Detection and treatment of copd-osa overlap syndrome

Abstract

A present ventilator system for detecting and treating concurrent chronic obstructive pulmonary disease (COPD) and overlap syndrome of obstructive sleep apnea (OSA events) includes a pressure generator for generating a pressurized flow of breathable gas for delivery to an airway of a subject, a sensor(s) for generating an output signal conveying information related to a parameter of the breathable gas, and a processor(s) operably connected to the sensor(s) and the pressure generator, configured to detect the presence of an OSA event and / or expiratory flow limitation (EFL) in the subject based on the output signal. In response to detecting the concurrent presence of an OSA event and EFL, the processor is configured to determine an OSA event therapy parameter for treating the detected OSA event in the subject, determine an EFL therapy parameter for treating the detected EFL in the subject, determine a priority treatment based on a comparison between the OSA event therapy parameter and the EFL therapy parameter, and control the pressure generator to deliver the determined priority treatment.

Description

[0001] Cross-reference to related applications

[0002] This patent application claims the benefit of U.S. Provisional Application No. 62 / 908,093, filed September 30, 2019, pursuant to Section 119(e) of Chapter 35 of the United States Code, the contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to ventilator systems and methods for detecting and treating COPD-OSA overlap syndrome. Background Technology

[0004] Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) events (and / or inspiratory flow limitation) can be associated with several comorbidities. The coexistence of these two conditions (known as COPD-OSA overlap syndrome) may be a contributing factor to a higher prevalence of the comorbidities compared to those associated with each condition individually. Currently, there are insufficient medical solutions to address both conditions simultaneously. Therefore, there is a need for a medical device that can treat subjects with COPD-OSA overlap syndrome. Summary of the Invention

[0005] Therefore, one or more aspects of this disclosure relate to a ventilator system for detecting and treating overlapping syndromes of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The system includes a pressure generator configured to generate a pressurized flow of breathable gas for delivery to a subject's airway. The system also includes one or more sensors configured to generate an output signal conveying information related to one or more breathable gas parameters.

[0006] The system includes one or more physical computer processors operatively connected to one or more sensors and a pressure generator, the physical computer processors being configured by computer-readable instructions to: detect the presence of obstructive sleep apnea (OSA) events and / or expiratory flow limitation (EFL) in a subject based on an output signal. In response to the simultaneous detection of both an OSA event and EFL, the one or more physical computer processors are configured to: determine one or more OSA event therapy parameters for treating the detected obstructive sleep apnea in the subject; determine one or more EFL therapy parameters for treating the detected expiratory flow limitation in the subject; determine a priority treatment based on a comparison between the one or more OSA event therapy parameters and the EFL therapy parameters; and control the pressure generator to deliver the determined priority treatment to the subject.

[0007] Another aspect of this disclosure relates to a method using a ventilator system for detecting and treating overlapping syndromes of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) events. The ventilator system includes a pressure generator, one or more sensors, and one or more physical computer processors operatively connected to the pressure generator and the one or more sensors. The method includes: generating a pressurized flow of breathable gas using the pressure generator for delivery to a subject's airway; generating an output signal using the one or more sensors, the output signal conveying information related to one or more parameters of the breathable gas; and using the one or more physical computer processors to detect the presence of obstructive sleep apnea (OSA) events and / or expiratory flow limitation (EFL) in the subject based on the output signal. In response to the simultaneous detection of an OSA event and EFL, one or more physical computer processors are used to determine one or more OSA event therapy parameters for treating detected obstructive sleep apnea or other upper airway problems causing flow restriction or reducing airway patency in the subject; one or more physical computer processors are used to determine one or more EFL therapy parameters for treating detected expiratory flow restriction in the subject; one or more physical computer processors are used to determine priority treatment based on a comparison between one or more OSA event therapy parameters and EFL therapy parameters; and one or more physical computer processors are used to control a pressure generator to deliver the determined priority treatment to the subject.

[0008] Another aspect of this disclosure relates to a ventilator system for detecting and treating overlapping syndromes of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The system includes: components for generating a pressurized flow of breathable gas for delivery to the airway of a subject; components for generating an output signal conveying information related to one or more breathable gas parameters; components for detecting the presence of obstructive sleep apnea (OSA) events and / or expiratory flow limitation (EFL) in the subject based on the output signal; components for determining one or more OSA event therapy parameters for treating the detected obstructive sleep apnea in the subject in response to the simultaneous detection of an OSA event and EFL; components for determining one or more EFL therapy parameters for treating the detected expiratory flow limitation in the subject; components for determining a preferred treatment based on a comparison between one or more OSA event therapy parameters and EFL therapy parameters; and components for controlling a pressure generator to deliver the determined preferred treatment to the subject.

