WO2021119305A1

WO2021119305A1 - Pulmonary function monitoring devices, systems and methods of use

Info

Publication number: WO2021119305A1
Application number: PCT/US2020/064302
Authority: WO
Inventors: Eric W. Starr; Jacob ZELTMAN; Molly KNEWTSON
Original assignee: Mylan, Inc.
Priority date: 2019-12-11
Filing date: 2020-12-10
Publication date: 2021-06-17

Abstract

A handheld monitoring device, system and method are provided. The handheld monitoring device, system and method allow monitoring of a patient's physiologic metrics and provide corresponding feedback, assessment, and/or therapeutic aid. In some embodiments, there is a monitoring system that can generate metrics on inhalation technique, record metrics, medicament and therapy utilization, and generate metrics on lung health so that a clinician monitoring a patient's respiratory disorder can track a patient's improvement.

Description

PULMONARY FUNCTION MONITORING DEVICES, SYSTEMS AND METHODS OF USE

BACKGROUND

[0001] Patients with compromised respiratory systems and respiratory disorders, such as asthma and chronic obstructive pulmonary disease (“COPD”), are commonly prescribed medicaments and may benefit from pulmonary rehabilitation, the latter of which typically requires a healthcare provider (e.g., physician, nurse, respiratory therapist, clinician, etc.) visit which can be costly, time consuming, and may not be an available option to all patients. For example, it may be difficult to visit a healthcare facility for those who live in remote locations, are homebound, and/or have busy schedules. Further, even when therapy is available, patients may infrequently visit the physician, respiratory therapist, etc. for various reasons. Thus, even with the availability of a therapy and medicaments, many patients have difficulty managing their respiratory disorder for several reasons, including inconsistent, under or over utilization of the medicament, ineffective inhaler technique, and/or infrequent assessment of and feedback on their lung health. Unfortunately, if left untreated or under- or mis-managed, respiratory disorders may often worsen and become a reason for increased concern to healthcare providers and their patients. For example, those who suffer from COPD may experience a worsening of gas exchange in the lungs, which can lead to low blood oxygen levels and high levels of carbon dioxide (CO2).

[0002] Therefore, it would be beneficial to provide a mobile device, such as a handheld device, which can monitor a patient’s physiologic metrics and provide corresponding feedback, assessment, and/or therapeutic aid. A wireless peak flow meter and method of use, which measures a peak expiratory flow (PEF), forced expiratory volume (FEV1), forced vital capacity (FVC), end tidal C02 (EtC02), volume C02 (VC02), arterial blood oxygen saturation (Sp02), and/or body temperature of a user, would be beneficial. It would also be beneficial to provide a monitoring system that can generate metrics on inhalation technique, record medicament and therapy utilization and generate metrics on lung health so that a healthcare provider monitoring a patient’s respiratory disorder can track a patient’s improvement. Further, it would be beneficial to provide a wireless peak flow meter that offers the inspiratory/expiratory muscle trainer and application with which a user as well as a healthcare provider may interact to provide treatment of the patient. SUMMARY

[0003] In some embodiments, there is a mobile device, which can monitor a patient’s pulmonary function and provide corresponding feedback, assessment, and/or therapeutic aid. In some embodiments, there is a wireless peak flow meter and method of use, which measures a peak expiratory flow (PEF), forced expiratory volume (FEV1) and/or forced vital capacity (FVC) of a user.

[0004] In some embodiments, there is a handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: differential pressure sensor or mass airflow sensor or air velocity sensor; C02 sensor; and a pulse oximeter sensor. [0005] In some embodiments, there is a handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: differential pressure sensor or mass airflow sensor or air velocity sensor; and pulse oximeter sensor.

[0006] In some embodiments, there is a handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: differential pressure sensor or mass airflow sensor or air velocity sensor; and C02 sensor.

[0007] In some embodiments, there is a handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: C02 sensor; and pulse oximeter sensor.

[0008] In some embodiments, there is a method of monitoring pulmonary function of a patient, the method comprising: instructing the patient to exhale air into a handheld monitoring device. [0009] In some embodiments, there is a handheld device for determining a pulse oximetry measurement, the handheld device comprising: a light transmitter configured to transmit a light into a pad of a digit which is holding the handheld device; a light receiver configured to receive reflected light from arterial blood vessels within the digit which is holding the handheld device; and a processor configured to determining the pulse oximetry measurement from the received reflected light. [0010] In some embodiments, there is a handheld device for inspiratory and/or expiratory muscle training and spirometry, the handheld device comprising: a housing configured to receive inspiratory and/or expiratory breaths; a user interface configured to guide the inspiratory and/or expiratory breaths; and a processor configured to determine a spirometric measurement based on the inspiratory and/or expiratory breaths.

[0011] In some embodiments, there is a handheld device for determining a body temperature, the handheld device comprising: a housing configured to receive an expiratory breath; a temperature sensor configured to measure a temperature of the expiratory breath; and a processor configured to determine the body temperature based on the expiratory breath.

[0012] In some embodiments, there is a handheld device for measuring a quantity of C02 in an expiratory breath, the handheld device comprising: a housing configured to receive the expiratory breath; a C02 sensor configured to measure the quantity of C02 in the expiratory breath; and a processor configured to indicate the measure of C02 in the expiratory breath.

[0013] In some embodiments, the mobile device will also measure C02 percentage exhaled, C02 partial pressure exhaled, C02 volume exhaled, arterial blood oxygen saturation, heartrate, body temperature, tidal volume, respiratory rate and inhale to exhale ratio.

[0014] In accordance with one or more embodiments, there is provided a handheld device for determining a pulse oximetry measurement, the handheld device including a light transmitter configured to transmit a light into a pad of a digit which is holding the handheld device; a light receiver configured to receive reflected light from arterial blood vessels within the digit which is holding the handheld device; and a processor configured to determining the pulse oximetry measurement from the received reflected light.

[0015] Further, in accordance with an or more embodiments, there is provided a handheld device for inspiratory and/or expiratory muscle training and spirometry. The handheld device including a housing configured to receive inspiratory and/or expiratory breaths; a user interface configured to guide the inspiratory and/or expiratory breaths; and a processor configured to determine a spirometric measurement based on the inspiratory and/or expiratory breaths.

[0016] Further still, in accordance with an or more embodiments, there is provided a handheld device for determining a body temperature, the handheld device including a housing configured to receive an expiratory breath; a temperature sensor configured to measure a temperature of the expiratory breath; and a processor configured to determine the body temperature based on the expiratory breath.

[0017] Additionally, in accordance with an or more embodiments, there is provided a handheld device for measuring a quantity of CO₂ in an expiratory breath, the handheld device including a housing configured to receive the expiratory breath; a CO₂ sensor configured to measure the quantity of CO₂ in the expiratory breath; and a processor configured to indicate the measure of CO₂ in the expiratory breath. The CO₂ sensor may be configured to measure the quantity of CO₂ in the expiratory breath as a partial pressure of CO₂ in the exhaled air at the end of the expiratory breath. The CO₂ sensor may be configured to measure the quantity of CO₂ in the expiratory breath as a volume of CO₂ in the exhaled air from the beginning to the end of an expiratory breath. [0018] While multiple embodiments are disclosed, still other embodiments of the present application will become apparent to those skilled in the art from the following detailed description, which is to be read in connection with the accompanying drawings. As will be apparent, the present disclosure is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the detailed description is to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE FIGURES

[0019] In part, other aspects, features, benefits and advantages of the embodiments will be apparent with regard to the following description, appended claims, and accompanying drawings in which:

[0020] FIG. 1 shows a schematic view of a portion of a pulmonary function monitoring system in accordance with embodiments of the present system;

[0021] FIG. 2 shows a schematic view of a portion of a Wireless Flow Meter (WFM) in accordance with embodiments of the present system;

[0022] FIG. 3 shows a schematic view of a portion of the flow chamber of embodiments including a flow restrictor coupled thereto in accordance with embodiments of the present system;

[0023] FIG. 4 shows a partially exploded cross sectional schematic side view of a portion of a WFM including the flow chamber enclosed in a body in accordance with embodiments of the present system; [0024] FIG. 5 shows a front side perspective view of a portion of a WFM with a slide-type battery compartment cover in the closed position in accordance with embodiments of the present system; [0025] FIG. 6 shows a rear side perspective view of a portion of a WFM with the slide-type battery compartment cover in an open position in accordance with embodiments of the present system; [0026] FIG. 7 shows a front side perspective view of a portion of a WFM in accordance with embodiments of the present system;

[0027] FIG. 8 shows a front side top perspective view of a portion of a WFM with a pulse oximeter, in accordance with embodiments of the present system;

[0028] FIG. 9 shows a rear side bottom perspective view of a portion of a WFM including the pulse oximeter and pulse oximetry sensor in accordance with embodiments of the present system; [0029] FIG. 10 shows a partially cutaway cross sectional schematic view of a portion of a WFM including a sidestream capnograph taken along lines 10-10 of FIG. 8 in accordance with embodiments of the present system;

[0030] FIG. 11 shows a partially cutaway cross sectional schematic view of a portion of a WFM including a mainstream capnograph in accordance with embodiments of the present system; [0031] FIG. 12 shows a front side perspective view of a portion of a WFM with interchangeable mouthpieces in accordance with embodiments of the present system;

[0032] FIG. 13 shows a front side perspective view of a portion of a WFM with a mouthpiece having an adjustable flow resistance through its flow channel in accordance with embodiments of the present system;

[0033] FIG. 14A and FIG. 14B show a functional flow diagram performed by a process in accordance with embodiments of the present system;

[0034] FIG. 15A shows a screenshot of a portion of an initialization screen rendered on a rendering device of the user device (UD) in accordance with embodiments of the present system;

[0035] FIG. 15B shows a screenshot of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system;

[0036] FIG. 15C shows a screenshot of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system;

[0037] FIG. 15D shows a screenshot of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system; [0038] FIG. 15E shows a screenshot of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system; and

[0039] FIG. 16 shows a series of screenshots which illustrate a process flow in accordance with embodiments of the present system.

[0040] It is to be understood that the figures are not drawn to scale. Further, the relation between objects in a figure may not be to scale and may in fact have a reverse relationship as to size. The figures are intended to bring understanding and clarity to the structure of each object shown, and thus, some features may be exaggerated in order to illustrate a specific feature of a structure.

DETAILED DESCRIPTION

[0041] The present disclosure may be understood more readily by reference to the following detailed description of the disclosure presented in connection with the accompanying drawings, which together form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure. The following description is presented to enable any person skilled in the art to make and use the present disclosure.

[0042] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the application are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in its respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of “1 to 10” includes any and all subranges between (and including) the minimum value of 1 and the maximum value of 10, that is, any and all subranges having a minimum value of equal to or greater than 1 and a maximum value of equal to or less than 10, e.g., 5.5 to 10.

DEFINITIONS [0043] As used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise.

[0044] Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. [0045] Spatially relative terms such as "under", "below", "lower", "over", "upper", and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as "first", "second", or the like, are also used to describe various elements, regions, sections, etc. and are also not intended to be limiting. Like terms refer to like elements throughout the description.

[0046] As used herein, the terms "having", "containing", "including", "comprising" and the like are open ended terms that indicate the presence of stated elements or features, but do not preclude additional elements or features.

[0047] For purposes of the description hereinafter, the terms “end”, “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary configurations of the invention. Hence, specific dimensions and other physical characteristics related to the configurations disclosed herein are not to be considered as limiting. [0048] As used herein, the terms “communication” and “communicate” may refer to the reception, receipt, transmission, transfer, provision, and/or the like of information (e.g., data, signals, messages, instructions, commands, and/or the like). For one unit (e.g., a device, a system, a component of a device or system, combinations thereof, and/or the like) to be in communication with another unit means that the one unit is able to directly or indirectly receive information from and/or transmit information to the other unit. This may refer to a direct or indirect connection (e.g., a direct communication connection, an indirect communication connection, and/or the like) that is wired and/or wireless in nature. Additionally, two units may be in communication with each other even though the information transmitted may be modified, processed, relayed, and/or routed between the first and second unit. For example, a first unit may be in communication with a second unit even though the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediary unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments, a message may refer to a network packet (e.g., a data packet, and/or the like) that includes data. It will be appreciated that numerous other arrangements are possible.

[0049] As used herein, the term wireless communication may include communication using any suitable wireless communication medium or mediums. For example, and without limitation, wireless communication systems may include any suitable radio communication method or methods such as Wi-Fi™, Bluetooth™ radio, etc. Without limitation, wireless communication may include untethered optical communication such as infrared communication, etc.

[0050] As used herein, the term wired communication may include any suitable wired communication system or systems. For example, and without limitation, wired communication system may include any suitable wired communication method or methods such as Ethernet™, wired buses, universal serial bus (USB), etc. Wired communication may include tethered optical communication such as fiber-optic communication.

[0051] As used herein, the term “computing device” may refer to one or more electronic devices that are configured to directly or indirectly communicate with or over one or more networks. The computing device may include a computer, a desktop computer, a server, a client device, a mobile device, and/or the like. As an example, a mobile device may include a cellular phone (e.g., a smartphone or standard cellular phone), a portable computer, a wearable device (e.g., watches, glasses, lenses, clothing, and/or the like), a PDA, and/or other like devices. In some non-limiting embodiments, the computing device may not include a mobile device. For example, the computing device may include a desktop computer. An “application” or “application program interface” (API) may refer to software or other data sorted on a computer-readable medium that may be executed by a processor to facilitate the interaction between software components, such as a client-side front-end and/or server-side back-end for receiving data from the client. An “interface” refers to a generated (e.g., rendered) display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, etc.). [0052] As used herein, the term “server” may refer to one or more computing device that are operated by or facilitate communication and processing for multiple parties (e.g., multiple computing devices) via a network (e.g., a public network, a private network, the Internet, and/or the like). In some non-limiting embodiments, multiple computing devices (e.g., computers, servers, and/or the like) directly or indirectly communicating in the network environment may constitute a “system.” In some non-limiting embodiments, reference to “a server” or “a processor,” as used herein, may refer to a previously recited server and/or processor that is recited as performing a previous step or function, a different server and/or processor, and/or a combination of servers and/or processors. For example, as used in the specification and the claims, a first server and/or a first processor that is recited as performing a first step or function may refer to the same or different server and/or a processor recited as performing a second step or function.

[0053] The term “client device,” as used herein, may refer to one or more computing devices that are configured to communicate with one or more servers via a network. In some non-limiting embodiments, a client device may include a device and/or a system configured to communicate with another device and/or another system that is remote from the client device (e.g., that is connected to a network that is different from the network to which the client device is connected). [0054] As used herein, the term “indication” refers to any conveyance of information which can be perceived by the human senses and/or by a processor or other electronic device in communication with the system, whether or not such conveyance of information may also be perceived by a human being. In non-limiting, illustrative examples, an indication may be a signal that can be perceived by sight, hearing, touch, smell, and/or taste. In further non-limiting examples, an indication may be an electronic signal sent to a processor or other electronic device in communication with the system. An indication may also be, for example, data displayed on an interface such as a graphical user interface (GUI). In non-limiting embodiments, an electronic device may be configured to perform an action in response to or otherwise based on the receipt of the indication (or lack thereof) or based on information conveyed as part of the indication. Indication may include rendering, to render, and/or formative thereof, such as to display, information or to otherwise produce user perceivable information. [0055] As used herein, the term peak expiratory flow (PEF), also referred to as peak expiratory flow rate (PEFR), is a user’s maximum speed of expiration, as measured with the pulmonary function monitoring device of the current application. PEF is used to monitor a user’s ability to breathe out air. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF, in some embodiments, can be measured in units of liters per minute (L/min). In some embodiments, peak expiratory flow rate is a general indicator of the presence or absence of an airway obstruction. Such a rate measurement can also, in some embodiments, be determinative of responsiveness to medication treatment, such as for example, bronchodilators and/or steroids.

