Improved continuous positive airway pressure device for neonates

Abstract

The application relates to an improved continuous positive airway pressure device for neonates. A continuous positive airway pressure system includes an inspiratory portion, an expiratory portion, and a controller. The aspirating portion is coupled to the patient interface to provide an airflow having a positive pressure to the patient. The aspirating portion includes a first sensor to measure a pressure or flow rate of the airflow at the aspirating portion. The exhalation portion is coupled to the patient interface to receive air exhaled from the patient. The expiration portion includes a second sensor for measuring the pressure or flow rate of air exhaled at the expiration portion. The controller (i) determines the pressure at the patient interface based on the air flow at the inspiratory portion and the measured pressure or flow rate of air exhaled at the expiratory portion and (ii) modifies the air flow provided by the inspiratory portion based on the determined pressure.

Description

[0001] This application is a divisional application of an application filed on October 11, 2019, with application number 201980084769.7 and invention name “Improved Continuous Positive Airway Pressure Device for Neonates”. Cross-references

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 836,993, filed on April 22, 2019, and U.S. Provisional Patent Application No. 62 / 748,274, filed on October 19, 2018, the entire contents of each of which are incorporated herein by reference. Background Art

[0003] The present disclosure relates generally to the field of respiratory support, and more particularly to an improved continuous positive airway pressure (CPAP) device designed for use with neonates suffering from respiratory distress syndrome (RDS).

[0004] Clinicians characterize neonatal respiratory distress (RD) as dyspnea and poor oxygen saturation of varying severity, with respiratory distress syndrome (RDS) causing the most severe cases. RDS most commonly occurs in premature infants; each year, approximately 3.2 million people worldwide suffer from CPAP-treatable RD. The primary goal of treatment is to maintain adequate oxygenation (measured as SpO2).

[0005] While the mortality rate for untreated RDS approaches 100%, with appropriate treatment, the mortality rate is only 2%. However, in low-income countries with poor health outcomes, the mortality rate remains as high as 75%. While there are multiple factors contributing to this high mortality rate, an important factor involved in the failure of current CPAP treatment is the need for constant monitoring, as current solutions only work when the nasal obstruction in the infant's nares is completely occluded, and the high baby:nurse ratios found in low-income countries do not allow nurses to provide adequate supervision of all newborns.

[0006] Therefore, there is a need for improved systems, devices, and methods for neonatal CPAP.

[0007] References that may be relevant to the disclosure herein may include U.S. Patents Nos. 4,340,044, 5,535,738, 5,694,923, 5,701,883, 5,794,615, 6,299,581, 6,360,741, 6,694,976, 7,284,554, 8,256,417, 8,261,742, 8,967,144, 9,302,066, 9,399,109, and 9,999,742 and U.S. Publications Nos. 2004,226,562, 2005,098,179, 2006,213,518, 2009,007, 11, 2010,319,691, 2013,228,180, 2016,022,954, and 2016,199,607. Summary of the invention

[0008] Aspects of the present disclosure provide a continuous positive airway pressure (CPAP) system. An exemplary CPAP system may include an inhalation module, which may include a first inlet for a compressed oxygen source, a second inlet for an ambient air source, a blender coupled to the first and second inlets to mix the compressed oxygen and ambient air from the first and second inlets, respectively, and a blower coupled to the blender and configured to generate an airflow directed toward a patient from the mixed air.

[0009] The inhalation module may include other features. The inhalation module may further include an outlet to couple to a patient interface and direct the airflow to the patient interface. The patient interface may include one or more of a nasal cannula, a nasal plug, a nasopharyngeal tube, an esophageal tube, a mouthpiece, or a mask. The inhalation module may further include a heater to provide heat to the airflow generated by the blower. The inhalation module may further include a temperature sensor to measure the temperature of the airflow. The inhalation module may further include a controller configured to control the amount of heat provided to the airflow by the heater based on the measured temperature. The inhalation module may further include a humidifier to provide humidity to the airflow generated by the blower. The inhalation module may further include a humidity sensor to measure the humidity of the airflow. The inhalation module may further include a controller configured to control the amount of humidity provided to the airflow by the humidifier based on the measured humidity.

[0010] The suction module may further include one or more sensors. The suction module may further include a pressure sensor to measure the pressure of the airflow generated by the blower. The suction module may further include a controller configured to control the blower based on the measured pressure. The suction module may further include a flow rate sensor to measure the flow rate of the airflow generated by the blower. The suction module may further include a controller configured to control the blower based on the measured flow rate. The suction module may further include an oxygen sensor to measure the oxygenation of the mixed air. The suction module may further include a controller configured to control the ratio of compressed air provided through the first inlet to ambient air provided through the second inlet based on the measured oxygenation.

