Carotid Artery Flow Redirection via Gravity-Driven Collection
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Solution Overview
Problem
Current carotid artery revascularization procedures using angioplasty catheters and stents face a risk of embolic material liberation during stent deployment, leading to stroke, and existing vascular embolic filters increase procedure time and complexity due to the need for reverse flow and additional filtration systems.
Innovation Solution
An introducer and flow redirection system that includes a sheath assembly with a stabilizer and hemostatic valve, allowing for selective reverse flow collection outside the body via a collection bag, reducing the need for aspiration or pumping and minimizing radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vascular embolic filters are used to prevent embolic material liberation, then stroke risk is reduced, but procedure time and complexity increase
Solution Approach 1:
The patent extracts the embolic material from the bloodstream by creating a controlled reverse flow that pulls embolic particles out of the carotid artery and into a collection bag positioned in the patient's back. This eliminates the need for complex in-line filtration systems while achieving the same protective effect against stroke.
Solution Approach 2:
Instead of using forward flow filtration where blood flows forward through a filter, the patent inverts the approach by creating reverse flow that pulls blood and embolic material backward out of the artery. This inversion simplifies the system by eliminating the need for complex filtration mechanisms within the arterial path.
2Reliability
If reverse flow systems are used to reduce embolic material flow toward the brain, then stroke risk is reduced, but procedure time increases due to additional filtration and pumping requirements
Solution Approach 1:
The patent employs gravity as the driving force for reverse flow, eliminating the need for mechanical pumps. The collection bag is positioned dependent on the patient's body, allowing gravity to naturally pull blood and embolic material out of the carotid artery and into the bag, significantly reducing procedure time and complexity.
Solution Approach 2:
The system uses gravitational hydraulic principles to create controlled reverse flow. By positioning the collection bag lower than the carotid artery access site, gravity creates a pressure gradient that drives blood flow in reverse without requiring mechanical pumping equipment.
3Reliability
If femoral artery reintroduction of blood is used for reverse flow, then embolic material is redirected, but procedure complexity and time increase
Solution Approach 1:
The patent extracts the reverse flow system from the traditional femoral artery route and relocates it to a direct carotid artery access point. The collection bag is positioned in the patient's back, creating a direct gravity-driven drainage path from the carotid artery without requiring femoral artery puncture or complex routing through the aorta.
Solution Approach 2:
The system segments the reverse flow pathway into a simple, direct route from the carotid artery access site through a stabilizer assembly directly into the collection bag. This segmentation eliminates the need for complex multi-site access and routing required by femoral artery-based systems.
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 system enables direct carotid artery revascularization with reduced procedural complexity, faster execution, and lower costs by capturing embolic material outside the body using gravity, thereby minimizing stroke risk and procedure duration.
Implementation Method 1
collect reverse flow outside a patient's body
Data Source
AI summary
Systems, methods, and kits include a sheath assembly including a stabilizer, a stabilizer foot coupled to the stabilizer and including a stabilizer eyelet configured to secure a suture, a gripping mechanism coupled to the stabilizer remote from the stabilizer foot and including a valve eyelet configured to secure the suture, an introducer sheath extending through the gripping mechanism, the stabilizer, and the stabilizer foot, and an entry luer coupled to the introducer sheath. A hemostatic valve includes a hemostatic valve entry port coupled to the entry luer, a bypass port, and an access port. A stopcock includes a stopcock entry port, a collection port, and a stopcock valve providing selective communication between the stopcock entry port and the collection port. A collection bag is connected to the collection port. An angioplasty device can be disposed within the introducer sheath.