Cross-Reference to Related Application(s)

[0001] This application claims benefit of and priority to U.S. Provisional Patent Application Serial No. 63/004,013, filed April 2, 2020, herein incorporated by reference in its entirety as if fully set forth below and for all applicable purposes.

BACKGROUND

Field of the Invention

[0001] This application relates generally to an apparatus and a method for manufacturing an apparatus used for non-invasive ventilation of a human, and more specifically, various closed-circuit assemblies for creating positive end-expiratory pressure (PEEP), controlling airflow and/or air delivery to a patient.

Description of the Related Technology

[0002] Respiratory conditions affect many people globally. When a patient shows signs of pathologies of the respiratory tract and/or lung edema, breathing support may facilitate oxygen and carbon dioxide exchange. In some cases, breathing support can provide a patient with additional oxygen (e.g., a higher fraction of inspired oxygen (Fi02)) and may, in certain cases, also generate a positive pressure inside the respiratory tract. Depending on the severity of the patient’s condition, breathing support may include non-invasive ventilation (NIV) (e.g., using a mask and non-intubated) or invasive ventilation (e.g., intubated with a breathing tube). When a patient is treated with NIV, the air exhaled by the patient is often released into the immediately surrounding environment resulting in a higher risk of infection for caregivers and other people close to the patient. In one example, caregivers in an emergency room or an ambulance coming into contact with a patient for the first time may not be aware of the infectious nature of the patient’s condition.

[0003] In some cases, respiratory conditions can develop into pneumonia, causing fluid to accumulate in a patient’s lung tissue and air spaces of the lungs resulting in pulmonary edema. In such cases, the exchange of oxygen and carbon dioxide via the respiratory tract is made difficult, and can result in a range of mild to life-threatening conditions. Other conditions, such as tuberculosis and severe acute respiratory syndromes (e.g., COVID-19) are infectious and can be life-threatening. For example, COVID-19 infections can develop acute lung injury (ALI) leading to acute respiratory distress syndrome (ARDS) in a patient. ARDS is characterized by inflammation of the alveoli and severe damage to the alveolo-capillary membrane and severe permeability edema. Positive end-expiratory pressure (PEEP) is a positive pressure generated within a patient’s respiratory tract and lungs to prevent the airways and alveoli from collapsing. If the airways and/or alveoli collapse, oxygen cannot reach the alveoli and transfer into the bloodstream. As a result, the oxygen saturation of the blood decreases, and C02 saturation of the blood might increase. Positive-end expiratory pressure (PEEP) from ventilation can reduce the alveolar edema and prevent shunting and severe hypoxia. Thus, patient’s suffering from respiratory conditions can benefit from breathing support, and more specifically, positive pressure induced in the respiratory tract.

[0004] However, invasive ventilation techniques may not diminish inflammation of a patient’s alveoli. Even if relatively high pressures are used, the condition may actually worsen due to the mechanical stress put on the patient’s lungs. Moreover, invasive ventilation therapy can increase the likelihood of a bacterial infection in a patient’s upper airway. For example, by intubating the patient, the effectivity of the patient’s own bacterial defenses are reduced, rendering the patient’s upper airway more susceptible to bacterial infection. Furthermore, patients undergoing invasive ventilation therapy require more recovery time. Therefore, invasive ventilation should be avoided when possible, and limited in the duration of its use. NIV provides an alternative to invasive ventilation.

[0005] Existing NIV provides patients with additional oxygen, often combined with an additional positive pressure in the respiratory tract to enable an effective transfer of oxygen into the bloodstream. However, these NIV setups are required to be connected to an electronically-driven machine used to adjust the positive pressure and other parameters of the NIV. For example, the machine may be used to adjust continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP), and bi-level positive airway pressure (BiPAP). Accordingly, NIV setups can be cost and space prohibitive. For example, the hospital or ambulance may only be able to afford and maintain a limited number machines, or may be limited by the space required to store the machines. In crises such as pandemics, hospitals may not have the capacity to address the high numbers of patients in need, as was seen during the worldwide COVID-19 pandemic.

[0006] Thus, there is a clear need for NIV solutions that prevent caregivers from being exposed to infectious particles exhaled by the patient, and that can be made available quickly and in high numbers when needed. SUMMARY

[0007] Certain aspects are directed to a non-invasive ventilation (NIV) system. The system may include an inlet comprising a one-way air valve configured to allow air from an ambient environment to be drawn into an adaptor and prevent gases exhaled from being released from the inlet into the ambient environment. The system may include a conduit configured to couple the adaptor to a controlled gas source. The system may include an outlet configured to allow the gases exhaled to be released from the adaptor.

[0008] Certain aspects are directed to a method of providing ventilation to a patient via an adaptor of a non-invasive ventilator (NIV) circuit. The method includes opening a one-way air valve located within an inlet of the adaptor, the one-way air valve configured to allow air from an ambient environment to be drawn into the inlet in response to inspiration of the patient, the one-way air valve further configured to prevent gases exhaled by the patient from being released from the inlet into the ambient environment. The method includes receiving a gas from a controlled gas source via a conduit coupled to the adaptor. The method includes releasing the gases exhaled into the ambient environment from an outlet of the adaptor in response to exhalation of the patient.

