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Abstract
A system for removal of blood or thrombus includes an aspiration catheter having an elongate shaft including an aspiration lumen having proximal end configured to couple to a vacuum source, and a distal end having an orifice, an elongate member configured for placement through the aspiration lumen and having a distal portion including a disruption element configured to disrupt thrombus within the aspiration lumen, and a monitoring device configured for removable connection in between the aspiration catheter and the vacuum source, and including a housing, a pressure sensor in fluid communication with an interior of the housing, a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure, and a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.
Core Innovation
The invention relates to an aspiration monitoring system for removing thromboembolic material from a blood vessel. The system includes an aspiration catheter having an aspiration lumen coupled to a vacuum source and an orifice positioned into or adjacent thromboembolic material, and an elongate member inserted into the aspiration lumen. A negative pressure is applied to draw at least a portion of the thromboembolic material into the aspiration lumen.
The invention includes rotating the elongate member within the aspiration lumen using a rotating device, where the rotating device includes a body and a rotator configured to rotate the elongate member when coupled. The system monitors the negative pressure with a pressure transducer and measures one or more deviations in the negative pressure with a measurement device coupled to the pressure transducer. The measured deviations quantify deviations in fluid pressure such as vacuum loss and other deviation conditions.
The system further generates alert signals using a communication device when the measured deviations exceed pre-set thresholds. The described alert modalities include visual alerts and tactile and audible alerts, including LEDs, a visible display, vibration, heat, and audible tones or messages. The monitoring is described as addressing difficulty detecting vacuum status, including clogging and air leaks, with pressure-vs-time signatures for conditions such as no thrombus, clog or stuck conditions, system leak, and active thrombus aspiration.
Claims Coverage
The independent claims cover thromboembolic removal using an aspiration catheter, a vacuum source, a rotatable elongate member, and negative-pressure monitoring via a pressure transducer with deviation measurement. The main inventive features are rotation-assisted aspiration, pressure monitoring, deviation-based measurement, and threshold-based alerting.
Pressure monitoring of negative pressure during thromboembolic removal
Monitoring the negative pressure with a pressure transducer, and measuring one or more deviations in the negative pressure with a measurement device coupled to the pressure transducer.
Rotating elongate member within aspiration lumen for aspiration
Coupling the proximal portion of the elongate member to a rotating device comprising a body and a rotator, and rotating the elongate member within the aspiration lumen of the aspiration catheter with the rotating device.
Negative-pressure thrombus aspiration using aspiration catheter and elongate member
Providing an aspiration catheter having an elongate shaft including an aspiration lumen with a proximal end coupled to a vacuum source and a distal end having an orifice; inserting the distal portion into a blood vessel and positioning the orifice into or adjacent thromboembolic material; inserting the elongate member into the aspiration lumen; and applying a negative pressure to draw at least a portion of the thromboembolic material into the aspiration lumen.
The claim coverage centers on aspiration catheter-based thromboembolic material removal using an elongate member that is rotated during negative-pressure aspiration, combined with pressure transducer-based monitoring and measurement of deviations in negative pressure.
Stated Advantages
Provides alert signals when measured negative-pressure deviations exceed pre-set thresholds.
Quantifies deviations in fluid pressure during aspiration, including vacuum loss and other deviation conditions.
Described as improving procedural safety and reducing blood loss.
Documented Applications
Removing thromboembolic material from a blood vessel in a patient using aspiration catheter aspiration with rotating elongate-member operation and negative-pressure monitoring.
Using pressure-vs-time signatures to distinguish conditions including no thrombus, clog or stuck conditions, system leak, and active thrombus aspiration during thrombus removal.
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