WO2024086651A1

WO2024086651A1 - Ventilation system

Info

Publication number: WO2024086651A1
Application number: PCT/US2023/077199
Authority: WO
Inventors: John O’MAHONY; Richard S. Walsh; Mark Gelfand; Edward RUPPEL; Daniel E. RUHLAND; Isaiah Ray LEINGANG
Original assignee: Corvent Medical, Inc.
Priority date: 2022-10-18
Filing date: 2023-10-18
Publication date: 2024-04-25

Abstract

Provided herein are systems for providing ventilation to one or more patients. The system includes a ventilator with a reservoir having: an internal chamber, an air inlet port placing the internal chamber in fluid communication with atmospheric air outside the reservoir, and an oxygen inlet port placing the internal chamber in fluid communication with a source of oxygen. The system can further include a primary blower having an air inlet in fluid communication with the internal chamber and an air outlet in fluid communication with an inspiration tube external of the ventilator. The internal chamber provides a volume for: gas mixing between the air inlet port, the oxygen inlet port, and the primary blower air inlet, and mixing of air entering in the reservoir via the air inlet port with oxygen entering in the reservoir via the oxygen inlet port before any gas reaches the primary blower air inlet.

Description

VENTILATION SYSTEM

DESCRIPTION

RELATED APPLICATIONS

[001] This application claims priority to United States Provisional Patent Application Serial Number 63/417,208 (Client Docket No. CRV-007-PR1), titled “Ventilation System”, filed October 18, 2022, the content of which is incorporated by reference in its entirety.

[002] This application is related to United States Provisional Patent Application Serial Number 63/122,773 (Client Docket No. CRV-001-PR1), titled “Automated Ventilator”, filed December 8, 2020, the content of which is incorporated by reference in its entirety.

[003] This application is related to United States Provisional Patent Application Serial Number 63/219,716 (Client Docket No. CRV-001-PR2), titled “Automated Ventilator”, filed July 8, 2021, the content of which is incorporated by reference in its entirety.

[004] This application is related to International PCT Patent Application Serial Number PCT/US2021/062300 (Client Docket No. CRV-001-PCT), titled “Automated Ventilator”, filed December 8, 2021, the content of which is incorporated by reference in its entirety.

[005] This application is related to United States Patent Application Serial Number 18/254,353 (Client Docket No. CRV-001-US), titled “Automated Ventilator”, filed May 24, 2023, the content of which is incorporated by reference in its entirety.

[006] This application is related to United States Design Patent Application Serial Number 29/764,658 (Client Docket No. CRV-002-US-DES1), titled “Ventilator Enclosure”, filed December 31, 2020, the content of which is incorporated by reference in its entirety.

[007] This application is related to United States Design Patent Number D989,290 (Client Docket No. CRV-003-US-DES1), titled “Ventilator Tubing Assembly”, issued June 13, 2023, the content of which is incorporated by reference in its entirety.

[008] This application is related to United States Design Patent Application Serial Number 29/764,666 (Client Docket No. CRV-004-US-DES1), titled “Ventilator User Interface”, filed December 31, 2020, the content of which is incorporated by reference in its entirety.

[009] This application is related to United States Design Patent Application Serial Number 29/764,670 (Client Docket No. CRV-005-US-DES1), titled “Ventilator User Interface and Front Panel”, filed December 31, 2020, the content of which is incorporated by reference in its entirety.

[010] This application is related to United States Design Patent Number D989,291 (Client Docket No. CRV-006-US-DES1), titled “Ventilator Tubing”, issued June 13, 2023, the content of which is incorporated by reference in its entirety.

TECHNICAL FIELD

[Oi l] The embodiments disclosed herein relate generally to methods, devices, and systems for assisted ventilation and, more specifically, to an automated ventilator.

BACKGROUND

[012] While many emergency and portable ventilators are on the market, an adequate low-cost automated ventilator with the required features to effectively support a patient with respiratory failure or respiratory insufficiency, for example, secondary to a viral infection such as COVID-19, is lacking.

[013] COVID-19 targets the lungs and can cause complications similar to pneumonia and Acute Respiratory Distress Syndrome (ARDS). Patients with medium to severe cases of COVID-19 require a ventilator to assist their breathing and to deliver enough oxygen to the lungs and the rest of the body. The number of COVID-19 cases requiring ventilation has overwhelmed the supply of available ventilators.

[014] In addition, conventional ventilators require complicated circuitry and equipment to maintain safety, which increases manufacturing and operating costs. Also, such circuitry and equipment can degrade over time, thereby making it difficult to store conventional ventilators over a long period of time. The ability to store ventilators over a long period of time would have allowed for a long-term stockpile of ventilators that could have avoided the shortage experienced during the onset of the COVID- 19 pandemic.

[015] Thus, there is an urgent need for a novel automated ventilator that is simple and inexpensive to fabricate, optimized for rapid and scalable manufacturing, suitable for long term storage with minimal maintenance while stored, and safe and effective for treating a patient. BRIEF SUMMARY

[016] According to an aspect of the present inventive concepts, a system for providing ventilation to one or more patients comprises: one or more ventilators, and each of the one or more ventilators comprises: a housing; a reservoir within the housing, and the reservoir comprises: an internal chamber, an air inlet port configured to place the internal chamber in fluid communication with atmospheric air outside the reservoir, and an oxygen inlet port configured to place the internal chamber in fluid communication with a source of oxygen; and a primary blower having an air inlet configured to be placed in fluid communication with the internal chamber of the reservoir, and an air outlet configured to be placed in fluid communication with an inspiration tube external of the ventilator housing, and the internal chamber of the reservoir provides a volume for gas mixing extending at least between the air inlet port, the oxygen inlet port, and the primary blower air inlet, and the volume is configured to allow for mixing of air entering in the reservoir via the air inlet port with oxygen entering in the reservoir via the oxygen inlet port before any gas reaches the primary blower air inlet.

[017] In some embodiments, the system further comprises a user device configured to communicate with each of the one or more ventilators. The user device can comprise a tablet. The communication can comprise wireless communication. The wireless communication can comprise Bluetooth. The user device can be configured to communicate with one or more other devices via a network. The system can further comprise a server, and the server can comprise one of the one or more other devices. The network can comprise the Internet. The user device can exchange information with each of the one or more ventilators. The user device can comprise a memory storage element that stores instructions to perform an algorithm, and the algorithm can be configured to perform an analysis of each of the one or more ventilators. The algorithm can be configured to determine one or more trends related to operational changes of the one or more ventilators.

[018] In some embodiments, the user device is configured to provide an alert to a user. The user device can comprise a transducer configured to provide the alert to the user. The transducer can comprise a haptic transducer configured to provide haptic feedback indicating the alert. The transducer can comprise a speaker configured to provide audible feedback indicating the alert. The speaker can comprise a wireless speaker. The wireless speaker can comprise a Bluetooth speaker. The user device can be configured to be positioned at a location remote from at least one of the one or more ventilators. The user device can be configured to be positioned at a location remote from each of the one or more ventilators. The user device can be configured to communicate with each of the one or more ventilators. At least one of the one or more ventilators can be configured to be positioned in a patient room, and the user device can be configured to be positioned outside of the patient room. The user device can be configured to be positioned at a nurse’s station that is located outside of the patient room.

[019] In some embodiments, each of the one or more ventilators further comprises a sensor. The sensor can comprise an oxygen sensor. The system can further comprise a user device, and at least one of the one or more ventilators communicates information captured by the sensor to the user device. The information can be related to an oxygen parameter of the at least one ventilator.

[020] In some embodiments, each of the one or more ventilators comprises a memory storage element, and one or more protocols are stored in the memory storage element. The one or more protocols can be implemented using a scripting language. The one or more protocols can be configured to provide reminders to one or more users of the system. The one or more reminders can each comprise a reminder to perform a task selected from the group consisting of: performing a suction on a patient; performing a suction of a pathway of at least one of the one or more ventilators; changing a heat and moisture exchanger (HME) of at least one of the one or more ventilators; delivering one or more specific drugs, such as via nebulization and/or infusion; waking of the patient, such as to determine alertness levels; repositioning of the patient; performing a readiness to wean protocol; and combinations thereof. Each of the one or more ventilators can further comprise a user interface, and the one or more protocols can be configured to be implemented via the user interface of the ventilator. The system can further comprise a user device, and the one or more protocols can be configured to be implemented via the user device. The one or more protocols can be configured to send a message from at least one of the one or more ventilators to the user device to remind the user to perform a task. The user device can comprise a cell phone and the message can comprise a text message. The system can further comprise a server, and each of the one or more ventilators can be configured to download one or more protocols from the server to the memory of the ventilator.

[021] In some embodiments, the system further comprises a camera and a memory storage element that stores instructions for performing an algorithm, and the algorithm is configured to analyze image data captured by the camera. The algorithm can comprise an artificial intelligence algorithm. A first patient can be being ventilated by a first ventilator of the one or more ventilators, and the algorithm can be configured to analyze the synchrony between the first patient and the first ventilator based on the image data. The image data can comprise data selected from the group consisting of: data related to patient synchrony data; data related to the adjustment of inspiratory and/or expiratory trigger sensitivity data; data related to instances in which the patient was “fighting” ventilation; data related to instances of extubation versus suction; data related to instances in which suctioning was required and/or performed; data related to instances in which water was present in a flow pathway of a ventilator of the one or more ventilators; data related to instances in which a patient was not adequately ventilated by a ventilator of the one or more ventilators; and combinations thereof.

[022] In some embodiments, each ventilator of the one or more ventilators comprises a pressure sensor configured to provide a signal, and each ventilator is configured to operate in a pressure-regulated volume control mode based on the pressure sensor signal. Each ventilator of the one or more ventilators can be configured to terminate breath when operating in the pressure-regulated volume control mode when a target volume is exceeded by a threshold. The threshold can be at least 3%, 5%, 10%, or 15%.

[023] In some embodiments, each ventilator of the one or more ventilators is configured to flush the reservoir with oxygen to rapidly increase the percentage of oxygen in the reservoir. The flush can be configured to increase the percentage of oxygen in the reservoir to reach a target oxygen level. The target oxygen level can be achieved in a time period of no more than 20 seconds.

[024] In some embodiments, the one or more ventilators comprises at least two ventilators, and the system further comprises a user device configured to communicate with each of the at least two ventilators. The user device can be configured to actively communicate with only one of the at least two ventilators at a given time, and the user device and/or the ventilator in active communication with the user device can be configured to indicate to the user which ventilator is actively communicating with the user device. The active communication can be indicated with a visual indicator.

[025] In some embodiments, each of the one or more ventilators further comprises a pressure relief valve, and the pressure relief valve comprises a 3/2-way valve.

[026] In some embodiments, each of the one or more ventilators further comprises a second blower.

[027] In some embodiments, the system is configured to determine a peak pressure and to determine a plateau pressure. The system can be further configured to prevent peak pressure form exceeding a threshold. The threshold can be based on the determined plateau pressure.

[028] In some embodiments, each of the one or more ventilators further comprises a valve and a pressure relief line, and the valve is configured to direct the flow of oxygen from the oxygen inlet port to the reservoir or to the pressure relief line. The pressure relief line exits the housing, such that the oxygen directed to the pressure relief line can be vented outside of the housing.

[029] In some embodiments, the system further comprises one or more filters, and each of the one or more filters is configured to operably attach to the air inlet port of one of the one or more ventilators. The one or more filters can comprise at least one CRBN filter. Each of the one or more ventilators can further comprise a manifold configured to operably attach at least two of the one or more filters to the inlet port of each ventilator in a parallel configuration. The system can further comprise one or more auxiliary blower assemblies, and each auxiliary blower assembly can be configured to operably attach to one or more of the one or more filters and to the air inlet port of one of the one or more ventilators. Each auxiliary blower assembly can be configured to draw atmospheric air through the one or more filters operably attached to the auxiliary blower assembly, and to provide atmospheric air to the attached ventilator with less air resistance than the air resistance caused by the attached filters.

[030] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

INCORPORATION BY REFERENCE

[031] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.

BRIEF DESCRIPTION OF THE DRAWINGS [032] The foregoing and other objects, features and advantages of embodiments of the present inventive concepts will be apparent from the more particular description of preferred embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same or like elements. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the preferred embodiments.

[033] Fig. 1 illustrates a schematic view of a ventilation system for a patient, consistent with the present inventive concepts.

[034] Fig. 1A illustrates a schematic view of another ventilation system for a patient, consistent with the present inventive concepts.

[035] Fig. 2 illustrates a front perspective view of an automated portable ventilator, consistent with the present inventive concepts.

[036] Fig. 3 illustrates a front perspective view of a ventilator with a detachable tubing assembly including inspiration and exhalation flow passages, consistent with the present inventive concepts.

[037] Fig. 4 illustrates a rear view of a ventilator showing a rear panel of the ventilator, consistent with the present inventive concepts.

[038] Fig. 5 illustrates a rear and top perspective view of a ventilator with the outside panels of the housing removed except for the front panel, consistent with the present inventive concepts.

[039] Fig. 6 illustrates a side view of the internal components of a ventilator and its front panel, consistent with the present inventive concepts.

[040] Fig. 7 illustrates a schematic diagram of the pneumatic components of a ventilator, consistent with the present inventive concepts.

[041] Fig. 8 illustrates a schematic diagram of the pneumatic and electronic components of a ventilator, consistent with the present inventive concepts.

[042] Fig. 8A illustrates an enlarged schematic view of pneumatic and electronic components of the ventilator of Fig. 8, consistent with the present inventive concepts.

[043] Figs. 8B-C illustrate graphs of maximum O2 settings, consistent with the present inventive concepts.

[044] Fig. 8D illustrates a schematic diagram of a 3/2-way valve of a ventilator, consistent with the present inventive concepts.

[045] Figs. 9A-B illustrate side views of a cross section of an exhalation valve in a ventilator, consistent with the present inventive concepts. [046] Fig. 10 is a flow chart showing the operation of an exhalation valve and switching between inspiration and exhalation phases of a ventilator, consistent with the present inventive concepts.

[047] Fig. 11 is a flow chart of a portion of a control algorithm for a primary blower of a ventilator, consistent with the present inventive concepts.

[048] Fig. 12 is a flow chart for resetting flow control sensors of a ventilator, consistent with the present inventive concepts.

[049] Figs. 13A-B are perspective views of a stand of a ventilator system, in compacted and expanded states, respectively, consistent with the present inventive concepts.

[050] Fig. 14 is a user view of a user interface of a ventilator system, consistent with the present inventive concepts.

[051] Fig. 15 is a perspective view of a ventilator, consistent with the present inventive concepts.

[052] Fig. 16 is a sectional perspective view of a valve, consistent with the present inventive concepts.

[053] Figs. 17A-B are partial perspective views of internal components of a ventilator, consistent with the present inventive concepts.

[054] Fig. 18 is a top view of a ventilator operably attached to a manifold of filters, consistent with the present inventive concepts.

[055] Fig. 19 is a partial cut away, side view of a ventilator attached to a secondary blower assembly and a filter, consistent with the present inventive concepts.

[056] Fig. 20 is a schematic view of a patient interface device configured to allow speaking by the patient during ventilation, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS

[057] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein.

[058] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

[059] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[060] It will be understood that the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[061] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[062] It will be further understood that when an element is referred to as being “on”, “attached”, “connected” or “coupled” to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being “directly on”, “directly attached”, “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[063] It will be further understood that when a first element is referred to as being “in”, “on” and/or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of two or more of these.

[064] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and/or within the second component or location. For example, a component positioned proximate an anatomical site of a patient, shall include components positioned near to the anatomical site, as well as components positioned in, on and/or within the anatomical site.

[065] Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and/or feature’s relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as “below” and/or “beneath” other elements or features would then be oriented “above” the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[066] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terals “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[067] The term “and/or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example, “A and/or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[068] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[069] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and/or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and/or one, two, three, or more of item C.

[070] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[071] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[072] As used herein, the term “threshold” refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and/or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a

-li safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values.

[073] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[074] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described herein.

[075] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[076] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[077] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening.

[078] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[079] As used herein, the term “transducer” is to be taken to include any component or combination of components that receives energy or any input and produces an output. In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb), sound (e.g., a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and/or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and/or an agent (e.g., to a patient), such as a transducer configured to deliver one or more of: heat energy; cryogenic energy; electrical energy (e.g., a transducer comprising one or more electrodes); light energy (e.g., a transducer comprising a laser, light emitting diode and/or optical component such as a lens or prism); mechanical energy (e.g., a transducer comprising a manipulating element); sound energy to tissue (e.g., a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of two or more of these. Alternatively or additionally, a transducer can comprise a mechanism, such as: a valve; a grasping element; an anchoring mechanism; an electrically-activated mechanism; a mechanically-activated mechanism; and/or a thermally activated mechanism.

[080] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element (e.g., comprising one or more sensors) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue parameter); a patient environment parameter; and/or a system parameter (e.g., temperature and/or pressure within the system). In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and/or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a patient anatomical parameter; and combinations of two or more of these. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as is described herein, such as a therapeutic function or a diagnostic function. A functional assembly can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter; a patient environment parameter; and/or a system parameter. A functional assembly can comprise one or more functional elements.

[081] As used herein, the term “normal level” refers to the level of a physiologic parameter that would be expected to be found in human subjects that are not afflicted with the disease or disorder being treated by the systems and/or methods of the present inventive concepts. The normal level can be associated with human subjects (e.g., healthy human subjects) that are of similar age, race, and/or sex as the patient being treated by the systems and/or methods of the present inventive concepts.

[082] It is an object of the present inventive concepts to provide systems, methods and devices for providing ventilation to one or more patients.

[083] Referring now to Fig. 1, a schematic view of a ventilation system is illustrated, consistent with the present inventive concepts. System 10 of Fig. 1 comprises ventilator 100 shown. Ventilator 100 can comprise one or more ventilators 100, such as two or more similar and/or dissimilar ventilators 100. In some embodiments, ventilator 100 is of similar construction and arrangement as that described in applicant’s co-pending United States Patent Application Serial Number 18/254,353, titled “Automated Ventilator”, and filed May 24, 2023, the contents of which is incorporated herein in its entirety for all purposes. Ventilator 100 and/or its components can be of similar construction and arrangement to the similar components described in reference to Figs. 2-12 herein.

[084] System 10 can further comprise user device 300 shown. User device 300 can comprise, one, two or more user devices as described herein. Each user device 300 can comprise a portable or non-portable device. For example, user device 300 can comprise a device selected from the group consisting of: personal computer; laptop computer; tablet; cell phone; smart watch; augmented reality device; key fob; nurse or other clinical workstation (e.g., a monitoring and/or control station); medical device controller; and combinations of these. In some embodiments, user device 300 comprises multiple devices that can be located at and/or otherwise used in multiple locations (e.g., multiple locations proximate and/or remote from one or more ventilators 100).

[085] System 10 can further comprise server 600 shown. Server 600 can comprise one, two, or more computer servers, such as servers configured to store, analyze, convert, combine, encrypt, and/or otherwise process data, such as data collected using system 10. Server 600 can be configured and arranged as described in reference to Fig. 1A and otherwise herein. Server 600 can comprise a server of the manufacturer of system 10, and/or a server of a third party that provides information relevant to use of system 10. Server 600 can comprise a server that is accessed by a component of system 10 when system 10 is configured to transfer information in a cloud-based arrangement.

[086] System 10 can further comprise network 500 shown. Network 500 can comprise one, two, or more wired and/or wireless networks configured to transfer data between components, such as between ventilator 100, user device 300, accessory device 400, server 600, and/or other system 10 component as described herein. Network 500 can comprise a cellular network, the Internet, a virtual private network (VPN), a router, and/or other wired and/or wireless network. Network 500 can comprise a network that is accessed by a component of system 10 when system 10 is configured to transfer information in a cloud-based arrangement. Network 500 can be configured and arranged as described in reference to Fig. 1A and otherwise herein.

[087] System 10 can further comprise one or more accessory devices, accessory device 400 shown. Accessory device 400 can comprise one or more devices used in ventilation therapy. Accessory device 400 can comprise one or more devices used to establish a ventilation parameter for a particular patient. In some embodiments, accessory device 400 comprises one, two, or more components selected from the group consisting of: a camera, such as a still image camera and/or a video camera; a patient diagnostic device (e.g., diagnostic device 700 described herein); a medical device; a consumer electronics device; and combinations of these.

[088] System 10 can further comprise stand 900 shown. Stand 900 can comprise one or more devices configured to support ventilator 100 and/or another component of system 10 a vertical distance above a floor. Stand 900 can be of similar construction and arrangement as stand 900 described in reference to Fig. 1A, Fig. 13, and/or otherwise herein.

[089] Two, three, or more of the various components of system 10 can be configured to transmit data between and/or among each other, such as via network 500 or directly from component to component, such as via wired connections or via wireless connections (e.g., via Bluetooth or other wireless transceivers of each component) as described in reference to Fig. 1A and otherwise herein. For example, ventilator 100 can be configured to transmit data to, and/or receive data from, one or more user devices 300 (connection shown), accessory device 400 (connection shown), and/or another component of system 10. User device 300 can be configured to transmit data to, and/or receive data from, ventilator 100 (connection shown), accessory device 400 (connection shown), another user device 300, and/or another component of system 10. Accessory device 400 can be configured to transmit data to, and/or receive data from, ventilator 100 (connection shown), one or more user devices 300 (connection shown), and/or another component of system 10.

[090] In some embodiments, the various components of system 10 of Fig. 1 are of similar construction and arrangement as the similar components described in reference to Fig. 1A and otherwise herein.

[091] Referring additionally to Fig. 1A, a schematic view of another ventilation system is illustrated, consistent with the present inventive concepts. Similar to system 10 of Fig. 1, system 10 of Fig. 1A comprises one or more ventilators, ventilator 100 shown. System 10 can include one or more of user device 300, accessory device 400, network 500, server 600, and/or stand 900. Ventilator 100 and the other components of system 10 of Fig. 1A can be of similar construction and arrangement to the similar components described in reference to Figs. 1 and 2-12 herein.

[092] Ventilator 100 can comprise multiple ventilators 100, such as ventilators 100, 100’ , 100” , and/or 100” ’ shown. In some embodiments, a unique identifier for each ventilator 100 is enabled or otherwise provided by system 10, such as a unique ID which can be input by the institution (e.g., by an operator that works for the institution). In these embodiments, information transmitted from each ventilator 100, as described herein, can include the unique ID, such that a separate component of system 10 receiving the information, can properly associate the information with that particular ventilator 100.

