Helical Separator for Vessel-Sparing Thrombus Cutting and Aspiration
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Solution Overview
Problem
Existing methods for removing occlusive materials from blood vessels, such as thrombosis and atherosclerosis, are inefficient, risky, or cause further complications, particularly with large or tough clots, and often damage the vessel walls.
Innovation Solution
A catheter system with a helical cutting instrument featuring a rounded distal end and a spiral-shaped body with both blunt and sharp edges, which rotates and axially moves to cut and pull occlusive material into the catheter lumen, using aspiration to remove fragments safely and effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If aggressive cutting methods (rotating blades, high pressure water jets, laser ablation) are used to break up tough clot or plaque, then the ability to remove large volumes of occlusive material is improved, but the risk of damaging the blood vessel wall increases
Solution Approach 1:
The cutting element is segmented into multiple discrete cutting surfaces arranged helically around a central axis. Each cutting surface operates independently to fragment occlusive material, allowing efficient removal of large volumes while distributing mechanical stress to minimize vessel wall damage.
Solution Approach 2:
The cutting element features varying local properties with sharp cutting surfaces for effective fragmentation and a rounded distal end for safe vessel navigation. This local differentiation allows aggressive cutting where needed while maintaining safety in other areas during advancement through the vasculature.
2Productivity
If rotating blades are used to fragment occlusive material, then the efficiency of breaking up tough thrombus is improved, but the effectiveness of removing fragmented material is reduced due to small lumens prone to clogging
Solution Approach 1:
The device merges the cutting function and removal function into a single integrated system. The helical cutting element not only fragments occlusive material but also actively propels fragments into the catheter lumen through its rotational motion, combining fragmentation and removal mechanisms to prevent lumen clogging.
Solution Approach 2:
The catheter lumen acts as an intermediary channel that receives and transports fragmented material away from the cutting site. The helical cutting element serves as a mediator that transfers fragmented material from the vessel lumen into the catheter lumen through controlled propulsion during rotation.
3Productivity
If blades are used to fragment clot or plaque, then the ability to remove adhered occlusive material is improved, but the risk of releasing fragments into downstream blood vessels increases
Solution Approach 1:
The device extracts fragmented occlusive material directly from the vessel lumen and transfers it into the catheter lumen during the cutting process. The helical cutting element actively propels fragments into the catheter as they are being generated, removing them from the bloodstream before they can travel downstream and cause embolic complications.
4Reliability
If a rounded distal end is used on the cutting instrument, then the safety of advancing through the vasculature is improved, but the effectiveness of cutting tough occlusive material is reduced
Solution Approach 1:
The cutting element features varying local properties with sharp cutting surfaces for effective fragmentation and a rounded distal end for safe vessel navigation. This local differentiation allows aggressive cutting where needed while maintaining safety in other areas during advancement through the vasculature.
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 efficiently fragments and removes occlusive materials within the catheter lumen, minimizing vessel damage and preventing dispersal of fragments into the bloodstream, ensuring complete and safe removal.
Implementation Method 1
the body includes at least one edge configured to promote the movement of a target substance towards a proximal end of the lumen upon contact
Implementation Method 2
using aspiration to remove fragments safely and effectively
Data Source
AI summary
In one embodiment, an aspiration thrombectomy system includes an aspiration catheter having a proximal end, a distal end, and a lumen to accommodate fluid, a first valve capable of removing fluids from the system to alter a level of pressure in the system in a first manner, a second valve capable of providing fluids into the system to alter the level of pressure in the system in a second manner, and a cutting instrument at the distal end of the aspiration catheter having a spiral body connected to a rounded element having a scooped-out portion for engaging a target occlusive material, the cutting instrument being capable of axial and rotational motion, and the system being capable of cutting and removing the occlusive material based on the motions of the cutting instrument and one or more of the first manner and the second manner of altering the level of pressure.