Systems and methods for automated fluid response measurement
Inventors
EIBL, Joseph • KENNY, Jon-Emile • Magnin, Paul • EIBL, Andrew
Assignees
1929803 Ontario Corp (d/b/a Flosonics Medical) • 1929803 Ontario Corp
Publication Number
US-11324476-B2
Publication Date
2022-05-10
Expiration Date
2036-12-09
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Abstract
A device is provided for automatically assessing functional hemodynamic properties of a patient is provided, the device comprising: a housing; an ultrasound unit coupled to the housing and adapted for adducing ultrasonic waves into the patient at a vessel; a detector adapted to sense signals obtained as a result of adducing ultrasonic waves into the patient at the vessel and to record the; and a processor adapted for receiving the recorded signals as data and transforming the data for output at an interface. Other devices, systems, methods, and/or computer-readable media may be provided in relation to assessing functional hemodynamics of a patient.
Core Innovation
The invention provides a portable hemodynamic monitoring device that automatically assesses a patient's functional hemodynamic properties by using an ultrasound unit to adduce ultrasonic waves continuously into a targeted vessel, such as the carotid artery, and detecting reflected ultrasonic signals affected by blood flow. This device includes a housing for removable coupling to the patient's body part, a processor to extract hemodynamic parameters in real-time using signal processing routines such as continuous wave Doppler ultrasound, and a sensory output device to provide feedback on data quality or other relevant information.
The device solves the problem of variability and lack of repeatability in functional hemodynamic assessments in unstructured environments where multiple care-providers with varying skill levels need to perform monitoring over protracted periods. Challenges addressed include ensuring accurate, specific, and reliable measurements despite noise, patient anatomical variations, and inconsistent device placement. The invention offers an automated, robust, and user-independent solution that minimizes the need for highly trained operators through features like a transducer pair arranged in a saw tooth pattern to produce ultrasonic waves at an optimal angle of incidence, redundant placement options, automatic vessel identification, and real-time feedback on device positioning.
Claims Coverage
The patent contains two independent claims focusing on a portable hemodynamic monitoring device and a corresponding method, covering features related to ultrasound transducer design, signal processing, data storage, and user interaction.
Ultrasound transducer pair oriented to produce continuous beam at optimal incidence angle
The device includes at least one transducer pair with separate transmitter and receiver piezoelectric elements arranged to produce ultrasonic waves at an angle between about 25 to 60 degrees relative to the fluid flow plane, generating a beam wide enough to capture arterial and venous signals entirely at a monitored cross-section.
Processing electronics configured for Doppler shift-based flow velocity measurement and data storage
The processing electronics amplify, filter, and digitize echo signals from the transducer pair to determine flow velocities in patient vessels, storing a number of measurements over time while maintaining the angle of incidence during measurement periods.
Hands-free housing fixed to skin surface enabling continuous measurement during interventions
The housing interfaces with patient's skin and is adapted to be fixed in place hands-free to remain coupled during pre- and post-hemodynamic intervention measurements, enabling comparison and determination of fluid responsiveness without repositioning.
Processor executing instructions to measure pre- and post-intervention flow velocities and determine fluid responsiveness
The processor receives Doppler shift data, measures flow velocities prior to an intervention, instructs performance of the intervention, measures flow velocities afterward, and compares the two to indicate the patient's fluid responsiveness to the intervention.
Flexible housing with chain of transducer pairs conforming to patient morphology
In some embodiments, the housing is made of flexible material and includes a chain of multiple transducer pairs connected to conform to patient body shapes, enhancing acoustic coupling and measurement accuracy.
Sensory output device providing audio or visual cues for placement guidance and responsiveness alerts
A sensory output device outputs audio or visual indicators reflecting signal strength relative to noise to guide device placement, and alerts when velocity-time integral ratios exceed thresholds after hemodynamic interventions.
Communication circuitry for transmitting hemodynamic data to remote systems
The device includes communication circuitry to transmit measured data and hemodynamic parameters from the portable device to an external remote computer system for further analysis or storage.
The independent claims cover a portable, hands-free ultrasound-based hemodynamic monitoring device and its operation method, focusing on transducer orientation for reliable Doppler measurements, continuous flow velocity data collection during interventions, flexible ergonomic design, user feedback mechanisms, and wireless data communication.
Stated Advantages
Enables automated, precise, and repeatable functional hemodynamic measurements in unstructured environments with minimal operator training.
Provides hands-free attachment to the patient to maintain consistent measurement positioning over time, improving reliability.
Allows measurement and comparison of pre- and post-interventional hemodynamic parameters for assessing fluid responsiveness.
Incorporates redundant transducer placement options and automated vessel identification to reduce dependency on skilled ultrasound operators.
Supports wireless communication to external systems for data storage and analysis, facilitating integration into clinical workflows.
Flexible device design improves patient comfort and adapts to different anatomies, enhancing acoustic coupling and measurement accuracy.
Documented Applications
Monitoring fluid responsiveness in critically ill patients by assessing blood flow velocity changes before and after hemodynamic interventions such as fluid challenges or administering medicaments.
Providing real-time feedback during cardiopulmonary resuscitation (CPR) to detect return of spontaneous circulation and indicate when chest compressions should cease.
Automated hemodynamic monitoring in various clinical care phases, enabling continuous assessment by multiple care providers over extended patient care periods.
Use in portable, disposable, or cart-mounted configurations to accommodate different care environments including hospitals and emergency settings.
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