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Definitions

• the present invention pertains methods for providing enhanced PAP metrics.
• the present invention also relates to systems for use in carrying out such methods.
• sleep apnea is a common example of such sleep disordered breathing suffered by millions of people throughout the world.
• One type of sleep apnea is obstructive sleep apnea (OSA), which is a condition in which sleep is repeatedly interrupted by an inability to breathe due to an obstruction of the airway; typically the upper airway or pharyngeal area.
• OSA obstructive sleep apnea
• Obstruction of the airway is generally believed to be due, at least in part, to a general relaxation of the muscles which stabilize the upper airway segment, thereby allowing the tissues to collapse the airway.
• Another type of sleep apnea syndrome is a central apnea, which is a cessation of respiration due to the absence of respiratory signals from the brain’s respiratory center.
• An apnea condition, whether obstructive, central, or mixed, which is a combination of obstructive and central, is defined as the complete or near cessation of breathing, for example a 90% or greater reduction in peak respiratory air flow.
• sleep apnea Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary- artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment.
• a hypopnea is typically defined as a 50% or greater reduction in the peak respiratory air-flow.
• Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring.
• UARS upper airway resistance syndrome
• snoring vibration of the airway
• CPAP continuous positive air pressure
• This positive pressure effectively“splints” the airway, thereby maintaining an open passage to the lungs.
• CPAP continuous positive air pressure
• This pressure support technique is referred to as bi-level pressure support, in which the inspiratory positive airway pressure (IPAP) delivered to the patient is higher than the expiratory positive airway pressure (EPAP).
• INP inspiratory positive airway pressure
• EPAP expiratory positive airway pressure
• EPAP expiratory positive airway pressure
• a positive pressure therapy in which the pressure is automatically adjusted based on the detected conditions of the patient, such as whether the patient is experiencing an apnea and/or hypopnea.
• This pressure support technique is referred to as an auto-titration type of pressure support, because the pressure support device seeks to provide a pressure to the patient that is only as high as necessary to treat the disordered breathing.
• Devices used in any of the aforementioned therapies may be generally referred to as positive airway pressure (PAP) devices.
• PAP positive airway pressure
• Pressure support therapies as just described involve the placement of a patient interface device including a mask component having a soft, flexible sealing cushion on the face of the patient.
• the mask component may be, without limitation, a nasal mask that covers the patient’s nose, a nasal/oral mask that covers the patient’s nose and mouth, or a full face mask that covers the patient’s face.
• Such patient interface devices may also employ other patient contacting components, such as forehead supports, cheek pads and chin pads.
• the patient interface device is typically secured to the patient’s head by a headgear component.
• the patient interface device is connected to a gas delivery tube or conduit and interfaces the pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.
• embodiments of the present invention improve upon existing systems and methods by providing a more complete picture of the patient’s sleep which may be utilized by healthcare providers to improve treatment provided to the patient.
• the system comprises: a pressure support device for use in providing a flow of breathing gas to the patient; a processing unit; and a number of auxiliary devices in wireless communication with the processing unit, each auxiliary device of the number of auxiliary devices being structured to detect and collect sleep-related data of the patient.
• the processing unit is programmed to: receive data obtained by a number of sensors of the pressure support device during operation of the pressure support device in providing the flow of breathing gas to the patient; receive supplemental data obtained by the number of auxiliary devices while the pressure support device is not providing the flow of breathing gas to the patient; and determine the enhanced PAP metrics of the sleep period of the patient utilizing the data and the supplemental data.
• the processing unit may be a portion of the pressure support device.
• the processing unit may be a portion of another device separate from the processing unit and the auxiliary devices.
• the processing unit may be a portion of one of the number of auxiliary devices.
• the number of auxiliary devices may comprise one or more of: a smart watch, a smart phone, a bedside sleep monitor, and an under-mattress-sensor.
• the processing unit may be further programmed to communicate the enhanced PAP metrics of the sleep period to another device.
• the number of auxiliary devices may comprise at least three devices, and the processing unit may be further programmed exclude data from one auxiliary device of the number of auxiliary devices which does not correspond to data from the other auxiliary device of the number of auxiliary devices.
• the processing unit may be further programmed to utilize the enhanced PAP metrics to determine and implement adjustments to the treatment provided to the patient by the pressure support device.
• a method for providing enhanced PAP metrics of a sleep period of a patient comprising: receiving data obtained during the first portion of the sleep period by a number of sensors of the pressure support device; receiving supplemental data obtained during the second portion of the sleep period by a number of auxiliary devices; and determining enhanced PAP metrics of the patient’s entire sleep period utilizing the data and the supplemental data.
• the method may further comprise communicating the enhanced PAP
• the method may further comprise analyzing the enhanced PAP metrics and adjusting the treatment given to the patient by the pressure support device.
• a method for providing enhanced PAP metrics of a sleep period of a patient comprising: receiving data obtained during the first portion of the sleep period by a number of sensors of the pressure support device; receiving
• supplemental data obtained during first portion of the sleep period by a number of auxiliary devices; determining the occurrence of one or more SDB events during the first portion of the sleep period from one or both of the data and the supplemental data;
• the method may further comprise communicating the enhanced PAP metrics.
• the method may further comprise utilizing the enhanced PAP metrics to adjust the treatment provided to the patient by the pressure support device.
• FIG. 1 is a partially schematic view of an airway pressure support system including a pressure generating device in accordance with one example embodiment of the present invention.
• FIGS. 2 and 3 are partially schematic views of systems for use in carrying out methods in accordance with example embodiments of the present invention.
• “fixedly coupled” or“fixed” means that two components are coupled so as to maintain a constant, fixed orientation relative to each other.
• “selectively coupled” means that two components are coupled in a manner which allows for the components to be readily coupled or uncoupled in a predictable, repeatable manner without damaging either of the components. Unless particularly described otherwise herein, any components which are described merely as being“coupled”, may also be“fixedly” or“selectively” coupled without varying from the scope of the present invention.
• the word“unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a“unitary” component or body.
• the statement that two or more parts or components“engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
• the term“number” shall mean one or an integer greater than one (i.e., a plurality).
• top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
• Airway pressure support system 2 which may be employed as a portion of one particular, non-limiting exemplary embodiment of the present invention is shown in FIG. 1.
• Airway pressure support system 2 includes a pressure support device 4 which houses a blower assembly 6, an example of which will be described in further detail below.
• Blower assembly 6 receives breathing gas, generally indicated by arrow C, from the ambient atmosphere through a filtered air inlet 8 provided as part of pressure support device 4, and generates a flow of breathing gas therefrom for delivery to an airway of a patient 10 at relatively higher and lower pressures, i.e., generally equal to or above ambient atmospheric pressure, to generate pressure to provide pressure compensation to patient 10 via a patient circuit 12,14.
• blower assembly 6 is capable of providing a flow of breathing gas ranging in pressure from 2-30 cmH20.
• the pressurized flow of breathing gas from blower assembly 6, generally indicated by arrow D, is delivered via a delivery conduit 12 to a breathing mask or patient interface 14 of any known construction, which is typically worn by or otherwise attached to patient 10 to communicate the flow of breathing gas to the airway of patient 10.
• Delivery conduit 12 and patient interface device 14 are typically collectively referred to as the patient circuit.
• Pressure support system 2 shown in FIG. 1 is what is known as a single limb system, meaning that the patient circuit includes only delivery conduit 12 connecting patient 10 to pressure support system 2.
• an exhaust vent 16 is provided in delivery conduit 12 for venting exhaled gases from the system as indicated by arrow E.
• exhaust vent 16 can be provided at other locations in addition to or instead of in delivery conduit 12, such as in patient interface device 14. It should also be understood that exhaust vent 16 can have a wide variety of configurations depending on the desired manner in which gas is to be vented from pressure support system 2.
• pressure support system 2 can be a two-limb system, having a delivery conduit and an exhaust conduit connected to patient 10.
• the exhaust conduit carries exhaust gas from patient 10 and includes an exhaust valve at the end distal from patient 10.
• the exhaust valve in such an embodiment is typically actively controlled to maintain a desired level or pressure in the system, which is commonly known as positive end expiratory pressure (PEEP).
• PEEP positive end expiratory pressure
• patient interface 14 is a nasaPoral mask. It is to be understood, however, that patient interface 14 can include a nasal mask, nasal pillows, a tracheal tube, an endotracheal tube, or any other device that provides a suitable gas flow communicating function. Also, for purposes of the present invention, the phrase“patient interface” can include delivery conduit 12 and any other structures that couple the source of pressurized breathing gas to patient 10.
• pressure support system 2 includes a
• valve 18 controls the pressure of the flow of breathing gas from blower assembly 6 that is delivered to patient 10.
• blower assembly 6 and valve 18 are collectively referred to as a pressure generating system because they act in concert to generate and control the pressure and/or flow of gas delivered to patient 10.
• valve 18 is optional depending on the technique used to control the pressure of the flow of breathing gas delivered to patient 10. If valve 18 is eliminated, the pressure generating system corresponds to blower assembly 6 alone, and the pressure of gas in the patient circuit is controlled, for example, by controlling the speed of blower assembly 6.
• Pressure support system 2 further includes a flow sensor 22 that measures the flow of the breathing gas within delivery conduit 20 and delivery conduit 12.
• flow sensor 22 is interposed in line with delivery conduits 20 and 12, most preferably downstream of valve 18.
• Pressure support system 2 additionally includes a pressure sensor 28 that detects the pressure of the pressurized fluid in delivery conduit 20. While the point at which the flow is measured by flow sensor 22 and the pressure is measured by pressure sensor 28 are illustrated as being within pressure support device 4, it is to be understood that the location at which the actual flow and pressure measurements are taken may be anywhere along delivery conduits 20 or 12.
• the flow of breathing gas measured by flow sensor 22 and the pressure detected by pressure sensor 28 are provided to a processing unit 24 to determine the flow of gas at patient 10 (QPATIENT) ⁇
• Processing unit 24 includes a processing portion which may be, for
• Processing unit 24 is structured to receive outputs of one or more sensors, such as those previously discussed, which are structured to gather data related to effectiveness of the pressure support therapy. Processing unit 24 is also structured to analyze outputs of the sensors while pressure support therapy is provided to the patient to determine patient airflow and pressure waveforms in the patient circuit.
• An input/output device 26 is provided for setting various parameters used by pressure support system 2, as well as for displaying and outputting information and data to a user, such as a clinician or caregiver.
• System 100 for use in carrying out a method for providing enhanced PAP metrics of a patient (not shown) in accordance with one example embodiment of the present invention is shown, partially schematically, in FIG. 2.
• System 100 includes a pressure support device, such as pressure support device 4, previously described in FIG.
• System 100 further includes a number (four are shown in the example) of auxiliary devices 102A, 102B, 102C, 102D which are structured to detect and collect sleep-related data and are each in wireless communication (e.g., via Bluetooth) with pressure support device 4 and processing unit 24 thereof. More particularly, the number of auxiliary devices includes a smart watch 102A, a smart phone 102B, a bedside sleep monitor 102C, and an under-mattress-sensor 102D. Smart watch 102A, which is structured to be worn by the patient, is structured to detect one or both of heart rate and actigraphy of the patient and wirelessly communicate data related thereto to processing unit 24.
• Smart phone 102B includes sensors which are structured to monitor breathing and other sounds of the patient and wirelessly communicate data related thereto to processing unit 24. Additionally, smart phone 102B may be employed to monitor bed vibrations and wirelessly communicate data related thereto to processing unit 24. Bedside sleep monitor 102C provides non-contact sensing of the patient’s breathing and body movements and wirelessly communicates data related thereto to processing unit 24.
