Heart Valve Sealing Devices for Minimally Invasive Regurgitation Control
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Solution Overview
Problem
Damaged heart valves, particularly the mitral and tricuspid valves, often result in regurgitation due to improper closure, leading to serious cardiovascular issues, and current treatments like open heart surgery are invasive and risky.
Innovation Solution
Implantable prosthetic devices with anchors and coaption elements are designed to secure to native valve leaflets, forming a seal to prevent regurgitation by filling the gap between leaflets and providing a more effective closure during heart contraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed to repair damaged heart valves, then the valve function can be restored, but the procedure is highly invasive and carries high risk of complications
Solution Approach 1:
A delivery catheter serves as an intermediary device to transport the prosthetic valve assembly from a remote access site through the vascular system to the target heart valve location, enabling minimally invasive implantation without open heart surgery
Solution Approach 2:
The prosthetic valve assembly is nested within the delivery catheter in a compressed state during delivery, then deployed outward to assume its functional configuration at the implantation site, allowing percutaneous access while maintaining device functionality
2Object-affected harmful factors
If trans-septal technique is used to access mitral and aortic valves, then invasive procedures are reduced, but the delivery path becomes more complex requiring septum puncture
Solution Approach 1:
The delivery catheter is designed with multi-functional capabilities to navigate through the septum and deliver different types of prosthetic valve assemblies to various heart valve locations, consolidating multiple specialized devices into one universal platform
Solution Approach 2:
The delivery catheter incorporates flexible and dynamically adjustable components that can adapt its configuration during navigation through the complex cardiac anatomy, allowing real-time adjustment to patient-specific anatomical variations
3Reliability
If prosthetic devices are implanted to prevent regurgitation, then sealing capability is improved, but device structure becomes more complex with multiple components
Solution Approach 1:
Multiple functional components including the prosthetic valve, sealing elements, and anchoring mechanisms are merged into a single integrated prosthetic assembly that functions as one unit, simplifying the implantation process while maintaining enhanced sealing capability
Solution Approach 2:
The prosthetic assembly is segmented into modular components that can be independently designed, manufactured, and positioned, allowing optimization of each component's function while maintaining overall system integration during deployment
Data Source
AI summary
An implantable prosthetic device has a coaption element, a pair of paddles, and at least one cover. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The cover can at least partially cover the coaption element and/or the pair of paddles. The cover is at least partially closed by alternating in and out stitches that are substantially unexposed when the cover is secured on the device.