WO2025032573A1

WO2025032573A1 - Automatic ventilation device

Info

Publication number: WO2025032573A1
Application number: PCT/IL2024/050762
Authority: WO
Inventors: Isaac SHPIRER
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-08-06
Filing date: 2024-08-01
Publication date: 2025-02-13
Anticipated expiration: 2026-02-06
Also published as: IL305249B2; IL305249A; IL305249B1

Abstract

According to a first aspect there is provided a portable emergency automatic ventilation device for use by untrained personnel, configured for CPR, relief of respiratory distress of a patient, and both, comprising: a blower/compressor connectable to a patient ventilation tube; a control unit comprising executable programs for regulating airflow and pressure; at least one air flow sensor for detecting inspiration and expiration; and, at least one pressure sensor for detecting pressure; wherein the compressor is programmable to deliver biphasic positive airway pressure (BiPAP) at a first inspiratory positive airway pressure (IPAP) and a second expiratory positive airway pressure, (EPAP), and the control unit comprises a manual selector for switching between the executable programs selected from predetermined CPR operative program instructing T mode ventilation and a respiratory distress operative program providing an S/T mode ventilation. A ventilation kit for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both, and methods of using thereof, are also provided.

Description

AUTOMATIC VENTILATION DEVICE

CROSS REFERENCE TO RELATED APPLICATIONS

[001] This application takes priority from provisional application for patent Ser. No. 63/530,983 filed on Aug. 6, 2023 entitled “AUTOMATIC VENTILATION DEVICE” and is incorporated as if fully set forth herein.

FIELD OF THE INVENTION

[002] The present invention is in the field of automatic ventilation devices, in particular ventilation devices for use in cardiopulmonary resuscitation (CPR) and respiratory distress.

BACKGROUND OF THE INVENTION

[003] Every year, approximately 10,000 people in Israel experience cardiac and respiratory arrest incidents outside hospitals, while about 300,000 people in the US face these situations. Unfortunately, only a mere 4% of these cases end in survival. The low survival rate can be attributed to improper cardiopulmonary resuscitation (CPR) techniques, primarily due to a lack of knowledge, difficulties with ventilation, and reluctance to perform mouth-to-mouth resuscitation.

[004] During the first 4 minutes of a respiratory arrest, the blood's oxygen saturation remains above 90%. After this critical window, it declines rapidly, leading to significant damage to all tissues, especially the brain. Complicating matters further, medical teams typically take more than 10 minutes to arrive at the scene.

[005] The key components of CPR involve chest compressions, rescue breathing, and defibrillation. The recommended chest compressions rate is between 100 and 120 compressions per minute. According to the current guidelines of the American Heart Association (AHA), professional healthcare provider should provide conventional CPR, involving a combination of chest compressions and rescue breaths, at a ratio of 30:2 compressions-to-breaths. For the general public or bystanders who witness an adult suddenly collapse, compression-only CPR, or Hands-Only CPR, are suggested, as these are preferred compared to no intervention at all.

[006] Nevertheless, adequate respiration during CPR plays a pivotal role in maintaining oxygenation, preventing brain damage, and increasing the chances of a successful resuscitation.

[007] When no oxygen is delivered during the first moments of resuscitation, the body enters a state of hypoxia, that may lead to irreversible brain damage, dysfunction of vital organs including the heart, liver, and kidneys, cardiac arrest persistence, and even comma or brain death. Therefore, the prompt initiation of CPR, including rescue breaths if applicable, within the first 4 minutes of the incident, is vital.

[008] US7980244B2 discloses an automatic emergency pulmonary resuscitation device that provides emergency breathing for use in techniques such as CPR. The ventilation device comprises a compressible bag allowing the artificial breathing similarly to an ambu or bag-valve-mask (BVM). However, proper and effective use of an ambu is known to require training and practice. Moreover, improper use of the ambu can lead to the unintentional delivery of air into the stomach instead of the lungs, known as gastric insufflation, or to barotrauma, i.e., damage caused by high-pressure ventilation, which can result in lung injuries, pneumothorax (collapsed lung), or other complications.

[009] CA2486993A1 discloses an automatic ventilator for CPR comprising: an automatic ventilating circuit adapted for delivering two cycles of positive pressure breathable gas flow ventilation. However, this ventilator transfers a fixed tidal volume of air; 0.5 Liter per cycle, which may lead to certain potential risks, including: inadequate ventilation, barotrauma, and hyperventilation which can lead to reduced cerebral blood flow, respiratory alkalosis, and other potential adverse effects on patient outcomes. Moreover, the ventilator disclosed in CA2486993A1 is not compatible to children or infants, known to have reduced tidal volume compared to adults.

[010] There is an unmet need for new automatic ventilation devices that allow the breathing of a patient in CPR, by a non-professional care-giver, until the emergency team arrives.

