Self-Expanding Embolic Filter with Pore Distribution
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Solution Overview
Problem
Current cerebral protection devices during surgical or interventional procedures are complex, invasive, and pose a high risk of additional trauma, often requiring additional anticoagulation and increased bleeding, failing to effectively block embolic debris while maintaining optimal perfusion.
Innovation Solution
A method using an embolic protection delivery catheter with a self-expandable wire frame and a filter membrane having a specific pore size distribution to block debris, deployed across the aortic arch to protect cerebral vessels, allowing for reduced anticoagulation and optimal perfusion during procedures like TAVR.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional embolic protection devices are used, then embolic debris can be blocked, but device complexity and invasiveness increase with additional trauma risk
Solution Approach 1:
The filter membrane is extracted as a separate component from the delivery catheter, allowing the catheter to be removed after filter deployment. This separates the protective function from the delivery mechanism, reducing overall device complexity while maintaining embolic protection capability.
Solution Approach 2:
Instead of requiring the delivery catheter to remain in place to maintain filter position, the design allows the catheter to be withdrawn after the self-expanding filter is deployed. The filter maintains its position through its own structural expansion and anchoring mechanisms, inverting the conventional approach where the catheter provides continuous support.
2Reliability
If additional hardware is inserted into the arterial system for protection, then embolic debris can be blocked, but risk of additional trauma and bleeding increases
Solution Approach 1:
The filter membrane pore size is optimized to capture embolic debris while allowing blood flow, and the filter's expansion characteristics are tuned to provide protection without excessive trauma to the vessel wall. These parameter optimizations enable effective embolic protection with minimal harmful effects.
Solution Approach 2:
The filter membrane is designed as a disposable component that can be removed after use, avoiding the need for permanent implants. This reduces long-term complications and bleeding risks associated with retained hardware, while providing effective protection during the procedure.
3Reliability
If increased anticoagulation is used with protection devices, then embolic protection can be achieved, but risk of bleeding including hemorrhagic stroke increases
Solution Approach 1:
By extracting the filter from the delivery catheter system, the design eliminates the need for prolonged anticoagulation to prevent catheter-related thrombus formation. The filter can be deployed and secured without requiring increased anticoagulant therapy, thereby reducing bleeding risk while maintaining embolic protection.
4Reliability
If a filter is deployed across the aortic arch to protect cerebral vessels, then embolic debris can be blocked, but pressure drop may affect optimal perfusion
Solution Approach 1:
The filter membrane pore size and density are optimized to capture embolic debris while maintaining adequate blood flow. The filter's expansion characteristics and positioning are tuned to provide protection with minimal pressure drop, ensuring optimal perfusion to the cerebral vessels.
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 solution effectively blocks embolic debris, reducing the risk of stroke and cognitive impairment by filtering debris of various sizes while maintaining minimal pressure drop and flexibility to accommodate varying aortic diameters and anatomy, thus enhancing patient safety and procedural outcomes.
Implementation Method 1
a filter membrane having a specific pore size distribution to block debris
Implementation Method 2
the filter having a self expandable wire frame
Data Source
AI summary
Methods and devices are provided for protecting the cerebrovascular circulation from embolic debris released during an index procedure. An embolic protection filter is delivered in a reduced profile configuration via an access catheter, and positioned in the aorta spanning the ostia to the three great vessels leading to the cerebral circulation. An index procedure catheter is thereafter advanced through the same access catheter to conduct the index procedure. The index procedure may be a transcatheter aortic valve replacement. A pore distribution in the filter blocks passage of debris greater than a predetermined threshold, minimizes total cumulative volume of debris passing through the filter and minimizes blood pressure drop across the filter.