Transfemoral Heart Valve Delivery With Staged Anchor Release
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Solution Overview
Problem
Challenges exist in developing prostheses, particularly replacement heart valves, that can be compacted for delivery and controllably expanded for secure placement within the body, with difficulties in accessing and deploying them to desired locations through minimally invasive procedures, and securing them to intralumenal tissue without causing trauma.
Innovation Solution
A delivery system comprising a first and second member, a tether, and a tether retention assembly, which allows controlled deployment of prostheses by restraining ends of the prosthesis and using a tether to radially restrain the prosthesis, along with a nose cone and sheath mechanism to facilitate controlled expansion and secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthesis is compacted for delivery through minimally invasive procedures, then the ease of operation and patient trauma are improved, but the device complexity and control of deployment increase
Solution Approach 1:
The prosthesis is nested within a delivery catheter, which itself may contain other components. The expandable frame and valve leaflets are compressed within the catheter lumen, allowing the entire assembly to be delivered through small access points while maintaining the capability for controlled expansion at the target site
Solution Approach 2:
The delivery system is divided into multiple functional components including the catheter, expandable frame, valve leaflets, and deployment mechanisms. This segmentation allows each component to be optimized for its specific function while enabling controlled deployment through coordinated action of the segments
2Reliability
If a prosthesis is designed to be controllably expanded for secure placement, then the reliability of placement is improved, but the device complexity increases
Solution Approach 1:
The prosthesis transitions from a static compressed state within the catheter to a dynamic expanded state at the target site. The expandable frame incorporates movable struts and joints that allow controlled transformation from a low-profile delivery configuration to a high-profile implanted configuration, providing reliable placement while managing complexity through controlled dynamics
3Object-affected harmful factors
If a prosthesis is secured to intralumenal tissue in an atraumatic manner, then the object-affected harmful factors are reduced, but the manufacturing precision requirements increase
Solution Approach 1:
The valve leaflets are constructed from flexible tissue or tissue-like materials that can conform to the native valve annulus and adjacent structures. This flexibility allows the prosthesis to secure to intralumenal tissue through gentle compression and conformal contact rather than rigid fixation, reducing tissue trauma while requiring precise manufacturing of the flexible components to ensure proper function
Data Source
AI summary
A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.