# US 2019/0167931 A1 · System and method for providing non-invasive ventilation

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- Number: US 2019/0167931 A1
- Document ID: US20190167931A1
- Status: Published application
- Kind: A1
- Application number: 16/270,131
- Filed: 2019-02-07
- Published: 2019-06-06
- Earliest claimed: 2012-11-12
- Assignees: Inovytec Medical Solutions Ltd.
- Applicants: Inovytec Medical Solutions Ltd
- Inventors: Ehud KANTOR; Mark SHAHAR; Nir BARKAI
- Web page: https://patentgrep.com/patent/US20190167931A1

## CPC

- A61M 16/022: {Control means therefor}
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- A61B 5/349: Detecting specific parameters of the electrocardiograph cycle
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61H 31/004: {Heart stimulation}
- A61M 16/0605: {Means for improving the adaptation of the mask to the patient}
- A61M 16/1005: {with O2 features or with parameter measurement}
- A61N 1/39044: {in combination with cardiopulmonary resuscitation [CPR] therapy}
- A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)}
- A61M 16/00: Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators (iron lungs A61H31/02); Tracheal tubes
- A61M 16/049: {Mouthpieces}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 2016/0033: {electrical}
- A61M 2016/103: {the CO2 concentration}
- A61M 2205/05: combined with other kinds of therapy
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61N 1/3993: {User interfaces for automatic external defibrillators}
- 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)

## Abstract

Disclosed is a system that comprises both an Airway and Ventilation device (AV) and an Automated External Defibrillator (AED) device. The system is provided with means for assisting only minimally trained persons to operate it in emergency situations involving respiratory failure and/or cardiac arrhythmias.

## Claims

### Claim 1

A system configured to assist minimally trained persons to operate it to provide treatment in emergency situations involving respiratory failure and/or cardiac arrhythmias, the system comprising:
A. an Airway and Ventilation device (AV) comprising:
i) an invasive ventilation tube;
ii)) a CO2 sensor configured to measure end tidal CO2 (ETCO2) in exhalations of a patient;
iii) at least one sensor adapted to monitor vital signs (VS);
iv) a pressurized oxygen source configured to provide a flow of oxygen via the invasive ventilation tube and an airway to the patient and to adjust the oxygen flow on the basis of the monitored vital signs;
B. an Automated External Defibrillator (AED) device comprising one or more electrocardiogram (ECG) detectors that are adapted to be attached to the chest of the patient and are configured to both monitor ECG and to apply electrical shock to the patient via one or more chest pads;
C. a user interface for providing audible or visual instructions to an operator;
D. components that provide communication functionality;
E. a data management unit adapted to operate the system, to provide instructions to the operator, and to record ECG and VS data, the data management unit comprising:
i) a processor;
ii) dedicated software; and
iii) memory units;
the system characterized in that the processor and dedicated software are configured to determine when to apply electric shock according to evaluation of the state of ventilation, wherein the state of ventilation is evaluated according to the ETCO2 measured in each chest compression applied by the operator to the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the invasive ventilation tube is one of: an endotracheal tube or laryngeal mask airway.

### Claim 3 (depends on 1)

The system of claim 1, wherein the AV additionally comprises at least one auxiliary ECG detector.

### Claim 4 (depends on 1)

The system of claim 1, wherein the at least one sensor adapted to monitor vital signs is at least one of: a respiration sensor, a heart rate sensor, a temperature sensor, a blood pressure sensor, and a pulse oxymeter saturation sensor.

### Claim 5 (depends on 1)

The system of claim 1, wherein the AED is configured to assume control over the AV, if the ECG detectors detect ventricular fibrillation and pulseless ventricular tachycardia (VF/VT) in the patient.

### Claim 6 (depends on 1)

The system of claim 1, adapted to activate the AV and to deactivate the AED when at least one ECG detector does not detect ventricular fibrillation and pulseless ventricular tachycardia (VF/VT) in the patient.

### Claim 7 (depends on 1)

The system of claim 1, further comprising a compact housing adapted to package the AV and AED as well as other components; the housing further adapted to function as at least one of:
A. a carrying case for transporting the components of the system; and
B. an airway management system providing neck support for tilting the head and opening the airways.

### Claim 8 (depends on 1)

The system of claim 1, wherein the data management unit is located in one of: the AV, the AED, or a housing.

### Claim 9 (depends on 1)

The system of claim 1, wherein the data management unit is remotely located at an emergency or medical center.

### Claim 10 (depends on 1)

The system of claim 1, additionally comprising at least one of: video cameras, suction units, and a location tracking unit.

### Claim 11 (depends on 10)

The system of claim 10, comprising at least one designated inhaler containing drugs to be administered to a patient, wherein the at least one designated inhaler is stored in a locked compartment which is only capable of being opened by a staff member in an emergency/medical center.

### Claim 12 (depends on 1)

The system of claim 1, wherein the state of ventilation is additionally evaluated according to at least one of: the number of effective chest compressions provided and the rhythm that the chest compressions were applied.