Self-Centering Embolic Filter for Dual-Route Delivery
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Solution Overview
Problem
Current embolic protection devices during endovascular procedures face challenges such as limited delivery routes, difficulty in securing position within blood vessels, potential for emboli to escape during filter removal, and obstruction of blood flow due to their design, which increases the risk of stroke and other neurologic deficits.
Innovation Solution
A filter designed for transapical delivery via a delivery system that can expand and self-center within the blood vessel, allowing for precise positioning and easy deployment and retrieval without cardiopulmonary bypass, featuring a conical shape with equi-sized pores to capture emboli while minimizing pressure drop and blood flow obstruction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a filter is inserted into the blood vessel to capture emboli, then the risk of stroke is reduced, but the filter may obstruct blood flow and create high pressure drop
Solution Approach 1:
The filter employs a porous mesh structure with controlled pore sizes that allow blood to pass through while trapping embolic debris. The porous design minimizes pressure drop and maintains blood flow while effectively capturing emboli, resolving the contradiction between stroke protection and blood flow obstruction.
Solution Approach 2:
The filter features a conical shape with equi-sized pores that are optimized for capturing emboli of specific sizes while maintaining open flow channels. The local quality of the mesh structure is designed to selectively trap emboli while allowing normal blood flow, reducing obstruction.
2Ease of operation
If a filter is delivered via transfemoral approach, then the procedure can be performed without cardiopulmonary bypass, but the filter is difficult to position and secure in position
Solution Approach 1:
The filter incorporates a self-expanding mechanism that automatically deploys to its operational configuration upon release from the delivery catheter. This self-service feature simplifies positioning and securing without requiring complex manual intervention or cardiopulmonary bypass, enhancing ease of operation while maintaining procedural safety.
Solution Approach 2:
The filter transitions from a compressed delivery configuration to an expanded operational configuration through a dynamic expansion mechanism. This dynamic design allows the filter to be delivered through the femoral artery in a compact state and then automatically expand to the desired size and shape in the target location, facilitating easy positioning and securing.
3Reliability
If a filter is designed to extend fully across the blood vessel, then coverage is improved, but the filter becomes more complex and harder to deliver
Solution Approach 1:
The filter is divided into multiple struts or segments that can be compressed into a compact configuration for delivery and then expand to form a full-vessel coverage structure. This segmentation allows the filter to achieve comprehensive coverage without increasing delivery complexity, as the segmented structure can be nested within a thin delivery catheter.
Solution Approach 2:
The filter employs a nested design where the mesh structure is collapsed into a compact form factor that fits within the delivery catheter. The conical shape with equi-sized pores is arranged to nest efficiently, allowing full-vessel coverage to be achieved without increasing delivery complexity. The nested configuration enables the filter to be delivered through the femoral artery and then expanded to full coverage.
4Reliability
If the filter mesh size is reduced to capture smaller emboli, then capture effectiveness is improved, but the filter becomes more prone to clogging and pressure drop
Solution Approach 1:
The filter utilizes a porous mesh structure with optimally sized pores that balance emboli capture effectiveness with resistance to clogging. The pore size is designed to capture clinically relevant emboli while maintaining open channels for blood flow, reducing the risk of filter clogging and excessive pressure drop.
Solution Approach 2:
The filter design optimizes the pore size parameter to achieve the desired balance between emboli capture and flow maintenance. By carefully selecting and controlling the pore dimensions, the filter captures smaller emboli effectively while minimizing clogging and pressure drop, resolving the contradiction between capture effectiveness and filter performance.
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 filter effectively captures embolic debris without obstructing blood flow, reduces the risk of stroke, and provides enhanced control and reliability during surgical procedures, allowing for accurate positioning and easy retrieval, thus improving patient safety.
Implementation Method 1
a filter for use in capturing embolic debris entrained within a blood vessel
Data Source
AI summary
Methods and apparatus for use in capturing embolic debris during a surgical procedure in a patient are provided. The methods include utilizing an embolic capture device that is configured for delivery into a patient via a transapical delivery approach and via an arterial delivery approach, and determining which of a transapical delivery approach and an arterial delivery approach should be used with the patient. The methods also include inserting the embolic capture device within a delivery system, and deploying the embolic capture device at a desired location within the patient's blood vessel that is downstream from the location of the surgical procedure. The same embolic capture device is configured for use with a transapical delivery approach and an arterial, such as a transfermoral, delivery approach.