Heart Valve Prosthesis Delivery System with Movable Retaining Means
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Solution Overview
Problem
Current catheter systems for delivering prostheses, such as heart valves, face challenges in securely loading and crimping the prosthesis without damaging the tissue, achieving precise positioning, and maneuvering through the vasculature with existing systems.
Innovation Solution
A catheter system with a steering mechanism and a delivery system that includes a catheter tip with movable retaining means for securing the heart valve, allowing for coaxial and rotational movement, and an introducer sheath for facilitating crimping and navigation through the vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the prosthesis is crimped to a small size for delivery through the vasculature, then the prosthesis can be delivered to the implantation site, but the tissue of the prosthesis may be damaged or stretched
Solution Approach 1:
The prosthesis is pre-loaded onto the delivery catheter in a crimped state before the procedure begins. The retaining means are pre-positioned to secure the prosthesis during delivery, allowing the crimping to be done in advance rather than during the delicate implantation process.
Solution Approach 2:
The retaining means are designed to be movable along the catheter shaft, allowing dynamic adjustment during the procedure. This enables the operator to secure the prosthesis at different positions and adjust the crimping force as needed, preventing excessive compression that could damage the tissue.
2Volume of moving object
If the catheter system has a small diameter to pass through narrow vasculature, then the delivery can be performed through femoral access, but the prosthesis may not be securely held or positioned
Solution Approach 1:
The delivery system employs a nested structure with an inner catheter shaft and an outer introducer sheath. The prosthesis is loaded onto the inner shaft, then the outer sheath is advanced over it to provide additional support and securing mechanisms. This nested arrangement allows the system to maintain a small overall diameter while providing multiple retention points for the prosthesis.
Solution Approach 2:
The retaining means act as an intermediary component between the prosthesis and the catheter system. These retaining elements provide a mechanical interface that securely holds the prosthesis during delivery through the narrow vasculature, then can be released at the implantation site to deploy the prosthesis.
3Ease of manufacture
If the prosthesis is loaded and crimped using existing systems, then the delivery can be performed, but the correct positioning and repositioning capability is limited
Solution Approach 1:
The retaining means are designed to be movable rather than fixed, allowing the operator to adjust the position of the prosthesis along the catheter shaft during the procedure. This dynamic retention system enables repositioning if the initial placement is not optimal, and allows for controlled release at the target site.
Solution Approach 2:
The system allows for changes in the operational parameters of prosthesis retention during the procedure. The retaining means can transition from a secure held state during delivery to a released state at implantation, providing flexibility in positioning while maintaining ease of loading and crimping.
Data Source
AI summary
The present disclosure relates to a delivery system, a catheter system and a method for the minimally invasive application of prostheses to an individual in need thereof and a method for loading a prosthesis onto a catheter system and/or a delivery system.