Split Distal Tip Delivery System for Heart Valve Positioning
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Solution Overview
Problem
Current transcatheter delivery methods for heart valve prostheses face challenges such as vessel trauma, inaccurate placement, conduction disturbances, and paravalvular leakage due to large delivery profiles and curved anatomy, necessitating improved positioning accuracy.
Innovation Solution
A delivery system featuring a handle with actuators, an inner shaft with a nosecone having cutout portions, and a push wire to radially center the prosthesis within the native valve annulus by contacting anatomical structures like the interventricular septum during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a large delivery profile prosthesis is used for transcatheter delivery, then the prosthesis can be delivered through the vasculature, but vessel trauma occurs due to percutaneous delivery within highly curved anatomy
Solution Approach 1:
The delivery system is divided into multiple components including an inner shaft, outer sheath, and nosecone that can move independently. The nosecone can be deployed separately from the main prosthesis delivery mechanism, allowing navigation through curved anatomy without traumatizing vessels while maintaining the necessary delivery profile for the prosthesis.
Solution Approach 2:
The delivery system employs dynamic components that can change configuration during delivery. The nosecone transitions from a retracted state during navigation to a deployed state for positioning, allowing the system to adapt to anatomical constraints while maintaining delivery capability.
2Reliability
If the prosthesis is positioned too deep relative to the native annulus, then the prosthesis is securely implanted, but conduction disturbances occur
Solution Approach 1:
The system incorporates visual feedback mechanisms including radiopaque markers on the nosecone and delivery system components that allow real-time monitoring of prosthesis position relative to the native annulus during deployment, enabling precise positioning to avoid conduction disturbances while ensuring secure implantation.
Solution Approach 2:
The nosecone is deployed in advance of prosthesis release to establish proper positioning and depth relative to the native annulus before the prosthesis is fully deployed, preventing both over-implantation that causes conduction disturbances and under-implantation that compromises security.
3Ease of operation
If the prosthesis is not circumferentially centered relative to the native annulus, then delivery is simplified, but the deployed prosthesis may dislodge and/or paravalvular leakage may occur
Solution Approach 1:
The nosecone features an asymmetric design with a flat distal end and radiopaque markers positioned at specific locations to provide visual reference for circumferential centering. This asymmetric configuration allows the operator to easily align the prosthesis with the native annulus while maintaining delivery simplicity.
Solution Approach 2:
The nosecone acts as an intermediary positioning element that facilitates circumferential centering of the prosthesis relative to the native annulus. By providing visual markers and a defined geometry, the nosecone mediates the alignment process without complicating the overall delivery procedure.
Data Source
Figure 1~1B
Figure 1C
Figure 2
AI summary
A delivery system includes a handle, an inner shaft having a distal portion configured to receive the heart valve prosthesis thereon, a push wire slidingly disposed through a lumen of the inner shaft, and an outer sheath configured to cover the heart valve prosthesis during delivery. A split distal tip or nosecone is attached to a distal end of the inner shaft and includes at least one cutout portion formed through a sidewall thereof. A proximal end of the push wire is operatively coupled to an actuator of the handle and a distal end of the push wire is attached to the cutout portion of the nosecone. When the nosecone is in a delivery configuration the cutout portion is substantially flush with the sidewall of the nosecone. When the nosecone is in a deployed configuration the cutout portion is spaced apart from the sidewall of the nosecone.