[0009] These and other objects, features, and characteristics of this disclosure, as well as the operation and function of structurally related elements and the economy of combination and manufacture of components, will become more apparent upon reference to the accompanying drawings, which form part of this specification, wherein like reference numerals designate corresponding portions in the various figures. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to be construed as limiting the scope of this disclosure. Attached Figure Description

[0010] Figure 1 An example of a ventilator system for detecting and treating COPD-OSA overlap syndrome is illustrated according to one or more embodiments;

[0011] Figure 2 A diagram illustrates an example of a ventilator system for detecting and treating COPD-OSA overlap syndrome according to one or more embodiments;

[0012] Figure 3 The illustration shows an example of an algorithm for a treatment delivered by system 100 according to one or more embodiments; and

[0013] Figure 4 The illustration shows a method for detecting and treating COPD-OSA overlap syndrome according to one or more embodiments. Detailed Implementation

[0014] As used herein, unless the context clearly specifies otherwise, the singular forms of “a,” “an,” and “the” include plural references. As used herein, a statement that two or more parts or components are “coupled” means that these parts are directly or indirectly (i.e., through one or more intermediate parts or components, provided a link exists) connected or operating together. As used herein, “direct coupling” means two elements in direct contact with each other. As used herein, “fixed coupling” or “fixed” means two components coupled so as to move as a whole while maintaining a constant orientation relative to each other.

[0015] As used herein, the term “monolithic” means that a component is created as a single piece or unit. That is, a component comprising pieces created separately and then coupled together as a unit is not a “monolithic” component or body. As used herein, a statement that two or more parts or components are “joined” to each other should mean that the parts exert forces on each other directly or through one or more intermediate parts or components. As used herein, the term “several” should mean an integer of one or more (i.e., multiples).

[0016] Directional phrases used herein, such as, for example but not limited to, top, bottom, left, right, up, down, front, back, and their derivatives, relate to the orientation of the elements shown in the figures and do not limit the claims unless expressly stated herein.

[0017] As used in this article, COPD refers to the occurrence of one or more symptoms of chronic obstructive pulmonary disease. As used in this article, OSA refers to obstructive sleep apnea events and / or inspiratory flow restriction.

[0018] Figure 1 and Figure 2 An example of a ventilator system for detecting and treating COPD-OSA overlap syndrome in subject 70, according to one or more embodiments, is illustrated. COPD and OSA events are two of the most common lung diseases. Unfortunately, they can occur simultaneously in a phenomenon commonly referred to as COPD-OSA overlap syndrome, causing double the unpleasant respiratory distress. As used herein, COPD-OSA overlap syndrome refers to chronic obstructive pulmonary disease with the simultaneous occurrence of obstructive sleep apnea events and / or upper airway obstruction events (which cause inspiratory flow restriction or reduce airway patency in the subject) and one or more of these conditions. A key characteristic of COPD is a condition affecting the lower airway, where the disease causes destruction of soft cell tissue and loss of elastic recoil, resulting in lower airway collapse during expiration. This is called expiratory flow restriction (EFL) and is defined as an increase in transpulmonary pressure without a corresponding increase in expiratory flow. Multiple OSA events may be caused by partial or complete obstruction of the upper airway, resulting in inspiratory flow restriction. Without treatment, the coexistence of these two lung conditions further increases the likelihood of complications such as heart disease, stroke, and type 2 diabetes, and may increase morbidity and mortality. Continuous positive airway pressure (CPAP) therapy using a face mask can be used to compensate for inspiratory flow limitation by increasing airway collapseability. CPAP levels can be titrated to maintain upper airway patency and mitigate (multiple) obstructive events. Optimal levels of CPAP have been shown to effectively eliminate expiratory flow limitation in subjects, reduce their respiratory workload, and treat (multiple) OSA events and / or upper airway obstruction. As used herein, COPD refers to the occurrence of one or more conditions of chronic obstructive pulmonary disease.

[0019] Expiratory flow restriction (EFL) may exhibit overlapping patterns in COPD, (multiple) OSA events and / or upper airway obstruction, and obesity-related hypoventilation syndrome (OHS). System 100 can be configured to titrate ventilator pressure by determining a preference for the airway pressure delivered to the subject. In some embodiments, the pressure required to treat the subject's upper airway obstruction may be prioritized over the pressure required to treat the subject's expiratory flow restriction.

[0020] In some embodiments, system 100 includes a pressure generator 20, one or more sensors 40, a subject interface 90, one or more physical computer processors 60, a user interface 120, an electronic storage device 130, and / or other components.

[0021] In some embodiments, pressure generator 20 may include any device, such as, for example, a pump, blower, piston, or bellows, capable of increasing the pressure of received gas for delivery to a subject. In some embodiments, pressure generator 20 may include one or more devices, such as, for example, a valve and / or a series of valves, capable of controlling pressure, flow rate, flow direction, and / or other parameters of gas flow. This disclosure contemplates controlling the operating speed of a blower, for example alone or in combination with one or more valves and / or other devices contained in and / or external to pressure generator 20, to control the pressure and / or flow rate of gas supplied to subject 70. In some embodiments, pressure generator 20 receives an airflow from a gas source such as ambient air and increases the pressure of that gas for delivery to the airway of subject 70. This disclosure contemplates the possibility of introducing gases different from ambient air into system 100 for delivery to a subject.

[0022] In some embodiments, pressure generator 20 is configured to generate a pressurized gas flow for delivery to the airway of subject 70. For therapeutic and / or other purposes, pressure generator 20 may control one or more parameters of the gas flow (e.g., flow rate, pressure, volume, temperature, gas composition, etc.). As a non-limiting example, pressure generator 20 may be configured to control the flow rate and / or pressure of the gas flow to provide pressure support to the airway of subject 70.