[0009] Certain aspects relate to a kit for use in providing a patient with non-invasive ventilation (NIV). The kit includes an adaptor comprising an inlet comprising a one-way air valve configured to allow air from an ambient environment to be drawn into the adaptor and prevent gases exhaled from being released from the inlet into the ambient environment, a conduit configured to couple the adaptor and receive a controlled gas, and an outlet configured to allow the gases exhaled to be released from the adaptor. The kit includes a positive end expiratory pressure (PEEP) mechanism coupled to the outlet of the adaptor, the PEEP mechanism configured to maintain a positive pressure in a patient’s lungs.

BRIEF DESCRIPTION OF THE DRAWINGS [0010] So that the manner in which the above-recited features of the present disclosure can be understood in detail, a more particular description, briefly summarized above, may be had by reference to aspects, some of which are illustrated in the drawings. It is to be noted, however, that the appended drawings illustrate only certain typical aspects of this disclosure and are therefore not to be considered limiting of its scope, for the description may admit to other equally effective aspects. [0011] FIG. 1 is an example of a system for designing and manufacturing three- dimensional (3D) objects.

[0012] FIG. 2 illustrates a functional block diagram of one example of the computer shown in FIG. 1.

[0013] FIG. 3 illustrates a high level process for manufacturing a 3D object.

[0014] FIGs. 4A and 4B illustrate example additive manufacturing apparatus with a recoating mechanism.

[0015] FIGs. 5A and 5B illustrate a front right perspective view of an example adaptor for non-invasive ventilation (NIV) attached to a frame of a patient interface.

[0016] FIGs. 6 A and 6B provide a front right perspective view of an example adaptor for NIV attached to a patient interface.

[0017] FIGs. 7A and 7B illustrate front perspective views of two different examples of an NIV circuit.

[0018] FIG. 8 is a flow chart illustrating example operations for using the NIV according to aspects of the disclosure.

DETAILED DESCRIPTION

[0019] While features of the present invention may be discussed relative to certain embodiments and figures below, all embodiments of the present invention can include one or more of the advantageous features discussed herein. In other words, while one or more embodiments may be discussed as having certain advantageous features, one or more of such features may also be used in accordance with various other embodiments discussed herein. In similar fashion, while exemplary embodiments may be discussed below as device, instrument, or method of use and/or manufacture, it should be understood that such exemplary embodiments can be implemented in various devices, instruments, and methods.

[0020] Systems and methods disclosed herein include an apparatus and a method for manufacturing an apparatus used for non-invasive ventilation (NIV) of a human. Specifically, in certain aspects, the systems and methods are configured to generate a positive end-expiratory pressure (PEEP) at the patient’s lungs without the use of a separate machine typically used in such cases. The systems and methods further provide a care giver with an ability to directly control and adjust the PEEP using one or more mechanisms such as a PEEP valve and/or the alternate mechanisms as described herein while protecting the care giver against the virulent particles that may be present in the patient’s exhaled air. In certain aspects, the apparatus may be used in the treatment of various pulmonology disorders and/or in a recovery processes such as after thoracic surgery, cardiac surgeries as it may help to reduce lung edema by generating a positive pressure in the respiratory tract, and/or facilitate oxygen uptake into the patient’s bloodstream.

[0021] In certain aspects, an NIV apparatus may be designed on a computing system using any suitable computer-aided design (CAD) software. Aspects of the disclosure may be practiced within a system for designing, simulating, and/or manufacturing 3D objects. Turning to FIG. 1, an example of a computer environment suitable for the implementation of 3D object design, build simulation, and manufacturing is shown. The environment includes a system 100. The system 100 includes one or more computers 102a- 102d, which can be, for example, any workstation, server, or other computing device capable of processing information. In some embodiments, each of the computers 102a-102d can be connected, by any suitable communications technology (e.g., an internet protocol), to a network 105 (e.g., the Internet). Accordingly, the computers 102a-102d may transmit and receive information (e.g., software, digital representations of three-dimensional (3D) objects, commands or instructions to operate an additive manufacturing device, etc.) between each other via the network 105.

[0022] The system 100 further includes one or more additive manufacturing devices (e.g., 3D printers) 106a-106b. As shown the additive manufacturing device 106a is directly connected to a computer 102d (and through computer 102d connected to computers 102a- 102c via the network 105) and additive manufacturing device 106b is connected to the computers 102a- 102d via the network 105. Accordingly, one of skill in the art will understand that an additive manufacturing device 106 may be directly connected to a computer 102, connected to a computer 102 via a network 105, and/or connected to a computer 102 via another computer 102 and the network 105.

[0023] It should be noted that though the system 100 is described with respect to a network and one or more computers, the techniques described herein also apply to a single computer 102, which may be directly connected to an additive manufacturing device 106.

[0024] FIG. 2 illustrates a functional block diagram of one example of a computer of FIG. 1. The computer 102a includes a processor 210 in data communication with a memory 220, an input device 230, and an output device 240. In some embodiments, the processor is further in data communication with an optional network interface card 260. Although described separately, it is to be appreciated that functional blocks described with respect to the computer 102a need not be separate structural elements. For example, the processor 210 and memory 220 may be embodied in a single chip.

