Manual resuscitator regulating system

A manual resuscitator regulating system for regulating the rate and volume of ventilation during manual resuscitation. The manual resuscitator regulating system may include an intake assembly configured to permit a selected volume of gas to flow into a chamber over a predetermined amount of time and/or an outtake assembly configured to permit a selected volume of gas flow out of the chamber over a predetermined amount of time. The intake assembly and/or the outtake assembly may include one or more adjustment mechanisms configured to allow a user to selectively adjust volume. The intake assembly and the outtake assembly may be configured to coordinate with one another to deliver a selected tidal volume and/or volume of gas. The manual resuscitator regulating system may include a placement indicator configured to indicate or guide a user where to squeeze or compress the chamber.

FIELD OF INVENTION

This disclosure generally relates to a system for manual resuscitators. More specifically, it relates to systems and methods for regulating the rate and volume of ventilation during manual resuscitation.

INTRODUCTION

Manual resuscitators, also known as bag-valve-masks or BVMs, provide positive pressure ventilation to patients suffering from significant respiratory distress or failure. A manual resuscitator generally consists of a face mask connected to a re-inflating bag or chamber with an air/oxygen intake. Ventilation is delivered to the patient by maintaining a face-to-mask seal and performing manual compression of the chamber. In instances where an advanced airway is used, the manual resuscitator is connected directly to that airway.

Operating or using a manual resuscitator may include maintaining a face-to-mask seal and compressing the chamber until adequate chest rise is achieved. The chest rise may be a clinical indicator that appropriate tidal volume (or the air/oxygen required for a breath) has been attained. For an average adult, the appropriate tidal volume is approximately 500 ml for each breath (or respiration). The American Heart Association recommends that adults receive each respiration at a rate of 10-12 breaths per minute during respiratory failure and 8-10 breaths per minute during cardiac arrest with any advanced airway in place. Tidal volumes and respiratory rates can vary based on patient size, age and morbidity.

Currently, manual resuscitators that are used throughout the emergency and hospital settings have no monitoring system in place to ensure proper volumes and respiratory rate. The respiratory rate and tidal volumes may be entirely dependent on the operator of the manual resuscitator. Since the operator of a manual resuscitator can vary in skill, training, coordination, size, and strength, the respiratory rates and tidal volumes can vary and be inconsistent. For example, an operator's ability to time chamber compression, often without the benefit of a clock or timer, can vary. Additionally, different hand sizes may deliver different amounts of gas, for example, air, upon compression of the chamber. This can create variability in tidal volumes and deliver overall higher volumes, which may increase pulmonary pressure. Studies have shown that when manual resuscitators are used, adult patients are receiving an average of 18 breaths per minute up to 37 breaths per minute (Kohler, Losert, Sterz, 2006). Pediatric patients often have similar experiences, especially because pediatric patients have respiratory requirements that can vary significantly by age and size.

Excessive tidal volumes and respiratory rates can cause hyperventilation. Hyperventilation has been linked to increased intrathoracic pressures, lung tissue damage, decreased coronary perfusion pressures and reduced survival rates (Kohler, Losert, Sterz, 2006). Hyperventilation may also decrease neurological outcomes in post-cardiac arrest patients. Another cause of morbidity and mortality post cardiac/respiratory arrest can include aspiration pneumonia, which is often caused by an overflow of air and/or oxygen volume entering the stomach. This can lead to vomiting and resulting aspiration.

Furthermore, manual resuscitators are typically required during stressful conditions where a number of things must be done quickly and competently. For example, this may include performing chest compressions, inserting an intravenous catheter, and/or administrating emergency medications, in addition to delivering breaths via the manual resuscitator, which may include maintaining face-to-mask seal, watching for adequate chest rise, assessing for suctioning needs, and ensuring appropriate respiratory rate is maintained. Because of this, respiratory rate is often inaccurately timed and tidal volume may be excessive and delivered at inappropriate pressures.

To try and solve this problem, some manual resuscitators have a sliding piston between the chamber and the face mask, but the piston can allow a variable volume between a minimum and maximum amount and does not regulate respiratory rate. Additionally, some manual resuscitators include a timer to assist an operator in monitoring respiratory rate, but the timer may require constant auditory or visual monitoring which can be challenging to hear or focus on during a stressful situation. Furthermore, some manual resuscitators have been significantly redesigned to try and solve this problem, but these redesigns can result in increased manufacturing and consumer costs due to the complexity, as well as additional training.

Accordingly, a simple, dependable and cost-effective manual resuscitator design that can address the above challenges and preserve the existing advantages of a manual resuscitator is desired.

Examples of manual resuscitator systems are disclosed in U.S. Pat. Nos. 6,792,947 and 7,392,805 and U.S. Application Serial No. 2014/0318544. The disclosures of these and all other publications referenced herein are incorporated by reference in their entirety for all purposes.

SUMMARY OF THE INVENTION

The present disclosure provides a system for regulating the rate and volume of ventilation during manual resuscitation. A manual resuscitator regulating system may include an intake assembly configured to permit a selected volume of gas to flow into a chamber over a predetermined amount of time and/or an outtake assembly configured to permit a selected volume of gas flow out of the chamber over a predetermined amount of time. The intake assembly and/or the outtake assembly may include one or more adjustment mechanisms configured to allow a user to selectively adjust gas volume flow. The intake assembly and the outtake assembly may be configured to coordinate with one another to deliver a selected tidal volume and/or volume of gas. In some examples, the manual resuscitator regulating system may include a feedback mechanism configured to provide one or more signals to a user when to squeeze or compress the chamber. In some examples, the manual resuscitator regulating system may include a placement indicator configured to indicate or guide a user where to squeeze or compress the chamber.

DETAILED DESCRIPTION

FIG. 1is a block diagram of a manual resuscitator regulating system, generally indicated at10. Manual resuscitator regulating system10may include any suitable structure configured to regulate the rate and volume of ventilation during manual resuscitation. For example, manual resuscitator regulating system10may include a chamber16, an intake assembly12, an outtake assembly14, and/or a patient interface respiratory device20. In some examples, the manual resuscitator regulating system may additionally, or alternatively, include a feedback mechanism18. The manual resuscitator regulating system may be configured to attach to and/or incorporate with other manual resuscitators. For example, one or more components and/or structures of the manual resuscitator regulating system, such as the intake assembly and/or the outtake assembly, may be included, incorporated and/or retrofitted on to a pre-existing manual resuscitator.

