Guide Catheter Aligner for Transcatheter Aortic Valve Implantation
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Solution Overview
Problem
Transcatheter aortic valve implantation procedures face challenges such as navigating large delivery catheters through tortuous and calcified vasculature, ensuring accurate positioning of prosthetic valves, and minimizing trauma to vascular walls, which can lead to complications like valve regurgitation and embolisms.
Innovation Solution
A guide catheter with a tubular delivery lumen that extends from the skin incision to the ascending aorta, featuring a collapsible and distensible design to protect the vasculature, an aligner for precise positioning, and an embolic protection filter to capture debris, allowing for single-stage introduction and removal of other catheters or devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large delivery catheter is used to accommodate the prosthetic valve, then the valve can be delivered and implanted, but the catheter causes trauma to the vasculature and is difficult to navigate through tortuous and calcified vessels
Solution Approach 1:
The delivery system is divided into multiple components: a guide catheter for navigation and protection, a delivery catheter for valve transport, and the prosthetic valve itself. This segmentation allows each component to be optimized for its specific function, with the guide catheter being soft and flexible for safe navigation while the delivery catheter provides structural support for valve deployment.
Solution Approach 2:
The guide catheter serves as an intermediary device that facilitates the passage of the delivery catheter through the vasculature. It provides a protective pathway and support structure that enables the delivery catheter to reach the implantation site without causing excessive trauma to the blood vessels.
2Ease of operation
If the delivery catheter is made soft and flexible for easy navigation, then it can traverse tortuous vasculature, but it loses the ability to provide sufficient support for force application from the proximal end
Solution Approach 1:
The system separates the navigation function (guide catheter) from the force application function (delivery catheter). The guide catheter is optimized for flexibility and navigation, while the delivery catheter is designed with sufficient rigidity to transmit forces for valve manipulation and deployment.
Solution Approach 2:
The guide catheter acts as an intermediary that transmits and amplifies forces applied at the proximal end to the distal end, enabling effective force transmission despite the flexibility needed for navigation through tortuous vessels.
3Force
If the delivery catheter is made rigid for force support, then it can provide support for force application, but it becomes difficult to navigate through tortuous and calcified vasculature
Solution Approach 1:
The delivery system is segmented into a flexible guide catheter for navigation and a more rigid delivery catheter for force application. This allows the rigid delivery catheter to be introduced through the flexible guide catheter, combining the advantages of both flexibility and rigidity in the overall system.
Solution Approach 2:
The delivery catheter is nested within the guide catheter during introduction and navigation. This nested configuration allows the rigid delivery catheter to benefit from the flexibility and protection of the guide catheter while maintaining its own structural integrity for force application.
4Reliability
If the prosthetic valve is placed in the proper position, then optimal valve function is achieved, but precise positioning is difficult to achieve remotely
Solution Approach 1:
The system incorporates imaging and positioning feedback mechanisms that allow the operator to monitor the location and orientation of the prosthetic valve during deployment. This feedback enables precise adjustments to achieve optimal positioning while minimizing the need for repositioning or additional procedures.
Data Source
AI summary
A guide catheter is described for introduction into a patient's vasculature, to provide a substantially continuous guide lumen within the vasculature to the ascending aorta, through which one or more other functional catheters may be introduced and removed during the procedure. The guide catheter includes an aligner at its distal region for aligning the position and/or inclination of the distal region of the guide catheter with respect to the ascending aorta. The aligner includes an embolic protection filter. The guide catheter is made of material collapsible/distensible in cross section to adopt a small shape when no catheter is present inside, and to distend to a large shape to accommodate passage of functional catheter therethrough. The cross-section shape collapses/distends by folding/unfolding of material without elastic stretching of the material.