Systems and methods for non-invasive ventilation

Abstract

A system and method for noninvasive ventilation are provided. The system may include a gas source that delivers breathing gas to a patient via one or more of a primary flow path (PFP) and a flushing flow path (FFP). The system may include a control component configured to open and restrict airflow through the PFP. When the PFP is open, a significant portion of the gas flows through the PFP, while the remaining gas flows through the FFP. When the PFP is restricted, a significant portion of the gas flows through the FFP. The increased flow through the FFP can have a higher velocity (especially relative to the flow through the PFP). The gas delivered through the FFP can be used to flush dead spaces. One or both of the flow paths can facilitate inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), and / or positive end-expiratory pressure (PEEP).

Description

Background Technology Technical Field

[0002] This application generally relates to a system and method for noninvasive ventilation, and more specifically to various control components for controlling airflow and / or delivery to a patient interface and ultimately to the patient.

[0003] Related technical descriptions

[0004] Respiratory therapy systems are typically used to treat respiratory conditions such as obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD). These systems typically deliver heated and humidified gas for use in various medical or therapeutic procedures, including respiratory therapy. Such systems can be configured to control temperature, humidity, and flow rate.

[0005] A respiratory therapy system typically includes a gas source such as a ventilator, CPAP generator, or other flow generator; a patient interface worn by the patient; and a breathing circuit that connects the gas source to the patient interface. A respiratory therapy system typically includes an inspiratory flow path and an expiratory flow path. Breathing gas is delivered from the gas source to the patient interface along the inspiratory flow path, and expiratory gas flows out of the patient along the expiratory flow path. The inspiratory and expiratory flow paths can be the same, but are usually different. The main components of the inspiratory path are often referred to as the inspiratory branch of the system, and typically include one or more sections of an inspiratory gas delivery catheter and one or more connectors connecting the catheter sections(s) between the breathing gas source and the patient interface. A humidifier may be included between the gas source and the breathing circuit to humidify the breathing gas.

[0006] One approach to treating respiratory distress and certain respiratory disorders, including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), is to provide continuous positive airway pressure (CPAP) or other forms of positive airway pressure (PAP) to support the user's respiratory system. One form of PAP therapy is noninvasive ventilation (NIV), which is administered by delivering pressurized breathing gas through the user's mouth and / or nose.

[0007] Noninvasive ventilation (NIV) is a class of treatments that includes at least continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BAP). NIV is used to improve alveolar gas exchange in patients with ventilatory difficulties such as chronic obstructive pulmonary disease (COPD), pulmonary edema, obesity-hypopnea syndrome (OHS), and other respiratory-related conditions. NIV (and especially BAP) can be operated at least in part by providing pressure support to the patient. Pressure can be beneficial because it can increase tidal volume, recruit more alveoli, reduce the work of breathing, and keep the airway open (which can be prone to collapse in some patients). These benefits can lead to improved alveolar gas exchange. CPAP delivers gas to the patient at a constant set pressure via a face mask that is sealed or substantially sealed against the patient's face. The pressure delivered during CPAP therapy is typically in the range of about 5–25 cmH2O, but can be as high as about 40 cmH2O. This treatment requires a flow source that controls the delivered pressure: examples of potential flow sources include CPAP generators, intensive care ventilators, or flow sources with PEEP valves (valve that controls the maximum pressure in the system). Challenges to successful CPAP therapy may include user intolerance to patient interface pressure (e.g., manifested as localized pain and / or pressure sores) and poor patient compliance (potentially due to increased treatment pressure and its potential downstream effects).

[0008] Bilevel therapy, for example, delivers gas to a patient at two different set pressures via a face mask that seals against the patient's face. Two different pressures can be set to provide inspiratory positive airway pressure (IPAP) during the inspiratory portion of the respiratory cycle and a lower expiratory positive airway pressure (EPAP) during the expiratory portion. The difference between IPAP and EPAP is often referred to as pressure support. With noninvasive ventilation, increasing IPAP pressure or pressure support (IPAP-EPAP) can advantageously improve alveolar gas exchange. Typical IPAP pressures range from about 8 cmH2O to 25 cmH2O, but can be as high as about 40 cmH2O. Typical EPAP pressures range from about 4 cmH2O to 12 cmH2O. However, the pressures used for IPAP and EPAP can vary considerably between clinicians and patients. To provide this therapy, a more sophisticated flow source may be required, as it must be actively synchronized with the patient's respiratory cycle. Suitable flow sources are typically bilevel devices or intensive care ventilators. These devices can also be used to deliver oxygen advantageously and accurately. In an acute setting, bilevel therapy can be used to treat patients with hypoxemia or hypercapnia (high levels of CO2 in the blood). Challenges to successful bilevel therapy may include user intolerance to patient interface pressure (e.g., manifested as localized pain and / or pressure sores), patient aversive to the ventilator, and poor patient compliance (potentially due to increased treatment pressure and its potential downstream effects).

[0009] While high treatment pressure is a primary mechanism by which noninvasive ventilation improves alveolar gas exchange in patients, it can also lead to conditions that contribute to treatment failure. For example, ventilation at higher pressures requires a more effective mask seal to the patient's face, which typically necessitates higher headband tension and results in greater force applied to the patient's skin. Over time, this high pressure can cause skin rupture (pressure sores), potentially leading to severe patient discomfort and, in some cases, penalties for the hospital. Higher pressures can also exacerbate the likelihood of flatulence (gas buildup in the stomach), barotrauma, and volutrauma (internal tissue damage caused by pressurized gas). Ultimately, these side effects often result in poor patient tolerance and treatment failure.

[0010] Traditional patient interfaces are configured to form a seal with the user's face or upper airway to facilitate adequate pressurization of the user's respiratory system. Eson TM Simplicity TM and Nivairo TMThis is an example of a sealing interface for breathing patients manufactured by Fisher & Paykel Healthcare Limited. The interface typically includes a mask body and a sealing liner, and is configured to seal against one or more of the user's face, mouth, nose, and nostrils. Typically, the mask body is more rigid than the liner and may include a connector for connecting the interface to a gas delivery tube. The connector may include a bend connector, which may further have misaligned inlets and outlets. The liner is typically made of a softer, more flexible material such as silicone, foam, and / or fabric, at least partially molded to the shape of the user's face.

[0011] The seal formed between the interface and the user's breathing system allows for regulation of mask pressure by reducing gas leakage and providing controlled breathing gas discharge. Gas can be discharged directly from the patient interface through the outlet port to the ambient atmosphere or to another component in the respiratory support system responsible for controlling the discharge of breathing gases. Summary of the Invention

[0012] A system and method for noninvasive ventilation are provided. The system may include a gas source that delivers breathing gas to a patient via one or more of a main flow path and a flushing flow path. The flushing flow path may have higher flow resistance than the main flow path. The system may include a control component configured to open and restrict airflow through the main flow path. When the main flow path is open, a significant portion of the airflow reaches the patient interface via the main flow path. When the main flow path is open, a relatively small portion of the airflow passes through the flushing flow path. When the main flow path is restricted, a greater portion of the airflow (e.g., the majority of the airflow) from the gas source passes through the flushing flow path. When a significant portion of the airflow from the gas source passes through the flushing flow path, it may have a higher velocity (particularly relative to the velocity of the airflow passing through the main flow path). The gas delivered via the flushing flow path can be used to flush dead spaces. One or both of the flow paths can facilitate at least one of inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), and positive end-expiratory pressure (PEEP).

[0013] The control component may be located between the gas source and the patient interface. The control component may be disposed in or form part of the main flow path. The control component may be integrated into the patient interface and / or the gas source. The control component may have a gas source side and a patient interface side. The control component may be operable such that when the pressure on the gas source side of the control component is higher than the pressure on the patient side of the control component, the flow rate through the main flow path is open or less restricted by the control component. An increase in pressure on the gas source side relative to the patient interface side may correspond to a decrease in restriction on the main flow path. The control component may be operable such that when the pressure on the patient interface side of the control component is greater than the pressure on the gas source side of the control component, the flow rate through the main flow path is restricted or more restricted by the control component. An increase in pressure on the patient interface side relative to the gas source side may correspond to an increase in restriction on the flow rate through the main flow path. The control component can therefore be configured to change the flow resistance of the main flow path.

[0014] The control component may include movable members such as baffles or valves. The movable member may be flexible. The movable member may form part of the main flow path. The movable member may close at an opening (which may be an inlet opening) in the main flow path. The movable member may have a gas source side and a patient interface side. The control component may include a housing in which the movable member is located, wherein the gas source side and the patient interface side of the movable member are volumes within the housing. The movable member may be operable such that when the pressure on the gas source side of the movable member is higher than the pressure on the patient side of the movable member, the flow rate through the main flow path is open or less restricted by the movable member. A greater pressure on the gas source side relative to the patient interface side may correspond to a reduced restriction on the main flow path. The movable member may be operable such that when the pressure on the patient interface side of the movable member is greater than the pressure on the gas source side of the movable member, the flow rate through the main flow path is restricted or more restricted by the movable member. The greater pressure on the patient interface side relative to the gas source side can correspond to increased restrictions on the main flow path.

[0015] This document discloses a system for delivering breathing gas to a patient, the system comprising: a patient interface; a breathing circuit for providing fluid communication between a breathing gas source and the patient interface, the breathing circuit and the patient interface defining a primary flow path and a flushing flow path from the breathing gas source; and a control component configured to dynamically change the flow rate through the primary flow path by opening and restricting the primary flow path in response to dynamic changes in airflow or airflow resistance, such that when the control component increases the restriction on the flow rate through the primary flow path, the flow rate of breathing gas through the flushing flow path increases.

[0016] The system may include an exhaust port for discharging gas at a certain exhaust leakage rate, and the exhaust port may be configured to provide an exhaust leakage rate greater than the patient's exhaled gas flow rate.

[0017] The system may include an exhaust port for discharging gas from the system, and the control component may be configured to open and restrict the flow rate through the exhaust port such that when the control component increases the restriction on the flow rate through the main flow path, the control component decreases the restriction on the flow rate through the exhaust port.

[0018] The primary flow path may have a first airflow resistance, the flushing flow path may have a higher second airflow resistance, and the control component may be configured to increase the airflow resistance of the primary flow path in response to pressure changes within the breathing chamber of the patient interface.

[0019] The system may include the control component, which may be configured to increase the resistance of the primary flow path to airflow when the pressure within the breathing chamber of the patient interface increases to substantially equal to or greater than approximately the gas source pressure.

[0020] This document also discloses a system for noninvasive ventilation, comprising: a gas source conduit adapted to be fluidly connected to a gas source at a first end and including a bifurcation having a first branch and a second branch at a second end; a main flow path conduit adapted to be connected to the first branch of the bifurcation as part of a main flow path; a flushing flow path conduit adapted to be connected to the second branch of the bifurcation as part of a flushing flow path, having higher airflow resistance than the main flow path; and a patient interface including a breathing cavity and a nasal flow delivery portion, the patient interface being configured... The device is configured such that the breathing chamber is located in the main flow path and the nasal flow delivery portion is located in the flushing flow path; and a control assembly coupled to or adapted to be coupled to the main flow path, the control assembly including a movable member movable between a first position and a second position, in the first position, the movable member increasing the resistance to airflow through the main flow path, and in the second position, the movable member not increasing the resistance to airflow through the main flow path, the movable member being configured to move between the first position and the second position in response to pressure changes within the breathing chamber of the patient interface.

[0021] The movable component can be configured to move to the first position when the gas pressure in the breathing chamber of the patient interface is greater than approximately the gas source pressure, and to move to the second position when the gas pressure in the breathing chamber is less than or equal to approximately the gas source pressure.

[0022] The control component may further include a feedback port adapted to be fluidly coupled to the breathing chamber of the patient interface and configured to increase the resistance of the airflow in the primary flow path when the feedback pressure coupled from the breathing chamber to the control component is greater than approximately the gas source pressure.

[0023] The control component may further include a feedback port adapted to be fluidly coupled to the breathing chamber of the patient interface, and the control component is configured to operate in response to a feedback pressure coupled from the control component to the breathing chamber.

[0024] The control component may include a movable member. The movable member may include a valve. The movable member may include a baffle. The control component may include a main flow port and a flush flow port, and the movable member is movable between a position where the main flow port is open and a position where the main flow port is restricted. The main flow port may surround the flush flow port, or the flush flow port may surround the main flow port, and the movable member is associated with the main flow port. The movable member may be arranged to open when the main gas flow pressure on the gas source side of the movable member is higher than the pressure on the opposite side of the movable member, and to restrict the main gas flow port when the pressure on the patient side of the movable member is higher than the main gas flow pressure on the gas source side of the movable member.

[0025] This document discloses a control component for a system for providing respiratory gas to a patient. The control component is configured between a respiratory gas source and a patient interface and includes: an airflow inlet; a main outlet; a flushing outlet; and a movable member configured to operate in response to the patient's inhalation and exhalation to limit the flow rate through the main outlet, thereby increasing the flow rate of respiratory gas through the flushing outlet when the pressure within the respiratory chamber increases during the patient's exhalation, and opening the airflow through the main outlet during the patient's inhalation. In embodiments, the control component may incorporate elements as described above.

[0026] This document discloses a system for providing breathing gas to a patient, the system comprising: a patient interface; a breathing gas source; and a breathing circuit arranged to provide fluid communication between the breathing gas source and the patient interface, wherein the system defines a main flow path and a flushing flow path, and is configured to provide breathing gas from the breathing gas source to the patient through the main flow path and the flushing flow path; and wherein the system further comprises: a control component configured to open and restrict the flow rate through the main flow path, wherein when the control component increases the restriction on the flow rate through the main flow path, the flow rate of breathing gas through the flushing flow path increases.

[0027] The respiratory gas source generates an airflow at a gas source pressure. The control component can be configured to limit the flow rate through the primary flow path in response to the pressure within the breathing chamber of the patient interface.

[0028] The control component can be configured to limit the flow rate through the primary flow path in response to the pressure within the breathing chamber of the patient interface relative to the gas source pressure.

[0029] The control component can be configured to limit the flow rate through the primary flow path in response to the difference between the pressure within the breathing chamber of the patient interface and the gas source pressure.

[0030] The restriction on the flow rate applied to the main flow path by the control component can be related to the difference between the pressure within the breathing chamber of the patient interface and the gas source pressure.

[0031] This document discloses a control component for use in a system for supplying respiratory gas to a patient. The control component is configured to be located between a respiratory gas source and a patient interface. The control component includes: a portion of a main flow path of the system; a portion of a flushing flow path of the system; and a movable member configured to open and restrict flow through the main flow path, wherein when the movable member increases the restriction on flow through the main flow path, the flow rate of respiratory gas through the flushing flow path increases.

[0032] This document discloses a system for providing breathing gas to a patient, the system comprising: a patient interface; a breathing gas source; a breathing circuit arranged to provide fluid communication between the breathing gas source and the patient interface; and an exhaust port for discharging gas from the system at a certain exhaust leakage rate, wherein the system is configured to provide an airflow from the breathing gas source at least during patient exhalation at a flow rate greater than the difference between the exhaust leakage rate and the flow rate of the patient's exhaled gas, and the exhaust leakage rate is greater than the flow rate of the patient's exhaled gas.

[0033] This document discloses a system for providing breathing gas to a patient, the system comprising: a patient interface; a breathing gas source; a breathing circuit arranged to provide fluid communication between the breathing gas source and the patient interface; and an exhaust port for discharging gas from the system, wherein the system defines a primary flow path and is configured to provide breathing gas to the patient from the breathing gas source through the primary flow path; and wherein the system further comprises: a control component configured to open and restrict flow through the primary flow path and to open and restrict flow through the exhaust port, wherein when the control component increases the restriction on flow through the primary flow path, the control component decreases the restriction on flow through the exhaust port.

[0034] This document discloses a control component for use in a system for providing respiratory gas to a patient. The control component is configured to be located between a respiratory gas source and a patient interface. The control component includes: a portion of a main flow path of the system; an exhaust port for discharging gas from the system; and a movable member configured to open and restrict flow through the main flow path and to open and restrict flow through the exhaust port, wherein when the movable member increases the restriction on flow through the main flow path, the control component decreases the restriction on flow through the exhaust port.

[0035] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow; a patient interface having a breathing chamber; a main flow path fluidly connected to both the gas source and the patient interface, the main flow path having a first airflow resistance; a flushing flow path fluidly connected to both the gas source and the patient interface, the flushing flow path having a second airflow resistance higher than the first airflow resistance; and a control component configured to increase the resistance of the main flow path in response to pressure within the breathing chamber.

[0036] The control component can be configured to increase the resistance of the primary flow path to a third resistance. The second resistance (of the flushing flow path) can be higher than the third resistance (of the primary flow path). The second resistance can be lower than the third resistance.

[0037] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow; a patient interface having a breathing chamber; a main flow path fluidly coupled to both the gas source and the patient interface, the main flow path having dynamic airflow resistance; a flushing flow path fluidly coupled to both the gas source and the patient interface, the flushing flow path having static airflow resistance; and a control component configured to increase the resistance of the main flow path in response to pressure within the breathing chamber.

[0038] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow; a patient interface having a breathing chamber; a main flow path fluidly coupled to both the gas source and the patient interface, the main flow path having dynamic airflow resistance that is variable between a higher dynamic resistance and a lower dynamic resistance; a flushing flow path fluidly coupled to both the gas source and the patient interface, the flushing flow path having static airflow resistance that is at least greater than the lower dynamic resistance of the main flow path; and a control component configured to increase the first dynamic resistance of the main flow path in response to pressure within the breathing chamber.

[0039] The gas source generates an airflow at a gas source pressure. The control component can be configured to change the resistance of the primary flow path in response to the pressure within the breathing chamber relative to the gas source pressure.

[0040] The control component can be configured to change the resistance of the main flow path in response to the difference between the pressure within the breathing chamber and the gas source pressure.

[0041] The resistance applied to the main flow path by the control component can be related to the difference between the pressure within the breathing chamber and the gas source pressure.

[0042] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow at a gas source pressure; a patient interface having a breathing chamber; a main flow path fluidly connected to both the gas source and the patient interface, the main flow path having dynamic airflow resistance that is variable between a higher dynamic resistance and a lower dynamic resistance; a flushing flow path fluidly connected to both the gas source and the patient interface, the flushing flow path having static airflow resistance that is at least greater than the lower dynamic resistance of the main flow path; and a control component configured to increase the first dynamic resistance of the main flow path when the pressure within the breathing chamber is greater than approximately the gas source pressure.

[0043] This document discloses a system for non-invasive ventilation, comprising: a gas source configured to generate an airflow; a gas source conduit having a first end and a second end, wherein the first end of the gas source conduit is fluidly connected to the gas source, and the second end of the gas source conduit includes a bifurcation having a first branch and a second branch; a main flow path connected to the first branch of the bifurcation, wherein the main flow path includes the first end and the second end and has a first airflow resistance; and a flushing flow path connected to the second branch of the bifurcation, wherein the flushing flow path includes the first end and the second end and has a second airflow resistance greater than the first airflow resistance, wherein the first end of the flushing flow path is connected to the gas source. The second branch of the bifurcation; a control assembly coupled to the main flow path, the control assembly including a movable member having a first position and a second position and being movable between the first position and the second position, wherein in the first position the movable member increases resistance to airflow through the main flow path, and in the second position the movable member does not increase resistance to airflow through the main flow path; a patient interface including a breathing chamber and a nasal delivery portion, wherein the breathing chamber is coupled to the second end of the main flow path, and the nasal delivery portion is coupled to the second end of the flushing flow path, wherein the movable member moves between the first position and the second position in response to pressure within the breathing chamber of the patient interface.

[0044] This document discloses a system for non-invasive ventilation, comprising: a gas source configured to generate an airflow at a gas source pressure; a gas source conduit having a first end and a second end, wherein the first end of the gas source conduit is fluidly connected to the gas source, and the second end of the gas source conduit includes a bifurcation having a first branch and a second branch; a main flow path connected to the first branch of the bifurcation, wherein the main flow path includes the first end and the second end, and has a dynamic first airflow resistance, the dynamic first airflow resistance being variable between a higher dynamic resistance and a lower dynamic resistance; and a flushing flow path connected to the second branch of the bifurcation, wherein the flushing flow path includes the first end and the second end, and has a second static airflow resistance, the second static airflow resistance being at least greater than the lower dynamic airflow resistance, wherein the flushing flow path... The first end is connected to the second branch of the bifurcation; a control assembly is connected to the main flow path, the control assembly including a movable member having a first position and a second position and being movable between the first position and the second position, wherein in the first position the main flow path has higher dynamic resistance and in the second position the main flow path has lower dynamic resistance; a patient interface including a breathing chamber and a nasal delivery portion, wherein the breathing chamber is connected to the second end of the main flow path and the nasal delivery portion is connected to the second end of the flushing flow path, wherein the movable member is configured to move to the first position when the pressure in the breathing chamber of the patient interface is greater than approximately the gas source pressure, and to move to the second position when the pressure in the breathing chamber of the patient interface is less than or equal to approximately the gas source pressure.

[0045] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow having a gas source pressure; a patient interface having a breathing chamber and a nasal delivery portion; a main flow path fluidly connecting the breathing chamber of the patient interface to the gas source and having a first flow resistance; a flushing flow path fluidly connecting the nasal delivery portion of the patient interface to the gas source and having a second flow resistance greater than the first flow resistance; a control component configured to dynamically change the flow resistance of the main flow path; and a feedback arrangement fluidly connecting the breathing chamber of the patient interface to the control component, wherein the control component is configured to increase the flow resistance of the main flow path when the pressure transmitted from the breathing chamber to the control component through the feedback arrangement is greater than approximately the gas source pressure.

[0046] This document discloses a system for noninvasive ventilation, comprising: a gas source configured to generate an airflow having a gas source pressure; a patient interface having a breathing chamber and a nasal delivery portion; a main flow path fluidly connecting the breathing chamber of the patient interface to the gas source and having a dynamic first flow resistance, the dynamic first flow resistance being variable between a higher dynamic resistance and a lower dynamic resistance; a flushing flow path fluidly connecting the nasal delivery portion of the patient interface to the gas source and having a static second flow resistance, the static second flow resistance being at least greater than the lower dynamic resistance of the main flow path; a control component configured to change the dynamic first flow resistance of the main flow path; and a feedback arrangement fluidly connecting the breathing chamber of the patient interface to the control component, wherein the control component is configured to increase the dynamic first flow resistance of the main flow path when the pressure transmitted from the breathing chamber to the control component through the feedback arrangement is greater than approximately the gas source pressure.

[0047] This document discloses a system for non-invasive ventilation, comprising: a gas source configured to generate an airflow; a gas source conduit having a first end and a second end, wherein the first end of the gas source conduit is fluidly connected to the gas source, and the second end of the gas source conduit includes a bifurcation having a first branch and a second branch; a main flow path connected to the first branch of the bifurcation, wherein the main flow path includes the first end and the second end, and a dynamic first airflow resistance that is variable between a higher dynamic resistance and a lower dynamic resistance; and a flushing flow path connected to the second branch of the bifurcation, wherein the flushing flow path includes the first end and the second end, and a second static airflow resistance that is at least greater than the lower dynamic resistance of the main flow path. The first end of the flushing flow path is coupled to the second branch of the bifurcation; a control assembly is coupled to the main flow path, the control assembly including a movable member having a first position and a second position and being movable between the first position and the second position, wherein the main flow path has higher dynamic resistance in the first position and lower dynamic resistance in the second position; a patient interface including a breathing cavity coupled to the second end of the main flow path and a nasal delivery portion coupled to the second end of the flushing flow path; a feedback arrangement fluidly coupling the control assembly to the breathing cavity of the patient interface, wherein the movable member is configured to move between the first position and the second position in response to pressure transmitted to the control assembly through the feedback arrangement.

