Ventilator with integrated sputum drainage assistance

Abstract

To provide a ventilator with integrated phlegm discharge assistance.SOLUTION: Provided is a ventilator with phlegm discharge assistance. The ventilator is for use of a patient connection part of a patient and a patient circuit in fluid communication therewith, and the ventilator can operate in a ventilation mode and a phlegm discharge assistance mode. The ventilator includes: a user input for switching operation from a ventilation mode to a phlegm discharge assistance mode without disconnecting the ventilator from the patient; and a controller capable of operating in response to the user input, and controlling the operation of the ventilator so as to provide the patient with the phlegm discharge assistance having an insufflation phase and a forced exhaust phase following it at least once in the phlegm discharge assistance mode. A phlegm discharge assistance valve, in a first condition for the insufflation phase, transfers positive pressure to a ventilator connection part, and in a second condition for the forced exhaust phase, transfers negative pressure to the ventilator connection part.SELECTED DRAWING: Figure 1

Description

Technical Field

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

Background Art

[0002] Respiration can be characterized as including both an inhalation phase and an exhalation phase. During the inhalation phase, inhaled gas is drawn into the lungs, and during the exhalation phase, exhaled gas is expelled from the lungs.

[0003] Mechanical ventilators are used to assist with respiration. Conventional ventilators typically push an inhaled gas containing oxygen into a patient's lungs. Many patients who use a ventilator also require other types of assistance related to the treatment and maintenance of the patient's airway and lungs. For example, some patients may use a nebulizer to deliver a drug to the patient's lungs and / or airway. Additionally, some patients may require assistance to remove secretions from the patient's lungs and / or airway. Such assistance is typically provided by a conventional suction device. Thus, in addition to a ventilator, many patients require multiple devices, and movement with such equipment can be particularly problematic.

[0004] Currently, in order to receive sputum clearance assistance, a patient must be disconnected from mechanical ventilation and connected to a separate sputum clearance assistance device. After the sputum clearance assistance procedure is performed, the patient must be disconnected from the sputum clearance 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 sputum clearance assistance device and reconnected to mechanical ventilation to remove secretions that were not properly removed from the patient's airway during the sputum clearance assistance procedure. During the period when the patient is not receiving mechanical ventilation, it is customary to deliver a high level of inhaled oxygen before removing mechanical ventilation from the patient in order to minimize the risk of the patient's hypoxemia. This process can be long and boring and is often not performed in the most advantageous manner for the patient.

[0005] Accordingly, there is a need for a ventilator that is portable and / or configured to provide additional functionality other than delivering inspiratory gas into a patient's lungs. The present application provides these and other advantages, which will be apparent from the following embodiments for carrying out the invention and the accompanying drawings. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0006] An embodiment includes a method of providing respiration to a human patient. The human patient has a patient connection portion connected to a ventilator device by a patient circuit. The respiration has an inspiratory phase with a start and an end. The method includes delivering a bolus of oxygen to the patient circuit at or before the start of the inspiratory phase of the respiration, ending the delivery of the bolus of oxygen before the end of the inspiratory phase of the respiration, and delivering a respiratory gas containing air to the patient circuit before the end of the inspiratory phase of the respiration. The patient circuit delivers the bolus of oxygen and the respiratory gas to the patient connection portion. Optionally, the method may further include waiting until the delivery of the bolus of oxygen delivered for the respiration ends before delivering the respiratory gas.

[0007] Optionally, the method may further include receiving a bolus volume value. In such an embodiment, the bolus of oxygen delivered for the respiration 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 portion than the first input location.

[0009] The bolus of combined oxygen and breathing gas delivered for respiration has a total inspiratory volume. Optionally, the bolus of oxygen delivered for respiration has a volume of less than about 75% of the total inspiratory volume. Optionally, the bolus of oxygen delivered for respiration has a volume from about 50% to about 75% of the total inspiratory 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 if continuously applied to the patient circuit from the start of the inspiratory phase of respiration to the end of the expiratory phase of respiration. In such an embodiment, the bolus of oxygen delivered for respiration has a second volume that is less than the first volume of oxygen.

[0011] Optionally, the method may further include detecting that the start of the inspiratory phase of respiration 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 start of the inspiratory phase of respiration 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 a bolus of oxygen at or before the start of the inspiratory phase of respiration includes opening the valve, thereby enabling an oxygen flow from the oxygen source to the patient circuit. Further, ending delivery of the bolus of oxygen before the end of the inspiratory phase of respiration includes closing the valve, thereby stopping the oxygen flow from the oxygen source to the patient circuit.

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

[0014] The method can be used with a user-specified total tidal volume. In such an embodiment, the breathing gas delivered for breathing has a first volume, the bolus of oxygen delivered for breathing has a second volume, and the combined first and second volumes are substantially equal to the user-specified total tidal volume.

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

[0016] The method can be used with a breathing gas delivery conduit and an oxygen delivery conduit. The breathing gas delivery conduit has a breathing gas output located at a first end portion of the patient circuit, away from the patient connection portion. The oxygen delivery conduit has an oxygen output located at a second end portion of the patient circuit, adjacent to the patient connection portion. Delivering the breathing gas to the patient circuit can include providing the breathing gas to the breathing gas output via the breathing gas delivery conduit. Further, 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 breathing gas delivered for breathing along at least a majority of the patient circuit prior to the patient connection portion.

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

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

[0019] Embodiments include a ventilator device for use with an oxygen source and a patient circuit. The patient circuit is configured to receive breathing gas and oxygen and provide it to a human patient having a patient connection portion connectable to the patient circuit. Breathing has an inhalation phase with a start and an end. The ventilator device includes a compressor configured to deliver breathing gas to the patient circuit, and a control system configured to (a) enable oxygen to flow from the oxygen source to the patient circuit at or before the start of the inhalation phase of breathing, (b) prevent oxygen from flowing from the oxygen source to the patient circuit before the end of the inhalation phase of breathing, and (c) cause the compressor to deliver breathing gas to the patient circuit before the end of the inhalation phase of breathing.

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

[0021] Optionally, the ventilator device may include an input configured to receive a user-specified peak inspiratory pressure value. In such embodiments, the combined pressure of the breathing gas delivered to the patient circuit and the oxygen enabled to flow into the patient circuit for respiration does not exceed the user-specified 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 it to a human patient having a patient connection that can couple the breathing to the patient circuit. Breathing has an inhalation phase with a start and an end. The ventilator device includes a compressor configured to deliver breathing gas to the patient circuit, a patient oxygen outlet couplable to the patient circuit, an oxygen source configured to deliver oxygen to the patient circuit, and a control system configured to (a) enable oxygen to flow from the oxygen source to the patient circuit at or before the start of the inhalation phase of breathing, (b) prevent oxygen from flowing from the oxygen source to the patient circuit before the end of the inhalation phase of breathing, and (c) cause the compressor to deliver breathing gas to the patient circuit before the end of the inhalation phase of breathing. Optionally, the ventilator device may include an input configured to receive a user-specified total tidal volume. In such an embodiment, the breathing gas delivered to the patient circuit for breathing has a first volume, the oxygen enabled to flow to the patient circuit for breathing has a second volume, and the combined first and second volumes are substantially equal to the user-specified total tidal volume. Optionally, the ventilator device may include an input configured to receive a user-specified peak inspiratory pressure value. In such an embodiment, the combined pressure of the breathing gas delivered to the patient circuit and the oxygen enabled to flow to the patient circuit for breathing does not exceed the user-specified peak inspiratory pressure value.

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

[0024] Optionally, the compressor and the ventilator connection portion can be components of a ventilator, and the oxygen source can 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 includes an external oxygen source in fluid communication with the oxygen inlet and can 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, and the oxygen generator delivers oxygen to the oxygen source. Each of the compressor, the oxygen source, and the oxygen generator can be components of a ventilator. Alternatively, each of the compressor and the oxygen source is a component 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-specified total one-time ventilation volume. The user interface is configured to provide the user-specified total one-time ventilation 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 breathing has a first volume, the oxygen delivered for breathing has a second volume, and the combined first and second volumes are substantially equal to the user-specified total one-time ventilation volume.

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

[0029] Embodiments include a method of providing breathing to a human patient. The patient has a patient connection that is connected to a ventilator having a first ventilator connection and a different second ventilator connection by a patient circuit. Each of the first and second ventilator connections is in fluid communication with the patient circuit. The method includes using the ventilator to identify the start of the inspiratory phase of breathing, delivering a bolus of oxygen to the first ventilator connection before or during the inspiratory phase, and delivering a breathing gas containing 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 a bolus of oxygen at the start of the inspiratory phase of breathing. Optionally, the ventilator may determine the volume of the bolus of oxygen delivered for breathing.

[0030] The method may further include using the ventilator to identify the end of the inspiratory phase of breathing and ending the delivery of the bolus of oxygen before the end of the inspiratory phase. The breathing gas may be delivered after the delivery of the bolus of oxygen has ended.

[0031] The method can be used with a user-specified total single-breath ventilation volume. In such an embodiment, the breathing gas delivered for breathing has a first volume, the bolus of oxygen delivered for breathing has a second volume, and the combined first and second volumes are substantially equal to the user-specified total single-breath ventilation volume.

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

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

[0034] Optionally, one or more second fluid 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 an 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. On the other hand, 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 is configured to (a) open the valve at or before the start of the inspiratory phase of breathing, 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 breathing, thereby preventing oxygen from flowing from the oxygen source to the patient oxygen outlet, and (c) include a control system configured to instruct a compressor to deliver breathing gas before the end of the inspiratory phase of breathing. Optionally, the control system can be configured to instruct the compressor to deliver breathing gas after the valve is closed.

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

[0036] Optionally, the ventilator device includes an input configured to receive a user-specified peak inspiratory pressure value. In such an embodiment, the combined pressure of the breathing gas delivered and the oxygen allowed to flow for breathing does not exceed the user-specified 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 determined at least in part based on the user-selected parameter value flows through the valve.

[0038] The oxygen source can be configured to store oxygen. In such embodiments, 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 the concentration of oxygen stored by the oxygen source and the pressure of the oxygen stored by the oxygen source. In such embodiments, the control system uses the signal to determine whether the amount of oxygen stored by the oxygen source is less than a threshold, and when the control system determines that the amount of oxygen stored by the oxygen source is less than the threshold, the oxygen generator is operated and configured to deliver oxygen to the oxygen source.

[0039] The patient circuit can have a sensor configured to detect the flow rate within the patient circuit and transmit a signal encoding the flow rate. In such embodiments, the control system can be configured to receive the signal from the sensor and use the signal to detect when the patient begins the inspiratory phase.

[0040] Optionally, the ventilator device includes a sensor configured to detect the flow rate within one of the one or more first fluid conduits and transmit a signal encoding the flow rate to the control system. In such embodiments, the control system is configured to use the signal to detect when the patient begins the inspiratory phase.

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

[0042] Embodiments of a pressure swing adsorption oxygen generator for separating oxygen from air for use with a pressure source that generates high and low pressures include an adsorption bed having a nitrogen-absorbing material bed, and a multi-position rotary valve that controls the pressure swing adsorption of the adsorption bed and is connectable to the pressure source to be in fluid communication with the pressure source and in fluid communication with the adsorption bed. The rotary valve includes a cam having first and second rotational positions, and in the first rotational position of the cam, the rotary valve conveys the high pressure generated by the pressure source to the adsorption bed, and in the second rotational position of the cam, the rotary valve conveys the low pressure generated by the pressure source to the adsorption bed.

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

[0044] Optionally, the pressure swing adsorption oxygen generator includes an oxygen storage unit, a first pressure regulator connected to the adsorption bed and connected to the oxygen storage unit, which adjusts the pressure of the adsorption bed to a preselected first pressure in response to the pressure of the adsorption bed rising to the preselected first pressure, and enables the 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, which adjusts the pressure of the adsorption bed to a preselected second pressure that is lower than the preselected first pressure in response to the pressure of the adsorption bed dropping to the preselected second pressure, and enables the oxygen stored in the oxygen storage unit to move through the second pressure regulator to the adsorption bed.

[0045] Optionally, a pressure swing adsorption oxygen generator may be configured such that a first pressure regulator prevents fluid communication through the first pressure regulator between the adsorption bed and the oxygen storage unit when the pressure of the adsorption bed falls below a preselected first pressure, and a second pressure regulator prevents fluid communication through the second pressure regulator between the oxygen storage unit and the adsorption bed when the pressure of the adsorption bed exceeds a preselected second pressure.

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

[0047] Optionally, the pressure source is a compressor, the generated high pressure is a positive pressure, and the generated low pressure 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 for generating high and low pressures includes an adsorption bed having a bed of nitrogen absorbent material, and a multi-position rotary valve coupled to the pressure source for fluid communication therewith and in fluid communication with the adsorption bed for controlling pressure swing adsorption of the adsorption 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. At the first rotational position of the cam, at least one of the valves transmits the high pressure generated by the pressure source to the adsorption bed, and at the second rotational position of the cam, at least one of the valves transmits the low pressure generated by the pressure source to the adsorption bed.

[0049] Optionally, when a pressure swing adsorption oxygen generator is for use with a pressure source that is a compressor that is at high pressure at the output port and at low pressure at the input port, the plurality of valves can include first, second, third, and fourth valves, each having a first port and a second port, which 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. 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 adsorption 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 adsorption bed, and the second port of the third valve is in fluid communication with the compressor input port. The first port of the fourth valve is in fluid communication with the compressor input port, and the 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 state and the second state in a repeated order in response to rotation of a cam, and when the cam is in a 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 a 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 in unison by the cam between the first state and the second state, and the second and fourth valves are moved in unison by the cam between the first state and the second state.

[0051] Optionally, the cam has first and second cam lobes and further has third and fourth rotational positions. When the cam is moved to the first rotational position, the first cam lobe moves the fourth valve to a first state, the second cam lobe moves the second valve to the first state, and the first and third valves are in a second state. When the cam is moved to the second rotational position, the first cam lobe moves the first valve to the first state, the second cam lobe moves the third valve to the first state, and the second and fourth valves are in a second 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 a 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 a 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 that abuts the cam for movement of the push rod in response to rotation of the cam between the rotational positions of the first cam and the second cam, and the poppet member is coupled to the push rod member for movement therewith to seat and unseat the poppet member with respect to the valve seat and to close and open the valve seat opening in response to rotation of the cam.

[0053] Furthermore, each of the valves may further include a housing with an end that opens toward the cam, and the poppet member and valve seat are positioned within the housing together with a push rod extending through the housing end opening, and each of the valves further includes a flexible diaphragm having an opening positioned between the valve seat and the cam and 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 to move with the push rod. 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 cancel out the force on the push rod resulting from the pressure in the chamber between the valve seat and the diaphragm when the poppet valve is in the seated arrangement with the valve seat, thereby reducing the force on the cam follower of the push rod member.

[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 nitrogen absorbent material bed, and a multi-position rotary valve that controls the pressure swing adsorption of the adsorption bed and is 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 first, second, third, and fourth valves. Each valve has a first port and a second port that are in fluid communication with each other in a first state, are 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 the rotational position of the cam. 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 adsorption 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 adsorption bed, and the second port of the third valve is in fluid communication with the compressor input port. The first port of the fourth valve is in fluid communication with the compressor input port, and the second port of the fourth valve is in fluid communication with a source of air from which oxygen is to be separated at the adsorption bed. The first, second, third, and fourth valves are moved between the first state and the second state in a repeated order in response to rotation of the cam. 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 conveyed to the adsorption bed to separate nitrogen from the air and generate oxygen. 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 adsorption bed.

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

[0056] Optionally, the pressure swing adsorption oxygen generator includes an oxygen storage unit and a first pressure regulator connected to the adsorption bed and to the oxygen storage unit, the first pressure regulator being configured to adjust the pressure of the adsorption bed to a preselected first pressure in response to the pressure of the adsorption bed rising to the preselected first pressure, and to enable oxygen generated within 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 to the oxygen storage unit, the second pressure regulator being configured to adjust the pressure of the adsorption bed to a preselected second pressure that is lower than the preselected first pressure in response to the pressure of the adsorption bed dropping to the preselected second pressure, and to enable oxygen stored within the oxygen storage unit to move through the second pressure regulator to the adsorption bed.

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

[0058] In the pressure swing adsorption oxygen generator, during a third period occurring after a second period, the second and fourth valves are in a first state and the first and third valves are in a 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 each other on opposite sides of a cam, and the second and fourth valves are positioned opposite each other on opposite sides of the cam.

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

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

[0062] Optionally, the sputum evacuation assist valve conveys sufficient positive pressure to the ventilator connection to generate a patient airway pressure of 10 to 70 cmH2O. When the sputum evacuation assist valve is in a second state for the forced exhalation phase of sputum evacuation assistance, the sputum evacuation assist valve conveys sufficient negative pressure to the ventilator connection to generate a patient airway pressure of -10 to -70 cmH2O.

