Loop-tip Hemodialysis Catheter Preventing Arterial Occlusion
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Solution Overview
Problem
Dual lumen dialysis catheters face issues such as blood clotting, fibrin sheath formation, arterial lumen occlusion, and recirculation of cleansed blood, which affect the efficiency and longevity of hemodialysis procedures.
Innovation Solution
A multi-lumen catheter design featuring a loop-like structure at the distal end to prevent sidewall occlusion, with embedded wires or balloons for patency maintenance and fibrin sheath removal, and a mechanism to minimize recirculation and air embolism risk, allowing for easy manufacturing and enhanced functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dual lumen catheter is used for hemodialysis, then blood can be aspirated and infused through separate lumens, but the arterial lumen becomes occluded by sidewall contact and fibrin sheath formation occurs
Solution Approach 1:
The catheter tip is formed into a loop configuration where the distal end curves back on itself, creating a rounded, non-linear geometry. This curvature prevents the arterial lumen from contacting the sidewall of the blood vessel, eliminating sidewall occlusion and reducing fibrin sheath formation while maintaining reliable catheter patency throughout the hemodialysis procedure
Solution Approach 2:
The loop configuration adds a spatial dimension to the catheter tip design, positioning the arterial and venous lumens in different spatial planes. This dimensional separation ensures that the arterial lumen does not contact the vessel sidewall while the venous lumen maintains proper positioning, thereby preventing occlusion and maintaining patency
2Productivity
If the arterial lumen is positioned to aspirate blood, then blood flow is achieved, but the lumen sucks against the vessel wall causing complete occlusion
Solution Approach 1:
The looped tip configuration creates a rounded geometry that directs blood flow through the arterial lumen away from the sidewall contact point. The curvature ensures that negative pressure during aspiration does not cause the lumen to collapse against the vessel wall, maintaining both blood flow productivity and lumen patency reliability
3Ease of manufacture
If the catheter tip is straight and simple, then manufacturing is easy, but the catheter causes vessel trauma and recirculation occurs
Solution Approach 1:
The loop configuration, while more complex than a straight tip, can be manufactured through standard catheter forming processes such as extrusion with a looped die or post-manufacturing shaping. The curved geometry minimizes vessel trauma by distributing contact forces along the rounded surface and prevents recirculation by positioning the tip in a configuration that promotes unidirectional blood flow, thereby addressing the harmful factors with acceptable manufacturing complexity
4Ease of operation
If the catheter is inserted with a straight configuration, then insertion is straightforward, but air embolism risk increases and recirculation occurs
Solution Approach 1:
The looped tip configuration can be collapsed into a compact form during insertion to maintain ease of operation, then expands to its functional loop shape once positioned in the vessel. The three-dimensional loop structure prevents air embolism by directing air bubbles away from the lumens and prevents recirculation by maintaining proper spatial separation between aspiration and infusion pathways
Data Source
AI summary
A hemodialysis catheter, including an elongate body with an outer wall enclosing an arterial lumen and a venous lumen, and a method of making same. The catheter includes a first continuous loop and a second continuous loop formed from a distal extension of the outer wall, the first continuous loop beginning at a first side of the distal end of the body to define a first enclosed opening, and the second continuous loop beginning at a second side of the distal end of the body to define a second enclosed opening.