• Under mattress sensor 102D includes sensors which are structured to detect the patient’s heart rate, respiratory rate, and movement and wirelessly communicate data related thereto to processing unit 24. It is to be appreciated that although four example auxiliary devices 102A-102D are employed in system 100, the quantity and/or type of such devices may be varied (devices other than those shown may be employed, e.g., without limitation, an Sp02 sensor) without varying from the scope of the present invention.
• processing unit 24 is
• processing unit 24 is further programmed to receive and analyze supplemental data from one or more of the number of auxiliary devices 102A- 102D and use such data to measure (or estimate) sleep quality of the patient when pressure support device 4 is not in use, but sleep is detected by one or more of auxiliary devices 102A-102D. Processing unit 24 is further programmed to utilize such
• supplemental data in addition to the data collected when pressure support device 4 was in use to create“total night” sleep quality metrics that reflect sleep quality of the patient for periods of the night when pressure support device 4 was in use as well as periods of the night when pressure support device 24 was not in use.
• the combined metrics may be more general sleep quality metrics (e.g. actigraphy indicating poor sleep).
• Such“total night” sleep quality metrics can then be communicated (via, local wireless, cellular, internet, or any suitable arrangement) to a remote electronic device or devices 104 (e.g., smart phone 106, tablet 108, or any other suitable electronic device) for further review by a physician or caregiver.
• a system 200 for use in carrying out a method for providing enhanced PAP metrics of a patient (not shown) in accordance with another example embodiment of the present invention is shown, partially schematically, in FIG. 3.
• System 200 includes generally the same components as system 100 which function in a similar manner as in system 200 with generally one notable exception.
• auxiliary components 102A- 102D communicating with processing unit 24 of pressure support device 4
• auxiliary components 102A-102D, as well as processing unit 24 wirelessly communicate (e.g., via any suitable local or distant arrangement) either directly or indirectly (e.g., via local wireless and internet) with a remote processing unit 210, which may be a portion of remote electronic device 104 (e.g., smart phone 106 or tablet 108) such as shown in FIG.
• Remote processing unit 210 is programmed in a similar manner as processing unit 24 to create “total night” sleep quality metrics that reflect sleep quality of the patient for periods of the night when pressure support device 4 was in use as well as periods of the night when pressure support device 24 was not in use.
• the start and stop times of pressure support device 4 could be used to segment the reporting of sleep quality-related data from data provided by auxiliary devices 102A-102D.
• the sleep therapy system could summarize actigraphy data from a smart watch separately for periods of the night in which the PAP was in use and those periods when the PAP was not in use in order to highlight how much more restful the patients sleep was (less movement) when the PAP was in use.
• a cross-checking protocol may be employed to exclude erroneous measurements. For example, if four auxiliary devices are connected and one of the devices detects an apnea, but the other three do not, the detected event may be excluded from the total night summary as being most likely an erroneous detection.
• Systems such as described herein may also include a“calibration mode” which concurrently collects data from a pressure support device and connected auxiliary devices in order to identify correlations between SDB events detected by the pressure support device and auxiliary data. Such calibration allows the sleep therapy system to better estimate SDB events when PAP is not in use (after calibration period is complete).
• data for the malfunctioning device can be estimated using trends in other system data (e.g. PAP sensor data or data from other auxiliary devices) in order to“fill in any holes” in the data.
• PAP sensor data or data from other auxiliary devices e.g. PAP sensor data or data from other auxiliary devices
• the missing data can be estimated using previously collected“normal” data from the malfunctioning device.
• any reference signs placed between parentheses shall not be construed as limiting the claim.
• the word“comprising” or“including” does not exclude the presence of elements or steps other than those listed in a claim.
• several of these means may be embodied by one and the same item of hardware.
• the word“a” or“an” preceding an element does not exclude the presence of a plurality of such elements.
• any device claim enumerating several means several of these means may be embodied by one and the same item of hardware.
• the mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

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• 2019
  • 2019-06-24 US US16/450,223 patent/US11638795B2/en active Active
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