Aortic Valve Debris Capture Screen for Open-Heart Access
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Solution Overview
Problem
Current embolic protection devices are not suitable for open heart aortic valve replacement surgery as they hinder access to the valve or do not effectively capture calcified fragments and tissue remnants during surgery, posing a risk of post-surgical stroke.
Innovation Solution
A protective device with a movable and deployable strut arrangement that expands radially to form a trap for debris, positioned below the aortic valve, allowing uninterrupted blood flow and easy access, using flexible struts and coupling mechanisms for deployment and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a filter type device is inserted in the bloodstream to trap debris, then embolic protection is improved, but access to the valve is hindered and blood flow is obstructed
Solution Approach 1:
The protective device employs a dynamic structure that can transition between a compressed delivery state and an expanded deployed state. The frame members are configured to expand radially outward from a low-profile delivery configuration to a large-radius protective configuration, allowing easy passage through the aortic valve during delivery while providing extensive debris trapping capability when deployed
Solution Approach 2:
The device utilizes a nested structure where the screen element and frame members are contained within a delivery catheter during delivery. The frame members themselves are nested within each other in a collapsed configuration, allowing the entire protective device to be delivered through a minimally invasive approach while maintaining the capability to expand to a large protective radius at the deployment site
2Reliability
If a screen element is expanded to trap debris effectively, then debris capture is improved, but blood flow obstruction increases
Solution Approach 1:
The screen element is designed with a porous or mesh structure that allows blood to pass through while trapping calcified fragments and tissue remnants. The porosity of the screen is optimized to capture debris particles while maintaining adequate blood flow, balancing debris capture effectiveness with hemodynamic considerations
Solution Approach 2:
The device transitions from a one-dimensional linear delivery configuration to a three-dimensional expanded protective structure at the deployment site. This dimensional transformation allows the screen element to provide comprehensive debris trapping in multiple directions while the radial expansion distributes the structure across a larger volume, reducing localized obstruction of blood flow
3Ease of operation
If the device is delivered in a compressed state, then delivery ease is improved, but deployment complexity increases
Solution Approach 1:
The device is pre-compressed into a low-profile configuration within the delivery catheter before delivery. This preliminary compression action simplifies the delivery process by reducing the profile of the device, allowing it to navigate through the aortic valve and be positioned at the target site without requiring complex delivery maneuvers
Solution Approach 2:
The frame members are designed with dynamic expansion capabilities that allow automatic or controlled transformation from the compressed delivery state to the expanded deployed state. This dynamic behavior reduces deployment complexity by allowing the structure to self-expand or expand with minimal actuation, rather than requiring complex mechanical assembly at the deployment site
Data Source
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AI summary
A protective device for open heart aortic valve replacement surgery in a patient, comprises a base element (2) having, on its proximal side (4), a first coupling member (10) and, on its distal side (6), a second coupling member (12). Moreover, the device comprises a longitudinally slidable elongated actuator member (14) distally provided with a third coupling member (18), a tip element (20) comprising a fourth coupling member (22) releasably connectable with the second coupling member (12) and a fifth coupling member (24) releasably connectable with the third coupling member (18). A flexible strut arrangement (26) forms a radially external connection between the base element (2) and the tip element (20), with a screen element (28) surroundingly attached to the strut arrangement (26). An elongated handling member (30) has a distal end (32) provided with a sixth coupling member (34) releasably connectable with the first coupling member (10), the handling member (30) having a longitudinal passageway (36) configured to slidingly receive the actuator member (14). In a deployed state of the device, the fourth coupling member (22) is connected with the second coupling member (12) and the strut arrangement (26) is radially expanded, thereby forming an anchoring support for attachment to a surrounding arterial wall segment (W) of the patient. In a movable state of the device, the fourth coupling member (22) is released from the second coupling member (12) and the tip element (20) is maintained distally displaced from the base element (2), whereby the strut arrangement (26) is longitudinally expanded so as to be movable within the surrounding arterial wall segment (W) and through the aortic valve of the patient.