[0063] In another embodiment of a ventilator with integrated sputum evacuation assistance for use with a patient circuit in fluid communication with the patient's patient connection, the ventilator is operable in a ventilation mode and a sputum evacuation assistance mode. In the sputum evacuation assistance mode, a controller controls the operation of the ventilator to provide at least one sputum evacuation assistance having an inspiratory phase followed by a forced exhalation phase to the patient, a ventilator connection to which the patient circuit can be connected for fluid communication therewith, a ventilator subsystem that directs the flow of ventilation air toward 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 being operable to accelerate a gaseous fluid input at the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet. The ventilator further includes a sputum evacuation assist valve that is in a first state for the inspiratory phase of sputum evacuation assistance and is then moved to a second state for the forced exhalation phase of sputum evacuation assistance. When the sputum evacuation assist valve is in the first state for the inspiratory phase of sputum evacuation assistance, the sputum evacuation assist valve directs the flow of air toward the compressor inlet and the accelerated flow of air toward the ventilator connection for delivery to the patient from the compressor outlet. When the sputum evacuation assist valve is in the second state for the forced exhalation phase of sputum evacuation assistance, the sputum evacuation assist valve directs the flow of forced exhalation gas from the patient toward the compressor inlet and exhausts the accelerated flow of forced exhalation gas from the compressor outlet.

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

[0065] Optionally, in the ventilation mode, the ventilator portion causes the flow of ventilation air to be directed to the ventilator connection for delivery to the patient by directing the ventilation air towards the compressor inlet using the sputum aspiration assist valve held for operation in the first state.

[0066] In yet another embodiment of a ventilator with integrated sputum evacuation assistance for use with a patient circuit in fluid communication with a patient connection portion of a patient, the ventilator is operable in a ventilation mode and a sputum evacuation assistance mode, and in the sputum evacuation assistance mode, a controller that controls the operation of the ventilator to provide to the patient at least one sputum evacuation assistance having an inspiratory phase followed by a forced expiratory phase, a ventilator connection portion to which the patient circuit can be connected for fluid communication therewith, a ventilator portion that directs the flow of ventilation air toward the ventilator connection portion for delivery to the patient in the ventilation mode, a compressor having a compressor inlet and a compressor outlet, the compressor being operable to accelerate a gaseous fluid input at the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet, and a sputum evacuation assistance valve that is in a first state for the inspiratory phase of the sputum evacuation assistance and then is moved to a second state for the forced expiratory phase of the sputum evacuation assistance. The sputum evacuation assistance valve includes a first chamber, a second chamber, a third chamber, a valve air intake opening in fluid communication with an air supply source, a valve exhaust outlet opening, an outlet opening from the valve to the compressor in fluid communication with the compressor inlet, an inlet opening from the compressor to the valve in fluid communication with the 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 the ventilator connection portion, 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 sputum evacuation assistance valve is in the first state for the inspiratory phase of the sputum evacuation 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 sputum evacuation assistance valve is in the second state for the forced expiratory phase of the sputum evacuation 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 sputum evacuation assisting valve further includes a valve actuator configured to move the first and second valve members to their first positions for the air supply phase of sputum evacuation assistance and to move the first and second valve members to their second positions for the forced exhaust phase of sputum evacuation assistance.

[0067] Optionally, when the ventilator is in the ventilation mode, the sputum evacuation assisting valve is held for operation in the first state.

[0068] Optionally, the ventilator part directs the flow of ventilation air towards the ventilator connection for delivery to the patient by using the sputum evacuation assisting valve held for operation in the first state to direct the ventilation air towards the compressor inlet in the ventilation mode.

[0069] Optionally, the first and second valve members are attached to a connection member, and the valve actuator is configured to move the connection member to a first position for moving the first and second valve members to their first positions for the air supply phase of sputum evacuation assistance and to a second position for moving the first and second valve members to their second positions for the forced exhaust phase of sputum evacuation assistance.

[0070] Optionally, the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet is attached to the connection member for movement as an integral unit, the other of the electromagnetic coil and the permanent magnet is stationary, and the electromagnetic coil and the permanent magnet interact magnetically when the electromagnetic coil is selectively excited 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 is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. One of the second permanent latch magnet and the second ferromagnetic member portion is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. The first permanent latch magnet is positioned sufficiently close to the first ferromagnetic member portion when the electromagnetic coil is de-energized and the first and second valve members are in their first positions for holding the first and second valve members in their first positions. The second permanent latch magnet is positioned sufficiently close to the second ferromagnetic member portion when the electromagnetic coil is de-energized and the first and second valve members are in their second positions for holding the first and second valve members in their second positions.

[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 is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. The permanent latch magnet is positioned sufficiently close to the ferromagnetic member portion when the electromagnetic coil is de-energized and the first and second valve members are in one of their first and second positions for holding the first and second valve members in such one of their first and second positions.

[0073] Optionally, the valve actuator includes a stationary electromagnetic coil and a movable permanent magnet. The electromagnetic coil is positioned within a stationary coil housing. The connecting member extends through the stationary coil housing. The permanent magnet is positioned within the coil housing. The electromagnetic coil extends around the permanent magnet. The permanent magnet is attached to the connecting member for movement with the connecting member as a unit and is positioned for magnetic interaction with the electromagnetic coil. 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.

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

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

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

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

[0078] Optionally, the connecting member is an elongated shaft having a first end portion extending completely through a second chamber and into the first chamber through a first opening, and a second end portion extending into a third chamber through a second opening. The first valve member is attached to the first end portion of the shaft within the first chamber between the valve air inlet opening and the first opening. The second valve member is attached to the second end portion of the shaft within 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 is attached to the connecting member for movement with the connecting member as an integral unit and is arranged concentrically with the connecting member. The other of the electromagnetic coil and the permanent magnet is stationary. The electromagnetic coil and the permanent magnet interact magnetically 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 array within the valve body, and the connecting member is an elongated shaft having a first end portion that extends completely through the second chamber and extends into the first chamber, and a second end portion that extends 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 a linear alignment, and the connecting member is an elongated shaft that is coaxially aligned with the valve air intake opening, the first opening, the second opening, and the valve exhaust outlet opening. The shaft extends completely through the second chamber. The shaft has a first end portion that extends into the first chamber through the first opening, where the first valve member is attached to the first end portion within the first chamber and is movable with the shaft between the first opening and the valve air intake opening, and a second end portion that extends into the third chamber through the second opening, where the second valve member is attached to the second end portion within the third opening and is movable with the shaft between the valve exhaust outlet opening and the second opening.

[0084] Optionally, the area of the first opening that is closed by the first valve member when the first valve member is in the first position, and the area of the valve exhaust outlet opening that is 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 from the air pressure within the second chamber transmitted from the third opening. Also, the area of the valve air intake opening that is closed by the first valve member when the first valve member is in the second position, and the area of the second opening that is 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 from the air pressure within the second chamber transmitted from the third opening.

[0085] In an additional embodiment of a ventilator with integrated sputum evacuation assistance for use with a patient circuit in fluid communication with a patient connection portion of a patient, the ventilator is operable in a ventilation mode and a sputum evacuation assistance mode, and in the sputum evacuation assistance mode, a controller that controls the operation of the ventilator to provide at least one sputum evacuation assistance having an inspiratory phase followed by a forced expiratory phase to the patient, a ventilator connection portion to which the patient circuit can be connected for fluid communication therewith, a ventilator portion that directs the flow of ventilation air towards the ventilator connection portion for delivery to the patient in the ventilation mode, a compressor having a compressor inlet and a compressor outlet, the compressor being operable to accelerate a gaseous fluid input at the compressor inlet and deliver the accelerated gaseous fluid out from the compressor outlet, and a sputum evacuation assistance valve that is in a first state for the inspiratory phase of the sputum evacuation assistance and is then moved to a second state for the forced expiratory phase of the sputum evacuation assistance. The sputum evacuation assistance valve further includes a valve air inlet in fluid communication with an air supply source, a valve exhaust outlet, an outlet from the valve to the compressor in fluid communication with the compressor input, an inlet from the compressor to the valve 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 a 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 portion. When the sputum evacuation assistance valve is in the first state for the inspiratory phase of the sputum evacuation assistance, the first valve member is in the first position of the first valve member, allowing the flow of air from the air supply source to enter the valve air inlet, flow through the outlet from the valve 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 first position of the second valve member, allowing the flow of accelerated air to enter from the compressor outlet into the inlet from the compressor to the valve and flow through the third opening to the ventilator connection portion for delivery to the patient, while blocking the flow of accelerated air from entering the compressor outlet into the inlet from the compressor to the valve and flowing through the valve exhaust outlet.When the sputum drainage assisting valve is in a second state for the forced exhaust phase of sputum drainage assistance, the first valve member is in a second position of the first valve member, the flow of forced exhaust gas from the patient enters the third opening, flows through the outlet from the valve to the compressor, and enters 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, the second valve member is in a second state of the second valve member, allowing the accelerated flow of forced exhaust gas to enter the inlet from the compressor to the valve and flow through the valve exhaust outlet, while blocking the accelerated flow of forced exhaust gas from entering the inlet from the compressor to the valve and flowing to the third opening. The valve actuator is configured to move the first and second valve members to the first positions of the first and second valve members for the air supply phase of sputum drainage assistance and to move the first and second valve members to the second positions of the first and second valve members for the forced exhaust phase of sputum drainage assistance.

[0086] Embodiments of the secretion trap are for use between a patient connection and a patient circuit. The secretion 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 connection portion and the second connection portion. 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 end portion and the second end portion and sized to capture and hold secretions entering the central portion therein.

[0087] Optionally, the first connection portion has a first cross-sectional area, the second connection portion has a second cross-sectional area, the secretion collection well has a portion extending in its longitudinal direction with at least a third cross-sectional area that is sufficiently larger than the first cross-section of the first connection portion, and is a chamber that captures secretions entering the central portion and holds them within the secretion collection chamber.

[0088] Optionally, the trap includes a drain in fluid communication with the secretion collection well for removal of the secretion trapped and held 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 the suction source for application of a suction force to the secretion collection well for removal of the secretion trapped and held 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 than the second end portion of the secretion collection well.

[0091] Another embodiment of the secretion trap is for use between a patient connection part with a connection part having an internal passage and an expectoration assistance conduit with a connection part having an internal passage. The secretion trap includes a first connection part connectable to the connection part of the patient connection part for fluid communication therewith, the first connection part having an internal passage, a second connection part connectable to the connection part of the expectoration assistance conduit for fluid communication therewith, the second connection part having an internal passage, and a secretion collection chamber located between the first connection part and the second connection part. The secretion collection chamber has a first end portion of the chamber located towards the first connection part and a second end portion of the chamber located towards the second connection part. One of the passage of the first connection part and the passage of the connection part of the patient connection part defines a flow opening for the secretion collection chamber at the first end portion of the chamber, and one of the passage of the second connection part and the passage of the connection part of the expectoration assistance conduit defines a flow opening for the secretion collection chamber at the second end portion of the chamber. The secretion chamber has a well portion sized to capture and hold secretions entering the central portion therein.

[0092] Optionally, the secretion chamber has a longitudinally extending portion with a cross-sectional area sized such that fluid flow with a flow rate entering the secretion chamber through a flow opening at a first end portion of the chamber is sufficiently reduced within the secretion chamber so that the secretion collection chamber captures and holds the secretion carried by the fluid flow.

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

[0094] 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 chamber and a second end portion connectable to the suction source for fluid communication with the suction source for applying a suction force to the secretion collection chamber for removal of the secretion captured and held by the secretion 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 connector with an integrated secretion trap for use with a patient circuit. The patient connector includes a patient breathing conduit portion and a secretion 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 to a patient circuit for fluid communication with the patient circuit. The patient breathing conduit portion and the first end portion of the chamber define a first end flow opening for the secretion collection chamber at the first end portion of the chamber. The secretion chamber has a longitudinally extending portion with a cross-sectional area sized such that fluid flow with a flow rate entering the secretion chamber through the first end flow opening is sufficiently reduced within the secretion chamber so that the secretion collection chamber captures and holds the secretion carried by the fluid flow.

[0097] Optionally, the patient connection portion further includes a drain that is in fluid communication with the secretion collection chamber for removal of the secretion captured and held by the secretion 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 secretion collection chamber and a second end portion connectable to the suction source for fluid communication with the suction source for applying a suction force to the secretion collection chamber for removal of the secretion captured and held by the secretion collection chamber.

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

[0100] Optionally, the patient circuit further includes a drain that is in fluid communication with the secretion collection chamber for removal of the secretion captured and held by the secretion 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 a secretion collection chamber and a second end portion connectable to the suction source for fluid communication with the suction source for applying a suction force to the secretion collection chamber for removal of the secretions captured and held by the secretion collection chamber.

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

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

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

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

[0106] Optionally, when controlling the operation of the ventilator in the sputum clearance aid mode, the controller controls the operation of the ventilator to provide at least one sputum clearance aid to the patient having an inspiratory phase followed by a forced expiratory phase. The ventilator further includes at least one sputum clearance aid valve for transmitting a positive pressure to the ventilator connection portion during at least a portion of the inspiratory phase of the sputum clearance aid and for transmitting a negative pressure to the ventilator connection portion during at least a portion of the forced expiratory phase of the sputum clearance aid.

[0107] Optionally, the ventilator further includes a drain in fluid communication with the secretions collection well for removal of secretions captured and held 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 a secretion collection well and a second end portion connectable to the suction source for applying a suction force to the secretion collection well for removal of the secretions captured and held by the secretion collection well.

[0109] Embodiments of the secretion trap are for use between a patient connection and a patient circuit. The secretion 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 positioned between the first connection portion and the second connection portion 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 secretion trap further includes a secretion collection drain sized and positioned to be in fluid communication with the central portion for removal of secretions entering the central portion.

[0110] The secretion trap can be used with a suction source. In that case, the secretion collection drain can have a first end portion in fluid communication with the central portion and a second end portion connectable to the suction source for applying a suction force to the central portion for removal of secretions entering 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 to be in fluid communication with the patient connection, a second valve body port in fluid communication with the internal chamber and configured to be in fluid communication with the ventilator, a valve body passage in communication with the internal chamber and the ambient air outside the valve body, and a check valve seal positioned to seal the valve body passage to allow flow of gas in the internal chamber to the outside of the valve body through the valve body passage and to prevent flow of ambient air outside the valve body into the internal chamber through the valve body passage.

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

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

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

[0115] Another embodiment of the passive valve is for use as a fixed leak valve with a ventilator by connection to a patient connection portion. 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 to be in fluid communication with the patient connection portion. The second body portion has a second fluid passage extending therethrough, and an outward end portion configured to be in fluid communication with the ventilator. The third body portion has a third fluid passage extending therethrough and is 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 around it, and the chamber has at least one internal opening in fluid communication with the body fluid passage and at least one external opening in fluid communication with the exterior of the body. A seal is included, at least a portion of which is positioned within the chamber, and the seal is movable between a closed position closing at least one internal opening of the chamber when the pressure in the body fluid passage is below a threshold pressure and an open position opening at least one internal opening when the pressure in the body fluid passage exceeds the threshold pressure.

[0116] Optionally, a 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 at least one internal opening in response to the pressure in the body fluid passage exceeding the 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 the closed position to the open position by bending away from at least one internal opening in response to the pressure in the body fluid passage exceeding the threshold pressure.

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

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

[0122] Optionally, the chamber is an annular chamber that extends completely around a 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 portion. The passive valve includes a seal having a seal center opening, first and second body portions, and a chamber. The first body portion has a first fluid passage extending therethrough and an outwardly directed first end portion configured to be in fluid communication with the patient connection portion and an inwardly directed second end portion. The second body portion has a second fluid passage extending therethrough and an outwardly directed first end portion configured to be in fluid communication with the ventilator and an inwardly directed second end portion. The inwardly directed second end portions of the first and second body portions are joined together with the seal positioned therebetween, and the seal center opening is aligned with the first and second fluid passages and defines a body fluid passage extending between the outwardly directed 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 the exterior of the body. The seal is located within the chamber and has a first peripheral portion movable between a closed position closing the at least one internal opening when the pressure within the body fluid passage is below a threshold pressure and an open position opening the at least one internal opening when the pressure within the body fluid passage exceeds the threshold pressure.

[0124] Optionally, the first peripheral portion of the annular 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 the pressure within the body fluid passage exceeding the 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 formed by at least one gap between the inwardly directed second end portions of the joined first and second body portions.

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

[0128] Another embodiment is a ventilator with integrated sputum clearance assistance 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 can be connected for fluid communication therewith, the ventilator portion being operable in a ventilation mode and a sputum clearance assistance mode. The ventilator portion directs the flow of ventilation air towards the ventilator connection for delivery to the patient via the patient circuit when the ventilator is in the ventilation mode, and the ventilation air produces a pressure in the patient circuit that exceeds a threshold pressure. The ventilator further includes a user input for selectively switching the operation of the ventilator from the ventilation mode to the sputum clearance assistance mode without disconnecting the ventilator from the patient, and a controller operable in response to the user input for switching the operation of the ventilator from operation in the ventilation mode to operation in the sputum clearance assistance mode, and in the sputum clearance assistance mode, controlling the operation of the ventilator to provide at least one sputum clearance assistance having an inspiratory phase followed by a forced expiratory phase to the patient. The ventilator also includes a sputum clearance assistance valve that is in a first state for the inspiratory phase of the sputum clearance assistance and is then moved to a second state for the forced expiratory phase of the sputum clearance assistance. When the sputum clearance assistance valve is in the first state for the inspiratory phase of the sputum clearance assistance, the sputum clearance assistance valve transmits a positive pressure to the ventilator connection at a pressure in the patient circuit that exceeds the threshold pressure for delivery to the patient via the patient circuit, and when the sputum clearance assistance valve is in the second state for the forced expiratory phase of the sputum clearance assistance, the sputum clearance assistance valve transmits a negative pressure to the ventilator connection for delivery to the patient via the patient circuit at a pressure in the patient circuit that is below the threshold pressure. 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 configured to be in fluid communication with the internal chamber and in fluid communication with the patient connection, a second valve body port configured to be in fluid communication with the internal chamber and in fluid communication with the ventilator connection, a valve body passage in communication with the internal chamber and the ambient air outside the valve body, and a check valve seal positioned to seal the valve body passage to allow the flow of gas in the internal chamber to the outside of the valve body through the valve body passage and to prevent the flow of ambient air outside the valve body into the internal chamber through the valve body passage.

[0129] Optionally, the valve body passage comprises a passage chamber that at least partially extends around the internal chamber of the valve body, and the valve body comprises a first valve body port having at least two internal openings of the passage chamber that provide fluid communication between the passage chamber and the internal chamber of the valve body, and a second valve body port having at least one external opening of the passage chamber that provides fluid communication between the passage chamber and the exterior of the valve body. The check valve seal is at least partially located within the passage chamber and extends between at least two internal openings of the passage chamber. A portion of the seal is movable between a closed position that closes at least two internal openings of the passage chamber when the pressure within the internal chamber of the valve body is below a threshold pressure, and an open position that opens at least two internal openings of the passage chamber when the pressure within the internal chamber of the valve body exceeds the threshold pressure.

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

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

[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 couplable to the patient to be in fluid communication with at least one lung of the patient, 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 to be in fluid communication with the fluid passageway of the patient interface, a second valve body port in fluid communication with the internal chamber and configured to be in fluid communication with the ventilator, a valve body passage in communication with the internal chamber and the ambient air external to the valve body, and a check valve seal positioned to seal the valve body passage to allow flow of gas in the internal chamber to the exterior of the valve body through the valve body passage and to prevent flow of ambient air external to the valve body into the internal chamber through the valve body passage.

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

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

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

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

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

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

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

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

[0141] Another embodiment of the active expiratory valve is for use with a patient connection portion and a ventilator having a pressure source that can be used to control the operation of the valve and control the flow of patient exhaled gas. The active expiratory valve includes a patient circuit connection port for fluid communication with the ventilator, a patient connection portion port for fluid communication with the patient connection portion, an expiratory gas port in fluid communication with the air outside the valve for removing patient exhaled gas from the valve, a pilot pressure port for fluid communication with the 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 face. The pilot pressure port is configured such that the active pressure applied to the pilot pressure port by the 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, and the pilot pressure port is in fluid communication with the internal bellows chamber.

[0143] Optionally, the inner bellows member has an inner bellows fluid passage extending through the inner bellows member for fluid communication with the patient circuit connection port and the patient connection portion port.

[0144] Optionally, during operation of the expiratory valve, the inner bellows fluid passage is in continuous fluid communication with the patient circuit connection port and the patient connection portion port and is disconnected from fluid communication with the internal bellows chamber between the inner bellows member and the outer bellows member.

[0145] Optionally, the inner bellows member has an inner bellows fluid passage extending through the inner bellows member for fluid communication with the patient circuit connection port and the patient connection portion port.

[0146] Yet another embodiment of the active expiratory valve is for use with a ventilator to control the operation of the valve and the flow of patient expiratory gas. The active expiratory valve includes a patient circuit connection port, a patient connection port, an expiratory 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 active pressure applied to the pilot pressure port moves the inner and outer members toward the valve seat, moves the poppet face to engage the valve seat, restricts the flow of patient expiratory gas to the expiratory gas port, and a reduction in the active 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, thereby allowing the flow of patient expiratory gas to the expiratory gas port and thus controlling the flow of patient expiratory gas from the valve.

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

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

[0149] Optionally, during operation of the expiratory valve, 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 bellows member and the outer bellows member.

[0150] Optionally, the inner member has an inner member fluid passageway extending through the inner member to be in continuous fluid communication with the patient circuit connection port and the patient connection port.

[0151] Another embodiment of the active expiratory valve is for use with a patient connection portion and a ventilator having a pressure source that can be used to control the operation of the valve. The active expiratory valve includes a valve body having an internal body chamber that carries therein a gas having a body chamber pressure, a first body port configured to be in fluid communication with the body chamber and in fluid communication with the patient connection portion, a second body port configured to be in fluid communication with the body chamber and in fluid communication with the ventilator, a passage in fluid communication with the 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 includes an outer member, an inner member positioned within the outer member, an internal seal chamber positioned 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 and outer members. The seal member has a first surface portion inside the seal chamber configured for movement of the valve seal toward the closed position in response to a pressure applied thereto by the pressure source, and a second surface portion outside the seal chamber configured for movement of the valve seal toward the open position in response to a pressure applied thereto by the body chamber pressure, and the amount and direction of movement of the valve seal respond to forces resulting from the pressure source and the body chamber pressure applied to the first and second surface portions.

[0152] Optionally, the inner member has an inner member fluid passage extending through the inner member to be 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.

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

[0154] Optionally, the inner member has an inner member fluid passage extending through the inner member and accompanied by a first opening in continuous fluid communication with the first body port and a second opening in continuous fluid communication with the second body port.

[0155] Optionally, the body is positioned outside the valve seal and has a wall portion that defines another chamber positioned outside the valve seal, and the passage is within the wall portion.

[0156] Optionally, the body has a peripheral wall portion that extends circumferentially around the body chamber, is positioned outside the valve seal, and defines an elongated peripheral chamber that at least partially extends around the body chamber, and the passage is within the peripheral wall portion.

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

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

[0159] Optionally, the inner wall extends through it to be in fluid communication with the body chamber and has an inner wall fluid passage 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, during operation of the exhalation valve, the inner wall fluid passage is in continuous fluid communication with the first and second body ports and is disconnected from fluid communication with the seal chamber between the inner and outer walls.

[0161] Optionally, the inner wall has an inner wall fluid passage extending through the inner wall and is accompanied by a first opening in continuous fluid communication with the first body port and a second opening in continuous fluid communication with the second body port.

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

[0163] The final embodiment of the active expiratory valve is for use with a patient connection portion and a ventilator having a pressure source that can be used to control the operation of the valve. The active expiratory valve includes an internal body chamber that carries gas having a body chamber pressure therein, a channel therein for fluid communication with the pressure source, and a valve body having 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 portion; 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 the body chamber and the ambient air outside 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-apart ends and an outer longitudinally extensible wall and an inner longitudinally extensible 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 closed position of the valve seal where the outer and inner walls are in a longitudinally expanded configuration and an open position of the valve seal where the outer and inner walls are in a longitudinally retracted configuration. The valve seal is moved toward the closed position in response to the pressure applied by the pressure source and is moved toward the open position in response to the pressure applied by the body chamber pressure, and the amount and direction of movement of the valve seal respond to the forces resulting from the pressure source and the body chamber pressure.

[0164] Optionally, the inner wall has an inner wall fluid passage that extends therethrough for fluid communication with the body chamber and has 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 passage is in continuous fluid communication with the first and second body ports during operation of the expiratory valve and is out of fluid communication with the seal chamber between the inner and outer walls.

[0166] Optionally, the inner wall has an inner wall fluid passage extending through the inner wall and includes a first opening in continuous fluid communication with the first body port and a second opening in continuous fluid communication with the second body port. For example, the present application provides the following items. (Item 1) A ventilator with integrated sputum evacuation assistance, the ventilator being for use with a patient circuit in fluid communication with a patient connection portion of a patient, the ventilator being operable in a ventilation mode and a sputum evacuation assistance mode, the ventilator A ventilator connection portion, wherein the patient circuit is connectable to the ventilator connection portion for fluid communication therewith, and In the ventilation mode, a ventilator portion that directs a flow of ventilation air toward the ventilator connection portion for delivery to the patient, and A user input for selectively switching the operation of the ventilator from the ventilation mode to the sputum evacuation assistance mode without disconnecting the ventilator from the patient, and A controller operable in response to the user input for switching the operation of the ventilator from operation in the ventilation mode to operation in the sputum evacuation assistance mode, the controller controlling the operation of the ventilator to provide at least one sputum evacuation assistance having an inspiratory phase followed by a forced expiratory phase to the patient in the sputum evacuation assistance mode, and A sputum evacuation assistance valve that is in a first state for the inspiratory phase of the sputum evacuation assistance and is then moved to a second state for the forced expiratory phase of the sputum evacuation assistance, wherein when the sputum evacuation assistance valve is in the first state for the inspiratory phase of the sputum evacuation assistance, the sputum evacuation assistance valve transmits a positive pressure to the ventilator connection portion, and when the sputum evacuation assistance valve is in the second state for the forced expiratory phase of the sputum evacuation assistance, the sputum evacuation assistance valve transmits a negative pressure to the ventilator connection portion, and A ventilator comprising the above. (Item 2) The sputum evacuation assisting valve transmits a positive pressure sufficient to generate a patient airway pressure of 10 to 70 cmH2O to the ventilator connection part, and when the sputum evacuation assisting valve is in the second state for the forced exhaust phase of the sputum evacuation assistance, the sputum evacuation assisting valve transmits a negative pressure sufficient to generate a patient airway pressure of -10 to -70 cmH2O to the ventilator connection part. The ventilator according to item 1. (Item 3) A ventilator with integrated sputum evacuation assistance, the ventilator being for use with a patient circuit in fluid communication with a patient connection part of a patient, the ventilator being operable in a ventilation mode and a sputum evacuation assistance mode, the ventilator In the sputum evacuation assistance mode, a controller that controls the operation of the ventilator to provide at least one sputum evacuation assistance to the patient having an inspiratory phase followed by a forced expiratory phase A ventilator connection part, the patient circuit being connectable to the ventilator connection part for fluid communication with the ventilator connection part In the ventilation mode, a ventilator subsystem that directs the flow of ventilation air towards the ventilator connection part for delivery to the patient A compressor having a compressor inlet and a compressor outlet, the compressor being operable to accelerate a gaseous fluid input to the compressor inlet and deliver the accelerated gaseous fluid out of the compressor outlet A sputum evacuation assistance valve that is in a first state for the inspiratory phase of the sputum evacuation assistance and is then moved to a second state for the forced exhalation phase of the sputum evacuation assistance. When the sputum evacuation assistance valve is in the first state for the inspiratory phase of the sputum evacuation assistance, the sputum evacuation assistance valve directs the flow of air toward the compressor inlet and directs the accelerated air flow from the compressor outlet toward the patient connection part for delivery to the patient. When the sputum evacuation assistance valve is in the second state for the forced exhalation phase of the sputum evacuation assistance, the sputum evacuation assistance valve directs the flow of forced exhalation gas from the patient toward the compressor inlet and exhausts the accelerated forced exhalation gas flow from the compressor outlet, and a sputum evacuation assistance valve A ventilator equipped with (Item 4) The ventilator according to item 3, wherein when the ventilator is in the ventilation mode, the sputum evacuation assistance valve is held for operation in the first state. (Item 5) The ventilator according to item 3, wherein in the ventilation mode, the ventilator part directs the flow of ventilation air toward the artificial respiratory connection part for delivery to the patient by using the sputum evacuation assistance valve held for operation in the first state to direct the flow of ventilation air toward the compressor inlet. (Item 6) A ventilator with integrated sputum evacuation assistance, the ventilator being for use with a patient circuit in fluid communication with a patient connection part of a patient, the ventilator being operable in a ventilation mode and a sputum evacuation assistance mode, the ventilator In the sputum evacuation assistance mode, a controller that controls the operation of the ventilator to provide at least one sputum evacuation assistance having an inspiratory phase followed by a forced exhalation phase to the patient; An artificial respiratory connection part, wherein the patient circuit is connectable to the artificial respiratory connection part for fluid communication with the artificial respiratory connection part; In the ventilation mode, an artificial respiratory part that directs the flow of ventilation air toward the artificial respiratory connection part for delivery to the patient; A compressor having a compressor inlet and a compressor outlet, the compressor being operable to accelerate a gaseous fluid input at the compressor inlet and deliver the accelerated gaseous fluid out from the compressor outlet, a compressor; A sputum evacuation assistance valve that is in a first state for the air supply phase of the sputum evacuation assistance and is then moved to a second state for the forced exhaust phase of the sputum evacuation assistance; Comprising; The sputum evacuation assistance valve; A first chamber; A second chamber; A third chamber; A valve air intake opening in fluid communication with an air supply source; A valve exhaust outlet opening; An outlet opening from the valve in fluid communication with the compressor input to the compressor; An inlet opening from the compressor in fluid communication with the compressor output to the valve; 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 the ventilator connection part; 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 sputum evacuation assistance valve is in the first state for the air supply phase of the sputum evacuation 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; When the sputum evacuation assistance valve is in the second state for the forced exhaust phase of the sputum evacuation 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. a second valve member, a valve actuator configured to move the first and second valve members to their first positions for the air supply phase of the sputum evacuation assistance and to move the first and second valve members to their second positions for the forced exhaust phase of the sputum evacuation assistance, and a ventilator comprising the same. (Item 7) The ventilator according to item 6, wherein when the ventilator is in the ventilation mode, the sputum evacuation assistance valve is held for operation in the first state. (Item 8) The ventilator according to item 6, wherein in the ventilation mode, the ventilator part causes the ventilation air to flow toward the artificial respiratory connection part for delivery to the patient by directing the ventilation air toward the compressor inlet using the sputum evacuation assistance valve held for operation in the first state. (Item 9) The ventilator according to item 6, wherein the first and second valve members are attached to a connection member, and the valve actuator moves the connection member to a first position for moving the first and second valve members to their first positions for the air supply phase of the sputum evacuation assistance and to a second position for moving the first and second valve members to their second positions for the forced exhaust phase of the sputum evacuation assistance. (Item 10) The ventilator according to item 9, wherein the valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet is attached to the connection member for movement with the connection member as a unit, the other of the electromagnetic coil and the permanent magnet is stationary, and the electromagnetic coil and the permanent magnet magnetically interact when the electromagnetic coil is selectively excited to move the first and second valve members between their first and second positions. (Item 11) It further includes a first and a second permanent latching magnet, and first and second ferromagnetic member portions. One of the first permanent latching magnet and the first ferromagnetic member portion is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. One of the second permanent latching magnet and the second ferromagnetic member portion is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. The first permanent latching magnet is positioned sufficiently close 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. The second permanent latching magnet is positioned sufficiently close 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. The ventilator according to item 10. (Item 12) It further includes a permanent latching magnet and a ferromagnetic member portion. One of the permanent latching magnet and the ferromagnetic member portion is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. The permanent latching magnet is positioned sufficiently close 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. The ventilator according to item 10. (Item 13) The valve actuator includes a stationary electromagnetic coil and a movable permanent magnet. The electromagnetic coil is positioned within a stationary coil housing. The connecting member extends through the stationary coil housing. The permanent magnet is positioned within the coil housing. The electromagnetic coil extends around the permanent magnet. The permanent magnet is attached to the connecting member for movement with the connecting member as a unit and is positioned for magnetic interaction with the electromagnetic coil. The electromagnetic coil and the permanent magnet magnetically interact when the electromagnetic coil is selectively excited to move the first and second valve members between their first and second positions, the ventilator according to item 9. (Item 14) It 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 is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. One of the second permanent latch magnet and the second ferromagnetic member portion is attached to the connecting member for movement with the connecting member as a unit, and the other is stationary. The first permanent latch magnet is positioned sufficiently close 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. The second permanent latch magnet is positioned sufficiently close 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, the ventilator according to claim 13. (Item 15) First and second permanent latch magnets attached to the connecting member within the coil housing for moving integrally with the connecting member, and first and second ferromagnetic member portions, wherein the first permanent latch magnet is positioned sufficiently close 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 is positioned sufficiently close 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. The ventilator according to claim 13. (Item 16) 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. The ventilator according to item 15. (Item 17) A permanent latch magnet attached to the connecting member within the coil housing for moving integrally with the connecting member, and a ferromagnetic member portion, wherein the permanent latch magnet is positioned sufficiently close 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. The ventilator according to claim 13. (Item 18) The connecting member is an elongated shaft that extends completely through the second chamber, the elongated shaft having a first end portion that extends into the first chamber through the first opening and a second end portion that extends into the third chamber through the second opening, the first valve member being attached to the first end portion of the shaft within the first chamber between the valve air inlet opening and the first opening, and the second valve member being attached to the second end portion of the shaft within the third chamber between the valve exhaust outlet opening and the second opening. The ventilator according to item 9. (Item 19) The valve actuator includes an electromagnetic coil and a permanent magnet, one of the electromagnetic coil and the permanent magnet being attached to the connecting member for movement with the connecting member as an integral unit and arranged concentrically with the connecting member, 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 excited to move the first and second valve members between their first and second positions. The ventilator according to item 9. (Item 20) The other of the electromagnetic coil and the permanent magnet is arranged concentrically with the connecting member. The ventilator according to item 19. (Item 21) The first, second, and third chambers are within the valve body. The ventilator according to item 6. (Item 22) The first, second, and third chambers are in a linear arrangement within the valve body, the connecting member being an elongated shaft that extends completely through the second chamber, the elongated shaft having a first end portion that extends into the first chamber and a second end portion that extends into the third chamber. The ventilator according to item 21. (Item 23) 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 elongated shaft that is coaxially aligned with the valve air intake opening, the first opening, the second opening, and the valve exhaust outlet opening. The shaft extends completely through the second chamber, and the shaft has a first end portion that extends into the first chamber through the first opening. The first valve member is attached to the first end portion within the first chamber and is movable with the shaft between the first opening and the valve air intake opening. The shaft also has a second end portion that extends into the third chamber through the second opening. The second valve member is attached to the second end portion within the third opening and is movable with the shaft between the valve exhaust outlet opening and the second opening. The ventilator according to item 6, having the second end portion. (Item 24) The area of the first opening that is closed by the first valve member when the first valve member is in the first position and the area of the valve exhaust outlet opening that is closed by the second valve member when the second valve member is in the first position are substantially equal and are sized to produce oppositely directed forces on the first and second valve members. The forces result from the air pressure within the second chamber transmitted from the third opening. The area of the valve air intake opening that is closed by the first valve member when the first valve member is in the second position and the area of the second opening that is closed by the second valve member when the second valve member is in the second position are substantially equal and are sized to produce oppositely directed forces on the first and second valve members. The forces result from the air pressure within the second chamber transmitted from the third opening. The ventilator according to item 6. (Item 25) A ventilator with integrated sputum clearance assistance, said ventilator being for use with a patient circuit in fluid communication with a patient connection part of a patient, said ventilator being operable in a ventilation mode and a sputum clearance assistance mode, said ventilator a controller for controlling the operation of the ventilator to provide to the patient at least one sputum clearance assistance having an inspiratory phase followed by a forced expiratory phase in the sputum clearance assistance mode, a ventilator connection part, wherein the patient circuit is connectable to the ventilator connection part for fluid communication therewith, a ventilator part for directing a flow of ventilation air towards the ventilator connection part for delivery to the patient in the ventilation mode, a compressor having a compressor inlet and a compressor outlet, said compressor being operable to accelerate a gaseous fluid input at the compressor inlet and deliver the accelerated gaseous fluid out from the compressor outlet, a sputum clearance assistance valve in a first state for the inspiratory phase of the sputum clearance assistance and then moved to a second state for the forced expiratory phase of the sputum clearance assistance comprising, said sputum clearance assistance valve 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, an inlet from the compressor to the valve in fluid communication with the compressor output, a first valve member, said first valve member being movable between a first position of the first valve member and a second position of the first valve member, a second valve member, said second valve member being movable between a first position of the second valve member and a second position of the second valve member, a third opening in fluid communication with the ventilator connection part, When the sputum evacuation assisting valve is in the first state for the air supply phase of the sputum evacuation assistance, the first valve member is in the first position of the first valve member, and the flow of air from the air supply source enters the valve air intake, flows through the outlet from the valve to the compressor, and can enter the compressor inlet. On the other hand, the flow of air is blocked from entering the valve air intake and flowing directly into the third opening. The second valve member is in the first position of the second valve member, and the accelerated air flow from the compressor outlet enters the inlet from the compressor to the valve, and for delivery to the patient, can flow through the third opening for flow to the ventilator connection portion. On the other hand, the accelerated air flow from the compressor outlet is blocked from entering the inlet from the compressor to the valve and flowing through the valve exhaust outlet. When the sputum evacuation assisting valve is in the second state for the forced exhaust phase of the sputum evacuation assistance, the first valve member is in the second position of the first valve member, and the flow of forced exhaust gas from the patient enters the third opening, flows through the outlet from the valve to the compressor, and can enter the compressor inlet. On the other hand, the flow of forced exhaust gas from the patient is blocked from entering the third opening and flowing through the valve air intake. The second valve member is in the second state of the second valve member, and the accelerated flow of forced exhaust gas enters the inlet from the compressor to the valve and can flow through the valve exhaust outlet. On the other hand, the accelerated flow of forced exhaust gas is blocked from entering the inlet from the compressor to the valve and flowing into the third opening. A third opening, and A valve actuator configured to move the first and second valve members to the first positions of the first and second valve members for the air supply phase of the sputum evacuation assistance and to move the first and second valve members to the second positions of the first and second valve members for the forced exhaust phase of the sputum evacuation assistance A ventilator comprising the same.

