Transcatheter Heart Valve Handle for Repositioning
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Solution Overview
Problem
Current transcatheter valve implantation technologies face challenges in achieving precise and adjustable placement of heart valves, leading to issues such as obstruction of coronary ostia, embolization, and paravalvular regurgitation due to limited repositioning and retrieval capabilities.
Innovation Solution
A medical device handle with a slide lock, pivot ring fitment, and spherical bearing surface allows for radial expansion, contraction, and lateral positioning control of a stent frame, enabling step-wise deployment and repositioning of percutaneously implanted heart valves through a system of filaments and adjustable arms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If instant deployment is used, then deployment speed is improved, but repositioning capability deteriorates
Solution Approach 1:
The system transitions from a static instant-deployment state to a dynamic multi-stage deployment process. The valve can be deployed in stages (first stage and second stage) and can be repositioned by manipulating the delivery system components (pusher, sheath, filaments) before final release. This dynamic control allows the operator to adjust valve position and perform retrieval if needed, resolving the contradiction between fast deployment and repositioning capability.
2Productivity
If valve is placed too high (proximal), then implantation speed is improved, but harmful effects worsen (coronary ostia obstruction, embolization)
Solution Approach 1:
The multi-stage deployment system provides feedback control for valve positioning. The operator can deploy the valve to a preliminary position, assess its location (particularly relative to coronary ostia), and then adjust the position by manipulating the delivery system components before final release. This feedback mechanism prevents harmful effects by allowing correction of improper positioning while maintaining efficient implantation.
3Ease of operation
If valve is placed too low (distal), then implantation simplicity is improved, but harmful effects worsen (AV node compression, conduction abnormalities)
Solution Approach 1:
The dynamic multi-stage deployment system allows the operator to control valve position precisely during the deployment process. By manipulating the pusher and sheath components in coordination, the operator can ensure the valve is positioned at the correct height relative to the AV node before final release, preventing conduction abnormalities while maintaining implantation simplicity through the standardized deployment procedure.
4Manufacturing precision
If repositioning capability is added, then positioning precision is improved, but device complexity worsens
Solution Approach 1:
The delivery system components (pusher, sheath, filaments) serve multiple functions: they deliver the valve, control its deployment timing, enable repositioning, and allow retrieval. This multi-functionality reduces the need for additional specialized components, thereby limiting the increase in device complexity while achieving precise positioning capability through coordinated manipulation of these universal components.
Data Source
Figure 1A~1F
Figure 2A~4B
Figure 5A~5E
AI summary
Improved catheter devices for delivery, repositioning and/or percutaneous retrieval of percutaneously implanted heart valves are described, including a medical device handle that provides an array of features helpful in conducting a percutaneous heart valve implantation procedure while variously enabling radial expansion or contraction and/or lateral positioning control over the heart valve during the medical procedure.