SUMMARY OF THE INVENTION

[Oi l] According to a first aspect there is provided a portable emergency automatic ventilation device for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both, comprising: (a) device portion of a device-patient breathing circuit comprising a blower/compressor connectable to a patient ventilation tube (2); (b) a control unit (12) comprising executable programs for regulating airflow and pressure in the patient-device breathing circuit; (c) at least one air flow sensor for detecting inspiration and expiration in said breathing circuit; and, (d) at least one pressure sensor for detecting pressure in said breathing circuit; the compressor is programmable to deliver biphasic positive airway pressure (BiPAP) at a first inspiratory positive airway pressure (IPAP) and a second expiratory positive airway pressure, (EPAP), in said breathing circuit, wherein the control unit comprises a manual selector for switching between the executable programs selected from a predetermined CPR operative program and a respiratory distress operative program, the respiratory distress operative program instructs an S/T mode ventilation triggered by patient's inspiratory effort, and the CPR operative program instructs immediately IPAP delivery followed by constant IPAP/EPAP cycles, and if the air flow sensor detects spontaneous breathing in the CPR operative program, the CPR operative program instructs IPAP/EPAP cycles triggered by patient's inspiratory effort.

[012] In some embodiments, the control unit comprises a manual selector configured for switching between a predetermined infant program, a predetermined child program and a predetermined adult program, providing IPAP and EPAP that are compatible to the infant program, the child program and the adult program.

[013] In some embodiments, the IPAP compatible to an infant is in the range of about 8 to about 20 cm H2O, and the EPAP compatible to an infant is in the range of about 4 to about 10 cm H2O, the IPAP compatible to a child is in the range of about 10 to about 25 cm H2O and the EPAP compatible to a child is in the range of about 5 to about 12 cm H2O; and, the IPAP compatible to an adult is in the range of about 10 to about 30 cm H2O and the EPAP compatible to an adult is in the range of about 5 to about 12 cm H2O.

[014] In some embodiments, the IPAP compatible to an adult is about 15 cm H2O, and the EPAP compatible to an adult is about 5 cm H2O.

[015] In some embodiments, the IPAP compatible to an infant is about 8 cm H2O, and the EPAP compatible to an infant is about 4 cm H2O.

[016] In some embodiments, the IPAP compatible to a child is about 12 cm H2O, and the EPAP compatible to a child is about 5 cm H2O.

[017] In some embodiments, the T mode ventilation comprises a constant breathing rate in the range of 10 to 12 breath per minute.

[018] In some embodiments, the ratio between inspiration time and the expiration time (EE ratio) is 1:5.

[019] In some embodiments, the inspiration time is about 1 second, and the expiration time is about 5 seconds.

[020] In some embodiments, the executable programs of the control unit calculate expiratory tidal volume based on measurements of the at least one flow sensor, and the display interface (12) exhibits the expiratory tidal volume. [021] In some embodiments, the display interface (12) comprises a visual and/or an audible notification of air leakage, the notification is present when the measurement of the at least one flow sensor, the at least one pressure sensor, or both, is below a predetermined threshold.

[022] In some embodiments, the control unit further comprises a wired or wireless electrical communication with a pulse oximeter sensor detecting blood oxygen saturation (SpO2), and the display interface (12) displays the blood oxygen saturation.

[023] In some embodiments, the control unit further comprises a wired or wireless electrical communication with CPR feedback sensor placed on the chest of the patient, and the display interface (12) displays at least one chest compression parameter selected from the group consisting of: compression rate (cpm), compression depth (mm), and compression release (g).

[024] In some embodiments, the portable emergency automatic ventilation device further comprising two-way audio communication, speaker and microphone, to connect with an emergency center, enabling remote assistance from the emergency center.

[025] According to another aspect, there is provided a ventilation kit for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both, comprising: (a) the portable emergency automatic ventilation device (1) disclosed herein; (b) a mask connector (3) comprising an oxygen input connector (14) and an exhalation hole (13); (c) a ventilation tube (2) configured for connecting between the ventilation device (1) and the mask connector (3); (d) an oxygen cylinder (4) and an oxygen tube (10); (e) a mask (5); (f) an airway device (6); (g) a CPR pillow (7); and (h) a CPR feedback device (8).

[026] According to another aspect, there is provided a method for performing CPR, or assisting respiratory distress of a patient, by untrained personnel, the method comprising: (a) call for emergency medical help immediately; (b) obtain the ventilation kit of claim 15 from the nearest ventilation station; (c) choose the appropriate infant/child/adult program; (d) assess the patient's breathing; the patient exhibits a respiratory distress symptom, choose the respiratory distress program, the patient is not breathing, choose the CPR program; (e) turn on the automatic ventilation device (1); (f) optionally, place the CPR feedback device (8) on the patient chest; (g) start chest compressions in a rate of between 100 and 120 compressions/minute, with or without defibrillation, according to a guidance protocol or instructions provided by the medical help center; (h) position the CPR pillow (7) to assist in airway opening; optionally, insert the airway device (6); (i) place the mask (5) over the patient's mouth, nose, or both, ensuring a proper seal; connect the mask connector (3), pre-connected to the ventilation tube (2), to the mask (5), optionally, connect the oxygen tube (10), preconnected to the oxygen cylinder (4) to the oxygen input connector (14) in the mask connector (3); (j) allow the automatic ventilation device to provide ventilations; don’t stop providing compressions during the ventilations; if CPR feedback device was placed on the patient chest, track chest compression parameters on the display interface (11); (k) optionally, connect the pulse oximeter sensor to the patient's finger and track oxygen saturation value on the display interface (11); and (1) continue step (g) until emergency medical responders arrive, make sure that there is no air leakage notification; optionally, report the tidal volume value to the emergency medical help.