Brief Description of the Drawings

[0167]

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DETAILED DESCRIPTION OF THE INVENTION

[0168] The same reference numerals 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 sputum clearance assist functionality for use by a patient 102. The ventilator 100 can be configured to provide both conventional volume control ventilation and pressure control ventilation. The ventilator 100 has a discretionary multi-lumen tube connection 103, a main ventilator connection 104, and a patient oxygen outlet 105. The patient 102 has a patient connection 106 (e.g., a tracheal tube, a nasal mask, a mouthpiece, etc.) that can be connected to the main ventilator connection 104 and / or the patient oxygen outlet 105 by a patient circuit 110.

[0170] As described below, the patient circuit 110 can 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 can include one or more ports 111 configured to be connected to the discretionary multi-lumen tube connection 103. The port 111 allows one or more pressure signals 109 to flow between the discretionary multi-lumen tube connection 103 and the patient circuit 110. As will be apparent to those skilled in the art, the pressure signal can be characterized as a gas obtained from a fluid (and / or gas) source where the pressure is to be measured. The resulting gas is at the same pressure as the fluid (and / or gas) source.

[0171] The main ventilator connection 104 is configured to provide a gas 112 that optionally includes room air 114 mixed with oxygen. Although identified as "room air," those skilled in the art will understand that the room air 114 can include air obtained from any source outside the ventilator 100. The gas 112 can be used as an inspiratory gas (in the inspiratory phase of respiration) or a delivery gas used in the expiratory phase of sputum clearance. The main ventilator connection 104 is configured to receive a gas 113 that can include the forced exhalation gas exhaled by the patient 102 during the forced exhalation phase of sputum clearance.

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

[0173] The patient oxygen outlet 105 is configured to provide a dose or pulse of oxygen 140 synchronized with the patient's breathing to the patient connection 106 (via the patient circuit 110). Unlike the gas 112 provided by the main ventilator connection 104, the pulse of oxygen 140 does not contain air 114.

[0174] Pulses of the gas 112 and / or oxygen 140 delivered to the patient circuit 110 are thereby transmitted, at least in part, as inspiratory or insufflation gas 108, to the patient connection 106 that conveys those gases into the patient's lungs 142. During the expiratory phase of breathing or the forced exhalation phase of sputum expectoration, with each exhalation by the patient, the exhaled gas 107 enters the patient circuit 110 via the patient connection 106. Thus, the patient circuit 110 can include one or more of the following gases: the gas 112 provided by the ventilator 100, the pulse of oxygen 140, and the exhaled gas 107. For ease of illustration, the gas inside the patient circuit 110 will hereinafter be referred to as "patient gas".

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

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

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

[0178] The ventilator 100 may be portable and configured to be 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) Figure 2A is an illustration of a first embodiment of a passive patient circuit 170 that can be used to implement the patient circuit 110. Referring to Figure 2A, the passive patient circuit 170 has a first end portion 172 and, opposite thereto, a second end portion 174. The first end portion 172 is configured to be connected or coupled to the main ventilator connection 104 (e.g., directly or using a hose, fluid line, conduit, or tube). The second end portion 174 is configured to be connected or coupled to the patient connection 106 (e.g., directly or using a hose, fluid line, conduit, or tube). Optionally, a secretion trap 1250 (described below with respect to Figures 27-29) can 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 main ventilator connection 104 into the patient connection 106 (optionally via the secretion trap 1250 illustrated 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 can be positioned between the first end portion 172 and the flexible tubing section 178. Gas 112 can flow over the patient connection 106 through the optional bacterial filter 176. When present, the bacterial filter 176 serves to prevent bacteria (e.g., received from the patient connection 106) from entering the ventilator 100 (via the main ventilator connection 104).

[0181] The leak valve 177 is coupled to the flexible tubing section 178 in the vicinity of 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 can be implemented as a conventional fixed leak valve configured to allow a threshold amount of the maximum pressure inside the passive patient circuit 170 in both the inhalation and exhalation phases.

[0182] The leak valve 177 can 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 each time the pressure inside the passive patient circuit 170 exceeds a threshold amount (e.g., ambient 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 is below the threshold amount. Thus, the leak valve 177 is closed when the pressure inside the passive patient circuit 170 is below the threshold amount.

[0183] On the other hand, the flap 179 is configured to be pushed outward and away from the outlet opening 180 when the pressure inside the passive patient circuit 170 exceeds a threshold amount (e.g., ambient pressure). Thus, the leak valve 177 is opened when the pressure inside the passive patient circuit 170 exceeds the threshold amount. During normal ventilation, the leak valve 177 is open during both the inhalation and exhalation phases. 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 inhalation and exhalation phases. On the other hand, as described below, during the forced exhalation phase of sputum evacuation, the leak valve 177 is closed. This prevents the patient gas inside the passive patient circuit 170 from flowing from 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] FIG. 2F is an illustration of an alternative embodiment of the first embodiment of the passive patient circuit 170 shown in FIG. 2A, where the leak valve 177 is incorporated into the patient connection portion 106 and the second end portion 174 of the flexible tubing section 178 is connected or coupled there. Alternatively, the leak valve 177 can be constructed as a separate component that is connected or coupled to both the second end portion 174 of the flexible tubing section 178 and the patient connection portion 106.

[0185] Figure 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 oxygen pulse delivery tube 446 with an open end, and a valve assembly 448. The flexible tubing section 444 may be implemented using conventional coiled or expandable ventilation hoses or tubes (e.g., circuit tubing). The flexible tubing section 444 has a first end portion 450 and, opposite thereto, 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, and a first end portion 454 is connected to the main ventilator connection 104 (e.g., directly or using a hose, fluid line, conduit, or tube) and is configured to receive gas 112 (optionally including air 114 mixed with oxygen) from the main ventilator connection 104. 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. The bacterial filter 176 helps prevent bacteria (e.g., received from the patient connection 106) from entering the ventilator 100 (via the main ventilator connection 104).

[0187] The connector housing 452 is coupled to the first end portion 450 of the flexible tubing 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 tubing section 444. The flexible tubing section 444 conveys the gas 112 to the valve assembly 448.

[0188] 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 is connected to the patient oxygen outlet 105 (e.g., directly or using a hose, flow line, conduit, or tube) and has an open free end portion 459 configured to receive a pulse of oxygen 140 therefrom. Inside the connector housing 452, the tube section 458 is connected to the oxygen pulse delivery tube 446 and provides a pulse 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 is coupled to the oxygen pulse delivery tube 446 and has an open free end 462 configured to provide a pulse of oxygen 140 thereto. The tube section 458 extends into the connector housing 452, but the tube section 458 only partially obstructs the flow of gas 112 through the connector housing 452. In other words, the gas 112, if present, passes near or along the tube section 458 and the branch tube 460.

[0189] In the illustrated embodiment, the oxygen pulse delivery tube 446 extends at least partway through the flexible tube section 444 and into the valve assembly 448. Thus, the oxygen pulse delivery tube 446 separates a pulse 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 a pulse of oxygen 140 from the branch tube 460 to the patient connection 106. At the same time, the passive patient circuit 440 conveys gas 112 (optionally including air 114 mixed with oxygen) from the main ventilator connection 104 into the patient connection 106.

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

[0191] Figures 2C - 2E illustrate exemplary 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 portion 106 (see FIG. 2A). Optionally, a secretion trap 1250 (see FIGS. 27 and 28) can be coupled between the first valve housing 468 and the patient connection portion 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 the ring-shaped leaf 470 positioned therebetween. The 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 to connect the chamber 474 to the 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 the patient gas inside the passive patient circuit 440 (see FIG. 2B) to the chamber 474.

[0193] As shown in 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 the pressure inside the passive patient circuit 440 (see FIG. 2B) exceeds a threshold amount (e.g., ambient 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 separates 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 one or more openings 478, allowing the chamber 474 to communicate with the patient gas inside and outside the passive patient circuit 440 (see FIG. 2B). Thus, gas can exit from inside the passive patient circuit 440 (see FIG. 2B) through the opening 478, the chamber 474, and the opening 476.

[0194] During the inhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a preset inhalation pressure, which positions or maintains the peripheral portion 473 of the leaf 470 in the open position, and the peripheral portion 473 of the leaf remains unblocked from the opening 478. 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 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 positions or maintains the peripheral portion 473 of the leaf 470 in the open position. A portion of the exhaled gas 107 (see FIG. 1) flows out through the opening 476 from the patient 102, and a portion of the exhaled gas 107 flows into the passive patient circuit 440 (e.g., into the flexible tubing section 444).

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

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

[0198] The combined area of the opening 476 can be characterized as providing a fixed orifice. Thus, the valve assembly 448 can be characterized as a one-way valve with a fixed orifice. If the combined area of the opening 476 is too large, most of the inhalation flow will leak through the opening 476 and little will remain for the patient 102. Conversely, if the combined area of the opening 476 is too small, the exhaled 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 can be configured to leak at about 20 - 50 liters per minute ("LPM") when the pressure inside the passive patient circuit 440 is about 10 centimeters of water column ("cmH2O").

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

[0200] In the illustrated embodiment, valve assembly 1448 includes a first valve housing 1468, a second valve housing 1469, and a flexible ring-shaped leaf 1470. As shown in FIGS. 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] Referring to FIG. 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 its first end portion 1480 and second end portion 1482. The first end portion 1480 is configured to be coupled to a 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 a second valve housing 1469 (see FIGS. 30 - 31C and 33). The second end portion 1482 includes an inner wall 1486 that extends in a ring - shaped longitudinal direction positioned along a channel 1484, and the inner wall 1486 defines a part of the channel 1484. The second end portion 1482 includes a first wall portion 1488 that extends radially outward from the inner wall 1486 and terminates in an outer wall 1489 that extends in a ring - shaped longitudinal direction. The outer wall 1489 is concentric with the inner wall 1486 and is spaced from the inner wall 1486 by the first wall portion 1488. The distal edge portion 1487 of the inner wall 1486 abuts against a leaf 1470 (see FIGS. 30 - 31C), presses the leaf 1470 against the second valve housing 1469 (see FIGS. 30 - 31C and 33), and is configured 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. In the vicinity of where the outer wall 1489 terminates the first wall portion 1488, the outer wall 1489 has a ring - shaped groove 1490 formed along the inner surface of the outer wall 1489 that faces towards the inner wall 1486. The outer wall 1489 has a longitudinally extending notch or keyway 1491 formed therein.

[0203] Referring to FIG. 33, in the illustrated embodiment, the second valve housing 1469 has a first end portion 1420 and, opposite thereto, a second end portion 1422. A through - channel 1424 with an open end extends through the second valve housing 1469 between its first end portion 1420 and its second end portion 1422. The second end portion 1422 of the second valve housing 1469 is configured to be coupled to a second end portion 451 (see FIG. 2B) of a 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 second wall portion 1428 that extends radially outwardly 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 inside a ring - shaped groove 1490 (see FIG. 32) formed within the outer wall 1489 (see FIG. 32) of the first valve housing 1468 (see FIGS. 30 - 32). The 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 that is configured to be received inside a keyway 1491 (see FIG. 32) formed within the 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 inside 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 protrusions 1434A - 1434D that are configured to be received inside a central through - hole 1436 (see FIG. 30) formed within a leaf 1470 (see FIGS. 30 - 31B). Referring to FIG. 31C, the leaf positioning protrusions 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 protrusions 1434A - 1434D extend into a channel 1484 (see FIG. 32) along the inner wall 1486 (see FIG. 32).

[0206] Referring to FIGS. 31A - 31C, the peripheral portion 1473 of the leaf 1470 is positioned within a ring - shaped chamber 1474 defined by the first and second valve housings 1468, 1469. Referring 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) 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, referring to FIGS. 31A and 31B, the opening 1476 is 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 is positioned between the tabs 1430A - 1430D (see FIG. 33).

[0208] One or more openings 1476 connect the chamber 1474 to the environment outside the passive patient circuit 440 (see FIG. 2B). In addition, one or more openings 1478 are formed within the second valve housing 1469 to connect the patient gas inside the passive patient circuit 440 (see FIG. 2B) to the chamber 1474. Referring to FIG. 33, 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] Referring to FIGS. 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., ambient 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 separating 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 FIG. 31B, the leaf 1470 no longer blocks one or more openings 1478, allowing the chamber 1474 to communicate with the patient gas inside the passive patient circuit 440 (see FIG. 2B). Thus, gas can exit from inside the passive patient circuit 440 (see FIG. 2B) through the opening 1478, the chamber 1474, and the opening 1476.