[0056] As used herein, the term Forced Expiratory Volume (FEV) refers to the volume of air which a person exhales during a forced breath over a certain amount of time, FEV 1 corresponding to one second, FEV3 to 3 seconds and FEV6 to six seconds. Thus, a forced breath over a time period, t, may be represented as FEV(t).

[0057] As used herein, the term Forced Vital Capacity (FVC) refers to the total volume which is exhaled during a FEV test.

[0058] As used herein, the term and/or and formatives thereof should be understood to mean that only one or more of the recited elements may need to be suitably present (e.g., only one recited element is present, two of the recited elements may be present, etc., up to all of the recited elements may be present) in a system in accordance with the claims recitation and in accordance with one or more embodiments of the present system.

[0059] Values of PEF, FEV(t) and FVC may be detected by embodiments of the present system. [0060] The headings below are not meant to limit the disclosure in any way; embodiments under any given heading may be used in conjunction with embodiments under any other heading.

[0061] Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments.

Flow Meter

[0062] With regard to users of the present system, it will be assumed that a user which uses or otherwise interacts with portions of systems designed for use by a patient will be referred to as a patient. Similarly, it will be assumed that a user which uses or otherwise interacts with portions of systems designed for use by a healthcare provider or medical practitioner such as, for example, a physician, a nurse, or a respiratory therapist will be referred to as a healthcare provider.

[0063] FIG. 1 shows a schematic view of a portion of a pulmonary function monitoring system (hereinafter system 100 for the sake of clarity) in accordance with embodiments of the present system. The system may include one or more user devices (UDs) 102-1, 102-2, etc., through 102- N (generally UDs 102-x, where N is an integer), sensing devices including sensor suites 104-1, 104-2, etc., through 104-N (generally sensor suites or SDs 104-x), a network 108, a respiratory therapist portal (RTP) 110, a healthcare provider interface (HPI) 112, a server 106, and a memory 114. One or more of the UDs 102-x, SDs 104-x, the network 108, the RTP 110, the HPI 112, the server 106, and the memory 114 may be operatively coupled to, and may communicate with, one another depending upon configuration via any suitable wired or wireless connection such as the network 108 or directly over a private network or bus. For example, the server 106 may communicate with the memory 114 via a local bus or the network 108. One or more of the UDs 102-x, the SDs 104-x, the RTP 110 and/or the HPI 112 may be considered client devices.

[0064] The server 106 may control an operation of the system 100 and may include one or more controllers 122 each of which may include one or more or more logic devices such as a processor (e.g., microprocessor (mR) 128) which may control the overall operation of the server 106. The processor may include one or more processors which may be local or distributed throughout the system and may communicate with one or more other processors of the system 100 or external to the system 100.

[0065] The processor may be operable for providing control signals and/or performing operations in response to input signals from any suitable user input device (e.g., a sensor, a keyboard, a touchscreen, a mouse, a microphone, a stylus, etc.) of the system 100 as well as in response to other devices of a network and executing instructions stored in the memory 114. The processor may include one or more of a microprocessor (e.g., see 128), an application- specific or general- use integrated circuit(s), a logic device, etc. Further, the processor may be a dedicated processor for performing in accordance with the present system or may be a general-purpose processor wherein only one of many functions operates for performing in accordance with the present system. The processor may operate utilizing a program portion, multiple program segments, and/or may be a hardware device utilizing a dedicated or multi-purpose integrated circuit. [0066] The network 108 may include any suitable wired or wireless network which may enable communication in accordance with embodiments of the present system. For example, the network 108 may include any suitable communication link such as one or more of a wide-area network (WAN), a local-area network (LAN), the Internet, an intranet, a system bus, a proprietary bus, a wired bus, a wireless bus, an ad-hoc network, etc. Accordingly, portions of the system may communicate with other portions of the system via the network 108. It is also envisioned that a user may communicate with the system using local and/or remote communication methods via the network 108.

[0067] The memory 114 may include one or more of a secure database 118 and/or non-transitory memories such as a local memory (LM) 120 which may be local and/or distributed throughout the system 100. The memory 114 may include any type of device for storing application data as well as other data related to the described operation of embodiments of the present system.

[0068] As used herein, the terms, processor, controller, microcontroller and formatives thereof are intended to encompass a device that may control the overall operation of the system, method, etc., and may include one or more logic devices such as processors, microprocessors, reduced instruction set computer(s) (RISC), Application Specific Integrated Circuit(s) (ASIC), field programmable gate array (FPGA) circuit(s), etc., and may include one or more interconnected semiconductor devices such as transistors, gates, impedance devices, metallization connections and the like, discrete and/or distributed logic gates, switching devices, circuits and/or the like. The processor may include hardware, software (e.g., application data) and/or firmware devices, circuits, etc., which may include instructions stored in a memory thereof. The application data and other data may be received by the processor for configuring (e.g., programming) the processor to perform operation acts in accordance with the present system. The processor so configured becomes a special purpose machine particularly suited for performing in accordance with embodiments of the present system.

[0069] The memory may store program or program portions such as application data which may be used to configure the controller 122 to implement the methods, operational acts, and functions disclosed herein. The memories may be distributed, for example between the clients and/or servers, or local, and the controller 122, where additional controllers/processors may be provided, may also be distributed or may be singular. The memories may be implemented as electrical, magnetic or optical memory, or any combination of these or other types of storage devices. Moreover, the term "memory" should be construed broadly enough to encompass any information able to be read from or written to an address in an addressable space accessible by the controller 122. With this definition, information accessible through a network is still within the memory, for instance, because the controller 122 may retrieve the information from the network for operation in accordance with the present system.

[0070] It should be appreciated that methods of the present system are particularly suited to be carried out by a computer software program, such program containing modules corresponding to one or more of the individual steps or acts described and/or envisioned by the present system. Such program may of course be embodied in a computer-readable medium, such as an integrated chip, a peripheral device or memory, such as the memory 120 or other memory coupled to the controller 122.

[0071] Secure database 118 may store information in compliance with one or more guidelines, regulations, rules, acts, and/or the like such as the Health Insurance Portability and Accountability (HIPA) Act. Accordingly, the server 106 may be configured to generate, store, and/or access information generated by the system 100 in accordance with any applicable laws, rules, regulations, and/or desired industry guidelines or standards as may be desired.

[0072] Each of the UDs 102-x may include any suitable computing device or devices with which a patient may interact such as a personal computer, network/stand-alone computers, personal digital assistants (PDAs), WebTV (or other Internet-only) terminals, pagers, smart phones, tablet, or other known (wired and/or wireless) communication devices, etc., and/or the like.

[0073] Each of the UDs 102-x may be the same as or different from each other and may include a user interface (UI) with which a patient may interact using one or more senses such as a display (e.g., a touch-screen display, etc.), a speaker, a haptic device, etc. Similarly, the UI may receive user inputs and, as such, may include any suitable device for receiving a user input such as a touchscreen, a microphone, a keyboard, stylus, a mouse, etc.

[0074] Each of the UDs 102-x may include a controller and may communicate with and/or receive information from one or more corresponding sensors of the system such as the sensor suites SD 104-x using a wired and/or wireless communication method or methods. For example, it will be assumed that the UDs 102-x may communicate with corresponding sensor suites SD 104-x using a low-power wireless communication method such as Bluetooth™, Wi-Fi™, and/or the like. It is further envisioned that the UDs 102-x may communicate with the server 106, and/or RTP 110 using a wired or wireless communication system such as Wi-Fi™, a cellular network, and/or other suitable methods. Each of the UDs 102-x may run an API which may communicate with paired sensor suites SD 104-x and may process SI received from the paired sensor suites SD 104-x in accordance with embodiments of the present system to determine one or more of PEF, FEV(t) and FVC and/or the like and may generate a graphical user interface to display this determined information.

[0075] The sensor suites SD 104-x may include one or more sensing devices (e.g., sensors) 124-1 through 124-M (generally 124-x, where M is an integer) which may sense one or more of an ambient condition (e.g., temperature, pressure, humidity, etc.) and/or metrics of a user (e.g., such as a patient’s vitals) such as one or more of blood pressure, pulse, heart rate, temperature, breath rate, PEF, FEV(t), FVC, etc.) and form corresponding sensor information (SI) which may be associated with patient information (PI) of a corresponding patient. The SI and/or the PI may be forwarded to the corresponding UD 102-x via any suitable communication method. For example, the SI may be streamed in real time to a paired UD 102-x. Then, an API of this UD 102-x may process the SI in accordance with embodiments of the present system.

[0076] For example, sensor SD 124-1 may include a flow meter such as a wireless flow meter (WFM) which may be employed to detect breath rate, PEF, FEV(t), FVC, etc., and sensor SD 124- 2 may include a heart rate monitor (HRM) or the like and may be configured to be worn about a wrist of a patient and detect the heart rate of a patient. The SDs 124-x may be paired to a corresponding UD 102-x using any suitable wired or wireless communication method or methods (e.g., Bluetooth™, Wi-Fi™, etc.). It is further envisioned that SDs 124-x including other sensor types may also be employed and may be paired to a corresponding UD 102-x. For example, the SDs 124-1 may include a Bluetooth™ radio which may attempt to establish a wireless connection (e.g., pair) with a corresponding UD 102-1 (e.g., a smartphone, a tablet, etc.) which may serve as the Bluetooth™ receiver before streaming data such as airflow metrics in real time to the paired UD 124-1. If a valid receiver cannot be found, a processor of the sensor 124-1 may indicate that a connection is not present via a status light emitting diode(s) (LED) on the SD 124-1, as described herein. Alternatively, the processor can store the airflow data in memory until a Bluetooth™ connection is established and the stored airflow data can be uploaded or downloaded accordingly. [0077] In some embodiments, the microcontroller of the SD 124-1 may transmit airflow data and/or airflow metrics to a cloud network. The cloud network is a data network environment in which the airflow data and/or airflow metrics from the SD 124-1 can be stored in a network- attached storage, instead of being solely stored in a local storage.

[0078] In some embodiments, airflow data, airflow metrics and/or oxygenation level, etc., collected from the SD 124-1 may be transmitted to a computer, a smartphone, and/or other database and associated with stored medical record data for the particular patient including, among other things, the patient’s name, date of birth, age, sex, address, name of the medicament prescribed, strength, number of days for the medicament to be used, quantity dispensed, prescriber name, prescription number, pharmacy where filled, number of refills and/or other information. This information may form at least part of a patient information (PI) and/or patient identification (ID) which may be commonly referred to as PI.

[0079] The PI may further include information related to the patient such as vitals (e.g., heart rate, breathing rate, etc.), condition (e.g., COPD), comorbidities (e.g., osteoporosis, etc.), contact information (e.g., phone number, email address, address, etc.) and patient identification (ID) (e.g., patient ID number, etc.). The PI may further include information related to the corresponding patient such as alerts (if any), workout history, a workout routine or routines for the corresponding patient (e.g., step ups, leg lifts, arm extensions, arm lifts, axial extensions, guided breathing, etc. as may be selected by the system and/or therapist), workout results for the corresponding patient (e.g., a number of repetitions (reps) and speed during a step up routine, a number of lifts and speed during a leg lift routine, a number of arm extensions and speed during an arm extension routine, number of breaths, resistance to airflow used, etc.). Accordingly, the PI related to the patient may be accessed, updated, stored, and/or rendered on a rendering device of the system such as a UI by the RTP 110.

[0080] The SDs 124-x may include one or more of a user interface (UI) with which a user such as a patient may interact with the corresponding SD 124-x as described herein. The system 100 may render information on the UI and/or a patient may enter selections via the UI. For the sake of clarity only a single UD 102-1 and corresponding SD 124-1 will now be discussed. However, it should be understood that the system may be operative with a plurality of UDs 102-x and/or corresponding SDs 124-x, one or more of which may generate sensor information (SI). Once generated, the SI may be transmitted (e.g., raw or processed) to a corresponding UD 102-x for further processing by an API at the UD 102-x and/or transfer to other portions of the system 100 for further processing, rendering, and/or storage. This data may be included in, or associated with, the PI.

[0081] It is envisioned that the SI may be processed and/or stored locally on corresponding sensor suites SD 104-x which generated the SI and may be accessed at a later time for transfer to other portions of the system 100. As discussed elsewhere, this may occur, for example, when the SD 104-x cannot pair to a corresponding UD 102-x. One or more of the SDs 124-x may include a user interface with which a user such a patient may interact. For example, SD 124-1 may include a UI which may include a button and multiple LED’s which display information to the patient.

[0082] The RTP 110 may include any suitable user interface (UI) 126, such as a graphic user interface (GUI) with which a user such as a respiratory therapist may interact with the system to view information related to a corresponding patient such as the PI at least a part of which may be accessed, stored, and/or generated by the system 100. Accordingly, the RTP 110 may render a GUI which may include the PI and/or other information generated and/or accessed by the system such as workout routine information (WRI) and/or may present selection items for selection by the respiratory therapist.

[0083] It is envisioned that the RTP 110 may generate information with which a respiratory therapist may view a corresponding patient progress, adjust a workout of a corresponding patient, and/or receive patient alerts. These alerts may be generated by, for example, the RTP 110 or one or more of the sensors 104-1 and/or UD 102-x, for example when it is determined that a corresponding patient has exceeded a threshold heart rate, misses a certain number of workouts, etc., and may be rendered or otherwise indicated on a rendering device of the system 100. Accordingly, the system 100 may continually monitor information generated and/or stored by the system 100 and may generate corresponding alerts which may be associated with a corresponding patient as PI of the patient and may be rendered for the convenience of the patient and/or therapy provider. The RTP 110 may then store the updated PI in a memory of the system 100 such as in the secure database 118.

[0084] It is further envisioned that the system may generate an indication of registered patients and render this indication on a UI of the system 100. Thereafter, a respiratory specialist may select one or more registered patients to view PI and/or to make selections related to the corresponding patient. Thus, one respiratory specialist may interact with one or more patients. [0085] As used herein, the UI 126 may include any suitable user interface which may render information for the convenience of the user such as graphical user interfaces (GUIs) generated by the system 100. Accordingly, the UI 126 may include a speaker (SPK), a display (e.g., a touch screen display, etc.), haptic device (e.g., vibrators, etc.), and/or the like. Further, the UI 126 may include a user interface with which a user may control one or more portions of the system 100. [0086] The HPI 112 may include a UI which may render information generated by a web dashboard of an API operating in accordance with embodiments of the present system. The web dashboard may obtain SI and PI from the server 106 and may generate and render a report on a UI of the system for the convenience of a medical practitioner.

[0087] FIG. 2 shows a schematic view of a portion of a Wireless Flow Meter (WFM) 225 in accordance with embodiments of the present system. The WFM 225 may be in a form of a mobile device such as a handheld device. The WFM 225 may be similar to the SD 124-1 of FIG. 1 and may include one or more of a processor 210, a communication module 262, a power supply (PSUPP) 264, a memory 258, and one or more sensors (e.g., sensor suite 255), one or more of which may be operatively coupled to each other and/or the processor 210 via any suitable wired or wireless communication method or methods. It is envisioned that one or more of the processor 210, the communication module 262, a pressure sensor 250, a flow chamber 230, a button 252, a pulse oximeter 254, a user interface (UI) 256, the memory 258, the power supply (PSUPP) 264, and a capnograph 260 may be formed integrally with, or separately from, each other.

[0088] For the sake of clarity, it will be assumed that the UD 102-1 is paired to WFM 225 and is shown for the sake of clarity. It will be assumed that the UD 102-1 may be running an API that may communicate with the WFM 225 to control the WFM and/or process information received from the WFM 225. The API may further render a GUI with which a user may interact in accordance with embodiments of the present system.

[0089] The PSUPP 264 may supply standalone power for overall operation of the WFM 225. The PSUPP 264 may include one or more power supplies such as batteries (e.g., two AA cells), capacitors, etc. which may supply power for the overall operation of the WFM 225. The PSUPP 264 may include one or more of a battery compartment and access door or cover which may be opened or otherwise removed to access or change one or more power sources such as batteries which may be contained within, and which may provide power to the WFM 225. [0090] The PSUPP 264 may include power conditioning circuitry which may be configured to determine a charge, temperature, power draw, and/or health or status of the one or more power supplies (e.g., batteries) and form corresponding sensor information and provide this information to the processor 210 for transmission and use by the API. The transmission may then render at least a portion of this information on the UI 256.

[0091] The power conditioning circuitry may be further configured to charge the one or more power supplies as may be desired using power from a wired (e.g., a USB, etc.) or wireless (e.g., a wireless charger) charger. Accordingly, the PSUPP 264 may include wireless charging circuitry and the one or more power supplies (e.g., batteries) may be rechargeable as may be desired. [0092] A charge port, such as the USB port (USB) of the communication portion 262, may be provided to receive power and/or to communicate with another device such as a UD 102-x via a wired coupling using any suitable method.

[0093] The processor 210 may control the overall operation of the WFM 225 and may include at least one logic device such as a least one microprocessor 228. The processor 210 may communicate with the communication module 262 to transmit and/or receive information such as operating instructions, SI, PI, etc. The processor 210 may include a clock to time stamp information that it receives and/or generates. For example, the processor 210 may time stamp the SI. Further, the processor 210 may then transmit the SI to a paired UD (e.g., the UD 102-1) or may store the SI in the memory 258 for later use such as transmission to the paired UD.

[0094] The communication module 262 may operate under the control of the processor 210 and may include one or more communicators which may communicate with a desired device (e.g., a corresponding paired UD such as UD 102-1 of FIG. 1) using any suitable wired or wireless communication method or methods. For example, for wireless communication, the communication module 262 may transmit and/or receive information, via at least one antenna (ANT) configured for the desired wireless communication method (e.g., Bluetooth™) in accordance with the present embodiments. Whereas for wired communication, to effect communication the processor 210 may control the communication module 262 to transmit and/or receive information, via a hardwired connector such as the USB and/or the like. It is also envisioned that the communication module 262 may include an optical communicator which may communicate via optical methods (e.g., infrared and/or fiber optic). The communication module 262 may include upconverters and/or downconverters to upconvert information for transmission and/or down convert information for reception, respectively. Information such as SI transmitted and/or received from the communication module 262 may be streamed in real time and/or may be stored in the memory for later use, transmission, and/or processing in accordance with embodiments of the present system. The USB port may further include circuitry for receiving power from an external power source such as a charging device.

[0095] The sensor suite 255 may include one or more sensors such as one or more of the pressure sensors 250, the button 252, a pulse oximeter 254, a capnograph 260, and an ambient sensor 268. Each of the one or more sensors in the sensor suite 255 may transmit corresponding sensor information, in any suitable format (e.g., raw or processed), to the processor 210 for further processing (e.g., inclusion within the SI, etc.) and/or transmission to a paired UD such as the UD 102-1 for further processing by a corresponding API. Thereafter the SI may be stored in a memory of the system such as a secure DB of the system (e.g., see, secure database 118, FIG. 1). The sensor information may be date and/or time stamped and stored in a memory of the system such as the memory 258 for later use as desired.

[0096] In some embodiments, one or more of the sensors in the sensor suite 255 may be selectively detachable from a body (e.g., housing) of the WFM 225 and may be coupled using any suitable coupling method such as adhesive, adhesive strips, Velcro®, clips, hooks, magnets, snaps, buttons, interference fittings, latches, friction fittings, compressive fittings, posts, connectors, screws. In accordance with one embodiment, it is envisioned that one or more of the sensors may be friction fit or snap fit into a recess and/or otherwise located on the exterior and/or interior surface of the flow chamber 230. This may facilitate initial build and/or service. It will be understood that, although the one or more of the sensor suite 255 may be shown as a rectangular shape, other shapes are contemplated such as, circular, crescent, oval, square, hexagonal, pentagonal, and/or triangular. Further, it is also envisioned that one or more of the sensors may include a photodetector sensor, a light intensity sensor, a, a pressure sensor, a temperature sensor, and/or a humidity sensor. Each of which may form corresponding sensor information and provide this sensor information to the processor 210. In accordance with one embodiment, a temperature sensor may sense a temperature of air expressed by the patient to measure a body temperature of the patient (e.g., directly measuring expressed air temperature, using a differential of expressed and ambient temperature, as the temperature of a patient finger (digit) in contact with the temperature sensor, etc.). Further, a pressure sensor may be employed at the button 252 to detect a patient depressing the button 252. [0097] The button 252 may include any suitable hard or soft switch with which a user may interact to operate the device. For example, the button 252 may be configured to generate an awake request signal (AW) (when depressed) which be received by the processor 210. For example, the button 252 may include a normally open switch (N/O) which a user may depress to generate the AW which may be provided to the processor 210 for further processing. For example, the processor 210 upon receiving the AW may determine a current operation mode (e.g., an operative state) of the WFM 225 such as on, off, and/or standby. Accordingly, in a case where it is detected that the current operation mode of the WFM 225 is off, the processor 210 may in response to receipt of the AW, turn the WFM 225 on and perform an initialization routine. In a case wherein it is detected that the current operation mode of the WFM 225 is on, the processor 210 may turn the WFM 225 off in response to the AW. Further, in a case where it is detected that the current operation mode of the WFM 225 is in standby, the processor 210 may turn the WFM 225 on in response to the AW and perform an initialization routine.

[0098] However, in accordance with embodiments of the present system, the WFM 225 may have two operating modes (e.g., states) which may be standby and awake. Thus, the processor 210 may cycle between an active mode (e.g., on operating mode) and a sleep mode (e.g., a low power mode wherein one or more components operate at reduced power or are powered off) in order to conserve battery life to enhance user convenience. With regard to these modes, when in the sleep mode and the button 252 is depressed, the WFM 225 may awake, perform an initialization routine in which it may attempt to pair to an available UD (e.g., the UD 102-1), initialize/calibrate its sensors, render indicia of its operating mode (e.g., green ready light), and thereafter run one or more airflow tests to monitor the patient. In accordance with embodiments, while the button 252 is depressed, the WFM 255 may remain awake, perform airflow tests (e.g., patient airflow tests, capnograph tests, monitor pulse and heart rate, etc.), may process information, and/or may communicate with paired devices and APIs running therein. When the button 252 is not depressed (e.g., is released), the WFM 225 may enter a sleep mode which may be a low power mode in which sensors other than the button 252 may be switched off or unmonitored, indicators (e.g., LEDs) and/or wireless communication may be switched off to conserve power. Thus, in accordance with embodiments of the present system, the patient may depress and hold the button 252 during airflow tests using the WFM 225. When in the sleep mode the processor 210 may monitor the AW signal and respond accordingly. It is further envisioned that one or more functions performed by the button 252 may be defined by the user and/or system and may be stored in a memory of the system for later use. Thus, one or more operation states and/or a state (e.g., mode) of the WFM 225 may be defined by the user and/or system and may be stored in a memory of the system for later use as mode information (MI). The processor 210 may then operate in accordance with the received MI. [0099] In accordance with embodiments of the present system and without limitation, the button 252 may include analog or digital switches such as a touch-sensitive switch (e.g., a capacitive switch, a touchscreen, etc.), an analog push-button type switch, etc.

[00100] The API may provide a GUI with which the user may interact to view, select, and/or edit the MI. Thus, user operation states and/or a state flow may be defined by the system and/or a user. This may provide for operation using a single step operation of the WFM 225 such as by depressing the button 252. It is envisioned that the button 252 may be operative functionally as a switch when depressed or otherwise selected.

[00101] The UI 256 may include any suitable user interface with which a user may interact with the WFM 225 such as hard or soft switches, a touchscreen display, illumination sources, etc. For example, the UI 256 may include a rendering device such as a display and/or illumination sources such as one or more light-emitting diodes (LEDs) which may render information related to operation of the system such as use instructions, test results, device parameters, etc., for the convenience of the user. For example, the system may include five LED indication lights - one which shows battery status and four which show test results. The rendering devices may provide indicia output by the processor 210.

[00102] The memory 258 may include any suitable non-transitory memory which may store information received, used or generated by the WFM 225 such as device parameters, operating instructions, status, test results, SI, time stamps, etc. The memory 258 may also store a device ID unique to the WFM 225 and which may be used to identify the WFM 225.

[00103] The pulse oximeter 254 may have any suitable sensor that may be configured to noninvasively measure blood oxygen saturation of the patient and may form corresponding information which may be referred to as pulse oximeter sensor information (POSI). In some embodiments, the pulse oximeter sensor is situated on the housing at a location that is opposite the activation switch. In other embodiments, the pulse oximeter sensor is situated proximate to the activation switch such that a user interfaces with the pulse oximeter when depressing the activation switch. In yet another embodiment, the pulse oximeter sensor may attach to the WFM 225 via a detachable wire. Suitable sensors may include, for example, an infrared sensor which may be configured to employ infrared detection methods to detect a blood oxygen saturation of the corresponding patient through the skin of the patient and form corresponding sensor information such as the POSI. The POSI may then be provided to the processor 210 for further processing and/or including within SI which may be provided for example through a network (e.g., the network 108 in FIG. 1) to a controller for processing, and/or may be provided to a paired UD 102- 1 for processing by a corresponding API at the corresponding UD 102-1.

[00104] The capnograph 260 may include any suitable sensor such as a CO2 sensor (C02) 261 that may be configured to noninvasively measure a concentration of CO2 in expiration gasses (e.g., exhalation gasses) of the patient sampled at the flow chamber 230 and may form corresponding capnograph information (Cl) that may them be provided to the processor 210 for further processing by a corresponding API at the corresponding UD and/or to a system controller. Accordingly, the CO2 sensor 261 may employ sidestream or mainstream capnometry methods. For example, assuming that the system employs sidestream capnometry, then the CO2 sensor 261 may be coupled to the flow chamber 230 via a flow path 245. A pump such as an air pump may, under the control of the processor 210, be operative to draw an expiration gas sample from the flow chamber 230 into the CO2 sensor 261 for sampling. The drawn expiration gas sample may be discarded via a suitable port to atmosphere or the like once it has been sampled or as necessary. The pump may be operative to prime portions of the flow path 245 and/or CO2 sensor. The CO2 sensor 261 may be situated before or after the pump along a flow path of the gas drawn by the pump.

[00105] The flow chamber 230 may include a proximal end opening 232 and a distal end opening 235 and a longitudinal axis, e.g., shown as AA, disposed therebetween. The flow chamber 230 may be defined by at least one wall 231, 236 and may be situated between the proximal end opening 232 and an orifice plate 234 defining the distal end opening 235. The flow chamber 230 may be flow coupled to a proximal port of a body of the WFM 225 to receive an expiration gas flow from the patient (e.g., an expiratory flow (PEF)) which may flow in a direction indicated by an arrow DA. In accordance with embodiments of the present system, the flow chamber 230 may be cylindrical or substantially cylindrical and for example may have a diameter (d_pr0x) of about 22 mm, however, other shapes (e.g., oval, etc.) and sizes and/or diameters are also envisioned. The proximal end opening 232 may have a diameter which may correspond with a diameter and/or shape and size of the flow chamber 230. However, other shapes and sizes and/or diameters are also envisioned. The distal end opening 235 for example may have a diameter (ddist) of about 15.5 mm and may be flow coupled to a distal port of a body the WFM 225, however, other diameters are also envisioned. The proximal end opening 232 may be flow coupled to a removable mouthpiece as described herein. Although a flow chamber 230 having a cylindrical shape is shown, other shapes, cross sections, volumes, etc., are also envisioned. In some embodiments, the flow chamber 230 has the shape of rectangle, pentagon, hexagonal or other polygons. In some embodiments, the flow chamber 230 has a length of from about 50 mm to about 150 mm, from about 50 mm to about 100 mm, from about 50 mm to about 75 mm, from about 50 mm to about 55 mm, from about 55 mm to about 60 mm, from about 60 mm to about 65 mm, from about 65 mm to about 70 mm, from about 70 mm to about 75 mm, from about 75 mm to about 80 mm, from about 80 mm to about 85 mm, from about 85 mm to about 90 mm, from about 90 mm to about 95 mm, from about 95 mm to about 100 mm, from about 100 mm to about 105 mm, from about 105 mm to about 110 mm, from about 110 mm to about 115 mm, from about 115 mm to about 120 mm, from about 120 mm to about 125 mm, from about 125 mm to about 130 mm, from about 130 mm to about 135 mm, from about 135 mm to about 140 mm, from about 140 mm to about 145 mm, from about 145 mm to about 150 mm. In some embodiments, the flow chamber 230 may have an approximate length of 97 mm. [00106] The pressure sensor 250 may include at least one pressure sensor, such as a pressure transducer 251 (XDR) having first and second input ports and which may sense pressures at these ports and may form corresponding pressure signals (Pi and/or P2) which may be output as pressure information. It is also envisioned that the XDR 251 may sense a pressure difference between these first and second input ports and form a corresponding pressure difference signal (PDS).

[00107] The first input port of the XDR 251 may be flow coupled to a first port 242 located within the flow chamber 230 via a first flow path 240 and may sense a pressure (Pi) within the flow chamber 230 at the first port 242. As readily appreciated, in accordance with embodiments the XDR 251 may be located within the flow chamber 230 to sense the pressure therein. The second input port of the XDR 251 may be flow coupled via a second flow path 244 to a second port 246 and may sense an ambient pressure (PATM) at this second port 246. It is also envisioned that the pressure sensor 250 may include an ambient pressure sensor to sense ambient pressure PATM and provide corresponding sensor information to the processor 210 for further processing and/or inclusion within SI for further processing and/or storage within a memory of the system.

[00108] Accordingly, the first flow path 240 may have proximal and distal ends, wherein the distal end may be coupled to the flow chamber 230 at a port 242 and a proximal end may be coupled to a first input port of the XDR 251. Similarly, the second flow path 244 may have proximal and distal ends, wherein the distal end may be exposed to atmospheric pressure and the proximal end may be coupled to a second input port of the XDR 251.

[00109] More particularly, when activated, the pressure transducer XDR 251 may be operative to detect pressures and/or a pressure difference across a flow restrictor such as the orifice plate 234 for example by detecting a difference between pressures Pi and P2 and may form a corresponding PDS.