[0011] The inhalation module may include two or more of: (i) a compressed oxygen sensor to measure one or more of a flow rate or pressure of compressed air from a first inlet, (ii) an ambient air sensor to measure one or more of a flow rate or pressure of ambient air from a second inlet, or (iii) a mixed air sensor to measure one or more of a flow rate or pressure of mixed air from a mixer. The inhalation module may further include a controller coupled to two or more of the (i) compressed oxygen sensor, (ii) the ambient air sensor, or (iii) the mixed air sensor to determine oxygenation of the mixed air based on flow rates or pressures from two or more of (i) compressed air, (ii) ambient air, and (iii) mixed air. The controller may be configured to control a ratio of compressed air provided through the first inlet to ambient air provided through the second inlet based on the determined oxygenation.

[0012] The source of compressed air may include one or more of wall oxygen, oxygen tanks, or a compressed oxygen line.

[0013] According to other aspects of the present disclosure, an exemplary continuous positive airway pressure (CPAP) system may include an inhalation module that may include a first inlet for a compressed oxygen source, a second inlet for an ambient air source, a mixer coupled to the first inlet and the second inlet to mix the compressed oxygen and ambient air from the first and second inlets, respectively, one or more sensors to determine oxygenation of the mixed air, and a controller configured to control a ratio of compressed air provided through the first inlet to ambient air provided through the second inlet based on the determined oxygenation. The ratio may be controlled to maintain a desired oxygen concentration range in the mixed air.

[0014] The air intake module may include other features. The air intake module may further include a heater to provide heat to the mixed air. The air intake module may further include a temperature sensor to measure the temperature of the mixed air. The air intake module may further include a controller configured to control the amount of heat provided to the mixed air by the heater based on the measured temperature. The air intake module may further include a humidifier to provide humidity to the mixed air. The air intake module may further include a humidity sensor to measure the humidity of the mixed air. The air intake module may further include a controller configured to control the amount of humidity provided to the mixed air by the humidifier based on the measured humidity.

[0015] The source of compressed air may include one or more of wall oxygen, oxygen tanks, oxygen concentrators, or compressed oxygen lines.

[0016] The one or more sensors may include an oxygen sensor.

[0017] The one or more sensors may include two or more of: (i) a compressed oxygen sensor to measure one or more of a flow rate or pressure of the compressed air from the first inlet, (ii) an ambient air sensor to measure one or more of a flow rate or pressure of the ambient air from the second inlet, or (iii) a mixed air sensor to measure one or more of a flow rate or pressure of the mixed air from the mixer. The induction module may further include a controller coupled to two or more of the (i) compressed oxygen sensor, (ii) the ambient air sensor, and (iii) the mixed air sensor to determine oxygenation of the mixed air based on flow rates or pressures from two or more of the (i) compressed air, (ii) ambient air, and (iii) mixed air.

[0018] Aspects of the present disclosure also provide methods for generating an airflow for continuous positive airway pressure therapy. A mixer may be provided with ambient air and compressed oxygen to generate mixed air. The airflow of the mixed air may be generated with a blower. The oxygenation of the mixed air may be determined. A ratio of compressed oxygen to ambient air provided to the mixer may be determined based on the determined oxygenation. The ratio may be controlled to maintain a desired oxygen concentration range in the mixed air.

[0019] The mixed air may be heated. The temperature of the mixed air may be measured, and the amount of heat provided to the mixed air may be controlled based on the measured temperature.

[0020] The mixed air may be humidified. The humidity of the mixed air may be measured, and the humidity provided to the mixed air may be controlled based on the measured humidity.

[0021] One or more of the flow rate or pressure of the airflow produced by the blower controlling one or more compressed air sources may be measured, and compressed air may be provided to the mixer, blender, or blower in response.

[0022] Compressed air may be provided by one or more of wall oxygen, oxygen tanks, oxygen concentrators, or compressed oxygen lines.

[0023] The oxygenation of the air mixture can be determined using an oxygenation sensor.

[0024] The mixed air may be determined based on one or more of a flow rate or pressure from the compressed oxygen, one or more of a flow rate or pressure from the ambient air, and one or more of a flow rate or pressure from the mixed air.

[0025] According to other aspects of the present disclosure, an exemplary continuous positive airway pressure (CPAP) system may include an inspiratory portion, an expiratory portion, and a controller. The inspiratory portion may be coupled to a patient interface to provide an airflow with a positive pressure to a patient through the patient interface. The inspiratory portion may include a first sensor to measure one or more of a pressure or a flow rate of the airflow at the inspiratory portion. The expiratory portion may be coupled to the patient interface to receive air exhaled from the patient. The expiratory portion may include a second sensor for measuring one or more of a pressure or a flow rate of the air exhaled at the expiratory portion. The controller may be configured to (i) determine a pressure at the patient interface based on one or more of a pressure or a flow rate of the airflow measured at the inspiratory portion, and one or more of a pressure or a flow rate of the exhaled air measured at the expiratory portion, and (ii) modify the airflow provided by the inspiratory portion based on the pressure determined at the patient interface.