[0210] As described above, during the inhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to achieve a preset inhalation pressure, which positions or maintains the peripheral portion 1473 of the leaf 1470 in the 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 positions or maintains the peripheral portion 1473 of the leaf 1470 in the open position (see FIG. 31B). A portion of the exhaled gas 107 from the patient 102 (see FIG. 1) flows out through the opening 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 a pause between the end of the exhalation phase and the start of the inhalation phase, the ventilator 100 adjusts the pressure inside the passive patient circuit 440 to PEEP, which positions or maintains the peripheral portion 1473 of the leaf 1470 in the open position (see FIG. 31B), allowing the flow of gas 112 from the ventilator 100 to flow through the opening 1476 from the passive patient circuit 440. During this time, at least a portion of the exhaled gas 107 that was caused to flow into the passive patient circuit 440 during the exhalation phase is "purged" through the opening 1476 by the forward moving flow of gas 112 from the ventilator 100.

[0213] The combined area of the openings 1476 can be characterized as providing a fixed orifice. Thus, the valve assembly 1448 can be characterized as a one-way valve with a fixed orifice. If the combined area of the openings 1476 is 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 area of the openings 1476 is too small, the exhaled 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 can be configured to leak approximately 20 - 50 LPM when the pressure inside the passive patient circuit 440 is about 10 cmH2O.

[0214] As described below, during the forced exhalation phase for sputum removal, 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 the valve assembly 1448 (instead of the valve assembly 448), the peripheral portion 1473 of the leaf 1470 is positioned in the closed position (see FIGS. 31A and 31C) when the pressure inside the passive patient circuit 440 (see FIG. 2B) is below the threshold amount, which prevents the patient gas inside the passive patient circuit 440 from flowing from 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] Note that the passive valve assembly described herein can be integrated into the patient mask, serving as the patient connection part, within the patient connection part 106, rather than being part of the passive patient circuit 170 or passive patient circuit 440. As described above and as shown in FIG. 1, the patient 102 has a patient connection part 106, which can be a tracheal tube, nasal mask, mouthpiece, etc. that can be connected to the main ventilator connection part 104 and / or the patient oxygen outlet 105 by the patient circuit 110.

[0216] (Active patient circuit) FIG. 3A depicts an active patient circuit 600 that can be used to implement the patient circuit 110 (see FIG. 1). Referring 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 tube assembly 602, and an active expiratory 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 tubing section 444 and the oxygen pulse delivery tube 446. The connector 442 receives the gases 112 and provides them to the flexible tubing section 444. Further, 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 part 106. As a non-limiting example, the pulses of oxygen 140 can exit the oxygen pulse delivery tube 446 within about 10 centimeters of the patient connection part 106. In the illustrated embodiment, the pulses of oxygen 140 exit the oxygen pulse delivery tube 446 at or near the active expiratory valve assembly 604.

[0218] Optionally, a bacterial filter 176 (see FIG. 2A) can be positioned between the connector 442 and the main ventilator connection portion 104. In such an embodiment, the gas 112 flows through the bacterial filter 176 to the connector 442. When present, the bacterial filter 176 serves to prevent bacteria (e.g., received from the patient connection portion 106) from entering the ventilator 100 (via the main ventilator connection portion 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 can include one or more ports 111 configured to allow one or more pressure signals 109 to flow between an optional multi-lumen tube connection portion 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 longitudinally from each other. Each of the ports 111A - 111C is formed within the active exhalation valve assembly 604. The port 111C is hereinafter referred to as the pilot port 111C.

[0220] FIG. 3B is an exploded perspective view of the 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 the first end portion 620 of the tube section 610 to an optional multi-lumen tube connection portion 103 (see FIG. 3A). The tube section 610 has a second end portion 622 and, opposite thereto, a first end portion 620. The second end portion 622 is connected to the connector member 612. Three separate and continuous channels 626A - 626C with open ends extend longitudinally through the tube section 610.

[0221] The connector member 612 has three connectors 630A - 630C configured to be connected 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 transmits the pressure signal 109C (see FIG. 5A) to and from the pilot port 111C.

[0222] The continuous channels 632A - 632C extend from connectors 630A - 630C to the end portion 634 of the connector member 612, respectively. 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 transmit the separate pressure signals 109A and 109B from ports 111A and 111B, respectively, to an optional multi - lumen tube connection 103. Further, the multi - lumen tube assembly 602 can be used to transmit the pressure signal 109C to and from an optional multi - lumen tube connection 103 to the pilot port 111C.

[0223] Referring to FIG. 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. Ports 111A and 111B are formed within the first valve housing member 640 and extend laterally outward therefrom. The pilot port 111C is formed within the second valve housing member 642 and extends laterally outward therefrom.

[0224] Figures 3E and 3F are enlarged longitudinal sectional views showing a part of the active patient circuit 600 including the active expiratory valve assembly 604, respectively. The oxygen pulse delivery tube 446 is omitted from Figures 3E and 3F. In the illustrated embodiment, the first valve housing member 640 is positioned between ports 111A and 111B and includes an internal obstruction 646 configured to restrict flow through the first valve housing member 640. Further, as shown in Figures 3E and 3F, the interior of the first valve housing member 640 includes a first constricted portion 647A adjacent to the obstruction 646 and port 111A, and a second constricted portion 647B adjacent to the obstruction 646 and port 111B. Thus, the first and second constricted portions 647A, 647B are longitudinally positioned opposite each other with respect to the obstruction 646, and the first constricted portion 647A is closer to the patient connection portion 106 (see Figure 3A) than the second constricted portion 647B. Ports 111A and 111B open into the first and second constricted portions 647A, 647B, respectively.

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

[0226] Referring to FIG. 3C, the first valve housing member 640 has a first end portion 650 configured to be coupled to the patient connection portion 106 (see FIG. 3A). Optionally, a secretion trap 1250 (see FIGS. 27 and 28) can be coupled between the first end portion 650 and the patient connection portion 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. The opening 658 of the pilot port 111C is formed within the bellows connector portion 657 of the second valve housing member 642.

[0227] Referring to FIG. 3D, the double bellows member 644 has a generally ring-shaped outer shape with a centrally located through-channel 660. The double bellows member 644 has a hollow interior 662 and is associated with a ring-shaped open end 664 and an opposite ring-shaped closed end 666 (see FIG. 3C). In the illustrated embodiment, the double bellows member 644 has concertina-like inner and outer side walls 668, 669. The inner side wall 668 extends between the open end 664 and the closed end 666 along the centrally located through-channel 660. The outer side wall 669 extends between the open end 664 and the closed end 666 and is radially outwardly spaced from the inner side wall 668. The hollow interior 662 is defined between the inner side wall 668 and the outer side wall 669. Each of the inner and outer side walls 668, 669 has bellows portions 668A and 669A (see FIG. 3C), respectively, each of which has a wavy longitudinal cross-sectional shape (also referred to as a serpentine or helical tubular shape). In an alternative embodiment, the inner and outer side walls 668, 669 can include a different number of turns that define a single turn or three or more turns.

[0228] The open end 664 is configured to fit over and cover the bellows connector portion 657 of the second valve housing member 642, like a sleeve. 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 bellows portions 668A and 669A (see FIG. 3C) of the inner and outer side walls 668, 669 are respectively positioned adjacent to the bellows connector portion 657 of the second valve housing member 642. Accordingly, the opening 658 of the pilot port 111C communicates with a part of the hollow interior 662 positioned between the bellows portion 668A of the inner side wall 668 and the bellows portion 669A (see FIG. 3C) of the outer side wall 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 the pressure signal 109C inside the double bellows member 644.

[0230] Referring to FIGS. 3E and 3F, as described above, 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 coupled together in that manner, 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 to connect the chamber 670 to the environment outside the active patient circuit 600 (see FIG. 3A). The bellows portions 668A and 669A (see FIG. 3C) of the outer side wall 669 and the peripheral portion 674 of the closed end 666 are positioned inside the chamber 670.

[0231] The double bellows member 644 is constructed from a flexible material (e.g., silicone rubber, etc.). The bellows portions 668A and 669A (see FIG. 3C) of the inner and outer side walls 668, 669 are each configured to contract so as to transition the closed end 666 from the closed position (see FIG. 3E) to the open position (see FIG. 3F). When the bellows portions 668A and 669A (see FIG. 3C) are not compressed, the closed end 666 is in the closed position depicted in FIG. 3E. In this configuration, the closed end 666 of the double bellows member 644 is formed within the first valve housing member 640 and abuts against a ring-shaped valve seat 680 that defines a part of the chamber 670. This seals the chamber 670 from the inside of the active patient circuit 600. On the other hand, when the bellows portions 668A and 669A (see FIG. 3C) are compressed toward the second valve housing member 642, the closed end 666 is in the open position depicted in FIG. 3F. In this configuration, the closed end 666 is spaced from the valve seat 680. This opens the chamber 670 by connecting the chamber 670 to the inside of the active patient circuit 600. Thus, when the closed end 666 of the double bellows member 644 is in the open position, the patient gas inside the active patient circuit 600 can exit therefrom through the chamber 670 and the opening 672 (see FIG. 3C).

[0232] The closed end 666 of the double bellows member 644 is selectively movable between an open position and a closed position by controlling the pressure inside the double bellows member 644 using the pilot port 111C. For example, the closed end 666 of the double bellows member 644 may be placed in the closed position (see FIG. 3E) during inhalation and in the open position during exhalation. In such an embodiment, at the start of inhalation, 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) into the hollow interior 662 of the double bellows member 644. The area of the double bellows member 644 that is exposed to the pressure provided by the patient 102 (see FIG. 1) via the patient connection 106 is less than the area that is exposed to the pressure of the pressure signal 109C, such that even when the two pressures are equal, the closed end 666 of the double bellows member 644 will move to or remain in the closed position relative to the valve seat 680. At the end of inhalation, the pilot port 111C provides a flow of gas (as pressure signal 109C) having a pilot pressure into the hollow interior 662 of the double bellows member 644. The pilot pressure is less than the pressure provided by the patient 102 (see FIG. 1) via the patient connection 106 and moves the closed end 666 of the double bellows member 644 to or leaves it in an open position spaced from the valve seat 680 (see FIG. 3F). Thus, during normal ventilation, the pressure inside the hollow interior 662 of the double bellows member 644 can be alternated between a closed pressure equal to the pressure of the gas 112 (provided to the active patient circuit 600) and an open pressure equal to the pilot pressure. Optionally, the pressure inside the hollow interior 662 of the double bellows member 644 can be adjusted by enabling a flow of gas (in pressure signal 109C) to flow from the hollow interior 662 to the pilot port 111C.

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

[0234] (Ventilator) FIG. 4 is a block diagram illustrating some exemplary components of the ventilator 100. Referring to FIG. 4, in addition to the components discussed with respect to FIG. 1, the 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. Since those skilled in the art are familiar with the conventional monitoring and alarm system 221, 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 that input to the control system 220 in the input information 196. The user interface 200 is also configured to display the output information 198 to the user.

[0236] As described above, referring to FIG. 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 tube connection 103 and the patient circuit 110. Referring to FIG. 3, the optional multi-lumen tube 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 the 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) FIGS. 5A and 5B are schematic diagrams illustrating some exemplary components of the ventilation assembly 190. FIG. 5E is a block diagram illustrating exemplary components of the control system 220, the control signals 192 transmitted by the control system 220 to the exemplary components of the ventilation assembly 190, and the data signals 194 received by the control system 220 from the exemplary components of the ventilation assembly 190.

[0239] Referring to FIGS. 5A and 5B, the ventilation assembly 190 includes a sputum evacuation 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 sputum evacuation assisting 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 converter 212 is omitted from FIGS. 5A and 5B.

[0241] The sputum evacuation assisting 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 sputum evacuation assisting valve 204 and the outlet port 166 is omitted from FIGS. 5A and 5B.

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

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

[0244] FIG. 5C is a schematic enlarged view of the sputum evacuation assisting valve 204 in the first configuration. FIG. 5C illustrates the gas 252 flowing through both the blower 222 and the sputum evacuation assisting valve 204 during the inhalation phase of respiration performed by the ventilator 100 (see FIGS. 1 and 4) or during the air supply phase of the sputum evacuation assisting treatment.

[0245] FIG. 5D is a schematic enlarged view of the sputum evacuation assisting valve 204 in the second configuration. FIG. 5D illustrates the forced exhaust gas 253 flowing through both the blower 222 and the sputum evacuation assisting valve 204 during the forced exhaust phase of the sputum evacuation assisting treatment performed by the ventilator 100 (see FIGS. 1 and 4). For ease of illustration, the ports 275A - 275C (see FIGS. 5A and 5B) are omitted from FIGS. 5C and 5D.

[0246] Referring to FIGS. 5C and 5D, the sputum evacuation assisting 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 portion 104 by a flow line 273. As shown in FIG. 5C, when the sputum evacuation assisting 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. Further, the exhaust outlet 1008 is closed, and both the valve / blower outlet 1002 and the air intake 1006 are disconnected from fluid communication with the opening 1010 except via the blower 222. Thus, the gas 252 can enter into the air intake 1006, pass through a part of the sputum evacuation assisting valve 204, flow from the valve / blower outlet 1002 into the blower 222. The gas 252 exiting from the blower 222 enters into the blower / valve inlet 1004, flows through a part of the sputum evacuation assisting valve 204, and exits from the sputum evacuation assisting valve 204 through the opening 1010. The opening 1010 is connected to the flow line 273, which conveys the gas 252 (see FIG. 5A) to the main ventilator connection portion 104.

[0247] As shown in FIG. 5D, when the sputum evacuation assisting valve 204 is in the second configuration, the air intake port 1006 is closed, and both the blower / valve inlet 1004 and the exhaust outlet 1008 are disconnected from fluid communication with the opening 1010 except via the blower 222. Further, 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 enters into the opening 1010, passes through a part of the sputum evacuation assisting valve 204, and flows from the valve / blower outlet 1002 into the blower 222. The forced exhaust gas 253 exiting from the blower 222 enters into the blower / valve inlet 1004, flows through a part of the sputum evacuation assisting valve 204, and exits from the sputum evacuation assisting valve 204 through the exhaust outlet 1008. The exhaust outlet 1008 is connected to the flow line 215 (see FIGS. 5A and 5B), which conveys the forced exhaust gas 253 (as the exhaust 167 shown in FIGS. 5A and 5B) to the outlet port 166.

[0248] FIGS. 17A and 17B are perspective views of the sputum evacuation assisting valve 204. FIGS. 18A and 18B are cross-sectional views of the sputum evacuation assisting valve 204. FIG. 18A depicts the sputum evacuation assisting valve 204 in the first configuration, and FIG. 18B depicts the sputum evacuation assisting valve 204 in the second configuration.

[0249] Referring to FIG. 17A, the sputum evacuation assisting valve 204 includes a housing 1020 having a generally cylindrical shape. In the illustrated embodiment, the air intake port 1006 is formed within the first open end 1022 of the housing 1020, the exhaust outlet 1008 (see FIG. 17B) is located at the second open end 1024 of the housing 1020, and the second open end 1024 is opposite to the first open end 1022. The valve / blower outlet 1002, the blower / valve inlet 1004, and the opening 1010 (see FIG. 17B) are formed within the side wall 1026 of the housing 1020 extending between its first open end 1022 and second open end 1024.

[0250] The first end cap assembly 1032 can be coupled to the first open end 1022, and the second end cap assembly 1034 can be coupled to the second open end 1024. The first and second end cap assemblies 1032, 1034 are substantially the same as each other. Referring 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 holding member 1042, a seal member 1044 (e.g., an O-ring), and a valve seat member 1046. The seal member 1044 is positioned between the valve seat member 1046 and the holding member 1042. Each of the first and second end cap assemblies 1032, 1034 can be coupled to the housing 1020 by one or more tabs 1048 and one or more fasteners 1049. Referring to FIGS. 17A and 17B, in the illustrated embodiment, the housing 1020 includes mounting portions 1050 that extend outwardly at each of the first and second open ends 1022, 1024 of the housing 1020, each of which is configured to receive one of the fasteners 1049.

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

[0252] Referring to FIG. 19A, the holding member 1042 has a ring-shaped base portion 1052 that defines an opening 1053. The side wall 1054 extends inwardly from the base portion 1052 toward the valve seat member 1046. Each tab 1048 abuts against the base portion 1052 and is configured to avoid obstructing the opening 1053. Thus, a gas (e.g., gas 252 or forced exhaust gas 253) can pass through the opening 1053 that is not obstructed by the tab 1048.

[0253] Referring to FIGS. 19B and 19C, the valve seat member 1046 has a ring-shaped peripheral portion 1056 that defines an opening 1058 therein. The 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 block the opening 1058. Thus, gas (e.g., gas 252 or forced exhaust gas 253) can pass through the opening 1058 around the magnet receiving portion 1060 and the support arms 1061, 1062, and 1063.

