Sheathing Aid Arms Guide Heart Valve Into Sheath
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Solution Overview
Problem
Current medical devices for delivering and deploying replacement heart valves are invasive and require significant recovery time, with challenges in efficiently guiding and deploying the valves within the cardiovascular system.
Innovation Solution
A medical device system comprising a braided anchor member connected to a delivery system with a sheathing aid that includes a plurality of arms extending from an inner catheter to guide the medical implant into an outer sheath, utilizing a flexible polymeric member and metallic core for efficient deployment and retraction of the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a braided anchor member is used for replacement heart valve delivery, then the valve can be delivered percutaneously with less invasiveness, but the device complexity increases due to the need for sheathing aid with multiple arms and flexible members
Solution Approach 1:
The sheathing aid employs a nested structure where the braided anchor member is contained within an outer sheath, and the flexible members are positioned between these layers. The multiple arms extend from the inner catheter to the proximal end of the braided anchor member, creating a nested configuration that enables percutaneous delivery while organizing complex components in a space-efficient manner.
Solution Approach 2:
The delivery system is segmented into distinct functional components: the outer sheath for containment, the inner catheter for support, and multiple flexible members distributed between them. This segmentation allows each component to perform its specific function independently while collectively enabling less invasive delivery of the replacement heart valve.
2Ease of operation
If multiple arms with flexible members are used to guide the medical implant into the outer sheath, then the ease of operation improves for positioning and deployment, but the device complexity increases
Solution Approach 1:
The flexible members are designed to automatically position and guide the braided anchor member into the outer sheath during deployment. The distal ends of the flexible members extend beyond the core member to engage with the braided anchor member, enabling self-guided positioning without requiring additional manual manipulation or complex control mechanisms.
Solution Approach 2:
The flexible members utilize flexible polymeric materials that can bend and conform during the deployment process. This flexibility allows the arms to navigate the deployment sequence smoothly, guiding the implant into the outer sheath through controlled movement rather than rigid mechanical guidance, thereby improving ease of operation.
3Reliability
If the flexible member extends beyond the core member to engage the braided anchor member, then the reliability of engagement improves, but the manufacturing precision requirements increase
Solution Approach 1:
The flexible member is designed with variable dimensions along its length, including a distal region that extends beyond the core member and an intermediate region with greater width. This parameter variation allows the flexible member to provide reliable engagement with the braided anchor member at its distal end while maintaining manufacturability through controlled dimensional changes rather than requiring extreme precision throughout the entire structure.
Data Source
AI summary
A medical device apparatus may include a medical implant including a braided anchor member configured to actuate between a delivery configuration and a deployed configuration operatively connected to a delivery system. The delivery system may include a handle, an outer sheath extending distally from the handle, and an inner catheter disposed within the outer sheath. A sheathing aid may connect the delivery system to the medical implant, the sheathing aid being configured to guide the medical implant into the outer sheath upon relative closing movement therebetween. The sheathing aid may include a plurality of arms extending from the inner catheter to a proximal end of the braided anchor member. At least one arm of the plurality of arms may comprise a core member having a width and a flexible member positioned about the core member.