Bubble bilevel positive airway pressure device

Abstract

A bubble bilevel positive airway pressure (BiPAP) device includes a water reservoir; a motor; at least one pressure sensor for measuring pressure provided to the patient; and a controller configured to, based on set or adjustable inhalation and exhalation pressures for a patient, vary a depth of the water in the water reservoir.

Description

[0001]BUBBLE BILEVEL POSITIVE AIRWAY PRESSURE DEVICE This PCT international application claims priority to U.S. Serial No.63 / 644,558 filed in the United States Patent and Trademark Office on 09 May 2024, the entirety of which is incorporated herein by reference. FIELD OF INVENTION The present invention is directed to a non-invasive ventilatory support device for respiratory diseases, in particular, a bubble bilevel positive airway pressure device (BiPAP). The bubble BiPAP can be used for both pediatric patients and for adults. BACKGROUND OF INVENTION Respiratory distress remains a leading cause of infant mortality around the world. Caring for these patients in austere settings remains challenging given the lack of available resources. Noninvasive ventilation (NIV) plays a crucial role in the management of pediatric respiratory distress. NIV encompasses various modalities such as continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP), which deliver ventilatory support without the need for endotracheal intubation. This approach is particularly beneficial for pediatric patients as it reduces the risk of complications associated with invasive ventilation, including ventilator-associated pneumonia, airway injury, and sedation-related adverse effects. NIV allows pediatric patients to breathe spontaneously while receiving ventilatory support, promoting comfort and minimizing the need for sedation. By avoiding the need for endotracheal intubation and mechanical ventilation, NIV reduces the risk of ventilator-induced lung injury, barotrauma, and volutrauma, which are significant concerns in pediatric patients with fragile lung tissue. Bubble CPAP is a simple and effective way to provide NIV in low resource settings. Pressure provided to the patient is measured in centimeters-water units and is directly proportional to a depth of an insertion tube or cannula. FIG.1 shows a bubble CPAP device with an oxygen source connected to an inspiratory limb or tube that provides oxygen to a patient and an expiratory limb or tube having a portion (cannula) that is inserted into a water container and which provides a back pressure and a bleed off valve. FIG.2 is an illustrative graph showing pressure versus time for a CPAP device and for a BiPAP device. At higher levels of pressure, however, which may be necessary in worsening respiratory distress, it becomes difficult for a patient to exhale carbon dioxide against the incoming column of air. Thus, there remains a need for a bubble BiPAP device that can be used, for example in low resource environments. SUMMARY OF INVENTION The invention provides in a first embodiment a bubble bilevel positive airway pressure (BiPAP) device comprising a water reservoir; a motor; at least one pressure sensor for measuring pressure provided to a patient; and a controller configured to, based on set or adjustable inhalation and exhalation pressures for a patient, vary a depth of water in the water reservoir. The invention provides in a second embodiment further to any of the previous embodiments a bubble bilevel positive airway pressure device comprising a controller unit having the motor, the at least one pressure sensor, a peristaltic pump, and an air outlet (“the peristaltic pump embodiment”). The water reservoir has a plurality of flow channels and is connectable to a BiPAP air inlet. The controller is configured to, based on set or adjustable inhalation and exhalation pressures for a patient, command the motor to drive the peristaltic pump thereby using air from the BiPaP air inlet to vary a depth of the water in one or more of the flow channels. The invention provides in a third embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein the water reservoir has at least one flow channel connectable to a CPAP air inlet. The invention provides in a fourth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein the controller unit comprises at least one of a battery, a display screen, a power connector, and a selector means to allow a user to switch between a BiPAP mode and a CPAP mode. The invention provides in a fifth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein the BiPaP air inlet is connected to peristaltic tubing of the peristaltic pump via a pressure transfer channel. The invention provides in a sixth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein the water reservoir comprises a tube in which the plurality of flow channels is insertable. The invention provides in a seventh embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device further comprising a base plate having at least one drainage port for water in the water reservoir. The invention provides in an eighth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device comprising a first flow channel connected to a BiPAP air inlet and a second flow channel connected to a CPAP air inlet. The invention provides in a ninth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein the controller unit never contacts water in the water reservoir. The invention provides in a tenth embodiment further to any of the previous peristaltic pump embodiments a bubble bilevel positive airway pressure device wherein a pressure level for inhalation and a pressure level for exhalation for a patient are adjustable via a selector means. The invention provides in an eleventh embodiment further to the first embodiment a bubble bilevel positive airway pressure device further comprising at least one sensor to measure a level