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

[0255] Referring to FIG. 19B, in the illustrated embodiment, the peripheral portion 1056 has an annular recessed portion 1076 along the outward-facing side 1071. The recessed portion 1076 is configured to receive at least the free end portions of the inwardly extending side walls 1054 of the seal member 1044 and the retaining member 1042, and the seal member 1044 is sandwiched between the valve seat member 1046 and the retaining member 1042.

[0256] On the side 1071 facing outward, the magnet receiving portion 1060 is configured to receive the magnet 1040 (see FIG. 19A). In the illustrated embodiment, the magnet receiving portion 1060 is implemented as a cylindrical shape with an open end. However, this is not a requirement. Along the side 1070 facing inward (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 a non-limiting example, the magnet 1040 (see FIG. 19A) can be held inside the magnet receiving portion 1060 by friction or an adhesive.

[0257] Referring to FIG. 23A, the first open end 1022 of the housing 1020 has a first inner spiral ramp portion 1092 that extends in an annular shape facing longitudinally outward and is configured to fit with the spiral ramp portion 1074 (see FIG. 19C) of the first end cap assembly 1032 (see FIGS. 17A, 18A, and 18B). The ring-shaped inner valve seat member 1096 is positioned inside the housing 1020 at the radially protruding inner wall 1185 that extends in the circumferential direction and is near the first open end 1022 but facing inward. The inner valve seat member 1096 has an annular protrusion 1097 that extends longitudinally outward and is substantially similar to the inward annular protrusion 1072 (see FIG. 19C).

[0258] Referring to FIG. 19C, the annular protrusion 1072 formed on the side 1070 facing inward of the valve seat member 1046 of the first end cap assembly 1032 functions as the first valve seat "S1" (see FIGS. 18A and 18B). The annular protrusion 1097 inside the housing 1020 at the first open end 1022 functions as the 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 towards each other and face each other.

[0259] Referring to FIG. 23B, the second open end 1024 of the housing 1020 has a second inner spiral lamp portion 1094 that extends annularly and faces outward in the longitudinal direction and is configured to fit with the spiral lamp 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 that extends circumferentially inwardly and is in the vicinity of the second open end 1024. The inner wall 1100 has an annular projection 1102 that extends outwardly in the longitudinal direction and is substantially similar to the annular projection 1072 (see FIG. 19C). The annular projection 1102 within the housing 1020 at the second open end 1024 functions as a third valve seat "S3" (see FIGS. 18A and 18B). As shown in FIGS. 18A and 18B, the third valve seat "S3" is positioned longitudinally inwardly from the second end cap assembly 1034. The annular projection 1072 (see FIG. 19C) of the valve seat member 1046 (see FIG. 19C) of the second end cap assembly 1034 functions as a fourth valve seat "S4". The third and fourth valve seats "S3", "S4" extend toward each other and face each other.

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

[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, the gas 252 entering the air inlet 1006 from the accumulator 202 is directed towards the blower 222 through the valve / blower outlet 1002. The gas 252 is then blown by the blower 222 into the blower / valve inlet 1004 and exits from the sputum evacuation assist valve 204 through the opening 1010 to the main ventilator connection portion 104.

[0262] As shown in FIG. 18B, when the first poppet valve assembly 1112 is pressed against the first valve seat "S1", the sputum evacuation assist valve 204 is in the second configuration illustrated in FIGS. 5B and 5D. In the second configuration, the first poppet valve assembly 1112 exits through the valve / blower outlet 1002 and enters the blower 222, allowing the flow of the forced exhaust gas 253 from the main ventilator connection portion 104 to flow through the opening 1010 into the second chamber and then through the first opening into the first chamber, while blocking the flow of the forced exhaust gas to the air inlet 1006 and also preventing the 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 the forced exhaust gas 253 through the second opening into the second chamber and to the opening 1010. In this configuration, the forced exhaust gas 253 entering the opening 1010 from the main ventilator connection portion 104 passes through the first chamber and is directed towards 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 from the sputum evacuation assist 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 the shaft 1116 and move together integrally with the shaft 1116. Referring to FIG. 22, in the illustrated embodiment, a guide member 1120 (e.g., a pin, a dowel, etc.) extends laterally outward from the shaft 1116. The shaft 1116 may include one or more circumferentially extending grooves 1122 and 1124 configured to receive respective different retaining rings 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) where the sputum evacuation assist valve 204 is in the first configuration and a second position (see FIG. 18B) where the sputum evacuation assist valve 204 is in the second configuration. Referring 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 sealing position with respect to the first valve seat "S1", and the second poppet valve assembly 1114 is in a sealing position with respect to 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 with respect to the second valve seat "S2", and the second poppet valve assembly 1114 is in a sealing position with respect to the fourth valve seat "S4".

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

[0266] The first and second poppet valve assemblies 1112, 1114 are substantially identical to each other. Referring 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 disc-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 secures 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 secures 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 connection between the shaft and the poppet member 1148 of the poppet valve assembly.

[0268] Referring to FIG. 18A, the magnet 1040 of the first end cap assembly 1032 attracts the ferromagnetic member 1144 of the first poppet valve assembly 1112 and, when approaching it after the shaft has been moved to the first position, maintains the shaft 1116 in the first position and holds the first poppet valve assembly 1112 in a fixed position on the first valve seat S1 of the first end cap assembly 1032. Similarly, referring 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, when approaching it after the shaft has been moved to the second position, maintains the shaft 1116 in the second position and holds the second poppet valve assembly 1114 in a fixed position 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 fixed positions relative to the first and fourth valve seats S1, S4, respectively, even when no power is applied to the actuator used to move the poppet valve assemblies.

[0269] Referring to FIG. 20, the sputum discharge assisting valve 204 includes an actuator 1170 configured to selectively move the shaft 1116 between a first position (see FIG. 18A) and a second position (see FIG. 18B) along the longitudinal direction identified by the 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 integrally therewith. Referring to FIGS. 18A and 18B, the stationary magnet subassembly 1176 is coupled to the actuator mounting portion 1190 of the housing 1020 (e.g., by one or more fasteners 1178).

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

[0271] The control signal 1180 (see FIG. 5E) selectively powers the movable coil subassembly 1174 to move either towards the first end cap assembly 1032 or the second end cap assembly 1034. When the movable coil subassembly 1174 moves towards the first end cap assembly 1032, the movable coil subassembly 1174 moves the shaft 1116 towards the first position. Referring to FIG. 18A, after the shaft 1116 has moved to the first position, the movable coil subassembly 1174 is powered off, and the magnet 1040 of the first end cap assembly 1032 (which is 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 towards the second end cap assembly 1034, the movable coil subassembly 1174 moves the shaft 1116 towards the second position. Referring to FIG. 18B, after the shaft 1116 has moved to the second position, the movable coil subassembly 1174 is powered off, and the magnet 1040 of the second end cap assembly 1034 (which is attracted to at least a portion of the second poppet valve assembly 1114 as described above) 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] Referring to FIG. 24B, the housing 1020 (see FIGS. 18A and 18B) includes a first internal support 1184 spaced inwardly from a 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. Referring to FIGS. 18A and 18B, the channel 1186 (see FIG. 24B) is configured such that the shaft 1116 can 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, the channel 1186 opens along the inner valve seat member 1096 and positions 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 the guide member 1120 (see FIG. 22), is positioned inside the channel 1186 (see FIG. 24B) and reciprocates therein. Referring to FIG. 24A, a longitudinally extending guide groove 1188 with an open end is formed in the first internal support 1184 along the channel 1186. The guide member 1120 (see FIG. 22) is positioned in the guide groove 1188 and moves therein. (This prevents rotation of the poppet assembly, which could damage the wire.) The first internal support 1184 optionally has an actuator mounting portion 1190 that includes one or more through-holes configured to receive 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 side wall 1192 configured to extend around a portion of the stationary magnet subassembly 1176.

[0273] Referring 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. Referring to FIGS. 18A and 18B, the through hole 1196 (see FIG. 25) is configured such that the shaft 1116 passes therethrough and positions 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 projection 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] Referring to FIGS. 17A, 17B, 18A, 18B, 23A, and 23B, in the illustrated embodiment, the housing 1020 includes an inlet body portion 1198 coupled to the exhaust gas portion 1199. The valve / fan outlet 1002, the air inlet 1006, the opening 1010, the first open end 1022, and the first internal support 1184 are formed within the inlet body portion 1198. The fan / valve inlet 1004, the exhaust outlet 1008, the second open end 1024, and the second internal support 1194 are formed within the exhaust gas portion 1199.

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

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

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

[0278] Referring to FIGS. 34A, 34B, 18A, and 18B, the sputum evacuation assist valve 2000 has a valve / fan outlet 2002, a fan / valve inlet 2004, an air intake 2006, an exhaust outlet 2008, and an opening 2010 that are substantially the same as the valve / fan outlet 1002, the fan / valve inlet 1004, the air intake 1006, the exhaust outlet 1008, and the opening 1010 of the sputum evacuation assist valve 204, respectively. Each of the valve / fan outlet 2002 and the fan / valve inlet 2004 is connected to a fan 222. The air intake 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 sputum evacuation assist valve 2000 has valve seats "S1'" to "S4'" that are substantially the same as the valve seats "S1" to "S4" of the sputum evacuation assist valve 204.

[0279] Referring to FIGS. 34A and 34B, the sputum discharge assisting valve 2000 includes a housing 2020 having a substantially cylindrical shape. The air intake port 2006 is formed in the first open end 2022 of the housing 2020, and the exhaust outlet 2008 is formed in the second open end 2024 of the housing 2020. The valve / fan outlet 2002, the fan / valve inlet 2004, and the opening 2010 are formed in the side wall 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 can be coupled to the first and second open ends 2022, 2024, respectively. The first and second end cap assemblies 2032, 2034 are substantially the same as each other. Referring to FIG. 35, each of the first and second end cap assemblies 2032, 2034 (see FIGS. 34A and 34B) includes a holding member 2042, a seal member 2044 (e.g., an O-ring), and a valve seat member 2046. Referring to FIGS. 34A and 34B, each of the first and second end cap assemblies 2032, 2034 can 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 configured to receive one of the fasteners 2049 at each of the first and second open ends 2022, 2024 of the housing 2020.

[0281] Referring to FIG. 35, the valve seat member 2046 has a ring-shaped peripheral portion 2056 that defines an opening 2058. The valve seat member 2046 has an inward-facing side 2070 and, opposite thereto, an outward-facing side 2071. Along the inward-facing side 2070, the valve seat member 2046 has an inwardly extending annular protrusion 2072 positioned adjacent to the opening 2058. In the illustrated embodiment, the peripheral portion 2056 has an externally threaded portion 2074 along the inward-facing side 2070 and an annular recessed portion 2076 along the outward-facing side 2071. The recessed portion 2076 is configured to receive at least the free end portions of the inwardly extending side walls 2054 of the seal member 2044 and the retaining member 2042, and the seal member 2044 is sandwiched between the valve 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 the tab 1048 (see FIG. 19A). Instead, the retaining 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 retaining 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 receives one of the fasteners 2049 and is thereby configured to be fastened to the corresponding mounting portion 2050 (see FIGS. 34A, 34B, and 38).

[0283] Referring to FIG. 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 that extends in the circumferentially inward direction and is in the vicinity of the first open end 2022. The inner wall 2095 has an annular projection 2097 that extends longitudinally outward and is substantially similar to the annular projection 2072 (see FIG. 35).

[0284] Referring to FIG. 35, the annular projection 2072 of the valve seat member 2046 of the first end cap assembly 2032 (see FIGS. 34A and 34B) functions as a first valve seat "S1'" (see FIGS. 34A and 34B). Referring to FIG. 37, the annular projection 2097 inside the first open end 2022 of the housing 2020 functions as a 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 towards each other 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] Referring to FIGS. 34A and 34B, the shaft 2116 is configured to move longitudinally within the housing 2020 between a first position (see FIG. 34A) where the sputum evacuation assist valve 2000 is in a first configuration and a second position (see FIG. 34B) where the sputum evacuation assist 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 the first position (see FIG. 34A), the first poppet valve assembly 2112 is in a sealing position with respect to the first valve seat "S1'", and the second poppet valve assembly 2114 is in a sealing position with respect to the third valve seat "S3'". When the shaft 2116 is in the second position (see FIG. 34B), the first poppet valve assembly 2112 is in a sealing position with respect to the second valve seat "S2'", and the second poppet valve assembly 2114 is in a sealing position with respect to the fourth valve seat "S4'".

[0288] Referring to FIG. 34A, longitudinal channels 2136 extend inwardly into the shaft 2116 at each of the ends of the shaft 2116. Referring 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 each other. Referring to FIG. 36, each of the first and second poppet valve assemblies 2112, 2114 includes a 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 that, as shown in FIG. 21, serve both to seal the poppet valve assembly to the end portion of the shaft 2116 and to provide a flexible connection between the shaft and the poppet valve member 2148 of the poppet valve assembly. The fastener 2140 of the first poppet valve assembly 2112 retains the other components of the first poppet valve assembly 2112 (i.e., the optional first washer 2146, the disc-shaped poppet member 2148, and the optional second washer 2152) to one end of the shaft 2116. Similarly, the fastener 2140 of the second poppet valve assembly 2114 retains the other components of the second poppet valve assembly 2114 to the other end of the shaft 2116.

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

[0290] Referring to FIGS. 34A and 34B, the stationary coil subassembly 2174 includes a coil 2177 stored inside the outer housing 2179. The outer housing 2179 is coupled to the actuator mounting portion 2190 of the housing 2020 (e.g., by one or more fasteners 2178). 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 outside the housing 2020. In the illustrated embodiment, the wire 2062 supplies power to the coil 2177. Each of the outer housing 2179 and the housing 2020 includes one or more openings through which the wire 2062 can pass. The PCB 2064 is connected by one or more wires (not shown) to the control system 220 (see FIG. 5E). The actuator 2170 receives a control signal 1180 from the control system 220 (via the PCB 2064 and the wire 2062) and is configured to move in accordance with one or more instructions within the control signal 1180. The PCB 2064 serves as a connector and passes the control signal 1180 to the coil 2177.

[0291] Referring to FIG. 36, the movable magnet subassembly 2176 has a main magnet 2150 and is accompanied by a first end 2151 and, opposite thereto, a second end 2153. A first latch magnet 2156 is mounted on the first end 2151, and a second latch magnet 2158 is mounted on the second end 2153. Each of the first and second latch magnets 2156, 2158 is attracted to the magnetic outer housing 2179 (see FIGS. 34A and 34B). Referring 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 the shaft 2116 has been moved to the first position (by powering the coil 2177). Similarly, referring 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 the shaft 2116 has been moved to the second position (by powering the coil 2177). Thus, the shaft 2116 can remain in the desired position after the power supply to the coil 2177 is stopped.

[0292] The control signal 1180 (see FIG. 5E) selectively supplies power to the coil 2177 and moves the movable magnet sub-assembly 2176 toward either the first end cap assembly 2032 or the second end cap assembly 2034. When the movable magnet sub-assembly 2176 moves toward the first end cap assembly 2032, the shaft 2116 moves with it toward the first position. Referring to FIG. 34A, after the shaft 2116 has moved to the first position, the coil 2177 is powered off, 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. On the other hand, when the movable magnet sub-assembly 2176 moves toward the second end cap assembly 2034, the shaft 2116 moves with it toward the second position. Referring to FIG. 34B, after the shaft 2116 has moved to the second position, the coil 2177 is powered off, 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. Therefore, no additional power is required to maintain the shaft 2116 in either the first or second position, which helps extend the battery life in embodiments powered by one or more batteries.

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

[0294] Referring 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. Referring to FIGS. 34A and 34B, the through hole 2196 (see FIG. 38) is configured such that the shaft 2116 can pass therethrough and position the second poppet valve assembly 2114 between the third valve seat "S3'" and the fourth valve seat "S4'". Referring to FIGS. 34A and 34B, the internal support 2194 abuts against 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 in the vicinity of the second valve seat "S2'", and the internal support 2194 abuts against the opposite end of the outer housing 2179 in the vicinity of the third valve seat "S3'".

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

[0296] Referring to FIG. 34A, in the first configuration, the first poppet valve assembly 2112 is pressed against the second valve seat "S2'", and the second poppet valve assembly 2114 is pressed against the fourth valve seat "S4'". Referring 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 to flow through the air inlet 2006, from the valve / blower outlet 2002, and into the blower 222. Further, the first poppet valve assembly 2112 blocks the gas 252 from entering directly into the opening 2010, and thus seals the opening 2010 from both the air inlet 2006 and the valve / blower outlet 2002. At the same time, the second poppet valve assembly 2114, which is pressed against the fourth valve seat "S4'", closes the exhaust outlet 2008 and allows the flow of gas 252 to the main ventilator connection 104. In this configuration, the gas 252 entering the air inlet 2006 from the accumulator 202 is directed towards the blower 222 through the valve / blower outlet 2002. The gas 252 is then blown by the blower 222 from within the blower / valve inlet 2004, through the opening 2010, and to the main ventilator connection 104.

