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-10987085-B2
Publication Date
2021-04-27
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
A device is presented for automatically assessing functional hemodynamic properties of a patient, comprising a housing configured for removable coupling to a body part containing at least one vessel of interest, an ultrasound unit adapted to adduce ultrasonic waves into the vessel in a continuous beam, and a detector to sense signals obtained from these ultrasonic waves. A processor receives and processes these recorded ultrasonic signals to output hemodynamic parameters via an interface such as a graphical or auditory display.
The device solves the problem of providing an innovative, affordable, portable, and non-invasive hemodynamic monitoring device that can reliably and precisely measure functional hemodynamics even in unstructured environments with care delivered by individuals of varying experience. It addresses the challenges of conventional invasive methods which carry risks such as infection, delays from surgical preparation, and the need for specialized skill and equipment, making non-invasive and portable monitoring highly desirable especially in emergency situations.
The invention includes a plurality of transducer pairs arranged in a saw tooth pattern to produce overlapping ultrasonic waves at an incidence angle optimized between about 25 to 60 degrees relative to blood flow, generating an unfocused ultrasonic curtain. This design enables multiple redundant effective placement positions on the body part, reducing the need for precise device placement and facilitating ease of use by untrained personnel. The device is also configured to continuously extract hemodynamic parameters in real-time by applying signal processing routines on reflected ultrasonic waves, store this data, and provide immediate feedback via sensory outputs. It is adapted for hands-free use and can track changes pre- and post-intervention to assess the efficacy of therapeutic procedures.
Claims Coverage
The claims present six main inventive features related to a vascular flow detection device focusing on ultrasound transducer configuration, signal processing, and data communication.
Unfocused overlapping ultrasonic curtain with angled transducer pairs
A device having multiple pairs of transmit and receive ultrasound transducer elements oriented to produce an unfocused overlapping ultrasonic signal pattern across a range of depths between approximately 1-4 centimeters. The pairs are axially aligned along the length of the case and configured to transmit and receive signals at an acute angle to the bottom surface plane of the case, enabling simultaneous transmission and reception of signals representing flow in multiple vessels.
Rectangular piezoelectric transducer elements with dimensional alignment
Each transmit and receive transducer element is a generally rectangular piece of piezoelectric material where the width is at least eight times the height. The transducer pairs are aligned such that their width dimension extends along the length of the case and oriented at approximately 45 degrees relative to the plane of the device's bottom surface.
Doppler shift measurement and indication to operator
Incorporates circuitry to measure Doppler shifts in received ultrasound echo signals and produce indications to an operator. Additionally, the processor executes instructions to determine Doppler shifts before and after procedures on the patient and indicate differences to aid clinical assessment.
Communication circuitry for external device connectivity
The device includes communication circuitry enabling connection to external devices (wired or wireless) for transmitting Doppler shift differences measured pre- and post-procedure for further analysis or storage.
Mounting blocks with angled grooves for transducer pairs
Transmit and receive transducer pairs are mounted in blocks with grooves angled at differing acute angles relative to the device's bottom surface, and adjacent mounting blocks are secured to a flexible printed circuit permitting flexibility along the device length.
Compact, handheld case configurated for patient attachment
A compact case designed to be hand-held and placed over target vessels comprising power circuitry, ultrasound transmit and receive circuitry, and a battery to operate the device, with all transducer pairs fully contained within the case and arranged as described above.
The independent claims cover a portable handheld ultrasound vascular flow detection device that features an array of rectangular piezoelectric transducer pairs configured in an angled and flexible arrangement to create an unfocused ultrasonic curtain. The device processes Doppler shifted echo signals to provide clinical flow information, communicates results externally, and incorporates design features facilitating ease of application and reliable measurement from multiple vessel flow directions.
Stated Advantages
The device provides innovative, affordable, portable, and non-invasive functional hemodynamic monitoring, reducing risks and complications associated with invasive methods.
A design enabling multiple redundant placement options significantly reduces the need for precise positioning, making it operable by unskilled or less trained users, especially in emergency situations.
Real-time or near-real-time extraction and output of hemodynamic parameters enable immediate clinical feedback, including monitoring of fluid responsiveness and detection of clinical events such as return of spontaneous circulation.
The device is capable of hands-free operation, freeing caregivers to perform other critical tasks.
Integration of wireless and wired communication supports data transfer to external processing or storage systems, enhancing functionality and interoperability.
Documented Applications
Use in emergency and critical care settings to provide real-time functional hemodynamic assessments including fluid responsiveness evaluation.
Monitoring blood flow through vessels such as the carotid artery, brachial artery, femoral artery to assess cardiovascular status and guide interventions like fluid challenges or CPR efficacy.
Application as an adhesive ultrasound bandage for continuous or repeated measurements pre-, during, and post-intervention to assess treatment effectiveness.
Use in automated protocols for clinical tests such as the end-expiratory occlusion test to assess volume responsiveness and to aid mechanical ventilator management.
Integration with external devices such as ventilators, defibrillators, or consumer electronics for coordinated patient monitoring and data analysis.
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