or height of water in the water reservoir and a plunger (“the plunger embodiment”). The controller is configured to, based on set or adjustable inhalation and exhalation pressures for a patient, command the motor to move the plunger vertically within the water reservoir to vary a depth of the plunger in the water reservoir. The invention provides in a twelfth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device further comprising a rotatable drive screw moveable by the motor and configured to vertically move the plunger within the water reservoir. The invention provides in a thirteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device wherein the plunger is at a first vertical position during inhalation of the patient and at a second vertical position higher than the first vertical position during exhalation of the patient. The invention provides in a fourteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device further comprising an air connector that is connectable to an expiratory limb or tube leading from a patient to the device. The invention provides in a fifteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device wherein an expiratory limb or tube is connectable to nasal prongs or a mask positioned at or near a nose of a patient. The invention provides in a sixteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device wherein, as the plunger moves, an expiratory limb or tube remains substantially or completely stationary. The invention provides in a seventeenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device further comprising an inspiratory limb or tube connectable to an oxygen source that provides positive pressure to the patient. The invention provides in an eighteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device wherein the controller is configured to, based on pressure measurements from the at least one pressure sensor; a measurement for a water level or height in the water reservoir; and set or adjustable inhalation and exhalation pressures for a patient, command the motor to move the plunger vertically within the reservoir to vary a depth of the plunger in the water reservoir. The invention provides in a nineteenth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device comprising a controller housing that contains all electronic components of the device. The invention provides in a twentieth embodiment further to any of the previous plunger embodiments a bubble bilevel positive airway pressure device further comprising an exhaust port for bubbles, wherein the exhaust port is substantially or completely stationary when the device is in use. The invention provides in a first method embodiment a method of providing ventilatory support to a patient comprising providing the bubble BiPaP device according to any one of the previous embodiments; providing positive pressure to the patient from an oxygen source; setting at least one of an inhalation pressure or an exhalation pressure for the patient; measuring a pressure via at least one pressure sensor; and varying a depth of water in the water reservoir based on set or adjustable inhalation and exhalation pressures for the patient. BRIEF DESCRIPTION OF THE FIGURES FIG.1 shows an exemplary bubble continuous positive airway pressure (CPAP) device attached to a child. FIG.2 is an illustrative graph showing pressure versus time for a CPAP device and for a BiPAP device. FIGS.3A-3C show a device according to one embodiment of the present invention. FIG.3A is a perspective top side view of part of the device. FIG.3B is a perspective angled top view of the device. FIG.3C is an exploded perspective side view of the device. FIGS.4A-4B show side views of the device according to an embodiment of the present invention. FIG.4A shows a plunger being raised to provide a lower exhalation pressure. FIG.4B shows a plunger being lowered to provide a higher inspiration pressure. FIGS.5A-5B are schematic side diagrams of the device according to an embodiment of the present invention. FIG.5A is a schematic side diagram. FIG.5B is an exploded side diagram. FIG.6 is an elevated perspective view of part of a device according to an embodiment of the present invention. FIG.7 is a block diagram of a bubble BiPaP system according to an embodiment of the present invention. FIGS.8A-8B show a device according to another embodiment of the present invention. FIG.8A is a side view of the device and FIG.8B is a perspective view of the device. FIGS.9A-9C show the device of FIGS.8A-8B. FIG.9A is a partially exploded perspective view of the device and FIG.9B is a more fully exploded perspective view of the device. FIG.9C is an exploded perspective top view of the device. FIGS.10A-10C show the device of FIGS.8A-8B. FIG.10A is a partially exploded bottom perspective view of the device and FIG.10B is an exploded perspective view of the top of the device. FIG.10C is an exploded perspective bottom view of the top of the device. FIG.11 is a schematic side view of the device of FIGS.8A-8B. DETAILED DESCRIPTION OF INVENTION The present invention is directed to a non-invasive ventilatory support device for respiratory diseases, in particular, a bubble bilevel positive airway pressure device (BiPAP). The bubble BiPAP can be used for both pediatric patients and for adults. In this detailed description, references to "one embodiment", "an embodiment", or “in embodiments” mean that the feature being referred to is included in at least one embodiment of the invention. Moreover, separate references to "one embodiment", "an embodiment", or “embodiments” do not necessarily refer to the same embodiment; however, neither are such embodiments mutually exclusive, unless so stated, and except as will be readily apparent to those skilled in the art. Thus, the invention can include any variety of combinations and / or integrations of the embodiments