Endovascular Catheter Air Block Module
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Solution Overview
Problem
Current devices and methods for preventing air entrainment into catheters during vascular procedures are inadequate, particularly in venous procedures, as they fail to effectively close the seal around catheters and can allow air to flow retrograde into the cardiovascular system, posing risks of air embolism and other complications.
Innovation Solution
An air block module is affixed to the proximal end of a primary sheath, featuring a main housing with a catheter entry and exit port, an inner channel with perforations, and a gas exit port, equipped with hemostasis valves and a gas removal subsystem to trap and remove air, ensuring air does not enter or escape the catheter lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a catheter is routed into the venous circulation during a venous procedure, then access to the cardiovascular system is achieved, but air can be forced retrograde through the catheter into the circulatory system due to negative pressure gradients, causing air embolism
Solution Approach 1:
The air block module serves as an intermediary device positioned between the external environment and the catheter hub. It includes a chamber that receives air bubbles and directs them away from the catheter lumen, preventing air from entering the cardiovascular system while allowing blood and catheter access to proceed normally
Solution Approach 2:
The air block module segments the flow path into separate channels: one for blood/catheter access and another for air bubble collection and removal. The internal structure divides the incoming flow to direct air bubbles to the side port while maintaining patency of the main catheter lumen
2Reliability
If hemostasis valves are used to prevent blood loss during arterial procedures, then blood leakage is controlled, but these valves are inadequate at preventing air backflow into the catheter
Solution Approach 1:
The air block module combines multiple functions into a single integrated device: it maintains hemostasis like traditional valves while adding air bubble collection, air evacuation capability, and catheter access. This merged design addresses both blood control and air prevention needs that separate devices could not satisfy
3Ease of operation
If the distal end of the sheath is exposed to pressures equal to or below the proximal end pressure, then venous access is achieved, but a negative pressure gradient occurs allowing air to be forced into the proximal end of the catheter
Solution Approach 1:
The air block module acts as a mediator that intercepts air bubbles before they can enter the catheter hub. The chamber design with side ports provides an alternative pathway that directs air away from the pressure gradient while allowing venous blood flow and catheter manipulation to continue unimpeded
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
The air block module effectively prevents air from entering or escaping the catheter, reducing the risk of air embolism and maintaining a secure seal during vascular procedures, thereby enhancing patient safety and procedure efficacy.
Implementation Method 1
The first hemostasis valve is affixed to the inner lumen of the core tube at the proximal end of the core tube, and the second hemostasis valve is affixed to the inner lumen of the core tube at the distal end of the core tube
Implementation Method 2
The core tube further comprises a plurality of fenestrations, wherein the fenestrations are large enough to permit air bubbles to escape through the core tube and into the outer shell
Implementation Method 3
Should the air reach the distal end of the catheter by way of a through lumen, it could escape into the blood stream in the form of large or small bubbles, resulting an air embolism
Data Source
AI summary
This invention is an air block for industrial, medical, and non-medical uses. For example, the air block is connected to the proximal end of a vascular access catheter. The air block is either removably connected to the proximal end of the catheter or it is integral to the proximal end of the catheter. The air block permits introduction of other catheters or instrumentation through its central lumen and on into a lumen of the catheter while minimizing fluid loss or gain into the catheter. The air block further prevents air from entering the catheter and provides for removal of the air or other gas from the central lumen before it can enter the catheter where it could cause harm to the patient. The air block can be attached to various standard proximal catheter terminations including Luer fittings and hemostasis valve outer barrels.