# US 12,214,130 B2 · Systems and methods for assisting patient airway management

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- Number: US 12,214,130 B2
- Document ID: US12214130B2
- Status: Granted
- Kind: B2
- Application number: 18/405,319
- Filed: 2024-01-05
- Published: 2024-09-05
- Granted: 2025-02-04
- Earliest claimed: 2018-01-17
- Assignees: ZOLL Medical Corporation
- Applicants: ZOLL Medical Corporation
- Inventors: Annemarie E Silver; Gary A Freeman; George Beck; Guy R Johnson; Ulrich R Herken; Wayne F Stanley; Shin-Luen Chai
- Web page: https://patentgrep.com/patent/US12214130B2

## CPC

- A61M 16/0488: {Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02)}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/7435: {Displaying user selection data, e.g. icons in a graphical user interface}
- A61H 31/00: Artificial respiration by a force applied to the chest; Heart stimulation, e.g. heart massage (applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers, A61N1/36 {; teaching or training models, demonstration models for medical purposes G09B23/288})
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/0084: {self-reinflatable by elasticity, e.g. resuscitation squeeze bags}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0411: {with means for differentiating between oesophageal and tracheal intubation}
- A61N 1/3904: {External heart defibrillators [EHD]}
- A61N 1/3925: {Monitoring; Protecting}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/0833: {Measuring rate of oxygen consumption}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/087: Measuring breath flow
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/72: {Signal processing specially adapted for physiological signals or for diagnostic purposes}
- A61H 2201/5089: Gas sensors, e.g. for oxygen or CO2
- A61H 2230/04: Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
- A61H 2230/08: Other bio-electrical signals
- A61H 2230/40: Respiratory characteristics
- A61M 16/0051: {with alarm devices}
- A61M 2016/003: {with a flowmeter}
- A61M 2016/0413: {with detectors of CO2 in exhaled gases}
- A61M 2016/1025: {the O2 concentration}
- A61M 2016/103: {the CO2 concentration}
- A61M 2205/15: Detection of leaks
- A61M 2205/18: with alarm
- A61M 2205/3303: Using a biosensor
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/70: with testing or calibration facilities
- A61M 2205/702: automatically during use
- A61M 2210/1039: Lungs
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/435: partial O2 pressure (P-O2)
- A61M 2230/60: Muscle strain, i.e. measured on the user
- A61M 2230/63: Motion, e.g. physical activity
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A medical system for assisting with an intubation procedure for a patient. The system comprising airflow sensors configured to obtain data indicative of airflow in the patient's airway and physiological sensors configured to obtain information regarding airflow in the patient's lungs. The system further including a monitoring device communicatively coupled to the airflow sensors and the physiological sensors. The patient monitoring device comprising at least one processor coupled to memory and configured to: provide a user interface on a display and assist the rescuer in determining proper placement of an endotracheal tube, receive the data indicative of the airflow in the patient's airway, receive the physiological information regarding the airflow in the patient's lungs, and determine whether the tube is properly placed based on the received physiological information, and present an output of the determination of whether the ET tube was properly placed.

## Claims

### Claim 1

A medical system for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the system comprising:
one or more airflow sensors configured to obtain data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume;
one or more physiological sensors to obtain configured to obtain physiological information regarding airflow in the patient's lungs; and
a patient monitoring device communicatively coupled to the one or more airflow sensors, the patient monitoring device comprising:
a user interface comprising a display; and
at least one processor and memory configured to:
receive the data indicative of airflow in the patient's airway and the physiological information regarding airflow in the patient's lungs,
determine presence of airflow in the patient's airway based on the data indicative of airflow,
analyze the physiological information regarding airflow in the patient's lungs to provide an indication of ET tube placement,
determine that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume,
based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube, output to the display of the user interface an alert to check the ET tube in relation to the leak that may be present.

### Claim 2 (depends on 1)

The system of claim 1, wherein analyzing the expiratory tidal volume relative to the inspiratory tidal volume comprises determining whether the expiratory tidal volume and the inspiratory tidal volume are approximately equal.

### Claim 3 (depends on 1)

The system of claim 1, wherein analyzing the expiratory tidal volume relative to the inspiratory tidal volume comprises determining whether the expiratory tidal volume is significantly smaller than the inspiratory tidal volume.

### Claim 4 (depends on 1)

The system of claim 1, wherein the alert to check the ET tube in relation to the leak that may be present comprises mitigation instructions relating to the leak that may be present.

### Claim 5 (depends on 1)

The system of claim 1, wherein the one or more physiological sensors comprises at least one of: at least one capnography sensor, at least one impedance sensor, and at least one acoustic sensor.

