Apparatus and method for expanding a ventilator circuit

Abstract

A device is described that houses a positive end-expiratory pressure (PEEP) valve and converts the PEEP valve into an in-line valve for use in a differential multiple ventilation system. The device includes a housing configured to house the PEEP valve. The housing also includes a ventilator-side arm, a pass-through arm, and a patient-side arm. The pass-through arm allows the multiple ventilation system to add one or more patients to the system.

Description

[Technical Field]

[0001] The present technology relates to systems for providing mechanical ventilation in healthcare settings, and more particularly to devices used to house in-line valves used in ventilator circuits. [Background technology]

[0002] A ventilator is a machine that provides mechanical ventilation by moving breathable air into and out of the lungs to deliver breaths to patients who are physically unable to breathe or whose breathing is insufficient. Modern ventilators are computerized, microprocessor-controlled machines. Patients can also be ventilated using a simple manual bag-valve-mask. Ventilators are primarily used in intensive care, home health care, and emergency medicine (as stand-alone units), in critical care transport or prehospital emergency medical services, and in anesthesia (as a component of anesthesia machines).

[0003] In its simplest form, a modern positive pressure ventilator consists of a compressed air reservoir or turbine, an air and oxygen supply, a set of valves and tubing, and a disposable or reusable "patient circuit." The air reservoir is compressed pneumatically several times per minute to deliver room air, often an air / oxygen mixture, to the patient. When a turbine is used, it pushes air through the ventilator, and a flow valve adjusts the pressure to meet patient-specific parameters. When the overpressure is released, the patient passively exhales due to lung elasticity, and the exhaled air is usually released through a one-way valve in the patient circuit, known as the patient manifold.

[0004] Modern conventional ventilators typically include monitoring and alarm systems for patient-related parameters (e.g., pressure, volume, and flow) and ventilator function (e.g., air leaks, power failure, mechanical failure), backup batteries, oxygen tanks, and remote controls. Often, a computer-controlled turbopump replaces the pneumatic system.

[0005] Modern ventilators are electronically controlled by miniature embedded systems that allow precise matching of pressure and flow characteristics to individual patient needs. Fine-tuned ventilator settings also serve to make ventilation more tolerable and comfortable for the patient. The patient circuit typically consists of a set of three durable yet lightweight plastic tubings separated by function (e.g., inspiration, patient pressure, expiration). The patient end of the circuit can be non-invasive or invasive, as determined by the type of ventilation required.

[0006] The 2019 novel coronavirus disease (COVID-19) pandemic has strained resources and led to actual or anticipated ventilator shortages, prompting health care systems to urgently seek ways to increase ventilator capacity. One proposed solution is the sharing of ventilators among multiple patients. Although so-called "shared ventilation" strategies have been used in New York State and have been designated a crisis by U.S. agencies, including the Department of Health and Human Services and the Federal Drug Administration, significant potential risks of such techniques have led major medical organizations to issue warnings against their use. To address these limitations, several international working groups have designed modified ventilator circuits that allow for individualized settings for patients sharing a ventilator. Known as differential multi-ventilation systems, these modified systems use flow restrictors and sensors to allow for individual adjustment and monitoring of inspiratory and expiratory variables. One exemplary system is shown in (Roy et al., 2020, Crit. Care Explor. 2(9):e0198, incorporated herein by reference in its entirety).

[0007] Many differential multiplexed ventilation systems use variations on the basic approach in an attempt to solve the problems associated with isolated ventilators. First, all patients must be passively ventilated because patient activation of the ventilator could result in hyperventilation of one or both patients and potentially dangerous patient-patient-ventilator interactions. Sufficient sedation, and paralysis if necessary, is used to prevent one or more patients from initiating a breath. Second, the ventilator must be in pressure-controlled mode. Using a pressure-regulated ventilator mode prevents a situation in which only one patient receives a tidal volume intended for two or more patients due to circuit or patient obstruction. As a secondary benefit, pressure-based modes also facilitate the individualization process, as pressure is easier to mechanically regulate than volume. Third, patient ventilation variables are individually monitored using digital or mechanical manometry, flow sensors, end-tidal CO2 monitors, and / or noninvasive cardiac output monitors. Finally, valves and flow restrictors are used in each patient circuit to individualize ventilation variables. While numerous flow restrictors have been described, many differential multiplex ventilation systems use adjustable in-line positive end-expiratory pressure (PEEP) valves in at least part of the system. In-line PEEP valves perform three important functions in differential multiplex ventilation systems: 1) reduce the peak inspiratory pressure (PIP) delivered to the individual patient circuits (flow restrictors), 2) increase PEEP for the individual patient circuits (pressure relief valves), and 3) act as one-way valves (also known as check valves) to ensure one-way gas flow through the divided circuits.

[0008] Under normal circumstances, the pressure in the lungs at the end of expiration is equal to atmospheric pressure. PEEP refers to the application of additional pressure at the end of expiration to maintain the pressure in the lungs just above atmospheric pressure. This pressure, trapped inside the lungs, acts as a force pushing outward against the alveoli and keeping them open, thereby increasing the amount of gas inside the lungs at the end of expiration. PEEP is a simple default setting on many mechanical ventilators. [Prior art documents] [Non-patent literature]

[0009] [Non-Patent Document 1] Roy et al., 2020, Crit. Care Explor. 2(9): e0198 [Non-patent document 2] Bunting et al., Am.J.Emerg.Med., 2020, https: / / doi.org / 10.1016 / j.ajem.2020.06.089 Summary of the Invention [Problem to be solved by the invention]

[0010] There remains a need for improvements in differential multiple ventilation systems. [Means for solving the problem]

[0011] In accordance with one aspect of the present technology, a device is provided for housing a positive end-expiratory pressure (PEEP) valve and converting the PEEP valve into an in-line valve for use in a differential multiple ventilation system. In one embodiment, the device includes a housing configured to house the PEEP valve. The housing includes a ventilator-side arm, a pass-through arm, and a patient-side arm. The pass-through arm allows the system to be expanded to add one or more patient circuits to the multiple ventilation system.

[0012] The ventilator-side arm and the pass-through arm can be sized to connect directly to one another such that the pass-through arm of the first device described above is connectable to the ventilator-side arm of the second device described above.

[0013] The device can be configured for use as an inspiratory in-line valve, with the ventilator arm and the pass-through arm coaxial with a first conduit passing through the housing. In this configuration, the first conduit is continuous with a substantially vertical second conduit generally centered within the housing, the second conduit configured to connect to a valve port of the PEEP valve when the PEEP valve is provided in the device. In this configuration, the second conduit is isolated from the patient arm when the PEEP valve is provided in the device and the PEEP valve is closed, and the second conduit allows gas flow to the patient arm when the PEEP valve is provided in the device and the PEEP valve is open.

[0014] The device can be configured for use as an exhalation in-line valve, with the patient arm continuing with a substantially vertical second conduit substantially centered within the housing. In this configuration, the second conduit is configured to connect to the main sleeve of the PEEP valve when the PEEP valve is provided in the device. In this configuration, the second conduit is isolated from the ventilator arm and the pass-through arm when the PEEP valve is provided in the device and the PEEP valve is closed, and the second conduit allows gas flow to the ventilator arm when the PEEP valve is provided in the device and the PEEP valve is open.

[0015] In any of the above embodiments, the housing can be defined by a main opening, and a cap can be coupled to the body over the main opening, the cap having an internal structure configured to connect to a pressure adjustment head of the PEEP valve, thereby allowing the cap to adjust the pressure adjustment head of the PEEP valve. The internal structure of the cap can include a sleeve sized to connect to the pressure adjustment head of the PEEP valve when the PEEP valve is installed in the device. The cap can be coupled to the housing by a threaded engagement, allowing the threaded engagement to adjust the pressure adjustment head of the PEEP valve.

[0016] In some embodiments, the outer sidewall of the housing includes markings indicative of valve pressure, and positioning of the edge of the cap relative to the markings indicates the valve pressure depending on the degree of threading.

[0017] In some embodiments, the inner sidewall of the housing includes a PEEP valve retention element.

[0018] According to another aspect of the present technology, there is provided a device set for assembling and connecting an inhalation in-line valve and an exhalation in-line valve to each other. In one embodiment, the set includes the inhalation device as described above, further including a first connector on a body of the inhalation device, and the exhalation device as described above, further including a second connector on the housing of the exhalation device. In this embodiment, the first connector and the second connector are configured to connect to each other.

[0019] In some embodiments of the device set, the housing of the inhalation device includes a first visual indicator to indicate inhalation, and the housing of the exhalation device includes a second visual indicator to indicate exhalation.

[0020] In accordance with another aspect of the present technology, there is provided a kit comprising the device set described above, the kit also comprising instructions for assembling a differential multiple ventilator system using the device set, and in some embodiments, the kit further comprises a plurality of PEEP valves.

[0021] According to another aspect of the present technology, there is provided a ventilator system including a ventilator and an in-line valve set formed from the above-described device having a PEEP valve, wherein the ventilator-side arms of both the inspiratory device and the expiratory device are connected to the ventilator, the patient-side arms of both the inspiratory device and the expiratory device are connected to a first patient circuit, and a bypass conduit is connected between the pass-through arms of the inspiratory device and the expiratory device.

[0022] According to another aspect of the present technology, there is provided a differential multiple ventilator system including a ventilator and a first in-line valve set formed from the PEEP-valved device described above. The ventilator-side arms of both the inspiratory and expiratory devices of the first in-line valve set are connected to the ventilator, and the patient-side arms of both the inspiratory and expiratory devices of the first in-line valve set are connected to a first patient circuit. The system further includes at least a second in-line valve set formed from the PEEP-valved device described above. The second in-line valve set is connected to the first in-line valve, and the pass-through arms of the inspiratory and expiratory devices of the first in-line valve set are connected to the ventilator-side arms of the inspiratory and expiratory devices of the second in-line valve set, and the patient-side arms of both the inspiratory and expiratory devices of the second in-line valve set are connected to at least a second patient. A bypass conduit is connected between the pass-through arms of the second in-line valve set or between the pass-through arms of the last in-line valve set connected after the second device set.

[0023] According to another aspect of the present technology, there is provided a method of assembling a differential multiple ventilator system, the method comprising the steps of: configuring a plurality of in-line valve sets by providing PEEP valves in a plurality of inspiratory and expiratory devices as described above; connecting a first in-line valve set of the plurality of in-line valves to a ventilator via the ventilator-side arm of the inspiratory device and the ventilator-side arm of the expiratory device of the first device set and connecting the first patient circuit to the patient-side arm of the first in-line valve set; connecting the pass-through arm of the inspiratory device of the first in-line valve set to the ventilator-side arm of at least a second in-line valve set, thereby connecting the second in-line valve set to the first in-line valve set and connecting at least a second patient circuit to the patient-side arm of the second in-line valve set, thereby resulting in an expanded in-line valve set; and connecting a bypass conduit between the pass-through arms of a last in-line valve set in the expanded in-line valve set.

[0024] In some embodiments of the above-described methods, the expanded in-line valve set includes two, three, four, five, or six in-line valve sets.

[0025] In some embodiments of the above-described method, for each in-line valve set of the expanded in-line valve set, the inhalation device is connected to the exhalation device by connecting the first connector to the second connector.

[0026] In some embodiments, the method further includes disconnecting the bypass conduit from the final in-line valve set, connecting an additional in-line valve set to the final in-line valve set, and connecting the bypass conduit between pass-through arms of the additional in-line valve set, thereby adding the additional in-line valve set to the expanded in-line valve set.

[0027] In some embodiments of the method, the ventilator is maintained in continuous operation and the first patient circuit continues to operate during the step of connecting at least a second in-line valve set.

[0028] Various objects, features, and advantages of the present technology will become apparent from the following description of specific embodiments of the technology, as illustrated in the accompanying drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of various embodiments of the technology. Like reference numerals refer to like elements. [Brief explanation of the drawings]

[0029] [Figure 1A] 1 is an exemplary diagram of a conventional PEEP valve in a closed position where air pressures below 5 cmH2O do not open the spring valve. [Figure 1B] FIG. 1 is an illustrative diagram of a conventional PEEP valve in the open position, where air pressure above 5 cmH2O opens the spring valve and releases air to the atmosphere. [Figure 2A] FIG. 1 is an exemplary diagram of an in-line (contained) PEEP valve in the expiratory limb of a differential multiple ventilation system in a closed position, where air pressures below 10 cmH2O do not open the spring valve. [Figure 2B] FIG. 1 is an exemplary diagram of an in-line (housed) PEEP valve in the expiratory limb of a differential multiple ventilation system in the open position, where air pressure above 10 cmH2O opens the spring valve and air enters the enclosure. [Figure 3A] FIG. 1 is an exemplary diagram of an in-line (housed) PEEP valve in the inspiratory limb of a differential multiple ventilation system in a closed position, where air pressures below 25 cmH2O do not open the spring valve. [Figure 3B] FIG. 1 is an exemplary diagram of an in-line (housed) PEEP valve in the inspiratory limb of a differential multiple ventilation system in the open position, where air pressure above 25 cmH2O opens the spring valve and air enters the enclosure. [Figure 4] FIG. 1 is a diagram of an example of a simplified differential multiple ventilation circuit. [Figure 5]1A-1C are diagrams of a set of in-line valves shown in different perspective views, including an inhalation valve 100 and an exhalation valve 200. [Figure 6] FIG. 1 is an exploded perspective view of an inhalation in-line valve 100 including a PEEP valve 500. [Figure 7] 5 is another exploded perspective view of the inhalation in-line valve 100 including the PEEP valve 500. FIG. [Figure 8] 1 is a perspective view of a PEEP valve 500 provided in a housing 110. FIG. [Figure 9] FIG. 2 is a top perspective view of the intake housing 110. [Figure 10] FIG. 2 is a side view of the exhalation housing 210. [Figure 11] FIG. 1 is a perspective view of a connected in-line valve set including an inhalation valve 100 and an exhalation valve 200 connected via base connectors 114 and 214. [Figure 12] 6A-C are perspective views of a differential multi-ventilator system showing three connected in-line valve sets 300A-C connected to a ventilator 600. DETAILED DESCRIPTION OF THE INVENTION

[0030] Principle explanation Basic function of the adjustable PEEP valve as a pressure relief valve PEEP valves are adjustable pressure-relief valves. These valves are commonly used in conjunction with bag-valve-masks and typically release exhaled gas to the atmosphere. When pre-valve pressure exceeds the valve setpoint, the diaphragm opens, allowing flow. When pre-valve pressure falls below the valve setpoint, the diaphragm closes, stopping flow across the valve. In-line PEEP valves also function as one-way or check valves in that backflow is prevented by the closed diaphragm. Typical PEEP valve function depends on the valve being closed by a spring (shown in Figures 1A and 1B). The spring can be manually tensioned to apply a set amount of pressure (e.g., 5 cmH2O). At atmospheric pressure, the valve remains closed; if the pre-valve pressure is lower than the pressure exerted by the tensioned valve, pressure builds up below the valve (Figure 1A). If the pre-valve pressure builds up to a point higher than the tensioned spring can exert, the valve opens and gas is released until the pre-valve gas pressure is again below the set point (Figure 1B).

[0031] When a PEEP valve is placed in an in-line enclosure, as shown in Figures 2A, 2B, 3A, and 3B, the PEEP valve can function at pressures other than local atmospheric pressure. In this configuration, the set point of the PEEP valve is the sum of the pressure exerted by the spring and the pressure exerted by the gas pressure in the post-valve compartment of the enclosure. The valve will open only if the pre-valve pressure is greater than the sum of the pressure at which the spring is tensioned and the post-valve gas pressure.

[0032] Adjustable in-line PEEP valve as a pressure relief valve When an in-line PEEP valve is placed in the expiratory limb of a differential multiplex ventilation system, such as the system shown in FIG. 4, the gas entering the enclosure is the expiratory flow from the patient, and the post-valve gas pressure is regulated by the ventilator. Because the post-valve gas pressure reflects the positive end-expiratory pressure (PEEP) set in the ventilator, the additional resistance to outflow from the individual expiratory circuit by the spring represents additional PEEP above the PEEP set by the ventilator. Thus, the in-line PEEP valve setting in the expiratory circuit is additive to the ventilator PEEP (i.e., if the in-line PEEP valve is set to 5 cmH2O and the ventilator is set to maintain 5 cmH2O of PEEP, the total PEEP is 10 cmH2O in the circuit).

[0033] Adjustable in-line PEEP valve as a flow restrictor The use of an in-line PEEP valve in the inspiratory limb of a differential multiplexed ventilator circuit, as opposed to the expiratory limb, results in different behavior (Figures 3A and 3B). Gas entering the enclosure inlet is the inspiratory flow from the ventilator, and the valve resists this flow by tension in the spring. The pre-valve gas pressure reflects the peak inspiratory pressure (PIP) set on the ventilator, and the in-line valve controls the prescribed PIP (PIP) for the individual patient. patient At the beginning of the inspiratory phase, the pressure in the individualized circuit is always equal to the PIP pressure (PIP vent ) is lower than the desired PIP. patient Allow gas introduction until a PIP of 25 cmH2O is achieved. At this point, the post-valve gas pressure combined with the spring tension is equal to or greater than the pre-valve pressure, and the valve closes. Thus, the in-line PEEP valve setting in the inspiratory circuit is subtractive to the ventilator PIP (i.e., the inspiratory in-line valve is set to 5 cmH2O and the ventilator is set to a PIP of 25 cmH2O). vent If set to deliver a net PIP patient is 20 cmH2O in the circuit).

[0034] In contrast to the behavior of in-line PEEP valves in the inspiratory circuit, many other types of flow restrictors described for use in differential multiplexed ventilator systems offer far less predictable performance characteristics. For example, flow restrictors such as ball or pin valves rely on variable constriction to provide flow restriction. This approach results in a constant pressure drop only as long as the inspiratory time remains constant. If the inspiratory / expiratory ratio is changed so that the inspiratory time is extended, the pressure in the post-valve circuit has more time to equalize with the pre-valve pressure and can increase despite no change in the valve setting. In addition to time-dependent inspiratory behavior, most valves have nonlinear flow restriction. For example, in a ball valve, the initial rotation of the control lever results in minimal change in flow because the threshold size of the constriction has not yet been achieved. As the lever is rotated further to create significant constriction, the lever rotation becomes progressively smaller, resulting in progressively greater flow restriction. Finally, the lack of numerical settings in critical units for ball and pin valves makes it difficult to reproduce or predict the desired settings. In contrast, adjustable in-line PEEP valves do not suffer from these major drawbacks in differential multiplexed ventilator systems; i.e., PEEP valves exhibit relatively time-independent behavior, near-linear adjustable flow restriction, and do so with predictable numerical settings in the correct units (cmH2O).

[0035] Check valve function of in-line PEEP valve In its basic configuration, the PEEP valve is a spring-loaded disc check valve. As soon as the pressure at the outlet, combined with the spring force, exceeds the inlet pressure, the membrane closes the valve and flow stops. This check valve behavior ensures one-way flow in the individual patient circuits and prevents re-inhalation of exhaled gases. In a differential, multiple-ventilator system, all limbs of the circuit require a check valve. Therefore, if in-line PEEP valves are used in both the inspiratory and expiratory limbs of the patient circuit, a conventional check valve is only required in the bypass circuit (Figure 4).

[0036] The effect of in-line PEEP valves on ventilator alarms The use of an in-line PEEP valve should not significantly affect ventilator alarms in a properly configured system. In fact, the use of an adjustable in-line PEEP valve in conjunction with a bypass circuit specifically allows ventilator alarms to remain unaffected by ensuring that two normal situations continue to occur: equal net inhaled and exhaled gas volumes at the inhalation and exhalation ventilator ports, and equal gas pressures at the inhalation and exhalation ports of the ventilator. In contrast to conventional PPEP valves, an in-line PEEP valve allows for a closed system because no gas is vented to the atmosphere. When constructed with a sufficiently sealed material, the in-line PPEP valve should not introduce any leaks into the system, so the amount of gas leaving the ventilator at the inhalation circuit port is the same as the amount received at the exhalation port. This situation allows the ventilator to identify leaks when a discrepancy between inhaled and exhaled volumes is detected, preventing false detection of patient effort and potentially resulting in automatic ventilator cycling. In general, differential multiple ventilation systems using in-line PEEP valves with ventilator self-checking should not activate "Patient Disconnect," "Low Pressure," or "Low Expiratory Volume" alarms unless a disconnect event or new leak occurs.

[0037] When an in-line PEEP valve is used in conjunction with a bypass circuit, the gas pressure at the expiratory port of the ventilator is adjusted to the PIP during inspiration. vent and equal to the ventilator setting PEEP at end-expiration. This condition is required to prevent "tube obstruction" and "high airway pressure" alarms, where the ventilator detects the in-line PEEP valve as an obstruction. A bypass circuit is necessary when using an in-line PEEP valve with many ventilators, not only to avoid these alarms but also to maintain predictable ventilator behavior.

[0038] The foregoing discussion has established that an in-line PEEP valve housed within a PEEP valve enclosure is a critical component of a differential multiplexed ventilator system used to ventilate multiple patients using a single ventilator. The inventor, a member of the International Working Group on Differential Multiplexed Ventilation, was the first to recognize the utility of converting traditional PEEP valves into in-line PEEP valves. One example of such an in-line PEEP valve (described in detail in Bunting et al., Am. J. Emerg. Med., 2020, https: / / doi.org / 10.1016 / j.ajem.2020.06.089, incorporated herein by reference in its entirety) is constructed by adding a 3D-printed collar to a standard PEEP valve and an outlet that connects to the upper port of the PEEP valve to collect expiratory flow from the PEEP valve and direct it to the ventilator. Another example of a structure that converts a conventional PEEP valve into an in-line PEEP valve is the enclosure shown in Figure 3C in Roy et al., 2020, Crit. Care Explor. 2(9):e0198, incorporated herein by reference in its entirety, in which the PEEP valve is completely enclosed within a plastic enclosure having an air inlet port, an air outlet port, and a valve pressure regulator that is connected to the PEEP valve and extends from the enclosure.

[0039] In considering alternative configurations of the PEEP valve enclosure for constructing an in-line PEEP valve, the inventors have discovered that the PEEP valve enclosure can be adapted to provide additional functionality for significantly improving the construction of differential multiple ventilator systems and for providing these systems with an easily accessed and manipulated location for operating the differential multiple ventilator system and expanding the system without halting its operation, thereby allowing the patient to continue to be ventilated.

[0040] In one aspect, it has been discovered that the PEEP valve enclosure can be configured with a third connector arm port to allow the configured in-line PEEP valve to function as a splitter to extend the conduit for assembly of additional patient circuits. Provided the additional patient circuits also include similar in-line PEEP valves with the same splitter feature, additional patient circuits can be added to the previously added patient circuit, and the process can continue. In providing this compatibility, many additional useful functional features have been discovered. These features are described below in the context of an exemplary embodiment and various alternatives with reference to FIGS. 5-12.

[0041] For purposes of illustration, the components shown in the figures are not necessarily drawn to scale in all instances. Rather, emphasis is placed on emphasizing the various contributions of the components to the functioning of various aspects of the present technology. Many possible alternative features are introduced within the context of this description. It will be understood that such alternative features may be substituted in various combinations to arrive at various embodiments of the present technology, according to the knowledge and judgment of those skilled in the art.

[0042] Illustrative Examples A device that uses a PEEP valve to create an in-line valve Referring to Figures 5-10, an exemplary embodiment of a device incorporating a PEEP valve to form an in-line valve is shown. The term "PEEP valve" is used to refer to a conventional, commercially available valve having a structure similar to that shown in Figures 1A and 1B. However, as used herein, the PEEP valve is translated to an in-line valve used in the inspiratory and expiratory circuits. Thus, in the case of the inspiratory circuit, the PEEP valve in the inspiratory in-line valve operates as a peak inspiratory pressure (PIP) valve. Nevertheless, to avoid confusion, the term PEEP valve will be used throughout the following description to refer to a valve having the features shown in Figures 1A and 1B, since the same PEEP valve is used in the inspiratory and expiratory in-line valves. Figure 5 shows an inspiratory valve 100 and an expiratory valve 200. The in-line valves 100 and 200 have generally similar configurations, with a few exceptions. One notable exception, visible in FIG. 5, is that in-line valves 100 and 200 are mirror images of each other across the mirror plane passing between base connectors 114 and 214. Thus, when in-line exhalation valve 200 is rotated to bring it into the same orientation as inhalation in-line valve 100, ventilator arm 211 of exhalation in-line valve 200 is positioned on the right side and pass-through arm 212 is positioned on the left side. There are further exceptions, which are described below. For simplicity in the following description, features of the devices used to form in-line valves 100 and 200 will be described with respect to inhalation valve 100, and then exceptions in the construction of exhalation valve 200 will be described when referring to the features that represent the exceptions.

[0043] 6 and 7, the inhalation device for valve 100 can be seen to include a housing 110 and a cap 130, and similarly, the exhalation device for in-line valve 200 can be seen to include a housing 210 and a cap 230. The inhalation and exhalation devices are each configured to hold a conventional PEEP valve 500 and convert it into an in-line inhalation valve 100 or an in-line exhalation valve 200, respectively. It should be understood, therefore, that PEEP valve 500 is not itself considered part of the inhalation or exhalation device. In FIG. 6, PEEP valve 500 can be seen to include a valve body 501, a pressure regulating head 503, a series of vents 505, and a main valve port 507. Pressure regulating head 503 is twisted to adjust the pressure required to counter an internal valve spring (not shown) to open PEEP valve 500 when flowing gas exits PEEP valve 500 through vent 505.

[0044] In this particular embodiment, the housing 110 of the intake valve 100 is injection molded or additively manufactured to include the ventilator-side arm 111, the coaxial pass-through arm 112, the patient arm 113, and the base connector 114. Similarly, the housing 210 of the intake valve 200 is injection molded or additively manufactured to include the ventilator-side arm 211, the coaxial pass-through arm 212, the patient arm 213, and the base connector 214. When comparing the base connectors 114 and 214, it can be seen that these connectors are complementary for connecting the intake valve 100 to the exhalation valve 200, as shown in FIGS. 11 and 12 . In this embodiment, the base connector 214 includes a peg that fits into a slot in the base connector 114 in a conventional quick-connect configuration. Other types of connectors may be used in alternative embodiments. Advantageously, the connected in-line valves 100 and 200 form a rigid set that resists accidental disconnection.

[0045] The housing 110 is provided with a retaining element 115 that holds the PEEP valve 500 in place within the housing 110 (see FIG. 8 ). In this embodiment, the retaining element 115 is in the form of a clip integrally formed with the housing 110, which is bendable and biased inward toward the center of the housing 110. Alternatively, the retaining element may be a separate component secured to the interior of the housing 110. FIG. 8 shows how the retaining element 115 engages and holds the valve disc 501 of the PEEP valve 500 in place. To deploy the PEEP valve 500, the retaining element is manually bent outward to hold it while the PEEP valve 500 is placed within the housing 110, and then the retaining element is released to allow its biased orientation to apply a force against the valve disc 501 of the PEEP valve 500.

[0046] Because the PEEP valve 500 is housed within the intake valve 100, pressure markings 116 are provided on the exterior sidewall of the housing 110 of the intake valve 100. These pressure markings 116 (showing conventional units of cm of HO) are positioned using calibration to coincide with the pressure markings 509 on the PEEP valve 500. The cap 130 engages the pressure adjustment head 503 of the PEEP valve 500 via a sleeve 135 (see FIG. 7 ) extending from the flat top surface of the cap 130. By turning the cap 130, which threads onto the housing 110, the cap 130 twists the pressure adjustment head 503, adjusting the spring tension of the PEEP valve 500 so that the pressure value indicated at the bottom edge of the cap 130 represents the pressure setting of the PEEP valve 500. The housing 210 of the exhalation valve 200 also includes pressure markings 216, and the cap 230 interacts with the pressure adjustment head 503 of the PEEP valve 500, which is also housed within the housing. This same arrangement operates within the exhalation valve 200, with the cap 230 twisting the pressure adjustment head 503 to adjust the spring tension of the PEEP valve 500.

[0047] In some embodiments, one or more components of the enclosure (e.g., the base, the cap, or both) are made of a transparent material to allow the setting markings on commercial PEEP valves to be read from outside the enclosure, thereby eliminating the need for calibrated external lines to be printed or embossed on the outside of the device.

[0048] The outer sidewall of the housing 110 is also defined by a graphic indicator 117 (in this example, a human head with an arrow indicating inhalation) to indicate that the housing 110 is for use with the inhalation valve 110. Similarly, the housing 210 includes a graphic indicator 217 (in this example, a human head with an arrow indicating exhalation) to indicate that the housing 210 is for use with the exhalation valve 200. In this manner, the two different in-line valves 100 and 200 can be easily distinguished, thereby conveniently avoiding pressure setting errors. Because the exhalation valve 200 is intended to be used in the reverse orientation relative to the inhalation valve 100, the pressure markings 216 and the graphic indicator 217 are oriented accordingly, so that when the inhalation valve 100 and the exhalation valve 200 are connected to each other via their base connectors 114 and 214, the pressure markings 116 and 216 and the graphic indicators 117 and 217 are appropriately oriented for convenient identification.

[0049] The threading of the caps 130 and 230 to the housing may be done in a conventional manner such that clockwise rotation of the caps 130 and 230 results in an increase in valve pressure.

[0050] 9 and 10, the internal structure of inhalation housing 110 and exhalation housing 210 is shown to illustrate the differences between them with respect to the placement of valves and conduits relative to the main cavities 121 and 221 of the housings. In the inhalation housing (FIG. 9), ventilator-side arm 111 is coaxial with and continuous with pass-through arm 112 so that gases entering from the ventilator through a port in ventilator-side arm 111 pass through housing 110 and exit pass-through arm 112, and is continuous with valve conduit 119, which extends upward from the center of main cavity 121 of housing 110 in the orientation shown. While not specifically shown in FIG. 9, it should be understood that valve port 507 of PEEP valve 500 connects to valve conduit 119 of housing 110. Thus, gases flowing into valve conduit 119 from the ventilator (which provides inspiration) exert pressure on PEEP valve 500. When the inspiratory pressure is sufficient to overcome the set pressure of the PEEP valve 500, gas exits the PEEP valve 500 through a vent 505 in the PEEP valve, enters the main cavity 121 of the housing 110, and exits the main cavity 121 via the patient conduit 120, which extends outward through the patient arm 113. In the expiratory housing 210 (FIG. 10), the direction of gas flow is opposite to the direction of gas flow described above for the inspiratory housing 110. The ventilator arm 211 and the pass-through arm 212 are continuous with the main cavity 221. The patient conduit 220, which extends from the patient arm 213, is continuous with the valve conduit 219. Although not specifically shown in FIG. 10, it should be understood that the valve port 507 of the PEEP valve 500 connects to the valve conduit 219 of the housing 210. Thus, gas (exhaled air) flowing from the patient into the valve conduit 219 exerts pressure on the PEEP valve 500 (not shown in FIG. 10 ). When the exhalation pressure is sufficient to overcome the set pressure of the PEEP valve 500, the gas exits the PEEP valve 500 through a vent 505 in the PEEP valve, enters the main cavity 221 of the housing 210, and exits the main cavity 221 via the ventilator arm 211 that extends to the ventilator.

[0051] Differential multi-ventilator systems and assembly methods Figures 11 and 12 show how an in-line valve set 300, comprised of connected in-line valves 100 and 200, can be connected to a patient circuit and used to form a differential multi-ventilator system. Figure 11 shows a patient circuit in which the inspiratory arm is connected to the patient arm 113 of inspiratory valve 100 and the expiratory arm is connected to the patient arm 213 of exhalation valve 200. Figure 12 shows the same configuration in an expanded series, including a conduit connecting a first in-line valve set 300A to a ventilator 600 and a second in-line valve set 300B whose ventilator-side arms 111 and 211 are connected to the pass-through arms 112 and 212 of the first in-line valve set 300A. Similarly, a third in-line valve set 300C is connected through its ventilator-side arms 111 and 211 to the pass-through arms 112 and 212 of the second in-line valve set 300B. A bypass circuit is connected to the pass-through arms 112 and 212 of the third in-line valve set 300C.

[0052] It should be appreciated that if it is desired to expand the series of in-line valve sets to include a fourth in-line valve set (not shown), this expansion can be accomplished in a convenient manner without disconnecting any of the patient circuits that are already in place and may be operating to ventilate the connected patient. The addition of the fourth in-line valve set is accomplished by simply disconnecting the bypass circuit from the pass-through arms 112 and 212 of the third in-line valve set 300C, then connecting the ventilator-side arms 111 and 211 (not shown) of the fourth in-line valve set to the pass-through arms 112 and 212 of the third in-line valve set 300C, and then attaching the bypass circuit to the pass-through arms 112 and 212 of the fourth in-line valve set. If the ventilator 600 is in operation during this procedure, a ventilator alarm will sound after the bypass circuit is removed from the third in-line valve set 300C, but because the addition of the fourth in-line valve set can be accomplished quickly, in less than about 20 seconds, and the bypass circuit can then be attached to the pass-through arms 112 and 212 of the fourth in-line valve set, the alarm will be inconsequential and patients connected to the differential multiple ventilator system via the first, second, or third in-line valve sets 300A-C will not be affected to any significant extent. Thus, a differential multiple ventilator system configured using the inspiratory and expiratory devices described herein provides a convenient way to expand the system without significant interruption to patients receiving ventilation from the system.

