WO2022203676A1

WO2022203676A1 - Bag and valve for advanced respiratory support

Info

Publication number: WO2022203676A1
Application number: PCT/US2021/024260
Authority: WO
Inventors: Jonathan Merrell; Adam SCOTT; Jacob Flagle; Kyle Edmondson; Daniel Lane
Original assignee: Compact Medical Solutions, Llc
Priority date: 2021-03-25
Filing date: 2021-03-25
Publication date: 2022-09-29

Abstract

A respiratory device (2000) for providing respiratory support to a patient includes an expandable bag (2004) and a rigid valve housing portion (2001). The expandable bag includes an air intake valve, an adjustable tidal volume and a hinge configured to maintain the expandable bag in the predetermined tidal volume in an uncompressed configuration. The valve housing portion is in fluid communication with the expandable bag, and includes a peak inspiratory pressure (PIP) mechanism (2100), an adjustable dial (2012) configured to adjust the tidal volume and a value of the PIP mechanism. A two-way valve (2124) is configured to allow air to move from the expandable bag in a first direction through and directs air in an opposing direction to create positive end-expiratory pressure (PEEP). A PEEP controller includes a PEEP dial (2010) configured to select a predetermined PEEP value provided by the two-way valve.

Description

BAG AND VALVE FOR ADVANCED RESPIRATORY SUPPORT

TECHNICAL FIELD

[0001] The present disclosure relates generally to a bag-valve-mask or resuscitator used to ventilate patients in a field setting.

BACKGROUND

[0002] A manual resuscitator, or a bag-valve-mask (BVM), is a device used to temporarily push air into the lungs of a patient who is unconscious or otherwise unable to breathe on their own. These devices are found in hospitals and in ambulances throughout the country and in most developed parts of the world.

[0003] BVMs have existed for many years. Numerous modifications and enhancements have been made to BVMs over the years, these include enhanced 2-way valves, the addition of a high-pressure relieving “pop-off’ valve, and the attachment of an oxygen reservoir to the bag to increase the percent of oxygen content of air flowing into the self-inflating bag portion of the device.

[0004] Self-inflating or self-expanding bags are bulky. They typically hold over a liter of air (in an adult model) even when not in use. Two-way valves are also bulky, and make use of a rigid plastic construct that is most commonly shaped in a 90-degree angle. The mask is similarly bulky and typically employs a rigid plastic triangular-shaped device with a soft rubber balloon about a perimeter that interfaces with and forms a seal around the mouth and nose of a victim. Each of these components is bulky in its own right and together, these form a device that is too large and obtuse to be carried in public by individuals who are trained to use them. Thus, when an emergency arises in most non- clinical settings, a BVM is not typically available until after an ambulance has arrived. [0005] Efforts have been made in the past to reduce the overall space occupied by these devices. This includes an entirely collapsible bag with a flexible hollow body that can be stowed into a container. In attempts to make the device smaller, thinner materials have been used. This results in bag-valve-masks that are suitable for one-time use, due to the device losing functionality after its use. Therefore, BVMs are typically only available in a hospital setting or similar clinical location.

[0006] In addition to their bulk, traditional BVMs are prone to cause hyperventilation. A condition in which a patient is given too much air. This can result in death. Traditional BVMs cause hyperventilation because they inflate too rapidly, leading lifesavers to give breaths more frequently than is recommended.

[0007] Finally, traditional BVMs are only capable of delivering a fixed tidal volume with or without a fixed pressure relief point depending on the size of the BVM (adult, pediatric, or neonatal).

SUMMARY

[0008] In general terms, this disclosure is directed towards a respiratory device having an expandable bag and a connection member. The respiratory device allows a user to provide respiratory support to a patient.

[0009] In an example embodiment, a respiratory device is described. A respiratory device for providing respiratory support to a patient includes an expandable bag and a rigid valve housing portion. The expandable bag includes an air intake valve, an adjustable predetermined tidal volume and a hinge configured to maintain the expandable bag in a predetermined tidal volume in an uncompressed configuration. The rigid valve housing portion in fluid communication with the expandable bag, the valve housing portion includes a peak inspiratory pressure (PIP) mechanism, an adjustable dial configured to adjust both the tidal volume of the expandable bag and a value of the PIP mechanism, a two-way valve configured to allow air to move from the expandable bag in a first direction through a first portion and directs air in an opposing direction through a second portion to create positive end-expiratory pressure (PEEP), and a PEEP controller comprising a PEEP dial configured to select a predetermined PEEP value provided by the two-way valve. The valve housing portion is capable of connecting to a patient breathing interface.

[0010] In a further aspect, a method of providing respiratory support to a patient is described. The method includes providing a respiratory device for providing respiratory support to the patient. The respiratory device includes an expandable bag comprising an air intake valve, the expandable bag having an adjustable predetermined tidal volume and a hinge, the hinge configured to maintain the expandable bag in a predetermined tidal volume in an uncompressed configuration; a rigid valve housing portion in fluid communication with the expandable bag. The valve housing portion includes a peak inspiratory pressure (PIP) mechanism, an adjustable dial configured to adjust both the tidal volume of the expandable bag and a value of the PIP mechanism, a PEEP controller comprising a PEEP dial configured to select a predetermined PEEP value provided by the two-way valve; and an intake mechanism comprising a plurality of adjustable apertures in fluid communication with the expandable bag, an ambient air intake valve, an oxygen intake valve, and an exhaust valve. The patient breathing interface in fluid communication with the rigid valve housing portion. The method further includes selecting a predetermined value of the tidal volume and the value of the PIP valve on the adjustable dial and selecting a PEEP value on the PEEP controller. The respiratory device is configured for single-handed use by a user.

[0011] In another aspect, a respiratory device for providing respiratory support to a patient is described. The respiratory device includes an expandable bag, an adjustable intake mechanism, and a rigid valve housing portion. The expandable bag includes an air intake valve, and having an adjustable predetermined tidal volume and a hinge, the hinge configured to maintain the expandable bag in a predetermined tidal volume in an uncompressed configuration. The adjustable intake mechanism in fluid communication with the expandable bag, and includes an ambient air intake valve, an oxygen intake valve, and an exhaust valve. The rigid valve housing portion is in fluid communication with the expandable bag, and includes a peak inspiratory pressure (PIP) mechanism, an adjustable dial configured to adjust both the tidal volume of the expandable bag and a value of the PIP mechanism, a two-way valve configured to allow air to move from the expandable bag in a first direction and directs air through a positive end-expiratory pressure (PEEP) valve in an opposing direction, and a PEEP controller comprising a PEEP dial and a lifting piece, wherein movement of the PEEP dial lifts the lifting piece relative to the two-way valve to adjust a distance between the lifting piece and the two-way valve, to select a predetermined PEEP value provided by the two-way valve. The valve housing portion is capable of connecting to a patient breathing interface.