[0048] This document discloses a control component for use in a system for supplying breathing gas to a patient. The control component is configured to be located between a gas source and a patient interface. The control component includes: a portion of a main flow path of the system having dynamic airflow resistance; a portion of a flushing flow path of the system having static airflow resistance; and a movable member having a first position and a second position and being movable between the first position and the second position, wherein the main flow path has higher dynamic resistance in the first position and lower dynamic resistance in the second position.

[0049] This document discloses a control component for use in a system for supplying breathing gas to a patient. The control component is configured to be located between a gas source and a patient interface. The control component includes: a portion of a main flow path of the system; a portion of a flushing flow path of the system; and a movable member having a first position and a second position and being movable between the first position and the second position. In the first position, the movable member increases resistance to airflow through the main flow path, and in the second position, the movable member does not increase resistance to airflow through the main flow path.

[0050] This article discloses a patient interface for providing breathing gases to a patient in conjunction with any of the control components described above.

[0051] This document discloses a patient interface for providing respiratory gases to a patient, comprising: a frame and liner defining a breathing cavity having a main airflow inlet leading to the breathing cavity; a nasal flow delivery portion for delivering a separate nasal flushing airflow; and a flow control valve system integrated with the interface and dynamically responsive to the patient's inhalation and exhalation to restrict the main airflow and increase the flushing airflow during the patient's exhalation and to enable the main airflow and reduce the flushing airflow during the patient's inhalation.

[0052] This document discloses a one-way valve for a patient interface for supplying breathing gases to a patient. The system includes an orifice and a valve associated with the orifice, the valve including an expansion-type airflow control element. The one-way valve can be incorporated into any system disclosed herein.

[0053] The airflow control element may include a hollow interior for the main airflow through the airflow control element and may be located within a valve body, defining an airflow space between the exterior of the expansion-type flow control element and the interior of the valve body, and is capable of expanding against the interior of the valve body under the intake main airflow pressure to close or restrict the airflow space.

[0054] The valve may also include a secondary flow control element between the expanding airflow control element and the gas port entering the valve, the secondary flow control element being arranged to operate at the patient's exhaled gas pressure to restrict the primary airflow path through the hollow interior of the exhaust flow control element.

[0055] The valve can be configured as a one-way exhaust valve, wherein the orifice is an exhaust orifice, and the expanding airflow control element is an expanding exhaust flow control element.

[0056] This document discloses a patient interface comprising a one-way valve as described above, wherein the orifice and the valve associated with the orifice are incorporated in a portion of the patient interface.

[0057] This article discloses a catheter that includes a one-way valve as described above, the one-way valve being adapted to be coupled to a patient interface, wherein the valve is incorporated into the catheter. Attached Figure Description

[0058] Figure 1 This is a schematic diagram of a respiratory system configured to supply pressurized and humidified breathing gas to the user via a patient interface.

[0059] Figure 2A This is a block diagram of an embodiment of a system that can be used for non-invasive ventilation.

[0060] Figure 2B-2E Several different embodiments of the patient interface are shown, each with a side view and a front view of the patient.

[0061] Figures 3A-3D This is a vertical cross-sectional view of a portion of an embodiment of a system that can be used for non-invasive ventilation, including at least a patient interface and control components. Figure 3A An interface with a control component is shown, where the control component is in the first configuration. Figure 3B Showing Figure 3A The interface, in which the control component is in the second configuration. Figure 3C Showing the status Figure 3A A magnified view of the configured control components. Figure 3D Showing the status Figure 3B A magnified view of the configured control components.

[0062] Figures 4A-4B These are multiple different views of an embodiment of an interface, which incorporates control components. Figure 4A The patient interface is shown from the patient's perspective. Figure 4B The patient interface is shown from the front.

[0063] Figures 5A-5B It consists of multiple different views of the various parts of the patient interface and control components. Figure 5A The patient interface and control components are shown from the patient's perspective. Figure 5B Showing Figure 5A Cross-sectional views, top views, or sagittal diagrams of some patient interfaces and control components.

[0064] Figures 6A-6B It shows Figures 5A-5B The operation diagram of the control components. Figure 6A Showing the first configuration Figures 5A-5B The control components. Figure 6B Showing the second configuration Figures 5A-5B Some control components.

[0065] Figure 7A-7K Several different views of various embodiments of the valve component of the control assembly are shown. Figures 7A-7C Several different views of a first embodiment of the valve are shown. Figures 7D-7E Several different views of a second embodiment of the valve are shown. Figure 7F-7G Several different views of a third embodiment of the valve are shown. Figure 7H-7I Several different views of a fourth embodiment of the valve are shown. Figure 7J-7K Several different views of a fifth embodiment of the valve are shown.

[0066] Figure 8 This is a block diagram of an embodiment of a system that can be used for non-invasive ventilation.

[0067] Figures 9A-9B These are multiple different views of embodiments of the patient interface and control components. Figure 9A The patient interface and control components were demonstrated. Figure 9B Only a side view of the patient interface is shown.

[0068] Figure 10 A vertical cross-sectional view of an embodiment of the patient interface is shown.

[0069] Figure 11A-11C Several different views are shown of embodiments of control components that can be used in conjunction with several different embodiments of the system. Figure 11A The exterior of the control components, including a variety of different gas ports, is shown. Figure 11B A three-quarter view of the partially disassembled control components is shown. Figure 11C A top view showing a portion of the disassembled control components is displayed.

[0070] Figures 12A-12C The first operating configuration is shown. Figure 11A-11C Multiple different views of the control component.

[0071] Figure 12A A partial exploded view of the control components is shown. Figure 12B A longitudinal cross-sectional view of the control component is shown. Figure 12C A cross-sectional view of the control component is shown.

[0072] Figures 13A-13B The second operating configuration is shown. Figure 11A-11C Multiple different views of the control component. Figure 13A A partial exploded view of the control components is shown. Figure 13B A longitudinal cross-sectional view of the control component is shown.

[0073] Figure 13C It shows Figure 11A-11C control components and Figure 10 The patient interface, shown in a vertical cross-section, is in the second operating configuration.

[0074] Figures 14A-14C Cross-sectional views of various parts of an embodiment of the patient interface and control components are shown. Figure 14B Shown in vertical section Figure 14A The control components and patient interface, wherein the control components are in the first operational configuration. Figure 14C Shown in vertical section Figure 14A The control components and patient interface, wherein the control components are in the second operating configuration.

[0075] Figures 15A-15B Several different views are shown of various parts of an embodiment of the patient interface and control components. Figure 15A The patient interface and control components are shown from the front. Figure 15B The patient interface and control components are shown from one side.

[0076] Figure 16 This is a block diagram of an embodiment of a system that can be used for non-invasive ventilation.

[0077] Figures 17A-17E Several different cross-sectional views of embodiments of the control component are shown. Figures 17A-17B The control components are shown in a longitudinal section and in the first operating configuration. Figure 17C-17D The control components are shown in a longitudinal section and in a second operating configuration. Figure 17E A virtual view of the control components is shown.

[0078] Figures 18A-18B Several different cross-sectional views of embodiments of the control component are shown. Figure 18A The control components are shown in a longitudinal section and in the first operating configuration. Figure 18B The control components are shown in a longitudinal section and in the second operating configuration. Figure 18C A virtual view of the control components is shown.

[0079] Figures 19A-19B The schematic diagram illustrates the operation process. Figures 18A-18C The control components (where the internal parts are shown in dashed outline). Figure 19A The first operating configuration is shown. Figures 18A-18C The control components. Figure 19B The second operating configuration is shown. Figures 18A-18C The control components.

[0080] Figures 20A-20CSeveral different views of another embodiment of the control component are shown. Figure 20A The control components are shown in a side view. Figure 20B The control components are shown in a longitudinal section and in the first operating configuration. Figure 20C The control components are shown in a longitudinal section and in the second operating configuration.

[0081] Figure 21A A patient interface with an exhaust port is shown (where the internal portion is shown in dashed outline). Figure 21B and 21C A longitudinal section view is shown, and Figure 21D and Figure 21E A schematic longitudinal cross-sectional view of the vent in different operating states is shown. Detailed Implementation

[0082] exist Figure 1 An exemplary respiratory therapy system is illustrated for supplying breathing gases to a user for non-invasive ventilation therapy. The exemplary respiratory therapy system 1 may include a gas source 3, a humidifier 5, a patient interface 7, and a breathing gas circuit 29 connecting the humidifier (or gas source) to the patient interface 7. The gas source 3 can provide a supply of breathing gases to the humidifier 5. The gas source may include a supplemental breathing gas source, such as pressurized supplemental oxygen, which can be provided in, for example, a hospital environment. Alternatively or additionally, the gas source may include a blower in which breathing gases (e.g., ambient air) are drawn into the gas source 3 through an inlet 9 in the gas source housing using an impeller 11. The rotational speed of the impeller 11 can be adjusted to regulate the amount of air drawn into the gas source 3 and the supply of breathing gases to the respiratory therapy system. The breathing gas may include any single gas or multiple gases that can be breathed by a user of the system 1.

[0083] The pressure and / or flow rate of the breathing gas leaving the gas source 3 can be adjusted by the controller 15. The controller 15 can adjust the rotational speed of the impeller 11 according to one or more predetermined algorithms and according to one or more user inputs that can be provided via user input 17.

[0084] Gas source 3 represents an actively controlled flow generator. Other gas sources, such as compressed air cylinders with appropriate pressure or flow regulation, can also be used to supply breathing gas. The outlet of gas source 3 can be connected to a separate humidifier 5. Humidifier 5 can be configured to heat and / or humidify the breathing gas before delivery (e.g., to a user). In some embodiments, the humidifier is integrated with the gas supply source. Humidifier 5 may include a base 19 and a humidifier chamber 21. Chamber 21 can be configured to contain a humidifying fluid 23, such as water, and can be disengaged from humidifier base 19 (e.g., temporarily or permanently) to allow filling or replacement of the chamber. Humidifier 5 receives gas from gas source 3 through chamber inlet 25. Humidifier base 19 may include a heater, such as a heating plate 27. Chamber 21 rests on heating plate 27 when engaged with humidifier base 19. Heating plate 27 dissipates heat to chamber 21, such as heat generated by resistance. The chamber 21 preferably has a heat-conducting base so that the heat generated by the heating plate 27 can be effectively transferred to the humidifying fluid 23. The controller 15 can also control the humidifier 5, and in particular control the supply of electrical energy to the heating plate 27 to regulate any function of the humidifier 5, such as the temperature and humidity of the breathing gas supplied to the user.

[0085] Breathing gas can be supplied to the user via chamber outlet 28 and a breathing gas circuit 29 in the form of a catheter, which may be combined with a heating or warming element (e.g., a heating wire) to heat or warm (e.g., maintain hot or warm) the breathing gas during delivery to patient interface 7. The electrical energy supplied to the heating wire can be controlled by controller 15. Controller 15 can receive feedback from one or more sensors integrated into a control network throughout the respiratory therapy system to monitor the properties of the breathing gas, such as, but not limited to, pressure, flow rate, temperature, and / or humidity.

[0086] The patient interface 7 connects the user to the respiratory therapy system 1, enabling the delivery of heated and humidified gas, such as from the humidifier 5, to the user's respiratory system. The respiratory gas can be delivered to the user at or near optimal temperature and humidity (e.g., warmed and fully saturated with water vapor at a temperature between 27°C and 37°C) as it is delivered to the user's nostrils and / or mouth. Simulating conditions in the lungs of a healthy adult (37°C, 44 mg / L humidity) can help maintain healthy mucosal function in users with respiratory diseases affecting secretion, and the humidified gas for all patients helps maintain comfort and compliance. Various different patient interface styles can be used in the systems and methods disclosed herein.

[0087] Figure 2AA block diagram illustrating an embodiment of a system for providing and / or maintaining non-invasive ventilation is shown. As shown, the non-invasive ventilation system 200 includes at least a gas source 210, a control assembly 220, a patient interface 230, a breathing circuit 235 connecting the gas source 210 to the patient interface 230, and an exhaust port 270. The gas source 210 may be, for example, a ventilator, a CPAP generator, a flow generator, or a pressurized gas cylinder.

[0088] The patient interface 230 connects a user to the non-invasive ventilation system 200, allowing breathing gas from the gas source 210 to be delivered to the user's respiratory system. In some embodiments, the patient interface 230 includes a mask that seals or substantially seals the user's face around its nose and / or mouth, and a nasal delivery portion for delivering gas into at least one of the user's nostrils. The nasal delivery portion has at least one opening located near or within one or more of the user's nostrils, such that, in use, gas exiting the nasal delivery portion is directed into at least one of the user's nostrils. The nasal delivery portion may include an unsealed nasal cannula comprising, for example, one or more nasal forks configured for insertion into one or more nostrils of a user; one or more nasal pillows at least partially sealing against the corresponding nostril of the user (e.g., one nasal fork abuts against the nostril into which it guides air, while another nasal fork does not abut against the nostril into which it guides air); one or more stems extending toward but not into one or more nostrils of the user; or one or more openings or holes configured to guide airflow toward or into one or more nostrils of the user. The nasal delivery portion may be occluded between the user's face and the mask of the patient interface 230. In some embodiments, the nasal delivery portion is integrally formed with the mask. In some embodiments, the nasal delivery portion is attached (e.g., reversibly, removably, or permanently), coupled (e.g., reversibly, removably, or permanently), or otherwise attached (e.g., reversibly, removably, or permanently) to the mask.

[0089] In some embodiments, the mask of the patient interface 230 is configured to seal at least around the nasal delivery portion to the patient's face. In some embodiments, the patient interface 230 has a single sealing portion, such as a seal, that seals to the face around both the mouth and nose. In some embodiments, the patient interface 230 has at least two sealing portions, for example, one sealing portion seals around the mouth and a second sealing portion seals around the nose. In some embodiments, the mask incorporates a separate opening to the nasal delivery portion (e.g., at least one opening of the nasal opening) to allow gas to flow from a gas source to the patient. The mask may define a breathing chamber such that the mask opening is an opening within the breathing chamber. Gas can flow from the breathing circuit into the breathing chamber through the mask opening. In use, the breathing chamber can be maintained at an elevated pressure, such as above atmospheric pressure, to provide non-invasive ventilation therapy to the patient. By sealing the mask to the patient's face around the nasal delivery portion, airflow not inhaled by the patient through the mask opening or the nasal delivery portion can be (at least temporarily) retained within the breathing chamber to help maintain the therapeutic pressure.

[0090] In this specification, references to patient interfaces may include a full-face mask that seals around the user's mouth and nose, and / or a nasal mask that covers only the user's nose. Figure 2B-2E This paper demonstrates a variety of different types of patient interfaces that can be used in conjunction with one or more different systems and / or treatments disclosed herein. Figure 2B A full-face mask-style interface 201 is shown, which includes a nasal cannula 202 that seals around the patient's nose and mouth and is supplied with airflow by a catheter 203. Figure 2C The entire facial interface 204 is shown, which includes a nasal cannula 202 and is substantially or completely sealed around the patient's face, including at least the patient's nose, mouth and eyes. Figure 2D A subnasal interface 205 is shown, which includes a nasal cannula 202 and is sealed on the underside of the nose around the patient's mouth and nostrils. Figure 2E A nasal interface 206 is shown, which includes a nasal cannula and is sealed only around the patient's nostrils. Where this specification relates to a nasal cannula, it should be understood that other forms of nasal delivery portions described elsewhere herein may be used.

[0091] The noninvasive ventilation system 200 can be configured such that a gas source 210 delivers breathing gas to a patient via at least a flushing flow path 250 and a main flow path 260. A control component 220 can be configured to control or adjust (e.g., increase, decrease, start, stop) the airflow to the patient through the main flow path 260. By controlling the main flow path 260, the control component can be configured to influence and thus indirectly control the airflow to the patient interface 230 through the flushing flow path 250. This control component is schematically shown integrated within the breathing circuit at a location between the patient interface and the gas source. However, as discussed elsewhere herein, the control component can be integrated into both the patient interface and / or the gas source.

[0092] In some embodiments, the flushing flow path 250 includes a nasal delivery portion of the patient interface 230 (e.g., a cannula or one or more nasal forks of the patient interface 230). In some embodiments, the main flow path 260 includes the breathing chamber of the patient interface 230.

[0093] In some embodiments, the airflow through flushing flow path 250 (which may include a nasal delivery portion) is continuous and unidirectional. In some embodiments, the airflow through flushing flow path 250 (which may include a nasal delivery portion) is discontinuous. In some embodiments, the airflow through flushing flow path 250 (which may include a nasal delivery portion) may continuously flush at least a portion of the patient interface 230 (e.g., a mask) and / or one or more anatomical dead chambers of exhaled air. In some embodiments, the airflow through flushing flow path 250 (which may include a nasal delivery portion) does not continuously flush a portion of the patient interface 230 (e.g., a mask) or one or more anatomical dead chambers of exhaled air. As used herein, “dead chamber” refers to either or both of a device dead chamber and an anatomical dead chamber. A device dead chamber is an area in any device of a system (e.g., a mask and a breathing circuit) in which exhaled air has not been completely cleared and may be re-inhaled. Anatomical dead chambers include areas in the nose, pharynx, trachea, and bronchi where CO2 levels may increase. The systems and methods disclosed herein can advantageously provide improved flushing of anatomical and / or device dead chambers.

[0094] CO2 re-inhalation can be reduced by continuously or intermittently washing or flushing the user's nostrils and / or nasal cavity (or other anatomical or device-ineffective cavities) with fresh gas (e.g., gas with a low CO2 concentration). Exhaled gas can be expelled from the patient interface 230, for example, through exhaust port 270. In some embodiments, the rate of respiratory gas delivered to the user via the nasal delivery portion dynamically increases and decreases due to one or more factors, including, for example, pressure provided by a gas source (which may be configured to cycle between relatively high and relatively low pressures, e.g., to deliver IPAP and EPAP, or may be configured to deliver a constant pressure flow to the interface), the expiratory flow pressure generated by the patient during their exhalation (which may be non-constant in a single breath and / or between different breaths), and / or the inspiratory flow pressure generated by the patient during their inhalation (which may be non-constant in a single breath and / or between different breaths). In some embodiments, the rate of respiratory gas delivered to the patient via the nasal delivery portion is passively controlled by a control component and may vary throughout the respiratory cycle.

[0095] Breathing gas can be delivered at a flow rate exceeding the patient's peak inspiratory flow requirement (e.g., delivered to a patient interface) to ensure the clearance of exhaled gas throughout one or more portions of the respiratory cycle (e.g., the entire respiratory cycle). Either or both of the delivery of breathing gas to the mask and the exhaust gas from the mask can be controlled, for example, passively or actively, to regulate the pressure within the mask. In some embodiments, the exhaust flow rate is actively regulated by components within the respiratory support system (e.g., regulated by a gas supply device). In some embodiments, the exhaust flow rate is passively regulated (e.g., by using a variable or invariant outlet orifice to fix the restriction on airflow). In some embodiments, the exhaust flow rate is regulated by a combination of active and passive ventilation. In some embodiments, exhaust can be adjusted (e.g., restricted or permitted) by movable components of a control assembly. For example, a septum of the control assembly can have a flow-limiting position where it restricts the primary flow path and allows flow through the exhaust flow path. A septum of the control assembly can have a smaller limiting position where it allows flow through the primary flow path and restricts flow through the exhaust flow path.

[0096] Using the systems and methods disclosed herein, a patient's airway pressure can be regulated / adjusted by manipulating one or more of the gas delivery flow rate supplied to the nasal delivery portion, the gas delivery flow rate supplied to the mask, and the outlet flow rate of exhaust or discharge from the mask. In some embodiments, the systems and methods disclosed herein are configured to generate and / or maintain inspiratory positive airway pressure (IPAP). In some embodiments, the systems and methods disclosed herein are configured to generate and / or maintain expiratory positive airway pressure (EPAP). In some embodiments, the systems and methods disclosed herein are configured to generate and / or maintain positive end-expiratory pressure (PEEP). Positive end-expiratory pressure (PEEP) can prevent airway and alveolar collapse at the end of expiration and is also used to reopen collapsed airways and alveolar collapse. PEEP can improve gas exchange (by reducing intrapulmonary shunting), reduce airflow resistance (by reducing intrapulmonary flow resistance), and can also increase oxygen and carbon dioxide levels, thereby reducing the need for supplemental oxygen and the patient's perception of dyspnea. PEEP can also improve cardiac function by increasing mean intrathoracic pressure. PEEP may be particularly beneficial in the treatment of obstructive pulmonary disease and heart failure, including emphysema, bronchiectasis, chronic bronchitis, cystic fibrosis, and pulmonary edema.

[0097] As described herein, delivering a high-velocity flow at a sufficiently high volumetric flow rate (and flushing dead space) during one or more portions of breathing (e.g., exhalation only) can adequately improve gas exchange in a patient to achieve or allow reduction of one or more of IPAP, EPAP, and PEEP in one or more noninvasive ventilation therapies. Alternatively, the amount of CO2 in dead space can be reduced and better gas exchange can be achieved at one or more approximately the same pressures compared to conventional noninvasive ventilation systems. Therefore, using the embodiments disclosed herein, better gas exchange can be achieved at the same IPAP, EPAP, and / or PEEP. In some embodiments, control component 220 is configured to control the airflow from gas source 210 to generate a primary pressure flow and / or a high (higher) velocity flow for flushing. In some embodiments, control component 220 is configured to control the airflow from gas source 210 to generate a primary flow, such as a high-pressure flow, which can be delivered via primary flow path 260, particularly or preferably during patient inspiration. In some embodiments, control component 220 is configured to control airflow from gas source 210 to generate a flushing flow, such as a high-velocity flow, which can be delivered via flushing flow path 250, particularly or preferably during patient exhalation. In this way, control component 220 can be configured to generate two flows with different characteristics from a single source (e.g., gas source 210). The control component is configured to provide airflow from a single gas source to a patient interface, which is configured (e.g., at all times) to maintain the therapeutic pressure required by the patient while also flushing dead space. Some embodiments of control component 220 disclosed herein provide passive control, such as passively controlling the airflow received from gas source 210 to divide it into flushing flow path 250 and main flow path 260.

[0098] One or more embodiments of the methods for noninvasive ventilation disclosed herein advantageously facilitate the flushing of dead space while maintaining the pressure required for noninvasive ventilation in a portion of the patient interface (e.g., in the mask of the patient interface) by including one or more of the following: guiding flow into a portion of the patient interface (e.g., a nasal delivery portion, which may include a nasal cannula or one or more nasal forks); maintaining flow into a portion of the patient interface (e.g., a nasal delivery portion, which may include a nasal cannula or one or more nasal forks); or increasing and / or decreasing flow into a portion of the patient interface (e.g., a nasal delivery portion, which may include a nasal cannula or one or more nasal forks) at appropriate times / periods during the patient's respiratory cycle.

[0099] In some embodiments, the gas source 210 includes a ventilator. In some embodiments, the gas source 210 is configured to operate at speeds between approximately 1 L / min and 240 L / min, approximately 2.5 L / min and 230 L / min, approximately 5 L / min and 220 L / min, approximately 7.5 L / min and 210 L / min, approximately 10 L / min and 200 L / min, approximately 12.5 L / min and 190 L / min, approximately 15 L / min and 180 L / min, approximately 17.5 L / min and 170 L / min, approximately 20 L / min and 160 L / min, approximately 22.5 L / min and 150 L / min, approximately 25 L / min and 140 L / min, approximately 27.5 L / min and 130 L / min, approximately 30 L / min and 120 L / min, or approximately 32.5 L / min and 110 L / min. The gas source 210 is configured to provide airflow at rates between approximately 35 L / min and 100 L / min, between approximately 37.5 L / min and 90 L / min, between approximately 40 L / min and 80 L / min, between approximately 42.5 L / min and 70 L / min, between approximately 45 L / min and 60 L / min, or between approximately 47.5 L / min and 50 L / min. In some embodiments, the gas source 210 is configured to provide airflow at rates less than approximately 240 L / min, less than approximately 230 L / min, less than approximately 220 L / min, less than approximately 210 L / min, less than approximately 200 L / min, less than approximately 190 L / min, less than approximately 180 L / min, less than approximately 170 L / min, less than approximately 160 L / min, less than approximately 150 L / min, less than approximately 140 L / min, less than approximately 130 L / min, less than approximately 120 L / min, or less than approximately 110 L / min.In some embodiments, the gas source 210 is configured to provide an airflow at a rate between about 1 L / min and 100 L / min, about 2.5 L / min and 95 L / min, about 5 L / min and 90 L / min, about 7.5 L / min and 85 L / min, about 10 L / min and 80 L / min, about 12.5 L / min and 75 L / min, about 15 L / min and 70 L / min, about 17.5 L / min and 65 L / min, about 20 L / min and 60 L / min, about 22.5 L / min and 55 L / min, about 25 L / min and 50 L / min, about 27.5 L / min and 45 L / min, or about 30 L / min and 40 L / min. Gas source 210 can be configured to provide airflow at a rate less than about 100 L / min, less than about 95 L / min, less than about 90 L / min, less than about 85 L / min, less than about 80 L / min, less than about 75 L / min, less than about 70 L / min, less than about 65 L / min, less than about 60 L / min, less than about 55 L / min, less than about 50 L / min, less than about 45 L / min, less than about 40 L / min, less than about 35 L / min, less than about 30 L / min, less than about 25 L / min, less than about 20 L / min, less than about 15 L / min, less than about 10 L / min, or any other flow rate that advantageously delivers the treatment disclosed herein (e.g., promoting the flushing of the user's nasal cavity and / or guiding or maintaining the delivery of pressure into the patient interface).

[0100] In some embodiments, the gas source 210 is configured to provide gas at pressures less than about 60 cmH2O, less than about 55 cmH2O, less than about 50 cmH2O, less than about 45 cmH2O, less than about 40 cmH2O, less than about 35 cmH2O, less than about 30 cmH2O, less than about 25 cmH2O, less than about 20 cmH2O, less than about 15 cmH2O, less than about 10 cmH2O, or less than about 5 cmH2O. In some embodiments, the gas source 210 is configured to provide a constant pressure, for example, during user inhalation and user exhalation. In some embodiments, the gas source 210 is configured to provide gas at a first pressure during inhalation and at a second pressure different from the first pressure during exhalation. In some embodiments, the gas source 210 is configured to deliver gas at a rate of approximately 5 cmH2O - 40 cmH2O, approximately 6 cmH2O - 38 cmH2O, approximately 7 cmH2O - 36 cmH2O, approximately 8 cmH2O - 34 cmH2O, approximately 9 cmH2O - 32 cmH2O, approximately 10 cmH2O - 30 cmH2O, approximately 11 cmH2O - 28 cmH2O, approximately 12 cmH2O - 26 cmH2O, approximately 13 cmH2O - 24 cmH2O, approximately 14 cmH2O - 22 cmH2O, approximately 15 cmH2O - 20 cmH2O, approximately 16 cmH2O - 18 cmH2O, or approximately 8 cmH2O - 25 cmH2O during the user's inhalation. In some embodiments, gas source 210 is configured to provide gas at pressures between 0 and 16 cmH2O, between 1 and 15 cmH2O, between 2 and 14 cmH2O, between 3 and 13 cmH2O, between 4 and 12 cmH2O, between 5 and 11 cmH2O, between 6 and 10 cmH2O, between 7 and 9 cmH2O, or any other pressure that advantageously delivers the treatment disclosed herein (e.g., generating or maintaining EPAP during user exhalation). In some embodiments, gas source 210 is configured to provide gas at a pressure sufficient to maintain PEEP.

[0101] Gas source 210 may be connected to breathing circuit 235, for example, via an outlet through which it supplies breathing gas. The pressure and flow rate at the outlet of gas source 210 (e.g., gas exiting gas source 210) may be at a first pressure P1 and a first volumetric flow rate F1. Gas source 210 may be controlled to provide the first pressure (P1) and the first flow rate (F1) to achieve a desired pressure at the patient interface, for example, within the breathing chamber of a mask. The first pressure (P1) and the first flow rate (F1) may be controlled to account for / compensate for losses between gas source 210 and patient interface 230, such as system pressure losses. As described above, the pressure at the patient interface may vary during the user's respiratory cycle (e.g., between IPAP and EPAP).

[0102] The breathing circuit 235 is divided, branched, or split into a flushing flow path 250 and a main flow path 260. Each of the flushing flow path 250 and the main flow path 260 may have a separate outlet within the patient interface through which breathing gas is delivered to the user. The pressure and flow rate at the outlet of the flushing flow path may be at a second pressure P2 and a second volumetric flow rate F2. The pressure and flow rate at the outlet of the main flow path may be at a third pressure P3 and a third volumetric flow rate F3.

[0103] Control component 220 may define the inlet of the main flow path 260, such as an inlet from gas source 210. Flushing flow path 250 may be connected to gas source 210 via a defined flow path (e.g., a flow path not directly altered or modified by control component 220). When control component 220 restricts the main flow path 260, one or more of the volume and velocity of the gas flowing through flushing flow path 250 may be increased. Control component 220 may be configured to have both a gas source side and a patient interface side. The gas source side of control component 220 may include an inlet for the control component. The patient interface side of control component 220 may include an outlet for the main flow path 260. Control component 220 may be configured to vary the flow resistance of the main flow path 260.

[0104] Control component 220 may be operable such that when the pressure on the gas source side of control component 220 (e.g., typically corresponding to P1 minus any pressure loss between gas source 210 and control component 220) is higher than the pressure on the patient interface side of control component 220 (typically corresponding to P3 plus any pressure loss between the patient interface side of control component and the outlet of the main flow path), the flow rate through main flow path 260 is open, unrestricted, or relatively less restricted by control component 220. Control component 220 may be configured to dynamically respond to the aforementioned pressure differential. For example, the amount of restriction provided by control component 220 may be related to the magnitude of the pressure differential. A larger pressure differential between the gas source side and the patient interface side of control component (where the pressure on the gas source side is higher than the pressure on the patient interface side) may correspond to a reduced restriction on main flow path 260.

[0105] Control component 220 may also be operable such that when the pressure on the patient interface side of control component 220 (typically corresponding to P3 plus any pressure loss from the patient interface side of control component and the outlet of the main flow path) is higher than the pressure on the gas source side of control component 220 (typically corresponding to P1 minus any pressure loss between gas source 210 and control component 220), the flow rate through the main flow path 260 is shut off, restricted, or relatively more restricted by control component 220. Control component 220 may be configured to respond dynamically to the aforementioned pressure differential. For example, the amount of restriction provided by control component 220 may be related to the magnitude of the pressure differential. A larger pressure differential between the gas source side and the patient interface side of control component (where the pressure on the patient interface side is higher than the pressure on the gas source side) may correspond to an increased restriction on the main flow path 260.

[0106] When control component 220 restricts the flow rate through main flow path 260, for the same pressure (P1) at the outlet of gas source 210, the flow rate (F3) through main flow path 260 decreases, and the flow rate (F2) through flushing flow path 250 increases, for example, by the volume (or approximately that volume) reduced by the flow rate through main flow path 260. As the volumetric flow rate (F2) through flushing flow path 250 increases, the velocity of the airflow through flushing flow path 250 also increases. The system can be configured such that the velocity and / or volumetric flow rate (F2) of the airflow through flushing flow path 250 is sufficiently high for a sufficient duration for the patient's respiratory cycle to achieve flushing of at least a portion of the anatomical and / or device dead space. Similarly, when control component 220 opens or reduces the flow restriction through main flow path 260, for the same pressure (P1) at the outlet of gas source 210, the flow rate (F3) through main flow path 260 increases, and the flow rate (F2) through flush flow path 250 decreases due to the reduced flow resistance through main flow path. As the volumetric flow rate (F3) through main flow path 260 increases, the velocity of the gas flow through main flow path 260 also increases. However, since the flow resistance of main flow path 260 when fully open or unrestricted can be relatively less than the flow resistance of flush flow path 250 when fully open or unrestricted, the increase in gas velocity through main flow path 260 when fully open is relatively less than the increase in gas velocity through flush flow path 250 when main flow path is closed, restricted, or more restricted (e.g., when control component closes or restricts main flow path 260).

[0107] The increase in pressure on the patient interface side of control component 220 relative to the pressure on the gas source side typically occurs during patient exhalation. This is because the patient is exhaling (exhaling) and adding mass to a fixed volume of gas in patient interface 230 (e.g., the breathing chamber of patient interface), thereby increasing the pressure P3 in the main flow path 260 (e.g., at the outlet of main flow path 260). During patient inhalation, the pressure on the patient interface side of control component 220 typically decreases relative to the pressure on the gas source side of control component 220 because the patient is inhaling air (inhaling) and removing mass from a fixed volume of gas in patient interface 230. System 200 may be configured to provide flushing of at least a portion of the anatomical and / or device dead space during exhalation, and in at least some embodiments, flushing is provided sparingly (if any) during inhalation.

[0108] When control component 220 restricts the flow rate (F3) through main flow path 260, the local back pressure on the airflow at the gas source side of control component 220 may increase. Therefore, to further restrict the flow rate (F3) through main flow path 260, higher pressure may be required at the patient interface side of control component 220. Thus, control component 220 may not completely close / restrict (e.g., may not be able to completely close / restrict) main flow path 260. It also provides smooth operation of control component 220. That is, control component 220 can provide controlled and smooth restriction and unrestriction of the flow rate through main flow path 260 without causing sudden and / or uncomfortable changes in the flow rate to / to the patient through main flow path 260 or flush flow path 250.

[0109] Pressure, flow rate, and / or velocity in different components or parts (e.g., flow paths) of the ventilator system can vary dynamically during use. For example, when gas source 210 operates at different IPAP and EPAP pressures, the first pressure (P1) can cycle between different pressures (e.g., the first pressure (P1) can cycle between IPAP and EPAP pressures). The second pressure (P2) and second flow rate (F2) and the third pressure (P3) and third flow rate (F3) in flushing flow path 250 and main flow path 250 may also vary due to variations in the first pressure (P1) and / or the operation of control component 220 (which themselves can vary according to or in response to the patient's breathing pattern). In some embodiments, flushing flow path 250 and main flow path 260 are configured to deliver gas at pressures sufficient to generate and / or maintain IPAP (e.g., when control component 220 is open, such as in a relatively unrestricted configuration, such as during the user's inhalation). In some embodiments, a substantially separate primary flow path 260 (e.g., contributing little, minimal, or virtually nothing from the flushing flow path 250) is configured to deliver gas at a pressure sufficient to generate and / or maintain IPAP (e.g., when control component 220 is open, such as in a relatively unrestricted configuration, such as during user inhalation). In some embodiments, the flushing flow path 250 and the primary flow path 260 are configured to deliver gas at a rate sufficient to completely, substantially, and / or partially flush at least a portion of the user's anatomical dead space (e.g., when control component 220 is closed, such as in a relatively restricted configuration, such as during user exhalation). In some embodiments, a substantially separate flushing flow path 250 (e.g., contributing little, minimal, or virtually nothing from the primary flow path 260) is configured to deliver gas at a rate and / or volumetric flow rate sufficient to completely, substantially, and / or partially flush at least a portion of the user's anatomical dead space (e.g., when control component 220 is closed, such as in a relatively restricted configuration, such as during user exhalation). In some embodiments, one or both of the flushing flow path 250 and the main flow path 260 are configured to supply gas at a pressure sufficient to maintain PEEP.

[0110] The third pressure (P3) and third flow rate (F3) in the main flow path 260, and the second pressure (P2) and second flow rate (F2) in the flushing flow path 250, depend on a number of factors, including but not limited to: the first pressure (P1) and first flow rate (F1) provided by the gas source 210, the flow rate limit provided by the flushing flow path 250, the length of the flushing flow path 250, the flow rate limit provided by the main flow path 260, the length of the main flow path 260, and the user's inhalation and exhalation flow rates. The control component 220 can be configured to increase or decrease the flow resistance of the main flow path 260. By modifying the length of one or both flow paths or the resistance of one or both flow paths, the system can be adapted for use in varying environments.

[0111] Compared to the main flow path 260, the flushing flow path 250 may have one or more characteristics that restrict or inhibit flow. Therefore, unimpeded (e.g., unobstructed by control component 220 or any other adjustment element), a larger volume of breathing gas will proceed to the patient interface 230 via the main flow path 260 compared to the flushing flow path 250. That is, unimpeded, the first flow rate (F1) is greater than the third flow rate (F3) (the first flow rate is split into a second and a third flow rate, and therefore must be greater), which in turn is greater than the second flow rate (F2). The sum of the second flow rate (F2) and the third flow rate (F3) equals the first flow rate (F1) minus any leakage or other losses between the gas source 210 in the system and the outlets of the main flow path 260 and the flushing flow path 250. In some embodiments, the sum of the second flow rate (F2) and the third flow rate (F3) is approximately equal to the first flow rate (F1). However, the second flow rate (F2) and the third flow rate (F3) can vary (e.g., depending on the action of control component 220 or one or more other adjusting components of the system).

[0112] The flushing flow path 250 can provide a flow path from the gas source 210 to the nasal delivery portion associated with the patient interface 230, such as a continuous or continuously open flow path. The flushing flow path 250 may have higher flow resistance than the main flow path 260. The higher flow resistance in the flushing flow path 250 can be attributed to the fact that at least a portion of the cross-sectional area of ​​the flushing flow path 250 is smaller than that of the main flow path 260. Therefore, given equal flow rates (e.g., when the main flow path 260 is not obstructed by the control component 220), the gas flowing through the flushing flow path 250 will have a higher velocity (e.g., substantially higher velocity) than the gas flowing through the main flow path 260.

[0113] The primary flow path 260 can provide a flow path from the gas source 210 to the patient interface 230 (e.g., the breathing chamber defined by the mask of the patient interface 230). Due to the flow rate that can pass through the primary flow path 260, the primary flow path 260 can be configured to substantially contribute to (e.g., generate and / or maintain) one or more of inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), and positive end-expiratory pressure (PEEP).

[0114] Control component 220 can be configured to respond to the pressure (P) within the breathing chamber of patient interface 230. PI Changes in the pressure within the breathing chamber of the patient interface 230, such as increases and decreases of one or more. For example, control component 220 can be configured to respond to changes in the pressure within the breathing chamber of the patient interface 230 (P...). PI When the pressure increases above a certain value (e.g., a dynamic value), the flow rate in the main flow path 260 is suppressed, reduced, or stopped. This value can be or corresponds to the pressure on the gas source side of the control component 220 (which can correspond to the gas source pressure (P1) minus any pressure loss in the system between the gas source and the control component). The pressure within the patient interface 230 may increase due to the patient's exhalation. Similarly, the control component 220 can be configured to suppress, reduce, or stop the flow rate when the pressure within the patient interface 230 (P1) increases above a certain value (e.g., a dynamic value). PI When the pressure decreases below a certain value (e.g., a dynamic value), the flow rate in the main flow path 260 is encouraged, increased, or initiated. This value may be or correspond to the pressure on the gas source side of the control component 220 (which may correspond to the gas source pressure (P1) minus any pressure loss in the system between the gas source and the control component). Since the volume of air inhaled by the patient is larger than the volume of air entering the mask, the pressure within the patient interface 230 may decrease due to patient inhalation. In some embodiments, the control component 220 is configured to respond to a relative or comparative pressure value, such as one or more pressures (P1, P2, P3, P4, P5, P6, P7, P8, P9, P1, P1, P2 ...2, P1, P2, P1 PI For example, a first pressure (P1), a second pressure (P2), a third pressure (P3), or some combination of the first pressure (P1), the second pressure (P2), and the third pressure (P3). In some embodiments, the control component 220 operates passively, for example, in response to system feedback or conditions, such as changes in system or local pressure.

[0115] Deliver breathing gas to Figure 2A The patient interface 230 can be determined based on pressure balance. When the pressure within the breathing chamber of the patient interface 230 (P...) PIWhen the pressure (P1) in the breathing chamber of the patient interface 230 exceeds a certain value (e.g., a dynamic value), which can be or corresponds to the pressure on the gas source side of the control component 220 (which can correspond to the gas source pressure (P1) minus any pressure loss in the system between the gas source and the control component), all, substantially all, most, or almost all of the gas delivered to the patient interface 230 will pass through the flushing flow path 250 because the control component 220 restricts, inhibits, or reduces the flow through the main flow path 260. When the pressure (P1) within the breathing chamber of the patient interface 230 exceeds a certain value (e.g., a dynamic value), this value can be or corresponds to the pressure on the gas source side of the control component 220 (which can correspond to the gas source pressure (P1) minus any pressure loss in the system between the gas source and the control component), all, substantially all, most, or almost all of the gas delivered to the patient interface 230 will pass through the flushing flow path 250 because the control component 220 restricts, inhibits, or reduces the flow through the main flow path 260. PI When the flow rate is equal to or below a certain value (e.g., a dynamic value), which may be or corresponds to the pressure on the gas source side of the control component 220 (which may correspond to the gas source pressure (P1) minus any pressure loss in the system between the gas source and the control component), gas will be delivered to the patient interface 230 through both the flushing flow path 250 and the main flow path 260, because the control component 220 does not restrict, inhibit, or reduce (or is slightly inhibiting or reducing) the flow rate through the main flow path 260. When the control component 220 does not inhibit the flow rate through the main flow path 260, the third gas flow rate (F3) through the main flow path 260 is greater than the second gas flow rate (F2) through the flushing flow path 250, because the flow resistance of the flushing flow path 250 is higher (or, in other words, because the main flow path 260 has lower flow resistance than the flushing flow path 250, the flow rate in the main flow path 260 may be higher than the flow rate in the flushing flow path 250).

[0116] In some embodiments, the control component 220 may be configured to respond to changes in the pressure within the breathing chamber of the patient interface 230 (P... PI When the pressure (P1) at the outlet of gas source 210 is greater than the pressure within gas source conduit 240, the flow rate through the main flow path 260 is closed, substantially closed, or limited. In some embodiments, control component 220 may be configured to close or substantially close or limit the flow rate through the main flow path 260 when the pressure (P1) within the breathing chamber of patient interface 230 is greater than the first pressure (P1) at the outlet of gas source 210 or the pressure within gas source conduit 240. PI When the pressure (P3) in the main flow path 260 is greater than the third pressure (P3) within the main flow path 260 (e.g., the pressure in the main flow path 260 on the gas source side of the control component), the flow rate through the main flow path 260 is closed, substantially closed, or limited.

[0117] The non-invasive ventilation system 200 can be balanced so that the pressure (P) within the breathing chamber of the patient interface 230 is balanced during or at least a portion of the patient's inspiration. PIThe pressure is equal to or less than a certain value (e.g., a dynamic value), which can be or corresponds to the pressure on the gas source side of the control component (which can correspond to the gas source pressure P1 minus any pressure loss in the system between the gas source and the control component). This is because during inspiration, the patient is drawing gas from the breathing chamber. Therefore, the control component 220 is opened or remains open so that the flow can pass through the main flow path 260 unimpeded or substantially unimpeded. When the control component 220 is open, the flow may be more favorable to the main flow path 260 than to the flushing flow path 250 because the main flow path 260 may have lower flow resistance than the flushing flow path 250. In other words, the flushing flow path 250 may have higher flow resistance than the main flow path 260; therefore, when the control component 220 is open, gas will flow through both the flushing flow path 250 and the main flow path 260, but due to the higher flow resistance of the flushing flow path 250, the gas will preferentially flow through the main flow path 260. Therefore, during inspiration, the control component 220 can supply gas to the patient substantially through the main flow path 260. During inspiration, the main flow path 260 can substantially contribute to (e.g., generating and / or maintaining) IPAP.

[0118] Noninvasive ventilation systems have ventilation arrangements to improve system performance. Ventilation is an intentional leak in a system (e.g., a mask or patient interface) that allows gas (e.g., a CO2-rich gas) to escape from the breathing circuit. Conventional systems typically deliver up to 20 to 50 liters per minute at typical therapeutic pressures. However, patients typically exhale at a rate of about 30 liters per minute. This means that in a conventional system (and assuming no major accidental leaks), 10 liters or more of exhaled gas (CO2-rich) per minute is exhaled into the patient interface and breathing circuit. Therefore, on the next inspiration, due to the reduced total mass of inspiratory gas (e.g., an increased CO2 concentration), the patient re-inhales this CO2-rich gas and receives suboptimal gas exchange. In some embodiments of the noninvasive ventilation systems disclosed herein, the system is configured to deliver ventilation at a volumetric flow rate higher than the patient's expiratory rate. To maintain EPAP, the first flow rate (F1) can be greater than (e.g., slightly or slightly greater than) the difference between the ventilation leak rate and the flow rate of the patient's exhaled gas. Therefore, for example, if the exhaust port 270 ventilates at a rate of approximately 50 liters per minute, the gas source 210 can advantageously supply gas to the patient interface 230 at a flow rate (F1) greater than approximately 20 liters per minute (approximately 30 L / min exhalation + approximately 20 L / min flow = approximately 50 L / m exhaust). Furthermore, for example, if the exhaust port 270 ventilates at a higher rate of approximately 70 liters per minute, the gas source 210 can advantageously supply gas to the patient interface 230 at a flow rate (F1) of approximately 40 liters per minute (approximately 30 L / min exhalation + approximately 40 L / min flow = approximately 70 L / m exhaust). In some embodiments, the second flow rate (F2) of the flushing flow path can be greater than (e.g., slightly or slightly greater than) the difference between the ventilation leakage rate and the flow rate of the patient's exhaled gas. In this way, EPAP can be maintained. Ventilation can be provided at the patient interface 230 (e.g., a patient mask, breathing circuit, or gas source).

[0119] In some embodiments, the vent 270 is configured to discharge exhaust gas, for example, to the atmosphere, at a rate of at least about 25 L / min, at least about 30 L / min, at least about 35 L / min, at least about 40 L / min, at least about 45 L / min, at least about 50 L / min, at least about 55 L / min, at least about 60 L / min, at least about 65 L / min, at least about 70 L / min, at least about 75 L / min, or at least about 80 L / min.

[0120] In some embodiments, the vent 270 is passive and provides some resistance to ventilation, for example, the vent 270 vents to the atmosphere based on the pressure inside the patient interface 230. In some embodiments, the vent 270 provides active resistance to ventilation, for example, the vent 270 vents to the atmosphere at a rate responsive to a sensor or other mechanism (e.g., venting faster or slower in response to sensor feedback). Therefore, during exhalation, the pressure within the breathing chamber of the patient interface 230 (P...) PI The pressure (P1) relative to the flow rate from gas source 210 increases. The non-invasive ventilation system 200 can be balanced such that during or at least a portion of the patient's exhalation, the pressure (P1) within the breathing chamber of the patient interface 230 increases. PI The pressure is greater than a certain value (e.g., a dynamic value), which may be or corresponds to the pressure on the gas source side of the control component 220 (which may further correspond to the gas source pressure P1 minus any pressure loss in the system between the gas source and the control component), and the control component 220 restricts the flow through the main flow path 260 such that the flow through the main flow path 260 is blocked or substantially blocked. When the flow through the main flow path 260 is blocked or substantially blocked, a portion of the airflow from the gas source 210, such as the majority of the airflow, can be diverted to the patient interface 230 via the flushing flow path 250 (e.g., which may specifically include the nasal delivery portion of the patient interface 230, such as a nasal cannula and / or one or more nasal forks). Thus, during expiration, a portion of the gas is supplied to the patient interface 230 at a high rate (relatively increased rate) via the flushing flow path 250. In addition, due to the favorable balance between volumetric gas delivery and ventilation, positive expiratory airway pressure ventilation can be maintained during expiration.

[0121] As disclosed herein, returning to the flow balance between the flushing flow path 250 and the main flow path 260, the non-invasive ventilation system 200 can be balanced such that when both the flushing flow path 250 and the main flow path 260 are unobstructed or substantially unobstructed, the flow is biased to the main flow path 260 due to the resistance provided by the flushing flow path 250. This higher flow resistance may be due to the diameter of all or part of the flushing flow path 250 (e.g., global restriction). Alternatively, the higher flow resistance may be due to one or more narrowing portions (e.g., local restriction) in the flushing flow path 250, such as, but not limited to, a reduced cross-sectional area of ​​one or more of the carrier tube and nasal delivery portion (e.g., nasal fork or nasal cannula) of the flushing flow path 250. For example, in some embodiments, the flushing flow path 250 restricts the flow by employing a relatively small diameter fitting. The flow restriction provided by the flushing flow path 250 can be located anywhere between the end of the flushing flow path 250 (e.g., the location where the flushing flow path 250 releases airflow into the patient's nostrils) and the proximal end of the flushing flow path 250 (e.g., the location where the breathing circuit 235 (e.g., the gas source conduit 240) bifurcates into the flushing flow path 250 and the main flow path 260).

[0122] Control assembly 220 may include a movable member, such as a baffle, a valve flap, or multiple valve flaps. The movable member may be flexible. The movable member may form part of a main flow path 260. The movable member may close or cover the inlet of the main flow path 260. The movable member may have a gas source side and a patient interface side. The control assembly may include a housing in which the movable member is located or held (e.g., the gas source side and patient interface side of the movable member may define or divide a first volume and a second volume within the housing). The first volume (e.g., on the gas source side of the movable member) may be located between the inlet of control assembly 220 and the inlet of the main flow path 260. The second volume (e.g., on the patient interface side of the movable member) may be located between the inlet of the main flow path 260 and the control assembly outlet of the main flow path.

[0123] In some embodiments, the control component 220 is operable such that when the pressure on the gas source side of the movable member (typically corresponding to P1 minus any pressure loss between the gas source outlet and the movable member) is greater than the pressure on the patient side of the movable member (typically corresponding to P3 plus any pressure loss from the patient interface side of the movable member and the outlet of the main flow path), the movable member reduces the flow resistance through the main flow path 260. In some embodiments, the greater the pressure difference between the gas source side and the patient interface side of the movable member (the greater the pressure on the gas source side than on the patient interface side), the less restricted the main flow path 260 will be.

[0124] In some embodiments, the control component is operable such that when the pressure on the patient interface side of the movable member (typically corresponding to P3 plus any pressure loss from the patient interface side of the movable member and the outlet of the main flow path) is greater than the pressure on the gas source side of the movable member (typically corresponding to P1 minus any pressure loss between the gas source outlet and the movable member), the movable member increases the flow resistance through the main flow path 260. In some embodiments, the greater the positive pressure differential between the patient interface side and the gas source side of the movable member (where the pressure on the patient interface side is higher than the pressure on the interface side), the more the flow rate through the main flow path 260 will be restricted.

[0125] Figures 3A-3B A selection section of embodiments of a system for non-invasive ventilation is shown. As will be discussed in more detail... Figure 3A The system is shown when a patient (not shown) is inhaling, and Figure 3B The system was demonstrated during the patient's exhalation. Figures 3A-3B The illustrated embodiments at least partially utilize bonding Figure 2A The more general systems discussed operate on the principles (e.g., Figures 3A-3B The embodiments shown can be combined with Figure 2A The diagram discloses at least a more specific embodiment of the selection principle.

[0126] Figure 3A A non-invasive ventilation system 300 is shown, comprising a patient interface 330, a flushing flow path 350, a main flow path 360, and a control assembly 320 including a valve in the form of an umbrella valve 321. The patient interface 330 may include a mask body 332 and a mask liner 331. The mask body 332 may be formed of a rigid or semi-rigid material, such as plastic. The edges of the mask body 332 may be surrounded by the mask liner 331. The mask liner 331 may be relatively soft and flexible and may be configured, through one or more choices of shape and material, to conform to the user's face during use, thereby preventing, reducing, or eliminating uncontrolled leakage of gas from the non-invasive ventilation system 300, for example, from the user's face (or a portion thereof) between the mask liner 331 and the patient interface 330. The mask body 332 and the mask liner 331 together define the breathing chamber of the patient interface 330. The non-invasive ventilation system 300 may also include a flushing flow path 350 and a main flow path 360.

[0127] The flushing flow path 350 includes a conduit entering the mask body 332, which connects to a nose elbow 353 at the mask body. The nose elbow is connected to the mask body 332 via a nose elbow fitting 352. The nose elbow 353 terminates in one or more nose forks 355. The individual nose elbow 353 (and therefore the nose elbow fitting 352) may be omitted, and instead, the flushing flow path 350 may include a conduit extending through the mask body 332 and to the nose fork 355. The nose elbow fitting 352 between the nose elbow 353 and the mask body 332 substantially seals off airflow between the conduit and the nose elbow 353. The nose connector may form an interference fit or a friction fit with the conduit, or the connector may include a faceted engagement mechanism, such as a snap-fit ​​mechanism. In some embodiments, the nose elbow fitting 352 allows a degree of rotation of the nose elbow 353 and therefore the nose fork 355 relative to the flushing flow path 350 and the mask body 332. The rotation of the nose elbow 353 and nose fork 355 can improve the user's fit and / or comfort, because the nose fork 355 can move relative to one or more of the mask pad 331 and mask body 332 to accommodate different sizes, positions, etc. of the patient's nostrils.

[0128] The nasal elbow 353 and nasal fork 355 can be configured to direct airflow received from a gas source, such as a ventilator, to the patient's nostrils, for example, as a flushing airflow 351. In some embodiments, one or more nasal forks 355 are not sealed to the patient's nostrils. In this way, the patient's nasal cavity is always in fluid communication with the interior of the patient interface 330, particularly the respiratory cavity. Because the patient's nasal cavity is in fluid communication with the respiratory cavity, safety and functionality can be improved. First, the communication between the nasal cavity and the respiratory cavity allows gas to be expelled from the patient's nasal cavity even when the patient's mouth is closed (e.g., instead of establishing uncomfortable or unsafe pressure within the nasal cavity or any other anatomical structure). Second, the communication between the nasal cavity and the respiratory cavity allows flushing of the nasal cavity to reduce and / or eliminate anatomically ineffective cavities. Additionally, the communication between the nasal cavity and the respiratory cavity of the patient interface 230 allows the flushing flow path 350 to provide or facilitate one or more of inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), and positive end-expiratory pressure (PEEP).

[0129] In some embodiments, the nasal fork 355 is configured to limit flow rate, for example, to limit the flushing airflow 351 flowing through the flushing flow path 350. For example, in some embodiments, the nasal fork 355 is configured to limit the flushing airflow 351 to less than about 60 L / min, less than about 55 L / min, less than about 50 L / min, less than about 45 L / min, less than about 40 L / min, less than about 35 L / min, less than about 30 L / min, less than about 25 L / min, less than about 20 L / min, or less than about 15 L / min, less than about 10 L / min, less than about 5 L / min, or any other flow rate sufficient to flush or partially flush anatomically ineffective cavities of the patient (e.g., the nasal cavity). The nasal fork 355 may limit the flushing airflow due to a reduced cross-sectional diameter. Flow restriction on the flushing airflow through the flushing flow path 250 provided by the nasal fork 355 can also be used to increase the velocity of the flushing airflow. For example, when control component 320 restricts the main flow path 360, the velocity of the flushing airflow leaving flushing flow path 250 is relatively greater than the velocity of the flushing airflow leaving flushing flow path 350 when control component 320 does not restrict the main flow path. The volume and velocity of the flushing airflow can be large enough to flush at least a portion of one or more dissecting dead cavities and device dead cavities.

[0130] In some embodiments, the flushing flow path 350, such as the nasal fork 355, is configured to accelerate (e.g., increase velocity) the flushing airflow 351. A significant volumetric flow rate providing the airflow through the flushing flow path 350 can be used to accelerate the flushing airflow 351 exiting the flushing flow path 350 (e.g., exiting the nasal fork 355), allowing it to flush or partially flush the patient's anatomically ineffective cavities (e.g., the nasal cavity). In some embodiments, a reduced / reduced cross-sectional dimension, such as diameter or area, of at least one of the flushing flow path 350 and the nasal fork 355 accelerates the flushing airflow 351 exiting the flushing flow path 350. The increased velocity of the flushing airflow 351 exiting the nasal fork 355 can be correlated with (reaching a limit) the increased efficiency of flushing the anatomically ineffective cavities.

[0131] The main flow path 360 can enter the mask body 332 at any location convenient for delivering a large volume of gas into the patient interface 330 and to the patient. In some embodiments, the main flow path 360 is configured to provide or facilitate one or more of inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), and positive end-expiratory pressure (PEEP). The mask body 332 may include a coupling portion 333 that allows one or more conduits of the breathing circuit (e.g., the main flow path 360 and / or the flushing flow path 350) to fluidly connect the patient interface 330 to a gas source, such as a ventilator. Figure 3A and Figure 3BIn the illustrated embodiment, separate conduits for the main flow path 360 and the rinsing flow path 350 are connected to the connection portion of the mask body 330.

[0132] exist Figures 3A-3B In the non-invasive ventilation system 300, a control component 320 is aligned with the main flow path 360. The control component 320 can be housed within the main flow path 360 of the breathing circuit. Figure 3C-3D As shown in the enlarged view, the control assembly 320 includes an umbrella valve 321 held within a main flow path 360. The umbrella valve 321 includes a generally circular valve flap 322 arranged to extend over one or more openings in the control assembly 320 (e.g., an opening between the gas source side and the patient interface side of the control assembly 320). The valve flap 322 may be flexible enough that at least a portion of the valve flap 322 can move in response to a pressure difference on either side of the valve flap 322 (e.g., pressure on the gas source side and pressure on the patient interface side of the control assembly 320). The umbrella valve 321 may have a stem 323 extending from a central portion of the valve flap 322. The stem 323 is received in a mounting frame 324 of the control assembly 320 to hold and position the umbrella valve 321 in place. The mounting frame 324 extends between the inner walls of the main flow path 360. The umbrella valve 321 of the control component 320 can be configured to allow a basic unidirectional airflow through the main flow path 360, such as the main airflow 361. Figure 3A The umbrella valve 321 is shown in a first state (e.g., open state), wherein the umbrella valve 321 of the control assembly 320 allows breathing gas to flow through the main flow path 360 and into the breathing chamber of the patient interface 330. Figure 3B The umbrella valve 321 is shown in a second state (e.g., closed state), wherein the umbrella valve 321 of the control assembly 320 is closed or substantially closed (e.g., suppressed / restricted or substantially suppressed / restricted) to limit airflow through the main flow path 360. Therefore, when the umbrella valve 321 is in its second state (e.g., restricted state), less (e.g., significantly less) of respiratory gas enters the breathing chamber of the patient interface 330 through the main flow path 360. Although the valve 321 is shown, other types of valves may be used.

[0133] The pressure within the breathing chamber of the patient interface 330 can change dynamically, and the umbrella valve 321 can be configured to change its state at appropriate times during the patient's respiratory cycle (e.g., in response to pressure generated by the patient). The umbrella valve 321 of the control component 320 can be configured to change its state based on characteristics of the ventilation system (e.g., the pressure within the breathing chamber of the patient interface 330 and / or the pressure of the main airflow 361), for example, from a second state to a first state and / or from a first state to a second state. In some embodiments, the umbrella valve 321 of the control component 320 is configured to change its state when the pressure on the patient interface side of the control component (e.g., the pressure within the breathing chamber of the patient interface 330 (P...)...) PI When the relevant value increases above a certain value (e.g., a dynamic value), the flow rate in the main flow path 360 is limited (e.g., suppressed, reduced, or stopped). This value can be the pressure on the gas source side of the control component 320 or related to that pressure (similar to combining). Figure 2A (Disclosed system). In some embodiments, the umbrella valve 321 of the control component 320 is configured to respond to pressure on the patient interface side of the control component (e.g., pressure within the breathing chamber of the patient interface 330, P). PI When the pressure (related to the flow rate) drops below a certain value (e.g., a dynamic value), the umbrella valve 321 opens or maintains the main flow path 360 open (e.g., reduces or minimizes the flow restriction in the main flow path 360), which may be the pressure on or related to the gas source side of the control component 320. When the pressure on the patient interface side of the valve is higher than the pressure on the ventilator side of the valve, the umbrella valve 321 may increase the restriction on the flow rate through the main flow path 360. When the pressure on the patient interface side of the valve is lower than the pressure on the ventilator side of the valve, the umbrella valve may decrease the restriction on the flow rate through the main flow path 360.

[0134] The vent 370 can be configured to ventilate at a rate such that excessive pressure does not build up within the patient interface 330, but ensures sufficient pressure is built up, for example, during or after the patient's exhalation, to cause the umbrella valve 321 of the control component 320 to close. The vent 370 of the non-invasive ventilation system 300 can be similar to... Figure 2A The exhaust port 270 is under discussion.

[0135] Figure 3A A non-invasive ventilation system 300 during patient inhalation is illustrated. In some embodiments, the flushing flow path 350, including the nose fork 355, is never closed. Therefore, breathing gas can be continuously delivered to the patient's nostrils through the nose fork 355. During inhalation, the inspiratory airflow 311 inhaled by the patient from the patient interface 330 into the patient's respiratory system reduces the pressure within the breathing chamber of the patient interface 330 of the non-invasive ventilation system 300, thereby allowing the umbrella valve 321 of the control assembly 320 to open. For example... Figure 3A and Figure 3C As shown, when umbrella valve 321 is open, it allows gas to travel with relatively little restriction through the main flow path 360 and into the patient interface 330. Because flushing flow path 350 is always open, some gas can flow through this path to the patient interface during inspiration. However, due to the preference for flow along the main flow path 360 (e.g., due to lower path resistance), the flow rate in flushing flow path 350 may be relatively low, for example, very low or negligible. However, in some embodiments, this flow rate may be sufficient for flushing. That is, during inspiration, the second flow rate (F2) may be substantially lower than the third flow rate (F3) (by means of...). Figure 2A (The system can be compared.) The minimum cross-sectional dimensions (e.g., diameter, radius, area, etc.) of the main flow path 360 can be substantially larger than the minimum cross-sectional dimensions (e.g., diameter, radius, area, etc.) of the flushing flow path 350 (at the cross-section of the nose fork). Therefore, when the control components are relatively open and do not impede (e.g., significantly impede) the flow through the main flow path 360, the main flow path 360 can have lower flow resistance than the flushing flow path 350.

[0136] Figure 3B This shows the patient's exhalation process. Figure 3A The non-invasive ventilation system 300. During exhalation, the expiratory airflow 312 forced from the patient's respiratory system into the breathing chamber of the patient interface 330 increases the pressure within the breathing chamber of the non-invasive ventilation system 300's patient interface 330, thus sufficiently allowing the umbrella valve 321 of the control component 320 to close. For example... Figure 3B As shown, when umbrella valve 321 is closed, the airflow through the main flow path 360 is blocked or substantially blocked (similar to a combination). Figure 2A (The control component 220 is discussed as a blockage). Therefore, most of the gas supplied by the ventilator flows through the flushing flow path 350 and flows to the patient, for example, into the patient's nostrils through the nasal fork 355. Due to the closed umbrella valve 321, the flushing airflow 351 traveling through the flushing flow path 350 advantageously flushes the nasal cavity with fresh air, so that when the patient's next inhalation begins, the nasal cavity is substantially filled with fresh air, rather than CO2-rich air.

[0137] During exhalation, the umbrella valve 321 of the control component 320 may not be completely closed (e.g., it may not completely block the main flow path 360). Therefore, during exhalation, when the control component 320 restricts or inhibits the flow through the main flow path 360, and during inhalation, when the control component 320 reduces the restriction on the main flow path, at least some gas can flow through the main flow path 360 to the patient interface 330.

[0138] During exhalation, even if airflow through the main flow path 360 is restricted, sufficient flow may still be available through one or more of the main flow path 360 and the flushing flow path 350 to generate and / or maintain at least one of EPAP and PEEP within the breathing chamber of the patient interface 330 during exhalation. In some embodiments, the restricted flow of respiratory gas through the main flow path 360 is sufficient to maintain at least one of EPAP and PEEP within the breathing chamber of the patient interface 330 during exhalation. In some embodiments, the increased flow of respiratory gas through the flushing flow path 350 is sufficient to maintain at least one of EPAP and PEEP within the breathing chamber of the patient interface 330 during exhalation. In some embodiments, the restricted flow of respiratory gas through the main flow path 360 is combined with the increased flow of respiratory gas through the flushing flow path 350 to maintain at least one of EPAP and PEEP within the breathing chamber of the patient interface 330 during exhalation. Airflow through an unsealed cannula (e.g., nasal fork 355) to the breathing chamber of the patient interface 330 (typically via the patient's nostrils) may contribute to the delivery of at least one of EPAP and PEEP.

[0139] Figures 4A-4B A portion of an embodiment of a system for non-invasive ventilation is shown. Figure 4A The patient-facing side of the non-invasive ventilation system 400 is shown, such as the rear side of the non-invasive ventilation system 400. Figure 4B The front of the non-invasive ventilation system 400 is shown.

[0140] The non-invasive ventilation system 400 may include and Figure 3A and Figure 3B Similar parts or components to the non-invasive ventilation system 300. The non-invasive ventilation system 400 typically includes a patient interface 430, a main flow path 460, a flushing flow path 450, and a control assembly 420. The structure of the non-invasive ventilation system 400 may be provided at least in part by the patient interface 430, which may include a mask body 432 and a mask pad 431. Figures 4A-4B The patient interface 430, mask body 432, mask pad 431, and breathing circuit 435 can be similar to Figures 3A-3B The patient interface 330, mask body 332, mask pad 331, and breathing circuit 335 are included. The breathing circuit 435 may have only a single tubing to deliver breathing gas from a gas source or ventilator to the patient interface 430.

[0141] Figures 5A-5B Showing Figures 4A-4B Multiple different views of selected sections of the non-invasive ventilation system 400. More specifically, Figure 5A A front view of selected portions of the patient interface 430 and control component 420 is shown. Figure 5B Showing Figure 5B The image shows a sagittal cross-sectional view of each block of the non-invasive ventilation system 400. (See also:) Figures 5A-5B As shown, the control assembly 420 divides the breathing circuit into two flow paths, such as two separate and / or different flow paths, including a flushing flow path 450 (which may ultimately be delivered to or terminate at a nasal delivery portion) and a main flow path 460. The control assembly 420 may be substantially located at the junction of the main flow path 460 and the mask body 432. The control assembly 420 includes a one-way valve 421 with multiple movable valve flaps and a mounting frame 452 for mounting the one-way valve 421 in the control assembly 420. The mask body 432 may include a port 480. In some embodiments, the port 480 may be used to transmit pressure to another part of the noninvasive ventilation system 400. Alternatively, the port 480 may be used for the passage of a catheter or tube, such as a nasogastric tube (NG tube).

[0142] In some embodiments, such as Figure 5A As shown, the mounting frame 452 of the control component 420 is substantially located at the center of the main flow path 460, for example, coaxially. In some embodiments, the mounting frame 452 of the control component 420 is positioned eccentrically relative to the main flow path 460. The mounting frame 452 may have full access to the main flow path 460 and may define the inlet of the flushing flow path 450.

[0143] like Figure 5A As shown, a one-way valve 421 may surround a mounting frame 452. The mounting frame acts as a separator to divert breathing gas flowing through the breathing circuit 435 into a main flow path 460 and a flushing flow path 450. The one-way valve 421 can be any type of valve that controls the flow rate into the main flow path while allowing continuous flow into the second flow path (flushing flow path). The one-way valve 421 can separate the breathing gas flow based on one or more factors, including but not limited to: the pressure (P) within the breathing chamber of the mask body 432. PI ), the pressure of the flow from the gas source (which can be combined in a similar way to the above). Figure 2A The discussion focuses on P1), and the pressure at the outlet of the main flow path (which can be combined similarly to the above). Figure 2A (See P3 for discussion). Figure 5B As shown, the one-way valve 421 is attached to the mounting frame 452, for example, in a recess in the base surrounding the mounting frame 452. Depending on the pressure in the system, the outer edge of the one-way valve 421 (e.g., the valve disc of the one-way valve 421) may lift off the frame, allowing a greater flow of breathing gas around the valve disc of the one-way valve 421 (e.g., through the one-way valve 421). In this way, the valve can be configured to dynamically regulate the amount of flow passing through due to the experienced pressure differential.

[0144] The irrigation flow path 450 may include (e.g., terminating at) a nasal delivery portion, which may include a nose fork. In some embodiments, the irrigation flow path 450 includes a nose fork attached to a mounting frame 452 of the control assembly 420. In some embodiments, the nose fork is integrally formed with the mounting frame 452. In some embodiments, the irrigation flow path 450 includes an elbow, similar to... Figure 3A The nose elbow 353 is shown. The flushing flow path 450 provides a continuous flow path through the mounting frame 452 to the outlet (e.g., nose fork 455) of the flushing flow path 450.

[0145] The nose fork 455 can be configured to restrict flow, such as limiting or constraining the flow of breathing gas through the flushing flow path 450. The nose fork 455 can be similar to a combination of... Figures 3A-3B The nose fork 355 is disclosed. The nose fork 455 can be configured to accelerate (e.g., increase velocity) the airflow through the flushing flow path 450. Reduced cross-sectional dimensions, such as diameter or area, can be used to accelerate the gas flowing through the flushing flow path 450. A large volumetric flow rate of gas is provided through the flushing flow path 450, such as accelerated airflow exiting the flushing flow path 450 via the nose fork 455 to flush or partially flush one or more anatomical dead spaces (e.g., nasal cavity) or device dead spaces of the patient. For example, the increased velocity of the airflow exiting the flushing flow path 450 via the nose fork 455 can be associated with an increase in the efficiency (reaching a limit) of dead space flushing.

