Passive Leak Valve

Abstract

To provide a ventilator with integrated phlegm discharge assistance.SOLUTION: A ventilator with integrated phlegm discharge assistance is provided. The ventilator is for use with a patient circuit in fluid communication with a patient connection part of a patient. The ventilator is operable in a ventilation mode and a phlegm discharge assistance mode. The ventilator includes: a user input for changing over its operation from the ventilation mode to the phlegm discharge assistance mode without disconnecting the ventilator from the patient; and a controller that is operable in response to the user input and controls operation of the ventilator so as to provide the patient with at least single phlegm discharge assistance including a gas delivery phase and a subsequent forcible gas discharge phase in the phlegm discharge assistance mode. A phlegm discharge assistance valve transfers positive pressure to a ventilator connection part in a first state for the gas delivery phase and transfers negative pressure to the ventilator connection part in a second state for the forcible gas discharge phase.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention is generally directed to an active exhalation valve for use with a ventilator having a pressure source that can be used to control the operation of the valve and thereby control the flow of patient exhaled gas. [Background technology]

[0002] Breathing may be characterized as including both an inhalation phase and an exhalation phase, during which inhaled gases are drawn into the lungs, and during which exhaled gases are expelled from the lungs.

[0003] Mechanical ventilators are used to assist breathing. Conventional ventilators typically push inhaled gas, including oxygen, into the patient's lungs. Many patients who use ventilators also require other types of assistance related to the treatment and maintenance of the patient's airways and lungs. For example, some patients may use nebulizers to deliver medication to the patient's lungs and / or airways. Additionally, some patients may require assistance to clear secretions from the patient's lungs and / or airways. Such assistance is typically provided by conventional suction devices. Thus, in addition to the ventilator, many patients require multiple devices, and travel with such equipment can be particularly problematic.

[0004] Currently, to receive expectoration assistance, the patient must be disconnected from mechanical ventilation and connected to a separate expectoration assistance device. After the expectoration assistance procedure is performed, the patient must be disconnected from the expectoration assistance device and reconnected to mechanical ventilation. In many cases, suctioning of the patient's airway is also performed after the patient is disconnected from the expectoration assistance device and reconnected to mechanical ventilation to remove secretions that were not properly removed from the patient's airway during the expectoration assistance procedure. During the period when the patient is not receiving mechanical ventilation, it is customary to deliver a high level of inspired oxygen before removing the mechanical ventilation from the patient to minimize the risk of hypoxemia in the patient. This process can be long and tedious, and is often not performed in a manner that is most favorable to the patient.

[0005] Thus, there is a need for a ventilator that is portable and / or configured to provide additional functionality beyond delivering inspiration gas into a patient's lungs. The present application provides these and other advantages that will become apparent from the following detailed description and accompanying figures. Summary of the Invention [Means for solving the problem]

[0006] An embodiment includes a method of providing a breath to a human patient. The human patient has a patient connection connected to a ventilator device by a patient circuit. The breath has an inspiratory phase with a beginning and an end. The method includes delivering a bolus of oxygen to the patient circuit at or before the beginning of the inspiratory phase of the breath, terminating delivery of the bolus of oxygen before the end of the inspiratory phase of the breath, and delivering breathing gas including air to the patient circuit before the end of the inspiratory phase of the breath. The patient circuit delivers the bolus of oxygen and the breathing gas to the patient connection. Optionally, the method may further include waiting until delivery of the bolus of oxygen delivered for the breath is finished before delivering the breathing gas.

[0007] Optionally, the method may further include receiving a bolus volume value, in such an embodiment, the bolus of oxygen delivered for breathing has a volume substantially equal to the bolus volume value.

[0008] Optionally, delivering the respiratory gas to the patient circuit includes providing the respiratory gas to the patient circuit at a first input location of the patient circuit, and delivering the bolus of oxygen to the patient circuit includes providing the bolus of oxygen to the patient circuit at a second input location of the patient circuit closer to the patient connection than the first input location.

[0009] The combined bolus of oxygen and breathing gas delivered for breathing has a total inspired volume. Optionally, the bolus of oxygen delivered for breathing has a volume that is less than about 75% of the total inspired volume. Optionally, the bolus of oxygen delivered for breathing has a volume that is between about 50% of the total inspired volume and about 75% of the total inspired volume.

[0010] Optionally, the method may further include receiving an oxygen flow equivalent value associated with an oxygen flow rate that would produce a first volume of oxygen when applied to the patient circuit continuously from the beginning of an inspiratory phase of a breath to the end of an expiratory phase of a breath, In such an embodiment, the bolus of oxygen delivered for the breath has a second volume that is less than the first volume of oxygen.

[0011] Optionally, the method may further include detecting that the initiation of an inspiratory phase of breathing has been initiated by the patient. In such an embodiment, the method may further include initiating delivery of a bolus of oxygen to the patient circuit in response to detecting that the initiation of an inspiratory phase of breathing has been initiated by the patient.

[0012] The method may be used with an oxygen source connected to a valve. In such an embodiment, delivering the bolus of oxygen at or before the beginning of the inspiratory phase of breathing includes opening the valve, thereby allowing oxygen flow from the oxygen source to the patient circuit. Further, terminating the delivery of the bolus of oxygen before the end of the inspiratory phase of breathing includes closing the valve, thereby ceasing oxygen flow from the oxygen source to the patient circuit.

[0013] The method may be used with an oxygen generator connected to an oxygen source. In such an embodiment, the oxygen source is configured to store oxygen generated by the oxygen generator, and the method further includes detecting a value including at least one of a concentration of oxygen stored by the oxygen source and a pressure of oxygen stored by the oxygen source, determining whether the detected value is below a threshold, and upon determining that the detected value is below the threshold, operating the oxygen generator and delivering oxygen generated by the oxygen generator to the oxygen source.

[0014] The method may be used in conjunction with a user-defined total tidal volume, in such an embodiment, the respiratory gas delivered for a breath has a first volume, and the bolus of oxygen delivered for a breath has a second volume, the combined first and second volumes being substantially equal to the user-defined total tidal volume.

[0015] The method may be used in conjunction with a user-defined peak inspiratory pressure value, in such an embodiment, the combined pressure of the breathing gas and the bolus of oxygen delivered for a breath does not exceed the user-defined peak inspiratory pressure value.

[0016] The method may be used with a respiratory gas delivery conduit and an oxygen delivery conduit. The respiratory gas delivery conduit has a respiratory gas output located at a first end portion of the patient circuit, remote from the patient connection. The oxygen delivery conduit has an oxygen output located at a second end portion of the patient circuit, adjacent the patient connection. Delivering the respiratory gas to the patient circuit may include providing the respiratory gas to the respiratory gas output via the respiratory gas delivery conduit. Additionally, delivering the bolus of oxygen to the patient circuit includes providing the bolus of oxygen to the oxygen output via the oxygen delivery conduit, thereby separating the bolus of oxygen delivered for breathing from the respiratory gas delivered for breathing along at least a majority of the patient circuit prior to the patient connection.

[0017] Optionally, the patient circuit includes a respiratory gas delivery conduit and an oxygen delivery conduit. In such an embodiment, delivering the respiratory gas to the patient circuit includes providing the respiratory gas to a respiratory gas delivery conduit that delivers the respiratory gas to a patient connection. Additionally, delivering the bolus of oxygen to the patient circuit includes providing the bolus of oxygen to an oxygen delivery conduit that delivers the bolus of oxygen to a patient connection, thereby separating the bolus of oxygen delivered for breathing from the respiratory gas delivered for breathing along at least a portion of the patient circuit prior to the patient connection. Optionally, the bolus of oxygen exits the oxygen delivery conduit and enters the respiratory gas delivery conduit at a location adjacent the patient connection. Optionally, the bolus of oxygen exits the oxygen delivery conduit and enters the respiratory gas delivery conduit at a location within about 2 centimeters of the patient connection.

[0018] The method may be used with a compressor operable to compress the breathing gas, in such an embodiment, delivering the breathing gas to the patient circuit includes delivering at least a portion of the breathing gas compressed by the compressor.

[0019] An embodiment includes a ventilator device for use with an oxygen source and a patient circuit. The patient circuit is configured to receive respiratory gas and oxygen and provide a breath to a human patient having a patient connection coupleable to the patient circuit. The breath has an inspiratory phase with a beginning and an end. The ventilator device includes a compressor configured to deliver respiratory gas to the patient circuit, and a control system configured to (a) allow oxygen to flow from the oxygen source to the patient circuit at or before the beginning of the inspiratory phase of the breath, (b) prevent oxygen from flowing from the oxygen source to the patient circuit before the end of the inspiratory phase of the breath, and (c) cause the compressor to deliver respiratory gas to the patient circuit before the end of the inspiratory phase of the breath.

[0020] Optionally, the ventilator device may include an input configured to receive a user-defined total tidal volume. In such an embodiment, the breathing gas delivered to the patient circuit for breathing has a first volume, and the oxygen allowed to flow to the patient circuit for breathing has a second volume, the combined first and second volumes being substantially equal to the user-defined total tidal volume.

[0021] Optionally, the ventilator device may include an input configured to receive a user-defined peak inspiratory pressure value. In such an embodiment, the combined pressure of breathing gas delivered to the patient circuit and oxygen allowed to flow to the patient circuit for breathing does not exceed the user-defined peak inspiratory pressure value.

[0022] Another embodiment includes a ventilator device for use with a patient circuit. The patient circuit is configured to receive breathing gas and oxygen and provide a breath to a human patient having a patient connection coupleable to the patient circuit. The breath has an inhalation phase with a beginning and an end. The ventilator device includes a compressor configured to deliver breathing gas to the patient circuit, a patient oxygen outlet coupleable to the patient circuit, an oxygen source configured to deliver oxygen to the patient circuit, and a control system configured to (a) allow oxygen to flow from the oxygen source to the patient circuit at or before the beginning of the inhalation phase of the breath, (b) prevent oxygen from flowing from the oxygen source to the patient circuit before the end of the inhalation phase of the breath, and (c) cause the compressor to deliver breathing gas to the patient circuit before the end of the inhalation phase of the breath. Optionally, the ventilator device may include an input configured to receive a user-defined total tidal volume. In such an embodiment, the breathing gas delivered to the patient circuit for breathing has a first volume, the oxygen allowed to flow to the patient circuit for breathing has a second volume, and the combined first and second volumes are substantially equal to a user-defined total tidal volume. Optionally, the ventilator device may include an input configured to receive a user-defined peak inspiratory pressure value. In such an embodiment, the combined pressure of the breathing gas delivered to the patient circuit and the oxygen allowed to flow to the patient circuit for breathing does not exceed the user-defined peak inspiratory pressure value.

[0023] An embodiment includes a ventilation system for use with a human patient having a patient connection coupleable to a patient circuit. The system includes a control system, an oxygen source configured to deliver oxygen to a patient oxygen outlet coupleable to the patient circuit, and a compressor configured to deliver breathing gas to a ventilator connection coupleable to the patient circuit. The ventilator connection is distinct from the patient oxygen outlet. The control system is configured to identify an inspiration phase of breathing and command the oxygen source to deliver oxygen to the patient oxygen outlet before or during the inspiration phase. The oxygen source is configured to deliver oxygen to the patient oxygen outlet in response to a command to deliver oxygen to the patient oxygen outlet. The control system is further configured to command the compressor to deliver breathing gas to the ventilator connection during the inspiration phase. The compressor is configured to deliver breathing gas to the ventilator connection in response to a command to deliver breathing gas to the ventilator connection.

[0024] Optionally, the compressor and ventilator connection may be components of the ventilator and the oxygen source may be external to the ventilator.

[0025] Optionally, the oxygen source is an internal oxygen source of the ventilator. The internal oxygen source has an oxygen inlet in fluid communication with the internal oxygen source. In such an embodiment, the ventilation system can include an external oxygen source in fluid communication with the oxygen inlet and deliver oxygen from the external oxygen source to the internal oxygen source.

[0026] Optionally, the ventilation system also includes an oxygen generator in fluid communication with the oxygen source, the oxygen generator delivering oxygen to the oxygen source. Each of the compressor, the oxygen source, and the oxygen generator may be components of the ventilator. Alternatively, each of the compressor and the oxygen source are components of the ventilator, and the oxygen generator is external to the ventilator.

[0027] Optionally, the ventilation system also includes a user interface having an input configured to receive a user-defined total tidal volume. The user interface is configured to provide the user-defined total tidal volume to the control system. The control system is configured to determine a first volume and a second volume. In such an embodiment, the breathing gas delivered for the breath has a first volume, and the oxygen delivered for the breath has a second volume, and the combined first and second volumes are substantially equal to the user-defined total tidal volume.

[0028] Optionally, the ventilation system also includes a user interface having an input configured to receive a user-defined peak inspiratory pressure value. In such an embodiment, the user interface is configured to provide the user-defined peak inspiratory pressure value to the control system, such that the combined pressure of the breathing gas and oxygen delivered for breathing does not exceed the user-defined peak inspiratory pressure value.

[0029] An embodiment includes a method of providing a breath to a human patient. The patient has a patient connection connected by a patient circuit to a ventilator having a first ventilator connection and a different second ventilator connection. Each of the first and second ventilator connections is in fluid communication with the patient circuit. The method includes identifying, with the ventilator, a beginning of an inspiratory phase of a breath, delivering a bolus of oxygen to the first ventilator connection before or during the inspiratory phase, and delivering a breathing gas including air to the second ventilator connection during the inspiratory phase. The ventilator separates the bolus of oxygen delivered to the first ventilator connection from the breathing gas delivered to the second ventilator connection. Optionally, the ventilator may deliver the bolus of oxygen at the beginning of the inspiratory phase of the breath. Optionally, the ventilator may determine a volume of the bolus of oxygen delivered for the breath.

[0030] The method may further include identifying, with the ventilator, an end of an inspiratory phase of breathing and terminating delivery of the bolus of oxygen before the end of the inspiratory phase. Respiratory gas may be delivered after delivery of the bolus of oxygen has terminated.

[0031] The method may be used in conjunction with a user-defined total tidal volume, in such an embodiment, the respiratory gas delivered for a breath has a first volume, and the bolus of oxygen delivered for a breath has a second volume, the combined first and second volumes being substantially equal to the user-defined total tidal volume.

[0032] The method may be used in conjunction with a user-defined peak inspiratory pressure value, in such an embodiment, the combined pressure of the breathing gas and the bolus of oxygen delivered for a breath does not exceed the user-defined peak inspiratory pressure value.

[0033] An embodiment includes a ventilator device for use with a human patient having a patient connection coupleable to a patient circuit. The ventilator device includes a ventilator connection coupleable to the patient circuit, one or more first flow conduits in fluid communication with the ventilator connection, and a compressor configured to deliver breathing gas to the one or more first flow conduits. The one or more first flow conduits deliver the breathing gas to the ventilator connection. The ventilator device also includes a patient oxygen outlet coupleable to the patient circuit, one or more second flow conduits in fluid communication with the patient oxygen outlet, and an oxygen source configured to deliver oxygen to the one or more second flow conduits. The one or more second flow conduits deliver oxygen to the patient oxygen outlet. The patient oxygen outlet and the one or more second flow conduits separate the oxygen from the breathing gas delivered to the one or more first flow conduits and the ventilator connection.

[0034] Optionally, the one or more second flow conduits include a first conduit and a second conduit, and the ventilator device further includes a valve. The first conduit is in fluid communication with the valve and delivers oxygen from the oxygen source to the valve. The second conduit is in fluid communication with the valve and delivers oxygen from the valve to a patient oxygen outlet. Opening the valve allows oxygen to flow from the oxygen source to the patient oxygen outlet through the first and second conduits, while closing the valve prevents oxygen from flowing from the oxygen source to the patient oxygen outlet through the first and second conduits. Optionally, the ventilator device includes a control system configured to (a) open the valve at or before the beginning of an inspiratory phase of a breath, thereby allowing oxygen to flow from the oxygen source to the patient oxygen outlet, (b) close the valve before the end of the inspiratory phase of a breath, thereby preventing oxygen from flowing from the oxygen source to the patient oxygen outlet, and (c) command the compressor to deliver breathing gas before the end of the inspiratory phase of a breath. Optionally, the control system may be configured to command the compressor to deliver breathing gas after the valve is closed.

[0035] Optionally, the ventilator device includes an input configured to receive a user-defined total tidal volume. In such an embodiment, the breathing gas delivered for a breath has a first volume, and the oxygen allowed to flow for a breath has a second volume, the combined first and second volumes being substantially equal to the user-defined total tidal volume.

[0036] Optionally, the ventilator device includes an input configured to receive a user-defined peak inspiratory pressure value. In such an embodiment, the combined pressure of the delivered breathing gas and the oxygen allowed to flow for breathing does not exceed the user-defined peak inspiratory pressure value.

[0037] Optionally, the ventilator device includes a user input configured to receive a user-selected parameter value, in such an embodiment, the control system is configured to keep the valve open until a volume of oxygen flows through the valve, the volume being determined at least in part based on the user-selected parameter value.

[0038] The oxygen source may be configured to store oxygen. In such an embodiment, the ventilator device may optionally include an oxygen generator in fluid communication with the oxygen source and a sensor configured to provide a signal to the control system. The signal encodes at least one of a concentration of oxygen stored by the oxygen source and a pressure of oxygen stored by the oxygen source. In such an embodiment, the control system is configured to use the signal to determine whether an amount of oxygen stored by the oxygen source is below a threshold value, and to operate the oxygen generator and deliver oxygen to the oxygen source when the control system determines that the amount of oxygen stored by the oxygen source is below the threshold value.

[0039] The patient circuit may have a sensor configured to detect flow in the patient circuit and transmit a signal encoding the flow, in such an embodiment, the control system may be configured to receive the signal from the sensor and use the signal to detect when the patient begins the start of an inspiratory phase.

[0040] Optionally, the ventilator device includes a sensor configured to detect a flow rate in one of the one or more first flow conduits and send a signal encoding the flow rate to the control system, in such an embodiment, the control system is configured to use the signal to detect when the patient begins the start of an inspiratory phase.

[0041] Optionally, the ventilator device includes an accumulator configured to deliver at least a portion of the breathing gas to the compressor via at least one of the one or more first flow conduits, and a sensor configured to (a) detect a flow rate inside at least one of the one or more first flow conduits and (b) send a signal encoding the flow rate to the control system. In such an embodiment, the control system is configured to use the signal to detect when the patient begins the inhalation phase.

[0042] An embodiment of a pressure swing adsorption oxygen generator for separating oxygen from air for use with a pressure source that generates high and low pressures includes an adsorbent bed having a bed of nitrogen adsorbent material, and a multi-position rotary valve in fluid communication with the adsorbent bed, couplable to a pressure source for controlling the pressure swing adsorption of the adsorbent bed and in fluid communication with the pressure source. The rotary valve includes a cam having first and second rotational positions, where in the first rotational position of the cam the rotary valve transmits a high pressure generated by the pressure source to the adsorbent bed, and in the second rotational position of the cam the rotary valve transmits a low pressure generated by the pressure source to the adsorbent bed.

[0043] Optionally, the pressure swing adsorption oxygen generator may include an oxygen storage unit connected to the adsorption bed, a first regulator that allows oxygen generated in the adsorption bed to move to the oxygen storage unit in response to a first condition sensed when the cam is in a first rotational position, and a second regulator that allows a portion of the oxygen in the oxygen storage unit to enter the adsorption bed to assist in purging nitrogen from the adsorption bed in response to a second condition sensed when the cam is in a second rotational position.

[0044] Optionally, the pressure swing adsorption oxygen generator may include an oxygen storage unit; a first pressure regulator connected to the adsorption bed and connected to the oxygen storage unit, the first pressure regulator responsive to a pressure in the adsorption bed increasing to a preselected first pressure, adjusting the pressure of the adsorption bed to the preselected first pressure and allowing oxygen generated in the adsorption bed to move through the first pressure regulator to the oxygen storage unit; and a second pressure regulator connected to the adsorption bed and connected to the oxygen storage unit, the second pressure regulator responsive to a pressure in the adsorption bed decreasing to a preselected second pressure below the first preselected pressure, adjusting the pressure of the adsorption bed to the preselected second pressure and allowing oxygen stored in the oxygen storage unit to move through the second pressure regulator to the adsorption bed.

[0045] Optionally, the pressure swing adsorption oxygen generator can be constructed such that a first pressure regulator prevents fluid communication between the adsorption bed and the oxygen storage unit through the first pressure regulator when the pressure in the adsorption bed is below a preselected first pressure, and a second pressure regulator prevents fluid communication between the oxygen storage unit and the adsorption bed through the second pressure regulator when the pressure in the adsorption bed is above a preselected second pressure.

[0046] Another embodiment of a pressure swing adsorption oxygen generator for separating oxygen from air includes a pressure source generating high and low pressures, an adsorbent bed having a bed of nitrogen adsorbent material, and a multi-position rotary valve in fluid communication with the pressure source and the adsorbent bed for controlling pressure swing adsorption of the adsorbent bed, the rotary valve including a cam having first and second rotational positions, where in the first rotational position of the cam the rotary valve communicates a high pressure generated by the pressure source to the adsorbent bed and in the second rotational position of the cam the rotary valve communicates a low pressure generated by the pressure source to the adsorbent bed.

[0047] Optionally, the pressure source is a compressor and the high pressure generated is a positive pressure and the low pressure generated is a negative pressure.

[0048] Another embodiment of a pressure swing adsorption oxygen generator for separating oxygen from air for use with a pressure source generating high and low pressures includes an adsorbent bed having a bed of nitrogen adsorbent material, and a multi-position rotary valve coupleable to a pressure source for fluid communication with the pressure source and in fluid communication with the adsorbent bed for controlling pressure swing adsorption of the adsorbent bed. The rotary valve has a cam having at least first and second rotational positions, a rotary actuator configured to rotate the cam, and a plurality of valves operable in response to the rotational position of the cam. In a first rotational position of the cam, at least one of the valves communicates a high pressure generated by the pressure source to the adsorbent bed, and in a second rotational position of the cam, at least one of the valves communicates a low pressure generated by the pressure source to the adsorbent bed.

[0049] Optionally, when the pressure swing adsorption oxygen generator is for use with a pressure source that is a compressor with high pressure at an output port and low pressure at an input port, the plurality of valves may include a first, second, third, and fourth valve, each having a first port and a second port that are in fluid communication with one another in a first state and out of fluid communication with one another in a second state and selectively movable between the first and second states. The first port of the first valve is in fluid communication with the compressor output port and the second port of the first valve is in fluid communication with the atmosphere. The first port of the second valve is in fluid communication with the adsorbent bed and the second port of the second valve is in fluid communication with the compressor output port. The first port of the third valve is in fluid communication with the adsorbent bed and the second port of the third valve is in fluid communication with the compressor input port. A first port of the fourth valve is in fluid communication with the compressor input port and a second port of the fourth valve is in fluid communication with a source of air from which oxygen is to be separated. The first, second, third, and fourth valves are moved between the first and second states in a repeating sequence in response to rotation of the cam, such that when the cam is in the first rotational position, the second and fourth valves are in the first state and the first and third valves are in the second state, and when the cam is in the second rotational position, the first and third valves are in the first state and the second and fourth valves are in the second state.

[0050] Optionally, the first and third valves are moved by a cam in unison between the first and second states, and the second and fourth valves are moved by a cam in unison between the first and second states.

[0051] Optionally, the cam has first and second cam lobes and further has third and fourth rotational positions, and when the cam is moved to the first rotational position, the first cam lobe moves the fourth valve to the first state and the second cam lobe moves the second valve to the first state, and the first and third valves are in the second state, and when the cam is moved to the second rotational position, the first cam lobe moves the first valve to the first state and the second cam lobe moves the third valve to the first state. when the cam is moved to the third rotational position, the first cam lobe moves the second valve to the first state, the second cam lobe moves the fourth valve to the first state, and the first and third valves are in the second state; when the cam is moved to the fourth rotational position, the first cam lobe moves the third valve to the first state, the second cam lobe moves the first valve to the first state, and the second and fourth valves are in the second state.

[0052] Optionally, each of the valves may include a poppet member, a valve seat having a valve seat opening, and a push rod having a cam follower abutting the cam for movement of the push rod in response to rotation of the cam between a first cam rotational position and a second cam rotational position, the poppet member coupled to the push rod member for movement therewith to move the poppet member into and out of seated alignment with the valve seat and to close and open the valve seat opening in response to rotation of the cam.

[0053] Additionally, each of the valves may further include a housing with an end that opens toward the cam, the poppet member and the valve seat being positioned within the housing with the push rod extending through the housing end opening, and each of the valves further including a flexible diaphragm positioned between the valve seat and the cam and having an opening through which the push rod extends. The diaphragm has a peripheral portion that closes the housing end opening and is coupled to the housing, and a central portion that is coupled to the push rod for movement therewith. The diaphragm may further have an effective area, and the poppet valve has a closing area that closes the valve seat opening. The effective area of ​​the diaphragm and the closing area of ​​the poppet valve are sized to counteract forces on the push rod resulting from pressure in a chamber between the valve seat and the diaphragm when the poppet valve is in a seated arrangement with the valve seat, thereby reducing the force of the push rod member on the cam follower.

[0054] Another embodiment of a pressure swing adsorption oxygen generator for separating oxygen from air includes a compressor having an input port and an output port, an adsorption bed having a bed of nitrogen adsorbent material, and a multi-position rotary valve controlling the pressure swing adsorption of the adsorption bed and in fluid communication with the compressor and the adsorption bed. The rotary valve has a cam, a rotary actuator configured to rotate the cam, and a first, second, third, and fourth valve. Each valve has a first port and a second port that are in fluid communication with each other in a first state and out of fluid communication with each other in a second state and are selectively movable between the first state and the second state in response to a rotational position of the cam. A first port of the first valve is in fluid communication with the compressor output port and a second port of the first valve is in fluid communication with the atmosphere. A first port of the second valve is in fluid communication with the adsorption bed and a second port of the second valve is in fluid communication with the compressor output port. A first port of the third valve is in fluid communication with the adsorbent bed and a second port of the third valve is in fluid communication with the compressor input port. A first port of the fourth valve is in fluid communication with the compressor input port and a second port of the fourth valve is in fluid communication with a source of air from which oxygen is to be separated in the adsorbent bed. The first, second, third and fourth valves are moved between first and second states in a repeating sequence in response to rotation of the cam, such that during a first period the second and fourth valves are in the first state and the first and third valves are in the second state, whereby air at high pressure is communicated to the adsorbent bed to separate nitrogen from the air and generate oxygen, and during a second period occurring after the first period the first and third valves are in the first state and the second and fourth valves are in the second state, whereby nitrogen is purged from the adsorbent bed.

[0055] Optionally, the pressure swing adsorption oxygen generator includes an oxygen storage unit connected to the adsorption bed, a first regulator that allows oxygen generated in the adsorption bed to transfer to the oxygen storage unit in response to a first sensed condition during a first time period, and a second regulator that allows a portion of the oxygen in the oxygen storage unit to enter the adsorption bed to assist in purging nitrogen from the adsorption bed in response to a second sensed condition during a second time period.

[0056] Optionally, the pressure swing adsorption oxygen generator may include an oxygen storage unit; a first pressure regulator connected to the adsorption bed and connected to the oxygen storage unit, the first pressure regulator responsive to the pressure of the adsorption bed increasing to the preselected first pressure, adjusting the pressure of the adsorption bed to the preselected first pressure and allowing oxygen generated in the adsorption bed to move through the first pressure regulator to the oxygen storage unit; and a second pressure regulator connected to the adsorption bed and connected to the oxygen storage unit, the second pressure regulator responsive to the pressure of the adsorption bed decreasing to a preselected second pressure below the first preselected pressure, adjusting the pressure of the adsorption bed to the preselected second pressure and allowing oxygen stored in the oxygen storage unit to move through the second pressure regulator to the adsorption bed.

[0057] Optionally, the first pressure regulator prevents fluid communication between the adsorption bed and the oxygen storage unit through the first pressure regulator when the pressure in the adsorption bed is below a preselected first pressure, and the second pressure regulator prevents fluid communication between the oxygen storage unit and the adsorption bed through the second pressure regulator when the pressure in the adsorption bed is above a preselected second pressure.

[0058] In the pressure swing adsorption oxygen generator, during a third period occurring after the second period, the second and fourth valves are in the first state and the first and third valves are in the second state, whereby air at high pressure is communicated to the adsorption bed to separate nitrogen from the air and generate oxygen, and during a fourth period occurring after the third period, the first and third valves are in the first state and the second and fourth valves are in the second state, whereby nitrogen is purged from the adsorption bed.

[0059] Optionally, the first and third valves are positioned opposite one another on opposite sides of the cam, and the second and fourth valves are positioned opposite one another on opposite sides of the cam.

[0060] Optionally, the cam has first and second cam lobes, and during a first period of time, the first cam lobe moves the fourth valve to the first state and the second cam lobe moves the second valve to the first state, and the first and third valves are in the second state, and during a second period of time, the first cam lobe moves the first valve to the first state and the second cam lobe moves the third valve to the first state, and the second and fourth valves are in the second state. During a third period, the first cam lobe moves the second valve to the first state and the second cam lobe moves the fourth valve to the first state and the first and third valves are in the second state and during a fourth period, the first cam lobe moves the third valve to the first state and the second cam lobe moves the first valve to the first state and the second and fourth valves are in the second state.

[0061] An embodiment of a ventilator with integrated expectoration assist for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator operable in a ventilation mode and an expectoration assist mode. The ventilator includes a ventilator connection to which the patient circuit is connectable for fluid communication, a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient, a user input for selectively switching the operation of the ventilator from the ventilation mode to the expectoration assist mode without disconnecting the ventilator from the patient, and a controller operable in response to the user input for switching the ventilator from operation in the ventilation mode to operation in the expectoration assist mode, and that, in the expectoration assist mode, controls the operation of the ventilator to provide the patient with at least one expectoration assist having an insufflation phase followed by a forced exhaust phase. The ventilator further includes an expectoration assist valve that is in a first state for the insufflation phase of the expectoration assist and is then moved to a second state for the forced exhaust phase of the expectoration assist. When the expectoration assist valve is in a first state for the air delivery phase of expectoration assistance, the expectoration assist valve transmits positive pressure to the ventilator connection portion, and when the expectoration assist valve is in a second state for the forced exhaust phase of expectoration assistance, the expectoration assist valve transmits negative pressure to the ventilator connection portion.

