Combined Respiratory Therapy Device, System, and Method

Abstract

The combined respiratory therapy management system generates combined respiratory therapy prescriptions that can be executed by combined respiratory therapy devices to provide multiple coordinated respiratory therapies to a patient. The system can update the combined respiratory therapy prescriptions and implement updates while the combined respiratory therapy devices are in use. An integrated graphical user interface provides patients and clinicians with customization options and quick access to preselected operations of the combined respiratory therapy devices. An additional feature of the system allows for remote access and control of the combined respiratory therapy devices by a remote clinician.

Description

Background Art

[0001] (Background) As a result of diseases such as stroke, spinal cord injury, head trauma, or muscular dystrophy and amyotrophic lateral sclerosis (ALS, i.e., Lou Gehrig's disease), patients suffering from neuromuscular weakness have an increased risk of morbidity and mortality due to weak cough and shallow breathing (hypoventilation). The number of chronic diseases causing weak cough and pulmonary ventilation insufficiency is large and expanding.

[0002] If a patient has an ineffective cough, chest secretions are retained within the respiratory system, causing pneumonia, lung collapse, or, if mucus fills the trachea, fatal respiratory arrest. In addition, shallow breathing causes low oxygen levels and high carbon dioxide levels in the patient's bloodstream, leading to a medically vulnerable state of chronic respiratory insufficiency that can result in severe respiratory diseases even from a common cold. For these reasons, pulmonary complications are regarded as the main cause of morbidity and death in patients suffering from neuromuscular weakness.

[0003] As the patient's condition worsens, it is likely that the patient will need both cough assistance and assisted ventilation. Respiratory therapy for dealing with a weak cough often involves a device that provides assisted coughing via mechanical positive pressure ventilation, while shallow breathing is generally addressed by a separate artificial ventilation device.

Summary of the Invention

Means for Solving the Problems

[0004] (Summary) According to one embodiment, there is provided a combined respiratory therapy device including a blower configured to provide negative pressurized air to a mouthpiece coupled to a patient's airway, and an air pulse generator configured to deliver an air pulse to at least one of a garment worn by the patient or a nasal interface worn by the patient. The device further includes a controller including a network interface that communicates with an associated computer network, and a processor that communicates with a memory storing instructions, the instructions being executable by the processor to execute a combined respiratory therapy prescription, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed over a time period by the combined respiratory therapy device, each of the plurality of different therapy sessions including a mucus extraction therapy. The combined therapy device further includes a display configured to communicate with the controller and display a graphical user interface associated with at least one operation of the combined respiratory therapy device.

[0005] According to another embodiment, a system for problem - priority device control of at least one combined respiratory therapy device is provided. The system includes at least one combined respiratory therapy device and at least one clinician device. The at least one combined respiratory therapy device is a controller including a network interface that communicates with an associated computer network, and a processor that communicates with a memory storing instructions, the instructions being executable by the processor to execute a combined respiratory therapy prescription, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed over a time period by the combined respiratory therapy device. The at least one combined respiratory therapy device further includes a display configured to communicate with the controller and display a graphical user interface associated with at least one operation of the combined respiratory therapy device. The at least one clinician computing device communicates with the at least one combined respiratory therapy device via an associated computer network and is configured to control at least one operation of the at least one combined respiratory therapy device.

[0006] In another embodiment, a method for remotely controlling at least one combined respiratory therapy device by a clinician device is provided. The method includes receiving, in a clinician device in data communication with the at least one combined respiratory therapy device, patient data representing at least one physiological parameter associated with a patient, and generating a graphic representation of the received patient data on an associated display of the clinician device. The method further includes receiving, via the associated display, selection data corresponding to a selected therapy adjustment, and communicating the selected therapy adjustment to the at least one combined therapy device. The clinician device includes a processor that communicates with a memory storing instructions, the instructions being executed by the processor to cause the processor to implement the method.

[0007] In yet another embodiment, a clinician device is provided for remotely controlling at least one combined respiratory therapy device by a clinician device. The clinician device includes a processor that communicates with a memory, a network interface configured to communicate with the processor and to communicate with at least one combined respiratory therapy device via an associated computer network, and a display configured to communicate with the processor and to display a graphical user interface associated with at least one operation of the at least one combined respiratory therapy device. The memory stores instructions that, when executed by the processor, cause the processor to receive, via an associated network, patient data representing at least one physiological parameter associated with a patient of the at least one combined respiratory therapy device, and to generate a graphical representation of the received patient data on the display. The memory further receives, via the display, selection data corresponding to a selected therapy adjustment, and stores instructions for communicating the selected therapy adjustment to the at least one combined respiratory therapy device via the associated computer network. The present invention provides, for example, the following items. (Item 1) A combined respiratory therapy device, a blower for providing negative pressurized air to a mouthpiece coupled to a patient's airway, an air pulse generator configured to deliver an air pulse to at least one of clothing worn by the patient or a nasal interface worn by the patient, a network interface communicating with an associated computer network, a controller including a processor communicating with a memory storing instructions, the instructions being executable by the processor to execute a combined respiratory therapy prescription, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combined respiratory therapy device over a time period, each of the plurality of different therapy sessions including a mucus extraction therapy, and a controller, a display configured to display a graphical user interface communicating with the controller and associated with at least one operation of the combined respiratory therapy device A combined respiratory therapy device comprising. (Item 2) The graphical user interface further comprises a cough icon associated with a cough on-demand operation of the combined respiratory therapy device, and in response to selection of the cough icon, the controller is configured to operate the air pulse generator for providing an inspiratory flow to the patient and the blower for providing an expiratory suction pressure to the patient. The combined respiratory therapy device according to item 1. (Item 3) The graphical user interface further comprises an emergency icon associated with an emergency operation of the combined respiratory device, and in response to selection of the emergency icon, the controller is configured to operate the blower and the air pulse generator to provide continuous pulmonary ventilation to the patient. The combined respiratory therapy device according to item 1. (Item 4) The graphical user interface further comprises a therapy enhancement icon associated with a therapy enhancement operation of the combined respiratory therapy device, and in response to selection of the therapy enhancement icon, the controller is configured to operate the combined respiratory therapy device at a preselected level. The combined respiratory therapy device according to item 1. (Item 5) The graphical user interface displays a first-level enhancement icon and a second-level enhancement icon in response to the selection of the therapy enhancement icon, and each of the first and second level enhancement icons corresponds to an individual first and second therapy enhancement operation of the combined respiratory therapy device. The combined respiratory therapy device according to item 4. (Item 6) The graphical user interface further includes a customization icon associated with the customization of the therapy operation of the combined respiratory therapy device. In response to the selection of the customization icon, the controller is configured to sequentially generate a series of screens associated with the operation of the combined respiratory therapy device. The combined respiratory therapy device according to item 1. (Item 7) The graphical user interface displays a cough inhalation pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the selection of the customization icon. The combined respiratory therapy device according to item 6. (Item 8) The graphical user interface displays a cough exhalation (inhalation) pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the selection of at least one of the low, normal, or high icons on the cough inhalation pressure adjustment screen. The combined respiratory therapy device according to item 7. (Item 9) The graphical user interface displays a cough cycle duration adjustment screen including icons for short duration, normal duration, and long duration in response to the selection of at least one of the low, normal, or high icons on the cough exhalation (inhalation) pressure adjustment screen. The combined respiratory therapy device according to item 8. (Item 10) The graphical user interface displays a cough sensitivity adjustment screen including icons for weak, normal, and strong in response to the selection of at least one of the short, normal, or long icons on the cough cycle duration adjustment screen. The combined respiratory therapy device according to item 9. (Item 11) The graphical user interface displays a ventilation inhalation pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the selection of at least one of the weak, normal, or strong icons on the cough sensitivity adjustment screen. The combined respiratory therapy device according to item 10. (Item 12) The combined respiratory therapy device according to item 11, wherein the graphical user interface displays a ventilation sensitivity adjustment screen including icons for weak, normal, and strong in response to selection of at least one of the low, normal, or high pressure icons of the ventilation intake adjustment screen. (Item 13) The combined respiratory therapy device according to item 8, wherein the graphical user interface displays a ventilation duration after a cough adjustment screen including icons for short duration, normal duration, and long duration in response to selection of at least one of the weak, normal, or strong icons of the ventilation sensitivity adjustment screen. (Item 14) The combined respiratory therapy device according to item 13, wherein the graphical user interface displays an oscillation adjustment screen including icons for slow / strong, normal, and rapid / shallow oscillation in response to selection of at least one of the short, normal, or long icons of the ventilation duration adjustment screen. (Item 15) The combined respiratory therapy device according to item 14, wherein the controller of the combined respiratory therapy memorizes each selection received via the graphical user interface in an associated memory. (Item 16) The combined respiratory therapy device according to item 1, wherein the graphical user interface includes a plurality of icons associated with corresponding multiple operations of the combined respiratory therapy device, and the controller is configured to receive selection of at least one of the plurality of icons from at least one of a physician computing device or a therapist computing device via the network interface. (Item 17) The combined respiratory therapy device according to item 16, wherein at least one of the physician computing device or the therapist computing device is located remotely from the combined respiratory therapy device. (Item 18) The combined respiratory therapy device according to item 1, wherein the blower and the air pulse generator reside on physically separate circuits. (Item 19) The combined respiratory therapy device according to item 18, wherein each of the plurality of different therapy sessions comprises a lung ventilation therapy or a lung volume increment therapy substantially immediately after the mucous extraction therapy. (Item 20) A system for problem priority device control of at least one combined respiratory therapy device, At least one combined respiratory therapy device, a network interface that communicates with an associated computer network, and a controller including a processor that communicates with a memory storing instructions executable by the processor to execute a combined respiratory therapy prescription, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combined respiratory therapy device over a time period, a display configured to communicate with the controller and display a graphical user interface associated with at least one operation of the combined respiratory therapy device At least one combined respiratory therapy device comprising: At least one clinician computing device configured to communicate with the at least one combined respiratory therapy device via the associated computer network and control at least one operation of at least one combined respiratory therapy device A system comprising: (Item 21) The system according to item 20, wherein the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one combined respiratory therapy device, and selection of one of the plurality of icons controls the at least one combined respiratory therapy device and performs the corresponding one of the plurality of operations. (Item 22) The system according to item 21, wherein selection of one of the plurality of icons is received via a display. (Item 23) The system according to item 21, wherein the at least one clinician computing device further comprises a graphical user interface corresponding to the graphical user interface of the at least one combined respiratory therapy device. (Item 24) The system according to item 23, wherein selection of one of the plurality of icons is received via the graphical user interface of the at least one clinician computing device via the associated computer network by the at least one combined respiratory therapy device. (Item 25) A method for remotely controlling at least one combined respiratory therapy device by a clinician device, the method comprising: Receiving, at the clinician device, patient data representing at least one physiological parameter associated with a patient in data communication with the at least one combined respiratory therapy device; Generating, on an associated display of the clinician device, a graphical representation of the received patient data; Receiving, via the associated display, selection data corresponding to a selected therapy adjustment; Communicating the selected therapy adjustment to the at least one combined therapy device; Including; The clinician device includes a processor communicating with a memory storing instructions, the instructions being executed by the processor to cause the processor to perform the method. (Item 26) The method according to item 25, further comprising establishing at least one of video communication or audio communication between the clinician device and the at least one combined respiratory therapy device. (Item 27) The method according to item 25, further comprising generating, on an associated display of the clinician device, a graphical user interface associated with at least one operation of the at least one combined respiratory therapy device. (Item 28) The graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one combined respiratory therapy device, selection of one of the plurality of icons controlling the at least one combined respiratory therapy device and performing the corresponding one of the plurality of operations. The method according to item 25. (Item 29) A clinician device for remotely controlling at least one combined respiratory therapy device by a clinician device, the clinician device comprising: A processor communicating with a memory; A network interface configured to communicate with the processor and communicate with at least one combined respiratory therapy device via an associated computer network; A display configured to communicate with the processor and display a graphical user interface associated with at least one operation of the at least one combined respiratory therapy device; Comprising; The memory stores instructions, which are executed by the processor, and cause the processor to receive patient data representing at least one physiological parameter associated with a patient of the at least one combined respiratory therapy device via the associated network; generate a graphic representation of the received patient data on the display; receive selection data corresponding to a selected therapy adjustment via the display; communicate the selected therapy adjustment to the at least one combined respiratory therapy device via the associated computer network A clinician device that causes it to perform. (Item 30) The memory of the clinician device according to item 29 further stores instructions for establishing at least one of video communication or audio communication between the clinician device and the at least one combined respiratory therapy device. (Item 31) The graphical user interface of the clinician device according to item 29 further comprises a plurality of icons corresponding to a plurality of operations of the at least one combined respiratory therapy device, and selection of one of the plurality of icons controls the at least one combined respiratory therapy device and performs the corresponding one of the plurality of operations.

Brief Description of the Drawings

[0008] This disclosure is illustrated as an example and is not illustrated as a limitation of the accompanying figures. The figures may illustrate one or more embodiments of the present disclosure, either alone or in combination. For the sake of simplicity and clarity of illustration, the elements illustrated in the figures are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated compared to other elements for the sake of clarity. Further, reference labels may be repeated between figures to indicate corresponding or similar elements if deemed appropriate.

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DETAILED DESCRIPTION

[0037] (Detailed Description) The concepts of the present disclosure are susceptible to various modifications and alternative forms, and specific embodiments thereof are shown by way of example in the drawings and are described in detail below. However, it should be understood that the intention is not to limit the concepts of the present disclosure to the specific forms disclosed, but rather to cover all modifications, equivalents, and alternatives consistent with the present disclosure and the appended claims.

[0038] Referring to FIG. 1, a system 100 for managing a combined respiratory therapy provided to a person using a combined respiratory therapy device 110 includes several different components of computerized functionality, represented herein as modules for ease of discussion. Illustratively, these modules include a configurable user interface module 114 and a combined respiratory therapy device control module 120. In various embodiments of the system 100, the configurable user interface module 114 may include one or more other modules 112, 122, 130, 132, 134, 140, 142, 144. Each of the modules 114, 120, 112, 122, 130, 132, 134, 140, 142, 144 may be implemented as computer software, firmware, hardware, or a combination thereof, according to the specific design or implementation requirements of the system 100. Further, any or all of the modules 114, 120, 112, 122, 130, 132, 134, 140, 142, 144 may, in some embodiments, be implemented as part of the combined respiratory therapy device 110 (e.g., as a “stand-alone” system), while in other embodiments, some of the modules 114, 120, 112, 122, 130, 132, 134, 140, 142, 144 may be implemented on one or more other computing devices (e.g., a mobile device or a more conventional desktop-style or laptop-style computer). As will be described in more detail below, the configurable user interface modules 112, 122, 130, 132, 134, 140, 142, 144 may be selectively activated and authorized in the device 110 or one or more other computing devices to facilitate interaction with and control of the combined device 110 by an authorized person or different types of authorized persons. Such authorized persons may include clinicians (e.g., physicians), respiratory therapists, nurses, family members, and other caregivers, as well as patients receiving the combined respiratory therapy.For ease of discussion, any such person may be referred to herein as a "user" or "users" of the system 100.

[0039] The prescription generator module 112 enables a user (e.g., a clinician) to generate a combined respiratory therapy prescription that is used in a user-friendly manner, e.g., using graphical, audio, and / or video features. Thus, the prescription generator module 112 alleviates the need for a user to spend time learning how to use non-intuitive buttons, dials, or the like on parts of the therapy device that often have limited footprint for higher performance user interface features. The combined respiratory therapy prescription can include one or more integrated combinations of different respiratory therapies that are scheduled to occur at various times of the day. For example, in some embodiments, the combined respiratory therapy prescription integrates repeated cycles of cough assistance (e.g., mucokinetics and / or mucus extraction therapy) with pulmonary ventilation therapy and / or lung volume recruitment therapy. The combined respiratory therapy prescription can be converted into machine-readable instructions by the prescription converter module 122. Such instructions can be read by the hardware components (e.g., a microprocessor) of the combined device 110 and executed to control the provision of the combined respiratory therapy to a patient. Once generated, the combined respiratory therapy prescription and / or its machine-readable version may be stored within a computer memory, e.g., within a computerized data structure such as the combined respiratory therapy prescription database 118.

[0040] The stored combined respiratory therapy prescription or a part thereof can be accessed and viewed by the person who generated the prescription or by other users (e.g., respiratory therapists, other clinicians, caregivers, or patients) using the data sharing module 136. Thus, the data sharing module 136 presents the combined respiratory therapy prescription in a form that is easy to understand and customizable by or for a particular user. In some embodiments, the data sharing module 136 may enable a certain category of authorized persons to view certain data or make certain types of changes to the combined respiratory therapy prescription. For example, a clinician may be enabled to view or change any aspect of the combined respiratory therapy prescription, while a therapist may be enabled to view the prescription and change only certain parts thereof (e.g., the inspiratory or expiratory (suck-in) pressure within a limited defined range, or the therapy start time), but not others (e.g., the therapy duration). Similarly, access restrictions may be imposed on the ability of a patient or a family member to view and change the combined respiratory therapy prescription.