[0026] The inhalation portion may include other features. The inhalation portion may include a blower to generate an airflow. The controller may be configured to modify the airflow by adjusting the speed of the blower. The inhalation portion may include a heater that provides heat to the airflow and a temperature sensor that measures the temperature of the airflow. The controller may be configured to control the amount of heat provided to the airflow by the heater based on the measured temperature. The inhalation portion may include a humidifier that provides humidity to the airflow and a humidity sensor that measures the humidity of the airflow. The controller may be configured to control the amount of humidity provided to the airflow by the humidifier based on the measured humidity. The inhalation portion may include a mixer that mixes ambient air with compressed oxygen, and one or more sensors to determine the oxygenation of the airflow. The controller may be configured to control the ratio of compressed air to ambient air based on the determined oxygenation. The inhalation portion may further include one or more of a blower that generates an airflow, a heater for the airflow, a humidifier for the airflow, or a mixer that mixes ambient air with compressed air. The inhalation portion may further include one or more of a flow rate sensor, a pressure sensor, a temperature sensor, a humidity sensor, or an oxygenation sensor. The controller may be configured to increase the airflow if the determined pressure has decreased.

[0027] The inspiratory portion may be removably coupled to the patient interface.

[0028] The air intake section can be a stand-alone module.

[0029] The exhalation portion may further include an air bubbler for exhaled air.

[0030] The expiratory portion may be removably coupled to the patient interface.

[0031] The exhalation part can be a stand-alone module.

[0032] The user interface may be coupled to the controller. The user interface may include a visual display. The visual display may be configured to display one or more of a measured pressure of the airflow at the inspiratory portion, a measured flow rate of the airflow at the inspiratory portion, a measured pressure of the airflow at the expiratory portion, a measured flow rate of the airflow at the expiratory portion, a determined pressure at the patient interface, or a calibration status of the system. The visual display may also be configured to display one or more of a measured temperature of the airflow at the inspiratory portion, a measured humidity, or a measured oxygenation level. The visual display may be configured to provide a visual alarm to a user or patient. The visual alarm may include a captioned alarm. The user interface may be configured to provide one or more of a visual alarm or an audio alarm to a user or patient. One or more of the visual alarm or the audio alarm may indicate one or more of low inspiratory pressure, high inspiratory pressure, low inspiratory oxygenation level, high inspiratory oxygenation level, low inspiratory air temperature, high inspiratory air temperature, battery charge, or a system error.

[0033] The patient interface may include one or more of a nasal cannula, nasal prongs, nasopharyngeal tube, esophageal tube, mouthpiece, or mask.

[0034] According to other aspects of the present disclosure, an exemplary method of generating an airflow for continuous positive airway pressure therapy may be provided. One or more of a pressure or a flow rate of an airflow generated at an inspiratory portion of a continuous positive airway pressure (CPAP) system may be measured. One or more of a pressure or a flow rate of air exhaled and received at an expiratory portion of the CPAP system may be measured. A pressure at a patient interface coupled to the CPAP system may be determined based on one or more of the measured pressures or flow rates of the airflow at the inspiratory portion and one or more of the measured pressures or flow rates of the air exhaled at the expiratory portion. The airflow provided by the inspiratory portion may be modified based on the determined pressure at the patient interface.

[0035] The airflow can be modified in a variety of ways. The airflow can be modified by adjusting the speed of the blower of the inspiratory portion of the CPAP system that produces the airflow. If it is determined that the pressure has decreased, the airflow can be modified by increasing the airflow.

[0036] The temperature of the airflow may be measured, and the amount of heat provided to the airflow by the heater may be controlled responsively.

[0037] The humidity of the airflow may be measured and the amount of humidity provided to the airflow by the humidifier may be controlled responsively.

[0038] The oxygenation of the gas flow may be determined, and the ratio of compressed oxygen to ambient air mixed by a mixer of the inspiratory portion of the CPAP system may be controlled based on the determined oxygenation.

[0039] The air flow may be directed to the patient through a patient interface coupled to the CPAP system.

[0040] The method may include displaying a number of different parameters. One or more of a measured pressure of the airflow at the inspiratory portion, a measured flow rate of the airflow at the inspiratory portion, a measured pressure of the airflow at the expiratory portion, a measured flow rate of the airflow at the expiratory portion, a determined pressure at the patient interface, or a calibration status of the system may be displayed. One or more of a measured temperature of the airflow at the inspiratory portion, a measured humidity, or a measured oxygenation level may be displayed.