[0025] The processor 210 can be a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any suitable combination thereof designed to perform the functions described herein. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0026] The processor 210 can be coupled, via one or more buses, to read information from or write information to memory 220. The processor may additionally, or in the alternative, contain memory, such as processor registers. The memory 220 can include processor cache, including a multi-level hierarchical cache in which different levels have different capacities and access speeds. The memory 220 can also include random access memory (RAM), other volatile storage devices, or non-volatile storage devices. The storage can include hard drives, flash memory, etc.

[0027] The processor 210 also may be coupled to an input device 230 and an output device 240 for, respectively, receiving input from and providing output to a user of the computer 102a. Suitable input devices include, but are not limited to, a keyboard, buttons, keys, switches, a pointing device, a mouse, a joystick, a remote control, an infrared detector, a bar code reader, a scanner, a video camera (possibly coupled with video processing software to, e.g., detect hand gestures or facial gestures), a motion detector, or a microphone (possibly coupled to audio processing software to, e.g., detect voice commands). Suitable output devices include, but are not limited to, visual output devices, including displays and printers, audio output devices, including speakers, headphones, earphones, and alarms, additive manufacturing devices, and haptic output devices.

[0028] The processor 210 further may be coupled to a network interface card 260. The network interface card 260 prepares data generated by the processor 210 for transmission via a network according to one or more data transmission protocols. The network interface card 260 also decodes data received via a network according to one or more data transmission protocols. The network interface card 260 can include a transmitter, receiver, or both. In other embodiments, the transmitter and receiver can be two separate components. The network interface card 260, can be embodied as a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any suitable combination thereof designed to perform the functions described herein.

[0029] FIG. 3 illustrates a process 300 for manufacturing a 3D object or device. As shown, at a step 305, a digital representation of the object is designed using a computer, such as the computer 102a. For example, two dimensional (2D) or 3D data may be input to the computer 102a for aiding in designing the digital representation of the 3D object. Continuing at a step 310, information corresponding to the 3D object is sent from the computer 102a to an additive manufacturing device, such as additive manufacturing device 106, and the device 106 commences a manufacturing process for generating the 3D object in accordance with the received information. At a step 315, the additive manufacturing device 106 continues manufacturing the 3D object using suitable materials, such as a polymer or metal powder. Further, at a step 320, the 3D object is generated.

[0030] FIG. 4A illustrates an exemplary additive manufacturing apparatus 400 for generating a 3D object. In this example, the additive manufacturing apparatus 400 is a laser sintering device. The laser sintering device 400 may be used to generate one or more 3D objects layer by layer. The laser sintering device 400, for example, may utilize a powder (e.g., metal, polymer, etc.), such as the powder 414, to build an object a layer at a time as part of a build process.

[0031] Successive powder layers are spread on top of each other using, for example, a recoating mechanism 415A (e.g., a re-coater blade). The recoating mechanism 415A deposits powder for a layer as it moves across the build area, for example in the direction shown, or in the opposite direction if the recoating mechanism 415A is starting from the other side of the build area, such as for another layer of the build. After deposition, a computer-controlled carbon dioxide (C02) laser beam scans the surface and selectively binds together the powder particles of the corresponding cross section of the product. In some embodiments, the laser scanning device 412 is an X axis and Y axis moveable infrared laser source. As such, the laser source can be moved along an X axis and along a Y axis in order to direct its beam to a specific location of the top most layer of powder. Alternatively, in some embodiments, the laser scanning device 412 may comprise a laser scanner which receives a laser beam from a stationary laser source, and deflects it over moveable mirrors to direct the beam to a specified location in the working area of the device. During laser exposure, the powder temperature rises above the material (e.g., glass, polymer, metal) transition point after which adjacent particles flow together to create the 3D object. The device 400 may also optionally include a radiation heater (e.g., an infrared lamp) and/or atmosphere control device 416. The radiation heater may be used to preheat the powder between the recoating of a new powder layer and the scanning of that layer. In some embodiments, the radiation heater may be omitted. The atmosphere control device may be used throughout the process to avoid undesired scenarios such as, for example, powder oxidation.

[0032] In some other embodiments, such as shown with respect to FIG. 4B, a recoating mechanism 415B (e.g., a leveling drum/roller) may be used instead of the recoating mechanism 415A. Accordingly, the powder may be distributed using one or more moveable pistons 418(a) and 418(b) which push powder from a powder container 428(a) and 428(b) into a reservoir 426 which holds the formed object 424. The depth of the reservoir, in turn, is also controlled by a moveable piston 420, which increases the depth of the reservoir 426 via downward movement as additional powder is moved from the powder containers 428(a) and 428(b) in to the reservoir 426. The recoating mechanism 415B, pushes or rolls the powder from the powder container 428(a) and 428(b) into the reservoir 426. Similar to the embodiment shown in FIG. 4A, the embodiment in FIG. 4B may use the radiation heater 416 alone for preheating the powder between recoating and scanning of a layer.