described herein. As used herein “substantially”, “generally”, “about”, and other words of degree are relative modifiers intended to indicate permissible variation from the characteristic so modified (e.g., ±0.1%, ±0.5%, ±1.0%, ±2%, ±5%, ±10%, ±20%). It is not intended to be limited to the absolute value or characteristic which it modifies but rather possessing more of the physical or functional characteristic than its opposite, and preferably, approaching or approximating such a physical or functional characteristic. According to the present invention, a bubble BiPAP device is used to vary pressure, for example, during inhalation and exhalation of a patient. In embodiments, a higher inhalation pressure and a lower exhalation pressure may synergistically improve oxygenation and ventilation, for example, in a patient with respiratory distress and / or having a respiratory disease. As shown in FIGS.3A-3C, FIGS.5A-5B, and FIG.6, a device 1 according to the present invention comprises a water reservoir 5, a displacement plunger 10, a drive motor 15, drive screw 20, and a controller or processor 25 (FIG.7). The device may have a housing 30 for the controller and a connector panel 35 that includes the drive motor and drive screw. A top of the housing 30 may include at least one of control means 40, a display 45, and on / off selector 50, and an air connector 55. There may also be a power supply 60 or a connector for a power supply. The device may have a water level sensor 65 (FIG.7) for measuring a water level in the water reservoir 5. The water sensor may include at least one of a laser sensor or buoy. In embodiments, the control means 40 may comprise at least one of a dial, button, knob, or screen (e.g., touchscreen or keypad). The control means 40 allows an operator or user of the device to set or adjust one or more pressures provided by the device. In a specific embodiment, a pressure level for inhalation (inspiratory pressure) and a pressure level for exhalation (expiratory pressure) for a patient can be set or adjusted. The control means may also allow an operator to set or adjust a respiratory rate corresponding to breaths per minute of a patient. The display 45 may be a screen that can display at least one of pressure level(s), water level in the water reservoir, respiratory rate, or any combination thereof. As shown in FIG.7, in embodiments, the device may have an expiratory limb or tube 70 that is connectable at least to one of nasal prongs that are positioned in or near the nasal passages of a patient or a mask that covers at least the nose of a patient. The device 1 and / or the nasal prongs or mask 75 may have at least one pressure sensor 80 to monitor the pressure being provided to a patient. The nasal prongs or mask are connectable to an oxygen source 85 via an inspiratory limb or tube 90. The oxygen source may be any appropriate oxygen source capable of providing a positive pressure including, but not limited to, an oxygen tank, an oxygen compressor, an oxygen concentrator, or an oxygen source having or connected to a heater and / or humidifier. Positive pressure oxygen is supplied to the patient from the oxygen source 85. The controller 25 obtains measurements or data from the at least one pressure sensor 80. In a specific embodiment, the controller, based on at least one of the pressure reading(s) from the at least one pressure sensor, the water level / height in the water reservoir, and the set inhalation and / or exhalation pressures, commands the drive motor 15 to move the plunger 10 vertically to vary the depth of the plunger 10 in the water reservoir 5. The drive motor 15 rotates a drive screw 20, which translates to vertical motion of the plunger 10. As shown in FIGS.4A-4B, as the plunger 10 moves, the displaced water level / height in water reservoir 5 varies, which controls the pressure provided to the patient. A small change in height of the plunger 10 may equate to a large change in depth due to the hydraulic design leading to fine motion control. FIG.4A shows the plunger being raised to provide a lower exhalation pressure, and FIG.4B shows the plunger being lowered to provide a higher inhalation pressure. According to the present invention, the expiratory limb or tube, which is connected via air connector 55 remains substantially or completely stationary. This configuration is advantageous, for example, because the expiratory limb or tube does not move and therefore applies minimal force to the nasal prongs or mask. As a result, a good fit and patient comfort is maintained. By using the plunger to displace the water up and down while exhaust port 57 (FIG.4B) is stationary, a compact and reliable system is achieved. Additionally, the drive motor does not have to move fast or travel a great distance to achieve the desired pressures. This feature may be mechanically beneficial to reduce load stress on the drive motor and drive screw when oscillating during use. In a specific embodiment, the device may also have an audible and / or visual fault alarm in the event a water level in the water reservoir gets too low or the pressure being provided to a patient falls outside of set points or a set range. In an embodiment, the controller housing, which contains most or all of the electronic components, may be reusable between different bubble BiPAP systems. The parts that contact water and / or the patient may be disposable and, in embodiments, may be made of medical grade plastic. In an embodiment, the device can compensate for when the water in the water reservoir evaporates over time. As the water volume decreases due to evaporation, the controller may sense the decreased pressure and the drive motor will move the plunger to a lower position to adjust for a decreased amount of water. In a specific embodiment, the exhaust port may be located approximately halfway from a bottom of the