[0012] In yet another aspect, a rigid valve housing portion for use in providing respiratory support to a patient is described. The valve housing portion includes a peak inspiratory pressure (PIP) mechanism, an adjustable dial configured to adjust both a tidal volume of an expandable bag and a value of the PIP mechanism, a two-way valve configured to allow air to move from the expandable bag in a first direction through a first portion and directs air in an opposing direction through a second portion to create positive end-expiratory pressure (PEEP), and a PEEP controller comprising a PEEP dial configured to select a predetermined PEEP value provided by the two-way valve. The valve housing portion is capable of connecting to a patient breathing interface. [0013] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate an embodiment of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

BRIEF DESCRIPTION OF THE DRAWINGS [0014] The inventive aspects of the present disclosure can be more easily understood, and further advantages and uses thereof can be more readily apparent, when considered in view of the detailed description and the following figures in which:

[0015] FIG. 1 shows the expandable bag device including an expandable bag.

[0016] FIG. 2 illustrates a rear view of the expandable bag device.

[0017] FIG. 3 illustrates an example embodiment of the valve housing member.

[0018] FIG. 4 illustrates a top view of the expandable bag device in an expanded configuration.

[0019] FIG. 5 illustrates an alternative side view of the expandable bag device.

[0020] FIG. 6 shows another side view of the expandable bag device.

[0021] FIG. 7 illustrates a bottom view of the expandable bag in an expanded configuration.

[0022] FIG. 8 shows another view of the expandable bag device.

[0023] FIG. 9 illustrates an isolated view of the valve housing member.

[0024] FIG. 10 illustrates a cutaway view of the valve housing member.

[0025] FIG. 11 illustrates a view of the valve housing member highlighting the PIP override tab.

[0026] FIG. 12 illustrates a cutaway view of the valve housing member.

[0027] FIG. 13 illustrates a partial cutaway view of the valve housing member.

[0028] FIG. 14 shows the location of the PIP override tab when viewed through the valve housing member.

[0029] FIG. 15 illustrates an exploded view of the valve housing member.

[0030] FIG. 16 shows the expandable bag device with the expandable bag in an expanded configuration.

[0031] FIG. 17 illustrates a cutout side view of the air intake mechanism.

[0032] FIG. 18 illustrates a top view of the expandable bag device in a compressed configuration.

[0033] FIG. 19 illustrates a partial cutaway view of the valve housing member. [0034] FIG. 20 illustrates an exploded view of the air intake mechanism.

[0035] FIG. 21 illustrates a bottom view of the valve connection member.

[0036] FIG. 22 illustrates a view of the expandable bag in an expanded configuration.

[0037] FIG. 23 illustrates an embodiment of the air intake mechanism with the slide in a first position.

[0038] FIG. 24 illustrates an embodiment of the air intake mechanism with the slide in a second position.

[0039] FIG. 25 illustrates an embodiment of the air intake mechanism with the slide in a third position.

DETAILED DESCRIPTION

[0040] The figures and descriptions provided herein may have been simplified to illustrate aspects that are relevant for a clear understanding of the herein described devices, systems, and methods, while eliminating, for the purpose of clarity, other aspects that may be found in typical devices, systems, and methods. Those of ordinary skill may recognize that other elements and/or operations may be desirable and/or necessary to implement the devices, systems, and methods described herein. Because such elements and operations are well known in the art, and because they do not facilitate a better understanding of the present disclosure, a discussion of such elements and operations may not be provided herein. However, the present disclosure is deemed to inherently include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the art.

[0041] References in the specification to "one embodiment," "an embodiment," "an illustrative embodiment," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may or may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. Additionally, it should be appreciated that items included in a list in the form of "at least one A, B, and C" can mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C). Similarly, items listed in the form of "at least one of A, B, or C" can mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C). [0042] In the drawings, some structural or method features may be shown in specific arrangements and/or orderings. However, it should be appreciated that such specific arrangements and/or orderings may not be required. Rather, in some embodiments, such features may be arranged in a different manner and/or order than shown in the illustrative figures. Additionally, the inclusion of a structural or method feature in a particular figure is not meant to imply that such feature is required in all embodiments and, in some embodiments, may not be included or may be combined with other features.

[0043] Generally, bag-valve-masks (BVM) are comprised of three key components: a self-inflating bag, a two-way valve, and a mask. The bag is designed to expand, fill and retain a volume of air. This volume constitutes the next “breath” that a patient is to receive. When the bag is compressed by a lifesaver's hand (herein referred to as the user), the breath is pushed through a valve and down into the mask portion of the device. The mask is kept in contact with the patient's face and directs the breath downward and into the mouth or nasal passage of the patient and into their lungs. When the bag compression is released, the bag expands and a new volume of “fresh” air is drawn into the bag while the original breath of “used” air exits the patient and is released into the ambient air via the two-way valve.

[0044] The disclosure is directed generally to a BVM device having an expandable bag and a connection member in fluid communication with the expandable bag. More specifically, the respiratory device is able to provide different tidal volumes and different PEEP values to a patient.

[0045] FIG. 1 shows the expandable bag device 2000 including an expandable bag 2004 located between a first side panel 2002a and a second side panel 2002b. The expandable bag device 2000 also includes a valve housing member 2001 extending from a first end of the first and second side panels 2002a, 2002b. The valve housing member 2001 may be attached to any type and size of mask or other patient breathing interface device, such as an endotracheal tube or laryngeal mask airway.

[0046] The first side panel 2002a and the expandable bag 2004 also includes an air intake mechanism 2040. The air intake mechanism 2040 includes at least one aperture that extends through the first side panel 2002a and into the expandable bag 2004. In an alternative embodiment, the air intake mechanism 2040 is located on the second side panel 2002b, and still further an air intake mechanism 2040 may be located on both the first side panel 2002a and the second side panel 2002b. The air intake mechanism 2040 is described in more detail below, for example at FIGS. 17 and 20. [0047] In an example embodiment, the expandable bag 2004 has an accordion-like design, comprising a plurality of folds 2005a, 2005b, 2005c, such as a bellow, or other similar mechanism. The plurality of folds 2005a, 2005b, 2005c allows the expandable bag 2004 to expand and contract while filling with air, but also being able to occupy a minimal amount of space when not in use. The expandable bag device 2000 includes a first side panel 2002a and a second side panel 2002b that are stiffer than the expandable bag 2004 to allow a user to hold the side panels 2002a, 2002b to compress the expandable bag 2004. [0048] The rigidity of the side panels 2002a, 2002b allow a user to compress the expandable bag 2004, and this combined with the rigidity of the valve housing portion 2001 allows a user to compress the expandable bag 2004 fully and with a single hand while also maintaining a seal with a patient breathing interface around a patient’s mouth with the same hand. As described in more detail below, the expandable bag device 2000 allows for single-handed use by a user.

