Expandable Impactor Struts for Fracturing Heart Valve Calcifications
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Solution Overview
Problem
Current devices for fracturing calcifications in heart valves, such as aortic valve leaflets, face limitations in effectively increasing leaflet pliability and mobility, which is crucial for treating calcific aortic valve disease and preparing the valve for trans-catheter implantation.
Innovation Solution
A device with a tube having longitudinal slits forming struts with notches, capable of expanding to impact and fracture calcifications, is introduced. The struts are designed to be contracted or expanded using an actuator, allowing for controlled deployment and fracture of calcifications within the heart valve, with a curved waist portion for conforming to the valve leaflet shape.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If the impactor arms are made rigid to deliver sufficient impact force, then the ability to fracture calcifications is improved, but the ability to conform to the curved valve leaflet shape deteriorates
Solution Approach 1:
The impactor is divided into multiple independent impactor arms that can be selectively positioned and activated. Each arm can be independently controlled to impact specific calcification locations while maintaining overall structural integrity for force delivery.
Solution Approach 2:
The impactor arms are designed to be dynamically adjustable, allowing them to transition between a compact configuration for delivery and an expanded configuration for impact. The arms can be selectively activated and deactivated to adapt to different valve geometries and calcification patterns.
2Productivity
If the impactor arms are expanded outwards to increase contact area with leaflets, then the effectiveness of fracture is improved, but the device complexity increases
Solution Approach 1:
The impactor arms are nested within the catheter assembly during delivery, allowing compact passage through the vascular system. Upon deployment, the arms expand outward from the nested configuration to engage with the valve leaflets, achieving increased contact area without increasing the delivery profile.
Solution Approach 2:
The impactor arms incorporate expandable and contractable mechanisms that allow dynamic adjustment of their configuration. The arms can be collapsed for delivery and expanded for treatment, providing adaptability while maintaining a relatively simple overall device architecture.
3Force
If the struts are made expandable to increase impact force, then the ability to fracture calcifications is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The strut structure is segmented into discrete expandable elements that can be independently controlled. This segmentation allows for simpler manufacturing of individual components while achieving complex overall expansion behavior through coordinated activation of the segmented elements.
Solution Approach 2:
The struts utilize material properties and geometric parameters that enable controlled expansion through changes in configuration rather than requiring precision manufacturing of complex shapes. The expandable design allows for adjustment of expansion parameters to achieve desired impact forces.
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 increases leaflet pliability and mobility by fracturing calcifications, enhancing the open cross-sectional area of the valve and preparing it for valve implantation, while providing adjustable impact force and improved contact with cardiac tissue.
Implementation Method 1
the struts having a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve
Data Source
AI summary
A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts. Each of the struts includes two or more pairs of notches formed on opposite sides of the strut. The struts have a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve.