IP Library Granted Patent US 12,194,237
Granted Patent B2
US 12,194,237 · App. 17/201,684 · Granted Jan 14, 2025

Clinical decision support system for patient-ventilator asynchrony detection and management

Inventors: Behnood Gholami (Hoboken, NJ); Timothy S. Phan (Brooklyn, NY)
Assignee: Autonomous Healthcare, Inc.
A61M16/024A61M16/026G16H20/40G16H40/63G16H50/20A61M2016/0027A61M2016/0033A61M16/0057A61M2205/3379A61M2205/3561A61M2205/3584A61M2205/502A61M2205/52
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,194,237
App. No.
17/201,684
Granted
Jan 14, 2025
Kind
B2
Abstract

The present disclosure describes a system that automatically detects patient-ventilator asynchrony and trends in patient-ventilator asynchrony. The present disclosure describes a framework that uses pressure, flow, and volume waveforms to detect patient-ventilator asynchrony and the presence of secretions in the ventilator circuit.

Claims (44)

1. A method for indicating patient-ventilator interaction, comprising:

a) receiving ventilator pressure, flow, and/or volume waveform data relating to a ventilator;

b) extracting a first feature set from the ventilator pressure, flow, and/or volume waveform data;

c) determining whether at least one feature is absent from the first feature set, which absence by way of a first classifier and/or labeling algorithm indicates an irregular breath;

d) generating a patient-ventilator interaction indicator waveform comprising a Delta waveform from said ventilator pressure and flow waveform data, wherein the Delta waveform represents a difference between normalized pressure, after correcting for positive end expiratory pressure (PEEP), and normalized flow waveforms;

e) extracting a second feature set from the Delta waveform and/or the ventilator pressure, flow, and/or volume waveform data;

f) determining at least one class and/or label by a second classifier and/or second labeling algorithm based at least on the second feature set; and

g) determining a presence or absence of one or more types of asynchronous patient-ventilator interactions based at least on the at least one class and/or label.

2. The method of claim 1 , wherein the ventilator pressure, flow, and/or volume waveform data are obtained directly or indirectly from the ventilator, directly or indirectly from another monitor or system for acquiring ventilator pressure, flow and/or volume waveform data, or from an archive of in vivo, ex vivo, in vitro and/or in silico data.

3. The method of claim 1 , further comprising:

providing a prompt for managing one or more of the types of asynchronous patient-ventilator interactions, if present.

4. The method of claim 1 , wherein the first classifier and/or labeling algorithm is a rule-based algorithm and/or machine-learning algorithm configured to determine the absence of the at least one feature from the first feature set.

5. The method of claim 4 , wherein the first classifier and/or labeling algorithm is configured to compare the_at least one feature in the first feature set with a predetermined threshold and to determine the absence of the at least one feature by being below the predetermined threshold.

6. The method of claim 1 , wherein the second classifier and/or labeling algorithm is a rule-based algorithm and/or machine-learning algorithm configured to classify the Delta waveform and/or the ventilator pressure, flow, and/or volume waveform data into one or more categories of asynchronous patient-ventilator interactions.

7. The method of claim 6 , wherein the second classifier and/or second labeling algorithm classifies the Delta waveform and/or the ventilator pressure, flow, and/or volume waveform data into one or more categories of asynchronous patient-ventilator interactions by comparing at least one feature in the second feature set with a predetermined threshold.

8. The method of claim 1 , wherein the types of asynchronous patient-ventilator interactions are chosen from one or more of inadequate ventilator support, double triggering, ineffective triggering, premature termination, delayed termination, flow starvation, air trapping, buildup of fluid in lungs and/or a ventilator circuit, and/or no asynchrony.

9. The method of claim 1 , wherein the extracting of the first feature set comprises computing a measure of similarity between the ventilator pressure, flow, and/or volume waveform data and a reference waveform or a series of reference waveforms.

10. The method of claim 1 , wherein the extracting of the second feature set comprises extracting one or more of the following features:

depth of valleys of the Delta waveform;

maximum value of the Delta waveform within inspiration phase;

area under the curve of the Delta waveform within inspiration phase;

maximum cross-correlation of the Delta waveform with a delivered tidal volume waveform;

area under the portion of the Delta waveform occurring within approximately the first third of the Delta waveform duration;

maximum value of the Delta waveform occurring within approximately the first third of the Delta waveform duration; and

locations of valleys of the Delta waveform.

