Single Leaflet Prosthetic Valve for Mitral Regurgitation
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Solution Overview
Problem
Current heart valve replacement methods are invasive, bulky, and often disrupt native valve functionality, requiring full replacement and invasive anchoring, which can lead to trauma and complications, and lack efficient positioning and recapture capabilities.
Innovation Solution
A prosthetic heart valve device with a single leaflet and anchoring structure that can be expanded and positioned within the heart chamber, allowing for supplementary or full replacement of native valve function, with a hinged leaflet design that minimizes interference with native leaflets and includes a collapsible structure for easier delivery and positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional multi-leaflet prosthetic valve is used, then blood flow management is effective, but the device is bulky and disrupts native valve functionality
Solution Approach 1:
The patent extracts only the essential function of a heart valve by using a single leaflet instead of traditional multi-leaflet structures. This simplification removes unnecessary complexity while maintaining the core function of controlling blood flow direction and preventing regurgitation.
Solution Approach 2:
The prosthetic valve is segmented into distinct functional components: an anchoring structure for securing the device and a single movable leaflet for flow control. This segmentation allows each component to be optimized independently, with the leaflet being thin and flexible to minimize disruption to native valve functionality.
2Reliability
If invasive anchoring methods are used, then the prosthetic valve is securely positioned, but trauma and complications increase
Solution Approach 1:
The anchoring structure employs dynamic expansion from a compressed delivery state to an expanded deployed state, allowing the device to be delivered through minimally invasive catheter access and then expanded to achieve secure anchoring. This dynamic transition reduces the need for invasive surgical anchoring methods.
Solution Approach 2:
The prosthetic valve is designed with a nested configuration where the leaflet and anchoring structure are compressed together within a delivery catheter. This nested design enables minimally invasive delivery while maintaining the integrity and positioning security of the device upon deployment.
3Reliability
If the prosthetic valve is designed for full replacement, then native valve functionality is eliminated, but the device must be bulky and invasive
Solution Approach 1:
The single leaflet is designed with localized functional zones: a thin flexible portion for flow control that minimizes interference with native valve tissue, and a reinforced attachment zone for secure connection to the anchoring structure. This local differentiation allows the device to function effectively while being minimally invasive.
Solution Approach 2:
The leaflet is constructed as a thin, flexible membrane that can conform to the native valve anatomy and move naturally with blood flow. This thin-film design reduces disruption to native valve functionality compared to bulky traditional prosthetic valves, while still providing effective flow management.
4Measurement precision
If the device is expanded for positioning, then positioning accuracy is improved, but recapture and repositioning become difficult
Solution Approach 1:
The device incorporates dynamic controllability allowing it to be expanded and collapsed controllably via the delivery catheter. This dynamic capability enables the operator to expand the device for accurate positioning, then collapse it for recapture and repositioning if needed, maintaining ease of operation throughout the procedure.
Solution Approach 2:
The device is pre-configured in a compressed state within the delivery catheter, allowing it to be delivered to the target location first. Once positioned accurately, the device is then expanded to achieve secure anchoring and functional deployment. This preliminary compression enables accurate positioning before final expansion.
Data Source
AI summary
Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.