[00110] For the sake of clarity, it will be assumed that direction of airflow is in the direction DA which corresponds with an expiratory flow of the patient into a mouthpiece. As the orifice plate 234 is situated at an end of the flow chamber 230 downstream of the expiratory airflow DA, during expiration, there will be a positive pressure on the upstream side of the orifice plate 234 (e.g., a side that is closer to the proximal end opening 232 and, thus, the mouthpiece) relative to atmospheric pressure downstream of the orifice plate 234. Thus, when sampling a pressure difference between pressures Pi and P2, Pi (which is sampled at port 242 upstream relative to the expiratory flow of the orifice plate 234) will be higher than P2 which is assumed to be at ambient pressure (PATM). Accordingly, during expiration PDS should be positive. The difference between pressures Pi and P2 reflects a pressure drop across the orifice plate 234 and may be represented using the corresponding PDS. However, in yet other embodiments, Pi and P2 may be provided to the processor 210 by the pressure sensor 250 and the processor may determine PDS.

[00111] Thus, during operation, the processor 210 may directly (e.g., by determining a difference between Pi and P2) or through the XDR 251, detect a difference in pressure between Pi and P2 (which is assumed to be equal to PATM) and may form a corresponding PDS and which may then be processed by the processor 210 to determine air flow metrics of the patient. The processor 210 may provide information corresponding to the PDS in any suitable format (e.g., raw or processed, analog and/or digital, etc.) to the UD 102-1 for further processing (e.g., inclusion within the SI, etc.) and analysis by, for example, a corresponding API operating at the UD 102-1. Thereafter, the SI and/or results of the analysis may be stored in a memory of the system such as a secure DB of the system as may be desired and/or may be processed by a server controller for analysis and/or rendering.

[00112] In accordance with embodiments of the present system, the processor 210 may determine a base level pressure. This base level pressure may include a “zero” value pressure differential which may be used for calibration of the pressure sensor 250 by one or more processors of the system such as the processor 210. This may account for inaccuracies in the P_DS formed by the XDR or determined by the processor 210. The “zero” value pressure differential may be included with SI output by the pressure sensor 250. This “zero” value may be stored in a memory of the system and may be added or subtracted to each data point (e.g., pressure data point or Pi, P2, or P_DS over time) to obtain higher accuracy in the test result when determining flow measurements. This may assure that a “zero” value may be obtained only before an inspiratory or expiratory flow is provided to the flow chamber 230.

[00113] In yet other embodiments, it is assumed that the “zero” value may be determined upon initial device sync and setup, and sensor information from the pressure sensor 250 may be collected while there is no flow going through the device to determine what a base level pressure without an inspiratory or expiratory flow should be. This “zero” value may be output to the API and may be saved along with the unique identifier for the WFM 225 and used when processing airflow information from the WFM 225.

[00114] The processor 210 may further detect whether there is any airflow (e.g., indicative of an inspiratory or expiratory flow) within the flow chamber 230.

[00115] For example, to determine whether there is any airflow within the flow chamber 230, the processor 210 may monitor P_DS and compare its absolute value with a threshold value (e.g., this value may be close to or equal to zero as may be set by the system and/or user to negate any system inaccuracies). Accordingly, if it is determined that the absolute value of P_DS is greater than the threshold flow value, it may be determined that there is sufficient airflow within the flow chamber 230 (e.g., sufficient for testing purposes of the system) and the system may determine one or more of direction and/or amount of airflow. However, if it is determined that the absolute value of P_DS is not greater than the threshold flow value, it may be determined that there is insufficient airflow within the flow chamber 230 and an indication to that effect may be provided (for example a red LED may be lit to indicate that there is insufficient airflow to attain a measurement). [00116] With regard to the flow direction, it is envisioned that the process may detect a direction of airflow within the flow chamber 230. This process may optionally be determined if it is determined that there is airflow within the flow chamber 230.

[00117] A processor of the system such as the processor 210 may determine a direction of airflow within the flow chamber 230 by determining whether PDS is positive or negative. Accordingly, if PDS is negative, the system may determine that the direction of airflow in the flow chamber 230 is reversed (from what is expected during expiratory testing) and may provide an indication of such negative pressure difference. For example, if the processor 210 detects that a patient has inhaled through the mouthpiece rather than exhaled through it during an airflow test, the processor 210 may provide indicia of such negative pressure difference (e.g., as an error signal such as a red flashing LED, etc.). However, if it is determined that PDS is positive, the process may determine that the direction of airflow in the flow chamber 230 is normal and may provide an indication of such (e.g., as a ready signal such as a green LED, etc.).

[00118] The optional ambient sensor 268 may include one or more sensors which may detect ambient conditions such as temperature and humidity and provide corresponding information to the processor 210 for further processing and/or inclusion within SI and/or storage within a memory of the system. This information may be used to enhance accuracy of determined volume of a detected airflow.

[00119] One or more of the sensor suites 255 may be actively or passively operated. For example, the processor 210 may selectively activate one or more of the sensor suites 255 such as the pulse oximeter 254, the UI 256, the capnograph 260, the pressure sensor 250, and the ambient sensor 268 in accordance with a current test routine and/or selection of the patient. The processor 210 may further provide an indication of a sensor that may be activated using any suitable method such as by rendering an instruction and/or illuminating a light source corresponding to activated or to be activated sensor or sensors. For example, when the pressure sensor 250 is activated, the processor 210 may illuminate a corresponding LED (e.g., LED1) to indicate such. Similarly, when the pulse oximeter 254 is activated, the processor 210 may illuminate a corresponding LED (LED2) to indicate such. The LEDs may further be configured to display a desired color such as red or green. These colors may be selected by the processor 210 to indicate operation status such as green to indicated ready and red to indicate an error. For example, the processor 210 may analyze airflow within the flow chamber 230 to determine a direction of travel. Accordingly, if it is detected that airflow within the flow chamber 230 is reversed, the processor 210 may provide an indication of such on the UI 256 by, for example, illuminating an LED in red, etc. If it is detected that airflow within the flow chamber 230 is in the proper direction (e.g., expected direction or directions for inspiratory and expiratory breaths), the processor 210 may provide an indication of such on the UI 256 by, for example, by illuminating an LED in green.

[00120] Although exemplary operation of a single WFM 225 and UD 102-1 is shown and described, it should be understood that other WFMs 225 and/or UDs 102-x may operate similarly and are not discussed for the sake of clarity.

[00121] FIG. 3 shows a schematic view of a portion of the flow chamber 230 for example of the embodiment shown in FIG. 2 including a flow restrictor 237 coupled thereto in accordance with embodiments of the present system. The flow restrictor 237 may be flow coupled to the proximal end opening 232 (as shown) or a distal end opening 235 to alter a restriction of a flow path which may include the flow chamber 230 of the present system. The flow restrictor 237 may have a predetermined length and/or diameter (or area) so as to provide a desired amount of flow restriction to a gas flow that may pass therethrough. Accordingly, a restriction of the flow through the flow chamber 230 may be influenced and/or changed or otherwise adjusted by coupling the flow restrictor to the flow chamber 230.

[00122] It is envisioned that the flow restrictor 237 may include one or more variable flow valves, etc., such as butterfly valve 239 which may be opened and/or closed by rotating about its axis as illustrated by arrow 233. In yet other embodiments other valve types such as, without limitation, ball valves, sliding valves, etc. and/or the like are also envisioned.

[00123] FIG. 4 shows a partially exploded cross sectional schematic side view of a portion of a WFM 425 including the flow chamber 230 enclosed in a body 470 in accordance with embodiments of the present system. The WFM 425 may include the body 470 and may include a mouthpiece 490 coupled to the body 470.

[00124] The body 470 may include at least one cavity 471 in which at least a portion of one or more of the flow chamber 230, a processor 410, a communication portion 462, one or more sensors 455, a PSUPP 464, a UI 456, a button 452, and a pulse oximeter 454, are located. It is also envisioned that one or more of the flow chamber 230, the processor 410, the communication portion 462, the sensors 455, the PSUPP 464, the UI 456, and the button 452 may be located, at least in part, outside of the cavity 471 as may be desired. For example, at least a portion of the UI 456, the button 452, and/or the pulse oximeter 454, may be surface mounted upon or form at least a portion of an exterior surface of the body 470. The body 470 may include an opening or port 446 which may be open to ambient pressure such that the cavity 471 may be maintained at ambient pressure (e.g., PATM) during operation.

[00125] The processor 410 may be similar to the processor 210 and may be coupled to one or more of the sensors 455, the communication portion 462, the PSUPP 464, the UI 456, etc. It is also envisioned that the processor 410 may be coupled to the mouthpiece 490 via a wired or wireless communication link. The processor 410 may control the overall operation of the WFM 425 and may receive sensor information from one or more sensors of the system and may timestamp, process, store, and/or transmit the sensor information to other portions of the system such as an API of the present system.

[00126] The sensors 455 may be similar to the sensor suite 255 and may communicate with the processor 410 and may provide corresponding sensor information (SI) to the controller 425 for further processing. It will be assumed that the sensor suite 255 may include one or more of a capnograph, a pressure sensor, a pulse oximeter, an ambient sensor, etc. The capnograph may be employ sidestream or mainstream capnometry method or methods to sample the expiratory flow through the body 470 and form corresponding sensor information which may be provided to the processor 410.

[00127] The communication portion 462 may be similar to the communication portion 262. The button 452 may include a hard and/or soft switch and may be similar to the button 252 and may provide a user interface with which a user may interact with for example to signal the processor 410 to change an operating mode of the WFM 425. For example, the button 452 may be operative as a toggle switch which may toggle the processor 410 from a sleep mode to an awake mode when the button 452 is depressed. The button 452 may include any suitable hard and/or soft button and/or switch such as a push-type switch which may be coupled to the processor 410. As used herein the term button may be used interchangeably with device button, switch, etc. Operating modes of the WFM 425 controlled by the button 452 may, without limitation, include sleep, standby (e.g., a low power mode) and/or off. However, other modes are also envisioned. It will be assumed that during a startup initialization from sleep, the system may calibrate one or more sensors. Additional or other operating modes may be defined by the system and/or user and may be stored in a memory of the system. The button/switch may form part of the UI 456. [00128] The UI 456 may be similar to the UI 256 and may be coupled to the processor 410. The UI 456 may include one or more rendering devices with which a user may interact such as illumination sources and/or a display. For example, it is envisioned that the illumination sources may include any suitable illumination sources such as LEDs or the like. One or more of the LEDs may be illuminated using colors, patterns, and/or sequences to indicate device status, instructions, and/or results. For example, the illumination sources may include LEDs 456-1 and 456-2 (generally LEDs 456-x) wherein LED(s) 456-1 may provide an indication of whether the WFM 425 is awake and ready for measurement (e.g., illuminated green) or sleeping and not ready for measurement (e.g., illuminated yellow), low battery (e.g., flashing yellow), etc.

LED(s) 456-2 may be illuminated using a sequential flashing pattern in green to indicate that patient metrics are being currently sensed for the current dataset and collected and may be flashed to indicate that a patient metrics (e.g., sensor information) have been obtained successfully or may be flashed in red to indicate that patient metrics have not been successfully obtained (e.g., as may happen if a user inspires instead of expires when an expiration is expected through the mouthpiece). In this way, the UI may provide an indication of measurement success, of operating mode, etc. Thereafter, the patient may have to reset the WFM 425 using any suitable method such as by depressing the button 452 to obtain another dataset. For example, the illumination sources may include LEDs 456-1 and 456-2 (generally LEDs 456-x) wherein LED(s) 456-1 may provide an indication of WFM 425 and battery status. The green color corresponding to being awake, ready for measurement, and/or “full” battery. The yellow color corresponding to being awake, ready for measurement, and/or “low” battery. Flashing yellow corresponding to being awake, not ready for measurement, and/or insufficient battery. LED(s) 456-2 may be illuminated after a patient has completed a measurement corresponding with the result of the measurement.

[00129] It is also envisioned that the UI 456 may employ a haptic device that may be engaged in a unique pattern to indicate a corresponding device status, instruction, and/or result. Other patterns, colors, sequences, and/or haptic outputs are also envisioned and may be set by the patient and/or system and may be stored in a memory of the system (e.g., in the PI).

[00130] It is envisioned that portions of the UI 456 such as the LEDs or covers thereof may be located on at or on surface of the WFM 425 and may indicate when the WFM 425 is awake, when the WFM 425 is connected to a paired UD such as a smartphone, a tablet, etc., and when pairing between the WFM 425 and the UD is occurring. In some embodiments, the indicia can be one or more LED lights used as visual indicators.

[00131] In some embodiments, the LEDs can be paired with an audio signature such as a speaker, a buzzer, and/or a haptic device such as a vibrator to provide desired indicia. The indicia may also include unique indicia comprising to at least one color, letter, sound, light, video, and/or haptic feedback. In some embodiments, the LEDs can be various colors, such as, for example, blue, red, yellow, white, green, purple, pink and/or orange.

[00132] The PSUPP 464 may be similar to the PSUPP 264 and may include a battery compartment 465 configured to receive any suitable power source, such as two AA battery cells, and may include one or more access covers which may protect and provide for access to the battery compartment 465 when opened or removed.

[00133] The battery cells may be arranged in any desired arrangement such as in a serial or parallel arrangement so as to form a serial or parallel circuit, respectively. The PSUPP 464 may provide power for the overall operation of the WFM 425 including one or more of the processors, UI, sensor(s), etc.

[00134] The pulse oximeter may be similar to the pulse oximeter 254 of FIG. 2 and may include a suitable transducer to transmit and/or receive signals which may be processed to determine a specific blood oxygen saturation and/or a pulse of a patient. It may then form corresponding sensor information and provide this information to the processor 210 for further processing.

[00135] The body 470 may include a proximal opening 472, distal opening 474, and the flow chamber 230 situated between a proximal flow chamber 475 and a distal flow chamber 473 such that the proximal flow chamber 475 may be adjacent to the proximal opening 472 and the distal flow chamber may be adjacent to the distal opening 474. Thus, a flow of gas such as an expiration from a patient may flow in the direction indicated by arrow DA into the body 470 through the proximal opening 472 and thereafter through the proximal flow chamber 475, the flow chamber 230, and the distal flow chamber 473 along a flow path through the body 470 before exiting the body 470 at the distal opening 474. This may be referred to as a main flow path (MFP) of the body 470. The proximal flow chamber may be defined by at least one sidewall 463. It is envisioned that the distal flow chamber 473 may be defined by at least one sidewall.

[00136] The proximal and distal ends of the body 470 may be configured with couplers to couple to one or more of the mouthpieces 490. For example, a coupler such as a collar 405 may be configured to couple to the mouthpiece 490 using an interference fit and a coupler such as a collar 467. Thus, the collars 405 and/or 467 may facilitate a snug interface between the body 470 and the mouthpiece 490. The collars 405 and/or 467 may be made of any suitable material such as a rubber and/or plastic material.

[00137] However, it should be understood that other methods of coupling the mouthpiece 490 to the body 470 are also envisioned. For example, and without limitation, it is envisioned that adhesives, adhesive strips, hook and loop fasteners (e.g., Velcro®), clips, hooks, magnets, snaps, buttons, friction fittings, compressive fittings, posts, connectors, screw mounts, may be used. However, for the sake of clarity, and without limitation, hereinafter only an interference fitting method of coupling the mouthpiece 490 to the body 470 are discussed herein.

[00138] The mouthpiece 490 may include a body 491 having at least one wall 407 defining a flow chamber 492 having a proximal end opening 493, and a distal end opening 494. The mouthpiece 490 may include a collar 403 configured to couple to the collar 405 of the body 470 using any suitable coupling such as in interference fitting method and may be detachable from the body 470. However, in yet other embodiments, it is envisioned that the mouthpiece 490 may be formed integrally with the body 470. The distal end of the mouthpiece 490 may be configured to couple to the collar 405. The mouthpiece 490 may be configured for engagement with the mouth of a patient who may provide the expiration flow and/or an inhalation flow. In some embodiments, the mouthpiece 490 of the inhaler and the collar 405 may be engaged via the interference fitting method to allow the mouthpiece of the inhaler to fit snugly about the collar 405, so that when engaged, the collar 405 will releasably hold the mouthpiece 490 to the body 470 and may release the mouthpiece 490 when twisted and/or pulled away from the body 470.

