Distal Pedal Embolism Filter via Inversion
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Solution Overview
Problem
Existing embolism protection devices for peripheral vascular interventions often require traversal of lesions to be placed, risking dislodgment of debris and embolization before intervention, as they are advanced from a proximal location.
Innovation Solution
An embolism protection device is inserted distally in lower limb arteries via the dorsalis pedis, posterior tibialis, or peroneal artery, deploying a compliant mesh filter with a shape-memory wire support to capture debris without traversing the lesion, allowing blood flow while preventing emboli passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolism protection devices are advanced from proximal location to filter debris, then embolism protection is provided, but the device risks dislodging debris and causing embolization during traversal of the lesion
Solution Approach 1:
The device is inverted in terms of deployment sequence: instead of advancing the filter from proximal to distal (which risks dislodging debris), the filter is first deployed at the distal location and then the sheath is withdrawn. This reversal eliminates the traversal risk while maintaining protection capability.
Solution Approach 2:
The filter is preliminarily deployed at the distal location before any intervention occurs. By pre-positioning the filter where it is needed, the system avoids the harmful action of traversing the lesion with the filter in place, thereby preventing debris dislodgment while ensuring protection is already active.
2Reliability
If the filter is deployed to capture all debris, then embolism protection is improved, but blood flow may be obstructed
Solution Approach 1:
The filter structure incorporates varying mesh densities or aperture sizes in different regions: finer mesh where debris capture is critical and coarser mesh where blood flow is prioritized. This local differentiation allows simultaneous optimization of both debris capture and blood flow maintenance.
Solution Approach 2:
The filter utilizes porous mesh materials with specifically engineered pore sizes and distributions that allow adequate blood flow while capturing embolic debris. The porous structure provides selective permeability that balances filtration effectiveness with hemodynamic compatibility.
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
This approach prevents embolization by capturing debris without traversing lesions, reducing the risk of embolism during peripheral interventions and ensuring effective filtration of embolic material, thereby protecting the patient from potential tissue damage.
Implementation Method 1
The embolism protection device may include a first (distal) portion formed from a compliant mesh material and a compliant wire support member that biases the first portion into a funnel
Data Source
AI summary
Disclosed herein are embolism protection devices that may be deployed in the peripheral arterial system for the collection of loosened or floating debris, such as embolic material dislodged during or thrombi formed as a result of a peripheral intervention, such as an angioplasty, stenting, or atherectomy. The disclosed embolism protection devices are designed to be inserted distal to lesion in a lower limb artery via one of the arteries of the foot, such as the dorsalis pedis, posterior tibialis, or peroneal (fibular) artery, and they include a compliant mesh portion supported by a compliant wire support member, and the compliant mesh portion extends to form or couples to a solid catheter portion that extends out of the body during use, and that may be coupled to a stopcock or syringe for removal of debris.