Heart Valve Implant Loading Structure for Stable Catheter Delivery
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Solution Overview
Problem
There is a need for alternative medical devices and methods for manufacturing and using replacement heart valve implants that improve the efficiency and effectiveness of implant delivery systems.
Innovation Solution
A replacement heart valve implant system featuring an expandable framework with a tubular wall and interconnected struts, lower and upper crowns, and a bend line configuration, coupled with an implant delivery system that includes a stent holder with a groove to securely hold the implant in a radially collapsed configuration, facilitating precise delivery and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the expandable framework is designed with a radially collapsed configuration for delivery, then the implant can be delivered through catheters, but the framework becomes unstable and difficult to control during deployment
Solution Approach 1:
The framework is designed to dynamically transition between a radially collapsed configuration for delivery and a radially expanded configuration for deployment. The expandable structure allows the framework to adapt its shape and size based on the operational phase, enabling easy catheter delivery while maintaining stability during implantation.
Solution Approach 2:
The framework utilizes parameter changes in radial expansion to transition between delivery and deployment states. By controlling the expansion parameters, the framework can be compressed for delivery through catheters and then expanded to its functional configuration, resolving the contradiction between deliverability and stability.
2Manufacturing precision
If the framework is made expandable for deployment, then the implant can be positioned precisely, but the structure becomes more complex
Solution Approach 1:
The framework is segmented into multiple expandable elements that can be independently controlled during deployment. This segmentation allows for precise positioning of the implant while maintaining a manageable structural complexity through modular design.
Solution Approach 2:
The framework employs a nested structure where the expandable elements are contained within a delivery catheter during delivery, and then deployed in sequence to achieve precise positioning. The nested configuration allows complex functionality to be achieved while maintaining simplicity during delivery.
3Length of moving object
If the implant is delivered in a collapsed configuration, then the delivery catheter can be smaller, but the implant requires more force to expand
Solution Approach 1:
The framework is pre-formed in a collapsed configuration that is optimized for delivery through small catheters. The structure is designed with inherent expansion mechanisms that reduce the force required to deploy the implant once it reaches the target location.
Solution Approach 2:
The framework utilizes curved and spherical geometric features that allow for compact collapse during delivery and controlled expansion during deployment. The curvature of the framework elements enables efficient space utilization in the collapsed state while facilitating smooth expansion with reduced force requirements.
Data Source
AI summary
A replacement heart valve implant includes a framework and a plurality of valve leaflets. The framework includes interconnected struts, a plurality of upper crowns, and a plurality of lower crowns. The lower crowns include a bend line extending circumferentially through each lower crown and disposed upstream of upstreammost intersections of the struts and downstream of an upstreammost extent of the lower crowns. A replacement heart valve system includes the implant and an implant delivery system including a handle and an elongate shaft assembly, wherein a distal portion of the shaft assembly includes an implant holding portion. A method of loading the implant includes positioning the implant adjacent the holding portion, positioning the lower crowns surrounding a stent holder of the delivery system, collapsing the framework such that the lower crowns extend into a groove of the stent holder, and shifting the holding portion over the implant.