[027] In some embodiments, the kit disclosed herein further comprises instructions for use thereof, in CPR, or assisting respiratory distress of a patient, by untrained personnel, setting forth the method disclosed herein.

[028] Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[029] Further embodiments and the full scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[030] The presently disclosed subject matter may be more clearly understood upon reading of the following detailed description embodiments of non-limiting exemplary embodiments thereof, with reference to the drawings.

[031] The following detailed description of embodiments of the presently disclosed subject matter refers to accompanying drawings. Dimensions of components and features shown in figures are chosen for convenience or clarity of presentation sand are not necessarily shown to scale. Wherever possible, the same reference numbers will be used throughout the drawings and the following description to refer to the same and like parts.

[032] Fig. 1 illustrates a scheme of CPR by an untrained user using a ventilation kit, comprising: a portable emergency ventilation device operating with bilevel positive airway pressure (BiPAP) (1); a ventilation tube (2); connecting between the ventilation device (1) and a mask connector (3); an oxygen cylinder (4); a mask (5); an airway device (6); a CPR pillow (7); a CPR feedback device (8), a power battery (9); and, an oxygen tube (10), delivering oxygen enriched airflow via the mask connector.

[033] Fig. 2 illustrates the outer interface of the portable ventilation device (1) comprising a display interface (11) and a control unit interface (12). The control unit (12) comprises manual selections, allowing the untrained user to choose a compatible program according to the patient age (infant/child/adult), and the medical condition required (CPR/respiratory distress). The display interface (11) indicates real-time expiratory tidal volume value, and the air leak in the breathing circuit, that are detected, by a flow sensor, a pressure sensor, or both. The display interface (11) may further comprise real-time data on blood oxygen saturation, and chest compressions parameters, received by a pulse oximeter sensor and a CPR feedback sensor, respectively.

[034] Fig. 3 illustrates the mask connector (3), configured for connecting the ventilation tube (2), the oxygen tube (10) and the mask (5), comprising an oxygen input connector (14) and an exhalation hole (13).

[035] Fig. 4 illustrates an emergency ventilation station, configured for being placed in a public place, comprising a portable housing or bag comprising the ventilation kit (16) and the oxygen cylinder (4).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[036] A recent randomized controlled study examined the efficiency of CPR by professional caregivers in the hospital's resuscitation room and compared between three ventilation methodologies: bilevel non-invasive positive airway pressure (BiPAP) with assisted spontaneous breathing, continuous positive airway pressure (CPAP) and volume-controlled ventilation (VCV). Outcomes were tidal volume, respiratory minute volume, and end-tidal CO2 during the study period. Results demonstrated that among the examined methodologies, BiPAP was superior due to the higher tidal volume (Fuest K et al., "Comparison of volume- controlled, pressure-controlled, and chest compression-induced ventilation during cardiopulmonary resuscitation with an automated mechanical chest compression device: A randomized clinical pilot study. Resuscitation. 2021; 166:85-92, herein incorporated by reference in its entirety).

Emergency Ventilation Device

[037] The current invention, in some embodiments, discloses a portable automatic ventilation device (1) for use by a non-professional, or untrained care-giver, configured for cardiopulmonary resuscitation (CPR), relief of respiratory distress, or both, of a patient, wherein the ventilation applied by the device is based on the non-invasive bilevel positive airway pressure (BiPAP) principle.

[038] The term "portable" refers to a light weighted mobile device that can be easily moved from place to place by a single user. In some embodiments, the portable device disclosed herein weights less than 10 kg. In some embodiments, the portable device weights less than 5 kg.

[039] As used herein, the terms "bilevel positive airway pressure", "biphasic positive airway pressure", and "BiPAP" are interchangeable, and refer to delivering controlled breathing assistance to a subject at two different pressure levels; "an inspiratory positive airway pressure (IPAP)" and an "expiratory positive airway pressure (EPAP)".

[040] IPAP is the pressure support applied during inspiration, whereas EPAP is the pressure support applied during expiration.

[041] The flow diagram of a BiPAP device is known in the art, and is based on several modifications to the positive end-expiratory pressure (PEEP, CPAP) system, that applies a single pressure during both inspiration and expiration phases (Hermann C, Baum M, Putensen C, Mutz NJ, Benzer H. "Biphasic positive airway pressure (BiPAP) - a new mode of ventilatory support". Eur J Anaesthesiol". 1994; 11:37-42, herein incorporated by reference in its entirety).

