# US 10,245,437 B2 · System and method for providing noninvasive ventilation

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- Number: US 10,245,437 B2
- Document ID: US10245437B2
- Status: Granted
- Kind: B2
- Application number: 14/440,957
- Filed: 2013-11-10
- Published: 2015-10-22
- Granted: 2019-04-02
- 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/US10245437B2

## CPC

- A61N 1/39044: {in combination with cardiopulmonary resuscitation [CPR] therapy}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/0057: {Pumps therefor}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0683: {Holding devices therefor}
- A61M 16/08: Bellows; Connecting tubes {(having means for taking samples G01N1/22); Water traps; Patient circuits}
- A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation}
- A61N 1/3925: {Monitoring; Protecting}
- A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)}
- A61M 16/049: {Mouthpieces}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 2016/0015: {inhalation detectors}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2205/05: combined with other kinds of therapy
- A61M 2205/054: with electrotherapy
- A61M 2205/35: Communication
- 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 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/581: by audible feedback
- A61M 2205/583: by visual feedback
- A61M 2209/06: Packaging for specific medical equipment
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/40: Respiratory characteristics
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/50: Temperature
- A61N 1/3993: {User interfaces for automatic external defibrillators}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- 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)
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system that includes both an Airway and Ventilation device (AV) and an Automated External Defibrillator (AED) device is described. The system allows minimally trained persons to operate it in emergency situations involving respiratory failure and/or cardiac arrhythmias. An integral part of the AV of the system is a face mask manufactured in two parts: a face attachment unit configured to attach to the patient's face and a mask body that is releasably connected to the face attachment unit by a quick release mechanism allowing quick removal of the mask body from the face attachment unit, leaving only the face attachment unit attached to the patients' face, in order to address urgencies such as vomiting. After vomiting ceases and is cleared, then the mask body may be reattached to continue ventilation.

## 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, said system comprising:
A) an Airway and Ventilation device (AV) comprising:
i) a face mask;
ii) at least one sensor adapted to monitor vital signs (VS);
iii) a pressurized oxygen source configured to provide a flow of oxygen via said face mask and an airway to a patient and to adjust the oxygen flow on the basis of said 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 said patient and are configured to both monitor ECG and to apply electrical shock to said 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 said system, to provide instructions to the operator, and to record ECG and VS data said data management unit comprising:
i) a processor;
ii) dedicated software; and
iii) memory units;
characterized in that the face mask comprises:
a) a face attachment unit configured to be attached and secured to the face of a patient by means of connectors that ensure a tight fitting of the face attachment unit to the face contours;
b) a mask body configured to be releasably connected to said face attachment unit by a quick release/attachment mechanism;
wherein said face mask body comprises:
i) a hollow tube that passes from the interior side to the exterior side of said face mask body and is configured to provide a mouth airway securing channel;
ii) a CO2 sensor configured to measure end tidal CO2 (ETCO2) in exhalations of said patient; and
iii) a ventilation tube connected to a portable ventilator configured to deliver air or oxygen to said patient and to remove exhaled air from said patient; and
wherein said quick release/attachment mechanism is configured to allow quick removal of said mask body from said face attachment unit, leaving only the face attachment unit attached by the connectors to the patients' face and leaving the mouth and nose of the patient exposed to the surroundings; and
additionally 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 AV additionally comprises at least one auxiliary ECG detector.

### Claim 3 (depends on 1)

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

### Claim 4 (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 5 (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 6 (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; said 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 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

The system of claim 1, wherein the proximal end of the hollow tube of the face mask is adapted to be connected to at least one of:
A) a catheter connected to a suction unit; and
B) an inhaler for administering a drug in a spray or aerosol form directly to the patient's mouth, said inhaler designed to have a closed body and to hermetically seal with said proximal end of said hollow tube in order to maintain the level of vacuum required for proper operation of said mask.

### 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 said 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.