[0041] The method may include providing multiple types of alarms. One or more of a visual alarm or an audio alarm may be provided to a user or patient. The visual alarm may include a subtitle alarm. One or more of the visual alarm or the audio alarm may indicate one or more of low inspiratory air pressure, high inspiratory air pressure, low inspiratory oxygenation level, high inspiratory oxygenation level, low inspiratory air temperature, high inspiratory air temperature, battery charge, or system error.

[0042] The patient interface may include one or more of a nasal cannula, nasal prongs, nasopharyngeal tube, esophageal tube, mouthpiece, or mask.

[0043] According to other aspects of the present disclosure, an exemplary continuous positive airway pressure (CPAP) system may include an inspiratory portion coupled to a patient interface to provide an airflow having a positive pressure to a patient through the patient interface, an expiratory portion coupled to the patient interface to receive air exhaled from the patient, a controller coupled to the inspiratory and expiratory portions to receive one or more sensor measurements therefrom, and a user interface including a display. The controller may be configured to cause the display to provide a visual alert to one or more of a user or a patient in response to the received one or more sensor measurements.

[0044] The user interface may further include an audio alarm.The controller may be further configured to cause the display to provide an audio alarm to one or more of the user or the patient in response to receiving the one or more sensor measurements.

[0045] One or more of the visual alarm or the audio alarm may indicate one or more of low inspiratory air pressure, high inspiratory air pressure, low inspiratory oxygenation level, high inspiratory oxygenation level, low inspiratory air temperature, high inspiratory air temperature, battery charge, or system error.

[0046] Visual alerts may include subtitle alerts.

[0047] The controller may be further configured to couple to one or more external sensors. The controller may be further configured to cause the display to provide a visual alarm in response to the one or more external sensor measurements. The one or more external sensors may be configured to measure or determine one or more of a patient's blood oxygenation level, a patient's blood carbon dioxide level, a patient's respiratory rate, a patient's temperature, a patient's cyanosis level, a patient's phonation, a patient's capillary refill rate, or input from a user.

[0048] The patient interface may include a nasal cannula, nasal prongs, nasopharyngeal tube, esophageal tube, mouthpiece, or mask.

[0049] According to other aspects of the present disclosure, an exemplary method of continuous positive airway pressure therapy can be provided. A positive pressure airflow can be provided to a patient. Air exhaled from the patient can be received. One or more sensor measurements of one or more of the provided airflow or the exhaled received air can be received. In response to the one or more received sensor measurements, a visual alarm can be provided to one or more of a user or a patient. In response to the one or more received sensor measurements, an audio alarm can be provided to one or more of a user or a patient.

[0050] One or more of the visual alarm or the audio alarm may indicate one or more of low inspiratory air pressure, high inspiratory air pressure, low inspiratory oxygenation level, high inspiratory oxygenation level, low inspiratory air temperature, high inspiratory air temperature, battery charge, or system error. The visual alarm may include a captioned alarm.

[0051] One or more external sensor measurements may be received, and a visual alarm may be provided in response to the one or more external sensor measurements. The one or more external sensor measurements may include one or more of a patient's blood oxygenation level, a patient's blood carbon dioxide level, a patient's respiration rate, a patient's temperature, a patient's cyanosis level, a patient's vocalizations, a patient's capillary refill rate, or input from a user.

[0052] Other aspects and advantages of the present disclosure will become readily apparent to those skilled in the art through the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. It will be appreciated that the present disclosure is capable of other and different embodiments, and that its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Therefore, the drawings and descriptions are to be regarded as illustrative in nature, and not restrictive. Incorporation by reference

[0053] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] The novel features of the present disclosure are particularly set forth in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description, which sets forth illustrative embodiments in which the principles of the present disclosure are utilized, and the accompanying drawings (also referred to herein as "diagrams" and "figures"):

[0055] Figure 1 is an exemplary schematic diagram of a known CPAP system; Figure 2 is an exemplary schematic diagram of an improved CPAP system according to an embodiment of the present disclosure; FIG. 3A to FIG. 3B is an exemplary schematic diagram of an improved inhalation module of a CPAP system according to an embodiment of the present disclosure; Figure 4 is an exemplary front view of an exemplary CPAP system according to an embodiment of the present disclosure; and Figure 5 is an exemplary schematic diagram of air flow in the inhalation and exhalation modules of the improved CPAP system according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0056] Although various embodiments of the present invention have been shown and described herein, it is readily understood to those skilled in the art that these embodiments are provided as examples only. Without departing from the present invention, those skilled in the art may conceive of many variations, changes and replacements. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0057] Existing systems, devices and methods for RD treatment include: Standalone CPAP, “indigenous” or “domestic” CPAP, high flow nasal cannula (HFNC), and ventilation / ventilator.

[0058] Standalone CPAP CPAP is an advanced form of respiratory therapy that provides patients with a source of pressurized, heated, humidified, mixed air, effectively keeping the airway open to facilitate gas exchange. Since RDS is characterized by airway collapse, CPAP is a widely accepted and very suitable treatment mode. Figure 1 An exemplary CPAP system 100 is shown. Figure 1 As shown, the method is flow-driven, with the flow rate set at the inspiratory limb or portion 170, and the pressure is limited by the use of a bubbler. In addition, self-contained CPAP uses a combination of air and oxygen to ensure proper oxygen saturation while using the least amount of oxygen possible. CPAP more than doubles the survival rate of RDS compared to oxygen therapy.

[0059] Figure 1 An exemplary CPAP system or machine 100 in generally includes a user interface 110, a power module 130, an expiratory portion 150, an inspiratory portion, and a patient circuit 190. The CPAP system can interface with a medical infrastructure INF, including an electrical power source EL, an oxygen source OS that delivers oxygen to the CPAP system 100 via an oxygen hose OH, and room air RA. A neonate NN is a MT that can be monitored simultaneously in a variety of ways, including pulse oximetry PX, blood gas measurements BG (e.g., oxygen and carbon dioxide), respiratory rate measurements, contractions, cyanosis, secretions, etc. RR, snoring monitoring, and capillary refill monitoring RE.

[0060] The user interface 110 typically includes a display and / or controls 112 for inspired oxygen fraction (FiO2), a display and / or controls 114 for temperature, a display and / or controls 116 for pressure, and a display and / or controls 118 for air flow provided to the neonate NN. The user interface 110 typically also includes a mode controller 120 for the system 100 and an audio alarm 122.

[0061] The power module 130 typically comprises a power source 132 which may be connected to a power source EL provided by a local medical infrastructure INF.

[0062] The inspiratory section 170 draws in air and / or oxygen from the medical infrastructure INF, in particular from the pressurized oxygen source OS and the room air RA. The compressed oxygen and the ambient or room air are mixed together by a mixer 172 at the inspiratory section 170. The mixer 172 is typically an external unit and is controlled by a flow rate controller 174. The mixed air is then directed to a heater and / or humidifier 176 and then to a patient interface circuit 190.

[0063] Patient interface circuit 190 includes inspiratory line tubing 196, patient interface 194, and expiratory line tubing 192 leading to expiratory portion 150. Patient interface 194 may be worn by the treated neonate NN and may be in the form of nasal cannula(s), nasal prong(s), nasopharyngeal tube, esophageal tube, mouthpiece, or mask.

[0064] The exhalation portion 150 receives exhaled air from the neonate NN and passes the air through a bubbler 152. The exhalation portion 150 may also include a pressure release valve 154 for the exhaled air.

[0065] "Local" or "domestic" CPAP: When self-contained CPAPs are not available or economically feasible, then homegrown CPAP can be used. With this method, oxygen is pressurized by placing one end of a tube under water (similar to the bubbler used in self-contained CPAPs). Homegrown CPAP methods are typically 100% oxygen, which can be delivered dry or passively humidified using a bottle of water. Similar to low-flow oxygen delivery, it carries the risk of oxygen toxicity, such as blindness.

[0066] High Flow Nasal Cannula (HFNC): A newer treatment modality called high flow nasal cannula (HFNC) also provides the patient with a source of heated, humidified blended air. HFNC is less labor intensive to deliver than CPAP, which is why it is gaining popularity in the neonatal community. However, it can be difficult to know what pressure is being delivered, so HFNC is more often used as a step-down therapy than a primary treatment modality.

[0067] Ventilator:Severe cases of respiratory distress, in which the patient is unable to breathe, may be treated with mechanical ventilation. A ventilator regulates the infant's breathing rather than simply supplementing it. In low-resource settings, when hospitals are understaffed or do not have the right CPAP equipment, infants are often unnecessarily upgraded to ventilators, which carry higher risks than traditional CPAP.

[0068] Now, the embodiment according to the present disclosure is described. Novel systems, devices and methods for the treatment of RD.

[0069] The neonatal CPAP system presented herein generally works by the same mechanism as described above for the CPAP system 100. It can provide heated, humidified, pressurized, mixed air to the infant to maintain the airway and provide adequate oxygenation. In addition, there are improvements that can reduce the burden on nurses, allowing more infants to receive this life-saving therapy and reducing the number of cases that need to be upgraded to more invasive, higher-risk therapies.

