Guidewireless Mitral Valve Delivery via Counter-Tensioning
Solution Overview
Problem
Current transseptal mitral valve delivery systems face difficulties in navigating large, rigid devices through the heart's vasculature due to their size and shape, often requiring forceful manipulation that can damage cardiac tissues and result in valve insufficiency.
Innovation Solution
A guidewireless system using coordinated pulling, pushing, and steering forces, facilitated by a Right-to-Left conduit, tracker balloon catheter, and Left Ventricle Redirector, to safely position mitral valve therapeutic devices within the mitral valve ring, eliminating the need for traditional guidewires and minimizing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional guidewire-based delivery systems are used to deliver mitral valve therapeutic devices, then the devices can be pushed over the guidewire, but the devices become stuck when attempting to negotiate the tight bends required for crossing into and navigating through the left atrium
Solution Approach 1:
The delivery system is divided into multiple independent components: a delivery catheter for introducing the device, a tensioning device for applying pulling force, and a pushing device for applying pushing force. This segmentation allows each component to perform its specific function independently, enabling the large rigid MVTD to navigate the complex cardiac anatomy without becoming stuck.
Solution Approach 2:
The guidewire is pre-positioned across the interatrial septum and into the left ventricle before the MVTD is delivered. This preliminary action creates a stable reference path and allows the delivery system to be properly aligned and tensioned before the actual device delivery begins, ensuring smooth navigation through the tight bends.
2Ease of operation
If force is applied to push the MVTD over the guidewire, then the device can be positioned within the mitral valve ring, but the force can damage delicate cardiac tissues
Solution Approach 1:
The system uses a tensioning device that applies a pulling force in the opposite direction to the pushing force. This counterbalancing approach allows the MVTD to be gently guided into position without requiring excessive pushing force that could damage cardiac tissues. The pulling force supports the device weight and reduces the burden on the pushing mechanism.
Solution Approach 2:
The delivery catheter acts as an intermediary between the pushing device and the MVTD, providing a compliant interface that distributes forces evenly. The catheter's flexible structure allows it to conform to the cardiac anatomy while transmitting the necessary forces, preventing concentration of stress on delicate tissues.
3Ease of operation
If snare devices are used to pull the MVTD into position, then the device can be directed to the target, but the snare pulls with great force across the aortic and mitral valve leaflets leading to valve insufficiency
Solution Approach 1:
The invention extracts the harmful pulling mechanism (snare device) from the delivery system and replaces it with a dedicated tensioning device integrated into the delivery catheter. This new approach applies pulling force through the catheter wall or via external tensioning elements that do not contact the valve leaflets, eliminating the risk of valve insufficiency while maintaining the ability to direct the MVTD to the target position.
Data Source
AI summary
A system and method used to deliver a valve delivery system carrying a valve to a target valve annulus in the heart includes a cable percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, transseptally through the heart, to a femoral artery. The valve delivery system device is passed over an end of the cable at the arterial side and is secured to the cable. The valve delivery system device is pushed in a distal direction while the venous end of the cable is pulled in the proximal direction, to advance the valve delivery system to the target valve annulus. A left ventricle redirector positionable on the cable from the venous end has a distal end actively steered during advancement and positioning of the valve delivery device, exerting forces that steer the distal nose of the valve delivery device as it moves towards the valve annulus.