Intravascular Sheath With Retrograde Flow for Carotid Emboli Control
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Solution Overview
Problem
Existing medical procedures for accessing carotid arteries face challenges in preventing emboli release during treatments like arterial stenoses and strokes, requiring improved devices and methods for safe vascular access and retrograde blood flow control.
Innovation Solution
A tubular sheath with a flexible distal section and radiopaque gradations for depth indication, a rigid proximal section with dual ports, and fixation clips for secure placement, along with a shunt tube for retrograde blood flow, enhancing procedural safety and control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sheath is inserted into the carotid artery for vascular access, then surgical procedures can be performed, but there is a risk of emboli entering the cerebral vasculature
Solution Approach 1:
The sheath is divided into a rigid proximal section and a flexible distal section, allowing the proximal portion to remain outside the artery while the distal portion navigates the vessel. This segmentation enables controlled access while isolating the brain from emboli generation sites.
Solution Approach 2:
The patent implements retrograde blood flow by connecting the arterial sheath to a venous cannula, reversing the normal flow direction. Blood flows from the internal carotid artery backward through the sheath into the venous system, preventing emboli from reaching the cerebral circulation while maintaining normal forward flow in the common carotid artery.
2Ease of operation
If the sheath is made flexible for percutaneous insertion, then insertion ease is improved, but depth control precision deteriorates
Solution Approach 1:
The sheath combines a rigid proximal section for stable insertion and depth control with a flexible distal section for easy navigation through the artery. The rigid portion acts as a guide while the flexible portion adapts to vessel anatomy, resolving the contradiction between insertion ease and depth precision.
Solution Approach 2:
Radiopaque gradations are incorporated into the flexible distal section, allowing precise depth measurement under fluoroscopic guidance. These visual markers enable the operator to accurately determine sheath penetration depth despite the flexibility of the distal section.
3Stability of the object's composition
If fixation clips are added to secure the sheath, then sheath stability is improved, but device complexity increases
Solution Approach 1:
Fixation clips serve as intermediary components that connect the sheath to the patient's skin or surrounding tissue. These simple clamping devices provide stable fixation without requiring complex anchoring mechanisms, balancing stability needs with device simplicity.
4Object-affected harmful factors
If a shunt tube is added for retrograde flow, then emboli protection is improved, but device complexity increases
Solution Approach 1:
The shunt tube is integrated with the existing sheath structure, combining the arterial access function with the retrograde flow diversion function in a single unified device. This merging approach provides emboli protection without requiring entirely separate complex systems.
Solution Approach 2:
The sheath system performs multiple functions: providing vascular access, enabling retrograde blood flow diversion, and protecting against emboli. The dual-port hub allows simultaneous connection to both arterial and venous systems, making the device universally applicable for protected carotid procedures.
Data Source
AI summary
Surgical apparatus includes a tubular sheath having a lumen passing longitudinally therethrough. The sheath includes a flexible distal section, configured for percutaneous insertion into an artery of a patient and including radiopaque gradations to indicate a depth of penetration of the sheath into the artery and having a distal port communicating with the lumen, and a rigid proximal section. A hub connected to a proximal end of the proximal section includes first and second proximal ports communicating with the lumen, such that the first proximal port is coaxial with the sheath and the second proximal port is angled relative to the sheath.