[00139] The mouthpiece 490 may include an ID portion 484 which may store a device ID for the mouthpiece 490, which may be unique to the mouthpiece 490 or may otherwise identify the mouthpiece such as the mouthpiece type, and may communicate the device ID using any suitable format, protocol, etc., to the processor 410 of the WFM 425 using any suitable wired and/or wireless communication method or methods such as RFID, Bluetooth™, and/or the like. Accordingly, the ID portion 484 may include wired and/or wireless communication portions. For example, with regard to wired communication, the mouthpiece 490 may include a wired communication port 481 which may couple to an adjacent communication port 480 of the body 470 when fitted together. For example, with regard to wireless communication, the mouthpiece 490 may include a wireless communicator which may communicate with the processor 410 using any suitable method or methods such as a low-power radio communication method (e.g., RFID, Bluetooth™, Wi-Fi, etc.) or analog coupling. The device ID may be associated with a flow restriction of the mouthpiece 490. Thus, the processor 410 may identify a flow restriction of the mouthpiece by identifying the device ID of the mouthpiece 490. Further, the processor 410 may identify a type of flow restrictor provided by the mouthpiece. For example, for an exercise that requires pursed lips for the exercise, the processor may identify whether the mouthpiece is a pursed lip mouthpiece and proceed with the exercise or otherwise, notify the patient to change the mouthpiece to a pursed lip mouthpiece via the UI prior to proceeding. Naturally, other types of mouthpieces may also be suitably identified.

[00140] The processor 410 may then use the identified flow restriction of the mouthpiece 490 for in flow calculations. While the result of the flowrate calculation will remain unaltered, an attribute will be attached to said result indicating the relevant resistance applied to the flow.

[00141] The proximal end 493 of the mouthpiece 490 may be shaped and sized so that it may receive an exhalation gas (e.g., an expiration and/or expiratory flow) which flow may travel for example in a direction indicated by the arrow DA during an expiratory flow or in the reverse direction during an inspiratory flow. The mouthpiece 490 may be water resistant or waterproof such that it may be cleaned using for example a liquid based cleaner as may be desired. This may enhance user hygiene, safety, and convenience. The distal end of the mouthpiece 490 may be configured to couple to the collar 405. The WFM 425 may include one or more flow restrictors 497-1 through 497-P (e.g., such as flow restrictors 497-1, 497-2, generally 497-x), where P is an integer, which may be fixed or adjustable, and may restrict a flow of gas through one or more flow paths of the WFM 425 such as its MFP.

[00142] Thus, an expiration by a user (e.g., an exhalation gas flow) at the mouthpiece 490 may travel into mouthpiece 490, the body 470, through one or more of the mouthpieces 490, the body 470 as indicated by arrows DA_IN, DA, and DA_OUT, respectively.

[00143] One or more flow restrictor adjusters (FLA), with which a user may interact to control a setting of a corresponding one flow restrictor 497-x, may be provided and may be coupled to one more corresponding flow restrictors 497-x. For example, the flow restrictor adjuster may include a slide-type lever or a rotating knob. For example, the mouthpiece 490 may include a flow restrictor 497-x, such as a butterfly valve, a sliding valve, or other suitable valve or valves which may be fixed or adjustable (e.g., variable flow), and may be configured to control a flow of gas (e.g., the expiratory flow) through the mouthpiece 490. For the sake of clarity, each of the flow restrictors 497 -x are illustrated as butterfly valves. However, it is envisioned that one or more of the flow restrictors 497-x, in an embodiment wherein one or more is provided, may be the same as or different from each other and may include any suitable valves or valves such as slide type valves, etc.

[00144] A flow restrictor adjuster (FLA) with which a user may interact to control a setting of the flow restrictor 497-x may be provided. For example, the flow restrictor adjuster may include a slide-type lever or a rotating knob. Further, although the flow restrictors 497-x are illustrated with axes that are parallel, it is envisioned that in an embodiment wherein more than one flow restrictor is provided, the axes may have other orientations as may be desired.

[00145] A flow restrictor position sensor may be coupled to a corresponding flow restrictor or flow restrictor adjuster and may determine a position of the coupled flow restrictor or flow restrictor adjuster. Thereafter, the flow restrictor position sensor may form corresponding sensor information (e.g., using a wired or wireless communication methods — e.g., via the ID portion of the corresponding to mouthpiece 490) and provide this information to the processor 410 for further processing such as for determining a position of a flow restrictor and/or for determining the flow restriction in a flow path of the WFM 425. Suitable flow restrictor position sensors may include analog or digital, linear, discrete, and/or brushed or brushless types of sensors. For example, it is envisioned that a potentiometric type sensor such as a slider that may have electric contacts at certain points corresponding to the amount of resistance at that position may be coupled to one or more of the FLA or the flow restrictor 497-x. However, other types of sensors are also envisioned such as hall effect sensors, inductive sensors, optical sensors, magneto-resistive sensors and the like. For example, flow restrictor position sensor may be coupled to the flow restrictor 497-1 at the mouthpiece 490 and may communicate with the ID portion 484 of the mouthpiece 490 to communicate a flow restrictor position to the processor 410. In embodiments wherein one or more flow restrictors are present and are variable, the setting of the flow restrictor may be communicated to the processor 410 manually by the patient through the UI.

[00146] FIG. 5 shows a front side perspective view of a portion of the WFM 525 with a slide-type battery compartment cover 557 in the closed position in accordance with embodiments of the present system. FIG. 6 shows a rear side perspective view of a portion of the WFM 525 with the slide-type battery compartment cover 557 in an open position in accordance with embodiments of the present system. FIG. 7 shows a front side perspective view of a portion of the WFM 525 in accordance with embodiments of the present system. A mouthpiece 590 may provide flow resistance such as variable flow resistance to an expiratory flow through the WFM 525 if desired. [00147] With reference to FIGS. 5 through 7, the WFM 525 may be similar to the WFM 425 and may include a body 570 and may include a mouthpiece such as a removable mouthpiece 590. [00148] The mouthpiece 590 may include a body 591 having at least one wall defining a flow chamber having a proximal end opening 593. The mouthpiece 590 may be configured to couple to a collar of the body 570 using any suitable coupling method.

[00149] A collar 567 defining at least a portion of a distal opening 574 may be situated at a distal end 553 of the body 570. A distal flow chamber 573 may be situated between a flow chamber and the collar 567 such that an expiratory flow may pass from the flow chamber through an orifice at an end of the flow chamber through the distal flow chamber and the collar 567 before exiting the body 570 at the distal opening 574.

[00150] The access door 557 may cover a battery compartment 565 in which one or more batteries such as battery cells 559 may be located. The access door 557 may slide telescopically as illustrated by arrow 529 relative to the body 570 to provide access to the battery compartment 565 and the battery 559 contained therein. The batteries 559 (e.g., two AA cells shown) may provide power to the WFM 525 and may be easily replaced or recharged. The access door 557 may include a telescopic coupler such as wings 541 which may engage a portion of the body 570 to telescopically couple the access door 557 in place relative to the body 570. An elasticity of the access door 557 may provide a biasing force to maintain its position relative to the body 570. [00151] A button 552 may be similar to the buttons 252 and 452 and may provide a user interface with which a user may interact with to signal a processor of the WFM 525 to change an operating mode of the WFM 425. For example, when it is determined that the button 552 is depressed, the processor of the WFM 425 may enter a wake mode (e.g., awake). And when it is determined that the button 552 is not depressed, the WFM 525 may enter a sleep mode or off mode. In order to extend battery life, the WFM 525 may remain in sleep or off mode when not in a wake mode (e.g., when in use) such as may occur when the button 552 is not depressed. However, it is envisioned that other functions may be assigned to the button 552 as may be set by the user and/or system and stored in a memory of the system. [00152] A UI 556 may include one or more indicators such as LEDs 556-1 and 556-2. In accordance with embodiments, LED 556-1 may indicate whether the WFM 525 is awake (e.g., illuminated yellow-green) or off (e.g., not illuminated), in addition to the battery status (e.g., green indicates high battery, yellow indicates “change soon” and flashing yellow indicates “change now”). LED 556-2 may indicate measurement success such as successful (e.g., solid green), However, other indicators may also be employed and may be set by the patient and/or system. LED 556-2 may indicate measurement success and result (e.g., two out of three green LED’s lit) [00153] FIG. 8 shows a front side top perspective view of a portion of the WFM 825 with a pulse oximeter, in accordance with embodiments of the present system. FIG. 9 shows a rear side bottom perspective view of a portion of the WFM 825 including the pulse oximeter 854 and pulse oximetry sensor 843 in accordance with embodiments of the present system. FIG. 10 shows a partially cutaway cross sectional schematic view of a portion of the WFM 825 including a sidestream capnograph taken along lines 10-10 of FIG. 8 in accordance with embodiments of the present system.

[00154] With reference to FIGS. 8 through 10, the WFM 825 may be similar to the WFM 425 and may include a body 870 and one or more of a removable mouthpiece 890 having at least one wall defining a flow chamber having a proximal end opening 893. A button 852 may be situated on a top surface of the WFM 825 and may be similar to the button 452. Accordingly, the button 852 may communicate with a processor 810, for example to turn on the WFM 825. The mouthpiece 890 may be configured to couple to a collar of the body 870.

[00155] A collar 867 defining at least a portion of a distal opening 874 may be situated at a distal end 853 of the body 870. As in a prior embodiment, a distal flow chamber 873 may be situated between a flow chamber 830 and the collar 867 such that an expiratory flow may pass from the flow chamber 830 through an orifice at end of the flow chamber, into the distal flow chamber, and the collar 867 before exiting the body 870 at the distal opening 874.

[00156] The pulse oximeter 854 may be similar to the pulse oximeter 454 of FIG. 4 and may include a suitable transducer such as the pulse oximetry sensor 843 to transmit and/or receive corresponding signals which may be processed to determine a blood oxygen saturation (Sp02) and/or a pulse of the patient. It may then form corresponding sensor information and provide this information to the processor 810 of the system for processing, storage, and/or transmission. [00157] In accordance with embodiments, the pulse oximetry sensor 843 may be situated on a bottom portion of the body 870 such that it is may situated opposite the button 852 on the top portion of the body 870. This opposed location may aid in locating the pulse oximetry sensor 843 during use by the patient. Accordingly, the patient may easily and conveniently place his or her fingers on the pulse oximetry sensor 843 and the button 852 at the same time during use.

[00158] The body 870 may further included indicia 831 which may aid a patient in locating the oximetry sensor 843. For example, such indicia 831 may include an indented area or an embossed area about at least a portion of the pulse oximetry sensor 843. The pulse oximetry sensor 843 may be situated substantially flush with the indented area. Thus, a user may easily and conveniently verify a location of the pulse oximetry sensor 843 by touch when using the WFM 825. A haptic feedback rendering device may also be provided to alert that patient that the pulse oximetry sensor 843 is sampling information.

[00159] An air pump 863 may be coupled to the flow chamber 830 and a CO2 sensor 861 directly or via tubing 877 under the control of the processor 810. Accordingly, the air pump 863 may be cycled (e.gt., turned on) to draw a sample of a portion of an expiratory flow present in the flow chamber 830 and provide this sample to the CO2 sensor 861 for further processing. The CO2 sensor 861 may then measure CO2 levels within the sample provided thereto and form corresponding sensor information and provide this sensor information (e.g., as capnograph information) to the processor 810 for further processing, transmission, and/or storage. The CO2 sensor 861 may then discard the sampled gas to any suitable location such as within the cavity 871 or through an output port within or external of the cavity 871. The cavity 871 may include one or more openings (e.g., similar to opening 446 of FIG. 4) through which sampled gas may pass and which may equalize the cavity 871 to ambient pressure (PATM).

[00160] A circuit board 837 (e.g., a printed circuit board or the like) may be coupled, without limitation, to one or more portions of the WFM 825, such as, the processor 810 and the pressure sensor 850. It should be understood that actual component locations and/or sizes within the WFM 825 may not be shown for the sake of clarity.

[00161] The pressure sensor 850 may be similar to the pressure sensor 250 and may include a pressure transducer 851 (XDR) having at least one input port and which may sense a pressure at the corresponding port and form a corresponding pressure signal (Pi and/or P2) and/or a pressure differential signal (PDS) that is provided to the processor 810 as discussed herein. The at least one input port of the XDR 851 may be flow coupled to a port 842 leading to the flow chamber 830 via tube 840. An optional second input port of the XDR 851 may be flow coupled to ambient pressure (PATM) as may be present within the cavity 871 or as may be present outside of the body 870. The pressure sensor 850 may optionally provide the pressure difference signal (PDS) to the processor 810 for further processing depending upon configuration. Components of the WFM may be powered by one or more power sources, such as batteries, contained in a battery compartment 865. [00162] The WFM 825 may be configured to measure and report patient vitals (e.g., metrics) such as peripheral capillary oxygen saturation (SpC ), as an estimate of arterial blood oxygen saturation, and a level of CO2 (e.g., as measured through an expiratory flow through the WFM 825 and reflective of CO2 present in the patient’s lungs), etc. This may be desirable as those with COPD may experience a worsening of gas exchange in the lungs, which can lead to low blood oxygen levels and high levels of CO2. Accordingly, patient monitoring through use of the WFM 825 may provide an indication of these metrics. The WFM 825 may be configured to measure a partial pressure of CO2 (e.g., through use of a CO2 sensor) in the exhaled air from the beginning to the end and/or at the end of an expiratory breath including FEV1, FEV3, FEV6 (e.g., with reference to the end of the breath) or FVC.

[00163] Various information such as SpC , EtCC and VCO2 measurements are substantially independent of patient effort, whereas PEF, FEV1 and FVC are dependent upon patient effort. [00164] Embodiments of the WFM such as the WFM 825 may be portable and may provide sensor information which may be processed to form PI which may be stored in a memory of the system for further use such as by a medical provider, a therapist, etc. which may eliminate the need for self-reporting of lung health metrics. Further, the WFM 825 may generate and provide comprehensive data which, for example, may be indicative of changes in lung health. Without limitation, this data may include: peak expiratory flow (PEF); forced expiratory volume in 1 second (FEV1); forced vital capacity (FVC); blood oxygen saturation (SpC ); Heart rate (e.g., pulse rate); end tidal CO2 exhaled (EtCC ); and volume CO2 exhaled (VCO2).

[00165] FIG. 11 shows a partially cutaway cross sectional schematic view of a portion of the WFM 825 of FIG. 8 including a mainstream capnograph in accordance with embodiments of the present system. In accordance with embodiments, the capnograph may be configured as a mainstream capnograph rather than a sidestream capnograph as shown in FIG. 10. Referring to FIG. 11, it is seen that at least a portion of the CO2 sensor 861 may be flow coupled directly to, inserted within, and/or form at least a part of, the flow chamber 830 and may directly sample the expiratory flow present in the flow chamber 830. Accordingly, the CO2 sensor 861 may directly measure CO2 in the flow chamber 830 and form corresponding CO2 information. The CO2 sensor 861 may then provide corresponding sensor information (e.g., the percentage of CO2 present in the expiratory breath and/or a signal indicative thereof) to the processor 810 for further processing, transmission, and/or storage.