[093] Each ventilator 100’, 100” and/or 100’” can include similar components as ventilator 100 shown. Two or more of the ventilators 100 can comprise multiple ventilators of similar and/or dissimilar construction and arrangement. In some embodiments, ventilator 100’ is configured for use in a hospital or other clinical setting, and ventilator 100” is configured for use in a home. For example, the ventilator 100’ ’ for home use may be configured to prevent an unauthorized user from changing one or more operational settings (e.g., ventilation parameters) of the ventilator. In some embodiments, a ventilator 100’ configured for operation in a hospital can be configured to provide particular modes of ventilation, such as endotracheal tube (ET tube) compensation, Proportional Assist Ventilation (PAV), airway pressure release ventilation (APRV), and the like, due to need for experienced clinicians being quickly available with these modes of operation. In some embodiments, a ventilator 100” configured for home use (e.g., configured for use in a patient’s home or other non-clinical setting), may be configured to not provide these clinician-required modes of operation. In these embodiments, the ventilator 100” can be manufactured to not include the capabilities to perform those modes, and/or can include a software-based and/or hardware-based lockout that simply “turns off’ (e.g., makes unavailable) those modes of operation. Correspondingly, a ventilator 100” configured for use in a patient’s home can include additional hardware configured to assess patient status (e.g., patient status information typically available via other medical devices present in a hospital), such as an assembly included in a home-use ventilator 100” comprising: 02 concentrator; 02 sensor; end tidal CO2 sensor (etCO2); pulse oximeter; blood pressure monitor; ECG sensor; humidifier (e.g., heated humidifier); and combinations of these. In some embodiments, a ventilator 100’” can comprise a ventilator configured to be routinely moved from place to place, a “transport ventilator”, such as a ventilator that is included in a vehicle such as an ambulance, a boat, and/or a plane. A ventilator 100” ’ configured as a transport ventilator may include similar additional features and/or components as a ventilator 100” configured for home use, including temperature monitoring sensing. A ventilator 100’” configured as a transport ventilator can include a more robust physical design to ensure long term reliability in its application (e.g., moving and changing) environment, for example, the ventilator 100’” can comprise a more durable housing, user-replaceable assemblies, a power supply configured for attachment to both DC sources (e.g., 12 volts available in a vehicle) and/or AC sources.

[094] Ventilator 100 can comprise one or more housings, housing 110 shown. Housing 110 can comprise one or more walls, walls 111. Walls 111 are configured to surround, support, and/or otherwise interface with various other components of ventilator 100.

[095] Ventilator 100 can comprise inhalation assembly 120 shown. Inhalation assembly 120 can comprise one or more reservoirs, reservoir 130 shown. Inhalation assembly can further comprise primary blower 140. Inhalation assembly 120, reservoir 130, and primary blower 140, and other associated components of ventilator 100 can be of similar construction and arrangement to the similar components described in reference to Figs. 2-12 herein.

[096] Ventilator 100 can comprise exhalation assembly 170 shown. Exhalation assembly 170 can be constructed and arranged as described in reference to the various exhalation components of Figs. 2-12.

[097] Ventilator 100 and/or another component of system 10 can include a user interface for providing and/or receiving information to and/or from one or more operators of system 10 (“user” or “operator” herein). Ventilator 100 of Fig. 1A includes user interface 150 shown. In some embodiments, user interface 150 is similar to user interface 150 described herein in reference to Fig. 14. In some embodiments, user interface 150 can comprise a component separate from ventilator 100, such as a display separate from, but operably attached to, ventilator 100 and/or another component of system 10 (e.g., user interfaces 350 and/or 450 described herein). User interface 150 can include one, two, or more user input components, user input component 151 shown (also referred to as UIC 151), and/or it can include one, two, or more user output components, user output component 152 shown (also referred to as UOC 152). UIC 151 can comprise a component selected from the group consisting of: joystick; keyboard; mouse; touchscreen; switch such as a toggle switch, membrane switch, touchscreen switch and/or foot pedal switch; microphone; camera (e.g., single image camera or video device); another human interface device; and combinations of these. In some embodiments, UIC 151 comprises one, two, or more single image cameras, video devices and/or other cameras, such as camera 1511 shown. UOC 152 can comprise a component selected from the group consisting of: display; touchscreen; speaker or other audio output device; a light or other visual output device; vibrational and/or other tactile transducer; thermal transducer; and combinations of these. In some embodiments, UOC 152 comprises a display (e.g., a touchscreen display), such as display 1521, also shown. In some embodiments, user interface 150 can be configured to provide a graphical user interface, GUI 155 shown, such as an interface to be presented on and/or provided by display 1521.

[098] Ventilator 100 can comprise one, two, or more controllers, controller 160 shown. Controller 160 can be configured to perform and/or facilitate one or more functions of ventilator 100 and/or another component of system 10, such as one or more processes, ventilation cycles (e.g., inhalation and/or exhalation cycles), data collections, data analyses, data transfers, data and/or signal processing, and/or other functions (“functions” herein). Controller 160 can be configured to interface one or more components of system 10 (e.g., of ventilator 100) with another component of system 10. Controller 160 can be configured to electrically, mechanically, acoustically, fluidically, optically, and/or otherwise operably connect two components of system 10 to each other. Controller 160 can comprise one or more electronic elements, electronic assemblies, and/or other electronic components, such as components selected from the group consisting of: memory storage components; analog-to- digital converters; digital-to-analog converters; rectification circuitry; state machines; microprocessors; microcontrollers; application specific integrated circuits (ASICs); mul tiplexers; filters and other signal conditioners; interface circuitry such as sensor interface circuitry and/or transducer interface circuitry; and combinations thereof.

[099] Controller 160 of Fig. 1A includes processor 161, memory 162, and/or algorithm 165, each as shown. Processor 161 can comprise one or more processing components (e.g., a central processing unit, real-time processor, microcontroller, and/or other processor). Memory 162 can store instructions for performing algorithm 165, and it can be coupled to processor 161. Controller 160 can further comprise one, two, or more data receiving components, and/or data transmitting components, transceiver 166 shown. Transceiver 166 can comprise a component configured to transmit data to, and/or receive data from, another component of system 10 via a wireless (e.g., Bluetooth) and/or a wired connection.

[0100] Ventilator 100 can comprise one or more additional blower assemblies, such as secondary blower assembly 180 shown.

[0101] Ventilator 100 can comprise one or more supplies of power, power supply 190 shown.

[0102] System 10 can comprise one or more sources of oxygen, oxygen source 40 shown. Oxygen source 40 can comprise a source of pure oxygen (O2) such as a portable oxygen tank or an oxygen distribution source in a hospital or other clinical setting. The oxygen source 40 may be a low flow and/or pressure source providing oxygen in a range of 3 to 70 liters per minute (Lpm), such as approximately 15 Lpm.

[0103] System 10 can comprise one or more sources of power external to ventilator 100, external power source 50. External power source 50 can comprise a component configured to attach to a standard wall outlet and to deliver energy to ventilator 100.

[0104] System 10 can comprise tubing assembly 200 shown, which can comprise one, two, or more assemblies for operable attachment of ventilator 100 to a patient, such that ventilator 100 can deliver inspiration gas to the patient. Tubing assembly 200 can comprise one or more conduits or flow pathways for inspiration, inspiration tube 210, as well as one or more conduits or flow pathways for exhalation, exhalation tube 220. Tubing assembly 200 can comprise an assembly for fluidly attaching to the patient’s mouth and/or nose, patient interface 230. In some embodiments, tubing assembly 200 comprises an assembly comprising one or more sensors, sensor assembly 240. Sensor assembly 240 can include electronic components for interfacing sensor assembly 240 with ventilator 100 and/or another component of system 10. [0105] System 10 can comprise one, two, or more user devices, user device 300 shown. User device 300 of Fig. 1A can comprise one or more devices as described in reference to user device 300 of Fig. 1 and/or otherwise herein. In some embodiments, user device 300 comprises multiple devices that can be located at and/or otherwise used in multiple locations (e.g., multiple locations proximate or remote from one or more ventilators 100). User device 300 can comprise multiple devices that each communicate with (e.g., wirelessly communicate with): one or more other user devices 300; one or more ventilators 100; network 500 (e.g., the Internet); server 600; one or more accessory devices 400; one or more diagnostic devices 700; and/or one or more other devices. In some embodiments, multiple operators of system 10 (e.g., multiple nurses, clinicians, and/or other caregivers) each have access to a user device 300, where each user device 300 can be used to remotely monitor and/or control one, two, or more ventilators 100 (e.g., via a wireless communication link as described herein), that can be placed in one, two, or more separate locations (e.g., patient rooms and/or other multiple clinical settings).

[0106] User device 300 can include a user interface, user interface 350, for providing and/or receiving information to and/or from an operator of system 10. User interface 350 can be integrated into user device 300 as shown. In some embodiments, user interface 150 of ventilator 100 comprises user interface 350 (e.g., user interface 350 can control operation of ventilator 100). User interface 350 can include one, two, or more user input components, user input component 351 shown (also referred to as UIC 351), and/or it can include one, two, or more user output components, user output component 352 shown (also referred to as UOC 352). UIC 351 can comprise a component selected from the group consisting of: joystick; keyboard; mouse; touchscreen; switch such as a toggle switch, membrane switch, touchscreen switch and/or foot pedal switch; microphone; camera (e.g., single image camera and/or video camera); another human interface device; and combinations of these. In some embodiments, UIC 351 comprises one, two, or more single image cameras, video devices, and/or other cameras, camera 3511 shown. UOC 352 can comprise a component selected from the group consisting of: display; touchscreen; speaker or other audio output device; a light or other visual output device; vibrational and/or other tactile transducer; thermal transducer; and combinations of these. In some embodiments, user UOC 352 comprises a display (e.g., a touchscreen display), such as display 3521, also shown. In some embodiments, processor 361 can be configured to provide a graphical user interface, GUI 355 shown, to be presented on and/or provided by display 3521. [0107] User device 300 can include controller 360, which can be configured to perform and/or facilitate one or more functions of user device 300 and/or another component of system 10, such as one or more processes, ventilation cycles, data collections, data analyses, data transfers, data and/or signal processing, and/or other functions (“functions” herein). Controller 360 can include processor 361, memory 362, and/or algorithm 365, each as shown. Controller 360, processor 361, memory 362, and/or algorithm 365 can be of similar construction and arrangement as controller 160, processor 161, memory 162, and algorithm 165, respectively, described in reference to Figs. 1 and 1A and otherwise herein. Memory 362 can store instructions for performing algorithm 365 and can be coupled to processor 361. Controller 360 can further comprise one, two, or more data receiving components, and/or data transmitting components, transceiver 366 shown. Transceiver 366 can comprise a component configured to transmit data to, and/or receive data from, another component of system 10 via a wireless (e.g., Bluetooth) and/or wired connection.

[0108] In some embodiments, ventilator 100 is configured to deliver an alarm volume at a relatively low audible volume (e.g., via commands provided by an operator using user interface 150). In these embodiments, ventilator 100 may be further configured to increase (e.g., automatically increase) the alarm volume over time (e.g., to its maximum or other elevated level), such as when a user does not respond to the alarm condition of the ventilator within a specific time period, such as a time period of no more than one minute, three minutes, or five minutes. The user’s response may be detected (e.g., automatically detected) by system 10 via: a camera (e.g., a functional element 199 comprising a camera and/or a UIC 151 comprising a camera) that detects motion of a user; a proximity sensor (e.g., a functional element 199 comprising a proximity sensor) that detects the presence of a user; and/or by a user making a ventilator setting change (e.g., silencing the alarm or adjusting a setting on ventilator 100). Once a specific series of alarms have been interpreted by system 10 to be acknowledged by a user in this manner, the increase in alarm volume can be cleared (e.g., the alarm turned off) by system 10 until the next new alarm is encountered and annunciated, and this process is reinitiated by system 10. In some embodiments, this function is disabled by a user and/or otherwise is not available, and ventilator 100 may have a predetermined time (e.g., at least 1 minute, 2 minutes, or 3 minutes) in which an alarm volume is increased (e.g., to a maximum volume).

[0109] In some embodiments, user device 300 is configured as an operator notification device (e.g., in which a user is notified of an alert condition of ventilator 100 or other component of system 10). In these embodiments, one or more user devices 300 can comprise a portable device that includes a transducer (e.g., a vibrational motor) configured to provide an alert (e.g., a haptic alert) to a user, such as a nurse or other clinical care person. Alternatively or additionally, an audible alert can be provided via a speaker or other audible transducer, and/or a visible alert can be provided via an indicator light and/or display. In some embodiments, system 10 can provide a tactile and/or visual alert, while being void of an audible alert (e.g., at least in an initial alert state), such as to avoid noise that might undesirably disturb the patient, an operator, and/or another person proximate system 10. In some embodiments, if an initial alert is broadcast (e.g., audibly, visually, and/or tactilely broadcast by system 10) by a user device 300, and if within a time period TA a user fails to acknowledge the initial alert (e.g., address the alarm condition or otherwise acknowledge the alert), the user device 300 will switch to a second alert comprising a different type of alert broadcast (e.g., different form of alert, level of alert, and the like, that is broadcast). For example, an initial alert can comprise a relatively “silent alarm” such as a tactile alert (e.g., from a vibrating transducer as described herein) and/or a visual alert (e.g., a blinking light or alert text presented on a screen) presented via user device 300, and a second alert can be a subsequent broadcast comprising an audible alert (e.g., a beeping sound, broadcast of spoken word, and/or other audible alert) that is presented via the user device 300 (e.g., the same user device 300). Alternatively or additionally, after a time period TA has elapsed in which an initial alert (e.g., a tactile or visual alert) has been broadcast on a first user device 300 and a user has not acknowledged the initial alert, a subsequent, second alert can be broadcast on a different device, such as a second user device 300 and/or another component of system 10. The second alert broadcast on a different device can comprise a silent alarm and/or an audible alarm (e.g., the same or different type of broadcast as the initial alarm). In some embodiments, system 10 can be configured to deliver a third level alert, such as when a user has not responded to the second level of alert after a time period TA2 has elapsed (e.g., a similar or dissimilar time period as time period TA). The third alert can comprise a different form of alert (e.g., audible, tactile, and/or visible), and/or it can comprise an alert broadcast by a different user device 300 and/or other different component of system 10 (e.g., a third alert broadcast on two, three, or more devices of system 10, simultaneously or sequentially). In some embodiments, different priorities of alert conditions (e.g., different levels of significance of the alert conditions), correlate to different durations of TA and/or TA2, and/or the type of alert broadcast (e.g., the sound level of an audible alert, the light or size level of a visual alert, and/or the vibration level of a tactile alert). These various configurations of system 10 have the benefit of reducing fatigue from various alert conditions, and allows patients (e.g., patients using ventilator 100 and patients proximate patients using ventilator 100) to sleep without continuous interruption (e.g., a condition which has been shown to be detrimental to patient recovery). Given that the source of the alert can be one of multiple devices of system 10, the user may be shown the specific device, its location, and/or a screen shot of the ventilator 100 in the alert condition, such as when the user is provided information related to patient status.

[0110] System 10 can comprise one, two, or more accessory devices, accessory device 400 shown. In some embodiments, accessory device 400 comprise one or more cameras (e.g., single image cameras and/or video cameras). In some embodiments, accessory device 400 comprises one or more audible transducers, such as one or more speakers (e.g., a public address system or intercom system in a hospital or other clinical setting) . In some embodiments, accessory device 400 comprises one, two, or more devices selected from the group consisting of: camera (e.g., single image camera and/or video camera); speaker or other audible transducer; microphone; medical device such as medical treatment device and/or medical diagnostic device; and combinations thereof. In some embodiments, accessory device 400 comprises a nebulizer, such as a nebulizer configured to deliver an agent 800 as described herein. Accessory device 400 can include a user interface, user interface 450 shown. User interface 450 can be of similar construction and arrangement as user interface 150 and/or 350 described herein. Accessory device 400 can include one, two, or more data receiving components, and/or data transmitting components, transceiver 466 shown. Transceiver 466 can comprise a component configured to transmit data to, and/or receive data from, another component of system 10 via a wireless (e.g., Bluetooth) and/or wired connection.

[0111] System 10 can comprise one, two, or more diagnostic devices, diagnostic device 700 shown. Diagnostic device 700 can comprise one, two, or more data receiving components, and/or data transmitting components, transceiver 766 shown. Transceiver 766 can comprise a component configured to transmit data to, and/or receive data from, another component of system 10 via a wireless (e.g., Bluetooth) and/or wired connection.

[0112] Diagnostic device 700 can comprise one or more imaging devices 700a, such as an imaging device selected from the group consisting of: X-ray imager; CT-Scanner; MRI; ultrasound imager; optical coherence tomography (OCT) imager; and combinations of these. Imaging device 700a can be configured to produce patient data PD comprising image data of the patient (e.g., image data of the patient’s lungs). Diagnostic device 700 can comprise one or more devices configured to gather patient physiologic information, such as physiologic information selected from the group consisting of: respiration data; blood oxygen or other blood gas level data; blood glucose data; tissue temperature data; neuronal firing data; blood pressure data; heart rate data; and combinations of these. In some embodiments, patient data PD collected by diagnostic device 700 is used to configure one or more parameters of system 10. For example, patient data PD collected by diagnostic device 700 can be used to operate ventilator 100 in a closed loop arrangement.

[0113] System 10 can comprise one, two, or more agents, agent 800 shown. In some embodiments, agent 800 comprises one or more nebulizing agents, such as when accessory device 400 comprises a nebulizer configured to deliver an agent 800 comprising a nebulizing agent. In these embodiments, the nebulizer can deliver relatively low additional flow to the “flow circuit” provided by ventilator 100, such as adding no more than 0.4mL/min while performing nebulization. In some embodiments, agent 800 comprises a mucolytic agent (e.g., acetylcysteine); a bronchodilator (e.g., salbutamol, albuterol, or epoprostenol), such as for improving oxygenation; and combinations of these.

[0114] System 10 can comprise one, two, or more tables, carts, stands, and/or other support devices, stand 900 shown. Stand 900 can comprise one or more devices configured to position ventilator 100, and/or one or more other system 10 components, at a convenient height for use (e.g., above a floor or other surface). In some embodiments, stand 900 is configured to transition from a relatively compacted state (e.g., for transportation), to an expanded state (e.g., for use with a patient, such as in the patient’s home, ambulance, and/or a field hospital), such as is described in reference to Fig. 13 herein. In these embodiments, stand 900 can be further configured to transition from the expanded state to the compacted state (e.g., for subsequent transportation or storage after use by one or more patients has been completed). Stand 900 can be configured to be assembled rapidly, such as when comprising a minimum number of components to be assembled by a user, such as only three components (e.g., a base, a column, and a shelf) which are configured to be assembled without the use of tools or other components. The various components of stand 900 to be assembled could comprise “quick-connect” fittings, such as comprising conical fittings with a ball detent that facilitates self-centering with the conical fit and a securement with the ball detent. In these and other embodiments, stand 900 can be configured to be assembled by a user in 30 seconds or less (e.g., for an emergency ventilation event). Stand 900 can comprise functional element 999 as shown. Functional element 999 can comprise one, two, or more extendable components, such as one, two, or more components selected from the group consisting of: extendable legs; telescoping components; sliding components; unfurling components; and combinations of these. In some embodiments, functional element 999 comprises one, two, or more attachment elements, such as to attach (e.g., removably attach) to a mating element of ventilator 100.

[0115] System 10 can comprise one or more functional elements, such as functional element 99 shown. In some embodiments, ventilator 100 comprises functional element 199, tubing assembly 200 comprises functional element 299, and/or user device 300 comprises functional element 399, each as shown. Functional elements 99, 199, 299, and/or 399 can comprise one, two, or more functional elements, such as: one, two or more sensors; one, two, or more transducers; and/or one, two, or more other functional elements, such as are described herein. Functional element 199, 299, and/or 399 can comprise an attachment element configured to attach (e.g., removably attach) to an attachment-based functional element 999 of stand 900, such as to attach ventilator 100, tubing assembly 200, and/or user device 300 to stand 900. In some embodiments, functional element 199 comprises a proximity sensor, such as a proximity sensor configured to detect the presence of a user proximate ventilator 100 (e.g., to allow ventilator 100 to change alarm states or other states when an operator is present). In some embodiments, functional element 199 comprises a camera (e.g., a camera integral to user interface 150 or other component of system 10), such as a camera used to detect presence of a user proximate ventilator 100.

[0116] In some embodiments, system 10 includes a data storage and/or processing device, server 600. Server 600 can comprise an “off-site” server (e.g., outside of the clinical site in which patient ventilation data is recorded), such as a server owned, maintained, and/or otherwise provided by the manufacturer of system 10. Alternatively or additionally, server 600 can comprise a cloud-based server. Server 600 can include controller 660 shown, which can be configured to perform one or more functions of system 10, such as one or more functions described herein. Controller 660 can include processor 661 as shown. Controller 660 can include one or more algorithms, algorithm 665, also as shown. Controller 660 can comprise memory, memory 662 shown, which can store instructions for performing algorithm 665, and can be coupled to processor 661. Controller 660, processor 661, memory 662, and/or algorithm 665 can be of similar construction and arrangement as controller 160, processor 161, memory 162, and algorithm 165, respectively, described in reference to Figs. 1 and 1A and otherwise herein. Server 600 can be configured to receive and store various forms of data, such as: ventilation data; image data, diagnostic data, planning data and/or outcome data described herein, data 670. In some embodiments, data 670 can comprise data collected from multiple patients (e.g., multiple patients treated with system 10), such as data collected during and/or after clinical procedures where ventilation and/or other data was collected from the patient via system 10. For example, data 670 can be collected via ventilator 100, recorded by controller 160 of ventilator 100, and sent to server 600 for analysis.

[0117] In some embodiments, ventilator 100 and server 600 can communicate over a network, network 500 shown, for example, a wide area network such as the Internet. Alternatively or additionally, network 500 can comprise a virtual private network (VPN) through which various devices of system 10 transfer data.

[0118] In some embodiments, system 10 of Figs. 1 and/or 1A is constructed and arranged as described in reference to any of Figs. 2 through 19.

[0119] As described herein, the one or more functions of system 10 performed by controller 160, 360, and/or 660 can be performed by one, two, or all of the controllers. For example, in some embodiments, ventilation 100 and/or other system 10 data, patient data, patient environment data, and/or other data is collected and processed (e.g., preprocessed) by controller 160 of ventilator 100. The processed data can then be transferred to server 600, where the data can be further processed. The processed data and/or further processed data (either or both “processed data” herein) can then be transferred back to ventilator 100 and/or another component of system 10, such as to be displayed to an operator (e.g., via user interface 150). Alternatively or additionally, the processed data can be used to modify a parameter of ventilator 100, such as to modify a ventilation setting of a ventilator 100 based on data collected from system 10 use with one or more other patients. In some embodiments, an algorithm of system 10 processes the data and determines one or more operational parameter adjustments to be made (e.g., and provided as a suggestion to an operator and/or automatically changed by the algorithm as described in the paragraph below).