[0146] In some embodiments, the noninvasive ventilation system 400 can use pressure generated by the patient to form a passive response system. Figures 6A-6B Showing Figures 4A-4B and Figures 5A-5B The noninvasive ventilation system 400 is in different states (e.g., operational state). When the pressure in the breathing chamber of the patient interface 430 is less than the pressure on the side of the valve opposite to the patient interface (e.g., on the gas source side), the one-way valve 421 opens due to the pressure differential, which reduces the restriction on the main flow path (see...). Figure 6B When the pressure within the breathing chamber of the patient interface 430 is greater than the pressure on the side of the valve opposite to the patient interface (e.g., on the gas source side), the one-way valve 421 is forced to increase the restriction on the primary flow path (see [link]). Figure 6AWhen check valve 421 is in its maximum unrestricted or open state, gas is allowed to flow relatively unrestricted through the main flow path 460 and into the patient interface 430 (some flow may also continue through the flushing flow path 350 and out of the nose fork 455). When check valve 421 is in a substantially closed or restricted state, flow is suppressed or substantially suppressed through check valve 421 of control assembly 420 into the main flow path 460. When the pressure inside the patient interface is higher than the pressure on the opposite side of the valve, this causes an increased portion (e.g., the majority) of the flow from, for example, a gas source to flow through the flushing flow path 450 and out of the nose fork 455 into the patient interface (e.g., on the gas source side), check valve 421. Due to the increased volume of breathing gas flowing through the nose fork 455, the breathing gas leaving the nose fork 455 can have a high velocity sufficient to flush at least a portion of the patient's anatomical dead space and at least one device dead space.

[0147] A valve (e.g., a one-way valve 421) in the control component 420 of the noninvasive ventilation system 400 can respond to the magnitude of the pressure difference across the valve 421. For example, when the pressure on the gas source side of the valve (typically corresponding to the pressure at the ventilator outlet minus any pressure loss between the ventilator and the valve) is significantly greater than the pressure on the patient interface side of the valve (typically corresponding to the pressure within the breathing chamber of the patient interface 430), the valve disc of the one-way valve 421 can rise significantly (e.g., as shown in 6B), thus allowing a relatively large volume to flow through. When the pressure on the gas source side of the valve is only slightly greater than the pressure on the gas source side of the valve (e.g., the pressure within the breathing chamber of the patient interface 430), the valve disc of the one-way valve 421 can rise only a short distance, thus allowing only a relatively small volume to flow through. As discussed herein, particularly with reference to... Figure 7A-7K The one-way valve 421 can be configured to allow more or less flow based on a specific (e.g., given or set) pressure differential. The ability of the one-way valve 421 to respond to pressure differentials can be advantageous in configuring the control components 420 of the non-invasive ventilation system 400 to dynamically respond to the breathing of a real patient (and the differences in breathing between different patients).

[0148] Figure 6BA control assembly 420 of a noninvasive ventilation system 400 during patient inspiration is shown. In some embodiments, the flushing flow path 450 connected to the nose fork 455 is never closed. However, when the one-way valve 421 is at least in its most open state, the flushing flow path 450 can impose greater flow restriction (e.g., higher resistance) compared to the main flow path 460. Therefore, when the control assembly 420 is open (e.g., during user inspiration), most of the breathing gas will flow from the main flow path 460 and through the one-way valve 421 of the control assembly 420, and only a relatively small, less, or minimal amount of gas will flow through the continuously open flushing flow path 450 and the nose fork 455 at its end. During inspiration, the breathing airflow inhaled by the patient from the patient interface 430 into the patient's respiratory system reduces the pressure within the breathing chamber of the patient interface 430 of the noninvasive ventilation system 400, sufficiently to allow the one-way valve 421 of the control assembly 420 to open because the pressure supplied by the gas source is lower than the pressure within the breathing chamber.

[0149] Figure 6A The control component 420 of the noninvasive ventilation system 400 during patient exhalation is shown. During exhalation, the expiratory gas forced from the patient's respiratory system into the breathing chamber of the patient interface 430 increases the pressure within the breathing chamber of the patient interface 430, sufficient to at least partially close the one-way valve 421 of the control component 420. As the one-way valve 421 moves toward closure, the respiratory airflow through the main flow path 460 is blocked or substantially blocked (similar to a combination). Figure 2A The control component 220 (discussed as a blockage). Closure of the one-way valve 421 may cause an increase in the volumetric flow rate of respiratory gas flowing through the flushing flow path 450 and entering the patient's nostrils through the nose fork 455, for example, a relatively immediate increase. Since the flushing flow path 450 includes the nose fork 455 with a relatively small outlet, the increased volumetric flow rate of respiratory gas through the flushing flow path 450 increases the velocity of the gas at the nose fork outlet.

[0150] Exhalation typically forces CO2-rich air into the patient's nasal cavity and out of the nostrils. The non-sealed nose fork 455 allows exhaled air to exit through the nostrils. Additionally, due to the substantially closed one-way valve 421, the increased volume and velocity of the exhaled air traveling through the flushing flow path 450 are used to flush the nasal cavity with fresh air, so that at the start of the patient's next inhalation, the nasal cavity is substantially filled with fresh air, rather than CO2-rich air.

[0151] During exhalation, even if the airflow from the main flow path 460 via the one-way valve 421 is restricted (e.g., severely restricted), there may still be sufficient flow from / through one or more of the main flow path 460 (via the one-way valve 421) and the flushing flow path 450 to generate and / or maintain at least one of EPAP and PEEP in the breathing chamber of the patient interface 430 during exhalation. In some embodiments, the restricted flow of respiratory gas from the main flow path 460 via the one-way valve 421 is sufficient to maintain at least one of EPAP and PEEP in the breathing chamber of the patient interface 430 during exhalation. In some embodiments, the increased flow of respiratory gas through the flushing flow path 450 is sufficient to maintain at least one of EPAP and PEEP in the breathing chamber of the patient interface 430 during exhalation. In some embodiments, the restricted flow of respiratory gas from the main flow path 460 via the one-way valve 421 is combined with the increased flow of respiratory gas (e.g., from the patient's exhaled air) to maintain at least one of EPAP and PEEP in the breathing chamber of the patient interface 430 during exhalation. Airflow through an unsealed cannula (e.g., nasal fork 455) is directed to the breathing chamber of the patient interface 430 (typically via the patient's nostrils) and may help provide at least one of EPAP and PEEP.

[0152] Figure 7A-7K Several different embodiments of a one-way valve in the form of a flap valve are shown. The flap valve includes an annular mounting structure having a bore through a generally cylindrical body. This mounting structure allows the flap valve to be installed in the main flow path. The flap valve further includes a plurality of protrusions arranged radially around the mounting structure. Each protrusion may be referred to as the flap of the flap valve. In some embodiments, each protrusion is offset from one side of the ring. This provides a raised lip to the mounting structure, making the installation in the flow path more secure. However, in other embodiments, each protrusion may have the same thickness as the annular body, such that the protrusion has a surface flush with the ring.

[0153] Each protrusion or valve disc may include a recessed area on one side of the valve disc, the recessed area being located near the junction between the ring and the protrusion. These recessed areas allow each protrusion to deform in one direction with a force significantly lower than that required to deform the valve disc in a second direction. In some embodiments, the recessed areas enable the protrusion valve to function as a one-way valve. In some embodiments, a limiting portion is provided in the flow path and / or on the mounting structure to limit the deformation of the valve disc in the second direction.

[0154] Figure 7A-7K Various different one-way valves that can be used with some embodiments of the non-invasive ventilation system disclosed herein are shown, such as Figures 4A-4B , Figures 5A-5B and Figures 6A-6BThe non-invasive ventilation system 400 is shown. As disclosed herein, a one-way valve can be configured such that each individual protrusion or valve disc of the valve can open independently to allow airflow. The use of valve discs can allow or improve the ease of valve opening (e.g., reduce the differential pressure required for valve opening / closing) and / or its ability to remain open even under relatively small differential pressure conditions.

[0155] Figures 7A-7C A first embodiment of a valve with a centrally positioned orifice is shown. The mounting structure is surrounded by six radially arranged valve discs, each equidistant from the periphery of the mounting surface. Figure 7B and Figure 7C The raised lip shown provides a positioning feature for mounting the valve in the main flow path. Each valve disc extends away from the central bore in a direction perpendicular to the annular surface. The valve discs are substantially flat and without curvature. The valve discs are radially spaced around the mounting surface, forming a gap between each valve disc so that they do not contact each other. This gap can correspond to a structure for mounting the valve in the main flow path, or to a structure for limiting the bending of the valve discs in one direction while allowing them to bend in an opposite second direction. Each valve disc extends equidistantly away from the annulus. The distal edge of each valve disc is curved. Combined, the distal edge of each valve disc defines a circle parallel to the annulus of the mounting structure.

[0156] One-way valves have an outer diameter (in) Figure 7A (as can be seen in the image), inner diameter (in the image) Figure 7A (as can be seen in the image), thickness (in the image) Figure 7C (As can be seen in the image), valve disc cutting depth (can be seen in the image). Figure 7A (as seen in the image), and multiple valve discs (which can be seen in the image). Figure 7A and Figure 7B (As seen in the image). The inner diameter of a check valve can be determined by the structure around which the check valve is fixed. For example, Figures 7A-7B The one-way valve shown has an inner diameter substantially equal to the diameter of the recess on the mounting frame fitting 452. This inner diameter allows the inner surface of the one-way valve to form an airtight or substantially airtight seal with the surrounding structure. The outer diameter of the one-way valve can be dimensioned such that it covers, substantially covers, or overlaps the outer edge of the covered port. Figure 7A (An example is shown in the figure). The thickness of a check valve can affect its performance; for example, a thicker check valve 421 may require a larger pressure differential to open, while a thinner check valve 421 may require a smaller pressure differential to open. Figures 7A-7CThe one-way valve shown has six valve discs. In some embodiments, the one-way valve has multiple valve discs of fewer than about 20, fewer than about 18, fewer than about 16, fewer than about 14, fewer than about 12, fewer than about 10, fewer than about 8, fewer than about 6, fewer than about 4, or fewer than about 2. In some embodiments, the one-way valve has a single valve disc.

[0157] Figures 7D-7E A second embodiment of a valve with a non-centrally positioned orifice is shown. This orifice is offset to one side of the valve. Three valve discs of non-uniform shape are spaced apart around the periphery of the mounting structure. Although the individual valve discs are non-uniform, their shape and position make the outer periphery of the valve discs substantially circular. The valve discs are spaced apart so that they do not contact each other. The valve includes a central main valve disc and two smaller side valve discs located on either side of the central valve disc. The central valve disc is larger than each side valve disc. The shape of the central valve disc differs from that of the side valve discs. The central valve disc is triangular with a distal edge that curves from the mounting structure.

[0158] Figure 7F-7G The illustrated one-way valve embodiment has a curved and inclined valve disc surface. Figure 7H-7I The illustrated one-way valve embodiment has a flat and inclined valve disc surface. Figure 7J-7K The illustrated one-way valve embodiment has a stepped valve disc surface.

[0159] Figure 7F-7G A third embodiment of a valve including a centrally located orifice is shown. The raised lip of the mounting structure is surrounded by six evenly spaced valve discs. The valve discs extend from the mounting structure along two dimensions (upward and outward). The valve discs curve away from the mounting structure. Each valve disc has a substantially quarter-elliptical profile.

[0160] Figure 7H-7I A fourth embodiment of a valve including a centrally located orifice is shown. The mounting structure has six valve discs arranged radially in a uniform manner, each valve disc being equidistantly spaced around the perimeter of the mounting structure. Each valve disc has a surface flush with the surface of the ring. The valve discs extend from the mounting structure along two dimensions (upward and outward). The valve discs are substantially planar. The lateral profile of each valve disc is substantially linear. In this embodiment, the spacing between the valve discs increases from the mounting surface toward the distal edge of the valve disc, thereby forming a triangular space between adjacent valve discs.

[0161] Figure 7J-7KA fifth embodiment of a valve including a centrally located orifice is shown. The mounting structure has six valve discs arranged radially in a uniform manner, each valve disc being equidistantly spaced around the perimeter of the mounting structure. When viewed from a side profile, the valve discs have a generally stepped profile. Each valve disc includes at least two stepped segments. Each stepped segment includes a first portion extending radially away from the mounting structure and a second portion extending at an angle to the first portion. The second portion may be substantially perpendicular to the first portion. The second portion may be substantially parallel to the central axis of the orifice in the mounting structure.

[0162] Figure 8 A block diagram illustrating an embodiment of a system for providing and / or maintaining non-invasive ventilation is shown. As illustrated, the non-invasive ventilation system 800 includes various components, including but not limited to a gas source 810, a control assembly 820, a patient interface 830, a breathing circuit 835, an exhaust port 870, and a feedback arrangement 880. The components of the non-invasive ventilation system 800 can be substantially similar in combination. Figure 2A The components of the non-invasive ventilation system 200 are discussed. For example, gas source 810 may correspond to gas source 210, breathing circuit 835 may correspond to breathing circuit 235, flushing flow path 850 may correspond to flushing flow path 250, and so on. Although some components may be similar, substantially similar or even identical between non-invasive ventilation system 800 and non-invasive ventilation system 200, they do not need to be similar, substantially similar or identical.

[0163] The non-invasive ventilation system 800 can be used with Figure 2A The non-invasive ventilation system 200 operates substantially the same. A gas source 210 has an outlet connected to a breathing circuit 835 through which the gas source supplies breathing gas. The pressure and flow rate at the outlet of the gas source are nominally a first pressure P1 and a first volumetric flow rate F1. The gas source 810 is controlled to provide the first pressure and the first flow rate (P1, F1) to achieve the desired pressure at the patient interface, particularly within the breathing chamber of the mask. Therefore, the first pressure and the first flow rate (P1, F1) can be controlled to account for any system pressure loss between the gas source 810 and the patient interface 830. As previously mentioned, the desired pressure at the patient interface may vary during the user's respiratory cycle (e.g., between IPAP and EPAP).

[0164] The breathing circuit 835 is divided, branched, or split into a flushing flow path 850 and a main flow path 860, each flow path having an independent outlet within the patient interface through which breathing gas is delivered to the user. The pressure and flow rate at the outlet of the flushing flow path are nominally a second pressure P2 and a second volumetric flow rate F2. The pressure and flow rate at the outlet of the main flow path are nominally a third pressure P3 and a third volumetric flow rate F3.

[0165] The feedback arrangement 880 takes the form of a connector, port, or line that transmits pressure within the patient interface 830 to the control assembly 820. The feedback arrangement can be separate from the breathing circuit 835 and the main flow path and flushing flow path. The control assembly 820 can adjust the permissible flow rate through the main flow path 860 based on the pressure of the gas within the patient interface 830 (e.g., the pressure transmitted to the control assembly 820 via the pressure arrangement 880).

[0166] Control component 820 at least partially defines the inlet from gas source 810 to main flow path 860. Flushing flow path 850 is connected to gas source 810 via a set flow path that is not directly altered or modified by the control component. Control component 820 has a gas source side and a patient interface side. The gas source side of the control component includes the inlet of the control component. The patient interface side of the control component includes a pressure feedback arrangement 880. The control component is configured to change the flow resistance of the main flow path. The control component is operable such that when the pressure on the gas source side of the control component (typically corresponding to P1 minus any pressure loss between the gas source outlet and the control component) is higher than the pressure on the patient side of the control component (typically corresponding to the pressure within the patient interface breathing chamber minus any pressure loss across the pressure feedback arrangement 880), the flow through the main flow path 860 is open or less restricted by the control component. The greater the pressure differential between the gas source side and the patient interface side of the control component (where the pressure on the gas source side is higher than the pressure on the patient interface side), the less restricted the main flow path 860 will be.

[0167] The control component can also be operated such that when the pressure on the patient interface side of the control component (typically corresponding to the pressure within the patient interface breathing chamber minus any pressure loss across the pressure feedback arrangement 880) is greater than the pressure on the gas source side of the control component (typically corresponding to P1 minus any pressure loss between the gas source outlet and the control component), the flow rate through the main flow path is restricted, or more significantly restricted by the control component. The greater the positive pressure differential between the patient interface side and the gas source side, the more restricted the flow rate through the main flow path may be.

[0168] When the control component restricts the flow rate through the main flow path, for the same pressure (P1) at the outlet of the gas source, the flow rate (F3) through the outlet of the main flow path decreases, while the flow rate (F2) through the outlet of the flushing flow path increases. As the volumetric flow rate through the flushing flow path increases, the velocity of the airflow through the flushing flow path also increases. The system is configured such that the velocity of the airflow through the flushing flow path is high enough to flush anatomical dead spaces and / or device dead spaces during the user's respiratory cycle. Similarly, when the control component opens the flow rate through the main flow path, for the same pressure (P1) at the outlet of the gas source, the flow rate (F3) through the outlet of the main flow path increases, and the flow rate (F2) through the outlet of the flushing flow path decreases due to the reduced resistance to flow through the main flow path.

[0169] The increase in pressure on the patient interface side of the control assembly relative to the pressure on the gas source side typically occurs during user exhalation. This is because the user is exhaling and adding mass to a fixed volume of gas within the patient interface, thus increasing the pressure within the patient interface breathing chamber. During user inhalation, the pressure on the patient interface side of the control assembly typically decreases relative to the pressure on the gas source side, as the user is inhaling from the patient interface and therefore removing mass from a fixed volume within the patient interface breathing chamber. The system can be configured to primarily provide flushing of anatomical dead spaces and / or device dead spaces during exhalation, and may provide flushing less frequently (if any) during inhalation.

[0170] Figures 9A-9B A selection portion of an embodiment of a system 900 for noninvasive ventilation is shown, the system including a patient interface 930 configured to receive gas from a flushing flow path 950 and a main flow path 960. Figure 9A A control assembly 920 with four ports / connectors, including a gas source connector 941, a flushing flow path connector 954, a main flow path connector 964, and a pressure feedback port 981, is also shown. The gas source connector 941 is configured to connect the control assembly 920 to a gas source conduit that positions the control assembly 920 in fluid communication with a gas source, such as a ventilator or other pressurized breathing gas source. The main flow path connector 964 is configured to connect the control assembly 920 to a main flow path 960 that extends between the control assembly 920 and the patient interface 930. The flushing flow path connector 954 is configured to connect the control assembly 920 to a flushing flow path 950 that extends between the control assembly 920 and the patient interface 930.

[0171] The patient interface 930 has three paths in fluid communication with the control assembly 920: a main flow path 960, a flushing flow path 950, and a pressure feedback arrangement 980. The pressure feedback arrangement 980 and the flushing flow path 950 can be continuously open, for example, in fluid communication with the breathing chamber of the patient interface. As described elsewhere herein, depending on the adjustments provided by the control assembly 920, the main flow path 960 can be open (e.g., fully or substantially open) or restricted (e.g., fully or substantially closed), which is discussed in further detail elsewhere herein. When the control assembly 920 is connected to a ventilator, breathing gas can be continuously delivered to the patient interface 930. When the control assembly 920 restricts the flow through the main flow path, a significant portion of the breathing gas is delivered to the patient interface 930 via the flushing flow path 950 (a portion of the gas blocked by the control assembly 920 from passing through the main flow path 960 will pass through the flushing flow path 950). When control assembly 920 is open and flow through the main flow path is not restricted, respiratory gas is delivered to patient interface 930 via both main flow path 960 and flushing flow path 950. Main flow path 960 may have lower flow resistance than flushing flow path 950. Therefore, when all paths are open, more gas from ventilator 910, essentially more gas, can pass through main flow path 960 because it is the path with the least resistance to patient interface 930. Flushing flow path 950, or a portion thereof (e.g., the nasal fork at the end of flushing flow path 950), may have increased flow resistance compared to main flow path 960. Therefore, when control assembly 920 is restricted, the increased volumetric flow rate of respiratory gas increases, thereby significantly increasing the velocity of gas leaving flushing flow path 950. Increased or high-velocity gas can be used to flush one or more anatomical dead spaces (e.g., the patient's nasal cavity) and device dead spaces.

[0172] Figure 9B and Figure 10 Showing Figure 9A The patient interface 930 includes a mask body 932 and a mask liner 931 attached to the mask body. The patient interface 930 also includes a vent 970, which can be configured to vent at a rate corresponding to the internal pressure of the patient interface 930. Unless disclosed herein, the patient interface 930 may be similar to... Figures 3A-3B Patient interface 330.

[0173] The mask body 932 may be formed of a rigid or semi-rigid material, such as polycarbonate. One or more edges of the mask body 932 are attached to the mask liner 931. The mask liner 931 is formed of a relatively soft and flexible material, such as silicone, foam, and / or fabric. The liner is configured, by one or more of a choice of shape and material, to conform to the user's face during use, thereby preventing, reducing, or eliminating uncontrolled leakage of gas, for example, from the user's face (or a portion thereof) between the mask liner 931 and the patient interface 330. The mask body 932 and the mask liner 931 together define the breathing chamber of the patient interface 930. One or more components of the patient interface 930 may be substantially similar to a combination. Figures 3A-3B The components of the non-invasive ventilation system 300 are discussed. For example, flushing flow path 950 may correspond to flushing flow path 350, main flow path 960 may correspond to main flow path 360, vent 970 may correspond to vent 370, nose fork 955 may correspond to nose fork 355, mask liner 931 may correspond to mask liner 331, and mask body 932 may correspond to mask body 332, etc. Although some components may be similar, substantially similar, or even identical in structure and / or function between the patient interface 930 and the non-invasive ventilation system 300, they do not need to be similar, substantially similar, or identical.

[0174] Figure 11A-11C Several different views of a control assembly 1100 that can be used with several different embodiments of a system for non-invasive ventilation are shown. Figure 11A The external view is shown when the control component 1100 is fully assembled. Figure 11B and Figure 11C Several different views of the control component 1100 are shown, which is partially disassembled for illustrative purposes.

[0175] The control assembly 1100 typically includes a housing or body comprising a lower body 1110 and an upper body 1112. The body of the control assembly 1100 includes structures and components configured to transfer or separate respiratory gas flows between different flow paths. The control assembly may include multiple ports for gas inlet, such as a single port for gas inlet, and multiple ports for gas outlet, such as two ports for gas outlet.

[0176] The control component 1100 may include a port, such as a ventilator port 1141, configured to receive an airflow from a gas source, such as a ventilator. The ventilator port 1141 may connect to a ventilator tubing and direct the gas received from the ventilator into the body of the control component 1100, such as the lower body 1110 of the control component. The ventilator port 1141 receives the gas at a first pressure (P1) minus any pressure loss between the ventilator and the ventilator port, and a first flow rate (F1).

[0177] The control assembly 1100 may include two ports, such as a flush flow port 1151 and a main flow port 1161, configured to direct gas out of the control assembly 1100, for example, out of the lower body 1110 of the control assembly. Gas may exit the flush flow port 1151 at a second pressure (P2) plus any pressure loss and a second flow rate (F2) generated between the flush flow port and the opening of the nasal cannula. Gas may exit the main flow port 1161 at a third pressure (P3) plus any pressure loss and a third flow rate (F3) generated between the main flow port in the mask body and the main flow path opening. Each of the ventilator port 1141, the flush flow port 1151, and the main flow port 1161 may be connected to or integrally formed with the lower body 1110 of the control assembly.

