Embolic Protection Filter with Balloon Occlusion
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Solution Overview
Problem
Current embolic protection filter devices face challenges in crossing stenosed areas without dislodging plaque, which can lead to emboli formation and complications such as stroke or death, due to the restricted diameter of the stenosed area.
Innovation Solution
A method involving a guidewire with an expandable member and a valve assembly, where the guidewire is advanced through the stenosed area with an inflatable balloon to restrict fluid flow, allowing a filter to be deployed in an expanded state to capture emboli, thereby reducing the risk of emboli formation during medical procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a filter device is deployed to capture emboli, then embolic protection is improved, but the device cannot cross stenosed areas with restricted diameter
Solution Approach 1:
The filter device is nested within a delivery catheter in a collapsed state, allowing it to pass through stenosed areas with restricted diameter. Once positioned distal to the stenosis, the filter is deployed from the catheter to its expanded filtering configuration, capturing emboli while maintaining access through previously inaccessible narrow regions.
Solution Approach 2:
The filter device transitions dynamically between two states: a collapsed low-profile state for navigation through stenosed vessels, and an expanded high-capacity state for effective embolic protection. This dynamic transformation allows the device to adapt its dimensions to different functional requirements during the procedure.
2Ease of operation
If a filter crosses a stenosed area, then access to distal vessels is improved, but plaque may be dislodged causing emboli formation
Solution Approach 1:
The filter device is positioned and deployed in advance, distal to the stenosed area, before any plaque dislodgment can occur. This preliminary placement creates a protective barrier that captures emboli as they are dislodged during subsequent balloon angioplasty or stenting procedures, preventing them from traveling to distal vessels.
Solution Approach 2:
The filter acts as an intermediary barrier between the stenosed area and distal vessels. It intercepts and captures embolic material dislodged during plaque treatment, mediating the interaction between the intervention and the distal circulation to prevent harmful embolic events.
3Reliability
If the filter is deployed before crossing the stenosis, then emboli can be captured, but the filter cannot pass through the restricted diameter
Solution Approach 1:
The filter device employs dynamic dimensionality, transitioning from a collapsed low-profile configuration that can navigate stenosed areas to an expanded high-capacity configuration that provides effective embolic protection. This dynamic transformation resolves the contradiction between passing through narrow vessels and providing sufficient filtering surface area.
Solution Approach 2:
The filter is nested within a delivery catheter in a compressed state, enabling it to pass through stenosed areas with restricted diameter. After positioning distal to the stenosis, the filter is deployed from the catheter to its expanded filtering configuration, capturing emboli while maintaining access through previously inaccessible narrow regions.
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 reduces the risk of emboli formation by allowing the guidewire to cross the stenosed area with a lower profile, minimizing the dislodgment of plaque and subsequent emboli, while enabling the filter to capture any dislodged material, thus enhancing the safety of medical procedures.
Implementation Method 1
activating the occlusion member of the first medical device to restrict fluid flow within the lumen
Implementation Method 2
passing the second medical device through the area to be treated, and deploying the filter member from a collapsed state to an expanded state
Implementation Method 3
the filter member opposes the lumen... allowing fluid to flow through the filter but retain embolic material within the filter
Implementation Method 4
guidewire with an expandable member... advanced through the stenosed area with an inflatable balloon to restrict fluid flow
Data Source
AI summary
Methods and devices for reducing emboli formation during medical procedures. In accordance with the present invention a first medical device is passed through a stenosed area and activated to block fluid flow through the lumen, a second medical device including a filter is passed through the stenosed area and deployed. The first medical device is then deactivated to restore fluid flow through the lumen.