Calculations

[00166] The calculations discussed below are non-limiting examples. It is envisioned that other formulas may also be used.

[00167] The WFM in accordance with embodiments of the present system may calculate a volume of CO2 exhaled ( Vcoi ) using Equation 1 below: where

[00168] where tl is a start time and t2 is an end time of a time period in which the sample was drawn, and %C02 is a detected percent of CO2 in the measured sample, and the airflow rate is a rate of airflow derived from the detected pressure differential within the flow channel of the WFM. As determined by benchmark testing on a given embodiment, Q=208.6*(pressure difference)^A0.5209 (accurate over the airflow range of 10-300 liters per minute). For example, in a case wherein the pressure sensor in this embodiment detects a pressure difference (PDS) of 0.65 in H20 vs. atmospheric pressure, an airflow of 167 liters per minute may be calculated. Naturally, other similar calculations may be determined for further embodiments.

[00169] The WFM in accordance with embodiments of the present system may calculate FEV 1 — which is a volume of air exhaled in the first second using Equation 2 below:

[00170] FEV 1 - volume of air exhaled in the first second

...Equation 2 [00171] In Equation 2, tl is set to 0 indicative of the start time and t2 is set to 1 second as FEV1 determines FEV over 1 second. Similarly, if this was FEV6, then t2 would be set to 6 seconds. [00172] The WFM in accordance with embodiments of the present system may calculate FVC — which is a total volume of air exhaled during the entire measurement using Equation 3 below: ... Equation 3

[00173] In Equation 3, tl is set to 0 to indicate a start time and t_fmai is an ending time for sampling pressure. This time may correspond with a threshold time (e.g., 10 seconds, etc. as may be set by the system or user) or may correspond to a time at which the patient stops exhaling as may be detected by a drop in P2 below a threshold value.

[00174] It is envisioned that embodiments of the present system may provide an exercise training device for use by patients inside or outside of a medical provider’s office.

[00175] In some embodiments, one or more sensors employed by the WFMs may be covered by a mesh, such as a hydrophobic mesh such that the one or more sensors are made waterproof. In other embodiments, one or more sensors of the WFM may be covered by a plastic sleeve that creates a waterproof environment for the corresponding one or more sensors. It is also envisioned that the one or more sensors may be coated using hydrophobic films. This will aid in preventing or reducing damage due to exposure to liquids such as may occur when the WFM is washed or due to water vapor in an exhalation breath.

[00176] A Virtual Pulmonary Rehabilitation Program (VPR) of an API in accordance with embodiments of the present system is provided herein. APIs of the present system may include functionality to launch a portion of the VPR automatically (e.g., upon launch of the API) or when requested, such as in response to a request to launch the VPR (e.g., by patient selection of a launch selection item, etc.) when, for example, the API is running. Portions of the API may include the VPR, which may run at a processor of the UD of the patient, portions at one or more exercise tracking devices (ETDs), and/or portions at a respiratory therapist (RT) portal as will be discussed below.

[00177] Exercise Training Devices may be provided and may employ WFMs with breathing muscle trainer (BMTs). For example, WFMs in accordance with embodiments of the present system may be coupled to a BMT device such as a mouthpiece with a variable or fixed flow restriction that may be selected so as to restrict an expiratory flow from the patient through the channel of a corresponding WFM. The BMT may include a fixed or variable flow restrictor in, for example, a mouthpiece which forms the BMT.

[00178] For example, a plurality of BMTs may be employed using, for example, mouthpieces each having a restricted flow rate different from the other. For example, FIG. 12 shows a front side perspective view of a portion of the WFM 525 such as the one shown in FIG. 5 with interchangeable mouthpieces 1090-1 through 1090-3 (generally 1090-x) in accordance with embodiments of the present system. Each of the mouthpieces 1090-x may have a flow channel with a flow resistance that is different from the flow resistance of other mouthpieces 1090-x. Thus, each mouthpiece 1090-x may have a unique flow resistance. Each mouthpiece 1090-x may include a body 1091 having at least one wall 1007 defining the flow chamber 1092 situated between a proximal end opening 1093 and a distal end opening 1094. Each flow chamber 1092 may have a different diameter so as to restrict flow through the corresponding mouthpiece 1090-x by a predetermined amount thus requiring different efforts from the patient to introduce a given flow rate into the WFM 525. Each of the mouthpieces 1090-x may include a collar 1003 configured to couple to a collar, such as the collar 505 of the body 570 of the WFM 525 using any suitable coupling such as an interference fit, etc. and may be detachable from the body 570. By varying the diameter (or area cross section) of a corresponding flow chamber 1092, each of the mouthpieces 1090-x may have a unique fixed flow resistance. Each mouthpiece 1090-x may include indicia to identify it to the patient and/or a controller of the WFM 525. For example, for identification by the patient, each mouthpiece 1090-x may include textual or graphical indicators 1015 on an exterior surface thereof to aid the patient in identifying the corresponding mouthpiece 1090-x. For identification by the controller, each mouthpiece 1090-x may further include an ID portion (e.g., an RFID for wireless communication if employed), which may include an ID, which may include information which the controller may use to identify one or more parameters of the corresponding mouthpiece 1090-x such as the flow resistance of the corresponding mouthpiece 1090-x. However, in the present embodiments it will be assumed that a physical coupling between the mouthpiece 1090-x and the WFM 525 may be employed for the controller to determine an ID of the corresponding mouthpiece 1090-x.

[00179] In yet other embodiments, it is envisioned that a mouthpiece may include variable flow resistance and may provide sensor information including information indicative of a flow resistance setting of the variable flow resistance to the controller of the WFM 525 using a suitable transmission method such as wired or wireless communication methods. For example, a variable resistance setting may include discrete or linear resistance settings each of which may correspond to a flow resistance setting of the corresponding mouthpiece. In some embodiments, the pulmonary function monitoring device comprises a plurality of mouthpieces, each mouthpiece having a different size, diameter and flow resistance such that the mouthpieces are interchangeable. In other embodiments, the flow resistance of the mouthpiece is adjustable manually, wirelessly and/or remotely by a healthcare provider. In various aspects, the processor can identify the mouthpiece based on different circuits closed by the mouthpiece due to different flow resistances. [00180] Thus, BRTs serving as mouthpieces with a determined flow resistance that may be fixed or variable may be employed with a corresponding WFM to provide a breathing exercise tracker (BET). During operation, a WFM may report to a controller of the system a patient’s breathing in real-time for further processing and/or biofeedback via any suitable rendering device of the system such as a rendering device of a UD employing an API. In some aspects, the biofeedback is displayed during a breathing exercise. In various embodiments, the biofeedback has the form of a circle expanding when the patient inhales and shrinks while the patient exhales. It is further envisioned that the WFM may determine a resistance setting of a corresponding BMT coupled to the WFM. To change resistance, the mouthpiece 1090-x (e.g., 1090-1) may be swapped out with a mouthpiece 1090-x (e.g., 1090-2) having a desired flow resistance. The UD may provide instructions for the patient such as which mouthpiece to use and how to perform the test. Further, a test may be selected from a plurality of tests stored in a memory of the system based upon the mouthpiece coupled to the WFM. The API may the render instructions to the user via a UI of the UD to perform the test. Thus, tests and/or test parameters (e.g., number of expiratory cycles and duration, etc.) may change dependent upon the identified mouthpiece.

[00181] With regard to variable flow rates, FIG. 13 shows a front side perspective view of a portion of the WFM 525 such as the WFM shown in FIG. 5 with a mouthpiece 1190 having an adjustable (e.g., variable) flow resistance through its flow channel in accordance with embodiments of the present system. The mouthpiece 1190 may include a body 1191 having at least one wall defining the flow chamber, a proximal end opening 1193 and a distal end opening. A slider 1115 may slide within a channel 1127 as indicated by arrow 1117 and may be coupled to a flow restrictor which may alter flow resistance through the flow channel of the mouthpiece 1190. A position of the slider 1115 may indicate an amount of flow resistance visually and/or electronically (e.g., resistively). Accordingly, a controller of the WFM may detect this resistance (e.g., using wired and/or wireless methods) and process it to determine flow resistance of the mouthpiece 1190. To determine electrical resistance, the slider 1115 may include electric contacts at certain points (stops of the slider) or may be continuous either of which may correspond with the amount of resistance or may correspond with an open or closed circuit depending upon a position of the slider 1115. In the present embodiments it will be assumed that a physical coupling between the mouthpiece 1090 and the WFM 525 may be employed for the controller to determine an ID of the mouthpiece 1190 and/or to determine a position of the flow restrictor and/or slider 1115 attached thereto.

[00182] In accordance with an embodiment, the WFM may be able to detect which flow resistance (e.g., variable and/or out of a set of preconfigured flow resistances) is set by the patient and/or set by an attached mouthpiece. The WFM may be enabled to measure one or more of the patient’s tidal volume, respiratory rate, etc., while breathing through the flow resistance.

[00183] Breathing exercises may be performed by attaching a BMT to a WFM and linking (e.g. pairing) to a UD of the system running an API of the system. The API may then render information (e.g., provide indicia) such as prompts, video instructions, graphic instructions, etc., on an interface of a UD which a user may follow to perform one or more breathing and/or pulmonary exercises. [00184] A method of using a WFM with an application interface such as an API in accordance with embodiments of the present system will now be shown and described with reference to FIG. 14A and FIG. 14B, which show a functional flow diagram performed by a process 1400 in accordance with embodiments of the present system. The process 1400 may be performed using one or more processors, computers, controllers, etc., communicating over a network and may obtain information from, and/or store information to one or more memories which may be local and/or remote from each other. The process 1400 may include one of more of the following acts. Further, one or more of these acts may be combined and/or separated into sub-acts, as desired. Further, one or more of these acts may be skipped depending upon settings and/or options available. For the sake of clarity, the process may be described with reference to a WFM and corresponding API of a paired device such as a UD although the WFM and the UD may, at times become unpaired and/or the WFM may communicate over a network to a remote device including a controller, such as a given server available over the Internet. However, without limitation, it should be understood that the process may employ a plurality of devices each of which may include a separate, or partially separate, workflow. Although it is envisioned that textual, audio, graphical, and/or haptic instructions may be rendered as indicia, for the sake of clarity, graphical and textual instructions may be shown and described with reference to the process described herein. Further, the terms button and device button may be interchangeably used and refer to the same button (e.g., switch 252, 452, 552, 852, etc.) of the WFM. Further, although reference will be made to pressing this button, this button may be substituted by a hard of soft keys or a selection item in which case the term pressing the button may be referred to an equivalent such as selecting the menu item or pressing the hard or soft key. In operation, the process may start during act 1401 and then proceed to act 1403. With regard to the acts of the process 1400, these acts may be divided by stages which may, without limitation, include one or more acts such as a test request stage 1451, a data acquisition stage 1453, data transmission stage 1455, a calculation stage 1457, and an optional reporting stage 1459.

[00185] During act 1403, the process may start when an API of the present system has been launched, started, or otherwise opened (hereinafter each of which may be referred to as launched unless the context indicates otherwise). The API may be launched using any suitable method such as by selecting a corresponding menu item on a device such as the UD. The API may be a mobile application launched on the UD of the patient (e.g., a smartphone, tablet, etc.) and may perform an initialization routine and thereafter render instructions indicating how to use the WFM and API in accordance with embodiments of the present system. For example, the API may instruct the patient to “Press & hold button on flow meter” to wake and connect it (e.g., the WFM) as illustrated with reference to FIG. 15A which shows a screenshot 1500A of a portion of an initialization screen rendered on a rendering device of the UD in accordance with embodiments of the present system. The API may render a textual instruction area 1501A, in which instructions may be rendered textually, and a graphic instruction area 1503 A, in which instructions for a current mode of the WFM may be rendered graphically. When the WFM is in a sleep mode, it may remain disconnected from the UD and API until the device button is depressed and the WFM awakes in response thereto. Thus, when asleep, pressing the device button on the WFM may awake the WFM and cause it to reestablish communication connection with the API when possible (e.g., when the UD of the patient is nearby) and pairing of the given WFM and the UD. Accordingly, passwords and other information for pairing the WFM and the UD may be stored in a memory of the system for later use. After completing act 1403, the process may continue to act 1405.

[00186] During act 1405, if it is determined that the device button of the WFM is depressed (e.g., by the patient who is assumed to be the user in the present process ), the WFM may wake from a sleep mode if asleep, attempt to establish a connection and/or pairing (e.g., Bluetooth™ pairing) with the UD to communicate with the API which may be running on UD, begin to acquire sensor information from one or more of its sensors (e.g., for example, the process may determine Pi prior to tO at which time it may begin a test routine, and may optionally perform a calibration routine on one or more sensors such as to determine a “zero” value which may be transmitted to the API for later use), and may render indicia which may instruct the patient on use of the WFM to perform a measurement (e.g., a test measurement or test routine). For example, the process may render instructions to blow into the flow meter (e.g., the WFM) such as “blow into device for measurement 1 and then release button,” as illustrated with reference to FIG. 15B which shows a screenshot 1500B of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system.

[00187] The WFM may remain in this awake mode until the device button is released at which time it may enter a sleep mode and discontinue communication with the UD or the WFM may remain in this awake mode for a given period of inaction (e.g., 30 seconds unless the device button is repressed) to enable further exercises. After completing act 1405, the process may continue to act 1407.

[00188] Referring back to FIG. 15B, screenshot 1500B may include a textual instruction area 1501B in which instructions may be rendered textually, a graphic instruction area 1503B in which instructions may be rendered graphically, and a device parameter area 1505B in which connection status (e.g., device connected, device disconnected, etc.) as well as battery life of the WFM may be rendered. The device parameters may be updated from the WFM to the UD in real time. [00189] At this time, the process may be ready to perform data acquisition from one or more sensors of the system so as to obtain one or more measurements from one or more sensors of the system. Data may be acquired synchronously from one or more sensors of the WFM. To begin data acquisition (e.g., to obtain measurements), the patient may continue to press and hold the device button while simultaneously breathing into the WFM and/or interacting with other sensors such as the pulse oximetry sensor. It should be understood that measurements may be dependent upon WFM configuration (e.g., whether sensors such as capnography and oximetry sensors are present on the WFM) and patient interaction such as whether the patient placed a digit (e.g., thumb) over the pulse oximetry sensor so that the process may obtain corresponding sensor information. [00190] During act 1407, it is assumed that the device button is simultaneously pressed and the patient exhales into the mouthpiece to provide an expiratory flow to be measured. After completing act 1407, the process may continue to act 1409 and/or act 1419. The expiratory flow may have a flow duration. [00191] During act 1409, the pressure sensor may detect pressure within the flow chamber (e.g., 230) in real time so as to sample the expiratory flow provided by the patient. To detect pressure within the flow chamber, the process may obtain pressure information from one or more pressure sensors of the system (e.g., from pressure sensors 250, 850). The pressure information may include information indicative of one or more pressures or differences thereof such as pressure Pi, P2_, PATM, and/or PDS, wherein Pi is pressure within the flow chamber, P2 is ambient (atmospheric) pressure which may be equal to PATM_, and PDS is a pressure difference signal indicative of a difference between Pi and P2, although PDS may be calculated separate from the pressure sensor. Depending upon pressure sensor configuration, Pi and P2 may be acquired simultaneously during a test (e.g., if using two pressure sensors) or P2may be acquired prior or subsequent to acquisition of Pi, with PI acquired during the expiratory breath. Accordingly, during this act, the process may activate the one or more pressure sensors of the system to acquire pressure information in real time. After completing act 1409, the process may continue to act 1411.

[00192] During act 1411 the process may transmit the pressure information to the paired UD (e.g., the UD of the patient) in real time for further processing and/or storage by the API. The process may employ any suitable wireless communication method such as a low power wireless communication method (e.g., Bluetooth™ , etc.) for transmission. It is also envisioned that a wired communication method may be employed. After completing act 1411, the process may continue to act 1413.

[00193] During act 1413, the process may convert the pressure information to airflow velocity or velocities and form corresponding airflow velocity information. Accordingly, the API may convert the pressure information received from the WFM to airflow velocity information. After completing act 1413, the process may continue to act 1415 and/or 1435 to compute information which may be used to determine measurements and/or exercises, respectively.

[00194] During act 1415, the process may compute values for PEF, FEV1, and FVC based upon the determined airflow velocity information and/or the sensor information including the pressure readings in accordance with embodiments of the present system. This act may be performed by the API at the UD and/or may be computed directly by the WFM. After completing act 1415, the process may continue to act 1417.

[00195] During act 1417, the process may share the computed values for PEF, FEV1, and FVC with a healthcare provider and/or the user for further analysis. Accordingly, the process may transmit the computed values for PEF, FEV1, and FVC and/or other information generated by the process along with corresponding identifying information such as patient information (e.g., patient ID, etc.), time and date stamp information, UD identifier, account identifier, etc. via a network (e.g., Network 108) of the system to a healthcare provider interface (e.g., see 112, of FIG. 1) via a respiratory therapist portal (e.g., see, 110, of FIG. 1). After completing act 1417, the process may continue to act 1441.

[00196] During act 1435, the process may compute a breath rate information for the patient in a case (e.g., exercise) wherein the patient provides more than one expiratory and/or inspiratory breath while pressing the device button. The breath rate information may reflect a breathing rate of the patient and may be based upon the determined airflow velocity (may include breath flow direction) information in accordance with embodiments of the present system. The process may compare the computed velocity or velocities in real time or may use corresponding time stamped information to determine the breath rate information. This act may be performed by the API at the UD. After completing act 1435, the process may continue to act 1437.

[00197] During act 1437, the process may compare the determined breath rate information to a threshold breathing rate for the patient and calculate breathing rate difference information between these two values. For example, the breathing rate difference information may be equal to a determined difference of the determined breath rate information and the threshold breathing rate for the patient. The threshold breathing rate may be obtained from patient information stored in a memory of the system (e.g., see, secure DB 118, FIG. 1) and/or may be set by one or more of the respiratory therapist or a healthcare provider, associated with the patient information, and may be stored in a memory of the system in association with the patient information and/or may be rendered to the patient for reference (e.g., see act 1441). After completing act 1437, the process may continue to act 1439.

[00198] During act 1439, the process may share the results of the breathing rate difference information with healthcare provider for further analysis. Accordingly, the process may transmit the computed breathing rate difference information, the breath rate information, the threshold breathing rate, along with corresponding identifying information such as patient information (e.g., patient ID, etc.), time and date stamp information, UD identifier, account identifier, etc. via a network (e.g., Network 108) of the system to a healthcare provider interface (e.g., see 112, FIG. 1) via a respiratory therapist portal (e.g., see, 110, FIG. 1). After completing act 1439, the process may continue to act 1441.

[00199] During act 1419 when a CO2 sensor is present, the process may detect CO2 levels in the flow chamber (e.g., 230) and form corresponding capnograph information (Cl) indicative of the determined CO2 levels in the flow chamber and, thus, the expiration gas from the patient. Accordingly, the process may control a CO2 sensor to determine CO2 levels in the flow chamber (e.g., 230) and may form corresponding capnograph information. After completing act 1419, the process may continue to act 1421.

[00200] During act 1421, the process may transmit (using any suitable wired or wireless communication method) the determined capnograph information (Cl) to the UD and/or to a remote server for further processing by the API. After completing act 1421, the process may continue to act 1423.

[00201] During act 1423, the process may determine percentage and volume of CO2 in the expiration gas sampled at the flow chamber. Accordingly, the API for example at the UD may analyze the Cl obtained from the WFM and determine the corresponding percentage and volume of CO2 in the sampled expiration gas using any suitable capnography method or methods, in accordance with embodiments of the present system. After completing act 1423, the process may continue to act 1425.

[00202] During act 1425, the process may share the results of the determinations of act 1423 such as the determined percentage and volume of CO2 in the expiration gas with a healthcare provider for further analysis. Accordingly, the process may transmit the determined percentage and volume of CO2 in the expiration gas along with corresponding identifying information such as patient information (e.g., patient ID, etc.), time and date stamp information, UD identifier, account identifier, etc. via a network (e.g., Network 108) of the system to a healthcare provider interface (e.g., see 112, FIG. 1) via a respiratory therapist portal (e.g., see, 110, FIG. 1). After completing act 1425, the process may continue to act 1441.

[00203] During act 1427, when the patient has simultaneously depressed the button and places a digit (e.g., a thumb, etc.) over (and in contact with) the pulse oximeter sensor, the process may form corresponding pulse oximeter sensor information (POSI), the process may continue to act 1429. [00204] During act 1429, in a case wherein a pulse and/or oximetry sensor is present and covered by a digit of the patient, the process may analyze the sensor information from the pulse oximeter such as the POSI and determine heart rate and blood oxygen saturation (SpC ) based upon an analysis of the POSI using any suitable pulse oximetry method or the like. After completing act 1429, the process may continue to act 1431.

[00205] During act 1431, the process may transmit the determined heart rate and/or Sp0₂ information to the paired UD using any suitable wired or wireless communication method to be further processed by the API on the paired UD and/or on a remote server. After completing act 1431, the process may continue 1433.

[00206] During act 1433, the process may share the determined heart rate and arterial blood oxygen saturation (SpC ) information with a healthcare provider for further analysis. Accordingly, the process may transmit the determined heart rate and arterial blood oxygen saturation (SpC ) information along with corresponding identifying information such as patient information (e.g., patient ID, etc.), time and date stamp information, UD identifier, account identifier, etc. via a network (e.g., Network 108) of the system to a healthcare provider interface (e.g., see 112, FIG. 1) via a respiratory therapist portal (e.g., see, 110, FIG. 1). After completing act 1433, the process may continue to act 1441.

[00207] During act 1441, the process may render results of the determination(s) of the process on the paired UD in real time. For example, FIG. 15C shows a screenshot 1500C of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system. The screenshot 1500C may include a textual instruction area 1501C in which instructions may be rendered textually, a graphic instruction area 1503C in which instructions may be rendered graphically, and a device parameter area 1505C in which connection status (e.g., device connected, device disconnected, etc.) as well as battery life of the WFM may be rendered. The screenshot 1500C may also include results of the current process 1509C and 1507 C (e.g., test results) for one or more tests of the process such as Peak flow, FEV1, and FEV6 in the current test sample. Unpopulated test result entries (e.g., see, FEV6) may be indicative of a lack of corresponding information during the test. For example, in the present embodiment, the user may not have exhaled into the device for six seconds required to obtain an FEV6 related measurement. Accordingly, an entry for FEV6 is unpopulated. [00208] The process may tabulate results of expiration test measurements in any suitable format. For example, the (h-1)^ώ, n^Lh, and (n+l )^Lh test results (e.g., measurements) for a current test period include three expiratory breaths (e.g., a first, a second, and a third expiration) by a user which breaths are arranged in corresponding columns (e.g., see, coll, col2, and col3 described with reference to FIG. 15E). This is illustrated with reference to FIGS. 15C, 15D and 15E, wherein FIG. 15D shows a screenshot 1500D of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system; and FIG. 15E shows a screenshot 1500E of a portion of a screen rendered on a rendering device of the UD in accordance with embodiments of the present system. With reference to FIGS. 15C through 15E, results of the process (e.g., measurements or test results) for first, second, and third test expiration measurements obtained by the WFM may be listed separately in a corresponding column in results areas 1507C, 1507D, and 1507E (e.g., coll, col2, col3). The process may do this for each new expiration test during a test period for the current test or until the WFM enters a sleep mode. The process may scroll the results on the rendering device if additional space is needed to display additional test results.

[00209] Thus, the process may assign data fields for corresponding test results as test measurements and may auto populate these fields during or after testing. For example, Peak Expiratory Flow (PEF) may be auto populated by the API and rendered on a UI of the UD as shown in results area 1509D for peak flow and FEV1 fields. Additional FEV1 and FVC may be measured and rendered if the patient continues to blow for longer than one second into the WFM during a test.

[00210] It should be noted that some measurement fields may be unpopulated (e.g., left blank), for example, with reference to FIG. 15E, FEV 1 in col2 and FEV6 in coll and col2 which are left blank and may indicate that these values were not measured during the corresponding test.

[00211] In addition to peak expiratory flow, the WFM may measure forced expiratory volume (FEV(t)) and forced vital capacity (FVC). For example, the WFM may measure forced expiratory volume (FEV(t)) and/or forced vital capacity (FVC) for various times such as FVC1 (1 second), FVC3 (3 seconds) and/or FVC6 (6 seconds). After the user blows into the WFM for one second, the API may determine FEV 1 and provide an indication of such for the convenience of the patient. For example, the API may control a rendering device of the UD such as a speaker to beep once (via a speaker of the UD) to signal completion of FEV 1. Once FEV 1 is measured and the patient’ s airflow has dropped to zero (e.g., as measured by the WFM), the API may control the rendering device such as the speaker to beep twice to signal completion of FVC. If the patient blows for less than one second, the FEV 1 and FVC are not measured and the fields may be left blank as discussed above.

[00212] With reference to FIGS. 15D and 15E, screenshot 1500D may include a textual instruction area 1501D in which instructions may be rendered textually, a graphic instruction area 1503D, 1503E in which instructions may be rendered graphically, device parameter areas 1505D, 1505E in which the connection status (e.g., device connected, device disconnected, etc.) as well as battery life of the WFM may be rendered, and results of the process 1509D, 1509E. Additional test results of the process such as max peak flow may be shown in a test results area 1510E once they are determined. At this point as the measurements have ended, the instruction area 1501D may be replaced by the test results area 1510E which may provide an indication of completion of the test (e.g., “measurements complete”) and results of the test such as a peak flow measurement selected from as the maximum of the three peak flow measurements obtained during the test cycle. It should be noted that a device parameter area 1505E illustrates that the device (e.g.., the WFM) has disconnected from the API which may indicate that the button is no longer pressed and the WFM has gone to sleep to conserve power.

[00213] It would be appreciated that if the patient closes the API, without completing all three peak flow measurements (e.g., peak flow, FEV1 and FEV6) for the test cycle, when the API is reopened it may return to the status/test measurement it had immediately before it was closed. [00214] Referring back to FIG. 14B, after completing act 1441, the process may continue to act 1443 where the PI (e.g., history) may be updated in accordance with the current test results. For example, the process may update patient information with results of the process and/or updated settings and store this updated patient information in a memory of the system such as the secure database (e.g., see, 118, FIG. 1). After completing act 1443, the process may continue to act 1447 where the process may end.

[00215] While the process is illustratively described as determining test measurements at a UD and/or remote server, in accordance with embodiments the test measurements may be determined and/or rendered (for example on a UI of the WFM) directly at the WFM which may thereafter transmit the measurements to the UD and/or remote server. [00216] FIG. 16 shows a series of screenshots 1600A through 1600D which illustrate a process flow in accordance with embodiments of the present system. When the API is launched, it may render instructions on a rendering device of the UD as shown in screenshot 1600A. Then, when it is detected that device button of the WFM is depressed and held depressed, the WFM may awake, establish communication and pair with a corresponding API of a UD, and begin to acquire information to measure airflow in its flow chamber (e.g., 230) to determine one or more measured values (e.g., of airflow). These measured values may be calculated in accordance with the determined pressure difference between Pi and P2 as previously described. The API may render measured values for peak flow, FEV 1 and FEV6, if available, on a display of the UD. For example, screenshot 1600B shows values corresponding with measurement #1 including peak flow and FEV 1 measured from an expiratory flow provided by the patient. It should be noted that FEV6 is as unavailable which may be indicative of the patient exhaling for less than 6 seconds into the WFM. The process may continue to render instructions on use of the WFM until the current test cycle of measurements (e.g., three measurements including measurements # 1 through #3, although, different numbers of measurements are also envisioned) has ended.

[00217] The API may then repeat the above process to obtain measurements #2 and #3 and corresponding values for peak flow, FEV and FEV6, if available. Each time a new measurement is obtained, the API may update measurement information in real time to reflect values of peak flow, FEV1 and FEV6, if available. For example, screenshot 1600C shows peak flow, FEV1 and FEV6 for measurement #2 in the column to the right of corresponding values for measurement #1. In screenshot 1600C, it should be noted that FEV1 and FEV6 are unavailable which is indicative of the patient exhaling for less than 1 second into the WFM. Screenshot 1600D shows peak flow, FEV1 and FEV6 for measurement #3 in the column to the right of corresponding values for measurements #1 and #2. After the current test cycle of measurements is completed, the API may provide an indication of such (e.g., see, “Measurements complete,” screenshot 1600D) and may determine and render the maximum value for peak flow selected from the three peak flow values obtained (e.g. see, “your max peak flow is 763,” screenshot 1600D).

[00218] In some embodiments, the API may render information which may include phrases that show patient progress or regression. For example, the phrases can include, but are not limited to “good job,” “please inhale deeper,” “please slow down,” and/or “please stop,” “please exhale into the mouthpiece,” etc. Longitudinal graphs on patient progress may also be rendered in accordance with embodiments of the present system. The system may compare results of a current test with stored results and may determine the progress of the patient. Without limitation, any suitable rendering device of the system such as a rendering device of the UD and/or WFM may be employed.

[00219] In addition to rendering the airflow data, inhalation technique coaching factors, body weight and height of the patient, title volume (TV), and inhalation time may be rendered.

[00220] Thus, embodiments of the present system may provide a WFM and a corresponding API which may measure airflow values such as PEF, FEV1, FEV6, and/or FVC and may transmit this data wirelessly to a database for storage and later use. For example the WFM may communicate with the API of a UD such as a smart phone, via any suitable wireless communication method such as Bluetooth™ or the like, and the API may communicate with the database via any suitable wired and/or wireless communication method such as a mobile telephony network (e.g., a cellular network), Wi-Fi™, and/or the like.

[00221] Upon initial WFM sync and setup, data from the pressure sensor of the WFM may be collected while there is no flow going through the WFM to determine what a base level pressure should be (e.g., atmospheric pressure). This “zero” value may then be transmitted to the API running on the UD of the user and saved along with the unique identifier for that UD. When the WFM is in use, the API may receive pressure data from the WFM in real time and may perform calculations and data management within the API. When pressure data is collected for flow measurements, the stored “zero” value may be added or subtracted to each data point (e.g., pressure data point over time) to obtain higher accuracy in the test results.

[00222] It is envisioned that a home screen of the API may offer an option of either taking measurements or performing breathing exercises using the WFM.

[00223] It is envisioned that measurements such as PEF, FEV1, FEV6, FVC, etc. may be determined by the API when it is supplied sufficient pressure data from the WFM. The API may receive pressure data from the WFM and process it using one or more formulas (e.g., such as described herein) to convert the pressure data from the WFM to corresponding flow values. The API may render information to guide a user such as a patient through usage of the WFM for taking measurements. Real time results may be displayed within a UI of the API as the user takes their measurements and/or may be rendered on a UI of the WFM. [00224] In addition to recording measurements that relate to lung health, the system may include the ability to guide users through breathing and/or physical exercises as desired. These exercises may be performed using the device for example in a form of a handheld device and be guided via an API on a UD.