[042] A BiPAP device is known to comprise an inspiratory limb of a CPAP device, and an expiratory limb comprising a pneumatically controlled membrane valve, controlled by a magnetic valve switching between the two independently adjustable pressures, IPAP and EPAP. The magnetic valve is operated by a control unit, controlling the duration of the IPAP and the EPAP.

[043] In some embodiments, the patient is any human subject who has become unconscious and is found to be pulseless. In some embodiments, the patient suffers from cardiac and/or respiratory arrest. In some embodiments, the patient exhibits respiratory distress. In some embodiments, the ventilation device is for use by an untrained or minimal trained care-giver. In some embodiments, the ventilation device is for use by a first responder to the emergency medical event, prior ambulance professional team arrival. In some embodiments, the ventilation device disclosed herein is for use in CPR performed out of the hospital.

[044] In some embodiments, the automatic ventilation device (1) comprises: (a) device portion of a device-patient breathing circuit comprising a blower/compressor connectable to a patient ventilation tube (2); (b) a control unit comprising executable programs for regulating airflow and pressure in the patient - device breathing circuit; (c) at least one air flow sensor for detecting inspiration and expiration in the breathing circuit; and, (d) at least one pressure sensor for detecting pressure in the breathing circuit.

[045] BiPAP devices can provide different pressures during inspiration and expiration; a higher- pressure during inspiration and a lower pressure during expiration. EPAP serves to maintain end-expiratory lung volume and airway patency. "End-expiratory lung volume (EELV)" refers to the amount of air that remains in the lungs at the end of a normal exhalation, also known as the end of tidal expiration. The pressure difference between EPAP and IPAP in BiPAP device serves to increase the tidal volume and hence the minute ventilation.

[046] As used herein, the term "breathing circuit" refers to the system of tubing and components that deliver the pressurized air to the patient and facilitate the exchange of gases during non- invasive positive pressure ventilation (NIPPV).

[047] In some embodiments, the breathing circuit comprises: (a) a compressor, responsible for generating the necessary IPAP and EPAP according to the control unit algorithm; (b) an air inlet; the port where the pressurized air from the BiPAP device enters the breathing circuit; (c) a patient interface; the part of the circuit that connects to the patient's airway. In some embodiments the patient interface comprises a mask; (d) a ventilation tube connecting between the blower/compressor to the patient interface; (e) an exhalation port/valve, allowing the patient to exhale the air without obstruction and preventing the patient from rebreathing exhaled carbon dioxide; and, (f) an air filter.

[048] The "device portion" of the breathing circuit is the portion of the breathing circuit that is in the device. In some embodiments, the device portion of the breathing circuit comprises: the compressor, the air inlet, an exhalation port/valve, and an air filter.

[049] As used herein, a "flow sensor" is a type of sensor used in a BiPAP device to measure the rate of airflow passing through the breathing circuit during inhalation and exhalation. In some embodiments, the flow sensor provides continuous feedback on the flow rate of the delivered air to the BiPAP device control unit.

[050] As used herein, a "pressure sensor" is a sensor used in a BiPAP device to measure the airway pressure within the breathing circuit. The ventilation device may incorporate multiple pressure sensors placed at various locations along the airflow path, such as within the BiPAP device itself or in the tubing close to the mask interface. In some embodiments, the pressure sensors continuously monitor the airway pressure during both inhalation and exhalation, allowing the control unit to maintain the prescribed IPAP and EPAP levels.

[051] As used herein: (a) "tidal volume (VT)" is the volume of air that is inhaled or exhaled during a single breath, "expiratory tidal volume" is the volume of air that is exhaled during a single breath, (b) "Minute ventilation (MV)" is the total volume of air moved into and out of the lungs in one minute. The formula for minute ventilation is: Minute Ventilation (MV) = Tidal Volume (VT) x Respiratory Rate (RR); and (c) "Respiratory rate (RR)" refers to the number of breaths in one minute (breaths per minute, bpm).

[052] The terms "respiratory rate", "ventilation rate", "breathing rate" and "breathing frequency" are herein interchangeably used. Minute ventilation (MV) reflects the overall efficiency of gas exchange and the respiratory system's ability to meet the oxygen and carbon dioxide requirements.

[053] BiPAP devices are known to ventilate in three different modes: (a) S (Spontaneous) - the device triggers IPAP when flow sensors detect spontaneous inspiratory effort and then cycles back to EPAP. The responsiveness level of the sensors can be adjusted; (b) T (Timed) - the cycling between IPAP and EPAP is merely machine-triggered, at a set rate expressed in breaths per minute (BPM); and, (c) S/T (Spontaneous/Timed) - In similar to the spontaneous mode, the device triggers to IPAP on patient inspiratory effort, however, in S/T mode a backup rate is also set to ensure a minimum number of breaths per minute even if the patient fails to breath spontaneously. As understood, in S/T mode IPAP is delivered only after a predetermined time in which no spontaneous breathing is detected.

[054] In some embodiments, the control unit (12) of the emergency ventilation device disclosed herein, comprises a manual selector configured for switching between a predetermined CPR operative program and a respiratory distress operative program.