Chamber16may be made of one or more suitable materials, such as rubber, plastic, and/or other materials with resilient properties. Chamber16may be configured to receive and/or retain gas, such as during a refill, and expel gas when a user compresses or squeezes the chamber. The chamber may be configured to regain its original shape after a user compresses or squeezes the chamber. The chamber may be any suitable size(s) or shape(s) to facilitate and/or support one or more components of the manual resuscitator regulating system. For example, the chamber may be sized to retain a predefined maximum volume of gas. In some examples, the chamber may be configured to retain a volume of approximately 1000 ml to 2,100 ml. In other examples, the chamber may be configured to retain a volume of approximately 500 ml. Chamber16may be shaped to help a user engage and/or compress the chamber with one and/or two hands. In some examples, the chamber may be shaped to provide an ergonomic fit for a user's hands. In other examples, the chamber may be configured to indicate or guide a user where to squeeze or compress the chamber, such as a placement indicator. Additionally, or alternatively, the chamber may be configured to help a user hold and/or support the chamber, such as by including non-slip gripping material and/or a strap that can be engaged by a user's hand(s).

Chamber16may extend between intake assembly12and outtake assembly14. Chamber16may be configured to receive gas from intake assembly12and expel gas from the chamber through outtake assembly14. Chamber16may attach to intake assembly12and/or outtake assembly14. In some examples, the chamber may include one or more structures configured to attach the chamber to one or more components and/or structures of the intake assembly and/or the outtake assembly. In other examples, the intake assembly and/or the outtake assembly may be releasably attached to the chamber. This may help facilitate the removal or replacement of the intake assembly and/or the outtake assembly. Chamber16may include any suitable structure configured to form or facilitate an air tight seal between the chamber and the intake assembly and/or the outtake assembly.

Intake assembly12may include any suitable structure configured to permit a selected volume of gas to flow into the chamber over a predetermined amount of time. For example, intake assembly12may include one or more valves, ports, discs, walls, plates, chambers, apertures, springs, seals, levers, and elastic bands, among others. In some examples, one or more of the above described structures may be configured to permit approximately 600 ml to flow in the chamber over a five (5) second period. In other examples, one or more of the above structures may be configured to permit approximately 450 ml to flow in the chamber over a three (3) second period. Additionally, the intake assembly may include one or more valves, or similar structures, to permit gas to flow in one direction.

This configuration may serve to help reduce the volume and/or rate of gas delivered to a patient and help provide a more consistent and controlled volume and/or rate delivered. For example, the volume and rate of gas that enters the chamber may be limited and/or slowed to a predetermined amount of time (e.g. five seconds) such that if a user compresses or squeezes the chamber prior to the predetermined amount of time, the user may be prevented from delivering a full tidal volume because the chamber has not reached the selected volume of gas. This in turn may help reduce the overall volume delivered to the patient. Additionally, the slowed rate of gas entering the chamber may serve to help signal and/or provide feedback, as part of a feedback mechanism18, to the user when to compress the chamber and deliver another breath to the patient, as described below in more detail.

Intake assembly12may be configured to allow a user to select, adjust, and/or toggle settings of the intake assembly. For example, the intake assembly may include one or more adjustment mechanisms configured to allow a user to selectively adjust the volume permitted to flow into chamber16. Intake assembly12may include any suitable structure to allow a user to select, adjust, and/or toggle between at least two volume amounts and/or settings. In some examples, the intake assembly may include one or more levers, buttons, dials, switches, and/or other suitable devices. In other examples, the intake assembly may be configured to allow a user to turn off or disable some or all of the functions of the intake assembly, such as an override setting.

Intake assembly12may be configured to coordinate with and/or support one or more components of outtake assembly14. For example, intake assembly12may be configured to coordinate with outtake assembly14to deliver a selected volume of gas, such as the tidal volume delivered to a patient. In some examples, one or more settings on the intake assembly may be configured to coordinate with and/or complement one or more settings on the outtake assembly to deliver a selected volume amount to a patient. In other examples, the intake assembly and the outtake assembly may be configured to deliver a selected tidal volume when a setting on the intake assembly is the same as a setting on the outtake assembly. Additionally, the intake assembly and the outtake assembly may be configured to deliver a selected tidal volume at a selected pressure. For example, the intake assembly and the outtake assembly may be configured to deliver a selected tidal volume at an increased pressure when a setting on the intake assembly is different than a setting on the outtake assembly. This may help deliver gas to a patient with decreased lung compliance. The intake assembly may include the same structures as the outtake assembly. In other examples, the intake assembly may include one or more different structures in relation to the outtake assembly.

Intake assembly12may include one or more references, indices, guides, symbols, and/or codes to help assist a user to select, adjust, and/or toggle settings of the intake assembly. The settings on the intake assembly may be configured for various ages and/or sizes of a patient, including adult, pediatric, and infant patients. For example, the intake assembly may include one or more numbers, colors, and/or letters configured to represent the volume of gas that may flow into the chamber when selected. In some examples, the intake assembly may include one or more numbers representing the tidal volume that may be delivered to the patient when selected. In other examples, the intake assembly may include one or more colors that correspond to the age and/or size of a patient, and when selected, may deliver a predetermined volume and/or tidal volume that is commensurate with the age and/or average size of the patient. In some examples, the intake assembly may include one or more colors that correspond to the color coding schemes of existing resuscitation systems such as, but not limited to, the Broselow-Luten system.

Intake assembly12may be operably connected to one or more sources of gas, including for example, an oxygen reservoir, an oxygen tank, and/or ambient air, and/or other gas composition(s). The intake assembly may include any suitable structure configured to receive and/or attach to a hose, tubing, or other similar structure. Intake assembly12may be made of one or more suitable materials, such as plastics, rubbers, textiles, metals, vinyls, foams, latexes, and/or other materials. Intake assembly12may be any suitable shape(s) and dimension(s) to facilitate and/or support one or more components of manual resuscitator regulating system10.

