Calcified Aortic Valve Leaflet Remodeling Device
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for repairing calcified aortic and cardiac valves are inadequate in effectively remodeling and restoring mobility to valve leaflets, as they fail to efficiently fracture and remove calcifications without causing damage to surrounding tissue.
Innovation Solution
A calcification treatment device featuring an expandable treatment member and fracturing elements, where the expandable member is arranged to radially expand and position the calcification against the fracturing elements, allowing for controlled fracture of calcified tissue while minimizing damage to the valve leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If impactor arms are used to fracture calcifications, then calcification removal is achieved, but damage to surrounding valve tissue occurs
Solution Approach 1:
The device divides the calcification treatment into two distinct functional components: fracturing elements for breaking calcifications and an expandable treatment member for protecting and supporting the valve tissue. This segmentation allows each component to perform its specific function without interfering with the other, thereby removing calcifications while minimizing damage to surrounding tissue.
Solution Approach 2:
The expandable treatment member acts as an intermediary between the fracturing elements and the valve tissue. It positions the calcification against the fracturing elements while simultaneously protecting the surrounding valve tissue from direct contact with the fracturing mechanism, thus enabling effective calcification removal while preventing tissue damage.
2Manufacturing precision
If expandable treatment member is used to position calcification, then controlled fracture is achieved, but device complexity increases
Solution Approach 1:
The device combines the expandable treatment member and fracturing elements into a single integrated assembly that can be delivered through a catheter. This merging allows the device to achieve controlled fracture positioning while maintaining a relatively simple delivery mechanism, as both components work together within the same device structure rather than requiring separate systems.
Solution Approach 2:
The expandable treatment member provides dynamic adjustability, allowing the device to adapt to different valve geometries and calcification positions. By expanding and contracting the treatment member, the device can precisely position the calcification against the fracturing elements at various locations along the valve leaflet, achieving controlled fracture positioning without requiring multiple fixed-device configurations.
3Reliability
If impactor arms are locked in expanded shape, then fracture generation is enabled, but inability to retract limits treatment flexibility
Solution Approach 1:
The expandable treatment member can be dynamically expanded and contracted along the catheter shaft, allowing the device to retract and reposition at different locations along the valve. This dynamic capability enables the treatment member to reach multiple positions along the valve leaflet and generate fractures at different locations, providing treatment flexibility while maintaining reliable fracture generation when expanded.
Solution Approach 2:
The device separates the fracturing function (impactor arms) from the positioning function (expandable treatment member). The impactor arms remain locked in their expanded shape to ensure reliable fracture generation, while the expandable treatment member can be independently retracted and repositioned to treat different locations along the valve, thereby maintaining both fracture generation capability and treatment flexibility.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively fractures calcifications, restoring mobility to valve leaflets and preventing damage to surrounding tissue, thereby improving valve function and mobility post-treatment.
Implementation Method 1
the expandable treatment member is arranged for buckling radially outwards
Implementation Method 2
expanding the expandable treatment member against the tissue to force the calcification against the one or more fracturing elements so as to fracture the calcification
Implementation Method 3
one or more fracturing elements capable of fracturing a calcification of a valve tissue
Implementation Method 4
The internal shaft is movable to cause the impactor arms to expand outwards and be locked in an expanded shape. An impacting element is movable to cause the impactor arms, while in the expanded shape, to move towards the tissue with sufficient energy so as to fracture a calcification
Data Source
AI summary
A calcification treatment device includes an outer body (12) including an inner cavity and at least one outer calcification treatment member (16) facing towards the inner cavity. An inner body (18) is movable into the inner cavity and includes at least one inner calcification treatment member (20) facing towards an inner surface of the outer body. One of the outer and inner calcification treatment members includes an expandable treatment member and one of the outer and inner calcification treatment members includes one or more fracturing elements capable of fracturing a calcification of a valve tissue.