Direct Carotid Stent Delivery With Integrated Embolic Filter
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Solution Overview
Problem
Current endovascular intervention tools designed for a transfemoral approach are cumbersome and unsuitable for direct carotid access, leading to inefficiencies and increased risk of periprocedural stroke during carotid artery interventions.
Innovation Solution
Development of a carotid artery access sheath with a tapered distal end, inflatable balloons for secure placement, and a stent delivery device with a self-expanding stent and filter system for direct carotid access, allowing for precise stent deployment and blood flow management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If standard transfemoral tools are used for direct carotid access, then existing equipment can be utilized, but the tools are cumbersome and inappropriate for direct carotid access
Solution Approach 1:
The access sheath is divided into multiple lumens (first lumen for device passage, second lumen for balloon inflation, third lumen for contrast injection) that are fluidly isolated from each other. This segmentation allows each lumen to serve its specific function independently, making the tool appropriately adapted for direct carotid access while maintaining ease of operation through dedicated pathways.
Solution Approach 2:
The distal end of the access sheath features a tapered configuration with a seal disposed over the distal opening, creating localized structural properties optimized for carotid artery engagement. The balloon is positioned at a specific location (proximally of the tapered distal end portion) to provide localized stabilization without interfering with distal device deployment.
2Reliability
If transfemoral approach is used, then access to anterior circulation can be obtained, but difficulties with navigating the aortic arch increase procedural complexity and risk
Solution Approach 1:
The invention extracts the aortic arch navigation step from the access pathway by enabling direct carotid artery puncture and access. The access sheath is designed to be inserted directly into the carotid artery, eliminating the need to navigate through the aortic arch, thereby reducing procedural complexity while maintaining reliable access to the anterior circulation.
Solution Approach 2:
The access sheath serves as an intermediary device that provides a stable platform for carotid artery access. With the balloon inflated in the carotid artery, the sheath creates a sealed access point that mediates between the external environment and the vascular system, allowing device passage without requiring aortic arch navigation.
3Reliability
If surgical exposure to carotid artery is performed for endovascular stenting, then periprocedural stroke risk is reduced by bypassing aortic arch, but surgical exposure increases procedural invasiveness
Solution Approach 1:
The access sheath with its sealed distal opening and inflatable balloon enables the carotid artery to serve itself as the access route. The balloon inflates within the carotid artery to seal the access site, allowing endovascular devices to be passed through the artery wall puncture without requiring external surgical exposure or clamping, thus reducing invasiveness while maintaining the stroke protection benefits of direct carotid access.
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
Facilitates safe and efficient direct carotid access for endovascular interventions, reducing procedural complications and enhancing the effectiveness of carotid stenting procedures.
Implementation Method 1
a seal disposed over the distal opening
Implementation Method 2
a balloon disposed coaxially with and over the elongated tubular body proximally of the tapered distal end portion
Implementation Method 3
a second lumen fluidly isolated from the first lumen and extending through the elongated tubular body and in fluid communication with the balloon, where a fluid is supplied through the second lumen to inflate the balloon
Implementation Method 4
a stent located within the outer sheath, the stent making frictional contact with and exerting an outward force on an inner surface of the outer sheath
Implementation Method 5
a filter disposed within the outer sheath and coupled to the first wire and distally of the stent
Data Source
AI summary
A method of deploying a stent is disclosed. The delivery device includes: an outer sheath including a stent located within, the stent making frictional contact with and exerting outward force on an inner surface of the outer sheath. A first wire located coaxially within the lumen and the stent. The first wire has a distal end extending distally of the outer sheath, and a proximal end. extending proximally of the outer sheath. A filter is disposed within the outer sheath and coupled to the first wire and distally of the stent and a distal tip detachably coupled to the distal end of the outer sheath. The method includes separating the outer sheath from the distal tip and withdrawing to deploy the stent and the filter. The method further includes withdrawing the distal tip to collapse the filter. as well as withdrawing the filter and the distal tip through the stent.