Mitral Valve Anchor and Expandable Valve for Regurgitation Reduction
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Solution Overview
Problem
Current methods for treating heart valve regurgitation, such as open-heart surgery and percutaneous procedures, are invasive and not suitable for all patients, particularly high-risk individuals, as they often require extracorporeal circulation and may not effectively address a wide range of heart valve defects.
Innovation Solution
A minimally invasive device and method using a blood flow controlling device with an expandable valve portion and anchor portion, delivered through a small incision in the chest, which expands to fill the gap between mitral valve leaflets, reducing regurgitation without the need for extracorporeal circulation, and can be customized to fit individual heart geometries using a three-dimensional anchor portion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is performed to treat heart valve regurgitation, then effective valve repair or replacement is achieved, but patient trauma and surgical invasiveness increase significantly
Solution Approach 1:
The device is divided into separate functional components: an anchor portion for securing to the heart wall, an elongate body for positioning, and a valve portion for treating the regurgitation. This segmentation allows each component to be optimized independently and delivered through minimally invasive access routes.
Solution Approach 2:
The device acts as an intermediary structure between the heart wall and the valve leaflets, providing mechanical support and positioning to improve valve function without requiring direct manipulation of the valve tissue itself or open surgical access.
2Object-affected harmful factors
If percutaneous procedures are used to treat mitral valve regurgitation, then patient trauma is reduced, but applicability to various heart valve defects is limited
Solution Approach 1:
The device is designed with universal applicability through its modular structure and adjustable components. The anchor portion can be positioned at different locations, the elongate body can accommodate various lengths and configurations, and the valve portion can be adjusted to treat different types and severities of regurgitation, making it suitable for multiple heart valve defects.
Solution Approach 2:
The device incorporates dynamic elements that allow it to adapt to different anatomical configurations. The elongate body can flex and conform to the heart's geometry, and the valve portion can be positioned at various angles and depths to address different defect locations and types while maintaining minimal invasiveness.
3Reliability
If coronary sinus implant is used to apply compressive force to mitral valve annulus, then regurgitation is reduced, but suitability for all patients is compromised due to anatomical variations
Solution Approach 1:
Instead of relying on the coronary sinus for force application, the device applies compressive force locally and directly to the mitral valve annulus through the anchor portion positioned in the heart wall. This local application of force eliminates dependence on coronary sinus anatomy and its variations, ensuring consistent effectiveness across diverse patient populations.
4Reliability
If edge-to-edge approach is used to attach mitral valve leaflet edges, then regurgitation is reduced, but patient suitability is limited by specific anatomical requirements
Solution Approach 1:
The device extracts the leaflet edges from their native positions and repositions them using the anchor and elongate body structure. This allows the leaflets to be brought into proper alignment and apposition without requiring the specific anatomical conditions needed for traditional edge-to-edge techniques, expanding patient eligibility.
Data Source
AI summary
The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.