Flexible Leaflet Reinforcement Patch for Heart Valve Repair
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical devices for improving heart valve function, such as those with support structures for regurgitant or prolapsed valve leaflets, may not provide sufficient rigidity and can be difficult for surgeons to handle during surgery, and may not effectively address issues like annulus dilation and leaflet perforation or rupture.
Innovation Solution
A flexible leaflet reinforcement patch with a tissue anchoring unit, such as a loop-shaped support, is used to reinforce heart valve leaflets by orienting its outer section towards the annulus and inner section towards the valve tissue, providing reinforcement while being securely attached to prevent dislocation due to pulsatile blood flow and heart dynamics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a support structure is used to reinforce valve leaflets, then the strength and function of the leaflets is improved, but the device becomes difficult to handle during surgery
Solution Approach 1:
The support structure is divided into multiple discrete elements (stents, struts, or framework components) that can be independently manipulated and deployed. This segmentation allows surgeons to handle and position each component separately during surgery, improving ease of operation while maintaining the overall structural support function for the leaflets
Solution Approach 2:
The support structure is designed with dynamic characteristics, allowing it to be compressed or collapsed for easy delivery through catheters and then expanded or deployed at the target site. This dynamic transformation enables the device to transition from a compact, easily handled delivery state to an expanded, structurally supportive implanted state, resolving the contradiction between ease of operation and leaflet strength
2Stability of the object's composition
If a rigid support structure is used to reinforce valve leaflets, then the structural stability is improved, but the natural movement of the leaflets is restricted
Solution Approach 1:
The support structure utilizes flexible materials and thin-film construction that allow the framework to bend and deform with the natural movement of the valve leaflets. This flexibility enables the structure to provide structural stability and reinforcement while adapting to the dynamic physiological motion of the heart valve, preventing restriction of natural leaflet movement
Solution Approach 2:
The support structure incorporates dynamic design features that allow it to transition between different states of rigidity and flexibility. The structure can maintain structural stability when needed while permitting natural leaflet movement during the cardiac cycle, resolving the contradiction between structural stability and adaptability
3Stability of the object's composition
If the annulus is allowed to remain dilated, then the natural anatomy is preserved, but the valve function deteriorates due to incomplete closure
Solution Approach 1:
The support structure is designed to provide localized reinforcement at specific segments of the annulus or leaflet attachment regions rather than uniformly altering the entire annular geometry. This local quality approach allows the annulus to maintain its overall natural anatomy while providing targeted structural support to improve leaflet coaptation and closure function in critical areas
Solution Approach 2:
The support structure divides the annular reinforcement into multiple discrete segments or zones, each addressing specific areas of weakness or dysfunction. This segmentation allows preservation of the natural annular geometry in healthy regions while providing targeted support to improve valve closure function in affected areas
Data Source
AI summary
A medical device is disclosed that reinforces weakened or degenerated areas of at least a portion of a leaflet (24) Of the heart valve. Function of a heart valve is thus improved. The medical device comprises at least a first partly flexible leaflet reinforcement patch (30) having an extension between an inner section (34) and an outer section (32), wherein said outer section (32) is configured to be oriented towards said annulus,and said inner section (34) is configured to be oriented towards said inner section of said valve tissue, and at least a portion of said inner section (34) of said flexible leaflet reinforcement patch (32) having at least one of said plurality of leaflets (24) in juxtaposition to said portion of said inner section (34), and said portion of said inner section (34) being positioned to provide reinforcement to said plurality of leaflets (24).