[0023] Multiple sensors 40 may be configured to generate an output signal that conveys information related to one or more parameters of the gas within system 100. The one or more parameters of the gas within system 100 may include gas parameters related to a pressurized breathable gas flow, respiratory parameters related to the breathing of subject 70, physiological parameters of subject 70, and / or other parameters. The one or more gas parameters of the pressurized breathable gas flow may include, for example, flow rate, volume, pressure, humidity, temperature, acceleration, velocity, and / or other gas parameters. Respiratory parameters related to the breathing of subject 70 may include tidal volume, timing (e.g., the start and / or end of inspiration, the start and / or end of expiration, etc.), respiratory rate, duration (e.g., the duration of inspiration, expiration, and respiratory cycles, etc.), respiratory rate, and / or other respiratory parameters. Physiological parameters may include blood oxygenation parameters, pulse, heart rate, temperature, blood pressure, and / or other physiological parameters.

[0024] The multiple sensors 40 may include one or more sensors that directly measure these parameters (e.g., through fluid communication with airflow in the subject interface 90). The multiple sensors 40 may also include one or more sensors that indirectly generate output signals associated with one or more parameters. For example, the multiple sensors 40 may include one or more sensors, and / or other sensors, configured to generate outputs based on operating parameters of the pressure generator 20 (e.g., subject flow rate and / or pressure estimates from motor current, voltage, rotational speed, and / or other operating parameters). In some embodiments, the multiple sensors 40 may include one or more of flow, position, volume, pressure, humidity, temperature, motion, acceleration, blood oxygen saturation, audio, video, light sensors, and / or other sensors. The multiple sensors 40 may include sensors disposed at multiple locations, such as, for example, within (or in communication with) the conduit 50, within the pressure generator 20, within (or in communication with) the subject interface 90, at various locations of the subject 70, and / or other locations.

[0025] The subject interface 90 is configured to deliver a pressurized breathable gas stream to the airway of the subject 70. Thus, in some embodiments, the subject interface 90 includes a conduit 50, an interface device 80, and / or other components. In some embodiments, the conduit 50 is configured to deliver a pressurized gas stream to the interface device 80. The interface device 80 is configured to deliver an airflow to the airway of the subject 70. In some embodiments, the interface device 80 is configured to be non-invasively engaged by the subject 70. Non-invasive engagement includes removably engaging one or more external openings (e.g., nostrils and / or mouth) of the subject 70's airway to deliver gas between the subject 70's airway and the interface device 80. In some embodiments, the interface device 80 is removably coupled to the conduit 50. The interface device 80 can be removed for cleaning and / or for other purposes. In some embodiments, the conduit 50 is configured as a mouthpiece to be engaged by the mouth of the subject 70.

[0026] In some embodiments, other interface devices may be configured as interface device 80. Some examples of interface device 80 may include, for example, a nasal cannula, a nasal mask, a nasal / mouth mask, a full face mask, a complete face mask, or other interface devices that communicate airflow to a subject's airway. This disclosure is not limited to these examples, and the use of any interface device to deliver airflow to a subject is contemplated. For example, endotracheal intubation, tracheostomy tubes, laryngeal mask airways, and / or other invasive interface devices.

[0027] Multiple processors 60 are configured to provide information processing capabilities in system 100. Thus, multiple processors 60 may include one or more digital processors, one or more analog processors, one or more digital circuits designed to process information, one or more analog circuits designed to process information, state machines, and / or other mechanisms for electronically processing information. In some embodiments, the multiple processors are operatively connected to a sensor (40) and / or a pressure generator (20). Although the multiple processors 60 are... Figure 1 The processor 60 is shown as a single entity, but this is for illustrative purposes only. In some implementations, the processor 60 comprises multiple processing units. These processing units may be physically located within the same device (e.g., pressure generator 20), or the processor 60 may represent the processing functionality of multiple devices operating in cooperation.

[0028] like Figure 1 As shown, processor(s) 60 are configured to execute one or more computer program components. The one or more computer program components may include one or more of parameter component 62, detection component 63, therapy determination component 64, comparison component 66, priority determination component 68, control component 69, and / or other components. Processor(s) 60 may be configured to execute components 62, 63, 64, 66, 68, and 69 via software; hardware; firmware; a combination of software, hardware, and / or firmware; and / or other mechanisms for configuring processing capabilities on processor(s) 60.

[0029] It should be understood that although components 62, 63, 64, 66, 68, and 69 are... Figure 1 While illustrated as coexisting within a single processing unit, in an implementation where processor(s) 60 comprises multiple processing units, one or more of components 62, 63, 64, 66, 68, and 69 may be positioned remotely from other components. The description below of the functionality provided by the different components 62, 63, 64, 66, 68, and 69 is for illustrative purposes and is not intended to be limiting, as any of components 62, 63, 64, 66, 68, and 69 may provide more or less functionality than described. For example, one or more of components 62, 63, 64, 66, 68, and 69 may be removed, and some or all of their functionality may be provided by other components 62, 63, 64, 66, 68, and / or 69. As another example, processor(s) 60 may be configured to execute one or more additional components that can perform some or all of the functionality attributed to one of components 62, 64, 66, 68, and / or 69.