[0041] In some embodiments, the user interface module 114 includes a problem priority device control module 140 that enables a user to adjust a patient's therapy administration schedule during the progress of the therapy, whether in response to changes in the patient's condition observed by the user or in response to some other trigger condition. For example, in some embodiments, the prescription converter module 122 may receive data such as information about the current status of the therapy or the patient's condition from the combined device 110 during the progress of the therapy. Such data obtained from the device 110 can be displayed to the user in a human-readable form using the data sharing module 136. Changes to the patient's therapy may be input by the user in response to data obtained from the combined device 110 or in response to changes in the patient's condition observed by a caregiver, for example, using the problem priority device control module 140.

[0042] Furthermore, in some embodiments, the user interface module 114 may include an audio interface module 142 and may also include a persona configuration module 144. Modules 142, 144 are designed to further improve human / device interaction. For example, the audio interface 142 may play a pre-recorded human voice message that explains how to use the device 110 or explains a therapy that is imminent. The persona configuration module 144 may allow the user to assign a "personality" to the device 110. For example, the persona configuration module 144 may allow the user to select graphical or animated characters and / or a specific voice tone or accent to be used by the device 110 when communicating with the user. Thus, using the system 100, the combined respiratory therapy device 110 can be used to provide a plurality of integrated and coordinated respiratory therapies to a respiratory patient over a period of time in a manner that is both intuitive and non-threatening to the user or patient. Also, the various treatments defined by the respiratory therapy prescription can be customized and adjusted down to the per-breath level as the patient's needs change or evolve over time. Such customization and adjustment can be implemented in response by the combined respiratory device 110.

[0043] The exemplary combination respiratory therapy device 110 is one of a group of combination respiratory therapy devices 110, each of which can be used to provide a plurality of integrated respiratory therapies. The combination device 110 includes a combined respiratory therapy control module 120, a positive pressure air flow patient interface 124, a negative pressure air flow patient interface 126, and in some embodiments, an air pulse patient interface 128. The positive pressure air flow patient interface 124 is designed to supply a positive (e.g., inhalation) pressure to a patient with which the interface 124 is engaged. The negative pressure air flow patient interface 126 is designed to supply a negative (e.g., exhalation) pressure to a patient with which the interface 126 is engaged. The air pulse patient interface 128 is designed to supply an air pulse to a patient's airway, lungs, or chest area and provide, for example, continuous high frequency oscillation (CHFO), continuous positive expiratory pressure (CPEP), and / or high frequency chest wall oscillation (HFCWO).

[0044] The exemplary control module 120 interfaces with the prescription generator module 112 to obtain user-defined and / or user-modified combined respiratory therapy prescriptions. A version of the prescription converter module 122 may be provided at the user interface level (e.g., as part of the configurable user interface module 114) and / or at the device level (e.g., as part of the control module 120) in various embodiments of the system 100. Regardless of whether it is at the user interface level or at the device level, the prescription converter module 122, as needed, converts the prescription into a machine-executable form that can be used to control the application of air flow to the patient via the interfaces 124, 126, 128. For example, if the prescription defines a treatment session to include a cough cycle followed by lung ventilation, the prescription converter module 122 generates the device settings required for the combined device 110 to perform the therapy session. Those device settings may include, for example, specific air pressure levels, indications of whether the air pressure should be positive (e.g., inflation) or negative (e.g., suction), durations for providing the air flow, the number of times to repeat the application of the air pressure, etc. As an example, the device settings for a combined respiratory therapy sequence may include "cough: interface 124 'on' at 25 cm H2O pressure, interface 126 'on' at -30 cm H2O pressure, ventilation: interface 124 'on' at +15 cm H2O pressure, interface 124 'on' at +4 cm H2O pressure, time = 2 minutes". The converter module 122 may further convert these device settings into specific "valve open" and "valve closed" control signals that can be directly received and acted upon by the specific electromechanical components of the device 110.

[0045] Using the combined respiratory therapy device 110, lung volume recruitment therapy and pulmonary ventilation therapy can be integrated with an assisted cough cycle so that assisted ventilation or lung volume recruitment can be automatically coordinated (e.g., alternated) with an assisted cough for each breath when needed. Thus, a mixture of cough assistance and pulmonary ventilation or lung volume recruitment therapy can be customized to the needs of each patient. Further, the combined device 110 eliminates the need to apply two separate devices sequentially. Sequential therapies can be difficult for a patient who is ill or weakened and can leave the patient in a clinically unstable state. Additionally, some embodiments of the combined device 110 are portable so that they can be mounted on and stored in a wheelchair, thereby improving the quality of life of the patient. Still further, in some embodiments, the inspiratory air circuit and the expiratory air circuit of the device 110 are physically separated so that the positive pressure circuit remains clean and unobstructed. Further details of an exemplary combined device 110 are described below in connection with FIG. 3.

[0046] More specifically, the exemplary prescription generator module 112 utilizes a framework of standardized terminology to describe the combined respiratory therapy prescription. Thus, this framework provides a means by which combined respiratory therapy prescriptions can be easily generated, understood, and shared by the various medical practitioners who may be involved in a patient's treatment. In that regard, the exemplary combined respiratory therapy prescription creator module 112 includes a layer formation module 130, a sequence determination module 132, and a patterning module 134. The layer formation module 130 enables a caregiver to select an appropriate combined respiratory therapy device 110 by simply defining different types or "layers" of therapy that the patient needs (e.g., in the graphical user interface of the configurable interface module 114).

[0047] The layer formation module 130 automatically maps the therapy layers selected by the caregiver to one or more combined respiratory therapy devices 110 capable of providing those therapies. In the illustrated embodiment, the therapy layers include a mucus mobilization layer, a mucus extraction layer, a lung volume increment layer, and a pulmonary ventilation therapy layer. Generally speaking, mucus mobilization refers to a respiratory therapy intended to relax chest secretions (e.g., mucus) so that they can be extracted from the lungs by a normal or assisted cough. Mucus mobilization therapy often involves the mechanical application of air pulses, vibrations, or oscillations to the patient's airway, lungs, chest, and / or back by devices such as the VEST or METANEB devices, both of which are available from the Hill-Rom Company, Inc.

[0048] Mucus extraction refers to a therapy that mechanically assists the patient's natural ability to cough or mechanically removes secretions from the lungs when the patient is unable to cough on their own. To perform mucus extraction therapy, the control module 120 may configure the combined device 110 to initiate the therapy, particularly by providing a very large inflation breath (e.g., a "deep lung forced inhalation"). This may be accompanied by the device 110 delivering an inspiratory pressure within a range that exceeds the "chronic" inspiratory pressure that the device 110 would normally use for ventilation or lung volume increment therapy by about 30% to 50%.

[0049] The deep breaths provided by the adjunct device 110 during mucous extraction therapy are intended to maximize the lung contraction force (more rapid flow during exhalation) and help expand any collapsed portions of the lungs. However, because they are large breaths, patients can typically tolerate mucous extraction therapy only in limited "doses". During mucous extraction therapy, the control module 120 synchronizes the assisted inhalation breaths provided by the device 110 with the patient's inhalation effort so that the patient does not exhale during the inhalation phase. The "deep forced inhalation" breaths are followed by an "active" exhalation or "forced exhalation" during which a suction (negative) pressure removes secretions from the airway. The control module 120 similarly synchronizes the suction (negative) pressure with the exhalation phase of the patient's breath. Thus, some forms of mucous extraction therapy that may be provided by the device 110 can be referred to as "mechanical forced inhalation / forced exhalation". With respect to mucous extraction, for example, the inhalation pressure may be set within the range of about +25 cm water column pressure, and the exhalation (suction) pressure may be set within the range of about -30 cm water column pressure. Accordingly, the mucous extraction portion of a combined respiratory therapy prescription may be described as "+25 / -30".

[0050] Mechanical ventilation refers to the therapy that mechanically assists the patient or breathes for the patient using their normal breathing pattern when the patient is unable to breathe on their own. Thus, mechanical ventilation therapy is generally applied in a continuous manner over a certain time period (rather than in a "cycle" - like mucus extraction therapy). In the illustrated embodiment integrated into a single combined respiratory therapy device 110, both mucus extraction and mechanical ventilation therapies include a software - controlled algorithm that synchronizes the machine - generated breathing or mucus extraction with the patient's natural breathing pattern. Mechanical ventilation can be achieved by using a positive - pressure air - flow patient interface 124 that delivers a higher positive pressure during the patient's inhalation and a lower positive pressure during exhalation. The difference between the higher inhalation positive - pressure level and the lower exhalation positive - pressure level (the "pressure span") is what ventilates the lungs. For mechanical ventilation, the inhalation pressure may be set to + 15 cm H2O pressure and the exhalation pressure may be set to + 4 cm H2O pressure. Thus, the mechanical ventilation portion of the combined respiratory therapy prescription may be described as "+15 / +4", whereby the lungs will be ventilated using a pressure span of 11 cm H2O pressure (15 - 4 = + 11).

[0051] To achieve more effectively efficient ventilation, two positive - pressure levels can be synchronized with the patient's breathing pattern. To do this, the combined respiratory therapy device 110 may detect a slight negative "sniff pressure" or negative (inhalation) flow generated by the patient such that the device senses that the patient has started an inhalation (is "desiring to breathe"), and then the device may support that breath using the commanded inhalation pressure. When the device 110 detects that the patient's inhalation flow / pressure / effort is decreasing, the device 110 can conclude that the patient is ready to exhale and switch to a lower (exhalation) positive - pressure setting, which may be known as PEEP (positive end - expiratory pressure).

[0052] In some embodiments, the control module 120 includes software that synchronizes the mechanical assisted breathing provided by the device 110 with the patient's spontaneous breathing. For example, in some embodiments, the control module 120 may track the patient's breathing pattern over time and use the previous breathing pattern to predict future breathing patterns in terms of, for example, the rate of breathing, the duration of inspiration, etc. In some embodiments, the flow waveform or “(chest) rise time” (the speed at which the device 110 reaches the set inspiratory pressure) generated by the device 110 during pulmonary ventilation therapy may be adjustable according to the patient's needs or preferences (a slower rise time is gentler, but a speed that is too slow may cause the patient to become short of breath). The combined respiratory therapy device 110 may use the same or similar techniques as described above to synchronize mucus extraction (assist coughing) with the patient's breathing pattern to maximize the effectiveness and comfort of mucus extraction therapy or for other reasons.

[0053] In addition, when the combined device 110 is used for lung ventilation, the control module 120 can command the device 110 to provide a respiratory "backup" rate when the patient stops breathing on their own or is sedated, in which case the device 110 will deliver automatic breaths based on a timer. Further, when the device 110 is used for lung ventilation, the control module 120 can initiate an alarm to alert the caregiver if the interface 124 becomes disconnected from the patient (e.g., tubing is pulled out, nasal mask drops, etc.). Thus, the combined device 110 can selectively provide several different features depending on the type of therapy it is being used for, where some features (such as backup breathing and alarms) may be applicable to some therapies but not others. The combined respiratory therapy device 110 can use the same or similar techniques as described above to automatically provide mucus extraction (assist cough) to a patient who is asleep, unconscious, or under sedation, e.g., by automatically providing mucus extraction based on a timer while the patient is asleep. Similarly, the control module 120 can initiate an alarm to alert the caregiver if the negative airflow interface 126 becomes disconnected from the patient (e.g., comes out of the patient's mouth).

[0054] Lung volume recruitment refers to a therapy that mechanically inflates the lungs suddenly rather than continuously. When the combined device 110 applies positive pressure airflow for lung volume recruitment, the positive pressure inflates the lungs and thus prevents them from collapsing. This can be done, for example, after each cough cycle during a daytime therapy session to help the patient recover their breath before the next cough. Lung volume recruitment therapy can also be applied after an assist cough therapy session to "consolidate" the lung volume improvements made during the assist cough session and can help the patient recover from the assist cough. Thus, lung volume recruitment therapy can be used when the patient is awake and cooperative.

[0055] Compared to lung ventilation therapy, lung volume recruitment is generally not as highly performant. When performing lung volume recruitment therapy, the adjunct device 110 can synchronize the inspiratory pressure with the patient's breathing pattern, but the need for positive end-expiratory pressure (PEEP) may not exist. The patient is typically awake during lung volume recruitment therapy and is assisting with the process, so more advanced software algorithms for tracking the patient's breathing pattern or providing backup rates or alarms are generally not required as they would be for lung ventilation. For lung volume recruitment therapy, the inspiratory pressure may be set within the range of about +15 cm H2O pressure, and the expiratory pressure may be set within the range of about 0 cm H2O pressure (e.g., not exhaling against any additional pressure). Thus, the lung volume recruitment portion of the combined respiratory therapy prescription can be described as "+15 / 0".

[0056] The sequence determination module 132 enables a caregiver to define, customize, and modify the details of each respiratory therapy treatment session according to the patient's needs (a "treatment session" generally refers to an instance or occurrence of a coordinated combination of respiratory therapies). A treatment session can include several sequentially executed therapies or treatment sequences (such as a treatment sequence consisting of cough assistance followed by lung ventilation therapy) involving the repetition of one or more types of therapies. For example, the sequence determination module 132 can be used to define or specify the number of cough cycles that will be sequentially applied at the start of each treatment sequence, which constitute each cough cycle, define or specify the positive and negative pressure settings for each cough cycle, define or specify the duration of lung volume recruitment or lung ventilation therapy to be applied substantially immediately after a defined number of cough cycles (e.g., without interruption) to complete each treatment sequence, and / or define or specify the number of treatment sequences that will be sequentially applied and that can constitute a treatment session.

[0057] The patterning module 134 enables a caregiver to define the overall pattern of respiratory treatments to be applied to a patient over a time period (e.g., a 24-hour period) defined at actual clock time. For example, a therapy pattern may include a specific number of treatment sequences as described above that start in the morning and end, and similar treatment sessions that start in the evening and end but are preceded immediately by the time period of the mucus mobilization therapy, and a lung ventilation therapy session that starts at night when the patient goes to sleep and ends in the morning when the patient wakes up. Thus, the patterning module 134 enables a caregiver to specify that the combination device 110 start or perform a therapy at a certain time of day. In other words, the patterning module 134 can be used to associate specific start and stop times with various coordinated therapies. The patterning module 134 can be used to illustrate the specific strata of patients for a therapy and their interrelationships at clock time. Thus, the patterning module 134 can provide a useful tool for generating, modifying, and sharing a combined respiratory therapy prescription among interested parties. Thus, in some embodiments, the patterning module 134 visually presents the pattern of respiratory therapy to the user interface of the system 100, for example, as a graphical timeline or other visual representation of the patient's 24-hour respiratory treatment plan. An illustrative example of one such visual representation is shown in FIG. 4, described below.

[0058] The configurable user interface module 114 includes a software-based user interface for various modules 112, 122, 136, 140, 142, 144. For example, in an embodiment including the prescription generator module 112, the user interface module 114 includes a software-based user interface that enables a physician or other qualified medical professional to generate a combined respiratory therapy prescription and store the prescription in a computing device of the system 100 (e.g., within the database 118). In other embodiments, the user interface may alternatively or additionally provide the user with access to the data sharing module 136, the problem priority device control module 140, and / or other modules of the system 100.

[0059] As described above, the data sharing module 136 provides a communication interface by which a combined respiratory therapy prescription or a portion thereof can be presented in a computing device of the system 100 used to generate the combined respiratory therapy prescription for the combined device 110, or by a respiratory therapist involved in the patient's treatment, in another computing device such as a mobile device, or in a computing device located in the vicinity of the patient or used by the patient (such as a personal computer or mobile computing device located in the patient's hospital room or the patient's home). In some embodiments, the prescription is shared between or among devices using an electronic communication interface accessed by the data sharing module 136 that includes one or more input / output modules for data communication via, for example, a standard wired or wireless network interface (e.g., WIFI, cellular, Ethernet®, etc.), one or more wired communication ports (e.g., a universal standard bus port or other port to which a flash drive or cable can be connected), or a combination thereof.

[0060] The prescription generation module 112 enables the generation of a combined respiratory therapy prescription using an interface that is "user-friendly" and then transferred to the combined device 110 for execution, while the exemplary data sharing module 136 enables a specialist respiratory clinician not at the patient's bedside to remotely change or update the patient's respiratory prescription in a timely manner in response to clinical changes in the patient's condition or for other reasons.

[0061] One exemplary implementation of a scenario in which the data sharing module 136 can be used is as follows. The configurable user interface module 114 is configured to include the prescription generator module 112. For example, the prescription generator module 112 is either installed or accessible via a network (e.g., "cloud"), such as a hospital computer used to manage electronic medical records. Using a computer, a physician generates a combined respiratory therapy prescription. The layer formation module 130 automatically selects the combined device 110 to be used to implement the prescription. The patterning module 134 displays the time-series pattern of the therapy prescribed at clock time. The sequence determination module 132 generates the specific details of the treatment sequence that forms the treatment session, including all of the necessary device settings for the selected combined device 110. As a result, the physician can quickly and accurately review, adjust, or modify the patient's combined respiratory prescription via the configurable user interface module 114, for example, using a hospital computer. Another version of the configurable user interface module 114, including the data sharing module 136, may be installed on another computer used by the physician, enabling the physician to view the combined respiratory prescription he or she generated from a remote location, and further from home.

[0062] Yet another version of the configurable user interface module 114, including the data sharing module 136, may be installed on a computer used by a respiratory therapist. By using the data sharing module 136, the respiratory therapist can review a combined respiratory therapy prescription previously generated by a physician (e.g., in a hospital computer). The computer may be a handheld device, or the therapist may transfer the prescription to another computing device that is a handheld or “mobile” device (such as a smartphone, tablet computer, or personal digital assistant) on which another instance of the configurable interface module 114 or a simplified version thereof, including the data sharing module 136, is installed.

[0063] Using data sharing module 136, which is installed directly on a handheld computing device or can be accessed via a network (e.g., "cloud"), a therapist can plan their shift schedule by viewing the 24-hour prescription timeline (e.g., treatment pattern) for all patients under their care and / or other details of the combined respiratory therapy prescriptions. Using a handheld device, a therapist can review the treatment plan at any time, whether the therapist is at the patient's bedside or in a remote location. Using data sharing module 136, a therapist's handheld device can be programmed to issue reminders that can help keep the therapist on schedule by generating audio and / or visual warnings at or before the start time of the patient's next scheduled therapy. Also, using data sharing module 136, a therapist's handheld device can be connected to an electronic communication network (e.g., a hospital paging system, a computer network, or a telecommunications network) and can alert the therapist, for example, when a new combined respiratory therapy prescription is generated or an existing prescription is modified by another caregiver. Further, using data sharing module 136, new or updated combined respiratory therapy prescriptions can be transferred in real time to a therapist's handheld device electronically (e.g., via a direct wired connection or via a wired or wireless network) (where it may be located) or can be downloaded, for example, from a hospital computer to the handheld device. When a therapist finishes their shift, they can transfer the combined respiratory therapy prescriptions for the patients under their care to the handheld device to be used by the next therapist starting their shift by connecting the handheld device using a wired or wireless (e.g., WIFI or Near Field Communication (NFC)) data communication connection.

[0064] When the patient is ready to move, for example, to a different hospital or care facility or to return home, the data sharing module 136 can be used to transmit the patient's combined respiratory therapy prescription, as described above, to the patient's new location via wired or wireless data communication. The combined respiratory therapy prescription should be transferred to a computing device located at the patient's new location in order to define the combined device 110 to be used to implement the combined respiratory therapy prescription, as well as the combination of respiratory therapies (including device settings) to be implemented for a particular schedule and patient, so that the patient's respiratory treatment can continue relatively seamlessly at the new location.

[0065] The illustrative problem priority device control module 140 interfaces with the prescription conversion module 122 and implements on-the-fly direct changes to the patient's combined respiratory therapy prescription according to the patient's preferences or as the patient's health status changes, e.g., in real time during the patient's therapy. The problem priority device control module 140 includes computer logic and data (e.g., a look-up table or the equivalent) that map the various device settings of the combined device 110 to different clinical states. For example, the problem priority module 140 may derive trigger conditions as well as desired therapy changes from evidence-based guidelines or the patient's own treatment history data (which may indicate therapies that have been successful or unsuccessful for the patient to date). Thus, the problem priority module 140 enables caregivers and others to modify the patient's combined respiratory therapy prescription simply by indicating clinical changes to the problem priority module 140. For example, a therapist may notice that the patient is currently unable to cough up secretions without assistance. In this scenario, the caregiver may enter "unable to cough secretions" into the problem priority module 140 using, for example, the graphical user interface provided by the configurable user interface module 114. The prescription conversion module 122 converts the clinical change into an appropriate device setting change for the combined device 110. In embodiments where the problem priority module 140 is not integrated with the combined device 110, the data sharing module 136 transfers the device setting change directly to the combined device 110 that implements the device setting change. In other words, the problem priority device control module 140 enables direct automatic prescription revision without requiring the user to view or configure the entire prescription.

[0066] The illustrative problem - priority device control module 140 can also enable a user to respond to data transmitted by the combined device 110 via the data sharing module 136. For example, based on changes in the data received from the combined device 110 that a caregiver can view using the data sharing module 136, the caregiver can determine that adjustments to the patient's combined respiratory therapy prescription are required as described above, and may use the problem - priority device control module 140 to implement those adjustments.

[0067] One illustrative example of a scenario in which the problem - priority device control module 140 can be used is as follows. Assume that a home care company accepts a new patient who has been discharged from the hospital. Using the data sharing module 136, the patient's combined respiratory therapy prescription is electronically transmitted to the home care company's computer. As a result, the company knows the combined device 110 that needs to be provided for the patient and also knows the patient's specific respiratory therapy treatment plan.

[0068] Using the data sharing module 136 as implemented on the handheld device, a home care therapist employed by the home care company downloads the patient's combined respiratory therapy prescription to the handheld device and brings it to the patient's home. The therapist may then use the data sharing module 136 to transfer the patient's combined respiratory therapy prescription directly to the control module 120 of the combined device 110 (for example, by connecting the handheld device to the combined device 110). If the prescription conversion module 122 is installed on the therapist's handheld device, the prescription may be converted into machine - readable instructions on the handheld device and then directly implemented by the combined device 110. Alternatively, the prescription may be converted by the prescription conversion module 122 of the control module 120.

[0069] During or after a therapy session, the companion device 110 can transmit data about the therapy session (e.g., in the form of a notification message), or data related to the patient's medical condition or the clinician's preferences for the patient's handheld device. Based on this notification and perhaps a phone follow-up with the patient, the clinician can use the problem prioritization module 140 to change the patient's combined respiratory prescription and use the data sharing module 136 to send the new prescription to the device 110. Using the data sharing module 136, the new or changed prescription can be made available on the display of the device 110 or other electronic devices for viewing by, for example, a home care company, other caregivers, the patient, and / or a member of the patient's family.

[0070] The audio interface module 142 includes a software-based user interface for the prescription generator module 112 that enables a patient and / or a family member or other person associated with the patient to view the patient's combined respiratory therapy prescription and compose reminders, warnings, and other messages related to the patient's therapy prescription. In some embodiments, the audio interface module 142 provides a software-driven human voice natural language interface to the companion device 110. The audio interface 142 maps pre-recorded human voice messages (or computer-synthesized spoken natural language messages) to various aspects of the patient's combined respiratory therapy prescription such that they can be desired by the patient or configured by a caregiver or family member. For example, the recorded message may provide instructions on how to use or adjust the settings of the companion device 110. These instructional types of messages may be timed to be played prior to the start of a therapy session or in response to a user's request. For example, the patient may enter a coded question such as "How do I turn on this device?", and in response, the audio interface 142 may provide the requested instructions.

[0071] In some embodiments, the audio interface 142 may be programmed to play recorded messages that are either triggering or reassuring at appropriate times before, during, or after a therapy session. In some cases, the content and timing of these types of messages are based on patient preferences, focus groups, and / or research related to the psychology of people with chronic diseases. For example, patients with chronic diseases may have a psychological profile that can impair their compliance with the use of respiratory therapy devices and other medical devices, such as chronic anxiety or social or behavioral disorders. In addition, pediatric patients may be particularly afraid of mechanical devices. Thus, the use of respiratory treatment devices and other medical devices may be perceived by many patients as a burden rather than a benefit, resulting in poor medication compliance and limited device effectiveness. The audio interface 142 is therefore designed to implement the concept of anthropomorphism (attribution of human characteristics to non-living things) to improve patient compliance with the combined respiratory therapy prescriptions by making the device 110 more attractive and enjoyable to use.

[0072] The audio interface 142 also enables a patient or other user to select the timing of a desired message (e.g., from a list of options presented on the touch screen display of the configurable user interface module 114). For example, the patient may specify that the message should be played in the morning, in response to the patient's awakening, before the start of a therapy session, during a therapy session, after a therapy session, and / or at bedtime. In other words, a particular recorded message may be linked to one or more portions of a patient's combined respiratory therapy prescription (e.g., a therapy session and / or a therapy sequence) over the course of a treatment pattern (e.g., a 24-hour timeline).

[0073] In an illustrative embodiment, the audio interface module 142 interfaces with a persona configuration module 144 that enables a patient to select an identity or personality to be assigned to the companion device 110. An example of a user interface that may be implemented by the configurable user interface module 114 in connection with the persona configuration module 144 is shown in FIG. 5. In FIG. 5, an illustrative display screen 500 includes several selectable options 510 that embody different personas or “mascots,” each of which may be attributed to the companion device 110. Selection of an option 510 automatically configures the characteristics of the voice (e.g., pace, tone) and the content of a prerecorded audio message to correspond to the selected persona / mascot. In some embodiments, a graphical or animated depiction of the selected character may also be displayed to the user.

[0074] The exemplary displacement screen 500 is a touch-sensor screen such that the selection of an option 510 can be accomplished by a patient or another user simply touching the desired option on the screen with a hand, finger, stylus, or the like. Once an option 510 is selected, the persona configuration module 144 configures the content, timing, voice, and intonation of a prerecorded audio message to correspond to the selected persona. To do so, the persona configuration module 144 may select and download a recorded message from a prerecorded message database that is labeled or otherwise associated with the selected or marked persona. For example, a prerecorded message database may associate the characteristics of "reliable," "indomitable," and "tough" with the persona of "Bulldog Winston." Thus, the combined device 110 can be customized to project a set of human characteristics that appeal to the patient so that the patient perceives the device 110 not as an inanimate object that is threatening or burdensome, but rather as a friend or ally, thereby facilitating the relationship between the patient and the combined device 110.

[0075] One illustrative example of a method that can be used to customize the message output provided by the combined device 110 by the audio interface module 142 and the persona configuration module 144 is as follows. Assume that the patient desires that the combined device 110 exhibit the humanity of "indomitable" and "trustworthy". The patient can use the touch screen display to input these desired characteristics into the audio interface module 142 (e.g., by selecting them from a drop-down list). The persona configuration module 144 maps the patient's options to one or more predefined personas that are displayed within a list 510 of selectable options on the display screen 500. From the list 510 of options, the patient selects option D, "Power Girl". As a result, the audio interface 142 plays a reassuring message such as "I'll help you breathe comfortably all night. If you need to cough, please press the thumb switch immediately. Please leave it to me with confidence. See you again tomorrow morning!" immediately before the combined device 110 starts a therapy session to assist the patient's breathing during sleep every night.

[0076] In some embodiments, aspects of the audio interface 142 are adapted for use by a clinician, therapist, or other user as an alternative to, or in addition to, its use related to the patient. For example, the audio interface 142 may be configured to output instructions for preparing a combined respiratory therapy prescription or instructions for using the combined device 110 in a natural spoken language form to a caregiver. As another example, the audio interface 142 may be configured as an interface to the problem priority module 140 of the device control module 140 as described above. Additional graphical user interface screens for display on the touch screen display 500 are discussed with respect to FIGS. 12-16L below.

[0077] Referring now to FIG. 2, an exemplary method 200 is shown that is executable as a computerized program, routine, logic, and / or instructions to generate a combined respiratory therapy prescription for a patient by one or more of the combined respiratory therapy prescription generator modules 112 and / or other modules of system 100. Method 200 may be considered as an example of how the combined respiratory prescription generator module 112 may operate. In that case, the primary user is likely to be a physician who uses method 200 to generate a prescription for one of that patient. At block 210, method 200 receives information about the patient's respiratory state. Such information may include, for example, symptoms or recent changes in the patient's clinical condition that may be input by a clinician such as a physician, or by a caregiver, or even by the patient or a family member (e.g., using the problem priority device control module 140). At block 212, method 200 determines a therapy layer (e.g., mucus mobilization 214, mucus extraction 216, lung volume increment 218, lung ventilation 220) associated with the information about the patient's medical condition received at block 210. For example, if the input at block 210 indicates that the patient is having difficulty generating a productive cough on their own, method 200 maps that information to one or more of the therapy layers 214, 216, 218, 220 that are targeted at providing cough assistance. In this case, those therapy layers include the mucus extraction layer and either the lung ventilation layer or the lung volume increment therapy layer. Alternatively, method 200 may receive information about the patient's respiratory state from a clinician who creates a combined respiratory therapy prescription as described above, and the clinician may select and determine the therapy layer (e.g., manually) by themselves, for example, using the combined respiratory therapy prescription generator module 112.

[0078] The determination of whether to select lung ventilation 220 or incremental lung volume 218 can be based on additional input received in one or more of modules 114, 120, or on stored information about the patient's current health status or clinical history. For example, in block 212, method 200 may access an electronic medical record associated with the patient and thereby determine that the patient has previously responded well to lung ventilation therapy provided after mucus extraction therapy. As another example, method 200 may access date and time information automatically maintained by system 100 and then determine that the patient is likely to be awake and able to participate in the therapy session at the time, and as a result, select the incremental lung volume therapy layer 218 instead of the lung ventilation therapy layer 220.

[0079] Once a therapy layer associated with the patient's condition is determined at block 222, method 200 automatically selects an appropriate combination device 110 from a group of combination respiratory therapy devices based on the therapy layer determined at block 212. Illustratively, the group of combination devices includes four combination devices 224, 226, 228, 230. The mapping of therapy layers 214, 216, 218, 220 that can be provided by each of devices 224, 226, 228, 230 is illustratively shown at block 222 by lines connecting the combination devices corresponding to the various therapies. For example, combination device 224 can be used to provide both mucus extraction therapy and lung ventilation therapy. Combination device 226 can provide both mucus extraction and lung volume increment. Combination device 228 can provide all three of mucus mobilization therapy, mucus extraction therapy, and lung ventilation therapy. Combination device 230 can provide all three of mucus mobilization therapy, mucus extraction therapy, and lung volume increment therapy. Method 200 determines at block 212 which of combination devices 224, 226, 228, 230 should be selected based on the capabilities of each device related to therapy layers 214, 216, 218, 220 that are determined to be required by the patient. For example, if the patient requires mucus mobilization, method 200 may select either device 228 or device 230 instead of device 224 or device 226. If the patient requires cough assist therapy but can breathe otherwise on their own, method 200 may select device 226 or device 230 instead of device 224 or device 228.

[0080] In block 232, once the combination device is selected, method 200 obtains from the user the information needed to prepare a combined respiratory therapy prescription for the patient using the combination device 110 selected in block 222. To do this, method 200 interfaces with the user, defines one or more treatment sessions 234, defines one or more treatment sequences 236 for each treatment session, and defines a treatment patterning 238 over the time period during which the patient undergoes the respiratory treatment. In the illustrated embodiment, a treatment session is composed of several treatment sequences that are applied continuously, e.g., a defined number of times, and are repeatedly continuously, and each treatment sequence includes one or more assisted cough cycles and a pulmonary ventilation or pulmonary volume augmentation therapy that substantially follows immediately thereafter. Thus, the duration of a treatment session can depend on the number of treatment sequences to be provided during the treatment session. Therefore, the process of defining a treatment session or sessions 234 involves method 200 interfacing with the user and specifying the number of treatment sessions to be performed, the start time for each treatment session, and the number of treatment sequences to be performed within each treatment session, over a respiratory treatment cycle or "pattern".

[0081] Next, method 200 interfaces with the user and defines the details of each of the treatment sequences 236 to be performed in each of the treatment sessions defined in block 234. To do this, method 200 interfaces with the user and specifies the number of assisted cough cycles within each treatment sequence, the inspiratory pressure and expiratory (inspiratory) pressure for each cough cycle (e.g., an inspiratory pressure of +25 cm H2O, an expiratory (inspiratory) pressure of -30 cm H2O), the amount (duration) of assisted ventilation to follow the cough cycle (e.g., 2 minutes), and the positive inspiratory and positive expiratory pressure levels for the assisted ventilation therapy (e.g., an inspiratory pressure of +15 cm H2O, an expiratory pressure of +4 cm H2O).

[0082] In block 238, method 200 may interface with the user to define additional respiratory therapies that may be applied to the patient during a respiratory treatment cycle or pattern (e.g., a 24-hour cycle). For example, a caregiver may desire to schedule one or more mucokinetic therapies to occur prior to a treatment session, or add additional daytime or nighttime pulmonary ventilation or lung volume recruitment therapies. Accordingly, in block 238, method 200 interfaces with the user to define start times, stop times, and device settings for each of the additional desired therapies. Additionally, in block 232, method 200 may interface with the user to receive other details related to the combined respiratory therapy prescription. For example, the user may desire to specify that certain portions of the patient's prescription may be modified by the patient or a family member, while other portions may only be modified by the user or an authorized physician, or that some portions may be modified by the patient or a family member with the authorization of the user or physician. Once the combined respiratory therapy prescription is complete (such that the user is satisfied), method 200 electronically communicates the combined respiratory therapy prescription to the combined device 110 for execution by the device 110. As described above, this can be done using a wired or wireless data communication method.