EXAMPLE TECHNIQUES FOR GENERATING AND USING A NON-INVASIVE

VENTILATOR (NIV) ADAPTOR

[0033] As discussed, aspects of the disclosure relate to apparatus or “adaptors” used for NIV, as well as the various configurations and methods of use and manufacture of the adaptors. In certain aspects, the adaptor is configured and manufactured according to existing quality standards (e.g., International Organization for Standardization (ISO), Occupational Health and Safety Assessment Series (OHSAS), etc.) as well as medical device interoperability standards (e.g., Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute (ANSI), Underwriter Laboratories (UL), etc.) to ensure safe and effective interoperability with existing medical equipment and instruments.

[0034] FIG. 5A is a front right perspective view of an example adaptor 500 for NIV attached to a frame 520 of a patient interface 550. In certain aspects, the adaptor 500 includes an attachment port 502 configured to removably attach the adaptor 500 to the frame 520 of the patient interface 550 and provide a seal at an attachment point between the attachment port 502 and the frame 520. In certain aspects, the adaptor 500 is part of the frame 520 and not meant to be removed. The attachment port 502 may provide a combined expiratory and inspiratory port at the attachment point through which a patient may breathe, aided by three additional ports: a first inlet port 504, a second inlet port 506, and an outlet port 508. Each port may include a channel or tubular structure having a proximal end (e.g., end closest to the attachment point) coupled to a proximal end of the other three ports at a central intersection 510. The central intersection 510 allows for mixing of inlet gases to occur in the adaptor 500 prior to delivery of the inlet gases to the patient when the NIV system includes more than one inlet port. Additionally, a filter in the form of a membrane may be included in the central intersection 510 to reduce a virulent particle count and prevent the patient from inhaling any previously exhaled virulent particles while inhaling ambient air and the controlled gas. Mixing the inlet gases inside the adaptor 500 reduces the complexity and bulk of the NIV system, as opposed to mixing the gases outside the NIV system. As illustrated, each port extends from the central intersection 510 along (e.g., parallel to) a common horizontal plane 512. It should be noted however, each port may extend from the central intersection 510 in any suitable direction, including one or more angles relative to the horizontal plane 512. Further, though two inlet ports and one outlet port are shown, the NIV system may have any number of one or more inlet ports and any number of one or more outlet ports. In this example, the adaptor 500 is connected to the patient interface 550 at a location that will be close to a patient’s mouth and nose when worn.

[0035] The first inlet port 504 may be configured to provide an ambient or atmospheric air intake to allow ambient air to be delivered to a patient wearing the patient interface 550. As illustrated, the first inlet port has an end that includes one or more air holes 514 and may optionally include the one-way membrane valve for allowing air in the surrounding environment to enter the adaptor 500. It should be noted that the air holes 514 may be arranged on any surface of the first inlet port 504 in any number and in pattern or (e.g., irregular) configuration. The air holes 514 may include a gap or opening of any suitable size or shape. In some examples, the first inlet port 504 may include an interior section (not shown). The interior section may include one or more of a filter for filtering airborne particulate, and/or a one-way valve (e.g., a flap valve in the form of an umbrella valve or a silicon membrane valve) to prevent air from being exhaled through the air holes 514. Any suitable air filter may be used, but the density and type of air filter (if any) may vary according a preferred ratio of ambient air to oxygen or other gas that the patient is to inhale. For example, a relatively thick filter may provide an effective barrier to airborne particulate, but will reduce the amount of ambient air that is inhaled by the patient. Any suitable one-way valve may also be used to prevent exhaled air from venting out of the adaptor through the first inlet port 504. The one-way valve may be placed at a location that provides optimum blockage such as immediately adjacent to the air holes 514, inserted midway or at any point along the length of the first inlet port 504, etc. In certain aspects, the filter may humidify inflowing ambient air.

[0036] The second inlet port 506 may be configured to provide delivery of a controlled gas intake (e.g., oxygen, mixed gases having medicinal properties such as drug particles or drug carrying aerosols) to allow a controlled gas to be delivered to a patient wearing the patient interface 550. The controlled gas may come from a gas source (e.g., an oxygen tank or other pressurized gas source) that is removably connected to the second inlet port 506 via a conduit 516. For example, an oxygen tank may be connected to the conduit 516 via a tube that transports pressurized oxygen or other gas(es) to the second inlet port. The second inlet port 506 may include any suitable number and sizes of conduits to support the use of multiple gas sources. In some examples, a humidifier may be included between the gas source and the second inlet port 506, or attached to a second conduit (not shown), to humidify the breathing gas.

[0037] Accordingly, on inhale, the patient may draw gases into the patient interface 550 from both the first inlet port 504 and the second inlet port 506 via the attachment port 502. The amount of gas the patient is able to draw from each port may be controlled by adjusting a controlled gas pressure at the second inlet port 506, and/or optionally, adjusting a filter density or type at the first inlet port 504 or an amount of force required to draw ambient air into the first inlet port 504 via the one-way valve. The attachment port 502 may provide a region of the adaptor 500 for gases and/or matter from the first inlet port 504 and the second inlet port 506 to be mixed before entering the patient interface 550.