[0070] Figure 2 A comparative diagram / schematic diagram between a conventional CPAP system 100 and a novel CPAP system 200 is provided in FIG. 1 , and an example of the novel CPAP system 200 is provided in FIG. Figure 4 . The CPAP system or machine 200 may include many of the same components as the conventional CPAP 100. The CPAP system 200 may include a user interface 210, a power module 230, an expiratory portion 250, an inspiratory portion 270, and a patient circuit 290. The CPAP system may interface with a medical infrastructure INF, including an electrical power source EL, an oxygen source OS that delivers oxygen to the CPAP system 200 via an oxygen hose OH, and room air RA. The neonate NN may be a MT that may be monitored simultaneously in a variety of ways, including pulse oximetry PX, blood gas measurements BG (e.g., oxygen and carbon dioxide), respiratory rate measurements, contractions, cyanosis, secretions, etc. RR, snoring monitoring, and capillary refill monitoring RE.

[0071] The user interface 210 typically includes a display and / or controls 212 for inspired oxygen fraction (FiO2), a display and / or controls 214 for temperature, a display and / or controls 216 for pressure, and a display and / or controls 218 for air flow provided to the neonate NN. The user interface 210 typically also includes a mode controller 220 for the system 200 and provides an alarm or alert 222. The alarm or alert 222 may include audio and visual alarms and / or alerts.

[0072] The power module 230 typically comprises a power source 232 which can be connected to a power source EL provided by a local medical infrastructure INF.

[0073] The inhalation portion 270 draws in air and / or from the medical infrastructure INF, in particular from a pressurized oxygen source OS and room air RA. The pressurized oxygen source OS may include one or more of a wall oxygen, an oxygen tank, an oxygen concentrator, or a compressed oxygen line. The compressed oxygen and ambient air or room air may be mixed together by a mixer 272, which is typically an internal unit and may be controlled by a flow rate sensor and a controller 274. The oxygen concentration of the mixed air may be between the oxygen concentration of the room air RA (typically about 21%) and the oxygen concentration of compressed oxygen (typically 100%). The oxygenation concentration of the mixed air may be determined using one or more oxygenation sensors, flow rate sensors, or pressure sensors as further described herein, and the mixing ratio of the room air RA and compressed oxygen may be changed, for example by user selection, to achieve a desired oxygen concentration.

[0074] The mixed air can then be directed to a heater and / or humidifier 276 having a blower 280 before being directed to the patient interface circuit 290. The heater and / or humidifier 267 can heat and / or humidify the mixed air so that the patient feels comfortable and safe to breathe. For example, the mixed air can be heated to a temperature close to the normal body temperature of the body, such as at 34°C to 41°C, preferably about 37°C. Moreover, for example, the mixed air can be humidified to 100% humidity or less, 95% humidity or less, 90% humidity or less, 85% humidity or less, 80% humidity or less, 75% humidity or less, 70% humidity or less, 65% humidity or less, 60% humidity or less, 55% humidity or less or 50% humidity or less. The mixed air can be directed to the patient through the patient interface circuit 290 at a flow rate sufficient to provide sufficient oxygen to the patient while minimizing the risk of injury, such as a flow rate of 3 to 15 L / min. A pressure sensor 278 and / or an oxygen sensor 282 may also be coupled to the air flow from the blower 280. The air intake portion 270 may be in the form of a stand-alone module.

[0075] The patient interface circuit 290 may include an inspiratory line tube 296, a patient interface 294, and an expiratory line tube 292 leading to the expiratory portion 250. The patient interface 294 may be worn by the treated neonate NN and may be in the form of nasal cannula(s), nasal prong(s), nasopharyngeal tube, esophageal tube, mouthpiece, mask, or any suitable patient interface.

[0076] The exhalation portion 250 may receive exhaled air from the neonate NN and may pass the exhaled air through a bubbler 252. The exhalation portion 250 may also include a pressure relief valve 254 for the exhaled air. A pressure sensor 256 and / or an oxygen sensor 258 may also be coupled to the exhaled air directed to the bubbler 252. The exhalation portion 250 may be in the form of a stand-alone module. Key device features:

[0077] Blower drive: The CPAP system 200 is intended to be pressure rather than flow driven, and may use a small brushless blower 280 to generate pressure. Pressure sensor(s) may be attached to both the inspiratory circuit 270 and the expiratory circuit 250 to allow for a feedback loop that can trigger adjustment of the blower speed to maintain a target pressure set by the clinician. Using a blower 280 rather than a pneumatic system may eliminate the need for a compressed air source (e.g., wall oxygen, oxygen tank, compressed air line). Compressed air may not be available in many rural hospitals, and a blower is a smaller, quieter, and more cost-effective solution than a traditional compressor. The blower and control components are Figure 3A Highlighted in.