[0083] One illustrative example of user interface 400 that may be provided in connection with a process for generating a respiratory therapy prescription to be used in conjunction with system 100 is shown in FIG. 4. User interface 400 displays a timeline 410, a legend 412 that explains important abbreviations used within timeline 410, various details of respiratory treatment patterns (described below) in their sequential order of events along timeline 410, and a simulation feature 440 that enables the user to view an animated simulation 442 (e.g., an animated graphic or video clip) of the respiratory therapy as it would be applied to the patient's lungs. To view the simulation, the user may select or highlight one of the therapies or treatment sessions displayed on timeline 410 and then select the view simulation button. System 100 then locates and accesses the stored simulation corresponding to the selected therapy or treatment session (e.g., such simulations may be indexed or labeled according to their associated therapies or treatment sessions and stored in a database).

[0084] The exemplary timeline 410 includes two treatment sessions TS-1 and TS-2, as well as a mucus mobilization therapy session M-2 and a nocturnal nasal ventilation therapy session NIV. Each of these sessions has an associated start time. For example, treatment session TS-1 has a start time of 8:00 am, the mucus mobilization therapy session has a start time of 7:50 pm, treatment session TS-2 has a start time of 8:00 pm, and the nocturnal nasal ventilation therapy session has a start time of 10:00 pm. The respective start times and / or end times and durations of these sessions can be varied using selectable markers 418, 420, 430, 432, 434, 436, 438. For example, a caregiver may select or "click" on a marker, drag or slide it horizontally to the right or left, and thereby change the patient's therapy pattern or schedule. Moving a start time marker (e.g., markers 418, 438, 430, 434) to the left will give the therapy an earlier start time, while moving a start time marker to the right will cause the therapy to start later in the day. Moving an end time marker (e.g., markers 420, 430, 432, 436) to the left will shorten the duration of the therapy, while moving an end time marker to the right will expand the therapy duration. In the illustrated embodiment, marker 430 is both a start time marker (for treatment session TS-2) and an end time marker (for mucus mobilization therapy MM). This indicates that the system 100 is where treatment session TS-2 starts substantially immediately in response to the completion of mucus mobilization session MM. Thus, the dependencies between the various therapies can be generated such that their performances can be automatically coordinated.

[0085] Therapy sessions (TS-1, MM, TS-2, NIV) can each have an associated expand / collapse button (e.g., 422, 426, 428). The expand / collapse buttons 422, 426, 428 can be selected to show or hide further details about the therapy session, such as the number of treatment sequences, device settings, etc. In the illustrated embodiment, the expand / collapse button 422 is selected to show further details of the treatment session TS-1. Those details are displayed within window 414. Window 414 shows that the treatment session TS-1 consists of five treatment sequences. The treatment sequences (SEQ1, SEQ2, SEQ3, SEQ4, SEQ5) each have their own start and end markers 444, 448, 450, 452, 454, 456 that the user can slide back and forth horizontally to adjust the duration of the treatment sequence (e.g., adjust the number of cough cycles or the duration of pulmonary ventilation within the treatment sequence). Markers 448, 450, 452, 454 act as both start and end markers, thereby making the start time for the next treatment sequence (e.g., SEQ2) depend on the completion of the previous treatment sequence (e.g., SEQ1) rather than a specific clock time. Each treatment sequence also has an associated expand / collapse button 424, 458, 460, 462, 464. Thus, a caregiver can view and / or modify the details of a specific treatment sequence by selecting the corresponding expand / collapse button 424, 458, 460, 462, 464. In the illustrated embodiment, button 424 is selected to show details for the treatment sequence SEQ1. As shown in window 416, these details include "4 cough cycles assisted with +25 inspiratory pressure / -30 expiratory (inspiratory) pressure and then 2 minutes of pulmonary ventilation at +15 inspiratory pressure / +4 expiratory pressure". The details shown in windows 414, 416 can be hidden again by selecting the corresponding expand / collapse button (e.g., 422, 424). Similarly, simulation 442 can also be hidden again by selecting button 440.In some embodiments, window 416 is bi-directional (e.g., it contains one or more text boxes) such that the details shown therein can be directly edited by a caregiver.

[0086] Referring now to FIG. 3, an illustrative control unit 300 for the combination device 110 is shown in more detail. The control unit 300 is embodied as a housing (e.g., plastic or metal) that, in some cases, contains or supports the electronic and mechanical components shown inside the dashed lines in FIG. 3. In some embodiments, the housing is sized and designed such that the control unit 300 is relatively lightweight and portable. For example, some embodiments of the control unit 300 are configured such that they can be mounted on a patient support device such as a wheelchair, stretcher, elevator, hospital bed, or other patient transport device.

[0087] The housing defines several ports therein to which several patient interfaces 322, 324, 326 can be connected to provide various forms of respiratory therapy to the patient. The positive air flow patient interface 322 is one exemplary embodiment of the positive pressure air flow patient interface 124 shown in FIG. 1. The patient interface 322 is embodied as a nasal-mounted device that contains a pair of air delivery conduits, each of which is configured to engage one of the patient's nostrils. Thus, the patient interface 322 is configured to supply a positive pressure air flow to the patient through the patient's nose.

[0088] Patient interface 324 is one exemplary embodiment of the negative airflow patient interface 126 of FIG. 1. The patient interface 324 is embodied as a mask that engages the patient's oral area and is designed to supply an airflow through the patient's mouth. In the embodiment of FIG. 3, the patient interface 322 is configured to supply only positive airflow, and the patient interface 324 is configured to supply only negative pressure airflow to the patient. In other words, the exemplary patient interface 324 is used only for the negative pressure portion of the assisted cough cycle and is not used to provide pulmonary ventilation or lung volume recruitment therapy. Similarly, the patient interface 322 is used only for pulmonary ventilation, lung volume recruitment, and the inspiratory pressure portion of the assisted cough cycle and is not used during the negative pressure portion of the assisted cough cycle. This configuration of interfaces 322, 324 keeps the positive airflow circuit and the negative airflow circuit separate and thus contamination-free. However, in other embodiments, the interfaces 322, 324 may be combined or integrated as a single patient interface, e.g., a single patient interface having a separate positive airflow circuit and a negative airflow circuit.

[0089] The air pulse patient interface 326 is one exemplary embodiment of the patient interface 128 shown in FIG. 1. In some embodiments, the interface 326 is embodied as a wearable element that can be connected, when worn, to tubing to supply air pulses to the patient's chest region. One example of such a device is the VEST, available from Hill-Rom Company, Inc. Alternatively, or in addition, some embodiments may provide a form of air pulse therapy that uses the negative airflow patient interface 324. For example, a METANEB device or other type of continuous high frequency oscillation (CHFO) device 364 may be connected to the negative airflow patient interface 324. Other devices that provide various forms of air pulse therapy may also be used in a similar manner.

[0090] In the embodiment of FIG. 3, all of the computer programs and other components that provide the functionality of system 100 reside within control unit 300. That is, all of the various features of system 100 provided by the various modules described above can be directly accessed and used in control unit 300. Thus, exemplary control unit 300 includes, therein, a controller 310 that may be embodied as one or more microprocessors, microcontrollers, digital signal processors, or the like. Controller 310 communicates electronically with many of the other elements of control unit 300 via a data communication link or bus 316 (e.g., a controller area network bus or the like). In some embodiments, any of the control module 120, configurable user interface module 114, prescription database 118, and / or their individual sub-modules described above are embodied as software that is stored, for example, in a disk storage device and then loaded into memory 312 (e.g., random access memory (RAM)) at runtime as needed. In some embodiments, a portion of data 118 and / or modules 114, 120 may be embodied as firmware that resides in non-volatile memory. Further, in some embodiments, memory 312 may be integrated with controller 310. Thus, the simplified diagram of FIG. 3 showing the configurable user interface module 114, prescription database 118, and control module 120 embodied within memory 312 that is accessible to controller 310 is intended to encompass all of the various possible embodiments of database 118 and modules 114, 120 regardless of whether they are implemented as software, firmware, hardware, or a combination thereof.

[0091] As shown by the schematic diagram of FIG. 3, control unit 300 may include a control panel 318 that may have its own power supply. An exemplary control panel 318 may include a display screen 320, which may be embodied as a touch screen display supported by the housing of control unit 300. During operation, information about the current device settings as well as the adjunct device 110 such as the therapy being implemented may be displayed on display screen 320. Features provided by modules 114, 120 and / or data accessed from database 118 may be made available through control panel 318 and / or display screen 320 as described above, or may be provided on other computing devices. In other words, any of the features of system 100 described above may be accessible to the user via control panel 318 and / or display screen 320 as described herein, or through other computing devices, in various embodiments of system 100.

[0092] Control unit 300 illustratively includes an audio circuit that consists of an audio interface 372, an audio driver 374, an amplifier 376, and an audio controller 378. The audio circuit is configured so that system 100 can process audio inputs and output audio as audible sound through speakers to implement the features of audio interface 142 described above. The embodiment of FIG. 3 shows the audio circuit as part of control unit 300, but it should be understood that part of audio interface 142 may be implemented in a computing device (such as the user's local computing device) using similar components. Thus, a patient or another user may interact with adjunct device 110 via either control panel 318 or another computing device in various embodiments of system 100.

[0093] The control unit 300 includes a data management module 382, a network connector 384, and a power management module 386. The data management module 382 uses the network connector 384 to manage the communication of data (e.g., a part of a patient's combined breathing prescription, data generated by the device 110 during operation, etc.) from the device 110 to other devices, and vice versa. The power management module 382 interfaces with a power supply source (e.g., a battery or a wall socket) and supplies power to various components of the control unit 300. The network connector 384 may include a wireless network interface, an Ethernet (registered trademark) adapter, and / or other components as required or desired to enable the control unit 300 to communicate electrically with other devices through either a wired network connection or a wireless network connection.

[0094] The finger switch 380 is also provided to the control unit 300 and communicates electronically with the controller 310. A part of the finger switch (e.g., a lever, a dial, a button, or a toggle) is mounted on the housing of the control unit 300 so that it is easily accessible to the patient. The controller 310 is configured to turn on or off the execution of the patient's combined respiratory therapy prescription in response to a signal received from the finger switch 380. For example, in some embodiments, the controller 310 activates or deactivates the assisted cough therapy in response to the finger switch 380. That is, if the patient feels blocked and needs to cough, the patient may activate the finger switch and start the assisted cough therapy. Similarly, if a certain therapy is progressing and the patient becomes uncomfortable, the patient may press the finger switch to interrupt or temporarily stop the therapy.

[0095] The remaining components of the control unit 300 shown in FIG. 3 include mechanical components and electromechanical components for effecting various aspects of a combined respiratory therapy prescription for a patient through patient interfaces 322, 324, 326. In operation, the controller 310 executes the combined respiratory therapy prescription by sending control signals to the various components at appropriate times via bus 316 and several servo control modules 350, 354, 356, 358, 368. Servo control modules 350, 358 control motors 386, 360, respectively, to operate control circuits to operate manifolds 332, 330, respectively, and to control the flow of air generated by air supply 328 (e.g., blower) to patient interfaces 322, 324, 326. Servo control module 354 operates a control circuit to control the generation of air pulses by air pulse generator 352 based on the air flow received from air supply 328 through manifolds 330, 332 and valve 348. Servo control module 356 controls the operation of air supply 328 based on parameters (e.g., on / off, positive / negative air flow, air pressure) supplied by controller 310 according to the combined respiratory therapy prescription. Servo control module 368 operates a control circuit to control the operation of air supply 362 (e.g., compressor) which, in some embodiments, may provide airway clearance therapy, such as intrapulmonary percussion ventilation (IPV), to nasal patient interface 322 through sustained high frequency oscillation (CHFO) device 364, valve 366, and moisture generator 345 (e.g., nebulizer).

[0096] Patient interfaces 322, 324 are each connected to an air supply 328 via manifolds 332, 330. The air circuit 340 for the positive pressure air flow patient interface 322 also includes an air flow sensor 334, a filter 336, and a humidifier 338 to ensure that the air supplied to the patient via the nose is clean, at the correct pressure for the combined respiratory therapy prescription, and slightly moist to avoid overly drying the patient's nasal passages. Similarly, the air circuit for the negative pressure air flow patient interface 324 includes an air flow sensor 342 and a filter 344. The air flow sensors 334, 342 and the pressure sensor 346 each sense air flow and air pressure within their respective circuits and provide air flow and air pressure data to a safety monitoring module 370. The safety monitoring module 370 monitors the air circuits for any malfunction and ensures that respiratory therapy is being provided in accordance with the patient's combined respiratory therapy prescription. In some embodiments, the sensors 334, 342, 346 are used to synchronize the operation of the device 110 (e.g., the timing of the application of positive or negative pressure) with the patient's normal breathing pattern as described above. For example, the sensor 346 may detect the onset of breathing by the patient based on a change in air pressure within the air circuit 340 and, in response, initiate an inspiration phase of a cough cycle, a lung volume recruitment therapy, or a lung ventilation therapy. As described above, in the illustrated embodiment, the air circuits that supply air to the positive pressure air flow patient interface 322 and the negative pressure air flow patient interface 324, including the tubing that connects the interfaces 322, 324 to their respective air manifolds 332, 330, are separated from each other.

[0097] Figures 6-9 illustrate a device control algorithm that can be implemented by system 100 to change in real time various aspects of a patient's combined respiratory therapy prescription (e.g., while the patient is undergoing a respiratory treatment) and its execution by the combined device 110. Using the problem priority module 140, for example, a user (e.g., a clinician, caregiver, patient, or, in some cases, a family member) can input information about the patient's current respiratory state, such as "the patient is unable to cough up secretions." The device control module 140 automatically implements therapy adjustments based on the input according to a defined algorithm and then queries the user to determine whether the adjustment was effective. If the user responds that the adjustment did not assist the patient's condition, system 100 will proceed to the next step in the algorithm as described below with reference to Figures 6-9. If the user responds that the adjustment was effective, system 100 will continue to provide therapy according to the current settings without making any additional changes.

[0098] Referring now to FIG. 6, an exemplary method 600 is shown that is executable as a computerized program, routine, logic, and / or instructions by one or more of the device control module 140 and / or other modules of the system 100 to adjust, either automatically or in response to user input, the patterned interval aspect of a patient's combined respiratory therapy prescription in real time. In this example, the system 100 detects (either automatically based on sensor data or through analysis of user input) that "the patient is unable to cough up secretions." Method 600 begins operating at a patterned (e.g., 24-hour timeline) level at block 610 and determines, at block 612, the intervals of the patient's various therapies over the course of the therapy timeline (e.g., either automatically or by issuing a query to the user). For example, at block 612, method 600 determines the current elapsed time between the patient's cough assist therapy sessions while the patient is awake (e.g., are the sessions more than 4 hours apart?). If the answer is "yes," method 600 updates the patient's prescription at block 614 to change the interval between cough assist therapy sessions during the patient's waking hours to occur every 4 hours (e.g., to increase the frequency of the therapy sessions). If the answer is "no," which means the patient is already receiving cough assist therapy at least every 4 hours while awake, method 600 determines at block 616 whether the interval between therapy sessions is 2 hours or more but less than or equal to 4 hours while the patient is awake. In other words, is the interval between therapy sessions 2 hours or more but not 4 hours or more? If the answer is "yes," method 600 updates the patient's combined respiratory therapy prescription at block 618 such that cough assist therapy sessions occur every 2 hours (e.g., to increase the frequency of the therapy sessions). If the answer is "no," method 600 maintains, at block 620, the current frequency of the cough assist therapy sessions (presumed to be less than or equal to 2 hours).

[0099] Referring now to FIG. 7, an exemplary method 700 is shown that is executable as a computerized program, routine, logic, and / or instructions by one or more of the device control module 140 and / or other modules of the system 100 to adjust in real time the therapy layer formation aspects of a patient's combined respiratory therapy prescription. Method 600 can be used to adjust the frequency of a respiratory therapy session over a period of time, while method 700 is directed to determining whether a particular combined device 110 being used by the patient should be changed. In block 710, a layer formation change algorithm is initiated, either automatically or in response to an input from the user, e.g., indicative of a clinical change in the patient's health status.

[0100] In block 712, method 700 determines (again, either automatically or based on user input) the characteristics of the combined device 110 that the patient is currently using, or the combined device 110 from the group of combined devices described above that is currently in use. For example, method 700 may determine whether the patient is already receiving mucokinetic therapy in addition to, for example, mucous extraction therapy and either lung volume recruitment therapy (e.g., via combined device 224) or lung ventilation (e.g., via combined device 226). If the answer is "yes", method 700 continues to provide the current therapy in block 714 without any changes. If the answer is "no", in block 716, method 700 automatically adds mucokinetic therapy to the patient's combined respiratory therapy prescription or instructs the user to do so. This can be accomplished, for example, by activating the air pulse patient interface 128 of the patient's existing combined device 110 or switching the patient to a different combined device (e.g., device 228 or device 230).

