Deformable Impactor Arms 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, may not effectively increase leaflet pliability and mobility, and are limited in preparing the 'landing zone' for trans-catheter valve implantation.
Innovation Solution
A device comprising a stabilizer and an impactor with deformable impactor arms and lever arms, where the lever arms are coupled to a shaft, allowing for controlled expansion and deformation to fracture calcifications, with a limiter controlling the radially-outward expansion of impactor arms and a mating structure for engagement with the stabilizer, facilitating precise positioning and fracture of calcifications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid impactor arms are used to fracture calcifications, then fracture effectiveness is improved, but device complexity and difficulty of delivery increase
Solution Approach 1:
The impactor arms are designed to be dynamically transformable between a compressed delivery configuration and an expanded working configuration. During delivery, the arms are compressed within the catheter to minimize profile. Upon deployment, they expand to provide the necessary rigidity for effective calcification fracturing. This dynamic transformation allows the device to achieve both deliverability and fracture effectiveness without requiring overly complex mechanisms.
Solution Approach 2:
The impactor arms are nested within the catheter body during the delivery phase, allowing the rigid fracturing elements to be contained within a flexible delivery system. The arms can be sequentially deployed or simultaneously expanded from the catheter tip, enabling the device to navigate complex vasculature while maintaining the capability for effective calcification fracture when deployed.
2Force
If impactor arms are expanded radially outwards to increase impact force, then fracture effectiveness is improved, but control over expansion amount becomes difficult
Solution Approach 1:
The device incorporates feedback mechanisms that provide real-time information about the expansion state of the impactor arms. This may include mechanical feedback through the operator's manual manipulation of the catheter, or more advanced feedback systems that monitor arm position and provide visual or tactile feedback to the operator. This feedback enables precise control over the expansion amount, ensuring optimal impact force is applied without excessive radial expansion that could cause complications.
Solution Approach 2:
The patent replaces complex mechanical expansion control mechanisms with a simpler system based on the operator's manual manipulation of the catheter. By designing the catheter with specific mechanical properties and expansion characteristics, the system leverages the operator's skill and tactile feedback to control expansion, rather than requiring complex mechanical actuators or control systems. This substitution simplifies the overall device while maintaining precise control.
3Manufacturing precision
If the device is designed for precise positioning and controlled expansion, then fracture precision is improved, but device complexity increases
Solution Approach 1:
The device is designed to be self-positioning and self-expanding to the appropriate degree without requiring complex external control mechanisms. The catheter and impactor arms are engineered with inherent mechanical properties that guide them into the correct position and expansion state once deployed. This self-service capability achieves precise fracture positioning while avoiding the addition of complex control systems, actuators, or sensors that would increase device complexity.
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 precisely fracturing calcifications, preparing the valve for potential trans-catheter valve implantation, and can be used as a standalone treatment or bridge treatment.
Implementation Method 1
proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform
Implementation Method 2
The impactor arms are pulled abruptly towards the leaflet tissue to impact the calcification, with the stabilizer serving as an anvil
Data Source
AI summary
A device for fracturing calcifications in heart valves includes a stabilizer and an impactor movable towards each other. The impactor includes one or more impactor arms, each of which extends distally from a proximal cap. The impactor further includes one or more lever arms each of which is distally coupled to a lever cap and proximally coupled to a corresponding one of the one or more impactor arms. The lever cap slides on a shaft which extends towards the proximal cap. Proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform.