Transvascular Heart Valve Repair with Force-Guided Leaflet Capture
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Solution Overview
Problem
Damaged heart valves, such as the mitral and tricuspid valves, often lead to regurgitation due to improper closure, which can result in serious cardiovascular complications, and current treatments like open heart surgery are invasive and risky.
Innovation Solution
A valve repair device with anchors and paddles that can be deployed transvascularly, featuring force measurement devices to ensure proper attachment and sealing, thereby preventing regurgitation by capturing and securing native valve leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed to repair damaged heart valves, then effective valve repair can be achieved, but the procedure becomes highly invasive with increased risk of complications
Solution Approach 1:
A delivery catheter serves as an intermediary device to transport the valve repair device through the bloodstream to the target heart valve location, enabling minimally invasive access without requiring open heart surgery. The catheter navigates through blood vessels and delivers the repair device directly to the damaged valve, bridging the gap between external access and internal repair.
Solution Approach 2:
The patent replaces the mechanical open heart surgical system with a transvascular catheter-based delivery system. Instead of requiring surgical incisions, sternotomy, and direct surgical access to the heart, the repair device is delivered through flexible catheters that navigate the cardiovascular system, substituting complex mechanical surgical access with a less invasive endovascular approach.
2Object-affected harmful factors
If transvascular techniques are used to deliver valve repair devices, then invasiveness is reduced, but precise positioning and secure attachment of the device become more difficult
Solution Approach 1:
Force measurement devices provide real-time feedback on the attachment forces between the valve repair device and native valve tissue. This feedback mechanism allows operators to monitor and adjust the deployment process to achieve optimal attachment, ensuring precise positioning and secure fixation without excessive force that could damage surrounding tissue.
Solution Approach 2:
The valve repair device incorporates movable paddles that can transition between open and closed positions during deployment. This dynamic capability allows the device to navigate through the catheter in a compact state, then expand to engage the native valve leaflets, providing both ease of delivery and secure attachment at the target site.
3Manufacturing precision
If force measurement devices are integrated into the valve repair device, then attachment precision can be monitored, but device complexity increases
Solution Approach 1:
The force measurement devices serve multiple functions: they monitor attachment forces, verify proper device deployment, and provide safety feedback to prevent excessive force application. This multi-functionality justifies the added complexity by providing critical information for successful device attachment while maintaining patient safety.
Solution Approach 2:
The force measurement devices act as intermediary sensors that mediate between the mechanical attachment process and the control system. These sensors translate physical attachment forces into measurable signals that can be monitored and used to guide the deployment process, bridging the gap between mechanical action and controlled response.
4Reliability
If the valve repair device uses movable paddles to attach to native valve leaflets, then secure capture can be achieved, but the mechanism becomes more complex
Solution Approach 1:
The movable paddles provide dynamic adaptation to the native valve leaflet geometry. The paddles can move to conform to the irregular shapes and positions of the leaflets, ensuring secure capture regardless of anatomical variations. This dynamic capability enhances attachment reliability while maintaining a relatively simple mechanical structure.
Solution Approach 2:
The attachment mechanism is divided into multiple independent paddles that can operate semi-independently to engage different portions of the native valve leaflets. This segmentation allows each paddle to optimize its engagement with the local tissue geometry while contributing to the overall secure attachment of the device.
Data Source
AI summary
A valve repair device and valve repair systems including a delivery device and a valve repair device for repairing a native valve of a subject. The valve repair device and/or the delivery device having one or more force measurement devices for detecting a force applied to the native valve of a subject due to the connection between the valve repair device and the native valve. The valve repair device and the delivery system are used in a method of determining if a tension force provided to a native valve of a subject due to an attachment between a valve repair device and the native valve is at a desired level.