[0053] Kits for constructing a differentiated multi-ventilator system One aspect of the present technology is a commercial kit for converting a conventional PEEP valve into an in-line valve for use in a differential multiple ventilator system. In one embodiment, the kit includes a device set, each device of the set including a housing configured to accommodate a PEEP valve, the housing including a ventilator arm, a pass-through arm, and a patient arm, the pass-through arm enabling expansion of the multiple ventilator system to add one or more circuits. In another embodiment, the kit includes a device set as described with respect to FIG. 5. In some embodiments, the kit includes instructions for assembling the differential multiple ventilator system. The instructions may include details of how to assemble the differential multiple ventilator system described above. In some embodiments, the kit includes multiple PEEP valves. In an alternative embodiment, the differential multiple ventilator system can be assembled using either of two tee fittings (splitters) on the ventilator side to place a bypass circuit in its place. In this case, a plug is installed in the distal pass-through arm of the distal valve set. Adding an additional valve set involves removing the plug and connecting the ventilator arm of the additional valve set to the pass-through arm of the previous distal valve set, then attaching a plug to the pass-through arm of the additional valve set.

[0054] Some alternative embodiments have a housing with one or more arms that have built-in self-closing push-fit connectors that can prevent the ventilator from sounding an alarm when a new valve set is added to a differential multiple ventilator system.

[0055] Some alternative embodiments can have the housing with the connector attached in various locations. In one such embodiment, the connector is formed in or attached to a side wall of the housing opposite the patient arm, so that the housings connect in a back-to-back arrangement instead of the bottom-to-bottom arrangement shown in FIGS. 11 and 12.

[0056] In some alternative embodiments, the pressure regulating head of the PEEP valve is removed and the spring of the spring valve is directly compressed by the action of the cap of the in-line valve.

[0057] In some alternative embodiments, the ventilator may be located at the opposite end relative to the arrangement shown in FIG. 12, or may be located between adjacent in-line valve sets with appropriate T-splitters.

[0058] advantage The embodiments of the in-line inspiratory and expiratory devices described herein have many advantages. They minimize excess volume, have minimal parts, can be conveniently manufactured by additive manufacturing or injection molding, are easily disassembled for cleaning, sterilization, and disinfection, and have a compact design that minimizes storage requirements. Furthermore, while designed for use with an equal number of patients (i.e., n), they can also be used in conjunction with two check valves in an N-1 configuration, allowing for sharing of the ventilator between two patients with only one unit (the inspiratory circuit with the lower PIP is connected to the unit as usual, as is the expiratory circuit with the higher PEEP; the other two circuits are connected to the pass-through section via check valves).

[0059] Equivalents and Scope Any patent, publication, internet site, or other disclosure material that is said to be incorporated by reference herein is incorporated herein, in whole or in part, only to the extent that the incorporated material does not contradict existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated herein by reference but that contradicts existing definitions, statements, or other disclosure material set forth herein is incorporated only to the extent that there is no conflict between the incorporated material and the existing disclosure material.

[0060] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs.

[0061] Although the present technology has been particularly shown and described with reference to examples thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the technology encompassed by the appended claims.

[0062] In the claims, articles such as "a," "an," and "the" may mean one or more, unless indicated otherwise or clear from the context. A claim or description including "or" between one or more members of a group is deemed to be satisfied if one, more than one, or all of the members of the group are present in, employed in, or otherwise relevant to a given product or process, unless indicated otherwise or clear from the context.

[0063] It should also be noted that the term "comprising" is intended to be broad and open, meaning that additional elements or steps may be included but are not required. Thus, when the term "comprising" is used herein, the term "consisting of" is also encompassed and disclosed. Where ranges are given, endpoints are included. It should be understood that any particular implementation of the present technology that falls within the prior art may be explicitly excluded from any one or more of the claims. Such implementations may be excluded even if the exclusion is not explicitly set forth herein, because they are deemed to be known to those of ordinary skill in the art.

Claims

1. 1. An apparatus for housing a positive end-expiratory pressure (PEEP) valve and converting the PEEP valve into an in-line valve for use in a differential multiple ventilation system, the apparatus comprising: a housing configured to house the PEEP valve, the housing including a ventilator-side arm, a pass-through arm, and a patient-side arm; each of the ventilator arm, the pass-through arm, and the patient arm is a conduit for allowing gas flow; the device is configured to allow gas flow between the ventilator arm and the pass-through arm when the PEEP valve is provided; the ventilator-side arm and the pass-through arm are separated from the patient-side arm by the PEEP valve when the PEEP valve is closed; gas flow between the patient arm and the ventilator arm is permitted when the PEEP valve is open; The pass-through arm is configured to allow expansion of the multiple ventilator system, including a housing that allows multiple patients to be ventilated by a common ventilator by connecting multiple devices in series.

2. 2. The device of claim 1, wherein the ventilator-side arm and the pass-through arm are sized to connect directly to one another such that the pass-through arm of a first device is connectable to the ventilator-side arm of a second device, the second device being the device of claim 1, and the second device being identical to the first device.

3. 3. The device of claim 1, wherein the device is configured for use as an inspiratory in-line valve, the ventilator-side arm together with the pass-through arm being connected via a first conduit through the housing and coaxial with the first conduit, the first conduit being continuous with a second conduit within the housing, the second conduit being configured to connect the patient-side arm to a valve port of the PEEP valve when the PEEP valve is provided in the device.

4. 4. The device of claim 3, wherein the second conduit is isolated from the patient arm when the PEEP valve is provided in the device and the PEEP valve is closed, and the second conduit allows gas flow to the patient arm when the PEEP valve is provided in the device and the PEEP valve is open.

