Heart Valve Delivery Catheters for Precise Anchor and Frame Placement
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Solution Overview
Problem
Existing methods for delivering prosthetic heart valves face challenges in navigating the complex anatomy of the heart and controlling the precise placement of anchors and valve frames, particularly for conditions like mitral valve regurgitation and stenosis, where precise positioning is crucial for effective treatment.
Innovation Solution
A delivery system comprising multiple catheters with advanced control mechanisms, including steerable and anchor control catheters, allows for precise axial, rotational, and deflection movements, enabling the separate delivery and controlled release of anchors and valve frames within the heart, utilizing mechanisms like guide arms, tethers, and multiple catheter systems to navigate and secure the prosthetic valve components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a simple delivery catheter is used, then the device complexity is reduced, but the ability to precisely control anchor and valve frame placement deteriorates
Solution Approach 1:
The delivery system is divided into separate functional components: an anchor delivery catheter for deploying the anchor, a valve frame delivery catheter for delivering the valve frame, and a guide catheter for navigation. This segmentation allows each component to be optimized for its specific function while maintaining overall system controllability and precision.
Solution Approach 2:
A guide catheter serves as an intermediary tool that facilitates the navigation and positioning of both the anchor delivery catheter and valve frame delivery catheter. The guide catheter provides a stable rail system that enables precise control of component placement while simplifying the overall delivery process through centralized navigation control.
2Measurement precision
If multiple catheters with advanced control mechanisms are used, then the control precision over anchor and valve frame placement is improved, but the ease of operation deteriorates
Solution Approach 1:
The proximal portions of the anchor delivery catheter and valve frame delivery catheter are merged into a single integrated handle assembly. This merging combines multiple control mechanisms into one unified interface, allowing the operator to control both catheters simultaneously from a single location, thereby reducing procedural complexity while maintaining precise positioning control.
Solution Approach 2:
The guide catheter serves multiple functions: it provides a navigation rail, supports both delivery catheters, enables positioning control, and facilitates the deployment sequence. This multi-functionality reduces the need for additional specialized devices, simplifying the overall procedure while maintaining high positioning precision.
3Reliability
If separate delivery of anchor and valve frame is implemented, then the reliability of valve implantation is improved, but the device complexity increases
Solution Approach 1:
The anchor is delivered and deployed in advance before the valve frame is delivered. This preliminary action ensures that the anchor is securely in place to receive and support the valve frame, thereby improving implantation reliability. The sequential delivery process is facilitated by the integrated delivery system that manages both components through a unified control interface.
Data Source
AI summary
Apparatuses and methods for delivering one or more parts of a valve prosthesis into a patient's heart. The apparatuses may include one or more catheters that are operationally coupled to one or more controls for controlling axial movement, rotational movement and/or deflection of the one or more catheters during the valve prosthesis delivery into the heart. The one or more controls may provide gross and fine movement control over multiple degrees of freedom of one or more catheter, thereby providing superior control for a practitioner during the valve prosthesis delivery procedure.