[0062] Optionally, the expectoration assist valve transmits sufficient positive pressure to the ventilator connection to generate a patient airway pressure of 10 to 70 cmH2O, and when the expectoration assist valve is in a second state for the forced exhaust phase of expectoration assistance, the expectoration assist valve transmits sufficient negative pressure to the ventilator connection to generate a patient airway pressure of -10 to -70 cmH2O.

[0063] In another embodiment of the ventilator with integrated expectoration assist for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator includes a controller operable in a ventilation mode and an expectoration assist mode, the controller controlling the operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode, the expectoration assist connection being connectable for fluid communication therewith, a ventilator subsystem directing a flow of ventilation air to the ventilator connection for delivery to the patient in the ventilation mode, and a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet. The ventilator further includes an expectoration assist valve that is in a first state for the expectoration assist insufflation phase and then moved to a second state for the expectoration assist forced exhaust phase. When the expectoration auxiliary valve is in a first state for the air delivery phase of expectoration assistance, the expectoration auxiliary valve directs the flow of air to the compressor inlet and the accelerated flow of air from the compressor outlet to the ventilator connection for delivery to the patient, and when the expectoration auxiliary valve is in a second state for the forced exhaust phase of expectoration assistance, the expectoration auxiliary valve directs the flow of forced exhaust gas from the patient to the compressor inlet and exhausts the accelerated flow of forced exhaust gas from the compressor outlet.

[0064] Optionally, when the ventilator is in a ventilation mode, the expectoration assist valve is held for operation in a first state.

[0065] Optionally, in a ventilation mode, the ventilator portion directs a flow of ventilation air to the ventilator connection for delivery to the patient by directing the ventilation air to the compressor inlet, with the expectoration assist valve held for operation in a first state.

[0066] In yet another embodiment of a ventilator with integrated expectoration assist for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator is operable in a ventilation mode and a expectoration assist mode and includes a controller that controls operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode having an insufflation phase followed by a forced exhaust phase; a ventilator connection to which the patient circuit is connectable for fluid communication; a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet; and an expectoration assist valve that is in a first state for the insufflation phase of the expectoration assist and then moved to a second state for the forced exhaust phase of the expectoration assist. The phlegm exhaust auxiliary valve includes a first chamber, a second chamber, a third chamber, a valve air intake opening in fluid communication with a source of air, a valve exhaust outlet opening, a valve-to-compressor outlet opening in fluid communication with a compressor input, a compressor-to-valve inlet opening in fluid communication with a compressor output, a first opening through which the first chamber and the second chamber are in fluid communication, a second opening through which the second chamber and the third chamber are in fluid communication, a third opening in fluid communication with a ventilator connection, a first valve member movable between a first position closing the first opening and a second position closing the valve air intake opening, and a second valve member movable between a first position closing the valve exhaust outlet opening and a second position closing the second opening. When the expectoration assist valve is in a first state for the air supply phase of phlegm expulsion assistance, the first valve member is in the first position of the first valve member and the second valve member is in the first position of the second valve member, and when the expectoration assist valve is in a second state for the forced exhaust phase of phlegm expulsion assistance, the first valve member is in the second position of the first valve member and the second valve member is in the second state of the second valve member.The expectoration assistance valve further includes a valve actuator configured to move the first and second valve members to their first positions for an air delivery phase of phlegm assistance and to move the first and second valve members to their second positions for a forced exhaust phase of phlegm assistance.

[0067] Optionally, when the ventilator is in a ventilation mode, the expectoration assist valve is held for operation in a first state.

[0068] Optionally, in a ventilation mode, the ventilator portion directs a flow of ventilation air to the ventilator connection for delivery to the patient by directing the ventilation air to the compressor inlet, with the expectoration assist valve held for operation in a first state.

[0069] Optionally, the first and second valve members are attached to a connecting member, and the valve actuator is configured to move the connecting member to a first position for moving the first and second valve members to their first positions for an air insufflation phase of phlegm removal assistance, and to a second position for moving the first and second valve members to their second positions for a forced exhaust phase of phlegm removal assistance.

[0070] Optionally, the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet mounted to the connecting member for movement with the connecting member as a unit and the other of the electromagnetic coil and the permanent magnet being stationary, and the electromagnetic coil and the permanent magnet magnetically interacting when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions.

[0071] Optionally, the ventilator further includes first and second permanent latch magnets and first and second ferromagnetic member portions, one of the first permanent latch magnet and the first ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, one of the second permanent latch magnet and the second ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic member portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic member portion when the first and second valve members are in their second positions to hold the first and second valve members in their second positions when the electromagnetic coil is de-energized.

[0072] Optionally, the ventilator further includes a permanent latch magnet and a ferromagnetic member portion, one of the permanent latch magnet and the ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, and the permanent latch magnet being positioned sufficiently proximate to the ferromagnetic member portion when the first and second valve members are in such one of their first and second positions to hold the first and second valve members in one of their first and second positions when the electromagnetic coil is de-energized.

[0073] Optionally, the valve actuator includes a stationary electromagnetic coil and a moveable permanent magnet, the electromagnetic coil positioned within the stationary coil housing, the connecting member extending through the stationary coil housing, the permanent magnet positioned within the coil housing, the electromagnetic coil extending around the permanent magnet, the permanent magnet attached to the connecting member for movement with the connecting member as a unit and positioned for magnetic interaction with the electromagnetic coil, the electromagnetic coil and the permanent magnet magnetically interacting when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions.

[0074] Optionally, the ventilator further includes first and second permanent latch magnets and first and second ferromagnetic member portions, one of the first permanent latch magnet and the first ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, one of the second permanent latch magnet and the second ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic member portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic member portion when the first and second valve members are in their second positions to hold the first and second members in their second positions when the electromagnetic coil is de-energized.

[0075] Optionally, the ventilator further includes first and second permanent latch magnets attached to the connecting member within the coil housing for moving with the connecting member as one unit, and first and second ferromagnetic member portions, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic member portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic member portion when the first and second valve members are in their second positions to hold the first and second valve members in their second positions when the electromagnetic coil is de-energized.

[0076] Optionally, the first ferromagnetic member portion is a first end portion of the coil housing and the second ferromagnetic member portion is a second end portion of the coil housing.

[0077] Optionally, the ventilator further includes a permanent latch magnet attached to the connecting member within the coil housing for moving with the connecting member as one unit, and a ferromagnetic member portion, the permanent latch magnet being positioned sufficiently proximate to the ferromagnetic member portion when the first and second valve members are in such one of their first and second positions to hold the first and second valve members in one of their first and second positions when the electromagnetic coil is de-energized.

[0078] Optionally, the connecting member is an elongate shaft extending completely through the second chamber and having a first end portion extending through the first opening into the first chamber and a second end portion extending through the second opening into the third chamber, the first valve member being attached to the first end portion of the shaft in the first chamber between the valve air intake opening and the first opening and the second valve member being attached to the second end portion of the shaft in the third chamber between the valve exhaust outlet opening and the second opening.

[0079] Optionally, the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet attached to and concentrically arranged with the connecting member for movement therewith as a unit, and the other of the electromagnetic coil and the permanent magnet being stationary, and the electromagnetic coil and the permanent magnet magnetically interacting when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions.

[0080] Optionally, the other of the electromagnetic coil and the permanent magnet is arranged concentrically with the connecting member.

[0081] Optionally, the first, second and third chambers are within the valve body.

[0082] Optionally, the first, second and third chambers are in a linear arrangement within the valve body, and the connecting member is an elongate shaft extending completely through the second chamber and having a first end portion extending into the first chamber and a second end portion extending into the third chamber.

[0083] Optionally, the valve air intake opening, the first opening, the second opening and the valve exhaust outlet opening are in linear alignment, and the connecting member is an elongate shaft in coaxial alignment with the valve air intake opening, the first opening, the second opening and the valve exhaust outlet opening, the shaft extending completely through the second chamber, the shaft having a first end portion extending into the first chamber through the first opening, the first valve member being attached to the first end portion within the first chamber and movable with the shaft between the first opening and the valve air intake opening, and a second end portion extending into the third chamber through the second opening, the second valve member being attached to the second end portion within the third opening and movable with the shaft between the valve exhaust outlet opening and the second opening.

[0084] Optionally, an area of ​​the first opening closed by the first valve member when the first valve member is in the first position and an area of ​​the valve exhaust outlet opening closed by the second valve member when the second valve member is in the first position are sized to produce substantially equal and oppositely directed forces on the first and second valve members resulting from air pressure in the second chamber transmitted from the third opening, and an area of ​​the valve air intake opening closed by the first valve member when the first valve member is in the second position and an area of ​​the second opening closed by the second valve member when the second valve member is in the second position are sized to produce substantially equal and oppositely directed forces on the first and second valve members resulting from air pressure in the second chamber transmitted from the third opening.

[0085] In an additional embodiment of a ventilator with integrated expectoration assist for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator is operable in a ventilation mode and a expectoration assist mode and includes a controller that controls operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode having an insufflation phase followed by a forced exhaust phase; a ventilator connection to which the patient circuit is connectable for fluid communication; a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet; and an expectoration assist valve that is in a first state for the insufflation phase of the expectoration assist and then moved to a second state for the forced exhaust phase of the expectoration assist. The expectoration auxiliary valve further includes a valve air intake in fluid communication with the source of air, a valve exhaust outlet, a valve-to-compressor outlet in fluid communication with the compressor input, a compressor-to-valve inlet in fluid communication with the compressor output, a first valve member movable between a first position of the first valve member and a second position of the first valve member, a second valve member movable between the first position of the second valve member and a second position of the second valve member, and a third opening in fluid communication with the ventilator connection. When the expectoration assist valve is in a first state for the expectoration assist air delivery phase, the first valve member is in the first valve member first position, allowing air flow from the air source to enter the valve air intake, flow through the valve-to-compressor outlet and enter the compressor inlet, while blocking air flow from entering the valve air intake and directly to the third opening, and the second valve member is in the second valve member first position, allowing accelerated air flow from the compressor outlet to enter the compressor-to-valve inlet and flow through the third opening to the ventilator connection for delivery to the patient, while blocking accelerated air flow from the compressor outlet to enter the compressor-to-valve inlet and flow through the valve exhaust outlet.When the expectoration assist valve is in the second state for the forced exhaust phase of phlegm exhaust assistance, the first valve member is in the first valve member second position and allows the flow of forced exhaust gas from the patient to enter the third opening, flow from the valve through the outlet to the compressor and enter the compressor inlet while blocking the flow of forced exhaust gas from the patient from entering the third opening and flowing through the valve air intake, and the second valve member is in the second valve member second state and allows the flow of accelerated forced exhaust gas to enter the inlet to the valve and flow through the valve exhaust outlet while blocking the flow of accelerated forced exhaust gas from the compressor to enter the inlet to the valve and flowing to the third opening. The valve actuator is configured to move the first and second valve members to their first positions for an air insufflation phase of phlegm assistance, and to move the first and second valve members to their second positions for a forced exhaust phase of phlegm assistance.

[0086] An embodiment of the secretions trap is for use between a patient connection and a patient circuit. The secretions trap includes a first connection portion connectable to the patient connection for fluid communication with the patient connection, a second connection portion connectable to the patient circuit for fluid communication with the patient circuit, and a central portion located between the first and second connection portions. The central portion has a first end portion in fluid communication with the first connection portion, a second end portion in fluid communication with the second connection portion, and a secretions collection well located between the first and second end portions and sized to capture and retain secretions entering the central portion.

[0087] Optionally, the first connecting portion has a first cross-sectional area and the second connecting portion has a second cross-sectional area, and the secretion collection well is a chamber located between the first end portion and the second end portion and having a longitudinally extending portion thereof with at least a third cross-sectional area substantially larger than the first cross-sectional area of ​​the first connecting portion, which captures secretions entering the central portion and retains them within the secretion collection chamber.

[0088] Optionally, the trap includes a drain in fluid communication with the secretion collection well for removal of secretions captured and retained by the secretion collection well.

[0089] Optionally, when used with a suction source, the secretion trap further includes a drain having a first end portion in fluid communication with the secretion collection well and a second end portion connectable to a suction source for fluid communication with the suction source for application of a suction force to the secretion collection well for removal of secretions captured and retained by the secretion collection well.

[0090] Optionally, the first end portion of the drain is in fluid communication with the secretion collection well at a location closer to the first end portion of the secretion collection well than the second end portion of the secretion collection well.

[0091] Another embodiment of the secretion trap is for use between a patient connection with a connection portion having an internal passageway and an auxiliary drainage conduit with a connection portion having an internal passageway. The secretion trap includes a first connection portion connectable to the connection portion of the patient connection for fluid communication with the patient connection, the first connection portion having an internal passageway, a second connection portion connectable to the connection portion of the auxiliary drainage conduit for fluid communication with the auxiliary drainage conduit, the second connection portion having an internal passageway, and a secretion collection chamber located between the first and second connection portions. The secretion collection chamber has a first end portion of the chamber located toward the first connection portion and a second end portion of the chamber located toward the second connection portion. One of the passages of the first connecting portion and the connecting portion of the patient connecting portion defines a flow opening for the secretions collection chamber at a first end portion of the chamber, and one of the passages of the second connecting portion and the connecting portion of the auxiliary drainage conduit defines a flow opening for the secretions collection chamber at a second end portion of the chamber. The secretions chamber has a well portion sized to capture and retain secretions entering the central portion.

[0092] Optionally, the secretions chamber has a longitudinally extending portion with a cross-sectional area sized such that fluid flow with a flow rate entering the secretions chamber through the flow opening at a first end portion of the chamber is sufficiently reduced within the secretions chamber for the secretions collection chamber to capture and retain therein secretions carried by the fluid flow.

[0093] Optionally, the secretions trap includes a drain in fluid communication with the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0094] Optionally, when used with a suction source, the secretions trap further includes a drain having a first end portion in fluid communication with the secretions collection chamber and a second end portion connectable to a suction source for fluid communication with the suction source for application of a suction force to the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0095] Optionally, the first end portion of the drain is in fluid communication with the secretion collection chamber at a location closer to the first end portion of the chamber than the second end portion of the chamber.

[0096] Yet another embodiment is a patient connection with an integrated secretions trap for use with a patient circuit. The patient connection includes a patient breathing conduit portion and a secretions collection chamber with first and second end portions of the chamber. The first end portion of the chamber is in fluid communication with the patient breathing conduit portion and the second end portion of the chamber is connectable with the patient circuit for fluid communication therewith. The patient breathing conduit portion and the first end portion of the chamber define a first end flow opening for the secretions collection chamber at the first end portion of the chamber. The secretions chamber has a longitudinally extending portion with a cross-sectional area sized such that a fluid flow with a flow rate entering the secretions chamber through the first end flow opening causes a flow rate to be sufficiently reduced within the secretions chamber for the secretions collection chamber to capture and retain therein secretions carried by the fluid flow.

[0097] Optionally, the patient connection further includes a drain in fluid communication with the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0098] Optionally, when used with a suction source, the patient connection portion further includes a drain having a first end portion in fluid communication with the secretions collection chamber and a second end portion connectable to a suction source for fluid communication with the suction source for application of a suction force to the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0099] Another embodiment is a patient circuit with an integrated secretions trap for use with a patient connection. The patient circuit includes a patient circuit conduit portion and a secretions collection chamber with first and second end portions of the chamber. The first end portion of the chamber is connectable with the patient connection for fluid communication with the patient connection, and the second end portion of the chamber is in fluid communication with the patient circuit conduit portion. The patient connection and the first end portion of the chamber, when connected together, define a first end flow opening for the secretions collection chamber at the first end portion of the chamber. The secretions chamber has a longitudinally extending portion with a cross-sectional area sized such that a fluid flow with a flow rate entering the secretions chamber through the first end flow opening causes the flow rate to be sufficiently reduced within the secretions chamber for the secretions collection chamber to capture and retain therein secretions carried by the fluid flow.

[0100] Optionally, the patient circuit further includes a drain in fluid communication with the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0101] Optionally, when used with a suction source, the patient circuit further includes a drain having a first end portion in fluid communication with the secretions collection chamber and a second end portion connectable to a suction source for fluid communication with the suction source for application of a suction force to the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0102] An additional embodiment of the patient connection has an integrated secretions trap and patient circuit. The secretions trap includes a patient breathing conduit portion, a patient circuit conduit portion, and a secretions collection chamber with first and second end portions of the chamber. The first end portion of the chamber is in fluid communication with the patient breathing conduit portion and the second end portion of the chamber is in fluid communication with the patient circuit conduit portion. The patient breathing conduit portion and the first end portion of the chamber define a first end flow opening for the secretions collection chamber at the first end portion of the chamber. The secretions chamber has a longitudinally extending portion with a cross-sectional area sized such that a fluid flow with a flow rate entering the secretions chamber through the first end flow opening is sufficiently reduced in the secretions chamber for the secretions collection chamber to capture and retain therein secretions carried by the fluid flow.

[0103] Optionally, the patient connection further includes a drain in fluid communication with the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0104] Optionally, when used with a suction source, the patient connection portion further includes a drain having a first end portion in fluid communication with the secretions collection chamber and a second end portion connectable to a suction source for fluid communication with the suction source for application of a suction force to the secretions collection chamber for removal of secretions captured and retained by the secretions collection chamber.

[0105] Yet another additional embodiment is a ventilator with an integrated expectoration assist and secretion trap for use in fluid communication with a patient connection. The ventilator is operable in a ventilation mode and an expectoration assist mode. The ventilator includes a ventilator connection and a secretion trap, the secretion trap having a first connection portion connectable to the patient connection for fluid communication with the patient connection, a second connection portion in fluid communication with the ventilator connection, and a central portion located between the first and second connection portions. The central portion has a first end portion in fluid communication with the first connection portion, a second end portion in fluid communication with the second connection portion, and a secretion collection well located between the first and second end portions and sized to capture and retain secretions entering the central portion. The ventilator also includes a ventilator portion that, in a ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a user input for selectively switching operation of the ventilator from the ventilation mode to a clearance assist mode without disconnecting the ventilator from the patient; and a controller operable in response to the user input for switching the ventilator from operation in the ventilation mode to operation in the clearance assist mode, and for controlling operation of the ventilator to provide at least one clearance assist to the patient in the clearance assist mode.

[0106] Optionally, when controlling operation of the ventilator in the expectoration assist mode, the controller controls operation of the ventilator to provide at least one expectoration assist to the patient having an insufflation phase followed by a forced exhaust phase, the ventilator further including at least one expectoration assist valve for communicating positive pressure to the ventilator connection during at least a portion of the insufflation phase of the expectoration assist and communicating negative pressure to the ventilator connection during at least a portion of the forced exhaust phase of the expectoration assist.

[0107] Optionally, the ventilator further includes a drain in fluid communication with the secretions collection well for removal of secretions captured and retained by the secretions collection well.

[0108] Optionally, when used with a suction source, the ventilator further includes a drain having a first end portion in fluid communication with the secretions collection well and a second end portion connectable to the suction source for fluid communication with the suction source for application of a suction force to the secretions collection well for removal of secretions captured and retained by the secretions collection well.

[0109] An embodiment of the secretions trap is for use between a patient connection and a patient circuit. The secretions trap includes a first connection portion connectable to the patient connection for fluid communication with the patient connection, a second connection portion connectable to the patient circuit for fluid communication with the patient circuit, and a central portion located between the first and second connection portions and having a first end portion in fluid communication with the first connection portion and a second end portion in fluid communication with the second connection portion. The secretions trap further includes a secretions collection drain located in fluid communication with the central portion sized and positioned for removal of secretions entering the central portion.

[0110] The secretions trap may be used with a suction source, in which case the secretions collection drain may have a first end portion in fluid communication with the central portion and a second end portion connectable to the suction source for fluid communication with the suction source for application of a suction force to the central portion for removal of secretions that enter into the central portion.

[0111] One embodiment of the passive valve is for use as a fixed leak valve with a ventilator by connection to a patient connection. The passive valve includes a valve body having an internal chamber, a first valve body port in fluid communication with the internal chamber and configured for fluid communication with a patient connection, a second valve body port in fluid communication with the internal chamber and configured for fluid communication with a ventilator, a valve body passage in communication with the internal chamber and ambient air outside the valve body, and a check valve seal positioned to allow flow of gas in the internal chamber through the valve body passage to the outside of the valve body and to seal the valve body passage to prevent flow of ambient air outside the valve body through the valve body passage into the internal chamber.

[0112] Optionally, the valve disc passage is an elongated, circumferentially extending channel extending at least partially around the valve disc.

[0113] Optionally, the passive valve further includes a plurality of first passages in fluid communication with the interior chamber and the channel.

[0114] Optionally, the check valve seal is an elongated, circumferentially extending flexible seal positioned within the channel and flexibly movable between a closed position that closes the first passageway and prevents fluid communication between the internal chamber and the channel through the first passageway when pressure in the internal chamber is below a threshold pressure, and an open position that opens the first passageway and allows fluid communication between the internal chamber and the channel through the first passageway when pressure in the internal chamber is above a threshold pressure, thereby providing a fluid communication path between the internal chamber and ambient air outside the valve body.

[0115] Another embodiment of the passive valve is for use as a fixed leak valve with a ventilator by connection to a patient connection. The passive valve includes a body having a first body portion, a second body portion, and a third body portion positioned between the first body portion and the second body portion. The first body portion has a first fluid passage extending therethrough and an outward end portion configured for fluid communication with the patient connection, the second body portion has a second fluid passage extending therethrough and an outward end portion configured for fluid communication with the ventilator, and the third body portion has a third fluid passage extending therethrough and in fluid communication with the first and second fluid passages. The first, second, and third fluid passages in combination define a body fluid passage. The third body portion has a chamber extending at least partially therearound, the chamber having at least one interior opening in fluid communication with the body fluid passage and at least one exterior opening in fluid communication with an exterior of the body. A seal is included, at least a portion of which is located within the chamber, the seal being movable between a closed position that closes at least one internal opening of the chamber when pressure in the body fluid passage is below a threshold pressure, and an open position that opens the at least one internal opening when pressure in the body fluid passage is above the threshold pressure.

[0116] Optionally, the portion of the seal is a first peripheral portion of the seal.

[0117] Optionally, the first peripheral portion of the seal is flexible and moves from the closed position to the open position by bending away from the at least one internal opening in response to pressure in the body fluid passage exceeding a threshold pressure.

[0118] Optionally, the seal further includes a second peripheral portion of the seal that is held stationary relative to the body.

[0119] Optionally, the seal is flexible and moves from a closed position to an open position by bending away from the at least one internal opening in response to pressure in the body fluid passage exceeding a threshold pressure.

[0120] Optionally, the at least one internal opening includes at least two internal openings, and a portion of the seal extends between the at least two internal openings of the chamber and is movable between a closed position that covers and closes the at least two internal openings when pressure in the body fluid passage falls below a threshold pressure, preventing fluid communication between the body fluid passage and the chamber through the at least two internal openings, and an open position that opens the at least two internal openings when pressure in the body fluid passage exceeds a threshold pressure, allowing fluid communication between the body fluid passage and the chamber through the at least two internal openings, thereby providing a fluid communication path between the body fluid passage and at least one external opening of the chamber.

[0121] Optionally, the seal has a first peripheral portion and a second peripheral portion, one of the first and second peripheral portions located outside the other of the first and second peripheral portions. The first peripheral portion of the seal extends between the at least two internal openings and is flexible and moves from a closed position to an open position by bending away from the at least two internal openings in response to pressure in the body fluid passage exceeding a threshold pressure. The second peripheral portion of the seal is held stationary relative to the body.

[0122] Optionally, the chamber is an annular chamber extending completely around the third fluid passageway and the seal is an annular seal.

[0123] Yet another embodiment of the passive valve is for use as a fixed leak valve with a ventilator by connection to a patient connection. The passive valve includes a seal having a seal central opening, first and second body portions, and a chamber. The first body portion has a first fluid passageway extending therethrough with an outwardly facing first end portion configured for fluid communication with a patient connection and an inwardly facing second end portion, and the second body portion has a second fluid passageway extending therethrough with an outwardly facing first end portion configured for fluid communication with a ventilator and an inwardly facing second end portion. The inwardly facing second end portions of the first and second body portions are joined together with a seal positioned therebetween, and the seal central opening is aligned with the first and second fluid passageways to define a body fluid passageway extending between the outwardly facing first end portions of the first and second body portions. The chamber extends around the body fluid passage and has at least one internal opening in fluid communication with the body fluid passage and at least one external opening in fluid communication with an exterior of the body. The seal is located within the chamber and has a first peripheral portion movable between a closed position that closes the at least one internal opening when pressure in the body fluid passage is below a threshold pressure and an open position that opens the at least one internal opening when pressure in the body fluid passage is above the threshold pressure.

[0124] Optionally, the first peripheral portion of the annular seal is flexible and moves from a closed position to an open position by bending away from the at least one internal opening in response to pressure in the body fluid passage exceeding a threshold pressure.

[0125] Optionally, the annular seal further has a second peripheral portion that is held stationary relative to the body.

[0126] Optionally, the at least one internal opening is defined by at least one gap between the inwardly facing second end portions of the joined first and second body portions.

[0127] Optionally, at least one exterior opening is formed in a flange portion of at least one of the inwardly facing second end portions of the joined first and second body portions.

[0128] Another embodiment is a ventilator with integrated expectoration assist for use with a patient. The ventilator includes a ventilator portion having a passive patient circuit for fluid communication with a patient connection and a ventilator connection to which the patient circuit is connectable for fluid communication, the ventilator portion operable in a ventilation mode and an expectoration assist mode. When the ventilator is in the ventilation mode, the ventilator portion directs a flow of ventilation air to the ventilator connection for delivery to the patient via the patient circuit, the ventilation air producing a pressure in the patient circuit above a threshold pressure. The ventilator further includes a user input for selectively switching operation of the ventilator from the ventilation mode to an expectoration assist mode without disconnecting the ventilator from the patient, and a controller operable in response to the user input for switching the ventilator from operation in the ventilation mode to operation in the expectoration assist mode, the controller controlling operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode, the expectoration assist having an insufflation phase followed by a forced exhaust phase. The ventilator also includes a sputum assist valve that is in a first state for a delivery phase of sputum assistance and is then moved to a second state for a forced exhaust phase of sputum assistance. When the sputum assist valve is in the first state for a delivery phase of sputum assistance, the sputum assist valve communicates a positive pressure to the ventilator connection at a pressure in the patient circuit above a threshold pressure for delivery to the patient via the patient circuit, and when the sputum assist valve is in the second state for a forced exhaust phase of sputum assistance, the sputum assist valve communicates a negative pressure to the ventilator connection at a pressure in the patient circuit below the threshold pressure for delivery to the patient via the patient circuit. The patient circuit of the ventilator includes a passive valve that can be used as a fixed leak valve. The passive valve includes a valve body having an internal chamber, a first valve body port in fluid communication with the internal chamber and configured for fluid communication with a patient connection, a second valve body port in fluid communication with the internal chamber and configured for fluid communication with a ventilator connection, a valve body passage in communication with the internal chamber and with ambient air outside the valve body, and a check valve seal positioned to allow flow of gas in the internal chamber through the valve body passage to outside the valve body and to seal the valve body passage to prevent flow of ambient air outside the valve body through the valve body passage into the internal chamber.

[0129] Optionally, the plug passage comprises a passage chamber extending at least partially around the interior chamber of the plug, the plug being associated with a first plug port comprising at least two interior openings of the passage chamber providing fluid communication between the passage chamber and the interior chamber of the plug, and a second plug port comprising at least one exterior opening of the passage chamber providing fluid communication between the passage chamber and an exterior of the plug. A check valve seal is located at least partially within the passage chamber and extends between the at least two interior openings of the passage chamber. A portion of the seal is movable between a closed position that closes the at least two interior openings of the passage chamber when pressure in the interior chamber of the plug is below a threshold pressure, and an open position that opens the at least two interior openings of the passage chamber when pressure in the interior chamber of the plug is above a threshold pressure.

[0130] Optionally, a portion of the seal located within the passage chamber is flexible and moves from a closed position to an open position by bending away from the at least two internal openings of the passage chamber in response to pressure within the internal chamber of the valve body exceeding a threshold pressure.

[0131] Optionally, the seal further includes a portion that is held stationary relative to the valve disc.

[0132] Another embodiment is a patient connection for use with a ventilator and a patient having at least one lung. The patient connection includes a patient interface portion having a fluid passageway coupleable to the patient for fluid communication with the patient's at least one lung, and a passive valve portion operable as a fixed leak valve. The valve portion includes a valve body having an internal chamber, a first valve body port in fluid communication with the internal chamber and configured for fluid communication with a fluid passageway of the patient interface, a second valve body port in fluid communication with the internal chamber and configured for fluid communication with a ventilator, a valve body passageway in communication with the internal chamber and with ambient air outside the valve body, and a check valve seal positioned to allow flow of gas in the internal chamber through the valve body passageway to the outside of the valve body and to seal the valve body passageway to prevent flow of ambient air outside the valve body through the valve body passageway into the internal chamber.

[0133] Optionally, the valve disc passage is an elongated, circumferentially extending channel extending at least partially around the valve disc.

[0134] Optionally, the patient connection further includes a plurality of first passageways in fluid communication with the interior chamber and the channel.

[0135] Optionally, the check valve seal is an elongated, circumferentially extending flexible seal positioned within the channel and flexibly movable between a closed position that closes the first passageway and prevents fluid communication between the internal chamber and the channel through the first passageway when pressure in the internal chamber is below a threshold pressure, and an open position that opens the first passageway and allows fluid communication between the internal chamber and the channel through the first passageway when pressure in the internal chamber is above a threshold pressure, thereby providing a fluid communication path between the internal chamber and ambient air outside the valve body.

[0136] One embodiment of an active exhalation valve is for use with a mechanical ventilator to control the flow of patient exhalation gas. The active exhalation valve includes a patient circuit connection port, a patient connection port, an exhalation gas port, a pilot pressure port, a valve seat, and a movable poppet. The movable poppet includes an inner bellows member, an outer bellows member, and a bellows poppet face. The pilot pressure port is configured such that an activation pressure applied to the pilot pressure port expands the inner and outer bellows members and moves the bellows poppet face into engagement with the valve seat, restricting the flow of patient exhalation gas to the expiratory gas port, and a reduction in activation pressure to the pilot pressure port allows the inner and outer bellows members to move the bellows poppet face away from and out of engagement with the valve seat, allowing the flow of patient exhalation gas to the expiratory gas port, thereby controlling the flow of patient exhalation gas from the valve.

[0137] Optionally, the inner and outer bellows members define an internal bellows chamber therebetween, the pilot pressure port being in fluid communication with the internal bellows chamber.

[0138] Optionally, the inner bellows member has an inner bellows fluid passageway extending therethrough in fluid communication with the patient circuit connection port and the patient connection port.

[0139] Optionally, the inner bellows fluid passage is in continuous fluid communication with the patient circuit connection port and the patient connection port and is out of fluid communication with the internal bellows chamber between the inner and outer bellows members during operation of the exhalation valve.

[0140] Optionally, the inner bellows member has an inner bellows fluid passageway extending therethrough in serial fluid communication with the patient circuit connection port and the patient connection port.

[0141] Another embodiment of the active exhalation valve is for use with a mechanical ventilator having a patient connection and a pressure source that can be used to control the operation of the valve and control the flow of patient exhalation gas. The active exhalation valve includes a patient circuit connection port for fluid communication with the mechanical ventilator, a patient connection port for fluid communication with the patient connection, an exhalation gas port for fluid communication with air outside the valve and for removing patient exhalation gas from the valve, a pilot pressure port for fluid communication with a pressure source, a valve seat, and a movable poppet. The movable poppet includes an inner bellows member, an outer bellows member, and a bellows poppet surface. The pilot pressure port is configured such that an active pressure applied to the pilot pressure port by a pressure source expands the inner and outer bellows members and moves the bellows poppet face into sealing engagement with the valve seat, restricting the flow of patient exhaled gas to the expiratory gas port, and a reduction in the active pressure applied to the pilot pressure port by the pressure source allows the inner and outer bellows members to move the bellows poppet face away from the valve seat and out of sealing engagement with the valve seat, allowing the flow of patient exhaled gas to the expiratory gas port, thereby controlling the flow of patient exhaled gas from the valve.

[0142] Optionally, the inner and outer bellows members define an internal bellows chamber therebetween, the pilot pressure port being in fluid communication with the internal bellows chamber.

[0143] Optionally, the inner bellows member has an inner bellows fluid passageway extending therethrough in fluid communication with the patient circuit connection port and the patient connection port.

[0144] Optionally, the inner bellows fluid passage is in continuous fluid communication with the patient circuit connection port and the patient connection port and is out of fluid communication with the internal bellows chamber between the inner and outer bellows members during operation of the exhalation valve.

[0145] Optionally, the inner bellows member has an inner bellows fluid passageway extending therethrough in serial fluid communication with the patient circuit connection port and the patient connection port.

[0146] Yet another embodiment of an active exhalation valve is for use with a ventilator to control the operation of the valve and control the flow of patient exhalation gas. The active exhalation valve includes a patient circuit connection port, a patient connection port, an exhalation gas port, a pilot pressure port, a valve seat, and a movable poppet. The movable poppet includes an inner member, an outer member, and a poppet face. The pilot pressure port is configured such that an activation pressure applied to the pilot pressure port moves the inner and outer members toward the valve seat and moves the poppet face into engagement with the valve seat, restricting the flow of patient exhalation gas to the exhalation gas port, and a reduction in activation pressure to the pilot pressure port allows the inner and outer members to move away from the valve seat and the poppet face to move out of engagement with the valve seat, allowing the flow of patient exhalation gas to the exhalation gas port, thereby controlling the flow of patient exhalation gas from the valve.

[0147] Optionally, the inner and outer members define an internal chamber therebetween, the pilot pressure port being in fluid communication with the internal chamber.

[0148] Optionally, the inner member has an inner member fluid passageway extending therethrough in fluid communication with the patient circuit connection port and the patient connection port.

[0149] Optionally, the inner member fluid passageway is in continuous fluid communication with the patient circuit connection port and the patient connection port and is out of fluid communication with the internal bellows chamber between the inner and outer bellows members during operation of the exhalation valve.

[0150] Optionally, the inner member has an inner member fluid passageway extending therethrough in serial fluid communication with the patient circuit connection port and the patient connection port.

[0151] Another embodiment of the active exhalation valve is for use with a patient connection and a ventilator having a pressure source that can be used to control the operation of the valve. The active exhalation valve includes a valve body having an internal body chamber with gas therein having a body chamber pressure, a first body port in fluid communication with the body chamber and configured for fluid communication with the patient connection, a second body port in fluid communication with the body chamber and configured for fluid communication with the ventilator, a passage in fluid communication with ambient air outside the body chamber and the valve body, and a valve seal movable between a closed position that seals the passage and an open position that opens the passage. The valve seal has an outer member, an inner member positioned within the outer member, an internal seal chamber located between the outer member and the inner member and in fluid communication with the pressure source, and a seal member extending between and movable with the inner member and the outer member. The seal member has a first surface portion inside the seal chamber configured for movement of the valve seal toward a closed position in response to pressure applied thereto by a pressure source and a second surface portion outside the seal chamber configured for movement of the valve seal toward an open position in response to pressure applied thereto by the body chamber pressure, the amount and direction of movement of the valve seal being responsive to resultant forces generated by the pressure source and the body chamber pressure on the first and second surface portions.

[0152] Optionally, the inner member has an inner member fluid passage extending therethrough in fluid communication with the body chamber, the inner member having a first end in fluid communication with the first body port and a second end in fluid communication with the second body port.

[0153] Optionally, the inner member fluid passageway is in continuous fluid communication with the first and second body ports and is out of fluid communication with the seal chamber between the inner and outer members during operation of the exhalation valve.

[0154] Optionally, the inner member has an inner member fluid passageway extending therethrough with a first opening in serial fluid communication with the first body port and a second opening in serial fluid communication with the second body port.

[0155] Optionally, the body has a wall portion defining another chamber positioned outside the valve seal, the wall portion being positioned outside the valve seal, the passageway being within the wall portion.

[0156] Optionally, the body has a peripheral wall portion extending circumferentially around the body chamber and positioned outwardly of the valve seal and defining an elongated peripheral chamber extending at least partially around the body chamber, the passage being within the peripheral wall portion.

[0157] Optionally, the passageway comprises a plurality of openings in an outer wall of the body for fluid communication with the body chamber and ambient air outside the valve body.

[0158] An additional embodiment of the active exhalation valve is for use with a patient connection and a ventilator having a pressure source that can be used to control the operation of the valve. The active exhalation valve includes a valve body having an internal body chamber with gas therein having a body chamber pressure, a channel therein for fluid communication with the pressure source and a body wall portion with an opening in fluid communication with the channel, a first body port in fluid communication with the body chamber and configured for fluid communication with the patient connection, a second body port in fluid communication with the body chamber and configured for fluid communication with the ventilator, a passage in fluid communication with ambient air outside the body chamber and the valve body, and a valve seal movable between a closed position that seals the passage and an open position that opens the passage. The valve seal has an outer longitudinally extending, longitudinally compressible wall, an inner longitudinally extending, longitudinally compressible inner wall positioned within the outer wall, each of the outer and inner walls having a first end and a second end, a sealing end wall closing a space between the first ends of the outer and inner walls and longitudinally movable with the first ends of the outer and inner walls, a body wall portion closing a space between the second end of the outer wall and the second end of the inner wall, and an internal seal chamber located between the outer and inner walls and extending between the sealing end wall and the body wall portion. An opening in the body wall portion is in fluid communication with the seal chamber and provides fluid communication with a pressure source. The sealing end wall is longitudinally movable within the valve body between a closed position in which the outer and inner walls are in an expanded configuration and an open position in which the outer and inner walls are at least partially compressed to a longitudinally compressed position. The sealing end wall has a first surface portion inside the seal chamber configured for movement of the valve seal toward a closed position in response to pressure applied thereto by a pressure source and a second surface portion outside the seal chamber configured for movement of the valve seal toward an open position in response to pressure applied thereto by the body chamber pressure, the amount and direction of movement of the valve seal being responsive to resultant forces generated by the pressure source and the body chamber pressure on the first and second surface portions of the sealing end wall.

[0159] Optionally, the inner wall has an inner wall fluid passage extending therethrough in fluid communication with the body chamber and having a first end in fluid communication with the first body port and a second end in fluid communication with the second body port.

[0160] Optionally, the inner wall fluid passageway is in continuous fluid communication with the first and second body ports and is out of fluid communication with the seal chamber between the inner and outer walls during operation of the exhalation valve.

[0161] Optionally, the inner wall has an inner wall fluid passageway extending therethrough with a first opening in serial fluid communication with the first body port and a second opening in serial fluid communication with the second body port.

[0162] Optionally, the longitudinally compressible outer and inner walls are serpentine with a plurality of ridges, and when in the at least partially longitudinally compressed position, two or more of the ridges are longitudinally compressed.

[0163] A final embodiment of the active exhalation valve is for use with a patient connection and a ventilator having a pressure source that can be used to control the operation of the valve. The active exhalation valve includes a valve body having an internal body chamber with gas therein having a body chamber pressure, a channel therein for fluid communication with the pressure source, and an opening in fluid communication with the channel, a first body port configured for fluid communication with the body chamber and for fluid communication with the patient connection, a second body port configured for fluid communication with the body chamber and for fluid communication with the ventilator, a passage in fluid communication with ambient air outside the body chamber and the valve body, and a valve seal movable between a closed position that seals the passage and an open position that opens the passage. The valve seal has a seal chamber defined by first and second longitudinally spaced ends and an outer longitudinally extendable wall and an inner longitudinally extendable wall positioned within the outer wall. The opening of the valve body is in fluid communication with the seal chamber and provides fluid communication with the pressure source. The first end of the seal chamber is longitudinally movable within the valve body between a valve seal closed position in which the outer and inner walls are in a longitudinally expanded configuration and a valve seal open position in which the outer and inner walls are in a longitudinally retracted configuration The valve seal is moved toward the closed position in response to pressure applied by a pressure source and toward the open position in response to pressure applied by a body chamber pressure, the amount and direction of movement of the valve seal responsive to resultant forces generated by the pressure source and the body chamber pressure.

[0164] Optionally, the inner wall has an inner wall fluid passage extending therethrough in fluid communication with the body chamber and having a first end in fluid communication with the first body port and a second end in fluid communication with the second body port.

[0165] Optionally, the inner wall fluid passageway is in continuous fluid communication with the first and second body ports and is out of fluid communication with the seal chamber between the inner and outer walls during operation of the exhalation valve.

[0166] Optionally, the inner wall has an inner wall fluid passageway extending therethrough with a first opening in serial fluid communication with the first body port and a second opening in serial fluid communication with the second body port. For example, the present application provides the following: (Item 1) 1. A ventilator with integrated expectoration support, the ventilator for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator operable in a ventilation mode and an expectoration support mode, the ventilator comprising: a ventilator connection, the patient circuit being connectable to the ventilator connection for fluid communication with the ventilator connection; a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a user input for selectively switching operation of the ventilator from a ventilation mode to a clearance assist mode without disconnecting the ventilator from the patient; a controller operable in response to the user input to switch the ventilator from operating in the ventilation mode to operating in the expectoration assistance mode, the controller controlling operation of the ventilator in the expectoration assistance mode to provide at least one expectoration assistance to the patient having an insufflation phase followed by a forced exhaust phase; a phlegm exhaust assist valve which is in a first state for the air supply phase of the phlegm exhaust assist and is then moved to a second state for the forced exhaust phase of the phlegm exhaust assist, wherein when the phlegm exhaust assist valve is in the first state for the air supply phase of the phlegm exhaust assist, the phlegm exhaust assist valve transmits a positive pressure to the artificial ventilator connection portion, and when the phlegm exhaust assist valve is in the second state for the forced exhaust phase of the phlegm exhaust assist, the phlegm exhaust assist valve transmits a negative pressure to the artificial ventilator connection portion; Equipped with an artificial respirator. (Item 2) The ventilator according to item 1, wherein the expectoration assist valve transmits to the ventilator connection section a positive pressure sufficient to generate a patient airway pressure of 10 to 70 cmH2O, and when the expectoration assist valve is in the second state for the forced exhaust phase of the expectoration assist, the expectoration assist valve transmits to the ventilator connection section a negative pressure sufficient to generate a patient airway pressure of -10 to -70 cmH2O. (Item 3) 1. A ventilator with integrated expectoration support, the ventilator for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator operable in a ventilation mode and an expectoration support mode, the ventilator comprising: a controller for controlling operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode, the expectoration assist mode including an insufflation phase followed by a forced exhaust phase; a ventilator connection, the patient circuit being connectable to the ventilator connection for fluid communication with the ventilator connection; a ventilator subsystem that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet; an expectoration assist valve which is in a first state for the air supply phase of the expectoration assist and is then moved to a second state for the forced exhaust phase of the expectoration assist, wherein when the expectoration assist valve is in the first state for the air supply phase of the expectoration assist, the expectoration assist valve directs a flow of air to the compressor inlet and directs the accelerated flow of air from the compressor outlet to the ventilator connection for delivery to the patient, and when the expectoration assist valve is in the second state for the forced exhaust phase of the expectoration assist, the expectoration assist valve directs a flow of forced exhaust gas from the patient to the compressor inlet and exhausts the accelerated flow of forced exhaust gas from the compressor outlet; Equipped with an artificial respirator. (Item 4) 4. The mechanical ventilator of claim 3, wherein the expectoration assist valve is held for operation in the first state when the mechanical ventilator is in the ventilation mode. (Item 5) 4. The ventilator of claim 3, wherein in the ventilation mode, the ventilator portion directs a flow of ventilation air to the ventilator connection for delivery to the patient by directing the ventilation air to the compressor inlet with the expectoration assist valve maintained for operation in the first state. (Item 6) 1. A ventilator with integrated expectoration support, the ventilator for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator operable in a ventilation mode and an expectoration support mode, the ventilator comprising: a controller for controlling operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode, the expectoration assist mode including an insufflation phase followed by a forced exhaust phase; a ventilator connection, the patient circuit being connectable to the ventilator connection for fluid communication with the ventilator connection; a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet; a phlegm exhaustion assist valve that is in a first state for the air supply phase of the phlegm exhaustion assist and is then moved to a second state for the forced exhaust phase of the phlegm exhaustion assist; Equipped with The phlegm drainage auxiliary valve is A first chamber; A second chamber; and A third chamber; and a valve air intake opening in fluid communication with a source of air; a valve exhaust outlet opening; an outlet opening from the valve to the compressor in fluid communication with the compressor input; a compressor-to-valve inlet opening in fluid communication with the compressor output; a first opening, the first chamber and the second chamber being in fluid communication through the first opening; a second opening, the second chamber and the third chamber being in fluid communication through the second opening; a third opening in fluid communication with the ventilator connection; a first valve member movable between a first position closing the first opening and a second position closing the valve air intake opening; a second valve member movable between a first position closing the valve exhaust outlet opening and a second position closing the second opening, When the expectoration assistance valve is in the first state for the air delivery phase of the expectoration assistance, the first valve member is in the first valve member first position and the second valve member is in the second valve member first position; When the expectoration assistance valve is in the second state for the forced exhaust phase of the expectoration assistance, the first valve member is in the first valve member second position, and the second valve member is in the second valve member second state. A second valve member; and a valve actuator configured to move the first and second valve members to their first positions for an insufflation phase of the expectoration assistance and to move the first and second valve members to their second positions for a forced exhaust phase of the expectoration assistance; Equipped with an artificial respirator. (Item 7) 7. The mechanical ventilator of claim 6, wherein the expectoration assist valve is held for operation in the first state when the mechanical ventilator is in the ventilation mode. (Item 8) 7. The ventilator of claim 6, wherein in the ventilation mode, the ventilator portion directs a flow of ventilation air to the ventilator connection for delivery to the patient by directing the ventilation air to the compressor inlet with the expectoration assist valve maintained for operation in the first state. (Item 9) 7. The ventilator of claim 6, wherein the first and second valve members are attached to a connecting member, and the valve actuator is configured to move the connecting member to a first position for moving the first and second valve members to their first positions for the insufflation phase of the expectoration assistance, and to move the first and second valve members to their second positions for the forced exhaust phase of the expectoration assistance. (Item 10) 10. The ventilator of claim 9, wherein the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet attached to the connecting member for movement with the connecting member as a unit, and the other of the electromagnetic coil and the permanent magnet being stationary, and wherein the electromagnetic coil and the permanent magnet magnetically interact when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions. (Item 11) Item 11. The ventilator of item 10, further comprising first and second permanent latch magnets and first and second ferromagnetic member portions, one of the first permanent latch magnet and the first ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, one of the second permanent latch magnet and the second ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic member portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic member portion when the first and second valve members are in their second positions to hold the first and second valve members in their second positions when the electromagnetic coil is de-energized. (Item 12) Item 11. The ventilator of item 10, further comprising a permanent latch magnet and a ferromagnetic member portion, one of the permanent latch magnet and the ferromagnetic member portion being attached to the connecting member for movement with the connecting member as one and the other being stationary, and the permanent latch magnet being positioned sufficiently proximate to the ferromagnetic member portion when the first and second valve members are in one of their first and second positions to hold the first and second valve members in one of their first and second positions when the electromagnetic coil is de-energized. (Item 13) 10. The ventilator of claim 9, wherein the valve actuator includes a stationary electromagnetic coil and a moveable permanent magnet, the electromagnetic coil positioned within a stationary coil housing, the connecting member extending through the stationary coil housing, the permanent magnet positioned within the coil housing, the electromagnetic coil extending around the permanent magnet, the permanent magnet attached to the connecting member for movement with the connecting member as one unit and positioned for magnetic interaction with the electromagnetic coil, the electromagnetic coil and the permanent magnet magnetically interacting when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions. (Item 14) 14. The ventilator of claim 13, further comprising first and second permanent latch magnets and first and second ferromagnetic member portions, one of the first permanent latch magnet and the first ferromagnetic member portion being attached to the connecting member for movement therewith as one unit and the other being stationary, one of the second permanent latch magnet and the second ferromagnetic member portion being attached to the connecting member for movement therewith as one unit and the other being stationary, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic member portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic member portion when the first and second valve members are in their second positions to hold the first and second valve members in their second positions when the electromagnetic coil is de-energized. (Item 15) 14. The ventilator of claim 13, further comprising first and second permanent latch magnets and first and second ferromagnetic material portions attached to the connecting member within the coil housing for moving with the connecting member as one unit, the first permanent latch magnet being positioned sufficiently proximate to the first ferromagnetic material portion when the first and second valve members are in their first positions to hold the first and second valve members in their first positions when the electromagnetic coil is de-energized, and the second permanent latch magnet being positioned sufficiently proximate to the second ferromagnetic material portion when the first and second valve members are in their second positions to hold the first and second valve members in their second positions when the electromagnetic coil is de-energized. (Item 16) Item 16. The ventilator of item 15, wherein the first ferromagnetic member portion is a first end portion of the coil housing and the second ferromagnetic member portion is a second end portion of the coil housing. (Item 17) 14. The ventilator of claim 13, further comprising a permanent latch magnet attached to the connecting member within the coil housing for movement therewith as a unit, and a ferromagnetic member portion, the permanent latch magnet positioned sufficiently proximate to the ferromagnetic member portion when the first and second valve members are in one of their first and second positions to hold the first and second valve members in one of their first and second positions when the electromagnetic coil is de-energized. (Item 18) 10. The ventilator of claim 9, wherein the connecting member is an elongate shaft extending completely through the second chamber, the elongate shaft having a first end portion extending through the first opening into the first chamber and a second end portion extending through the second opening into the third chamber, the first valve member attached to the first end portion of the shaft in the first chamber between the valve air intake opening and the first opening, and the second valve member attached to the second end portion of the shaft in the third chamber between the valve exhaust outlet opening and the second opening. (Item 19) 10. The ventilator of claim 9, wherein the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet attached to and concentrically arranged with the connecting member for movement with the connecting member as a unit, and the other of the electromagnetic coil and the permanent magnet being stationary, and the electromagnetic coil and the permanent magnet magnetically interacting when the electromagnetic coil is selectively energized to move the first and second valve members between their first and second positions. (Item 20) 20. The ventilator of claim 19, wherein the other of the electromagnetic coil and the permanent magnet is arranged concentrically with the connecting member. (Item 21) 7. The ventilator of claim 6, wherein the first, second, and third chambers are within a valve body. (Item 22) Item 22. The ventilator of item 21, wherein the first, second, and third chambers are in a linear arrangement within the valve body, the connecting member is an elongate shaft extending completely through the second chamber, the elongate shaft having a first end portion extending into the first chamber and a second end portion extending into the third chamber. (Item 23) 7. The ventilator of claim 6, wherein the valve air intake opening, the first opening, the second opening, and the valve exhaust outlet opening are in linear alignment, and the connecting member is an elongate shaft in coaxial alignment with the valve air intake opening, the first opening, the second opening, and the valve exhaust outlet opening, the shaft extending completely through the second chamber, the shaft having a first end portion extending through the first opening into the first chamber, the first valve member attached to the first end portion within the first chamber and movable with the shaft between the first opening and the valve air intake opening, and a second end portion extending through the second opening into the third chamber, the second valve member attached to the second end portion within the third opening and movable with the shaft between the valve exhaust outlet opening and the second opening. (Item 24) an area of ​​the first opening closed by the first valve member when the first valve member is in a first position and an area of ​​the valve exhaust outlet opening closed by the second valve member when the second valve member is in a first position are sized to produce substantially equal and oppositely directed forces on the first and second valve members, the forces resulting from air pressure in the second chamber transmitted from the third opening; 7. The ventilator of claim 6, wherein an area of ​​the valve air intake opening closed by the first valve member when in the first position and an area of ​​the second opening closed by the second valve member when in the second position are sized to produce substantially equal and oppositely directed forces on the first and second valve members, the forces resulting from air pressure in the second chamber transmitted from the third opening. (Item 25) 1. A ventilator with integrated expectoration support, the ventilator for use with a patient circuit in fluid communication with a patient connection of a patient, the ventilator operable in a ventilation mode and an expectoration support mode, the ventilator comprising: a controller for controlling operation of the ventilator to provide at least one expectoration assist to the patient in the expectoration assist mode, the expectoration assist mode including an insufflation phase followed by a forced exhaust phase; a ventilator connection, the patient circuit being connectable to the ventilator connection for fluid communication with the ventilator connection; a ventilator portion that, in the ventilation mode, directs a flow of ventilation air to the ventilator connection for delivery to the patient; a compressor having a compressor inlet and a compressor outlet, the compressor operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet; a phlegm exhaustion assist valve that is in a first state for the air supply phase of the phlegm exhaustion assist and is then moved to a second state for the forced exhaust phase of the phlegm exhaustion assist; Equipped with The phlegm drainage auxiliary valve is a valve air intake in fluid communication with a source of air; a valve exhaust outlet; an outlet from the valve to the compressor in fluid communication with the compressor input; a compressor-to-valve inlet in fluid communication with the compressor output; a first valve member, the first valve member movable between a first valve member first position and a first valve member second position; a second valve member, the second valve member movable between a second valve member first position and a second valve member second position; a third opening in fluid communication with the ventilator connection, when the expectoration assist valve is in the first state for the expectoration assist air delivery phase, the first valve member is in the first valve member first position, allowing a flow of air from the air source to enter the valve air inlet, flow from the valve through an outlet to the compressor and enter the compressor inlet, while blocking the flow of air from entering the valve air inlet and flowing directly to the third opening; and the second valve member is in the second valve member first position, allowing a flow of accelerated air from the compressor outlet to enter the inlet to the valve and flow through the third opening for flow to the ventilator connection for delivery to the patient, while blocking the flow of accelerated air from the compressor outlet to enter the inlet to the valve and flow through the valve exhaust outlet; When the expectoration assistance valve is in the second state for the forced exhaust phase of the expectoration assistance, the first valve member is in the first valve member second position and allows the flow of forced exhaust gas from the patient to enter the third opening, flow from the valve through the outlet to the compressor and enter the compressor inlet, while blocking the flow of forced exhaust gas from the patient from entering the third opening and flowing through the valve air intake, and the second valve member is in the second valve member second state and allows the flow of accelerated forced exhaust gas to enter the inlet to the valve from the compressor and flow through the valve exhaust outlet, while blocking the flow of accelerated forced exhaust gas from the compressor to the inlet to the valve and flowing to the third opening. A third opening; and a valve actuator configured to move the first and second valve members to first positions of the first and second valve members for an air insufflation phase of the expectoration assistance and to move the first and second valve members to second positions of the first and second valve members for a forced exhaust phase of the expectoration assistance; Equipped with an artificial respirator. [Brief description of the drawings]