[0049] The expandable bag 2004 is a self-inflating bag, in which the expandable bag 2004 takes on an expanded configuration without any external input from the environment. The expandable bag device 2001 includes a spring (not shown) that pushes the side panels 2002a, 2002b away from each other to increase the volume of the expandable bag 2004. The maximum volume of the expandable bag 2004 is controlled by a tidal volume controller within a control dial 2012, as described in more detail below. [0050] The expandable bag device 2000 includes a valve housing member 2001, which is made from a rigid material. The valve housing member 2001 connects the expandable bag 2004 to a patient breathing interface. The valve housing member 2001 includes a pressure relief opening 2013 capped by a control dial 2012. The valve housing member 2001 also includes at least, a PEEP dial 2010, a port 2008, and a mask connection member 2006.

[0051] The pressure relief opening 2013 is located at the top of the valve housing member 2001 and is a one-way valve that only lets air flow from inside the valve housing member 2001 to the external environment when the pressure within the valve housing member 2001 is above a predetermined level. This opening 2013 in alternative embodiments may be moved to another location within the valve housing member.

[0052] The control dial 2012 simultaneously controls the tidal volume of the expandable bag 2004 and the peak inspiratory pressures that the patient’s lungs will experience. In other words, the control dial 2012 restricts how far the first and second side panels 2002a, 2002b of the expandable bag 2004 expand, which determines the volume of air being administered to the patient and the PIP that the patient’s lungs will experience. The control dial 2012 includes a plurality of predetermined settings, including for example, large adult, adult, pediatric, and infant. Each of these settings provides an appropriate tidal volume, which is dependent on the size of the patient. As shown in the figure, an indicia, such as “LA,” “A,” “P,” and “I” are used so a user can select the appropriate tidal volume size for the patient. An adult patient generally requires about 500 mL to about 750 mL of a volume of air, a pediatric patient generally requires about 150 mL to about 500 mL of a volume of air, and an infant patient generally requires about 30 mL to about 150 mL of a volume of air.

[0053] In order for a user to change the setting of the control dial 2012, the user must press down on the control dial 2012 and simultaneously rotate the control dial 2012 to adjust it to a desired setting. This safety feature prevents a user from accidentally turning the control dial 2012 to an inappropriate volume for the patient. In alternative embodiments, other safety mechanisms are contemplated, such as the use of a latch, or requiring the user to pull upward on the control dial before rotating, or another locking mechanism to prevent an inadvertent adjustment of the tidal volume.

[0054] The control dial 2012 includes at least one hollow portion that mates with a tab (not shown) of the first side panel 2002a and another tab on the second side panel 2002b to restrict the width at which the first and second side panels 2002a, 2002b open By doing so, when a user then compresses the expandable bag 2004 from this restricted width to a fully closed position, the volume of air delivered will be consistent and known within a small degree of variance. In an alternative embodiment, the control dial 2012 can permit the first and second side panels 2002a and 2002b to open fully while instead restricting how much the first and second side panels 2002a, 2002b close. The mechanism of control of the control dial 2012 is described in more detail below.

[0055] As shown in the figures, the control dial 2012 is located on a top portion of the valve housing member 2001. However, in other embodiments, the control dial 2012 may be located on a vertical side panel or other location of the valve housing member 2001. [0056] In addition to controlling tidal volume, the control dial 2012 can also adjust a length of a spring of an internal PIP valve (shown in more detail at FIGS. 14-15). Adjustment of this spring makes it possible to apply a variable amount of downward pressure on the upper aspect of the PIP valve (not shown). When the PIP valve is fully restricted, it will not allow venting of excess pressure (simulating the infinite peak pressure valve that is sometimes needed for large adults). Thus an adjustment of PIP can modify the pressure at which excess pressure is vented from inside the valve housing member 2001 to the periphery.

[0057] As the control dial 2012 is rotated to a smaller patient setting, the control dial 2012 will adjust the length of a pop-off spring mechanism and allow the PIP valve to exhaust at lower pressures (a multiplicity depending on chosen settings). In an embodiment, the PIP values are infinite for a large adult, meaning there is no pressure release, 60 cm H20 for a small adult, and 40 cm H20 for a child or infant; however other values for relief pressures or sizes or grouping of patients are possible. The control dial 2012 allows for simultaneous adjustment of both tidal volume and PIP to a setting that is desired and appropriate for a given size of patient. In an alternative embodiment the adjustment of tidal volume and PIP may be decoupled.

[0058] The PEEP dial 2010 controls an ability of the two-way valve (not shown) to move vertically within the valve housing member 2001. When the PEEP dial 2010 is turned, it changes the pressure required for the patient to exhale. The PEEP dial 2010 can have different values such as from 0 to 20 cm H20 in slidable increments that may be selectable on the PEEP dial 2010. Alternatively, the PEEP dial 2010 may be adjustable in discrete increments, such as increments of 5 cm H20 or less.

[0059] The port 2008 may be used for a plurality of connections, including for example a medication injection device and end-tidal C02 detector. The port 2008 is located between the two-way valve and the mask connection member 2006. This allows for monitoring of C02 release from the patient during resuscitation or for the administration of medication directly to a patient’s airway, without having to go through one of the valves of the valve housing member 2001.

[0060] The valve housing member 2001 is made from a rigid material, and in combination with a rigidity of the first side panel 2002a and the second side panel 2002b allows a user to hold the expandable bag device 2000 in one hand. A user is able to compress the expandable bag 2004 with one hand, while maintaining a seal of a mask on a patient’s face with the same hand. The stiffness of the valve housing member 2001 and the first and second side panels 2002a, 2002b allows for single-handed use of the expandable bag device 2000.

[0061] FIG. 2 illustrates an alternative view of the expandable bag device 2000. The expandable bag 2004 is attached to the valve housing member 2001 via a bag connection member 2030 that allows air to flow from the expandable bag 2004 through the valve housing member 2001 and to the patient. The valve housing member 2001 is connected to the first and second side panels 2002a, 2002b.

[0062] The expandable bag device 2000 is designed so the compression of the expandable bag 2004 by the first and second side panels 2002a, 2002b, occurs along a plane that is parallel to the plane of a mask on a patient. Still further, the plane that the expandable bag 2004 compresses along is normal or perpendicular to the mask connection member 2006. In other words, in an expanded configuration, the expandable bag 2004 is larger at an end opposite the valve housing member 2001 than an end adjacent the valve housing member 2001.

[0063] Also shown is a PIP override tab 2020. The PIP override tab 2020 has two configurations. In a first configuration, the PIP override tab 2020 is in an override state, where no air is allowed to vent through the PIP valve, simulating an infinite PIP value. In a second configuration, when the PIP override tab 2020 is rotated such as 90° or 180°, the PIP override tab 2020 is not in an override state, where air is allowed to vent through the pressure relief opening 2013. The side panel 2002b is shaped so as to hang slightly over the PIP override tab 2020 when the expandable bag 2004 is in an expanded state. In this embodiment, a user must first fully compress the bag in order to rotate the PIP override tab 2020 into a locked or unlocked position. This serves as a safety mechanism to prevent unintentional manipulation of the PIP override tab 2020.