5. 3. The device of claim 1, wherein the device is configured for use as an exhalation in-line valve, and a second conduit connects the patient arm to a main sleeve of the PEEP valve when the PEEP valve is provided in the device.

6. 6. The device of claim 5, wherein the second conduit is isolated from the ventilator-side arm and the pass-through arm when the PEEP valve is present in the device and the PEEP valve is closed, and the second conduit allows gas flow to the ventilator-side arm when the PEEP valve is present in the device and the PEEP valve is open.

7. 7. The device of claim 1, wherein the housing is defined by a main opening, a cap is coupled to the body over the main opening, the cap having an internal structure configured to connect to a pressure adjustment head of the PEEP valve, thereby enabling the cap to adjust the pressure adjustment head of the PEEP valve.

8. 8. The device of claim 7, wherein the internal structure of the cap is a sleeve sized to couple to the pressure regulating head of the PEEP valve when the PEEP valve is installed in the device.

9. 9. The device according to claim 7 or 8, wherein the cap is connected to the housing by a threaded engagement, the threaded engagement allowing adjustment of the pressure regulating head of the PEEP valve.

10. 10. The device of claim 9, wherein the outer sidewall of the housing includes markings indicative of valve pressure, and positioning of the edge of the cap relative to the markings indicates the valve pressure depending on the degree of threading.

11. 11. The device of claim 1, wherein the inner sidewall of the housing includes a PEEP valve retention element.

12. A device set, the set comprising:

5. An intake system including the device of claim 3 or 4, further including a first connector on the housing of the intake system; An exhalation device comprising the device according to claim 5 or 6, further comprising a second connector on the housing of the exhalation device; Including, The first connector and the second connector are configured to connect to each other.

13. 13. The device set of claim 12, wherein the housing of the inhalation device includes a first visual indicator to indicate inhalation, and the housing of the exhalation device includes a second visual indicator to indicate exhalation.

14. 14. A kit comprising the device set of claim 12 or 13, further comprising instructions for assembling a differential multi-ventilator system using said device set.

15. 15. The kit of claim 14, further comprising a plurality of PEEP valves.

16. 1. A ventilator system, comprising: A ventilator and an in-line valve set; Including, The in-line valve set at least one device set according to claim 12; a plurality of PEEP valves, each of the inspiratory and expiratory devices having the plurality of PEEP valves disposed therein; Including, A ventilator system, wherein the ventilator-side arms of both the inspiratory device and the expiratory device are connected to the ventilator, the patient-side arms of both the inspiratory device and the expiratory device are connected to a first patient circuit, and a bypass conduit is connected between the pass-through arms of the inspiratory device and the expiratory device.

17. 1. A differential multiple ventilator system, the differential multiple ventilator system comprising: A ventilator and a first set of in-line valves; Including, The first in-line valve set comprises: at least one device set according to claim 12; a plurality of PEEP valves, each of the inhalation device and the exhalation device of the first in-line valve set having the plurality of PEEP valves disposed therein; Including, the ventilator-side arms of both the inspiratory and expiratory devices of the first in-line valve set are connected to the ventilator, and the patient-side arms of both the inspiratory and expiratory devices of the first in-line valve set are connected to a first patient circuit; The differential multiple ventilator system also includes a second in-line valve set; The second in-line valve set comprises at least one device set according to claim 12; a plurality of PEEP valves, each of the inhalation and exhalation devices of the second in-line valve set having the plurality of PEEP valves disposed therein; Including, the second in-line valve set is connected to the first in-line valve set, the pass-through arms of the inspiratory device and the expiratory device of the first in-line valve set are connected to the ventilator-side arms of the inspiratory device and the expiratory device of the second in-line valve set, and the patient-side arms of both the inspiratory device and the expiratory device of the second in-line valve set are connected to at least a second patient; A differential multiple ventilator system, wherein a bypass conduit is connected between the pass-through arms of the second in-line valve set or between the pass-through arms of a last in-line valve set connected after the second device set.

18. 1. A method of assembling a differential multiple ventilator system, comprising: forming a plurality of in-line valve sets by providing a PEEP valve in each of the inspiratory and expiratory devices of a plurality of device sets according to claim 12; connecting a first in-line valve set of the plurality of in-line valves to a ventilator via the ventilator-side arm of the inspiratory device and the ventilator-side arm of the expiratory device of the first device set, and connecting a first patient circuit to the patient-side arm of the first in-line valve set; connecting the pass-through arm of the inspiratory device of the first in-line valve set to the ventilator-side arm of a second in-line valve set, thereby connecting at least the second in-line valve set to the first in-line valve set and connecting at least a second patient circuit to the patient-side arm of the second in-line valve set, thereby providing an expanded in-line valve set; connecting a bypass conduit between the pass-through arms of a last in-line valve set in the expanded in-line valve sets; A method comprising:

19. 20. The method of claim 18, wherein the expanded in-line valve sets include two, three, four, five, or six in-line valve sets.

20. 20. The method of claim 18 or 19, wherein for each in-line valve set of the expanded in-line valve set, the inhalation device is connected to the exhalation device by making a connection between the first connector and the second connector.

21. 21. The method of any one of claims 18 to 20, further comprising: disconnecting the bypass conduit from the final in-line valve set; connecting an additional in-line valve set to the final in-line valve set; and connecting the bypass conduit between the pass-through arms of the additional in-line valve set, thereby adding the additional in-line valve set to the expanded in-line valve set.

22. 22. The method of any one of claims 17 to 21, wherein the ventilator is kept in continuous operation and the first patient circuit continues to operate at least during the step of connecting a second in-line valve set.

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