water reservoir to a top of the water reservoir to allow the plunger to be lowered to displace the water to a desired height. Less water volume means more of the plunger needs to be submerged in the water to achieve the same water column height. The device may have an alarm (audible and / or visual) to tell a user to replace the water. The a non-invasive ventilatory support device of the present invention may also be directed to a bubble bilevel positive airway pressure (BiPAP) device that also has continuous positive airway pressure (CPAP) functionality. The device may have any desired shape. In a particular embodiment, the device may be substantially cylindrical. FIGS.8A-8B show a bubble BiPaP device 100 according to another embodiment of the present invention. This embodiment may require a smaller motor and may have less friction and wear. The BiPaP device 100 includes a water reservoir section 105 comprising a water reservoir 110 having a plurality of flow channels 120 for holding air, water, or a combination thereof. The device has both a BiPAP air inlet 130 and a CPAP air inlet 140, both of which may be independently connectable to an expiratory limb. As shown in FIGS.8A-8B and FIG.9A, the device 100 includes a top section 150 comprising a controller unit 155. The controller unit 155 may include at least one of a battery 190 (FIG.10C), a display screen 195, a power connector 200, and a selector means 205. The selector means 205, alone or in combination with the display screen 195, may allow an operator or user to switch between a BiPAP mode and a CPAP mode of the device and / or to set or adjust an inhalation and exhalation pressures for a patient. In embodiments, the selector means 205 may be at least one of a dial, button, knob, or screen (e.g., touchscreen or keypad). In specific embodiments, the water reservoir 105 may comprise a tube 138 (FIG.9B and FIG.10A) into which the plurality of flow channels 120 are insertable. In embodiments, the device 100 may further comprise a base plate 215 having at least one drainage port 220 for water in the water reservoir 110 (FIG.9B and FIG.10A). In embodiments, the water reservoir may have an overflow channel (e.g., a central overflow channel 139 with flow channels along an outer surface) in the event that water gets too high in one or more flow channels. As shown in FIGS.9B-9C, the controller unit 155 may have at least one of a motor 160, a peristaltic pump 165 having a peristaltic rotor 167, at least one pressure sensor 170 (FIGS.10B-10C), and an air outlet 175. In embodiments, the BiPaP air inlet 130 is connected to peristaltic tubing 180 of the peristaltic pump 165 via a pressure transfer channel 185 and a pressure transfer port 186. In embodiments, the peristaltic pump does not need to be cleaned after each use of the device. In embodiments, the at least one pressure sensor 170 may be located within and close to a top of a flow channel and near the BiPAP air inlet 130 (FIG.11). As shown in FIG.10C, the controller unit 155 device may have a controller or processor 210 which is configured to, based at least in part on set or adjustable inhalation and exhalation pressures for a patient, command the motor to drive the peristaltic pump, thereby using air from the BiPaP air inlet to vary a depth of the water in the flow channels in the water reservoir. Thus, the peristaltic pump acts like an air piston. In specific embodiments, it is possible to set a BiPaP mode so that the water level in the water reservoir is low and the bubbles increase. The water level may rise to match the inhalation and / or expiration pressure of a patient. According to the present invention, the controller unit 155 may never contact water in the water reservoir 110. Thus, the controller unit 155 and its components do not need to be sterilized. In specific embodiments, the device may not need a water level sensor. Based on the speed of the motor and the movement (e.g., steps or spin) of the peristaltic rotor, as well as any pressure reading(s) from the at least one pressure sensor, the level of the water in the water reservoir can be approximately determined. As shown in FIG.11, in specific embodiments, a first flow channel 125 is connected to BiPAP air inlet 130 near at a top of the device. A second flow channel 135 is connected to CPAP air inlet 140 near at a top of the device. There may be two or more flow channels 125a connected to the BiPAP air inlet, thereby forming a BiPAP side of the device and one or more flow channels 135a connected to the CPAP air inlet, thereby forming a separate CPAP side of the device. The present invention allows an operator or user to select or switch between a BiPaP mode and a CPAP mode or therapy. This feature may be helpful when there is no electricity or power, which is required in a BiPAP mode, but not a CPAP mode. In addition, if there is a problem in BiPaP mode, a user may switch to CPAP mode, thereby allowing the user to troubleshoot the BiPaP features of the device while maintaining CPAP ventilatory support to a patient. INDUSTRIAL APPLICABILITY The present invention is directed to a non-invasive ventilatory support device for respiratory diseases, in particular, a bubble bilevel positive airway pressure device (BiPAP). The bubble BiPAP can be used for both pediatric patients and for adults. Although the present invention has been described in terms of particular exemplary and alternative embodiments, it is not limited to those embodiments. Alternative embodiments, examples, and modifications which would still be encompassed by the invention may be made by those skilled in the art, particularly in light of the foregoing teachings. Those skilled in the art will appreciate that various adaptations and modifications of the exemplary and alternative embodiments described above can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.

