Embolic Filter With Working Lumen to Limit Debris Release
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Solution Overview
Problem
Conventional embolic protection devices face risks of unintentional release of captured embolic debris during removal and potential complications from redirected debris migration.
Innovation Solution
An embolic filter system with an elongate element and a filter portion, featuring a self-expanding wire braid and perforated covering, allows for filtering and redirecting embolic debris while maintaining a working lumen for medical device delivery, with a distally directed force for deployment and a mechanism to evacuate captured debris.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional embolic protection devices capture embolic debris in the device, then embolic debris is trapped and prevented from circulating, but the captured embolic debris may be unintentionally released back into the vasculature during the removal process
Solution Approach 1:
The device is divided into separate functional components: a filter portion for capturing embolic debris and a delivery sheath for protection and removal. The filter portion can be deployed and left in place while the delivery sheath is removed, separating the capture function from the removal function and eliminating the risk of releasing captured debris during extraction.
Solution Approach 2:
The filter portion is extracted as a separate component that remains in the vasculature after the delivery sheath is removed. This allows the embolic debris to be captured and retained in the filter portion while the delivery mechanism is taken out, preventing any interaction between the removal process and captured debris.
2Object-affected harmful factors
If conventional embolic protection devices redirect the embolic debris to areas of the vasculature where its presence is associated with a lower risk of harm, then embolic debris is redirected to safer locations, but complications may arise as a result of the redirected embolic debris migrating to another anatomical region
Solution Approach 1:
Instead of redirecting embolic debris to potentially harmful locations, the device captures and retains the debris in the filter portion, converting the harmful circulating debris into a contained collection. The filter portion acts as a permanent trap that prevents any further migration of embolic debris to other anatomical regions.
3Reliability
If the filter portion is made blood permeable with perforations, then blood can flow through the filter portion while embolic debris is filtered, but the structural integrity may be compromised
Solution Approach 1:
The filter portion is constructed as a composite structure combining a structural element (wire braid or mesh) with a covering material containing perforations. The structural element provides mechanical strength and support, while the perforated covering material enables blood permeability and embolic debris filtration. This composite design allows both filtering function and structural integrity to coexist.
Solution Approach 2:
Different portions of the filter portion have different properties: the structural element provides strength throughout, while the covering material with perforations provides filtering capability. The structural element is positioned to bear mechanical loads, while the perforated covering allows fluid passage, creating local functional differentiation that resolves the strength-permeability contradiction.
4Ease of operation
If the elongate element is made self-expanding, then the filter portion can be deployed without requiring an introducer, but the structural complexity increases
Solution Approach 1:
The elongate element transitions from a compressed, deliverable state to an expanded, functional state through self-expansion. The structure is designed to maintain a compact configuration for delivery then automatically expand to its operational diameter upon release, eliminating the need for complex mechanical expansion mechanisms while providing dynamic adaptability between delivery and deployment states.
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
Minimizes the risk of debris release during removal and reduces complications by effectively filtering and redirecting embolic debris, ensuring safe and controlled retrieval of medical devices.
Implementation Method 1
a portion of the second covering material includes a plurality of perforations configured to filter embolic debris from blood flowing into the filter portion
Implementation Method 2
a distally directed force applied to the proximal end of the elongate element is operable to cause a distal translation of the elongate element and the filter portion relative to a delivery sheath
Data Source
AI summary
Various aspects of the present disclosure are directed toward an embolic filter system. The embolic filter system generally includes a filter and an elongated element. In some examples, the elongate element extends to a position distal to a proximal end of the filter and operates to protect against medical devices entangling with the filter. In some examples, the elongate element is soft and compliant and operates with a hemostatic seal to provide for a hemostatic seal within a lumen of the elongate element while maintaining the lumen as a working lumen through which medical devices can be passed.