CN116325015A - Combined respiratory therapy apparatus, systems, and methods - Google Patents

Abstract

A joint respiratory therapy management system creates a joint respiratory therapy prescription that is executable by a joint respiratory therapy device to provide a plurality of collaborative respiratory therapies to a patient. The system may update the combined respiratory therapy prescription and effect the update when the combined respiratory therapy apparatus is in use. The integrated graphical user interface provides the patient and clinician with customized options and quick access to preselected operation of the integrated respiratory therapy apparatus. An additional feature of the system enables remote clinicians to remotely access and control the combined respiratory therapy device.

Description

Combined respiratory therapy apparatus, systems, and methods

Background

Patients with neuromuscular weakness due to cough weakness and shallow breathing (hypoventilation), due to stroke, spinal cord injury, head trauma, or diseases such as muscular dystrophy and amyotrophic lateral sclerosis (ALS or Luge herly disease) have increased risk of morbidity and mortality. There are a number of chronic diseases that cause cough weakness and impaired pulmonary ventilation, and there is an increasing number of diseases.

When a patient experiences an ineffective cough, chest secretions can remain in the respiratory system, causing pneumonia, lung collapse, or, in the case of mucus filling the trachea, a fatal respiratory arrest. In addition, shallow breathing causes low oxygen and high carbon dioxide levels in the patient's blood stream, leading to a medically fragile state of chronic respiratory failure, in which even the common cold may lead to serious respiratory diseases. For these reasons, pulmonary complications are considered to be the leading cause of morbidity and mortality in patients with neuromuscular weakness.

As the patient's condition worsens, the patient is more likely to require cough assist and assisted ventilation. Respiratory therapy for resolving cough weakness typically involves providing a device to assist in the cough via mechanical insufflation/exsufflation, whereas shallow breathing is typically resolved by a separate mechanical ventilation device.

Disclosure of Invention

According to one embodiment, a combination respiratory therapy apparatus is provided that includes a blower for providing negative pressure air to a mouthpiece connected to an airway of a patient, and an air pulse generator for delivering pulses of air to at least one of a garment worn by the patient or a nasal interface worn by the patient. The device also includes a network interface in communication with an associated computer network, and a controller including a processor in communication with a memory storing instructions executable by the processor to perform a joint respiratory therapy prescription defining a plurality of different therapy periods to be performed by the joint respiratory therapy device over a period of time, each of the plurality of different therapy periods including mucus withdrawal therapy. The combination therapy device also includes a display in communication with the controller, the display configured to display a graphical user interface associated with at least one operation of the combination respiratory therapy device.

According to another embodiment, a system is provided for problem-priority device control of at least one combined respiratory therapy device. The system includes at least one combined respiratory therapy device and at least one clinician device. At least one of the joint respiratory therapy devices includes a network interface in communication with an associated computer network, and a controller including a processor in communication with a memory storing instructions executable by the processor to execute a joint respiratory therapy prescription defining a plurality of different therapy periods to be executed by the joint respiratory therapy device over a period of time. The at least one combined respiratory therapy device further includes a display in communication with the controller, the display configured to 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.

In another embodiment, a method of remotely controlling at least one combined respiratory therapy device by a clinician device is provided. The method includes receiving, at a clinician device in data communication with at least one joint respiratory therapy device, patient data representing at least one physiological parameter associated with a patient, and generating, at an associated display of the clinician device, a graphical representation of the received patient data. The method further includes receiving, via an associated display, selection data corresponding to the selected therapy adjustment and transmitting the selected therapy adjustment to at least one combination therapy device. The clinician device includes a processor in communication with a memory storing instructions for execution by the processor, such that the processor performs the method.

In yet another embodiment, a clinician device is provided for remotely controlling at least one combined respiratory therapy device by the clinician device. The clinician device includes a processor in communication with the memory, a network interface in communication with the processor and configured to communicate with the at least one combined respiratory therapy device via an associated computer network, and a display in communication with the processor and configured 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 are 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 at least one combined respiratory therapy device, and generate a graphical representation of the received patient data on a display. The memory also stores instructions to receive selection data corresponding to the selected therapy adjustment via the display and communicate the selected therapy adjustment to the at least one combined respiratory therapy device over an associated computer network.

Drawings

The present disclosure is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings. The drawings may illustrate one or more embodiments of the disclosure, alone or in combination. For simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

FIG. 1 is a simplified block diagram of at least one embodiment of a joint respiratory therapy management system;

FIG. 2 is a simplified flow diagram of at least one embodiment of a method for configuring a combined respiratory therapy device;

FIG. 3 is a simplified schematic diagram of at least one embodiment of a joint respiratory therapy management system;

FIG. 4 is a simplified elevation view of at least one embodiment of a user interface for a prescription creator module of at least one embodiment of the system of FIG. 1;

FIG. 5 is a simplified elevation view of at least one embodiment of another user interface for a patient interface module of at least one embodiment of the system of FIG. 1;

FIG. 6 is a simplified flow diagram of at least one embodiment of a method of configuring respiratory therapy using the system of FIG. 1;

FIG. 7 is a simplified flowchart of at least one embodiment of another method of configuring respiratory therapy using the system of FIG. 1;

FIG. 8 is a simplified flowchart of at least one embodiment of another method of configuring respiratory therapy using the system of FIG. 1;

FIG. 9 is a simplified flowchart of at least one embodiment of another method of configuring respiratory therapy using the system of FIG. 1;

FIG. 10 is a simplified flowchart of at least one embodiment of a method of respiratory therapy using the system of FIG. 1; and

FIG. 11 is a simplified block diagram of an exemplary computing environment in conjunction with which the system of FIG. 1 may be implemented.

Fig. 12 is a graphical user interface representation of a home screen for operating a combined respiratory therapy device according to one embodiment of the present application.

Fig. 13 is a graphical user interface representation of an emergency screen of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 14 is a graphical user interface representation of an intensive therapy screen of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 15 is a graphical user interface representation of a custom therapy screen of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16A is a graphical user interface representation of a cough setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16B is a graphical user interface representation of a cough inhalation pressure setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16C is a graphical user interface representation of a cough exhalation (inhalation) setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16D is a graphical user interface representation of a cough cycle duration adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16E is a graphical user interface representation of a cough sensitivity setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16F is a graphical user interface representation of a ventilation settings adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16G is a graphical user interface representation of a ventilation and inhalation pressure setting adjustment screen for customizing therapy of a combination respiratory therapy device according to one embodiment of the present application.

Fig. 16H is a graphical user interface representation of a ventilation sensitivity setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16I is a graphical user interface representation of a post-cough ventilation duration setting adjustment screen for customizing therapy of a combined respiratory therapy device according to one embodiment of the present application.

Fig. 16J is a graphical user interface representation of an initial oscillation (mucus transfer) settings adjustment screen for customizing therapy of a combination respiratory therapy device according to one embodiment of the present application.

Fig. 16K is a graphical user interface representation of an oscillation (mucus transfer) adjustment screen following fig. 16J for customizing therapy for a combination respiratory therapy device according to one embodiment of the present application.

Fig. 16L is a graphical user interface representation of a setup completion screen for customizing therapies of a combined respiratory therapy device according to one embodiment of the application.

Fig. 17 is a flowchart illustrating an example method for remote access and control of a combined respiratory therapy device according to one embodiment of the present application.

Detailed Description

While the concepts of the present invention are susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and are herein described in detail. It should be understood, however, that there is no intention to limit the concepts of the present disclosure to the specific forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure and the appended claims.

Referring to fig. 1, a system 100 for managing a combined respiratory therapy provided to an individual using a combined respiratory therapy device 110 includes a number of different computerized functions, which are represented herein as modules for ease of discussion. Illustratively, these modules include a configurable user interface module 114 and a joint 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, depending on the particular design or implementation requirements of the system 100. Moreover, in some embodiments, any or all of the modules 114, 120, 112, 122, 130, 132, 134, 140, 142, 144 may be implemented as part of the joint 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., mobile devices or more conventional desktop or laptop computers). As described in more detail below, the configurable user interface modules 112, 122, 130, 132, 134, 140, 142, 144 may be selectively activated on the device 110 or on one or more other computing devices to interact with the federated device 110 and control the federated device 110 by authorized personnel or different types of authorized personnel. Such authorized personnel may include clinicians (e.g., physicians), respiratory therapists, nurses, family members, and other caregivers, as well as patients receiving combination respiratory therapy. For ease of discussion, any of these persons may be referred to herein as one or more "users" of system 100.

The prescription creator module 112 enables a user (e.g., clinician) to create a joint respiratory therapy prescription in a user-friendly manner using, for example, graphical, audio, and/or video features. In this way, the prescription creator module 112 alleviates the need for users to spend time learning how to use non-intuitive buttons, dials, etc. on a therapy device that typically has limited space for more complex user interface features. The joint respiratory therapy approach may include one or more integrated combinations of different respiratory therapies arranged to be performed at different times of the same day. For example, in some embodiments, the combined respiratory therapy prescription combines a repetition period of cough assistance (e.g., mucus transfer and/or mucus withdrawal therapies) with lung ventilation therapies and/or lung volume restoration therapies. The prescription translator module 122 may translate the joint respiratory therapy prescription into machine-readable instructions. The instructions may be read and executed by a hardware component (e.g., a microprocessor) of the combination device 110 to control the provision of the combined respiratory therapy to the patient. Once created, the joint respiratory therapy prescription and/or machine-readable version thereof may be stored in computer memory, for example, in a computerized data structure such as the joint respiratory therapy prescription database 118.

A prescription creator or other user (e.g., respiratory therapist, other clinician, caregiver, or patient) may access and view the stored joint respiratory therapy prescription, or portion thereof, using the data sharing module 136. In this way, the data sharing module 136 presents the joint respiratory therapy prescription in a format that is easy to understand and customizable or customized for a particular user. In some embodiments, the data sharing module 136 may allow authorized personnel of a particular type to view particular data or make particular types of changes to the combined respiratory therapy prescription. For example, a clinician may be allowed to view and change any aspect of a combined respiratory therapy prescription, while a therapist may be allowed to view the prescription, but may only change certain portions of the prescription (e.g., cough inhalation or cough exhalation (inhalation) pressure or therapy start time within a defined pressure range) and not other portions (e.g., therapy duration). Similarly, the ability of a patient or family member to view and change the prescription of a combination respiratory therapy may be limited.

In some embodiments, the user interface module 114 includes a question priority device control module 140 that allows a user to adjust the patient's therapy regimen as therapy is being administered, 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 translator module 122 may receive data from the union device 110 while the therapy is in progress, such as the current state of the therapy or information about the patient's condition, and the like. This data obtained from the device 110 may be displayed to the user in a human-understandable form using the data sharing module 136. Changes to patient therapy may be entered by a user, for example, using the problem priority device control module 140, in response to data obtained from the combination device 110 or in response to changes in patient conditions observed by a caregiver.

Furthermore, in some embodiments, the user interface module 114 includes an audio interface module 142 and may also include a character configuration module 144. The modules 142, 144 are designed to further enhance human-machine interaction. For example, audio interface 142 may play a pre-recorded voice message to explain how to use device 110 or to explain an upcoming therapy. The role configuration module 144 may allow the user to attribute "personality" to the device 110. For example, the character configuration module 144 may allow the user to select a graphical or animated character and/or a particular intonation or accent to be used by the device 110 when communicating with the user. Thus, with the system 100, the combined respiratory therapy device 110 may be used to provide a plurality of integrated and coordinated respiratory therapies to a respiratory patient in a manner that is both intuitive and non-threatening to the user or patient over a period of time. Furthermore, the various therapies prescribed by the respiratory therapy prescription may be customized and adjusted according to the needs of the patient, even as accurate as the respiratory grade, as they may change or develop. Such customization and adjustment may be responsively implemented by the federated respiratory device 110.

The illustrative combined respiratory therapy device 110 is one of a series of combined respiratory therapy devices 110, each of which may be used to provide a variety of integrated respiratory therapies. The combination device 110 includes a combination respiratory therapy control module 120, a positive pressure airflow patient interface 124, a negative pressure airflow patient interface 126, and in some embodiments, an air pulse patient interface 128. The positive pressure airflow patient interface 124 is designed to provide positive (e.g., inhalation) pressure to a patient engaged with the interface 124. The negative pressure airflow patient interface 126 is designed to provide negative (e.g., exhalation) pressure to a patient engaged with the interface 126. The air pulse patient interface 128 is designed to supply air pulses to the airway, lung, or chest regions of a patient to provide, for example, continuous High Frequency Oscillations (CHFO), continuous Positive Expiratory Pressure (CPEP), and/or High Frequency Chest Wall Oscillations (HFCWO).

The illustrative control module 120 interfaces with the prescription creator module 112 to obtain a user-defined and/or modified joint respiratory therapy prescription. In various embodiments of the system 100, the version of the prescription translator 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). At either the user interface level or the device level, the prescription translator module 122 converts the prescription into a machine executable form that can be used to control the application of airflow to the patient via the interfaces 124, 126, 128 as needed. For example, where the prescription specifies a treatment period including a cough period following lung ventilation, the prescription translator module 122 generates device settings required by the combined device 110 to perform the treatment period. These device settings may include, for example, a particular air pressure level, an indication of whether the air pressure is positive (e.g., inflation) or negative (e.g., inhalation), a duration of time to provide an air flow, a number of repeated applications of air pressure, etc. For example, device settings for a joint respiratory therapy sequence may include "cough: opening interface 124 at a position of +25cm of water and opening interface 126 at a position of-30 cm of water; ventilation: the port 124 was opened at a position of +15cm of water, and the port 124 was opened at a position of +4cm of water, time=2 minutes. The translator module 122 may further translate these device settings into specific "valve open" and "valve close" control signals that may be directly received and acted upon by specific electromechanical components of the device 110.

With the combined respiratory therapy apparatus 110, lung volume recovery and lung ventilation therapy may be combined with an assisted cough cycle such that assisted ventilation or lung volume recovery and assisted cough may be automatically coordinated (e.g., alternated) on a per breath basis, if desired. This allows for the tailoring of the combined cough assist and lung ventilation or lung volume recovery therapy to the needs of each patient. Furthermore, the federated device 110 eliminates the need to apply two independent devices in sequence. Sequential therapy is intolerable to patients suffering from illness or weakness and may cause the patient to become clinically unstable. Furthermore, some embodiments of the combination device 110 are portable such that they may be mounted or stored on a wheelchair, thereby improving the quality of life of the patient. Furthermore, in some embodiments, the inspiratory and expiratory air circuits of the device 110 are physically separated such that the positive pressure circuit remains clean and unobstructed. Further details of the illustrative combined device 110 are described below in conjunction with FIG. 3.