[0167] [Figure 1] FIG. 1 is a block diagram illustrating an exemplary system including a ventilator for use by a human patient. [Figure 2A] FIG. 2A is an illustration of a first embodiment of a passive patient circuit for use with the ventilator of FIG. 1. [Figure 2B] 2B is a cross-sectional view of a second embodiment of a passive patient circuit for use with the ventilator of FIG. 1. [Figure 2C] 2C is an enlarged cross-sectional view of the valve assembly of the passive patient circuit of FIG. 2B shown in a closed configuration. [Figure 2D] FIG. 2D is an enlarged cross-sectional view of the valve assembly of the passive patient circuit of FIG. 2B shown in an open configuration. [Figure 2E] FIG. 2E is an exploded view of the valve assembly of the passive patient circuit of FIG. 2B. [Figure 2F] FIG. 2F is an illustration of an alternative embodiment to the first embodiment of the passive patient circuit shown in FIG. 2A, where a leak valve is incorporated into the patient connection. [Figure 3A] 3A is a cross-sectional view of an embodiment of an active patient circuit for use with the ventilator of FIG. 1. [Figure 3B] FIG. 3B is an exploded view of the multi-lumen tubing assembly of the active patient circuit of FIG. 3A. [Figure 3C] FIG. 3C is an exploded view of the active exhalation valve assembly of the active patient circuit of FIG. 3A. [Figure 3D] 3D is an enlarged perspective view of the dual bellows member of the active exhalation valve assembly of FIG. 3C. [Figure 3E] 3E is an enlarged cross-sectional view of the active patient circuit of FIG. 3A shown with the dual bellows member of the active exhalation valve assembly in a closed position. [Figure 3F] 3F is a first enlarged cross-sectional view of the active patient circuit of FIG. 3A shown with the dual bellows member of the active exhalation valve assembly in an open position. [Figure 3G] 3G is a second enlarged cross-sectional view of the active patient circuit of FIG. 3A shown with the dual bellows member of the active exhalation valve assembly in an open position. [Figure 4] FIG. 4 is a block diagram illustrating some example components of the ventilator of FIG. [Figure 5A] FIG. 5A is a schematic diagram illustrating some example components of the ventilator assembly of the ventilator of FIG. 1 with the ventilator assembly's exhaust assist valve depicted in a first configuration. [Figure 5B] FIG. 5B is a schematic diagram illustrating the auxiliary expectoration valve of the ventilator assembly in a second configuration. [Figure 5C] FIG. 5C is an enlarged portion of the schematic diagram of FIG. 5A showing the auxiliary expectoration valve in a first configuration. [Figure 5D] FIG. 5D is an enlarged portion of the schematic diagram of FIG. 5B showing the auxiliary expectoration valve in a second configuration. [Figure 5E] FIG. 5E is a block diagram illustrating exemplary components of a control system for a ventilator, control signals sent by the control system to exemplary components of a ventilation assembly, and data signals received by the control system from exemplary components of the ventilation assembly. [Figure 6] FIG. 6 is a block diagram illustrating some example components of a user interface of the ventilator of FIG. [Figure 7A] FIG. 7A is a schematic diagram illustrating some example components of the oxygen assembly of the ventilator of FIG. [Figure 7B] FIG. 7B is a block diagram illustrating example control signals sent by the control system to example components of the oxygen assembly and data signals received by the control system from example components of the oxygen assembly. [Figure 8A] FIG. 8A is a block diagram illustrating the adsorbent bed of the oxygen assembly during the first phase of a vacuum pressure swing adsorption ("VPSA") process. [Figure 8B] FIG. 8B is a block diagram illustrating the adsorbent beds of the oxygen assembly during the second phase of the VPSA process. [Figure 8C] FIG. 8C is a block diagram illustrating the adsorbent bed of the oxygen assembly during the third phase of the VPSA process. [Figure 8D] FIG. 8D is a block diagram illustrating the adsorbent bed of the oxygen assembly during the fourth phase of the VPSA process. [Figure 9] FIG. 9 is an illustration of the metering valve of the oxygen assembly. [Figure 10A] FIG. 10A is a perspective view of a first side of a first rotary valve assembly of an oxygen assembly. [Figure 10B] FIG. 10B is a perspective view of a second side of the first rotary valve assembly. [Figure 10C] FIG. 10C is a perspective view of a first side of the first rotary valve assembly, including the shaft of the motor assembly and omitting other parts of the motor assembly. [Figure 10D] FIG. 10D is a perspective view of a second side of the first rotary valve assembly with its outer housing and printed circuit board removed. [Figure 10E] FIG. 10E is an exploded perspective view of one of the four poppet valves of the first rotary valve assembly shown with an end cap and fastener. [Figure 10F] FIG. 10F is a cross-sectional view of the first rotary valve assembly with its second and fourth poppet valves open. [Figure 10G] FIG. 10G is a cross-sectional view of the first rotary valve assembly with its first and third poppet valves open. [Figure 11] FIG. 11 is a graph showing the pressure and feed flow rate experienced by the nitrogen adsorbent bed of the oxygen generator during the four phases of the VPSA process. [Figure 12] FIG. 12 is a flow diagram of a method performed by the control system of the ventilator of FIG. [Figure 13A] FIG. 13A is an illustration of the optional second rotary valve assembly of the oxygen assembly, depicted with the first of its four poppet valves open. [Figure 13B] FIG. 13B is an illustration of the optional second rotary valve assembly of the oxygen assembly, depicted with the second of its four poppet valves open. [Figure 13C] FIG. 13C is an illustration of the optional second rotary valve assembly of the oxygen assembly, depicted with the third of its four poppet valves open. [Figure 13D] FIG. 13D is an illustration of the optional second rotary valve assembly of the oxygen assembly, depicted with the fourth of its four poppet valves open. [Figure 14A] FIG. 14A is a graph showing patient airway flow using a prior art ventilator during both the inspiration and expiration phases. [Figure 14B] FIG. 14B is a graph showing patient airway pressure using a prior art ventilator during both the inspiration and expiration phases. [Figure 15A] FIG. 15A is a graph showing patient airway flow using the ventilator of FIG. 1 during both the inspiration and expiration phases. [Figure 15B] FIG. 15B is a graph showing patient airway pressure using the ventilator of FIG. 1 during both the inspiration and expiration phases. [Figure 16] FIG. 16 is a block diagram illustrating an exemplary suction assembly for use with the ventilator of FIG. 1. [Figure 17A] FIG. 17A is a perspective view of the auxiliary exhaust valve of the ventilator assembly showing the air intake side of the auxiliary exhaust valve. [Figure 17B] FIG. 17B is a perspective view of the auxiliary phlegm discharge valve showing the exhaust outlet side of the auxiliary phlegm discharge valve. [Figure 18A] FIG. 18A is a cross-sectional view of the expectoration auxiliary valve in a first configuration used during the delivery phase of normal ventilation and expectoration. [Figure 18B] FIG. 18B is a cross-sectional view of the expectoration auxiliary valve in a second configuration used during the forced exhaust phase of expectoration. [Figure 19A] FIG. 19A is an exploded perspective view of the end cap assembly of the expectoration assist valve. [Figure 19B] 19B is an enlarged perspective view of the second side of the valve seat member of the end cap assembly of FIG. 19A. [Figure 19C] 19C is an enlarged perspective view of a first side of the valve seat member of the end cap assembly of FIG. 19A. [Figure 20] FIG. 20 is a perspective view of a subassembly of the auxiliary expectoration valve, including a moving coil actuator, a shaft, and a pair of poppet valve assemblies. [Figure 21] FIG. 21 is an exploded perspective view of one of the poppet valve assemblies of the phlegm evacuation auxiliary valve. [Figure 22] FIG. 22 is an exploded perspective view of a subassembly of the auxiliary expectoration valve, including a shaft, a guide member, and a retaining ring. [Figure 23A] FIG. 23A is a perspective view of the air intake side of the expectoration assist valve, omitting both its end cap assembly and the poppet valve assembly. [Figure 23B] FIG. 23B is a perspective view of the exhaust outlet side of the expectoration assist valve without its end cap assembly. [Figure 24A] FIG. 24A is a perspective view of a first side of an intake body portion of a housing of the auxiliary expectoration valve. [Figure 24B] FIG. 24B is a perspective view of a second side of the intake body portion of the housing of the auxiliary expectoration valve. [Diagram 25] FIG. 25 is a perspective view of the exhaust body portion of the housing of the auxiliary phlegm discharge valve. [Figure 26] Figure 26 is a pair of graphs, the upper graph showing airway pressure during both the insufflation and forced exhaust phases of a sputum removal assisted procedure performed using a ventilator, and the lower graph showing airway flow during both the insufflation and forced exhaust phases of a sputum removal assisted procedure performed using a ventilator. [Figure 27] FIG. 27 is a side view of the secretion trap. [Figure 28] FIG. 28 is a side view of the secretion trap of FIG. 27 connected to both the patient connection and the patient circuit connection. [Figure 29] FIG. 29 is a side view of the embodiment of the secretion trap of FIG. 28 including a drain. [Diagram 30] FIG. 30 is an exploded view of an alternative embodiment of a valve assembly for use in the passive patient circuit of FIG. 2B. [Figure 31A]31A is an enlarged longitudinal cross-sectional view of the valve assembly of FIG. 30 shown in a closed configuration. [Figure 31B] FIG. 31B is an enlarged longitudinal cross-sectional view of the valve assembly of FIG. 30 shown in an open configuration. [Figure 31C] FIG. 31C is an enlarged longitudinal cross-sectional view of the valve assembly of FIG. 31A rotated approximately 45° about its longitudinal axis from the position depicted in FIG. 31A. [Diagram 32] 32 is a perspective view of a first valve housing of the valve assembly of FIG. 30. FIG. [Diagram 33] 33 is a perspective view of a second valve housing of the valve assembly of FIG. 30. FIG. [Figure 34A] FIG. 34A is a longitudinal cross-sectional view of an alternative embodiment of an expectoration auxiliary valve for use with the ventilator assembly of FIG. 5A depicted in a first configuration used during the insufflation phase of normal ventilation and expectoration. [Figure 34B] FIG. 34B is a longitudinal cross-sectional view of the expectoration auxiliary valve of FIG. 34A depicted in a second configuration used during the forced exhaust phase of expectoration. [Diagram 35] FIG. 35 is an exploded perspective view of the end cap assembly of the auxiliary expectoration valve of FIG. 34A. [Diagram 36] FIG. 36 is a perspective view of a subassembly of the auxiliary expectoration valve of FIG. 34A, including a movable magnet subassembly of the actuator, a shaft, and a pair of poppet valve assemblies. [Figure 37] FIG. 37 is a perspective view of the intake body portion of the housing of the auxiliary phlegm evacuation valve of FIG. 34A. [Figure 38] FIG. 38 is a perspective view of an exhaust body portion of the housing of the auxiliary phlegm expulsion valve of FIG. 34A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0168] The same reference numbers are used in the figures to identify the same components.

[0169] FIG. 1 is a block diagram illustrating an exemplary system 10 including a ventilator 100 with integrated expectoration support functionality for use by a patient 102. The ventilator 100 can be configured to provide both traditional volume-controlled ventilation and pressure-controlled ventilation. The ventilator 100 has an optional multi-lumen tubing connection 103, a primary ventilator connection 104, and a patient oxygen outlet 105. The patient 102 has a patient connection 106 (e.g., tracheal tube, nasal mask, mouthpiece, etc.) connectable to the primary ventilator connection 104 and / or the patient oxygen outlet 105 by a patient circuit 110.

[0170] As described below, the patient circuit 110 may be implemented as an active patient circuit or a passive patient circuit. Optionally, when the patient circuit 110 is implemented as an active patient circuit, the patient circuit 110 may include one or more ports 111 configured to be connected to the optional multi-lumen tubing connection 103. The ports 111 allow one or more pressure signals 109 to flow between the optional multi-lumen tubing connection 103 and the patient circuit 110. As would be apparent to one skilled in the art, the pressure signal may be characterized as a gas derived from a fluid (and / or gas) source whose pressure is to be measured. The derived gas is at the same pressure as the fluid (and / or gas) source.

[0171] The primary ventilator connection 104 is configured to provide gas 112, which may include room air 114, optionally mixed with oxygen. Although identified as "room air," one skilled in the art will appreciate that room air 114 may include air obtained from any source external to the ventilator 100. Gas 112 may be used as inspiration gas (during the inspiration phase of breathing) or as an insufflation gas used during the insufflation phase of expectoration. The primary ventilator connection 104 is configured to receive gas 113, which may include forced air exhaled by the patient 102 during the forced air phase of expectoration.

[0172] Air 114 is received by ventilator 100 via patient air intake 116. Oxygen, which is optionally mixed with air 114, may be generated internally by ventilator 100 and / or received from optional low pressure oxygen source 118 (e.g., an oxygen concentrator) and / or optional high pressure oxygen source 120. When oxygen is generated internally, ventilator 100 may output exhaust gas (e.g., nitrogen-rich gas 122) via outlet vent 124. Optionally, ventilator 100 may include a low pressure oxygen inlet 126 coupled to optional low pressure oxygen source 118 and configured to receive optional low pressure oxygen 128 therefrom. Ventilator 100 may include an optional high pressure oxygen inlet 130 coupled to optional high pressure oxygen source 120 and configured to receive optional high pressure oxygen 132 therefrom.

[0173] The patient oxygen outlet 105 is configured to provide doses or pulses of oxygen 140 to the patient connection 106 (via the patient circuit 110) that are synchronized with the patient's breathing. Unlike the gas 112 provided by the primary ventilator connection 104, the pulses of oxygen 140 do not include air 114.

[0174] The pulses of gas 112 and / or oxygen 140 delivered to the patient circuit 110 are conducted to a patient connection 106 which conducts them, at least in part, into the patient's lungs 142 as inspired or insufflated gas 108. Each time the patient exhales during the expiratory phase of breathing or the forced-exhaust phase of expectoration, expiratory gas 107 enters the patient circuit 110 via the patient connection 106. Thus, the patient circuit 110 may include one or more of the following gases: gas 112 provided by the ventilator 100, pulses of oxygen 140, and expiratory gas 107. For ease of illustration, the gas inside the patient circuit 110 will hereafter be referred to as "patient gas."

[0175] Optionally, the ventilator 100 includes a suction connection 150 configured to be coupled to an optional suction assembly 152. The ventilator 100 may provide suction 154 to the optional suction assembly 152 via the optional suction connection 150. The suction assembly 152 may be configured to be connected to the patient connection 106, a suction catheter 812 (see FIG. 16 ) positionable inside the patient connection 106, and / or a drain 1280 (see FIG. 29 ).

[0176] 1 , optionally, ventilator 100 includes a nebulizer connection 160 configured to be coupled to an optional nebulizer assembly 162. Ventilator 100 may provide gas 164 (e.g., air 114) to optional nebulizer assembly 162 via optional nebulizer connection 160. Optional nebulizer assembly 162 may be configured to be connected to patient circuit 110. However, this is not a requirement.

[0177] Optionally, the ventilator 100 may include an outlet port 166 through which exhaust air 167 may exit the ventilator 100.

[0178] Ventilator 100 may be configured to be portable and powered by an internal battery (not shown) and / or an external power source (not shown), such as a conventional wall electrical outlet.

[0179] (Passive Patient Circuit) FIG. 2A is an illustration of a first embodiment of a passive patient circuit 170 that may be used to implement the patient circuit 110. With reference to FIG. 2A, the passive patient circuit 170 has a first end portion 172 and, conversely, a second end portion 174. The first end portion 172 is configured to be connected or coupled to the primary ventilator connection 104 (e.g., directly or using a hose, flow line, conduit, or tubing). The second end portion 174 is configured to be connected or coupled to the patient connection 106 (e.g., directly or using a hose, flow line, conduit, or tubing). Optionally, a secretions trap 1250 (described below with respect to FIGS. 27-29) may be positioned between the second end portion 174 and the patient connection 106. The passive patient circuit 170 conveys gas 112 (optionally including air 114 mixed with oxygen) from the primary ventilator connection 104 into the patient connection 106 (optionally via a secretion trap 1250 shown in Figures 27-29).

[0180] In the illustrated embodiment, the passive patient circuit 170 includes an optional bacterial filter 176, a leak valve 177, and a flexible tubing section 178. The optional bacterial filter 176 may be positioned between the first end portion 172 and the flexible tubing section 178. The gas 112 may flow through the optional bacterial filter 176 onto the patient connection 106. When present, the bacterial filter 176 helps to prevent bacteria (e.g., received from the patient connection 106) from entering the ventilator 100 (via the primary ventilator connection 104).

[0181] A leak valve 177 is coupled to the flexible tubing section 178 near the second end portion 174. The leak valve 177 is configured to allow gas to flow from the passive patient circuit 170 into the environment outside the passive patient circuit 170. The leak valve 177 may be implemented as a conventional fixed leak valve configured to allow up to a threshold amount of pressure inside the passive patient circuit 170 during both the inspiration and expiration phases.

[0182] The leak valve 177 may be implemented as a positive pressure valve that allows a portion of the patient gas to flow from the passive patient circuit 170 into the environment outside the passive patient circuit 170 whenever the pressure inside the passive patient circuit 170 exceeds a threshold amount (e.g., environmental pressure). The leak valve 177 includes a flexible member or flap 179 that covers and seals the outlet opening 180 when the pressure inside the passive patient circuit 170 falls below a threshold amount. Thus, the leak valve 177 is closed when the pressure inside the passive patient circuit 170 falls below a threshold amount.

[0183] On the other hand, the flap 179 is configured to be pushed outwardly and away from the outlet opening 180 when the pressure inside the passive patient circuit 170 exceeds a threshold amount (e.g., environmental pressure). Thus, the leak valve 177 is opened when the pressure inside the passive patient circuit 170 exceeds a threshold amount. During normal ventilation, the leak valve 177 is open during both the inspiration phase and the expiration phase. This means that a portion of the patient gas inside the passive patient circuit 170 flows from the passive patient circuit 170 through the outlet opening 180 into the environment outside the passive patient circuit 170 during both the inspiration phase and the expiration phase. On the other hand, as will be explained below, during the forced exhaust phase of expectoration, the leak valve 177 is closed. This prevents the patient gas inside the passive patient circuit 170 from flowing out of the passive patient circuit 170 through the outlet opening 180. It also prevents air from entering the passive patient circuit 170 through the outlet opening 180.

[0184] 2F is an illustration of an alternative embodiment of the first embodiment of the passive patient circuit 170 shown in FIG. 2A, in which a leak valve 177 is incorporated into the patient connection 106 to which the second end portion 174 of the flexible tubing section 178 is connected or coupled. Alternatively, the leak valve 177 may be constructed as a separate piece that is connected or coupled to both the second end portion 174 of the flexible tubing section 178 and the patient connection 106.

[0185] 2B is an illustration of a second embodiment of a passive patient circuit 440 that may be used to implement the patient circuit 110. The passive patient circuit 440 includes a connector 442, a flexible tubing section 444, an open-ended oxygen pulse delivery tube 446, and a valve assembly 448. The flexible tubing section 444 may be implemented using conventional serpentine or expandable ventilation hose or tubing (e.g., circuit tubing). The flexible tubing section 444 has a first end portion 450 and, conversely, a second end portion 451. The first end portion 450 is configured to be connected or coupled to the connector 442. The second end portion 451 is configured to be connected or coupled to the valve assembly 448.

[0186] The connector 442 has a generally tubular connector housing 452 with a first end portion 454 configured to connect to the primary ventilator connection 104 (e.g., directly or using a hose, flow line, conduit, or tube) and receive gas 112 (optionally including air 114 mixed with oxygen) from the primary ventilator connection 104. Optionally, a bacterial filter 176 (see FIG. 2A ) may be positioned between the connector 442 and the primary ventilator connection 104. In such an embodiment, the gas 112 flows through the bacterial filter 176 to the connector 442. The bacterial filter 176 helps to prevent bacteria (e.g., received from the patient connection 106) from entering the ventilator 100 (via the primary ventilator connection 104).

[0187] The connector housing 452 is coupled to the first end portion 450 of the flexible tube section 444 and has a second end portion 456 configured to provide the gas 112 received by the first end portion 454 to the flexible tube section 444. The flexible tube section 444 communicates the gas 112 to the valve assembly 448.

[0188] The connector 442 includes a hollow tube section 458 that extends outside the connector housing 452. In the illustrated embodiment, the tube section 458 substantially traverses the connector housing 452. However, this is not a requirement. The tube section 458 has an open free end portion 459 that is configured to be connected to the patient oxygen outlet 105 (e.g., directly or using a hose, flow line, conduit, or tube) and to receive pulses of oxygen 140 therefrom. Inside the connector housing 452, the tube section 458 is connected to the oxygen pulse delivery tube 446 and provides pulses of oxygen 140 thereto. In the illustrated embodiment, the tube section 458 is connected to or includes a branch tube 460 that extends longitudinally inside the connector housing 452. The branch tube 460 has an open free end 462 that is coupled to the oxygen pulse delivery tube 446 and configured to provide pulses of oxygen 140 thereto. Although the tube section 458 extends into the connector housing 452, the tube section 458 only partially obstructs the flow of the gas 112 through the connector housing 452. In other words, the gas 112 passes near or along the tube section 458 and the branch tube 460, if present.

[0189] In the illustrated embodiment, the oxygen pulse delivery tube 446 extends through the flexible tube section 444 at least partway into the valve assembly 448. Thus, the oxygen pulse delivery tube 446 separates the pulses of oxygen 140 from the gas in the flexible tube section 444 along most of the passive patient circuit 440. The oxygen pulse delivery tube 446 has a first end portion 464 configured to be coupled to the branch tube 460. The oxygen pulse delivery tube 446 has a second end portion 465 that terminates at or near the patient connection 106. As a non-limiting example, the second end portion 465 may terminate within about 2 centimeters of the patient connection 106. The oxygen pulse delivery tube 446 conveys the pulses of oxygen 140 from the branch tube 460 to the patient connection 106. At the same time, a passive patient circuit 440 conducts gas 112 (optionally including air 114 mixed with oxygen) from the primary ventilator connection 104 into the patient connection 106 .

[0190] In alternative embodiments, the oxygen pulse delivery tube 446 may be connected (e.g., directly or using a hose, flow line, conduit, or tubing) to the patient oxygen outlet 105 and receive pulses of oxygen 140 from the patient oxygen outlet 105. In such embodiments, the oxygen pulse delivery tube 446 may extend along the outside of the flexible tubing section 444. A second end portion 465 of the oxygen pulse delivery tube 446 may be connected to a portion of the passive patient circuit 440 at or near the patient connection 106 and provide pulses of oxygen 140 from the branch tube 460 to the patient connection 106.

[0191] 2C-2E illustrate example components of the valve assembly 448. In the illustrated embodiment, the valve assembly 448 includes a first valve housing 468, a second valve housing 469, and a flexible ring-shaped leaf 470.

[0192] The first valve housing 468 is configured to be coupled to the patient connection 106 (see FIG. 2A). Optionally, a secretion trap 1250 (see FIGS. 27 and 28) may be coupled between the first valve housing 468 and the patient connection 106. The second valve housing 469 is configured to be coupled to the second end portion 451 of the flexible tube section 444. The first and second valve housings 468 and 469 are configured to be coupled together with a ring-shaped leaf 470 positioned therebetween. A peripheral portion 473 of the leaf 470 is positioned within a ring-shaped chamber 474 defined by the first and second valve housings 468 and 469. One or more openings 476 are formed in the second valve housing 469 and connect the chamber 474 with an environment outside the passive patient circuit 440 (see FIG. 2B). Additionally, one or more openings 478 are formed in the second valve housing 469 to connect patient gas inside the passive patient circuit 440 (see FIG. 2B) with the chamber 474 .

[0193] Like the flap 179 (see FIG. 2A), the peripheral portion 473 of the leaf 470 is configured to transition or deflect from a closed position (see FIG. 2C) and an open position (see FIG. 2D) when pressure inside the passive patient circuit 440 (see FIG. 2B) exceeds a threshold amount (e.g., environmental pressure). When the peripheral portion 473 of the leaf 470 is in the closed position depicted in FIG. 2C, the leaf 470 blocks one or more openings 478 and isolates the chamber 474 from the environment inside the passive patient circuit 440 (see FIG. 2B). On the other hand, when the peripheral portion 473 of the leaf 470 is in the open position depicted in FIG. 2D, the leaf 470 no longer blocks the one or more openings 478 and allows the chamber 474 to communicate with patient gas inside and outside the passive patient circuit 440 (see FIG. 2B). Thus, gas may exit from the interior of the passive patient circuit 440 (see FIG. 2B) through opening 478, chamber 474, and opening 476.

[0194] During the inspiration phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a preset inspiration pressure, which places or maintains the peripheral portions 473 of the leaves 470 in an open position, which leaves the openings 478 unobstructed. A portion of the patient gas flows to the patient 102 (see FIG. 1 ) and a portion of the patient gas flows out through the openings 476.

[0195] During the exhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a baseline or positive end-expiratory pressure ("PEEP"), which places or maintains the peripheral portions 473 of the leaves 470 in an open position. A portion of the exhaled gas 107 (see FIG. 1) flows out from the patient 102 through openings 476, and a portion of the exhaled gas 107 flows into the passive patient circuit 440 (e.g., into the flexible tubing section 444).

[0196] The breath may pause between the end of the expiratory phase and the beginning of the inhalation phase. This pause may be characterized as the dead time occurring between phases. During the pause, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to PEEP, which places or maintains the peripheral portion 473 of the leaf 470 in an open position, allowing the flow of gas 112 from the ventilator 100 to flow from the passive patient circuit 440 through the opening 476. During this time, at least a portion of the exhaled gas 107 that was forced into the passive patient circuit 440 during the expiratory phase is "purged" through the opening 476 by the forward moving flow of gas 112 from the ventilator 100.

[0197] As will be explained below, during the forced evacuation phase, the pressure inside the passive patient circuit 440 (see FIG. 2B) is below a threshold amount (e.g., ambient pressure). This places the peripheral portion 473 of the leaf 470 in a closed position, and the peripheral portion 473 of the leaf blocks the opening 478, which prevents patient gas inside the passive patient circuit 440 from flowing out of the passive patient circuit 440 through opening 476. It also prevents air from entering the passive patient circuit 440 through opening 476.

[0198] The combined areas of the openings 476 may be characterized as providing a fixed orifice. Thus, the valve assembly 448 may be characterized as a one-way valve with a fixed orifice. If the combined areas of the openings 476 are too large, most of the inhalation flow will leak through the openings 476, leaving little to the patient 102. Conversely, if the combined areas of the openings 476 are too small, the exhalation gas 107 will not be completely purged from the passive patient circuit 440 during the exhalation phase and during the pause between the inhalation and exhalation phases. As a non-limiting example, the valve assembly 448 may be configured to leak approximately 20-50 liters per minute ("LPM") when the pressure inside the passive patient circuit 440 is approximately 10 centimeters of water ("cmH2O").

[0199] 30 is an exploded view of an alternative embodiment of a valve assembly 1448 that may be used in the passive patient circuit 440 (see FIG. 2B) in place of the valve assembly 448. In such an embodiment, a flexible tubing section 444 (see FIG. 2B) conveys the gas 112 (see FIG. 2B) to the valve assembly 1448, and an oxygen pulse delivery tube 446 may extend at least part way through the flexible tubing section 444 (see FIG. 2B) into the valve assembly 1448.

[0200] In the illustrated embodiment, the valve assembly 1448 includes a first valve housing 1468, a second valve housing 1469, and a flexible ring-shaped leaf 1470. As shown in Figures 31A-31C, the first and second valve housings 1468, 1469 are configured to be coupled together with the ring-shaped leaf 1470 positioned therebetween.

[0201] 32, in the illustrated embodiment, the first valve housing 1468 has a first end portion 1480 and, opposite thereto, a second end portion 1482. An open-ended through channel 1484 extends through the first valve housing 1468 between the first end portion 1480 and the second end portion 1482. The first end portion 1480 is configured to be coupled to the patient connection 106 (see FIG. 2B). Optionally, a secretion trap 1250 (see FIGS. 27-29) can be coupled between the first end portion 1480 of the first valve housing 1468 and the patient connection 106 (see FIG. 2B).

[0202] The second end portion 1482 is configured to be coupled to the second valve housing 1469 (see FIGS. 30-31C and 33). The second end portion 1482 includes a ring-shaped, longitudinally extending inner wall 1486 positioned along a channel 1484, the inner wall 1486 defining a portion of the channel 1484. The second end portion 1482 includes a first wall portion 1488 extending radially outward from the inner wall 1486 and terminating in a ring-shaped, longitudinally extending outer wall 1489. The outer wall 1489 is concentric with the inner wall 1486 and spaced from the inner wall 1486 by the first wall portion 1488. A distal edge portion 1487 of the inner wall 1486 is configured to abut the leaf 1470 (see FIGS. 30-31C ) and press the leaf 1470 against the second valve housing 1469 (see FIGS. 30-31C and 33 ) to form an annular seal between the first valve housing 1468 and the second valve housing 1469 along the distal edge portion 1487 of the ring-shaped inner wall 1486. ​​Near where the outer wall 1489 terminates the first wall portion 1488, the outer wall 1489 has a ring-shaped groove 1490 formed along an inner surface of the outer wall 1489 that faces toward the inner wall 1486. ​​The outer wall 1489 has a longitudinally extending notch or keyway 1491 formed therein.

[0203] 33, in the illustrated embodiment, the second valve housing 1469 has a first end portion 1420 and, opposite thereto, a second end portion 1422. An open-ended through channel 1424 extends through the second valve housing 1469 between its first end portion 1420 and second end portion 1422. The second end portion 1422 of the second valve housing 1469 is configured to be coupled to the second end portion 451 (see FIG. 2B) of the flexible tube section 444 (see FIG. 2B).

[0204] The first end portion 1420 is configured to be coupled to the first valve housing 1468 (see FIGS. 30-32). The first end portion 1420 of the second valve housing 1469 includes a radially outwardly extending second wall portion 1428 having a distal portion 1429. A plurality of tabs 1430A-1430D are positioned along the distal portion 1429 of the second wall portion 1428. The tabs 1430A-1430D are configured to be received within a ring-shaped groove 1490 (see FIG. 32) formed in an outer wall 1489 (see FIG. 32) of the first valve housing 1468 (see FIGS. 30-32). Engagement between the tabs 1430A-1430D and the groove 1490 couples the first and second valve housings 1468, 1469 together. The tab 1430D includes a key member 1432 configured to be received within a keyway 1491 (see FIG. 32) formed in an outer wall 1489 (see FIG. 32) of the first valve housing 1468 (see FIGS. 30-32). When the first and second valve housings 1468, 1469 are coupled together, the key member 1432 is received within the keyway 1491 and prevents rotation of the first valve housing 1468 relative to the second valve housing 1469.

[0205] The second valve housing 1469 includes a plurality of leaf positioning projections 1434A-1434D configured to be received inside a central through hole 1436 (see FIG. 30) formed in a leaf 1470 (see FIG. 30-31B). With reference to FIG. 31C, the leaf positioning projections 1434A-1434D serve to position the leaf 1470 relative to the first and second valve housings 1468, 1469. When the first and second valve housings 1468, 1469 are coupled together, the leaf positioning projections 1434A-1434D extend along an inner wall 1486 (see FIG. 32) and into a channel 1484 (see FIG. 32).

[0206] 31A-31C, a peripheral portion 1473 of a leaf 1470 is positioned within a ring-shaped chamber 1474 defined by first and second valve housings 1468, 1469. With reference to FIGS. 31A and 31B, in the illustrated embodiment, the chamber 1474 is defined by an inner wall 1486, a first wall portion 1488, an outer wall 1489, and a second wall portion 1428.

[0207] One or more openings 1476 are defined between the first valve housing 1468 and the second valve housing 1469. In the illustrated embodiment, the second wall portion 1428 extends only part way toward the outer wall 1489 of the first valve housing 1468. However, as shown in FIG. 31C, tabs 1430A-1430D (see FIG. 33), which are mounted on the distal portion 1429 (see FIG. 33) of the second wall portion 1428, contact the outer wall 1489 of the first valve housing 1468. Thus, with reference to FIGS. 31A and 31B, the openings 1476 are defined between the distal portion 1429 (see FIG. 33) of the second wall portion 1428 and the outer wall 1489 of the first valve housing 1468, and are positioned between the tabs 1430A-1430D (see FIG. 33).

[0208] One or more openings 1476 connect the chamber 1474 with an environment outside the passive patient circuit 440 (see FIG. 2B). Additionally, one or more openings 1478 are formed in the second valve housing 1469 and connect the chamber 1474 with patient gas inside the passive patient circuit 440 (see FIG. 2B). With reference to FIG. 33, the one or more openings 1478 are positioned between the distal portion 1429 of the second wall portion 1428 and the leaf positioning protrusions 1434A-1434D.

[0209] 31A-31C, the flexible ring-shaped leaf 1470 is substantially similar to the flexible ring-shaped leaf 470 (see FIGS. 2C-2E). The peripheral portion 1473 of the leaf 1470 is configured to transition or deflect from a closed position (see FIGS. 31A and 31C) and an open position (see FIG. 31B) when the pressure inside the passive patient circuit 440 (see FIG. 2B) exceeds a threshold amount (e.g., environmental pressure). When the peripheral portion 1473 of the leaf 1470 is in the closed position depicted in FIGS. 31A and 31C, the leaf 1470 blocks one or more openings 1478 into the chamber 1474, thereby isolating the chamber 1474 from the environment inside the passive patient circuit 440 (see FIG. 2B). On the other hand, when the peripheral portion 1473 of the leaf 1470 is in the open position depicted in Figure 31B, the leaf 1470 no longer blocks the one or more openings 1478, allowing the chamber 1474 to communicate with patient gas inside the passive patient circuit 440 (see Figure 2B). Thus, gas may exit from the interior of the passive patient circuit 440 (see Figure 2B) through the openings 1478, the chamber 1474, and the openings 1476.

[0210] As previously described, during the inspiration phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a preset inspiration pressure, which places or maintains the peripheral portion 1473 of the leaf 1470 in an open position (see FIG. 31B). A portion of the patient gas flows to the patient 102 (see FIG. 1) and a portion of the patient gas flows out through the opening 1476.

[0211] During the exhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a baseline or positive end-expiratory pressure ("PEEP"), which places or maintains the peripheral portions 1473 of the leaves 1470 in an open position (see FIG. 31B). A portion of the exhaled gas 107 (see FIG. 1) from the patient 102 flows out through the openings 1476, and a portion of the exhaled gas 107 flows into the passive patient circuit 440 (e.g., into the flexible tubing section 444).