[055] Given that a CPR operative program is chosen by the user, a T mode is applied, ventilation is triggered automatically, in a constant breathing rate, in IPAP for inspiration and EPAP for expiration. In some embodiments, the constant breathing rate is between 8 to 12 breathing per minute. In some embodiments, the constant breathing rate is about 10 breathing per minute.

[056] The CPR operative program disclosed herein is unique, as it instructs immediate IPAP delivery followed by a constant ventilation rate, i.e., constant IPAP/EPAP cycles. In some embodiments, if the airflow sensor detects spontaneous breathing while the CPR program is operable, the CPR operative program instructs IPAP/EPAP cycles triggered by the patient's inspiratory effort.

[057] There is no automatic switch between T mode and S/T mode in BiPAP devices known in the art. In some embodiments, the CPR mode disclosed herein is a unique mode that delivers a constant breathing rate (i.e., T mode) and further enables an automatic transition, with no external intervention, from T mode to S/T mode if spontaneous breathing is detected by the airflow sensor (e.g., if the patient starts to breathe spontaneously during the CPR).

[058] Given that a respiratory distress operative program is chosen by the user, an S/T mode is applied, ventilation is triggered by the patient's inspiratory effort, in IPAP for inspiration and EPAP for expiration.

[059] In some embodiments, conventional S/T mode is not compatible for CPR program, as during S/T mode IPAP is delivered only after a predetermined time in which no spontaneous breathing is detected whereas the CPR operative program necessitates immediately IPAP delivery.

[060] In some embodiments, the S/T mode comprises a backup breathing rate, that is automatically operated if no spontaneous inspiration is sensed after a predetermined time. In some embodiments, the backup breathing rate is between 8 to 12 breathing per minute. In some embodiments, the backup breathing rate is about 10 breathing per minute. In some embodiments, the predetermined time is between 3 and 7 seconds. In some embodiments, the predetermined time is about 5 seconds.

[061] In one specific embodiment, given that a CPR operative program is chosen by the user, a T mode is applied, and ventilation is triggered automatically, given that the ventilated patient starts spontaneous breathing during the CPR, the control unit corresponds by switching from T mode to S/T mode.

[062] In some embodiments, the emergency ventilation device is configured to deliver breaths at a constant breathing rate, without a break for CPR compressions, as described in the 2020 American Heart Association Guidelines for CPR and ECC (Circulation, 2020). However, it is noted that the emergency ventilation device is designed so that other protocols may be followed and so that the parameters of the emergency breaths may be adjusted as protocols change.

[063] As used herein, "respiratory distress" is a medical term used to describe a condition in which a person experiences difficulty or discomfort in breathing. Respiratory distress can manifest in various ways, depending on the underlying cause and severity, and may include symptoms such as: shortness of breath, rapid or labored breathing, shallow breathing, use of accessory muscles to aid breathing, flaring of the nostrils, grunting during exhalation, bluish discoloration of the skin, particularly around the lips, tongue, fingers, or toes, resulting from inadequate oxygen levels in the blood (cyanosis), and confusion or disorientation resulted from reduced oxygen supply to the brain.

[064] Respiratory distress can arise from various medical conditions including respiratory infections, asthma exacerbation, chronic obstructive pulmonary disease (COPD) exacerbation, heart failure, pneumonia, anaphylaxis (severe allergic reaction), and acute respiratory distress syndrome (ARDS).

[065] In some embodiments, the control unit comprises a manual selector configured for switching between a predetermined infant program, a predetermined child program and a predetermined adult program. In some embodiments, IPAP and EPAP, are predetermined according to the infant program, the child program and the adult program.

[066] As used herein, an infant is between 0 and 12 months of age, a child is in the age of 1-11, and an adult is in the age of 12 and above.

[067] Children typically require lower IPAP and EPAP settings compared to adults in BiPAP therapy.

In some embodiments, infants IPAP is set in the range of 8 to 20 cm H2O, infants EPAP is set in the range of 4 to 10 cm H2O, children IPAP is set in the range of 10 to 25 cm H2O, children EPAP is set in the range of 5 to 12 cm H2O, adults IPAP is set in the range of 10 to 30 cm H2O, and adults EPAP is set in the range of 5 to 12 cm H2O.

[068] In some embodiments, infants IPAP is set in the range of 12 to 18 cm H2O, infants EPAP is set in the range of 7 to 8 cm H2O, children IPAP is set in the range of 13 to 20 cm H2O, children EPAP is set in the range of 8 to 10 cm H2O, adults IPAP is set in the range of 15 to 20 cm H2O, and adults EPAP is set in the range of 10 to 12 cm H2O.

[069] In one further example, infants IPAP is about 8 cm H2O, and infants EPAP is about 4 cm H2O. In one further example, children IPAP is about 12 cm H2O, and children EPAP is about 5 cm H2O. In one further example, adults IPAP is about 15 cm H2O, and adults EPAP is about 5 cm H₂O.