[0038] The outlet port 508 may be configured to provide venting for gases exhaled from the patient. Because of the one-way valve of the first inlet port 504 and the controlled gas of the second inlet port 506, all gas and particulate matter exhaled by the patient may be routed out of the patient interface 550 and the adaptor 500 via the outlet port 508. Although not shown, a distal end of the outlet port 508 may include a conventional connector to allow a patient or administrator to attach additional medical devices and/or instruments to the distal end of the outlet port 508. For example, as discussed in more detail below, attachments may include one or more of a filter, a positive end expiratory pressure (PEEP) valve, a container, and/or any other suitable device or instrument. It should be noted that, in certain aspects, the first inlet port 504 and the outlet port 508 face opposing ends of the adaptor 500 to help limit the patient’s inhalation of air previously exhaled.

[0039] FIG. 5B is a front right perspective view of the example adaptor 500 showing gas intake and venting directions. For example, controlled gas 562a may enter the adaptor 500 via the conduit 516 of the second inlet port 506, and ambient gas 562b may enter the adaptor 500 via openings 514 in the first inlet port 504. Any gas exhaled 564 by the patient may be vented from the patient interface 550 and the adaptor 500 via the outlet port 508.

[0040] In certain aspects, the patient interface 550 that uses the adaptor 500 may include one or more components that are assembled together to make a mask configuration. Various components that make up the patient interface 550 may include one or more of: a cushion or a seal that sits on the patient’ s nasal bridge and forms a seal to prevent leakage or escape of intake and vented gases, a headgear assembly that fastens the patient interface 550 the patient’s head to stabilize the cushion or seal and hold the assembly in place while allowing head movements, one or more buckle(s) and/or clip(s) 522 attach a frame 520 of the patient interface 550 to the patient’s head via the headgear assembly, and/or an adaptor seal to prevent leakage or escape of intake and vented gases through the interface between the patient interface 550 and the adaptor 500. Although FIGs. 5 A and 5B illustrate several of these components, FIGs. 6A and 6B and the following disclosure provide additional example illustrations. In some aspects, the patient interface 550, the frame 520 and the adaptor 500 may be customized to be patient- specific to meet the patient’s personal needs. For example a pediatric patient may require a relatively smaller patient interface 550, and a patient may have breathing difficulties that require additional or wider inlets.

[0041] In certain aspects, the buckle(s) and/or clip(s) 522 of the frame 520 may be adjustable for attachment to any existing, standard, off-the-shelf mask, helmet, or headgear assembly. The frame 520 and headgear assembly may be customized to be patient-specific, for example in patients requiring long term assisted respiratory care, such as sleep apnea, cancer patients, and other respiratory pathologies. Each buckle 522 and/or clip 522 may be an integrated part of the frame 520. In certain aspects, each buckle 522 and/or clip 522 may fit to one or more components of a mask assembly such as the cushion or seal using a snap fit connection mechanism or adhesive glue or hooks.

[0042] As illustrated, the frame 520 may not cover a patient’s entire face. For example, the frame 520 may cover the nasal-mouth region, and may be designed to only cover enough area to ensure a positive seal of the cushion to the patient’s mouth and/or nose, and proper fastening of the patient interface 550 to the patient’s head. It should be noted that due to the close proximity of the adaptor 500 to the patient’s mouth and nose in certain aspects, the patient interface 550 may provide an optimized gas flow to the patient by increasing the volume of the inlet gases reaching the mouth and/or nose of the patient.

[0043] In certain aspects, one or more of the components (e.g., the adaptor 500 and the patient interface 550, and the various components that make up the adaptor 500 and patient interface 550) illustrated in FIGs. 5A and 5B may be included in a kit for NIV in accordance with aspects disclosed herein.

[0044] FIGs. 6 A and 6B provide a front right perspective view of an example adaptor 600 for NIV attached to a patient interface 650. Similar to the adaptor 500 of FIGs. 5 A and 5B, the adaptor 600 illustrated in FIGs. 6A and 6B includes an attachment port 602 configured to removably attach the adaptor 600 to a frame 620 of the patient interface 650 and provide a seal at an attachment point between the attachment port 602 and the frame 620. It should be noted that in certain aspects, the adaptor 600 is integrally built with the frame 620, as it not removable. The attachment port 602 is coupled to an expiratory port 608. The attachment port 602 may be configured to provide an ambient or atmospheric air intake to allow ambient air to be delivered to a patient wearing the patient interface 650. As illustrated, a distal end of the attachment port 602 (e.g., an end of the attachment port 602 furthest from the frame 620 and attachment point) may include one or more air holes 614 for allowing air from the surrounding environment to enter the adaptor 600. It should be noted that the air holes 614 may be arranged on any surface of the attachment port 602 in any pattern or irregular configuration. The air holes 614 may include a gap or opening of any suitable size or shape. In one example, the central circular hole shown is an air hole 614, and may be the only air hole. In some examples, the attachment port 602 may include an interior section (not shown). The interior section may include one or more of a filter for filtering airborne particulate, and/or a one-way valve (e.g., a flap valve in the form of an umbrella valve) to prevent air from being exhaled through the air holes 614.