[0120] In some embodiments, algorithm 165, algorithm 365, and/or algorithm 665 (singly or collectively, “algorithm 165/365/665”) is configured to semi-automatically adjust (e.g., an adjustment that includes clinician confirmation or other clinician involvement) and/or automatically adjust (e.g., an adjustment made without clinician involvement) one or more operational parameters of system 10, such as a ventilation setting and/or other operational parameter of ventilator 100, such as in a closed-loop arrangement. Additionally or alternatively, algorithm 165/365/665 can be configured to adjust an operational parameter of a separate device, such as user device 300, accessory device 400, and/or diagnostic device 700 described herein. In some embodiments, algorithm 165/365/665 is configured to adjust an operational parameter based on data collected from the patient currently using ventilator 100, and/or based on data collected from previous patients using the current system 10 and/or other systems 10 used by a large group of patients. In some embodiments, algorithm 165/365/665 is configured to adjust an operational parameter based on one or more sensor signals, such as a sensor signal provided by a sensor-based functional element of the present inventive concepts as described herein. Algorithm 165/365/665 can be configured to adjust (e.g., automatically adjust and/or recommend the adjustment of) an operational parameter selected from the group consisting of: mode of ventilation, such as a mode that contains settings based upon flow and/or pressure control parameters; a flow-based mode parameter such as tidal volume, breath rate and inspiratory time, PEEP, plateau period, % oxygen and/or trigger sensitivity; a pressure-based mode parameter such as inspiratory pressure, breath rate and inspiratory time, PEEP, % oxygen and/or trigger sensitivity; and combinations of these. Algorithm 165/365/665 can be configured to automatically adjust: modes of operation, operational parameters, and/or alarm settings, such as to optimize ventilation based upon end tidal CO2, and/or pulse oximetry, and/or to optimize how the patient responds physiologically to setting changes.

[0121] In some embodiments, algorithm 165/365/665 comprises one, two, or more machine learning, neural network, and/or other artificial intelligence algorithms (“Al algorithm” herein).

[0122] When a ventilator 100 of system 10 is manufactured, is first installed at a clinical site, and/or at other times, a calibration routine can be performed. A trained operator (e.g., a clinician and/or technician) can review the results of the calibration routine and/or otherwise participate in the calibration routine. Ventilator 100 can comprise one or more pressure sensors (e.g., as described herein) that can be configured to be calibrated (e.g., in manufacturing and/or in a clinical setting), such as a calibration comprising an adjustment of offset and/or gain of the pressure sensor and/or its associated circuitry. Alternatively or additionally, one or more oxygen sensors can be configured to be calibrated, such as a calibration for offset (e.g., at 21%) that can be performed (e.g., during a system 10 self-test) when system leaks, resistances and/or compliances are determined. In some embodiments, system 10 is configured to perform a self-test (e.g., a “System Self Test”), such as a test that checks the accuracy of one or more pressure and/or flow sensors of system 10, and to calibrate any offsets identified by the test. In some embodiments, system 10 comprises one or more functional elements, for example, functional element 199, that are used during the system self test, such as one or more functional elements 199 comprising additional pressure and/or flow sensors that are used to calibrate other sensors of system 10. In some embodiments, the system self test checks one or more circuits of system 10 (e.g., checks the circuit compliance of one or more circuits). Additionally or alternatively, the system self test can measure the resistance of one or more filters of system 10. In some embodiments, the system self test checks the tolerances of one or more pressure sensors and/or cross flow sensors of system 10, for example, to ensure the tolerances are within expected ranges.

[0123] In some embodiments, ventilator 100 comprises a functional element 199 comprising an oxygen sensor. In these embodiments, information related to an oxygen parameter of a ventilator 100 can be captured by the functional element, such as to be displayed on user interface 150, and/or to be transmitted (e.g., via Bluetooth and/or other wireless communication transmitted via transceiver 166) to a user device 300 (e.g., a tablet or nurse’s station) and/or another component of system 10, such that oxygen levels and/or other oxygen information can be displayed (e.g., via user interface 350) to an operator remote from ventilator 100. In embodiments comprising multiple ventilators 100, one or more user devices 300 can receive (e.g., wirelessly receive) the oxygen information from any of the ventilators 100, such as oxygen information which also includes information related to the particular ventilator 100 sending the information (e.g., via its unique ID as described herein, and/or a unique protocol), such that the particular ventilator 100 providing the oxygen information can be uniquely identified to the caregiver (e.g., via user interface 350 or other user interface of system 10). In a hospital or other clinical setting in which multiple ventilators 100 are present, each ventilator 100 can be configured to be differentiated from one or more other ventilators 100. For example, each ventilator 100 can include color coding, symbols, and/or differentiable alarms (e.g., different audible alarms and/or indicator light flashing frequency) that can be used to ensure the user is directed to the correct ventilator 100. Indicator light colors can be achieved with an indicator light (e.g., a functional element 199 comprising one or more indicator lights) comprising one or more RBG LEDs that may be located on an exposed surface of the ventilator 100 and/or a separate alert-capable device of system 10 (e.g., one or more user devices 300). Color coding along with ventilator-specific flashing sequences and/or audible alerts, that is present on both ventilator 100 and user device 300 dramatically improves identification by a user. In some embodiments, a user device 300 transmits alerts (e.g., visible, audible, and/or tactile alerts) that uniquely identify the particular ventilator from which an alert signal was received. A plan of the ICU or ward can be displayed to the user (e.g., via user device 300) indicating the specific room, ventilator 100, and/or patient identification number associated with a current alert, which can be used to direct clinical attention to the correct patient (e.g., to the correct ventilator 100).

[0124] In some embodiments, system 10 comprises one or more audible transducers or other user output components (e.g., visual displays or indicator lights) for providing alert or other information related to one or more ventilators 100 or other system 10 components. These one or more output components can be positioned at one or more locations remote from the ventilator(s) 100, such as when positioned at a central location at which nurses and/or other caregivers may be present while one or more patients are receiving ventilation from a corresponding one or more ventilators 100. These one or more output components can be used to provide audio or other information related to the use of each ventilator 100, such as to signify when a ventilator 100 is in an alert condition. A device (e.g., a user device 300) remote from the ventilator 100 broadcasting an alarm or other alert, can display the location and particular ventilator 100 generating the alert. For example, information containing the specific information can be conveyed through a display (e.g., an LCD) with a color-coded indicator (e.g., with a color coded LED) to ensure when the user arrives at a ventilator 100 in the alert condition, the correct ventilator 100 can be identified and/or confirmed, such as to minimize the potential for erroneous setting changes. In some embodiments, the user device 300 receiving the alert can comprise a pager, cell phone (e.g., smart phone), and/or other text-enabled device that can be configured to provide further clarification via text. Temporary silencing of an alert broadcast by a user device 300 that is remote from ventilator 100 can be achieved via text acknowledging the alert, such as to allow the user time to respond. In some embodiments, user device 300 comprises a user output component 352 (e.g., a speaker or other audible transducer, or other output component) that can be positioned outside the room in which one or more ventilators 100 are located. Alternatively or additionally accessory device 400 can comprise a similar speaker or other output component that can similarly be positioned remote from the ventilators 100. In these embodiments, user device 300 and/or accessory device 400 can receive an alert signal from a ventilator 100 via a wired or wireless (e.g., Bluetooth) transmission sent by transceiver 166 of ventilator 100. The one or more output components of devices 300 and/or 400 can alert (e.g., via an audible and/or visual alert signal) caregivers that are remote from the particular ventilator 100 that is sending the transmission. The alert provided by the output components can be an audible alert that can be provided at a range of sound pressure levels, such as at a variable sound pressure level that is configured to be adjusted by an operator (e.g., via user interface 150, 350 and/or another user interface of system 10). In embodiments comprising multiple ventilators 100, one or more user devices 300 and/or accessory devices 400 can receive (e.g., wirelessly receive) an alert signal from any of the ventilators 100, such as an alert signal which identifies (e.g., via a unique ID as described herein) the particular ventilator 100 sending the alert signal, such that the particular ventilator 100 can be uniquely identified by the caregiver (e.g., via a particular pattern of sounds or an audible voice, and/or via a visual information).

[0125] In some embodiments, various protocols (e.g., implemented with a scripting language) can be stored in memory of system 10, such as in memory 162 of ventilator 100. These protocols can be configured to provide reminders (e.g., reminders provided on an hourly or other routine basis) to one or more operators of system 10. The reminders can be provided on user interface 350 of user device 300 (e.g., a tablet, cell phone, nurse working station, and/or other portable or non-portable device), and/or another user interface of system 10. In some embodiments, a reminder provided via a protocol stored in memory 162 comprises a reminder about performing one, two, or more tasks selected from the group consisting of: performing a suction on the patient and/or of pathways of ventilator 100; changing a heat and moisture exchanger (HME) of ventilator 100; delivery of specific drugs (e.g., agents 800), such as via nebulization and/or infusion (e.g., via an accessory device 400 comprising a nebulizer and/or infusion device); waking of the patient, such as to determine alertness levels; reposition patient; perform a readiness to wean protocol; and combinations of these. Storage of these types of protocols in memory 162 of system 10 can provide a significant advantage, particularly in use of system 10 in low-resource clinical environments, such as environments in which patient computer management systems may not be available, and/or non-nursing qualified staff may sometimes oversee patient care, such that reminders are critical to patient safety. For example, these types of environments can be home care and/or long term care nursing facilities. These protocols can be implemented on a ventilator 100, accessory device 400, and/or a user device 300. In some embodiments the protocols are included on a system 10 component other than ventilator 100 (e.g., user device 300, accessory device 400, and/or server 600), and can be transferred (e.g., wirelessly transferred) to one or more ventilators 100. System 10 can be configured to allow operators of system 10 to receive single or multiple reminders via texts (e.g., to one or more user devices 300 comprising a cell phone) that are initiated by the protocols stored in memory 162. These protocols included in memory 162 can include both text and graphical information, such that instructions including pictures could be presented to an operator. System 10 can be configured to customize the reminder information sent, based on an individual institution’s needs (e.g., an individual hospital’s needs and/or other patient care center’s needs). In some embodiments, a set of multiple protocols can be stored at a central location, such as on a server 600 of the manufacturer of system 10, and each institution can download (e.g., via network 500) one or more individual scripts from a library of scripts stored on server 600. In some embodiments, system 10 can be configured to track whether or not specific tasks were performed (e.g., and by whom), such as to collect tracking information which can later be transferred to another component of system 10 (e.g., to a user device 300 and/or server 600), via a wired or wireless connection, such as to be stored as patient data records. When a user reviews tasks to be performed, system 10 can be configured to inform (e.g., via a user interface of system 10) the user of the tasks, such as tasks that are in arears, and/or tasks that are to be performed in the near immediate future. System 10 can be configured to provide the benefit of allowing a first user to transfer knowledge to one or more other users (e.g., between shifts of users), as a simplified, secure way of conveying important information.

[0126] In some embodiments, user device 300 comprises one, two, or more tablets, cell phones, and/or other portable devices that communicates (e.g., wirelessly communicates) with one or more ventilators 100 (e.g., at least two ventilators 100). In these embodiments, the user device 300 can further communicate with other devices, such as with server 600 via network 500 (e.g., the Internet). In some embodiments, user device 300 comprises two, three, or more devices that can send information to and/or receive information from one, two, or more ventilators 100, one or more other user devices 300, and/or one or more other components of system 10. In some embodiments, an algorithm 165/365/665 performs an analysis on the various ventilators 100 information and/or other system 10 information, such as to determine trends related to operational changes of the one or more ventilators 100, and/or other changes related to use of system 10 (e.g., that are not ventilator 100 operational changes). Identified trends can be used to modify future use of system 10, and/or modify future care of current and/or future patients using a ventilator 100. In some embodiments, one or more user devices 300 are located (at least temporarily) outside of the clinical setting in which the associated one or more ventilators 100 are located, such as at a manufacturer of system 10 (e.g., where the user device 300 communicates with the one or more ventilators 100 via network 500). System 10 can be configured to gather and/or store trending information (e.g., trending information that would be made immediately available to the user) related to one, two, or more parameters selected from the group consisting of: inspired and/or expired volume; expired volume divided by patient’s ideal body weight; fraction of inspired oxygen (FiO2); peak inspiratory pressure; plateau pressure; frequency of one or more alarms; pareto of a number of alarms over a time period (e.g., top 5 alarms over the past 24hrs); frequency of suctioning over time; readiness to wean parameters, such as to be presented all in one page (e.g., parameters such as RR, FiO2, PEEP, PaO2/FiO2, Minute Ventilation (the amount of gas that enters the lungs per minute), Tidal Volume, and/or mL/kg); comparison between previous readiness to wean assessment; comparison of previous weaning trials and parameters used for spontaneous weaning trials; and combinations of these.

[0127] In some embodiments, user device 300 is configured to send commands to and/or receive information from multiple ventilators 100. In these embodiments, user interface 350 of user device 300 and the user interface 150 of each ventilator 100 can be configured to indicate to an operator that an active connection is present between user device 300 and the particular ventilator 100 currently being controlled by user device 300. System 10 can be configured to ensure that the correct user device 300 is connected to (e.g., in communication with) the correct ventilator 100, and that any settings changes are not being made on a different ventilator in error. For example, each user interface 150 can comprise a visual indicator, with the user interface 150 of each ventilator 100 (e.g., each ventilator 100 in a room) displaying a unique visual indicator (e.g., a unique color, icon, picture, QRS code, and/or barcode, and/or a pattern of flashing LEDs or other lights), and user interface 350 of device 300 displaying a matching indicator when communicating with that particular ventilator 100. In some embodiments, user device 300 and a ventilator 100 in active communication with user device 300 can be configured to collectively provide an output (e.g., combinations of musical and/or visual cues) indicating the active connection between the two devices. In some embodiments, each ventilator 100 is configured to enter an alarm state if the connection between that ventilator 100 (e.g., the ventilator in active communication with user device 300) and user device 300 is lost (e.g., after power loss to either or both devices). Each user device 300 can use (e.g., include or otherwise use) a camera (e.g., a single image camera and/or a video camera) and/or a microphone to ensure that the correct attachments and/or communications are in place, such as to automatically confirm that any device remote from ventilator 100 (e.g., a remote user device 300) is connected to the correct ventilator 100. This confirmation can be achieved if the remote device includes a built-in microphone and/or camera.

[0128] In some embodiments, system 10 comprises an algorithm 165/365/665, such as an Al algorithm, and system 10 further comprises one, two, or more cameras (e.g., camera 1511, camera 3511, and/or accessory device 400 comprising one, two, or more single image cameras, video camera, and/or other cameras). In these embodiments, the Al-based algorithm 165/365/665 can analyze image data captured by the one, two, or more cameras, such as image data comprising patient images (e.g., images of the patient using ventilator 100), clinician images (e.g., images of a nurse or other caregiver administering therapy to the patient), and/or other images. The captured image data can be stored (e.g., in memory 162 of ventilator 100, in memory 362 of user device 300, and/or in memory 662 of server 600), such as to be searchable by an operator of system 10 and/or used by algorithm 165/365/665 in a closed-loop arrangement. Camera data can include data captured prior to, during, and/or after an alert condition is encountered (e.g., 5 minutes of data recorded prior to, during, and/or after an alert condition occurs). In some embodiments, vent measurements and/or other ventilator 100 data is recorded and stored (e.g., in a synchronized manner) along with the image data. Alternatively or additionally, patient medication data (e.g., use of one or more agents 800) can be stored in memory along with the camera and/or other system 10 data. In some embodiments, information stored includes data related to: patient synchrony with ventilator 100 (synchrony of breath delivery initiation), including any adjustments of inspiratory and expiratory trigger sensitivity (e.g., to optimize synchrony); instances when the patient was “fighting” with ventilation provided by ventilator 100; instances of extubation versus suction (e.g., when a nurse is present); instances of requiring suctioning, such as data related to measurement of frequency of suctioning; presence of water in flow pathway (e.g., along with data related to operation of ventilator 100 prior to, during, and/or after the time water was present); and/or instances when the patient was not adequately ventilated (e.g., automatic change in FiO2), for example, based on the pallor of the patient. The data gathered by system 10 during an alert condition and/or other event can be reviewed by a physician and/or nurse remotely via a user interface (e.g., user interface 350 of a user device 300), such as when presented in graph, event log, and/or video form, such as to determine the best next steps to take in the use of ventilator 100 or otherwise. For example, this data can be used to improve patient synchrony and/or optimize ventilator parameter settings.

[0129] In some embodiments, one or more cameras of system 10 (e.g., cameras 1511 and/or 3511), one or more microphones of system 10 (e.g., a functional element 99, 199, and/or 399 and/or diagnostic device 700 comprising a microphone), and/or one or more other sensors and/or diagnostic devices of system 10 are configured to record one, two, or more sets of data that is used by an algorithm 165/365/665 (e.g., an Al algorithm) to classify an alert condition of a patient on a ventilator 100. The one or more cameras of system 10 can capture data comprising patient images, patient environment images, clinical setting images, and/or other images. The one or more microphones of system 10 can capture patient sounds, patient environment sounds, device alerts or other device sounds, and/or clinical personnel sounds (e.g., spoken word sounds). The other sensors and/or diagnostic devices of system 10 can capture patient physiologic information (e.g., data related to respiration, blood oxygen or other blood gas level, blood glucose, tissue temperature, neuronal firing, blood pressure, and/or heart rate) and/or patient environment information (e.g., noise level, temperature, pressure, and/or humidity level of the patient room). One, two, or more sets of these types of data collected by these system 10 components can be analyzed by an algorithm 165/365/665, such as to classify a patient health status (e.g., to identify a patient condition and/or to confirm or refute a separate diagnosis of a patient condition). The data analyzed can comprise data selected from the group consisting of: images and/or other diagnostic data related to patient pallor or other patient skin conditions; images, sounds, and/or other diagnostic data related to patient breathing and/or coughing (e.g., data related to synchrony of patient breathing related to ventilation provided by ventilator 100); images and/or other diagnostic data related to patient body position (e.g., standing, sitting, or lying down); images and/or other diagnostic data related to patient body motion (e.g., motion related to walking, breathing, shaking, tremors, and/or seizures); diagnostic data related to patient physiologic information (e.g., respiration, blood oxygen or other blood gas level, blood glucose, tissue temperature, neuronal firing, blood pressure, and/or heart rate); and combinations of these. In some embodiments, this data analysis performed by algorithm 165/365/665 can result in system 10 providing a recommended treatment for the patient, such as a recommended treatment selected from the group consisting of: suctioning of the patient (e.g., due to detected coughing of the patient); ventilation 100 setting change; pharmaceutical drug or other agent 800 administration to the patient; patient body position change; adjustment of ventilator mode and/or ventilation setting parameters; and combinations of these. Depending on the patient disease state, a physician or other clinician may transition system 10 from operating in mandatory and assist breath modes to operating in spontaneous mode of ventilation and extubating over short or long durations of time. Patients may require a spontaneous breath trial before extubating, such as to assess patient endurance and strength to breathe spontaneously. Some clinical methods of assessment are a function of visually assessing how well a patient tolerates the weaning trial and having photo or video for review can greatly help in the physician assessment.

[0130] In some embodiments, system 10 is configured to terminate the breath when operating in pressure-regulated volume control (PRVC) mode, and when the target volume (TV) is exceeded by a threshold, such as a threshold of at least 3%, 5%, 10%, and/or 15%. Rapid changes in lung compliance can result in high volumes being delivered, which can result in volutrauma. One method to prevent this adverse event, would be for system 10 to cease the inspiration period at the expense of reaching the set inspiratory time even if the desired inspiratory time has not been reached. This limit can be set based upon the high exhaled tidal volume limit. In some embodiments, system 10 is configured to allow an operator (e.g., by pressing a button or other control of a user interface) to disable adjustment of a target volume during suction and/or to keep the previous pressure target and inspiratory time before suctioning occurred (e.g., to avoid following an improper target during suctioning).

[0131] In some embodiments, system 10 is configured to flush reservoir 130 with oxygen to rapidly increase the percentage of oxygen in reservoir 130, such as to achieve a target oxygen level (e.g., a target higher than the current level) in a relatively short time period. If the %C>2 has increased, the deficit volume of O2 could be replenished by system 10 keeping the O2 pathway (e.g., solenoid) open until this volume of O2 has been delivered to the reservoir 130. This deficit can be determined (e.g., calculated by system 10) from the volume of O2 deficit in the reservoir 130 plus any additional volume delivered to the patient from the reservoir 130 in the intervening period. Alternatively or additionally, system 10 can be configured to flush reservoir 130 with air (e.g., atmospheric air and/or other non-pure oxygen gas) to rapidly decrease the percentage of oxygen in reservoir 130, such as to achieve a target oxygen level (e.g., a target lower than the current level) in a relatively short period of time. For example, either of these flush procedures can be performed to achieve a target oxygen level in a time period of no more than 20 seconds at nominal settings. Decreasing the level of O2 in the reservoir 130 can be achieved (e.g., automatically by system 10) by controlling the flow through the exhalation valve via an inspiratory flow sensor (e.g., a functional element 99 comprising an inspiratory flow sensor) in the exhalation pathway. Given that the O2 flow into the reservoir 130 can be set to a level of 15 L/min to 60 L/min, and the air flow to dilute the reservoir can be set between 15 L/min and 60 L/min, such as to dilute reservoir 130 (e.g., a 2.5 liter reservoir) depending upon the patient I:E ratio (ratio of inspiratory and expiratory phases). The lower the expiratory time in relation to the inspiratory time, the higher the flush flow during exhalation. Once the desired volume of air has been entrained to achieve the desired %O2 the flushing can cease (e.g., system 10 can be configured to stop the flushing). [0132] In some embodiments, ventilator 100 comprises two blowers, such as primary blower 140, and secondary blower assembly 180. A system 10 comprising two blowers enables the use of a low flow O2 source for achieving a full range of FiO2s (e.g., 21 to 100%). The limitation of a low flow O2 source is the volume of oxygen it can deliver continuously and if the patient’s minute ventilation exceeds this level. If the low flow O2 source is only capable of delivering 15 L/min of O2 and the patient minute ventilation is less (e.g., 12 L/min), a full range of FiO2 can be achieved by system 10 because the volume of O2 required is less than that available. Alternatively, if the base flow (typically used in ventilators to aid in flow triggering) or leak of 10 L/min is present, this means an oxygen flow of 12 + 10 L/min = 22 L/min is required to achieve a 100% FiO2. To minimize leak, an exhalation valve can be included that uses an area ratio valve resulting in a PEEP pilot pressure of one-half that of PEEP. A single blower system cannot easily provide a PEEP pilot pressure while maintaining PEEP without additional gas losses. In some embodiments, a higher flow O2 flow meter is used by ventilator 100 (e.g., made available at the clinical setting), such as an 02 flow meter up to 70 L/min. The PEEP pilot pressure and PEEP pressure by a separate blower eliminates any gas leak attributed to attempting to use the same pump. When a ventilator 100 uses a parabolic leak or provides a base flow for trigger, these configurations result in the equivalent of large circuit leak, and make the use of low flow oxygen impossible to achieve accurate O2 levels over a full settable O2 range. The parabolic leak can leak 30 L/min at 10 cmlLO which is much greater than 15 L/min at 10 cmlLO PEEP. A system 10 comprising a second blower allows one blower to provide PEEP and the second blower to be prepared for a patient effort while minimizing the potential gas loss. The PEEP blower can deliver PEEPs as great as 60 cmlLO if the maximum pilot pressure it can generate is 30 cmlLC). In some embodiments, ventilator 100 comprises a pressure relief valve (e.g., for safety), such as a functional element 199 comprising a pressure relief valve and/or such as is described herebelow in reference to Fig. 8A.

