protection during delivery and when cutting is not required, thereby preventing unintended cutting while maintaining operational accessibility.
Data Source
AI summary
An aortic septotomy device for cutting aortic tissue between a true lumen and a false lumen. The aortic septotomy device having a handle device having a jaw actuator member and an optional cutter actuator member; a distal head assembly having a pair of jaw members movable between an opened position and a clamping position and a cutting mechanism movable within a channel; and a sheath member extending from the handle device to the distal head assembly; wherein at least one of the pair of jaw members is movable in response to actuation of the jaw actuator member to selectively grasp aortic tissue, and the cutting mechanism is movable within the channel in response to actuation of the cutter actuator member to cut at least a portion of the aortic tissue while the pair of jaw members grasps the aortic tissue.