Venous-to-Arterial Vascular Access via Nested Sheath System
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Solution Overview
Problem
Current vascular access methods for performing interventional procedures in the neck and head area are hindered by diseased and tortuous arterial pathways, leading to unstable and inconsistent access, which can result in failed procedures and complications, especially in cases of acute ischemic stroke and cerebral aneurysms.
Innovation Solution
A system for accessing arterial vasculature from a venous insertion site using a curved outer sheath, guiding catheter, stylet sheath/dilator, and stylet, which allows for targeted puncture of the venous and arterial walls, enabling access to the internal jugular vein and common carotid artery, bypassing diseased aorto-iliac vasculature and providing a more stable and direct route to the cerebral circulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If arterial access is performed through traditional femoral or radial arteries, then the access route is straightforward, but diseased and tortuous arterial pathways lead to unstable and inconsistent access
Solution Approach 1:
The patent inverts the traditional approach by accessing the arterial system through the venous system rather than through the arterial system itself. The sheath is inserted into a vein (e.g., internal jugular vein) and then advanced to pierce through the arterial wall (e.g., common carotid artery) to reach the arterial lumen. This inversion allows access to the arterial circulation while avoiding diseased and tortuous arterial pathways, thereby improving access stability and reliability.
2Ease of operation
If a curved distal portion is included in the sheath to navigate tortuous vessels, then vessel navigation is improved, but the curved portion may straighten when components are placed through it
Solution Approach 1:
The patent employs a nested configuration where multiple components (stylet, stylet sheath/dilator, guiding catheter, and outer sheath) are inserted concentrically through the curved distal portion of the sheath. This nesting approach allows the curved portion to maintain its shape during component placement, as each component is carefully maneuvered through the curve without exerting excessive force that would cause straightening. The nested structure enables systematic deployment while preserving the curved geometry needed for navigating tortuous vessels.
3Loss of time
If direct arterial puncture is performed, then access is obtained quickly, but diseased aorto-iliac vasculature complicates the route
Solution Approach 1:
The patent uses the venous system as an intermediary pathway to reach the arterial circulation. Instead of attempting direct puncture of diseased aorto-iliac arteries, the sheath is first inserted into a healthy vein and advanced through the venous system. The venous pathway serves as a reliable mediator that bypasses the diseased arterial segments, allowing consistent and reliable access while maintaining procedural efficiency.
Data Source
AI summary
A system for accessing arterial vasculature from a venous insertion site includes a first elongate tubular member, a second elongate tubular member configured to be disposed within a lumen of the first elongate tubular member, an elongate crossing member including a distal tip comprising a frusto-conical outer surface, and configured to be disposed within a first lumen of the second elongate tubular member, and a stylet configured to be disposed within a lumen of the elongate crossing member, wherein placement of the second elongate tubular member, elongate crossing member, and stylet together through the lumen of the first elongate tubular member does not substantially straighten a curved distal portion of the first elongate tubular member, and wherein the elongate crossing member and stylet are removable from the first lumen of the second elongate tubular member when it is within the lumen of the first elongate tubular member with at least its distal end extending out of the first elongate tubular member.