[0078] Mixing and FiO2 Control: The blower 280 can draw room air RA into the mixing chamber through the vents on the housing of the device. If additional oxygen is needed, any oxygen source OS (e.g., wall oxygen, oxygen breathing bag, oxygen tank, oxygen concentrator, or compressed oxygen line) can be connected to the mixer 272, where it will be mixed with the room air RA and pushed into the blower 280. The target oxygen concentration can be set by the user and monitored by the oxygen sensing unit or sensor 282. Alternatively or in combination, as further described herein, the flow rate or pressure of the room air RA, compressed oxygen, and mixed air can be used to determine the oxygen concentration of the mixed air. A proportional valve 271 placed between the oxygen source OS and the mixer 272 can control the flow rate of oxygen to maintain the target FiO2 despite the change in flow rate. Many home-grown CPAP settings, as well as some bubble CPAP systems, do not use a mixer. This often results in 100% oxygen delivery to the infant and increases the risk of retinopathy of prematurity (ROP). Those CPAPs that do require a mixer usually require the purchase of a separate mixer. The CPAP system 200 will typically have a mixer 280 integrated into the device itself. While current mixers can be electronic or mechanical, the proposed mixer 272 can be electronic to allow for integration for FiO2 automation at a lower cost than traditional mechanical options. Figure 3B Highlighted in.

[0079] Figure 5A schematic diagram of airflow in the novel CPAP system 200 is shown. Starting from the inhalation portion 270, room air RA and compressed oxygen OH can be inhaled and mixed with the mixer 272. A flow rate sensor 274a can be provided at the air inlet of the room air RA to determine the flow rate of the room air RA entering the system 200. Alternatively or in combination, a pressure sensor can be provided at the air inlet of the room air RA to determine the pressure of the room air RA entering the system 200. The mixed air can then be directed to the heater and / or humidifier 276. The flow rate sensor 274a and / or the pressure sensor 278 can be provided to determine the flow rate and / or pressure of the mixed air directed to the heater / humidifier 276, respectively.

[0080] The ratio of room air RA to compressed oxygen OH in the mixed air, and therefore the oxygenation of the mixed air (assuming that the oxygenation of the room air RA (typically 21%) and compressed oxygen (typically 100%) is known), can be determined based on the flow rate and / or pressure of the mixed air directed compared to the flow rate and / or pressure of the room air RA and / or compressed oxygen OH directed into the mixer 272. For example, the flow rate of the mixed air can be equal to the flow rate of the room air RA combined with the flow rate of the compressed oxygen OH directed into the mixer 272 (suitably, such as normalized based on a known cross-sectional area of ​​the air flow), and by measuring the flow rate of the mixed air using the sensor 274b and measuring the flow rate of the room air RA using the flow rate sensor 274a, the flow rate of the compressed oxygen OH can be determined, and the ratio of room air RA to compressed oxygen OH in the mixed air can be determined, and the oxygenation of the mixed air can be determined based on the ratio. Similar calculations may be made for pressures instead of flow rates, where the flow rate and / or pressure of compressed oxygen OH directed into the mixer 272 is measured instead of the flow rate and / or pressure of the room air RA, and / or the flow rate and / or pressure of both the room air RA and compressed oxygen OH directed into the mixer 272 is measured instead of the flow rate and / or pressure of the mixed air. As described above, the determined oxygenation may be displayed to the user. The CPAP system 200 may allow the user or other medical professional to set the CPAP system 200 to have a desired oxygenation percentage in the mixed air, for example by varying the flow rates of the room air RA and the compressed oxygen OH.

[0081] Reference again Figure 5 , the mixed air can then be directed to the infant or newborn 262 after being heated and / or humidified. A temperature sensor 284 can be provided to measure the heated and / or humidified mixed air. Now referring to the exhalation portion 250, the exhaled air from the infant and / or newborn NN can be discharged into the room. A pressure sensor 256 and / or a flow rate sensor 258 can be provided to measure the pressure and / or flow rate of the exhaled air, respectively.

[0082] Console side detection and control: Many known CPAP devices rely on pressure and / or flow rate sensors at a patient interface (e.g., nasal cannula(s), nasal prong(s), nasopharyngeal tube, esophageal tube, mouthpiece, or mask) to detect airflow parameters so that the CPAP device can be controlled accordingly. The CPAP system or machine 200 can provide pressure and / or flow rate sensors at the inspiratory circuit 270 and expiratory circuit 250 of the CPAP system or machine 200 (i.e., at the console or system box itself). The measurements from the inspiratory circuit and expiratory circuit sensors can be used to determine the airflow parameter(s) at the patient interface. The CPAP system or machine 200 can then be adjusted accordingly to adjust the air flow rate parameter(s) at the patient interface to a desired level or levels. In doing so, the CPAP system or machine 200 can advantageously work with many types of patient interfaces, including those without any sensors. For optimal use of a particular user interface, as further described herein, the CPAP system or machine 200 can be calibrated to accurately determine the air flow rate parameter(s) at the patient interface.