Outtake assembly14may include any suitable structure configured to permit a selected volume of gas to flow out of the chamber over a predetermined amount of time. For example, outtake assembly14may include one or more valves, ports, discs, walls, plates, chambers, apertures, springs, seals, levers, and elastic bands, among others. In some examples, one or more of the above described structures may be configured to permit approximately 600 ml to flow out of the chamber over a one (1) second period. In other examples, one or more of the above structures may be configured to permit approximately 450 ml to flow out of the chamber over a one (1) second period. Additionally, the outtake assembly may include one or more valves, or similar structures, to permit gas to flow in one direction.

This configuration may serve to help reduce the volume and/or rate of gas delivered to a patient and help provide a more consistent and controlled volume and/or rate delivered. For example, the volume and rate of gas that exits the chamber may be limited and/or slowed such that the physical compression of the chamber may be limited and/or slowed. This in turn may help prevent a user from delivering a selected volume of gas faster than a predetermined amount of time (e.g. one second), which may help reduce the overall volume delivered to the patient. Additionally, the slowed rate of gas delivered to the patient may serve to help moderate pressure(s) of the gas delivered to a patient.

Outtake assembly14may be configured to allow a user to select, adjust, and/or toggle settings of the outtake assembly. For example, the outtake assembly may include one or more adjustment mechanisms configured to allow a user to selectively adjust the volume permitted to flow out of chamber16. Outtake assembly14may include any suitable structure to allow a user to select, adjust, and/or toggle to between at least two volume amounts and/or settings. In some examples, the outtake assembly may include one or more levers, buttons, dials, switches, and/or other suitable devices. In other examples, the outtake assembly may be configured to allow a user to turn off or disable some or all of the functions of the outtake assembly, such as an override setting.

Outtake assembly14may be configured to coordinate with and/or support one or more components of intake assembly12. For example, outtake assembly14may be configured to coordinate with intake assembly12to deliver a selected volume of gas, such as the tidal volume delivered to a patient. In some examples, one or more settings on the outtake assembly may be configured to coordinate with and/or complement one or more settings on the intake assembly to deliver a selected volume amount to a patient. In other examples, the outtake assembly and the intake assembly may be configured to deliver a selected tidal volume when a setting on the outtake assembly is the same as a setting on the intake assembly. Additionally, the intake assembly and the outtake assembly may be configured to deliver a selected tidal volume at a selected pressure. For example, the intake assembly and the outtake assembly may be configured to deliver a selected tidal volume at an increased pressure when a setting on the intake assembly is different than a setting on the outtake assembly. This may help deliver gas to a patient with decreased lung compliance. The outtake assembly may include the same structures as the intake assembly. In other examples, the outtake assembly may include one or more different structures in relation to the intake assembly.

Outtake assembly14may include one or more references, indices, guides, symbols, and/or codes to help assist a user to select, adjust, and/or toggle settings of the outtake assembly. The settings on the outtake assembly may be configured for various ages and/or sizes of a patient, including adult, pediatric, and infant patients. For example, the outtake assembly may include one or more numbers, colors, and/or letters configured to represent the volume of gas that may flow into the chamber when selected. In some examples, the outtake assembly may include one or more numbers representing the tidal volume that may be delivered to a patient when selected. In other examples, the outtake assembly may include one or more colors that correspond to the age and/or size of a patient, and when selected, may deliver a predetermined volume and/or tidal volume that is commensurate with the age and/or average size of the patient. In some examples, the outtake assembly may include one or more colors that correspond to the color coding schemes of existing resuscitation systems such as, but not limited to, the Broselow-Luten system.

Outtake assembly14may be attached and/or operably connected to patient interface respiratory device20. The patient interface respiratory device is configured to deliver gas to a patient and may include a mask, endotracheal tube, laryngeal mask airway, etc. The outtake assembly may include any suitable structure configured to receive and/or attach to a hose, tubing, or other similar structure. Outtake assembly14may be made of one or more suitable materials, such as plastics, rubbers, textiles, metals, vinyls, foams, latexes, and/or other materials. Outtake assembly14may be any suitable shape(s) and dimension(s) to facilitate and/or support one or more components of manual resuscitator regulating system10.

In some examples, manual resuscitator regulating system10may include a feedback mechanism18, which may be configured to provide a user visual, audio, and/or tactile feedback. For example, chamber16may transition between a deflated state to a fully inflated state, whereby the fully inflated state may indicate and/or signal to a user through visual and/or tactile feedback that the selected amount of gas has entered the chamber and that the chamber may and/or should be compressed. In some examples, feedback mechanism18may be configured to provide a visual alarm, a sound alarm, and/or other suitable alarms to indicate when the chamber may be compressed. In other examples, feedback mechanism18may include one or more light sources configured to emit light and/or change colors to indicate when the chamber may or should be compressed by the user. The feedback mechanism may be operably connected to the chamber, intake assembly, and/or outtake assembly. For example, a setting on the intake assembly may be configured to permit an approximate gas flow into the chamber such that it takes approximately five seconds for the chamber to completely refill after compressing the chamber for about one second. The user receives a tactile signal from the refilled chamber that it is time to administer another one second compression, followed again by a five second refill phase. Alternatively, it may be desirable for some patients to adjust the intake and/or outtake valve(s) so that the ratio of intake time (It) to outtake time (Ot) is greater or less than 5:1 depending on the circumstances. For example, an optimal It::Otfor a pediatric or infant patient may depend on size and intubation status.

FIGS. 2-6show an embodiment of a manual resuscitator regulating system, which is generally indicated at100, according to aspects of the present teachings.FIG. 2depicts manual resuscitator regulating system100including a chamber102with a first end108and a second end110, an intake assembly generally indicated at104, and an outtake assembly generally indicated at106. Intake assembly104is attached to first end108of the chamber. Outtake assembly106is attached to second end110of the chamber. Intake assembly104is operably attached and/or connected to a gas connector112and hosing114. In other embodiments, intake assembly104may be operably attached and/or connected to other gas sources and/or structures. Outtake assembly106is operably connected and/or attached to a mask116through a mask connector118. In other embodiments, outtake assembly106may be operably connected and/or attached to other alternative airways, such as an endotracheal tube or laryngeal mask airway. Each of intake assembly104and outtake assembly106has a one-way valve device only allowing gas to flow into the chamber through intake assembly104and out of the chamber through outtake assembly106.

FIG. 3is an exploded view of outtake assembly106of manual resuscitator regulating system100with valve housing material removed for clarity. AlthoughFIGS. 3-6depict an outtake assembly, except as indicated below, intake assembly104of manual resuscitator regulating system100may include the same and/or similar structures, components, and functions of outtake assembly106. Outtake assembly106includes a valve housing120, a regulator disc122, a seal124, and a control disc126. Additionally, outtake assembly106may include and/or incorporate a flapper valve or a one-way valve (not shown) to facilitate one-way movement of gas. For example, the flapper valve may facilitate one-way movement of gas from chamber102to mask116in the outtake assembly and facilitate one-way movement of gas from gas connector112and/or hosing114to chamber102in the intake assembly. The flapper valve may be attached to and/or adjacent to the regulator disc.

Valve housing120is configured to enclose and/or contain the regulator disc, the sealer, and the control disc. Valve housing120has an inner surface128and an outer surface130defining an opening132configured to facilitate the movement of gas through the valve housing to and/or from one or more components of the manual resuscitator regulating system. In other embodiments, valve housing120may partially enclose and/or contain more or less components of outtake assembly106. AlthoughFIGS. 3 and 6depict a generally tubular valve housing, the valve housing may have any suitable size(s) or shape(s) to support the outtake assembly and/or other components of the manual resuscitator regulating system.

Valve housing120may be configured and/or oriented to position regulator disc122further away from or closer to chamber102in relation to control disc126. For example, the valve housing of the outtake assembly may be oriented to position regulator disc122further away from chamber102in relation to control disc126, and a valve housing of the intake assembly may be oriented to position a regulator disc adjacent or closer to chamber102in relation to a control disc, such that the valve housing of the outtake assembly and the valve housing of the intake assembly are oriented in the same direction in relation to the chamber. More specifically, when gas moves from gas connector112to chamber102, the gas first flows to and/or through the control disc then to and/or through the regulator disc in the intake assembly, and when gas moves from chamber102to mask connector118, the gas first flows to and/or through the control disc then to and/or through the regulator disc in the outtake assembly. In other examples, the valve housing of the outtake assembly and the valve housing of the intake assembly may be oriented in a different direction.

Regulator disc122includes a baseline aperture144, at least one subsequent aperture146, and an override aperture148disposed on a body138of the regulator disc. The baseline aperture and/or subsequent apertures are configured to permit a selected volume of gas through each aperture for a predetermined amount of time. Baseline aperture144is sized to permit a baseline or minimum amount of volume of gas through the baseline aperture for a predetermined amount of time. Subsequent apertures146are sized to permit an additional volume of gas through each aperture. Override aperture148is configured to disable some or all of the functions of the outtake assembly and/or manual resuscitator regulating system. For example, override aperture148may be sized to permit a maximum amount of gas through the override aperture.

The regulator disc in the outtake assembly may have a larger baseline aperture and/or larger subsequent apertures in relation to a baseline aperture and/or subsequent apertures in a regulator disc in the intake assembly. For example, the baseline aperture in the outtake assembly may be sized to permit approximately 400 ml of gas over a one (1) second time period and each subsequent aperture may be sized to permit approximately 100 ml of gas over a one (1) second period. In the intake assembly, the baseline aperture may be sized to permit approximately 400 ml of gas over a five (5) second time period and each subsequent aperture may be sized to permit approximately 100 ml of gas over a five (5) second period. Additionally, the override aperture in the outtake assembly may have a different size and/or shape in relation to an override aperture in the intake assembly.

Each subsequent aperture146may be a different size or shape. In some examples, each subsequent aperture146may be the same size and shape. In this embodiment, there is one (1) baseline aperture, four (4) subsequent apertures, and one (1) override aperture, but regulator disc122may have any suitable number of baseline apertures, subsequent apertures, and/or override apertures. Furthermore, in some embodiments, the outtake assembly and/or intake assembly may include at least one aperture configured to adjustable open and/or close.

Regulator disc122may be fixedly attached to inner surface128of valve housing120. Regulator disc includes an attachment member134disposed in a central aperture136of body138of the regulator disc. The attachment member extends generally perpendicular from the body of the regulator disc and is configured to attach and/or connect to control disc126. Attachment member134includes an annular collar140disposed on a distal end142of the attachment member. Annular collar140may be any suitable shape and size to facilitate attachment and/or connection to the control disc. In some examples, the annular collar may have a diameter approximately equal to or slightly greater than the diameter of the distal end of attachment member134. Control disc126includes a body150, a protrusion152, a vent154, and an adjustment arm156. Control disc126is configured to rotate in relation to regulator disc122to expose and/or conceal the baseline aperture, subsequent apertures, and/or override aperture. Protrusion152is disposed on body150of the control disc and is configured to attach and/or connect to attachment member134to facilitate rotational movement of the control disc in relation to the regulator disc. Vent154may be sized to selectively conceal and/or expose baseline aperture144, one or more subsequent apertures146, and/or override aperture148. Subsequent apertures146and baseline aperture144may be positioned on the regulator disc to allow vent154on the control disc to expose the baseline aperture and conceal and/or expose one or more subsequent apertures when the control disc is rotated in relation to the regulator disc. The vent on the control disc may be sized to expose all subsequent apertures146and baseline aperture144at a predetermined position of the control disc in relation to the regulator disc. In some embodiments, the vent on the control disc may be sized to expose baseline aperture144and all subsequent apertures146at a predetermined position of the control disc in relation to the regulator disc while concealing the override aperture.

Adjustment arm156on control disc126extends away from body150of the control disc. The adjustment arm is configured to allow a user to selectively rotate the control disc to a desired position in relation to the regulator disc. The adjustment arm may have any suitable shape(s) or size(s) to facilitate selecting, adjusting, and/or toggling between one or more apertures on the regulator disc, volume amounts, and/or settings.

Seal124is configured to facilitate and/or support sealing one or more of the subsequent apertures, the baseline aperture, and/or the override aperture. Seal124may be configured to prevent and/or limit gas from flowing through the covered and/or concealed apertures. Seal124may be attached to body150of the control disc adjacent to vent154substantially covering the body of the control disc. The seal may be sized to subtend less than 360 degrees to facilitate movement of gas through the vent. The seal may be made of any suitable materials, such as foams or plastics, among others, to facilitate an air tight seal.