[0297] Referring to FIG. 34B, in the second configuration, the first poppet valve assembly 2112 is pressed against the first valve seat "S1'", and the second poppet valve assembly 2114 is pressed against the third valve seat "S3'". Referring to FIGS. 5B and 34B, in the second configuration, the first poppet valve assembly 2112 allows the flow of the forced exhaust gas 253 from the main ventilator connection portion 104 to flow from the valve / fan outlet 2002 through the opening 2010 into the fan 222. Further, the first poppet valve assembly 2112 blocks the flow of the forced exhaust gas to the air intake port 2006, thus preventing the gas 252 from the accumulator 202 from reaching the valve / fan 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 the forced exhaust gas 253 to the opening 2010. In this configuration, the forced exhaust gas 253 entering the opening 2010 from the main ventilator connection portion 104 is directed towards the fan 222 through the valve / fan outlet 2002. The forced exhaust gas 253 is then blown by the fan 222 from within the fan / valve inlet 2004 through the exhaust outlet 2008.

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

[0299] The expiratory assist valve, whether it is the expiratory assist valve 204 or the expiratory assist valve 2000, is designed such that the pressures acting on the first and second poppet valve assemblies 1112, 1114 of the expiratory assist valve 204 or the first and second poppet valve assemblies 2112, 2114 of the expiratory assist valve 2000 are balanced. This results in the actuator 1170 of the expiratory assist valve 204 and the actuator 2170 of the expiratory assist valve 2000 not having to act against the patient pressure. Since all of the seat areas of the valve seats S1 - S4 of the expiratory assist valve 204 are the same as all of the seat areas of the valve seats S1’ - S4’ of the expiratory assist valve 2000, the patient pressure inside the expiratory assist valve that occurs through the port 1010 (see, for example, FIGS. 5C and 5D) acting on the poppet valve assembly of the expiratory assist valve is equal and generates opposing forces. Thus, the forces applied to the first and second poppet valve assemblies 1112, 1114 of the expiratory assist valve 204 are substantially equal and in opposite directions 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 applied to the first and second poppet valve assemblies 2112, 2114 of the expiratory assist valve 2000 are substantially equal and in opposite directions 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 applied to the first and second poppet valve assemblies of the expiratory assist valve are not balanced, the actuator 1170 / 2170 of the expiratory assist valve would need to be much larger, and the power required to operate the actuator would be greater.

[0300] As described above, the ventilation assembly 190 may include either the expiratory assist valve 204 or the expiratory assist valve 2000. When the ventilation assembly 190 includes the expiratory assist valve 204, during normal ventilation, the expiratory assist valve 204 is in the first configuration shown in FIGS. 5A and 18A. On the other hand, when the ventilation assembly 190 includes the expiratory assist valve 2000 (see FIGS. 34A and 34B), during normal ventilation, the expiratory assist valve 2000 is in the first configuration shown in FIG. 34A.

[0301] Referring to FIG. 5A, at the start of the inhalation phase of breathing (and the start of the expiratory phase of sputum removal), air 114 can be drawn into the ventilator 100 (see FIGS. 1 and 4) through a patient air inlet 116 that can be configured to filter dust and / or other types of particles from the air. At least a portion of the air 114 flows into the accumulator 202, where the air 114 can 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 FIG. 1), combinations and / or partial combinations thereof, etc. As illustrated in FIG. 4, high-pressure oxygen 132 (received from a high-pressure external oxygen source 120 depicted in FIG. 1) flows into the oxygen assembly 210 and can be delivered as oxygen 250 to the accumulator 202 (see FIG. 5A).

[0302] Referring to FIG. 5A, the accumulator 202 can also serve as a muffler for the patient air inlet 116.

[0303] The inlet silencer 229 helps to dampen the sound generated by the oxygen assembly 210 (e.g., by the compressor 302 illustrated in FIG. 7A).

[0304] The oxygen sensor 227 is connected to the accumulator 202 and measures the 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. Referring to FIG. 5E, the oxygen sensor 227 provides an oxygen concentration signal 276 encoding the oxygen concentration value to the control system 220. 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). Referring to FIG. 4, the output information 198 transmitted to the user interface 200 by the control system 220 can include a measure of the amount of oxygen in the gas 252. The user interface 200 can display this measure to the user (e.g., the patient 102 depicted in FIG. 1).

[0305] Referring to FIG. 5A, optionally, the accumulator 202 includes or is connected to a low-pressure oxygen inlet 126. When 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 oxygen concentration resulting from flowing to the patient 102. In other words, the low-pressure oxygen 128 may simply flow into the accumulator 202, be mixed with 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 inspiratory gas 108 (see FIG. 1), and controls the delivery of the inspiratory gas 108 during the inspiratory 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 conveyed to the internal flow transducer 212 via the flow line 214. The gas 252 flows through the internal flow transducer 212, and the internal flow transducer 212 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. Referring 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 can be used to detect when patient 102 (see FIG. 1) begins breathing. In particular, the internal flow transducer 212 can 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 completely determined by the blower 222. Instead, the patient's breathing effort can cause a change in the flow rate through the flow line 214. Thus, the control system 220 can identify that patient 102 has begun breathing by identifying a change in the flow rate through the flow line 214 (encoded in the flow rate signal 270).

[0308] The internal flow transducer 212 can include, or be connected to, an automatic zero solenoid valve SV5 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 can drift over time and cause a flow measurement error. To compensate for this error, the control system 220 can, at any time (e.g., periodically), excite (or activate) the automatic zero solenoid valve SV5 (using the control signal 285) to determine an offset value for the internal flow transducer 212. After determining the offset value, the control system 220 can use the offset value to compensate future read values as appropriate (based on the flow rate signal 270).

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

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

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

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

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

[0314] Referring to FIG. 1, as described above, the patient circuit 110 can include one or more optional ports 111. FIG. 5A illustrates the implementation of a ventilation assembly 190 configured for use with a patient circuit 110 implemented as an active patient circuit (e.g., 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 (e.g., 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 can be omitted from the ventilation assembly 190.

[0315] The airway flow transducer module 225 and the 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 first and second pressure signals 109A, 109B to the differential pressure transducer PT4, respectively (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 into a signal 277 (see FIG. 5E), and transmits the signal 277 to the control system 220 (as illustrated 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 can be used to detect when patient 102 (see FIG. 1) begins to breathe. The flow of gas through the active patient circuit 600 (see FIG. 3A) is not completely determined by the blower 222. Instead, the patient's breathing effort can cause a change in the flow rate through the active patient circuit 600. Thus, the control system 220 can identify that patient 102 has begun to breathe by identifying a change in the flow rate through the active patient circuit 600 (encoded within signal 277).

[0317] The automatic zero solenoid valves SV1 and SV2 are each connected to the input ports PA, PB of the differential pressure transducer PT4. Further, each of the automatic zero solenoid valves SV1 and SV2 is connected to the ambient pressure. The differential pressure transducer PT4 can drift over time and cause a flow measurement error. To compensate for this error, the control system 220 periodically (e.g., at any time) activates (or energizes) the automatic zero solenoid valves SV1 and SV2 (using control signals 281 and 282 respectively) to determine an offset value for the differential pressure transducer PT4. The control system 220 then deactivates the automatic zero solenoid valves SV1 and SV2 (using control signals 281 and 282 respectively). After determining the offset value, the control system 220 uses the offset value to compensate future read values as appropriate (based on signal 277).

[0318] The purge solenoid valves SV3 and SV4 are connected to port 275A. Referring to FIG. 5E, the control system 220 intermittently (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 sputum evacuation assist valve 204 (illustrated in FIG. 5A) (or the sputum evacuation assist valve 2000 illustrated in FIG. 34A) to flow through lines, ports, and / or channels (e.g., optional multi-lumen tube connection 103, channels 626A and 626B, channels 632A, 632B, ports 111A and 111B, etc.), transmit pressure signals 109A and 109B, and purge any moisture in those structures that can 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, measures the internal pressure inside the accumulator A2, and transmits this value to the control system 220 in an electrical pressure signal 271 (see FIG. 5E).

[0320] Referring to FIG. 5E, the solenoid valves SV6 - SV8 are configured to be selectively activated and deactivated by control signals 286 - 288 respectively transmitted to the solenoid valves SV6 - SV8 by the control system 220. Looking at FIG. 5A, the solenoid valve SV6 is connected to the first port 267 of the accumulator A2, port 275B, and the pilot port 111C (see FIG. 3C) of the active patient circuit 600 (see FIG. 3A). The solenoid valve SV7 is connected to the second port 268 of the accumulator A2 and port 275B. The solenoid valve SV8 is connected between the third port 269 of the accumulator A2 and the outlet port 166.

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

[0322] Similarly, at the start of the insufflation phase of sputum evacuation, the control system 220 activates the solenoid valve SV6 (using control signal 286), which connects the pressure of gas 252 to the pilot port 111C (via port 275B). This closes the active expiratory valve assembly 604. At the end of the insufflation phase, the control system 220 deactivates the solenoid valve SV6 (using control signal 286), which connects the internal pressure of accumulator A2 (or pilot pressure) to the active expiratory valve assembly 604. As will be discussed below, instead of opening the active expiratory valve assembly 604, this maintains the active expiratory valve assembly 604 in a closed configuration. It should be noted that during the start of the forced exhalation phase, the double bellows member 644 can move to the open position as a result of the patient pressure applied to the double bellows member being higher than atmospheric pressure, but automatically closes when the pressure provided by the patient 102 drops below atmospheric pressure.

[0323] The control system 220 uses the feedback provided by the pressure transducer PT8 (via the electrical pressure signal 271 depicted in FIG. 5E) and uses the solenoid valves SV7 and SV8 to control the inner pilot pressure of the accumulator A2 and set the pilot pressure for the expiratory phase of respiration to achieve the desired PEEP. For example, the control system 220 can activate the solenoid valve SV8 (using the control signal 288) and release a portion of the gas inside the accumulator A2 as exhaust 167 via the outlet port 166 to reduce the pilot pressure inside the accumulator A2. Conversely, the control system 220 can activate the solenoid valve SV7 (using the control signal 287) and increase the pilot pressure by adding a portion of the gas 252 (obtained via the port 275B) inside the accumulator A2.

[0324] Referring to FIG. 5E, the control system 220 utilizes the electrical pressure signal 274 (received from the airway pressure transducer 224) to assist in controlling the blower 222. The control system 220 transmits the control signal 278 to the motor 272, which instructs the blower 222 to provide the desired flow rate and / or the desired amount of pressure to the patient 102. As described above, the flow signal 270 is used to assist in controlling the flow rate of the gas 252 during both the inspiratory and expiratory phases of respiration. Similarly, the electrical pressure signal 274 is used to control the patient pressure during both the inspiratory and expiratory phases of respiration. The flow signal 270 can be used to assist in controlling the flow rate of the gas 252 during the inspiratory phase and / or the flow rate of the forced exhaust gas 253 during the forced exhaust phase for sputum removal. Similarly, the electrical pressure signal 274 is used to control the patient pressure during the inspiratory phase and / or the forced exhaust phase for sputum removal.

[0325] As described above, the ventilator 100 adjusts the pressure inside the patient circuit 110 (e.g., the passive patient circuit 440 shown in FIG. 2B), achieving a preset inspiratory pressure during the inspiratory phase, a baseline pressure or PEEP during the expiratory phase, and a PEEP during the pause between the inspiratory and expiratory phases. These adjustments (and those made during the sputum clearance assistance procedure) are performed by the control system 220, which monitors the electrical pressure signal 274, increases or decreases the speed of the motor 272, and uses the control signal 278 to achieve the desired pressure inside the patient circuit 110.

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

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

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

[0329] Referring to FIG. 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 includes a display device 240 (e.g., a liquid crystal display), a mode input 235, an inspiratory time input 236, a pressure control input 237, a pressure support input 238, an oxygen generator activation input 239 (described below) for activating oxygen generation, a tidal volume input 242, an oxygen flow equivalent value 244, an inspiratory oxygen fraction ("FI02") input 246, a respiratory rate input 247, an oxygen pulse volume input 251, a sputum clearance activation input 241, a suction activation input 248 for activating the suction 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 inspiratory phase is referred to as "start." The mode input 235 is configured to receive an instruction regarding whether the ventilator 100 determines when each breath is initiated or the patient 102 determines when each breath is initiated. The respiratory rate input 247 is configured to receive the rate at which breaths are to be delivered (e.g., breaths per minute). If the user indicates (using the mode input 235) that the ventilator 100 determines when each breath is initiated, the ventilator 100 will deliver breaths according to the rate received by the respiratory rate input 247 (e.g., at regularly timed intervals). On the other hand, if the user indicates (using the mode input 235) that the patient 102 initiates each breath, the ventilator 100 will automatically deliver breaths as needed to ensure that the patient 102 receives breaths at a frequency indicated by at least the rate received by the respiratory rate input 247.

[0331] The ventilator 100 may identify the end of the inspiratory phase using the time or flow rate of the gas 112 flowing to the patient 102. In the latter case, the patient 102 determines when the inspiratory phase has ended. The inspiratory time input 236 is the duration T from the start of each breath to the end of the inspiratory phasei configured to receive a value indicating. The ventilator 100 can identify the end of the inspiration phase using a value (indicating a duration T i ). The pressure support input 238 receives an indication that the user desires to end the inspiration phase using the flow rate of gas 112 to patient 102 (instead of the value indicating a duration T i ). For example, the ventilator 100 can end the inspiration phase of respiration when the flow rate of gas 112 is only about 25% of the peak flow rate that occurred during respiration.

[0332] The ventilator 100 is configured to deliver only gas 112 or a combination of gas 112 and pulses of oxygen 140. As described above, the ventilator 100 can be configured to provide both conventional volume control ventilation and pressure control ventilation. To use pressure control, the user can enter a peak inspiratory pressure value using the pressure control input 237. The ventilator 100 uses the peak inspiratory pressure value to configure only gas 112 or a combination of gas 112 and pulses of oxygen 140 such that the pressure during the inspiration phase is at most the peak inspiratory pressure value.

[0333] The FI02 input 246 is configured to receive an oxygen concentration value. The ventilator 100 uses the oxygen concentration value to configure 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., represented 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 of the pulses of oxygen 140 to have a volume equal to or close to the oxygen pulse volume value.

[0335] The single breath volume input 242 is configured to receive a desired total single breath volume value. Referring to FIG. 15A, the ventilator 100 uses the desired total single breath volume value to output, during each breath, the 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). For each breath delivered, the total single breath volume delivered is the combined volume of the 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 per minute) that identifies the rate at which a hypothetical continuous oxygen flow can be sent 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 of the pulses of oxygen 140 (see FIG. 1) to deliver the amount of oxygen that would provide equivalent oxygen administration to the patient 102 (see FIG. 1) as a hypothetical continuous oxygen flow.

[0337] The sputum clearance assist activation input 241 indicates that the user desires to perform a sputum clearance assist procedure (discussed below).

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

[0339] Referring to FIG. 7A, the oxygen assembly 210 is configured to receive 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 oxygen of approximately 90% purity at up to about 2 liters per minute ("LPM"). In the illustrated embodiment, the oxygen assembly 210 includes an adsorption 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, the first rotary valve assembly 306, the adsorption bed 300, and the pressure regulators R1 and R2 may together be characterized as an oxygen generator or oxygen concentrator. The oxygen generator, illustrated in the figure and described below, implements a vacuum pressure swing adsorption ("VPSA") process. In an alternative embodiment, the ventilator 100 may include an oxygen generator that implements at least one of a polymer membrane separation process, an ion transport separation process, a cryogenic process, etc. Further, the VPSA process described below is part of a 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 the air 114 received through the patient air inlet 116. As described below, the adsorption bed 300 can be configured to implement a VPSA process that includes a cycle (described below) with at least four phases. The cycle alternately generates 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. Then, the cycle is restarted or accelerated as needed. The nitrogen-rich gas 122 generated by each cycle is exhausted to the outside environment through the outlet vent 124.

[0341] FIGS. 8A - 8D are block diagrams illustrating some exemplary components of the adsorption bed 300. Referring to FIGS. 8A - 8D, in the illustrated embodiment, the adsorption 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 adsorption material bed 344 (such as zeolite) between its first end 341 and second end 343. The nitrogen adsorption material bed 344 preferentially absorbs nitrogen. For ease of illustration, the adsorption bed 300 will be described as including a single housing with a single nitrogen adsorption material bed. In alternative embodiments, the adsorption bed 300 can include two or more beds such as the nitrogen adsorption material bed 344, each stored inside a separate housing such as the housing 340.

[0342] As described above, the VPSA process includes a cycle with four phases. FIG. 8A illustrates the adsorption bed 300 in the first phase. Referring to FIG. 8A, in the first phase, air 114 is pumped into the housing 340 by a compressor 302 (see FIG. 7A). When the housing 340 is pressurized with air 114 (by the compressor 302), nitrogen in the air is preferentially adsorbed by the nitrogen adsorption material bed 344, which leaves the unadsorbed oxygen. The nitrogen adsorption material bed 344 may include an interstitial space in which the unadsorbed oxygen is retained or trapped.

