Expandable Embolic Filter Deployment for Catheter Procedures
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Solution Overview
Problem
Cerebral and vital organ embolism during catheter-based procedures for structural heart diseases poses a significant risk of neurological deficits, stroke, and organ dysfunction, necessitating effective embolic protection systems.
Innovation Solution
An embolic protection apparatus (EPA) with an expandable filter and shaft, featuring a filter deployment helix, control handle, and dilator system, allows for controlled deployment and retrieval of emboli, ensuring minimal blood flow interruption and capturing particles larger than the pore size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an embolic protection system is implemented during catheter-based procedures, then the risk of cerebral and vital organ embolism is reduced, but the device complexity increases
Solution Approach 1:
The filter is nested within the shaft in a compressed configuration during delivery, then expanded at the target site. This allows the filter to be stored compactly within the catheter system and then deployed when needed, resolving the contradiction between having a protective filter in place and maintaining system compactness for delivery.
Solution Approach 2:
The filter transitions from a compressed static state within the shaft to an expanded dynamic state at the target site. This dynamic transformation allows the system to adapt its configuration based on operational needs, providing embolic protection only when and where required rather than continuously throughout the entire procedure.
2Reliability
If an expandable filter is deployed to capture emboli, then embolic protection is improved, but blood flow interruption increases
Solution Approach 1:
The filter is constructed with a porous structure containing multiple openings that allow blood to pass through while trapping embolic particles. The pore size is carefully selected to be small enough to capture emboli but large enough to maintain adequate blood flow, resolving the contradiction between effective embolic capture and minimal blood flow interruption.
Solution Approach 2:
The filter provides embolic protection locally at the target site rather than throughout the entire vascular system. The filter's porous structure creates a localized barrier that captures emboli while allowing blood flow to continue through the pores, concentrating the protective effect where it is most needed while minimizing overall flow disruption.
3Ease of operation
If a filter deployment mechanism is added to control filter expansion, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The deployment mechanism uses a screw thread engagement between the control knob and the helix, replacing complex mechanical actuation systems. This simple threaded mechanical interface allows controlled translation of rotational motion into linear motion for filter deployment, achieving ease of operation with minimal added complexity.
Solution Approach 2:
The screw thread mechanism is self-contained and self-regulating, requiring no external power source or complex control systems. The operator simply rotates the control knob, and the threaded engagement automatically translates this rotation into controlled linear movement of the filter deployment, making the system easy to operate without adding significant 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 EPA effectively traps emboli, reducing the risk of cerebral and vital organ embolism, thereby improving procedural outcomes and patient safety.
Implementation Method 1
an expandable filter arranged on a distal end of the apparatus and including a plurality of pores sized to allow the flow of the blood with limited interruption and capture of emboli greater than the pore size
Implementation Method 2
a control handle including a filter deployment knob configured to move along a filter deployment helix
Data Source
AI summary
Embodiments of the present disclosure are directed to methods, systems and devices for embolic protection, and more specifically, to methods, systems, and devices for embolic protection for surgical systems and methods including, for example, delivery/implanting systems as well as methods for delivering or implanting prosthetic heart valves into the heart, or performing a cardiac or blood vessel procedure, where capturing or otherwise trapping emboli dislodged or created during the procedure is necessary so as to prevent complications associated therewith (e.g., strokes).