[0133] In some embodiments, system 10 is configured to monitor and/or otherwise determine pressure (e.g., peak pressure), to monitor and/or otherwise determine plateau pressure (e.g., pressure measured at end-inspiration with an inspiratory hold maneuver on ventilator 100), or both. Clinical trials have shown that exposing a patient to lung pressures higher than 30 cmlLO results in higher mortality. Thus, clinicians routinely measure plateau pressure which indicates a lung pressure that can be used to prevent over pressurization of the lung. Setting adjustments to ventilator 100 parameters can be made if the plateau pressure exceeds 30 cmlLO. System 10 can be configured to prevent peak pressure from exceeding a “peak pressure plateau limit” (e.g., in an open loop and/or closed loop arrangement). System 10 can be configured to issue an alert (e.g., an alarm or other alerting of the patient, a clinician, and/or other user of system 10) when system 10 detects that a peak plateau pressure exceeds a “peak plateau pressure threshold” (e.g., a threshold pressure at, above, or below the peak plateau pressure limit). System 10 can be configured to periodically perform an inspiratory pause maneuver, such as to measure plateau pressure and enter an alert state (e.g., an alarm state) if the level is exceeded. Ventilator 100 can be set to do this maneuver based upon time (e.g., time of day, a time duration, or the like), and/or on a number of breath counts (e.g., every 30 breaths). In some embodiments, system 10 is configured to enter an alert state (e.g., a state in which an alert is issued, and/or a ventilation parameter is modified). In these embodiments, an alert state can be entered when the peak plateau pressure is at or above the threshold level for a period of time (e.g., a time period of at least 0.5, 1.0, 3.0 and/or 30.0 seconds) and/or for a number of breath counts. In some embodiments, system 10 enters an alert state when a measured pressure (e.g., an operating pressure of ventilator 100) it at the peak pressure plateau limit for a period of time (e.g., a time period of at least 0.5, 1.0, 3.0 and/or 20.0 seconds).

[0134] Alternatively, the lung pressure can be estimated based upon an estimate of the lung pressure.

Plung — Pairway ^— Qairway * RSTAT where Piun is the estimate of the lung pressure, and Pairway is the measured airway pressure, Qairway is the measured airway flow, and RSTAT is the measured airway resistance (e.g., determined during an inspiratory hold maneuver). Thus, the lung pressure is estimated by subtracting the effects of airway resistance.

[0135] A peak pressure threshold and/or a plateau pressure threshold of system 10 can each comprise two or more thresholds, where when any of the thresholds is reached, system 10 enters an alert state (e.g., provides a particular alert signal and/or changes a ventilation parameter accordingly). For example, system 10 can include multiple peak pressure thresholds, and a first alert state can be entered when a first pressure threshold is exceeded for at least a first time period, and a second alert state can be entered when a second pressure threshold (e.g., higher than the first pressure threshold) is exceeded for a second time period (e.g., shorter in duration than the first time period).

[0136] In some embodiments, system 10 includes one or more filters, such as filter 60 shown, configured to filter contaminants from entering ventilator 100 (e.g., a filter configured to be positioned on the inlet of ventilator 100). For example, filter 60 can be configured to filter atmospheric air prior to entering ventilator 100 (e.g., atmospheric air entering reservoir 130). In some embodiments, filter 60 comprises a filter configured to filter airborne contaminants such as chemical, biological, radiological, and/or nuclear (CBRN) contaminants (e.g., a CBRN 40mm NATO filter). In some embodiments, a filter 60 comprising two or more filters are operably attached in parallel to ventilator 100, such as to decrease the overall resistance to airflow entering ventilator 100 caused by filter 60. Additionally or alternatively, ventilator 100 can comprise a separate blower configured to overcome the air resistance caused by filter 60, for example, such that the effective resistance seen by ventilator 100 is less than or equal to O.lmbar, such as O.Ombar, or -O.lmbar. In some embodiments, filter 60 can be attached to ventilator 100 as described in reference to Fig. 18 and/or Fig. 19 herein. Filtering atmospheric air prior to entering ventilator 100 can prevent or at least limit contaminants from entering ventilator 100 and thus contaminating one or more air handling components therein (e.g., reservoir 130, blower 140, and inspiration conduit 142).

[0137] In some embodiments, ventilator 100 is configured to periodically perform one or more self-tests configured to verify the proper functionality of one or more components and/or processes of ventilator 100 and/or of any one or more components of system 10. For example, ventilator 100 can be configured to perform a self-test to confirm the proper functionality of a UOC 152, such as a UOC 152 comprising a speaker. Ventilator 100 can be configured to perform a test of a speaker that can comprise playing an audio file via the speaker, and measuring a response, such as an audible response and/or an electronic response, for example by measuring the electric current through the speaker when the audio file is played by the speaker. In some embodiments, an audio file for a speaker test can comprise a frequency outside of the human audible range, such as above and/or below the human audible range, such that ventilator 100 can perform the speaker test without producing an audible sound. Measuring the current through a speaker during the audio test can be used to confirm proper functionality of the speaker, and/or to identify a disconnection (e.g., an open circuit caused by a broken connection or other open-circuit condition between a control board of ventilator 100 and UOC 152 comprising a speaker). In some embodiments, ventilator 100 can perform one or more self-tests at regular intervals and/or at irregular intervals, for example when performed at least once per hour, such as at least once per minute, or at least once per second. In some embodiments, ventilator 100 is configured to avoid performing a scheduled self-test if the component to be tested is currently in use, for example if an audible alarm is sounding when a speaker self-test is to be performed. [0138] As described herein, ventilator 100 can be configured to operate in a pressure control (PC) mode and/or a volume control (VC) mode. Switching between PC and VC modes can cause perturbation in pressure and/or volume, and these perturbations have the potential for causing volutrauma and/or barotrauma to the patient. Volutrauma and barotrauma are both associated with increased mortality in ventilated patients. To avoid perturbations in pressure and/or volume when switching between PC and VC ventilation modes, ventilator 100 can be configured to match one or more parameter settings of the new mode to the current mode, before switching between the modes. For example, when switching from PC to VC, the tidal volume setting for the VC mode can be automatically set to the tidal volume setting of the PC mode ventilation, such as to prevent a rapid increase in volume delivered by ventilator 100. As another example, when switching from VC to PC, the peak pressure setting for the previous PC mode can be automatically set to the peak pressure setting of the previous VC mode ventilation, such as to prevent a rapid increase in pressure delivered by ventilator 100. In some embodiments, VC and/or PC ventilation modes each comprise one or more default settings, and/or each comprise one or more user input settings (e.g., user settings that are input prior to switching modes). Ventilator 100 can be configured to automatically adjust these settings when switching between PC and VC modes, and/or to recommend these adjustments for user confirmation prior to switching modes. In some embodiments, ventilator 100 is configured to automatically reduce a pressure and/or a volume setting (e.g., to reduce a default setting based on a current mode setting). Additionally or alternatively, ventilator 100 can be configured to require a user confirmation to change (e.g., to increase) a pressure and/or volume setting (e.g., to increase a default setting based on a current mode setting). In some embodiments, when ventilator 100 adjusts a pressure and/or volume setting prior to switching between PC and VC modes, after the mode change, ventilator 100 can gradually adjust the setting, such as adjusting the setting over a period of at least one breath, such as at least two breaths (e.g., at least one or at least two inhalation and exhalation cycles of ventilator 100) to match the pre-adjustment setting. In some embodiments, ventilator 100 is configured to provide a “sigh breath” between mode changes, such as in inhalation cycle configured to deliver an increased volume of air to the patient that is performed intermittently. In some embodiments, ventilator 100 can comprise a volume threshold, such as a maximum volume threshold that is set by the clinician. When the maximum volume threshold is reached, ventilator 100 can be configured to automatically switch from inhalation to exhalation. [0139] Referring to Figs. 2-4, an automated portable ventilator 100 including a housing 110 with a front panel 1111 having a user interface 150 (which may include a display), an inspiration port 102 for inspiration air being pumped to the patient, an exhalation port 103, an exhalation exhaust 104, and a run/standby switch, switch 101 shown, that is used for entering or exiting “ventilation” mode.

[0140] Fig. 3 shows a tubing assembly 200 which is releasably attached to the housing 110. The tubing assembly 200 includes an inspiration portion that includes an inspiration tube 210, a gas filter 215 (e.g., a bacterial and virus filter) coupled to the inspiration tube 210, and a coupling 211 for connecting the inspiration tube 210 and/or filter 215 to the inspiration port 102 of the housing 110. An outlet end of the inspiration tube 210 attaches to a first port of a Y-junction coupling, Y-junction 231 shown. A second port of the Y-junction 231 connects to an inlet of an exhalation tube 220. A third port of the Y-junction 231 joins a connection tube 232, which connects to a user ventilation device such as a face mask or an intubation tube. A heat and moisture exchanger (HME) 233 may be optionally coupled to the connection tube 232 using conical fittings (or other coupling devices). A coupling device, coupler 234 is at the distal end of the connection tube 232 or HME 233. The coupler 234 connects to a face mask or intubation device, patient interface 235 (Fig. 7) mounted to the patient.

[0141] A flow sensor 241 may be connected to the connection tube 232. The flow sensor 241 collects flow data regarding the gas flow rate, timing and direction of the gas flow passing through the connection tube 232, such as gas flow into and out of the patient. The proximity of the flow sensor 241 to the patient ensures that the flow data accurately indicates the breathing conditions of the patient, such as when the patient initiates inhalation and exhalation, and the volume and/or gas flow rate of the gas being inhaled and exhaled by the patient.

[0142] A communication cable 242 transmits the data collected by the flow sensor 241 to a data link connection 243 on the front panel 1111 of the housing 110 of the ventilator 100. The data from the flow sensor 241 may alternatively be transmitted wirelessly and thereby avoid the need for the communication cable 242.

[0143] The outlet end of the exhalation tube 220 may include an air filter 225 to ensure that viruses and bacteria from the patient do not enter the housing 110 of the ventilator 100. In addition, the exhalation tube 220 may be connected to the exhalation port 103 of the housing 110 by a coupling 221. Exhaled gas passes from the exhalation tube 220, into the exhalation port 103, through tubing in the housing 110 and out the exhalation exhaust 104 on the front panel 1111 of the ventilator .

[0144] The tubing assembly 200 may be an integrated assembly of components of inspiration and exhalation tubing 210, 220, air filters 215, 225, the Y-junction 231, the flow sensor 241, the connection tube 232, and/or the HME 233. The coupler 234 may or may not be part of the integrated assembly. The integrated assembly may be manufactured to form a single piece, disposable unit that is attachable to the housing 110 of the ventilator 100.

[0145] The filters 215, 225 in the tubing assembly 200 ensure that bacteria and viruses are not transmitted from the ventilator 100 into the patient and are not transmitted from the patient through the exhalation exhaust 104 and into the air where health care professionals are working.

[0146] As shown in Fig. 4, the housing 110 of the ventilator 100 may be generally rectangular with substantially flat panels for the front panel 1111 (Fig. 3), as well as side, top, bottom and rear panels. The rectangular, flat shape of the panels for the ventilator 100 allows the ventilator to be stacked with other ventilators 100 for storage. Handles 1118 (Fig. 3), can comprise recessed handles positioned on the side panels of the housing, such as allow a person to easily grasp and move the ventilator.

[0147] The housing 110 may be formed in a rectangular cuboid shape and configuration with each panel having a rectangular shape, although other shapes and configurations such as, but not limited to, circular or oval are contemplated to be within the scope of the disclosure. The rectangular cuboid shape and configuration allows for multiple ventilators to be stacked on top of one another for storage, transportation, and stock piling purposes. The ventilator 100 may be light weight, such as no more than fifteen (15) pounds. The light weight allows one person to carry the ventilator from storage to a location near a patient.

[0148] As shown in Fig. 4, the rear panel 1112 includes an electric power connection 1901 connectable to an external power source 50 (Fig. 8). The power connection 1901 may include an AC/DC converter and transformer 51. The power source may be a low-voltage DC (direct current) source such as a source of 24 volts DC. The power source may include a battery, capacitor, and/or other energy storage element, battery 1902, such as a back-up battery supply. The power source may also receive electrical power from a conventional source such as 120/240 volts of AC current. A power switch, power switch 1903 (Fig. 5) on the rear panel 1112 is used to turn the ventilator 100 on or off and may be recessed to avoid inadvertently turning the ventilator 100 on or off. [0149] The combination of switch 101 and the power switch 1903 may act as a safety feature. In particular, the user may be prevented from actuating the power switch 1903 to turn the ventilator 100 off (i.e., terminate power to the ventilator) before the switch 101 is set to “standby” mode. In “standby” mode, the primary blower 140 and a secondary blower 181 (e.g., a blower configured as a PEEP blower) are shut down so that ventilation is turned off. Once the ventilator 100 is in “standby” mode, the power switch 1903 may be actuated to turn off the ventilator 100. If the user actuates the power switch 1903 to turn off the ventilator 100 before setting the ventilator 100 to “standby” mode, an alarm may sound. It is also contemplated that the power switch 1903, the switch 101, and/or the ventilator 100 as a whole may be configured so that the user cannot turn off the ventilator before setting the ventilator to “standby” mode. Preventing the ventilator 100 from being shut down before being set to “standby” mode may prevent damage to the components of the ventilator 100 and/or damage to the patient. It is contemplated that the ventilator 100 may also include a cover 1904 that covers the power switch 1903 to prevent inadvertent actuation of the power switch 1903. For example, the cover 1904 may be rotated to an uncover position that allows access to the power switch 1903 and may be rotated back to a cover position that prevents access to the power switch 1903.

[0150] An atmospheric air inlet port, inlet port 112 shown, may be always open and covered by a shield 1121 displaced from the flat surface of the rear panel 1112 to prevent a blockage of atmospheric air entering the port. An outer oxygen (O2) inlet port 135 on the rear panel 1112 is connectable to a source 40 (Fig. 8) of pure oxygen (O2) such as a portable oxygen tank or an oxygen distribution source in a hospital or other clinical setting. The oxygen source 40 may be a low flow and/or pressure source providing oxygen in a range of 10 to 20 liters per minute (Lpm) or up to 15 Lpm. The outer oxygen inlet port 135 may be a low flow oxygen port that restricts the flow of oxygen to 15 Lpm or less.

[0151] Figs. 5 and 6 are views of the ventilator 100 with the outside panels of the housing 110 removed (for illustrative clarity) except for the front panel 1111. A blower and reservoir assembly, inhalation assembly 120 shown, is positioned within the housing 110 (Fig. 3). The inhalation assembly 120 includes a reservoir 130 that holds a gas to be pumped to the patient as inspiration gas. The gas may be atmospheric air or a mixture of atmospheric air and oxygen (O2) that is received by way of the inlet port 112 and/or oxygen inlet port 135. For example, atmospheric air may flow directly into the reservoir 130 from the inlet port 112, while pure oxygen may flow directly into the reservoir 130 from the outer oxygen inlet port 135. Once received in the reservoir 130, the gas is drawn from the reservoir 130 and pumped by the primary blower 140, under a pressure above atmospheric, through an outlet of the primary blower 140 and to a passage, inspiration conduit 142 shown, that directs the gas mixture from the primary blower 140 to the inspiration port 102.

[0152] The ventilator 100 may operate without being connected to a source 40 (Fig. 8) of oxygen (O2). It is further contemplated that the flow of oxygen through the outer oxygen inlet port 135 into the reservoir 130 may be turned off during some operational conditions of the ventilator 100. Oxygen typically comprises about 21% of atmospheric air. Thus, if the patient needs inspiration gases with a concentration of oxygen greater than 21%, supplemental oxygen (O2) may be added to the atmospheric air in the reservoir 130 to increase the oxygen level in the gas mixture.

[0153] One feature of the inhalation assembly 120 is that the maximum pressure that can be generated by the primary blower 140 is less than the maximum inspiration pressure that is safe for a patient. These high pressures may only be generated at low flows and as a function of the construction and arrangement of the primary blower 140. Thus, the primary blower 140 can be configured as a safeguard preventing inspiration air flowing to the patient at an unsafe pressure level.

[0154] Another feature of the inhalation assembly 120 is to ensure that the gas mixture pumped to the patient by the primary blower 140 does not exceed an unsafe level of O2. In particular, oxygen in the ventilator 100 can present a fire risk if the concentration of oxygen leaking into chassis of the ventilator exceeds a particular level (e.g., greater than 25% of the total composition of the gas mixture).

[0155] In order to prevent the concentration of oxygen from exceeding an unsafe level, it is contemplated that the inlet port 112 to the reservoir 130 may be always open to allow atmospheric air into the reservoir 130. Thus, the reservoir 130 can be configured to always receive a constant supply of atmospheric air at a rate equal to the flow rate at the blower outlet minus the flow rate of supplemental O2 from the outer oxygen inlet port 135 into the reservoir 130. Atmospheric air flows into the reservoir 130 due to the slight pressure reduction in the reservoir 130 caused by the primary blower 140 drawing in air and moving gas into the inspiration conduit 142. The reservoir is sealed to be gas tight at the expected pressure levels preventing gas leakage into the chassis.

[0156] The reservoir 130 defines an internal chamber having a relatively large interior volume, such as a volume of 2 liters or 2.5 liters. It is contemplated that the internal chamber may have a volume above a threshold volume, such as a threshold volume of at least 1.5 liters, at least 2.0 liters, and/or at least 2.5 liters. The reservoir 130 can comprises a volume of at most 3 liters. The volume of the reservoir chamber is substantially larger than the volume of gases delivered to a patient during an inspiration phase, for example, a breath. The relatively large volume of the reservoir 130 minimizes ripples, i.e., variations in the concentration of oxygen in the gas (fractional inspired oxygen (FiO2)) delivered to the patient’s airways. The volume of the reservoir 130 is also substantially larger than the volume of the air passage between the primary blower 140 and the mask or other patient interface, patient interface 235, through which the gas mixture is delivered to the patient. This air passage may include the inspiration conduit 142, the inspiration tube 210, the Y-junction 231, the flow sensor 241, and the patient interface 235. A large interior volume of the reservoir 130 provides a large mixing volume for oxygen and atmospheric air to mix before the mixture enters the primary blower 140 minimizing delivered FiO2 ripple.

[0157] Oxygen (O2) enters the reservoir 130 through an inner oxygen inlet port 132 positioned on a sidewall 1311 of the reservoir 130 that is between a rear wall 1312 and a front wall 1313 of the reservoir 130. The inner oxygen inlet port 132 may be positioned in a region on the sidewall 1311 that is centered on the middle of the sidewall 1311 and has a range that is 20% the distance between the rear wall 1312 and the front wall 1313 so that the inner oxygen inlet port 132 can be located about equal distance between the rear wall 1312 and the front wall 1313, closer to the rear wall 1312, or closer to the front wall 1313. In addition, a conduit 1122 is internal to the housing 110 and connects the outer oxygen inlet port 135 to the inner oxygen inlet port 132.

[0158] The inlet port 112 is at or near the rear panel 1112 of the housing 110 and is connected to an inlet port 137 in the rear wall 1312 of the reservoir 130 via an air passage 1123. The primary blower 140 may be at or near the front wall 1313. The primary blower 140 may also be housed within the front wall 1313. In addition, the air inlet to the primary blower 140 is in fluid communication with the internal chamber of the reservoir 130. The inner oxygen inlet port 132 may be positioned away from the air inlet of the primary blower 140 to reduce the risk that excess oxygen will enter the primary blower 140 and be pumped towards the patient. Also, positioning the inner oxygen inlet port 132 away from the air inlet of the primary blower 140 allows the oxygen to mix with the atmospheric air in the reservoir 130 before the mixture enters the primary blower 140. The position of the inner oxygen inlet port 132 can be positioned away from the inlet port 112 to prevent oxygen loss from the reservoir 130 during exhalation when oxygen continues to flow.

[0159] The reservoir 130 may be hermetically sealed except for the inlet port 137, the inner oxygen inlet port 132 and an outlet, primary blower outlet 141 shown, for the primary blower 140. Sealing the reservoir 130 reduces the risk of oxygen leaking from the reservoir 130 into other regions inside the housing 110, and aids in controlling the oxygen level in the reservoir 130.

[0160] The inner oxygen inlet port 132, conduit 1122, and/or outer oxygen inlet port 135 may form an oxygen flow passage(s) 1125. In addition, the inlet port 137, the air passage 1123, and/or the inlet port 112 may form an atmospheric flow passage(s) 1126. The oxygen flow passage(s) 1125 may have a cross-sectional area that is substantially smaller than the cross-section area of the atmospheric flow passage(s) 1126, for example, less than 75%, 50%, 25% or 10% of the cross-sectional area of the atmospheric flow passage(s) 1126.

[0161] A baffle plate(s) 133 (Fig. 8) within the reservoir 130 may form a partition which divides the internal chamber of the reservoir 130 into sections. The baffle plate(s) 133 may be supported and/or reinforced by one or more support devices to limit movement of the baffle plate(s) 133 due to pressure from the flow of oxygen and air in the reservoir 130. For example, the baffle plate(s) 133 may be supported by one or more posts that extend from the baffle plate(s) 133 to the rear wall 1312 or to the sidewall 1311. The baffle plate(s) 133 may be between the inlet port 137 and the inner oxygen inlet port 132 along an axis of the reservoir 130. The baffle plate(s) 133 may comprise a flat plastic or metal plate having an outer edge configured to abut and engage an inner side of one of the walls of the reservoir 130. The baffle plate(s) 133 includes openings to allow the atmospheric air to freely move through the baffle plate(s) 133. The openings may be arranged closer to the outer edge than to the center of the baffle plate(s) 133. The baffle plate(s) 133 can be configured to muffle noise from the primary blower 140 from emanating out of the reservoir 130 and into the area near the ventilator 100 and it aids in mixing the gas when the air is entrained. Noise is also muffled by an air filter, filter 1321 shown (Fig. 8), positioned within the air passage 1123.

[0162] The reservoir 130 may include a bucket-shaped housing, housing 131 and a base plate 1314 mounted to a bracket plate 113 in the housing 110. The reservoir 130 is supported by the bracket plate 113 in the housing 110. The primary blower 140 is mounted to the base plate 1314 such that the primary blower 140 is within the reservoir 130. An open generally circular edge of the housing 131 is attached to the base plate 1314 to form a seal between the housing 131 and the base plate 1314. The base plate 1314 may be generally circular and includes ribs to provide structural support to the housing 131 and the reservoir 130 and the primary blower 140. The housing 131 may have a generally cylindrical outer wall. There may be a recessed side portion 1315 of the housing 131 to accommodate the primary blower outlet 141, the conduit 1122 and the inner oxygen inlet port 132. The recessed side portion 1315 may be used to reduce the volume needed inside the housing 110.

[0163] The primary blower 140 may be mounted to the base plate 1314. The primary blower 140 may include a centrifugal impeller within a cylindrical housing. The centrifugal impeller may be a single centrifugal impeller having an axial extension significantly smaller, optionally 50% or 25% or 10% smaller than its radius to provide the primary blower 140 with a thin discoidal conformation. An inlet (not shown) to the primary blower 140 faces the interior of the reservoir 130. The outlet 141 of the primary blower 140 is connected by the coupling 1411 to the inspiration conduit 142.

[0164] In operation, the primary blower air inlet receives the gas from the interior of the reservoir 130. The gas in the reservoir 130 comes as atmospheric air through inlet port 137 and as oxygen entering through the inner oxygen inlet port 132. Atmospheric air enters at a far end of the reservoir 130 and moves through the interior of the reservoir 130 and through the baffle plate 133. The atmospheric air is drawn through the reservoir 130 by the suction created at the primary blower air inlet. The oxygen, if present, enters the reservoir 130 through the inner oxygen inlet port 132 and mixes with the atmospheric air in the reservoir 130. The oxygen and atmospheric air are well mixed when they reach the primary blower 140.

[0165] The sound of the primary blower 140 is suppressed by the baffle plate 133 before the sound emanates through the inlet port 112. The sound of the primary blower 140 is also suppressed due to a filter 1321 at the inlet port 112 to the internal chamber of the reservoir 130. The baffle plate 133 and filter 1321 may suppress the sound of the primary blower 140 by five (5) decibels. It is contemplated that the baffle plate 133 and filter 1321 may suppress the sound of the primary blower 140 by at least two (2) or three (3) decibels.

[0166] The relatively large volume of the reservoir 130, the continuously open inlet port 112 and the separation between the primary blower 140 and the inner oxygen inlet port 132 ensure that the mixture of gases reaching the primary blower 140 has an oxygen concentration below levels that pose risks such as fire.

[0167] The inhalation assembly 120 is supported by the bracket plate 113 within the housing 110. The bracket plate 113 may have an L-shape with a narrow foot mounted to a bottom panel of the housing 110 and a leg panel supporting the base plate 1314 of the reservoir 130.

[0168] A fan 109 (Fig. 8) may be mounted to the bottom panel of the housing 110 such that gases within the housing 110 are exhausted through the bottom panel to atmospheric air. The fan 109 continually moves gases from the housing 110 to atmospheric air. The fan 109 ensures that any build-up of oxygen in the housing 110 is exhausted from the housing 110 before a level of oxygen in the housing 110 becomes excessive, such as above 20 percent of the total volume of gas in the housing 110. Atmospheric air may enter the housing 110 through several designated vent openings. The flow rate of the fan 109 may be, for example, at least 40 liters per minute and/or at most 400 liters per minute while the oxygen flow rate from the oxygen source 40 may be less than 20 Lpm. Because the flow rate from the fan 109 is substantially, for example, at least 20% greater, than the oxygen flow rate, the fan 109 will exhaust gases from the housing 110 at a greater rate than oxygen enters the housing 110.

[0169] The mixture of atmospheric air and oxygen pumped by the primary blower 140 flows through the primary blower outlet 141, through the inspiration conduit 142, through the inspiration port 102 and into the inspiration tube 210. The inspiration conduit 142 may include a one-way-valve, valve 143 shown, a flow sensor 144, a pressure tap 145, and/or a pressure sensor 146. The proximity of the pressure sensor 146 and the flow sensor 144 to the primary blower 140 allows these sensors to collect data of the gas conditions at the primary blower outlet 141, such as data related to gas pressure and/or flow rate. The pressure and flow rate may be used by a controller 160 (Fig. 7) of the ventilator 100 to adjust the rotational speed of the impeller of the primary blower 140 to match the actual gas mixture pressure and/or flow rate to a desired pressure and/or flow rate.

[0170] The valve 143 prevents air from the exhalation tube 220 from entering the primary blower 140. The valve 143 allows gas to flow through the inspiration tube 210 into the connection tube 232 and to the patient during the inhalation phase. Additionally, the valve 143 prevents gas exhaled by the patient flowing into the primary blower 140 from the inspiration tube 210. The valve 143 can also be configured to minimize the amount of exhaled air from the patient entering the inspiration tube 210 by effectively closing an end of the inspiration tube 210 during the exhalation phase. By minimizing the exhaled breath entering the inspiration tube, the one-way valve minimizing the exhaled breath that is inhaled during a subsequent inspiration phase.

[0171] An oxygen sensor, such as oxygen sensor 149 (Fig. 8) may be in the inspiration gas passage between the inspiration port 102 and the filter 215. The oxygen sensor 149 can generate data indicative of an oxygen level in the inspiration gas. An oxygen monitor(e.g., a circuit of main control board 1605) may be configured to analyze the data from the oxygen sensor 149 to determine the oxygen level, for example, the FiO2 level, of the inspiration gas. The oxygen monitor may output information regarding the oxygen level to a display (e.g., of the user interface 150 described herein) that is read by a health care professional. The oxygen level information may also be used by the controller 160 to adjust a flow of oxygen into the reservoir 130, such as by turning on or off the flow of oxygen, or by regulating the flow of oxygen.

[0172] During operation, exhaled air from the patient passes through the exhalation tube 220 and enters the housing 110 through the exhalation port 103 on the front panel 1111. After the exhaled air passes through the exhalation port 103, the exhaled air enters an exhalation conduit 171 that directs the exhaled air and other gases to the exhalation exhaust 104 on the front panel 1111. The exhalation conduit 171 may include a pressure sensor 172 and an exhalation valve 173 (e.g., valve 173 shown on Fig. 15) that opens or obstructs the exhalation conduit 171 depending on whether the ventilator 100 is in an inspiration phase, wherein the valve 173 is closed, or in an exhalation phase, wherein the valve 173 is open. In some embodiments, valve 173 comprises a pilot-actuated valve, for example, as described in reference to Figs. 9 A and 9B herein.

[0173] Fig. 7 is a schematic diagram of the ventilator 100 including a patient coupler, coupler 234 shown, that connects to a mask or intubation tube, patient interface 235, that is applied to a patient. The inspiration tube 210 is coupled to the air inspiration port 102 and the exhalation tube 220 is coupled to the air exhalation port 103. The inspiration air filter 215 is included in the inspiration tube 210 near the inspiration port 102 at the ventilator housing 110. Similarly, air filter 225 is included in the exhalation tube 220 near the air exhalation port 103 at the ventilator housing.

[0174] The filters 215, 225 prevent contaminates, such as bacteria and/or viruses, from entering the inspiration tube 210 and flowing into the patient, and these filters prevent bacteria and viruses from entering the ventilator through the exhalation tube 220. Although gas flow does not enter the ventilator housing 110 through the inspiration tube 210 during any phase of operation of the ventilator 100, the filter 215 is included to prevent bacteria and viruses from entering the ventilator 100 via the inspiration tube 210. Because the tubing assembly 200 of the patient circuit prevents bacteria and viruses from entering the ventilator housing 110, the housing 110 is not contaminated with bacteria and viruses that may be present in the breath of the patient.

[0175] The filter 1321 at the inlet port 112, and the baffle plate 133 within the reservoir 130 provide a small amount of flow resistance that is sufficient to prevent the mixture of oxygen and atmospheric air flowing out of the inlet port 112 and thus leaking oxygen. The resistance due to the filter 1321 and the baffle plate 133 are intentionally low to not significantly limit the peak pressure that the primary blower 140 can deliver.

[0176] The overall inspiratory resistance (i.e., what a patient has to inhale against if the system was turned off to entrain ambient air) may be held to be less than six (6) cmlTO at 30L/min. The overall inspiratory resistance is the resistance to air flow due to the filter 1321 and resistances in the inspiration tube 210 all the way to the coupler 234, which can include the baffle plate 133, the pressure tap 145, the flow sensors 241, 144, the pressure sensor 146, the filter 215 and/or the valve 143.

[0177] Internal regions of the housing 110 are shielded from bacteria and viruses, especially those coming from the patient. The filter 1321 at the inlet port 137 of the reservoir 130, and the filters 215, 225 in the tubing assembly 200 of the patient circuit, prevent bacteria and viruses from entering the reservoir 130, as well as primary blower 140, the inspiration conduit 142, and the air passage 1123 within the housing 110.

[0178] While unfiltered air may enter the internal region of the housing 110 due to the fan 109 moving air out of the housing 110, unfiltered air in the housing 110 does not enter the passages for inspiration air that reach the patient. The internal components, for example, primarily the inhalation assembly 120 and associated passages 142, 1123 within the housing 110 can be configured to not require cleaning and/or sterilization between patients and/or between treatment sessions of a patient because they are protected by filters from bacteria and viruses.

[0179] The tubing assembly 200 of the patient circuit can be configured to be disposable after each use. Also, the relatively flat surfaces of the housing 110 are easy to clean, for example, by being wiped with standard hospital cleaning agents. Thus, the process of readying the ventilator 100 from one use to the next may primarily comprise removing the prior tubing assembly 200 and installing a new tubing assembly 200.

[0180] Further, the tubing 210, 220, of the tubing assembly 200 may be long, for example, five feet or 2.5 meters, or greater, which may allow the patient to be separated from the ventilator housing 110 by a sufficient distance to maintain social distancing between the patient and the health care provider operating the ventilator 100. This social distancing reduces the risk of transmitting bacteria and viruses between the patient and the health care provider.

[0181] The controller 160 in the housing 110 controls the blowers, valves, solenoids, user display, monitors the sensors of the ventilator 100 and receives inputs from the user input of the user interface 150 (e.g., positioned on the front panel 1111 of the housing 110) and/or via a wireless controller. Power for the controller 160, blowers and other electrical components of the ventilator 100 can be provided by the external power source 50, such as a low voltage DC power supply. A capacitor 1905 as shown can be configured to provide emergency power for a short period, such as a few minutes, to operate alarms or perform other functions after a loss of external electrical power for the ventilator.

[0182] The power consumption of the ventilator 100 may be low, such as less than less than 50 watts. A ventilator 100 has been manufactured and tested by the applicant which uses as little as 20 watts at nominal operation and a maximum of 50 watts at peak power consumption with a mean airway pressure of 28 cmEEO. A ventilator 100 with low power consumption, such as below 80 Watts, 60 Watts and/or no greater than 50 Watts at peak power consumption and with a low nominal operation, such as below 30 Watts or no more than 20 Watts, is advantageous because the ventilator 100 may be operated for hours, such as seven hours, solely on the electrical power stored in the battery 1902, which may be a backup battery.

[0183] The ventilator 100 may have component(s) configured to operate with low power consumption, such as the controller 160 with a single low power consumption processor and a low power consumption display, for example, a liquid crystal display; and blowers to (e.g., primary blower 140 and/or secondary blower 181) pump inspiration gases to the patient and control the positive end-expiratory pressure (PEEP) pressure. Further, the oxygen supply may provide O2 at a relatively low pressure and/or low rate, for example, 15L/min, into a reservoir 130 and/or the primary blower 140 and can be continuously open to atmospheric air. This inhalation assembly 120 of the reservoir 130 and the primary blower 140 provides a low power and simple means to mix oxygen and atmospheric air that provides a stable gas mixture to the patient. Further, the primary blower 140 may have a maximum pressure below a pressure that would harm the lungs of a patient. For example, the maximum inspiration pressure may be no more than 50 cmlEC) or 40 cmlEC). Eimiting the maximum inspiration pressure from the primary blower 140 to a safe pressure for inspiration avoids any need for pressure relief valves and monitoring circuits to avoid an overpressure condition.

[0184] A primary control function of the ventilator 100 is volume delivery of mixed gases to the patient at defined parameters such as mixed gas volume or inspiratory pressure, inspiratory time and breath rate. The defined parameters may be set by manual inputs to the user interface 150 of the ventilator 100. The control functions may include controlling: mixed gas delivered volume, a mechanical valve activated by positive end-expiratory pressure (PEEP), the breath rate, the inspiratory time, triggering of inspiration and exhalation flows, and watchdog control functions. The monitor functions may include monitoring: flow sensors 144 at the primary blower 140 and at or near the patient; electrical current or power to the motor and system; angular position of the motor and impeller; timing of breath, for example, inspiration and exhalation; voltage levels in the electrical circuits of the ventilator; pressure at the inspiration port 102; and pressure at the exhalation port 103.

[0185] Fig. 8 is a schematic diagram of the pneumatic and electronic components of an embodiment of a ventilator 100. Fig. 8 A is an enlarged view of the dashed-line-indicated portion of Fig. 8, showing additional components. Atmospheric air enters inlet port 112, passes through filter 1321 and enters the internal chamber of the reservoir 130. Pure oxygen from oxygen source 40 enters the inner oxygen inlet port 132 (e.g., low flow port) and flows into the reservoir 130 where the oxygen mixes with atmospheric air. The filter 1321 may be a viral and/or bacterial particulate filter. Sounds (e.g., noise) emanating from the primary blower 140 are muffled by the baffle plate 133 in the reservoir 130 and by the filter 1321.

[0186] The volume of the reservoir 130 can be at least two liters, or in a range of 2.3 to 2.8 liters or 2.4 liters. The volume of the internal chamber of the reservoir 130 is substantially greater than the volume of a typical breath, which is typically a tidal volume of two liters. Because the internal chamber of the reservoir 130 has a volume of at least two liters, and preferably in a range of two to three liters, two to four liters, or two to five liters, the reservoir 130 functions as a gas reservoir of a mixture of oxygen and atmospheric air. The reservoir 130 is not depleted during the inspiration phase during which the primary blower 140 is pumping a maximum flow of mixed gas to the patient.

[0187] The oxygen level in the internal chamber in the reservoir 130 is relatively stable because of the relatively large volume of the internal chamber. Also, the rate of oxygen entering the reservoir 130 remains relatively constant but can be subject to adjustment by a user of the ventilator. During the inspiration phase, the suction due to the primary blower 140 pulls atmospheric air into the reservoir 130 at a flow rate greater than during the exhalation phase when the primary blower 140 is pumping at a reduced rate. During the inspiration phase the oxygen level in the reservoir 130 may drop slightly due to the higher flow of atmospheric air. Conversely, during the exhalation phase the oxygen level in the chamber of the reservoir 130 may rise slightly due to a reduced flow of atmospheric air entering the chamber. The volume of the internal chamber of the reservoir 130 is sufficient to moderate the level of oxygen to relatively stable level(s).

[0188] The primary blower 140 is located in the reservoir 130 and draws gas from the reservoir 130 consisting of a mix of atmospheric air and oxygen. The primary blower 140 includes a centrifugal impeller enclosed in a housing. A brushless DC blower motor in the primary blower 140 may drive the impeller. Hall sensors in the primary blower 140 may monitor the motor or impeller position and generate data indicating the actual rotational speed of the impeller. This data can be processed by a motor controller (or motor control board) 1604 and used as feedback to commutate the phasing of the motor and control the speed of the impeller, pressure at the output of the primary blower outlet 141 and/or the flow rate at the primary blower outlet 141. Using a blower to pressurize the inspiratory gas eliminates the need for an external supply of compressed air and limits the maximum pressure of the gas reaching the patient.

[0189] The primary blower outlet 141 is coupled to the inspiration conduit 142. The inspiration conduit 142 may include the pressure tap 145, the pressure sensor 146, the valve 143 and/or the flow sensor 144. The inspiration conduit 142 has an outlet at the inspiration port 102 on the front panel 1111 of the housing 110 of the ventilator 100. The inspiration port 102 connects to the inspiration tube 210 and/or the filter 215 as described above. Similarly, the exhalation tube 220 and/or the filter 225 connects to the air exhalation port 103.

[0190] Exhaled air from the patient passes through the exhalation tube 220, the air exhalation port 103 and enters the exhalation conduit 171. The exhalation conduit 171 can include a second pressure sensor 172 and/or the exhalation valve 173. Exhaled air passes through the exhalation conduit 171, while the exhalation valve 173 is open, and is exhausted from the exhalation exhaust 104.

[0191] The controller 160 may include an oxygen control board 1602, a main controller (or main control board) 1605, and the motor controller (or motor control board) 1604. The controller 160 generates a motor control signal using feedback from a sensor (as described herein) monitoring the speed of the motor of primary blower 140 to correct any difference between a desired speed of the motor and the actual speed as detected by the sensor. The motor speed may be calculated to achieve a desired pressure of mixed gases pumped from the primary blower 140. The controller 160 may include an algorithm(s) that correlates the motor speed and pressure to the volume per period, for example, cubic centimeters per minute, of mixed gases that are pumped. The actual volume of delivered gas may be calculated from integrating the delivered volume with the airway flow sensor 241. The algorithm may be a simple equation and/or a look-up chart that relates motor speed to volume per period, and the algorithm may be configured to make adjustments for ambient temperature and altitude with respect to sea level of the ventilator 100. The motor control signal may set a desired revolutions per minute (RPM) level for the blower motor. In addition to the speed, the motor control signal determines the inspiration period.

[0192] Electrical power from the external power source 50 or the battery 1902 may be initially received by the power management board 1603 and distributed to the motor control board 1604, the main control board 1605, and the oxygen control board 1602. The pressure sensors 146 and 172, and the flow sensors 241 and 144 send data via wires to the main control board 1605. The primary blower 140 and a secondary blower 181 communicate with the motor control board 1604 and may also communicate with the main control board 1605. The motor control board 1604 sends commands to the primary blower 140 and the secondary blower 181 to control the speed and torque of the respective blowers. The motor control board 1604 may also control a first switch and/or valve, switch/valve 182, such as a solenoid valve and/or other electrically activatable valve (“solenoid valve” herein). The switch/valve 182 is connected to the output of the secondary blower 181. The secondary blower 181 controls the PEEP (Positive End Expiratory Pressure) pilot pressure which is used to control exhalation pressure during an exhalation phase of the breathing cycle. The PEEP pilot pressure may be in a range of 0 to 15 cmlRO or 0 to 10 cmlEC). This PEEP pilot pressure is multiplied by the area ratio of the exhalation valve to determine the actual PEEP delivered. This pressure is similar to the pressure generated by the secondary blower 181 and used to control the exhalation valve 173 during the exhalation phase.

[0193] The user interface 150 allows a health care professional to input settings for a ventilation treatment, such as; inspiratory pressure; tidal volume, for example, the volume of mixed gases to be delivered to a patient; the inspiratory time; inspiratory and/or expiratory trigger sensitivity; the breathing rate, for example, breaths per minute (BPM); and the trigger sensitivity, for example, the flow which triggers the ventilator to switch from inspiration to exhalation. The input settings can be loaded into memory of the controller 160, such as a memory on the main control board 1605.

[0194] The user interface may include a hand-held user interface device (not shown), for example, a smart phone with a software application to communicate wirelessly with the controller 160 to transmit input settings and receive information from the ventilator 100 on the ventilation treatment of the patient, such as rate of breathing, alarms issued by the ventilator 100, inspiration and exhalation volumes, inspiratory and expiratory pressures, and/or system parameters, such as motor current and position and/or voltage levels in the ventilator 100. The hand-held user interface device allows the operator, for example, a nurse or other health care professional to monitor the patient and the ventilator 100 away from the patient, which is especially useful if the patient is isolated due to a virus infection.

[0195] The controller 160 and/or an oxygen control board 1602 controls a second switch or valve, switch/valve 136 shown, which in turn regulates oxygen flow through the conduit 1122 (which may include a one-way valve 1124 as shown), extending from the outer oxygen inlet port 135 on the rear panel 1112 of the housing 110, to the inner oxygen inlet port 132 on the sidewall 1311 of the reservoir 130. The switch/valve 136 may be a solenoid valve and/or other electrically activatable valve (“solenoid valve” herein, for example, valve 1481’ described in reference to Fig. 8D herein). The switch/valve 136 is controlled by an oxygen control board 1602 (which is connected to the main control board 1605) to open and close the flow of oxygen based on a duty cycle determined by the error in oxygen delivery and/or the flow of oxygen into the reservoir as measured by a flow sensor, such as oxygen flow sensor 134, shown. In some embodiments, switch/valve 136 is fluidly attached to a conduit, pressure relief line 1361, that exits housing 110, as shown, such that O2 diverted from conduit 1122 into pressure relief line 1361 by switch/valve 136 is vented outside of the housing (e.g., to prevent O2 buildup inside of housing 110, thus preventing a fire hazard within housing 110). The duty cycle determines the portion of a cycle that the switch/valve 136 opens the oxygen flow into the reservoir 130. This opening of the switch/valve 136 may be initiated at the start of inspiration and may terminate during or after inspiration or at some point during exhalation. In the case of 100% O2, the switch/valve 136 may be powered on continuously during ventilation (e.g., ventilation delivering maximum flow). The main control board 1605 includes a processor with memory storing instructions and data, such as an algorithm and/or a look-up table. The look-up table or calculated algorithm correlates oxygen levels of the gas mixture in the reservoir 130, the delivered minute ventilation measured by the internal flow sensor 144, the user desired FiO2, and the user set O2 flow rate to the switch/valve 136 duty cycle that opens the conduit 1122 to oxygen flow and/or the portion of the duty cycle that the switch/valve 136 closes the conduit 1122. A user inputs a desired oxygen level, such as between 21% to 30% FiO2 or higher levels of FiO2. The processor on the main control board 1605 calculates the duty cycle corresponding to the selected oxygen level such as by using the stored look-up table or by performing a calculation based upon the patient’s minute ventilation as measured by the flow sensor 144 and the oxygen flow sensor 134. The user can be requested to set the external flow meter to a default of 15 to 50 standard liters per minute (SLPM). This setting would allow the duty cycle to account for variations in minute ventilation and keep the desired O2 level constant in situations where the patient’s minute ventilation is varied, for example, as shown in the following equations.