[0178] Figure 11B and Figure 11C A control assembly 1100 is shown without a properly positioned upper body 1112. The lower body 1110 of the control assembly splits into two distinct flow paths after the ventilator port inlet: a main flow path fluidly communicating with a main flow port 1161 and a flushing flow path fluidly communicating with a flushing flow port 1151. The flushing flow path extends directly from the ventilator port 1141 to the flushing flow port 1151. The flushing flow path maintains constant fluid communication with the flushing flow port 1151. Therefore, during operation of the non-invasive ventilation system 1100, a constant amount of gas always travels freely from the ventilator port 1141 through the lower body 1110 of the control assembly and exits from the flushing flow port 1151. The main flow path extends from the ventilator port 1141, turning towards the upper body 1112 of the control assembly to extend through an opening 1165 in the lower body 1110 of the control assembly and reach the main flow port 1161. The main flow path can be restricted, constrained, or closed by a movable member in the form of a partition 1121. The movable component is arranged to block, obstruct, or restrict an opening in the lower body of the control assembly in order to restrict airflow through the main flow path. The opening 1165 is defined or delimited by a tubular portion of the lower body 1110. The tubular portion has a substantially cylindrical cross-section. The tubular portion has an annular or ring-shaped end face 1167.

[0179] A partition 1121 is held between the lower body 1110 and the upper body 1112 of the control assembly. The partition 1121 may be a generally circular member. The partition 1121 may be formed of a flexible material. The partition 1121 may be clamped between the upper body 1112 and the lower body 1110 of the control assembly at or towards its peripheral edge. When the pressure on the upper side of the partition 1121 (e.g., the side facing the upper body 1112 of the control assembly or the patient interface side of the partition) is greater than the pressure on the lower side of the partition 1121 (e.g., the side facing the lower body 1110 of the control assembly or the gas source side of the partition), the partition 1121 moves toward a restricted position. When the pressure on the upper side of the partition is less than the pressure on the lower side of the partition 1121, the partition 1121 moves toward a less restricted or open position. The movement of the partition 1121 toward the restricted position involves movement toward the opening in the lower body 1110 of the control assembly, and specifically, movement toward the annular end face 1167 of the tubular portion. The movement of the partition 1121 toward the open position involves movement away from the opening 1165 in the lower body 1110 of the control assembly, and specifically, movement away from the annular end face 1167 of the tubular portion.

[0180] The septum 1121 of the control assembly 1100 can provide a non-binary response to the pressure difference across the septum 1121. For example, when the pressure on the lower side of the septum 1121 is only slightly greater than the pressure on the upper side of the septum 1121, only a small flow rate (e.g., a small volume of gas) can be allowed to flow from the ventilator port 1141 through the opening (passing through the annular end face 1167 and the septum 1121) and out of the main flow port 1161. If the pressure on the patient interface side of the septum 1121 is sufficiently large / high relative to the pressure on the gas source side, the septum 1121 will move to engage with the annular end face 1167 of the tubular portion to at least partially seal the opening in the lower body 1110 of the control assembly. When the pressure on the lower side of the septum 1121 is significantly greater than the pressure on the upper side of the septum 1121, a significant volume of flow rate can be allowed to flow from the ventilator port 1141 through the opening 1165 and out of the main flow port 1161. In other words, there may be a relationship between the volumetric flow rate flowing out of the main flow port 1161 and the pressure difference between the lower and upper sides of the baffle 1121.

[0181] The response of baffle 1121 and the flow rate allowed through main flow port 1161 can be altered by changing the structure of baffle 1121 (e.g., thickness, compliance, diameter, shape, and / or material selection). For example, baffle 1121 can be made of a thinner or thicker material and / or baffle 1121 can be made of less or more compliant material. When the thickness of baffle 1121 approaches zero and the compliance of baffle 1121 approaches infinity, the control assembly becomes more responsive to pressure differentials.

[0182] Figures 12A-12C The airflow via control assembly 1100 is demonstrated when partition 1121 is in the restricted position. Figure 12B A cross-sectional view of the control assembly 1100 is shown when the pressure on the lower side of the partition 1121 (e.g., in the lower body 1110 of the control assembly or on the gas source side of the partition 1121) is lower than the pressure on the upper side of the partition 1121 (e.g., in the upper body 1112 of the control assembly or on the patient interface side of the partition 1121). A ventilator airflow 1143 is provided, for example, by a ventilator and enters the control assembly 1100 via a ventilator port 1141. When the pressure of the ventilator airflow 1143 is less than the pressure within the upper body 1112 of the control assembly (e.g., the pressure provided by the pressure feedback port 1181, which could be the patient interface breathing chamber pressure minus any pressure loss at the feedback port)), the partition 1121 is forced toward the annular end face 1167 that defines an opening 1165 in the main flow path. Figures 12A-12C The diagram shows a septum 1121 engaging with an annular end face 1167. However, this engagement may not be a sealed one, in which case some gas will still pass between the annular wall and the septum (and enter the main flow path). However, in the illustrated configuration, the septum 1121 significantly restricts the flow through the main flow path. Therefore, a majority of the ventilator airflow 1143 entering the ventilator port 1141 is forced through the flushing flow path and exits from the flushing flow port 1151 as flushing airflow 1153. In some embodiments, the velocity of the flushing airflow 1153 may be no higher than or substantially no higher than the velocity of the ventilator airflow 1143 entering the ventilator port 1141. Instead, the flushing flow port 1151 may be connected to a catheter that delivers the flushing airflow 1153 to a final destination, such as a patient interface, where it is ultimately accelerated to high speed by means of a cannula, for example, with a reduced cross-sectional area. A pressure feedback port 1181 may be connected to the breathing chamber of the patient interface, for example, in a pressure or fluid communication manner. Therefore, when the patient exhales, the pressure in the upper body 1112 of the control assembly, for example, provided by the pressure feedback port 1181, may increase, for example, increasing the pressure within the breathing chamber of the patient interface relative to the pressure from the flow from the ventilator, and thus the pressure in the lower body 1110 of the control assembly. Therefore, the partition 1121 can be configured to face towards the lower body 1110 of the control assembly when the patient exhales. Figures 12A-12C The closed or restricted configuration shown can be moved.

[0183] In addition to removing the upper main body 1112 of the control component, Figure 12C A perspective sectional view of the control assembly 1100 shown in 12B is displayed. Ventilator airflow 1143 enters the lower body 1110 of the control assembly 1100 through ventilator port 1141. (As shown...) Figure 12CAs shown, the diaphragm 1121 is in a restricted position (because the pressure above the diaphragm 1121 is higher than the pressure below the diaphragm 1121, for example, higher than the pressure of the ventilator airflow 1143). Therefore, the ventilator airflow 1143 entering the ventilator port 1141 is restricted / restricted from flowing into the main flow path by the diaphragm 1121, and a significant portion of the ventilator airflow 1143 is forced through the flushing flow path and out of the control assembly 1100 through the flushing flow port 1151. The flushing airflow 1153 travels along the flushing flow path 950 to the patient interface 930, including through and out of a pair of nose forks 955. As discussed elsewhere herein, the nose forks may include a reduced cross-sectional dimension that, when leaving the flushing flow path, is used to accelerate the flushing airflow 1153, thereby generating a high-speed airflow that can be directed into the patient's nostrils. Such a high-speed airflow can advantageously flush at least partially at least one anatomical dead space (e.g., the nasal cavity) and device dead space. Because the baffle 1121 may not be able to perfectly seal against the annular end face 1167, at least some gas can travel through the main flow path and out of the main flow port 1161.

[0184] The airflow exiting the main flow port 1161 travels along the main flow path to the patient interface, where the gas enters the breathing chamber of the patient interface through the mask body. At least one of the flushing airflow 1153 and the main airflow 1163 can substantially contribute to (e.g., generate and / or maintain) positive expiratory airway pressure (EPAP) and / or positive end-expiratory pressure (PEEP) during expiration.

[0185] Figures 13A-13C The airflow is demonstrated by controlling the assembly 1100 when the partition 1121 is in the relatively open position. Figure 13BA cross-sectional view of the control assembly 1100 is shown when the pressure on the lower side of the partition 1121 (e.g., in the lower body 1110 of the control assembly or on the gas source side of the partition) is higher than the pressure on the upper side of the partition 1121 (e.g., in the upper body 1112 of the control assembly or on the patient interface side of the partition). Ventilator airflow 1143 enters the control assembly 1100 via ventilator port 1141. When the pressure of the ventilator airflow 1143 is greater than the pressure provided within the upper body 1112 of the control assembly, for example by the pressure feedback port 1181 (which is the patient interface breathing chamber pressure minus any pressure loss at the feedback port), the partition 1121 is forced away from an opening defined in the annular end face 1167, allowing gas to pass through the opening with relatively low restriction and exit the main flow port 1161. As discussed herein, the diaphragm 1121 may be at least partially responsive to pressure within the lower body 1110 of the control assembly. For example, the higher the pressure within the lower body 1110 of the control assembly relative to the pressure within the upper body 1112 of the control assembly, the more the diaphragm 1121 opens, and the more gas is allowed to exit through the opening via the main flow port 1161. The ventilator airflow 1143 entering the ventilator port 1141 is split. A portion of the gas entering the ventilator port 1141 flows through a continuous, unobstructed (or continuously open) flushing flow path and exits the flushing flow port 1151 as flushing airflow 1153. With the diaphragm 1121 in the open or unrestricted position, most of the gas entering the ventilator port 1141 passes between the annular end face 1167 and the diaphragm 1121 and exits the main flow port 1161 as the main airflow 1163 in the main flow path. When the patient inhales, the pressure in the upper body 1112 of the control assembly, provided by the pressure feedback port 1181, may decrease due to the decrease in pressure within the breathing chamber of the patient interface. Therefore, the partition 1121 is configured to move to a more open position when the patient inhales.

[0186] Because the septum 1121 is open, and the flow resistance of the main flow path is less than that of the flushing flow path, a large portion of the ventilator airflow 1143 is diverted through the opening, across the septum 1121, and through the main flow path to exit the main flow port 1161 as the main airflow 1163. As discussed herein, although the flushing flow path has higher flow resistance (e.g., due to local or global limitations, such as the nasal fork or a relatively small cross-sectional area), the flushing flow path is always open, and a certain amount of gas can travel through this path. Therefore, when the septum 1121 does not restrict the flow into / through the main flow path, a relatively small volume of ventilator airflow 1143 exits the control assembly 1100 through the flushing flow port 1151. During inspiration, when the septum 1121 is in its substantially open position, the main gas flow 1163 makes a major contribution to the generation and / or maintenance of inspiratory positive airway pressure (IPAP), although the flushing airflow may also contribute. As disclosed elsewhere in this document, the control component 1100 can interface with one or more components of the system for non-invasive ventilation.

[0187] Figures 14A-14B Patient interface 1430 is shown in conjunction with control component 1420, as illustrated in 15A-15B. In other words, patient interface 1430 is integrally formed with control component 1420. Figure 14A The patient interface 1430 is structurally and functionally compatible with... Figures 9A-9BSimilar to the patient interface 930. The structure for the patient interface 1430 may be provided at least partially by a mask housing 1432 and a mask pad 1431. The mask housing 1432 and the mask pad 1431 together define the breathing chamber of the patient interface 1430. The mask housing 1432 and the mask pad 1431 form a pad module. The mask housing 1432 is constructed of a rigid material such as polycarbonate or any other hard plastic, while the mask pad 1431 is constructed of a flexible material such as silicone. A frame 1434 is connected to the pad module. The frame 1434 is also formed of a rigid material. The frame 1434 includes a body covering the outer surface of the pad module, a pad module connector portion 1494, and a catheter connector portion 1490. The pad module connector portion 1494 is in the form of a collar, extending rearward from the frame body 1433 and being formed to be received in an opening in the mask housing 1432. Frame 1434 can be permanently or removably connected to the liner module. A catheter connector portion 1490 extends downward from frame body 1433 at an angle to liner module connector portion 1494. The catheter connector portion 1490 has a generally cylindrical distal end configured to connect to a generally cylindrical catheter in the breathing circuit for connecting the patient interface to a gas source. Control components are incorporated into frame 1434 of the patient interface. Specifically, control components are incorporated into catheter connector portion 1490 of frame 1434.

[0188] One or more components of the non-invasive ventilation system 1400 can correspond to Figures 9A-9B The non-invasive ventilation system 900. For example, a mask liner 1431 may correspond to a mask liner 931, a patient interface 1430 may correspond to a patient interface 930, a main flow path 1460 may correspond to a main flow path 960, and an irrigation flow path 1450 may correspond to an irrigation flow path 950. The patient interface 1430 may include a nasal delivery portion, which may include a nasal cannula or nasal fork, similar to a combination Figures 9A-9B Those disclosed. Although some components may be similar, substantially similar or even identical in structure and / or function between non-invasive ventilation system 900 and non-invasive ventilation system 1400, they do not need to be similar, substantially similar or identical.

[0189] In roughly the same way, Figure 14A The control component 1420 can be similar in structure and function to Figure 11A-13CThe control component 1100. The control component 1420 may include a lower control component body 1410 corresponding to the lower control component body 1110, an upper control component body 1412 corresponding to the upper control component body 1112, an inlet port 1441 corresponding to the ventilator port 1141, a flushing flow port 1451 corresponding to the flushing flow port 1151, a main flow port 1461 corresponding to the main flow port 1161, a pressure feedback port 1481 corresponding to the pressure feedback port 1181, and a partition 1421 corresponding to the partition 1121. Although some components may be similar, substantially similar, or even identical in structure and / or function between the control component 1420 and the control component 1100, they do not need to be similar, substantially similar, or identical.

[0190] exist Figures 14A-14B In the patient interface 1430 of 15A-15B, the control assembly 1420 is located within the catheter connector portion 1490, which is configured to be permanently connected to the patient interface 1430. The catheter connector portion 1490 is permanently connected to the frame body 1433. The catheter connector portion 1490 may be fixed relative to the frame body 1433, or connected to the frame body 1433 via a rotatable connector, such as a swivel or ball-and-socket connection. When the catheter connector portion 1490 is fixed to the frame body 1433, the catheter connector portion 1490 may include a swivel connection to the breathing circuit. The rotatable connection (either via a swivel connection to the breathing circuit or a swivel connection between the catheter connector portion 1490 and the mask body) allows the catheter of the breathing circuit connected to the patient interface 1430 to rotate, thereby reducing the effects of tubing tension and allowing flexibility in patient positioning relative to the catheter. The catheter connector portion 1490 is generally constructed of the same material as the mask body 1432. The conduit connector portion 1490 is constructed of a rigid plastic, such as polycarbonate.

[0191] The catheter connector portion 1490 includes an inlet port 1441 configured to connect to a flow source and two outlet ports, including a flushing flow port and a main flow port 1461 configured to guide flow into at least one of the mask housing or the patient's nostrils. Two main flow paths are formed between the inlet and outlet ports; a flushing flow path 1450 is formed between the inlet port 1441 and the flushing flow port, and a main flow path 1460 is formed between the inlet port 1441 and the main flow port 1461. A vent 1470 is also provided on the catheter connector portion 1490, configured to discharge gas from the liner module to the atmosphere. The catheter connector portion 1490 also includes a pressure flow path configured to transmit pressure within the patient housing to one side of the control assembly.

[0192] Control assembly 1420 includes a movable member in the form of a partition 1421. The partition 1421 is located within the conduit connector portion 1490 and is configured to influence both the flow rate through the main flow path 1460 and the flow rate through the vent 1470. The vent 1470 is formed at the end of a hollow or annular protrusion that projects inwardly onto the conduit connector portion 1490 (e.g., from the inner surface of the conduit connection portion). The protrusion is typically cylindrical. The protrusion includes an annular lip at one end, which is configured to serve as a sealing surface. When the partition 1421 deforms toward the lip of the vent protrusion, the flow rate through the vent 1470 is restricted. If the partition 1421 contacts the sealing surface provided by the lip, the partition will at least partially seal and close the vent 1470.

[0193] The control assembly 1420 includes a second hollow or annular protrusion that protrudes from the inner wall within the conduit connection portion toward the vent port. The second protrusion is located within the main flow path 1460. The second protrusion is generally cylindrical. At one end, the second protrusion includes an annular lip configured to serve as a sealing surface. When the baffle 1421 deforms toward the second lip, it restricts the flow rate through the main flow path 1460. This second lip is positioned opposite to the vent port lip. The baffle 1421 is located between the lips of the two protrusions of the control assembly and is configured to be elastically deformable. The baffle 1421 can thus deform to substantially block either the vent port 1470 or the main flow path 1460, but only one at a time.

[0194] The control component's inlet port 1441 branches at a shunt arrangement 1495 located within the catheter connector portion 1490, forming a flushing flow path 1450 and a main flow path 1460. The flushing flow path 1450 begins at this branch and flows unimpeded through the catheter connector portion 1490 and into the mask housing, where it is configured to continue through the nasal delivery portion for delivery to the patient's nostrils. The flushing flow path 1450 is always open and has no variable limitations. The main flow path 1460 also begins at this branch and extends between the septum 1421 and the second lip, through the second protrusion, and continues to the main outlet port, which opens through the mask housing into the breathing chamber defined by the liner module.

[0195] The diverter arrangement 1495 includes a flushing flow path wall 1493 and a baffle 1491. The baffle 1491 is disposed within the duct connector portion 1490 such that it substantially faces the inlet port 1441. In other words, the baffle 1491 is arranged in a plane substantially perpendicular to the airflow in the inlet duct connector portion 1490. The baffle 1491 extends partially across the width of the duct connector portion 1490. The baffle 1491 provides a portion of a second protrusion that provides a lip against which a baffle can abut to restrict the flow through the main flow path 1460.

[0196] The flushing flow path wall 1493 extends along most of the length of the conduit connector portion 1490. The flushing flow path wall 1493 extends from the baffle 1491 to the gasket module connector portion 1494 of the frame 1434. The flushing flow path wall 1493 is located within the conduit connector portion 1490 and is opposite to the outer wall of the conduit connector portion 1490. The flushing flow path wall 1493 thus forms a separate gas space within the conduit connector portion 1490. The flushing flow path wall 1493, together with a portion of the gasket module connector portion 1494 of the frame 1434, forms the flushing flow port 1451.

[0197] The control assembly 1420 also includes a cavity 1492 on the vent side of the partition 1421, which leads to a main flow path 1460 near the inlet of the liner module (e.g., near the main flow port 1461). The cavity 1492 defines at least a portion of the main flow path 1460 and is configured to deliver a gas pressure sufficiently similar to the pressure within the liner module. A pressure flow path passes through the main flow path 1460 and connects to the cavity 1492, such that it transmits pressure within the mask housing to the vent side of the partition 1421. The cavity 1492 includes a side chamber extending from the main flow path 1460. The side chamber is located near and below the liner module. The side chamber forms a rearward extension of the conduit connector portion 1490. The side chamber is in fluid communication with a hollow or annular protrusion of the vent 1470.

[0198] In this way, the partition 1421 is subjected to pressure on both sides, with the pressure on one side being the same as or closely similar to the internal pressure of the gasket module connected via the pressure flow path, and the pressure on the second side being the pressure provided by the gas source minus any pressure loss between the gas source and the partition 1421.

[0199] In addition to integrating the control component 1420 and the patient interface 1430 into a single unit, the non-invasive ventilation system 1400 can be similar to Figures 17A-17D The system shown (e.g.) Figures 14A-14C As shown). When similar to Figures 17A-17D At that time, the non-invasive ventilation system 1400 is activated at least by, for example, primarily by, a control component 1420 similar to... Figures 17A-17D The exhaust port of the exhaust port 1770 shown (e.g., the exhaust port in the upper body 1412 of the control assembly 1420) discharges gas to the atmosphere. The non-invasive ventilation system 1400 can be similar to [other systems where] the control assembly 1420 and patient interface 1430 are integrated into a single unit. Figure 13C The system shown. When similar to Figure 13C At that time, the non-invasive ventilation system 1400 expels air through the vent in the patient interface, similar to... Figure 13C The exhaust port 970 is shown. The integrated control component 1420 and patient interface 1430 provide a more compact system that is easier to set up and use due to fewer connections between system components.

[0200] Figure 14B A cross-sectional view of the control assembly 1420 is shown when the pressure on the lower side of the partition 1421 (e.g., in the lower body 1410 of the control assembly or on the gas source side of the partition) is higher than the pressure on the upper side of the partition 1421 (e.g., in the upper body 1412 of the control assembly or on the patient interface side of the partition) and the partition 1421 is in a less restricted position. Figure 14B A noninvasive ventilation system 1400 is illustrated when a patient is inhaling, causing a pressure drop within the breathing chamber of the patient interface 1430. This pressure drop within the breathing chamber of the patient interface 1430 is transmitted to the control assembly 1420 via a pressure feedback port 1481. In its less restricted position, a diaphragm 1421 allows gas to flow through a primary flow path 1460, for example, through the diaphragm 1421, through the primary flow path 1460, and into the breathing chamber of the patient interface 1430 (as discussed, some gas may also flow through a flushing flow path 1450). The control assembly 1420 and its components may behave similarly to a combination of... Figure 12B The control assembly 1100 is described. The pressure in the upper body 1412 of the control assembly (e.g., the pressure in the volume of the control assembly 1420 from the partition 1421 toward the patient interface) is determined by the pressure feedback port 1481. Figure 14B In the illustrated embodiment, pressure feedback port 1481 is in fluid communication with the main flow path 1460 upstream of partition 1421. However, the connection of pressure feedback port 1481 is close enough to the outlet of the main flow path 1460 into the breathing chamber of patient interface 1430 that the pressure drop between pressure feedback port 1481 and the breathing chamber of patient interface 1430 is insufficient to affect system performance. In some embodiments, pressure feedback port 1481 is directly connected to the breathing chamber of patient interface 1430.

[0201] As can be seen, when the patient inhales, the pressure in the patient interface 1430 decreases, thereby lifting the partition 1421 away from the annular end face 1467 (relieving the restriction on flow through the main flow path 1460) and upward against the port 1470 (increasing the restriction on flow through the vent 1470). As the partition 1421 is lifted away from the annular end face 1467, an increased gas volume is allowed to flow through the partition 1421, through the main flow path 1460, and into the patient interface. As the partition 1421 rises toward and restricts the vent 1470, a reduced volume of gas is allowed to escape through the vent 1470. Similar to a combination... Figures 17A-17E The control assembly 1720 under discussion, and the partition 1421 of the control assembly 1420, can have two extreme positions. In one extreme position, the partition 1421 is as close as possible to the annular end face 1467, for example, in contact with the annular end face 1467, and as far away as possible from the vent hole 1470 sealing ring (similar to the vent hole sealing ring 1777). When the partition 1421 is as close as possible to the annular end face 1467, the partition 1421 restricts airflow through the main flow path 1460. When the partition 1421 is as far away as possible from the vent hole 1470 sealing ring, the partition 1421 allows gas to flow unimpeded through the vent hole 1470. In the other extreme position, the partition 1421 is as close as possible to the vent hole 1470 sealing ring (e.g., in contact with the ring), and as far away as possible from the annular end face 1467. When the baffle 1421 is as close as possible to the sealing ring of the vent 1470, the baffle 1421 restricts the airflow through or from the vent 1470. When the baffle 1421 is as far away as possible from the annular end face 1467, the baffle 1421 allows gas to flow unimpeded through the main flow path 1460.