[070] In some embodiments, the automatic ventilation delivered by the emergency ventilation device disclosed herein comprises a continuous cyclic operation, wherein each cycle comprises ventilating in IPAP, for an inspiration time, configured to allow inspiration, followed by ventilating by EPAP, for an expiration time, configured to allow expiration. In some embodiments, the ratio between the inspiration time and the expiration time (EE ratio) is 1:5. In some embodiments, the inspiration time is about 1 second. In some embodiments, the expiration time is about 5 seconds. In some embodiments, each cycle comprises ventilating in IPAP, for about 1 second, followed by ventilating by EPAP, for about 5 seconds. In some embodiments, the control unit receives inputs from: (a) the at least one flow sensor, (b) the at least one pressure sensor, (c) the CPR/ respiratory distress manual selector; and, (d) the infant/child/adult manual selector, and processes this information to determine the appropriate IPAP and EPAP, the breathing respiratory rate, and switching between S/T and T modes.

[071] In some embodiments, the display interface (12) comprises a display of measured tidal volume. In some embodiments, tidal volume is expiratory tidal volume. In some embodiments, the ventilation device comprises a sensor configured for measurement of expiratory tidal volume. In some embodiments, the sensor configured for measurement of expiratory tidal volume is a spirometer or a flow sensor integrated into the breathing circuit.

[072] In some embodiments, the control unit calculates the expiratory tidal volume based on at least one parameter selected from: flow rate, respiratory rate, expiratory time, and any combination thereof.

[073] In some embodiments, the ventilation device comprises a sensor configured for detecting air leakage, airway obstruction, or both. In some embodiments, the sensor configured for detecting air leakage is a flow sensor, a pressure sensor, or both. In some embodiments, the display interface (12) comprises a display indicating the volume of air leak. In some embodiments, the display interface (12) displays a visual with or without an audible notification of air leakage, the notification is present when the measurement of the at least one flow sensor, the at least one pressure sensor, or both, is below a predetermined threshold.

[074] In some embodiments, the control unit of the ventilation device receives information from a pulse oximeter device, comprising a sensor that measures oxygen saturation (SpO2) in the blood, typically placed on the patient's finger. In some embodiments, the display interface (12) further comprises a display of the measured oxygen saturation in the blood by the pulse oximeter sensor.

[075] In some embodiments, the control unit receives information from a CPR feedback device, designed to provide real-time feedback to the user performing the CPR.

[076] As used herein, a "CPR feedback device" is a specialized device used during cardiopulmonary resuscitation (CPR) to provide real-time feedback and guidance to the rescuer. In some embodiments, the CPR feedback device comprises a CPR feedback sensor or an accelerometer that is placed on the chest of the patient, measures the depth and frequency of the chest compressions and provides a visual or audio feedback to the rescuer.

[077] In some embodiments, the display interface (12) further comprises a visual display, with or without an audio alert, indicating information of at least one chest compression parameter, when a CPR operative program is selected by the user. In some embodiments, the chest compression parameter is selected from: compression rate (cpm), compression depth (mm), and compression release (g).

[078] In some embodiments, the communication interface between the control unit and at least one of: (a) the pulse oximeter sensor, (b) the CPR feedback sensor; (c) and, both (a) and (b), is a wired connection or a wireless connection. In some embodiments, the communication interface between the control unit and at least one of: (a) the pulse oximeter sensor, (b) the CPR feedback sensor; (c) and, both (a) and (b), is a wireless connection, including Bluetooth, Wi-Fi, or other wireless protocols.

[079] In some embodiments, the automatic ventilation device further comprises two-way audio communication, speaker and microphone, to connect with an emergency center, enabling remote assistance from the emergency center.

[080] In some embodiments, the portable emergency automatic ventilation device disclosed herein further comprises a humidity and/or fluid sensor. During CPR, the patient may aspirate, leading to blockage of the airway by stomach-derived fluids. In some embodiments, the CPR operative program disclosed herein includes instructions to inform the user that fluids are detected in the breathing circuit. The user is instructed to temporarily stop ventilating the patient, remove the mask from the patient, tilt the patient to the side, remove the fluids from the patient's mouth, and only then reconnect the device and continue CPR while the CPR program is operating.

[081] Other features of BiPAP devices are known in the art. Non-limiting examples include a capnography sensor configured for measurement of CO2 concentration in exhaled breath, an 13

SUBSTITUTE SHEET (RULE 26) oxygen sensor configured for monitoring the oxygen concentration in the exhaled breath, and temperature and humidity sensor.

Ventilation Kit and Use Thereof

[082] According to another aspect, there is provided a ventilation kit for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both. In some embodiments, the ventilation kit comprises: (a) the portable emergency automatic ventilation device (1) disclosed herein; (b) a mask connector (3) comprising an oxygen input connector (14) and an exhalation hole (13); (c) a ventilation tube (2) configured for connecting between the ventilation device (1) and the mask connector (3); (d) an oxygen cylinder (4); (e) a mask (5); (f) an airway device (6); (g) a CPR pillow (7); and, (h) a CPR feedback device (8).

