Rotating Spinner Catheter Thrombectomy for Clot Fragmentation Control
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Solution Overview
Problem
Current thrombectomy techniques fail to restore optimal blood flow in a significant percentage of patients, with aspiration methods having a failure rate of 25-33%, and there is a need for devices that can effectively reduce clot volume, separate clot components, and prevent fragmentation during thrombectomy procedures.
Innovation Solution
A thrombectomy device with a spinner device introduced through a catheter that mechanically reduces clot volume by separating red blood cells from fibrin and applies localized suction and shear force to dissolve or compress the clot, optionally using additional devices to enhance spinning and suction, and includes safety features to prevent the spinner head from being exposed beyond the catheter end.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional aspiration or stent retriever thrombectomy is used, then clot removal is attempted, but thrombus fragmentation occurs causing downstream emboli and treatment failure
Solution Approach 1:
The device segments the thrombus into distinct components (red blood cells and fibrin network) through differential manipulation. The spinner device separates these components by applying rotational forces that exploit their different viscosities and densities, allowing selective removal of RBCs while preserving the fibrin scaffold, thereby preventing fragmentation
Solution Approach 2:
The patent introduces an intermediary substance (saline or other fluid) that facilitates the separation process. This fluid is delivered through the catheter to interact with the thrombus components, enhancing the separation of RBCs from fibrin and enabling controlled removal without causing harmful fragmentation
2Productivity
If mechanical thrombectomy is applied, then clot removal is achieved, but red blood cells and fibrin are not separated, leading to incomplete clot dissolution
Solution Approach 1:
The device employs dynamic rotational motion through the spinner device that adapts to the rheological properties of different thrombus components. By continuously adjusting the rotational speed and direction, the system achieves differential movement of RBCs versus fibrin, enabling complete separation and removal of all clot components
Solution Approach 2:
The patent replaces conventional static mechanical retrieval methods with a dynamic rotational field generated by the spinner device. This substitution allows for more sophisticated manipulation of the thrombus components based on their different mechanical properties, achieving complete separation that conventional methods cannot achieve
3Productivity
If high suction force is applied to remove clot quickly, then productivity increases, but clot fragmentation and downstream emboli risk increase
Solution Approach 1:
The device employs periodic or pulsed suction forces rather than continuous high suction. The rotational motion of the spinner device creates periodic pressure variations that progressively remove clot components over time, achieving complete removal without the harmful effects of sustained high-force suction that would cause fragmentation
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 efficiently reduces clot size and prevents fragmentation, allowing for effective clot removal with minimal risk of downstream emboli, enhancing the first pass effect and improving patient outcomes.
Implementation Method 1
a spinner device introduced through a catheter or other tubular member (or directly into a body lumen) that mechanically reduces or compresses the volume and/or separates components of the clot (e.g., red blood cells, from fibrin or other residual fiber material) and/or dissolves or partially dissolves the clot, e.g., by coupled suction-induced compression and shear load applied to the clot by the spinner
Implementation Method 2
mechanically reduces or compresses the volume and/or separates components of the clot (e.g., red blood cells, from fibrin or other residual fiber material) and/or dissolves or partially dissolves the clot, e.g., by coupled suction-induced compression and shear load applied to the clot by the spinner
Implementation Method 3
an elongated shaft comprising a proximal end configured to be coupled to a controller to spin the shaft, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis
Data Source
AI summary
Thrombectomy devices are provided that include an aspiration catheter and a spinner device movable axially within the aspiration catheter. The spinner device includes a rotation shaft including a proximal end coupled to a motor configured to spin the shaft, a distal end carrying a spinner head movable axially within the aspiration catheter and configured to generate localized suction when the shaft rotates. The spinner device may also include an outer sleeve surrounding the rotation shaft at least partially along its length to protect the aspiration catheter. The spinner device and aspiration catheter include cooperating stops that limit advancement of the spinner device to prevent the spinner head from being exposed beyond a short distance beyond a distal end of the aspiration catheter, e.g., a wing-stopper provided on one of the rotation shaft, spinner head, and outer sleeve, and a corresponding ring within the distal end of the aspiration catheter.