Systems and methods for automated fluid response measurement
Inventors
EIBL, Joseph • KENNY, Jon-Emile • Magnin, Paul • EIBL, Andrew • Gatzke, Ronald
Assignees
1929803 Ontario Corp (o/a Flosonics Medical) • 1929803 Ontario Corp
Publication Number
US-11642104-B2
Publication Date
2023-05-09
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 relates to a portable, non-invasive hemodynamic monitoring device configured to automatically assess functional hemodynamic properties of a patient by utilizing an ultrasound unit adapted to adduce ultrasonic waves into a vessel of interest. The device comprises a housing configured for removable coupling to a body part (e.g., the neck, targeting the carotid artery), an ultrasound unit including a plurality of transducer pairs oriented to produce overlapping ultrasonic waves at an angle of incidence between about 25 to 60 degrees with respect to the plane of fluid flow through the vessel, a processor configured to extract hemodynamic parameters in real or near real-time by applying a signal processing routine, and a sensory output device providing feedback to the user.
The core problem addressed is the need for an innovative, affordable, and portable non-invasive hemodynamic monitoring device that facilitates user-independent, precise, and repeatable measurements across a variety of patients and clinical circumstances. Challenges include ensuring accurate and reliable readings accounting for noise, transient signals, variations in physical patient dimensions, device placement, and user skill levels. Existing invasive methods or conventional ultrasound devices are either bulky, require skilled use, or present infection risks and other complications, making them less suitable for emergency or prolonged care settings.
The disclosed device seeks to overcome these challenges by providing an ultrasound bandage with a chain of transducer pairs in a saw tooth pattern that produces an unfocused continuous curtain of ultrasonic waves. This design offers multiple redundant effective placement positions on the body part, reducing the precision required for device positioning and enabling use by untrained or less skilled users. The system is designed for hands-free continuous monitoring and automated data processing, enabling functional hemodynamic assessments before, during, and after interventions such as fluid challenges or cardiopulmonary resuscitation.
Claims Coverage
The independent claims define inventive features primarily directed to a device for detecting vascular flow with integrated ultrasound transducer elements, processing circuitry, and positioning mechanisms.
Integrated transducer pairs in an unfocused overlapping signal pattern
The device comprises pairs of transmit and receive ultrasound transducer elements fully contained in a case, axially aligned and electrically connected along the length of the case, configured to provide ultrasound signals forming a shaped, unfocused overlapping pattern to interrogate blood vessels.
Processing circuitry with directional signal output and selective signal processing
Circuitry in the case transmits and receives the ultrasound signals and processes them to provide directional signals responsive to flow direction in two different vessels, with the ability to select and process signals from a subset of receive transducer elements based on signal levels, improving measurement reliability.
Physical housing and securing mechanisms
The device includes a rigid or configured case sealed to contain the circuitry and battery, removably attachable to a patient using adhesives and/or tensioning materials that apply a securing force to maintain acoustic coupling and fixed angles of the transducer elements relative to the vessel flow plane.
Battery-powered portable design with automated operation
A battery contained within the device powers the transmit and receive circuitry and processing units. The device may be programmed to power on at pre-set times or enter sleep modes automatically, enhancing portability and usability in varied clinical settings.
In summary, the claims cover a portable, battery-powered ultrasound device featuring integrated, aligned transducer pairs producing an unfocused ultrasonic signal for vascular flow detection; processing circuitry capable of directional flow signal discrimination and selection of signals based on quality; and physical means for secure, repeatable attachment maintaining proper transducer orientation relative to the vessel to enable reliable, automated hemodynamic monitoring under variable placement conditions.
Stated Advantages
Provides a portable and affordable non-invasive hemodynamic monitoring device suitable for critically ill patients and emergency situations.
Enables precise, repeatable, and user-independent measurements accommodating variability in patient anatomy and device placement.
Reduces the training required for operation by allowing redundant and non-critical placement due to unfocused ultrasonics curtain generated by transducer arrays.
Facilitates hands-free use, continuous monitoring, and automated evaluation before, during, and after interventions such as fluid challenges or CPR.
Minimizes the risk and complications associated with invasive monitoring techniques by providing non-invasive assessment.
Integrates signal processing to provide real-time or near real-time hemodynamic feedback with visual and auditory outputs to aid clinical decision-making.
Documented Applications
Automated functional hemodynamic assessments of blood flow in vessels including the carotid artery, brachial artery, and femoral artery.
Monitoring fluid responsiveness of patients pre- and post-intervention such as fluid challenges, passive leg raises, medication administration, and cardiopulmonary resuscitation.
Detection of return of spontaneous circulation (ROSC) events during CPR by analyzing Doppler waveform patterns indicative of blood flow changes.
Identification of compensated shock by monitoring the ratio of heart rate to velocity time integral of blood flow.
Use in emergency, intensive care, and protracted patient monitoring environments allowing continuous flow monitoring with minimal user skill.
Integration with other medical equipment including ventilators and defibrillators for coordinated patient care and automated alerts.
Potential use in mechanical ventilation liberation protocols by measuring carotid flow changes during end-expiratory and end-inspiratory occlusion tests.
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