Nested Dilator-Sheath Introducer for Faster Percutaneous Catheterization
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Solution Overview
Problem
Existing methods for percutaneous catheterization, particularly using the Seldinger technique, are time-consuming and complex, lacking a simple, reliable, and time-saving approach for automated catheterization.
Innovation Solution
A biomedical device and system that includes an introducer assembly with a dilator and sheath, guided by an inner unit, allowing the dilator to be advanced without fully retracting the cannula, and featuring atraumatic designs and actuation mechanisms for simplified catheterization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Seldinger technique is used for percutaneous catheterization, then the catheter can be introduced into the body duct, but the procedure becomes time-consuming and complex due to multiple steps including complete retraction of the cannula
Solution Approach 1:
The device divides the catheterization process into distinct functional modules: a puncturing element for initial access, a dilator for widening the tract, and a sheath for catheter delivery. These segments can be independently manipulated and positioned, allowing the dilator to be advanced over the puncturing element without requiring complete cannula retraction, thereby reducing procedural steps and time while maintaining reliability
Solution Approach 2:
The device employs a nested configuration where the dilator is received within the sheath, and the puncturing element is received within the dilator. This nested arrangement allows compact storage and systematic deployment of components during the procedure, enabling the dilator to advance over the puncturing element in a controlled manner without full retraction, thus simplifying the procedure and reducing time
2Extent of automation
If the Seldinger technique is used for automated guidewire placement, then automation is achieved, but the cannula removal step remains particularly time-consuming and complex
Solution Approach 1:
The device segments the catheterization components into independently controllable units (puncturing element, dilator, sheath) that can be automatically manipulated by robotic systems. The dilator's ability to advance over the puncturing element without complete retraction creates a simpler automated sequence, reducing the complexity of robotic control algorithms while achieving high extent of automation
Solution Approach 2:
The puncturing element is pre-positioned and retained within the dilator before the procedure begins. The dilator is pre-configured to receive and guide the puncturing element during advancement. This preliminary arrangement eliminates the need for complex real-time coordination during cannula removal, simplifying automated control while maintaining precision
3Object-affected harmful factors
If a standardized technique for atraumatic catheterization is implemented, then patient safety is improved, but the procedure requires optimization of multiple components including dilator, sheath, and guiding unit
Solution Approach 1:
The device applies local quality by providing different functional characteristics to different components: the puncturing element has a sharp distal end for clean penetration, the dilator has a tapered outer section for gradual tissue expansion, and the sheath provides a smooth bore for catheter delivery. Each component is optimized for its specific function, reducing trauma while the standardized interface between components simplifies overall configuration
Solution Approach 2:
The nested configuration of the puncturing element within the dilator and both within the sheath creates a standardized, systematic assembly that simplifies component configuration. The concentric arrangement ensures proper alignment and reduces the complexity of assembling and positioning multiple components, while each component maintains its atraumatic design characteristics
Data Source
AI summary
A biomedical device for percutaneous catheterization of a body duct. The device comprising an introducer assembly which has a dilator for widening an insertion site of a patient to access the duct, a sheath for introduction into the duct, and an inner guiding unit for guiding the dilator and/or sheath into the duct. The dilator having a tapered outer section and a distal opening and being arranged at least partially concentrically around the guiding unit. The sheath having distal opening and being arranged at least partially concentrically around the dilator, such that the guiding unit, dilator, and sheath are movable relative to each other in a longitudinal direction of the introducer assembly. The dilator may be guided along the guiding unit without removal of a puncturing element for puncturing the duct at a proximal end of the introducer assembly after insertion of the puncturing element into the duct.