[0064] FIG. 3 illustrates an example embodiment of the valve housing member 2001. The valve housing member 2001 includes the control dial 2012 at a first end, such as the top of the valve housing member 2001 when oriented on a patient in use, a mask connection member 2006 at a bottom end, and the PIP override tab 2020, a manometer port (not shown), the PEEP dial 2010, and the medication port or end-tidal C02 connection port 2008 located therebetween.

[0065] A manometer port (not shown) can be used to indicate the internal pressure levels of the expandable bag device 2000. In this embodiment the manometer port 2022 extends from the middle portion of the valve housing member 2001, however in other embodiments, the manometer port 2022 may extend from any other portion of the valve housing member 2001 or the bag connection member 2030.

[0066] The control dial 2012 surrounds an internal mechanism (not shown) that is capable of simultaneously controlling tidal volume and PIP. The internal mechanism of the control dial 2012 is shown in more detail at FIGS. 30, 32, and 34. The control dial 2012 includes settings identified by indicia to indicate which type of patient the expandable bag device 2000 is being used for. For example, “I” indicates infant use, “P” indicates pediatric use, and “A” indicates adult use. In an embodiment, the control dial 2012 may include additional settings, such as a large adult. The control dial 2012 provides for different tidal volumes and PIP within a given patient size class.

[0067] As shown in FIG. 3, the expandable bag 2004 is in an expanded configuration. An end of the expandable bag 2004 located away from the valve housing member 2001 has a width that is greater than a width of the expandable bag 2004 located near the valve housing member 2001.

[0068] The mask connection member 2006 extends from a second end of the valve housing member 2001 and is capable of connecting to a mask or other patient interfacing device, such as an endotracheal tube or laryngeal mask airway.

[0069] FIG. 4 illustrates a top view of the expandable bag device 2000 in an expanded configuration. As shown, the expandable bag 2004 has a generally triangular-shape when in the expanded configuration. The bag could assume other shapes such as spherical, ovoid, square, rectangular, or another polygonal shape. An end 2154 of the expandable bag 2004 opposite the valve housing member 2001 expands more than an end 2156 adjacent the valve housing member 2001.

[0070] A bag connection member 2030 is shown, which provides fluid communication between the expandable bag 2004 and the valve housing member 2001 to provide air to a patient. The bag connection member 2030 can also include a valve 2031 that prevents back flow of air from the valve housing member 2001 to the expandable bag 2004.

[0071] The valve housing member 2001 may also include a light 2152. To aid the user in preventing hyperventilation, or more specifically from inducing hyperventilation, the valve housing member 2001 includes a battery-powered, blinking light 2152. The light 2152 works in conjunction with the control dial 2012, blinking at a cadence specific to the tidal volume and PIP chosen on the control (infant, pediatric, adult, large adult) to indicate to the user the rate that is appropriate to deliver air to the patient. Additionally, the duration of the light blink indicates the time that it should take for the user to deliver air to the patient.

[0072] The light 2152 may blink at different speeds for different sizes of patients. For example, the light 2152 may blink every 1-2 seconds for an infant, 2-3 seconds for an infant or pediatric patient, and 5-6 seconds for an adult. However, other time periods are contemplated. The blinking light indicates to a user how often to compress the expandable bag 2004. [0073] The light 2152 can be attached to the control dial 2012 via a conductive band that receives an input depending on what size of patient is selected on the control dial 2012. The light 2152 can determine the cadence at which the light 2152 blinks to display the appropriate timing for the user to squeeze the bag and give air to the patient. The light 2152 may also blink for a duration of time, such as 1 second, which corresponds to how long a user should take to fully compress the expandable bag 2004.

[0074] In an embodiment, the light 2152 can blink in a first color when the expandable bag device 2000 is being used properly by the user. When a user is not using the expandable bag device 2000 properly, the light 2152 can blink in a different color. For example, when the expandable bag 2004 is being compressed at a correct speed and correct duration, the light 2152 blinks with a green color. If the expandable bag 2004 is being compressed too quickly or too slow, the light 2152 may blink a red color.

[0075] The light 2152 may also be associated with a sound, such as an alarm or metronome. If the expandable bag 2004 is being compressed too quickly or too slow, in addition to or instead of a red colored blinking light, an alarm may sound. Still further, only a sound may be utilized to indicate the correct cadence, rate, compression time, or signal errors or provide other feedback to the user.

[0076] The light 2152 may be an LED or other type of light powered by a battery, such as a rechargeable battery or a non-rechargeable battery, or powered by a mechanical charging system utilizing the compression of the expandable bag 2004 to power the light 2152.

[0077] FIG. 5 illustrates an alternative side view of the expandable bag device 2000.

As discussed above, the expandable bag device 2000 includes an expandable bag 2004 connected to a valve housing member 2001. The expandable bag device 2000 is shown in a compressed embodiment, where the expandable bag device 2000 takes up minimal space.

[0078] The first side panel 2002a also includes an air intake mechanism 2040. The air intake mechanism 2040 includes an oxygen exhaust valve 2044, an ambient air inlet valve 2046, and an oxygen inlet port 2042. The air intake mechanism 2040 allows air to flow into the expandable bag 2004.

[0079] The air intake mechanism 2040 includes the oxygen inlet port 2042, the oxygen exhaust valve 2044, an air inlet valve 2046, an expandable bag inlet valve (not shown), and a hyperventilation override slide (not shown). [0080] In use, supplementary oxygen may be provided to the expandable bag 2004 via the oxygen inlet port 2042. The air intake mechanism 2040 includes a check valve system that allows the user to add supplementary oxygen to the ambient air within the expandable bag 2004 at a controlled rate by only letting a specified volume of oxygen into the expandable bag 2004 over time, while excess oxygen is exhausted through an oxygen exhaust valve 2044 to the periphery. This system regulates the rate at which oxygen and ambient air are allowed into the expandable bag regardless of the rate at which oxygen is set to flow into the oxygen inlet port 2042 such as at lOL/min, 15L/min, etc.

[0081] In a further embodiment, an auditory indicator may provide a first sound while the expandable bag 2004 is inflating, and a second sound when the expandable bag has reached maximum volume.

[0082] FIG. 6 shows another side view of the expandable bag device 2000. The expandable bag device 2000 is shown in a compressed embodiment, where the expandable bag device 2000 takes up minimal space. Further, the second side panel 2002b does not include an air intake mechanism 2040. However, in other embodiments, the second side panel 2002b may include the air intake mechanism 2040 or a duplicate or alternative air intake mechanism.

[0083] FIG. 7 illustrates a bottom view of the expandable bag device 2000 in an expanded configuration. The valve housing member 2001 is connected to the expandable bag 2004 via the bag connection member 2030, which includes a one-way valve (not shown) that allows air to flow from the expandable bag 2004 to the valve housing member 2001. Also shown is a mask connection lumen 2007 within the mask connection member 2006, which is in fluid communication with the expandable bag 2004 via the bag connection member 2030 to deliver air to a patient through a mask or other patient interface device (not shown).