DesiredExternalCLFlowRate = DelMin Ventilation *(%C>2-21)/79 (1)

DutyCycle = DesiredExternalCLFlowRate/ ActualExternalCLFlowRate (2) where: DesiredExternalChFlowRate is the flow rate measured in SLPM that is required to achieve the set %C>2- DelMinVentilation is the minute ventilation measured in SLPM delivered by the blower to the patient circuit. %C>2 is the user set FiO2 in %. DutyCycle is the % time on for the switch/valve 136 to achieve the desired %C>2- Based upon the oxygen flow rate, ventilator 100 can also calculate the maximum FiO2 setting possible and limit the user- available settings to not exceed this maximum oxygen setting (e.g., thus preventing alarms). Alternatively or additionally, the duty cycle can be set based on the reservoir volume and the oxygen error, where the oxygen error is based upon oxygen flow rate into the reservoir and the blower flow rate out of the reservoir.

[0196] The frequency of the duty cycle can be set based upon several parameters such as, for example, the ventilator breath rate, the tidal volume, the minute ventilation and the acceptable %C>2 ripple in delivery. It should be understood that in standard use, there is less O2 ripple for higher solenoid frequencies. However, higher frequencies can lead to solenoid and/or other valve portion wear out and associated increased power consumption. Thus, the valve-activation frequency may be set to a level of at most 2 Hz and/or at least 0.03 Hz. Knowing the selected duty cycle, the main control board 1605 controls the switch/valve 136 to open and close according to the selected duty cycle at the desired frequency. The duty cycle is repeated by the main control board 1605 during the ventilation treatment of patient. The duty cycle may have a cycle time of a few hundred milliseconds to 60 seconds, such as at least 0.4 seconds and/or at most 15 seconds.

[0197] In some embodiments, system 10 can be configured such that the maximum %C>2 that can be set by the user is based on one or more parameters of the patient and/or one or more parameters of ventilator 100. The limitations of the settable %C>2 can be displayed to the user, for example, when the %C>2 is being adjusted by the user. The maximum settable %C>2 can be based on the O2 flow available, the average delivered flow by ventilator 100 (e.g., average flow delivered by main blower 140), or both. In some embodiments, the maximum settable %C>2 is calculated (e.g., calculated by an algorithm of system 10) as follows: MaxO2Limit — ((O2flow / (cF actor * buffer * blow erDelMiriV ent )) * 79 ) + 21

If (MaxO2Limit > 95) {

MaxO2Limit — 95

// The maximum settable %02 is 95%.

} where MaxO2Limit is the maximum settable %C>2. O2flow is the measured O2 flow rate when oxygen is flowing from O2 source 40 to reservoir 130 (e.g., when switch/valve 136 is open). In some embodiments, O2flow is based upon an average of the plateau flow over a time period (e.g., a few milliseconds) after the flow becomes asymptotic. The eFactor can include a correction factor used to fine tune the results of the calculation. The buffer can be set to bias the calculation towards a higher limit (e.g., when the buffer is set to a value less than 1) or towards a lower limit (e.g., when the buffer is set to a value more than 1). The blowerDelMinVent correlates to the volume of air delivered from ventilator 100 to the patient per minute (L/min, referred to herein as “minute ventilation”). In some embodiments, the minute ventilation is determined based on an average calculated over multiple inhalation cycles, for example, seven cycles measured by system 10 when ventilation is started on the patient. In some embodiments, the maximum settable %C>2 can have an upper limit, for example, 95%, as shown.

[0198] In some embodiments, the maximum settable %C>2 is calculated by system 10 to prevent the user from setting a parameter that ventilator 100 would be unable to achieve. For example, the maximum achievable %C>2 can be based on the flow from ventilator 100 into the patient during inhalation, and the flow rate of O2 provided by O2 source 40. In some embodiments, if the minute ventilation changes (e.g., increases), system 10 may be unable to achieve the %C>2 level set by the user. Ventilator 100 can be configured to alarm if the %C>2 delivered to the patient is detected to be below the %C>2 set by the user (e.g., as measured by oxygen sensor 149). Based on the minute ventilation and the O2 flow rate, system 10 can be configured to inform the user if the deficiency in O2 being delivered to the patient may be caused by an unachievable %C>2 setting (based on the current measured parameters of the system).

[0199] Fig. 8B illustrates a graph showing an example of the maximum settable %C>2 relative to the minute ventilation based on a 15L/min O2 Flow rate (O2flow) from O2 source 40. For example, with a minute ventilation of 20L/min, the maximum %C>2 setting is 57%. Fig. 8C illustrates a graph showing another example of maximum settable %C>2 relative to the minute ventilation based on a 50L/min O2 Flow rate (O2flow) from O2 source 40.

[0200] In some embodiments, the volume of O2 to be delivered to reservoir 130 from O2 source 40 is calculated based on flow rate of ventilator 100 (e.g., flow rate of blower 140), the set %C>2, and the %C>2 being delivered to the patient. The flow rate of ventilator 100 can be measured using flow sensor 144, and the %C>2 being delivered to the patient can be measured using oxygen sensor 149. The volume of O2 to be delivered is accumulated in reservoir 130 during exhalation, and the volume of O2 in reservoir 130 is depleted during inhalation. System 10 (e.g., an algorithm of system 10) can be configured to estimate the difference between the desired volume of O2 in reservoir 130 and desired volume O2 to be delivered (e.g., based on the set %C>2). In some embodiments, the algorithm can include a correction factor, eFactor, based on the %C>2 setting (e.g., the desired %C>2 set by the user to be delivered to the patient). For example, a eFactor can be determined by system 10 (e.g., an algorithm of system 10) per the following equations: cF actor = 1.0

If(%O2 —— 75%) // boost the 02 flow if the %O2 — 75%

{ eFactor = 1.1

}

Elseif (%O2 == 80%) // boost the 02 flow if the %O2 = 80%

{ eFactor = 1.15

}

Elseif (%O2 = = 85%) // boost the 02 flow if the %O2 = 85%

{ cF actor = 1.20

}

Elseif (%O2 == 90%) // boost the 02 flow if the %O2 = 90%

{ cF actor = 1.30

}

Elseif (%O2 == 95%) // boost the 02 flow if the %O2 = 95% { cF actor - 1.40

} Elseif (%02 —— 100%) // boost the 02 flow if the %02 — 100% { cF actor — 1.50

}

[0201] At the start of ventilation (e.g., when ventilator 100 is powered on), reservoir 130 can have a level of 21% O2 (e.g., when reservoir 130 is filled with atmospheric air). O2 from O2 source 40 must be mixed with the air in reservoir 130 to correct the volume of O2 in reservoir 130 to the desired level of O2 to be delivered. The difference between the current and desired O2 volume can be calculated as follows:

O2VolError = 2500mL * (%O2-21)/79 where the volume of reservoir 130 is 2500mL. The correction factor can be applied to calculate a first volume error (“old” error) as follows:

O2VolError_oid - cF actor * O2VolError where O2VolError_oid is the previous volume error used by the algorithm to calculate a current volume error (“new” error). The algorithm can be configured to calculate the volume error semi-continuously, for example, at a pre-determined interval (e.g., a 5msec interval). The error in O2 volume in reservoir 130 can be determined based on the previously determined error, O2VolError_oid, plus the volume of O2 required, less the volume of O2 delivered, as follows:

O2VolError_new - O2VolError_oid + (((Qinsp *1000 / 60 / 200) * (%O2-21 )/79) - (QO2 * 1000/60/200))* eFactor)

O2VolError_oid - O2VolError_new where Q02 * 1000/60/200 1.25 mL equals the volume of oxygen delivered in 5msec at

15L/min (e.g., QO2, the rate O2 is delivered from O2 source 40, equals 15 L/min). QO2 can be measured directly by flow sensor 134. Qinsp, the rate air from reservoir 130 is delivered to the patient, can be measured directly by flow sensor 144.

[0202] In some embodiments, if a change is made to the desired %C>2 setting, the algorithm can be configured to adjust the volume of O2 (e.g., adjust up or down) based on the new setting. For example, the algorithm can first estimate the current %C>2 in reservoir 130, as follows: currentperO2Resr — ((O2VolError * 79)/2500) +21 then calculate the effect of the current O2 percentage on the O2 volume error, as follows:

O2VolError_oid - 2500mL * (%O2- currentperO2Resr)/79 and this new calculation of O2VolError_oid can be used to calculate O2VolError_new, as described hereabove. System 10 can use the calculation of the O2 volume error, O2VolError_new, to control the flow of O2 into reservoir 130, for example, by controlling switch/valve 136, which opens and/or closes to allow O2 to flow into reservoir 130. For example, switch/valve 136 can be turned on (e.g., put in an “open” position) when the O2VolError_new is greater than a threshold, for example, a volume greater than 12.5mL of O2. Switch/valve 136 can also be opened for a minimum time period at the start of inspiration, for example, a time period of at least 50msecs.

[0203] In some embodiments, switch/valve 136 can be controlled as follows:

If (exhSolJustOn && O2VolError_new > 12.5 mL II eFactor * O2VolError_new > 100 mL)

{

O2SolOn(TRUE)

}

If (SOLON && O2VolError <1.25)

{ turnO2SolOn( FALSE ) SOLON = FALSE

} where exhSolJustOn, representing the start of inhalation, is true for a period of time (e.g., 5msec) after the end of the exhalation phase (e.g., at the start of inhalation, when switch/valve 182 is turned on to cause exhalation valve 173 to close). Switch/valve 136 can be activated (O2SolOn - True), such that O2 is allowed to flow into reservoir 130, when either inhalation has begun and the volume error is above a first threshold (e.g., above a volume of 12.5mL), or at any time when the volume error is above a second threshold (e.g., a volume of lOOmL). In some embodiments, the second threshold is compared to the volume error multiplied by a correction factor, such as cF actor as shown. Switch/valve 136 can be deactivated (O2SolOn - False), such that the flow of O2 is stopped when the volume error is below a third threshold (e.g., a volume of 1.25mL).

[0204] Ventilator 100 can comprise pressure relief assembly 148. A pressure relief line 1483 of assembly 148 provides a means for discharging gas from the primary blower 140 to atmosphere during the exhalation phase. The pressure relief line 1483 is a passage that branches off of the inspiration conduit 142 and discharges to atmosphere. The pressure relief line 1483 has an inlet connected to the inspiration conduit 142 near the primary blower outlet 141 and an outlet at one of the panels of the housing 110. Alternatively the pressure relief line 1483 may be tied to an exhalation flow passage, exhalation flow passage 1732 (Figs. 9A-B). A pressure relief valve 1481 of assembly 148 in the pressure relief line 1483 allows gas in the inspiration conduit 142 to be discharged to atmosphere (or into the exhalation flow passage 1732). In some embodiments, pressure relief valve 1481 can comprise a pilot-actuated valve (as shown), for example, similar to valve 173 described in reference to Figs. 9A and 9B herein. Alternatively or additionally, pressure relief valve 1481 can comprise a solenoid valve, for example, a 3/2-way valve, such as are described herein.

[0205] During normal operation, the primary blower 140 continues to draw gas from the reservoir 130 while the patient’s respiration is in the exhalation phase. The primary blower 140 need not stop during the exhalation phase and may be kept at a pressure just below PEEP. This has the advantage of preventing unnecessary leakage through the PEEP valve which would increase the 02 losses which are limited in a low flow system. Keeping the primary blower 140 running at a lower speed and hence pressure ensures that a mixture of oxygen and atmospheric air is pumped into the inspiration tube 210 and is ready to quickly flow to the patient at the start of the next inspiration phase. [0206] Providing the pressure relief line 1483 with the pressure relief valve 1481 also has the advantage of allowing the reservoir 130 to be rapidly flushed to obtain the desired oxygen concentration in the air mixture contained within the reservoir 130. Also, the pressure generated by the primary blower 140 provides resistance to the gas being exhaled by the patient, which helps ensure that the patient does not exhale more breath than is desirable and that an adequate amount of air remains in the lungs minimizing atelectasis. Another benefit of continuously operating the primary blower 140 through both the inspiratory and expiratory phases of the patient’s breathing cycle is that the primary blower 140 becomes more efficient and consumes less energy because the primary blower 140 does not need to be repeatedly shut down and restarted.

[0207] The pressure relief valve 1481 may be regulated to control the amount of gas discharged to atmosphere (or into the exhalation conduit 171 at the exhaust 104) from the inspiration conduit 142, which in turn allows for more accurate control of the gas pressure in the inspiration conduit 142. In particular, if the pressure in the inspiration conduit 142 is greater than the desired pressure (e.g., the pressure in the inspiration conduit 142 is interfering with the patient’s exhalation), the pressure relief valve 1481 is adjusted to allow more gas to flow through the pressure relief line 1483. Conversely, if the pressure in the inspiration conduit 142 is less than desired (e.g., the pressure in the inspiration conduit 142 is not enough to prevent the exhalation gas from infiltrating the primary blower 140) the pressure relief valve 1481 is adjusted to restrict the flow of gas through the pressure relief line 1483. Although Fig. 8 shows two locations for the exhalation exhaust 104, the two exhausts 104 can be combined into one exhaust 104 (as is the case when the pressure relief line discharges into the exhalation conduit 171 at the exhaust 104).

[0208] It is contemplated that the pressure relief valve 1481 may be a one-way valve and may be configured to only open when the pressure difference across the pressure relief valve 1481 exceeds a threshold level (e.g., when pressure relief valve 1481 comprises a pilot- actuated valve). Alternatively, the pressure relief valve 1481 may be a continuous flow 3/2- way valve, valve 1481’, such as a 3/2-way valve that includes a pressure sensor (Fig. 8D). As can be seen, the inlet port in the 3/2-way valve may be connected to the inspiration conduit 142, while a first outlet port may be connected to the pressure relief line 1483. The second outlet port may be permanently closed. The 3/2-way valve may be used to cyclically control the oxygen flow (e.g., in the form of a duty cycle) between the reservoir 130 and atmosphere (either directly or by way of the exhalation flow passage 1732). When the gas in the reservoir 130 is directed to atmosphere, the pressure relief valve 1481 limits the gas pressure in the exhalation conduit 171, which can reach as much as 50 psi (or greater) if the exhalation conduit 171 becomes occluded. Thus, the pressure relief valve 1481 can help avoid high pressures that could exceed safety limits while at the same time allowing for the continuous flow of oxygen and atmospheric air.

[0209] It is further contemplated (as shown in Fig. 8A) that the main control board 1605 may control the pressure relief valve 1481 by way of a solenoid valve 1482 of assembly 148. In particular, the main control board 1605 may output signals to the solenoid valve 1482 based on input from the flow sensor 144, the pressure sensor 146, and/or the pressure sensor 172 to regulate the pressure relief valve 1481 and control the flow of gas through the pressure relief line 1483. In some embodiments, solenoid valve 1482 can be of similar construction and arrangement to valve 1481’ described in reference to Fig. 8D herein.

[0210] The pressure relief line 1483 and the pressure relief valve 1481 may also provide a second flow path for exhaled gas when there is a blockage in the exhalation tube 220 or exhalation conduit 171 (e.g., debris or a kink in the tubing) to prevent a buildup of exhaled gases in the ventilator 100. A blockage in the exhalation tube 220 or exhalation conduit 171 will result in a significant pressure difference between the inspiration tube 210 (and/or the inspiration conduit 142) and the exhalation tube 220 (and/or the exhalation conduit 171).

[0211] The pressure relief valve 1481 is configured to open in response to a substantial pressure difference between at least part of the inhalation passage and at least part of the exhalation passage (the inhalation passage comprising at least the inspiration conduit 142 and the inspiration tube 210 and the exhalation passage comprising at least the exhalation conduit 171 and the exhalation tube 220). The pressure difference sufficient to open the pressure relief valve 1481 may be in a range of 3 to 5 crnFfcO or 4 to 5 crnFfcO. This pressure is slightly below the pressure generated by the secondary blower 181 and is used to control the exhalation valve 173 during the exhalation phase.

[0212] The main control board 1605 may be configured, for example, programmed, to operate the primary blower 140 in a “blower back up” mode in the event of a failure of one or more of the flow and/or pressure sensors. During normal operation, these sensors generate signals processed by the main control board 1605 to determine the pressure of gases being pumped into the exhalation passage by the primary blower 140. The main control board 1605 may be configured to detect a sensor failure (e.g., failure of one or more sensors, such as those described herein) and respond to the sensor failure by operating the primary blower 140 at predefined rotational speeds (RPM) that correspond to the desired inspiratory and expiratory pressure levels. The processor and memory in the main control board 1605 execute stored instructions that cause the main control board 1605 to detect a sensor failure and respond to such a failure by operating the primary blower 140 in a “blower backup” mode. While in the “blower backup” mode, the main control board 1605 may determine a desired pressure of the gas to be pumped by the primary blower 140 based on, for example, a look-up table stored in memory or the existing user setting at a designated breath rate. The look-up table correlates pressure for inhalation to a rotational speed for the primary blower 140. The desired pressure for inhalation gases may be input by a user or selected by the main control board 1605 based on inputs such as height and predicted body weight of the patient. Knowing the desired inhalation gas pressure the main control board 1605 uses the look-up table to select a primary blower speed corresponding to the desired pressure. The main control board 1605 then operates the primary blower 140 at the selected blower speed to achieve the desired inhalation gas pressure. While the “blower backup” mode does not have the benefit of feedback from sensors, this mode will provide inhalation gas at a pressure that is at or reasonably close to the desired inhalation gas pressure. It is also a better response than simply ceasing ventilation. During such an episode a high priority alarm could be annunciated bringing the user’s attention to the issue and allowing them time to resolve the issue. During such occurrences in the ICU (intensive care unit), clinicians often resort to a manual resuscitation bag which is essentially the equivalent of the proposed design with the added advantage that there is no delay in the response and that the patient is still ventilated. It is contemplated that the oxygen control board 1602, the power management board 1603, the motor control board 1604, and the main control board 1605 may all be different regions of the same control board, may be two or more separate components, and/or may be located in the same region of the ventilator.

[0213] In some embodiments, ventilator 100 includes one or more oxygen sensors, such as an external oxygen sensor (not shown) and/or an internal (e.g., an internally mounted) oxygen sensor, oxygen sensor 149 as shown. Oxygen sensor 149 can generate data indicative of an oxygen level in the inspiration gas. An oxygen monitor of controller 160 may be configured to analyze the data from the oxygen sensor 149 to determine the oxygen level, for example, the FiO2 level, of the inspiration gas. The oxygen monitor can be configured to output information regarding the oxygen level to a display (e.g., of the user interface 150 described herein) that is read by a health care professional. The oxygen level information can also be used by the controller 160 to adjust a flow of oxygen into the reservoir 130, such as by turning on or off the flow of oxygen, or by regulating the flow of oxygen. Oxygen sensor 149 can comprise an ultrasound-based oxygen sensor. Oxygen sensor 149 can comprise a sensor that does not require calibration (e.g., an ultrasound-based sensor that does not require calibration). Oxygen sensor 149 can comprise a sensor with an extended useful life (e.g., shelf life), such as an extended useful life of at least 1 year, 2 years, and/or 5 years. These oxygen sensors may be mounted internal to the chassis, such as to reduce electrostatic discharge (ESD) issues, and/or at the outlet of the primary blower 140 on the inspiration conduit 142. In some embodiments, oxygen sensor 149 comprises one, two, or more ultrasound-based sensors, and a microprocessor can be included to calculate the time of flight measurements in the gas medium (e.g., to be used to calculate the percentage oxygen). In these embodiments, the interface may be digital, thus eliminating noise issues that are associated with conducting analog signals used with chemical based oxygen sensors.

[0214] In some embodiments, ventilator 100 includes one, two or more components configured to control flow of oxygen, such as switch/valve 136 (e.g., a solenoid valve) and/or an oxygen flow sensor 134.

[0215] Ventilator 100 can include an internal power supply (e.g., a battery), that can be configured to function as an emergency power supply and/or a backup power supply (e.g., in the condition of a power failure). The internal power supply can comprise a capacity to provide at least 30 minutes, or at least 120 minutes of use of ventilator 100 using the internal power supply. The internal power supply can be charged by an internal charging component and/or an external charging component.

[0216] In some embodiments, ventilator 100 is configured to perform and/or provide: PS, PC, VC Square and/or Ramp Wave modes of operation; PC-SIMV, VC-SIMV modes of operation; Flow Trigger Sensitivity : FiO2 control; leak compensation; plateau mode; HME and Heated Humidification; a test of the HME circuit and HH circuit; Bluetooth communication with a separate component of system 10 (e.g., as described herein via transceiver 166); VC HP; VC; LP; loss of AC power detection; low internal battery detection and/or alarm; battery not charging detection and/or alarm; FiO2 accuracy detection and/or alarm (e.g., high detection and/or low detection); and/or 02 flow sensor alarm. The ventilator can be configured to deliver invasive or non-invasive breath types.

[0217] In some embodiments, while ventilator 100 is operating in a pressure control (PC) ventilation mode, system 10 can be configured to allow a user to set one or more (e.g., all) of the following parameters: inspiratory pressure target (Pi); inspiratory time (Ti); and/or breath rate (f). In some embodiments, when ventilator 100 is operating in a volume control (VC) ventilation mode, system 10 can be configured to allow a user to set one or more of: tidal volume (VT); inspiratory time (Ti); plateau period (TPL); and/or breath rate (f). In some embodiments, when ventilator 100 is operating in a pressure support (PS) ventilation mode, system 10 can be configured to allow a user to set one or more of: pressure support target (PSUPP) and/or exhalation sensitivity (ESENS). In some embodiments, when operating in a PC- SIMV mode (combined PC and PS modes), system 10 can be configured to allow a user to set one or more of: inspiratory pressure target (Pi); inspiratory time (Ti); breath rate (f); pressure support target (PSUPP); and/or exhalation sensitivity (ESENS). In some embodiments, when operating in a VC-SIMV mode (combined VC and PS modes), system 10 can be configured to allow a user to set one or more of: tidal volume (VT); inspiratory time (Ti); plateau period (TPL); breath rate (f); pressure support target (PSUPP); and/or exhalation sensitivity (ESENS).