In more detail, the illustrative prescription creator module 112 utilizes a standardized term framework to describe a joint respiratory therapy prescription. In this way, the framework provides a tool by which various healthcare practitioners, who may be involved in patient care, can easily create, understand and share a joint respiratory therapy prescription. In this regard, the illustrative joint respiratory therapy prescription creator module 112 includes a layering module 130, a ranking module 132, and a patterning module 134. The layering module 130 allows the caregiver to select the appropriate combination respiratory therapy device 110 by simply specifying (e.g., on the graphical user interface of the configurable interface module 114) different types or "layers" of therapy that the patient needs.

The layering module 130 automatically maps the caregiver selected therapy layers to one or more combined respiratory therapy devices 110 that are capable of providing these therapies. In an illustrative embodiment, the therapy layer includes a mucous transfer layer, a mucous extraction layer, a lung volume recovery layer, and a lung ventilation therapy layer. In general, mucus transfer refers to respiratory therapy that aims at loosening chest secretions (e.g., mucus) such that the chest secretions can be extracted from the lungs by normal or assisted coughing. Mucus transfer therapy typically involves the mechanical application of air pulses, vibrations or oscillations to the airway, lungs, chest and/or back of a patient by means of a device such as fast or metaeb available from Hill-Rom company.

Mucus extraction refers to a therapy that mechanically aids the patient's ability to cough spontaneously, or that mechanically removes patient's pulmonary secretions when the patient is unable to cough spontaneously. To perform mucus extraction therapies, the control module 120 may configure the combination device 110 to initiate therapies by providing oversized extended breaths (e.g., "deep lung blowing"). This may involve the device 110 delivering an inspiratory pressure that is about 30% -50% higher than the "chronic" inspiratory pressure that it is typically used for ventilation or lung volume recovery therapies.

The deep breath provided by the combination device 110 during mucus withdrawal therapy is intended to maximize lung recoil (faster airflow upon exhalation) and may help dilate any collapsed portions of the lung. But because of the large mouth breath, patients are typically only able to tolerate limited "doses" of mucus withdrawal therapies. During the mucus draw therapy, the control module 120 synchronizes the assisted inhalation breath provided by the device 110 with the patient's inhalation effort so that the patient does not exhale during the inhalation phase. The "deep-blown" breath is followed by an "active" exhalation or "blow out" during which inhalation (negative) pressure removes secretions from the airways. The control module 120 also synchronizes the inhalation (negative) pressure with the exhalation phase of the patient's breath. Thus, some forms of mucus withdrawal therapies that may be provided by the device 110 are referred to as "mechanical insufflation/exsufflation". For example, for mucus extraction, the inspiratory pressure may be set in the range of about +25cm of water and the expiratory (inspiratory) pressure may be set in the range of about-30 cm of water. Thus, the mucus withdrawal portion of the combination respiratory therapy prescription may be written as "+25/-30".

Pulmonary ventilation refers to therapies that are intended to provide mechanical assistance to the patient's normal breathing pattern, or to provide mechanical respiration to the patient when the patient is unable to breathe spontaneously. Thus, pulmonary ventilation therapy is typically applied in a continuous manner for a period of time (rather than in a "periodic" manner as in mucus-withdrawal therapy). In the illustrative embodiment, both the mucus extraction and lung ventilation therapies integrated within a single combined respiratory therapy apparatus 110 include software controlled algorithms that synchronize machine-generated respiration or mucus extraction with the patient's natural breathing patterns. Pulmonary ventilation can be achieved by delivering a higher positive pressure during patient inhalation and a lower positive pressure during exhalation using the positive pressure airflow patient interface 124. The difference between the higher inspiratory positive pressure level and the lower expiratory positive pressure level ("pressure span") is the cause of lung ventilation. For pulmonary ventilation, the inspiratory pressure may be set to +15cm of water and the expiratory pressure may be set to +4cm of water. Thus, the lung ventilation portion of the combined respiratory therapy prescription can be written as "+15/+4", whereby lung ventilation is achieved with a pressure span of 11cm of water (15-4= +11).

To better achieve effective lung ventilation, the two positive pressure levels may be synchronized with the patient's breathing pattern. To this end, the combined respiratory therapy device 110 may detect a small negative "inspiratory pressure" or negative (inspiratory) flow produced by the patient to sense that the patient begins to inhale ("desired breath"), and then the device may support the breath with the commanded inspiratory pressure. As the device 110 detects a gradual decrease in the patient's inspiratory flow/pressure/effort, the device 110 may conclude that the patient is ready to exhale and switch to a lower (expiratory) positive pressure setting (which may be referred to as PEEP or positive end-expiratory pressure).

In some embodiments, the control module 120 includes software that synchronizes the mechanically 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 breathing pattern of the patient over time and use the previous breathing pattern in terms of breathing rate, inhalation duration, etc. to predict future breathing patterns. In some embodiments, the flow waveform or "(chest) rise time" (how fast the device 110 reaches a set inspiratory pressure) generated by the device 110 during pulmonary ventilation therapy may be adjusted according to the needs or preferences of the patient (slower rise times are milder, but too slow may make the patient breathing difficult). To maximize the efficacy and comfort of mucus withdrawal therapies, or for other reasons, the combined respiratory therapy apparatus 110 may use the same or similar techniques as described above to synchronize mucus withdrawal (secondary cough) with the patient's breathing pattern.

Furthermore, when combination device 110 is used for pulmonary ventilation, control module 120 may instruct device 110 to provide a "standby" respiratory rate if the patient self-stops breathing or sedates, in which case device 110 will provide automatic breathing via a timer. Furthermore, when the device 110 is used for pulmonary ventilation, if the interface 124 is disconnected from the patient (e.g., tube pulled away, nasal mask pulled off, etc.), the control module 120 may activate an alarm to alert the caregiver. In this way, the combination device 110 may selectively provide a number of different features depending on the type of therapy it is being used, some of which (e.g., backup respiration and alerting) may be applicable to some therapies, but not others. The combination respiratory therapy device 110 may use the same or similar techniques as described above to automatically provide mucus extraction (assisted cough) to a sleeping, unconscious, or sedated patient; for example, mucus extraction is automatically provided by a timer when the patient is asleep. Likewise, if the negative airflow interface 126 is disconnected from the patient (e.g., falls out of the patient's mouth), the control module 120 may activate an alarm to alert the caregiver.

Pulmonary volume recovery refers to therapy in which the lungs are mechanically inflated intermittently rather than continuously. When the combination device 110 applies a positive pressure airflow for lung volume recovery, the positive pressure expands the lung to prevent the lung from collapsing. This may be done, for example, after each cough cycle of the daytime therapy session to help the patient resume his breath before the next cough. Pulmonary volume recovery therapy may also be applied after the end of the secondary cough therapy period to "consolidate" the pulmonary volume improvement obtained during the secondary cough therapy period and assist the patient in recovering from the secondary cough. Thus, when the patient is awake and in collaboration, lung volume recovery therapy may be used.

Compared to pulmonary ventilation therapy, lung volume recovery is generally less complex. When performing lung volume restoration therapy, the combination device 110 may synchronize the inspiratory pressure with the patient's breathing pattern, but may not require positive expiratory pressure (PEEP). Because patients are typically awake and will assist in this process during lung volume restoration therapy, it is generally not necessary to use more advanced software algorithms to track the patient's breathing patterns or provide back-up frequencies or alarms as with lung ventilation. For lung volume recovery therapy, the inspiratory pressure may be set in the range of about +15cm of water and the expiratory pressure may be set in the range of about 0cm of water (e.g., expiratory to no boost). Thus, the lung volume recovery portion of the combined respiratory therapy prescription can be written as "+15/0".

The ordering module 132 allows the caregiver to define, customize, and modify the details of each respiratory therapy treatment session according to the needs of the patient, where "treatment session" generally refers to an instance or occurrence of a coordinated combination of respiratory therapies. The treatment session may include multiple therapies performed sequentially, or a repeated sequence of therapies involving one or more types of therapies (e.g., a sequence of therapies consisting of cough assist and subsequent lung ventilation therapies). For example, ranking module 132 may be used to define or specify positive and negative pressure settings that include each cough cycle; defining or specifying a number of cough cycles to be applied sequentially at the beginning of each treatment sequence; defining or specifying a duration of lung volume recovery or lung ventilation therapy to be applied substantially immediately after a specified number of cough cycles (e.g., without interruption) to complete each treatment sequence; and/or defining or specifying the number of sequentially applied treatment sequences including treatment periods.

The modeling module 134 allows the caregiver to define the overall pattern of respiratory care to be administered to the patient for a prescribed period of time (e.g., 24 hours) at real-time clock time. For example, a therapy pattern may include a treatment period consisting of a specific number of treatment sequences, which, as described above, begin and end in the morning; a similar treatment period for mucous transfer therapy that starts and ends at night but proceeds for a period of time immediately before that; and a pulmonary ventilation therapy period that begins at night when the patient falls asleep and ends in the morning when the patient wakes up. In this way, the patterning module 134 allows the caregiver to specify that the combination device 110 begin or perform a particular therapy at a particular time of day. In other words, the patterning module 134 may be used to associate specific start and stop times with various co-therapies. The modeling module 134 may be used to account for patient specific therapy layers and their interrelationships in clock time. In this way, the patterning module 134 may provide a useful tool for creating, modifying, and sharing a joint respiratory therapy prescription among stakeholders. Thus, in some embodiments, the patterning module 134 visually presents the pattern of respiratory therapy on the user interface of the system 100, for example, as a graphical schedule or other visual representation of the 24-hour respiratory care plan of the patient. An illustrative example of this visual representation is shown in fig. 4, described below.

The configurable user interface module 114 includes software-based user interfaces of the various modules 112, 122, 136, 140, 142, 144. For example, in embodiments that include a prescription creator module 112, the user interface module 114 includes a software-based user interface that allows a physician or other qualified health professional to create a joint respiratory therapy prescription and store the prescription on a computing device of the system 100 (e.g., in 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 issue priority device control module 140, and/or other modules of the system 100.

As described above, the data sharing module 136 provides a communication interface through which the joint respiratory therapy prescription, or portions thereof, may be presented on a computing device of the system 100 for creating a joint respiratory therapy prescription for the joint device 110, or on another computing device such as a mobile apparatus used by a respiratory therapist responsible for patient care, or a computing device located near or used by a patient (such as a personal computer or mobile computing device located in a patient ward or patient home). In some embodiments, prescriptions are shared between devices using an electronic communication interface accessed by the data sharing module 136, the data sharing module 136 including, for example, one or more input/output modules for data communication via a standard wired or wireless network interface (e.g., WIFI, cellular, ethernet, etc.), one or more hard wired communication ports (e.g., a universal standard bus port or other port connectable by a flash drive or cable), or a combination thereof.

However, the prescription creator module 112 allows the creation of a joint respiratory therapy prescription using a "user friendly" interface, which is then transmitted to the joint device 110 for execution, and the illustrative data sharing module 136 enables a professional respiratory clinician not at the patient's bedside to remotely alter or update the patient's respiratory prescription in order to respond timely to clinical changes in the patient's condition or for other reasons.

Illustrative examples of scenarios in which the data sharing module 136 may be utilized are as follows. Using, for example, a hospital computer that manages electronic medical records, wherein the configurable user interface module 114 on the computer is configured to include a prescription creator module 112, for example, the prescription creator module 112 is installed or accessible via a network (e.g., the "cloud"), a physician creates a joint respiratory therapy prescription. The layering module 130 automatically selects the union device 110 for implementing the prescription. The modeling module 134 displays the chronological pattern of the prescribed therapy in clock time. The ordering module 132 generates specific details of the treatment sequence that form the treatment session, including all necessary device settings of the selected combined device 110. As a result, via the configurable user interface module 114, a physician may quickly and accurately examine and adjust or modify the patient's joint respiratory prescription using, for example, a hospital computer or the like. 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 to allow the physician to view the joint respiratory prescription created by it from a remote location, even from home.

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. Using the data sharing module 136, the respiratory therapist views the joint respiratory therapy prescription previously created by the physician (e.g., on a hospital computer). The computer may be a handheld device, or the therapist may transfer the prescription to another computing device, which is a handheld or "mobile" device (e.g., a smart phone, tablet computer, personal digital assistant, or the like) on which another instance of the configurable interface module 114 or a simplified version thereof including the data sharing module 136 is installed.

With the data sharing module 136, which may be mounted directly on a handheld computing device or accessed through a network (e.g., a "cloud"), a therapist is able to plan his shift schedule by looking at the 24-hour prescription schedule (e.g., treatment pattern) and/or other detailed information of the joint respiratory therapy prescription for all patients he is attending to. With the handheld device, the therapist can view the treatment plan at any time, whether the therapist is at the patient's bedside or at a remote location. With the data sharing module 136, the therapist's handheld device may be programmed to issue a reminder that may help the therapist maintain the predetermined time by generating an audio and/or visual alert at or before the beginning time of the next predetermined therapy for the patient. Still with the data sharing module 136, the therapist's handheld device may be linked to an electronic communication network (e.g., a hospital paging system, a computer network, or a telecommunications network) to alert the therapist when, for example, a new joint respiratory therapy prescription is created or other caregivers modify an existing prescription. Furthermore, with the data sharing module 136, new or updated joint respiratory therapy orders may be electronically transferred to the therapist's handheld device (wherever it is located), in real-time (e.g., via a direct hardwired connection or through a wired or wireless network), or downloaded to the handheld device from, for example, a hospital computer. When going off, the therapist may link the handheld device using a wired or wireless (e.g., WIFI or Near Field Communication (NFC)) data communication connection to communicate the joint respiratory therapy prescription of the patient they are attending to the handheld device used by the therapist on the next duty.

When the patient is ready to change sites, for example, to be moved to a different hospital or nursing home, or returned to the patient's own home, the data sharing module 136 may be used to send the patient's combined respiratory therapy prescription to its new site via wired or wireless data communications as described above. Because the joint respiratory therapy prescription specifies the joint device 110 to be used to perform the joint respiratory therapy prescription, as well as the particular schedule and combination of respiratory therapies to be performed for the patient (including device settings), communicating the prescription to the computing device at the new location of the patient should enable respiratory care of the patient to continue relatively seamlessly at the new location.