### Claim 6 (depends on 1)

The system of claim 1, wherein the at least one processor is configured to compare one or more measured physiological parameters to one or more thresholds in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 7 (depends on 6)

The system of claim 6, wherein the at least one processor in configured to compare measured end-tidal carbon dioxide (ETCO2) to at least one threshold in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 8 (depends on 6)

The system of claim 6, wherein the at least one processor is configured to compare the one or more measured physiological parameters to at least one baseline associated with the one or more measured physiological parameters in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 9 (depends on 8)

The system of claim 8, wherein the at least one baseline is a continually updated dynamic baseline.

### Claim 10 (depends on 6)

The system of claim 6, wherein the at least one processor is configured to make determinations regarding, and use in the analysis of the physiological information regarding airflow in the patient's lungs, at least one of: falling outside of a range associated with at least one of the measured one or more physiological parameters, and falling within a range associated with at least one of the measured one or more physiological parameters.

### Claim 11 (depends on 7)

The system of claim 7, wherein the at least one processor is configured to compare the measured ETCO2 to at least one ETCO2 baseline in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 12 (depends on 9)

The system of claim 9, wherein the at least one processor is configured to determine and use deviation from the dynamic baseline in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 13 (depends on 1)

The system of claim 1, wherein the data indicative of airflow in the patient's airway comprises at least one of: inspiratory flow rate and expiratory flow rate.

### Claim 14 (depends on 1)

The system of claim 1, wherein the at least one processor is configured to:
determine that the ET tube may be dislodged, and
based on the determination that the ET tube may be dislodged, output to the display of the user interface an alert to check the ET tube for possible dislodgement.

### Claim 15 (depends on 1)

The system of claim 1, wherein the at least one processor is configured to:
determine that the ET tube may be misplaced, and
based on a determination that the ET tube may be misplaced, output to the display of the user interface an alert indicating possible ET tube misplacement.

### Claim 16 (depends on 15)

The system of claim 15, wherein the alert indicating possible ET tube misplacement indicates that the ET tube may be misplaced in the patient's esophagus.

### Claim 17

A method, executed by a processor of a patient monitoring device, the patient monitoring device comprising the processor and a memory, for assisting a rescuer with an intubation procedure with an endotracheal (ET) tube for a patient, the method comprising:
obtaining from one or more airflow sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, data indicative of airflow in the patient's airway and data indicative of inspiratory tidal volume and expiratory tidal volume;
obtaining from one or more physiological sensors coupled to the patient monitoring device, and storing in the memory of the patient monitoring device, physiological information regarding airflow in the patient's lungs;
determining presence of airflow in the patient's airway based on the data indicative of airflow in the patient's lungs;
analyzing the physiological information regarding airflow in the patient's lungs to provide an indication of ET tube placement;
determining that a leak may be present in relation to the ET tube based on an analysis of the expiratory tidal volume relative to the inspiratory tidal volume; and
outputting based on the indication of ET tube placement and the determination that the leak may be present in relation to the ET tube, to a display of a user interface of the patient monitoring device, an alert to check the ET tube in relation to the leak that may be present.

### Claim 18 (depends on 17)

The method of claim 17, wherein analyzing the expiratory tidal volume relative to the inspiratory tidal volume comprises determining whether the expiratory tidal volume and the inspiratory tidal volume are approximately equal.

### Claim 19 (depends on 17)

The method of claim 17, wherein analyzing the expiratory tidal volume relative to the inspiratory tidal volume comprises determining whether the expiratory tidal volume is significantly smaller than the inspiratory tidal volume.

### Claim 20 (depends on 17)

The method of claim 17, wherein the alert to check the ET tube in relation to the leak that may be present comprises mitigation instructions relating to the leak that may be present.

### Claim 21 (depends on 17)

The method of claim 17, comprising comparing one or more measured physiological parameters to one or more thresholds in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 22 (depends on 21)

The method of claim 21, comprising comparing measured end-tidal carbon dioxide (ETCO2) to at least one threshold in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 23 (depends on 21)

The method of claim 21, comprising comparing the one or more measured physiological parameters to at least one baseline associated with the one or more measured physiological parameters in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 24 (depends on 23)

The method of claim 23, wherein the at least one baseline is a continually updated dynamic baseline.

### Claim 25 (depends on 22)

The method of claim 22, comprising comparing the measured ETCO2 to at least one ETCO2 baseline in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 26 (depends on 24)

The method of claim 24, comprising determining and using deviation from the dynamic baseline in the analysis of the physiological information regarding airflow in the patient's lungs.

### Claim 27 (depends on 17)

The method of claim 17, comprising:
determining that the ET tube may be dislodged, and
based on the determination that the ET tube may be dislodged, outputting to the display of the user interface an alert to check the ET tube for possible dislodgement.

### Claim 28 (depends on 17)

The method of claim 17, comprising:
determining that the ET tube may be misplaced, and
based on a determination that the ET tube may be misplaced, outputting to the display of the user interface an alert indicating possible ET tube misplacement.

### Claim 29 (depends on 28)

The method of claim 28, wherein the alert indicating possible ET tube misplacement indicates that the ET tube may be misplaced in the patient's esophagus.