FIGS. 4-5depict various views of regulator disc122and control disc126of the outtake assembly of manual resuscitator regulating system100. As shown inFIG. 4, annular collar140of attachment member134may have teeth158formed on an internal surface160of the annular collar. The teeth may be configured to engage with complementary teeth162on protrusion152on the control disc. In other embodiments, the annular collar and/or attachment member may have any suitable shape(s) and size(s) to attach and/or engage with the control disc. As shown inFIG. 5, seal124is attached to control disc126and positioned adjacent vent154.

FIG. 6is an isometric view of valve housing120of the outtake assembly of manual resuscitator regulating system100. Valve housing120includes an index164on outer surface130of the valve housing. Adjustment arm156is disposed in a slot166of the valve housing extending away from the valve housing. The slot may have any suitable shape(s) or size(s) to facilitate and/or support a user to selectively move the adjustment arm to one or more positions or settings.

Index164may include a series of letters, numbers, colors, codes, among others, corresponding with the position of adjustment arm156of control disc126. For example, the index of the outtake assembly may include an “s” or “small” setting that is configured to be positioned to permit a selected volume of gas (e.g. 400 ml) over a one (1) second period of time. In the intake assembly, the index may include an “s” or “small” setting that is configured to be positioned to permit a selected volume of gas (e.g. 400 ml) over a five (5) second period of time. In some examples, the index of intake assembly may include an “s” or “small” setting that is configured to be positioned to permit a selected volume of gas (e.g. 400 ml) over a three (3) second period of time. The intake assembly and the outtake assembly may be configured to coordinate and/or complement the other, such that when both are adjusted to be on the same setting (e.g. small, 400 ml, blue, etc.), the intake assembly permits a selected volume of gas to allow the outtake assembly to permit a selected volume of gas (e.g. 400 ml) to be delivered to the patient. In some examples, when both the intake assembly and the outtake assembly are adjusted to be on the override setting (e.g. both set to “0”), the intake assembly and the outtake assembly permit a predetermined maximum amount of volume of gas to be delivered to the patient, such that the intake assembly and outtake assembly are disabled.

FIGS. 7-9show another embodiment of an outtake assembly of a manual resuscitator regulating system, which is generally indicated at200, according to aspects of the present teachings.FIG. 7is an exploded view of outtake assembly200and depicts outtake assembly200including a valve housing202, a regulator disc204, a first seal206, a second seal208, a control disc210, and a fastener212.FIG. 8is a top view of valve housing showing regulator disc204attached within valve housing202, andFIG. 9is a perspective view of outtake assembly200. Most of the features of this embodiment may be the same or similar to one or more embodiments described above and shown inFIGS. 1-6. For example, regulator disc204may have a body217, an attachment member218, a baseline aperture220, at least one subsequent aperture222, and an override aperture224. Additionally, althoughFIGS. 7-9depict an outtake assembly, an intake assembly, except as indicated below, may include the same and/or similar structures, components, and functions of outtake assembly200.

Valve housing202has an inner surface214and an outer surface216defining an opening226. Inner surface214forms a slotted groove228extending along the inner surface configured to receive and/or secure fastener212. The slotted groove may be any suitable shape or size to receive and/or secure fastener212to and/or within the valve housing. In some examples, the slotted groove may be defined by inner surface214and regulator disc204. Fastener212is configured to secure and/or retain one or more components of the outtake assembly to and/or within valve housing202. For example, the fastener may be configured to secure and retain control disc210and/or seal206within the valve housing adjacent to regulator disc204. This configuration may also serve to help facilitate an airtight seal between the control disc and regulator disc. AlthoughFIG. 7portrays the fastener to be substantially C-shaped, other shapes and dimensions may be appropriate depending on the size and shape of the slotted groove and/or valve housing.

Regulator disc204may be attached and/or incorporated to inner surface214of valve housing202. Baseline aperture220, subsequent apertures222, and override aperture224are disposed on body217of the regulator disc. Attachment member218extends substantially perpendicular to the body of the regulator disc and is configured to receive first seal206and/or control disc210. Attachment member includes an annular collar230on a distal end232of the attachment member and is configured to facilitate rotational movement of control disc210in relation to the regulator disc. The annular collar may rotate independently of the body of the regulator disc to allow the control disc to rotate while regulator disc remains in a fixed position in relation to the control disc. Annular collar230may include teeth234formed on an outer surface236of the annular collar and configured to engage with complementary teeth238on control disc210. In some examples, the regulator disc and/or annular collar may be configured to variably resist the rotation of the control disc, such as a saw tooth clicking mechanism.

First seal206is configured to prevent and/or limit gas from flowing through and/or between the regulator disc, control disc, and/or valve housing. First seal206includes complementary apertures240shaped and sized to substantially resemble and correspond with the baseline aperture, subsequent apertures, and override aperture of the regulator disc. First seal206has a central aperture configured to engage with attachment member218of the regulator disc. The first seal may be attached to the body of the regulator disc substantially covering the body of the regulator disc. In some examples, the first seal may be physically separated from the regulator disc.

Control disc includes a body244, a central hole246, a vent248, and an adjustment arm250. Control disc is configured to rotate in relation to regulator disc204to expose and/or conceal the baseline aperture, subsequent apertures, and/or override aperture. Central hole246is configured to receive attachment member218of regulator disc204. A protuberance252is disposed on body244of the control disc adjacent to the central hole. Protuberance252has complementary teeth238configured to engage with teeth234of the attachment member. AlthoughFIGS. 7 and 9depict two complementary teeth on the protuberance of control disc, the protuberance and/or body of control disc may include one, three, four, or more complementary teeth. Adjustment arm250defines a longitudinal recess254extending to a notch256. The longitudinal recess may be configured to align with one or more letters, numbers, colors, codes, etc. on the outer surface of valve housing202(not shown), to facilitate a user to select one or more settings and/or positions. The adjustment arm may include any suitable structure(s), shape(s), or indicator(s) to facilitate a user to select one or more settings and/or positions. For example, the adjustment arm may include one or more symbols or shapes, such as arrows, dots, colors, triangles, etc. affixed on the adjustment arm.

Valve housing forms a slot258configured to receive adjustment arm250of control disc210. The slot may have any suitable shape(s) or size(s) to facilitate a user to selectively move the adjustment arm to one or more positions or settings. Additionally, slot258may be configured to receive second seal208. The second seal is configured to prevent and/or limit gas from flowing through the slot. The second seal may have any suitable size(s) or shape(s) to facilitate movement of the adjustment arm but limit and/or prevent gas from flowing through the slot.