The illustrative problem priority device control module 140 interfaces with the prescription translator module 122 to effect changes to the patient's joint respiratory therapy prescription directly "on the fly", for example, in real-time during patient treatment, according to patient preferences or as patient health changes. The problem priority device control module 140 includes computer logic and data (e.g., look-up tables, etc.) that map the various device settings of the combined device 110 to different clinical conditions. For example, the question priority module 140 may derive the trigger condition and the desired therapy change from a evidence-based guideline or from the patient's own therapy history data (which may indicate past successful or unsuccessful therapies for the patient). In this way, the problem priority module 140 allows caregivers and others to modify the patient's joint respiratory therapy prescription simply by indicating clinical changes to the problem priority module 140. For example, a therapist may notice that his patient is currently unable to expectorate secretions without assistance. In such a scenario, the caregiver may input "unable to expectorate secretions" to the question-priority module 140 using, for example, a graphical user interface provided by the configurable user interface module 114. The prescription translator module 122 translates the clinical changes into appropriate device setting changes for the union device 110. In embodiments where the problem priority module 140 is not integrated with the federated device 110, the data sharing module 136 communicates the device setting changes directly to the federated device 110, with the device setting changes being effected by the federated device 110. In other words, the issue priority device control module 140 enables direct, automatic recipe revisions without requiring the user to view or write the entire recipe.

The illustrative question-first device control module 140 may also allow users to respond to data transmitted by the federated device 110 via the data sharing module 136. Based on the changes in the data received from the combination device 110, the caregiver may view the changes using the data sharing module 136, e.g., the caregiver may determine that adjustments to the patient's combination respiratory therapy prescription are needed and implement the adjustments using the problem priority device control module 140 as described above.

Illustrative examples of scenarios in which the issue priority device control module 140 may be used are as follows. Assume that the home care company receives a new patient who has just discharged. With the data sharing module 136, the patient's joint respiratory therapy prescription has been electronically sent to the home care company's computer. As a result, the company knows which combination device 110 it needs to provide to the patient, and also knows the patient's particular respiratory treatment plan.

With the data sharing module 136 implemented on the handheld device, a home care therapist employed by the home care company downloads the patient's joint respiratory therapy prescription to its handheld device and brings it to the patient's home. The therapist may then use the data sharing module 136 to communicate the patient's joint respiratory therapy prescription directly to the control module 120 of the joint device 110 (e.g., by connecting his handheld device to the joint device 110). If the prescription translator module 122 is installed on the therapist's handheld device, the prescription may be translated into machine-readable instructions on the handheld device and then implemented directly by the union device 110. Alternatively, the prescriptions may be translated by a prescription translator module 122 of the control module 120.

During or after therapy, the union device 110 may send data regarding the therapy session or data related to the patient's condition or preferences (e.g., in the form of notification messages) to the clinician's handheld device. Based on the notification and possibly the telephone follow-up to the patient, the clinician may use the problem priority module 140 to change the patient's joint respiratory prescription and send the new prescription to the device 110 using the data sharing module 136. With the data sharing module 136, new or changed prescriptions are available on the display of the device 110 or on other electronic devices for viewing by, for example, a home care company, other caregivers, patients, and/or family members of patients, etc.

The audio interface module 142 includes a software-based user interface of the prescription creator module 112 that allows the patient and/or family member or other person associated with the patient to view the patient's joint respiratory therapy prescription and configure reminders, alerts, and other information 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 union device 110. The audio interface 142 maps pre-recorded voice messages (or computer synthesized spoken natural language messages) to various aspects of the patient's joint respiratory therapy prescription, which may 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 the union device 110 or adjust its settings. These instructional messages may be played at regular intervals prior to the beginning of the therapy session or upon request by the user. For example, the patient may enter a coding question, such as "how do i turn on this device? In response, audio interface 142 may provide the requested instructions.

In some embodiments, the audio interface 142 may be programmed to play encouraging or comforting recorded messages at the appropriate time before, during, or after the therapy session. In some cases, the content and time of these types of messages are based on patient preferences, focus groups, and/or studies related to the psychology of the population suffering from chronic disease. For example, patients suffering from chronic diseases may have psychological conditions that may affect their compliance with respiratory therapy devices and other medical devices, such as chronic anxiety or social or behavioral disorders. Furthermore, pediatric patients may be particularly afraid of mechanical equipment. Thus, the use of respiratory care devices and other medical devices may be viewed by many patients as a burden rather than a benefit, resulting in poor compliance and limited device efficacy. Thus, the audio interface 142 is designed to implement the concept of personification (attributing human features to non-living) to enhance patient compliance with their joint respiratory therapy prescription by making the device 110 more attractive and pleasant to use.

The audio interface 142 also allows the patient or other user to select (e.g., from a list of options presented on the touch screen display of the configurable user interface module 114) the time of the desired message. For example, the patient may specify that the message be played in the morning, when the patient wakes up, before the treatment period begins, during the treatment, after the treatment period, and/or at bedtime. In other words, during the treatment mode (e.g., 24 hour schedule), a particular recorded message may be linked to one or more portions (e.g., treatment periods and/or treatment sequences) of the patient's combined respiratory therapy prescription.

In the illustrative embodiment, the audio interface module 142 is connected to a persona configuration module 144, which persona configuration module 144 allows the patient to select the identity or personality attributed to the federated device 110. An example of a user interface that may be implemented by configurable user interface module 114 in conjunction with role configuration module 144 is shown in FIG. 5. In fig. 5, the illustrative display screen 500 includes a plurality of selectable options 510, each of which embodies a different character or "mascot" attributable to the union device 110. Selection of option 510 automatically configures the characteristics of the voice (e.g., pace, pitch) and content of the pre-recorded audio message to correspond to the selected character/mascot. In some embodiments, a graphical or animated depiction of the selected character may also be displayed to the user.

The illustrative display screen 500 is a touch sensitive screen such that a patient or another user may simply touch a desired option on the screen with a hand, finger, stylus, or the like to complete selection of option 510. Once option 510 is selected, character configuration module 144 configures the content, time, voice, and intonation of the pre-recorded audio message to correspond to the selected character. To this end, character configuration module 144 may select and download recorded messages tagged or otherwise associated with the selected character from a pre-recorded message database. For example, a pre-recorded message database may associate "reliable", "stubborn" and "firm" features with the "bulldog wenston" role, and so on. In this way, the federated device 110 may be customized to exhibit a set of human characteristics that appeal to the patient so that the patient may perceive the device 110 as a alliance and partner, rather than a threatening or burdened inanimate object, thereby facilitating interaction between the patient and the federated device 110.

One illustrative example of how the audio interface module 142 and the persona configuration module 144 may be used to customize the message output provided by the federated device 110 is as follows. Suppose that the patient wishes that their combination 110 exhibit tough and reliable human quality. The patient may use the touch screen display to input these desired features to the audio interface module 142 (e.g., by selecting them from a drop down list). The character configuration module 144 maps the patient's selection to one or more predefined characters that are displayed in a selectable options list 510 on the display screen 500. The patient selects option D, "girl active," from option list 510. As a result, audio interface 142 plays a placebo message every night before the combination device 110 begins the therapy session, e.g., "i will help you breathe comfortably overnight, if you need to cough, press your thumb switch to let me know that i will not disappoint you, see the morning! ", to assist the patient in breathing during sleep.

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

Referring now to fig. 2, an illustrative method 200 is shown, which method 200 is capable of being executed as a computerized program, routine, logic, and/or instruction by the joint respiratory therapy prescription creator module 112 and/or one or more other modules of the system 100 to create a joint respiratory therapy prescription for a patient. The method 200 may be considered an example of how the joint respiratory therapy prescription creator module 112 works, when the primary user is most likely a physician creating a prescription for his/her one patient through the method 200. In step 210, the method 200 receives information related to a respiratory condition of a patient. The information may include symptoms or recent changes in the patient's clinical condition, which may be entered, for example, by a clinician such as a physician or caregiver (e.g., using the problem priority device control module 140), even by the patient himself or herself or a family member thereof. In step 212, the method 200 determines which therapy layers (e.g., mucus transfer 214, mucus withdrawal 216, lung volume restoration 218, lung ventilation 220) are relevant to the patient's condition information received in step 210. For example, if the input of step 210 indicates that the patient has difficulty initiating a cough with sputum itself, the method 200 maps this information to one or more therapy layers 214, 216, 218, 220 intended to assist in the cough. In this case, the therapy layers include a mucus extraction therapy layer and a lung ventilation or lung volume recovery therapy layer. Alternatively, as described above, the method 200 may receive information related to the patient's respiratory condition from a clinician creating a combined respiratory therapy prescription, and the clinician may select and determine the therapy layers himself/herself (e.g., manually) by, for example, the combined respiratory therapy prescription creator module 112.

Based on additional inputs received from one or more of the modules 114, 120, or based on stored information related to the patient's current health or clinical history, it may be determined whether to select lung ventilation 220 or lung volume restoration 218. For example, in step 212, the method 200 may access an electronic medical record associated with the patient to determine that the patient has previously responded well to lung ventilation therapy provided after the mucus withdrawal therapy. For another example, the method 200 may access date and time information automatically saved by the system 100, determine that the patient is most likely awake and able to participate in the therapy during the therapy, and may select the lung volume recovery therapy layer 218 instead of the lung ventilation therapy layer 220.

Once a therapy level associated with the patient condition is determined, the method 200 automatically selects an appropriate combination device 110 from the combination respiratory therapy device system according to the therapy level determined in step 212 in step 222. Illustratively, the federated device family includes four federated devices 224, 226, 228, 230. In step 222, the mapping of the therapy layers 214, 216, 218, 220 that each device 224, 226, 228, 230 can provide may be illustratively shown by the wiring between the therapies and the corresponding associated devices. For example, the combination device 224 can be used to provide mucus extraction and lung ventilation therapies; the combination device 226 is capable of providing mucus extraction and lung volume restoration simultaneously; the combination 228 is capable of providing three therapies, mucous transfer, mucous extraction and pulmonary ventilation; and the combination device 230 is capable of providing three therapies, mucus transfer, mucus extraction, and lung volume restoration. The method 200 determines which combination device 224, 226, 228, 230 to select based on the functionality of each device associated with the patient's desired therapy layer 214, 216, 218, 220 determined in step 212. For example, if the patient requires mucus transfer, the method 200 may select device 228 or device 230, but not device 224 or device 226. If the patient requires cough assist therapy, but may breathe himself, method 200 may select device 226 or device 230, but not device 224 or device 228.

Once the combination device is selected, the method 200 may obtain the required information from the user in step 232, thereby formulating the patient with the combination respiratory therapy prescription via the combination device 110 selected in step 222. To this end, the method 200 may interact with a user to define one or more treatment periods 234, one or more treatment sequences 236 for each treatment period, and a treatment pattern 238 for the patient during the respiratory care to be received. In an illustrative example, a treatment session may consist of several consecutively applied treatment sequences, e.g., may include a defined number of sequentially repeated treatment sequences, wherein each treatment sequence includes one or more secondary cough cycles, followed by a substantially immediate lung ventilation or lung volume recovery therapy. Thus, the duration of one treatment session may depend on the number of treatment sequences provided during the treatment session. Thus, the process of defining one or more treatment periods 234 involves interaction of the method 200 with the user to specify the number of treatment periods to be performed during respiratory care or "mode", the start time of each treatment period, and the number of treatment sequences to be performed in each treatment period.

The method 200 then interacts with the user to define details of each treatment sequence 236 to be performed in each treatment session defined in step 234. To this end, the method 200 interacts with the user to specify the number of auxiliary cough cycles in each treatment sequence, the inhalation and exhalation (inhalation) pressures for each cough cycle (e.g., +25cm of water absorption pressure, -30cm of water exhalation (inhalation) pressure), the auxiliary ventilation (length of time) following the cough cycle (e.g., 2 minutes), and the inhalation positive pressure and exhalation positive pressure levels of auxiliary ventilation therapy (e.g., +15cm of water absorption pressure, +4cm of water exhalation pressure).

In step 238, the method 200 may interact with the user to define additional respiratory therapy to be applied to the patient during respiratory care or in a pattern (e.g., during 24 hours). For example, a caregiver may want to schedule one or more mucous transfer therapies prior to the treatment session, or add an additional day or night lung ventilation or lung volume recovery therapy. Accordingly, in step 238, the method 200 interacts with the user to specify the start time, stop time, and device settings for each additional therapy desired. Further, in step 232, the method 200 may interact with the user to receive additional details related to the joint respiratory therapy prescription. For example, a user may want to designate that certain portions of a patient's prescription may be modified by the patient or family member, while other portions may be modified only by the user or authorized physician, or that certain portions may be modified by the patient or family member via the user's or physician's authorization. Once the combined respiratory therapy prescription is completed (to the satisfaction of the user), the method 200 electronically communicates the combined respiratory therapy prescription to the combined device 110 for execution by the device 110. As described above, the above transfer may be performed by a wired or wireless data communication method.

Fig. 4 shows an illustrative example of a user interface 400, the provision of which user interface 400 relates to the process of creating a joint respiratory therapy prescription by the system 100. Displayed on the user interface 400 are a timeline 410, a legend 412 describing the abbreviations of the keys used by the timeline 410, various details of the respiratory care mode that occur sequentially along the timeline 410 (described below), and a simulation feature 440. The simulated feature 440 enables a user to see simulated animation 442 (e.g., animated graphics or video clips) of the respiratory therapy as it is applied to the patient's lungs. To view the simulation, the user may select or highlight one from the plurality of therapies or treatment periods shown on the timeline 410 and then select the view simulation button. The system 100 will then locate and access the stored simulation corresponding to the selected therapy or treatment session (where the simulation may be indexed or marked and stored in a database, for example, according to the associated therapy or treatment session).

The illustrative schedule 410 includes two treatment periods TS-1 and TS-2, a mucous transfer treatment period M-2, and a nocturnal nasal pulmonary ventilation treatment period NIV. Each of the above treatment periods has an associated start time. For example, the treatment period TS-1 starts at 8:00 a.m., the mucous transfer therapy period starts at 7:50 a.m., the treatment period TS-2 starts at 8:00 a.m., and the nasal cavity pulmonary ventilation therapy period starts at 10:00 a.m. The start time and/or end time and duration of each of the above-described treatment periods may be varied by selectable markers 418, 420, 430, 432, 434, 436, 438. For example, the caregiver may select or "click" on a marker and drag or slide it horizontally to the right or left to change the patient's treatment pattern or plan. Moving the start time stamp (e.g., the stamps 418, 438, 430, 434) to the left will cause the start time of the treatment to be earlier, while moving the start time stamp to the right will cause the treatment on that day to begin later. Moving the end time stamp to the left (e.g., markers 420, 430, 432, 436) will shorten the duration of the treatment, while moving the end time stamp to the right will lengthen the duration of the treatment. In the illustrative example, the marker 430 is both a start time marker (for treatment period TS-2) and an end time marker (for mucous transfer therapy MM). This is intended to suggest to the system 100 that the treatment period TS-2 is initiated substantially immediately after completion of the mucous transfer period MM. In this way, correlations between the various therapies can be established to automatically coordinate their performance.

Each treatment session (TS-1, MM, TS-2, NIV) may have an extend/retract button (e.g., 422, 426, 428) associated therewith. Further details regarding the treatment session, such as the number of treatment sequences, device settings, etc., may be displayed or hidden by selecting the deploy/retract buttons 422, 426, 428. In the illustrative example, the extend/retract button 422 is selected to display further details of the treatment session TS-1, which are displayed in window 414. As shown in window 414, treatment period TS-1 consisted of 5 treatment sequences. Each treatment sequence (SEQ 1, SEQ 2, SEQ 3, SEQ 4, SEQ 5) has its own start and end markers 444, 448, 450, 452, 454, 456, which the user can slide back and forth in the horizontal direction to adjust the duration of the treatment sequence (e.g., the number of cough cycles or the duration of lung ventilation in the treatment sequence can be adjusted). Markers 448, 450, 452, 454 serve as both start and end markers such that the start time of the next therapeutic sequence (e.g., SEQ 2) is dependent upon the completion of the previous therapeutic sequence (e.g., SEQ 1) and not upon a particular clock time. Each treatment sequence also has an extend/retract button 424, 458, 460, 462, 464 associated therewith. Accordingly, the caregiver can view and/or modify the details of a particular treatment sequence by selecting the corresponding deploy/retract buttons 424, 458, 460, 462, 464. In the illustrative example, button 424 is selected to display details of the treatment sequence SEQ 1. As shown in window 416, these details include four secondary cough cycles at +25 inhalation pressure/-30 exhalation (inhalation) pressure, followed by two minutes of lung ventilation at +15 inhalation pressure/+4 exhalation pressure. Details displayed in windows 414, 416 may be hidden by again selecting the corresponding expand/retract button (e.g., 422, 424). Likewise, the simulation 442 may be hidden by selecting the button 440 again. In some embodiments, window 416 is interactive (e.g., it contains one or more text boxes) so that the caregiver can edit the details displayed therein directly.

Referring now to fig. 3, an illustrative control unit 300 of the combined device 110 is shown in more detail. The control unit 300 is embodied as a housing (e.g., plastic or metal shell) that contains or supports (as the case may be) the electronic and mechanical components shown within the dashed lines of fig. 3. In some embodiments, the housing is sized and designed such that the control unit 300 is relatively lightweight and portable. For example, according to some embodiments, the control unit 300 is configured to be mountable on a patient support device, such as a wheelchair, stretcher, elevator, hospital bed, or other patient transport apparatus.

A number of ports are defined in the housing for connection with patient interfaces 322, 324, 326 to provide various forms of respiratory therapy to the patient. Positive pressure airflow patient interface 322 is an exemplary embodiment of positive pressure airflow patient interface 124 shown in fig. 1. Patient interface 322 is embodied as a nose-mounted device that includes a pair of air delivery tubes, each configured to engage one nostril of a patient. Accordingly, patient interface 322 is configured to provide a positive pressure flow of air to the patient through the patient's nose.

Patient interface 324 is an exemplary embodiment of negative pressure airflow patient interface 126 shown in fig. 1. Patient interface 324 is specifically a mask that is designed to engage with an oral area of a patient to supply an airflow through the patient's oral cavity. In the embodiment shown in fig. 3, patient interface 322 is configured to provide only positive pressure airflow and patient interface 324 is configured to provide only negative pressure airflow to the patient. In other words, the illustrated patient interface 324 is only used to assist in the negative pressure portion of the cough cycle, and is not used to provide lung ventilation or lung volume recovery therapy. Likewise, patient interface 322 is used only for lung ventilation, lung volume recovery, and the inspiratory pressure portion of the assisted cough cycle, and is not used for the negative pressure portion of the assisted cough cycle. According to the above configuration, the interfaces 322, 324 separate the positive and negative airflow circuits, thereby avoiding contamination. However, in other embodiments, the interfaces 322, 324 may be combined or integrated into a single patient interface; for example, it may be designed as a single patient interface with a separate positive and negative airflow circuit.

Air pulse patient interface 326 is an exemplary embodiment of patient interface 128 shown in fig. 1. In some embodiments, interface 326 is embodied as a wearable element that is connectable with a catheter to provide pulses of air to the chest region of a patient when worn. THE THE VEST manufactured by Hill-Rom company may be used as THE interface. Alternatively or additionally, according to some embodiments, some form of air pulse therapy may be provided using the negative pressure airflow patient interface 324. For example, a device METANEB or other type of Continuous High Frequency Oscillation (CHFO) device 364 may be connected with the negative pressure airflow patient interface 324. Other devices that provide various forms of air pulse therapy may also be used in a similar manner.

In the embodiment shown in fig. 3, all computer programs and other components providing the functionality of the system 100 are located in the control unit 300. That is, all of the various features of the system 100 provided by the various modules described above may be accessed and used directly in the control unit 300. Thus, the illustrative control unit 300 includes a controller 310 disposed therein, the controller 310 may be embodied as one or more microprocessors, microcontrollers, digital signal processors, or the like. The controller 310 is in electronic communication with a number of other elements of the control unit 300 via a data communication link or bus 316 (e.g., a controller area network bus, etc.). In some embodiments, the control module 120, the configurable user interface module 114, the prescription database 118, and/or any sub-modules of each as described above are embodied in software stored, for example, in disk storage, which is then loaded into memory 312 (e.g., random Access Memory (RAM)) as needed at runtime. In some embodiments, the data 118 and/or portions of the modules 114, 120 may be embodied as firmware located in non-volatile memory. Further, in some embodiments, the memory 312 may be integrated with the controller 310. Accordingly, as shown in the simplified fig. 3, the configurable user interface module 114, prescription database 118, and control module 120 are specifically disposed in memory 312, which is accessible by the controller 310 to encompass all the various possible embodiments of the database 118 and modules 114, 120, whether implemented as software, firmware, hardware, or a combination thereof.

The control unit 300 includes a control panel 318, which may have its own power supply as shown schematically in fig. 3. The illustrative control panel 318 includes a display screen 320, which may be embodied as a touch screen display supported by the housing of the control unit 300. During operation, information related to the union device 110, such as current device settings, and ongoing therapy, may be displayed on the display screen 320. The features provided by the modules 114, 120 and/or the data accessed through the database 118 may be provided through the control panel 318 and/or the display screen 320, as well as through other computing devices as described above. In other words, in various embodiments of the system 100, a user may access any of the features of the system 100 described above through the control panel 318 and/or display screen 320, or through other computing devices described herein.

The control unit 300 includes illustrative audio circuitry consisting of an audio interface 372, an audio driver 374, an amplifier 376, and an audio controller 378. The audio circuitry is configured to allow the system 100 to process audio input and output audio as audible sound through a speaker to implement the features of the audio interface 142 described above. As shown in the fig. 3 embodiment, the audio circuitry is part of the control unit 300, but it should be understood that portions of the audio interface 142 may be implemented using similar components on a computing device (e.g., the user's local computing device). Thus, in various embodiments of the system 100, a patient or other user may interact with the union device 110 through the control panel 318 or through another computing device.

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 manages data communications from the device 110 to other devices (e.g., portions of the patient's joint respiratory prescription, data generated by the device 110 during operation, etc.) and vice versa via the network connector 384. The power management module 382 interacts with a power source (e.g., a battery or a wall outlet) to provide power to the various components of the control unit 300. The network connector 384 may include a wireless network interface, an ethernet adapter, and/or other components as may be required to enable the control unit 300 to electronically communicate with other devices via a wired or wireless network connection.

Also provided on the control unit 300 is a finger switch 380 in electronic communication with the controller 310. The components of the finger switch (e.g., its joystick, dashboard, buttons, or toggle keys) are mounted on the housing of the control unit 300 for patient use. The controller 310 is configured to start or stop 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 secondary cough therapy in response to a signal from the finger switch 380. That is, if the patient feels a mucus obstruction and a cough is desired, the patient may activate the finger switch to initiate the assisted cough therapy. Also, if the patient becomes uncomfortable while the treatment is being performed, the patient may press the finger switch to discontinue or halt the treatment.

The remaining components of the control unit 300 shown in fig. 3 include mechanical and electromechanical components to implement aspects of the patient's combined respiratory therapy prescription via the patient interfaces 322, 324, 326. In operation, the controller 310 sends control signals to the various components via the bus 316 and the several servo control modules 350, 354, 356, 358, 368 as appropriate to execute a combined respiratory therapy prescription. The servo control modules 350, 358 operate control circuitry to operate the motors 386, 360 of the manifolds 332, 330, respectively, to control the flow of air generated by the air supply 328 (e.g., blower) to the patient interfaces 322, 324, 326. The servo control module 354 operates the control circuitry to control the air pulse generator 352 to generate air pulses in accordance with the air flow from the air source 328 received through the manifolds 330, 332 and the valve 348. The servo control module 356 controls the operation of the air supply 328 in accordance with the combined respiratory therapy prescription based on parameters (e.g., on/off, positive/negative air flow, air pressure) provided by the controller 310. The servo control module 368 operates control circuitry to control operation of the air supply 362 (e.g., a compressor). In some embodiments, the servo control module 368 may provide airway clearance therapy, such as intra-pulmonary ventilation (IPV), to the nasal patient interface 322 via a Continuous High Frequency Oscillation (CHFO) device 364, a valve 366, and a moisture generator 345 (e.g., a nebulizer).

Patient interfaces 322, 324 are connected to air supply 328 via manifolds 332, 330, respectively. 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 moisture generator 338 to ensure that the air supplied to the patient through the nose is clean, the pressure at which the combination respiratory therapy prescription is administered is correct, and the air is somewhat moist to avoid over-drying of the patient's nasal cavities. Likewise, the air circuit of the negative pressure airflow patient interface 324 includes an airflow sensor 342 and a filter 344. The airflow sensors 334, 342 and the pressure sensor 346 are used to sense airflow and air pressure, respectively, in their respective circuits and provide airflow and air pressure data to the safety monitoring module 370. The safety monitoring module 370 monitors the air circuit for any failure and ensures that respiratory therapy is provided in accordance with the patient's joint respiratory therapy prescription. In some embodiments, the sensors 334, 342, 346 are used to synchronize the operation of the device 110 (e.g., the time at which positive or negative pressure is applied) with the patient's normal breathing pattern as described above. For example, sensor 346 may identify that the patient is beginning to breathe based on a change in air pressure in air circuit 340, thereby initiating a cough cycle, lung volume recovery therapy, or an inhalation phase of lung ventilation therapy in response thereto. As described above, in the illustrative embodiment, the air circuits supplying air to the positive pressure air flow patient interface 322 and the negative pressure air flow patient interface 324 include tubing to connect the interfaces 322, 324 and their respective air manifolds 332, 330, and the air circuits are separate from each other.

Fig. 6-9 illustrate device control algorithms that can be implemented by the system 100 to change a patient's joint respiratory therapy prescription and to perform various aspects thereof by the joint device 110 in real-time (e.g., as the patient receives respiratory therapy). For example, a user (who may be, for example, a clinician, caregiver, patient, or family member, as the case may be) may enter information regarding the patient's current respiratory condition, such as "the patient cannot expectorate secretions," through the question prioritization module 140. The device control module 140 automatically performs therapy adjustments according to defined algorithms based on the entered information and then queries the user to determine if the adjustments are valid. If the user answers that the adjustment does not help with the patient's condition, the system 100 will proceed to the next step of the algorithm as shown in FIGS. 6-9 below. If the user answers that the adjustment is valid, the system 100 will continue to provide treatment according to the current setting without any additional changes.

Referring now to fig. 6, an illustrative method 600 is shown that the method 600 can be performed as a computerized program, routine, logic, and/or instructions by the device control module 140 and/or one or more other modules of the system 100 to adjust the settings of the modeling-interval aspects in the patient's joint respiratory therapy prescription in real-time, either automatically or in response to user input. In this example, the system 100 (automatically based on sensor data or by analyzing user input) detects "patient is unable to expectorate secretions". First, step 610 is performed, the method 600 is operated at a patterned (e.g., 24 hour time axis) level, and in step 612, the intervals of various therapies for the patient throughout the treatment timeline are determined (e.g., automatically or by querying the user). For example, in step 612, the method 600 determines how long the patient has been in the wake of the patient between the current cough assist therapy sessions (e.g., whether each therapy session is more than four hours. If the answer is "no," this means that the patient has received cough assist therapy at least once every four hours while awake. In step 616, the method 600 determines if the interval between treatment periods exceeds two hours but is less than or equal to four hours while the patient is awake. In other words, is the interval between treatment periods greater than two hours but not greater than four hours? If the answer is "yes," then method 600 proceeds to step 618 to update the patient's combined respiratory therapy prescription such that the cough assist therapy session occurs every two hours (e.g., to increase the frequency of the therapy session). If the answer is "no," then method 600 proceeds to step 620 to maintain the frequency of the current cough assist therapy session (inferred to be less than or equal to two hours).

Referring now to fig. 7, an illustrative method 700 is shown, which method 700 can be executed as computerized programs, routines, logic, and/or instructions by the device control module 140 and/or one or more other modules of the system 100 to adjust settings of therapy stratification aspects in a patient's joint respiratory therapy prescription in real-time. The method 600 may be used to adjust the frequency of respiratory therapy sessions over a period of time, while the method 700 is directed to determining whether a particular combination device 110 being used by a patient should be changed. In step 710, a hierarchical change algorithm may be initiated automatically or in response to a user input, wherein the input may, for example, indicate that a clinical change in the patient's health condition has occurred.

In step 712, the method 700 determines (again, automatically or based on user input) which features of the union device 110 the patient is currently using, or which of the union devices 110 in the above-described series of union devices are currently being used. For example, the method 700 may determine whether the patient is already receiving mucus transfer therapy in addition to mucus withdrawal therapy and lung volume restoration therapy (e.g., by the combination device 224) or lung ventilation (e.g., by the combination device 226). If the answer is "yes," then method 700 proceeds to step 714 to continue providing the current therapy without any change. If the answer is "no," then the method 700 proceeds to step 716 to automatically add mucus transfer therapy to the patient's joint respiratory therapy prescription, or instruct the user to do so. This may be accomplished, for example, by activating the air pulse patient interface 128 of the patient's existing combination 110 or switching the patient to a different combination (e.g., device 228 or device 230).

Further, in step 716, the method 700 updates the patient's combined respiratory therapy prescription to increase the phase of mucus transfer therapy ten minutes prior to each predetermined cough assist therapy phase. In step 718, the method 700 determines whether the patient is already receiving mucus transfer therapy with a combination device 110 (e.g., device 230) that also provides lung volume restoration therapy to the patient. If the patient is already receiving mucus transfer therapy and lung volume restoration therapy, then method 700 displays information in step 720 suggesting that the user switch the patient to a device 110 (e.g., device 228) that can provide lung ventilation therapy (in lieu of lung volume restoration therapy) as well as mucus transfer therapy. If the answer is "no" (i.e., the patient is already receiving mucus transfer and lung ventilation therapy), then the method 700 proceeds to step 722 to display information advising the patient to continue using the same device 110 without any change.

Referring now to fig. 8, an illustrative method 800 is shown, which method 800 can be executed as computerized programs, routines, logic, and/or instructions by the device control module 140 and/or one or more other modules of the system 100 to adjust settings in a patient's joint respiratory therapy prescription in real-time in terms of modeling-duration. Method 600 may be used to adjust the interval or time span between treatment periods throughout respiratory care (e.g., time axis), while method 800 may be used to adjust the length or duration of individual treatment periods in a patient prescription, either automatically or in response to user input. In step 810, the mode duration change algorithm is turned on in response to the system 100 determining, for example, a clinical change in the patient's condition. In step 812, the method 800 determines whether the treatment period currently defined in the patient's combined respiratory therapy prescription is less than fifteen minutes. If "yes," method 700 performs step 814 to adjust the patient's combined respiratory therapy prescription to increase the duration of the treatment period to fifteen minutes. If "no," the method 700 does not make any changes to the existing parameters of the patient treatment session, such that it remains for the current fifteen minutes or longer. In step 818, the method 800 determines whether the patient received at least fifteen minutes of lung ventilation or lung volume restoration therapy after each treatment session. If "yes," method 800 maintains the current settings for lung ventilation or lung volume restoration, as appropriate. If "no," the method 800 adjusts the patient's combined respiratory therapy prescription to increase the duration of the patient's lung ventilation or lung volume recovery therapy to fifteen minutes.

Referring now to fig. 9, an illustrative method 900 is shown, which method 900 can be executed as computerized programs, routines, logic, and/or instructions by the device control module 140 and/or one or more other modules of the system 100 to adjust settings of sequential aspects in a patient's joint respiratory therapy prescription in real-time. That is, the method 900 is directed to adjusting specific details of the cough assist therapy sequence, such as clinical changes in patient condition, and the system 100 can automatically detect or receive clinical changes in patient condition via user input. In response to determining that the patient is difficult to self-clear of chest secretions, the method 900 first proceeds to step 910. In step 912, the method 900 determines whether the treatment sequence in the patient's current combined respiratory therapy prescription already includes four secondary cough cycles, and whether secondary ventilation will follow for at least two minutes. If yes, then in step 914, the method 900 continues with the therapy according to the existing prescription without any change. If "no," then in step 916, the method 900 adjusts the patient's existing respiratory prescription to include four cough cycles and continues with two minutes of assisted ventilation.

In step 918, method 900 determines whether the inspiratory pressure used during the cough period is less than 30cm of water (e.g., the inspiratory pressure delivered through nasal patient interface 322). If "no" (meaning that the inspiratory pressure has been at least 30cm of water), then the method 900 proceeds to step 920 where treatment is continued according to the existing prescription without any change. If yes, method 900 proceeds to step 922 where the inspiratory pressure is increased by 1cm of water (e.g., to a maximum of 33cm of water) for each of the next three treatment phases. In step 924, the method 900 checks whether the expiratory (inhalation) pressure (now toward the mouth) during the secondary cough cycle is less than-40 cm of water (inhalation), i.e. the force of the negative pressure is less than 40cm of water. If "no" (meaning that the exhalation (inhalation) pressure has been at least-40 cm of water), the method 900 proceeds to step 926 without any change, continuing the treatment according to the existing prescription. If "Yes", the method 900 updates the patient's prescription to increase the expiratory (inspiratory) pressure by two cm of water (e.g., to a maximum of-40 cm of water) during each of the next three treatment phases. For example, if the negative pressure is currently set at-30 cm of water, then in each of the next three treatment phases the suction pressure will increase by 2cm of water, i.e. a maximum of-36 cm of water. In step 930, the method 900 determines whether the treatment period of the patient is currently defined to include at least five treatment sequences. If "yes," method 900 continues the therapy according to the existing prescription without any change. If "no," the method 900 updates the patient's prescription, increasing the number of consecutive treatment sequences per treatment session to five.

Referring now to fig. 10, an illustrative method 1000 is shown, which method 1000 can be executed as computerized programs, routines, logic, and/or instructions by the control module 120 and/or one or more other modules of the system 100 to operate the combined device 110 in real-time to provide appropriate respiratory therapy to a patient at an appropriate time. In step 1010, the method 1000 monitors the clock time to determine whether to partially begin the patient's therapy based on the patient's combined respiratory therapy prescription. For example, if the patient's prescription indicates that a treatment session is to begin at 8:00 am, then the method 1000 compares the current clock time to the beginning of 8:00 am and when the comparison is successful, then step 1012 is performed. If no therapy is scheduled to begin at the current clock time according to the patient's prescription, method 1000 proceeds to step 1010 where the clock time continues to be monitored.

In step 1012, the method 1000 determines the type of therapy that it is required to initiate by the union device 110. If the type of therapy is mucus withdrawal, then in steps 1014 and 1018, method 1000 initiates a therapy sequence, illustratively including a number of consecutively performed cough cycles. If the type of therapy is other than mucus withdrawal, then the method 1000 proceeds to step 1016 where the settings of the combination device 110 for the therapy are configured according to the patient's prescription (e.g., therapy pressure, duration, etc.), thereby beginning to provide the therapy, and proceeds to step 1036 where the therapy is performed for a prescribed period of time. While therapy is being performed in step 1036, the system 100 may receive input from a user (e.g., clinician, caregiver, patient, or family member) in step 1038 and adjust the settings of the device in step 1040 based on the input. For example, the patient may want to decrease the inspiratory or expiratory pressure and inform the device 110 of the corresponding operation via the finger switch 380 described above. The method 1000 monitors the time elapsed during the execution of the therapy in step 1036 and determines in step 1042 whether it is time for the end of the therapy (based on the duration of the therapy prescribed in the patient's respiratory prescription). If the desired period of time has elapsed, the method proceeds to step 1052, ending the therapy session. If not, the method returns to step 1036 to continue the current treatment.

Returning to step 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 repetitions of the predetermined cough period, and not on the clock time. Thus, the method 1000 tracks the number of treatment sequences that have been performed during the current treatment session to determine the treatment sequence. Therefore, in step 1018, the initial value of the treatment sequence counter is zero. Once the treatment sequence is initiated in step 1018, the method proceeds to step 1020 where the combination device 110 is configured for the mucus withdrawal therapy and the number of cough cycles specified in the patient prescription. In step 1022, the method 1000 begins to perform mucus withdrawal therapy (e.g., by providing the number of cough cycles specified in the prescription). The cough cycle is substantially followed by a short time of lung volume restoration or lung ventilation therapy, as prescribed by the treatment sequence. Accordingly, method 1000 configures the combined device 110 to provide lung volume restoration therapy or lung ventilation therapy after the cough cycle is completed in step 1024 and performs lung volume restoration or lung ventilation therapy in step 1026. To this end, the method 1000 changes the setting of pressure from the pressure setting for mucus withdrawal therapy to a pressure setting suitable for lung volume restoration or lung ventilation therapy.

Upon completion of the lung volume recovery therapy or the lung ventilation therapy (e.g., upon expiration of the time to provide the therapy or the duration of the therapy), method 1000 marks the end of the completed cough assist therapy sequence in step 1028 and increases the number of therapy sequences in step 1030. In step 1032, the method 1000 compares the number of current treatment sequences (e.g., the value of the treatment sequence counter) to the total number of treatment sequences to be performed during the treatment period as specified in the patient's combined respiratory therapy prescription. If the value of the treatment sequence counter is equal to the total number of treatment sequences to be performed during the treatment period, then the treatment period has completed and method 1000 proceeds to step 1034, resets the treatment sequence counter to zero, and then proceeds to step 1052 to end the treatment period. If the value of the treatment sequence counter is less than the total number to be performed during the therapy session, the method returns to step 1022 to perform another treatment sequence. As with other forms of therapy, the treatment sequence may be interrupted and modified in real time by user input. This is illustrated by loops 1044, 1046 and 1048, 1050, each of which operates in a similar manner to loops 1038, 1040 described above. Therefore, description will not be repeated here. In step 1052, the method 1000 returns to the start, step 1010, to continue monitoring the clock time of the next therapy to be started according to the patient's combined respiratory therapy prescription.

The methods 600, 700, 800, 900, and 1000 described above may refer to "determining," "checking," "querying a user," etc. in the method or system 100. It should be appreciated that each time computer logic is executed by another aspect of the method or system 100, the required inputs may be received from a user, or automatically calculated, or accessed through a memory location in the computer memory. For example, if the illustrative method described herein indicates that the method requires user input, it should be understood that other embodiments may not require such user input, but may obtain the desired information by, for example, computing or by accessing a stored database or look-up table. Also, the illustrative methods of "determining" something described herein may be implemented by obtaining user input, accessing stored information, or performing calculations, as desired. Further, in the illustrative methods 600, 700, 800, 900, and 1000, and in other examples described herein, specific values (e.g., air pressure, duration, etc.) are mentioned. It should be understood that these values are provided for illustration only and the disclosure is not limited thereto.

Referring now to FIG. 11, an exemplary computing environment 1100 is illustrated in which the system 100 may be implemented. In the embodiment shown in fig. 3, all of the features of the system 100 may be accessed directly on the federated device 110, while in the embodiment shown in fig. 11, some of the features of the system 100 may be provided on other devices. Even so, as illustrated, while computing environment 1100 is directed to multiple components and devices, it should be appreciated that in some embodiments computing environment 1100 may be combined with device 110 and/or other devices to form a single computing device (e.g., a hospital computer or mobile computing device). In other words, the terms "system" and "environment" as used herein may refer to a single computing device or a combination of computing devices and/or other components.

The illustrative 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 enable electronic communication with each other, with other computing devices or systems 1170, and with the joint respiratory therapy device 110 via one or more electronic communication networks and/or telecommunications networks 1180. Each device 1110, 1130, 1150 is configured to use a variation of the system 100 that is compatible with the type of user. For example, in some embodiments, various permissions and access controls may be selected for each type of user when initially setting up the system 100 or when adding a new user.

Illustratively, the prescription creator module 112 is located on the physician computing device 1110 and the components 118A, 118B, 118C of the joint respiratory therapy prescription database 118 are stored in each computing device 1110, 1130, 1150, respectively. Each of the different components 118A, 118B, 118C of the database 118 includes a subset of the database 118. For example, components 118A and 118B may include only prescriptions for patients being cared for by a particular physician or therapist using devices 1110, 1130, while component 118C may include only prescriptions for a particular patient using device 1150. Similarly, the components 136A, 136B, 136C of the data sharing module 136, the components 140A, 140B, 140C of the device control module 140, and the components 122A, 122B, and 122C of the prescription translator module 122 may be specifically configured for the users of the respective computing devices 1110, 1130, 1150. For example, based on the target users of the respective computing devices 1110, 1130, 1150, the data sharing component 136A and the device control component 140A may include an extended set of features and functions, while the data sharing component 136B, 136C and the device control component 140B, 140C may include relatively limited functionality. The prescription translator components 122A, 122B, 122C may each have the same or similar functionality; alternatively, in some embodiments, the prescription translation function of component 122A may be more than that of components 122B or 122C, for example. As shown, the audio interface 142 and the character configuration module 144 are located on a patient computing device 1150. However, as described above, components or variations of these modules 142, 144 may be adapted for use by other users, such as physicians or therapists, and these components or alternatives may be located on one or both of the physician computing device 1110 and therapist computing device 1130, respectively.

In some embodiments, the computerized modules of the system 100 are specifically downloadable software applications or "applications" that can be obtained from a centralized store in the network (e.g., an "app store" or "app marketplace" of a private hospital or home care company). In these embodiments, there is a single application that all types of users can download, which, once installed on the user's local computing device, is configured for that particular user. Alternatively, the application store may provide different downloadable applications for different types of users so that users can select and download applications containing the functions desired by the users. For example, an application may contain a prescription creator module 112, while another application may contain audio interface and character configuration modules 142, 144, but not the prescription creator module 112. Of course, the rights and access controls for downloading applications may be set by an authorizer (e.g., a hospital system administrator).

Each illustrative computing device 1110, 1130, 1150 includes at least one processor 1112, 1132, 1152 (e.g., microprocessor, microcontroller, digital signal processor, etc.), 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, an enterprise computer system, a computer network, a combination of computers and other electronic devices, a personal electronic device such as a mobile or portable or handheld computing device, a smart phone, a personal digital assistant, a notebook, a tablet, or a desktop.

Although not specifically shown, it should be appreciated that I/O subsystems 1116, 1136, 1156 typically include, among other components, an I/O controller, a memory controller, and one or more I/O ports. The processors 1112, 1132, 1152 and the I/O subsystems 1116, 1136, 1156 are communicatively coupled to memories 1114, 1134, 1154. The memories 1114, 1134, 1154 may be embodied as any type of suitable computer memory device (e.g., volatile memory in various forms of random access memory). In the illustrative environment 1100, the I/O subsystems 1116, 1136, 1156 are communicatively coupled to a number of hardware components. The hardware components include various input devices 1118, 1140, 1158 (e.g., a touch screen, microphone, physical keyboard or keypad, buttons or hard board controls), at least one data store 1126, 1146, 1166, various output devices 1120, 1140, 1160 (e.g., LEDs, display screen, speakers), one or more other peripheral devices 1122, 1142, 1162 (e.g., sound, graphics, or media adapters), and one or more network interfaces 1124, 1144, 1164.

The data stores 1126, 1146, 1166 may include one or more hard disks or other suitable data storage devices (e.g., flash memory, memory cards, memory sticks, and/or others). In some embodiments, components 118A, 118B, 118C of the prescription database are at least temporarily located in data stores 1126, 1146, 1166. During operation, components 118A, 118B, 118C of the prescription database may be copied into memory 1114, 1134, 1154 to speed up processing or for other purposes. Further, in some embodiments, components of any of the software modules of the system 100 may be stored in the data stores 1126, 1146, 1166 and loaded into memory at runtime.

Network interfaces 1124, 1144, 1164 may communicatively couple computing devices 1110, 1130, 1150 with one or more networks 1180. The network may include a local area network, a wide area network, an enterprise cloud, and/or the internet. Thus, the network interfaces 1124, 1144, 1164 may include wired or wireless ethernet, mobile/cellular networks, WI-FI, bluetooth, virtual Private Network (VPN), or Near Field Communication (NFC) devices or adapters as desired, depending on the specifications and/or design of the particular network 1180. Accordingly, those skilled in the art will appreciate that the network interfaces 1124, 1144, and 1164 enable bi-directional communication between the devices 1110, 1130, and 1150.

Each of the other computing devices/systems 1170 may be embodied as any suitable type of computing device, such as a server, an enterprise computer system, a computer network, a combination of computers and other electronic devices, a mobile device, any of the types of electronic devices described above, or other electronic device. For example, in some embodiments, other computing devices 1170 may include other computers or computer systems of a hospital or other medical facility that run enterprise-type software applications, such as an Electronic Medical Records (EMR) system 1172, an admission, discharge and transfer (ADT) system 1174, and a healthcare communication system (such as a nurse call system) 1176. Thus, in some embodiments, the system 100 may communicate with one or more systems 1172, 1174, 1176. For example, if a clinical change in the health of a patient receiving combination respiratory therapy via device 110 occurs that requires medical care, system 100 may alert a responsible nurse or therapist via healthcare communication system 1176. For another example, the system 100 may obtain data from the electronic medical records system 1172 relating to the patient's medical history or once-used medical history and use that information to configure or adjust the patient's current therapy prescription. Further, the system 100 may interact with a medical facility's admittance, transfer and discharge system 1174, for example, to automatically transmit a patient's joint respiratory prescription to a remote computing device upon discharge of the patient.

The computing environment 1100 may include other components, sub-components, and devices, which are not shown in fig. 11 for clarity. In general, as shown in FIG. 11, components of computing environment 1100 may be communicatively coupled by signal paths, which may be embodied as any type of wired or wireless signal paths that facilitate communications between the devices and components.

Turning now to fig. 12, a home screen 1200 is shown that is a graphical user interface that interacts with the combined respiratory therapy devices 224, 226, 228, and 230 described in fig. 2. It will be appreciated that while the embodiment shown in fig. 2 illustrates four combined respiratory therapy devices 224-230, any number of such devices may be utilized in accordance with the systems and methods described herein, and that the use of four devices 224-230 is merely intended to be an exemplary embodiment. As shown in fig. 12, a main screen 1200 is appropriately displayed by the touch screen 500. The home screen 1200 includes four button icons, preferably color coded, to allow a patient, therapist, clinician, etc. to interact with the devices 224-230 to control the devices 224-230, as will be described in more detail below.

Further, those skilled in the art will appreciate that the home screen 1200 may be adjusted based on the underlying device 224, 226, 228, or 230 with which the display 500 is associated. Thus, for example, device 1224 (mucus extraction and lung ventilation) and device 3228 (mucus extraction, lung ventilation and mucus transfer (oscillation)) may show all four icons, while device 2226 (mucus extraction and lung volume restoration) and device 4230 (mucus extraction, lung volume restoration and mucus transfer) may show only three of the icons, as will be described in greater detail below.

Fig. 12 shows an "emergency" button icon 1202, an "intensive therapy" button icon 1206, a "custom therapy" button icon 1208, and a "cough" button icon 1204. According to an embodiment, the emergency button icon 1208 is illustrated with a phrase of "problem first", e.g., "I cannot breathe-! ", thereby indicating to a user of the patient, etc., what the question is about the underlying button icons 1202-1208. In various embodiments, the icons 1202-1208 are color coded to provide further distinguishing features in the event of patient confusion, distress, etc. According to the illustration of fig. 12, emergency icons 1202 are depicted as red on touch screen display 500 associated with the combined respiratory therapy devices 1 and 3, respectively designated 224 and 228 in fig. 2.

Upon pressing a button (i.e., touching icon 1202) corresponding to an emergency, a corresponding emergency algorithm stored in memory 312 and executed by controller 310 (shown in fig. 3) is activated according to an embodiment of the present application. As will be appreciated by those skilled in the art, activation of the emergency button icon 1202 can cause the device 224 and/or 228 to implement sustained pulmonary ventilation thereto in accordance with patient conventional settings, thereby immediately reacting to acute respiratory distress and shortness of breath. Fig. 13 provides an illustrative graphical user interface screen 1300 displayed on the touch screen 500 after selection of the emergency button icon 1202.

As depicted in fig. 13, screen 1300 provides an indication of the selected mode, in this example presenting an emergency button icon 1202 that blinks or emits other visual indications associated therewith, indicating that the emergency algorithm has been activated. The screen 1300 still displays a cough button icon 1204, while also displaying a new "exit" button icon 1302, including a description of the problem priority, e.g., "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 as desired.

According to embodiments contemplated herein, when the emergency button icon 1202 is selected and emergency operation is initiated, the device 224 and/or 228 may automatically switch to battery power if a power outage, unplugging the device, or the like occurs, such as when an ambulance arrives and must transport a patient. It will be appreciated by those skilled in the art that "conventional settings" refers to a conventional treatment regimen, i.e., a combination respiratory therapy prescription as discussed and described in U.S. patent 9,795,752, specifically by layering (selecting specific devices 224-230 based on functions such as mucus extraction and lung ventilation (device 1 224)), modeling (indicating a 24 hour time axis for the entire treatment period, such as overnight lung ventilation and once every four hours cough treatment), and sequencing (a specific number of cough periods and settings for the included treatment periods, e.g., a pressure of +30/-30cm water pressure per cough period, one minute of assisted ventilation for the patient after every 5 cough periods, each treatment period including 5 cough periods and ventilation subsequent thereto).

Returning to the home screen 1200 displayed to the patient/caregiver, selection of the "intensive therapy" button icon 1206 causes the touch screen 500 to display the interface screen 1400 shown in fig. 14. As shown in FIG. 14, the intensive and custom therapy button icons 1206-1208 are removed, while two new options are newly shown, namely a "primary intensive 12 hours" button icon 1402 and a "secondary intensive 25 hours" button icon 1404. The intensive care screen 1400 also includes a cough icon button 1204, an exit button icon 1302, and an emergency button icon 1202, which are individually accessible to the patient/caregiver through the intensive care screen 1400.

Upon selection of the "first-level, 12-hour, or" second-level, 25-hour " button icon 1402, 1404, the selected icon begins to flash or provide other suitable visual or audible indication related to its selection. It will be appreciated that problems associated with weakness may occur with the patient/caregiver, for example, expectoration during the course of a conventional treatment. The patient/caregiver may then select the intensive therapy button icon 1206 to automatically enhance therapy when the patient fails to expectorate the airway resident secretions due to weakness such as cold. The therapy can be enhanced immediately at home by an automatic algorithm, so that the patient is prevented from hospitalization due to lung atrophy, pneumonia and respiratory failure. Furthermore, it will be appreciated by those skilled in the art that buttons 1202-1208 and corresponding algorithms associated therewith may also be used by clinicians/caregivers in home care, hospital and rehabilitation environments because they simplify administration and allow immediate response to changes in the patient's clinical status.

By the enhanced level button icons 1402-1404, not only can the frequency of cough treatment periods be increased, but also the duration of lung ventilation per 24 hour period can be increased for devices that provide lung ventilation. In some embodiments, the device 224, 226, 228, or 230 can continue to administer therapy at the final reinforcement level of the algorithm (e.g., providing a treatment session every four hours around the clock) until the exit button icon 1302 is activated, returning the therapy to the patient's conventional settings/prescriptions. Selecting the exit button icon 1302 on screen 500 will stop the devices 224-230 from continuing to ventilate and return to the regular treatment plan.

For device 2 226 (mucus withdrawal and lung volume recovery), an enhancement level 1 was provided once an hour for a treatment period of four hours, then once every two hours for eight hours, then once every four hours, around the clock. During this procedure, after each set of cough cycles, a recovery of lung volume is performed according to the patient's conventional pressure settings. For example, one minute of lung volume recovery is performed after each group of 5 cough cycles. The enhancement level 2 of device 2 226 provides a treatment period of once every twenty minutes for one hour, then once every hour for eight hours, then once every two hours for sixteen hours, then once every four hours, around the clock. During this procedure, after each set of cough cycles, a recovery of lung volume is performed according to the patient's conventional pressure settings. For example, one minute of lung volume recovery is performed after each group of 5 cough cycles. The treatment continues until the exit button icon 1302 is selected, returning to the patient's regular treatment plan.

For device 4 230 (mucus aspiration, lung volume restoration, and mucus transfer), an enhancement level 1 is to provide a treatment period once every hour for four hours, then every two hours for eight hours, then every four hours, around the clock. During this procedure, an oscillating mucous transfer is performed prior to each treatment session, followed by a recovery of lung volume according to the patient's conventional pressure settings. The fortification level 4 of device 2 230 was provided once every twenty minutes for a treatment period of one hour, then every hour for eight hours, then every two hours for sixteen hours, then every four hours, around the clock. As with enhancement class 1, oscillatory mucus transfer followed by lung volume recovery was performed prior to each treatment session. The treatment continues until the exit button icon 1302 is selected, returning to the patient's regular treatment plan.

For device 1224 (mucus extraction, lung ventilation), an enhancement level 1 is to provide a treatment period once every hour for 4 hours, and to continue assisted ventilation after the treatment period. Thereafter, every two hours, for eight hours, and ventilation was assisted for one hour after each treatment session. Then, treatment was provided every four hours, around the clock, and ventilation was assisted for two hours after each treatment period. According to an embodiment, assisted ventilation over the entire patient's sleep time may be allowed with exceptions if the patient's conventional therapy prescription indicates. The enhancement level 2 of device 1224 is to provide a treatment session every twenty minutes for one hour, then every hour for eight hours, then every two hours for sixteen hours, then every four hours, around the clock. Continuous assisted ventilation is performed after each treatment session. The treatment continues until the exit button icon 1302 is selected, returning to the patient's regular treatment plan.

For device 3228 (mucus extraction, lung ventilation, and mucus transfer (oscillation)), intensity level 1 would provide a treatment period once every hour for four hours, and assisted ventilation after the treatment period. Thereafter, every two hours, for eight hours, and ventilation was assisted for one hour after each treatment session. Then, treatment was provided every four hours, around the clock, and ventilation was assisted for two hours after each treatment period. Oscillating mucous transfer is performed prior to each treatment session. According to an embodiment, assisted ventilation over the entire patient's sleep time may be allowed with exceptions if the patient's conventional therapy prescription indicates. The enhancement level 2 of device 3228 is to provide a treatment session every twenty minutes for one hour, then eight hours each hour, then sixteen hours each, then four hours each, around the clock. Each treatment session was preceded by an oscillatory mucous transfer and then continued assisted ventilation. The treatment continues until the exit button icon 1302 is selected, returning to the patient's regular treatment plan.

The custom therapy button icon 1208 may be selected by the patient/caregiver to customize the therapy applied to the patient. It is appreciated that in accordance with embodiments of the present application, custom therapy button icons 1208 are displayed on the touch screen 500 of each device 1-4 (224-230). Upon selection of the custom icon 1208, a series of successive subsequent displays may be presented to the patient/caregiver to enable the user to fine tune the settings of the devices 224-230 according to the algorithms presented herein and according to each patient's preferences to optimize comfort and effectiveness.

Turning now to fig. 15, a graphical user interface display 1500 associated with the initiated customization is shown after the patient/caregiver selects the customization button icon 1208. Fig. 16A-16L provide additional illustrations of various selection components displayed in a selection box 1502 for custom device 1-4 (224-230) settings according to embodiments of the present application. It will be appreciated by those skilled in the art that the sequence illustrated in fig. 16A-16L is intended to provide one possible implementation of interactions between devices 224-230 and the user (patient/caregiver) during customization, other interaction sequences are contemplated herein. Accordingly, the sequencing of the graphical user interfaces for customizing the combined respiratory therapy devices 224, 226, 228, or 230 depicted in fig. 16A-16L may occur in the illustrated order, or may be modified according to the functionality of the devices 224-230 or the existing treatment method of the patient.

Beginning with fig. 16A, a user is provided with custom options for adjusting cough settings 1504 on touch screen display 500 of any of devices 1-4 (224-230). However, those skilled in the art will appreciate that the emergency button icons 1202 are not displayed for devices 2 and 4 (226 and 230). The user may adjust the cough setting by selecting the "yes" button icon 1506 or rejecting the option and jumping to the ventilation setting (as discussed in fig. 16F). Upon selection of the "yes" icon 1506, the display 500 proceeds to fig. 16B, at which point three choices of cough inhalation pressure are presented to the user: low 1512, normal 1514, and high 1516.

After selecting the inhalation pressure, display 500 advances to FIG. 16C, where the user is presented with three options for adjusting the cough exhalation (inhalation) pressure 1518: low 1520, normal 1522, and high 1524. As used herein, the inhalation and exhalation (inhalation) pressure levels of a cough cycle will control the inhalation pressure level at the beginning of the cough cycle and the exhalation (inhalation) pressure level at which the cough cycle is completed and mucus is extracted. In an exemplary embodiment, the pressures (low, normal, high) of the inhalation and exhalation (inhalation) pressures may include the following: "low" means 2cm of water below the preset pressure level of inhalation pressure, 2cm of water below the preset pressure level of exhalation (inhalation) pressure; the "normal" inhalation and exhalation (inhalation) pressures are preset pressure levels; and "high" means that the inhalation pressure is 2cm water column higher than the preset pressure level and the exhalation (inhalation) pressure is 2cm water column more negative than the preset pressure level.

After the exhalation (inhalation) pressure 1518 is selected, the custom screen 1500 of the touch screen display 500 advances to adjust the cough cycle duration 1526 as shown in fig. 16D. In fig. 16D, the user is presented with three options for the duration of the cough period: short 1528, normal 1530, and long 1532. According to an embodiment, the duration 1526 of the cough period may control the inhalation pressure, the exhalation (inhalation) pressure, and the length of the pause. In an embodiment, the presented options 1528-1532 include the following ranges: short = inhalation pressure for 1 second, exhalation (inhalation) pressure for 1 second, then pause for 1 second; normal = inhalation pressure for 2 seconds, exhalation (inhalation) pressure for 2 seconds, then pause for 2 seconds; and long = inhalation pressure for 3 seconds, exhalation (inhalation) pressure for 3 seconds, then dwell for 3 seconds.

Thereafter, the customization screen 1500 advances to enable the user to adjust the cough sensitivity 1534 as shown in fig. 16E. As used herein, cough sensitivity may control the level of inspiratory pressure that triggers the inspiratory phase of the cough cycle. The user may select an option corresponding to the sensitivity of the devices 224-230 to assist in coughing, namely weak 1536, normal 1538, or strong 1540. In an exemplary embodiment, the inspiratory pressure triggered by weak 1536 is minimal (e.g., 1 liter/minute flow or 1cm water pressure); normal 1538 triggers an average pressure (e.g., 2 liters/minute flow or 1.5cm water pressure); the pressure of the strong 1540 trigger is higher than the average pressure (e.g., 3 liters/min flow or 2cm water pressure).

After adjusting the cough sensitivity 1534, or clicking directly on the skip option 1508 shown in fig. 16A, the customization screen 1500 may enter fig. 16F, at which point the user can adjust the ventilation settings 1542. It will be appreciated that the option of the ventilation settings 1542 applies to devices 1 and 3 (224 and 228), while devices 2 and 4 (226 and 230) would directly skip the steps (screens) associated with the ventilation settings as shown in fig. 16F-16I. As shown in fig. 16F, the user may select the yes button icon 1544 to adjust the ventilation settings 1542 of devices 1 and 3 (224 and 228) or select no, jump to the oscillation button icon 1546 (for devices 3 and 4 228-230). Upon selection of the "yes" icon 1544, custom display screen 1500 may show that it can adjust ventilation and inhalation pressure 1548, as shown in fig. 16G. In fig. 16G, the user has three options: 1550 = 2cm water column below the preset suction pressure; normal 1552 = preset pressure level; high 1554 = 2cm water column above the preset pressure level. The custom display screen 1500 then proceeds to show the user that the ventilation sensitivity can be adjusted 1556 as shown in fig. 16H.

Fig. 16H shows three options that enable a user (i.e., patient/caregiver) to customize the ventilation sensitivity of device 224 or 228, namely weak 1558, normal 1560, and strong 1562. As contemplated herein, the weak 1558 trigger has a minimum inspiratory pressure or flow (e.g., 1 liter/minute flow or 1cm water pressure); normal 1560 triggers an average pressure or flow (e.g., 2 liters/minute flow or 1.5cm water pressure); the pressure triggered by force 1562 (e.g., 3 liters/minute flow or 2cm water pressure) is higher than the average pressure or flow. Once the user adjusts the sensitivity 1556, the custom display screen 1500 advances to show the user the ability to adjust the post-cough ventilation duration 1564.

Fig. 16I shows a custom option for the device 224 or 228 to adjust the post-cough ventilation duration 1564. Post-cough lung ventilation duration 1564 controls the length of time that the patient "recovers" from an assisted cough through lung ventilation. For example, after each group of 5 cough cycles, the device provides lung ventilation for the following period of time during each treatment session: short 1566 = 30 seconds; normal 1568 = 1 minute; length 1570=3 minutes. After the device 3 228 is set for the post-cough ventilation duration, or after the device 4 (230) bypasses FIGS. 16H-16I as described above, the custom screen 1500 enters the adjust oscillation setting 1572 as shown in FIG. 16J, at which point the user is provided with the option of moving the touch display 500 back to the home screen 1200 as shown in FIG. 12 by entering the adjust or no button icon 1576 through the yes button icon 1574 to FIG. 16K.

When the user selects the "yes" button icon 1574, the customization screen 1500 advances to the adjust oscillation 1578 setting as shown in fig. 16K. With fig. 16K, the user is able to control the rate and depth of oscillation provided by devices 3 and 4 (228 and 230), allowing slow/strong oscillation 1580 (e.g., 4 hz), normal oscillation 1582 (e.g., 8 hz), and fast/shallow oscillation 1584 (e.g., 12 hz). According to an embodiment, the slow/strong 1580 option provides slower, deeper oscillations, the normal 1582 option provides oscillations of average frequency and depth, and the fast/shallow 1584 option provides faster, shallower oscillations.

Once the user selects the desired value of oscillation adjustment, customization screen 1500 proceeds to fig. 16L, where an indication of completion 1586 of the setting is depicted as 16L, and two options are provided to the user. The user may select the start button icon 1588 to start a new setting or exit/return to the home screen 1200 or select the return button icon 1590 to return to fig. 16A for further adjustment. According to various embodiments, other customization options may be provided, such as expanding the scale, at which point the advanced user may expand the scale through the touch screen 500 to preset the intermediate settings for each parameter. For example, the cough cycle duration may include: short IIIIIIIIIIIIIIIIIII is normally IIIIIIIIIIIIIIIIIIIIIIIII long, where symbol III represents a number of intermediate levels between named settings.

Referring now to fig. 17, in combination with the features and structures disclosed and described above with respect to fig. 11-16L, those skilled in the art will appreciate that the functions of the combination respiratory therapy devices 224-230 may be remotely controlled by a physician (via physician computing device 1110) or therapist (via therapist computing device 1130) as provided herein. Through interaction of the graphical user interfaces described in fig. 12-16L, the functionality and functionality associated with the components described above in fig. 11 can be extended so that a user (patient) can initiate an algorithm (e.g., an action associated with the selection of an icon described above in fig. 12-16L) by selecting the icon (as described below), thereby allowing remote control of the combined respiratory therapy device 1-4 (224-230) through a physician computing device 1110 or therapist computing device 1130, etc.

Fig. 17 shows an illustrative method for enabling bi-directional 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 in accordance with an embodiment of the present application. The illustrative method begins at step 1702, where a clinician device 1110, 1130 establishes a bi-directional communication link with one or more of the combined respiratory therapy devices 224-230. It will be appreciated that bi-directional communication may be established through the network interfaces 1124, 1144, 1164 between the various devices 1110, 130, 224-130 as described above in connection with fig. 11. To achieve this example, the physician device 1110 may be referred to as a clinician device, i.e., tablet, smartphone, notebook, etc., and therefore, one skilled in the art will appreciate that the term "clinician device" refers to the physician device 1110 and/or therapist device 1130.

After two-way communication is established between the clinician devices 1110, 1130 and one or more of the combined respiratory therapy devices 224-230, operation proceeds to step 1704. In step 1704, the clinician devices 1110, 1130 receive patient data from one or more of the combined respiratory therapy devices 224-230 over a computer network 1180. According to an exemplary embodiment, the devices 224-230 transmit data (i.e., patient physiological data) to a clinician (e.g., clinician devices 1110, 1130). The data received by the clinician devices 1110, 1130 from the devices 224-230 may include, for example, but is not limited to: vital signs such as heart rate, respiration rate, body temperature, oxyhemoglobin saturation (which may be acquired by an auxiliary device, e.g., respiration rate from a nose warmer, oxyhemoglobin saturation from a pulse oximeter); as well as physiological data acquired by the combination devices 224-230 themselves, such as minute ventilation (tidal volume for devices capable of providing assisted ventilation) of the patient, tidal volume (volume of gas per breath), percentage of assisted breathing triggered by the patient, air leakage, actual delivered inspiratory and expiratory pressures (as compared to preset pressures), and patient compliance with prescribed therapies (as described above), such as the duration of use of the devices 224-230 per day.

In step 1706, the clinician device 1110, 1130 generates a graphical display of the received patient data. It is further understood that any or all of the vital sign or physiological data (i.e., parameters) mentioned above can be presented on the clinician device 1110, 1130 in a graphical display or on the associated output device 1120, 1140 in a montage manner. According to an embodiment, the relevant parameter values may be displayed green if normal, red if abnormal, etc. In this embodiment, a range of normal values associated with a particular parameter may be shown, wherein the measured/actual value of the patient is displayed within or outside the expected range. In step 1708, the clinician can select a particular parameter by interacting with the clinician device 1110, 1130 to obtain additional information or access the therapy device 224-230. The clinician device 1110, 1130 then initiates a query to the particular therapy device 224-230 according to the selected parameters in step 1710.

In step 1712, the clinician device 1110, 1130 receives data related to the selected parameter from the particular therapy device 224-230, at which point the graphical display on the clinician device 1110, 1130 is updated to reflect the selected parameter and the data received in step 1714. Then, in step 1716, it is determined whether the clinician needs to make a voice/video connection with the patient associated with the therapy devices 224-230. Upon an affirmative decision being made, a real-time, bi-directional audio and/or video connection is established between the therapy devices 224-230 and the clinician devices 1110, 1130 in step 1718. After establishing the connection in step 1718 or after determining that no connection with the patient is needed in step 1716, operation proceeds to step 1720 to determine whether a therapy adjustment has been selected. According to an embodiment, the graphical user interface shown by the clinician device 1110, 1130 shows button icons similar to those described above with respect to FIGS. 16A-16L. That is, the clinician may remotely view one of the button icons of the clinician devices 1110, 1130 from the patient and associated therapy devices 224-230 and may select and activate various algorithms associated therewith, i.e., providing three coughs, emergencies, intensive therapies, etc. In the event that no therapy adjustment is selected, such as the clinician simply wishes to talk to the patient or directly reposition a sensor or mask, etc., operation proceeds from step 1720 to step 1732, as will be described in greater detail below.

After determining that a therapy adjustment is needed, operation proceeds to step 1722, where a graphical user interface displayed on the clinician device 1110, 1130 shows patient parameters and expected ranges associated with the therapy to be adjusted. Operation then proceeds to step 1724, where the clinician device 1110, 1130 receives therapy adjustments associated with the selected parameters. Next, in step 1726, the therapy adjustments are communicated from the clinician device 1110, 1130 to the particular therapy device 224-230. As described above, therapy adjustment may be accomplished by way of direct interaction with the graphical user interface 1200 of the therapy devices 224-230 shown in FIGS. 12-16L, described above.

Thereafter, operation proceeds to step 1728, where the clinician device 1110, 1130 receives update data from the therapy devices 224-230 in response to the administration of the adjusted therapy. According to an exemplary embodiment, after the therapy devices 224-230 provide the adjusted therapy to the patient, the clinician devices 1110, 1130 provide vital signs, physiological parameters, etc. (as suggested above in steps 1706 and 1722) to enable the clinician to determine whether the adjusted therapy is valid/successful. Then, in step 1730, it is determined whether any additional adjustments to the therapy are needed, e.g., whether additional coughing is to be provided or inhalation/exhalation pressure is to be increased, etc. If the determination at step 1730 is affirmative, operation returns to step 1722, where patient parameters and expected ranges associated with the selected therapy adjustment are generated and displayed on the clinician device 1110, 1130. Thereafter, operation proceeds to steps 1724-1730, as described above. After determining that no additional adjustments to the selected therapy are necessary in step 1730, operation proceeds to step 1732.

In step 1732, a determination is made as to whether another parameter is selected on the clinician device 1110, 1130. When another parameter is to be viewed and/or adjusted by the remote clinician device 1110, 1130, operation returns to step 1708 and, as described above, operation of method 1700 continues for operation of the next selected parameter. The relevant operations of fig. 17 are thereafter terminated without additional therapy adjustments.

The foregoing method 1700 can be better understood in connection with an example of interactions between clinician devices 1110, 1130 and therapy devices 224-230. In this example, the display of the clinician device 1110, 1130 includes button icons (for devices 224-230 capable of providing lung ventilation) associated with tidal volume adjustment. Thereafter, the displays of the clinician devices 1110, 1130 generate a graphical interface that displays the expected range of physiological parameters and the values of the patient tidal volume parameters. For example, if the tidal volume is predicted to be 4 liters +/-0.5 liters, then the graphical display will appear green to indicate normal at a value of 4.25 and red to indicate abnormal at a value of 3 liters. As shown above in step 1722, the clinician can contact the patient directly (via devices 224-230) via the clinician devices 1110, 1130, through electronic communication (e.g., audio and/or video) by the respective devices 1110, 1130, 224-230, or by telephone. When the tidal volume button icon is selected on the clinician device 1110, 1130 (e.g., steps 1716-1726 of FIG. 17), the clinician device 1110, 1130 may 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.

As with the interactions described above with respect to Figs. 12-16L, control of the combined respiratory therapy devices 224-230 is achieved by selection of a button icon by the clinician device 1110, 1130 that can trigger a corresponding control algorithm to direct operation of the corresponding therapy device 224-230. Thus, if the clinician touches the "tidal volume too low" button icon displayed on the clinician device 1110, 1130, an algorithm (stored in memory 1114, 1126 and executed by processor 1112) is activated, increasing the inspiratory ventilation pressure by 2cm water column, and communicating the new settings to the device controller 120 of the therapy devices 224-230. Likewise, if the clinician touches the "tidal volume too high" button icon displayed on the clinician device 1110, 1130, an algorithm (also stored in memory 1114 or 1126 and executed by processor 1112) will also be activated, lowering the inspiratory ventilation pressure by 2cm water column, and communicating the new settings to the device controller 120 of the corresponding therapy device 224-230.

The clinician may then observe the change in tidal volume at the new setting and determine if the tidal volume is now within an acceptable range, i.e., within the green area. When the tidal volume returns to the green area, the clinician may select the exit button icon displayed on the clinician device 1110, 1130 (as described above for the therapy device 224-230 of fig. 12-16L) and continue with the new settings on the corresponding therapy device 224-230. When the tidal volume is still abnormal, the clinician may re-touch the appropriate button, i.e., point "D" if the tidal volume is still too low, and point "E" if the tidal volume is still too high. According to a particular embodiment of the method 1700 shown in fig. 17, after 4 adjustments, the clinician can no longer use the button to change the inspiratory airway pressure setting, thereby increasing the safety profile.

It will be appreciated that not all parameters transmitted from the therapy devices 224-230 to the clinician devices 1110, 1130 can be adapted to the button icons associated with the device control algorithm. For example, if the information transmitted by the therapy devices 224-230 is hyperthermia, meaning that the patient is feverish, the clinician may choose to initiate an audio/video connection through the clinician devices 1110, 1130 or contact the patient or caregiver by telephone. If the therapy devices 224-230 deliver a high air leak, meaning that the patient's nasal mask may not be appropriate, the clinician may choose to contact the patient and caregiver by telephone or electronically via the clinician devices 1110, 1130, thereby troubleshooting.

Also, sometimes the clinician may choose to manually change the joint breathing apparatus prescription, for example by entering a custom therapy button (as detailed above) to semi-quantitatively adjust individual apparatus settings with the associated algorithm, or quantitatively set custom settings for each parameter using a balance (as described above). At this point, the bi-directional connection between the clinician devices 1110, 1130 and the therapy devices 224-230 allows the above-described changes to be accomplished remotely, thereby maintaining the patient in an isolated state and limiting clinician access to potential pathogens.

In addition to the foregoing, the various embodiments contemplated herein also provide for incorporating graphical representations of vital signs and physiological parameters into an electronic medical record of a patient. As will be appreciated by those skilled in the art, a clinician who is reviewing an electronic medical record of a patient or who is writing medical notes can recall real-time data and see if any adjustments or communications are required. In another embodiment, the method 1700 described herein can store various parameters recorded over a particular period of time by the memory of the clinician device 1110, 1130 (or the memory of the devices 224-230). Those skilled in the art will appreciate that the trend of various parameters over a particular period of time (e.g., 6 hours, 24 hours, 3 days, and 1 week) is visible, thereby providing the clinician with valuable insight data such as patient response to treatment, prognosis, and effect of changes.

It will be appreciated that according to this embodiment, multiple combination respiratory therapy devices at a remote location may be managed, for example, with a certain location as a center, or simply outside the room of an inpatient, so that the clinician does not have to enter the room nor touch pathogens exhaled by the patient.

In this embodiment, the physician computing device 1110 or therapist computing device 1130 may be implemented as a tablet, smart phone application, personal computer, or other suitable electronic computing device that is located outside of the patient's room and in data communication with the corresponding joint respiratory therapy device that is taking care of the patient. It will be appreciated by those skilled in the art that the displays generated on the computing devices described above correspond to the displays shown in fig. 12-17, or that the displays generated on the computing devices described above may include specialized views that add additional configuration options for use only by a clinician. For example, a remotely observed clinician can determine that the patient is in an extreme stress state, such as by video or audio monitoring of the patient. Instead of entering the patient's room, the clinician may remotely select the "emergency" button icon 1202 to instruct the combination respiratory therapy device 1 or 3 (224 or 228) to perform the emergency algorithm described above.

According to another embodiment, a remotely observed clinician may observe that a patient associated with a combination respiratory therapy device is experiencing some discomfort that may be alleviated by the particular operation of the combination respiratory therapy device. The clinician can then remotely instruct the combined respiratory therapy device 1, 2, 3, or 4 (224, 226, 228, or 230) via either the physician computing device 1110 or the therapist computing device 1130 to increase the amount of therapy provided to the patient, i.e., can remotely select the "intensive therapy" button icon 1206 to trigger an algorithm associated with increasing therapy as shown in fig. 12-17 above.

From the above systems and methods, those skilled in the art will appreciate that: 1) The patient or caregiver can adjust the settings by enabling the algorithm through the touch screen of the device itself or with a tablet or other remote control, which provides the patient/caregiver with autonomy, enabling them to customize the therapy and react quickly to clinical changes; and 2) the clinician can remotely manage the patient's device through an algorithm, the implementation of which relies on a two-way communication connection between the clinician device 1110, 1130 and the device controller 120 of the respective device 224-230, and can activate a "professional algorithm". As discussed in detail above, the home care therapist or its office physician can remotely adjust settings via the clinician device 1110, 1130 in response to a clinical change that is either 1) reported by the patient/caregiver or 2) triggered by data received while the device is in communication with the clinical management center. Thus, as will be appreciated by those skilled in the art, the foregoing embodiments enable a clinician to remotely manage the devices 224-230 without accessing the patient's clinical environment, thereby enabling exposure to aerosol pathogens, such as Covid-19, to be avoided. In some cases, the clinician devices 1110, 1130 may be tablet computers or smartphones in electronic communication with the devices 224-230, which may be located outside the patient's room, albeit in close proximity, but still in remote management of the devices 224-230. Also, as will be appreciated by those skilled in the art, a team of clinicians may remotely manage many patients, which may enable a limited expert to remotely manage more patients, thereby preventing clinicians from inadvertently exposing one patient to pathogens obtained from another patient, thereby reducing the number of personal protection devices used per patient, etc. It will be appreciated that this is particularly important in the case of pandemics (such as Covid-19) as in this case care works can be affected in view of the lack of a skilled clinician who is well known to manage the provision of assisted ventilation and mucus clearance equipment.

In light of the foregoing, numerous specific details, examples, and scenarios are set forth in order to provide a more thorough understanding of the present disclosure. However, it is understood that embodiments of the present disclosure may be practiced without the specific details set forth. Further, these examples and scenarios are provided for illustration purposes, and are not intended to limit the disclosure in any way. Those of ordinary skill in the art, with the included descriptions, will be able to implement appropriate functionality without undue experimentation.

Reference in the specification to "an embodiment" or the like means that a particular feature, structure, or characteristic may be included in the described embodiment, but every embodiment may not necessarily include the particular feature, structure, or characteristic. The above terms 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 submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Embodiments according to the present disclosure may be implemented in hardware, firmware, software, or any combination thereof. Embodiments of the invention may also be implemented as instructions stored on one or more machine-readable media, which 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.

In the drawings, a specific arrangement or sequence of illustrated elements may be shown for ease of description. However, the particular order or arrangement of these elements does not imply that a particular order of processing or separation is required in all embodiments.

Generally, the illustrated elements for representing blocks or modules of instructions may be implemented in any suitable form of machine-readable instructions, and each of the above-described instructions may be implemented in any suitable programming language, library, application Programming Interface (API), and/or other software development tool or framework. Likewise, the illustrated elements for representing data or information may be implemented by any suitable electronic arrangement or data structure. Furthermore, some connections, relationships, or associations between elements may be simplified or not shown in the drawings to avoid obscuring the present disclosure.

The present disclosure is to be considered as illustrative and not restrictive, and all changes and modifications that come within the spirit of the disclosure are desired to be protected. For example, while various aspects of the present disclosure may be described in connection with particular types and features of respiratory therapy devices, it should be understood that other types and features of the devices are also applicable to the described aspects.

Claims (31)

1. A combination respiratory therapy apparatus comprising:

a blower for providing negative pressure air to a mouthpiece connected to an airway of a patient;

an air pulse generator configured to deliver air pulses to at least one of a garment worn by the patient or a nasal interface worn by the patient;

a network interface in communication with an associated computer network;

a controller comprising a processor in communication with a memory storing instructions executable by the processor to perform a joint respiratory therapy prescription defining a plurality of different treatment periods to be performed by the joint respiratory therapy device over a period of time, each of the plurality of different treatment periods comprising mucus withdrawal therapy; and

a display in communication with the controller and configured to display a graphical user interface associated with at least one operation of the combined respiratory therapy device.

2. The combination respiratory therapy apparatus according to claim 1, wherein the graphical user interface further comprises a cough icon associated with an on-demand cough operation of the combination respiratory therapy apparatus, wherein, in response to selecting the cough icon, the controller is configured to operate the air pulse generator to provide an inspiratory air flow to the patient and to operate the blower to provide an expiratory inhalation pressure to the patient.

3. The combination respiratory therapy apparatus according to claim 1, wherein the graphical user interface further comprises an emergency icon associated with emergency operation of the combination respiratory apparatus, wherein in response to selecting the emergency icon, the controller is configured to operate the blower and the air pulse generator to provide continuous lung ventilation to the patient.

4. The combined respiratory therapy device of claim 1, wherein the graphical user interface further comprises an intensive therapy icon associated with intensive therapy operation of the combined respiratory therapy device, wherein, in response to selecting the intensive therapy icon, the controller is configured to operate the combined respiratory therapy device at a preselected level.

5. The combined respiratory therapy apparatus according to claim 4, wherein in response to selecting the enhanced therapy icon, the graphical user interface displays a first and second level enhanced icon, wherein each of the first and second level enhanced icons corresponds to a respective first and second therapy enhanced operation of the combined respiratory therapy apparatus, respectively.

6. The joint respiratory therapy device according to claim 1, wherein the graphical user interface further comprises a custom icon associated with a customization of a therapy operation of the joint respiratory therapy device, wherein in response to selecting the custom icon, the controller is configured to sequentially generate a series of screens associated with the operation of the joint respiratory therapy device.

7. The combination respiratory therapy apparatus according to claim 6, wherein in response to selecting the custom icon, the graphical user interface displays a cough inhalation pressure adjustment screen comprising icons for low pressure, normal pressure, and high pressure.

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

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

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

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

12. The combination respiratory therapy apparatus of claim 11, wherein the graphical user interface displays a ventilation sensitivity adjustment screen in response to selection of at least one of the low pressure, normal pressure, or high pressure icons of the ventilation inhalation adjustment screen, the ventilation sensitivity adjustment screen including icons for weak, normal, and strong.

13. The combination respiratory therapy apparatus of claim 8, wherein the graphical user interface displays a post-cough ventilation duration adjustment screen in response to selection of at least one of the weak, normal, or strong icons of the ventilation sensitivity adjustment screen, the post-cough ventilation duration adjustment screen including icons for short duration, normal duration, and long duration.

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

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

16. The combined respiratory therapy device of claim 1, wherein the graphical user interface comprises a plurality of icons associated with a respective plurality of operations of the combined respiratory therapy device, wherein 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 combination respiratory therapy device of claim 16, wherein at least one of the physician computing device or therapist computing device is remote from the combination respiratory therapy device.

18. The combination respiratory therapy apparatus according to claim 1, wherein the blower and the air pulse generator are located in physically separate circuits.

19. A combined respiratory therapy apparatus according to claim 18, wherein each of the plurality of different treatment periods comprises a lung ventilation therapy or a lung volume recovery therapy substantially immediately following the mucus withdrawal therapy.

20. A system for problem-priority device control of at least one combined respiratory therapy device, comprising:

at least one combined respiratory therapy apparatus comprising:

a network interface in communication with an associated computer network,

a controller comprising a processor in communication with a memory storing instructions executable by the processor to perform a joint respiratory therapy prescription defining a plurality of different treatment periods to be performed by the joint respiratory therapy device over a period of time, and

a display in communication with the controller and configured to display a graphical user interface associated with at least one operation of the combined respiratory therapy device; and

at least one clinician computing device in communication with the at least one combined respiratory therapy device via the associated computer network and configured to control at least one operation of the at least one combined respiratory therapy device.

21. The system of claim 20, wherein the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one joint respiratory therapy device, wherein selection of one of the plurality of icons controls the at least one joint respiratory therapy device to perform a respective one of the plurality of operations.

22. The system of claim 21, wherein selection of one of the plurality of icons is received via the display.

23. The system of claim 21, wherein the at least one clinician computing device further comprises a graphical user interface corresponding to a graphical user interface of the at least one joint respiratory therapy device.

24. The system of claim 23, wherein selection of one of the plurality of icons is received by the at least one joint respiratory therapy device via a graphical user interface of the at least one clinician computing device over the associated computer network.

25. A method of remotely controlling at least one combined respiratory therapy device by a clinician device, the method comprising:

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 a patient;

generating a graphical representation of the received patient data on an associated display of the clinician device;

receive, via the associated display, selection data corresponding to the selected therapy adjustment; and

Transmitting the selected therapy adjustment to the at least one combination therapy device,

wherein the clinician device includes a processor in communication with a memory storing instructions that are executed by the processor to cause the processor to perform the method.

26. The method of claim 25, further comprising establishing at least one of video or audio communication between the clinician device and the at least one joint 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 joint respiratory therapy device on an associated display of the clinician device.

28. The method of claim 25, wherein the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one joint respiratory therapy device, wherein selection of one of the plurality of icons controls the at least one joint respiratory therapy device to perform a respective one of the plurality of operations.

29. A clinician device for remotely controlling at least one combined respiratory therapy device by a clinician device, the clinician device comprising:

A processor in communication with the memory;

a network interface in communication with the processor and configured to communicate with at least one joint respiratory therapy device via an associated computer network; and

a display in communication with the processor and configured to display a graphical user interface associated with at least one operation of the at least one combined respiratory therapy device,

wherein the memory stores instructions that are executed by the processor to cause the processor to:

receiving, via the associated network, patient data representing at least one physiological parameter associated with a patient of the at least one combined respiratory therapy device;

generating a graphical representation of the received patient data on the display;

receiving, via the display, selection data corresponding to the selected therapy adjustment; and

the selected therapy adjustment is communicated to the at least one combined respiratory therapy device via the associated computer network.

30. The clinician device of claim 29, wherein said memory further stores instructions for establishing at least one of video or audio communication between said clinician device and said at least one joint respiratory therapy device.

31. The clinician device of claim 29, wherein the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations of the at least one joint respiratory therapy device, and wherein selection of one of the plurality of icons controls the at least one joint respiratory therapy device to perform a respective one of the plurality of operations.

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