[0343] FIG. 8B illustrates the adsorption bed 300 in the second phase of the VPSA process cycle. In 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] FIG. 8C illustrates the adsorption bed 300 in the third phase of the VPSA process cycle. In the third phase, the nitrogen-rich gas 122 is drawn from the nitrogen adsorption material bed 344 in the housing 340 (by the compressor 302 shown in FIG. 7A) and discharged to the outside environment through the outlet vent 124 (see FIG. 7A).

[0345] FIG. 8D illustrates the adsorption bed 300 in the fourth phase of the VPSA process cycle. In the fourth phase, the flow of "purge" oxygen 348 (e.g., from the oxygen tank 312 shown in FIG. 7A) can be used to draw out the nitrogen-rich gas 122 and help regenerate the nitrogen adsorption material bed 344.

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

[0347] During each cycle, compressor 302 is configured to alternately push air 114 into adsorption bed 300 (through the first rotary valve assembly 306) and draw nitrogen-rich gas 122 from adsorption bed 300 (through the first rotary valve assembly 306). 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 encoding the direction and speed of rotation of motor 350 to control system 220. Referring to FIG. 7B, motor 350 is configured to receive commands from control system 220 encoded in control signal 356. The commands in control signal 356 command motor 350 to switch on or off and / or indicate the direction in which motor 350 should rotate when switched on. Further, control signal 356 may command motor 350 as to the speed at which it should operate. Referring to FIG. 7A, when motor 350 operates in a first direction, compressor 302 pushes air into adsorption bed 300. On the other hand, when motor 350 operates in a second direction, compressor 302 draws nitrogen-rich gas 122 (see FIGS. 8C and 8D) from adsorption bed 300. As a non-limiting example, motor 350 may be implemented as a brushless DC motor.

[0348] FIG. 9 is an illustration of measurement valve 320. Referring to FIG. 9, pressure transducer PT3 is connected across measurement valve 320. Thus, pressure transducer PT3 may determine the pressure difference value across measurement valve 320. Referring to FIG. 7B, pressure transducer PT3 provides a pressure difference signal 358 encoding the pressure difference value to control system 220.

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

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

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

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

[0353] The random solenoid valves SV9 and SV10 can 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). The solenoid valves SV9 and SV10 are connected to a conduit or flow line (not shown) that conveys high-pressure oxygen 132 (e.g., from the high-pressure oxygen source 120 shown in FIG. 1) to the oxygen tank 312 in a parallel arrangement. The control system 220 uses control signals 380 and 382 (see FIG. 7B) to selectively activate and deactivate the solenoid valves SV9 and SV10 respectively, and maintain the pressure within the oxygen tank 312 between the minimum threshold pressure value and the maximum threshold pressure value. Thus, the control system 220 and the solenoid valves SV9 and SV10 together perform the function of a digital (on / off) regulator.

[0354] When the high-pressure external oxygen source 120 is connected, the control system 220 can automatically stop the oxygen assembly 210 from performing the VPSA process. For example, when the pressure within the oxygen tank 312 exceeds the upper threshold (e.g., 10 PSIG), the control system 220 can decelerate or shut down the VPSA process. Thus, the control system 220 can decelerate 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, when the pressure inside the oxygen tank 312 drops below the lower pressure threshold (e.g., 4 PSIG), the control system 220 can restart or accelerate the VPSA process.

[0355] The oxygen tank 312 can 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 mute the sound generated by the compressor 302.

[0356] Referring to FIGS. 7A and 7B, the oxygen sensor 314 measures the oxygen concentration within the oxygen tank 312 and encodes an oxygen concentration value in an oxygen concentration signal 378 provided to the control system 220. The control system 220 may use the oxygen concentration signal 378 to monitor the oxygen assembly 210 and ensure that it is operating 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] The 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). Referring to FIG. 7B, the pressure transducer PT2 provides an electrical pressure signal 374 encoding that pressure value to the control system 220.

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

[0359] Referring to FIG. 10B, a 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 an end of the shaft 836 opposite the motor assembly 830 may pass.

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

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

[0362] Referring to Figure 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 each closed by end caps 851 - 854. The end caps 851 - 854 can be fastened to the outer housing 832 by fasteners 855.

[0363] Referring to FIG. 10B, the arms 841-844 each include an inlet opening 856A-856D configured to receive a gas or a gas mixture, and an outlet opening 858A-858D through which the gas or gas mixture can exit, respectively.

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

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

[0366] The poppet valves CV1-CV4 are substantially the same as each other. For simplicity purposes, only the poppet valve CV1 will be described in detail. FIG. 10E is an exploded perspective view of the poppet valve CV1, the end cap 851, and the fastener 855. Referring to FIG. 10E, the housing 860 has an open proximal end portion 870 and, opposite thereto, an open distal end portion 872. The open distal end portion 872 is closed by the end cap 851 when the end cap 851 is fastened to the outer housing 832. Similarly, the housings 860 of the poppet valves CV2-CV4 are each closed at their open distal end portions 872 by the end caps 852-853 when the end caps 852-854 are fastened to the outer housing 832.

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

[0368] Referring to FIG. 10F, a guide portion 876 having a generally cylindrical shape extends inwardly from the open proximal end portion 870 (see FIG. 10E) of the housing 860. A channel 877 with an open end is formed within the guide portion 876. A shoulder 878 is formed inside the housing 860 between the side inlet 862 and the side outlet 864.

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

[0370] A ring-shaped diaphragm 886 can extend around the push rod 880 in the vicinity of 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 the inner edge portion of the central portion P2 is positioned within the recess 879, whereby the central portion P2 firmly grips the push rod 880. The diaphragm 886 can close and seal the open proximal end portion 870 of the housing 860. However, the diaphragm 886 can 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 firmly clamped in place.

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

[0372] Looking at FIG. 10E, the push rod 880 has a distal end portion 882 and, opposite thereto, a proximal end portion 881. The proximal end portion 881 has a cam follower 883 (see FIGS. 10C and 10E) formed therein. In the illustrated embodiment, the proximal end portion 881 can be outwardly tapered and generally conical in shape. The cam follower 883 (see FIG. 10C) can be mounted as a planar or contoured lower surface of the proximal end portion 881.

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

[0374] The distal end portion 882 of the push rod 880 has a longitudinally extending channel 885 formed therein. The channel 885 is open at the distal end portion 882 of the push rod 880. A disc-shaped poppet member 892 is fastened to the distal end portion 882 of the push rod 880 by a fastener 894 (e.g., bolt, screw, etc.) that extends into the open end of the channel 885. Thus, the fastener 894 couples the poppet member 892 to the distal end portion 882 of the push rod 880, and it moves integrally therewith when the push rod 880 moves inside the housing 860.

[0375] Referring to FIG. 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. Thus, the poppet member 892 can seal the proximal and distal chambers 900, 902 from each other. The side inlet 862 communicates with the proximal chamber 900, and the side outlet 864 communicates with the proximal chamber 900. On the other hand, referring to FIG. 10G, when the poppet member 892 is distally spaced from the valve seat 896, the central through-hole 897 is exposed and the proximal and distal chambers 900, 902 communicate with each other. Thus, in this configuration, gas or a mixture of gases can flow between the proximal chamber 900 and the distal chamber 902. In other words, the path is open between the side inlet and outlet 862 and 864.

[0376] The distal end portion 882 of the push rod 880 is adjacent to the 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 applies a force directed inwardly to the push rod 880, which helps to ensure that the push rod 880 maintains contact with the cam 850. The end cap 890 is seated on the fastener 894 and positioned between the disc-shaped poppet member 892 and the end cap 851. The biasing member 888 extends between the end cap 890 and the end cap 851, applying a biasing force to the end cap 890, which transfers that 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 one another. 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 presses the push rod 880 outwardly toward the end cap 851. This presses the disc-shaped poppet member 892 away from the valve seat 896 (as shown in FIG. 10G), opening the central through hole 897. This opens the poppet valve CV1 and allows gas or a mixture of gases to flow through the poppet valve CV1. On the other hand, as shown in FIG. 10G, when neither 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 push rod 880 is biased inwardly away from the end cap 851 by the biasing assembly 884. The push rod 880 thereby draws the disc-shaped poppet member 892 toward the valve seat 896, covering or closing the central through hole 897 in the poppet member 892. This closes the poppet valve CV1 and prevents gas or a mixture of gases from flowing through the poppet valve CV1.

[0378] Since the ventilator 100 may be required to function over a long service life (e.g., exceeding about 30,000 hours), the first rotary valve assembly 306 may experience about 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 closes, 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 a vacuum), the force directed inwardly (towards the proximal chamber 900) acts on the effective area of the diaphragm 886. At the same time, the force directed inwardly (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, the force directed outwardly (away from the proximal chamber 900) acts on the effective area of the diaphragm 886, and the force directed outwardly (or distally) 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, the forces directed in opposite directions 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. Since (as described above) 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, the net force on the push rod 880 is zero. This balanced feature helps reduce the force on the push rod 880 on the cam follower 883 and the cam 850, thereby reducing wear and extending the 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 the cam 850. As the cam 850 rotates, it presses the opposing ones of the poppet valves CV1-CV4 outwardly, opening them. When the poppet valves CV1 and CV3 are in the open position, the poppet valves CV2 and CV4 come to the closed position, and vice versa. Referring to FIG. 7B, the first rotary valve assembly 306 (e.g., the stepper motor 833) is configured to receive a control signal 376 from the control system 220 that encodes the cam position. The first rotary valve assembly 306 (e.g., the stepper motor 833) is also configured to rotate the cam 850 to the position encoded within the control signal 376.

[0380] Referring to FIG. 7A, the poppet valve CV3 (see FIG. 10G) is connected to the compressor 302 and the adsorption bed 300. The control system 220 configures the compressor 302 to provide a suction force to the distal chamber 902, making the pressure inside the distal chamber 902 of the poppet valve CV3 less than the pressure inside the proximal chamber 900 of the poppet valve CV3.

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

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

[0383] Referring to FIG. 7A, the poppet valve CV4 (see FIG. 10F) is connected to the compressor 302 and the patie...

Claims

1. A ventilator operable in a ventilation mode providing a breath having an inhalation phase and an exhalation phase, and a sputum evacuation assistance mode providing sputum evacuation having a ventilation phase and a forced exhalation phase, the ventilator comprising: A patient circuit having a conduit for delivering gas between the ventilator and a patient, the conduit including a leak valve movable between an open position and a closed position, the open position allowing gas to flow from within the conduit to the external environment when the pressure within the conduit is greater than ambient pressure, the closed position preventing gas from flowing from within the conduit to the external environment when the pressure within the conduit is less than the ambient pressure; a patient circuit; A ventilator connection portion to which the patient circuit is connectable for fluid communication with the ventilator connection portion; a ventilator connection portion; A blower having an inlet and an outlet, the blower being configured to move gas from the inlet to the outlet; a blower; A sputum evacuation assistance feature coupled to the blower, the sputum evacuation assistance feature being configured to move between (a) a first position fluidly connecting the outlet of the blower to the ventilator connection portion and (b) a second position fluidly connecting the inlet of the blower to the ventilator connection portion; a sputum evacuation assistance feature; A controller Comprising The controller is configured to Control the position of the sputum evacuation assistance feature such that during the inhalation phase of the breath, the sputum evacuation assistance feature is in the first position, and during the forced exhalation phase of the sputum evacuation, the sputum evacuation assistance feature is in the second position; Control the speed of the blower to provide a desired pressure and / or a desired flow rate during the inhalation and exhalation phases of the breath and during the ventilation and forced exhalation phases of the sputum evacuation; And is configured to perform The leak valve is in the open position during the inhalation phase of the breath and in the closed position during the forced exhalation phase of the sputum evacuation. A ventilator.

2. The ventilator according to claim 1, wherein the controller is configured to increase the speed of the blower during the forced exhalation phase of the sputum evacuation.

3. The controller is configured to increase the speed of the blower while instructing the sputum evacuation assistance feature to transition from the first position to the second position, the ventilator according to claim 2.

4. The controller is configured to continuously control the speed of the blower, the ventilator according to claim 1.

5. The ventilator further comprises a pressure sensor configured to measure the pressure between the ventilator connection part and the blower, The controller is configured to control the speed of the blower based at least in part on the measured pressure, the ventilator according to claim 1.

6. The controller is further configured to control the position of the sputum evacuation assistance feature such that the sputum evacuation assistance feature is in the first position during the exhalation phase of the respiration and during the air supply phase of the sputum evacuation, the ventilator according to claim 1.

7. The ventilator further comprises an input device configured to receive user input for selectively switching the operation of the ventilator from the ventilation mode to the sputum evacuation assistance mode, the ventilator according to claim 1.

8. The sputum evacuation assistance feature is a valve, the ventilator according to claim 1.

9. The ventilator is a portable ventilator having a housing, and the blower and the sputum evacuation assistance feature are positioned within the housing, the ventilator according to claim 1.

10. A respiratory therapy system operable in a ventilation mode providing a respiration having an inhalation phase and an exhalation phase and a sputum evacuation assistance mode providing a sputum evacuation having an air supply phase and a forced exhalation phase, the respiratory therapy system comprising: A patient circuit having a conduit for delivering gas between the ventilator and a patient, the conduit including a leak valve movable between an open position and a closed position, the open position allowing gas to flow from within the conduit to the external environment when the pressure within the conduit is greater than ambient pressure, and the closed position preventing gas from flowing from within the conduit to the external environment when the pressure within the conduit is less than the ambient pressure, the patient circuit; A ventilator, wherein the ventilator is A ventilator having an inlet and an outlet, the ventilator being configured to move gas from the inlet to the outlet, and a ventilator, A sputum evacuation assisting feature coupled to the ventilator, the sputum evacuation assisting feature being configured to move between (a) a first position fluidly connecting the outlet of the ventilator to the patient circuit and (b) a second position fluidly connecting the inlet of the ventilator to the patient circuit, and a sputum evacuation assisting feature An artificial respirator comprising A controller Comprising The controller is During the inspiratory phase of the respiration, controlling the position of the sputum evacuation assisting feature such that the sputum evacuation assisting feature is in the first position, and during the forced exhalation phase of the sputum evacuation, the sputum evacuation assisting feature is in the second position; During the inspiratory and expiratory phases of the respiration and during the insufflation and forced exhalation phases of the sputum evacuation, controlling the speed of the ventilator to achieve a target pressure and / or a target flow rate in the patient circuit Is configured to perform The leak valve is in the open position during the inspiratory and expiratory phases of the respiration and during the insufflation phase of the sputum evacuation, and is in the closed position during the forced exhalation phase of the sputum evacuation, a respiratory therapy system.

11. The patient circuit extends between the artificial respirator and the patient connection portion, and gas flows along the general length of the patient circuit between both the ventilation mode and the sputum evacuation assisting mode. The respiratory therapy system according to claim 10.

12. The respiratory therapy system further comprises a pressure sensor configured to measure pressure in an artificial respirator system, The controller is configured to control the speed of the ventilator based at least in part on the measured pressure. The respiratory therapy system according to claim 10.

13. The measured pressure indicates the pressure in the patient circuit. The respiratory therapy system according to claim 12.

14. The controller is configured to increase the speed of the ventilator during the forced exhalation phase of the sputum evacuation. The respiratory therapy system according to claim 10.

15. The controller is configured to increase the speed of the ventilator while commanding the sputum evacuation assisting feature to transition from the first position to the second position. The respiratory therapy system according to claim 14.

16. The respiratory therapy system according to claim 10, wherein the controller is configured to continuously control the speed of the blower.

17. A control system programmed with instructions for controlling a respiratory therapy system, the respiratory therapy system comprising a patient circuit having a leak valve, and a ventilator having a sputum evacuation assist feature and a blower connectable to a patient via the patient circuit, the instructions, when executed, providing a positive pressure of gas flow to the patient via the patient circuit via the blower, providing the positive pressure of gas flow including positioning the sputum evacuation assist feature in a first position, in which the sputum evacuation assist feature fluidly connects the outlet of the blower to the patient circuit, and the leak valve is configured to be in an open position when the sputum evacuation assist feature is in the first position by the positive pressure of the gas provided by the blower; after providing the positive pressure of the gas, transitioning the sputum evacuation assist feature to a second position, in which the sputum evacuation assist feature fluidly connects the inlet of the blower to the patient circuit; changing the speed of the blower to achieve a target negative pressure and / or a target negative flow rate in the patient circuit during and / or after transitioning the sputum evacuation assist feature to the second position, and the leak valve is configured to be in a closed position when the sputum evacuation assist feature is in the second position by the negative pressure of the gas provided by the blower; A control system that instructs the respiratory therapy system to perform the above.

18. The control system according to claim 17, wherein the operation of transitioning the sputum evacuation assist feature to the second position is performed in response to receiving a user request for inducing sputum evacuation.

19. The control system according to claim 17, wherein the operation of changing the speed of the blower includes increasing the speed of the blower.

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