Heart Valve Stabilizer Assembly for Calcification Fracture
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Solution Overview
Problem
Current methods for fracturing calcifications in heart valves, such as aortic valve leaflets, are inadequate in effectively increasing leaflet pliability and mobility, particularly in heavily calcified or asymmetrically calcified valves, which can lead to reduced cross-sectional area and increased risk of paravalvular leaks during trans-catheter valve implantation.
Innovation Solution
A device comprising a stabilizer assembly with distal stabilizer struts and loops, used in conjunction with an impactor assembly, to fracture calcifications by applying sufficient energy, where the stabilizer assembly includes a shaft with arms, bridge sections, and curved struts that deploy from a sheath to sandwich and break calcifications between the stabilizer and impactor, thereby increasing the cross-sectional area of the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If current methods are used to fracture calcifications in heavily calcified valves, then some calcification reduction is achieved, but leaflet pliability and mobility are insufficiently improved
Solution Approach 1:
The stabilizer assembly is divided into multiple struts and loops that can be independently positioned along the valve annulus, allowing targeted fracture of calcifications while preserving healthy tissue. Each strut can be adjusted to apply force at specific locations, enabling segmented treatment of asymmetric calcification patterns.
Solution Approach 2:
The stabilizer assembly is deployed and positioned on the valve annulus before the impactor is applied. This preliminary stabilization ensures that when the impactor fractures calcifications, the force is properly distributed and the valve structure is prepared to receive the fractured pieces, maximizing the effect on leaflet pliability.
2Area of stationary object
If more aggressive fracturing is applied to increase cross-sectional area, then valve opening area improves, but risk of paravalvular leaks increases
Solution Approach 1:
The stabilizer struts and loops are positioned to provide localized support at specific regions of the valve annulus. This allows aggressive fracturing of heavily calcified areas to increase cross-sectional area while maintaining stability and sealing in other regions, thereby reducing the risk of paravalvular leaks.
Solution Approach 2:
The stabilizer assembly can be adjusted to change the distribution and magnitude of stabilizing forces at different locations around the valve. By modifying these parameters, the system optimizes the balance between achieving sufficient cross-sectional area through fracturing and maintaining adequate sealing to prevent paravalvular leaks.
3Device complexity
If a simple impactor is used without stabilizer, then device complexity is reduced, but effective energy transmission to calcifications is insufficient
Solution Approach 1:
The stabilizer assembly is combined with the impactor to form an integrated system. The stabilizer struts and loops work together with the impactor to transmit energy more effectively to the calcifications while maintaining overall device manageability. The combination allows for better energy distribution without proportionally increasing complexity.
Solution Approach 2:
The stabilizer loops are designed with curved geometries that conform to the natural curvature of the valve annulus. This curved design improves contact and energy transmission to calcifications located on the curved valve surface, enhancing the effectiveness of the impactor while maintaining a relatively simple overall structure.
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 solution effectively fractures calcifications, enhancing leaflet mobility and reducing the risk of paravalvular leaks by increasing the cross-sectional area of the implanted valve, allowing for successful trans-catheter valve implantation even in heavily calcified native valves.
Implementation Method 1
relative motion between the impactor assembly and the stabilizer assembly with sufficient energy fractures a calcification located in tissue which is sandwiched between the stabilizer assembly and the impactor assembly
Data Source
AI summary
A device for fracturing calcifications in heart valves includes a stabilizer assembly (20) for use with an impactor assembly (10). Relative motion between the impactor assembly (10) and the stabilizer assembly (20) with sufficient energy fractures a calcification located in tissue which is sandwiched between the stabilizer assembly (20) and the impactor assembly (10). The stabilizer assembly (20) includes a plurality of distal stabilizer struts (28) connected by stabilizer loops (30) which extend proximally backwards.