[0212] During the pause between the end of the expiratory phase and the beginning of the inhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to PEEP, which places or maintains the peripheral portion 1473 of the leaf 1470 in an open position (see FIG. 31B ), forcing the flow of gas 112 from the ventilator 100 from the passive patient circuit 440 through the opening 1476. During this time, at least a portion of the exhaled gas 107 that is forced into the passive patient circuit 440 during the expiratory phase is "purged" through the opening 1476 by the forward moving flow of gas 112 from the ventilator 100.

[0213] The combined areas of the openings 1476 may be characterized as providing a fixed orifice. Thus, the valve assembly 1448 may be characterized as a one-way valve with a fixed orifice. If the combined areas of the openings 1476 are too large, most of the inhalation flow will leak through the openings 1476 and little will remain for the patient 102. Conversely, if the combined areas of the openings 1476 are too small, the exhalation gas 107 will not be completely purged from the passive patient circuit 440 during the exhalation phase and during the pause between the inhalation and exhalation phases. As a non-limiting example, the valve assembly 1448 may be configured to leak approximately 20-50 LPM when the pressure inside the passive patient circuit 440 is approximately 10 cmH2O.

[0214] As will be explained below, during the forced evacuation phase, the pressure inside the passive patient circuit 440 (see FIG. 2B) is below a threshold amount (e.g., ambient pressure). When the passive patient circuit 440 (see FIG. 2B) includes a valve assembly 1448 (instead of the valve assembly 448), the peripheral portion 1473 of the leaf 1470 is placed in a closed position (see FIGS. 31A and 31C) when the pressure inside the passive patient circuit 440 (see FIG. 2B) is below a threshold amount, which prevents patient gas inside the passive patient circuit 440 from flowing out of the passive patient circuit 440 through the opening 1476. It also prevents air from entering the passive patient circuit 440 through the opening 1476.

[0215] It should be noted that the passive valve assemblies described herein may be integrated into the patient connection 106, such as in a patient mask that serves as the patient connection, rather than being part of the passive patient circuit 170 or passive patient circuit 440. As previously discussed and shown in FIG. 1, the patient 102 has a patient connection 106, which may be a tracheal tube, nasal mask, mouthpiece, etc., connectable by the patient circuit 110 to the primary ventilator connection 104 and / or the patient oxygen outlet 105.

[0216] (active patient circuit) 3A depicts an active patient circuit 600 that may be used to implement the patient circuit 110 (see FIG. 1). With reference to FIG. 3A, the active patient circuit 600 includes a connector 442, a flexible tubing section 444, an oxygen pulse delivery tube 446, a multi-lumen tubing assembly 602, and an active exhalation valve assembly 604.

[0217] As in the passive patient circuit 440 (see FIG. 2B), the connector 442 is coupled to both the first end portion 450 of the flexible tube section 444 and the oxygen pulse delivery tube 446. The connector 442 receives the gas 112 and provides them to the flexible tube section 444. In addition, the connector 442 receives the pulses of oxygen 140 and provides them to the oxygen pulse delivery tube 446. The pulses of oxygen 140 exit the oxygen pulse delivery tube 446 at or near the patient connection 106. As a non-limiting example, the pulses of oxygen 140 may exit the oxygen pulse delivery tube 446 within about 10 centimeters of the patient connection 106. In the illustrated embodiment, the pulses of oxygen 140 exit the oxygen pulse delivery tube 446 at or near the active exhalation valve assembly 604.

[0218] Optionally, a bacterial filter 176 (see FIG. 2A) may be positioned between the connector 442 and the main ventilator connection 104. In such an embodiment, the gas 112 flows through the bacterial filter 176 to the connector 442. When present, the bacterial filter 176 helps to prevent bacteria (e.g., received from the patient connection 106) from entering the ventilator 100 (via the main ventilator connection 104).

[0219] The second end portion 451 of the flexible tube section 444 is configured to be coupled to the active exhalation valve assembly 604. As previously described with respect to FIG. 1, the patient circuit 110 may include one or more ports 111 configured to allow one or more pressure signals 109 to flow between the optional multi-lumen tube connection 103 and the patient circuit 110. Referring to FIG. 3C, in the illustrated embodiment, the port 111 (see FIG. 1) includes ports 111A-111C spaced apart from one another longitudinally. Each of the ports 111A-111C is formed in the active exhalation valve assembly 604. The port 111C is hereinafter referred to as the pilot port 111C.

[0220] 3B is an exploded perspective view of a multi-lumen tube assembly 602. Referring to FIG. 3B, the multi-lumen tube assembly 602 includes a coupler 608, an elongated tube section 610, and a connector member 612. The coupler 608 is configured to couple a first end portion 620 of the tube section 610 to an optional multi-lumen tube connection 103 (see FIG. 3A). The tube section 610 has a second end portion 622 and, conversely, the first end portion 620. The second end portion 622 is connected to the connector member 612. Three separate and continuous open-ended channels 626A-626C extend longitudinally through the tube section 610.

[0221] Connector member 612 has three connectors 630A-630C configured to connect to ports 111A-111C (see FIG. 3C), respectively. Connectors 630A and 630B receive pressure signals 109A and 109B (see FIG. 5A), respectively, from ports 111A and 111B. Connector 630C conveys pressure signal 109C (see FIG. 5A) to and from pilot port 111C.

[0222] The continuous channels 632A-632C extend from the connectors 630A-630C, respectively, to the end portion 634 of the connector member 612. When the connector member 612 is connected to the tube section 610, the continuous channels 626A-626C of the tube section 610 align and communicate with the continuous channels 632A-632C, respectively. Thus, the multi-lumen tube assembly 602 can be used to convey separate pressure signals 109A and 109B from the ports 111A and 111B, respectively, to the optional multi-lumen tube connection 103. Additionally, the multi-lumen tube assembly 602 can be used to convey a pressure signal 109C from the optional multi-lumen tube connection 103 to the pilot port 111C and vice versa.

[0223] 3C, the active exhalation valve assembly 604 includes a first valve housing member 640, a double bellows member 644, and a second valve housing member 642. The ports 111A and 111B are formed in the first valve housing member 640 and extend laterally outward therefrom. The pilot port 111C is formed in the second valve housing member 642 and extends laterally outward therefrom.

[0224] 3E and 3F are enlarged longitudinal cross-sectional views of a portion of the active patient circuit 600 including the active exhalation valve assembly 604. The oxygen pulse delivery tube 446 is omitted from FIGS. 3E and 3F. In the illustrated embodiment, the first valve housing member 640 includes an internal obstruction 646 positioned between the ports 111A and 111B and configured to partially restrict flow through the first valve housing member 640. Further, as shown in FIGS. 3E and 3F, the interior of the first valve housing member 640 includes a first narrow portion 647A adjacent the obstruction 646 and the port 111A, and a second narrow portion 647B adjacent the obstruction 646 and the port 111B. Thus, the first and second narrow portions 647A, 647B are positioned longitudinally opposite one another relative to the obstruction 646, with the first narrow portion 647A being closer to the patient connection 106 (see FIG. 3A) than the second narrow portion 647B. The ports 111A and 111B open into the first and second narrow portions 647A, 647B, respectively.

[0225] 3G, the obstruction 646, the first and second narrowed portions 647A and 647B, and the ports 111A and 111B together define an airway flow transducer 648 (e.g., a fixed orifice differential pressure type flow meter) inside the interior of the first valve housing member 640. During an inhalation phase, gas 112 may flow around the obstruction 646 along a flow path identified by curved arrows 649A and 649B. During an exhalation phase, exhaled gas 107 may flow around the obstruction 646 along an opposite flow path identified by curved arrows 649A and 649B.

[0226] 3C, the first valve housing member 640 has a first end portion 650 configured to be coupled to the patient connection 106 (see FIG. 3A). Optionally, a secretion trap 1250 (see FIGS. 27 and 28) may be coupled between the first end portion 650 and the patient connection 106. The first valve housing member 640 has a second end portion 652 configured to be coupled to the second valve housing member 642. The second valve housing member 642 has a first end portion configured to be coupled to the second end portion 652 of the first valve housing member 640 and a second end portion 656 configured to be coupled to the second end portion 451 of the flexible tube section 444. The first end portion 654 of the second valve housing member 642 has a bellows connector portion 657 having a generally cylindrical shape. An opening 658 for pilot port 111C is formed in a bellows connector portion 657 of second valve housing member 642.

[0227] 3D, dual bellows member 644 has a generally ring-like outer shape with a centrally located through channel 660. Dual bellows member 644 has a hollow interior 662 with a ring-shaped open end 664 and an opposing ring-shaped closed end 666 (see FIG. 3C). In the illustrated embodiment, dual bellows member 644 has concertina-like inner and outer sidewalls 668, 669. Inner sidewall 668 extends between open end 664 and closed end 666 along centrally located through channel 660. Outer sidewall 669 extends between open end 664 and closed end 666 and is spaced radially outward from inner sidewall 668. Hollow interior 662 is defined between inner sidewall 668 and outer sidewall 669. Each of the inner and outer sidewalls 668, 669 has a bellows portion 668A and 669A, respectively (see FIG. 3C), each of which has an undulating longitudinal cross-sectional shape (also referred to as a serpentine or convoluted tubular shape). In alternative embodiments, the inner and outer sidewalls 668, 669 may include a different number of convolutions, defining a single convolution or three or more convolutions.

[0228] Open end 664 is configured to fit, like a sleeve, over bellows connector portion 657 of second valve housing member 642. When bellows connector portion 657 of second valve housing member 642 is received inside open end 664 of dual bellows member 644, bellows portions 668A and 669A (see FIG. 3C) of inner and outer sidewalls 668, 669, respectively, are positioned adjacent to bellows connector portion 657 of second valve housing member 642. Thus, opening 658 of pilot port 111C communicates with a portion of hollow interior 662 positioned between bellows portion 668A of inner sidewall 668 and bellows portion 669A (see FIG. 3C) of outer sidewall 669.

[0229] Referring to FIG. 3C, when the bellows connector portion 657 of the second valve housing member 642 is received inside the open end 664 of the double bellows member 644, the opening 658 of the pilot port 111C can provide a pressure signal 109C to the interior of the double bellows member 644.

[0230] 3E and 3F, as previously described, the second end portion 652 of the first valve housing member 640 is configured to be coupled to the first end portion 654 of the second valve housing member 642. When so coupled together, a ring-shaped chamber 670 is defined between the second end portion 652 of the first valve housing member 640 and the first end portion 654 of the second valve housing member 642. One or more openings 672 (see FIG. 3C) are formed in the first valve housing member 640 and connect the chamber 670 to an environment outside the active patient circuit 600 (see FIG. 3A). The bellows portions 668A and 669A (see FIG. 3C) of the outer sidewall 669 and the peripheral portion 674 of the closed end 666 are positioned within the chamber 670.

[0231] Dual bellows member 644 is constructed from a flexible material (e.g., silicone rubber, etc.). Bellows portions 668A and 669A (see FIG. 3C) of inner and outer sidewalls 668, 669, respectively, are configured to contract to transition closed end 666 from a closed position (see FIG. 3E) to an open position (see FIG. 3F). When bellows portions 668A and 669A (see FIG. 3C) are uncompressed, closed end 666 is in the closed position depicted in FIG. 3E. In this configuration, closed end 666 of dual bellows member 644 abuts a ring-shaped valve seat 680 formed within first valve housing member 640 and defining a portion of chamber 670. This seals chamber 670 from the interior of active patient circuit 600. On the other hand, when bellows portions 668A and 669A (see FIG. 3C) are compressed toward second valve housing member 642, closed end 666 is in the open position depicted in FIG. 3F. In this configuration, closed end 666 is spaced from valve seat 680. This opens chamber 670 by connecting chamber 670 with the inside of active patient circuit 600. Thus, when closed end 666 of dual bellows member 644 is in the open position, patient gas inside active patient circuit 600 may exit therefrom through chamber 670 and opening 672 (see FIG. 3C).

[0232] The closed end 666 of the dual bellows 644 is selectively moved between an open position and a closed position by controlling the pressure inside the dual bellows 644 using the pilot port 111C. For example, the closed end 666 of the dual bellows 644 may be placed in a closed position (see FIG. 3E) during an inspiration phase and placed in an open position during an expiration phase. In such an embodiment, at the beginning of the inspiration phase, the pilot port 111C provides a flow of gas (as pressure signal 109C) having the same pressure as the gas 112 (provided to the active patient circuit 600) to the hollow interior 662 of the dual bellows 644. The area of ​​the dual bellows 644 exposed to the pressure provided by the patient 102 (see FIG. 1) via the patient connection 106 is less than the area exposed to the pressure of the pressure signal 109C, such that the closed end 666 of the dual bellows 644 will move to or remain in the closed position against the valve seat 680 even if the two pressures are equal. At the end of the inspiration phase, pilot port 111C provides a flow of gas having a pilot pressure (as pressure signal 109C) to hollow interior 662 of dual bellows 644. The pilot pressure is less than the pressure provided by patient 102 (see FIG. 1) via patient connection 106, causing closed end 666 of dual bellows 644 to move or remain in an open position (see FIG. 3F) spaced from valve seat 680. Thus, during normal ventilation, the pressure inside hollow interior 662 of dual bellows 644 can alternate between a closing pressure at the same pressure as gas 112 (provided to active patient circuit 600) and an opening pressure equal to the pilot pressure. If desired, the pressure inside hollow interior 662 of dual bellows 644 can be adjusted by allowing a flow of gas (at pressure signal 109C) to flow from hollow interior 662 to pilot port 111C.

[0233] As described below, during the forced exhaust phase of expectoration, the closed end 666 of the dual bellows member 644 can be placed in a closed position (see FIG. 3E). This prevents forced exhaust gases (exhaled by the patient 102) into the active patient circuit 600 from exiting the active patient circuit 600 through opening 672 (see FIG. 3C). It also prevents air from entering the active patient circuit 600 through opening 672 (see FIG. 3C). Note that during the start of the forced exhaust phase, when pressure is still positive, the dual bellows member 644 is in the open position and automatically closes when the pressure provided by the patient 102 drops below atmospheric pressure.

[0234] (ventilator) Figure 4 is a block diagram illustrating several example components of ventilator 100. With reference to Figure 4, in addition to the components discussed with respect to Figure 1, ventilator 100 includes a ventilation assembly 190, a user interface 200, an oxygen assembly 210, a control system 220, and a conventional monitoring and alarm system 221. Those skilled in the art are familiar with conventional monitoring and alarm systems 221, so they will not be described in detail herein.

[0235] The control system 220 receives input information 196 (e.g., settings, parameter values, etc.) from the user interface 200 and provides output information 198 (e.g., performance information, status information, etc.) to the user interface 200. The user interface 200 is configured to receive input from a user (e.g., a caregiver, clinician, etc. associated with the patient 102 depicted in FIG. 1 ) and provide the input in input information 196 to the control system 220. The user interface 200 is also configured to display the output information 198 to the user.

[0236] As previously discussed, with reference to Figure 1, the patient circuit 110 may include an optional port 111 configured to allow one or more pressure signals 109 to flow between the optional multi-lumen tubing connection 103 and the patient circuit 110. With reference to Figure 3, the optional multi-lumen tubing connection 103 is configured to provide the pressure signal 109 to the ventilation assembly 190.

[0237] As described below, the ventilation assembly 190 may receive one or more control signals 192 from the control system 220, and the ventilation assembly 190 may provide one or more data signals 194 to the control system 220. Similarly, the oxygen assembly 210 may receive one or more control signals 260 from the control system 220, and the oxygen assembly 210 may provide one or more data signals 262 to the control system 220. The control signals 192, 260 and data signals 194, 262 may be used by the control system 220 to monitor and / or control the internal operation of the ventilator 100.

[0238] (Ventilation Assembly) 5A and 5B are schematic diagrams illustrating some example components of a ventilation assembly 190. FIG 5E is a block diagram illustrating example components of a control system 220, control signals 192 sent by the control system 220 to the example components of the ventilation assembly 190, and data signals 194 received by the control system 220 from the example components of the ventilation assembly 190.

[0239] Referring to Figures 5A and 5B, the ventilation assembly 190 includes an expectoration assist valve 204, an accumulator 202, an internal flow transducer 212, a blower 222, an airway pressure transducer 224, an airway flow transducer module 225, an exhalation control assembly 226, an oxygen sensor 227, an ambient pressure transducer 228, an inlet silencer 229, and an internal bacterial filter 230.

[0240] The expectoration auxiliary valve 204 is connected to the accumulator 202 by a conduit or flow line 214. For ease of illustration, a portion of the flow line 214 between the accumulator 202 and the internal flow transducer 212 has been omitted from Figures 5A and 5B.

[0241] The expectoration auxiliary valve 204 is connected to the outlet port 166 by a conduit or flow line 215. For ease of illustration, a portion of the flow line 215 between the expectoration auxiliary valve 204 and the outlet port 166 has been omitted from Figures 5A and 5B.

[0242] The exhaust assist valve 204 is connected to the main ventilator connection 104 by a conduit or flow line 273. For ease of illustration, a portion of the flow line 273 between the exhaust assist valve 204 and the internal bacterial filter 230 has been omitted from Figures 5A and 5B.

[0243] FIG. 5A depicts the expectoration auxiliary valve 204 in a first configuration, and FIG. 5B depicts the expectoration auxiliary valve 204 in a second configuration. Referring to FIG. 5A, in the first configuration, the expectoration auxiliary valve 204 receives gas 252 from the accumulator 202 (via flow line 214) and outputs gas 252 to the main ventilator connection 104 (via flow line 273). During normal breathing and ventilation, the expectoration auxiliary valve 204 remains in the first configuration. When the expectoration auxiliary functionality (described below) is used to perform expectoration auxiliary treatment, the expectoration auxiliary valve 204 is in the first configuration during the insufflation phase of expectoration, and the expectoration auxiliary valve 204 is in the second configuration during the forced exhaust phase of expectoration. Referring to FIG. 5B, in the second configuration, the expectoration auxiliary valve 204 receives the forced exhaust gas 253 via flow line 273 and outputs the forced exhaust gas 253 (as exhaust 167) to the outlet port 166 via flow line 215.

[0244] 5C is an enlarged schematic view of the expectoration assist valve 204 in a first configuration. FIG 5C illustrates gas 252 flowing through both the blower 222 and the expectoration assist valve 204 during the inhalation phase of breathing or the inhalation phase of an expectoration assist procedure performed by the ventilator 100 (see FIGS. 1 and 4).

[0245] Fig. 5D is an enlarged schematic view of the exhaust assist valve 204 in a second configuration. Fig. 5D illustrates the exhaust gas 253 flowing through both the blower 222 and the exhaust assist valve 204 during the exhaust phase of the exhaust assist procedure performed by the ventilator 100 (see Figs. 1 and 4). For ease of illustration, ports 275A-275C (see Figs. 5A and 5B) have been omitted from Figs. 5C and 5D.

[0246] 5C and 5D, the expectoration auxiliary valve 204 has a valve / blower outlet 1002, a blower / valve inlet 1004, an air intake 1006, an exhaust outlet 1008, and an opening 1010. The opening 1010 is connected to the main ventilator connection 104 by a flow line 273. As shown in FIG. 5C, when the expectoration auxiliary valve 204 is in the first configuration, the air intake 1006 is in fluid communication with the valve / blower outlet 1002, and the blower / valve inlet 1004 is in fluid communication with the opening 1010. Additionally, the exhaust outlet 1008 is closed, and both the valve / blower outlet 1002 and the air intake 1006 are out of fluid communication with the opening 1010, except via the blower 222. Thus, gas 252 may flow into air intake 1006, through a portion of exhaust assist valve 204, and out valve / blower outlet 1002 into blower 222. Gas 252 exiting blower 222 enters blower / valve inlet 1004, flows through a portion of exhaust assist valve 204, and exits exhaust assist valve 204 through opening 1010. Opening 1010 is connected to flow line 273, which conveys gas 252 (see FIG. 5A ) to main ventilator connection 104.

[0247] 5D , when the expectoration auxiliary valve 204 is in the second configuration, the air intake 1006 is closed, and the blower / valve inlet 1004 and the exhaust outlet 1008 are both out of fluid communication with the opening 1010, except through the blower 222. In addition, the opening 1010 is in fluid communication with the valve / blower outlet 1002, and the blower / valve inlet 1004 is in fluid communication with the exhaust outlet 1008. Thus, the forced exhaust gas 253 flows into the opening 1010, through a portion of the expectoration auxiliary valve 204, from the valve / blower outlet 1002, and into the blower 222. Forced exhaust gases 253 exiting the blower 222 enter into the blower / valve inlet 1004, flow through a portion of the expectoration auxiliary valve 204, and exit the expectoration auxiliary valve 204 through an exhaust outlet 1008. The exhaust outlet 1008 is connected to the flow line 215 (see FIGS. 5A and 5B), which conveys the forced exhaust gases 253 (as exhaust 167 shown in FIGS. 5A and 5B) to the outlet port 166.

[0248] Figures 17A and 17B are perspective views of the auxiliary expectorant valve 204. Figures 18A and 18B are cross-sectional views of the auxiliary expectorant valve 204. Figure 18A depicts the auxiliary expectorant valve 204 in a first configuration, and Figure 18B depicts the auxiliary expectorant valve 204 in a second configuration.

[0249] Referring to Fig. 17A, the expectoration auxiliary valve 204 includes a generally cylindrically shaped housing 1020. In the illustrated embodiment, an air intake 1006 is formed in a first open end 1022 of the housing 1020, and an exhaust outlet 1008 (see Fig. 17B) is located in a second open end 1024 of the housing 1020, the second open end 1024 being opposite the first open end 1022. The valve / blower outlet 1002, the blower / valve inlet 1004, and the opening 1010 (see Fig. 17B) are formed in a sidewall 1026 of the housing 1020 extending between its first open end 1022 and second open end 1024.

[0250] The first end cap assembly 1032 may be coupled to the first open end 1022, and the second end cap assembly 1034 may be coupled to the second open end 1024. The first and second end cap assemblies 1032, 1034 are substantially identical to one another. With reference to FIG. 19A, each of the first and second end cap assemblies 1032, 1034 (see FIGS. 17A, 17B, 18A, and 18B) includes a magnet 1040, a retaining member 1042, a sealing member 1044 (e.g., an O-ring), and a seat member 1046. The sealing member 1044 is positioned between the seat member 1046 and the retaining member 1042. Each of the first and second end cap assemblies 1032, 1034 may be coupled to the housing 1020 by one or more tabs 1048 and one or more fasteners 1049. 17A and 17B, in the illustrated embodiment, the housing 1020 includes mounting portions 1050 extending outwardly at each of the first and second open ends 1022, 1024 of the housing 1020, each configured to receive one of the fasteners 1049.

[0251] In the illustrated embodiment, the magnet 1040 is generally cylindrical or disc shaped, however, this is not a requirement.

[0252] 19A, the retention member 1042 has a ring-shaped base portion 1052 that defines an opening 1053. A sidewall 1054 extends inwardly from the base portion 1052 toward the seat member 1046. Each tab 1048 is configured to abut the base portion 1052 and avoid obstructing the opening 1053. Thus, gas (e.g., gas 252 or forced exhaust gas 253) may pass through the opening 1053 unobstructed by the tabs 1048.

[0253] 19B and 19C, the valve seat member 1046 has a ring-shaped peripheral portion 1056 that defines an opening 1058 therein. A central magnet receiving portion 1060 is supported within the opening 1058 by radially extending support arms 1061-1063 that are connected to the peripheral portion 1056. Together, the magnet receiving portion 1060 and the support arms 1061, 1062, and 1063 only partially obstruct or occlude the opening 1058. Thus, gas (e.g., gas 252 or forced exhaust gas 253) may pass through the opening 1058 around the magnet receiving portion 1060 and the support arms 1061, 1062, and 1063.

[0254] The seat member 1046 has an inwardly facing side 1070 (see FIG. 19C) and an opposite outwardly facing side 1071 (see FIG. 19B). With reference to FIG. 19C, a peripheral portion 1056 along the inwardly facing side 1070 is configured to be received, at least in part, within one of the first and second open ends 1022, 1024 (see FIGS. 17A-18B) of the housing 1020. Along the inwardly facing side 1070, the peripheral portion 1056 has an inwardly extending annular protrusion 1072 positioned adjacent the opening 1058. In the illustrated embodiment, the peripheral portion 1056 has an annularly extending helical ramp portion 1074 that faces longitudinally inwardly along the inwardly facing side 1070. As will be explained in more detail below, the ramp portion 1074 is used to adjustably longitudinally position the valve seat members 1046 of the first and second end cap assemblies 1032, 1034 within the housing 1020.

[0255] 19B, in the illustrated embodiment, the peripheral portion 1056 has an annular-shaped recessed portion 1076 along an outwardly facing side 1071. The recessed portion 1076 is configured to receive at least a free end portion of the inwardly extending sidewall 1054 of the seal member 1044 and the retaining member 1042, such that the seal member 1044 is sandwiched between the seat member 1046 and the retaining member 1042.

[0256] At the outwardly facing side 1071, the magnet receiving portion 1060 is configured to receive a magnet 1040 (see FIG. 19A). In the illustrated embodiment, the magnet receiving portion 1060 is implemented as an open-ended cylinder. However, this is not a requirement. Along the inwardly facing side 1070 (see FIG. 19C), the magnet receiving portion 1060 has an inner stop wall 1066 configured to prevent the magnet 1040 from passing through the central magnet receiving portion 1060 into the housing 1020. As non-limiting examples, the magnet 1040 (see FIG. 19A) may be held inside the magnet receiving portion 1060 by friction or adhesive.

[0257] 23A, the first open end 1022 of the housing 1020 has a longitudinally outwardly facing annularly extending first inner helical ramp portion 1092 configured to mate with the helical ramp portion 1074 (see FIG. 19C) of the first end cap assembly 1032 (see FIGS. 17A, 18A, and 18B). A ring-shaped inner seat member 1096 is positioned inside the housing 1020 near but inwardly of the first open end 1022 at a circumferentially extending radially protruding inner wall 1185. The inner seat member 1096 has a longitudinally outwardly extending annular protrusion 1097 substantially similar to the inwardly facing annular protrusion 1072 (see FIG. 19C).

[0258] 19C, an annular protrusion 1072 formed on an inwardly facing side 1070 of the valve seat member 1046 of the first end cap assembly 1032 functions as a first valve seat "S1" (see FIGS. 18A and 18B). An annular protrusion 1097 in the housing 1020 at the first open end 1022 functions as a second valve seat "S2" (see FIGS. 18A and 18B). As can be seen in FIGS. 18A and 18B, the second valve seat "S2" is positioned longitudinally inward from the first cap assembly 1032. The first and second valve seats "S1", "S2" extend toward and face each other.

[0259] 23B, the second open end 1024 of the housing 1020 has a longitudinally outwardly facing annularly extending second inner helical ramp portion 1094 configured to mate with a helical ramp portion 1074 (see FIG. 19C) of the second end cap assembly 1034 (see FIGS. 17B, 18A, and 18B). The housing 1020 has a radially inwardly projecting inner wall 1100 extending in a circumferential direction adjacent but inwardly of the second open end 1024. The inner wall 1100 has a longitudinally outwardly extending annular protrusion 1102 substantially similar to the annular protrusion 1072 (see FIG. 19C). The annular protrusion 1102 in the housing 1020 at the second open end 1024 serves as a third valve seat "S3" (see FIGS. 18A and 18B). As shown in Figures 18A and 18B, the third valve seat "S3" is positioned longitudinally inward from the second end cap assembly 1034. An annular projection 1072 (see Figure 19C) of the valve seat member 1046 (see Figure 19C) of the second end cap assembly 1034 functions as the fourth valve seat "S4". The third and fourth valve seats "S3", "S4" extend toward and face each other.

[0260] A first valve seat "S1" is positioned adjacent to the air intake 1006 and a fourth valve seat "S4" is positioned adjacent to the exhaust outlet 1008. The valve / blower outlet 1002 is positioned inside the housing 1020 between the first valve seat "S1" and the second valve seat "S2". Similarly, the blower / valve inlet 1004 is positioned between a third valve seat "S3" and a fourth valve seat "S4" formed within the housing 1020.

[0261] The expectoration auxiliary valve 204 includes first and second poppet valve assemblies 1112, 1114 connected together by a shaft 1116 to move together in unison. The expectoration auxiliary valve 204 has first, second, and third internal chambers, as described below. The first poppet valve assembly 1112 is located in a first chamber between a first valve seat "S1" and a second valve seat "S2" and moves longitudinally between the first valve seat "S1" and the second valve seat "S2", and the second poppet valve assembly 1114 is located in a third chamber between a third valve seat "S3" and a fourth valve seat "S4" and moves longitudinally between the third valve seat "S3" and the fourth valve seat "S4". The second chamber is located between the second valve seat "S2" and the third valve seat "S3", and thus between the first chamber and the third chamber. The second valve seat "S2" defines a first opening through which the first and second chambers are in fluid communication, and the first poppet valve assembly 1112 controls flow through the first opening, and the third valve seat "S3" defines a second opening through which the second and third chambers are in fluid communication, and the second poppet valve assembly 1114 controls flow through the second opening. As shown in FIG. 18A, when the first poppet valve assembly 1112 is pressed against the second valve seat "S2", the expectoration auxiliary valve 204 is in the first configuration illustrated in FIGS. 5A and 5C. In the first configuration, the first poppet valve assembly 1112 allows the flow of gas 252 from the accumulator 202 through the air intake 1006 into the first chamber and then to the valve / blower outlet 1002 and into the blower 222, while blocking the flow of gas 252 directly into the opening 1010, thus sealing the opening 1010 from both the air intake 1006 and the valve / blower outlet 1002. At the same time, the second poppet valve assembly 1114 is pressed against the fourth valve seat "S4" such that the second poppet valve assembly 1114 closes the exhaust outlet 1008 and directs the flow of gas 252 into the third chamber and then through the second opening into the second chamber for exit through the opening 1010 to the primary ventilator connection 104.In this configuration, gas 252 entering the air intake 1006 from the accumulator 202 is directed through the valve / blower outlet 1002 to the blower 222. The gas 252 is then blown by the blower 222 into the blower / valve inlet 1004 and exits the expectorant auxiliary valve 204 through opening 1010 to the primary ventilator connection 104.

[0262] As shown in Fig. 18B, when the first poppet valve assembly 1112 is pressed against the first valve seat "S1", the expectoration auxiliary valve 204 is in the second configuration shown in Fig. 5B and 5D. In the second configuration, the first poppet valve assembly 1112 allows the flow of forced exhaust gas 253 from the main ventilator connection 104 through the opening 1010 into the second chamber and then through the first opening into the first chamber to exit through the valve / blower outlet 1002 and enter the blower 222, while blocking the flow of forced exhaust gas to the air intake 1006 and also preventing gas 252 from the accumulator 202 from reaching the valve / blower outlet 1002. At the same time, the second poppet valve assembly 1114 is pressed against the third valve seat "S3" such that the second poppet valve assembly 1114 opens the exhaust outlet 1008 and blocks the flow of forced exhaust gas 253 through the second opening into the second chamber and to the opening 1010. In this configuration, forced exhaust gas 253 entering the opening 1010 from the main ventilator connection 104 passes through the first chamber and is directed to the blower 222 through the valve / blower outlet 1002. The forced exhaust gas 253 is then blown by the blower 222 into the blower / valve inlet 1004 and into the third chamber and exits the expectoration auxiliary valve 204 through the exhaust outlet 1008 to the outlet port 166.

[0263] The first and second poppet valve assemblies 1112, 1114 are coupled to opposite ends of a shaft 1116 and move together as one unit in unison with the shaft 1116. With reference to FIG. 22, in the illustrated embodiment, a guide member 1120 (e.g., a pin, dowel, etc.) extends laterally outwardly from the shaft 1116. The shaft 1116 may include one or more circumferentially extending grooves 1122 and 1124, each configured to receive a different retaining ring 1126. The shaft 1116 has a first end portion 1132 and, opposite thereto, a second end portion 1134. Longitudinal channels 1136 and 1138 extend inwardly into the shaft at the first and second end portions 1132, 1134, respectively. Each of the channels 1136 and 1138 is configured to receive a fastener 1140 (see FIG. 21).

[0264] The shaft 1116 is configured to move longitudinally within the housing 1020 between a first position (see FIG. 18A) in which the expectoration auxiliary valve 204 is in a first configuration and a second position (see FIG. 18B) in which the expectoration auxiliary valve 204 is in a second configuration. With reference to FIGS. 18A and 18B, as the shaft 1116 moves, the first poppet valve assembly 1112 moves between a first valve seat "S1" and a second valve seat "S2" and the second poppet valve assembly 1114 moves between a third valve seat "S3" and a fourth valve seat "S4". When the shaft 1116 is in the first position (see FIG. 18A), the first poppet valve assembly 1112 is in a sealed position against the first valve seat "S1" and the second poppet valve assembly 1114 is in a sealed position against the third valve seat "S3". When the shaft 1116 is in the second position (see FIG. 18B), the first poppet valve assembly 1112 is in a sealing position against the second valve seat "S2" and the second poppet valve assembly 1114 is in a sealing position against the fourth valve seat "S4".

[0265] The ramp portion 1074 of the seat member 1046 of the first end cap assembly 1032 slidingly engages the ramp portion 1092 within the first open end 1022 of the housing 1020, whereby rotation of the seat member 1046 causes adjustable longitudinal movement relative to the housing 1020 to precisely adjust the position of the first seat S1 of the seat member 1046 relative to the first poppet valve assembly 1112 during assembly and calibration to achieve the desired seal and seating therebetween. Similarly, the ramp portion 1074 of the seat member 1046 of the second end cap assembly 1034 slidingly engages with the ramp portion 1094 within the second open end 1024 of the housing 1020, whereby rotation of the seat member 1046 causes adjustable longitudinal movement relative to the housing 1020 to precisely adjust the position of the fourth seat S4 of the seat member 1046 relative to the second poppet valve assembly 1114 during assembly and calibration to achieve the desired seal and seating therebetween.

[0266] The first and second poppet valve assemblies 1112, 1114 are substantially identical to one another. With reference to FIG. 21, each of the first and second poppet valve assemblies 1112, 1114 includes a fastener 1140, a ferromagnetic member 1144, a first seal member 1146 (e.g., an O-ring), a disk-shaped poppet member 1148, a second seal member 1150 (e.g., an O-ring), and an optional washer 1152.

[0267] The fastener 1140 of the first poppet valve assembly 1112 fastens the other components of the first poppet valve assembly 1112 (i.e., the ferromagnetic member 1144, the first seal member 1146, the poppet member 1148, the second seal member 1150, and optionally the washer 1152) to the first end portion 1132 of the shaft 1116. Similarly, the fastener 1140 of the second poppet valve assembly 1114 fastens the other components of the second poppet valve assembly 1114 to the second end portion 1134 of the shaft 1116. The first and second seal members 1146, 1150 of each of the first and second poppet valve assemblies 1112, 1114 serve both to seal the poppet valve assembly to the end portion of the shaft 1116 and to provide a flexible coupling between the shaft and the poppet member 1148 of the poppet valve assembly.

[0268] 18A, the magnet 1040 of the first end cap assembly 1032 attracts the ferromagnetic member 1144 of the first poppet valve assembly 1112 and maintains the shaft 1116 in the first position when it comes into close proximity therewith after the shaft is moved to the first position, holding the first poppet valve assembly 1112 in place on the first valve seat S1 of the first end cap assembly 1032. Similarly, with reference to FIG. 18B, the magnet 1040 of the second end cap assembly 1034 attracts the ferromagnetic member 1144 of the second poppet valve assembly 1114 and maintains the shaft 1116 in the second position when it comes into close proximity therewith after the shaft is moved to the second position, holding the second poppet valve assembly 1114 in place on the fourth valve seat S4 of the second end cap assembly 1034. The ferromagnetic member 1144 holds the poppet valve assemblies 1112, 1114 in position relative to the first and fourth valve seats S1, S4, respectively, even when power is not applied to the actuator used to move the poppet valve assemblies.

[0269] 20, the expectoration auxiliary valve 204 includes an actuator 1170 configured to selectively move a shaft 1116 between a first position (see FIG. 18A) and a second position (see FIG. 18B) along a longitudinal direction identified by a double-headed arrow 1172. In the illustrated embodiment, the actuator 1170 is a linear actuator implemented using a voice coil, including a movable coil subassembly 1174 and a stationary magnet subassembly 1176. The shaft 1116 is coupled to the movable coil subassembly 1174 and moves therewith as a unit. With reference to FIGS. 18A and 18B, the stationary magnet subassembly 1176 is coupled to an actuator mounting portion 1190 of the housing 1020 (e.g., by one or more fasteners 1178).

[0270] 18A, the movable coil subassembly 1174 is connected by one or more wires 1059 to a printed circuit board ("PCB") 1064 mounted on the outside of the housing 1020. In the illustrated embodiment, the wires 1059 provide power to the movable coil subassembly 1174. The housing 1020 includes one or more openings 1065 (see FIG. 24A) through which the wires 1059 may pass. The PCB 1064 is connected by one or more wires (not shown) to the control system 220 (see FIG. 5E). The actuator 1170 is configured to receive a control signal 1180 (see FIG. 5E) from the control system 220 (via the PCB 1064 and the wires 1059) and move according to one or more instructions in the control signal 1180. The PCB 1064 acts as a connector and passes the control signal 1180 to the movable coil subassembly 1174.

[0271] A control signal 1180 (see FIG. 5E) selectively energizes the movable coil subassembly 1174 to move toward either the first end cap assembly 1032 or the second end cap assembly 1034. When the movable coil subassembly 1174 moves toward the first end cap assembly 1032, the movable coil subassembly 1174 moves the shaft 1116 toward the first position. Referring to FIG. 18A, after the shaft 1116 moves to the first position, the movable coil subassembly 1174 is de-energized and the magnet 1040 of the first end cap assembly 1032 (attracted to at least a portion of the first poppet valve assembly 1112 as described above) maintains the shaft 1116 in the first position. On the other hand, when the movable coil subassembly 1174 moves toward the second end cap assembly 1034, the movable coil subassembly 1174 moves the shaft 1116 toward the second position. 18B, after the shaft 1116 has moved to the second position, the movable coil subassembly 1174 is de-energized and the magnet 1040 of the second end cap assembly 1034 (which, as previously described, is attracted to at least a portion of the second poppet valve assembly 1114) maintains the shaft 1116 in the second position. Thus, no additional power is required to maintain the shaft 1116 in either the first or second position, which helps to extend battery life in embodiments powered by one or more batteries.

[0272] With reference to FIG. 24B, the housing 1020 (see FIGS. 18A and 18B) includes a first internal support 1184 spaced inwardly from the first open end 1022. In the illustrated embodiment, the first internal support 1184 extends radially inwardly from an inner wall 1185 that extends circumferentially inwardly. The first internal support 1184 has a longitudinally extending channel 1186 formed therein. With reference to FIGS. 18A and 18B, the channel 1186 (see FIG. 24B) is configured to allow the shaft 1116 to pass completely therethrough and position the first poppet valve assembly 1112 between the first internal support 1184 and the first end cap assembly 1032. As can be seen in FIG. 23A, a channel 1186 opens along the inner seat member 1096 to position the first poppet valve assembly 1112 between the first valve seat "S1" and the second valve seat "S2" as shown in FIGS. 18A and 18B. A portion of the shaft 1116 near the first end portion 1132, including a guide member 1120 (see FIG. 22), is positioned inside the channel 1186 (see FIG. 24B) and reciprocates therein. Referring to FIG. 24A, an open-ended, longitudinally extending guide groove 1188 is formed in the first inner support 1184 along the channel 1186. The guide member 1120 (see FIG. 22) is positioned within the guide groove 1188 and moves therein. (This prevents rotation of the poppet assembly, which may damage the wires.) The first internal support 1184 optionally has an actuator mounting portion 1190 that includes one or more through holes configured to receive the fasteners 1178 (see FIGS. 18A and 18B). The stationary magnet subassembly 1176 (see FIGS. 18A and 18B) is coupled to the actuator mounting portion 1190 that secures the stationary magnet subassembly to the housing 1020 (see FIGS. 18A and 18B). In the illustrated embodiment, the actuator mounting portion 1190 includes an inwardly extending peripheral sidewall 1192 configured to extend around a portion of the stationary magnet subassembly 1176.

[0273] With reference to FIG. 25, the housing 1020 (see FIGS. 18A and 18B) includes a second internal support 1194 spaced inwardly from the second open end 1024. In the illustrated embodiment, the second internal support 1194 extends radially inwardly from the inner wall 1100. The second internal support 1194 has a through hole 1196 formed therein. With reference to FIGS. 18A and 18B, the through hole 1196 (see FIG. 25) is configured to allow the shaft 1116 to pass therethrough and position the second poppet valve assembly 1114 between the second internal support 1194 and the second end cap assembly 1034. As can be seen in FIG. 25, the through hole 1196 opens along the annular protrusion 1102 and positions the second poppet valve assembly 1114 between the third valve seat "S3" and the fourth valve seat "S4", as shown in FIGS. 18A and 18B.

[0274] 17A, 17B, 18A, 18B, 23A, and 23B, in the illustrated embodiment, the housing 1020 includes an intake body portion 1198 coupled to an exhaust body portion 1199. The valve / blower outlet 1002, the air intake 1006, the opening 1010, the first open end 1022, and the first internal support 1184 are formed in the intake body portion 1198. The blower / valve inlet 1004, the exhaust outlet 1008, the second open end 1024, and the second internal support 1194 are formed in the exhaust body portion 1199.

[0275] In the illustrated embodiment, the expectoration auxiliary valve 204 includes ports 275A, 275B, and 275C (described below) formed in the housing 1020. Ports 275A and 275B may be formed in the exhaust body portion 1199, and port 275C may be formed in the intake body portion 1198. However, this is not a requirement. Optionally, the expectoration auxiliary valve 204 includes port 275D (see FIGS. 17B and 23A) configured to be connected to a redundant airway pressure transducer (not shown).

[0276] 34A and 34B are cross-sectional views of an alternative embodiment of an expectorant auxiliary valve 2000 that may be used in the ventilation assembly 190 (see FIGS. 4 and 5A) instead of the expectorant auxiliary valve 204 (see FIGS. 5A-5D and 17A-18B). Referring to FIGS. 5A and 5B, like the expectorant auxiliary valve 204, the expectorant auxiliary valve 2000 (see FIGS. 34A and 34B) is configured to be connected to the accumulator 202 by a flow line 214, to the outlet port 166 by a flow line 215, and to the main ventilator connection 104 by a flow line 273.

[0277] FIG. 34A depicts the expectoration auxiliary valve 2000 in a first configuration, and FIG. 34B depicts the expectoration auxiliary valve 2000 in a second configuration. The first and second configurations of the expectoration auxiliary valve 2000 correspond to the first and second configurations of the expectoration auxiliary valve 204 (see FIGS. 5A-5D and 17A-18B), respectively, and provide the same functionality. Thus, during normal breathing and ventilation, the expectoration auxiliary valve 2000 remains in the first configuration. When the expectoration auxiliary functionality (described below) is used to perform an expectoration auxiliary procedure, the expectoration auxiliary valve 2000 is in the first configuration during the insufflation phase of expectoration, and the expectoration auxiliary valve 2000 is in the second configuration during the forced exhaust phase of expectoration.

[0278] 34A, 34B, 18A, and 18B, the expectoration auxiliary valve 2000 has a valve / blower outlet 2002, a blower / valve inlet 2004, an air inlet 2006, an exhaust outlet 2008, and an opening 2010, which are substantially the same as the valve / blower outlet 1002, the blower / valve inlet 1004, the air inlet 1006, the exhaust outlet 1008, and the opening 1010 of the expectoration auxiliary valve 204, respectively. Each of the valve / blower outlet 2002 and the blower / valve inlet 2004 is connected to the blower 222. The air inlet 2006 is connected to the accumulator 202 by a flow line 214. The exhaust outlet 2008 is connected to the outlet port 166 by a flow line 215. The opening 2010 is connected to the main ventilator connection 104 by a flow line 273. The phlegm exhaustion auxiliary valve 2000 has valve seats "S1'" to "S4'" which are substantially the same as the valve seats "S1" to "S4" of the phlegm exhaustion auxiliary valve 204, respectively.

[0279] 34A and 34B, the expectoration auxiliary valve 2000 includes a generally cylindrically shaped housing 2020. An air intake 2006 is formed in a first open end 2022 of the housing 2020, and an exhaust outlet 2008 is formed in a second open end 2024 of the housing 2020. The valve / blower outlet 2002, the blower / valve inlet 2004, and the opening 2010 are formed in a sidewall 2026 of the housing 2020 extending between the first open end 2022 and the second open end 2024 thereof.

[0280] The first and second end cap assemblies 2032, 2034 may be coupled to the first and second open ends 2022, 2024, respectively. The first and second end cap assemblies 2032, 2034 are substantially identical to one another. With reference to FIG. 35, each of the first and second end cap assemblies 2032, 2034 (see FIGS. 34A and 34B) includes a retaining member 2042, a sealing member 2044 (e.g., an O-ring), and a valve seat member 2046. With reference to FIGS. 34A and 34B, each of the first and second end cap assemblies 2032, 2034 may be coupled to the housing 2020 by one or more fasteners 2049. In the illustrated embodiment, the housing 2020 includes one or more outwardly extending mounting portions 2050 at each of the first and second open ends 2022, 2024 of the housing 2020, each configured to receive one of the fasteners 2049.

[0281] 35, the seat member 2046 has a ring-shaped peripheral portion 2056 that defines an opening 2058. The seat member 2046 has an inwardly facing side 2070 and an opposite outwardly facing side 2071. Along the inwardly facing side 2070, the seat member 2046 has an inwardly extending annular protrusion 2072 positioned adjacent the opening 2058. In the illustrated embodiment, the peripheral portion 2056 has an outer threaded portion 2074 along the inwardly facing side 2070 and an annular shaped recessed portion 2076 along the outwardly facing side 2071. The recessed portion 2076 is configured to receive at least a free end portion of the inwardly extending sidewall 2054 of the seal member 2044 and the retaining member 2042 such that the seal member 2044 is sandwiched between the seat member 2046 and the retaining member 2042 .

[0282] The first and second end cap assemblies 2032, 2034 (see FIGS. 34A and 34B) do not include tabs 1048 (see FIG. 19A). Instead, the retention member 2042 of the first end cap assembly 2032 (see FIGS. 34A and 34B) includes an outwardly extending mounting portion 2057 for each of the outwardly extending mounting portions 2050 (see FIGS. 34A, 34B, and 37) located at the first open end 2022 (see FIGS. 34A and 34B) of the housing 2020. Similarly, each mounting portion 2057 of the retention member 2042 of the second end cap assembly 2034 (see FIGS. 34A and 34B) corresponds to one of the outwardly extending mounting portions 2050 (see FIGS. 34A, 34B, and 38) located at the second open end 2024 of the housing 2020. Each mounting portion 2057 is configured to receive one of the fasteners 2049 so as to fasten the mounting portion 2057 to its corresponding mounting portion 2050 (see FIGS. 34A, 34B, and 38).

[0283] 37, the first open end 2022 of the housing 2020 (see FIGS. 34A and 34B) has a first internally threaded portion 2092 configured to mate with the externally threaded portion 2074 (see FIG. 35) of the first end cap assembly 2032 (see FIGS. 34A and 34B). The housing 2020 (see FIGS. 34A and 34B) has a radially inwardly projecting inner wall 2095 extending inwardly and circumferentially, but near the first open end 2022. The inner wall 2095 has a longitudinally outwardly extending annular projection 2097 substantially similar to the annular projection 2072 (see FIG. 35).

[0284] With reference to FIG. 35, an annular projection 2072 of the valve seat member 2046 of the first end cap assembly 2032 (see FIGS. 34A and 34B) serves as the first valve seat "S1'" (see FIGS. 34A and 34B). With reference to FIG. 37, an inner annular projection 2097 of the first open end 2022 of the housing 2020 serves as the second valve seat "S2'" (see FIGS. 34A and 34B). As can be seen in FIGS. 34A and 34B, the second valve seat "S2'" is positioned longitudinally inward from the first cap assembly 2032. The first and second valve seats "S1'", "S2'" extend toward and face each other.

[0285] Referring to FIG. 38, the second open end 2024 of the housing 2020 (see FIGS. 34A and 34B) has a second internally threaded portion 2094 configured to mate with the externally threaded portion 2074 (see FIG. 35) of the second end cap assembly 2034 (see FIGS. 34A and 34B). The housing 2020 (see FIGS. 34A and 34B) has a radially inwardly projecting inner wall 2100 that extends inwardly and circumferentially, but near the second open end 2024. The inner wall 2100 has a longitudinally outwardly extending annular protrusion 2102 that is substantially similar to the annular protrusion 2072 (see FIG. 35). Referring to FIGS. 34A and 34B, the annular protrusion 2102 (see FIG. 38) in the housing 2020 at the second open end 2024 functions as a third valve seat "S3'". The third valve seat "S3'" is positioned longitudinally inward from the second end cap assembly 2034. An annular projection 2072 (see FIG. 35) of the valve seat member 2046 (see FIG. 35) of the second end cap assembly 2034 functions as the fourth valve seat "S4'". The third and fourth valve seats "S3'", "S4'" extend toward and face each other.

[0286] 34A and 34B, the expectoration auxiliary valve 2000 includes first and second poppet valve assemblies 2112, 2114 connected together by a shaft 2116 for movement together in unison. The first poppet valve assembly 2112 is positioned between and moves longitudinally between a first valve seat "S1'" and a second valve seat "S2'", and the second poppet valve assembly 2114 is positioned between and moves longitudinally between a third valve seat "S3'" and a fourth valve seat "S4'".

[0287] 34A and 34B, the shaft 2116 is configured to move longitudinally within the housing 2020 between a first position (see FIG. 34A) in which the expectoration auxiliary valve 2000 is in a first configuration, and a second position (see FIG. 34B) in which the expectoration auxiliary valve 2000 is in a second configuration. As the shaft 2116 moves, the first poppet valve assembly 2112 moves between a first valve seat "S1'" and a second valve seat "S2'", and the second poppet valve assembly 2114 moves between a third valve seat "S3'" and a fourth valve seat "S4'". When the shaft 2116 is in a first position (see FIG. 34A), the first poppet valve assembly 2112 is in a sealing position against the first valve seat "S1'" and the second poppet valve assembly 2114 is in a sealing position against the third valve seat "S3'". When the shaft 2116 is in a second position (see FIG. 34B), the first poppet valve assembly 2112 is in a sealing position against the second valve seat "S2'" and the second poppet valve assembly 2114 is in a sealing position against the fourth valve seat "S4'".

[0288] With reference to FIG. 34A, a longitudinal channel 2136 extends inwardly into the shaft 2116 at each of its ends. With reference to FIG. 36, each of the channels 2136 (see FIG. 34A) is configured to receive a fastener 2140 (see FIG. 21). The first and second poppet valve assemblies 2112, 2114 are substantially identical to one another. With reference to FIG. 36, each of the first and second poppet valve assemblies 2112, 2114 includes the fastener 2140, an optional first washer 2146, a disc-shaped poppet member 2148, and an optional second washer 2152. Although not visible in FIG. 36, each of the first and second poppet valve assemblies 2112, 2114 includes first and second seal members 1146, 1150, which serve both to seal the poppet valve assembly to an end portion of the shaft 2116 and to provide a flexible connection between the shaft and a poppet valve member 2148 of the poppet valve assembly, as shown in FIG. 21. A fastener 2140 of the first poppet valve assembly 2112 fastens the other components of the first poppet valve assembly 2112 (i.e., optional first washer 2146, disc-shaped poppet member 2148, and optional second washer 2152) to one end of the shaft 2116. Similarly, a fastener 2140 of the second poppet valve assembly 2114 fastens the other components of the second poppet valve assembly 2114 to the other end of the shaft 2116.

[0289] 34A and 34B, the expectoration assisted valve 2000 includes an actuator 2170 configured to selectively move a shaft 2116 between a first position (see FIG. 34A) and a second position (see FIG. 34B) along a longitudinal direction identified by a double-headed arrow 2172 (see FIG. 36). In the illustrated embodiment, the actuator 2170 is a linear actuator including a stationary coil subassembly 2174 and a moveable magnet subassembly 2176. The shaft 2116 is coupled to the moveable magnet subassembly 2176 and moves therewith as a unit.

[0290] 34A and 34B, the stationary coil subassembly 2174 includes a coil 2177 housed inside an outer housing 2179. The outer housing 2179 is coupled (e.g., by one or more fasteners 2178) to an actuator mounting portion 2190 of the housing 2020. The outer housing 2179 is constructed from a magnetic material. The coil 2177 is connected by one or more wires 2062 to a printed circuit board ("PCB") 2064 mounted on the outside of the housing 2020. In the illustrated embodiment, the wires 2062 provide power to the coil 2177. The outer housing 2179 and the housing 2020 each include one or more openings through which the wires 2062 may pass. The PCB 2064 is connected to the control system 220 (see FIG. 5E) by one or more wires (not shown). Actuator 2170 is configured to receive control signals 1180 (see FIG. 5E) from control system 220 (via PCB 2064 and wires 2062) and move according to one or more instructions in the control signals 1180. PCB 2064 acts as a connector, passing the control signals 1180 to coil 2177.

[0291] 36, the movable magnet subassembly 2176 has a main magnet 2150 with a first end 2151 and, oppositely, a second end 2153. A first latch magnet 2156 is mounted to the first end 2151 and a second latch magnet 2158 is mounted to the second end 2153. Each of the first and second latch magnets 2156, 2158 is attracted to a magnetic outer housing 2179 (see FIGS. 34A and 34B). With reference to FIG. 34A, the attractive force between the first latch magnet 2156 (see FIG. 36) and the outer housing 2179 maintains the shaft 2116 in the first position after it has been moved to the first position (by energizing the coil 2177). Similarly, with reference to FIG. 34B, the attractive force between the second latch magnet 2158 (see FIG. 36) and the outer housing 2179 maintains the shaft 2116 in the second position after it is moved to the second position (by energizing the coil 2177). Thus, the shaft 2116 can remain in a desired position after the coil 2177 is de-energized.

[0292] A control signal 1180 (see FIG. 5E) selectively energizes the coil 2177 to move the movable magnet subassembly 2176 toward either the first end cap assembly 2032 or the second end cap assembly 2034. As the movable magnet subassembly 2176 moves toward the first end cap assembly 2032, the shaft 2116 moves therewith toward the first position. Referring to FIG. 34A, after the shaft 2116 moves to the first position, the coil 2177 is de-energized and the attractive force between the first latch magnet 2156 (see FIG. 36) and the outer housing 2179 maintains the shaft 2116 in the first position. Meanwhile, as the movable magnet subassembly 2176 moves toward the second end cap assembly 2034, the shaft 2116 moves therewith toward the second position. 34B, after the shaft 2116 moves to the second position, the coil 2177 is de-powered and the attractive force between the second latch magnet 2158 (see FIG. 36) and the outer housing 2179 maintains the shaft 2116 in the second position. Thus, no additional power is required to maintain the shaft 2116 in either the first or second position, which helps to extend battery life in embodiments powered by one or more batteries.

[0293] 37, the actuator mounting portion 2190 includes one or more through holes spaced inwardly from the first open end 2022 and optionally configured to receive a fastener 2178 (see FIGS. 34A and 34B). With reference to FIGS. 34A and 34B, an outer housing 2179 is coupled to an inwardly facing side of the actuator mounting portion 2190 by a fastener 2178 that secures the stationary coil subassembly 2174 to the housing 2020. With reference to FIGS. 34A and 34B, the actuator mounting portion 2190 has a through hole 2186 (see FIG. 37) configured to allow the shaft 2116 to pass completely therethrough and position the first poppet valve assembly 2112 between the first valve seat "S1'" and the second valve seat "S2'".

[0294] With reference to FIG. 38, the housing 2020 (see FIGS. 34A and 34B) includes an internal support 2194 spaced inwardly from the second open end 2024. In the illustrated embodiment, the internal support 2194 extends radially inwardly from the inner wall 2100. The internal support 2194 has a through hole 2196 formed therein. With reference to FIGS. 34A and 34B, the through hole 2196 (see FIG. 38) is configured to allow the shaft 2116 to pass therethrough and position the second poppet valve assembly 2114 between the third valve seat "S3'" and the fourth valve seat "S4'". With reference to FIGS. 34A and 34B, the internal support 2194 abuts and helps position the outer housing 2179 of the actuator 2170. In the illustrated embodiment, the actuator mounting portion 2190 is coupled to one end of the outer housing 2179 near the second valve seat "S2'", and the internal support 2194 abuts the opposite end of the outer housing 2179 near the third valve seat "S3'".

[0295] 34A and 34B, the housing 2020 includes an intake body portion 2198 (also shown in FIG. 37) coupled to an exhaust body portion 2199 (also shown in FIG. 38). The valve / blower outlet 2002, the air intake 2006, the opening 2010, the first open end 2022, and the actuator mounting portion 2190 are formed in the intake body portion 2198. The blower / valve inlet 2004, the exhaust outlet 2008, the second open end 2024, and the internal support 2194 are formed in the exhaust body portion 2199.

[0296] 34A, in the first configuration, the first poppet valve assembly 2112 presses against the second valve seat "S2'" and the second poppet valve assembly 2114 presses against the fourth valve seat "S4'". With reference to FIGS. 5A and 34A, in the first configuration, the first poppet valve assembly 2112 allows the flow of gas 252 from the accumulator 202 through the air intake 2006, out the valve / blower outlet 2002 and into the blower 222. Additionally, the first poppet valve assembly 2112 blocks the gas 252 from directly entering the opening 2010, thus sealing the opening 2010 from both the air intake 2006 and the valve / blower outlet 2002. At the same time, the second poppet valve assembly 2114 pressing against the fourth valve seat "S4'" closes the exhaust outlet 2008 and allows the flow of gas 252 to the primary ventilator connection 104. In this configuration, gas 252 entering the air intake 2006 from the accumulator 202 is directed through the valve / blower outlet 2002 to the blower 222. The gas 252 is then blown by the blower 222 out of the blower / valve inlet 2004 through opening 2010 to the primary ventilator connection 104.

[0297] 34B, in the second configuration, the first poppet valve assembly 2112 presses against the first valve seat "S1'" and the second poppet valve assembly 2114 presses against the third valve seat "S3'". With reference to FIGS. 5B and 34B, in the second configuration, the first poppet valve assembly 2112 allows the flow of forced exhaust gas 253 from the primary ventilator connection 104 through the opening 2010, out the valve / blower outlet 2002 and into the blower 222. Additionally, the first poppet valve assembly 2112 blocks the flow of forced exhaust gas to the air intake 2006, thus preventing gas 252 from the accumulator 202 from reaching the valve / blower outlet 2002. At the same time, the second poppet valve assembly 2114, which is pressed against the third valve seat "S3'", opens the exhaust outlet 2008 and blocks the flow of forced exhaust gases 253 to the opening 2010. In this configuration, forced exhaust gases 253 entering the opening 2010 from the primary ventilator connection 104 is directed through the valve / blower outlet 2002 to the blower 222. The forced exhaust gases 253 are then blown by the blower 222 out of the blower / valve inlet 2004 and through the exhaust outlet 2008.