[0218] In some embodiments, system 10 is configured to allow a user to set one, two, or more of (e.g., all or at least a majority of): trigger sensitivity (A/C); 02%; PEEP; and/or an alarm limit, such as VC HP limit; VC LP limit; relative HP; relative LP; disconnect limit; low %O2; high %O2; high exhaled tidal volume threshold; low exhaled tidal volume threshold; apnea limit; high respiratory rate limit; high PEEP; and/or low PEEP.

[0219] In some embodiments, system 10 is configured to allow a user, via menu options provided by user interface 150, to perform a task selected from the group consisting of: perform a self-diagnostic test (e.g., while in standby mode); produce (e.g., in a viewable fashion) an event log; produce an alert log (e.g., of active and/or inactive alerts); enter an apnea backup ventilation mode; select HME/HH; select invasive/NIV; view and or adjust leakage compensation; enable and/or disable an O2 sensor; view and/or modify time and/or date; produce system information; produce SST results; pause an alarm; reset an alarm; adjust audio volume; and/or increase FiCh (e.g., a 2 minute increase in FiCh).

[0220] Figs. 9A-B show the exhalation valve 173 in schematic diagrams that show a side view of a cross section of the valve. The exhalation valve 173 may have a housing 1731 including an exhalation flow passage 1732 that is coupled to and in fluid communication with the exhalation conduit 171. An inlet of the exhalation flow passage 1732, inlet 1733 shown, is connected to the exhalation conduit 171 to receive exhalation air (Q_exh), and an outlet, outlet 1734 shown, is coupled to the exhalation conduit 171 to discharge exhalation air into the exhalation conduit 171.

[0221] Within the housing 1731 is a valve portion 174 that, when closed (fig. 9A), blocks air flow through the exhalation flow passage 1732 and, when open (fig. 9B), allows air to pass through the exhalation flow passage 1732. The valve portion 174 may include a first wall (or annular wall) 1741, for example, an annular disc, and a second wall 1742, for example, a circular disc. The second wall 1742 is downstream of the first wall 1741. Between the walls 1741, 1742 is an opening 1743 in a sidewall 1744 of the exhalation flow passage 1732. The opening 1743 is selectively opened and closed by a selecting element: for example, the opening 1743 in Figs. 9A-B is covered by a diaphragm and/or selecting element, diaphragm 1745 shown, which may be a circular disc or strip of a deformable material. The diaphragm 1745 is between the opening 1743 and a chamber 1746 (e.g., a pilot pressure chamber) within a side housing 1747 of the housing 1731 of the exhalation valve 173. As shown in Fig. 9A, when the diaphragm 1745 seats on the opening 1743, the diaphragm 1745 closes the valve portion 174 and blocks airflow through the exhalation flow passage 1732. When the diaphragm 1745 bows away from the opening 1743, the valve portion 174 opens and air (Qexh) flows through an opening 1748 in the first wall 1741, the gap between the walls 1741, 1742, between the diaphragm 1745 and a top edge of the second wall 1742 and through the exhalation flow passage 1732 to the outlet 1734 of the exhalation valve 173.

[0222] The diaphragm 1745 moves between a sealing position (fig. 9A) which closes the opening 1743 and a bowed position (fig. 9B) which opens a gap between the opening 1743 and the diaphragm 1745. The diaphragm 1745 moves between the sealing position and the bowed position based on a gas pressure difference between the exhalation flow passage 1732 and the chamber 1746. Chamber 1746 has an inlet 1749 that is in fluid communication with a tube 175 which extends between the inlet 1749 and the switch/valve 182. The switch/valve 182 may be a solenoid valve (e.g., similar to valve 1481’ described in reference to Fig. 8D herein) that pressurizes the air in tube 175 and the chamber 1746 with outlet air from the primary blower 140 or outlet air from the secondary blower 181. As the diaphragm 1745 is hermetically coupled to side housing 1747, the diaphragm 1745 hermetically separates the air chamber 1746 from the exhalation flow passage 1732, such that pressure in the chamber 1746 may be controlled to adjust the pressure in the chamber 1746 that provides a force biasing the diaphragm 1745 against the pressure in the valve portion 174 which is substantially the pressure of the exhalation gas flowing through the exhalation valve 173.

[0223] The diaphragm 1745 has a first surface exposed to the chamber 1746 and a second surface, opposite to the first, exposed to the opening 1743 and the exhalation flow passage 1732. The gas force Fl acting on the first surface of the diaphragm 1745 is the pressure in the chamber 1746 times the area of the first area. Similarly, the gas force F2 acting on the second surface of the diaphragm 1745 is the pressure in the exhalation flow passage 1732 times the area of the opening 1743. The diaphragm 1745 is in the closed position when the force Fl is greater than F2 and in the bowed, open position when force F2 is greater than Fl. The area of the first surface may be greater than the area of the second surface such as by a factor of two (2).

[0224] Having the area of the first surface greater than the area of the second surface allows relatively low pressure air flow from the primary blower 140 and the secondary blower 181 to be used to control the position of the diaphragm 1745 and thereby open and close the exhalation valve 173. The primary blower 140 and the secondary blower 181 close the exhalation valve 173 by generating a pressure which when multiplied by the ratio of the first and second areas of the diaphragm 1745 is greater than the exhalation gas pressure in the exhalation flow passage 1732.

[0225] The exhalation valve 173 may be mounted within the housing of the ventilator 100. Alternatively, the exhalation valve 173 may be integrated in the tubing assembly 200 or be a separate component that is releasably attached to the housing 110, such as at the exhalation exhaust 104.

[0226] The exhalation valve 173 may be shielded from viruses and bacteria in an exhaled breath. In particular, the exhaust gas passing through the exhalation valve 173 can be cleaned by filter 225. The exhalation valve 173 is not contaminated by viruses or bacteria exhaled by the patient. Similarly, other components within the housing 110 of the ventilator 100 exposed to inspiration or exhalation gases are shielded from bacteria and viruses due to these filters. In particular, the inhalation assembly 120 and inspiration conduit 142 are protected by the filter 1321 at the inlet port 112, and the exhalation conduit 171 is protected by the filter 225.

[0227] Fig. 10 is a flow chart showing the control of the exhalation valve 173. The exhalation valve 173 is closed while the ventilator 100 pumps a mixture of atmospheric air and oxygen to the patient (the inspiration phase) and at the end of the exhalation phase when the pressure of the air exhaled by the patient falls below the PEEP expiratory pressure. The opening and closing of the exhalation valve 173 are controlled by the pressure, for example, the pilot pressure, in the chamber 1746 of the valve.

[0228] During inspiration (STEP 202), the pilot pressure in the chamber 1746 equals the inspiration pressure. The inspiration pressure is the pressure at the outlet of the primary blower 140 while the primary blower 140 is operating to pump inspiration gases into the inspiration tube 210, through the Y-junction 231 and to the patient via the connection tube 232. Because the passages in the Y-junction 231 and the connection tube 232 may contain gas at a pressure at or near, for example, within 95%, the inspiration pressure, the pressure in the exhalation tube 220 and in the exhalation flow passage 1732 in the exhalation valve 173 are also at the inspiration pressure. Thus, pressure in the exhalation flow passage 1732 and the chamber 1746 are at substantially the same inspiration pressure. Due to the greater area of the first surface of the side of the diaphragm 1745 exposed to the chamber 1746 than the second surface of the side of the diaphragm 1745 exposed to the exhalation flow passage 1732, the diaphragm 1745 is forced against the opening 1743 and closes the exhalation valve 173 during the inspiration phase. Closing the exhalation valve 173 during inspiration prevents inspiration gases from leaking out the exhalation tube 220 and assists in forcing the inspiration gases into the patient.

[0229] In STEP 204, the controller 160, for example, main control board 1605, determines that an inspiration phase is completed and a new exhalation phase is to start. The controller 160 switches between inspiration and exhalation phases based on control algorithms that may include regular cyclical inspiration and exhalation periods, based on the detection by the flow sensor 241 of a patient-initiated inhalation or exhalation of a breath, or based on other parameters for determining when to initiate inspiration and exhalation.

[0230] When the controller 160 determines that an exhalation phase is to be initiated, the rotational speed of the impeller in the primary blower 140 is slowed (STEP 206). The impeller of the primary blower 140 is slowed to reduce the loss of oxygen from the inhalation assembly 120 during an exhalation phase. Oxygen continuously flows into the reservoir 130 from the source of oxygen (O2) via ports 135, 132. Slowing the impeller in the primary blower 140 reduces the pressure drop in the reservoir 130 due to the suction of the primary blower 140 which slows the rate of oxygen into the reservoir 130 and the rate of atmospheric air entering through inlet port 112 and passing through filter 1321. The primary blower 140 need not stop during the exhalation phase and may be kept at a pressure just below PEEP. This continued operation of the primary blower 140 has the advantage of preventing unnecessary leakage through the PEEP valve which would increase the 02 losses which are limited in a low flow system. Keeping the primary blower 140 running at a lower speed and corresponding lower pressure ensures that a mixture of oxygen and atmospheric air is pumped into the inspiration tube 210 and is ready to quickly flow to the patient at the start of the next inspiration phase.

[0231] When the controller 160 determines that an exhalation phase is to be initiated (STEP 208), the controller 160 actuates the switch/valve 182 to direct the output of the secondary blower 181 to the tube 175 and the inlet 1749 of the chamber 1746 of the exhalation valve 173. The switch/valve 182 also closes the tube 175 from the primary blower 140 when pressure is being provided by the secondary blower 181 to the chamber 1746. During exhalation, the pilot pressure is set to the desired PEEP pilot pressure divided by the area ratio of the diaphragm 1745 to ensure that the expiratory pressure in the exhalation conduit 171 and exhalation tube 220 remains above PEEP. Thus, the patient’s exhalation pressure has to exceed the desired PEEP pilot pressure for the exhalation conduit 171 to remain open. The area ratio of the diaphragm 1745 is the ratio of the first surface area of the diaphragm 1745 exposed to chamber 1746 and the second surface area exposed to the opening 1743 to the exhalation conduit 171. Maintaining the pressure in the exhalation conduit 171 and exhalation tube 220 at PEEP pressure ensures that the patient does not exhale more breath than is desirable and that an adequate amount of air remains in the lungs minimizing atelectasis.

[0232] The secondary blower 181 pressurizes the chamber 1746 of the exhalation valve 173 during the entirety of the exhalation phase. During exhalation, the patient exhales at a pressure above the desired PEEP pressure such that the exhaled air flows from the patient through the exhalation tube 220, the exhalation conduit 171, the exhalation valve 173, the exhalation exhaust 104 and out to atmosphere.

[0233] In STEP 210, the end of exhalation may be detected by the patient initiating a new inhaled breath, such as by the flow sensor 241 detecting air flowing into the patient rather than out. Alternatively, data from the pressure sensor 172 in the exhalation conduit 171 may be analyzed by the controller 160 to determine the end of exhalation, such as by detecting an exhalation air pressure at or below PEEP. The end of exhalation may also be determined by the end of a certain exhalation period.

[0234] The controller 160 determines the end of exhalation and beginning of inspiration. Exhalation and inspiration may be the two operating phases of the ventilator 100. Thus, the end of exhalation is the beginning of inspiration and vice versa. The use of a plateau pressure extends the inspiratory phase without gas delivery.

[0235] In STEP 212, the impeller speed of the primary blower 140 is accelerated to cause the primary blower 140 to output a mixture of atmospheric air and oxygen at a desired inspiration air pressure. This mixture is pumped through the inspiration conduit 142, inspiration tube 210 and to the patient. The controller 160 controls the motor speed and accelerates the primary blower 140 to a speed to produce the desired inspiration pressure and/or air flow.

[0236] In response to the detection of the end of exhalation (STEP 210), the controller 160 restarts the steps shown in Fig. 10 and at the commencement of an inspiration phase, actuates the switch/valve 182 to switch the gas pressure from PEEP pressure produced by the secondary blower 181 to the inspiration pressure produced by the primary blower 140, in STEP 202. The pressure flows from the primary blower 140, through the switch/valve 182, through the tube 175 and to the chamber 1746 of the exhalation valve 173. Pressurizing the chamber 1746 to the inspiration pressure closes the exhalation valve 173 and prevents airflow through the exhalation tube 220 during the inspiration phase.

[0237] The ventilator 100 may be configured as an inexpensive ventilator that can be quickly brought online after being in storage for years. The ventilator 100 may be used when there is a surge of patients needing ventilation, such as during a pandemic or other epidemic (e.g., the COVID-19 pandemic). The ventilator 100 may be used to ventilate patients who have less severe conditions, which tend to be a majority of patients during surge conditions. To keep the cost low and to provide for long term storage, the ventilator 100 may be designed to provide patients with basic ventilation and not have the ability to provide sophisticated ventilation functions required of some patients in an intensive care unit (ICU). Thus, the ventilator 100 may be used to free-up beds in an ICU by treating patients who need to be ventilated but do not require an ICU bed. The ventilator 100 may have a single, basic mode of mandatory ventilator support which assists to facilitate ease of use and reduction on the burden of highly specialized personnel to operate or can include multiple modes (e.g., mandatory, assist and spontaneous modes) of ventilation. The ventilator 100 is electro- mechanically and pneumatically operated, providing mechanical ventilation using: two blowers 140, 181 to generate air pressure and air flow, wherein the primary blower 140 pumps inspiration gases at a pressure determined by the controller and the secondary blower 181 pumps a pilot pressure to the exhalation valve 173 which closes if the exhalation gas pressure falls below PEEP pressure.

[0238] The switch/valve 182 switches the pilot pressure applied to the chamber 1746 of the exhalation valve 173 between the inspiration pressure from the primary blower 140 and the secondary blower 181 pressure. The pilot pressures are applied to the exhalation valve 173 to hold the exhalation valve 173 closed during inspiration and keep the exhalation valve 173 open during exhalation as long as the exhalation pressure remains above PEEP pressure.

[0239] The ventilator 100 may be configured, such as with executable algorithms stored in the controller, to operate in different ventilation modes. The modes are selected by the user, for example, a health care professional operating the ventilator 100. The modes may include: Pressure Control Ventilation (PCV) mode for which a health care professional may, via the user interface, set: Inspiratory Pressure Target (PI); Inspiratory Time (Tl) and/or Breath Rate (f); Pressure Support Ventilation (PSV) mode the health care professional may set: Pressure Support Target (PSUPP) and/or Exhalation Sensitivity (ESENS); SIMV mode which is a hybrid of PCV and PSV mode in which the user may set: Inspiratory Pressure Target (Pl); and Inspiratory Time (Tl); Breath Rate (f); Pressure Support Target (PSUPP) and Exhalation Sensitivity (E_SENS).

[0240] In addition to the modes of ventilation, the various common settings of the ventilator 100 may be set by the user. These Common Settings may include: Trigger Sensitivity (Lpm or unitless); desired oxygen percent in inspiration gas (02%); PEEP pressure level; alarm settings; Low Exhaled Tidal Volume; High Respiratory Rate (HRR); Disconnect Limit; Low Inspiratory Pressure Limit; High Pressure Limit and Apnea Limit. These user settable features provide functionality to the ventilator to provide life supporting ventilation to a patient.

[0241] As shown in the flow chart of Fig. 11, the flow sensor 241 and the pressure sensor 146 near the primary blower outlet 141 measures pressure and/or flow volume of the gas mixture discharged by the primary blower 140. In STEP 302, the controller 160 uses the measured pressure and/or flow as feedback to adjust the impeller speed of the primary blower 140 to achieve desired inspiration gas pressure and/or flow volume levels. In STEP 304, the flow sensor 241 near the patient interface measures the flow direction and/or flow volume being inhaled and exhaled by the patient. In STEP 306, the controller 160 uses the sensing of flow direction and/or flow measurement from the flow sensor 241 to detect the patient initiating an inhale or exhale of a breath. In STEP 308, the controller 160 initiates an inspiration phase of the ventilator 100 in response to the patient inhaling and initiates an exhalation phase in response to the patient exhaling.

[0242] The controller 160 may adjust the volume or rate of the gas mixture being pumped by the primary blower 140 to account for gas leakage between the primary blower 140 and the patient. In STEP 310, the controller 160 determines a difference between the flow rate measured by flow sensor 144 at the primary blower outlet 141 and the flow rate measured by flow sensor 241 near the patient. The difference in flow rates is indicative of leakage of the gas mixture. In STEP 312, the controller 160 adjusts the speed of the impeller of the primary blower 140 or the timing of the inspiration phase to compensate for the difference in the flow rates and thus the gas leakage.

[0243] Fig. 12 is a flow chart showing a failsafe operation to reset the flow sensors 241, 144. This method can be used for any CMOS interface which facilitates the status determination of a CMOS device. The first and second flow sensors 241, 144 may be subject to a failure mode in which they latchup. Latching is a concern for any devices based on CMOS technology. A latchup of the flow sensor(s) may occur due to a ground bounce during an electrostatic discharge (ESD), such as a nearby lightning strike, or due to electromagnetic interference (EMI) due to a nearby, high-powered medical device. In STEP 402, the controller 160 detects a latchup condition or other signal loss in either or both of the flow sensors 241, 144. The detection may be the controller 160 sensing a loss of communication signals from one or both of the flow sensors 241, 144. In STEP 404, the controller 160 responds to a detected latchup by turning off power to either or both the flow sensors 241, 144. In STEP 406, the controller 160 applies power to either or both of the flow sensors 241, 144 after a certain delay such as a delay of five to ten seconds. In STEP 408, the flow sensors 241, 144 reboot in response to the resumption of power. The rebooting allows the flow sensors 241, 144 to resume communication with the controller 160 by eliminating the latchup.

[0244] Referring now to Figs. 13A-B, perspective views of a stand for a ventilator in compacted and expanded configurations, respectively, are illustrated, consistent with the present inventive concepts. Stand 900 can be configured to support ventilator 100 and/or one or more other components of system 10 during use of ventilator 100. Stand 900 can be configured to be collapsed and/or otherwise compacted in a first configuration, and to expand into a second configuration (e.g., a functional configuration) in which stand 900 can support ventilator 100 and/or other components of system 10 at a convenient height for use (e.g., at a patient’s bedside). In some embodiments, stand 900 is configured to transition into one of a set of multiple heights, such as to position ventilator 100 at various height positions for use. In some embodiments, stand 900 comprises a telescoping configuration as shown. Alternatively or additionally, one or more components of stand 900 can be configured to: unfold to expand stand 900; inflate to expand stand 900; magnetically engage to expand stand 900; pivot to expand stand 900; rotate to expand stand 900; unfurl to expand stand 900; and combinations of these. Stand 900 can be configured to expand (e.g., by a user) without the use of tools. In some embodiments, ventilator 100 comprises stand 900 (e.g., stand 900 is integral to a housing of ventilator 100), such as when ventilator 100 comprises a set of foldable legs, such that ventilator 100 can be self-supported at a convenient height. In some embodiments, a stand 900 integral to ventilator 100 can comprise a relatively flat bottom surface (e.g., the bottom surface of ventilator 100 comprises a stable surface when stand 900 is in the compacted configuration), such that ventilator 100 can be placed on a separate stand (e.g., a bedside stand in a hospital setting) without removing stand 900.

[0245] As shown in Figs. 13A and 13B, stand 900 can comprise two, three, or more telescopic sections, sections 901 (four shown). The uppermost section, section 901T can comprise a surface 902, configured to support ventilator 100 when positioned on surface 902. Fig. 13A shows stand 900 in a compacted configuration, where at least a portion of each section 901 is positioned within the neighboring section. Fig. 13B shows stand 900 in an expanded, functional configuration, with each section 901 extending from the next.

[0246] Referring now to Fig. 14, a user view of a user interface of a ventilator system is illustrated, consistent with the present inventive concepts. The user interface of Fig. 14 can represent a user interface 150 of a ventilator 100, as shown, or any user interface of system 10. User interface 150 can comprise a membrane keypad, a screen (e.g., an LCD screen, a touch screen, and the like), and/or one or more other user input and/or user output components.

[0247] User interface 150 can comprise an indicator (e.g., an indicator light) that indicates whether ventilator 100 is in a non-invasive ventilation mode, NIV indicator 1522 shown.

[0248] User interface 150 can comprise one, two, or more indicators (e.g., an indicator light, bar graph, and/or other indicator) that indicates a power condition, such as power indicator 1523 which indicates whether or not ventilator 100 is attached to AC power, and battery indicator 1524 which indicates the level of an internal power supply (e.g., a battery ) of ventilator 100.

[0249] User interface 150 can comprise a user input control (e.g., a button such as a membrane keypad button), volume button 1512 which can be configured to cause ventilator 100 to: display current status of an alert volume; enter a state in which the current alert volume can be changed (e.g., via the up and down arrow buttons shown); and/or change the current alert volume (e.g., by repetitively pressing volume button 1512).

[0250] User interface 150 can comprise a user input control (e.g., a button such as a membrane keypad button), Enriched O2 button 1513 which can be configured to, when pressed, cause ventilator 100 to enter (or exit if already in) an Enriched O2 mode of operation, if possible under current operational conditions of ventilator 100. If entering an Enriched O2 mode is not possible at the time of pressing of button 1513 (e.g., due to minute ventilation and/or O2 flow available), ventilator 100 can be configured to alert the user of that status. Enriched O2 button 1513 can include an indicator light, as shown, which can be configured to indicate (e.g., when lit) that ventilator 100 is in an increased FiCL mode (e.g., for two minutes or other determined time period).

[0251] User interface 150 can include a display, screen 1525 shown, which can comprise an LCD, touch screen, and/or other display configured to provide alphanumeric information and/or graphics to a user. Screen 1525 can be configured to provide ventilator 100 use information, alert condition information, and/or other system 10 information.

[0252] User interface 150 can include a menu request button, menu control 1526 shown. Menu control 1526 can include an indicator light (e.g., an LED), as shown, which can indicate (e.g., by providing a blinking light, a yellow or other colored light, and the like) to a user that attention from the user should be provided (e.g., when an alert condition is encountered and/or has been cleared, use information should be viewed, a battery is missing, and/or other information is available for user review).

[0253] User interface 150 can include various other buttons, indicators (e.g., indicator lights) and other user input and user output components as shown in Fig. 14. For example, user interface 150 can display when PC, PS, VC, PSUPP, T;/TPL, ESENS, and/or other modes of operation are active, such as with the use of LEDs and/or text on the screen.

