Adjustable Sheath Stopper for Carotid Access and Emboli Control
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Solution Overview
Problem
Existing methods for accessing and treating arterial vasculature, particularly the carotid artery, fail to effectively prevent the release of emboli into the cerebral vasculature during procedures like carotid artery stenting, which can lead to complications such as stroke.
Innovation Solution
A system is disclosed that facilitates retrograde blood flow by using an arterial access device and a venous return device to create a shunt, with a flow control assembly to regulate blood flow, minimizing emboli release. This system includes a sheath stopper to control sheath insertion depth and occlusion elements to manage blood flow direction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sheath is inserted into the carotid artery for accessing and treating arterial vasculature, then procedural access and treatment capability are improved, but the risk of emboli release into the cerebral vasculature increases
Solution Approach 1:
The patent introduces a filter device as an intermediary component within the sheath system that captures emboli particles while allowing blood flow to pass through. This filter acts as a mediator between the procedural access need and the emboli prevention requirement, enabling both goals to be achieved simultaneously.
Solution Approach 2:
The patent employs preliminary anti-action by pre-positioning occlusion balloons and filter devices within the sheath before arterial access is established. These devices are prepared in advance to counteract the potential harmful effect of emboli release during the procedure, allowing the operator to proceed with confidence that protection is already in place.
2Length of moving object
If the sheath insertion depth is increased to reach target vessels, then access to distal arterial segments is improved, but the risk of dislodging plaque and generating emboli increases
Solution Approach 1:
The patent applies preliminary action by deploying protection devices such as distal protection balloons or embolic filters at the target site before performing plaque manipulation procedures. This ensures that when the sheath is advanced to the necessary depth, any plaque dislodgement is immediately captured rather than allowed to enter the cerebral circulation.
Solution Approach 2:
The patent utilizes a nested structure where multiple protective and functional devices are contained within the sheath in a compact, nested arrangement. The sheath itself nests the protection devices, which in turn may nest additional components, allowing all elements to be delivered through a single access point and deployed in sequence as needed.
3Reliability
If occlusion elements are used to prevent emboli release, then emboli capture capability is improved, but blood flow obstruction and potential ischemia worsen
Solution Approach 1:
The patent applies local quality by designing occlusion elements that selectively occlude only the necessary portions of the vessel while leaving other segments open for flow. The filter devices have local filtration zones that capture emboli while allowing normal blood flow to continue through unfiltered portions, and occlusion balloons can be inflated to localized segments rather than the entire vessel.
Solution Approach 2:
The patent employs dynamic control of occlusion elements, allowing them to be inflated or activated only when and where needed during the procedure. The occlusion balloons can be selectively inflated at different positions and for different durations, and filters can be deployed or activated based on real-time procedural needs, rather than maintaining constant occlusion throughout the vessel.
Data Source
AI summary
System and methods are configured for accessing an artery such as a carotid artery. The system comprising a sheath stopper positioned on an exterior of a distal section of an arterial access sheath such that a portion of the distal section of the sheath is covered by the sheath stopper and a portion of the distal section of the sheath is exposed,. The sheath stopper is configured to limit insertion of the sheath into an artery to the exposed portion wherein a length of the exposed portion is adjustable.