FIG. 10shows an embodiment of a manual resuscitator regulating system, which is generally indicated at300, according to aspects of the present teachings.FIG. 10depicts manual resuscitator regulating system300including a chamber302with a first end304and a second end306, an intake assembly generally indicated at310, an outtake assembly generally indicated at312, hosing308, a mask connector314, a mask316, and a placement indicator generally indicated at320. Most of the features of this embodiment may be the same or similar to one or more embodiments described above and shown inFIGS. 1-9. For example, intake assembly may include a valve housing, a regulator disc, a seal, and a control disc (not shown). In other examples, manual resuscitator regulating system300may include more or less components. For example, manual resuscitator regulating system300may include an intake assembly and no outtake assembly. In other examples, manual resuscitator regulating system300may not include the intake assembly or the outtake assembly.

Placement indicator320may be attached to, or formed with, an outer surface318of chamber302. Placement indicator320may be configured to guide or indicate to a user where to squeeze or compress the chamber to facilitate the delivery of a selected volume of gas. For example, placement indicator320may include indicia corresponding to one or more volumes of gas, such that if a user compresses or squeezes the chamber where indicated, the selected volume of gas may be delivered. In some examples, the placement indicator may be configured to help a user identify where to properly place a user's hand and/or finger(s) on the chamber. This configuration may serve to help limit variations or inconsistency in the volume of gas delivered between different users with different hand size.

Placement indicator320may be configured to provide visual, auditory, and/or tactile indicators to a user. For example, the placement indicator may include one or more references, indices, guides, charts, symbols, letters, numbers, colors, and/or codes corresponding with a selected volume of gas and/or patient size. In some examples, the placement indicator may include defined compression zones or areas indicating where to compress to deliver a selected volume of gas and/or for a selected size of patient (e.g. grip chart). In other examples, the placement indicator may include grooves, ribs, projections, teeth, tabs, among others. Additionally, or alternatively, placement indicator320may include tabs that are configured to press together to indicate finger and/or hand placement on the chamber. In some examples, the placement indicator may include a groove or recess shaped to receive one or more portions of a user's hand or finger(s).

Placement indicator320may be configured to allow a user to selectively move or adjust finger and/or hand placement to a selected volume of gas and/or size of patient. For example, the placement indicator may be configured to allow a user to selectively adjust or vary the user's grip circumferentially in a plane perpendicular to longitudinal axis A. Additionally, or alternatively, the placement indicator may be configured to allow a user to selectively adjust or vary the user's grip longitudinally along longitudinal axis A. The placement indicator may be configured to allow a user to selectively move or adjust finger and/or hand placement in any suitable direction, including vertically, horizontally, and/or diagonally.

Although placement indicators320a-dare shown to be shaped the same, the placement indicators may have any suitable shape(s) and/or sizes. For example, placement indicators320a-dmay each be generally rectangular, as shown inFIG. 10. In other examples, the placement indicators may be cylindrical, triangular, or ovular. In some examples, the placement indicator may be sized to at least partially extend and/or surround the circumference of the chamber, such as a sleeve.

Placement indicator320may be configured to attach to, retrofit and/or incorporate with existing manual resuscitators. For example, placement indicator320may be configured to be releasably attached, such as a sleeve or wrap. In some examples, the placement indicator may include one or more adhesive materials, snaps, locks, among others. In other examples, the placement indicator may be configured to allow a user to interchange one or more placement indicators.

Additionally, althoughFIG. 10depicts manual resuscitator regulating system300and/or chamber302including one placement indicator320, manual resuscitator regulating system300may include two or more placement indicators. For example, the chamber may include a second placement indicator (not shown) positioned generally opposite from placement indicator320. In some examples, the second placement indicator may mirror the first placement indicator. The second placement indicator may be configured to complement, correspond and/or facilitate placement indicator320.

The placement indicator may be in any suitable orientation(s) or position(s). For example, the placement indicator may be oriented to increase visibility of the indicia or other visual information to facilitate placement on the chamber. The placement indicator may include any suitable structure(s) to facilitate visual, tactile, and/or auditory indicators of the placement indicator.

Placement indicator320may be used in conjunction with or independently from the intake assembly and/or outtake assembly. For example, the indicia or indicators may be configured to coordinate with and/or complement one or more settings on the outtake assembly and/or intake assembly.

FIG. 11is a flowchart illustrating steps performed in an exemplary method, and may not recite the complete process or all steps of the process.FIG. 11depicts multiple steps of a method, generally indicated at400, which may be performed in conjunction with the manual resuscitator regulating systems according to aspects of the present disclosure. Although various steps of method400are described and depicted inFIG. 11, the steps need not necessarily all be performed, and in some cases may be performed in a different order than the order shown.

At step402, a manual resuscitator regulating system is provided. The manual resuscitator regulating system may include and/or incorporate some or all of the characteristics described above with respect toFIGS. 1-10, such as an intake assembly configured to permit a selected volume of gas to flow over a predetermined amount of time, an outtake assembly configured to permit a selected volume of gas flow over a predetermined amount of time, a chamber, and a patient interface respiratory device configured to deliver gas to the patient. The intake assembly and the outtake assembly may include one or more adjustment mechanisms configured to allow a user to selectively adjust the volume of gas that flows in and out of the chamber. The intake assembly and the outtake assembly may be configured to coordinate with one another to deliver a selected tidal volume and/or volume of gas. The manual resuscitator regulating system may include a feedback mechanism configured to provide one or more signals to a user when to squeeze or compress the chamber. The manual resuscitator regulating system may include a placement indicator configured to indicate or guide a user where to squeeze or compress the chamber. The functions and structures of the various components of the manual resuscitator regulating system also may be as described previously.

At step404, the setting(s) on the intake assembly and/or the outtake assembly may be customized based on one or more characteristics of a patient to deliver a selected volume of gas to the patient, for example as described above. A user may approximate a patient's age and/or size to determine the customized setting(s) on the intake assembly and/or the outtake assembly. The setting(s) on the intake assembly and the outtake assembly may be customized and/or adjusted to be on the same setting or on different setting(s). For example, a user may adjust the setting on the intake assembly to be on the same setting as the outtake assembly, such as both on the same number, color, code, letter, or alternatively, the user may adjust the setting on the intake assembly to be on a different setting from the outtake assembly. Additionally, or alternatively, the user's finger(s) and/or hand may be positioned on the placement indicator based on selected volume of gas and/or size of patient.

