Steerable Catheter Control for Precise Heart Valve Delivery
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Solution Overview
Problem
The precise delivery and deployment of replacement heart valves in cardiac procedures is challenging due to the bulkiness of the implants, the tortuous paths to the target areas, and the need for precise alignment and orientation, which existing catheter guiding systems often fail to address effectively.
Innovation Solution
A steerable catheter system with control wires made of high-tensile strength materials, such as titanium, and a handle with steering mechanisms, along with deployable sheaths and hydraulic or magnetic deployment methods, allows for precise positioning and controlled deployment of replacement heart valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter system is used to deliver replacement heart valves through the vascular system, then the procedure becomes less invasive, but precise positioning and alignment of the implant becomes more difficult
Solution Approach 1:
A guide catheter is introduced as an intermediary device to facilitate the delivery of the replacement heart valve. The guide catheter provides a stable platform and directional control, enabling precise positioning of the implant while maintaining the less invasive percutaneous approach. The guide catheter acts as a mediator between the operator and the implant, transferring control and alignment capabilities.
Solution Approach 2:
The patent replaces traditional mechanical steering mechanisms with a control wire system that uses tension and flexibility to steer the catheter. The control wires allow the catheter to be steered by applying tension to specific wires, which bends the catheter in desired directions. This substitution enables more precise and flexible positioning compared to rigid mechanical steering.
2Reliability
If the replacement heart valve implant is made bulkier to ensure proper function, then valve performance is improved, but steering and positioning of the implant becomes more difficult
Solution Approach 1:
The delivery system is segmented into multiple functional components: a guide catheter for navigation, a delivery catheter for transporting the implant, and control wires for steering. This segmentation allows the bulkier implant to be delivered through a coordinated system where each component handles a specific aspect of the delivery, reducing the overall difficulty of steering and positioning.
Solution Approach 2:
The catheter system incorporates dynamic flexibility through control wires that can be tensioned and relaxed to steer the catheter in real-time. The control wires allow the operator to dynamically adjust the catheter's shape and direction during navigation, enabling precise positioning of the bulky implant despite its size. The system transitions from static to dynamic control, improving maneuverability.
3Adaptability or versatility
If the catheter diameter is increased to accommodate the replacement heart valve, then implant delivery capability is improved, but navigation through tortuous paths becomes more difficult
Solution Approach 1:
The catheter is constructed with flexible materials and a thin-walled structure that allows it to bend and conform to tortuous vascular paths. The flexible shell design enables the catheter to navigate complex anatomical routes while maintaining the structural integrity needed to deliver the replacement heart valve. The thin film construction reduces stiffness, improving navigability through curved and twisted pathways.
4Manufacturing precision
If high-tensile strength materials are used for control wires to improve steering precision, then positioning accuracy is improved, but control wire flexibility and ease of manipulation may be reduced
Solution Approach 1:
The control wires are constructed from composite materials that combine high-tensile strength properties with maintained flexibility. This allows the control wires to provide sufficient structural support for precise positioning while retaining the flexibility needed for easy manipulation and steering. The composite construction balances conflicting mechanical properties, achieving both positioning accuracy and operational ease.
Data Source
AI summary
The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.