Expandable Nitinol Agitator for Intravascular Thrombus Fragmentation
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Solution Overview
Problem
Current treatments for deep vein thrombosis (DVT) and other thrombosis conditions are limited in effectiveness and safety due to challenges in removing large blood clots from vessels, with existing intravascular agitators struggling to reach the full circumference of vessel lumens and potentially causing vessel wall damage.
Innovation Solution
A catheter system with an intraluminal agitator that can rotate 360 degrees, featuring nitinol wire loops for minimal trauma and accommodating various vessel diameters, allowing for effective clot fragmentation while minimizing vessel wall damage, and enabling infusion of thrombolytic drugs directly into the treatment zone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional intravascular agitators are used to fragment blood clots, then clot removal capability is improved, but vessel wall trauma increases
Solution Approach 1:
The agitation element is designed with flexible wire construction that allows dynamic adaptation to vessel geometry. The wire can bend and conform to the vessel wall contour, enabling effective clot engagement while reducing rigid contact forces that cause trauma. The element can rotate and move freely within the catheter lumen to optimize fragmentation while maintaining gentle contact with the vessel wall.
Solution Approach 2:
The agitation element utilizes a thin, flexible wire structure that can deform to match the vessel wall shape. This flexibility allows the wire to engage clots effectively through rotation and movement while distributing contact forces, thereby minimizing localized trauma to the vessel wall compared to rigid agitator designs.
2Productivity
If agitator loops are made rigid to exert shear forces on blood clots, then fragmentation efficiency is improved, but forces on the vessel wall increase
Solution Approach 1:
The wire construction provides the necessary flexibility to allow the agitation element to rotate and move dynamically during operation. This dynamic behavior enables the element to generate effective shear forces on clots through rotational motion while the flexible wire absorbs and distributes reaction forces, preventing excessive forces from being transmitted to the vessel wall.
3Productivity
If the agitator is designed to reach full circumference of the vessel lumen, then clot engagement is improved, but vessel wall contact and potential damage increase
Solution Approach 1:
The flexible wire construction allows the agitation element to expand and reach the full circumference of the vessel lumen to engage clots effectively. At the same time, the wire's flexibility enables it to conform to the vessel wall contour, distributing contact forces and minimizing localized trauma compared to rigid structures that would concentrate forces at discrete contact points.
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 system enables safe and efficient fragmentation and removal of blood clots, reducing the risk of vessel wall trauma and improving the effectiveness of clot removal procedures by accommodating vessel irregularities and allowing for targeted thrombolytic treatment.
Implementation Method 1
The agitator accommodates various vessel lumen dimensions and is passively compressible and expandable allowing for usage in a range of vascular diameters by having agitator loops with flexural rigidity that both exert shear forces on blood clots and limit forces on the vessel wall
Implementation Method 2
The agitator accommodates various vessel lumen dimensions and is passively compressible and expandable allowing for usage in a range of vascular diameters by having agitator loops with flexural rigidity
Data Source
AI summary
Described herein are systems, devices, and methods for treating an intravascular thrombosis. In some embodiments, an apparatus may include a catheter and an agitation device slidably coupled to the catheter, the agitation device comprising at least one agitation element configured to reshape or macerate a thrombus.