[0045] The attachment port 602 may include one or more conduits 616 coupled to the attachment port 602 and configured to provide a path for controlled gas to enter the attachment port 602. The controlled gas may come from a gas source (e.g., an oxygen tank or other pressurized gas source) that is removably connected to the conduit 616 via a tube 676 that transports pressurized oxygen and/or other gas(es) to the attachment port 602. Accordingly, on inhale, the patient may draw atmospheric gases and one or more controlled gases into the attachment port 602 and patient interface 650 from both the air holes 614 and the conduit 616. The attachment port 602 may provide a region of the adaptor 600 for gases and/or matter from the ambient environment and the controlled gas source to be mixed before entering the patient interface 650.

[0046] The adaptor 600 may also include an outlet port 608 coupled to the attachment port 602. Both the attachment port 602 and the outlet port 608 may include a channel or tubular structure, wherein a proximal end (e.g., end closest to the attachment point) of the outlet port 608 may be coupled to a proximal end or a side of the attachment port 602. The outlet port 608 may be configured to provide venting for gases and particular matter exhaled from the patient. Because of the one-way valve of the attachment port 602 and the controlled gas from the conduit 616, all gas and particulate matter exhaled by the patient may be routed out of the patient interface 650, into the adaptor 600, and out via the outlet port 608. In some examples, the outlet port 608 may be larger (e.g., have a greater diameter relative to the diameter of the attachment port 602) to increase the exhaled flow volume and prevent buildup of liquid within the adaptor 600. For example, the increased flow volume of the outlet port 608 may prevent build-up of liquid in the lungs because the liquid can be pushed out via an enlarged outlet. [0047] A distal end of the outlet port 608 may include a conventional connector to allow a patient or administrator to attach additional medical devices and/or instruments to the distal end of the outlet port 608. For example, as shown in FIGs. 6 A and 6B, a filter 622 is removably attached to the outlet port 608, and a PEEP valve 618 is removably attached to an outlet of the filter 622. The filter 622 may include any suitable filtering mechanism, for example, a bidirectional filter for reducing or collecting airborne pathogens and liquid exhaled by a patient, such as a Gibeck® heat and moisture exchanger- filter (HMEF). Accordingly, the filter 622 may collect gases and any particulate liquid and matter so that outgoing gases such as C02 can be released into the atmosphere without infectious and/or poisonous particulate matter. This may help prevent further spread of the disease by containing the released virulent particles. The outgoing gases include the patient’ s exhaled air released by the lungs at the end of the breathing cycle. Although the filter 622 is illustrates as connected directly to the distal end of the outlet port 608, the filter 622 may be connected at any desired location along the length of the outlet port 608. The filter may be changed at regular intervals to prevent buildup of the virulent particles and other particles in the filter, which can cause an increased resistance to outflowing air. The need to change the filter may be indicated by a visible change in color or when the indicated shelf life is passed or based on output measurements. [0048] The PEEP valve 618 may be used, among other things, for controlling exhalation and maintaining an adjustable pressure in the patient’s lungs during exhale to prevent the lungs from collapsing. Maintaining the positive end-expiratory pressure may help give the patient’s alveoli a larger exchange surface for respiration. The PEEP valve may be fitted at a desired location along the length of the outlet port 608, or to another device, such as the filter 622. In some examples, the PEEP valve may be adjusted to generate the level of PEEP that suits the patient’s need, such as within the range of 0-20cmH20. It should be noted that any combination of medical devices and/or instruments may be attached to the outlet port 608, including one or more filters, one or more PEEP or other pressure-maintaining valves, and/or combinations thereof.

[0049] Still referring to FIGs. 6A and 6B, the patient interface 650 may include or removably couple to a cushion mask or a seal 624 that sits on the patient’s nasal bridge and forms a seal against the nasal bridge and areas around the patient’ s mouth to prevent leakage or escape of intake and vented (exhaled) gases. In certain aspects, the cushion mask or seal 624 may include an oro-nasal mask. For example, the frame 620 may removably couple to the cushion mask or a seal 624. The patient interface 650 may also include a headgear assembly 626 that fastens the patient interface 650 to the patient’s head to stabilize the seal 624 and hold the frame 620 in place while allowing head movements. In some examples, the headgear assembly 626 may include one or more Velcro straps, buckles, or clips for fastening the headgear assembly 626 to the frame 620.

[0050] In certain aspects, one or more of the components (e.g., the adaptor 600 and the patient interface 650, and the various components that make up the adaptor 600 and patient interface 650) illustrated in FIGs. 6A and 6B may be included in a kit for NIV in accordance with aspects disclosed herein.

[0051] FIG. 7A is a front perspective view of the example adaptor 700 in a first example circuit 700 for NIV. As discussed, the adaptor 700 is removably attached to or part of the frame 520 of the patient interface 550 at an attachment point between an attachment port (not visible) and the frame 520. An optional first inlet port 784 may include a one-way valve to facilitate drawing ambient air 702 into the adaptor 700 while preventing exhaled air and particulate matter from entering the surrounding environment. Although the first inlet port 784 is optional, the first inlet port 784 may advantageously provide a patient with a supplemental air supply if the patient requires additional air. A second inlet port 786 includes a conduit 716 that is removably connected to a controlled gas source 704 (e.g., oxygen tank) via a hose or tube 706. The second inlet port 786 allows the controlled gas to enter the adaptor 700. The close proximity of the optional first inlet port 784 to the second inlet port 786 facilitates mixing of the ambient air 702 with the controlled gas within the adaptor 700 immediately prior to inhalation of the gases by the patient. In certain aspects, the first inlet port 784 may include a valve (not shown) to open, partially open, or close the first inlet port 784.

