Retrograde Carotid Flow Using Occlusion Balloons for Embolic Protection
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Solution Overview
Problem
Current carotid artery stenting procedures face challenges with embolic protection devices that are difficult to advance, deploy, and remove through tight stenosis, and do not filter 100% of embolic particles, while transcarotid access methods require complex manipulation of multiple access and occlusion components, and existing systems have flow restrictions and pressure differentials that can lead to antegrade flow.
Innovation Solution
A system for transcarotid access using a sheath with integrated occlusion balloons and a flow control assembly to regulate retrograde blood flow, allowing percutaneous or surgical access, and includes a shunt with a flow control mechanism to manage blood flow rates and prevent emboli release into the cerebral vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If distal filters are used for embolic protection during carotid stenting, then embolic particles can be captured, but the filters are difficult to advance, deploy, and remove through tight stenosis and do not filter 100% of particles
Solution Approach 1:
The patent reverses the conventional approach by establishing retrograde flow from the internal carotid artery back through the common carotid artery, rather than attempting to advance filters distally through stenotic lesions. This inversion eliminates the difficulty of navigating tight stenosis while providing complete flow reversal for embolic protection
Solution Approach 2:
The patent extracts the embolic protection function from complex filter devices and implements it through flow reversal using a sheath with occlusion balloons. This simplifies the device architecture by removing the need for filter elements, allowing easier advancement and deployment while achieving complete particle capture through total flow reversal
2Ease of manufacture
If transcarotid access is used for carotid stenting, then percutaneous procedures can be performed, but complex manipulation of multiple access and occlusion components is required
Solution Approach 1:
The patent combines multiple functions (arterial access, flow occlusion, and retrograde flow establishment) into a single integrated sheath assembly. The sheath incorporates occlusion balloons that can be inflated to stop antegrade flow and redirect it retrograde, eliminating the need for separate access and occlusion devices
Solution Approach 2:
The sheath assembly serves multiple functions: it provides percutaneous arterial access, occludes the common carotid artery through integrated balloons, establishes retrograde flow pathway, and enables embolic protection. This multi-functionality reduces the number of components while achieving comprehensive procedural capabilities
3Reliability
If flow reversal is established using existing systems, then embolic protection is achieved, but flow restrictions and pressure differentials can lead to antegrade flow
Solution Approach 1:
The patent employs dynamically adjustable occlusion balloons that can be inflated to different pressures to control flow reversal. The balloons are positioned to create optimal pressure differentials, and their inflation pressure can be adjusted in real-time to maintain consistent retrograde flow despite variations in patient anatomy or procedural conditions
Solution Approach 2:
The patent introduces a shunt as an intermediary component to facilitate controlled flow reversal. The shunt provides a dedicated pathway for retrograde flow and includes flow control mechanisms that mediate between the occlusion balloons and the cerebral vasculature, ensuring stable flow direction while simplifying pressure management
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 system facilitates efficient retrograde blood flow, reduces procedural complications, and enables percutaneous procedures by minimizing emboli release, enhancing safety and ease of access, and allowing for automatic closure of arterial penetrations.
Implementation Method 1
Flow in the common carotid artery is occluded, typically by inflating a balloon on the distal tip of the sheath... in order to establish a reverse or retrograde flow from the internal carotid artery through the sheath
Implementation Method 2
The sheath is then connected to a venous location or to a low pressure external receptacle in order to establish a reverse or retrograde flow from the internal carotid artery through the sheath
Data Source
AI summary
Devices and methods establish and facilitate retrograde or reverse flow blood circulation in the region of the carotid artery bifurcation in order to limit or prevent the release of emboli into the cerebral vasculature such as into the internal carotid artery. The methods are particularly useful for interventional procedures performed through a transcarotid approach or transfemoral into the common carotid artery.