[0298] In the illustrated embodiment, the expectoration auxiliary valve 2000 (see FIGS. 34A and 34B) includes ports 275A, 275B, and 275C (described below and illustrated in FIGS. 5A and 5B) formed in the housing 2020 (see FIGS. 34A and 34B). With reference to FIG. 38, the ports 275A and 275B may be formed in the exhaust body portion 2199. With reference to FIGS. 34A and 34B, the port 275C may be formed in the intake body portion 2198. However, this is not a requirement. Optionally, with reference to FIG. 37, the expectoration auxiliary valve 2000 includes a port 275D configured to be connected to a redundant airway pressure transducer (not shown).

[0299] The exhaust assist valve, whether the exhaust assist valve 204 or the exhaust assist valve 2000, is designed such that the pressure acting on the first and second poppet valve assemblies 1112, 1114 of the exhaust assist valve 204 or the first and second poppet valve assemblies 2112, 2114 of the exhaust assist valve 2000 is balanced. This results in the actuator 1170 of the exhaust assist valve 204 and the actuator 2170 of the exhaust assist valve 2000 not having to act against the patient pressure. Because the valve seat areas of the valve seats S1-S4 of the exhaust assist valve 204 are all the same, as are the valve seat areas of the valve seats S1'-S4' of the exhaust assist valve 2000, patient pressure inside the exhaust assist valve arising through the port 1010 (see, for example, FIGS. 5C and 5D) acting on the poppet valve assembly of the exhaust assist valve generates equal and opposite forces. Thus, the forces on the first and second poppet valve assemblies 1112, 1114 of the exhaust assist valve 204 are substantially equal and opposite when seated against the first and third valve seats S1, S3 and when seated against the second and fourth valve seats S2, S4. Similarly, the forces on the first and second poppet valve assemblies 2112, 2114 of the exhaust assist valve 2000 are substantially equal and opposite when seated against the first and third valve seats S1', S3' and when seated against the second and fourth valve seats S2', S4'. If the forces on the first and second poppet valve assemblies of the exhaust assist valve were not balanced, the actuator 1170 / 2170 of the exhaust assist valve would need to be much larger and the power required to operate the actuator would be greater.

[0300] As previously mentioned, the ventilation assembly 190 may include either the expectoration auxiliary valve 204 or the expectoration auxiliary valve 2000. If the ventilation assembly 190 includes the expectoration auxiliary valve 204, then during normal ventilation the expectoration auxiliary valve 204 is in the first configuration shown in Figures 5A and 18A. On the other hand, if the ventilation assembly 190 includes the expectoration auxiliary valve 2000 (see Figures 34A and 34B), then during normal ventilation the expectoration auxiliary valve 2000 is in the first configuration shown in Figure 34A.

[0301] With reference to Figure 5A, at the start of the inhalation phase of breathing (and the start of the inhalation phase of expectoration), air 114 may be drawn into the ventilator 100 (see Figures 1 and 4) through a patient air intake 116, which may be configured to filter dust and / or other types of particles from the air. At least a portion of the air 114 flows into an accumulator 202, where the air 114 may optionally be mixed with oxygen 250 received from the oxygen assembly 210, low pressure oxygen 128 (received from an external low pressure oxygen source 118 depicted in Figure 1), combinations and / or subcombinations thereof, and the like. As illustrated in Figure 4, high pressure oxygen 132 (received from a high pressure external oxygen source 120 depicted in Figure 1) may flow into the oxygen assembly 210 and be delivered to the accumulator 202 (see Figure 5A) as oxygen 250.

[0302] With reference to FIG. 5A, the accumulator 202 may also act as a muffler for the patient air intake 116.

[0303] The inlet silencer 229 helps to muffle sounds generated by the oxygen assembly 210 (eg, by the compressor 302 illustrated in FIG. 7A).

[0304] The oxygen sensor 227 is connected to the accumulator 202 and measures an oxygen concentration value of the gas inside the accumulator 202. This value is close to the oxygen concentration value of the gas 252 exiting the accumulator 202. With reference to FIG. 5E, the oxygen sensor 227 provides an oxygen concentration signal 276 to the control system 220 that encodes the oxygen concentration value. The control system 220 processes the oxygen concentration signal 276 to obtain a measure of the amount of oxygen in the gas 252 (e.g., expressed as a percentage). With reference to FIG. 4, the output information 198 sent by the control system 220 to the user interface 200 may include the measure of the amount of oxygen in the gas 252. The user interface 200 may display this measure to a user (e.g., the patient 102 depicted in FIG. 1).

[0305] 5A, optionally, the accumulator 202 includes or is connected to a low pressure oxygen inlet 126. If the low pressure oxygen 128 is supplied by an external low pressure oxygen source 118 (see FIG. 1), the control system 220 may not control the resulting oxygen concentration flowing to the patient 102. In other words, the low pressure oxygen 128 may simply flow into the accumulator 202, mix with the air 114, and be pushed into the patient circuit 110 (see FIG. 1) by the blower 222. When this occurs, the ventilator 100 does not control the oxygen concentration delivered to the patient 102 in the inspiration gas 108 (see FIG. 1), but rather controls the delivery of the inspiration gas 108 during the inspiration phase of each breath.

[0306] The gas 252 exiting the accumulator 202 includes air 114 and, optionally, one or more of oxygen 250 and oxygen 128. The gas 252 may be communicated via flow line 214 to an internal flow transducer 212. The gas 252 flows through the internal flow transducer 212, which measures the flow rate of the gas 252 and provides a flow signal 270 (see FIG. 5E) encoding the flow rate to the control system 220 (see FIG. 5E). The flow signal 270 may be implemented as an analog electrical signal. With reference to FIG. 5E, the control system 220 uses the flow signal 270 to control the blower 222. As a non-limiting example, as shown in FIG. 5A, the internal flow transducer 212 may be implemented using a flow transducer having a fixed orifice differential pressure configuration.

[0307] The internal flow transducer 212 may be used to detect when the patient 102 (see FIG. 1) begins to breathe. In particular, the internal flow transducer 212 may be used in this manner when the patient circuit 110 (see FIG. 1) is implemented as a passive patient circuit (e.g., passive patient circuit 170, passive patient circuit 440, etc.). The flow of gas through the flow line 214 is not determined entirely by the blower 222. Instead, the patient's breathing effort may cause a change in the flow rate through the flow line 214. Thus, the control system 220 may identify when the patient 102 begins to breathe by identifying a change in the flow rate through the flow line 214 (encoded within the flow signal 270).

[0308] The internal flow transducer 212 may include or be connected to an auto-zero solenoid valve SV5 that is configured to be selectively activated and deactivated by a control signal 285 (see FIG. 5E) transmitted by the control system 220. The internal flow transducer 212 may drift over time, resulting in flow measurement error. To compensate for this error, from time to time (e.g., periodically), the control system 220 energizes (or activates) the auto-zero solenoid valve SV5 (using the control signal 285) and determines an offset value for the internal flow transducer 212. After determining the offset value, the control system 220 uses the offset value to compensate future readings, as appropriate (based on the flow signal 270).

[0309] Referring to FIG. 5A, after the internal flow converter 212, the gas 252 is conveyed into the blower 222 via the flow line 214 and the expectoration auxiliary valve 204 (or the expectoration auxiliary valve 2000). Referring to FIG. 5E, the blower 222 may be implemented as a radial blower driven by a motor 272. As a non-limiting example, the motor 272 may be implemented as a brushless DC motor. As an additional non-limiting example, the blower 222 may be implemented as a compressor, a pump, or the like. The motor 272 has an operating speed that is controlled by the control system 220. As a non-limiting example, the control system 220 may continuously control the operating speed of the motor 272.

[0310] 5A, the gas 252 flows from the blower 222 into the exhaust assist valve 204 (or the exhaust assist valve 2000). Each of the ports 275A-275C is configured to provide access to the flow of the gas 252 within the exhaust assist valve 204 (or the exhaust assist valve 2000). The flow line 273 conveys the flow of the gas 252 from the exhaust assist valve 204 (or the exhaust assist valve 2000) to the internal bacterial filter 230.

[0311] With reference to FIG. 5A, the airway pressure transducer 224 measures the airway pressure of the gas 252 flowing from the blower 222 towards the primary ventilator connection 104. In the illustrated embodiment, the airway pressure transducer 224 is connected to port 275C. With reference to FIG. 5E, the airway pressure transducer 224 provides an electrical pressure signal 274 encoding these pressure values ​​to the control system 220. The electrical pressure signal 274 is used to control the patient pressure during inspiration and expiration phases. The electrical pressure signal 274 is also used by the monitoring and alarm system 221 (see FIG. 4). Optionally, the ventilator 100 (see FIGS. 1 and 4) may include one or more redundant airway pressure transducers (not shown) such as the airway pressure transducer 224 to provide a fail-safe backup for the airway pressure transducer 224. In an embodiment including a redundant airway pressure transducer (not shown), the redundant airway pressure transducer may be connected to port 275D (see FIG. 17B).

[0312] The airway pressure transducer 224 may be used by the control system 220 to detect pressure changes and, in response to detecting the pressure change, command the blower 222 to increase or decrease its speed to adjust the pressure inside the flow line 273. Thus, the control system 220 may use the electrical pressure signal 274 to deliver pressure ventilation and / or to help ensure that the pressure inside the flow line 273 does not exceed a user-supplied peak inspiration pressure value (e.g., input via pressure control input 237 depicted in FIG. 6).

[0313] 5A, airway flow transducer module 225 includes differential pressure transducer PT4, auto-zero solenoid valves SV1 and SV2, and purge solenoid valves SV3 and SV4. Referring to FIG. 5E, control system 220 may selectively activate or deactivate solenoid valves SV1-SV4 using control signals 281-284, respectively.

[0314] 1, as previously discussed, the patient circuit 110 may include one or more optional ports 111. FIG 5A illustrates an implementation of a ventilation assembly 190 configured for use with a patient circuit 110 implemented as an active patient circuit (such as the active patient circuit 600 depicted in FIG 3A). In an alternative embodiment configured for use with a patient circuit 110 implemented as a passive patient circuit (such as the passive patient circuit 170 depicted in FIG 2A, the passive patient circuit 440 depicted in FIG 2B, etc.), the ports 275A and 275B, the airway flow transducer module 225, and the exhalation control assembly 226 may be omitted from the ventilation assembly 190.

[0315] The airway flow transducer module 225 and exhalation control assembly 226 illustrated in FIG. 5A are configured for use with an active patient circuit (e.g., the active patient circuit 600 depicted in FIG. 3A) that includes an airway flow transducer 648 (see FIG. 3G). Referring to FIG. 5A, the first and second ports 111A, 111B (see FIG. 3C) transmit the first and second pressure signals 109A, 109B, respectively, to the differential pressure transducer PT4 (e.g., via separate lines or channels). The differential pressure transducer PT4 has input ports PA and PB configured to receive the first and second pressure signals 109A, 109B, respectively. The differential pressure transducer PT4 determines a differential pressure based on the first and second pressure signals 109A, 109B, converts the differential pressure to a signal 277 (see FIG. 5E), and transmits the signal 277 to the control system 220 (as shown in FIG. 5E) for further processing by the control system 220. As a non-limiting example, the signal 277 can be an analog signal.

[0316] Signal 277 may be used to detect when the patient 102 (see FIG. 1) begins to breathe. The flow of gas through the active patient circuit 600 (see FIG. 3A) is not determined entirely by the blower 222. Instead, the patient's breathing effort may cause a change in the flow rate through the active patient circuit 600. Thus, by identifying a change in the flow rate through the active patient circuit 600 (encoded within signal 277), the control system 220 may identify that the patient 102 has begun to breathe.

[0317] The auto-zero solenoid valves SV1 and SV2 are connected to input ports PA, PB, respectively, of the differential pressure transducer PT4. Additionally, each of the auto-zero solenoid valves SV1 and SV2 is connected to ambient pressure. The differential pressure transducer PT4 may drift over time, resulting in flow measurement errors. To compensate for this error, from time to time (e.g., periodically), the control system 220 activates (or excites) the auto-zero solenoid valves SV1 and SV2 (using control signals 281 and 282, respectively) and determines an offset value for the differential pressure transducer PT4. The control system 220 then deactivates (using control signals 281 and 282, respectively). After determining the offset value, the control system 220 uses the offset value to compensate future readings as appropriate (based on signal 277).

[0318] Purge solenoid valves SV3 and SV4 are connected to port 275A. Referring to Fig. 5E, the control system 220 occasionally (e.g., periodically) energizes (or activates) the purge solenoid valves SV3 and SV4 (using control signals 283 and 284, respectively), which allows dry gas from the expectorant auxiliary valve 204 illustrated in Fig. 5A (or the expectorant auxiliary valve 2000 illustrated in Fig. 34A) to flow through lines, ports, and / or channels (e.g., optional multi-lumen tubing connection 103, channels 626A and 626B, channels 632A, 632B, ports 111A and 111B, etc.) to convey pressure signals 109A and 109B and purge those structures of any moisture that may be concentrated from the moist patient breathing gas.

[0319] Referring to FIG. 5E, the exhalation control assembly 226 includes an accumulator A2, a pressure transducer PT8, and solenoid valves SV6-SV8. The accumulator A2 has three ports 267-269 and an internal pressure (referred to as "pilot pressure"). The pressure transducer PT8 is connected to the accumulator A2 and measures the internal pressure inside the accumulator A2 and transmits this value in an electrical pressure signal 271 (see FIG. 5E) to the control system 220.

[0320] With reference to Figure 5E, solenoid valves SV6-SV8 are configured to be selectively activated and deactivated by control signals 286-288 respectively transmitted by control system 220 to solenoid valves SV6-SV8. Turning to Figure 5A, solenoid valve SV6 is connected to the first port 267, port 275B and pilot port 111C (see Figure 3C) of accumulator A2 (see Figure 3A). Solenoid valve SV7 is connected to the second port 268 and port 275B of accumulator A2. Solenoid valve SV8 is connected between the third port 269 and outlet port 166 of accumulator A2.

[0321] The exhalation control assembly 226 provides pilot pressure (from the accumulator A2) to the pilot port 111C (see FIG. 3C) of the active patient circuit 600 (see FIG. 3A), which controls the active exhalation valve assembly 604 as described above. At the start of the inhalation phase of the breath, the control system 220 activates (using the control signal 286) the solenoid valve SV6, which connects the pressure of the gas 252 to the pilot port 111C (via port 275B). This closes the active exhalation valve assembly 604. At the end of the inhalation phase of the breath, the control system 220 deactivates (using the control signal 286) the solenoid valve SV6, which connects the internal pressure (or pilot pressure) of the accumulator A2 to the active exhalation valve assembly 604, which opens the active exhalation valve assembly 604.

[0322] Similarly, at the beginning of the expectoration insufflation phase, the control system 220 activates (using the control signal 286) the solenoid valve SV6, which connects the pressure of the gas 252 to the pilot port 111C (through the port 275B). This closes the active exhalation valve assembly 604. At the end of the insufflation phase, the control system 220 deactivates (using the control signal 286) the solenoid valve SV6, which connects the internal pressure (or pilot pressure) of the accumulator A2 to the active exhalation valve assembly 604. Instead of opening the active exhalation valve assembly 604, as discussed below, this keeps the active exhalation valve assembly 604 in a closed configuration. Note that during the beginning of the forced exhaust phase, the dual bellows member 644 may move to an open position as a result of the patient pressure applied to the dual bellows member being higher than atmospheric pressure, but will automatically close when the pressure provided by the patient 102 drops below atmospheric pressure.

[0323] Using feedback provided by pressure transducer PT8 (via electrical pressure signal 271 depicted in FIG. 5E), control system 220 uses solenoid valves SV7 and SV8 to control the inside pilot pressure of accumulator A2 to set the pilot pressure for the expiratory phase of breathing that will achieve the desired PEEP. For example, control system 220 may decrease the pilot pressure inside accumulator A2 by activating solenoid valve SV8 (using control signal 288) to release some of the gas inside accumulator A2 as exhaust 167 via outlet port 166. Conversely, control system 220 may increase the pilot pressure by activating solenoid valve SV7 (using control signal 287) to add some of the gas 252 (available via port 275B) inside accumulator A2.

[0324] 5E, the control system 220 uses the electrical pressure signal 274 (received from the airway pressure transducer 224) to help control the blower 222. The control system 220 sends a control signal 278 to the motor 272, which instructs the blower 222 to provide a desired flow rate and / or a desired amount of pressure to the patient 102. As previously described, the flow signal 270 is used to help control the flow rate of the gas 252 during the inspiration and expiration phases of breathing. Similarly, the electrical pressure signal 274 is used to control the patient pressure during the inspiration and expiration phases of breathing. The flow signal 270 may be used to help control the flow rate of the gas 252 during the insufflation phase and / or the flow rate of the forced exhaust gas 253 during the forced exhaust phase of expectoration. Similarly, the electrical pressure signal 274 is used to control the patient pressure during the insufflation phase and / or the forced exhaust phase of expectoration.

[0325] As explained above, the ventilator 100 adjusts the pressure inside the patient circuit 110 (e.g., the passive patient circuit 440 illustrated in FIG. 2B) to achieve a preset inspiratory pressure during the inhalation phase, a baseline pressure or PEEP during the exhalation phase, and a PEEP during the pause between the inhalation and exhalation phases. These adjustments (as well as adjustments made during assisted expectoration procedures) are made by the control system 220, which monitors the electrical pressure signal 274 and uses the control signal 278 to increase or decrease the speed of the motor 272 to achieve the desired pressure inside the patient circuit 110.

[0326] Ambient pressure transducer 228 measures the atmospheric pressure value. Ambient pressure transducer 228 provides an ambient electrical pressure signal 280 to control system 220 that encodes the atmospheric pressure value. Control system 220 uses ambient electrical pressure signal 280 to correct the flow value (received via flow signal 270) and / or the expiratory tidal volume value (calculated by control system 220) to a desired standard condition.

[0327] 5A, as previously described, flow line 273 conveys the flow of gases 252 from the exhaust assist valve 204 (or exhaust assist valve 2000) to the internal bacterial filter 230. After the gases 252 pass through the internal bacterial filter 230, they exit the internal bacterial filter 230 as gases 112 and enter the patient circuit 110 (see FIG. 1) via the main ventilator connection 104. The internal bacterial filter 230 helps prevent bacteria in the patient circuit 110 from contaminating the ventilator 100.

[0328] (User Interface) Figure 6 is a block diagram illustrating some example components of the user interface 200. As mentioned above, Figure 4 illustrates output information 198 sent by the control system 220 to the example components of the user interface 200, and input information 196 received by the control system 220 from the example components of the user interface 200.

[0329] 6, the user interface 200 is configured to receive operating parameter values ​​from a user (e.g., a clinician) and display information to the user. For example, the user interface 200 may include a display device 240 (e.g., a liquid crystal display), a mode input 235, an inspiration time input 236, a pressure control input 237, a pressure support input 238, an oxygen generator activation input 239 for activating oxygen generation (described below), a tidal volume input 242, an oxygen flow equivalent value 244, a fraction of inspired oxygen ("FI02") input 246, a respiratory rate input 247, an oxygen pulse volume input 251, an expectoration assist activation input 241, an aspiration activation input 248 for activating the aspiration assembly 152 (see FIG. 1), and a nebulizer activation input 249 for activating the nebulizer assembly 162 (see FIG. 1).

[0330] The start of the inspiration phase is referred to as "onset." Mode input 235 is configured to receive an indication as to whether ventilator 100 will determine when each breath is initiated or whether patient 102 will determine when each breath is initiated. Breath rate input 247 is configured to receive the rate (e.g., breaths / min) at which breaths should be delivered. If the user indicates (using mode input 235) that ventilator 100 will determine when each breath is initiated, ventilator 100 will deliver breaths according to the rate received by breath rate input 247 (e.g., at regularly timed intervals). On the other hand, if the user indicates (using mode input 235) that patient 102 will initiate each breath, ventilator 100 will automatically deliver breaths as necessary to ensure that patient 102 receives breaths at least as frequently as indicated by the rate received by breath rate input 247.

[0331] The ventilator 100 may use the time or flow rate of the gas 112 to the patient 102 to identify the end of the inspiration phase. In the latter case, the patient 102 determines when the inspiration phase ends. The inspiration time input 236 is the duration T from the beginning of each breath to the end of the inspiration phase.i The ventilator 100 is configured to receive a value indicative of the duration T i ) may be used to identify the end of the inspiratory phase. The pressure support input 238 allows the user to adjust the flow rate of gas 112 to the patient 102 (for a duration T i ) to receive an indication of the desire to terminate the inspiratory phase. For example, the ventilator 100 may terminate the inspiratory phase of a breath when the flow rate of gas 112 is only about 25% of the peak flow experienced during the breath.

[0332] The ventilator 100 is configured to deliver either the gas 112 alone or a combination of the gas 112 and pulses of oxygen 140. As previously described, the ventilator 100 may be configured to provide both traditional volume-controlled ventilation and pressure-controlled ventilation. To use pressure control, a user may input a peak inspiratory pressure value using the pressure control input 237. The ventilator 100 uses the peak inspiratory pressure value to configure either the gas 112 alone or a combination of the gas 112 and pulses of oxygen 140 such that the pressure during the inspiration phase is up to the peak inspiratory pressure value.

[0333] The FI02 input 246 is configured to receive the oxygen concentration value. The ventilator 100 uses the oxygen concentration value to configure the gas 112 to have an oxygen concentration equal to or close to the oxygen concentration value.

[0334] The oxygen pulse volume input 251 is configured to receive an oxygen pulse volume value (e.g., expressed in milliliters, or a value within a predetermined range, such as 1 to 10, etc.). The ventilator 100 uses the oxygen pulse volume value to configure each pulse of oxygen 140 to have a volume equal to or close to the oxygen pulse volume value.

[0335] The tidal volume input 242 is configured to receive a desired total tidal volume value. Referring to Figure 15A, the ventilator 100 uses the desired total tidal volume value to output a volume of gas 112 (illustrated by area 586 and described below) and one of the pulses of oxygen 140 (illustrated by area 584 and described below) during each breath. For each breath delivered, the total tidal volume delivered is the combined volume of gas 112 and the pulse of oxygen 140 delivered during the breath.

[0336] The oxygen flow equivalent value 244 is configured to receive a desired oxygen delivery rate (expressed in liters / minute) that identifies the rate at which an assumed continuous oxygen flow rate may be delivered from an external source (e.g., a stand-alone oxygen concentrator) into a conventional ventilator or patient circuit 110 (see FIG. 1). The ventilator 100 uses this value to configure each pulse of oxygen 140 (see FIG. 1) to deliver an amount of oxygen that would provide an equivalent oxygen delivery to the patient 102 (see FIG. 1) as the assumed continuous oxygen flow rate.

[0337] Assisted expectoration activation input 241 indicates that the user desires to perform an assisted expectoration procedure (discussed below).

[0338] (Oxygen Assembly) Figure 7A is a schematic diagram illustrating some exemplary components of oxygen assembly 210. Figure 7B illustrates control signals 260 sent by control system 220 to the exemplary components of oxygen assembly 210, and data signals 262 received by control system 220 from the exemplary components of oxygen assembly 210.

[0339] 7A, the oxygen assembly 210 is configured to receive the high pressure oxygen 132 and / or generate oxygen 346 (see FIG. 8B), provide oxygen 250 to the accumulator 202 (see FIG. 5A) of the ventilation assembly 190, and / or provide pulses of oxygen 140 to the patient oxygen outlet 105. The oxygen assembly 210 may be configured to provide up to about 2 liters per minute ("LPM") of about 90% purity oxygen. In the illustrated embodiment, the oxygen assembly 210 includes an adsorbent bed 300, a compressor 302, a first rotary valve assembly 306, two pressure transducers PT2 and PT3, two pressure regulators R1 and R2, an outlet silencer 311, optional solenoid valves SV9 and SV10, an oxygen tank 312, an oxygen sensor 314, a metering valve 320, and an optional second rotary valve assembly 330. The compressor 302, first rotary valve assembly 306, adsorption bed 300, and pressure regulators R1 and R2 together may be characterized as an oxygen generator or an oxygen concentrator. The oxygen generator illustrated in the figures and described below implements a vacuum pressure swing adsorption ("VPSA") process. In alternative embodiments, the ventilator 100 may include an oxygen generator that implements at least one of a polymeric membrane separation process, an ion transport separation process, a cryogenic process, or the like. Additionally, the VPSA process described below is a subset of pressure swing adsorption (PSA), and the oxygen generator may be configured to implement a PSA process other than the VPSA process described below.

[0340] The adsorption bed 300 is configured to recover oxygen from air 114 received via the patient air intake 116. As described below, the adsorption bed 300 may be configured, at least in part, to implement a VPSA process that includes a cycle (described below) with four phases. The cycle alternates between generating oxygen 346 (see FIG. 8B) and nitrogen-rich gas 122. When the ventilator 100 is operating, the cycle is repeated until sufficient oxygen is generated to fill the oxygen tank 312. When the oxygen tank 312 is full, the cycle is stopped or slowed down until a sufficient amount of oxygen in the oxygen tank 312 is removed. The cycle is then resumed or accelerated as needed. The nitrogen-rich gas 122 generated by each cycle is exhausted to the outside environment via the outlet vent 124.

[0341] 8A-8D are block diagrams illustrating some exemplary components of an adsorbent bed 300. With reference to FIGS. 8A-8D, in the illustrated embodiment, the adsorbent bed 300 includes at least one housing 340 having a first end 341 and, opposite thereto, a second end 343. The housing 340 includes a nitrogen adsorbent material bed 344 (such as a zeolite) between the first end 341 and the second end 343. The nitrogen adsorbent material bed 344 preferentially adsorbs nitrogen. For ease of illustration, the adsorbent bed 300 will be described as including a single housing that includes a single nitrogen adsorbent material bed. In alternative embodiments, the adsorbent bed 300 may include two or more beds, such as the nitrogen adsorbent material bed 344, each housed inside a separate housing, such as the housing 340.

[0342] As previously mentioned, the VPSA process includes a cycle with four phases. Figure 8A illustrates the adsorbent bed 300 during the first phase. With reference to Figure 8A, during the first phase, air 114 is pumped by compressor 302 (see Figure 7A) into housing 340. When housing 340 is pressurized with air 114 (by compressor 302), the nitrogen in the air is preferentially adsorbed by nitrogen adsorbent bed 344, which leaves behind unadsorbed oxygen. Nitrogen adsorbent bed 344 may include interstitial spaces where unadsorbed oxygen is retained or captured.

[0343] 8B illustrates the adsorbent bed 300 during a second phase of the VPSA process cycle. During the second phase, oxygen 346 is pumped out of the housing 340. The oxygen 346 flows from the interstitial space into the oxygen tank 312 (see FIG. 7A).

[0344] 8C illustrates the adsorbent bed 300 during a third phase of the cycle of the VPSA process. During the third phase, nitrogen-rich gas 122 is drawn from the nitrogen adsorbent material bed 344 within the enclosure 340 (by the compressor 302 illustrated in FIG. 7A) and discharged to the outside environment via the outlet vent 124 (see FIG. 7A).

[0345] 8D illustrates the adsorbent bed 300 during a fourth phase of the VPSA process cycle. During the fourth phase, a flow of "purge" oxygen 348 (e.g., from the oxygen tank 312 illustrated in FIG. 7A) may be used to draw off the nitrogen-rich gas 122 and help regenerate the nitrogen adsorbent material bed 344.

[0346] Returning to Figure 7A, oxygen 346 (see Figure 8B) removed from adsorption bed 300 flows through pressure regulator R2 and into oxygen tank 312, where oxygen 346 is stored. While this occurs, metering valve 320 may be closed and pressure regulator R1 may also be closed to prevent backflow into adsorption bed 300. Alternatively, metering valve 320 may be at least partially open to allow a portion of oxygen 346 to flow to optional second rotary valve assembly 330.

[0347] During each cycle, the compressor 302 is configured to alternately push air 114 into the adsorption bed 300 (through the first rotary valve assembly 306) and withdraw nitrogen-rich gas 122 from the adsorption bed 300 (through the first rotary valve assembly 306). The compressor 302 may be driven by a motor 350 and may include a sensor 352 (e.g., an encoder) configured to provide a signal 354 to the control system 220 that encodes the direction and speed of rotation of the motor 350. With reference to FIG. 7B, the motor 350 is configured to receive instructions from the control system 220 encoded in a control signal 356. The instructions in the control signal 356 may command the motor 350 to turn on or off and / or indicate the direction in which the motor 350 should rotate when turned on. Additionally, the control signal 356 may command the motor 350 the speed at which to run. 7A, when motor 350 runs in a first direction, compressor 302 pushes air into adsorbent bed 300. Meanwhile, when motor 350 runs in a second direction, compressor 302 pulls nitrogen-rich gas 122 (see FIGS. 8C and 8D) from adsorbent bed 300. As a non-limiting example, motor 350 may be implemented as a brushless DC motor.

[0348] Figure 9 is an illustration of metering valve 320. With reference to Figure 9, pressure transducer PT3 is connected across metering valve 320. Thus, pressure transducer PT3 can determine a pressure differential value across metering valve 320. With reference to Figure 7B, pressure transducer PT3 provides a pressure differential signal 358 to control system 220 that encodes the pressure differential value.

[0349] 7B and 9, the metering valve 320 may be driven by a stepper motor 322 configured to receive a control signal 360 from the control system 220 that encodes a stepper position value. The stepper motor 322 is configured to move to the stepper position value encoded in the control signal 360. In the illustrated embodiment, the metering valve 320 is a stepper-driven proportional valve characterized by three variables: (1) valve position, (2) differential pressure across the valve (measured by pressure transducer PT3), and (3) flow rate. When a particular flow rate is desired (e.g., entered via user flow rate input 248 depicted in FIG. 6), the control system 220 uses the pressure differential signal 358 (which encodes a pressure differential value) and the particular flow rate to "look up" a corresponding stepper position value in the characterization table 362. In other words, the characterization table 362 stores stepper position values, each associated with a flow rate value and a pressure differential value. Thus, a particular pressure differential value and a particular flow rate value can be used by the control system 220 to determine a stepper position value, which the control system 220 then encodes in a control signal 360 and sends to the stepper motor 322. This process can be repeated from time to time (e.g., every few milliseconds) to provide the instantaneous desired oxygen flow rate.