11. A system for detecting patient-ventilator interaction comprising:

a detection module comprising computer-executable instructions stored on a non-transitory computer-readable storage medium in operable communication with one or more computer processors, the detection module configured for acquiring mechanical ventilator airway pressure, flow, and/or volume waveform data; and

a patient-ventilator interaction indicator module in operable communication with the detection module, the patient-ventilator interaction indicator module comprising computer-executable instructions stored in a non-transitory computer-readable storage medium in operable communication with the one or more computer processors for:

a) extracting a first feature set from a ventilator pressure, flow, and/or volume waveform data;

b) determining whether at least one feature is absent from the first feature set, which absence by way of a first classifier and/or labeling algorithm indicates an irregular breath;

c) generating a patient-ventilator interaction indicator waveform comprising a Delta waveform from said ventilator pressure and flow waveform data, wherein the Delta waveform represents a difference between normalized pressure, after correcting for positive end expiratory pressure (PEEP), and normalized flow waveforms;

d) extracting a second feature set from the Delta waveform and/or the ventilator pressure, flow, and/or volume waveform data;

e) determining at least one class and/or label by a second classifier and/or second labeling algorithm based at least on the second feature set; and

f) determining the presence or absence of one or more types of asynchronous patient-ventilator interactions based at least on the at least one class and/or label.

12. The system of claim 11 , wherein the detection module is configured for acquiring a mechanical ventilator airway pressure, flow, and/or volume waveform data directly or indirectly from the mechanical ventilator, directly or indirectly from another monitor or system for producing the mechanical ventilator airway pressure, flow, and/or volume waveform data, or directly or indirectly from an archive of in vivo, ex vivo, in vitro and/or in silico data.

13. The system of claim 11 , wherein one or more of the computer processors is embedded in a mechanical ventilator, or another monitor or system or a networked computer system.

14. The system of claim 11 , wherein the patient-ventilator interaction module further generates an asynchrony index based on the types of asynchronous patient-ventilator interactions present or the absence thereof.

15. The system of claim 11 , further including a graphical user interface comprising:

at least one window for displaying detection of one or more asynchronous patient-ventilator interactions and/or irregular breaths;

one or more elements within the at least one window for communicating the detected asynchronous patient-ventilator interactions and/or the irregular breath, recommendations for mitigating the detected asynchronous patient-ventilator interactions, educational information on the detected asynchronous patient-ventilator interactions, and/or communicating an asynchrony index.

16. The system of claim 11 , further including a transmission module to transmit the determined and indicated types of asynchronous patient-ventilator interactions or absence thereof or the presence of the irregular breath to a remote server and/or smartphone and/or tablet.

17. The system of claim 16 , wherein the patient-ventilator interaction indicator module further generates an asynchrony index based on the types of asynchronous patient-ventilator interactions present or the absence thereof and the transmission module transmits a notification to a user when the asynchrony index exceeds a pre-determined threshold.

18. The system of claim 11 , wherein the first classifier and/or first labeling algorithm is a rule-based algorithm and/or machine-learning algorithm configured to determine the absence of the at least one feature from the first feature set and/or configured to compare the at least one feature in the first feature set with a predetermined threshold and to determine the absence of the at least one feature by being below the predetermined threshold.

19. The system of claim 11 , wherein the second classifier and/or second labeling algorithm is a rule-based algorithm and/or machine-learning algorithm configured to classify the Delta waveform and/or the ventilator pressure, flow, and/or volume waveform data into one or more categories of asynchronous patient-ventilator interactions.