[0030] Parameter component 62 may be configured to receive, determine, and / or acquire one or more parameters within system 100. For example, one or more parameters may be determined based on output signals from sensor(s)40. In some embodiments, parameter component 62 is configured to determine one or more parameters of the gas within system 100 (e.g., parameters associated with a pressurized breathable gas flow), one or more respiratory parameters associated with the breathing of subject 70, one or more physiological parameters of subject 70, and / or other parameters. One or more gas parameters of the pressurized breathable gas flow may include, for example, flow rate, volume, pressure, humidity, temperature, acceleration, velocity, and / or other gas parameters. Respiratory parameters associated with the breathing of subject 70 may include tidal volume, timing (e.g., the start and / or end of inspiration, the start and / or end of expiration, etc.), respiratory rate, duration (e.g., the duration of inhalation, exhalation, and a single respiratory cycle, etc.), respiratory rate, AHI index (apnea and hypoventilation index = the number of apneas and hypoventilations counted per sleep period divided by the number of hours in each sleep period), and / or other respiratory parameters. Physiological parameters may include blood oxygenation parameters, pulse, heart rate, temperature, blood pressure, exercise and / or other physiological parameters.

[0031] Detection component 63 can be configured to detect the presence of one or more respiratory conditions in a subject. In some embodiments, detection component 63 can be configured to detect one or more respiratory conditions based on information received from parameter component 62 or from one or more components of system 100. In some embodiments, detection component 63 can be configured to detect one or more respiratory disturbances and receive information about the presence of one or more other respiratory disturbances from other components inside or outside system 100. For example, from a remote database, from another medical device, or from a user (e.g., a patient, healthcare provider, user, etc.). In some embodiments, the one or more respiratory conditions detected by detection component 63 can be simultaneous, continuous, or asynchronous.

[0032] In some embodiments, respiratory status can indicate the subject's respiratory condition. For example, respiratory status can indicate that the subject's breathing is normal. For example, one or more respiratory parameters are within normal values ​​(e.g., values ​​for a healthy individual). In some embodiments, respiratory status can indicate the presence of an abnormality. For example, when one or more respiratory parameters are outside the normal range. In some embodiments, one or more respiratory statuses detected by detection component 63 can indicate the presence of one or more respiratory disorders. For example, one or more detected conditions can indicate upper airway obstruction, lower airway obstruction, airway restriction, inspiratory flow restriction (IFL), expiratory flow restriction (EFL), and / or other disorders.

[0033] (Multiple) Obstructive sleep apnea (OSA) events are conditions in which a subject experiences a reduction or complete cessation of airflow during sleep, despite the subject continuing to attempt to breathe. Snoring is the vibration of the respiratory structures, and the sound produced is due to the obstruction of air movement during breathing during sleep. In some cases, the sound may be soft, but in most cases, it can be loud and unpleasant. Snoring during sleep can be a sign or the first warning of (multiple) obstructive sleep apnea (OSA) events. (Multiple) These events occur during sleep when muscles relax, causing the soft tissue at the back of the throat to collapse and obstruct the upper airway. This results in partial reduction of breathing (called hypopnea) and complete cessation of breathing (called apnea). An apnea event is defined as a cessation of airflow for at least 10 seconds during sleep. Hypopnea is defined as an abnormal breathing event lasting at least 10 seconds, with at least a 30% reduction in chest and abdominal movement or airflow and at least a 4% decrease in oxygen saturation compared to baseline. (Multiple) Most apnea events last between 10 and 30 seconds, but some may last a minute or longer. This can lead to a sudden drop in blood oxygen saturation, with blood oxygen levels falling by as much as 40% or more in severe cases.

[0034] In some embodiments, the detection component 63 is configured to detect (multiple) OSA events (and / or the occurrence of inspiratory flow restriction) based on partial or complete obstruction of the subject's upper airway. In some embodiments, the detection of (multiple) OSA events (and / or the occurrence of inspiratory flow restriction) is based on an increase in airway inspiratory resistance due to measurable collapse of the upper airway during sleep. For example, airway collapse or upper airway obstruction in a subject is determined by an increase in airway inspiratory resistance. In some embodiments, forced oscillation technique (FOT) can be used to detect (multiple) OSA events (and / or the occurrence of inspiratory flow restriction). FOT is a method for quantitatively assessing airway mechanics (which can be delivered by the ventilator system 100). In some embodiments, FOT is well tolerated and easily integrated with conventional ventilator sleep settings. FOT works by comparing the phase shift of small oscillations on the flow signal with the phase shift of oscillations on the pressure signal. For example, in a healthy, open lung, both signals arrive at the sensor simultaneously. However, whenever lung obstruction or changes in the inertial properties of the lung occur, the arrival time between the two signals shifts. Airway impedance can be inferred from the mechanical response to these small time-varying changes. Impedance can be further decomposed into two components: resistance and reaction. The resistance component is dominant in subjects with airway limitations, such as those with upper airway obstruction. In some embodiments, impedance measurements can be further decomposed into inspiratory and expiratory phases. The field of upper airway impedance (FOT) allows for the analysis of upper airway impedance, thereby detecting obstructive sleep apnea.

[0035] Other techniques can be used to detect (multiple) OSA events. For example, in some embodiments, the detection component 63 can be configured to detect (multiple) OSA events based on the analysis and / or monitoring of the subject's snoring sounds (e.g., when the subject is sleeping). In some embodiments, the detection component 63 can be configured to detect (multiple) OSA events (and / or the occurrence of inspiratory flow restriction) while the subject is awake. For example, by measuring compensatory muscle activation in the upper airway (muscles of the neck, tongue, and / or throat) during wakefulness. This muscle activation appears to be particularly prevalent in the genioglossus (GG) muscles, which are the muscles that run from the jaw to the tongue in the human body. The GG muscles are the primary muscles responsible for protruding (or extending) the tongue. This increased compensatory muscle activation appears to be a product of increased muscle tonic activation combined with an increase in negative pressure generated during inspiration. In some embodiments, the detection component 63 can be configured to measure the subject's compliance in the presence and absence of magnetic stimulation of the upper airway muscles. Magnetic stimulation is used to stimulate the muscles of the upper airway used to stabilize an individual whose (multiple) nocturnal apnea events are associated with decreased muscle tone. Multiple sensors 40 monitor the physiological characteristics of the subject, the coil is excited to stimulate the appropriate muscles associated with the upper airway, a power source provides power to excite the coil, and a control system controls the power applied to the coil based on the output of the multiple sensors 40.

[0036] In other embodiments, acoustic laryngometric measurements are used during wakefulness to measure tremors caused by increased muscle activation (e.g., GG muscles) in order to identify characteristic modulations (e.g., 30-40 Hz or some other frequency range or range) associated with OSA events, thereby determining whether the subject is experiencing an OSA event. As is known in the art, acoustic laryngometric measurements are a dynamic test that determines the size of the oral airway passing through the glottis while the subject is breathing. Specifically, acoustic laryngometric measurements use acoustic reflection techniques to measure the cross-sectional area of ​​at least a portion of the subject's upper airway during inspiration.

[0037] In some embodiments, the detection component 63 can be configured to detect lower airway collapse during expiration. Lower airway collapse during expiration can become and / or cause expiratory flow limitation (EFL), a condition where an increase in transpulmonary pressure does not result in a corresponding increase in expiratory flow—due to “blockage points” in many bronchial branches (which are hallmarks of COPD). COPD is a progressive and irreversible disease that affects lung function but also has significant extrapulmonary effects. Subjects with more severe COPD often experience acute exacerbations (AE-COPD: sudden worsening of symptoms), which may require hospitalization. Better home management of subjects, including predicting acute exacerbations with sufficient lead time, can reduce hospitalizations, morbidity, mortality, and improve quality of life. Lower airway collapse during expiration can cause lung gases, including carbon dioxide, to become trapped in alveolar regions, resulting in poor gas exchange and carbon dioxide buildup in the blood. In addition to EFL, COPD can also be detected using cough monitoring, blood oxygenation measurements, questionnaires, and / or other techniques.

[0038] In some embodiments, EFL can be detected based on the output signal, parameters determined by parameter component 62, and / or other information. For example, EFL can be detected based on the output signal from a pulse oximeter (e.g., included in sensor(s)40), electromyography, a pressure sensor, a flow sensor, forced oscillation technology, and / or other detection techniques. In some embodiments, forced oscillation technology (FOT) can be used to detect EFL. As explained above, FOT works by comparing the phase shift of small-amplitude oscillations on the flow signal with the phase shift of oscillations on the pressure signal. When there is lung obstruction or a change in the inertial properties of the lungs, the arrival time between these two signals shifts. Airway impedance can be inferred from the mechanical response to these small time-varying changes. Impedance can be further mathematically decomposed into two components, resistance and resistance. The expiratory resistance component has been shown to correlate with the degree of expiratory flow limitation (EFL) in the subject.

[0039] Therapy determination component 64 can be configured to determine one or more therapy parameters for treating one or more respiratory disorders in response to the detection of a respiratory disorder. In some embodiments, therapy determination component 64 can be configured to determine therapy parameters for one or more disorders in response to a request from a user and / or from one or more components of system 100. The one or more therapy parameters may include pressure, flow rate, volume, and / or other parameters. For example, in some embodiments, in response to the detection of the presence of OSA(s) events, determination component 64 can be configured to determine one or more therapy parameters for treating OSA(s) events (and / or the occurrence of inspiratory flow restriction). In some embodiments, in response to the detection of EFL, determination component 64 is configured to determine one or more EFL therapy parameters for treating EFL detected in a subject. In some embodiments, the one or more therapy parameters for OSA(s) events may include pressure for treating OSA(s) events, and the one or more therapy parameters for EFL include pressure for treating EFL(PEFL). In some embodiments, the therapy determination component 64 can be configured to reduce the AHI (apnea-hypopnea index, which is the number of apneas and hypopneas per hour). For example, by capturing OSA events(s), calculating the AHI, and then changing the ventilator pressure to reduce the “running AHI” score.

[0040] In some embodiments, comparison component 66 is configured to compare one or more therapeutic parameters for one or more diseases (e.g., between OSA event therapeutic parameters and EFL therapeutic parameters and / or other diseases). For example, comparison component 66 may be configured to compare POA and PEFL. In some embodiments, comparison component 66 may be configured to compare other therapeutic parameters. In some embodiments, comparison component 66 may be configured to compare other parameters received from other components inside or outside system 100. In some embodiments, the comparison step may be performed in conjunction with other components of system 100 (e.g., priority component 68, treatment determination component, or other components described below).

[0041] Prioritization component 68 is configured to determine the preferred treatment for one or more conditions. In some embodiments, the determination of preferred treatment is based on comparison by comparison component 66. In some embodiments, priority component 68 may be configured to determine the preference for airway pressure delivered to a subject based on the inspiratory phase value of the real part of the impedance (indicating its airway resistance) or the expiratory phase value of the imaginary part—that is, the resistance component of the subject's airway impedance (indicating its expiratory flow limitation). In some embodiments, airway collapse or upper airway obstruction in a subject can be determined by an increase in airway inspiratory resistance, and a subject's expiratory flow limitation can be determined by a decrease (negative) in their expiratory resistance. In some embodiments, priority component 68 may be configured to prioritize the pressure required to treat the subject's upper airway obstruction over the pressure required to treat the subject's expiratory flow limitation, and the ventilator adjusts its pressure settings accordingly. This prioritizes treatment of upper airway obstruction over lower airway expiratory flow limitation. This logic may be advantageous because treating (multiple) OSA events in subjects is more clinically significant due to its profound medical implications (e.g., increased risk of heart failure, and subjects with untreated (multiple) OSA events typically have a significantly greater risk of morbidity and mortality). Maintaining upper airway patency or reducing or eliminating inspiratory flow restriction may be a better priority, as managing expiratory flow restriction becomes nearly impossible if (multiple) OSA events are left unmanaged. Furthermore, at the therapeutic pressure levels required to treat (multiple) OSA events in subjects, it is likely that most subjects will also benefit from improved expiratory flow (EFL).

[0042] The table below illustrates an example of therapy determination based on EFL (associated with COPD) and / or OSA event detection:

[0043]

[0044]

[0045] For example, priority component 68 may decide to increase the pressure of the breathable gas delivered to the subject in response to the detection of the presence of EFL (regardless of the presence of (multiple) OSA events); the presence of (multiple) OSA events (regardless of the presence of EFL); or the simultaneous presence of EFL and OSA events. In response to the absence of detected EFL and / or (multiple) OSA events, priority component 68 may decide to decrease the pressure of the breathable gas delivered to the subject.

[0046] In some embodiments, the prioritization component 68 may prioritize the higher of the two pressures. However, if the obstruction pressure required to eliminate the obstruction is greater than the pressure required to reduce or eliminate their expiratory flow restriction, this could lead to overinflation of the subject, or undertreatment of their obstructive disease if the expiratory pressure is deemed too high. In some embodiments, if the ventilator determines that the pressure required to resolve the subject's EFL is higher than the pressure at which the subject's OSA event was determined, then based on a proprietary COPD-OSA overlap rule within the ventilator, the pressure delivered by the ventilator will be positively offset by 0.1 cmH2O, or 0.2 cmH2O, or 0.3 cmH2O, etc., up to 2 cmH2O above the determined OSA event pressure, and the pressure will be set accordingly. This rule takes into account the difference between the two determined pressures and the percentage of expiratory flow restriction in the breathing.

[0047] Control component 69 can be configured to control pressure generator 20 to generate airflow according to one or more treatment protocols. In some embodiments, control component 69 can be configured to control pressure generator 20 to deliver priority treatments determined by priority component 68. Control component 69 can be configured to control pressure generator 20 based on output signals from sensor(s)40, information from parameter component 62, comparison by comparison component 66, priority determined by priority component 68, and / or based on other information. In some embodiments, control component 69 can be configured to control pressure generator 20 based on user information (or input).

[0048] Figure 3 An example 300 of an algorithm for a treatment delivered by system 100 is illustrated. In this example, detection component 63 (as described above and not shown here) can determine whether inspiratory and expiratory flow restriction occurs (e.g., successive breaths or respiratory rate) 302. In response to determination 302, treatment determination component 64 (described above and not shown here) can determine treatment parameters 304 for treating the obstruction and treatment parameters 306 for treating the expiratory flow restriction. In some embodiments, forced oscillation technique (FOT) may be used to determine treatment parameters 304 and / or 306. In some embodiments, other techniques for determining treatment parameters may be used as explained above. In some embodiments, treatment parameter 304 may include pressure (POSA) for treating OSA(s) events(s), and treatment parameter 306 may include pressure (PEFL) for treating COPD-related EFLs.

[0049] In some embodiments, in response to one or more therapy parameters 304 being greater than one or more therapy parameters 306 (e.g., POSA > PEFL) 308, control component 69 (as described above and not shown here) is configured to set the ventilator pressure to POSA + offset pressure 312. For example, a positive offset of 0.1 cmH2O, or 0.2 cmH2O, or 0.3 cmH2O, etc., up to 2 cmH2O above the determined POSA. In response to one or more therapy parameters 306 being greater than or equal to one or more therapy parameters 304 (e.g., PEFL ≥ POSA) 309, control component 69 is configured to set the ventilator pressure to PEFL 312. In response to one or more therapy parameters 304 not being greater than one or more therapy parameters 306, and one or more therapy parameters 306 not being greater than or equal to one or more therapy parameters 304, control component 69 may be configured to set the ventilator pressure to a default pressure 314 (e.g., a default pressure that can be set by the user).

[0050] User interface 120 is configured to provide an interface between system 100 and subject 70 and / or other users through which subject 70 and / or other users can provide and receive information from system 100. Other users may include caregivers, physicians, and / or other users. This enables data, prompts, results, and / or instructions, as well as any other communicable items (collectively, “information”), to communicate between the user (e.g., subject 70) and one or more of the pressure generator 20, processor(s) 60, and / or other components of system 100. For example, the user may use user interface 120 to specify one or more treatment protocols and one or more treatment setpoints, which will be delivered to subject 70. For example, the user may use interface 120 to define treatment setpoints, including a baseline expiratory pressure level and a baseline inspiratory pressure level for positive pressure support therapy. Control component 69 may then customize the treatment protocol delivered to the subject based on one or more inputs made by the user to the user interface. As another example, treatment pressure, subject 70’s respiratory rate, and / or other information may be displayed to the user (e.g., subject 70) via user interface 120. Examples of interface devices suitable for inclusion in user interface 120 include keypads, buttons, switches, keyboards, knobs, joysticks, displays, touchscreens, speakers, microphones, indicator lights, audible alarms, printers, haptic feedback devices, and / or other interface devices. In one embodiment, user interface 120 includes multiple separate interfaces.

[0051] It should be understood that this disclosure also contemplates other communication technologies, whether hardwired or wireless, as user interface 120. For example, this disclosure contemplates that user interface 120 may be integrated with a removable storage interface provided by electronic storage device 130. In this example, information can be loaded from a removable storage device (e.g., a smart card, flash drive, removable disk, etc.) into system 100, enabling (multiple) users to customize the implementation of system 100. Other exemplary input devices and technologies suitable for use with system 100 as user interface 120 include, but are not limited to, RS-232 ports, RF links, IR links, modems (telephone, cable, or others). In short, this disclosure contemplates any technology used to transmit information with system 100 as user interface 120.

[0052] In some embodiments, electronic storage device 130 includes an electronic storage medium that electronically stores information. The electronic storage medium of electronic storage device 130 may include one or both of a system storage device provided integrally with system 100 (i.e., substantially non-removable) and a removable storage device that can be removably connected to system 100 via, for example, a port (e.g., USB port, FireWire port, etc.) or a drive (e.g., disk drive, etc.). Electronic storage device 130 may include one or more of optically readable storage media (e.g., optical disc, etc.), magnetically readable storage media (e.g., magnetic tape, magnetic hard disk drive, floppy disk drive, etc.), charge-based storage media (e.g., EEPROM, RAM, etc.), solid-state storage media (e.g., flash memory drive, etc.), and / or other electronically readable storage media. Electronic storage device 130 may store software algorithms, information determined by processor(s)60, information received via user interface 120, and / or other information that enables system 100 to function properly. The electronic storage device 130 may be (in whole or in part) a separate component within the system 100, or the electronic storage device 130 may be (in whole or in part) integrated with one or more other components of the system 100 (e.g., user interface 120, processors 60, etc.).

[0053] Information determined by the processor(s) 60 and / or stored by the electronic storage device 130 may include information relating to the subject 70’s breathing, compliance, frequency of use, and / or other information. The information stored by the electronic storage device 130 may be viewed via the user interface 120, by connection (wired and / or wireless) to a separate computer, and / or via other methods. The information stored by the electronic storage device 130 may be used, for example, to adjust therapy settings, by physicians to make medical decisions, and / or for other purposes. In some embodiments, the system 100 may include a wireless transmitter (not shown), and information determined by the processor(s) 60, information stored by the electronic storage device 130, and / or other information may be transmitted to caregivers, for example, via a wireless network. As a non-limiting example, caregivers may receive usage information, subject status, and / or other information, thereby allowing caregivers to remotely monitor the therapy delivered by the system 100.

[0054] Figure 4 The illustration depicts a method 400 for detecting and treating overlapping syndromes of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea events (OSA) using a ventilator system. The ventilator system includes a pressure generator, one or more sensors, one or more physical computer processors, and / or other components. The operation of method 400 presented below is intended to be illustrative. In some embodiments, method 400 may be performed with one or more additional operations not described and / or without one or more of the operations discussed. Furthermore, in Figure 4 The order of operations of method 400, illustrated in the diagram and described below, is not intended to be restrictive.

[0055] In some embodiments, method 400 may be implemented in one or more processing devices (e.g., a digital processor, an analog processor, a digital circuit designed to process information, an analog circuit designed to process information, a state machine, and / or other mechanisms for electronically processing information). The one or more processing devices may include one or more devices that perform some or all of the operations of method 400 in response to instructions electronically stored on an electronic storage medium. The one or more processing devices may include one or more devices configured by hardware, firmware, and / or software to specifically design for performing one or more operations of method 400.

