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Publication Number
US-11744600-B2
Publication Date
2023-09-05
Expiration Date
Abstract
A system for real time monitoring of catheter aspiration includes a pressure sensor configured for placement in fluid communication with a lumen which at least partially includes an aspiration lumen of a catheter, the aspiration lumen configured to couple to a vacuum source, 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 a continuous signal which is proportional to measured fluid pressure.
Core Innovation
The invention is an aspiration catheter monitoring system that performs real time monitoring of catheter aspiration using a pressure sensor configured for placement in fluid communication with a lumen that includes an aspiration lumen of a catheter and that is configured to couple to a negative pressure source. The pressure sensor measures negative fluid pressure and the processor measures changes in the negative fluid pressure. The processor and communication device generate a continuous signal to communicate the changes in the negative fluid pressure to a user using an algorithm that depends on the measured negative fluid pressure or changes in the measured fluid pressure.
The described system characterizes the measured negative fluid pressure by comparing pressure deviations and variations, including absolute and relative comparisons such as a baseline pressure and a pressure differential (ΔP). The pressure waveform comparison supports detecting conditions including presence or absence of vacuum, loss of vacuum, system leaks, clog/stuck conditions, and thrombus encountered during active aspiration versus non-thrombus blood aspiration, as well as other aspiration-related flow conditions. The system provides continuous and/or alert signaling proportional to the measured pressure and its deviations.
The continuous signal is configured to be sensed in real-time by the user for characterizing the changes in the measured fluid pressure. The output modalities described include audible sound with characteristics such as sound amplitude and/or sound frequency/pitch, visible light via LEDs/displays, and tactile vibration/heat, including possible combined psychoacoustic schemes. The algorithm is further described as constraining the continuous signal according to a stored model/library, thresholds, and user-detectable human ranges to maintain usability.
Claims Coverage
The document provides two independent claims. Both independent claims define a real time catheter aspiration monitoring system based on a pressure sensor measuring negative fluid pressure in an aspiration lumen, a processor measuring pressure changes, and a communication device generating a continuous user signal using a pressure-dependent algorithm.
Pressure sensor in fluid communication with aspiration lumen measuring negative fluid pressure
A pressure sensor configured for placement in fluid communication with a lumen which at least partially includes an aspiration lumen of a catheter, wherein the aspiration lumen couples to a negative pressure source, and the pressure sensor measures negative fluid pressure.
Processor measuring changes in the negative fluid pressure
A processor coupled to the pressure sensor and programmed to measure changes in the negative fluid pressure (or fluid pressure changes).
Continuous signal based on pressure-dependent algorithm communicated to a user
A communication device coupled to the processor and configured to generate a continuous signal characterized by an algorithm that depends on the measured negative fluid pressure (or varies depending on the changes in the measured fluid pressure) for communicating the changes to a user, where the continuous signal can be sensed real-time by a user for characterizing the changes in the measured fluid pressure.
User-sensible continuous signal algorithm variations for real-time characterization
For the second independent claim, the continuous signal is based on an algorithm that varies depending on the changes in the measured fluid pressure, and the continuous signal can be sensed real-time by a user for characterizing the changes in the measured fluid pressure to the user.
Across both independent claims, the inventive coverage centers on measuring negative (aspiration) fluid pressure in an aspiration lumen with an in-fluid pressure sensor, computing pressure changes in a processor, and producing a continuous user-perceivable signal derived from an algorithm that varies with the measured negative pressure or pressure changes.
Stated Advantages
Provides continuous and real time monitoring of catheter aspiration.
Communicates changes in negative fluid pressure to a user via a continuous signal.
Allows the user to characterize changes in measured fluid pressure in real time.
Outputs continuous signal modalities that can be sensed by a user (e.g., audible, visible, and tactile modalities).
Documented Applications
Detecting conditions during catheter aspiration including presence/absence of vacuum, loss of vacuum, system leaks, clog/stuck conditions, and thrombus encountered during active aspiration versus non-thrombus blood aspiration.
Monitoring hemostasis valve seal/leak status using a pressure sensor.
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