Assignments (2)
CONFIRMATORY LICENSE Recorded Apr 2, 2025
From: AUTONOMOUS HEALTHCARE, INC.
To: NATIONAL SCIENCE FOUNDATION
Reel/Frame 070705/0592 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 8, 2024
From: GHOLAMI, BEHNOOD; PHAN, TIMOTHY S.
To: AUTONOMOUS HEALTHCARE, INC.
Reel/Frame 068834/0619 →
Continuity (4)
Continuation 17014778 · Sep 8, 2020
Continuation 16762224
Provisional Application 62583558 · Nov 9, 2017
Related Publication 20210220587A1 · Jul 22, 2021
References Cited (101)
US 7212850B2 · Prystowsky et al. · 2007 [cited by applicant]
US 7907996B2 · Prystowsky et al. · 2011 [cited by applicant]
US 8573207B2 · Gutierrez · 2013 [cited by applicant]
US 8920333B2 · Younes · 2014 [cited by applicant]
US 9027552B2 · Angelico et al. · 2015 [cited by applicant]
US 9392964B2 · Mulqueeny et al. · 2016 [cited by applicant]
US 10874811B2 · Gholami et al. · 2020 [cited by applicant]
US 11000656B2 · Gholami et al. · 2021 [cited by applicant]
US 20080110461A1 · Mulqueeny · 2008 [cited by examiner]
US 20090107502A1 · Younes · 2009 [cited by applicant]
US 20110297155A1 · Shelly · 2011 [cited by examiner]
US 20120167885A1 · Masic et al. · 2012 [cited by applicant]
US 20140012150A1 · Milne et al. · 2014 [cited by applicant]
US 20140034054A1 · Angelico et al. · 2014 [cited by applicant]
US 20140053840A1 · Liu · 2014 [cited by applicant]
US 20140060539A1 · Korten · 2014 [cited by applicant]
US 20140276173A1 · Banner et al. · 2014 [cited by applicant]
US 20150013674A1 · Doyle et al. · 2015 [cited by applicant]
US 20150090258A1 · Milne et al. · 2015 [cited by applicant]
US 20160279361A1 · Mulqueeny · 2016 [cited by examiner]
US 20180304034A1 · Vicario · 2018 [cited by examiner]
US 20180317808A1 · Wang et al. · 2018 [cited by applicant]
US 20190371460A1 · Gutierrez · 2019 [cited by applicant]
US 20200054520A1 · Johnson · 2020 [cited by examiner]
US 20200261674A1 · Gholami et al. · 2020 [cited by applicant]
US 20200405987A1 · Gholami et al. · 2020 [cited by applicant]
US 20210205558A1 · Vicario · 2021 [cited by examiner]
AU 2018366291B2 · 2020 [cited by applicant]
EP 3308819A1 · 2018 [cited by applicant]
WO 2017068464A1 · 2017 [cited by applicant]
WO 2017140500A1 · 2017 [cited by applicant]
WO 2019094736A1 · 2019 [cited by applicant]
(Gholami, Behnood et al.) Co-pending U.S. Appl. No. 16/762,224, filed May 7, 2020, Specification, Claims, and Figures. [cited by applicant]
(Gholami, Behnood et al.) Co-pending U.S. Appl. No. 17/014,778, filed Sep. 8, 2020, Specification, Claims, Figures. [cited by applicant]
(Gholami, Behnood et al.) Co-pending Australian Application No. 2018366291, filed May 22, 2020, Specification, Claims, Figures, 66 pages. [cited by applicant]
(Gholami, Behnood et al.) Co-pending European Application No. 18876990.5, filed Jun. 3, 2020, Specification (see PCT/US18/60056) and Claims. [cited by applicant]
(Gholami, Behnood et al.) Co-pending International Application No. PCT/US18/60056, filed Nov. 9, 2018, Specification, Claims, Figures. [cited by applicant]
Autonomous Healthcare Announces Successful Completion of a Validation Study for Its Automated Patient-Ventilator Asynchrony Detection Technology, Dec. 18, 2019, Cision PR Newswire. [cited by applicant]
Blanch, Lluis, et al. “Asynchronies during mechanical ventilation are associated with mortality.” Intensive care medicine 41.4 (2015): 633-641. [cited by applicant]
Blanch, Lluis, et al. “Validation of the Better Care® system to detect ineffective efforts during expiration in mechanically ventilated patients: a pilot study.” Intensive care medicine 38.5 (2012): 772-780. [cited by applicant]
Breiman, Leo “Random Forests.” Statistics Department, University of California, Jan. 2001, 33 pages. [cited by applicant]
Breiman, Leo. “Random Forests.” Machine Learning, 45, 5-32, 2001. [cited by applicant]
Carlucci, Annalisa et al. “Patient-ventilator asynchronies: may the respiratory mechanics play a role?” Critical Care, 2013, 17:R54, 8 pages. [cited by applicant]
Chang, Lan, Pau-Choo Chung, and Chang Wen Chen. “Combining Neural Network and Wavelet Transform for Trigger Asynchrony Detection.” CIBCB. 2007. [cited by applicant]
Chanques, Gerald, et al. “Impact of ventilator adjustment and sedation—analgesia practices on severe asynchrony in patients ventilated in assist-control mode.” Critical care medicine 41.9 (2013): 2177-2187. [cited by applicant]
Chao, David C., David J. Scheinhorn, and Meg Stearn-Hassenpflug. “Patient-ventilator trigger asynchrony in prolonged mechanical ventilation.” Chest 112.6 (1997): 1592-1599. [cited by applicant]