[0056] At operation 402, a pressurized breathable gas flow is generated for delivery to the subject's airway. In some embodiments, the pressurized breathable gas flow is generated by a pressure generator 20 (in... Figure 1 and Figure 2 (As shown in the figure and described herein) similar and / or the same pressure generator is used to generate it.

[0057] At operation 404, an output signal is generated that conveys information related to one or more parameters of the breathable gas. In some embodiments, operation 404 is controlled by sensors 40(in...) Figure 1 and Figure 2 (As shown in and described herein) one or more sensors that are the same or similar to perform this action.

[0058] At operation 406, the presence of obstructive sleep apnea (OSA) events and / or expiratory flow restriction (EFL) is detected. In some embodiments, operation 406 is controlled by processor 60 (in... Figure 1 and Figure 2 (As shown in the figure and described in this document) to perform the same or similar physical computer processor.

[0059] At operation 408, one or more OSA event therapy parameters are determined for treating the detected obstructive sleep apnea events (and / or inspiratory flow restriction) in the subject. In some embodiments, operation 408 is controlled by processor 60 (in... Figure 1 and Figure 2 (As shown in the figure and described in this document) to perform the same or similar physical computer processor.

[0060] At operation 410, one or more EFL therapy parameters are determined for treating the detected EFL in the subject. In some embodiments, operation 410 is performed by processor 60 (in... Figure 1 and Figure 2 (As shown in the figure and described in this document) to perform the same or similar physical computer processor.

[0061] At operation 412, a priority treatment to be delivered to the subject is determined. In some embodiments, the priority treatment is determined based on a comparison between one or more OSA event therapy parameters and EFL therapy parameters. In some embodiments, operation 412 is performed by the processor 60 (in... Figure 1 and Figure 2 (As shown in the figure and described in this document) to perform the same or similar physical computer processor.

[0062] At operation 414, the generation of a pressurized breathable gas flow is controlled to provide preferential treatment. In some embodiments, operation 408 is controlled by processor 60 (in... Figure 1 and Figure 2 (As shown in the figure and described in this document) to perform the same or similar physical computer processor.

[0063] In the claims, any reference symbols placed between parentheses should not be construed as limiting the claims. The words "comprising" or "including" do not exclude the presence of elements or steps other than those listed in the claims. In an apparatus claim enumerating several means, these means may be embodied by the same item of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any apparatus claim enumerating several means, these means may be embodied by the same item of hardware. The fact that certain elements are enumerated in mutually different dependent claims does not imply that these elements cannot be combined.

[0064] While the description provided above is based on embodiments currently considered to be most practical and preferred, and provides for illustrative purposes, it should be understood that such details are for that purpose only, and this disclosure is not limited to the explicitly disclosed embodiments; on the contrary, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that this disclosure contemplates, to the extent possible, that one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A ventilator system (100) for detecting and treating concurrent chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) event overlap syndrome, the ventilator system comprising: a pressure generator (20) configured to generate a pressurized flow of breathable gas for delivery to an airway of a subject (70); one or more sensors (40) configured to generate output signals conveying information related to one or more parameters related to the breathable gas; and one or more physical computer processors (60) operably connected to the one or more sensors and the pressure generator, the one or more physical computer processors configured by computer-readable instructions to: detect, based on the output signals, the presence of an obstructive sleep apnea (OSA) event and / or expiratory flow limitation (EFL) in the subject; and in response to detecting the concurrent presence of the OSA event and the EFL: determine one or more OSA event therapy parameters indicative of one or more of a first pressure, a first flow rate, and a first volume for treating the detected obstructive sleep apnea in the subject; determine one or more EFL therapy parameters indicative of one or more of a second pressure, a second flow rate, and a second volume for treating the detected expiratory flow limitation in the subject; determine a priority treatment based on a comparison between the one or more OSA event therapy parameters and the one or more EFL therapy parameters; and control the pressure generator to deliver the determined priority treatment to the subject. detect, based on the output signals, upper airway obstruction in the subject.

2. The ventilator system of claim 1, wherein detecting the presence of an OSA event in the subject comprises:

3. The ventilator system of claim 1, wherein the one or more physical computer processors are further configured to: in response to a first OSA event therapy parameter being greater than a corresponding first EFL therapy parameter, control the ventilator system to deliver a cumulative first parameter, the cumulative first parameter being a cumulative of a first parameter offset and the first OSA event therapy parameter; and in response to the first EFL therapy parameter being greater than or equal to the first OSA event therapy parameter, control the ventilator system to deliver the first EFL therapy parameter. the first pressure for treating OSA events (POSA).

4. The ventilator system of claim 1, wherein the one or more OSA event therapy parameters comprise:

5. The ventilator system of claim 1, wherein the one or more EFL therapy parameters include the second pressure for treating EFL (PEFL).

6. The ventilator system of claim 1, wherein the one or more physical computer processors are further configured to deliver forced oscillation technology (FOT) to determine the one or more OSA event therapy parameters and / or the one or more EFL therapy parameters.

7. The ventilator system of claim 1, wherein the one or more physical computer processors are further configured to prioritize treatment of detected OSA events over treatment of detected EFL. ​ 8. The ventilator system of claim 1, wherein detecting the presence of the OSA event in the subject comprises: detecting upper airway obstruction in the subject based on an apnea hypopnea index (AHI).

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