[0083] Calibration / automatic pressure control (leak compensation): Unlike conventional CPAP systems that typically require specific bite (nasal) plugs or other specific user interfaces, the CPAP system 200 herein can be configured to be used with any brand of bite or non-bite nasal plugs or other user interfaces. This can be achieved by using pressure and flow rate sensors at both the inspiratory portion 270 and the expiratory portion 250 and a calibration sequence that is run before each use. During calibration, the blower 280 can be turned on to one or more known levels, and the pressure and flow rate are measured in the system 200. The controller or processor of the CPAP system 200 can calculate the resistance of the circuit (inspiratory portion 270, expiratory portion 250, and patient interface portion 290), and can then calculate the pressure at the patient interface 294 based on the pressure and flow rate in the inspiratory portion 270 and expiratory portion 250. If the pressure in the system 200 changes for any reason (e.g., the nasal plug becomes loose in the baby's nose), the sensor can measure the change in pressure, and the blower can change its speed to compensate for the change in pressure. The system 200 may also monitor the flow rate to ensure that it never exceeds a target maximum flow rate.

[0084] This new feature may provide a dual benefit: it may allow any circuit to be used with the CPAP system 200 (other stand-alone CPAPs cannot), and it may also reduce the need for nurse supervision since slipping nasal plugs will no longer reduce treatment effectiveness or require excessive time to triage.

[0085] Subtitle alarm:If the nasal plug slips out of the baby's nose, current CPAP methods will not work, but not all systems will sound an alarm if this happens. In addition, those who sound the alarm cannot explain why the system malfunctioned, which requires the nurse to sort out the entire system. The CPAP system 200 can combine both alarms and screens that will usually display the cause of the alarm so that the nurse can quickly correct the problem and return to other work. This can reduce the amount of time that the baby spends without treatment and the amount of time that the nurse spends on CPAP with each baby. Other alarms or alarms 222 that the user interface 210 can provide include those indicating low inspiratory pressure, high inspiratory pressure, low inspiratory oxygenation level, high inspiratory oxygenation level, low inspiratory air temperature, high inspiratory air temperature, battery power, or system errors.

[0086] Although preferred embodiments of the present disclosure have been shown and described herein, it is readily understood by those skilled in the art that these embodiments are provided only as examples. Without departing from the present disclosure, those skilled in the art will now appreciate that many variations, changes and substitutions are possible. It should be understood that in practicing the invention of the present disclosure, various alternatives of the embodiments of the present disclosure described herein may be adopted. It is intended that the claims define the scope of the present invention, and thus encompass methods and structures and their equivalents within the scope of these claims.

Claims

1. A continuous positive airway pressure (CPAP) system comprising: A suction module, comprising: (i) a first inlet for a source of compressed oxygen, (ii) a second inlet for a source of ambient air, (iii) a mixer coupled to the first inlet and the second inlet to mix the compressed oxygen and ambient air respectively from the first inlet and the second inlet, (iv) a blower coupled to the mixer and configured to generate an airflow from the mixed air directed toward a patient; (v) a controller configured to receive one or more sensor measurements from the inhalation module; The controller is further configured to cause the display to provide a captioned alert to one or more of a user or a patient in response to the received one or more sensor measurements.

2. The system of claim 1, wherein the inhalation module further comprises an outlet to couple to a patient interface and direct the airflow thereto.

3. The system of claim 2, wherein the patient interface comprises one or more of a nasal cannula, a nasal prong, a nasopharyngeal tube, an esophageal tube, a mouthpiece, or a mask.

4. The system of claim 1, wherein the air induction module further comprises a heater to provide heat to the airflow generated by the blower.

5. The system of claim 4, wherein the air induction module further comprises a temperature sensor to measure the temperature of the air flow. 6 . The system of claim 5 , wherein the controller is configured to control an amount of heat provided to the airflow by the heater based on the measured temperature.

7. The system of claim 1, wherein the air induction module further comprises a humidifier to provide humidity to the airflow generated by the blower.

8. The system of claim 7, wherein the air induction module further comprises a humidity sensor to measure the humidity of the air flow.

9. The system of claim 8, wherein the controller is configured to control an amount of humidity provided to the airflow by the humidifier based on the measured humidity.

10. The system of claim 1, wherein the air induction module further comprises a pressure sensor to measure the pressure of the airflow generated by the blower.

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