Retractable Flat-Wire Coupling for Self-Expanding Valve Delivery
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Solution Overview
Problem
Existing transcatheter delivery systems for heart valve prostheses face complications such as vessel trauma, inaccurate placement, conduction disturbances, coronary artery obstruction, and undesirable paravalvular leakage due to their large delivery profile and curved anatomy.
Innovation Solution
A delivery system utilizing retractable flat wires as a coupling and deployment mechanism, comprising an outer sheath, an elongate tube with wires, and self-expanding frames, where the wires are woven through the frames to couple and deploy the prosthesis, allowing controlled and predictable expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a large delivery profile is used for the prosthesis, then the prosthesis can be delivered percutaneously, but vessel trauma and complications increase
Solution Approach 1:
The prosthesis frame is nested within a delivery catheter assembly, with the frame compressed to a small diameter for delivery and then expanded at the target site. The valve leaflets are attached to the interior of the compressed frame, allowing the entire prosthesis to be delivered through a catheter while maintaining a small delivery profile that reduces vessel trauma.
Solution Approach 2:
The prosthesis frame is designed to be dynamically changeable between a compressed delivery configuration and an expanded operational configuration. The frame can be compressed to pass through vessels and then expanded at the target site to provide the necessary structural support and valve function, adapting the delivery profile to the operational requirements.
2Object-affected harmful factors
If the prosthesis is compressed to a small diameter for delivery, then vessel trauma is reduced, but placement accuracy becomes difficult to achieve
Solution Approach 1:
The delivery system incorporates imaging guidance (such as fluoroscopy or echocardiography) that provides real-time feedback on the prosthesis position during deployment. This allows the operator to adjust the placement to achieve accurate positioning while maintaining the benefits of compressed delivery for reducing vessel trauma.
Solution Approach 2:
The prosthesis is pre-compressed to a small diameter for delivery through the catheter, and then expanded at the target site using a balloon catheter or by removal from the delivery catheter. This preliminary compression enables safe delivery while subsequent expansion and positioning steps ensure accurate placement at the target location.
3Ease of operation
If the prosthesis is delivered using a catheter-based system, then invasive surgery is avoided, but conduction disturbances and coronary artery obstruction may occur
Solution Approach 1:
The delivery catheter is designed with specific local characteristics at its tip, such as a curved or angled configuration, to navigate the vasculature and position the prosthesis accurately at the target site. This localized design allows minimal invasive delivery while reducing the risk of conduction disturbances and coronary artery obstruction by avoiding unnecessary tissue manipulation in critical areas.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables safer, more precise implantation of heart valve prostheses by minimizing vessel trauma and improving placement accuracy, reducing complications like paravalvular leakage.
Implementation Method 1
self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein
Data Source
AI summary
A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.