[0101] Further, at block 716, method 700 updates the patient's combined respiratory therapy prescription to add a 10-minute mucolytic therapy session before each scheduled cough assist therapy session. At block 718, method 700 determines whether the patient is already receiving mucolytic therapy using a combined device 110 (e.g., device 230) that is also providing the patient with lung volume recruitment therapy. If the patient is already receiving mucolytic therapy with lung volume recruitment therapy, then at block 720, method 700 displays a message suggesting that the user switch to a device 110 (e.g., device 228) that can provide the patient with lung ventilation therapy as well as mucolytic therapy (instead of lung volume recruitment therapy). If the response is "no" (which means the patient is already receiving both mucolytic and lung ventilation therapy), then at block 722, method 700 displays a message suggesting that the patient continue to use the same device 110 without any changes.

[0102] Referring now to FIG. 8, an exemplary method 800 is shown that is executable as a computerized program, routine, logic, and / or instructions by one or more of the device control module 140 and / or other modules of system 100 to adjust in real time the patterned duration aspect of a patient's combined respiratory therapy prescription. Method 600 can be used to adjust the intervals or time intervals between treatment sessions over the course of a respiratory treatment cycle (e.g., a timeline), while method 800 can be used to adjust the length or duration of individual treatment sessions within a patient's prescription, either automatically or in response to user input. At block 810, a patterned duration change algorithm is initiated in response to system 100, e.g., to determine a clinical change in a patient's medical condition. At block 812, method 800 determines whether the treatment sessions currently defined in a patient's combined respiratory therapy prescription have a duration less than 15 minutes. If so, method 700, at block 814, adjusts the patient's combined respiratory therapy prescription to extend the duration of the treatment sessions to 15 minutes. If not, method 700 makes no changes to any existing specifications regarding the duration of the patient's treatment sessions and leaves them at their current duration of 15 minutes or longer. At block 818, method 800 determines whether the patient is receiving either ventilation or lung volume recruitment therapy for at least 15 minutes after each treatment session. If so, method 800, in some cases, maintains the current settings for ventilation or lung volume recruitment. If not, method 700 adjusts the patient's combined respiratory therapy prescription to extend the duration of the patient's ventilation or lung volume recruitment therapy to 15 minutes.

[0103] Referring now to FIG. 9, an exemplary method 900 is shown that is executable as a computerized program, routine, logic, and / or instructions by one or more of the device control module 140 and / or other modules of system 100 to adjust in real time the sequencing aspects of a patient's combined respiratory therapy prescription. That is, method 900 is directed to adjusting the specific details of a cough assist treatment sequence, for example, in response to clinical changes in the patient's condition that system 100 can automatically detect or receive via user input. Method 900 begins at block 910 in response to determining that the patient is having difficulty removing chest secretions on their own. At block 912, method 900 determines whether the treatment sequence within the patient's current combined respiratory therapy prescription already includes four assisted cough cycles followed by at least two minutes of assisted ventilation. If so, at block 914, method 900 continues therapy according to the existing prescription without making any changes. If not, at block 916, method 900 adjusts the patient's existing respiratory prescription to include four cough cycles followed by two minutes of assisted ventilation.

[0104] In block 918, method 900 determines whether the inspiratory pressure used within the cough cycle is less than 30 centimeters (cm) of water column pressure (e.g., delivered via the nasal patient interface 322). If the answer is "no" (which means the inspiratory pressure is already at least 30 cm of water column pressure), method 900 continues therapy according to the existing prescription without making any changes in block 920. If the answer is "yes", method 900 increases the inspiratory pressure by 1 cm of water column pressure (e.g., up to a maximum of 33 cm of water column pressure) for each of the next three treatment sessions in block 922. In block 924, method 900 checks to see whether the expiratory (inspiratory) pressure (in this case, to the mouth) during the assisted cough cycle is less than -40 cm of water column pressure (inspiratory), i.e., whether the negative pressure is not stronger than 40 cm of water column pressure. If the answer is "no" (which means the expiratory (inspiratory) pressure is already at least -40 cm of water column pressure), method 900 continues therapy according to the existing prescription without making any changes in block 926. If the answer is "yes", method 900 updates the patient's prescription to increase the expiratory (inspiratory) pressure by 2 cm of water column pressure (e.g., up to a maximum of -40 cm of water column pressure) for each of the next three treatment sessions. For example, if the negative pressure is currently set at -30 cm of water column pressure, the suction pressure will increase by 2 cm of water column pressure, i.e., up to a maximum of -36 cm of water column pressure, for each of the next three treatment sessions. In block 930, method 900 determines whether the patient's treatment session is currently defined to include at least five treatment sequences. If the answer is "yes", method 900 continues therapy according to the existing prescription without making any changes. If the answer is "no", method 900 updates the patient's prescription to increase the number of consecutive treatment sequences within each treatment session to five.

[0105] Referring now to FIG. 10, an exemplary method 1000 is shown that is executable as a computerized program, routine, logic, and / or instructions to operate the combination device 110 in real time to provide appropriate respiratory therapy to a patient at an appropriate time by one or more of the control module 120 and / or other modules of the system 100. At block 1010, the method 1000 monitors the clock time to determine whether to initiate a portion of the patient's therapy according to the patient's combined respiratory therapy prescription. For example, if the patient's prescription indicates that the treatment session is to start at 8:00 am, the method 1000 compares the current clock time with the start time of 8:00 am, and if the comparison is successful, proceeds to block 1012. If no therapy is scheduled to start from the current clock time according to the patient's prescription, the method 1000 simply continues to monitor the clock time at block 1010.

[0106] In block 1012, method 1000 determines the type of therapy that needs to be initiated using the combination device 110. If the therapy type is mucus extraction, in blocks 1014 and 1018, method 1000 illustratively initiates a treatment sequence that includes several consecutive coughing cycles. If the therapy type is something other than mucus extraction, method 1000, in block 1016, starts providing therapy by configuring the settings of the combination device 110 for the therapy according to the patient's prescription (e.g., therapy pressure, duration, etc.), and in block 1036, performs the therapy over the prescribed time period. In block 1036, while the therapy is in progress, system 100 receives, in block 1038, input from a user (e.g., a clinician, caregiver, patient, or family member), and in block 1040, adjusts the device settings according to the input. For example, the patient desires to reduce the inspiratory or expiratory pressure and signals the device 110 to do so using the finger switch 380 described above. Method 1000 monitors, in block 1036, the time elapsed during the implementation of the therapy and determines, in block 1042, whether the time has come for the therapy to end (based on the therapy duration specified in the patient's breathing prescription). If the required amount of time has elapsed, the method proceeds to block 1052 and ends the therapy session. If not, the method returns to block 1036 and continues the current therapy.

[0107] Upon returning to block 1014, the difference between the treatment sequence and other types of therapies is that the duration of the treatment sequence is based at least in part on the number of prescribed cough cycle repetitions rather than clock time. Thus, with respect to the treatment sequence, method 1000 keeps track of the number of treatment sequences already carried out in the current treatment session. Thus, in block 1018, the treatment sequence counter is initially set to zero. In block 1018, once the treatment sequence is started, the method proceeds in block 1020 to configure the combined device 110 for the mucus extraction therapy and the number of cough cycles specified in the patient's prescription. In block 1022, method 1000 begins to perform the mucus extraction therapy (e.g., by providing the number of cough cycles specified in the prescription). Since the treatment sequence specifies that the cough cycle is immediately followed by either a short-duration lung volume increment or pulmonary ventilation therapy, method 1000 configures the combined device 110 in block 1024 to provide a lung volume increment therapy or pulmonary ventilation therapy in response to the completion of the cough cycle, and in block 1026, performs the lung volume increment or pulmonary ventilation therapy. To do so, method 1000 changes the pressure setting from that used for the mucus extraction therapy to that appropriate for the lung volume increment or pulmonary ventilation therapy.

[0108] In response to the completion of lung volume augmentation therapy or lung ventilation therapy (e.g., in response to the expiration of the time or duration of therapy provided for such therapy), method 1000, in block 1028, marks the end of the completed cough assist therapy sequence and, in block 1030, increments the number of therapy sequences. In block 1032, method 1000 compares the current number of therapy sequences (e.g., the therapy sequence counter value) with the total number of therapy sequences to be performed during a therapy session as defined within the patient's combined respiratory therapy prescription. If the value of the therapy sequence counter is equal to the total number of therapy sequences to be performed during the therapy session, the therapy session is complete and method 1000 proceeds to block 1034 where it resets the therapy sequence counter to zero and then, in block 1052, ends the therapy session. If the value of the therapy sequence counter is less than the total number to be performed during the therapy session, the method returns to block 1022 to perform another therapy sequence. Similar to other forms of therapy, the therapy sequence may be interrupted and modified by user input in real time. This is illustrated by loops 1044, 1046 and 1048, 1050, each of which operates on loops 1038, 1040 described above in a similar manner. Thus, this description will not be repeated here. In block 1052, method 1000 returns to block 1010, the starting point, and continues to monitor the clock time for the start of the next therapy that is to occur according to the patient's combined respiratory therapy prescription.

[0109] In the foregoing descriptions of methods 600, 700, 800, 900, and 1000, it may be mentioned that the method or system 100 "determines", "checks", "asks the user", etc. Whenever a method or another aspect of system 100 executes computer logic, it should be understood that the required input can be received from the user, automatically calculated, or accessed from a storage location within the computer memory. For example, in the illustrative methods described herein, if the method shows asking the user for input, other embodiments may not require such user input. Instead, for example, the information required may be obtained by accessing from calculations or a stored database or lookup table. Similarly, the illustrative methods described herein as "determining" something may do so by obtaining user input, accessing stored information, or performing calculations as needed. Further, in the illustrative methods 600, 700, 800, 900, and 1000 and other examples described herein, specific values (e.g., air pressure, duration, etc.) are stated. It should be understood that such values are provided for illustrative purposes only and that the present disclosure is not limited thereby.

[0110] Referring now to FIG. 11, an exemplary computing environment 1100 in which the system 100 may be implemented is shown. FIG. 3 illustrates an embodiment in which all features of the system 100 may be directly accessible in the combined device 110, while FIG. 11 illustrates an embodiment in which some of the features of the system 100 may be provided on other devices. Even so, the computing environment 1100 is shown as involving a plurality of components and devices, but in some embodiments, the computing environment 1100 may, in combination with the device 110 and / or other devices, constitute a single computing device (e.g., a hospital computer or a mobile computing device). In other words, as used herein, the terms "system" and "environment" may refer to a single computing device or a combination of a computing device and / or other components.

[0111] The exemplary computing environment 1100 includes a physician computing device 1110, a therapist computing device 1130, a patient computing device 1150, and one or more other computing devices 1170 that communicate electronically with each other and with other computing devices or systems 1170 and the combined respiratory therapy device 110 via one or more electronic communication networks and / or an electrical communication network 1180. The devices 1110, 1130, 1150 are each configured to use a variation of the system 100 that is appropriate for the type of user. For example, in some embodiments, various permissions and access controls may be selected for each type of user when the system 100 is first set up or as new users are added.

[0112] Exemplarily, the prescription generator module 112 resides on the physician computing device 1110, and the portions 118A, 118B, 118C of the combined respiratory therapy prescription database 118 are stored on the respective computing devices 1110, 1130, 1150, respectively. Different portions 118A, 118B, 118C of the database 118 may each include a subset of the database 118. For example, portions 118A and 118B may include prescriptions only for those patients under the care of a particular physician or therapist using devices 1110, 1130, and portion 118C may contain prescriptions only for a particular patient using device 1150. Similarly, portions 136A, 136B, 136C of the data sharing module 136, portions 140A, 140B, 140C of the device control module 140, and portions 122A, 122B, as well as 122C of the prescription converter module 122 may also be specifically configured for the users of the corresponding computing devices 1110, 1130, 1150. For example, the data sharing portion 136A and the device control portion 140A may include an extended set of features and capabilities, while the data sharing portions 136B, 136C and the device control portions 140B, 140C may include more limited functionality based on the intended users of the individual computing devices 1110, 1130, 1150. The prescription conversion portions 122A, 122B, 122C may each have the same or similar functionality, or, in some embodiments, portion 122A may have, for example, a greater prescription conversion ability than portions 122B or 122C. As shown, the audio interface 142 and the persona configuration module 144 reside on the patient computing device 1150. However, as discussed above, some or variations of these modules 142, 144 may be adapted for use by other users such as physicians or therapists, and those portions or alternative versions may reside on one or both of the physician computing device 1110 and the therapist computing device 1130, respectively.

[0113] In some embodiments, the computerized modules of system 100 may be embodied as downloadable software applications, i.e., “apps,” that can be obtained from a centralized storage location on a network (such as an “app store” or “app marketplace” of a private hospital or a home care company). In these embodiments, there may be a single app that is downloadable by all types of users and that is then configured for the user once installed on a particular user's local computing device. Alternatively, the app store may provide different downloadable apps for different user types so that a user can select and download an app that contains the functionality needed by that user. For example, one app may contain the prescription generator module 112, while another app may contain the audio interface and persona configuration modules 142, 144 but may not contain the prescription generator module 112. Of course, permissions and access controls for downloading apps may be set by an authorized person such as a hospital system administrator.

[0114] Exemplary computing devices 1110, 1130, 1150 each include at least one processor 1112, 1132, 1152 (e.g., a microprocessor, a microcontroller, a digital signal processor, etc.), a memory 1114, 1134, 1154, and an input / output (I / O) subsystem 1116, 1136, 1156. Computing devices 1110, 1130, 1150 may be embodied as any type of computing device, such as a server, a corporate computer system, a network of computers, a combination of a computer and other electronic devices, a mobile, portable, or handheld computing device, a smartphone, a personal digital assistant, a laptop computer, a tablet computer, or a desktop computer, etc.

[0115] Although not specifically shown, it should be understood that I / O subsystems 1116, 1136, 1156 typically include, among other things, an I / O controller, a memory controller, and one or more I / O ports. Processors 1112, 1132, 1152 and I / O subsystems 1116, 1136, 1156 are communicatively coupled to memories 1114, 1134, 1154. Memories 1114, 1134, 1154 may be embodied as any suitable type of computer memory device (e.g., volatile memory such as various forms of random access memory). In illustrative environment 1100, I / O subsystems 1116, 1136, 1156 are communicatively coupled to several hardware components including various input devices 1118, 1140, 1158 (e.g., touch screen, microphone, physical keyboard or keypad, buttons, or hard panel controls), at least one data storage device 1126, 1146, 1166, various output devices 1120, 1140, 1160 (e.g., LED, display screen, speaker), one or more other peripheral devices 1122, 1142, 1162 (e.g., audio, graphic, or media adapter), and one or more network interfaces 1124, 1144, 1164.

[0116] Data storage devices 1126, 1146, 1166 may include one or more hard drives or other suitable data storage devices (e.g., flash memory, memory card, memory stick, and / or others). In some embodiments, a portion of prescription databases 118A, 118B, 118C resides, at least temporarily, within data storage devices 1126, 1146, 1166. A portion of prescription databases 118A, 118B, 118C may be replicated into memories 1114, 1134, 1154 during operation for faster processing or other reasons. Further, in some embodiments, a portion of any of the software modules of system 100 may be stored within data storage devices 1126, 1146, 1166 and loaded into memory at runtime.

[0117] The network interfaces 1124, 1144, 1164 may communicatively couple the computing devices 1110, 1130, 1150 to one or more networks 1180. Such other networks may include, for example, local area networks, wide area networks, enterprise clouds, and / or the Internet. Thus, the network interfaces 1124, 1144, 1164 may include wired or wireless Ethernet®, mobile / cellular networks, WI-FI, Bluetooth®, VPN (virtual private network), or NFC (near field communication) devices or adapters, as required, in accordance with the specifications and / or design of a particular network 1180. Accordingly, one of ordinary skill in the art will understand that the network interfaces 1124, 1144, and 1164 enable two-way communication between the individual devices 1110, 1130, and 1150.

[0118] Each of the other computing devices / systems 1170 may be embodied as any suitable type of computing device, such as, for example, a server, a corporate computer system, a network of computers, a combination of a computer and other electronic devices, a mobile device, any one of the foregoing types of electronic devices, or other electronic devices. For example, in some embodiments, the other computing device 1170 may include another computer or computer system in a hospital or other medical facility that launches enterprise-type software applications such as an electronic medical record (EMR) system 1172, an admission, discharge, and transfer (ADT) system 1174, and a medical communication system (e.g., a nurse call system) 1176. Thus, in some embodiments, the system 100 may communicate with one or more of the systems 1172, 1174, 1176. For example, if a patient receiving a combined respiratory therapy using the device 110 has a clinical change in their health condition that requires medical attention, the system 100 may communicate a warning to a nurse or therapist involved via the medical communication system 1176. As another example, the system 100 may obtain data about the patient's medical history or previous treatment history from the electronic medical record system 1172 and use that information to construct or adjust the patient's current therapy prescription. Additionally, the system 100 may interface with the admission, transfer, and discharge system 1174 of a medical facility and, for example, automatically transmit the patient's combined respiratory prescription to a remote computing device in response to the patient's discharge from the facility.

[0119] The computing environment 1100 may include other components, sub-components, and devices not shown in FIG. 11 for clarity of illustration. Generally, the components of the computing environment 1100 are communicatively coupled by signal paths that may be embodied as any type of wired or wireless signal path capable of facilitating communication between individual devices and components, as shown in FIG. 11.

[0120] Turning now to FIG. 12, a main screen 1200 is shown that depicts a graphical user interface for interaction with the combined respiratory therapy devices 224, 226, 228, and 230 depicted in FIG. 2. The implementation shown in FIG. 2 depicts four combined respiratory therapy devices 224-230, although any number of such devices may be utilized in accordance with the systems and methods described herein, and the use of the four devices 224-230 is intended as one exemplary embodiment alone. As shown in FIG. 12, the main screen 1200 is appropriately displayed via the touch screen 500 described above. The main screen 1200 preferably is color-coded and includes four button icons that enable interaction with the devices 224-230 by a patient, therapist, clinician, etc. for control of the devices 224-230 as described below.

[0121] Furthermore, one of ordinary skill in the art will understand that the main screen 1200 may be adapted according to the underlying device 224, 226, 228, or 230 with which the display 500 is associated. Thus, for example, device 1, 224 (mucus extraction and lung ventilation) as well as device 3, 228 (mucus extraction, lung ventilation, and mucus mobilization (oscillation)) may illustrate all four icons, while device 2, 226 (mucus extraction and lung volume augmentation) and device 4, 230 (mucus extraction, lung volume augmentation, and mucus mobilization) may illustrate only three icons, as discussed in more detail below.

[0122] FIG. 12 illustrates an "Emergency" button icon 1202, a "Therapy Enhancement" button icon 1206, a "Customize Therapy for You" button icon 1208, and a "Cough" button icon 1204. According to one embodiment, the Emergency button icon 1208 is illustrated with a "Problem Priority" statement, such as "Can't Breathe!", to provide an indication to a user, such as a patient, about the problems associated with the underlying button icons 1202-1208. In various embodiments, the icons 1202-1208 are color-coded, thereby providing additional distinctive characteristics in cases where the patient is confused, suffering, etc. According to the figure of FIG. 12, the Emergency icon 1202 is depicted in red on the touch screen display 500 and is associated with the combined respiratory therapy devices 1 and 3, respectively, described as 224 and 228 in FIG. 2.

[0123] In response to pressing the button corresponding to the emergency situation (i.e., touching the icon 1202), the corresponding emergency algorithm stored in the memory 312 and executed by the controller 310 (shown in FIG. 3) is activated according to one embodiment of the target application. Those skilled in the art will understand that such activation of the Emergency button icon 1202 enables the devices 224 and / or 228 to immediately respond to acute dyspnea and shortness of breath through the performance of continuous pulmonary ventilation based on the patient's normal settings. FIG. 13 provides an exemplary graphical user interface screen 1300 displayed on the touch screen 500 in response to the selection of the Emergency button icon 1202.

[0124] As depicted in FIG. 13, in this example, the screen 1300 provides an indication for the selected mode and emits a flash associated therewith, or has another visual mark, and the emergency button icon 1202 indicating that the emergency algorithm is activated is presented. The cough button icon 1204 remains displayed on the screen 1300, and a new "Cancel" button icon 1302 is presented on the screen 1300, including a diagram of problem priority explanations, such as "Return to Normal Settings". When the patient presses, i.e., selects, the cough button icon 1204, the device 224 or 228 provides three cough cycles in response to the request.

[0125] According to one implementation contemplated herein, when the emergency button icon 1202 is selected and the emergency operation starts, the devices 224 and / or 228 may automatically switch to battery power in the event of a power loss, such as a power outage, when the ambulance arrives and the patient has to be transported, or unplugging the device, or the like. "Normal settings" refer to a prescription for combined respiratory therapy as discussed and described in U.S. Patent No. 9,795,752 by a layer formation (specific devices 224 - 230 (device 1, 224) selected for its ability such as mucus extraction and lung ventilation), patterning (a 24 - hour timeline indicating the timing of all treatments, such as nocturnal lung ventilation and cough treatment every 4 hours), and sequence determination (the specific number and settings of cough cycles that make up a treatment session, for example, each cough cycle is applied at a pressure of +30 / -30 cm water column pressure, after every 5 cough cycles, the patient gets 1 minute of assisted ventilation, and each treatment session consists of 5 sets of cough cycles followed by ventilation). This will be understood by those skilled in the art.

[0126] When the patient / caregiver turns their attention to the main screen 1200, selecting the "Therapy Enhancement" button icon 1206 prompts the touch screen 500 to display the interface screen 1400 of FIG. 14. As shown in FIG. 14, the "Therapy Enhancement" and "Customize Therapy for You" button icons 1206-1208 are removed, and two new options are presented: the "Enhancement Level 1 - 12-hour Treatment" button icon 1402 and the "Enhancement Level 2 - 25-hour Treatment" button icon 1404. The enhanced treatment screen 1400 further includes a cough icon button 1204, a stop button icon 1302, and an emergency button icon 1202, each of which is accessible to the patient / caregiver from the enhanced treatment screen 1400.

[0127] In response to the selection of the Enhancement Level 1 - 12-hour Treatment button icon 1402 or the Enhancement Level 2 - 25-hour Treatment button icon 1404, the selected icon begins to flash or provides some other suitable visual or auditory indication related to that selection. It should be understood that the patient / caregiver may present issues related to, for example, the inability to cough up phlegm during a normal treatment session. The patient / caregiver may then select the Therapy Enhancement button icon 1206 to automatically enhance the therapy when the patient is retaining respiratory secretions that cannot be coughed up, for example, due to weakness associated with a cold. By using an automated algorithm to immediately enhance the therapy at home, the patient can avoid inpatient care due to lung collapse, pneumonia, and respiratory failure. Further, those skilled in the art will understand that the buttons 1202-1208 and the corresponding algorithms associated with them can also be used by clinicians / caregivers in home care, hospital, and rehabilitation settings simply to manage the patient's clinical status and enable an immediate response to changes.

[0128] The Intensity Level Buttons Icons 1402 - 1404 enable an increase in the frequency of cough treatment sessions and relate to a device that provides lung ventilation, and also increase the duration of lung ventilation per 24 - hour time period. In some embodiments, the devices 224, 226, 228, or 230 may continue convalescence at the final intensity level of the algorithm until the Stop Button Icon 1302 is activated and the treatment is returned to the patient's normal settings / prescription (e.g., treatment sessions every 4 hours over 24 hours). Selection of the Stop Button Icon 1302 on the screen 500 causes the devices 224 - 230 to stop continuous ventilation and return to the normal treatment plan.

[0129] For Device 2, 226 (mucus extraction and lung volume increment), Intensity Level 1 provides treatment sessions every hour for 4 hours, then every 2 hours for 8 hours, then every 4 hours for 24 hours. During this operation, all sets of cough cycles are followed by a lung volume increment based on the patient's normal pressure settings. For example, a 1 - minute lung volume increment after each set of 5 cough cycles. Intensity Level 2 for Device 2, 226 provides treatment sessions every 20 minutes for 1 hour, then every hour for 8 hours, then every 2 hours for 16 hours, then every 4 hours for 24 hours. During this operation, all sets of cough cycles are followed by a lung volume increment based on the patient's normal pressure settings. For example, a 1 - minute lung volume increment after each set of 5 cough cycles. These treatments continue until such time as the Stop Button Icon 1302 is selected for return to the patient's normal treatment plan.

[0130] For device 4, with respect to 230 (mucus extraction, increasing lung volume, and mucus mobilization), intensity level 1 provides treatment sessions every hour for 4 hours, then every 2 hours for 8 hours, and then every 4 hours for 24 hours. During this operation, each session is preceded by oscillatory mucus mobilization, followed by an increase in lung volume based on the patient's normal pressure settings. For intensity level 2 of 230, which is device 4, treatment sessions are provided every 20 minutes for 1 hour, then every hour for 8 hours, then every 2 hours for 16 hours, and then every 4 hours for 24 hours. Similar to intensity level 1, each session is preceded by oscillatory mucus mobilization and followed by an increase in lung volume. These treatments continue until such time as the stop button icon 1302 is selected for return to the patient's normal treatment plan.

[0131] For device 1, with respect to 224 (mucus extraction, pulmonary ventilation), intensity level 1 provides treatment sessions every hour for 4 hours, followed by continuous assisted ventilation after the treatment session. Thereafter, after each treatment session, assisted ventilation is provided every 2 hours for 8 hours, with 1 hour of assisted ventilation. Then, the treatment is provided every 4 hours for 24 hours, with 2 hours of assisted ventilation after each treatment session. According to one embodiment, if an exception regarding assisted ventilation is indicated within the patient's normal treatment prescription, it may be provided throughout the patient's entire sleep time. For intensity level 2 of 224, which is device 1, treatment sessions are provided every 20 minutes for 1 hour, then every hour for 8 hours, then every 2 hours for 16 hours, and then every 4 hours for 24 hours. Each session is followed by continuous assisted ventilation. These treatments continue until such time as the stop button icon 1302 is selected for return to the patient's normal treatment plan.

[0132] Regarding Device 3, for 228 (mucus extraction, lung ventilation, and mucus mobilization (oscillation)), Intensity Level 1 provides treatment sessions every hour for 4 hours, followed by continuous assisted ventilation after each treatment session. Thereafter, treatment sessions are provided every 2 hours for 8 hours, followed by 1 hour of assisted ventilation after each treatment session. Then, treatment is provided every 4 hours for 24 hours, followed by 2 hours of assisted ventilation after each treatment session. Each session is preceded by oscillatory mucus mobilization. According to one embodiment, if an exception regarding assisted ventilation is indicated within the patient's normal treatment prescription, it may be provided throughout the patient's entire sleep time. Intensity Level 2 for 228, which is Device 3, provides treatment sessions every 20 minutes for 1 hour, then every hour for 8 hours, then every 2 hours for 16 hours, then every 4 hours for 24 hours. Each session is preceded by oscillatory mucus mobilization and followed by continuous assisted ventilation. These treatments continue until the stop button icon 1302 is selected for return to the patient's normal treatment plan.

[0133] The therapy customization button icon 1208 tailored to you can be selected by the patient / caregiver to customize the therapy applied to the patient. It should be understood that the therapy customization button icon 1208 tailored to you is visible on the touch screen 500 of each of Devices 1-4 (224-230) according to one embodiment of the subject application. In response to the selection of the customization icon 1208, a series of sequential subsequent displays are presented to the patient / caregiver, enabling the user to fine-tune the settings of Devices 224-230 based on the algorithms presented herein and on each patient's preferences to optimize comfort and effectiveness.

[0134] Turning now to FIG. 15, there is shown a graphical user interface display screen 1500 associated with customization initiated by selection of the customization button icon 1208 by a patient / caregiver. FIGS. 16A-16L provide additional views of various selection components displayed within a selection box 1502 for customizing the settings of devices 1-4 (224-230) according to one embodiment of the target application. The order in which FIGS. 16A-16L are shown is intended to provide one possible implementation of the interaction between devices 224-230 and the user (patient / caregiver) during customization, and other sequences of interaction are also envisioned herein, as will be understood by those skilled in the art. Thus, the sequential series of graphical user interfaces depicted in FIGS. 16A-16L, used for customization of the respiratory therapy devices 224, 226, 228, or 230 employed, may occur in the illustrated sequence or may be modified according to the capabilities of devices 224-230 or the patient's existing therapy.

[0135] Starting with FIG. 16A, the user is presented with customization options for adjusting the cough setting 1504 on the touch screen display 500 of any of devices 1-4 (224-230). However, those skilled in the art will understand that for devices 2 and 4 (226 and 230), the emergency button icon 1202 is not displayed. The user is presented with the option to adjust the cough setting by selecting the "Yes" button icon 1506 or rejecting the option and skipping to the ventilation setting (discussed in FIG. 16F). In response to selection of the "Yes" icon 1506, the display 500 advances to FIG. 16B, in response to which the user is presented with three options for the cough inhalation pressure, namely, low 1512, normal 1514, and high 1516.

[0136] After selection of the inhalation pressure, the display 500 advances to FIG. 16C, and in response, the user is presented with three options for adjusting the cough exhalation (suction) pressure 1518, namely, low 1520, normal 1522, and high 1524. As used herein, the inhalation and exhalation (suction) pressure levels of the cough cycle control the level of the inhalation pressure at the start of the cough cycle and the level of the exhalation (suction) pressure that completes the cough cycle and extracts mucus. In an exemplary embodiment, the pressures (low, normal, high) for inhalation and exhalation (suction) may incorporate the following, namely, "low" which is 2 cm water column pressure below the set pressure level for inhalation pressure and -2 cm water column pressure below the set pressure level for exhalation (suction) pressure, "normal" where both the inhalation pressure and the exhalation (suction) pressure are at the set pressure level, and "high" which is 2 cm water column pressure above the set pressure level for inhalation pressure and +2 cm water column pressure below the set pressure level for exhalation suction pressure.

[0137] After selection of the exhalation (suction) pressure 1518, the customization screen 1500 advances on the touch screen display 500 to the adjustment of the cough cycle duration 1526 in FIG. 16D. In FIG. 16D, the user is presented with three options regarding the duration of the cough cycle, namely, short 1528, normal 1530, and long 1532. According to one embodiment, the duration of the cough cycle 1526 controls the inhalation pressure, the exhalation suction pressure, and the length of the pause. In one embodiment, the following ranges, namely, short = duration 1 second (inhalation pressure), 1 second (exhalation suction pressure), then 1 second (pause), normal = duration 2 seconds (inhalation pressure), 2 seconds (exhalation suction pressure), then 2 seconds (pause), and long = duration 3 seconds (inhalation pressure), 3 seconds (exhalation suction pressure), then 3 seconds (pause) may be used for the presented options 1528 - 1532.

[0138] After that, the customization screen 1500 proceeds to enable the user to adjust the cough sensitivity 1534 in FIG. 16E. As used herein, the cough sensitivity controls the inspiratory pressure level that triggers the inspiratory phase of the cough cycle. The user may select an option of weak 1536, normal 1538, or strong 1540 corresponding to the sensitivity at which the device 224-230 assists with coughing. In one exemplary embodiment, weak 1536 triggers using a minimum inspiratory pressure (e.g., 1 lpm flow rate or 1 cm water column pressure), normal 1538 triggers using an average pressure (e.g., 2 lpm flow rate or 1.5 cm water column pressure), and strong 1540 triggers using an average overpressure (e.g., 3 lpm flow rate or 2 cm water column pressure).

[0139] After adjusting the cough sensitivity 1534 or proceeding directly from the skip option 1508 presented in FIG. 16A, the customization screen 1500 advances to FIG. 16F, and accordingly, the user is enabled to adjust the ventilation setting 1542. It should be understood that the options 1542 for the ventilation setting apply to devices 1 and 3 (224 and 228), and devices 2 and 4 (226 and 230) skip the related steps (screens) shown in FIGS. 16F-16I. As shown in FIG. 16F, the user is presented with options 1542 for adjusting the ventilation setting for devices 1 and 3 (224 and 228) via the selection of the "Yes" button icon 1544 or the "No, skip to oscillation" button icon 1546 (for devices 3 and 4, 228-230). After selecting the "Yes" icon 1544, the customization display screen 1500 presents the ability to adjust the ventilation inspiratory pressure 1548 as shown in FIG. 16G. The user is presented in FIG. 16G with three options, namely, low 1550 = below the set inspiratory pressure by 2 cm water column pressure, normal 1552 = the set pressure level, and high 1554 = above the set pressure level by 2 cm water column pressure. The customization display screen 1500 then proceeds to present the user with the ability to adjust the ventilation sensitivity 1556 as shown in FIG. 16H.

[0140] Figure 16H illustrates three options, namely weak 1558, normal 1560, and strong 1562, for the user (i.e., patient / caregiver) to customize the ventilation sensitivity of device 224 or 228. As envisioned herein, weak 1558 triggers using a minimum inspiratory pressure or flow rate (e.g., 1 lpm flow rate or 1 cm water column pressure), normal 1560 triggers with an average pressure or flow rate (e.g., 2 lpm flow rate or 1.5 cm water column pressure), and strong 1562 triggers with a pressure or flow rate above average (e.g., 3 lpm flow rate or 2 cm water column pressure). Once the sensitivity 1556 is adjusted by the user, the customization display screen 1500 advances to present the user with the ability 1564 to adjust the duration of ventilation after a cough.

[0141] Figure 16I illustrates the options for customizing the duration adjustment 1564 of ventilation after a cough for device 224 or 228. The duration 1564 of pulmonary ventilation after a cough cycle controls the length of time it takes for the patient to "recover" from an assisted cough with pulmonary ventilation. For example, after each group of 5 cough cycles within a treatment session, the device provides pulmonary ventilation for the following time periods, namely short 1566 = 30 seconds, normal 1568 = 1 minute, and long 1570 = 3 minutes. As discussed above, after setting the duration of ventilation after a cough for device 228, which is device 3, or after bypassing Figures 16H - 16I for device 4 (230), the customization screen 1500 advances as shown in Figure 16J to adjust the oscillation setting 1572, and the user is presented with the option to proceed with the adjustment via the "Yes" button icon 1574 or "No" button icon 1576 for Figure 16K. Accordingly, the touch screen display 500 returns to the main screen 1200 shown in Figure 12.

[0142] When the user selects the "Yes" button icon 1574, the customization screen 1500 progresses as shown in FIG. 16K and progresses to the oscillation adjustment 1578 setting. Through FIG. 16K, the user can control the rate and depth of oscillation provided by devices 3 and 4 (228 and 230), enabling oscillations of "slow / strong" (e.g., 4 Hz) 1580, "normal" (e.g., 8 Hz) 1582, and "fast / shallow" (e.g., 12 Hz) 1584. According to one embodiment, the "slow / strong" 1580 option provides a slower and deeper oscillation, the "normal" 1582 option provides an oscillation of average frequency and depth, and the "fast / shallow" 1584 option provides a faster and shallower oscillation.

[0143] Once the user selects the desired value regarding the oscillation adjustment, the customization screen 1500 progresses to FIG. 16L, depicting a setting complete 1586 indication and presenting two options to the user. The user may select the "Start" button icon 1588 to start a new setting, cancel / return to the main screen 1200, or the "Back" button icon 1590 to return to FIG. 16A for further adjustment. In various embodiments, for example, using the touch screen 500, advanced users may zoom in and program intermediate settings for each parameter. For example, additional customization may be provided, such as zooming in on the scale regarding the cough cycle duration, i.e., short IIIIIIIIIIIIIIIIIIIIIIII normal IIIIIIIIIIIIIIIIIIIIIIIIII long, where the symbol III represents multiple intermediate levels between the indicated settings.

[0144] Referring now to FIG. 17, in conjunction with the features and structures disclosed and described above with respect to FIGS. 11 - 16L, one of ordinary skill in the art will understand the capabilities provided herein for a physician (via physician computing device 1110) or a therapist (via therapist computing device 1130) to remotely control the combined respiratory therapy devices 224 - 230. The capabilities and functionality with respect to the components described in FIG. 11 above are further extended through the interaction of the graphical user interfaces depicted in FIGS. 12 - 16L such that user (patient) selection of an icon (as described below) initiates an algorithm (e.g., an action associated with icon selection as described above with respect to FIGS. 12 - 16L) and enables remote control of the combined respiratory therapy devices 1 - 4 (224 - 230) by the physician computing device 1110, the therapist computing device 1130, or the equivalent.

[0145] FIG. 17 provides an illustrative methodology regarding the bidirectional interaction between a clinician device (e.g., devices 1110, 1130 of FIG. 11) and any one or more of the combined respiratory therapy devices 224 - 230, according to one embodiment of the subject application. The illustrative method begins at 1702, in response to which the clinician devices 1110, 1130 establish a bidirectional communication link with one or more of the combined respiratory therapy devices 224 - 230. It should be understood that the bidirectional communication can be established between the various devices 1110, 1130, 224 - 130 via network interfaces 1124, 1144, 1164 as described above with respect to FIG. 11. For illustrative purposes herein, a clinician device such as physician device 1110, i.e., a tablet, smartphone, laptop, etc., is referenced, and thus one of ordinary skill in the art will understand that the term "clinician device" represents either the physician device 1110 and / or the therapist device 1130.

[0146] After establishing two-way communication between clinician devices 1110, 1130 and one or more co-therapy devices 224 - 230, the operation proceeds to 1704. At 1704, patient data is received by clinician devices 1110, 1130 from one or more co-therapy devices 224 - 230 via computer network 1180. According to one exemplary embodiment, devices 224 - 230 transmit data (i.e., physiological patient data) to a managing clinician (e.g., clinician devices 1110, 1130). Examples of data that clinician devices 1110, 1130 may receive from devices 224 - 230 include, but are not limited to, vital signs such as heart rate, respiratory rate, body temperature, hemoglobin oxygen saturation (which may be captured by a nasal thermistor for respiratory rate, for example, and a pulse oximeter for hemoglobin oxygen saturation), minute ventilation of the patient (tidal volume × respiratory rate, for devices capable of providing assisted ventilation), tidal volume (the volume of gas in each breath), the percentage of patient-triggered assisted breaths, leak flow, the inspiratory and expiratory pressures actually delivered (compared to the set pressure), physiological data captured by the co-devices 224 - 230 themselves, and the time of device 224 - 230 use per day, including the patient's compliance with the prescribed therapy (as discussed above).

[0147] In 1706, the clinician devices 1110, 1130 generate a graphical display of the received patient data. It should be further understood that any or all of the vital signs or physiological data (i.e., parameters) referred to above can be presented on the clinician devices 1110, 1130 in a graphical representation or montage on the associated output devices 1120, 1140. According to one embodiment, the values of the associated parameters that are normal may be displayed in green, and the abnormal ones may be shown in red, etc. In such an embodiment, the range of normal values associated with a particular parameter may be displayed in a state where the patient's measured / actual value is shown within or outside the expected range. A particular parameter may be selected in 1708 through a clinician interaction with the clinician devices 1110, 1130 for additional information or access to the therapy devices 224 - 230. The clinician devices 1110, 1130 then send a query to a particular therapy device 224 - 230 in accordance with the selected parameter in 1710.

[0148] The data associated with the selected parameter is then received at 1712 by the clinician devices 1110, 1130 from the particular therapy devices 224 - 230, and in response, the graphical displays on the clinician devices 1110, 1130 are updated at 1714 to reflect the selected parameter and the received data. A determination is then made at 1716 as to whether the clinician requests an audio / video connection with the patient associated with the therapy devices 224 - 230. In response to an affirmative determination, a real-time two-way audio and / or video connection is established at 1718 between the therapy devices 224 - 230 and the clinician devices 1110, 1130. At 1718, after the connection is established, or in response to a determination at 1716 that no patient connection is requested, the operation proceeds to 1720, and in response, a determination is then made as to whether a therapy adjustment has been selected. According to one embodiment, the graphical user interface displayed on the clinician devices 1110, 1130 illustrates button icons similar to those described above with respect to FIGS. 16A - 16L. That is, the clinician may be presented with one of the button icons described above on the clinician devices 1110, 1130, which are remote from the associated therapy devices 224 - 230, and select and activate the various algorithms associated therewith, i.e., provide three coughs, an emergency situation, therapy enhancement, etc. If no therapy adjustment is selected, for example, if the clinician simply desires to talk to the patient, instruct repositioning of a sensor or mask, etc., the operation proceeds from 1720 to 1732 as discussed in more detail below.

[0149] After it is determined that therapy adjustment is desired, the operation proceeds to 1722, and in response thereto, the graphical user interface displayed on clinician devices 1110, 1130 generates a display of patient parameters and expected ranges associated with the selected therapy being adjusted. The operation then proceeds to 1724, and in response thereto, a therapy adjustment associated with the selected parameter is received at clinician devices 1110, 1130. The therapy adjustment is then communicated from clinician devices 1110, 1130 to specific therapy devices 224 - 230 at 1726. As shown above, the therapy adjustment can occur in the manner described above with respect to direct interaction in the graphical user interface 1200 of therapy devices 224 - 230 in FIGS. 12 - 16L.

[0150] The operation then proceeds to 1728, and clinician devices 1110, 1130 receive updated data from therapy devices 224 - 230 in response to the administration of the adjusted therapy. According to one exemplary embodiment, after the therapy devices 224 - 230 provide the adjusted therapy to the patient, vital signs, physiological parameters, etc. (as mentioned above at 1706 and 1722) are provided on clinician devices 1110, 1130, enabling the clinician to confirm whether the adjusted therapy is effective / successful. At 1730, a determination is then made as to whether any additional adjustments to the therapy are required, such as an additional cough, increasing the inspiratory / expiratory pressure, etc. In response to an affirmative determination at 1730, the operation returns to 1722, and in response thereto, a display of patient parameters and expected ranges associated with the selected therapy adjustment is generated on clinician devices 1110, 1130. The operation then proceeds to 1724 - 1730 as discussed above. In response to a determination at 1730 that no additional adjustments to the selected therapy are required, the operation proceeds to 1732.

[0151] Accordingly, in 1732, a determination is made as to whether another parameter has been selected in clinician devices 1110, 1130. When another parameter is to be viewed and / or adjusted by remote clinician devices 1110, 1130, the operation returns to 1708, and the operation of methodology 1700 continues as described above for the next selected parameter. If no additional therapy adjustment is required, the operation regarding FIG. 17 then terminates.

[0152] The foregoing methodology 1700 can be most deeply understood in conjunction with one exemplary interaction between clinician devices 1110, 1130 and therapy devices 224-230. In this example, the display of clinician devices 1110, 1130 includes button icons associated with the adjustment of tidal volume (with respect to devices 224-230 capable of providing pulmonary ventilation). Thereafter, the display of clinician devices 1110, 1130 generates a graphical interface showing the expected range of physiological parameters and the value of the patient's tidal volume parameter. For example, if the tidal volume is expected to be 4 liters + / - 0.5 liters, the graphical display can register a value of 4.25 liters in green indicating normal and a value of 3 liters in red indicating abnormal. As shown above in 1722, the clinician may directly contact the patient (via device 224-230) through the clinician devices 1110, 1130, through individual devices 1110, 1130, 224-230, or via electronic communication (such as audio and / or video) via a telephone. When the tidal volume button icon is selected in clinician devices 1110, 1130 (e.g., steps 1716-1726 of FIG. 17), the clinician devices 1110, 1130 modify the displayed graphical user interface to present new button icons, such as a "tidal volume too low" button icon and a "tidal volume too high" button icon.

[0153] Similar to the interactions described above with respect to FIGS. 12-16L, the control of the respiratory therapy devices 224-230 being used is effected by the clinician devices 1110, 1130 via the selection of button icons that trigger corresponding control algorithms for the operation of the corresponding therapy devices 224-230. Thus, when a clinician touches the "Tidal volume too low" button icon displayed on the clinician devices 1110, 1130, this activates an algorithm (stored in memories 1114, 1126 and executed by processor 1112) that increases the inspiratory ventilation pressure by 2 cm H2O and transmits the new setting to the device controller 120 of the corresponding therapy devices 224-230. Similarly, when a clinician touches the "Tidal volume too high" button icon displayed on the clinician devices 1110, 1130, an algorithm (stored in memories 1114, 1126 and executed by processor 1112) that decreases the inspiratory ventilation pressure by 2 cm H2O and transmits the new setting to the device controller 120 of the corresponding therapy devices 224-230 is activated.

[0154] The clinician may then observe the change in tidal volume that results with the new setting and determine whether the tidal volume has now entered the acceptable range, i.e., the range of the green zone. When the tidal volume has been restored to the green zone, the clinician may select the stop button icon displayed on the clinician devices 1110, 1130 (as described above with respect to the therapy devices 224-230 of FIGS. 12-16L), and the new setting will be persistent for the corresponding therapy devices 224-230. When the tidal volume is still abnormal, the clinician can touch the appropriate button again, i.e., touch "D" again if the tidal volume is still too low, or touch "E" again if the tidal volume is still too high. According to one particular embodiment of the methodology 1700 of FIG. 17, as an added safety feature, after four adjustments, the clinician can no longer use the buttons to change the inspiratory ventilation pressure setting.

[0155] It should be understood that not all of the parameters transmitted from the therapy devices 224 - 230 to the clinician devices 1110, 1130 are appropriate for the button icons associated with the device control algorithms. For example, if the therapy device 224 - 230 is transmitting a body temperature that is too high, the patient has a fever, and the clinician may choose to contact the patient or caregiver via the audio / video connection using the clinician devices 1110, 1130, or alternatively, via telephone. If the therapy device 224 - 230 is transmitting the presence of a high leak flow, the patient's nasal mask may not be fitting properly, and the clinician may choose to electronically troubleshoot this via telephone or with the patient and caregiver who are using the clinician devices 1110, 1130.

[0156] Similarly, sometimes the clinician may choose to manually change the bi-level ventilator prescription by pressing the therapy customization button (as described in more detail above), using the relevant algorithm semi - quantitatively, or using a scale to program specific settings for each parameter (as discussed above) quantitatively, such as by adjusting the individual device settings. In such situations, the bi - directional connection between the clinician devices 1110, 1130 and the therapy devices 224 - 230 makes it possible to effect these changes remotely, thereby allowing the patient to remain in isolation and limiting the clinician's exposure to potential pathogens.

[0157] In addition to the foregoing, various embodiments contemplated herein provide for the incorporation of graphic representations of vital signs and physiological parameters into a patient's electronic medical record. As will be understood by those skilled in the art, a clinician reviewing a patient's electronic chart or documenting a medical note can pull real-time data and ascertain whether any adjustments or communications are needed. In further embodiments, the methodology 1700 described herein enables the use of clinician devices 1110, 1130 memory (or device 224-230 memory) to store various parameters recorded over a specific time period. Those skilled in the art will understand that the ability to grasp the trends of various parameters over a defined time period, such as 6 hours, 24 hours, 3 days, and 1 week, provides valuable insights to the clinician regarding the patient's response to treatment, prognosis, and the impact of changes.

[0158] For example, such an implementation from a central location enables the specialized management of multiple combined respiratory therapy devices at a remote site or alternatively, simply outside the room of a hospitalized patient, so that it should be understood that the clinician does not need to enter the room and be exposed to the pathogens exhaled by the patient.

[0159] In such an implementation, the physician computing device 1110 or the therapist computing device 1130 may be implemented as a tablet, a smartphone app, a personal computer, or other suitable electronic computing device that is located outside the patient's room and is in data communication with the corresponding combined respiratory therapy device in contact with the patient. One of ordinary skill in the art will understand that the displays generated on such a computing device may correspond to the displays illustrated in FIGS. 12 - 17 or, alternatively, may constitute a specialized view that adds additional configuration options for use by the clinician alone. For example, a clinician observing remotely may determine that a patient is under extreme duress, e.g., via video or audio monitoring of the patient. Instead of entering the patient's room, the clinician may remotely select the "Emergency" button icon 1202 and instruct the combined respiratory therapy device 1 or 3 (224 or 228) to implement the emergency algorithm described above.

[0160] According to another exemplary implementation, a clinician observing remotely may observe that a patient associated with a combined respiratory therapy device is experiencing a discomfort that may be alleviated via a particular operation of the combined respiratory therapy device. The clinician may remotely instruct the combined respiratory therapy device 1, 2, 3, or 4 (224, 226, 228, or 230) to increase the amount of therapy provided to the patient via the physician computing device 1110 or the therapist computing device 1130, i.e., via remote selection of the "Therapy Intensification" button icon 1206 that triggers the algorithm associated with the increased therapy described above with respect to FIGS. 12 - 17.

[0161] According to the systems and methods described above, those skilled in the art will understand that: 1) a patient or caregiver can adjust settings via the touch screen on the device itself or perhaps using a tablet or other remote control using an algorithm, and this provides the patient / caregiver with self-directed therapy customization and a rapid response to clinical changes; and 2) a clinician can remotely manage a patient's device via the algorithm and activate a "specialized algorithm" that depends on two-way communication connecting clinician devices 1110, 1130 to the device controller 120 of corresponding devices 224 - 230. As discussed in more detail above, a home care therapist or physician in their office can remotely adjust settings in response to clinical changes that are either 1) reported by the patient / caregiver or 2) triggered by data received from the device when communicating with the managed clinical center via clinician devices 1110, 1130. Thus, as will be understood by those skilled in the art, the foregoing embodiments enable a clinician to remotely manage devices 224 - 230 without entering the patient's clinical environment and avoid exposure to aerosolized pathogens such as the novel coronavirus. In some situations, clinician devices 1110, 1130 may be tablets or smartphones that enable electronic communication with devices 224 - 230 just outside the patient's room, allowing for proximal management and even more remote management of devices 224 - 230. Even further, those skilled in the art will understand that a group of clinicians can remotely manage many patients, enabling a limited number of specialists to remotely manage many patients, preventing clinicians from inadvertently exposing one patient to pathogens obtained from another patient, reducing the amount of individual protective equipment used per patient, and performing equivalents. This is particularly appropriate in the case of a global pandemic such as the novel coronavirus, where treatment is impaired by a shortage of skilled clinicians with knowledge to manage devices that deliver assisted ventilation and mucus clearance.

[0162] In the foregoing description, numerous specific details, examples, and scenarios are set forth in order to provide a more thorough understanding of the present disclosure. It should be understood, however, that embodiments of the present disclosure may be practiced without such specific details. Furthermore, such examples and scenarios are provided for illustration purposes only and are not intended to limit the present disclosure in any way. A person of ordinary skill in the art should be able to implement appropriate functionality using the descriptions provided without undue experimentation.

[0163] References to "an embodiment" in this specification, etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes that particular feature, structure, or characteristic. Such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is within the knowledge of those skilled in the art to bring such feature, structure, or characteristic in connection with other embodiments whether or not explicitly shown.

[0164] Embodiments according to the present disclosure may be implemented in hardware, firmware, software, or any combination thereof. Embodiments may also be implemented as instructions stored using one or more machine-readable media that may be read and executed by one or more processors. A machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device or a "virtual machine" running on one or more computing devices). For example, a machine-readable medium may include any suitable form of volatile or non-volatile memory.

[0165] In the drawings, a specific arrangement or order of schematic elements may be shown for ease of explanation. However, such specific order or arrangement of elements is not intended to imply that a particular order or sequence of processing or intervals of a process are required in all embodiments.

[0166] Generally, the schematic elements used to represent instruction blocks or modules can be implemented using machine-readable instructions in any suitable form, and each such instruction can be implemented using any suitable programming language, library, application programming interface (API), and / or other software development tools or frameworks. Similarly, the schematic elements used to represent data or information can also be implemented using any suitable electronic arrangement or data structure. Further, some of the connections, relationships, or associations between elements may be simplified or not shown in the drawings so as not to obscure the present disclosure.

[0167] The present disclosure should be regarded as illustrative and not restrictive in nature, and all changes and modifications within the spirit of the present disclosure are desired to be protected. For example, aspects of the present disclosure may be described in relation to a particular type and features of a respiratory therapy device, but it should be understood that various aspects are also applicable to other types and features of such devices.

Claims

Claim 1 A combined respiratory therapy device configured to provide a plurality of coordinated respiratory therapies to a patient, wherein the plurality of coordinated respiratory therapies are associated with a patient's normal treatment plan and are configured to provide on-demand immediate respiratory therapy to the patient to treat acute symptoms experienced by the patient during the provision of the patient's normal treatment plan, the combined respiratory therapy device comprising: A blower configured to provide negative pressurized air to a mouthpiece coupled to the patient's airway; An air pulse generator configured to deliver an air pulse to at least one of clothing worn by the patient or a nasal interface worn by the patient; A network interface in communication with an associated computer network; A controller including a processor in communication with a memory storing a plurality of instructions, the plurality of instructions being executable by the processor to perform 1) the patient's normal treatment plan including a combined respiratory therapy prescription and 2) the on-demand immediate respiratory therapy for treating acute symptoms experienced by the patient during the execution of the patient's normal treatment plan, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed over a prescribed period by the combined respiratory therapy device, each of the plurality of different therapy sessions including a mucus extraction therapy, the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions available to the patient during the patient's normal treatment plan, the plurality of different on-demand immediate respiratory therapy sessions being capable of being repeatedly activated by the patient during the execution of the patient's normal treatment plan during the prescribed period, one of the plurality of different on-demand immediate respiratory therapy sessions different from the patient's normal treatment plan being activated by the patient and configured to return the controller to the execution of the patient's normal treatment plan after the execution of the on-demand immediate respiratory therapy or after the patient activates a return to normal patient plan commands, a controller; A user interface display that communicates with the controller, wherein the user interface display is configured to display a graphical user interface including a plurality of icons or a plurality of buttons associated with the plurality of different on-demand immediate respiratory therapy sessions, and the user interface display is configured to activate each of the plurality of different on-demand immediate respiratory therapy sessions when one of the plurality of icons or the plurality of buttons associated with each of the plurality of different on-demand immediate respiratory therapy sessions is selected by the patient, and a user interface display A combined respiratory therapy device comprising the same. **Claim 2** The plurality of icons or the plurality of buttons of the graphical user interface include a cough icon associated with a cough on-demand operation of the combined respiratory therapy device, and in response to the patient selecting the cough icon, the controller is configured to provide the patient with a predetermined number of cough cycle repetitions and return to executing the patient's normal treatment plan after providing the patient with the predetermined number of cough cycle repetitions. Each cough cycle is configured to operate the air pulse generator to provide the patient with an immediate inspiratory flow and to operate the blower to provide the patient with an expiratory suction pressure. The combined respiratory therapy device according to claim 1. **Claim 3** The plurality of icons or the plurality of buttons of the graphical user interface include an emergency icon associated with an emergency operation of the combined respiratory therapy device, and in response to the patient selecting the emergency icon, the controller is configured to operate the blower and the air pulse generator to provide the patient with continuous pulmonary ventilation. The combined respiratory therapy device according to claim 1. **Claim 4** The plurality of icons or the plurality of buttons of the graphical user interface include therapy enhancement icons associated with a therapy enhancement operation of the combined respiratory therapy device, and in response to the patient selecting the therapy enhancement icon, the controller is configured to operate the combined respiratory therapy device at a preselected level. The combined respiratory therapy device according to claim 1.

5. The plurality of icons or the plurality of buttons of the graphical user interface display a first level enhancement icon and a second level enhancement icon in response to the patient selecting the therapy enhancement icon, and each of the first level enhancement icon and the second level enhancement icon corresponds to a first therapy enhancement operation and a second therapy enhancement operation of the combined respiratory therapy device, respectively. The combined respiratory therapy device according to claim 4.

6. The plurality of icons or the plurality of buttons of the graphical user interface include customization icons associated with customization of a therapy operation of the combined respiratory therapy device, and in response to the patient selecting the customization icon, the controller is configured to sequentially generate a series of screens associated with the operation of the combined respiratory therapy device. The combined respiratory therapy device according to claim 1.

7. The graphical user interface displays a cough inspiration pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the patient selecting the customization icon. The combined respiratory therapy device according to claim 6.

8. The graphical user interface displays a cough expiration (inhalation) pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the patient selecting at least one of the icons for low pressure, normal pressure, or high pressure of the cough inspiration pressure adjustment screen. The combined respiratory therapy device according to claim 7.

9. The graphical user interface of the combined respiratory therapy device according to claim 8 displays a cough cycle duration adjustment screen including icons for short duration, normal duration, and long duration in response to the patient selecting at least one of the icons for low pressure, normal pressure, or high pressure on the cough exhalation (inhalation) pressure adjustment screen.

10. The graphical user interface of the combined respiratory therapy device according to claim 9 displays a cough sensitivity adjustment screen including icons for weak, normal, and strong in response to the patient selecting at least one of the icons for short duration, normal duration, or long duration on the cough cycle duration adjustment screen.

11. The graphical user interface of the combined respiratory therapy device according to claim 10 displays a ventilation inhalation pressure adjustment screen including icons for low pressure, normal pressure, and high pressure in response to the patient selecting at least one of the icons for weak, normal, or strong on the cough sensitivity adjustment screen.

12. The graphical user interface of the combined respiratory therapy device according to claim 11 displays a ventilation sensitivity adjustment screen including icons for weak, normal, and strong in response to the patient selecting at least one of the icons for low pressure, normal pressure, or high pressure on the ventilation inhalation pressure adjustment screen.

13. The graphical user interface of the combined respiratory therapy device according to claim 12 displays the ventilation duration after the cough adjustment screen including icons for short duration, normal duration, and long duration in response to the patient selecting at least one of the icons for weak, normal, or strong on the ventilation sensitivity adjustment screen.

14. The combined respiratory therapy device according to claim 13, wherein the graphical user interface displays an oscillation adjustment screen including icons for slow / strong, normal, and rapid / shallow oscillation in response to the patient selecting at least one of an icon for the short duration of the ventilation duration after the cough adjustment screen, an icon for the normal duration, or an icon for the long duration.

15. The combined respiratory therapy device according to claim 14, wherein the controller of the combined respiratory therapy device stores each selection received via the graphical user interface in an associated memory.

16. The combined respiratory therapy device according to claim 1, wherein the graphical user interface includes a plurality of icons associated with corresponding multiple operations of the combined respiratory therapy device, and the controller is configured to receive a selection of at least one of the plurality of icons from at least one of a physician computing device or a therapist computing device via the network interface.

17. The combined respiratory therapy device according to claim 16, wherein at least one of the physician computing device or the therapist computing device is disposed remotely from the combined respiratory therapy device.

18. The combined respiratory therapy device according to claim 1, wherein the blower and the air pulse generator reside on physically separate circuits.

19. The combined respiratory therapy device according to claim 18, wherein each of the plurality of different therapy sessions comprises pulmonary ventilation therapy or pulmonary volume increment therapy substantially immediately after the mucous extraction therapy.

20. A system for problem-priority device control of at least one combined respiratory therapy device, wherein the system comprises at least one combined respiratory therapy device and at least one clinician computing device. The at least one combined respiratory therapy device is configured to provide a plurality of coordinated respiratory therapies to a patient, the plurality of coordinated respiratory therapies being associated with a patient's normal treatment plan and configured to provide on-demand immediate respiratory therapy to the patient to treat acute symptoms experienced by the patient while the patient's normal treatment plan is being provided to the patient. The at least one combined respiratory therapy device includes a network interface that communicates with an associated computer network and a controller that includes a processor that communicates with a memory storing a plurality of instructions, the plurality of instructions being executable by the processor to perform 1) the patient's normal treatment plan including a combined respiratory therapy prescription and 2) the on-demand immediate respiratory therapy to treat acute symptoms experienced by the patient during execution of the patient's normal treatment plan, the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed over a prescribed period by the combined respiratory therapy device, the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions that are activated by the patient, the plurality of different on-demand immediate respiratory therapy sessions being different from the patient's normal treatment plan and configured to return the controller to execution of the patient's normal treatment plan after execution of the on-demand immediate respiratory therapy or after the patient activates a return to normal patient plan commands. The at least one combined respiratory therapy device includes a user interface display that communicates with the controller, the user interface display being configured to display a graphical user interface including a plurality of icons or a plurality of buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate each of the plurality of different on-demand immediate respiratory therapy sessions when the icon or the button associated with each of the plurality of different on-demand immediate respiratory therapy sessions is selected by the patient. and comprises. The at least one clinician computing device is configured to communicate with the at least one combined respiratory therapy device via the associated computer network and to control at least one operation of the at least one combined respiratory therapy device. The on-demand immediate respiratory therapy includes a plurality of different on-demand immediate respiratory therapy sessions available to the patient during the patient's normal treatment plan, and the plurality of different on-demand immediate respiratory therapy sessions can be repeatedly activated by the patient during the execution of the patient's normal treatment plan during the prescribed period. One session different from the patient's normal treatment plan among the plurality of different on-demand immediate respiratory therapy sessions is activated by the patient, and after the execution of the on-demand immediate respiratory therapy or after the patient activates a return to normal patient plan commands, the controller is configured to return to the execution of the patient's normal treatment plan. Claim 21 The graphical user interface further includes a plurality of icons corresponding to the plurality of different on-demand immediate respiratory therapy sessions of the at least one combined respiratory therapy device, and selection of one of the plurality of icons controls the at least one combined respiratory therapy device to execute a corresponding one of the plurality of different on-demand immediate respiratory therapy sessions. The system according to claim 20. Claim 22 Selection of one of the plurality of icons is received via the user interface display. The system according to claim 21. Claim 23 The at least one clinician computing device further includes a graphical user interface corresponding to the graphical user interface of the at least one combined respiratory therapy device. The system according to claim 21.

24. The selection of one of the plurality of different on-demand immediate respiratory therapy sessions for the patient is received via the associated computer network by the at least one clinician computing device via the graphical user interface of the at least one clinician computing device by the at least one combined respiratory therapy device, the system of claim 23.

25. A method for remotely controlling at least one combined respiratory therapy device by a clinician device, wherein the at least one combined respiratory therapy device is configured to provide a plurality of coordinated respiratory therapies to a patient, the plurality of coordinated respiratory therapies are associated with a patient's normal treatment plan, and are configured to provide on-demand immediate respiratory therapy to the patient to treat acute symptoms experienced by the patient while the patient's normal treatment plan is being provided to the patient, The method comprises receiving, at a clinician device in data communication with the at least one combined respiratory therapy device, patient data representing at least one physiological parameter associated with the patient; generating, on an associated display of the clinician device, a graphical representation of the received patient data; receiving, via the associated display, selection data, the selection data corresponding to a change to the patient's normal treatment plan for therapy for the patient, and a plurality of activation buttons corresponding to the on-demand immediate respiratory therapy for treating acute symptoms experienced by the patient while the patient's normal treatment plan is being provided to the patient; communicating to the at least one combined respiratory therapy device a change in therapy for the patient or activation of the on-demand immediate respiratory therapy; comprising the clinician device includes a processor in communication with a memory storing a plurality of instructions, the plurality of instructions, when executed by the processor, cause the processor to perform the method for remotely controlling at least one combined respiratory therapy device by a clinician device; the processor is configured to execute a combined respiratory therapy prescription and a plurality of different on-demand immediate respiratory therapy sessions. The co-administered respiratory therapy prescription is part of the patient's normal treatment plan, the co-administered respiratory therapy prescription is prescribed over a prescribed period, the on-demand immediate respiratory therapy includes the plurality of different on-demand immediate respiratory therapy sessions available to the patient during the patient's normal treatment plan, the plurality of different on-demand immediate respiratory therapy sessions can be repeatedly activated by the patient or by the clinician device during the execution of the patient's normal treatment plan during the prescribed period, and one session different from the patient's normal treatment plan among the plurality of different on-demand immediate respiratory therapy sessions is activated by the patient or by the clinician device and, after the execution of the on-demand immediate respiratory therapy or after the patient or the clinician device activates a return to normal patient plan commands, is configured to return the processor to the execution of the patient's normal treatment plan, method.

26. The method of claim 25, further comprising establishing at least one of video communication or audio communication between the clinician device and the at least one co-administered respiratory therapy device.

27. The method of claim 25, further comprising generating a graphical user interface associated with at least one operation of the at least one co-administered respiratory therapy device on the associated display of the clinician device.

28. The graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one co-administered respiratory therapy device, and selection of one of the plurality of icons controls the at least one co-administered respiratory therapy device and executes the corresponding operation of the plurality of operations, the method of claim 27.

29. A clinician device for remotely controlling at least one combined respiratory therapy device by a clinician device, wherein the at least one combined respiratory therapy device is configured to provide a plurality of coordinated respiratory therapies to a patient, the plurality of coordinated respiratory therapies being associated with a patient's normal treatment plan, and configured to provide on-demand immediate respiratory therapy to the patient to treat acute symptoms experienced by the patient while the patient's normal treatment plan is being provided to the patient. The clinician device A processor communicating with a memory, A network interface communicating with the processor, the network interface being configured to communicate with at least one combined respiratory therapy device via an associated computer network. A display communicating with the processor, the display being configured to display a graphical user interface associated with at least one operation of the at least one combined respiratory therapy device. Comprising The memory stores a plurality of instructions, which when executed by the processor Receive patient data representing at least one physiological parameter associated with the patient of the at least one combined respiratory therapy device via the associated network. Generate a graphical representation of the received patient data on the display. Receive selection data via the display, the selection data corresponding to a change to the patient's normal treatment plan for the patient's therapy, and a plurality of activation buttons corresponding to the on-demand immediate respiratory therapy for treating acute symptoms experienced by the patient while the patient's normal treatment plan is being provided to the patient. Communicate a change in the patient's therapy or activation of the on-demand immediate respiratory therapy to the at least one combined respiratory therapy device via the associated computer network. Cause the processor to perform The processor is configured to execute a combined respiratory therapy prescription and a plurality of different on-demand immediate respiratory therapy sessions. The combined respiratory therapy prescription is part of the patient's normal treatment plan, the combined respiratory therapy prescription is prescribed over a prescribed period, the on-demand immediate respiratory therapy includes the plurality of different on-demand immediate respiratory therapy sessions available to the patient during the patient's normal treatment plan, the plurality of different on-demand immediate respiratory therapy sessions can be repeatedly activated by the patient or by the clinician device during the execution of the patient's normal treatment plan during the prescribed period, one session different from the patient's normal treatment plan among the plurality of different on-demand immediate respiratory therapy sessions is activated by the patient or by the clinician device, and after the execution of the on-demand immediate respiratory therapy or after the patient or the clinician device activates a return to normal patient plan commands, the processor is configured to return to the execution of the patient's normal treatment plan, a clinician device.

30. The memory further stores instructions for establishing at least one of video communication or audio communication between the clinician device and the at least one combined respiratory therapy device, the clinician device according to claim 29.

31. The graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one combined respiratory therapy device, selection of one of the plurality of icons controls the at least one combined respiratory therapy device and executes the corresponding operation among the plurality of operations, the clinician device according to claim 29.

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