Chen, Chang-Wen, et al. “Detecting ineffective triggering in the expiratory phase in mechanically ventilated patients based on airway flow and pressure deflection: feasibility of using a computer algorithm.” Critical ca… [cited by applicant]
Cohen, Jacob “A Coefficient of Agreement for Nominal Scales.” Educational and Psychological Measurement, vol. XX, No. 1, 1960, 37-46. [cited by applicant]
Colombo, Davide, et al. “Efficacy of ventilator waveforms observation in detecting patient—ventilator asynchrony.” Critical care medicine 39.11 (2011): 2452-2457. [cited by applicant]
Colombo, Davide, et al. “Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure.” Intensive care medicine 34.11 (2008): 2010. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Final Office Action, dated Oct. 30, 2020, 10 pages. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Non-Final Office Action, dated Jul. 27, 2020, 17 pages. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Notice of Allowance, dated Nov. 16, 2020, 7 pages. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Preliminary Amendment, filed May 7, 2020, 10 pages. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Response to Final Office Action filed Nov. 9, 2020, 8 pages. [cited by applicant]
Co-pending U.S. Appl. No. 16/762,224, Response to Non-Final Office Action filed Oct. 13, 2020, 13 pages. [cited by applicant]
Co-pending U.S. Appl. No. 17/014,778, file history through Apr. 2021, 44 pages. [cited by applicant]
Co-pending Australian Application No. 2018366291, Claims as Accepted, dated Jul. 31, 2020, 4 pages. [cited by applicant]
Co-pending Australian Application No. 2018366291, Examination Report No. 1, dated Jul. 23, 2020, 8 pages. [cited by applicant]
Co-pending Australian Application No. 2018366291, Notice of Acceptance, dated Aug. 20, 2020, 3 pages. [cited by applicant]
Co-pending Australian Application No. 2018366291, Response to Examination Report No. 1, filed Jul. 31, 2020, 76 pages. [cited by applicant]
Co-pending European Application No. 18876990.5, Amended Claims, filed Jun. 3, 2020, 4 pages. [cited by applicant]
Co-pending European Application No. 18876990.5, Communication under Rule 71(3) EPC dated May 2, 2023 and Documents Intended for Grant, 64 pages. [cited by applicant]
Co-pending European Application No. 18876990.5, Extended European Search Report, dated Jul. 15, 2021, 11 pages. [cited by applicant]
Co-pending European Application No. 18876990.5, Response to Communication pursuant to Rules 70(2) and 70a(2) EPC dated Aug. 3, 2021, filed Feb. 10, 2022, 69 pages. [cited by applicant]
Co-pending International Application No. PCT/US18/60056, Invitation to Pay Additional Fees dated Jan. 25, 2019, 3 pages. [cited by applicant]
Co-pending International Application No. PCT/US18/60056, Search Report and Written Opinion, Mar. 21, 2019, 11 pages. [cited by applicant]
De Haro, Candelaria, et al. “Patient-ventilator asynchronies during mechanical ventilation: current knowledge and research priorities.” Intensive care medicine experimental 7.1 (2019): 43. [cited by applicant]
De Wit, Marjolein et al. “Observational study of patient-ventilator asynchrony and relationship to sedation level.” Journal of Critical Care (2009) 24, 74-80. [cited by applicant]
De Wit, Marjolein, et al. “Ineffective triggering predicts increased duration of mechanical ventilation.” Critical care medicine 37.10 (2009): 2740-2745. [cited by applicant]
De Wit, Marjolein. “Monitoring of patient-ventilator interaction at the bedside.” Respiratory care 56.1 (2011): 61-72. [cited by applicant]
Dres, M., Rittayami, N., Brochard, L., Monitoring patient—ventilator asynchrony, Curr. Opin. Crit. Care 22 (2016) 246-253. [cited by applicant]
Epstein, Scott K. “How Often Does Patient-Ventilator Asynchrony Occur and What are the Consequences?” Respiratory Care, Jan. 2011, vol. 56, No. 1, 25-38. [cited by applicant]
Garg, Amit X. et al. “Effects of Computerized Clinical Decision Support Systems on Practitioner Performance and Patient Outcomes: a Systematic Review.” Journal of the American Medical Association, Mar. 9, 2005, vol. 293… [cited by applicant]
Gholami et al. “Replicating human expertise of mechanical ventilation waveform analysis in detecting patient-ventilator cycling asynchrony using machine learning.” Computers in Biology and Medicine, vol. 97, 2018, pp. 1… [cited by applicant]
Gholami, Behnood et al., “Replicating human expertise of mechanical ventilation waveform analysis in detecting patient-ventilator cycling asynchrony using machine learning,” Computers in Biology and Medicine 97 (2018) 1… [cited by applicant]