[083] As used herein, the term "mask connector" refers to a connector used in respiratory therapy equipment, to securely connect a patient interface (e.g., mask) to the delivery system of gases or airflow.

[084] The term "mask" used herein, encompasses a device that covers the nose and the mouth, or a device that covers the mouth, and a nose seal, or a device that covers the nose and a mouth seal. The mask disclosed herein provides a sealed interface between the patient's airway and the delivery system of gases or airflow. In some embodiments, the mask is an infant mask, a child mask, an adult mask, or any combination thereof.

[085] "An airway device" is a supraglottic device configured for management of the patients' airway. In some embodiments, the airway device is selected from: a guedel airway, an oropharyngeal airway, a laryngeal mask airway, a laryngeal tube, and an endotracheal tube.

[086] In some embodiments, the airway device is an infant airway device, a child airway device, an adult airway device, or any combination thereof.

[087] "A CPR pillow" is a support pillow designed to aid with opening the patient airway during the CPR and/or intubation. In some embodiments, airway opening is by head tilt-chin lift maneuver or by jaw-thrust maneuver.

[088] In some embodiments, the mask connector (3) in the ventilation kit is connected the ventilation tube (2). In some embodiments, the other end of the ventilation tube is connected to the portable emergency automatic ventilation device (1).

[089] In some embodiments, the oxygen cylinder (4) in the ventilation kit is connected to the oxygen tube (10). [090] According to another aspect there is provided a method for performing CPR, or assisting respiratory distress of a patient, by untrained personnel, the method comprising: (a) call for emergency medical help immediately; (b) obtain the ventilation kit disclosed herein from the nearest ventilation station; (c) choose the appropriate infant/child/adult program; (d) assess the patient's breathing; the patient exhibits a respiratory distress symptom, choose the respiratory distress program, the patient is not breathing, choose the CPR program; (e) turn on the automatic ventilation device; (f) optionally, place the CPR feedback device (8) on the patient chest; (g) start chest compressions with or without defibrillation according to a guidance protocol or instructions provided by the medical help center; (h) position the CPR pillow (7) to assist in airway opening; optionally, insert the airway device (6); (i) place the mask (5) over the patient's mouth, nose, or both, ensuring a proper seal; connect the mask connector (3), preconnected to the ventilation tube (2), to the mask (5), optionally, connect the oxygen tube (10), pre-connected to the oxygen cylinder (4) to the oxygen input connector (14) in the mask connector (3); (j) allow the automatic ventilation device to provide ventilations; don’t stop providing compressions during the ventilations; if CPR feedback device was placed on the patient chest, track chest compression parameters on the display interface (11); (k) optionally, connect the pulse oximeter sensor to the patient's finger and track oxygen saturation value on the display interface (11); and (1) continue step (g) until emergency medical responders arrive, make sure that there is no air leakage notification; optionally, report the tidal volume value to the emergency medical help.

[091] As used herein, the term "about" when combined with a value refers to plus and minus 10% of the reference value. For example, a length of about 1000 nanometers (nm) refers to a length of 1000 nm ± 100 nm.

[092] It is noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[093] In those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B or "A and B."

[094] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. All combinations of the embodiments pertaining to the invention are specifically embraced by the present invention and are disclosed herein just as if each and every combination was individually and explicitly disclosed. In addition, all sub-combinations of the various embodiments and elements thereof are also specifically embraced by the present invention and are disclosed herein just as if each and every such sub-combination was individually and explicitly disclosed herein.

[095] Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination.

Claims

1. A portable emergency automatic ventilation device for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both, comprising: a. device portion of a device -patient breathing circuit comprising a blower/compressor connectable to a patient ventilation tube (2); b. a control unit (12) comprising executable programs for regulating airflow and pressure in the patient-device breathing circuit; c. at least one air flow sensor for detecting inspiration and expiration in said breathing circuit; and, d. at least one pressure sensor for detecting pressure in said breathing circuit; said compressor is programmable to deliver biphasic positive airway pressure (BiPAP) at a first inspiratory positive airway pressure (IPAP) and a second expiratory positive airway pressure, (EPAP), in said breathing circuit, wherein said control unit comprises a manual selector for switching between said executable programs selected from a predetermined CPR operative program and a respiratory distress operative program, said respiratory distress operative program instructs an S/T mode ventilation triggered by patient's inspiratory effort, and said CPR operative program instructs immediately IPAP delivery followed by constant IPAP/EPAP cycles, and if said air flow sensor detects spontaneous breathing in said CPR operative program, said CPR operative program instructs IPAP/EPAP cycles triggered by patient's inspiratory effort.

2. The portable emergency automatic ventilation device of claim 1, wherein said control unit comprises a manual selector configured for switching between a predetermined infant program, a predetermined child program and a predetermined adult program, providing IPAP and EPAP that are compatible to said infant program, said child program and said adult program.

