Hemostatic Device Malecot and Tube for Arterial Sealing
Solution Overview
Problem
Current methods for controlling blood loss after medical procedures, such as cardiac catheterizations, often rely on manual pressure, which can be inefficient and may not effectively seal arterial openings, leading to excess blood loss and potential patient trauma.
Innovation Solution
A hemostatic device comprising a first tube with a malecot and a second tube that can transition from a neutral to a stopper configuration, allowing a hemocoagulant agent to be selectively exposed to seal the puncture site, facilitating faster hemostasis and ambulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure is used to control blood loss, then the method is simple to apply, but it is inefficient and may not effectively seal arterial openings
Solution Approach 1:
The device is divided into multiple functional segments: an inner tube for vessel access, an outer tube containing the hemocoagulant agent, and a malecot for sealing. This segmentation allows each component to perform its specific function efficiently while maintaining overall system reliability for sealing arterial openings.
Solution Approach 2:
The hemocoagulant agent is pre-loaded into the outer tube before the procedure. When needed, the device is advanced into position and the agent is automatically delivered to the puncture site, eliminating the need for manual preparation and ensuring immediate effective sealing.
2Loss of time
If a hemostatic device with multiple tubes and configurations is used, then hemostasis time is reduced, but the device structure becomes more complex
Solution Approach 1:
The malecot is designed to be selectively actuatable between a neutral configuration (collapsed) and a stopper configuration (expanded). This dynamic transformation allows the device to adapt its structure during the procedure: the collapsed state minimizes profile for insertion, while the expanded state provides effective sealing against the vessel wall, reducing hemostasis time without requiring a permanently complex structure.
Solution Approach 2:
The inner tube is nested within the outer tube, with the hemocoagulant agent contained within the outer tube's lumen. This nested arrangement allows both tubes to be integrated in a compact configuration during storage and insertion, reducing the effective device complexity while enabling sequential deployment: the inner tube is advanced first, then the outer tube is positioned to deliver the agent, achieving rapid hemostasis.
3Ease of operation
If the hemocoagulant agent is retained in the device, then controlled delivery is achieved, but the device requires additional mechanisms for agent exposure
Solution Approach 1:
The device utilizes the natural blood flow and pressure differential to automatically deliver the hemocoagulant agent. When the outer tube is positioned at the puncture site and the malecot is expanded, the agent is passively extruded through the tube wall or opening by blood flow pressure, eliminating the need for complex active delivery mechanisms such as pumps or valves, while maintaining controlled delivery.
Solution Approach 2:
The outer tube serves as an intermediary structure that contains and protects the hemocoagulant agent during insertion and positioning. The tube wall or controlled opening acts as the interface between the contained agent and the blood flow, allowing selective exposure of the agent to the puncture site without requiring complex delivery mechanisms.
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 device effectively reduces the time required for hemostasis and ambulation by sealing the arterial opening with a hemocoagulant agent, providing a more controlled and efficient method compared to manual pressure.
Implementation Method 1
retaining a hemocoagulant agent in the second lumen... selectively orienting the second tube such that the hemocoagulant agent is at least partially exposed... sealing the puncture of a vessel
Data Source
AI summary
A hemostatic device for sealing a puncture of a vessel includes a first tube defining a first lumen, and a malecot coupled to the first tube. The malecot is selectively actuatable from a neutral configuration to a stopper configuration. The hemostatic device also includes a second tube circumscribing at least a portion of the first tube. The second tube at least partially defines a second lumen and a third lumen. The second tube includes a first opening in flow communication with the third lumen and positioned proximally relative to the malecot. The second tube is selectively orientable to at least partially expose a hemocoagulant agent retained in the second lumen.