Catheter Control Handle Segmentation for Sheath Flexibility
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Solution Overview
Problem
Existing interventional delivery systems for prosthetic heart valves face challenges in the flexibility of outer sheath operation and potential displacement or misalignment of prosthetic implants during balloon expansion procedures, posing safety risks.
Innovation Solution
The interventional delivery system includes a catheter assembly with an inner and outer sheath, where the outer sheath has a loading section for compressing the prosthetic implant and a sheath section for deployment. The control handle features a main handle connected to the inner sheath and an auxiliary handle slidably fitted over the inner sheath, enhancing the flexibility of outer sheath operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional control handle is used, then the basic delivery function is achieved, but the flexibility of outer sheath operation is insufficient
Solution Approach 1:
The control handle is divided into a main handle and an auxiliary handle. The auxiliary handle is slidably fitted over the inner sheath and can move independently along the catheter assembly, allowing separate control of the outer sheath from the main handle. This segmentation enables flexible operation of the outer sheath without requiring complex integrated control mechanisms.
2Reliability
If balloon expansion method is used, then the prosthetic implant can be delivered to the lesion site, but displacement or misalignment may occur during early deployment stages
Solution Approach 1:
The outer sheath is designed with a loading section that encloses and compresses the prosthetic implant before deployment. The auxiliary handle allows the operator to pre-position and stabilize the outer sheath at the desired location before balloon expansion begins. This preliminary positioning action ensures the implant is correctly aligned and secured before the expansion process starts, preventing displacement during deployment.
Data Source
AI summary
The present disclosure relates to the technical field of medical devices, and in particular to catheter implant systems and included associated device, prosthetic heart valves and method. The interventional delivery system included includes a catheter assembly and a control handle connected to the catheter assembly, the catheter assembly has opposing distal and proximal ends and includes an inner sheath and an outer sheath slidably engaged with each other, the outer sheath includes a loading section and a sheath section in sequence from the distal end to the proximal end, the loading section is configured to enclose and keep the interventional device in a compressed state; the control handle includes a main handle and an auxiliary handle slidably fitted over the inner sheath, the proximal end of the inner sheath is connected to the main handle and the proximal end of the outer sheath is connected to the auxiliary handle.