Steerable Catheter for Transseptal pVAD Delivery
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Solution Overview
Problem
Percutaneous ventricular assist devices (pVADs) face difficulties in minimally invasive delivery to the heart due to their large size and rigidity, which prevents them from navigating through the heart's tortuous paths without causing cardiac tissue damage, as traditional guidewire-based methods are ineffective for these bulky devices.
Innovation Solution
A system that includes a Right-to-Left conduit and a Left Ventricle Redirector, allowing for direct steering and precise positioning of pVADs across the interatrial septum and through the heart, using a conveyor cable and engagement devices to guide the device safely and avoid delicate cardiac structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If traditional guidewire-based delivery is used, then the delivery system can navigate through the heart, but large and rigid pVAD devices cannot be delivered safely without causing cardiac tissue damage
Solution Approach 1:
The patent introduces an intermediary delivery system consisting of a steerable catheter and guide wire that acts as a mediator between the operator and the large pVAD device. The catheter provides a protected pathway through the heart, allowing the large device to be delivered without direct contact between the device and delicate cardiac structures, thus preventing tissue damage while enabling delivery of larger devices
Solution Approach 2:
The delivery system incorporates dynamic steering capabilities through a steerable catheter with adjustable tip orientation. This allows the delivery system to dynamically adapt its path through the heart, navigating around delicate structures and providing controlled, safe delivery of the large pVAD device rather than following a fixed rigid path
2Ease of operation
If large rigid pVAD devices are forced through tortuous cardiac paths, then delivery may be achieved, but the device fails to follow the guidewire course and protrudes into delicate cardiac tissues
Solution Approach 1:
The steerable catheter provides dynamic control over the delivery path, allowing real-time adjustment of the catheter tip orientation to match the desired navigation path through the heart. This dynamic steering capability ensures the large pVAD device follows the intended course reliably without protruding into delicate cardiac tissues
Solution Approach 2:
The system performs preliminary navigation using the steerable catheter and guide wire to establish a safe pathway through the heart before delivering the large pVAD device. This preliminary action creates a pre-established track that guides the subsequent device delivery, ensuring reliable and safe navigation
3Ease of manufacture
If non-guidewire based delivery systems are used, then minimally invasive access is enabled, but the systems lack the flexibility to navigate tight bends in the heart
Solution Approach 1:
The system combines minimally invasive percutaneous access with dynamic steering capability through a steerable catheter design. The catheter can be adjusted in real-time to follow tortuous cardiac paths, providing both the ease of percutaneous access and the adaptability needed to navigate tight bends in the heart
Data Source
AI summary
A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.