Girard, Timothy D. et al. “Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised control… [cited by applicant]
Guglielminotti, Jean et al. “Bedside Detection of Retained Tracheobronchial Secretions in Patients Receiving Mechanical Ventilation.” Chest, 118, 4, Oct. 2000, 1095-1099. [cited by applicant]
Gutierrez, Guillermo, et al. “Automatic detection of patient-ventilator asynchrony by spectral analysis of airway flow.” Critical Care 15.4 (2011): R167. [cited by applicant]
Haddad, Wassim M., et al. “Clinical decision support and closed-loop control for intensive care unit sedation.” Asian Journal of Control 15.2 (2013): 317-339. [cited by applicant]
Horng, Steven et al. “Creating an automated trigger for sepsis clinical decision support at emergency department triage using machine learning.” PLOS ONE, Apr. 6, 2017, 1-16. [cited by applicant]
Hunt, DL et al. “Effects of computer-based clinical decision support systems on physician performance and patient outcomes: a systematic review.” Journal of the American Medical Association, Oct. 21, 1998; 280(15):1339-… [cited by applicant]
Jubran, Amal et al. “Use of Flow-Volume Curves in Detecting Secretions in Ventilator-dependent Patients.” Am J Respir Crit Care Med vol. 150, pp. 766-769, 1994. [cited by applicant]
Kondili, Eumorfia, et al. “Identifying and relieving asynchrony during mechanical ventilation.” Expert review of respiratory medicine 3.3 (2009): 231-243. [cited by applicant]
Kress, John P. et al. “Daily Interruption of Sedative Infusions in Critically III Patients Undergoing Mechanical Ventilation.” The New England Journal of Medicine, vol. 342, No. 20, May 18, 2000, 1471-1477. [cited by applicant]
Landis, J. Richard et al. “The Measurement of Observer Agreement for Categorical Data.” Biometrics, Mar. 1977, 33, 159-174. [cited by applicant]
Leclerc, F. et al. “Use of the flow-volume loop to detect secretions in ventilated children.” Intensive Care Medicine, 22, 88 (1995). [cited by applicant]
Li, Hancao, and Wassim M. Haddad. “Optimal determination of respiratory airflow patterns using a nonlinear multicompartment model for a lung mechanics system.” Computational and mathematical methods in medicine 2012 (20… [cited by applicant]
Mellott, Karen G. et al. “Patient-Ventilator Dyssynchrony Clinical Significance and Implications for Practice.” Critical Care Nurse, vol. 29, No. 6, Dec. 2009, 41-55. [cited by applicant]
Mulqueeny, Qestra, et al. “Automated detection of asynchrony in patient-ventilator interaction.” 2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 2009. [cited by applicant]
Nilsestuen, Jon O. et al. “Using Ventilator Graphics to Identify Patient-Ventilator Asynchrony.” Respiratory Care, Feb. 2005, vol. 50, No. 2, 202-234. [cited by applicant]
Phan, Timothy S., et al. “Validation of an automated system for detecting ineffective triggering asynchronies during mechanical ventilation: a retrospective study.” Journal of Clinical Monitoring and Computing (2019): 1… [cited by applicant]
Reade, Michael C. et al. “Sedation and Delirium in the Intensive Care Unit.” The New England Journal of Medicine, 2014, 370:444-454. [cited by applicant]
Robinson, Bryce R.H. et al. “Patient-Ventilator Asynchrony in a Traumatically Injured Population.” Respiratory Care, Nov. 2013, vol. 58, No. 11, 1847-1855. [cited by applicant]
Schweickert, William D. et al. “Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial.” Lancet, 2009, 373:1874-1882. [cited by applicant]
Thille, Arnaud W., et al. “Patient-ventilator asynchrony during assisted mechanical ventilation.” Intensive care medicine 32.10 (2006): 1515-1522. [cited by applicant]
Vicario, Francesco et al. “Noninvasive Estimation of Respiratory Mechanics in Spontaneously Breathing Ventilated Patients: a Constrained Optimization Approach.” IEEE Transactions on Biomedical Engineering, vol. 63, No. … [cited by applicant]
Vignaux, Laurence et al. “Patient-ventilatory asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study.” Intensive Care Med (2009) 35:840-846. [cited by applicant]
Vignaux, Lawrence et al. “Performance of noninvasive ventilation algorithms on ICU ventilators during pressure support: a clinical study.” Intensive Care Med (2010) 36:2053-2059. [cited by applicant]
Wyner, Abraham J., et al. “Explaining the success of adaboost and random forests as interpolating classifiers.” The Journal of Machine Learning Research 18.1 (2017): 1558-1590. [cited by applicant]
Younes, Magdy, et al. “A method for monitoring and improving patient: ventilator interaction.” Intensive care medicine 33.8 (2007): 1337-1346. [cited by applicant]