At step406, the patient interface respiratory device may be applied to the patient. The patient interface respiratory device may include a mask, endotracheal tube, laryngeal mask airway, and/or any other suitable device to deliver gas to a patient.

At step408, the chamber may be compressed for X amount of time to deliver a selected volume of gas to a patient, for example as described above. In some examples, the chamber may be compressed for approximately 1 second.

At step410, the chamber may be allowed to refill (or fill) with the selected volume of gas for a predetermined amount of time, for example as described above.

At step412, the user may wait for one or more signals from a feedback mechanism, for example as described above. In some examples, one or more signals may alert a user five (5) seconds after the chamber began to refill.

At step414, the user may repeat steps408through412.

FIGS. 12A and 12Bdepict another embodiment of a manual resuscitator regulating system, which is generally indicated at500, according to aspects of the present teachings.FIGS. 12A and 12Bdepict manual resuscitator regulating system500including a chamber502with a first end504and a second end506, an intake assembly indicated at508, an outtake assembly indicated at510, a first placement indicator512, a second placement indicator514, and a patient interface respiratory device516. Most of the features of this embodiment may be the same or similar to one or more embodiments described above and shown inFIGS. 1-10. For example, manual resuscitator regulating system500may include a feedback mechanism configured to provide one or more signals to a user when to squeeze or compress the chamber. Intake assembly508includes an adjustment mechanism generally indicated at518. Outtake assembly510may include and/or incorporate a flapper valve or a one-way valve (not shown) to facilitate one-way movement of gas. In other examples, manual resuscitator regulating system500may include more or less components. For example, outtake assembly510may include an adjustment mechanism configured to coordinate with intake assembly508to deliver a selected tidal volume and/or volume of gas.

First placement indicator512and second placement indicator514are attached to a sleeve540disposed circumferentially around chamber502. Sleeve540may be releasably attached to chamber502and configured to allow chamber502to regain its original shape after a user compresses or squeezes the chamber. Sleeve540may be made of one or more suitable materials, such as rubber (neoprene), polymer, elastic, mesh, and/or other materials with resilient properties. In some examples, sleeve540may be one or more suitable colors, such as yellow, green, black, and/or orange. In some examples, sleeve540may include one or more bright or fluorescent colors or reflective bands for increased visibility. Additionally, or alternatively, the sleeve may be configured to help a user hold and/or support the chamber, such as by including non-slip gripping material and/or a strap that can be engaged by a user's hand(s). Although first and second placement indicators are attached to sleeve540, first and second placement indicators may be attached to, and/or formed with, an outer surface of chamber502.

First placement indicator512is positioned generally opposite from second placement indicator514on the sleeve of chamber502. The first and second placement indicators are configured to guide and/or indicate to a user where to squeeze or compress the chamber to facilitate the delivery of a selected volume of gas. In some examples, the first and second placement indicators may be configured to deliver a selected volume of gas if a user squeezes or compresses in the defined areas or zones of the first and second placement indicators. Additionally, first and second placement indicators may include tactile feedback or targets configured to provide one or more tactile signals to a user when a selected volume of gas flows out of chamber. For example, when a user squeezes or compresses the first and second placement indicators and a user's fingers and/or hand on the first placement indicator touch and/or are palpable to the user's fingers and/or hand on the second placement indicator, this may signal to a user when a selected volume of gas flows out of chamber. This configuration may indicate to a user when to release the chamber and/or allow the chamber to refill. Although second placement indicator514is positioned generally opposite first placement indicator512, the second placement indicator may be positioned further away from or closer to the first placement indicator. Additionally, although first and second placement indicators are mirror images of the other, first and second placement indicators may be in any suitable orientation or direction.

The first and second placement indicators are configured to allow a user to selectively adjust or vary a user's grip circumferentially and longitudinally in relation to chamber502to deliver a selected volume of gas. For example, first placement indicator512includes a first placement512apositioned longitudinally in relation to the chamber from a second placement512band a third placement512c. Second placement512bis positioned circumferentially in relation to the chamber from third placement512c. Although second placement indicator514has the same or similar orientation to first placements512a-c, a first placement514a, a second placement514b, and a third placement514cof the second placement indicator may be any suitable direction, including vertically, horizontally, and/or diagonally, to complement, correspond and/or facilitate first placement indicator512.

FIGS. 13-14depict various views of intake assembly508of manual resuscitator regulating system500.FIG. 13is a side view of intake assembly508and depicts a valve housing520with a distal portion522and a proximate portion524, and an adjustment collar528rotationally connected to valve housing520.FIG. 14is an exploded view of intake assembly508showing distal portion522and proximate portion524of the valve housing, adjustment collar528, and a regulator disc526. Intake assembly508may include one or more features described above and shown inFIGS. 1-10. For example, intake assembly508may include a plurality of seals530and a fastener536. Valve housing may include an index534. Regulator disc526may include a central aperture552, a baseline aperture554, at least one subsequent aperture556, and an override aperture558.

Distal portion522of the valve housing includes a body538, a vent542, and an attachment extension546. Distal portion is configured to facilitate movement of air through the valve housing from one or more sources of gas to regulator disc526. Body may be configured to attach and/or connect to proximate portion524of the valve housing. For example, body538may be configured to receive and/or retain fastener536. Vent542is configured to facilitate the movement of gas through the distal portion of the valve housing. Attachment extension546is configured to removably attach and/or connect to a hose apparatus, tubing apparatus, or other similar structure from one or more sources of gas. The attachment extension includes one or more screw threads548on an outer surface550of the attachment extension that may engage with complementary screw threads on a hose apparatus, tubing apparatus, or other similar structure. In other embodiments, the attachment extension may be configured to slip-on and/or snap-on a hose apparatus, tubing apparatus, or other similar structure.

Proximate portion524of the valve housing includes a body560, a vent562, and an attachment extension564. Proximate portion524is configured to facilitate movement of air through the valve housing from regulator disc526to chamber502. Body560may be configured to attach and/or connect to distal portion522of the valve housing. In some examples, proximate portion524may be fixedly attached to, or formed with, distal portion522.

