Embolic Filter Frame for Valve Procedures With Ongoing Blood Flow
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Solution Overview
Problem
Minimally invasive cardiac valve replacement procedures face challenges in preventing embolisms due to the liberation of particulate material and soluble mediators, with existing occlusion and filtering methods posing risks of debris shunting and reduced maneuverability.
Innovation Solution
The development of embolic protection devices comprising a filter frame with U-shaped members and a filter sheet, delivered via antegrade or retrograde methods using sheaths and balloon catheters to minimize sheath diameters and increase device flexibility, allowing for effective debris filtration without occluding blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If occlusion methods are used for embolic protection, then debris evacuation is simplified, but shunting of debris into side branches and end-organ ischemia occur
Solution Approach 1:
A distal protection device is introduced as an intermediary component between the treatment site and the distal circulation. The device includes a filter element that intercepts debris before it can enter the systemic circulation, and a proximal occlusion element that prevents debris from traveling proximally. This intermediary device resolves the contradiction by providing a mechanism for debris evacuation without causing shunting or ischemia, as the filter selectively captures debris while maintaining controlled blood flow paths.
2Reliability
If distal filtering is used for embolic protection, then ongoing perfusion is maintained, but larger-diameter sheaths are required and maneuverability is reduced
Solution Approach 1:
The distal protection device is segmented into distinct functional components: a filter element for debris capture, a proximal occlusion element for preventing proximal debris travel, and a delivery system. This segmentation allows each component to be optimized independently - the filter maintains perfusion by selectively capturing debris, while the delivery system can be designed with reduced diameter for better maneuverability. The modular design resolves the contradiction by separating the perfusion-maintaining function from the maneuverability requirement.
3Productivity
If percutaneous methods are used for valve replacement, then minimally invasive approach is achieved, but device flexibility and sheath diameter reduction are limited
Solution Approach 1:
The delivery system incorporates dynamic elements including a self-expanding frame that transitions from a compressed delivery state to an expanded operational state, and a balloon catheter that provides controlled expansion. The frame includes flexible struts that can be compressed for delivery through small sheaths and then expand to provide the necessary structural support and filter deployment. This dynamic design resolves the contradiction by enabling minimally invasive delivery while maintaining device flexibility and operational effectiveness.
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 devices effectively reduce the risk of embolisms by capturing debris during cardiac valve procedures, minimizing sheath diameters, and enhancing maneuverability, thus reducing the risk of stroke and other ischemic events.
Implementation Method 1
a filter sheet attached to the filter frame. The filter frame may be expanded to an expanded configuration within a valve annulus. The filter sheet may be comprised of a material selected from the group consisting of polyester monofilament mesh, nylon monofilament mesh, screen printing mesh, nylon mesh, or metallic wire mesh.
Data Source
AI summary
Devices and methods are discussed herein for protection from embolisms and microembolisms in a subject undergoing catheter-based intravascular procedures. The embolic protection devices have an expandable support frame comprising U-shaped members and leg members which facilitate proper placements in a defective valve annulus. The filtering devices expand in the vessels and allow blood flow to continue through the vessels, thereby catching and removing debris of the flowing blood. Also disclosed are embolic protection devices for use with a sutureless valve prosthesis which is implanted via catheter-based methods.