Claims

WHAT IS CLAIMED IS:

1. A bubble bilevel positive airway pressure (BiPAP) device, comprising: a water reservoir; a motor; at least one pressure sensor for measuring pressure provided to a patient; and a controller configured to, based on set or adjustable inhalation and exhalation pressures for a patient, vary a depth of the water in the water reservoir.

2. The bubble BiPAP device of Claim 1, comprising: a controller unit having the motor, the at least one pressure sensor, a peristaltic pump, an air outlet, and a controller; and the water reservoir having a plurality of flow channels and connectable to a BiPAP air inlet; wherein the controller is configured to, based on set or adjustable inhalation and exhalation pressures for a patient, command the motor to drive the peristaltic pump thereby using air from the BiPaP air inlet to vary a depth of the water in one or more of the flow channels.

3. The device of Claim 2, wherein the water reservoir has at least one flow channel connectable to a continuous positive airway pressure (CPAP) air inlet.

4. The device of Claim 2, wherein the controller unit comprises at least one of a battery, a display screen, a power connector, and a selector means to allow a user to switch between a BiPAP mode and a CPAP mode.

5. The device of any one of Claims 2-4, further comprising a base plate having at least one drainage port for water in the water reservoir.

6. The device of any one of Claims 2-4, wherein the BiPaP air inlet is connected to peristaltic tubing of the peristaltic pump via a pressure transfer channel.

7. The device of any one of Claims 2-4, wherein the water reservoir comprises a tube in which the plurality of flow channels is insertable.

8. The device of any one of Claims 2-4, comprising a first flow channel connected to the BiPAP air inlet and a second flow channel connected to a CPAP air inlet.

9. The device of any one of Claims 2-4, wherein the controller unit never contacts water in the water reservoir.

10. The bubble BiPAP device any one of Claims 2-4, wherein a selector means allows a user to switch between a BiPAP mode and a CPAP mode and / or to set or adjust inhalation and exhalation pressures for a patient.

11. The bubble BiPAP device any one of Claims 2-4, further comprising an overflow channel in the water reservoir.

12. The bubble BiPAP device of Claim 1, further comprising: at least one sensor to measure a level or height of water in the water reservoir; and a plunger; wherein the controller is configured to, based on set or adjustable inhalation and exhalation pressures for a patient, command the motor to move the plunger vertically within the water reservoir to vary a depth of the plunger in the water reservoir.

13. The bubble BiPAP device of Claim 12, further comprising a rotatable drive screw moveable by the motor and configured to vertically move the plunger within the water reservoir.

14. The bubble BiPAP device of Claim 12, wherein the plunger is at a first vertical position during inhalation of the patient and at a second vertical position higher than the first vertical position during exhalation of the patient.

15. The bubble BiPAP device of Claim 12, further comprising an air connector that is connectable to an expiratory limb or tube leading from a patient to the device.

16. The bubble BiPAP device of Claim 15, wherein the expiratory limb or tube is connectable to nasal prongs or a mask positioned at or near a nose of the patient.

17. The bubble BiPAP device of any one of Claims 15-16, wherein, as the plunger moves, the expiratory limb or tube remains substantially or completely stationary.

18. The bubble BiPAP device of any one of Claims 12-16, further comprising an inspiratory limb or tube connectable to an oxygen source.

19. The bubble BiPAP device of any one of Claims 12-16, wherein the controller is configured to, based on pressure measurements from the at least one pressure senor; a measurement for a water level or height in the water reservoir; and set or adjustable inhalation and exhalation pressures for a patient, command the motor to move the plunger vertically within the reservoir to vary a depth of the plunger in the water reservoir.

20. The bubble BiPAP device of any one of Claims 12-16, comprising a controller housing that contains all electronic components of the device.

21. The bubble BiPAP device of any one of Claims 12-16, further comprising an exhaust port for bubbles, wherein the exhaust port is substantially or completely stationary when the device is in use.

22. A method of providing ventilatory support to a patient, comprising: providing the bubble BiPaP device according to any one of Claims 1-4 and 12- 16; providing positive pressure to a patient from an oxygen source; setting at least one of an inhalation pressure or an exhalation pressure for the patient; measuring a pressure via the at least one pressure sensor; and varying a depth of water in the water reservoir based on set or adjustable inhalation and exhalation pressures for the patient.

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