[0350] 9, a position sensor 368 may be operatively coupled to the metering valve 320 and used to determine a home position. The position sensor 368 provides a position signal 370 to the control system 220 that encodes whether the metering valve 320 is in a home position (e.g., true or "on") or a position other than the home position (e.g., false or "off").

[0351] With reference to FIG. 7A, pressure regulator R2 may be characterized as a backpressure regulator. Pressure regulator R2 may be configured to prevent the pressure inside adsorption bed 300 from exceeding a first threshold pressure value (e.g., about 10 pounds per square inch ("PSIG")). For example, pressure regulator R2 may be configured to allow oxygen to automatically flow out of adsorption bed 300 when the pressure inside adsorption bed 300 reaches a first threshold. Pressure regulator R2 may also be configured to prevent gas from flowing into adsorption bed 300. This allows pressure regulator R2 to control pressure during a first phase (see FIG. 8A) and a second phase (see FIG. 8B).

[0352] Pressure regulator R1 may be characterized as a vacuum regulator. Pressure regulator R1 may be configured to prevent the pressure inside adsorption bed 300 from dropping below a second threshold pressure value (e.g., about -7 PSIG). Thus, pressure regulator R1 regulates the pressure in adsorption bed 300 to the second threshold pressure during the third phase (see FIG. 8C) and the fourth phase (see FIG. 8D). For example, pressure regulator R1 may be configured to allow oxygen to automatically flow into adsorption bed 300 (e.g., from oxygen tank 312) when the pressure inside adsorption bed 300 drops below the second threshold. Pressure regulator R1 may also be configured to prevent gas inside adsorption bed 300 from flowing out of adsorption bed 300 toward metering valve 320 (see FIG. 1).

[0353] Optional solenoid valves SV9 and SV10 may be configured to maintain the pressure inside the oxygen tank 312 between a minimum threshold pressure value (e.g., about 4 PSIG) and a maximum threshold pressure value (e.g., about 10 PSIG). Solenoid valves SV9 and SV10 are connected in a parallel arrangement to a conduit or flow line (not shown) that conveys high pressure oxygen 132 (e.g., from high pressure oxygen source 120 illustrated in FIG. 1) to the oxygen tank 312. Control system 220 selectively activates and deactivates solenoid valves SV9 and SV10, respectively, using control signals 380 and 382 (see FIG. 7B) to maintain the pressure in the oxygen tank 312 between the minimum and maximum threshold pressure values. Thus, control system 220 and solenoid valves SV9 and SV10 together perform the function of a digital (on / off) regulator.

[0354] The control system 220 may automatically stop the oxygen assembly 210 from performing the VPSA process when the high pressure external oxygen source 120 is connected. For example, the control system 220 may slow down or shut down the VPSA process when the pressure in the oxygen tank 312 exceeds an upper threshold (e.g., 10 PSIG). Thus, the control system 220 may slow down or shut down the VPSA process when the adsorption bed 300 is operating or when the high pressure external oxygen source 120 is connected. On the other hand, the control system 220 may resume or accelerate the VPSA process when the pressure inside the oxygen tank 312 drops below a lower pressure threshold (e.g., 4 PSIG).

[0355] The oxygen tank 312 may be implemented as a rigid chamber configured to store a predetermined amount of oxygen (e.g., about 56 cubic inches of oxygen). The outlet silencer 311 helps to muffle sounds generated by the compressor 302.

[0356] 7A and 7B, the oxygen sensor 314 measures the oxygen concentration in the oxygen tank 312 and encodes the oxygen concentration value in an oxygen concentration signal 378 that is provided to the control system 220. The control system 220 may use the oxygen concentration signal 378 to monitor the oxygen assembly 210 to ensure that it is working properly. If the oxygen concentration signal 378 indicates that the oxygen concentration is too low, the control system 220 may conclude that the oxygen assembly 210 is not functioning properly.

[0357] Pressure transducer PT2 monitors the pressure between the first rotary valve assembly 306 and the second rotary valve assembly 330 (which may be characterized as the pump pressure supplied to the second rotary valve assembly 330). With reference to Figure 7B, pressure transducer PT2 provides an electrical pressure signal 374 to the control system 220 that encodes the pressure value.

[0358] (First Rotary Valve Assembly) FIG 10A is a perspective view of a first side of an exemplary embodiment of first rotary valve assembly 306. FIG 10B is a perspective view of a second side of first rotary valve assembly 306 opposite the first side. With reference to FIG 10A, first rotary valve assembly 306 includes a motor assembly 830 mounted to an outer housing 832. Motor assembly 830 includes a stepper motor 833 (see FIG 7B) and a shaft 836 (see FIG 10B and 10C). Stepper motor 833 is configured to rotate shaft 836.

[0359] 10B, the position sensor 834 may be mounted on a printed circuit board ("PCB") 837 fastened to the outer housing 832 opposite the motor assembly 830. In such an embodiment, the PCB 837 may include an opening through which the end of the shaft 836 opposite the motor assembly 830 may pass.

[0360] FIG. 10C depicts a first side of the first rotary valve assembly 306 and a shaft 836 of the motor assembly 830. Other components of the motor assembly 830 are omitted in FIG. 10C. Referring to FIG. 10C, in the illustrated embodiment, the outer housing 832 has a generally cross- or cruciform outer shape. Thus, the outer housing 832 has four arms 841-844 extending outwardly from a central region 845 of the outer housing 832. In the illustrated embodiment, the motor assembly 830 (see FIG. 10A) is mounted to the central region 845.

[0361] FIG. 10D depicts a second side of the first rotary valve assembly 306 with the outer housing 832 and PCB 837 removed. As shown in FIG. 10D, arms 841-844 (see FIG. 10B) house poppet valves CV1-CV4, respectively. Inside the outer housing 832 (see FIG. 10B), poppet valves CV1 and CV3 are positioned opposite one another, and poppet valves CV2 and CV4 are also positioned opposite one another. The first rotary valve assembly 306 includes a cam 850 mounted on a shaft 836 (see FIGS. 10B and 10C) and configured to selectively actuate the poppet valves CV1-CV4. The cam 850 rotates with the shaft 836 when the motor assembly 830 (see FIG. 10A) rotates the shaft 836. Referring to FIG. 7B, position sensor 834 provides a position signal 835 to control system 220 that encodes whether cam 850, stepper motor 833 (see FIGS. 10A and 10B), and / or shaft 836 (see FIGS. 10B and 10C) are in a home position (e.g., true or “on”) or in a position other than the home position (e.g., false or “off”).

[0362] 10C, each of the arms 841-844 is open at its distal end 846. The open distal ends 846 of the arms 841-844 are closed by end caps 851-854, respectively. The end caps 851-854 may be fastened to the outer housing 832 by fasteners 855.

[0363] With reference to FIG. 10B, arms 841-844 include inlet openings 856A-856D, respectively, configured to receive a gas or mixture of gases, and outlet openings 858A-858D, respectively, through which the gas or mixture of gases may exit.

[0364] 10D, each of poppet valves CV1-CV4 includes an open-ended housing 860 with a side inlet 862 and a side outlet 864. The side inlets 862 of poppet valves CV1-CV4 are aligned with and in fluid communication with inlet openings 856A-856D, respectively, of outer housing 832. Similarly, the side outlets 864 of poppet valves CV1-CV4 are aligned with and in fluid communication with outlet openings 858A-858D, respectively, of outer housing 832.

[0365] One or more seals 866 and 868 (e.g., O-ring type seals) may be positioned between outer housing 832 and housing 860. For example, seal 868 may be positioned between side inlet 862 and side outlet 864. As another non-limiting example, one of the seals 866 may be positioned between each of the open distal ends 846 of arms 841-844 and end caps 851-854.

[0366] Poppet valves CV1-CV4 are substantially identical to one another. For simplicity purposes, only poppet valve CV1 will be described in detail. FIG. 10E is an exploded perspective view of poppet valve CV1, end cap 851, and fastener 855. Referring to FIG. 10E, housing 860 has an open proximal end portion 870 and, conversely, an open distal end portion 872. Open distal end portion 872 is closed by end cap 851 when end cap 851 is fastened to outer housing 832. Similarly, housing 860 of poppet valves CV2-CV4 is closed at its open distal end portion 872 by end caps 852-853, respectively, when end caps 852-854 are fastened to outer housing 832.

[0367] Figure 10F is a cross-sectional view of the first rotary valve assembly 306 with cam 850 positioned to open poppet valves CV2 and CV4, and Figure 10G is a cross-sectional view of the first rotary valve assembly 306 with cam 850 positioned to open poppet valves CV1 and CV3.

[0368] 10F, a generally cylindrically shaped guide portion 876 extends inwardly from the open proximal end portion 870 (see FIG. 10E) of the housing 860. An open ended channel 877 is formed in the guide portion 876. A shoulder 878 is formed on the inside of the housing 860 between the side inlet 862 and the side outlet 864.

[0369] 10E, inside the housing 860, poppet valve CV1 has a push rod 880 that is biased away from end cap 851 by biasing assembly 884. Referring to FIG. 10F, push rod 880 extends through channel 877 and exits housing 860 through open proximal end portion 870 (see FIG. 10E). Turning to FIG. 10E, push rod 880 may have a circumferential recess 879 formed near its proximal end portion 881.

[0370] A ring-shaped diaphragm 886 may extend around the push rod 880 near the proximal end portion 881. In the illustrated embodiment, the diaphragm 886 has a circular central portion P2 with a central opening 887 through which the push rod 880 extends, and an inner edge portion of the central portion P2 is positioned within the recess 879, whereby the central portion P2 tightly grips the push rod 880. The diaphragm 886 may close and seal the open proximal end portion 870 of the housing 860. However, the diaphragm 886 may bend or stretch longitudinally to allow the push rod 880 to move longitudinally relative to the housing 860. In the embodiment illustrated in FIG. 10F, the diaphragm 886 has a circular outer peripheral portion P1 positioned between the open proximal end portion 870 of the housing 860 and the outer housing 832, whereby the outer peripheral portion P1 is tightly clamped in place.

[0371] 10E, a circular outer peripheral portion P1 of diaphragm 886 is connected to a circular central portion P2 by a curved or contoured intermediate portion P3. The intermediate portion P3 may be characterized as a convolution. A circular shape located midway between outer peripheral portion P1 and central portion P2 may be characterized as being located at the center of the convolution. Diaphragm 886 has an effective area extending from the circular shape at the center of the convolution to central portion P2.

[0372] 10E, push rod 880 has a distal end portion 882 and, oppositely, a proximal end portion 881. Proximal end portion 881 has a cam follower 883 (see FIGS. 10C and 10E) formed therein. In the illustrated embodiment, proximal end portion 881 is outwardly tapered and may be generally conical in shape. Cam follower 883 (see FIG. 10C) may be implemented as a planar or contoured lower surface of proximal end portion 881.

[0373] A ring-shaped valve seat 896 is fixedly mounted to a shoulder 878 formed on the inside of the housing 860. In the embodiment shown, the valve seat 896 has a central through hole 897 through which the push rod 880 extends unobstructed.

[0374] Distal end portion 882 of push rod 880 has a longitudinally extending channel 885 formed therein. Channel 885 is open at distal end portion 882 of push rod 880. A disk-shaped poppet member 892 is fastened to distal end portion 882 of push rod 880 by fasteners 894 (e.g., bolts, screws, etc.) that extend into the open end of channel 885. Fasteners 894 thus couple poppet member 892 to distal end portion 882 of push rod 880 so that it moves therewith as a unit when push rod 880 moves inside housing 860.

[0375] 10F, when the poppet member 892 is pressed against the valve seat 896, the poppet member 892 closes the central through hole 897 and divides the interior of the housing 860 into a proximal chamber 900 and a distal chamber 902. The poppet member 892 may thus seal the proximal and distal chambers 900, 902 from one another. The side inlet 862 communicates with the proximal chamber 900 and the side outlet 864 communicates with the proximal chamber 900. Meanwhile, referring to FIG. 10G, when the poppet member 892 is spaced distally from the valve seat 896, the central through hole 897 is exposed and the proximal and distal chambers 900, 902 communicate with one another. Thus, in this configuration, a gas or mixture of gases may flow between the proximal chamber 900 and the distal chamber 902. In other words, a path is open between the side entrances and exits 862 and 864 .

[0376] A distal end portion 882 of the push rod 880 abuts a biasing assembly 884. In the illustrated embodiment, the biasing assembly 884 includes a biasing member 888 (e.g., a coil spring) and an end cap 890. The biasing member 888 exerts an inwardly directed force on the push rod 880, which helps ensure that the push rod 880 maintains contact with the cam 850. The end cap 890 is seated on a fastener 894 and positioned between a disk-shaped poppet member 892 and the end cap 851. The biasing member 888 extends between the end cap 890 and the end cap 851 and exerts a biasing force on the end cap 890, which transfers the force to the fastener 894 and / or the poppet member 892. In turn, the fastener 894 and / or the poppet member 892 transfer the biasing force to the push rod 880.

[0377] The cam 850 may be characterized as having two lobes or high points 910 and 912 opposite each other. When one of the high points 910 and 912 is adjacent to the cam follower 883 (see FIGS. 10C and 10E) of the push rod 880 of the poppet valve CV1, the high point 910 or 912 urges the push rod 880 outward toward the end cap 851. This urges the disk-shaped poppet member 892 away from the valve seat 896 (as shown in FIG. 10G) and opens the central through hole 897. This opens the poppet valve CV1 and allows the gas or mixture of gases to flow through the poppet valve CV1. On the other hand, as shown in Figure 10G, when neither of high points 910 nor 912 is adjacent to cam follower 883 (see Figures 10C and 10E) of push rod 880 of poppet valve CV1, push rod 880 is biased inwardly, away from end cap 851, by biasing assembly 884. Push rod 880 thereby draws disk-shaped poppet member 892 toward valve seat 896, causing poppet member 892 to cover or close central throughbore 897. This closes poppet valve CV1 and prevents gas or mixture of gases from flowing through poppet valve CV1.

[0378] Since the ventilator 100 may be required to function for a long life time (e.g., greater than about 30,000 hours), the first rotary valve assembly 306 may experience approximately 15,000,000 VPSA cycles. To meet this requirement, each of the poppet valves CV1-CV4 may have a "balanced" valve configuration. Each time one of the poppet valves CV1-CV4 is closed, the pressure inside the proximal chamber 900 acts on both the effective area of ​​the diaphragm 886 and the portion of the poppet member 892 that covers (or closes) the central through-hole 897 of the valve seat 896. The area of ​​the portion of the poppet member 892 that covers (or closes) the central through-hole 897 of the valve seat 896 is approximately equal to the effective area of ​​the diaphragm 886. When the pressure inside the proximal chamber 900 is negative (or vacuum), an inwardly directed force (towards the proximal chamber 900) acts on the effective area of ​​the diaphragm 886. At the same time, an inwardly directed force (towards the proximal chamber 900) acts on the portion of the poppet member 892 that covers the central through hole 897 of the valve seat 896. Similarly, when the pressure inside the proximal chamber 900 is positive, an outwardly directed force (away from the proximal chamber 900) acts on the effective area of ​​the diaphragm 886, and an outwardly directed (or distally) force acts on the portion of the poppet member 892 that covers the central through hole 897 of the valve seat 896. Thus, when the proximal chamber 900 is sealed by the poppet member 892, opposing forces act on the effective area of ​​the diaphragm 886 and the area of ​​the portion of the poppet member 892 that covers (or closes) the central through-hole 897 of the valve seat 896. Because the effective area of ​​the diaphragm 886 and the area of ​​the portion of the poppet member 892 that covers (or closes) the central through-hole 897 of the valve seat 896 are approximately equal (as discussed above), the net force on the push rod 880 is zero. This balancing feature helps reduce the force of the push rod 880 on the cam follower 883 and cam 850, thereby reducing wear and increasing life.

[0379] As described above, each of the poppet valves CV1-CV4 is biased to a closed position by its biasing assembly 884. Each of the poppet valves CV1-CV4 includes a cam follower 883 (see FIGS. 10C and 10E) that abuts a cam 850. As the cam 850 rotates, it pushes the poppet valves CV1-CV4 counters outward, opening them. When the poppet valves CV1 and CV3 are in an open position, the poppet valves CV2 and CV4 will come to a closed position, and vice versa. Referring to FIG. 7B, the first rotary valve assembly 306 (e.g., stepper motor 833) is configured to receive a control signal 376 from the control system 220 that encodes a cam position. The first rotary valve assembly 306 (e.g., stepper motor 833) is also configured to rotate the cam 850 to a position encoded in the control signal 376.

[0380] 7A, poppet valve CV3 (see FIG. 10G) is connected to compressor 302 and adsorbent bed 300. Control system 220 configures compressor 302 to provide suction to distal chamber 902, thereby causing the pressure inside distal chamber 902 of poppet valve CV3 to be less than the pressure inside proximal chamber 900 of poppet valve CV3.

[0381] Poppet valve CV1 (FIG. 10G) is connected to compressor 302 and outlet vent 124. Control system 220 configures compressor 302 to force nitrogen-rich gas 122 (see FIGS. 8C and 8D) into proximal chamber 900, thereby causing the pressure inside distal chamber 902 of poppet valve CV1 to be less than the pressure inside proximal chamber 900 of poppet valve CV1.

[0382] When poppet valves CV1 and CV3 are opened as shown in FIG. 10G, poppet valve CV3 receives nitrogen-rich gas 122 (see FIGS. 8C and 8D) from adsorption bed 300 and provides it to compressor 302. At the same time, poppet valve CV1 allows nitrogen-rich gas 122 pumped from adsorption bed 300 by compressor 302 (through poppet valve CV3) to flow out of compressor 302 and exit ventilator 100 through outlet vent 124. Optionally, poppet valve CV3 may be connected to a second rotary valve assembly 330. As described below, compressor 302 may provide suction force 154 to suction assembly 152 through second rotary valve assembly 330.

[0383] 7A, poppet valve CV4 (see FIG. 10F) is connected to compressor 302 and patient air intake 116. Control system 220 configures compressor 302 to provide suction to proximal chamber 900, thereby causing the pressure inside proximal chamber 900 of poppet valve CV4 to be less than the pressure inside distal chamber 902 of poppet valve CV4.

[0384] Poppet valve CV2 (see FIG. 10F) is connected to compressor 302 and to adsorbent bed 300. Control system 220 causes the pressure inside distal chamber 902 of poppet valve CV2 to exceed the pressure inside proximal chamber 900 of poppet valve CV2 by configuring compressor 302 to provide pressurized air 114 pumped by compressor 302 to distal chamber 902.

[0385] 10F, poppet valve CV4 allows air 114 to be pumped into compressor 302 via patient air intake 116. At the same time, poppet valve CV2 provides pressurized air 114 from compressor 302 to adsorption bed 300. Optionally, poppet valve CV2 may be connected to a second rotary valve assembly 330. As described below, gas 164 provided to second rotary valve assembly 330 may be used to populate nebulizer assembly 162.

[0386] As mentioned above, in the illustrated embodiment, the oxygen assembly 210 generates oxygen 364 (see FIG. 8B) using a VPSA process, which may have four phases, labeled "Phase 1," "Phase 2," "Phase 3," and "Phase 4" across the top of FIG. 11.

[0387] In Figure 11, the upper line 400 depicts the pressure experienced by the nitrogen adsorbent material bed 344 (see Figures 8A-8D) during the four phases of the VPSA process. With reference to Figure 11, the line 400 may be determined by the control system 220 based on the electrical pressure signal 374 (see Figure 7B) provided by pressure transducer PT2. The lower line 410 depicts the feed flow rate through the nitrogen adsorbent material bed 344 (see Figures 8A-8D) during the four phases of the VPSA process.

[0388] Lines 421 and 423 show that poppet valves CV1, CV3, respectively, are transitioned from open ("passing") to closed ("non-passing") at the beginning of the first phase, and then poppet valves CV1 and CV3 are transitioned from closed ("non-passing") to open ("passing") at the beginning of the third phase. Thus, poppet valves CV1 and CV3 are closed during most of the first phase and the entire second phase. Additionally, poppet valves CV1 and CV3 are open during most of the third phase and the entire fourth phase.

[0389] Conversely, lines 422 and 424 indicate that poppet valves CV2, CV4, respectively, are transitioned from closed ("non-passing") to open ("passing") at the beginning of the first phase, and then poppet valves CV2 and CV4 are transitioned from open ("passing") to closed ("non-passing") at the beginning of the third phase. Thus, poppet valves CV2 and CV4 are open during most of the first phase and the entire second phase. Additionally, poppet valves CV2 and CV4 are closed during most of the third phase and the entire fourth phase.

[0390] 12 is a flow diagram of a method 500 performed by control system 220. Method 500 implements, at least in part, a VPSA process. As method 500 is performed, pressure transducer PT2 (see FIGS. 7A and 7B) obtains pressure values ​​for adsorbent bed 300 from time to time and transmits electrical pressure signal 374 to control system 220.

[0391] In a first block 502, the control system 220 begins the first phase of the VPSA process by opening poppet valves CV2 and CV4 and closing poppet valves CV1, CV3. At this point, pressure regulator R2 is closed.

[0392] Next, in block 504, the control system 220 commands the motor 350 of the compressor 302 to pump the air 114 from the patient air intake 116 and into the adsorbent bed 300. The motor 350 of the compressor 302 may run at a relatively high speed while drawing air 114 from the patient air intake 116.

[0393] In block 506, the control system 220 determines that the pressure inside the adsorption bed 300 has reached a first threshold pressure value (e.g., about 10 PSIG). When the pressure inside the adsorption bed 300 reaches the first threshold pressure value, the pressure regulator R2 automatically opens. At this point, the first phase ends and the second phase begins. During the second phase, nitrogen is adsorbed from the air 114 by the adsorption bed 300, and, referring to FIG. 8B, oxygen 346 (e.g., 90% purity oxygen) flows from the adsorption bed 300 through the pressure regulator R2. During the second phase, the oxygen passing through the pressure regulator R2 is stored in the oxygen tank 312.

[0394] Returning to FIG. 12, next at block 508, at the beginning of the second phase, the control system 220 reduces the speed of the motor 350. Referring to FIG. 8B, during the second phase, the mass transfer zone 430 moves from the first end 341 (in the direction identified by the arrow "D1") to the second end 343. The gas on the first side 432 of the mass transfer zone 430 near the first end 341 is air, and the gas on the second side 434 of the mass transfer zone 430 near the second end 343 is about 90% oxygen. The compressor 302 may run at a relatively slow speed during the second phase to promote effective nitrogen adsorption. At block 510, the control system 220 detects the end of the second phase, which occurs when the mass transfer zone 430 reaches the second end 343. The control system 220 may determine that the second phase has ended after a predetermined amount of time has elapsed (e.g., about 1 second). In some embodiments, the control system 220 may use a secondary measure (e.g., pressure) to help determine when the second phase has ended. At this point, the adsorbent bed 300 is completely saturated with nitrogen, the second phase has ended, and the third phase has begun.

[0395] At the beginning of the third phase, the control system 220 opens poppet valves CV1 and CV3 and closes poppet valves CV2 and CV4 in block 512. At this point, pressure regulator R1 is closed.

[0396] Next, in block 514, the control system 220 commands the motor 350 of the compressor 302 to pump the nitrogen-rich gas 122 from the adsorption bed 300 through the exit vent 124 and into the external environment. The compressor 302 may be run at a relatively high speed as it withdraws the nitrogen-rich gas 122 from the adsorption bed 300.

[0397] In block 516, the control system 220 determines that the pressure inside the adsorbent bed 300 reaches a second threshold pressure value (e.g., about -7 PSIG), at which point the third phase ends and the fourth phase begins.

[0398] At the start of the fourth phase, in block 518, the control system 220 may reduce the speed of the motor 350 to a relatively low speed.

[0399] In block 520, the control system 220 purges the adsorption bed 300 with oxygen from the oxygen tank 312. In block 520, the pressure regulator R1 automatically opens, allowing the flow of "purge" oxygen 348 (see FIG. 8D) from the oxygen tank 312 to flow through the adsorption bed 300 (e.g., in the direction identified by arrow "D2"). The mass transfer zone 430 also moves away from the second end 343 (in the direction identified by arrow "D2") to the first end 341. The low pressure inside the adsorption bed 300 combined with the flow of the purge oxygen 348 draws out nitrogen and regenerates the adsorption bed 300. Once the purge is complete, the fourth phase ends, which has completed one four-phase cycle, and the method 500 ends. The control system 220 may begin another cycle by returning to block 502 of the method 500.

[0400] 13A-13D are schematic diagrams of a second rotary valve assembly 330. The second rotary valve assembly 330 may be substantially similar to the first rotary valve ...

Claims

1. 1. A ventilator system having a ventilator and a patient circuit configured to fluidly couple the ventilator to a patient, The patient circuit includes: a conduit configured to transfer gas received from the ventilator towards the patient; a port positioned along a portion of the conduit, the portion of the conduit configured to transfer the gas received from the ventilator towards the patient, the port configured to fluidly connect an interior of the conduit with an external environment; and a valve movable between an open position allowing gas flow between an interior of the conduit and the external environment through the port and a closed position blocking gas flow between the interior of the conduit and the external environment through the port; Including, the ventilator is operable in (i) a ventilation mode to provide patient expiration and patient inspiration, and (ii) a clearance assist mode to provide expectoration, the valve being operable in both the ventilation mode and the clearance assist mode; the valve is in the open position when a first pressure in the conduit is greater than a second pressure in the external environment; the valve is in the closed position when the first pressure in the conduit is less than the second pressure in the external environment; the system is configured such that the first pressure in the conduit is greater than the second pressure in the external environment during patient exhalation and patient inhalation to allow the valve to remain in the open position; The ventilator system includes a blower that provides positive and negative pressure.

2. 10. The ventilator system of claim 1, wherein when the valve is in the closed position, the valve does not block the flow of gas through the conduit.

3. 10. The ventilator system of claim 1, wherein the patient circuit includes a plurality of ports extending circumferentially about the patient circuit.

4. The valve is a flexible annular ring movable between the open position to open the plurality of ports and the closed position to close the plurality of ports.

4. The ventilator system of claim 3, wherein:

5. 10. The ventilator system of claim 1, wherein the patient circuit further comprises a passage separating an interior of the conduit and the port.

6. 6. The ventilator system of claim 5, wherein the valve is positioned within the passageway.

7. 2. The ventilator system of claim 1, wherein the patient circuit includes a patient connection and an elongated tube configured to fluidly connect the patient connection and the ventilator, the elongated tube at least partially defining the conduit.

8. 1. A ventilator system having a ventilator, a patient connection, a fluid passageway between the ventilator and the patient connection, and a passive valve for use as a fixed leak valve, the passive valve being positioned along a portion of the fluid passageway; The passive valve includes a valve body, The valve body is an internal chamber; a first valve body port in fluid communication with the internal chamber and the patient connection; a second valve body port in fluid communication with the internal chamber and the ventilator; a plug passage in fluid communication with the interior chamber and with ambient air external to the plug, the plug passage including a third plug port open to the ambient air; a check valve seal having an open position and a closed position, in which in the open position, the check valve seal is configured to allow flow of gas in the interior chamber through the valve disc passage to an exterior of the valve disc, and in which in the closed position, the check valve seal is configured to prevent flow of ambient air exterior to the valve disc through the valve disc passage into the interior chamber; Including, the ventilator is operable in (i) a ventilation mode to provide patient expiration and patient inspiration, and (ii) a clearance assist mode to provide sputum, the passive valve being operable in both the ventilation mode and the clearance assist mode; the check valve seal is in the open position when a first pressure in the interior chamber is greater than a second pressure exterior to the valve body; the check valve seal is in the closed position when the first pressure in the interior chamber is less than the second pressure exterior to the valve body; the system is configured such that the first pressure within the interior chamber is greater than the second pressure exterior to the valve body during patient exhalation and patient inhalation to allow the check valve seal to remain in the open position; The ventilator system includes a blower that provides positive and negative pressure.

9. 9. The ventilator system of claim 8, wherein the check valve seal allows gas flow between the first valve disc port and the second valve disc port when in the open position and when in the closed position.

10. 1. A ventilator system having a ventilator, a patient connection, and a passive valve for use as a fixed leak valve, comprising: The passive valve includes a valve body, The valve body is an internal chamber; a first valve body port in fluid communication with the internal chamber and the patient connection; a second valve body port in fluid communication with the internal chamber and the ventilator; a plug passage in fluid communication with the interior chamber and with ambient air external to the plug, the plug passage including a third plug port open to the ambient air; a check valve seal having an open position and a closed position, in which in the open position, the check valve seal is configured to allow flow of gas in the interior chamber through the valve disc passage to an exterior of the valve disc, and in which in the closed position, the check valve seal is configured to prevent flow of ambient air exterior to the valve disc through the valve disc passage into the interior chamber; Including, the ventilator is operable in (i) a ventilation mode to provide patient expiration and patient inspiration, and (ii) a clearance assist mode to provide sputum, the passive valve being operable in both the ventilation mode and the clearance assist mode; the check valve seal is in the open position when a first pressure in the interior chamber is greater than a second pressure exterior to the valve body; the check valve seal is in the closed position when the first pressure in the interior chamber is less than the second pressure exterior to the valve body; The valve disc passage is an elongated, circumferentially extending channel that extends at least partially around the valve disc.

11. 11. The ventilator system of claim 10, further comprising a plurality of first passageways in fluid communication with the interior chamber and the channel.

12. 12. The ventilator system of claim 11, wherein the check valve seal is an elongated, circumferentially extending, flexible seal positioned within the channel and flexibly movable between the closed position to close the first passageway to prevent fluid communication between the interior chamber and the channel through the first passageway when the first pressure is less than the second pressure, and the open position to open the first passageway to allow fluid communication between the interior chamber and the channel through the first passageway when the first pressure is greater than the second pressure, thereby providing a fluid communication path between the interior chamber and ambient air exterior to the valve body.

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