Apparatus and method for the determination of endothelial dysfunction and sepsis risk using nitric oxide concentrations in exhaled breath
Inventors
Anderson, Carter R. • Morris, Russell L. • Burke, Thomas W. • Anderson, Clayton J.
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Assignees
Member
Vail Scientific Vail Scientific has developed a non-invasive, breathalyzer, rapid sepsis detection technology designed for point-of-care and early intervention, such as Triage, alongside other vital signs and clinical assessments.
The technology may be utilized in many diverse settings including hospitals, urgent care, nursing homes and even mobile military field hospitals. Vail's portable proprietary analyzer weighs less than 9 lbs.
The company leverages exhaled nitric oxide (Nobel Prize in Medicine winning molecule) measurement for enhanced sensitivity and speed in sepsis screening, aiming to reduce mortality rates and improve patient outcomes.
Since 2019, Vail Scientific has focused on clinical research, device innovation, and advancing toward commercialization/regulatory clearance.
Vail Scientific has developed a non-invasive, breathalyzer, rapid sepsis detection technology designed for point-of-care and early intervention, such as Triage, alongside other vital signs and clinical assessments. The technology may be utilized in many diverse settings including hospitals, urgent care, nursing homes and even mobile military field hospitals. Vail's portable proprietary analyzer weighs less than 9 lbs. The company leverages exhaled nitric oxide (Nobel Prize in Medicine winning molecule) measurement for enhanced sensitivity and speed in sepsis screening, aiming to reduce mortality rates and improve patient outcomes. Since 2019, Vail Scientific has focused on clinical research, device innovation, and advancing toward commercialization/regulatory clearance.
Publication Number
US-12539073-B1
Publication Date
2026-02-03
Expiration Date
Abstract
A method for determining a risk of sepsis in a patient is disclosed. The method includes collecting an exhaled breath sample, determining a NO concentration in the exhaled breath sample; and determining a sepsis risk score correlated to the NO concentration, wherein the sepsis risk score is indicative of a risk of a patient having or developing sepsis. The method may further include determining an additional measurement of the patient's vital statistics including one or more of: end tidal CO2, respiratory rate, pulse rate, body temperature, cognitive assessment score, systolic blood pressure, diastolic blood pressure, or hemoglobin oxygen saturation level, and further determining the sepsis risk score based on the additional measurement.
Core Innovation
The invention provides non-invasively determining a sepsis risk score by analyzing exhaled breath. An exhaled breath sample is collected while controlling a rate of exhalation using a flow regulator, and an end tidal nitric oxide (NO) concentration is determined in the exhaled breath sample. The end tidal NO concentration is correlated to a sepsis risk score indicative of a patient having or developing systemic sepsis.
The approach correlates the end tidal NO concentration with explicit thresholds for establishing an elevated sepsis risk score. In response to the end tidal NO concentration having a value lower than 13 ppb, or lower than 10 ppb, the end tidal NO concentration is correlated to an elevated sepsis risk score indicative of the patient having or developing systemic sepsis.
The invention also provides weighting the sepsis risk score by additional measurements of one or more vital statistics of the patient, including body temperature. Longitudinal monitoring is provided by collecting a second exhaled breath sample at a second controlled rate of exhalation, determining a second end tidal NO concentration, and determining a changed sepsis risk score based on a difference between the first sepsis risk score and the second sepsis risk score, where improvement or worsening of a systemic sepsis condition is determined based on the changed sepsis risk score. The controlled rate is independent of an inlet pressure of the exhaled breath sample and is less than or equal to 50 mL/sec.
Claims Coverage
The independent claims cover 6 inventive features. Across the claims, the core inventive features include controlled exhalation sampling, determining end tidal nitric oxide (NO) concentration, correlating NO to a sepsis risk score using explicit NO thresholds, weighting the score with body temperature and other vital statistics, determining a changed sepsis risk score from first and second measurements, and treating based on the resulting score.
Controlled exhalation and end tidal NO sepsis risk scoring
Controlling a rate of exhalation from a patient; analyzing an exhaled breath sample collected at the controlled rate of exhalation; determining an end tidal nitric oxide (NO) concentration in the exhaled breath sample; determining a sepsis risk score correlated to the end tidal NO concentration.
Elevated risk correlation to end tidal NO below a threshold
Determining a sepsis risk score correlated to the end tidal NO concentration, wherein in response to the end tidal NO concentration having a value lower than 13 ppb the end tidal NO concentration is correlated to an elevated sepsis risk score indicative of the patient having or developing systemic sepsis.
Quantified controlled sampling at a first and second exhalation
Controlling a first rate of exhalation; collecting a first exhaled breath sample at the first controlled rate of exhalation of 50 mL/sec; determining an end tidal nitric oxide (NO) concentration and a first sepsis risk score; controlling a second rate of exhalation; collecting a second exhaled breath sample at a time after collecting the first exhaled breath sample, the second exhaled breath collected at the second controlled rate of exhalation of 50 mL/sec; determining a second end tidal NO concentration and a second sepsis risk score.
Weighting sepsis risk scores by vital statistics including body temperature
Weighting the first sepsis risk score by additional measurements of one or more vital statistics of the patient, the vital statistics including body temperature; weighting the second sepsis risk score by a second measurement of the one or more vital statistics of the patient.
Changed sepsis risk score and determining improvement or worsening
Determining a changed sepsis risk score based on a difference between the first sepsis risk score and the second sepsis risk score; determining an improvement or a worsening of a systemic sepsis condition in the patient based on the changed sepsis risk score; treating the patient based on the changed sepsis risk score.
Controlled rate independent of inlet pressure with combined NO and body temperature trigger
Collecting an exhaled breath sample at a controlled rate that is independent of an inlet pressure of the exhaled breath sample and less than or equal to 50 mL/sec; determining an end tidal nitric oxide (NO) concentration; receiving a body temperature of the patient; based on the end tidal NO concentration and the body temperature, determining a sepsis risk score for the patient, wherein in response to the end tidal NO concentration having a value lower than 4 ppb and a body temperature either lower than 96.8 deg F or greater than 100.4 deg F an elevated sepsis risk score is established that is indicative of the patient having or developing systemic sepsis.
The claims cover non-invasive determination of a sepsis risk score from end tidal nitric oxide (NO) in exhaled breath collected under a controlled rate of exhalation, using explicit end tidal NO thresholds to establish elevated sepsis risk, and treatment based on the score. The claims also include weighting by body temperature, a longitudinal changed-score determination, and a controlled sampling rate independent of inlet pressure.
Stated Advantages
Combining NO with body temperature improves discrimination to reduce unnecessary treatment.
Documented Applications
Non-invasively determining a sepsis risk score for a patient having or developing systemic sepsis and treating the patient based on the elevated sepsis risk score.
Determining improvement or worsening of a systemic sepsis condition based on a changed sepsis risk score, and treating based on the changed sepsis risk score.
Treating infection for a patient having an elevated sepsis risk score established based on end tidal NO and body temperature.
Interested in licensing this patent?