[0202] Figure 14C A cross-sectional view of the control assembly 1420 is shown when the pressure on the lower side of the partition 1421 (e.g., in the lower body 1410 of the control assembly or on the gas source side of the partition) is lower than the pressure on the upper side of the partition 1421 (e.g., in the upper body 1412 of the control assembly or on the patient interface side of the partition) and the partition 1421 is in a restricted position. Figure 14CA noninvasive ventilation system 1400 is illustrated when a patient is exhaling, causing an increase in pressure within the breathing chamber of the patient interface 1430. This pressure increase in the patient interface 1430 is transmitted to the control assembly 1420 via a pressure feedback port 1481. In its restricted position, the diaphragm 1421 is close to the annular end face 1467 and restricts airflow through the main flow path 1460, thereby forcing gas to flow through the flushing flow path 1450 (as mentioned above, the diaphragm 1421 may not seal against the annular end face 1467 and gas may continue to flow through the main flow path 1460, even when the diaphragm 1421 is in its restricted position). As can be seen, when the patient exhales, the pressure increase in the patient interface 1430 pushes the diaphragm 1421 toward the annular end face 1467 (increasing the restriction on flow through the main flow path 1460) and away from the exhaust port 1470 (reducing the restriction on flow through the exhaust port 1470). When the diaphragm 1421 is pushed toward the annular end face 1467, the diaphragm 1421 restricts airflow through the main flow path, thereby allowing a relatively reduced volume of gas to flow through the diaphragm 1421, through the main flow path 1460, and into the patient interface. As the diaphragm 1421 drops or moves away from the vent 1470, gas is more freely allowed to escape through the vent 1470 into the atmosphere. In this case, the pressure feedback port 1481 also serves as a leak path, allowing gas to escape through the vent 1470 and flow out of the mask into the atmosphere. The reduction in airflow through the main flow path 1460 corresponds to a corresponding increase in airflow through the flushing flow path 1450. As discussed elsewhere herein, the flushing flow path 1450 can be configured to accelerate the flushing airflow 1453 through the flushing flow path 1450. The accelerated flushing airflow 1453 can exit the flushing flow path 1450 via one or more nose forks and can flush at least a portion (e.g., some or all) or one or more of the anatomical and device invalid cavities. The patient's exhaled air can travel through the main flow port 1461, through the pressure feedback port 1481, and out through the exhaust port 1470 integrated into the upper body 1412 of the control assembly. Some embodiments of the flow-controlled patient interface 1400 integrate the exhaust port 1470 in both the upper body 1412 of the control assembly 1420 and the mask housing 1432. Some embodiments of the flow-controlled patient interface 1400 integrate the exhaust port 1470 only in the upper body 1412 of the control assembly 1420.

[0203] Figure 16A block diagram illustrating an embodiment of a system for providing and / or maintaining noninvasive ventilation is shown. The noninvasive ventilation system 1600 includes various components, including a gas source 1610, a control assembly 1620, a patient interface 1630, a breathing circuit 1635, and a feedback arrangement 1680. These components define a gas source conduit 1640, a main flow path 1660, and a flushing flow path 1650. The components of the noninvasive ventilation system 1600 can be substantially similar in combination. Figure 8 The non-invasive ventilation system 800 discussed and combined with Figure 2A The components of the non-invasive ventilation system 200 are discussed. For example, gas source 1610 may correspond to gas source 810, gas source catheter 1640 may correspond to gas source catheter 840, main flow path 1660 may correspond to main flow path 860, flushing flow path 1650 may correspond to flushing flow path 850, control component 1620 may correspond to control component 820, patient interface 1630 may correspond to patient interface 830, and feedback arrangement 1680 may correspond to feedback arrangement 880. Although some components may be similar, substantially similar or even identical between non-invasive ventilation system 800 and non-invasive ventilation system 200, they do not need to be similar, substantially similar or identical.

[0204] Gas source 1610 has an outlet connected to breathing circuit 1635 through which the gas source supplies breathing gas. The pressure and flow rate at the outlet of the gas source are nominally a first pressure P1 and a first volumetric flow rate F1. Gas source 1610 is controlled to provide the first pressure and the first flow rate (P1, F1) to achieve the desired pressure at patient interface 1630, particularly within the breathing chamber of the mask. Therefore, the first pressure and the first flow rate (P1, F1) can be controlled to account for any system pressure loss between gas source 1610 and patient interface 1630. As previously mentioned, the desired pressure at patient interface 1630 may vary during the user's breathing cycle (e.g., between IPAP and EPAP).

[0205] The breathing circuit 1635 is divided, branched, or split into a flushing flow path 1650 and a main flow path 1660, each flow path having an independent outlet in the patient interface 1630 through which breathing gas is delivered to the user. The pressure and flow rate at the outlet of the flushing flow path 1650 are nominally a second pressure P2 and a second volumetric flow rate F2. The pressure and flow rate at the outlet of the main flow path 1660 are nominally a third pressure P3 and a third volumetric flow rate F3.

[0206] The feedback arrangement 1680 takes the form of a connector, port, or line that transmits the pressure within the breathing chamber of the patient interface 1630 to the control assembly 1620. The control assembly 1620 can adjust the flow rate allowed through the main flow path 1660 based on the pressure of the gas within the patient interface 1630 (e.g., the pressure transmitted to the control assembly 1620 via the pressure arrangement line 1680).

[0207] Control component 1620 at least partially defines the inlet from gas source 1610 to main flow path 1660. Flushing flow path 1650 is connected to gas source 1610 via a set flow path that is not directly altered or modified by control component 1620 (although it may be indirectly altered and / or modified). Control component 1620 has a gas source side and a patient interface side. The gas source side of control component 1620 includes the inlet of control component 1620. The patient interface side of control component 1620 includes a pressure line 1680. Control component 1620 is configured to change the flow resistance of main flow path 1660. Control component 1620 is operable such that when the pressure on the gas source side of control component 1620 (typically corresponding to P1 minus any pressure loss between the gas source outlet and the control component) is higher than the pressure on the patient side of control component 1620 (typically corresponding to the pressure within the patient interface breathing chamber minus any pressure loss across the pressure feedback arrangement 1680), the flow rate through the main flow path 1660 is open or less restricted by control component 1620. The greater the pressure differential between the gas source side and the patient interface side of control component 1620 (where the pressure on the gas source side is higher than the pressure on the patient interface side), the less restricted the main flow path 1660 will be.

[0208] The control component 1620 can also be operated such that when the pressure on the patient interface side of the control component 1620 (typically corresponding to the pressure within the patient interface breathing chamber minus any pressure loss across the pressure feedback arrangement 1680) is greater than the pressure on the gas source side of the control component 1620 (typically corresponding to P1 minus any pressure loss between the gas source outlet and the control component), the flow rate through the main flow path 1660 is restricted, or more significantly restricted by the control component 1620. The greater the positive pressure differential between the patient interface side and the gas source side, the more likely the flow rate through the main flow path 1660 will be restricted.

[0209] When the control component restricts the flow rate through the main flow path 1660, for the same pressure (P1) at the outlet of the gas source, the flow rate (F3) through the outlet of the main flow path 1660 decreases, while the flow rate (F2) through the outlet of the flushing flow path 1650 increases. As the volumetric flow rate through the flushing flow path 1650 increases, the velocity of the airflow through the flushing flow path 1650 also increases. The system is configured such that the velocity of the airflow through the flushing flow path 1650 is sufficiently high to flush anatomical dead spaces and / or device dead spaces during the user's respiratory cycle. Similarly, when the control component 1620 opens the flow rate through the main flow path 1660, for the same pressure (P1) at the outlet of the gas source 1610, the flow rate (F3) through the outlet of the main flow path 1660 increases, and the flow rate (F2) through the outlet of the flushing flow path 1650 decreases due to the reduced flow resistance through the main flow path 1660.

[0210] The increase in pressure on the patient interface side of the control component 1620 relative to the pressure on the gas source side typically occurs during user exhalation. This is because the user is exhaling and adding mass to a fixed volume of gas in the patient interface 1630, thereby increasing the pressure within the breathing chamber of the patient interface. During user inhalation, the pressure on the patient interface side of the control component 1620 typically decreases relative to the pressure on the gas source side of the control component 1620 because the user is inhaling air from the patient interface into the patient interface 1630. Therefore, the system can be configured to primarily provide flushing of anatomical dead spaces and / or device dead spaces during exhalation, and may provide little (if any) flushing during inhalation. The noninvasive ventilation system 1600 also includes a ventilation airflow path 1690. The ventilation airflow path 1690 is configured to provide a flow path for gas to be exhausted from the patient interface 1630 through the control component 1620. In some embodiments, the airflow path 1690 may be combined with the feedback arrangement 1680; for example, instead of separate airflow paths 1690 and feedback arrangements 1680, a single conduit connects both pressure and exhaust flow between the patient interface 1630 and the control assembly 1620. When the patient exhales, exhaled gas is collected by the breathing chamber of the patient interface 1630 and flows out of the breathing chamber through the airflow path 1690 to the control assembly 1620. After reaching the control assembly 1620, the exhaled or expired gas can affect the performance of the control assembly 1620 and / or the exhaled or expired gas can be discharged from the control assembly 1620 into the atmosphere. For example, if the pressure of the exhaled gas is higher than the pressure of the flow rate received by the control assembly 1620 from the gas source, the exhaled or expired gas can be exhaled into the atmosphere. In this way, the control assembly 1620 can dynamically respond to the patient's respiratory cycle.

[0211] In some embodiments, the noninvasive ventilation system 1600 provides active ventilation of exhaled gases. The control component 1620 can be configured to respond to pressure (P) within the patient interface. PI When the pressure in another part of the system is lower than that in the airflow path 1690, the flow rate through the airflow path 1690 is closed or limited. In some embodiments, the control component 1620 is configured to close or limit the flow rate through the airflow path 1690 when the pressure in the patient interface (P) is lower than that in another part of the system. PI When the pressure of the airflow at the outlet of the gas source (P1) is less than the first pressure (P1) of the airflow minus any pressure loss between the gas source and the control component, the flow rate through the airflow path 1690 is closed or restricted. In other words, when the pressure on the patient interface side of the control component is less than the pressure on the gas source side of the control component, the airflow path 1690 is closed or restricted. When the pressure within the patient interface (P1) is less than the first pressure (P1) of the airflow at the outlet of the gas source minus any pressure loss between the gas source and the control component, the flow rate through the airflow path 1690 is closed or restricted. PI When the pressure is relatively low, closing or limiting the flow rate through the ventilation path 1690 can advantageously prevent atmospheric air from responding to the lower pressure (P) within the patient interface. PI The gas is inhaled through the airflow path 1690 in the inhalation system. This also means that the gas source does not have to overcome exhaust port leakage during inspiration, and therefore the overall workload is less when providing the same pressure of gas to the patient. The control component 1620 can be configured to respond to pressure (P) within the patient interface. PI When the pressure in the patient interface is greater than the pressure in another part of the system, the restriction on the airflow path 1690 is opened or reduced. In some embodiments, the control component 1620 is configured to open or reduce the restriction on the airflow path 1690 when the pressure in the patient interface is greater than the pressure in another part of the system. PI The restriction on the airflow path 1690 is opened or reduced when the pressure (P1) of the airflow at the outlet of the gas source is greater than the pressure between the gas source and the control assembly. In other words, the airflow path 1690 is opened or reduced when the pressure on the patient interface side of the control assembly is greater than the pressure on the gas source side of the control assembly.

[0212] Figures 17A-17E An embodiment of control component 1720 is shown, which can form various non-invasive ventilation systems disclosed herein (e.g., Figure 16 Part of the non-invasive ventilation system 1600 shown. Figures 17A-17D The control component 1720 includes components that can be connected with Figure 11A-11B The components of the control assembly 1100 are substantially similar to those of other components. For example, the lower body 1710 of the control assembly can correspond to the lower body 1110 of the control assembly, the inlet flow port 1741 can correspond to the ventilator port 1141, and the flushing flow port 1751 (in...) Figures 17A-17D(Some figures not shown) may correspond to flushing flow port 1151, openings in the main flow path and associated main flow sealing surface 1767 may correspond to openings and main flow sealing surface 1167, and baffle 1721 may correspond to baffle 1121. While some components may be similar, substantially similar, or even identical in structure and / or function between control assembly 1720 and control assembly 1100, they do not need to be similar, substantially similar, or identical. For example, Figures 17A-17D The control component 1720 may differ from its upper main body 1712 in structure and function. Figure 11A-11B Control component 1100.

[0213] As described herein, the upper control assembly body 1112 of the control assembly 1100 serves as a cover for the lower control assembly body 1110, which covers the baffle 1121. Pressure changes in the upper control assembly body 1112 relative to the pressure in the lower control assembly body 1110 cause the baffle 1121 to increase and decrease the restriction imposed by the baffle on the flow rate through the main flow path. These changes result in changes in the relative volumetric flow rate of the gas through the main flow path and the flushing flow path.

[0214] Control assembly 1720 includes a pressure feedback port 1781 that directs gas from the breathing chamber of the patient interface into the upper body 1712 of the control assembly. Pressure feedback port 1781 can be configured to receive a feedback airflow 1783, which may include some, substantially all, or all of the gas exhaled by the patient (e.g., the patient interface connected to control assembly 1720 may be hermetically attached to the patient's face and configured such that most or all of the gas exhaled into the patient interface is forced to be delivered to pressure feedback port 1781 as feedback airflow 1783). Pressure changes in the upper body 1712 of the control assembly (e.g., pressure changes caused by fluid (e.g., pressure) communication between the upper body 1712 of the control assembly and the breathing chamber of the patient interface via pressure feedback port 1781) may cause the partition 1721 to move toward or away from an opening in the main flow path. When the pressure of the ventilator airflow 1743 is less than the pressure within the upper body 1712 of the control assembly (e.g., the pressure provided by the pressure feedback port 1781, which is the patient interface breathing chamber pressure minus any pressure loss in the feedback port), the diaphragm 1721 is forced toward the primary flow seal surface 1767 that defines an opening in the primary flow path. This restricts the flow rate out of the primary flow port 1761 through the primary flow path, and if a significant restriction is created in the primary flow path, most of the flow from the ventilator travels only through the flushing flow path. When the pressure of the ventilator airflow 1743 is greater than the pressure within the upper body 1712 of the control assembly (e.g., the pressure provided by the pressure feedback port 1781, which is the patient interface breathing chamber pressure minus any pressure loss in the feedback port), the diaphragm 1721 is forced away from the primary flow seal surface 1767 that defines an opening in the primary flow path. Opening the primary flow path to the extent that the diaphragm does not significantly restrict the flow rate through the primary flow path results in most of the ventilator airflow preferentially flowing along the primary flow path over the flushing flow path due to the greater flow resistance of the flushing flow path.

[0215] The upper body 1712 of the control assembly may further include an exhaust port 1770 with a ventilation opening and an exhaust port sealing surface 1777. The exhaust port 1770 can be used to expel air exhaled by the patient and receive air in the control assembly via a pressure feedback port 1781 from the patient interface. The exhaust port is formed in the exhaust port sealing surface 1777. Ventilation capability may be particularly advantageous when the exhaust port 1770 is connected to a sealed (or substantially sealed) patient interface, such as an interface sealed against the patient's face without an exhaust port. The exhaust port sealing surface 1777 can be configured to seal against the partition 1721 to close the ventilation opening when the partition 1721 is in the open position and does not restrict flow through the main flow path. Figures 17A-17BAs shown, when the baffle 1721 is in its fully open position (e.g., allowing gas to travel unrestricted through the main flow path and out of the main flow port 1761), the baffle 1721 rises toward the upper body 1712 of the control assembly and abuts against the vent sealing surface 1777. When the baffle 1721 is in a sealing engagement with the vent sealing surface 1777, gas received through the pressure feedback port 1781 (e.g., exhaled gas) is not allowed to escape from the vent port 1770 (or only a small amount of gas is allowed to escape). As the baffle 1721 begins to close or restrict the flow through the main flow path, the baffle 1721 moves away from the vent sealing surface 1777 and toward the main flow sealing surface 1767. When this occurs, the airflow path opens, allowing gas received through the pressure feedback port 1781 to exit the control assembly 1720 through the vent port 1770.

[0216] During inhalation, for example in Figures 17A-17B As shown, the patient's inhalation (e.g., relative to the airflow from the ventilator) reduces the pressure within the breathing chamber of the patient interface. This reduced pressure within the breathing chamber of the patient interface is transmitted to the control assembly 1720 via pressure feedback port 1781, causing a pressure drop in the upper body 1712 of the control assembly above the partition 1721 relative to the pressure below the partition. When this occurs, the partition 1721 can be opened (partially or substantially open), allowing most of the gas received from the ventilator to flow through the main flow path, out from the main flow port 1761, and to the patient interface. When the partition 1721 is open, the upper side of the partition 1721 restricts or closes the vent in the vent sealing surface 1777, for example, by sealing or substantially sealing against the vent sealing surface 1777. This limits gas leakage from the patient interface through the airflow path during inhalation.

[0217] During exhalation, for example in Figure 17C-17DAs shown, the patient's exhalation increases the pressure within the breathing chamber of the patient interface relative to the airflow from the ventilator. This is transmitted to the control assembly 1720 via pressure feedback port 1781, and causes the pressure in the upper body 1712 of the control assembly above the partition 1721 to increase relative to the pressure below the partition. When this occurs, as described herein, the partition 1721 can be (partially or substantially) closed, and the gas received from the ventilator is blocked or restricted through the main flow path, with most of the gas flowing through the flushing flow path and exiting from the flushing flow port 1751 (as discussed herein, the gas through the flushing flow path can be accelerated such that, upon release from the nasal fork, the gas can advantageously flush at least one of the anatomical dead space and the device dead space). Simultaneously, the movement of the partition toward closing or restricting the flow through the main flow path also causes the upper side of the partition 1721 to move away from the exhaust port sealing surface 1777, thereby opening the ventilation air path and allowing the exhaled air received from the patient interface through the pressure feedback port 1781 to be discharged into the atmosphere from the exhaust port 1770, so that dead space flushing occurs at the same time as the patient's exhaled air is discharged into the atmosphere.

[0218] The control assembly housing 1708 includes two bodies, each comprising a cylindrical structure closed at one end and open at the other. The two open ends of the bodies are configured to interact with each other such that they are joined to create a cavity defining the control assembly housing 1708 between them. The upper control assembly body 1712 includes an internal protrusion extending from the closed end. One and the opposite ends of the internal protrusion are open, and a plurality of holes are configured to extend through the housing. In use, the plurality of holes provide vent holes 1770. A cylindrical external protrusion projects from the sidewall of the housing and defines an inlet port to allow flow into the upper control assembly body 1712.

[0219] The lower body 1710 of the control assembly includes three external cylindrical protrusions projecting from the sidewall of the lower body of the housing. Two external protrusions are positioned adjacent to each other on one side of the housing, while the third external protrusion is located on the opposite side of the lower body 1710 of the control assembly. The separately positioned external protrusions define an inlet flow port 1741 and are in fluid communication with the interior cavity of the control assembly housing 1708. Of the other two external protrusions, one external protrusion defines a flush flow port 1751. The third external protrusion is configured to extend through the sidewall of the control assembly housing 1708 and intersect with an internal cylindrical protrusion extending upward from the closed end of the lower body, such that a flow path is defined from the interior of the housing, downward from the internal protrusion extending upward from the closed end of the lower body 1710 of the control assembly and along the external protrusion extending through the sidewall of the lower body 1710 of the control assembly.

[0220] The control assembly 1720 further includes a partition 1721 located at or near the junction between the upper control assembly body 1712 and the lower control assembly body 1710 of the control assembly 1720. The partition 1721 can be sandwiched between the upper control assembly body 1712 and the lower control assembly body 1710 of the control assembly 1720.

[0221] Both the exhaust flow path and the main flow path 1760 are configured to be directly affected by the operation of the baffle 1721 within the control assembly 1720. An internal protrusion extending upward from the closed end of the lower body 1710 of the control assembly has an edge that provides a sealing surface (e.g., a main flow sealing surface 1767) at one end and an outlet at the other end. When the baffle 1721 deforms toward the sealing surface 1767 of the internal protrusion of the lower body 1710 of the control assembly, the flow rate through the main flow path 1760 is restricted. The exhaust flow path includes an internal protrusion extending downward from the closed end of the upper body 1712 of the control assembly. The internal protrusion has an edge that defines a sealing surface at one end. When the baffle 1721 deforms toward the sealing surface 1777 of the internal protrusion of the upper body 1712 of the control assembly, the flow rate through the exhaust flow path is restricted.

[0222] The baffle 1721 is configured to be movable between two extreme positions. In one position, the baffle 1721 deforms such that it contacts the sealing surface of the main flow path 1767 and substantially blocks the flow through the main flow path 1760, allowing unobstructed flow from the mask through the exhaust flow path and out to the atmosphere. In the second position, the baffle 1721 is configured to contact the sealing surface 1777 of the exhaust flow path and substantially block the flow through the exhaust flow path, while allowing unobstructed flow through the main flow path 1760.

[0223] Figures 18A-18C Embodiments of control component 1820 are shown in 19A-19B, which can form various non-invasive ventilation systems disclosed herein (e.g., Figure 16 Part of the non-invasive ventilation system 1600 shown. Figures 18A-18C The control assembly 1820 of the 19A-19B includes various components that can be substantially similar to... Figures 17A-17D Control component 1720 and / or Figure 11A-11BThe components of control assembly 1100. For example, ventilator port 1841 may correspond to inlet flow port 1741, main flow port 1861 may correspond to main flow port 1761, flushing flow port 1851 may correspond to flushing flow port 1751, pressure feedback port 1881 may correspond to pressure feedback port 1781, and exhaust port 1870 may correspond to exhaust port 1770. Although some components may be similar, substantially similar, or even identical in structure and / or function between control assembly 1820 and control assembly 1720, they do not need to be similar, substantially similar, or identical.

[0224] Control component 1820 includes a ventilator port 1841 configured to receive an airflow 1843 from a gas source. Like other control components discussed herein, control component 1820 is configured to divert, split, or branch the airflow 1843 into one or both a main flow path and a flushing flow path, the main flow path exiting control component 1820 through a main flow port 1861, and the flushing flow path exiting control component 1820 through a flushing flow port 1851. The flushing flow path can be continuously open and is not directly affected by the operation of the control component. The main flow path can be more or less restricted by control component 1820 (which can define the inlet, origin, or opening of the main flow path). As discussed elsewhere, the flushing flow path can have higher flow resistance than the main flow path. Therefore, when the main flow path is less restricted by the control component 1820, the gas flow 1843 may preferentially flow (e.g., most of the volume of gas will flow through) through the main flow path and out of the main flow port 1861 (in which case, only a certain volume of gas will flow through the flushing flow path). Gas that does not flow through the main flow path is diverted to the flushing flow path and exits the control component 1820 through the flushing flow port 1851. Therefore, when the main flow path is restricted by the control component 1820, a relatively large volume of gas flow 1843 will flow through the flushing flow path and out of the flushing flow port 1851 (although the control component 1820 typically does not completely seal the main flow path, and even when the main flow path is restricted, a certain volume of gas is allowed to flow through the main flow path and out of the main flow port 1861).