[0052] In certain aspects, if the adaptor 700 does not include the first inlet port 784, a gas mixing component 780 (e.g., any suitable air-oxygen blender) may be used to mix ambient air 702 with gas provided by the controlled gas source 704. In this way, both ambient air 702 and controlled gas may enter the adaptor 700 via the same second inlet port 786. The mixing component 780 may be configured to mix the ambient air 702 and the controlled gas while maintaining a positive pressure in the system. Although the mixing component 780 is illustrated as attached to the controlled gas source 704, in other examples, the mixing component may be attached between the conduit 716 and the tube 706, or as part of the tube 706 and between the conduit 716 and the controlled gas source 704. This configuration advantageously helps maintain a positive pressure at the patient’s lungs by mixing the ambient air with the gas at the gas source 704 using the pressure of the controlled gas source 704 to further pressurize any ambient air 702 that enters the mixing component 780. Here, a filter 722 is removably attached to the outlet port 508, and a PEEP valve 718 is removably attached to an outlet of the filter 722.

[0053] Ambient air 702 and controlled gas from the gas source 704 is drawn into the adaptor 700 when the patient inhales. The PEEP valve 718 may prevent any ambient air 702 from entering the adaptor 700 through the outlet port 708. In certain aspects, the outlet port 708 may include a one-way valve that only allows gases and incident particulate matter to exit through the outlet port 708 when the patient exhales. In this manner, all particulate matter including liquid and/or pathogen are collected at the filter 722 and are thereby prevented from entering the ambient atmosphere, while the PEEP valve 718 maintains a configurable positive pressure in the patient’ s lungs. Thus, in such a configuration, the adaptor 700 prevents pathogen from entering the ambient environment while also providing positive pressure in the patient’s lungs without a need to have the adaptor attached to a separate breathing machine (e.g., respiratory compressor or mechanical ventilator). This provides the patient with improved mobility as the patient does not have to have a separate machine attached to a breathing apparatus. For the same reasons, this configuration also provides a cost effective solution to maintaining a positive pressure at the patient’s lungs while preventing contaminated air and pathogen from being introduced into the area surrounding the patient. As the particulate matter is collected at the filter 722, this setup further provides protection to the caregiver against the exhaled, virulent air from the patient such as in the case of COVID-19 pandemic.

[0054] FIG. 7B is a front perspective view of the example adaptor 700 of FIG. 7A in a second example circuit 750 for NIV. In this example, the adaptor 700 is removably attached to or part of the frame 520 of the patient interface 550 at an attachment point between an attachment port (not visible) and the frame 520. In this example, the outlet port 708 may be attached to a delivery tube 756 that delivers outgoing, exhaled gases and any associated particulate or pathogen into a container 752 of a liquid 754 or solution such as water or other suitable liquid (e.g., an antiviral or antiviral mixture). The container 752 may be a personal container sized to allow the patient to carry or attach the container 752 to their person, and may include containers such as beaker, flask, bucket, or other liquid housing. In this example, the delivery tube 756 delivers the exhaled gases to the container 752 and releases the gases into the liquid 754. The container 752 may include an exhaust port 760 that allows the exhaled gases to be released back into the surrounding environment after passing through the liquid 754. Any virulent particles or pathogen are released into the liquid 754 and captured therein. In some examples, the exhaust port includes a one-way valve to prevent the ambient air 702 from entering the container 752.

[0055] In this manner, the combination of the container 752 and liquid 754 functions as an alternative to the combination of the filter and the PEEP valve illustrated in FIGs. 6 A, 6B, and 7A. The amount of liquid 754 may be used to maintain the desired positive end exhalation pressure. For example, the delivery tube 756 may be immersed in the liquid 754 to the desired level such as 5cm deep (e.g., equivalent of 5cmH20 reading on the PEEP valve). Other immersion levels can be used according to the patient’s needs. For example, the delivery tube may be immersed in the range of 0-20cmH20 or any other suitable range required by the patient.

[0056] The exhaust port 760 may also include a filter to trap any pathogen. In some examples, the container 752 includes a cover 758 that provides a replaceable filter to trap any additional escaping or air-bome virulent particles while allowing passage of filtered air back into the ambient environment. The filter may be made of any permeable material such as one or more of medical grade filters, cloth, selectively permeable material, porous mesh and/or combinations thereof. The filter material may be customized based on the particulate size to be trapped. [0057] The exhaust port 760 may be configured to release trapped air to avoid moisture build up in the container 752. Because the exhaled air being delivered to the container 752 is generally warmer than the ambient environment, the warmer air may increase the positive pressure in the container 752 to levels inappropriate for the desired PEEP effect. Thus, in some examples, a one-way valve of the in the exhaust port 760 may allow release of pressure in the container if the pressure reaches a threshold level.