[0084] FIG. 8 shows another view of the expandable bag device 2000. As described above, the expandable bag device 2000 includes the valve housing member 2001 in fluid communication with the expandable bag 2004. The air intake mechanism 2040 is located on a first side panel 2002a.

[0085] FIG. 9 illustrates an isolated view of the valve housing member 2001. The valve housing member 2001 is shown in a use orientation. A mask connection member 2006 is located at a bottom end of the valve housing member 2001, and the control dial 2012 is located at a top end of the valve housing member 2001. [0086] A body 2032 of the valve housing member 2001 is located below the control dial 2012, and houses at least the light (not shown) and the PIP override tab 2020. Below the body 2032 is the PEEP dial 2010. A port 2008 is located near the mask connection member 2006, although its exact location may be anywhere along the path of the air coming from the expandable bag (not shown) and below the two-way valve. In an embodiment, the port 2008 may be a medication port, which allows direct administration to a patient without having to administer the medication through any of the valves.

[0087] The PIP override tab 2020 has a tab 2606 that is pointing along a plane perpendicular to the expandable bag (not shown). The tab 2606 can be rotated by a user to point along a plane that extends perpendicular to the valve housing member 2001, which creates an infinite PIP valve.

[0088] FIG. 10 illustrates a cutaway view of the valve housing member 2001. In particular, the cutaway view of the valve housing member 2001 illustrates a two-way valve 2124 located centrally in the mask connection lumen 2007. The two-way valve 2124 functions to deliver air from the expandable bag (not shown) to the patient, while also providing a PEEP functionality.

[0089] In an embodiment, the two-way valve 2124 is a duckbilled valve that includes two flaps that meet each other in a center of the mask connection lumen 2007 and pointing in a direction towards a mask (not shown). In another embodiment, the two-way valve

2124 is an umbrella valve that is secured within the mask connection lumen 2007.

[0090] The desired PEEP value is controlled by the PEEP dial 2010 and can be adjusted to a predetermined PEEP value as desired by the user. The two-way valve 2124 in combination with a lifting piece 2125 creates PEEP to maintain predetermined pressure in the lungs of the patient. The two-way valve 2124 allows air from the expandable bag 2004 to be provided to the patient and forces exhaled air to lift the two-way valve 2124 off of the lifting piece 2125.

[0091] The PEEP dial 2010 controls the PEEP value via an internal thread 2120. For example, rotating the PEEP dial 2010 increases or decreases the tension of a lifting piece

2125 against the two-way valve 2124, which effectively changes the force required for a patient to exhale air through the PEEP valve. No tension between the lifting piece 2125 results in no generation of PEEP. Low tension at the connection of the lifting piece 2125 and the two-way valve 2124 results in a low PEEP value, while higher tension between the lifting piece 2125 and the two-way valve 2124 results in a higher PEEP value. The PEEP valve and mechanism is shown in more detail at FIG. 15. [0092] At higher breath pressures coming from the patient, the pressure will surmount the PEEP value, but as the breath pressures decrease, the two-way valve 2124 returns to its resting position against the lifting piece 2125, which forces the pressure to be maintained within the patient’s lungs. This allows for easier administration of subsequent breaths into the patient, thus more efficient and effective bagging.

[0093] Also shown is the PIP control mechanism 2100, which is also controlled by the control dial 2012. By adjusting the control dial 2012, the pressure at which air vents to the periphery is changed and the tidal volume provided by the expandable bag 2004 is changed. The adjustment of the control dial 2012 modifies the pressure at which excess pressure is vented from inside the expandable bag device 2000 to the periphery.

[0094] When the PIP value is fully restricted, it will not allow venting of excess pressure (simulating the infinite peak pressure valve that is sometimes needed for certain clinical scenarios). As the control dial 2012 is rotated and then released to the various patient settings, the height of the control dial 2012 will be restricted by the use of inverted wells 2112, 2114, 2116, 2118. The relative height of these inverted wells 2112, 2114, 2116, 2118 will adjust the length of the pop-off spring 2119 and allow the pop-off valve to exhaust at a variety of pressures. Predetermined PIP values are infinite for a large adult,

60 cm H20 for a small adult, and 40 cm H20 for a child or infant; however, other values are possible.

[0095] The PIP control mechanism 2100 includes at least four settings, or inverted wells 2112, 2114, 2116, 2118, which correspond to the predetermined PIP values. When the control dial 2012 is turned, a desired setting is selected. In an embodiment, a first inverted well 2112 has a short length, and corresponds to a PIP value of 60 cm of H20 for adults. A second inverted well 2114 has a medium length, and corresponds to a PIP value of 40 cm of H20 for pediatric patients. A third inverted well 2116 has a long length, and corresponds to a PIP value of 40 cm of H20 for infants. A fourth inverted well 2118 has a shortest length and corresponds to an infinite PIP value.

[0096] The PIP control mechanism 2100 includes four inverted wells, where each inverted well corresponds to the inverted wells 2112, 2114, 2116, 2118. The control dial 2012 also includes a spring which requires a predetermined amount of force to turn the control dial 2012. In an alternative embodiment the same mechanism could be achieved using right-side-up wells. This would particularly apply in an embodiment wherein the control dial 2012 is pulled upward and rotated to adjust instead of being depressed and rotated to adjust. [0097] The two-way valve 2124 also provides additional functionally, by restricting a flow of fluids back into the valve housing member 2001. For example, if a patient vomits, the two-way valve 2124 prevents fluid from entering the valve housing member 2001 and directs it out of the valve housing member 2001, similar to the direction air flows as a result of the PEEP setting.

[0098] FIG. 11 illustrates a view of the valve housing member 2001 highlighting the PIP override tab 2020. When a user activates the PIP override tab 2020, the PIP valve will not activate and thus at no pressure will air vent through the pressure relief opening. The PIP override tab 2020 extends out from a center of the valve housing member 2001. In a first embodiment, when the PIP override tab 2020 is in an override state, the tab 2606 is pointed towards the expandable bag 2004. In a second embodiment, when the PIP override tab 2020 is not in an override state, the tab 2606 is pointed in a direction opposite the expandable bag 2004, such as in line with the mask connection member 2006. However, the direction of the tab 2606 corresponding to the first or second embodiment should not be seen as limiting, as other directions are possible.

[0099] The user is able to rotate the PIP override tab 2020 as desired, for example from the first embodiment to the second embodiment, and back, if needed. The PIP override tab 2020 has a tab 2606, and an extension portion 2602 connecting to a concentric spring mechanism 2604. An end 2608 of the extension portion 2602 has a semicircular or other shape that mates with a corresponding shape of the PIP valve (not shown).