Proximate portion524includes index534disposed circumferentially on an outer surface532of the proximate portion (see, for example,FIG. 13). Index534includes a series of letters, numbers, and colors configured to correspond with the rotational position of regulator disc526to indicate a selected volume of gas. For example, an “s” or “small” setting may be configured to be positioned to permit a selected volume of gas (e.g. 400 ml) over a five (5) second period of time, an “avg” or “average” setting may be configured to be positioned to permit a selected volume of gas (e.g. 500 ml) over a five (5) second period of time, and a “lg” or “large” setting may be configured to be positioned to permit a selected volume of gas (e.g. 600 ml) over a five (5) second period of time. In some examples, index534may include settings configured for a pediatric patient. Although index534includes letters, numbers, and colors, index534may include any combination of letters, numbers, colors, or other indicia. Additionally, index534may include color-coding schemes (e.g. Broselow-Luten system).

Regulator disc526is disposed between distal portion522and proximate portion524and is fixedly attached to, and/or formed with adjustment collar528. Distal and proximate portions are configured to facilitate rotational movement of regulator disc526. The regulator disc may rotate independently of the distal and proximate portions of the valve housing while the distal and proximate portions remain in a fixed position in relation to the regulator disc.

Adjustment collar528is configured to facilitate a user to selectively move the adjustment collar to one or more positions or settings to permit a selected volume of gas. The adjustment collar includes a first notch566and a second notch568configured to expose one or more settings of index534. Although first notch566is positioned generally opposite from second notch568, the first notch and the second notch may be in any suitable position(s). In some examples, the first notch and second notch may be configured to expose the same indicia on index534to facilitate visibility of the indicia. In other examples, the first notch may be configured to expose different indicia than the second notch. The first and second notches may be any suitable shape(s) and size(s) to facilitate visibility of the index. Although the adjustment collar includes two notches, adjustment collar528may include one, three, or more notches. Index534may include the same indicia in one or more locations on the index to facilitate visibility, such that the same indicia may be visible in two or more notches. In other examples, index534may include complementary indicia in one or more locations, such that the complementary indicia may be visible in two or more notches.

Adjustment collar528is depicted as including a plurality of grooves or recesses570disposed on an outer surface572of the adjustment collar. Recesses570are configured to facilitate a user to select, adjust, and/or toggle between at least two volume amounts and/or settings on index534. Recesses570may extend generally perpendicular to the rotational direction of the adjustment collar. Recesses570may have any suitable shape(s) and size(s). Additionally, adjustment collar528may be any suitable color and/or have any suitable structure to facilitate visibility to a user, such as yellow, orange, and/or reflective material.

Intake assembly508may include a click stop mechanism574for making the adjustment collar stop with a click at any one of a plurality of click stop positions disposed on the regulator disc when the adjustment collar is rotated. This configuration may help a user select, adjust, and/or toggle between volume amounts and/or settings on index534. The click stop mechanism may be configured to facilitate a spring-biased ball bearing, or similar. For example, click-stop mechanism574may include a plurality of depressions576which determine the plurality of click stop positions; a ball guide groove578formed on the regulator disc, one or more balls580positioned at the ball guide groove and configured to engage with, and/or disengage from, the depressions, and one or more pegs582configured to support and/or press balls580into contact with the click stop positions. Pegs582may be made of one or more suitable materials, such as rubber, plastic, and/or other materials with resilient properties.

FIG. 15shows another embodiment of a manual resuscitator regulating system, which is generally indicated at600, according to aspects of the present teachings.FIG. 15depicts manual resuscitator regulating system600including a chamber602with a first end604and a second end606, an intake assembly generally indicated at610, an outtake assembly generally indicated at612, hosing608, a mask connector614, a mask616, a valve617, and a placement indicator generally indicated at620. Most of the features of this embodiment may be the same or similar to one or more embodiments described above and shown inFIGS. 1-14. For example, placement indicator may include multiple placements indicating small (or “S”), average (or “AVG”), and large (or “LG”) settings. In some examples, intake assembly and/or outtake assembly may include a valve housing, a regulator disc, a seal, a control disc, an adjustment arm, and/or an adjustment collar (not shown). In other examples, manual resuscitator regulating system600may include more or less components. For example, manual resuscitator regulating system600may include an intake assembly and no outtake assembly.

As shown inFIG. 15, intake assembly610and outtake assembly612are operably connected and/or attached to first end604of the chamber. Intake assembly610is operably connected and/or attached to the chamber through an intake hose618. Outtake assembly612is operably connected and/or attached the chamber through an outtake hose620. Intake hose618may partially form with and/or attach to outtake hose620. In other examples, intake hose618may be structurally separate from outtake hose620. Although manual resuscitator regulating system600depicts the intake assembly and outtake assembly operably connected and/or attached to the chamber through intake hose618and outtake hose620, manual resuscitator regulating system600may include any suitable structure to connect and/or attach the intake assembly and/or outtake assembly to the chamber.

While embodiments of one or more manual resuscitator regulating systems have been particularly shown and described, many variations may be made therein. This disclosure may include one or more independent or interdependent embodiments directed to various combinations of features, functions, elements and/or properties. Other combinations and sub-combinations of features, functions, elements and/or properties may be claimed later in a related application. Such variations, whether they are directed to different combinations or directed to the same combinations, whether different, broader, narrower or equal in scope, are also regarded as included within the subject matter of the present disclosure. Accordingly, the foregoing embodiments are illustrative, and no single feature or element, or combination thereof, is essential to all possible combinations that may be claimed in this or a later application.

The disclosure set forth above may encompass multiple distinct inventions with independent utility. Although each of these inventions has been disclosed in its preferred form(s), the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense, because numerous variations are possible. The subject matter of the invention(s) includes all novel and nonobvious combinations and subcombinations of the various elements, features, functions, and/or properties disclosed herein. Similarly, where any claim recites “a” or “a first” element or the equivalent thereof, such claim should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements. Furthermore, any aspect shown or described with reference to a particular embodiment should be interpreted to be compatible with any other embodiment, alternative, modification, or variance.

The following is a list of applicable reference numbers, along with descriptions of each numbered component: