Aspiration Catheter Pulsatile Control for Low-Blood-Loss Thrombectomy
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Solution Overview
Problem
Current aspiration thrombectomy systems face challenges with excessive blood loss and catheter clogging during the removal of large clots, particularly in peripheral vasculature, leading to prolonged procedures and increased risk of vessel damage.
Innovation Solution
The system employs a thrombectomy catheter assembly with pulsatile energy control and a vent fluid system to maintain cyclic aspiration, automatically adjusting aspiration based on clot contact and preventing excessive blood loss and catheter clogging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If continuous aspiration is applied to remove large clots in peripheral vasculature, then clot removal efficiency is improved, but excessive blood loss occurs
Solution Approach 1:
The system implements cyclic aspiration by periodically opening and closing the aspiration valve, creating pulses of negative pressure that draw clot material into the catheter while allowing blood to flow back during the relaxation phase. This periodic action maintains clot removal efficiency while significantly reducing net blood loss compared to continuous aspiration.
Solution Approach 2:
The system uses pressure sensors to detect the presence of clot material during aspiration. When clot is detected (indicated by pressure changes), the system maintains aspiration; when only blood is detected, the system automatically reduces or stops aspiration, preventing excessive blood loss while maintaining efficient clot removal.
2Productivity
If large diameter catheter is used to remove large clots, then clot removal capability is improved, but blood loss increases
Solution Approach 1:
By applying cyclic aspiration to large diameter catheters, the system creates intermittent blood flow patterns that reduce the volume of blood entering the catheter during clot removal procedures, thereby maintaining clot removal capability while reducing overall blood loss.
Solution Approach 2:
The system maintains continuous engagement with the clot through repeated aspiration cycles, ensuring that the large diameter catheter continuously removes clot material without prolonged exposure to healthy blood flow that would occur with intermittent manual operation.
3Productivity
If catheter is moved through large clot multiple times, then complete clot removal is achieved, but procedure time increases
Solution Approach 1:
The automated cyclic aspiration system allows the catheter to remain continuously engaged with the clot during multiple passes, automatically maintaining aspiration pressure throughout the procedure. This eliminates delays associated with manual activation/deactivation and reduces overall procedure time while ensuring complete clot removal.
Solution Approach 2:
The pressure sensing system continuously monitors clot presence during catheter movement, automatically adjusting aspiration to maintain effective clot removal throughout multiple passes without requiring manual intervention or prolonging the procedure.
4Loss of substance
If automated aspiration control is implemented, then blood loss mitigation is improved, but device complexity increases
Solution Approach 1:
The system incorporates pressure sensors that provide real-time feedback on clot presence, automatically controlling the aspiration valve to open or close based on detected pressure changes. This automated feedback control effectively mitigates blood loss without requiring complex manual coordination or multiple operators.
Solution Approach 2:
The aspiration system automatically adjusts its own operation based on sensor feedback, with the control system self-regulating aspiration pressure and timing without external intervention, thereby reducing blood loss while maintaining manageable device complexity through autonomous operation.
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 effectively minimizes blood loss and reduces catheter clogging, optimizing clot removal procedures by maintaining pulsatile energy and automatically adjusting aspiration, thereby enhancing procedural safety and efficiency.
Implementation Method 1
a vacuum source 12, a collection canister 14, a vacuum tube or extension line 17, and a catheter 18 for removal of a thrombus 2
Implementation Method 2
a vent fluid source 22 containing vent fluid 24... a controller 108 configured to... open the vent valve 26 to supply vent fluid 24 to the operable lumen
Implementation Method 3
at least one sensor 102 disposed in the operable lumen upstream of the vacuum valve input and configured to sense a pressure waveform within the operable lumen
Implementation Method 4
cyclic aspiration including, for example, pulsed or pulsatile aspiration... the controller 108 is configured to open and close the vacuum valve 25, to open and close the vent valve 26
Data Source
AI summary
An aspiration thrombectomy system includes a thrombectomy catheter assembly that maintains pulsatile energy of cyclic aspiration while the catheter is occluded. A system configuration includes a catheter, vacuum and vent fluid sources respectively connected to vacuum and vent valves, a vent catheter valve connecting a catheter lumen to the vent fluid source, a manifold connected to the catheter and vacuum and vent valves, a pressure sensor upstream of the vacuum valve, and a controller configured to operate the vacuum, vent, and vent catheter valves, receive sensor pressure data, control the vent catheter valve dependent upon the data. An operable lumen of the system includes a volume of the catheter lumen and an interior of the manifold up to an input of the vacuum valve input and an output of the vent valve.