[00100] In an embodiment, the PIP override tab 2020 and semicircular mating portion do not form concentric semicircles and do not interact allowing air to vent from the top of the device at the desired pressure. When the PIP override tab 2020 is in the override state, a cutout in the extension portion 2602 and the semicircle portion of the PIP override tab 2020 interact and become concentric. The semicircular mating portion is now locked in position, closing off the pressure relief opening at the top of the valve housing member 2001, and not allowing air to vent out (or setting the PIP valve to an infinite pressure). In an embodiment the PIP override tab may be external to the valve housing member 2001 and function by being lifted and applying downward force on the upper aspect of the control dial 2012 to compress the spring over the rod 2602 and prevent venting of excess pressures.

[00101] FIG. 12 illustrates a cutaway view of the valve housing member 2001 with a different style of two-way valve 2124. The valve housing member 2001 also includes the control dial 2012, which controls the tidal volume of the expandable bag (not shown) and the PIP inverted wells 2112, 2114, 2116, 2118. Further shown is the internal threads 2120 which dictates the amount that the two-way valve 2124 is allowed to move, and provides PEEP.

[00102] FIG. 13 illustrates the valve housing member 2001 and indicating a direction that air flows. Air flow follows the path A from the inflatable bag (not shown) through the bag connection member 2030, into the valve housing member 2001, through the mask connection member 2006, and eventually to the patient through a mask (not shown). [00103] Upon expiration, the patient exhales, and the air follows path B. The exhaled air moves back through the mask connection member 2006 and out through an opening created by moving the two-way valve within the valve housing member 2001.

[00104] FIG. 14 shows the location of the PIP override tab 2020, when viewed through the valve housing member 2001. As described above, the PIP override tab 2020 has a tab (not shown), a rod (not shown) connecting to a concentric spring mechanism (not shown). An end 2608 of the rod has a circular shape that mates with a corresponding shape of the PIP mechanism (not shown).

[00105] FIG. 15 illustrates an exploded view of the valve housing member 2001. The control dial 2012 is located at an end of the valve housing member 2001; however, the exact location of the control dial 2012 is variable. As the control dial 2012 rotates it communicates with one of the inverted wells 2112, 2114, 2116, 2118, which correspond to a predetermined PIP value. A spring (not shown) maintains the control dial 2012 in the correct position, such that to turn the control dial 2012 the strength of the spring must be overcome.

[00106] The control dial 2012 also controls the tidal volume provided by the expandable bag. The control dial 2012 includes a tidal volume controller that communicates with the first side panel 2002a and the second side panel 2002b to control the width at which the panels are allowed to expand. In a first configuration, a tidal volume controller has an octagonal shape (four pairs of settings) that restrict the width that the first side panel 2002a and the second side panel 2002b are allowed to expand. A hinge located with the expandable bag 2004 forces the first side panel 2002a and the second side panel 2002b to open, and the tidal volume controller determines how much the first side panel 2002a and the second side panel 202b are allowed to open.

[00107] In an alternative configuration, the tidal volume controller restricts the width that the first side panel 2002a and the second side panel 2002b are allowed to close relative to each other. The hinge located with the expandable bag 204 forces the first side panel 2002a and the second side panel 2002b to open, and the tidal volume controller determines how much the first side panel 2002a and the second side panel 2002b are allowed to close when being compressed by a user.

[00108] The bag connection member 2030 includes a valve 2031 that only allows air to from the expandable bag to the valve housing member 2001. The valve 2031 prevents any backflow of air from the valve housing member 2001 into the expandable bag. In an embodiment, the valve 2031 is an umbrella valve.

[00109] The two-way valve 2124 allows air to flow to the patient from the valve housing member 2001 in a first direction and forces exhaled air from the patient to exhaust into the periphery. As shown, the PEEP dial 2010 is located within an internal thread 2120, and the extent to which the lifting piece 2125 is allowed to move vertically within the valve housing member 2001 is dictated by the location of the PEEP dial 2010 along the internal thread 2120. In an embodiment as shown, the two-way valve 2124 is a duck-billed valve, and in alternative embodiments, the two-way valve 2124 may be an umbrella valve.

[00110] The PEEP dial 2010 surrounds the location of the two-way valve 2124. The PEEP dial 2010 is capable of being turned by a user to a desired PEEP value, which corresponds to amount of tension between the lifting piece 2125 and the two-way valve 2124. The force required by exhaled air to move the two-way valve 2124 off of the lifting piece 2125 corresponds to the PEEP value selected.

[00111] The two-way valve 2124 also prevents backflow of fluids into the valve housing member 2001. The two-way valve 2124 prevents fluid from entering the valve housing member 2001 and directs fluid out of the valve housing member 2001, similar to the direction air flows as a result of the PEEP setting

[00112] FIG. 16 shows the expandable bag device 2000 with the expandable bag 2004 in an expanded configuration. The first side panel 2002a includes the air intake mechanism 2040. The air intake mechanism 2040 includes an oxygen inlet port 2042, an oxygen exhaust valve 2044, an air inlet valve 2046, a bellows inlet valve (not shown), and a hyperventilation override slide 2048.

[00113] The oxygen inlet port 2042 is capable of connecting to an oxygen source, to provide oxygen to the expandable bag. The oxygen exhaust valve 2044 vents excess oxygen from the air intake mechanism 2040 to the periphery when the pressure within the air intake mechanism 2040 is too high. The air inlet valve 2046 allows ambient air to enter the air intake mechanism 2040, and ultimately into the expandable bag 2004 via plurality of apertures (not shown).

[00114] FIG. 17 illustrates a cutout side view of the air intake mechanism 2040. An inlet pressure valve 2050 allows external air to enter the inflatable bag from the interior of the air intake mechanism 2040. The inlet pressure valve 2050 is an umbrella valve. The air may be external ambient air or a combination of ambient air and oxygen. Ambient air enters the air intake mechanism 2040 through an air inlet valve 2046, and oxygen enters the air intake mechanism 2040 through an oxygen inlet port (not shown). The air inlet valve 2046 is also an umbrella valve.

[00115] The air intake mechanism 2040 includes the oxygen inlet port (not shown) to control the proportion of oxygen entering the inflatable bag. In use, oxygen flows into the air intake mechanism 2040 at a rate specified on the oxygen tank, which is usually between 10-15 L/min. The pressure from the oxygen inlet port 2042, combined with the atmospheric pressure, creates a pressure differential between the air intake mechanism 2040 and the expandable bag 2004. Oxygenated air will fill the expandable bag 2004 if the pressure is above that of the inlet pressure valve 2050 and less than the oxygen exhaust valve 2044.

[00116] In an embodiment, the flow rate from the oxygen tank is high (for example 10- 15 L/min) and the cracking pressure for the oxygen exhaust valve 2044 is kept low to limit the pressure differential created by oxygen flowing into the air intake mechanism 2040. [00117] The air intake mechanism 2040 allows the expandable bag 2004 to fill with oxygen at a consistent flow rate no matter the flow rate from the oxygen tank. The air intake mechanism 2040 also provides for a consistent inflation rate for the expandable bag 2004, no matter the source of the air (straight ambient air, pure oxygen, or a mixture of ambient air and oxygen).