[0254] When non-invasive ventilation (NIV) is enabled, NIV LED 1522 is lit (e.g., turned on to produce an indicator light). When power (e.g., AC power) is provided to ventilator 100 and an internal power supply is in proper operation, LED of power indicator 1523 is lit. The LED of power indicator 1523 can be configured to be in different states (e.g., produce different color lights) when AC power is attached versus not attached (e.g., yellow light is shown when disconnected). When the LED of battery indicator 1524 is lit, an internal battery is connected and in proper operation. Blinking of the LED of battery indicator 1524 can be used to indicate the charge level of the internal battery (e.g., as it is charging and/or discharging). Volume button 1512 can be configured to allow a user to mute a current audible alarm (e.g., by pressing of button 1512). Activation of volume button 1512, and/or any other control of ventilator 100, can be configured to provide an indication that a clinician is present when an alarm is annunciated (e.g., to cause system 10 to reduce alarm volume, stop an increase in alarm volume, and/or otherwise change states, such as is described herein).

[0255] Referring now to Fig. 15, a perspective view of a ventilator is illustrated, consistent with the present inventive concepts. Ventilator 100 can be of similar construction and arrangement to ventilator 100 described in reference to Fig. 1 and otherwise herein. In some embodiments, exhalation valve 173 is positioned outside of housing 110 as shown (e.g., such as to provide physical user access to the valve, such as to replace and/or perform maintenance on the valve, such as to avoid the need for tools to repair, maintain, and/or replace valve 173). The exhalation manifold 176 may be removed using spring latches 1761 (e.g., using one hand) and can be disposed of and replaced if manifold 176 becomes contaminated. The exhalation manifold 176 connects to PEEP Pilot pressure (e.g., provided by secondary blower 181 via switch/valve 182 to exhalation manifold 176), the exhalation pressure sensor 172 (not shown), the exhalation filter 225 (not shown) and the exhalation valve 173, and acts as a conduit for exhaled gas through the exhalation filter 225, exhalation manifold 176 and exhalation valve 173. The PEEP pilot pressure (provided by secondary blower 181) is connected to the exhalation valve 173 using a flexible tube 175 which transfers the PEEP pilot pressure to the inlet 1749 of the exhalation valve 173. The PEEP pilot pressure and exhalation pressure sensor connection are the only connections to the internal parts of ventilator 100, and these are achieved using a floating pressure connection eliminating alignment issues. The exhalation manifold 176 uses a flat at the bottom to make it obvious to the user how the component should be inserted and is only capable of being inserted correctly with the latches making a clicking sound if the manifold is inserted in the correct orientation.

[0256] Referring now to Fig. 16, a sectional perspective view of an inspiration valve is illustrated, consistent with the present inventive concepts. Valve 143 of Fig. 16 can be similar to valve 143 described in reference to Figs. 8 and 8A and otherwise herein. Valve 143 can comprise a one-way valve, which can be configured to allow flow of air from a blower (e.g., primary blower 140 not shown but described herein) to a patient (e.g., one-way flow of air via inspiration conduit 142). In some embodiments, valve 143 comprises a housing, housing 1431, which can comprise a two-part design that includes housing portion 1431a which is used to mount the oxygen sensor 149 of Fig. 17A on the inspiratory limb and housing portion 1431b, each as shown. In some embodiments, housing 1431 comprises a clamshell design. Valve 143 can include a sealing element, O-ring 1432 shown, that creates a seal between (e.g., creates an airtight seal between) housing portion 1431a and housing portion 1431b. In some embodiments, valve 143 includes one or more ports in addition to the inflow and outflow ports, such as a port configured to fluidly attach to a sensor (such as oxygen sensor 149), port 1433a, and/or a pressure port configured to attach to a tube, port 1433b, each as shown. The valve assembly diameter can be increased to accommodate a larger one-way valve, such as to minimize the pressure drop across the valve and the potential for pressure fluctuations due to low and high flows, and to maximize the lowering of the pressure drop. Valve 143 can include one or more flow restrictors, diaphragm 1435 shown. Diaphragm 1435 can comprise a resiliently biased flexible material that when in a biased configuration (as shown), seals against a surface of housing portion 1431b preventing reverse air flow (e.g., air flow from the patient to blower 140). Diaphragm 1435 can be configured to flex (e.g., transition) to an open position (e.g., to deflect into an open chamber of housing portion 1431a), removing the seal created with the surface of housing portion 1431b, and allowing the flow of air from blower 140 to the patient. In some embodiments, the force of air provided by blower 140 causes the deflection of diaphragm 1435 that allows air flow.

[0257] Referring now to Figs. 17A and 17B, partial perspective views of components on the inspiratory limb at the output of the blower of a ventilator are illustrated, consistent with the present inventive concepts. Ventilator 100 of Figs. 17A-B can be of similar construction and arrangement to ventilator 100 described in reference to Fig. 1 and otherwise herein. Fig. 17A shows oxygen sensor 149 operably attached to valve 143. Valve 143 is supported by a bracket, bracket 1434. Fig. 17B shows a second bracket, bracket 1421, supporting flow sensor 144 before the inspiratory limb exits the chassis of the ventilator as the TO PATIENT PORT (inspiration port 102) of the ventilator.

[0258] Referring now to Fig. 18, a top view of a ventilator operably attached to a manifold of multiple filters is illustrated, consistent with the present inventive concepts. Ventilator 100 of Fig. 18 can be of similar construction and arrangement to ventilator 100 described in reference to Fig. 1 and otherwise herein. System 10 can include a manifold 61, configured to attach to inlet port 112 and to a filter 60 comprising two or more filters (6 filters 60a-f shown), such that the filters are attached in parallel to inlet port 112. In these embodiments, the overall air resistance caused by the one, two, or more filters of filter 60 attached to ventilator 100 is decreased by a factor of the number of parallel filters of filter 60, for example, filters 60a-f provide one-sixth the resistance of that of a single filter 60. In some embodiments, filter 60 comprises at least one CBRN filter, such as a CBRN 40mm NATO filter. The pressure drop across a CBRN 40mm NATO filter is approximately 6mBar. As such, the pressure drop to ventilator 100 attached to a filter 60 comprising six CBRN filters in parallel would be approximately Imbar. [0259] Referring now to Fig. 19, a partial cut away, side view of a ventilator attached to a secondary blower assembly and a filter is illustrated, consistent with the present inventive concepts. Ventilator 100 of Fig. 19 can be of similar construction and arrangement to ventilator 100 described in reference to Fig. 1 and otherwise herein. System 10 can include auxiliary blower assembly 70. Auxiliary blower assembly 70 can include one or more blowers, blower 71 shown, and one or more flow sensors and/or pressure sensors, sensor 72 shown. Auxiliary blower assembly 70 includes an inlet port 73 and an outlet port 74, where port 73 is configured to attach to one or more filters 60 and outlet port 74 is configured to attach to inlet 112 of ventilator 100, respectively. Auxiliary blower assembly 70 can be configured to draw atmospheric air through filter 60, such as to provide atmospheric air to ventilator 100 with little to no resistance (e.g., to eliminate or at least reduce air resistance caused by filter 60). In some embodiments, flow and/or pressure information from sensor 72 is analyzed (e.g., analyzed by an algorithm, such as algorithm 165 of ventilator 100) to control blower 71 in a closed loop fashion. For example, the speed of blower 71 can be adjusted in a closed-loop fashion to maintain a pressure of approximately room pressure, such that air entering inlet 112 is not over pressurized (above room pressure) and/or under pressurized (below room pressure). Blower 71 can be controlled to eliminate the air resistance caused by filter 60 without pressurizing the air entering ventilator 100. Additionally or alternatively, the speed of one or more blowers of ventilator 100 (e.g., blower 140) can be adjusted to account for resistance caused by filter 60, and/or additional flow caused by auxiliary blower assembly 70.

[0260] Referring now to Fig. 20, a schematic view of a patient interface device configured to allow speaking by the patient during ventilation is illustrated, consistent with the present inventive concepts. As described herein, system 10 can include one or more accessory devices, accessory device 400 described herein. In some embodiments, accessory device 400 comprises a ventilator-patient interface device, speaking valve assembly (SVA) 4100 shown in Fig. 20. SVA 4100 can be configured to allow a patient to speak while being ventilated, such as by temporarily allowing exhaled air to pass by the vocal cords. Accessory device 400, ventilator 100, and/or other components of system 10 of Fig. 20 can be of similar construction and arrangement to the similar components described in reference to Fig. 1 and otherwise herein. SVA 4100 can comprise a patient interface, tube 4110, which can comprise an endotracheal tube or similar component. Tube 4110 can include a flow limiting element, cuff 4111, that creates a seal between the outer wall of tube 4110 and the patient’s airway, such that air flowing into and out of the lungs of the patient travels through tube

4110. Tube 4110 can attach to ventilator 100 via tubing assembly 200 (not shown but both described herein), such as when coupler 234 of tubing assembly 200 operably attaches to the proximal end of tube 4110. Cuff 4111 can comprise an expandable cuff (e.g., an inflatable cuff) that can be expanded to create a seal, and can be collapsed (e.g., deflated) to allow air to flow around tube 4110, such that air exhaled by the patient can flow past the vocal cords, allowing the patient to speak without removing tube 4110.

[0261] SVA 4100 can include a control assembly, controller 4120, that is configured to control the expansion and contraction (e.g., inflation and deflation) of cuff 4111. Controller 4120 can be fluidly attached to cuff 4111 via one or more fluid conduits, tube 4121 shown. Tube 4121 can include a connector, connector 4122, that fluidly attaches tube 4121 to controller 4120. Controller 4120 can include a cuff manipulation mechanism, such as pump 4130 shown. Pump 4130 can be configured to pump air into cuff 4111 to inflate, and/or to draw air from cuff 4111 to deflate the cuff. Controller 4120 can include a set of conduits, conduits 4123, that fluidly attach various components of controller 4120 to one another. Controller 4120 can include one or more valve assemblies, valve 4140 shown. Valve 4140 can be configured to open and/or close a fluid connection between pump 4130 and tube 4121, such as via a conduit 4123 shown. In some embodiments, valve 4140 comprises a solenoid valve. Valve 4140 can be configured to switch the connection from tube 4121 between the outlet of pump 4130 and the inlet of pump 4130, such that pump 4130 can provide air to, and draw air from, cuff 4111 (e.g., when pump 4130 comprises a non- reversable pump). Alternatively, pump 4130 can comprise a reversable pump, and valve 4140 can be configured to open and/or close the fluid connection without switching the fluid pathway. In some embodiments, for example when pump 4130 comprises a reversable pump, controller 4120 does not include (i.e., is void of) a valve, for example when pump 4130 is configured to maintain pressure within cuff 4111 when pump 4130 is not activated (e.g., when in an unpowered state). In some embodiments, controller 4120 includes one or more sensors, such as pressure sensor 4124 shown. Pressure sensor 4124 can be fluidly attached to a conduit 4123 that is fluidly attached to cuff 4111, such that pressure sensor 4124 can be used to monitor the fluid pressure within cuff 4111. In some embodiments, pressure sensor 4124 provides feedback to controller 4120, such as during inflation and/or deflation of cuff

4111.

[0262] Controller 4120 can include circuitry and/or other electromechanical control components, control board 4150 shown. Control board 4150 can operably attach to pump 4130, valve 4140, and/or pressure sensor 4124, such as to provide and/or monitor the pressure within cuff 4111. Control board 4150 can be configured to communicate with ventilator 100 (e.g., to transfer power and/or data between controller 4120 and ventilator 100). In some embodiments, control board 4150 is configured for wired communication and/or wireless communication with ventilator 100 and/or other components of system 10 described herein. SVA 4100 can include a user (e.g., patient) interface component, switch 4160 shown. Switch 4160 can comprise a momentary switch (e.g., a momentary button) that when activated (e.g., when pressed by the patient or other user) causes deflation of cuff 4111, allowing the patient to speak. In some embodiments, when switch 4160 is released, cuff 4111 is automatically inflated (e.g., cuff 4111 is only deflated while switch 4160 is activated). Alternatively or additionally, cuff 4111 is inflated when switch 4160 is activated a second time (e.g., activated by the patient to indicate the patient has finished speaking). In some embodiments, controller 4120 includes a maximum time period that cuff 4111 can be deflated, such as a time period of no more than 20 seconds, before cuff 4111 is reinflated such that ventilation can continue. In some embodiments, during this deflation period, one or more alarms of ventilator 100 can be automatically adjusted (e.g., one or more thresholds for one or more alarms can be automatically adjusted), such as to prevent a false alarm from triggering (e.g., a disconnect alarm, low exhaled tidal volume alarm, and/or low exhaled minute volume alarm). For example, control board 4150 can be configured to communicate with ventilator 100, as described herein, to adjust one or more alarms based on the state of cuff 4111. In some embodiments, controller 4120 includes a minimum inflation period. Control board 4150 can operably connect to ventilator 100, such as to provide a signal to ventilator 100 indicating the status of cuff 4111. In some embodiments, ventilator 100 is configured to provide a constant flow of air while cuff 4111 is deflated (e.g., during exhalation, such that sufficient air is provided for the patient to speak). Alternatively or additionally, ventilator 100 can be configured to provide no ventilation (e.g., not provide inhalation nor exhalation) while cuff 4111 is deflated.

[0263] In some embodiments, controller 4120 includes one or more pressure relief mechanisms, such as pressure relief valve 4125 shown. Pressure relief valve 4125 can prevent over pressurization of cuff 4111, such as to ensure the pressure within cuff 4111 does not exceed a threshold, such as a threshold of no more than 50 cmFhO, such as no more than 30 cmFFO, 25 cmFFO, 20 cmFFO, or 10 cmtCC). In some embodiments, cuff 4111 comprises a biased geometry (e.g., an elastic bias in a collapsed geometry), such that when positive pressure from pump 4130 is removed (e.g., when pump 4130 is turned off, and/or when a valve such as valve 4140 is opened to atmospheric pressure), cuff 4111 automatically deflates (e.g., without the need to pump the air from cuff 4111).

[0264] While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Modification or combinations of the above-described assemblies, other embodiments, configurations, and methods for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims. In addition, where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth below not be construed as being order-specific unless such order specificity is expressly stated in the claim.

Claims

WHAT IS CLAIMED IS:

1. A system for providing ventilation to one or more patients, the system comprising: one or more ventilators, wherein each of the one or more ventilators comprises: a housing; a reservoir within the housing, wherein the reservoir comprises: an internal chamber, an air inlet port configured to place the internal chamber in fluid communication with atmospheric air outside the reservoir, and an oxygen inlet port configured to place the internal chamber in fluid communication with a source of oxygen; and a primary blower having an air inlet configured to be placed in fluid communication with the internal chamber of the reservoir, and an air outlet configured to be placed in fluid communication with an inspiration tube external of the ventilator housing, wherein the internal chamber of the reservoir provides a volume for gas mixing extending at least between the air inlet port, the oxygen inlet port, and the primary blower air inlet, and wherein said volume is configured to allow for mixing of air entering in the reservoir via the air inlet port with oxygen entering in the reservoir via the oxygen inlet port before any gas reaches the primary blower air inlet.

2. The system as claimed in at least one of the preceding claims, further comprising a user device configured to communicate with each of the one or more ventilators.

3. The system according to claim 2, wherein the user device comprises a tablet.

4. The system according to claim 3, wherein the communication comprises wireless communication.

5. The system according to claim 4, wherein the wireless communication comprises Bluetooth.

6. The system according to claim 3, wherein the user device is configured to communicate with one or more other devices via a network. The system according to claim 6, further comprising a server, wherein the server comprises one of the one or more other devices. The system according to claim 6, wherein the network comprises the Internet. The system according to claim 3, wherein the user device can exchange information with each of the one or more ventilators. The system according to claim 9, wherein the user device comprises a memory storage element that stores instructions to perform an algorithm, and wherein the algorithm is configured to perform an analysis of each of the one or more ventilators. The system according to claim 10, wherein the algorithm is configured to determine one or more trends related to operational changes of the one or more ventilators. The system as claimed in at least one of the preceding claims, wherein the user device is configured to provide an alert to a user. The system according to claim 12, wherein the user device comprises a transducer configured to provide the alert to the user. The system according to claim 13, wherein the transducer comprises a haptic transducer configured to provide haptic feedback indicating the alert. The system according to claim 13, wherein the transducer comprises a speaker configured to provide audible feedback indicating the alert. The system according to claim 15, wherein the speaker comprises a wireless speaker. The system according to claim 16, wherein the wireless speaker comprises a Bluetooth speaker. The system according to claim 12, wherein the user device is configured to be positioned at a location remote from at least one of the one or more ventilators. The system according to claim 18, wherein the user device is configured to be positioned at a location remote from each of the one or more ventilators. The system according to claim 12, wherein the user device is configured to communicate with each of the one or more ventilators. The system according to claim 12, wherein at least one of the one or more ventilators is configured to be positioned in a patient room, and wherein the user device is configured to be positioned outside of the patient room. The system according to claim 21, wherein the user device is configured to be positioned at a nurse’s station that is located outside of the patient room. The system as claimed in at least one of the preceding claims, wherein each of the one or more ventilators further comprises a sensor. The system according to claim 23, wherein the sensor comprises an oxygen sensor. The system according to claim 24, further comprising a user device, wherein at least one of the one or more ventilators communicates information captured by the sensor to the user device. The system according to claim 25, wherein the information is related to an oxygen parameter of the at least one ventilator. The system as claimed in at least one of the preceding claims, wherein each of the one or more ventilators comprises a memory storage element, and one or more protocols are stored in the memory storage element. The system according to claim 27, wherein the one or more protocols are implemented using a scripting language. The system according to claim 27, wherein the one or more protocols are configured to provide reminders to one or more users of the system. The system according to claim 29, wherein the one or more reminders each comprise a reminder to perform a task selected from the group consisting of: performing a suction on a patient; performing a suction of a pathway of at least one of the one or more ventilators; changing a heat and moisture exchanger (HME) of at least one of the one or more ventilators; delivering one or more specific drugs, such as via nebulization and/or infusion; waking of the patient, such as to determine alertness levels; repositioning of the patient; performing a readiness to wean protocol; and combinations thereof. The system according to claim 29, wherein each of the one or more ventilators further comprises a user interface, and wherein the one or more protocols are configured to be implemented via the user interface of the ventilator. The system according to claim 29, further comprising a user device, wherein the one or more protocols are configured to be implemented via the user device.

The system according to claim 32, wherein the one or more protocols are configured to send a message from at least one of the one or more ventilators to the user device to remind the user to perform a task. The system according to claim 33, wherein the user device comprises a cell phone and the message comprises a text message. The system according to claim 27, further comprising a server, wherein each of the one or more ventilators is configured to download one or more protocols from the server to the memory of the ventilator. The system as claimed in at least one of the preceding claims, further comprising a camera and a memory storage element that stores instructions for performing an algorithm, wherein the algorithm is configured to analyze image data captured by the camera. The system according to claim 36, wherein the algorithm comprises an artificial intelligence algorithm. The system according to claim 36, wherein a first patient is being ventilated by a first ventilator of the one or more ventilators, and wherein the algorithm is configured to analyze the synchrony between the first patient and the first ventilator based on the image data. The system according to claim 36, wherein the image data comprises data selected from the group consisting of: data related to patient synchrony data; data related to the adjustment of inspiratory and/or expiratory trigger sensitivity data; data related to instances in which the patient was “fighting” ventilation; data related to instances of extubation versus suction; data related to instances in which suctioning was required and/or performed; data related to instances in which water was present in a flow pathway of a ventilator of the one or more ventilators; data related to instances in which a patient was not adequately ventilated by a ventilator of the one or more ventilators; and combinations of these. The system as claimed in at least one of the preceding claims, wherein each ventilator of the one or more ventilators comprises a pressure sensor configured to provide a signal, and wherein each ventilator is configured to operate in a pressure- regulated volume control mode based on the pressure sensor signal. The system according to claim 40, wherein each ventilator of the one or more ventilators is configured to terminate breath when operating in the pressure- regulated volume control mode when a target volume is exceeded by a threshold. The system according to claim 41, wherein the threshold is at least 3%, 5%, 10%, or 15%. The system as claimed in at least one of the preceding claims, wherein each ventilator of the one or more ventilators is configured to flush the reservoir with oxygen to rapidly increase the percentage of oxygen in the reservoir. The system according to claim 43, wherein the flush is configured to increase the percentage of oxygen in the reservoir to reach a target oxygen level. The system according to claim 44, wherein the target oxygen level is achieved in a time period of no more than 20 seconds. The system as claimed in at least one of the preceding claims, wherein the one or more ventilators comprises at least two ventilators, and wherein the system further comprises a user device configured to communicate with each of the at least two ventilators. The system of claim 46, wherein the user device is configured to actively communicate with only one of the at least two ventilators at a given time, and wherein the user device and/or the ventilator in active communication with the user device are configured to indicate to the user which ventilator is actively communicating with the user device. The system according to claim 47, wherein the active communication is indicated with a visual indicator. The system as claimed in at least one of the preceding claims, wherein each of the one or more ventilators further comprises a pressure relief valve, and wherein the pressure relief valve comprises a 3/2-way valve. The system as claimed in at least one of the preceding claims, wherein each of the one or more ventilators further comprises a second blower. The system as claimed in at least one of the preceding claims, wherein the system is configured to determine a peak pressure and to determine a plateau pressure. The system according to claim 51, wherein the system is further configured to prevent peak pressure form exceeding a threshold. The system according to claim 52, wherein the threshold is based on the determined plateau pressure. The system as claimed in at least one of the preceding claims, wherein each of the one or more ventilators further comprises a valve and a pressure relief line, wherein the valve is configured to direct the flow of oxygen from the oxygen inlet port to the reservoir or to the pressure relief line. The system according to claim 54, wherein the pressure relief line exits the housing, such that the oxygen directed to the pressure relief line is vented outside of the housing. The system as claimed in at least one of the preceding claims, further comprising one or more filters, wherein each of the one or more filters is configured to operably attach to the air inlet port of one of the one or more ventilators. The system according to claim 56, wherein the one or more filters comprise at least one CRBN filter. The system according to claim 56, wherein each of the one or more ventilators further comprises a manifold configured to operably attach at least two of the one or more filters to the inlet port of each ventilator in a parallel configuration. The system according to claim 56, further comprising one or more auxiliary blower assemblies, wherein each auxiliary blower assembly is configured to operably attach to one or more of the one or more filters, and to the air inlet port of one of the one or more ventilators. The system according to claim 59, wherein each auxiliary blower assembly is configured to draw atmospheric air through the one or more filters operably attached to the auxiliary blower assembly, and to provide atmospheric air to the attached ventilator with less air resistance than the air resistance caused by the attached filters.