[0225] The control assembly 1820 includes a control assembly body 1810 that typically provides structure for the rest of the device. On one side (e.g., the top) of the control assembly body 1810 is a control assembly upper cover 1812, and on the other side (e.g., the bottom) is a control assembly lower cover 1813. Between the control assembly body 1810 and the control assembly upper cover 1812 is an upper partition 1821. Between the control assembly body 1810 and the control assembly lower cover 1813 is a lower partition 1822. Figures 17A-17DThe control assembly 1720 discussed relies on pressure on the upper and lower sides of its partition 1721 (e.g., the patient side and gas source side of partition 1721) to increase and / or decrease the restriction of its primary flow path. The control assembly 1820 may be independent of the pressure between the upper partition 1821 and the control assembly upper cover 1812 or the pressure between the lower partition 1822 and the control assembly lower cover 1813. Therefore, the volume between the upper partition 1821 and the control assembly upper cover 1812, and the volume between the lower partition 1822 and the control assembly lower cover 1813, may be in fluid communication with the atmosphere. In some embodiments, the volume between the upper partition 1821 and the control assembly upper cover 1812, and the volume between the lower partition 1822 and the control assembly lower cover 1813, may be closed and operated at least partially in conjunction with one or more pressure port lines.

[0226] The upper baffle 1821 is configured to lift from the main flow path sealing surface 1867, which defines the main flow path. The upper baffle 1821 has a flow-limiting position and a flow-allowing position. When the upper baffle 1821 is in its flow-limiting position, the lower side of the upper baffle 1821 approaches or is close to the main flow path sealing surface 1867, restricting gas flow through the main flow path opening (e.g., when the upper baffle 1821 is close to the main flow path sealing surface 1867 and restricts the main flow path, a relatively large volume of gas is forced through the flushing flow path and out of the flushing flow port 1851). When the upper baffle 1821 is in its less restrictive or flow-allowing position, the lower side of the upper baffle 1821 is raised away from the main flow path sealing surface 1867, allowing gas to pass between the main flow path surface 1867 and the upper baffle 1821, thereby allowing gas to flow through the opening to the main flow path and out of the control assembly 1820 via the main flow port 1861.

[0227] When not restricted by control component 1820, the primary flow path through control component 1820 can have a much lower flow restriction than the flushing flow path through control component 1820. Therefore, when the upper diaphragm 1821 is in its less restricted or flow-allowed position, most of the volume of gas entering ventilator port 1841 will flow through the primary flow path and exit via primary flow port 1861. When the upper diaphragm 1821 restricts the primary flow path, the volume of gas flowing through the primary flow path decreases, while the volume of gas flowing through the flushing flow path increases.

[0228] The lower baffle 1822 has a less restrictive or flow-allowing position and a restricted position. When the lower baffle 1822 is in its restricted position, the upper side of the lower baffle 1822 is close to or near the exhaust duct sealing surface 1877, restricting gas flow through the pressure feedback port 1881 and out of the exhaust port 1870. When the lower baffle 1822 is in its less restrictive or flow-allowing position, the upper side of the lower baffle 1822 moves away from the exhaust duct sealing surface 1877, allowing gas to travel from the pressure feedback port 1881 between the exhaust duct sealing surface 1877 and the lower baffle 1822 and out of the exhaust port 1870.

[0229] The upper partition 1821 can be connected to the lower partition 1822 via a partition connector 1823. The partition connector 1823 can be a connector with a substantially fixed length; for example, the partition connector 1823 may have little or no compliance or elasticity. The partition connector 1823 may have a length such that when the lower partition 1822 is in its flow-allowed or less restricted position, the partition connector 1823 forces the upper partition 1821 into its restricted position (e.g., when the lower partition 1822 descends, for example, moving away from the exhaust duct sealing surface 1877, the partition connector 1823 pulls down on the upper partition 1821, thereby restricting the main flow path). The length of the partition connector 1823 may be such that when the upper partition 1821 is in its flow-allowed or less-restricted position, the partition connector 1823 forces the lower partition 1822 into its restricted position (e.g., when the upper partition 1821 rises, for example, when it moves away from the main flow path sealing surface 1867, the partition connector 1823 pulls upward on the lower partition 1822, thereby restricting the flow between the pressure feedback port 1881 and the vent 1870).

[0230] The control assembly 1820 includes a pressure feedback port 1881 that directs gas from the breathing chamber of the patient interface into the control assembly 1820 above the lower partition 1822. The pressure feedback port 1881 can be configured to receive a feedback airflow 1883, which may include exhaled gas from the patient (e.g., the patient interface connected to the control assembly 1820 may be hermetically attached to the patient's face and configured such that most or all of the gas exhaled into the patient interface is directed as feedback airflow 1883 via a conduit to the pressure feedback port 1881). Pressure changes in the portion of the control assembly body 1810 connected to the pressure feedback port 1881 (above the lower diaphragm 1822) (e.g., due to fluid (e.g. pressure) communication between the control assembly body 1810 and the breathing chamber of the patient interface via the pressure feedback port 1881) can cause the lower diaphragm 1822 (and due to the diaphragm connector 1823, upper diaphragm 1821) to move toward or away from the exhaust port sealing ring 1877, respectively increasing or decreasing the flow restriction from the pressure feedback port 1881 and out of the exhaust port 1870.

[0231] The vent 1870 allows air exhaled by the patient and received from the patient interface via the pressure feedback port 1881 to be discharged. The lower partition 1822 is configured to move toward and away from the exhaust duct sealing surface 1877 to increase and decrease restriction on airflow from the pressure feedback port 1881 and out of the vent 1870. Figure 18A As shown, when the upper baffle 1821 is in its minimum restricted position (e.g., allowing gas to travel substantially unrestricted through the main flow path and out of the main flow port 1861), the lower baffle 1822 rises toward the exhaust duct sealing surface 1877. As the lower baffle 1822 moves toward the exhaust duct sealing surface 1877, gas received through the pressure feedback port 1881 (e.g., exhaled gas) is restricted (e.g., substantially restricted) from venting through the exhaust port 1870 (e.g., allowing only a relatively small volume of gas to be released). As the upper baffle 1821 moves toward the main flow path sealing surface 1867 and restricts the main flow path, the lower baffle 1822 moves away from the exhaust duct sealing surface 1877. As the lower baffle 1822 moves away from the exhaust duct sealing surface 1877, the airflow from the pressure feedback port is less restricted, thereby allowing gas received through the pressure feedback port 1881 to exit the control assembly 1820 through the exhaust port 1870. In this way, the control component 1820 can respond to (e.g., dynamically respond to) the pressure generated by the patient during the respiratory process.

[0232] During inhalation, for example, as Figure 18A and Figure 19AAs shown, the patient's inhalation removes the mass of a fixed volume of gas from the breathing chamber of the patient interface, thus reducing the pressure within the patient interface. This reduced pressure within the breathing chamber of the patient interface is transmitted to the control assembly 1820 via pressure feedback port 1881, causing a pressure drop in the control assembly body 1810 above the lower partition 1822. As discussed herein, when the pressure above the lower partition 1822 decreases, the lower partition 1822 can move toward the exhaust port sealing ring 1877. As the lower diaphragm 1822 moves toward the vent sealing ring 1877, it pushes upward on the diaphragm connector 1823, which in turn pushes upward on the upper diaphragm 1821, thereby biasing the upper diaphragm 1821 upward and placing it in a less restricted or flow-allowed position, allowing gas received from the gas source via port 1841 to flow through the main flow path, out of the main flow port 1861, and to the patient interface (as discussed herein, due to the relatively lower flow resistance of the main flow path compared to the flushing flow path, gas can preferentially flow through the open main flow port 1861 rather than the open flushing flow port 1851). When the lower diaphragm 1822 is in its maximum restricted position (and the upper diaphragm 1821 is in its minimum restricted position), the upper side of the lower diaphragm 1822 moves toward the vent duct sealing surface 1877, thereby reducing the inflow of atmospheric air, which may increase the pressure in the pressure feedback port 1881 and allow the upper diaphragm 1821 to seal prematurely.

[0233] During exhalation, for example in Figure 18B and Figure 19BAs shown, the patient's exhalation adds additional gas to the fixed volume of the breathing chamber of the patient interface, and increases the pressure within the breathing chamber. This increased pressure within the breathing chamber of the patient interface is transmitted to the control assembly 1820 via the pressure feedback port 1881, and causes an increase in pressure within the control assembly body 1810 above the lower partition 1822. When the pressure above the lower partition 1822 increases (e.g., initially in the pressure feedback port 1881), the lower partition 1822 moves away from the exhaust port sealing ring 1877, thereby pulling downwards on both the partition connector 1823 and the upper partition 1821, thus pulling the upper partition 1821 closer to the main flow path sealing surface 1867. As the upper diaphragm 1821 moves toward the main flow path sealing surface 1867, gas received from the gas source is confined through the main flow path and forced through the flushing flow path and out of the flushing flow port 1851 to reach the patient interface (as discussed herein, the gas through the flushing flow path can be accelerated such that, upon release within the patient interface, the gas can flush at least one of the anatomical dead space and the device dead space). As the lower diaphragm 1822 moves away from the exhaust port sealing ring 1877, gas is allowed to flow more freely from the pressure feedback port 1881 through the lower diaphragm 1822 and out of the exhaust port 1870. In this way, the control assembly 1820 can passively expel gas exhaled by the patient during exhalation.

[0234] Figures 20A-20C Several different views of another embodiment of the control component are shown. Figure 20A The control components are shown in a side view. Figure 20B The control components are shown in longitudinal section and in the first operating state. Figure 20C The control assembly is shown in longitudinal section and in a second operating state. In this embodiment, the movable component of the control assembly 2000 includes a valve 2024 coupled to a diaphragm 2021 configured to move the valve to adjust the main airflow and flushing airflow.

[0235] The control assembly 2000 includes a housing with an internal airflow port that branches from the gas source port 2031 to the main flow port 2032 and the flushing flow port 2033. Figure 20B and Figure 20C Arrows P1F1, P2F2, and P3F3 indicate the source airflow, flushing airflow, and main airflow, respectively. The flexible baffle 2021 is held within the baffle chamber 2022 of the control assembly by its outer edge. A first gas pressure feedback port 2027 is provided in the baffle chamber 2022 on one side of the baffle. Figure 20B and Figure 20CAs schematically shown by arrow 2027a, the first gas pressure feedback port 2027 is connected in use to receive gas source pressure. A second gas pressure feedback port 2028 is provided in the partition chamber 2022 on the opposite side of the partition. (See image below.) Figure 20B and Figure 20C As schematically shown by arrow 2028a, the second gas pressure feedback port 2028 is connected during use to receive gas pressure indicating the pressure within the patient interface. The pressure within the patient interface changes depending on whether the patient wearing the interface is inhaling or exhaling, and indicates whether the patient is inhaling or exhaling.

[0236] One end of connector 2023 is connected to partition 2021, such that connector 2023 moves with the movement of partition 2021. Connector 2023 engages with valve 2024 at the opposite end. Connector 2023 may or may not be permanently connected to valve 2024. Valve 2024 is positioned within the control assembly in the main flow path. Valve 2024 is mounted for pivoting about a pivot or hinge point 2025. Valve 2024 may, for example, be attached to an inner wall 2026 within the control assembly that divides the interior of the control assembly into a main airflow path and a flushing airflow path. Valve 2024 may, for example, be attached to inner wall 2026 at 2025 via a movable hinge. Partition 2021 and valve 2024 may be... Figure 20B The first operating state shown is the same as Figure 20C The system moves between two operating states, in which the valve 2024 allows the maximum main airflow and therefore the flushing airflow is relatively minimum, and in which the valve 2024 closes (or substantially restricts) the main airflow and therefore the flushing airflow is at its maximum or any intermediate position between the two.

[0237] In operation, the diaphragm 2021 moves the valve 2024 between these two states. During patient inhalation, the pressure on the gas source side of the diaphragm 2021 is higher than the pressure on the opposite patient side of the diaphragm, causing the diaphragm to move. This causes the linked valve 2024 to move, maximizing the flow of gas from the main airflow port 2033 to the gas source and relatively reducing the flushing airflow. During patient exhalation, the exhaled pressure from the patient on the patient side of the diaphragm 2021 is higher than the pressure on the gas source side of the diaphragm, causing the diaphragm to move. This causes the linked valve 2024 to move to restrict gas flow from the gas source through the main airflow port 2033 and increase the airflow through the flushing airflow port 2032. Therefore, in use and as in other embodiments, the control assembly operates dynamically in response to patient inhalation and exhalation to adjust the flushing airflow and the main airflow. In this embodiment, the control assembly is configured to bias the flow rate toward the flushing flow path during exhalation, but this is not necessary; i.e., no bias is required. In the earlier described embodiments and other embodiments, the control components may or may not be configured to bias the flow toward the flushing flow path during exhalation.

[0238] Figure 21A An embodiment of a patient interface combined with a one-way valve as an exhaust port is shown. Figure 21B and 21C A longitudinal section view is shown, and Figure 21D and Figure 21E A schematic longitudinal sectional view of the exhaust port in different operating states is shown in Figure 21. The patient interface, indicated by 2330, may include a mask body 2332 and a mask liner 2331, which together define the breathing chamber of the patient interface. The patient interface may be any form described herein or any other form. Figure 21A In the illustrated embodiment, the interface includes a flushing flow path 2350, which includes a conduit connected to the mask body 2332 via a nasal elbow fitting 2352, and may terminate, for example, at one or more nasal cannulas or nasal forks. Figure 21A (Not shown, but as previously described, for example, with respect to Figure 3) or any other structure that directs airflow to the patient's nostrils. The interface includes a main flow path 2360, which includes a conduit connected to the mask body 2332 via a coupling portion 2333. A control assembly 2320, included in the embodiment of Figure 3, is aligned with the main flow path 2360. In other embodiments, the control assembly may be any other form described, and / or a single conduit may be available from a gas source supplying the interface, and the main flow path and flushing flow path may be separate within the interface or at their inlet to the interface. In other embodiments, in NIV or CPAP or other respiratory applications, the interface, which may be any form as described above, may provide only a respiratory airflow instead of both a main airflow and a flushing airflow to the patient.

[0239] The patient interface 2320 includes a one-way valve system as an exhaust valve 2370, which includes an expansion-type exhaust flow control element 2371. In the illustrated embodiment, the exhaust valve 2370 is disposed in a main flow path conduit 2360 below the connection portion 2333 and the control assembly 2320. The exhaust valve 2370 includes an exhaust valve body 2372 having a hollow interior defining an internal through-passage and accommodating the expansion-type exhaust flow control element 2371. The flow control element 2371 also includes a hollow interior defining an internal through-passage 2373 that allows the main airflow through the flow control element 2371 and thus through the exhaust valve.

[0240] An exhaust flow space 2374 is defined between the exterior of the flow control element 2371 and the interior of the exhaust valve body 2372, as detailed below. Figure 21C It shows the flow control element 2371 in its unexpanded state. For example... Figure 21C As shown, when the flow control element 2371 is not expanded, an exhaust flow path is defined around or through the space between the exterior of the expanded flow control element 2321 and the interior of the exhaust valve body 2372, as indicated by arrow 2375 in 21E. In the illustrated embodiment, this occurs under pressure from the patient's expiratory gas against the main flow pressure, and also when the control assembly umbrella valve member 2322 closes (or restricts) the main flow 2378 from the gas source to the interface under the patient's expiratory pressure. Figure 21E In the diagram, arrow 2378 indicates the main airflow. The orifice 2379 entering this space includes an exhaust port. Conversely, under the inspiratory gas pressure from the patient, and also when the control component umbrella valve member 2322 opens, allowing the main flow from the gas source to the interface, the flow control element 2321, formed of an elastic or deformable material, expands against the interior of the exhaust valve body 2372 without the external surrounding pressure of the patient's exhaled gas. Figure 21B As shown. This closes the exhaust flow path between the exterior of the expansion-type flow control element 2321 and the interior of the exhaust valve body 2372, as also as... Figure 21E As shown. In use, the exhaust valve operates dynamically in response to the patient's inhalation and exhalation, closing or restricting the flow during inhalation and opening the flow during exhalation, as described, to provide a pathway for high-CO2 flushing gas from the patient interface to the outside atmosphere during exhalation, but closing this pathway during inhalation.

[0241] In the described embodiment, the vent valve 2370 is incorporated into a catheter adapted for connection to a patient interface, and specifically into the interface end of a guide catheter used with the interface. Alternatively, the vent valve 2370, in the form shown or any other, may be incorporated into the patient interface. For example, the vent valve may be incorporated into the frame portion of the interface (e.g., interface body 2332) of the interface supporting a gasket or seal. The vent valve may be incorporated into an elbow connection of the interface. The vent valve may be incorporated into a short airflow conduit permanently or removably attached to the frame portion of the interface.

[0242] The foregoing descriptions and examples are for illustrative purposes only and are not intended to be limiting. Each aspect and embodiment of this disclosure may be considered individually or in combination with other aspects, embodiments, and variations of this disclosure. Furthermore, unless otherwise stated, the steps of the methods disclosed are not limited to any particular order of execution. Modifications to the disclosed embodiments incorporating the spirit and substance of this disclosure are possible to those skilled in the art, and such modifications are within the scope of this disclosure.

[0243] In the context of the illustrated embodiments, orientation terms used herein, such as “top,” “bottom,” “horizontal,” “vertical,” “longitudinal,” “transverse,” and “end,” are used. However, this disclosure should not be limited to the orientations shown. In fact, other orientations are possible and within the scope of this disclosure. Terms relating to circular shapes (such as diameter or radius) as used herein should not be construed as requiring a perfectly circular structure, but should be applied to any suitable structure whose cross-sectional area can be measured from one side to the other. Generally, shape-related terms such as “circular,” “cylindrical,” “semicircular,” or “semi-cylindrical,” or any related or similar terms, do not need to strictly conform to the mathematical definition of a circle, cylinder, or other structure, but may include fairly close approximations.

[0244] Unless otherwise explicitly stated, articles such as "an" or "a" should generally be interpreted as including one or more of the stated items. Therefore, phrases such as "a device configured to" are intended to include one or more of the stated devices. Such one or more of the stated devices may be configured together to perform the stated expressions. For example, "a processor configured to perform expressions A, B, and C" may include a first processor configured to perform expression A working in conjunction with a second processor configured to perform expressions B and C.

[0245] The terms “including,” “contains,” “has,” etc., are synonymous and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Similarly, the terms “some,” “certain,” etc., are synonymous and used in an open-ended manner. Likewise, the term “or” is used in its inclusive sense (rather than its exclusive sense), such that, for example, when used to connect lists of elements, the term “or” refers to one, some, or all of the elements in the list.

[0246] The term “restriction” regarding a gas or airflow port can include, in the absence of contextual indication or otherwise, the complete closure or blockage of the gas or airflow port, and “restricting” and “restriction” have similar meanings.

[0247] While systems and methods for improved ventilation, including non-invasive ventilation, have been disclosed in the context of certain embodiments and examples, this disclosure extends beyond the specific embodiments disclosed, and extends to other alternative embodiments and / or uses of embodiments, modifications thereof, and their equivalents. Various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form variations of systems and methods for improved ventilation, including non-invasive ventilation. The scope of this disclosure should not be limited by the specific embodiments described herein.

[0248] Certain features described in this disclosure in the context of a single implementation may be implemented in combination within that single implementation. Conversely, different features described in the context of a single implementation may be implemented separately or in any suitable sub-combination in multiple implementations. Although features may be described herein as functioning in certain combinations, in some cases, one or more features of a claimed combination may be removed from the claimed combination, and the combination may be claimed as any sub-combination or a variation thereof.

Claims

1. A system for non-invasive ventilation, comprising: A gas source conduit, the gas source conduit being adapted to be fluidly connected to a gas source at a first end and including a bifurcation having a first branch and a second branch at a second end; A main flow path conduit, which is adapted to connect to the first branch of the bifurcation as part of the main flow path; A flushing flow path duct, which is adapted to connect to the second branch of the bifurcation as part of the flushing flow path, has a higher airflow resistance than the main flow path; A patient interface including a breathing cavity and a nasal flow delivery portion, the patient interface being configured such that the breathing cavity is located in the main flow path and the nasal flow delivery portion is located in the flushing flow path; as well as A control component, coupled to or adapted to be coupled to the main flow path, includes a movable member movable between a first position and a second position, wherein in the first position the movable member increases resistance to airflow through the main flow path, and in the second position the movable member does not increase resistance to airflow through the main flow path. The movable member is configured to move between the first and second positions in response to pressure changes within the breathing chamber of the patient interface, and wherein the movable member is configured to move to the first position when the gas pressure within the breathing chamber of the patient interface is greater than the gas source pressure, and to move to the second position when the gas pressure within the breathing chamber is less than or equal to the gas source pressure.

2. The system according to claim 1, wherein, The control component also includes a feedback port adapted to be fluidly coupled to the breathing chamber of the patient interface and configured to increase resistance to airflow in the primary flow path when the feedback pressure coupled from the breathing chamber to the control component is greater than the gas source pressure.

3. The system according to claim 1, wherein, The control component includes a feedback port adapted to be fluidly coupled to the breathing chamber of the patient interface, and wherein the control component is configured to operate in response to a feedback pressure coupled from the breathing chamber to the control component.

4. The system according to claim 1, wherein, The movable component includes a valve.

5. The system according to claim 1, wherein, The movable component includes a partition.

6. The system according to claim 1, wherein, The control component includes a main flow port and a flush flow port, and the movable member is movable between a position where the movable member opens the main flow port and a position where the movable member restricts the main flow port.

7. The system according to claim 6, wherein, The main flow port surrounds the flush flow port, or the flush flow port surrounds the main flow port, and the movable member is associated with the main flow port.

8. The system according to claim 6 or claim 7, wherein, The movable member is arranged to open when the main airflow pressure on the gas source side of the movable member is higher than the pressure on the opposite side of the movable member, and to restrict the main flow port when the pressure on the patient side of the movable member is higher than the main airflow pressure on the gas source side of the movable member.

9. The system according to claim 4, wherein, The valve is connected to a diaphragm to move the valve.

10. The system according to claim 9, wherein, The control assembly includes a main flow port and a flush flow port, and the baffle is arranged to allow the valve to move between a position where the valve opens the main flow port and a position where the valve restricts the main flow port.

11. The system according to claim 10, wherein, The baffle is arranged such that the valve moves between a position where the valve opens the main flow port when the main airflow pressure on the gas source side of the baffle is higher than the pressure on the opposite side of the baffle, and a position where the valve restricts the main flow port when the pressure on the opposite side of the baffle is higher than the airflow pressure on the gas source side of the baffle.

12. The system according to claim 1, wherein, The control component includes a gas pressure feedback port leading to one side of the movable member for receiving feedback gas pressure indicating the gas pressure within the patient interface.

13. The system of claim 1, comprising an exhaust port and an exhaust valve including an expansion-type exhaust flow control element.

14. The system according to claim 13, wherein, The expanding exhaust flow control element includes a hollow interior for the main airflow through the expanding exhaust flow control element and is located within the exhaust valve body of the exhaust valve. An exhaust flow space is defined between the exterior of the expanding exhaust flow control element and the interior of the exhaust valve body, and the expanding exhaust flow control element is capable of expanding against the interior of the exhaust valve body under the pressure of the main intake airflow to limit the exhaust flow space.

15. The system according to claim 14, wherein, The exhaust valve also includes a secondary flow control element between the expanding exhaust flow control element and the gas port entering the exhaust valve, the secondary flow control element being arranged to operate at the patient's exhaled gas pressure to restrict the primary airflow path through the hollow interior of the expanding exhaust flow control element.

16. The system according to any one of claims 13 to 15, wherein, The exhaust valve is integrated into the patient interface.

17. The system according to any one of claims 13 to 15, wherein, The vent valve is integrated into a catheter adapted for connection with a patient interface.

18. The system according to claim 1, wherein, The control components are integrated into the patient interface.

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