[00118] In a further embodiment, the air intake mechanism 2040 includes the override slide 2048. The override slide 2048 may be a sliding wheel, a cinch threading mechanism, two sliding plates, or a push button mechanism. The override slide 2048 may be used to allow for hyperventilation by controlling the size of the plurality of apertures (not shown) that allow air to enter the expandable bag 2004. In an embodiment, the override slide 2048 aligns an aperture on side panel 2002a with a corresponding aperture on the override slide 2048. This slide may be a barrel valve or other mechanism which allows for a plurality of aperture sizes and thus a plurality of inflation rates of the expandable bag 2004 between a fully restricted (slow) rate and a fully open (fast) rate. [00119] FIG. 18 illustrates a top view of the expandable bag device 2000 in a compressed configuration. The first side panel 2002a and the second side panel 2002b are generally parallel to each other, with the expandable bag 2004 located there between. [00120] FIG. 19 illustrates a partial cutaway view of the valve housing member 2001 highlighting the bag connection member 2030. Air flow from the expandable bag 2004 through a valve 2131 in the bag connection member 2030 and into the valve housing member 2001. The valve 2131 prevents air from flowing from the valve housing member 2001 back into the expandable bag 2004.

[00121] FIG. 20 illustrates an exploded view of the air intake mechanism 2040 and the expandable bag 2004. Ambient air enters the air intake mechanism 2040 through an air inlet valve 2046, and oxygen enters the air intake mechanism 2040 through an oxygen inlet port 2042. The ambient air and the oxygen mix within the air intake mechanism 2040 and enter the expandable bag 2004 via a plurality of apertures 2158a, 2158b, the size and number of which are opened to the expandable bag 2004 are controlled by the override slide 2048.

[00122] The air intake mechanism 2040 includes the oxygen inlet port 2042 which provides the flow of oxygen with the atmospheric air through the air intake mechanism 2040. The oxygen inlet port 2042 only allows oxygen to flow into the air intake mechanism 2040.

[00123] The oxygen exhaust valve 2044 vents excess oxygen into the atmosphere, so it does not enter the expandable bag 2004 and allows for consistent filling times of the expandable bag 2004 regardless of oxygen flow rates from the oxygen source into the air intake mechanism. The override slide 2048 controls an aperture covering mechanism 2052 that determines either the size or the number of apertures 2158 that air is allowed to enter the expandable bag 2004 from the air intake mechanism 2040.

[00124] FIG. 21 illustrates a cutaway bottom view of the valve connection member 2001 highlighting the control dial 2012. The control dial 2012 extends around an exterior of the valve housing member 2001. The control dial 2012 comprises the tidal volume controller that has an octagonal shape (four pairs of settings 2202a, 2202b, 2204a, 2204b, 2206a, 2206b, 2208a, 2208b) that restrict the width that the first side panel 2002a and the second side panel 2002b are allowed to expand

[00125] FIG. 22 illustrates a view of the expandable bag in an expanded configuration. As shown, an end 2154 of the expandable bag 2004 opposite the valve housing member 2001 expands more than an end 2156 adjacent the valve housing member 2001. In the embodiment shown, the air intake mechanism 2040 is located near the end 2154 of the side panel; however the air intake mechanism 2040 may be located in other places in fluid communication with the expandable bag 2004.

[00126] FIGS. 23-25 illustrates an embodiment of the air intake mechanism 2040 with the slide in various positions. FIG. 23 illustrates an embodiment of the air intake mechanism with the slide in a first position. FIG. 24 illustrates an embodiment of the air intake mechanism with the slide in a second position. FIG. 25 illustrates an embodiment of the air intake mechanism with the slide in a third position.

[00127] Each position of the override slide 2048 corresponds to a different flow rate from the air intake mechanism 2040 to the expandable bag 2004. The first position of the override slide 2048 allows for air to flow into the expandable bag 2004 at a first rate, the second position of the override slide 2048 allows for air to flow into the expandable bag 2004 at a second rate, and the third position of the override slide 2048 allows for air to flow into the expandable bag 2004 at a third rate.

[00128] Embodiments of the present invention, for example, are described above with reference to block diagrams and/or operational illustrations of methods, systems, and computer program products according to embodiments of the invention. The functions/acts noted in the blocks may occur out of the order as shown in any flowchart. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality/acts involved.

[00129] The description and illustration of one or more embodiments provided in this application are not intended to limit or restrict the scope of the invention as claimed in any way. The embodiments, examples, and details provided in this application are considered sufficient to convey possession and enable others to make and use the best mode of claimed invention. The claimed invention should not be construed as being limited to any embodiment, example, or detail provided in this application. Regardless of whether shown and described in combination or separately, the various features (both structural and methodological) are intended to be selectively included or omitted to produce an embodiment with a particular set of features. Having been provided with the description and illustration of the present application, one skilled in the art may envision variations, modifications, and alternate embodiments falling within the spirit of the broader aspects of the claimed invention and the general inventive concept embodied in this application that do not depart from the broader scope.

Claims

CLAIMS:

1. A respiratory device for providing respiratory support to a patient, the respiratory device comprising: an expandable bag comprising an air intake valve, the expandable bag having an adjustable predetermined tidal volume and a hinge, the hinge configured to maintain the expandable bag in a predetermined tidal volume in an uncompressed configuration; a rigid valve housing portion in fluid communication with the expandable bag, the valve housing portion comprising: an adjustable peak inspiratory pressure (PIP) mechanism; an adjustable dial configured to adjust the tidal volume of the expandable bag and a value of the PIP mechanism; a two-way valve configured to allow air to move from the expandable bag in a first direction through a first portion and directs air in an opposing direction through a second portion to create positive end-expiratory pressure (PEEP); a PEEP controller comprising a PEEP dial configured to select a predetermined PEEP value provided by the two-way valve; and wherein the valve housing portion is capable of connecting to a patient breathing interface.

2. The respiratory device of claim 1, wherein the two-way valve is selected from a duckbilled valve and an umbrella valve.

3. The respiratory device of claim 1, wherein the PEEP controller comprises the PEEP dial, a two-way valve, and a lifting piece, wherein movement of the PEEP dial lifts the lifting piece relative to the two-way valve to adjust a tension between the lifting piece and the two-way valve, and wherein when the lifting piece is in a lifted configuration, a variable seal is formed by the lifting piece and the two-way valve.

4. The respiratory device of claim 3, wherein the lifting piece forms a tight junction against an underside of the two-way valve to prevent the flow of liquid fluids from the patient into an opposing side of the two-way valve.

5. The respiratory device of claim 1, wherein the adjustable dial has a plurality of predetermined settings to simultaneously select the value of the PIP mechanism and the tidal volume of the expandable bag that correspond to a size of the patient.

6. The respiratory device of claim 5, wherein the adjustable dial comprises a plurality of inverted wells, wherein each well corresponds to the predetermined setting of the value of the PIP mechanism and the tidal volume.