3. The portable emergency automatic ventilation device of claim 2, wherein: a. said IPAP compatible to an infant is in the range of about 8 to about 20 cm H2O, and said EPAP compatible to an infant is in the range of about 4 to about 10 cm H2O,

17

SUBSTITUTE SHEET (RULE 26) b. said IPAP compatible to a child is in the range of about 10 to about 25 cm H2O and said EPAP compatible to a child is in the range of about 5 to about 12 cm H2O; and, c. said IPAP compatible to an adult is in the range of about 10 to about 30 cm H2O and said EPAP compatible to an adult is in the range of about 5 to about 12 cm

H₂O.

4. The portable emergency automatic ventilation device of claim 3, wherein said IPAP compatible to an adult is about 15 cm H2O, and said EPAP compatible to an adult is about 5 cm H2O.

5. The portable emergency automatic ventilation device of claim 3 or 4, wherein said IPAP compatible to an infant is about 8 cm H2O, and said EPAP compatible to an infant is about 4 cm H2O.

6. The portable emergency automatic ventilation device of any one of claims 3 to 5, wherein said IPAP compatible to a child is about 12 cm H2O, and said EPAP compatible to a child is about 5 cm H2O.

7. The portable emergency automatic ventilation device of any one of claims 1 to 6, wherein said T mode ventilation comprises a constant breathing rate in the range of 10 to 12 breath per minute.

8. The portable emergency automatic ventilation device of any one of claims 1 to 7, wherein the ratio between inspiration time and the expiration time (EE ratio) is 1:5.

9. The portable emergency automatic ventilation device of claim 8, wherein said inspiration time is about 1 second, and said expiration time is about 5 seconds.

10. The portable emergency automatic ventilation device of any one of claims 1 to 9, wherein said executable programs of said control unit calculate expiratory tidal volume based on measurements of said at least one flow sensor, and said display interface (12) exhibits said expiratory tidal volume.

11. The portable emergency automatic ventilation device of any one of claims 1 to 10, wherein said display interface (12) comprises a visual and/or an audible notification of air leakage, said notification is present when the measurement of said at least one flow sensor, said at least one pressure sensor, or both, is below a predetermined threshold.

12. The portable emergency automatic ventilation device of any one of claims 1 to 11, wherein said control unit further comprises a wired or wireless electrical communication with a pulse oximeter sensor detecting blood oxygen saturation (SpO2), and said display interface (12) displays said blood oxygen saturation.

13. The portable emergency automatic ventilation device of any one of claims 1 to 12, wherein said control unit further comprises a wired or wireless electrical communication with CPR feedback sensor placed on the chest of said patient, and said display interface (12) displays at least one chest compression parameter selected from the group consisting of: compression rate (cpm), compression depth (mm), and compression release (g).

14. The portable emergency automatic ventilation device of any one of claims 1 to 13, further comprising two-way audio communication, speaker and microphone, to connect with an emergency center, enabling remote assistance from said emergency center.

15. A ventilation kit for use by untrained personnel configured for CPR, relief of respiratory distress of a patient, and both, comprising: a. the portable emergency automatic ventilation device (1) of any one of claims 1 to 14; b. a mask connector (3) comprising an oxygen input connector (14) and an exhalation hole (13); c. a ventilation tube (2) configured for connecting between said ventilation device (1) and said mask connector (3); d. an oxygen cylinder (4) and an oxygen tube (10); e. a mask (5); f. an airway device (6); g. a CPR pillow (7); and h. a CPR feedback device (8).

16. A method for performing CPR, or assisting respiratory distress of a patient, by untrained personnel, the method comprising: a. call for emergency medical help immediately; b. obtain the ventilation kit of claim 15 from the nearest ventilation station; c. choose the appropriate infant/child/adult program; d. assess the patient's breathing; said patient exhibits a respiratory distress symptom, choose the respiratory distress program, said patient is not breathing, choose the CPR program; e. turn on the automatic ventilation device (1); f. optionally, place the CPR feedback device (8) on the patient chest; g. start chest compressions in a rate of between 100 and 120 compressions/minute, with or without defibrillation, according to a guidance protocol or instructions provided by the medical help center; h. position the CPR pillow (7) to assist in airway opening; optionally, insert the airway device (6); i. place the mask (5) over the patient's mouth, nose, or both, ensuring a proper seal; connect the mask connector (3), pre-connected to said ventilation tube (2), to said mask (5), optionally, connect the oxygen tube (10), pre-connected to the oxygen cylinder (4) to the oxygen input connector (14) in said mask connector (3); j . allow the automatic ventilation device to provide ventilations; don’t stop providing compressions during said ventilations; if CPR feedback device was placed on the patient chest, track chest compression parameters on said display interface (11); k. optionally, connect the pulse oximeter sensor to the patient's finger and track oxygen saturation value on said display interface (11); and l. continue step (g) until emergency medical responders arrive, make sure that there is no air leakage notification; optionally, report the tidal volume value to the emergency medical help.

17. The kit of claim 15, further comprising instructions for use thereof, in CPR, or assisting respiratory distress of a patient, by untrained personnel, setting forth the method of claim 16.