Segmented Capsule and Cinch Mechanism for Heart Valve Delivery
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Solution Overview
Problem
Current catheter delivery systems for heart valve prostheses face challenges in minimizing the crossing profile, particularly for mitral valve replacement, due to the need for a capsule covering the full length of the prosthesis, which limits positioning and feasibility, especially in the confined spaces of the left atrium.
Innovation Solution
A delivery catheter design featuring a capsule segment that encircles only a portion of the heart valve prosthesis and a cinch mechanism to hold the remainder in a reduced diameter state, allowing for a two-stage deployment without overlapping, enabling more flexible navigation and reduced size for delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a capsule covers the full length of the heart valve prosthesis, then the prosthesis is securely held in a reduced diameter state for delivery, but the catheter crossing profile increases and positioning flexibility is limited
Solution Approach 1:
The capsule is divided into a distal capsule segment and a proximal capsule segment with a gap between them. The distal segment holds the distal portion of the prosthesis while the proximal segment holds the proximal portion, allowing the prosthesis to be securely held in a reduced diameter state without requiring a continuous full-length capsule, thus reducing the catheter crossing profile.
Solution Approach 2:
The capsule segments are configured to be movable relative to each other and to the prosthesis, allowing dynamic adjustment during delivery and deployment. The segments can move independently to facilitate navigation through tortuous vasculature while maintaining secure holding of the prosthesis in a compressed state.
2Reliability
If a capsule covers the full length of the heart valve prosthesis, then the prosthesis is securely held during delivery, but positioning precision in the native valve annulus is reduced
Solution Approach 1:
The segmented capsule design allows independent positioning of the distal and proximal segments relative to the prosthesis and the native valve annulus. This enables precise positioning of the prosthesis by controlling the relative positions of the capsule segments during deployment, improving positioning precision while maintaining secure holding.
Solution Approach 2:
The capsule segments are configured to hold the prosthesis in a predetermined reduced diameter state before deployment. This preliminary constriction allows the prosthesis to be delivered through the vasculature in a compact form, and then deployed in a controlled manner at the precise location of the native valve annulus.
3Shape
If a full-length capsule is used, then the prosthesis is contained in a reduced diameter state, but the device complexity increases
Solution Approach 1:
The capsule is segmented into separate distal and proximal portions that can be independently controlled and deployed. This segmentation reduces the overall complexity of the capsule structure compared to a full-length continuous capsule, as each segment can be designed and actuated independently, simplifying the overall system architecture.
Solution Approach 2:
The dynamic configuration of the capsule segments, with their ability to move independently and change relative positions, allows the system to achieve the reduced diameter state functionality with a simpler overall structure. The segments can be actuated in sequence or independently, reducing the complexity of control mechanisms compared to a monolithic full-length capsule.
Data Source
Figure 1
Figure 2A~2B
Figure 3A
AI summary
A delivery system including a heart valve prosthesis and a delivery catheter. The delivery catheter includes an outer shaft component, an inner shaft component and a cinch mechanism. The outer shaft component has a capsule segment configured to encircle a first portion of the heart valve prosthesis and to thereby hold the first portion of the heart valve prosthesis in a reduced diameter state for delivery to a treatment site. The cinch mechanism surrounds a second portion of the heart valve prosthesis and is configured to hold the remainder of the heart valve prosthesis in a reduced diameter state for delivery to the treatment site. The capsule segment ends proximal of the cinch mechanism when the delivery catheter is in a delivery configuration. The capsule segment and the cinch mechanism in tandem hold the heart valve prosthesis in the reduced diameter state.