Intravascular Emboli Filter With Aortic Arch Stabilizers
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Solution Overview
Problem
Existing intravascular devices are inadequate in preventing larger emboli from entering critical arteries, such as those leading to the brain, during medical procedures, posing a risk of stroke and other adverse outcomes.
Innovation Solution
An intravascular device with a frame and stabilizers that deploy in the aortic arch, featuring a filter to capture emboli and stabilizers that anchor to the aorta and innominate artery, utilizing a tether and dilator tip for stability and deployment, with optional radiopaque elements for tracking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing intravascular devices are used, then the device structure is simple, but the device is inadequate in preventing larger emboli from entering critical arteries
Solution Approach 1:
The device is divided into multiple functional segments: a filter portion with varying aperture sizes (larger apertures in some regions, smaller in others), stabilizer portions with tethers, and radiopaque elements. This segmentation allows each portion to perform its specific function optimally while contributing to overall reliability without requiring the entire device to be uniformly complex.
Solution Approach 2:
The filter portion incorporates regions with different aperture sizes tailored to specific functional needs. Some regions have larger apertures to allow blood flow, while other regions have smaller apertures to capture larger emboli. This local variation in quality enables the device to effectively prevent larger emboli while maintaining adequate blood flow.
2Reliability
If the device is deployed to effectively filter emboli, then the filter captures emboli larger than 50 µm, but the device requires complex stabilizers and tethers for secure anchoring
Solution Approach 1:
The stabilizer portions are integrated with the filter portion to form a single cohesive device. The tethers extend from the stabilizer portions and can be attached to the filter, creating a unified structure that performs both filtration and stabilization functions. This merging reduces the need for separate anchoring devices and simplifies the overall deployment process.
Solution Approach 2:
The tethers act as intermediary elements between the stabilizer portions and the filter. They provide a flexible connection that allows the device to anchor securely to the aortic wall while maintaining the filter's positioning and orientation. This intermediary structure enables reliable emboli capture without requiring rigid or overly complex anchoring mechanisms.
3Difficulty of detecting and measuring
If radiopaque elements are added for tracking, then the device can be monitored during deployment, but the device complexity increases
Solution Approach 1:
Radiopaque elements are incorporated into the device structure to enable visualization during deployment and positioning. These elements appear as distinct radiopaque features on imaging systems, allowing operators to track the device's location and orientation without adding significant structural complexity. The radiopaque elements serve as visual markers that integrate seamlessly with the device's functional components.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3B
AI summary
In general, the invention features an intravascular device, a delivery system, and methods for filtering or deflecting emboli or other large objects from entering a protected secondary vessel or vessels The intravascular device of the invention may prevent passage of a particle in a blood vessel from passing through a filter supported by a frame, upper and lower stabilizers, and a wire. The wire may be used to stabilize the device upon its deployment and installation within a blood vessel. Further, in some embodiments, the invention features a delivery system and methods for introduction of the device into a blood vessel.