Proximal Carotid Embolic Protection With Retrograde Flow Access
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Solution Overview
Problem
Existing medical devices for carotid artery procedures face challenges in effectively preventing embolic events by capturing dislodged particles, as distal protection devices risk dislodging particles during advancement and proximal protection devices require complex occlusion methods.
Innovation Solution
A method involving an arterial sheath with an inflatable balloon is advanced to occlude antegrade blood flow in the common carotid artery, coupled with a venous sheath for retrograde blood flow, creating a fluid path to capture debris in the venous system, ensuring minimal disruption and efficient embolic protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If distal protection devices are used to capture dislodged particles, then embolic protection is provided, but the devices risk dislodging particles during advancement
Solution Approach 1:
The patent inverts the traditional distal protection approach by implementing proximal protection. Instead of placing the protection device at the distal end of the carotid artery (beyond the lesion), the device is positioned at the proximal end (common carotid artery). The occlusion balloon is inflated proximal to the lesion to prevent embolic debris from entering the intracranial circulation, thereby avoiding the particle dislodgement risk associated with advancing distal protection devices across the lesion.
2Reliability
If proximal protection devices are used to occlude blood flow, then embolic protection is provided, but complex occlusion methods are required
Solution Approach 1:
The patent segments the occlusion function into a dedicated occlusion balloon component that is separate from the delivery system. The occlusion balloon is a self-contained element that can be independently inflated and deflated, simplifying the occlusion process. This segmentation allows the occlusion function to be performed by a single, well-defined mechanism rather than requiring complex multi-component systems.
Solution Approach 2:
The patent utilizes parameter changes in the form of balloon inflation and deflation to achieve occlusion and release. By controlling the inflation pressure and volume of the occlusion balloon, the system can reliably occlude the common carotid artery during the procedure and then easily release the occlusion by deflating the balloon. This parameter-based control simplifies the occlusion method compared to mechanical locking or complex actuation systems.
3Ease of operation
If a large-bore arterial sheath is used to maintain vascular access, then interventional tool access is enabled, but retrograde blood flow capacity is reduced
Solution Approach 1:
The patent employs a dynamic solution where the arterial sheath can be selectively positioned and removed. During the embolic protection phase, the sheath is removed to maximize retrograde blood flow capacity. During interventional tool delivery, the sheath is re-introduced to provide access guidance and support. This dynamic positioning allows the system to optimize for blood flow capacity when needed and for tool access when needed, without compromising either function.
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 method effectively captures and redirects embolic debris away from the brain, maintaining vascular access for interventional tools while minimizing occlusion of non-target arteries, enhancing safety during carotid stenting.
Implementation Method 1
The inflatable balloon is inflated within the patient's common carotid artery to occlude antegrade blood flow through the patient's common carotid artery
Implementation Method 2
A fluid connection is established between the venous sheath and the arterial sheath to enable retrograde blood flow through the arterial sheath
Data Source
AI summary
A method of providing embolic protection for carotid stenting includes advancing an arterial sheath into a patient's arterial system and advancing a venous sheath into the patient's venous system. A fluid connection may be established between the venous sheath and the arterial sheath that enables retrograde blood flow through the arterial sheath. The arterial sheath may be advanced through the vasculature and into the patient's carotid artery, and an inflatable balloon may be inflated within the patient's carotid artery in order to occlude antegrade blood flow therethrough. An interventional tool may be advanced through the inner lumen of the arterial sheath, the interventional tool dimensioned such that a portion of the cross-sectional area of an inner lumen of the arterial sheath remains open for retrograde blood flow.