Rotating Impeller Thrombectomy Catheter for Clog-Free Aspiration
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Solution Overview
Problem
Current thrombectomy devices face issues with clogging due to high aspiration pressure, leading to blood loss and increased procedural risks when dealing with thrombus and soft plaque, as they are not effective in treating larger and longer regions without becoming obstructed.
Innovation Solution
A thrombectomy system featuring a rotating impeller that can be translated and locked within a catheter lumen, with a distal portion extending outside to break up thrombus and soft plaque, allowing for lower aspiration pressure and effective aspiration without clogging, utilizing a controller with executable instructions to manage the impeller's rotation based on its position within the catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high aspiration pressure is used to draw thrombus particles through the catheter, then the removal of thrombus material is enhanced, but the catheter becomes clogged and blood loss increases
Solution Approach 1:
The impeller device segments the thrombus removal process into two distinct stages: (1) disruption phase where the impeller breaks up thrombus into smaller fragments, and (2) aspiration phase where the catheter suction draws the fragmented material through. This segmentation allows each stage to be optimized independently, preventing clogging by ensuring particles are sufficiently fragmented before aspiration attempts.
Solution Approach 2:
The impeller performs preliminary action by disrupting and fragmenting the thrombus material before the aspiration process begins. The impeller rotates to mechanically break up the thrombus into smaller, more manageable particles that can be easily drawn through the catheter without causing blockages, thus preparing the material in advance for successful removal.
2Ease of operation
If high aspiration pressure is applied to clear clogged catheters, then particle removal is achieved, but blood loss and procedural risks increase
Solution Approach 1:
The impeller performs preliminary disruption of thrombus material before aspiration, preventing catheter clogging in the first place. By fragmenting particles upstream, the system eliminates the need for high-pressure unclogging maneuvers, thereby avoiding the harmful effect of increased blood loss associated with forceful catheter clearing.
Solution Approach 2:
The system converts the potential harm of thrombus accumulation (which would require high-pressure flushing) into a benefit by using the impeller to deliberately fragment the thrombus. This controlled fragmentation transforms what would be a harmful clogging event into a beneficial pre-processing step that facilitates gentle, low-blood-loss removal.
3Device complexity
If a generic catheter is used for suction, then the device is simple, but it clogs with moderately sized thrombus particles
Solution Approach 1:
The invention merges two previously separate functions into a single integrated device: the impeller (for disruption) and the catheter (for aspiration). This combination allows the system to handle moderately sized thrombus particles effectively while maintaining relative design simplicity. The impeller is positioned within or near the catheter, creating a unified thrombus removal system that overcomes the limitations of generic catheters alone.
Solution Approach 2:
The thrombus removal function is segmented into disruption (performed by the impeller) and aspiration (performed by the catheter). This segmentation allows the catheter to maintain its simple suction design while the impeller handles the complex task of particle fragmentation, enabling the removal of moderately sized thrombus without complicating the catheter's fundamental aspiration function.
4Strength
If the impeller is positioned entirely outside the catheter lumen, then thrombus disruption is maximized, but the device cannot effectively aspirate the disrupted material
Solution Approach 1:
The impeller is nested within or positioned at the distal end of the catheter lumen, allowing it to extend slightly beyond while remaining functionally integrated with the catheter. This nested arrangement enables the impeller to disrupt thrombus effectively at the catheter tip while the disrupted material remains within easy reach of the catheter's aspiration opening, ensuring both disruption strength and aspiration efficiency.
Solution Approach 2:
The impeller positioning utilizes a transitional dimensional arrangement where it is not completely inside nor completely outside the catheter lumen, but rather at the boundary or distal extension. This dimensional positioning allows the impeller to access thrombus material effectively for disruption while maintaining close proximity to the catheter's aspiration pathway, optimizing both disruption and removal functions.
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
Enables the effective removal of thrombus and soft plaque with lower aspiration pressure, preventing clogging and allowing treatment of larger and longer areas, thereby reducing blood loss and procedural risks.
Implementation Method 1
A thrombectomy system featuring a rotating impeller that can be translated and locked within a catheter lumen, with a distal portion extending outside to break up thrombus and soft plaque
Implementation Method 2
enabling a much lower aspiration pressure while allowing the physician to keep the device tip clear from clogging
Data Source
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AI summary
A thrombectomy system is provided that, in various embodiments, a rotating impeller that may be translated within limits along a guidewire and within a catheter. The rotating impeller is, during operation, either located entirely outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen, whereby rotation is prevented if the impeller is completely within the catheter's lumen.