[0058] The liquid level may fall below an optimum level over longer periods of time due to natural evaporation or in case of warmer surroundings. Accordingly, the container 752 may be manually replenished with liquid to maintain an optimum liquid level so that there is no disruption in the positive pressure support provided by the container 752. In some examples, the liquid level in the container may be maintained automatically via a separate reservoir of liquid. In such an example, liquid is automatically released from the reservoir via a channel or a tube into the container 752 when the liquid level falls to the threshold level or depth. In some examples, the reservoir liquid is gravity fed into the container 752. In other examples, the liquid 754 may be fed into the container 752 via pumps, fill valves, levers, floats, sensors, or any other suitable mechanism. In some examples, one or more additional containers may be connected in series or parallel to the container 752 to maintain the overall liquid level in the container 752.

[0059] The circuit 750 illustrated in FIG. 7B may provide a cost effective approach when demand for PEEP valves and/or filters does not meet current supply. In other words, using liquid containers as an alternative to filters and PEEP valves may be used when the demand for NIV is high and the supply of medical grade equipment is low, such as during a pandemic. Here, the circuit 750 provides a NIV breathing support assembly without requiring a mechanical ventilation system.

[0060] In certain aspects, one or more of the components (e.g., the adaptor 700, the patient interface 550, the container 752, and controlled gas source 704, and the various components that make up the patient interface 550, the container 752, and controlled gas source 704) illustrated in FIGs. 7A and 7B may be included in a kit for NIV in accordance with aspects disclosed herein.

[0061] FIG. 8 is a block diagram illustrating operations 800 for using the NIV in accordance with aspects disclosed herein.

[0062] At a first block 802, the operations 800 include opening a one-way air valve located within an inlet of the adaptor, the one-way air valve configured to allow air from an ambient environment to be drawn into the inlet in response to inspiration of the patient, the one-way air valve further configured to prevent gases exhaled by the patient from being released from the inlet into the ambient environment.

[0063] At a second block 804, the operations 800 include receiving a gas from a controlled gas source via a conduit coupled to the adaptor.

[0064] At a third block 806, the operations 800 include releasing the gases exhaled into the ambient environment from an outlet of the adaptor in response to exhalation of the patient. [0065] In certain aspects, the operations 800 include routing, by the outlet, the gases exhaled to a filtering device comprising a filter for trapping liquid and pathogen from the gases exhaled prior to releasing the gases exhaled into the ambient environment.

[0066] In certain aspects, the operations 800 include routing, by the filtering device, the gases exhaled to a positive end expiratory pressure (PEEP) valve for maintaining a positive pressure prior to releasing the gases exhaled into the ambient environment.

[0067] In certain aspects, a first end of the filtering device is removably attached to the outlet, and a second end of the filtering device is removably attached to the PEEP valve. [0068] In certain aspects, the outlet is coupled to a container having a volume of liquid and a filtered venting mechanism, the method further comprising routing the gases exhaled into the volume of liquid prior to releasing the gases exhaled into the ambient environment via the filtering.

[0069] In certain aspects, the volume of liquid maintains a positive pressure at the patient’ s lungs, wherein the method further comprises adjusting the positive pressure by adding or reducing the volume of liquid in the container.

[0070] In certain aspects, the adaptor and its components, and one or more of the patient interface components, may be manufactured using additive manufacturing. In certain embodiments, certified medical material and protocol may be used in additive manufacturing. In certain aspects, the adaptor may be transparent, opaque, semi-transparent or colored. In certain aspects, the patient interface, such as the frame and cushion or seal may be customized to meet the patient and/or health care requirements.

ADDITIONAL CONSIDERATIONS

[0071] Various embodiments disclosed herein provide for the use of a computer control system. A skilled artisan will readily appreciate that these embodiments may be implemented using numerous different types of computing devices, including both general purpose and/or special purpose computing system environments or configurations. Examples of well-known computing systems, environments, and/or configurations that may be suitable for use in connection with the embodiments set forth above may include, but are not limited to, personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments (e.g., networks, cloud computing systems, etc.) that include any of the above systems or devices, and the like. These devices may include stored instructions, which, when executed by a microprocessor in the computing device, cause the computer device to perform specified actions to carry out the instructions. As used herein, instructions refer to computer-implemented steps for processing information in the system. Instructions can be implemented in software, firmware or hardware and include any type of programmed step undertaken by components of the system.

[0072] A microprocessor may be any conventional general purpose single- or multi-chip microprocessor such as a Pentium® processor, a Pentium® Pro processor, a 8051 processor, a microprocessor without interlocked pipelined stages (MIPS®) processor, a Power PC® processor, or an Alpha® processor. In addition, the microprocessor may be any conventional special purpose microprocessor such as a digital signal processor or a graphics processor. The microprocessor typically has conventional address lines, conventional data lines, and one or more conventional control lines.

[0073] Aspects and embodiments of the inventions disclosed herein may be implemented as a method, apparatus or article of manufacture using standard programming or engineering techniques to produce software, firmware, hardware, or any combination thereof. The term "article of manufacture" as used herein refers to code or logic implemented in hardware or non- transitory computer readable media such as optical storage devices, and volatile or non-volatile memory devices or transitory computer readable media such as signals, carrier waves, etc. Such hardware may include, but is not limited to, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic arrays (PLAs), microprocessors, or other similar processing devices.