7. The respiratory device of claim 1, wherein the valve housing portion comprises a first end adjacent the patient breathing interface and an opposing second end, and wherein the adjustable dial is at a location selected from the opposing second end of the valve housing portion and between the first end and the opposing second end of the valve housing portion.

8. The respiratory device of claim 1, wherein the rigid valve housing portion comprises an inlet connected to the expandable bag, the inlet having a central axis, and an outlet configured to be connected to the patient breathing interface, and the outlet having a central axis perpendicular to the central axis of the inlet.

9. The respiratory device of claim 8, wherein the expandable bag comprises a first end connected to the inlet of the rigid valve housing portion, and wherein a second end of the expandable bag expands a greater amount than the first end of the expandable bag when viewed along a plane defined by the central axis of the inlet and perpendicular to the central axis of the outlet.

10. The respiratory device of claim 1, further comprising an intake mechanism in fluid communication with the expandable bag, the intake mechanism comprising: a plurality of adjustable apertures in fluid communication with the expandable bag; an ambient air intake valve; an oxygen intake valve; and an exhaust valve.

11. The respiratory device of claim 10, wherein the intake mechanism further comprises an override switch, configured to modify a size of the adjustable apertures to control a speed of entry of gasses into the expandable bag.

12. The respiratory device of claim 1, wherein the rigid valve housing portion further comprises a PIP override mechanism, wherein in an engaged configuration, the PIP override mechanism prevents a lifting of the PIP mechanism and provides an infinite value of PIP.

13. The respiratory device of claim 1, wherein the rigid valve housing portion further comprises a light, wherein the light is configured to blink at an adjustable predetermined interval and for a predetermined duration of time corresponding to a rate and a speed at which the expandable bag is to be compressed by a user, and wherein the rate and speed corresponds to the value of the adjustable dial.

14. The respiratory device of claim 1, wherein the rigid valve housing portion further comprises a light, wherein the light is configured to provide feedback to the user based on user compliance.

15. The respiratory device of claim 1, wherein the rigid valve housing portion further comprises a manometer port.

16. The respiratory device of claim 1, wherein the rigid valve housing portion further comprises a medication and an end-tidal CO2 port located at an end of the rigid valve housing portion between a location of the two-way valve and the patient breathing interface.

17. The respiratory device of claim 1, further comprising a first side panel and a second side panel enclosing the expandable bag, and wherein the adjustable dial comprises a tidal volume controller configured to control a width at which the first side panel and the second side panel expand or contract from each other to control the tidal volume of the expandable bag.

18. The respiratory device of claim 1, wherein the adjustable dial is configured to simultaneously adjust the tidal volume of the expandable bag and a value of the PIP mechanism.

19. A method of providing respiratory support to a patient, the method comprising: providing the respiratory device of claim 1; selecting a predetermined value of the tidal volume and the value of the PIP mechanism on the adjustable dial; selecting a PEEP value on the PEEP controller; and wherein the respiratory device is configured for single-handed use by a user.

20. A respiratory device for providing respiratory support to a patient, the respiratory device comprising: an expandable bag comprising an air intake valve, the expandable bag having an adjustable predetermined tidal volume and a hinge, the hinge configured to maintain the expandable bag in a predetermined tidal volume in an uncompressed configuration; an adjustable intake mechanism comprising at least one adjustable aperture in fluid communication with the expandable bag, the intake mechanism comprising an ambient air intake valve, an oxygen intake valve, an exhaust valve, and a switch configured to modify a size of the at least one adjustable aperture to control a speed of entry of gasses into the expandable bag; a rigid valve housing portion in fluid communication with the expandable bag, the valve housing portion comprising: a peak inspiratory pressure (PIP) mechanism; an adjustable dial configured to adjust both the tidal volume of the expandable bag and a value of the PIP mechanism; a two-way valve configured to allow air to move from the expandable bag in a first direction and directs air through a positive end-expiratory pressure (PEEP) valve in an opposing direction; a PEEP controller comprising a PEEP dial and a lifting piece, wherein movement of the PEEP dial lifts the lifting piece relative to the two-way valve to adjust a tension between the lifting piece and the two-way valve, to select a predetermined PEEP value provided by the two-way valve; and wherein the valve housing portion is capable of connecting to a patient breathing interface.

21. The respiratory device of claim 19, wherein the rigid valve housing portion further comprises a PIP override mechanism, wherein in an engaged configuration, the PIP override mechanism provides an infinite value of the PIP mechanism.

22. The respiratory device of claim 19, wherein the two-way valve is selected from a duckbilled valve and an umbrella valve.

23. A rigid valve housing portion for use in providing respiratory support to a patient, the valve housing portion comprising: a peak inspiratory pressure (PIP) mechanism; an adjustable dial configured to adjust both a tidal volume of an expandable bag and a value of the PIP mechanism; a two-way valve configured to allow air to move from the expandable bag in a first direction through a first portion and directs air in an opposing direction through a second portion to create positive end-expiratory pressure (PEEP); a PEEP controller comprising a PEEP dial configured to select a predetermined PEEP value provided by the two-way valve; and wherein the valve housing portion is capable of connecting to a patient breathing interface.

24. The rigid valve housing portion of claim 23, wherein the PEEP controller comprises the PEEP dial and a lifting piece, wherein movement of the PEEP dial lifts the lifting piece relative to the two-way valve to adjust a tension between the lifting piece and the two-way valve, and wherein when the lifting piece is in a lifted configuration, a variable seal is formed by the lifting piece and the two-way valve.

25. The rigid valve housing portion of claim 23, wherein the adjustable dial has a plurality of predetermined settings to simultaneously select the value of the PIP mechanism and the tidal volume of the expandable bag that correspond to a size of the patient.

26. The rigid valve housing portion of claim 25, wherein the adjustable dial comprises a plurality of inverted wells, wherein each well corresponds to the predetermined setting of the value of the PIP mechanism and the tidal volume.

27. The rigid valve housing portion of claim 23, wherein the valve housing portion comprises a first end adjacent the patient breathing interface and an opposing second end, and wherein the adjustable dial is at a location selected from the opposing second end of the valve housing portion and between the first end and the opposing second end of the valve housing portion.

28. The rigid valve housing portion of claim 21, wherein the rigid valve housing portion further comprises a PIP override mechanism, wherein in an engaged configuration, the PIP override mechanism prevents a lifting of the PIP mechanism and provides an infinite value of PIP.

29. The rigid valve housing portion of claim 23, wherein the rigid valve housing portion further comprises a light, wherein the light is configured to blink at an adjustable predetermined interval and for a predetermined duration of time corresponding to a rate and a speed at which the expandable bag is to be compressed by a user, and wherein the rate and speed corresponds to the value of the adjustable dial.

30. The rigid valve housing portion of claim 23, wherein the rigid valve housing portion further comprises a light, wherein the light is configured to provide feedback to the user based on user compliance.