[00225] In some embodiments, the WFM may include a display on the exterior surface that may display indicia to instruct a patient to inhale and/or exhale and may provide an indication of measured airflow in a flow chamber of the WFM. For example, in some embodiments it is envisioned that the information instructing a patient to inhale and/or exhale, which may include an indication of a number of times to inhale and/or exhale, may be rendered. In some embodiments, the display may visually display the airflow data/metrics to the patient in the form of a graph or data points. In some embodiments, the display may visually display reminders to patients to take their medicament, and may provide coaching alerts, etc.

[00226] In accordance with embodiments, the UD may be loaded with a software program (e.g., smartphone application or API) that stores the airflow data/metrics and interfaces with the patient such that the airflow data/metrics can be searched, retrieved and displayed by the patient and/or the medical practitioner. The software program may also be associated with a message digest for example with a date and time stamp of testing use that may form a part of a history log of metrics for that patient. In some embodiments, the airflow data may also be transmitted via Wi-Fi to a web dashboard on a computer. The web dashboard may generate a report for patient, for the medical practitioner and/or the like.

[00227] In some embodiments, the airflow data may be downloaded in one or more textual/graphical formats (e.g., RTF, PDF, TIFF, JPEG, STL, XML, XDFL, TXT etc.), or set for alternative delivery to the smartphone and/or the web dashboard of the computer. The patient may view the airflow data results at a user interface, which allows viewing on a display, such as the screen or monitor of the smartphone and/or the computer.

[00228] In some embodiments, the patient and/or the medical practitioner can interface with the computer (e.g., smartphone, a computer of the medical practitioner, etc.) via a user interface that may include one or more display devices (e.g., CRT, LCD, or other known displays) or other rendering devices (e.g., printer, etc.), and one or more input devices (e.g., keyboard, mouse, stylus, touch screen interface, and/or other known input mechanisms) for facilitating interaction of the patient and/or the medical practitioner with the airflow data from the WFM via the user interface. The user interface may be directly coupled to an airflow database or directly coupled to a network server system via the Internet or cloud computing.

[00229] In some embodiments, the user interface device may be implemented as a graphical user interface (GUI) containing a display or the like, or may link to other user input/output devices known in the art. Individual or a plurality of devices (e.g., network/stand-alone computers, personal digital assistants (PDAs), WebTV (or other Internet-only) terminals, set-top boxes, smart phones, tablets, or other known (wired or wireless) communication devices, etc.) may similarly be used to execute one or more computer programs (e.g., universal Internet browser programs, dedicated interface programs, etc.) to allow patients to interface with the airflow data in the manner described. Database hardware and software may be utilized to access the data by patients and/or medical practitioners through personal computers, mainframes, and other processor-based devices. Patients and/or medical practitioners may access the data stored locally on one or more memories, such as hard drives, CD-ROMs, etc., and/or may be stored on network storage devices through a local area network, and/or may be stored on remote database systems through one or more disparate network paths (e.g., the Internet).

[00230] In some embodiments, the electronic circuitry in the WFM may include some or all of the capabilities of a computer (e.g., the microcontroller or microprocessor) which may include communication with a network and/or communication directly with other computers. The computer may include a processor, a storage device, a display and/or other rendering device(s), an input device, and a network interface device, all connected via a bus. A battery may be provided to couple and power the computer. The computer may communicate with a network. The processor may provide a central processing unit of any type of architecture, such as a CISC (Complex Instruction Set Computing), RISC (Reduced Instruction Set Computing), VLIW (Very Long Instruction Word), and/or a hybrid architecture, although any appropriate processor may be used. The processor executes instructions and includes that portion of the computer that controls the operation of the computer such as one or more sensors. The processor typically includes a control unit that organizes data and program storage in memory and transfers data and other information between the various parts of the computer. The processor receives input data from the input device (e.g., the at least one sensor) and the network reads and stores instructions (for example processor executable code) and data in a main memory, such as random access memory (RAM), static memory, such as read only memory (ROM), and/or a storage device. The processor may present data to a user via a rendering device which may include a user interface, as described above, such as the screen of the smartphone or the monitor of the web dashboard of the practitioner’s computer or on the display that may be located on the WFM.

[00231] Embodiments of the present system may be used to track the inhalation technique of the patient such that when the at least one sensor detects the direction of airflow, volumetric flow rate is measured throughout the duration of inhalation. From airflow data compiled, the processor may calculate the total inhaled volume and duration which may then be used to guide the patient on breathing technique(s) through an application of a personal computer, such as a smartphone (e.g., the UD). A medical practitioner may also be enabled to view these results via a web dashboard, as described above.

[00232] In accordance with embodiments, a handheld device may collect measurements from one, two, three, four or more of the following respiratory device types including: a. capnometry: CO2 percentage, CO2 partial pressure and/or CO2 volume exhaled; b. pulse oximetry: arterial blood oxygen saturation; c. spirometry: PEF - peak expiratory flow, FVC - forced vital capacity, FEV1 - forced expiratory volume in the first (1) second and/or FEV6 - forced expiratory volume in the first 6 seconds; and d. respiratory monitoring: tidal volume, respiratory rate and/or inhale to exhale ratio.

[00233] Embodiments of the present system may determine pulse oximetry measurements for example by shining light into the pad of a digit which is holding the handheld device and then receiving the reflected light from the arterial blood vessels within the digit.

[00234] Further, inspiratory and/or expiratory muscle training and spirometry may be performed using a single device (e.g., a handheld device in accordance with embodiments) or using the single device together with other connected devices.

[00235] The present device may measure the partial pressure of CO2 in the exhaled air at the end of a forced breath (spirometry maneuver - e.g., one or more of FEV1, FEV3, FEV6 or FVC). The present device may measure the volume of CO2 in the exhaled air from the beginning to the end of a forced breath (spirometry maneuver - e.g., one or more of FEV1, FEV3, FEV6 or FVC). [00236] In accordance with embodiments, the present system may determine what type of mouthpiece, if any, is affixed. For example, in this way, the device may alert the patient when a mouthpiece which does not accommodate pursed lip breathing and/or another exercise is in use so that if the patient is being asked, for example, to do pursed a lip breathing exercise by the accompanying UI, and they are not using a mouthpiece which enables pursed lip breathing, the patient is notified. Similarly, when a suitable/unsuitable mouthpiece and/or flow resistance is used for a given exercise, the patient may be notified.

[00237] It will be apparent to those skilled in the art that various modifications and variations can be made to various embodiments described herein without departing from the spirit or scope of the teachings herein. Thus, it is intended that various embodiments cover other modifications and variations of various embodiments within the scope of the present teachings.

[00238] Further variations of the present system would readily occur to a person of ordinary skill in the art and are encompassed by the following claims.

[00239] Finally, the above discussion is intended to be merely illustrative of the present system and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments. Thus, while the present system has been described with reference to exemplary embodiments, it should also be appreciated that numerous modifications and alternative embodiments may be devised by those having ordinary skill in the art without departing from the broader and intended spirit and scope of the present system as set forth in the claims that follow. In addition, any section headings included herein are intended to facilitate a review but are not intended to limit the scope of the present system. Accordingly, the specification and drawings are to be regarded in an illustrative manner and are not intended to limit the scope of the appended claims.

[00240] In interpreting the appended claims, it should be understood that: a) the word "comprising" does not exclude the presence of other elements or acts than those listed in a given claim; b) the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements; c) any reference signs in the claims do not limit their scope; d) several "means" may be represented by the same item or hardware or software implemented structure or function; e) any of the disclosed elements may be comprised of hardware portions (e.g., including discrete and integrated electronic circuitry), software portions (e.g., computer programming), and/or any combination thereof; f) hardware portions may be comprised of one or both of analog and digital portions; g) any of the disclosed devices or portions thereof may be combined together or separated into further portions unless specifically stated otherwise; h) no specific sequence of acts or steps is intended to be required unless specifically indicated; and i) the term "plurality of" an element includes two or more of the claimed element, and does not imply any particular range of number of elements; that is, a plurality of elements may be as few as two elements, and may include an immeasurable number of elements.

Claims

WHAT IS CLAIMED IS:

1. A handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: a) differential pressure sensor or mass airflow sensor or air velocity sensor; b) C02 sensor; c) pulse oximeter sensor.

2. A handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: a) differential pressure sensor or mass airflow sensor or air velocity sensor; b) pulse oximeter sensor.

3. A handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: a) differential pressure sensor or mass airflow sensor or air velocity sensor; b) C02 sensor.

4. A handheld monitoring device which calculates physiologic metrics from the following sensors which are physically connected to and in communication with a processor contained within the housing of the device: a) C02 sensor; b) pulse oximeter sensor.

5. The handheld monitoring device of claims 1, 2, 3 or 4 where the processor is in communication with a secondary processor located on a mobile device which operates a mobile application for calculating physiologic metrics. 6. The handheld monitoring device of claims 1, 2, 3 or 4 where the processor is in communication with a secondary processor located on a mobile device which operates a mobile application for rendering physiologic metrics.

7. The handheld monitoring device of claims 1, 2, or 3 further comprising a barometric pressure sensor which is physically connected to and in communication with a processor contained within the housing of the handheld monitoring device and is used to increase the accuracy of said physiologic metrics.

8. The handheld monitoring device of claims 1, 2, or 3 further comprising a temperature sensor which is physically connected to and in communication with a processor contained within the housing of the handheld monitoring device and is used to increase the accuracy of said physiologic metrics.

9. The handheld monitoring device of claim 8 in which the temperature sensor is configured to measure the temperature of the user’s exhaled breath.

10. The handheld monitoring device of claims 1, 2, 3 or 4, further comprising a flow chamber which the user breaths through.

11. The handheld monitoring device of claim 10, wherein the processor is further configured to receive, from the differential pressure sensor or mass airflow sensor or air velocity sensor the data corresponding to the user’s volumetric airflow through the flow chamber, and determine data corresponding to peak expiratory flow (PEF), forced expiratory volume (FEV(t)), forced vital capacity (FVC), tidal volume, respiratory rate and/or inhale to exhale ratio.

12. The handheld monitoring device of claim 5, wherein the secondary processor is further configured to receive data corresponding to the user’s volumetric airflow through the flow chamber during a period of exhalation, and determine data corresponding to peak expiratory flow (PEF), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), tidal volume, respiratory rate and/or inhale to exhale ratio. 13. The handheld monitoring device of claims 1, 3 or 4, further comprising a carbon dioxide (CO2) sensor flow coupled to the flow chamber and configured to form data corresponding to an amount of carbon dioxide detected in the flow chamber during a period of exhalation.

14. The handheld monitoring device of claim 13, wherein the processor is further configured to receive, from the differential pressure sensor or mass airflow sensor or air velocity sensor, the data corresponding to the user’s volumetric airflow through the flow chamber during a period of exhalation, and determine, in conjunction with the data corresponding to the amount of carbon dioxide detected in the flow chamber during the period of exhalation, data corresponding to a volume of carbon dioxide and partial pressure of carbon dioxide that was exhaled by the user during the period of exhalation.

15. The handheld monitoring device of claim 5, wherein the secondary processor is further configured to receive data corresponding to the user’s volumetric airflow and data corresponding to the amount of carbon dioxide detected through the flow chamber during a period of exhalation, and determine data corresponding to a volume of carbon dioxide and partial pressure of carbon dioxide that was exhaled by the user during the period of exhalation.

16. The handheld monitoring device of claims 1, 2 or 4, further comprising a pulse oximeter sensor in communication with the processor configured to measure at least one of a heart rate and Sp02 of the user and form corresponding data.

17. The handheld monitoring device of claim 5, wherein the secondary processor is further configured to receive data corresponding to the user’s Sp02 and heart rate; and determine the user’s Sp02 and heart rate.

18. The handheld monitoring device of claim 16, further comprising an activation switch on the housing and in communication with the processor. 19. The handheld monitoring device of claim 18, wherein the pulse oximeter further comprises a pulse oximeter sensor for sensing the at least one of heart rate and blood oxygen concentration of the user, the pulse oximeter sensor situated on the housing at a location that is opposite the activation switch.

20. The handheld monitoring device of claim 18, wherein the pulse oximeter sensor is situated proximate to the activation switch such that a user interfaces with the pulse oximeter when depressing the activation switch.

21. The handheld monitoring device of claims 1, 2, 3, or 4, further comprising a mouthpiece for receiving the exhaled air from a user and for conveying the exhaled air from the user to the flow chamber, wherein the housing further comprises a coupler for removably coupling the mouthpiece to the housing.

22. The handheld monitoring device of claim 21, wherein the mouthpiece further comprises a body having first and second openings and a mouthpiece channel situated between the first and second openings of the mouthpiece, wherein the mouthpiece is flow coupled to the flow chamber when the mouthpiece is removably coupled to the housing.

23. The handheld monitoring device of claim 21, wherein the mouthpiece has a predetermined flow resistance selected from a plurality of flow resistances.

24. The handheld monitoring device of claim 21, wherein the mouthpiece (i) has a variable resistance to flow or (ii) the mouthpiece comprises a plurality of mouthpieces having different sizes and diameters and/or different flow resistances such that the mouthpieces are interchangeable with each other or (iii) the mouthpiece comprises a plurality of mouthpieces having different shapes that accommodate different methods of breathing such that the mouthpieces are interchangeable with each other 25. The handheld monitoring device of claim 24, further comprising at least one adjuster coupled to corresponding ones of the at least one flow restrictor and configured to be grasped by a user for controlling the flow setting of the at least one flow restrictor.

26. The handheld monitoring device of claim 25, further comprising: a flow setting adjuster sensor configured to: measure a flow setting of the at least one flow restrictor; form corresponding flow setting information; and communicate the flow setting information to the first processor.

27. The handheld monitoring device of claim 23, wherein the mouthpiece further comprises a unique identifier (ID) which corresponds with the flow resistance or shape of the mouthpiece.

28. The handheld monitoring device of claim 26, wherein the processor is further configured to determine the unique identifier; and determine the flow resistance or shape of the mouthpiece based on the determined unique identifier.

29. The handheld monitoring device of claim 27, wherein the processor identifies the mouthpiece based on different circuits closed by the mouthpiece due to different flow resistances or shapes.

30. The handheld monitoring device of claim 27, wherein the flow resistance or shape of the mouthpiece is associated with a breathing exercise or physiologic metric.

31. The handheld monitoring device of claim 29, wherein the secondary processor is configured to determine if the correct mouthpiece is being used for the current breathing exercise being performed and/or the physiologic metric being collected.

32. The handheld monitoring device of claim 27, wherein the flow resistance of the mouthpiece is adjustable manually, wirelessly and/or remotely by a healthcare provider. 33. The handheld monitoring device of claims 1, 2, 3 or 4, wherein the housing further comprises a user interface (UI) in communication with the processor and configured to render information generated by the processor related to an operating state of the handheld monitoring device.

34. The handheld monitoring device of claims 1-32, wherein the handheld device is used to monitor a respiratory disease.

35. A method of monitoring pulmonary function of a patient, the method comprising: instructing the patient to exhale air into a handheld monitoring device as defined in any one or more of claims 1-32.

36. The method of claim 34, wherein the handheld monitoring device determines peak expiratory flow (PEF), forced expiratory volume (FEV), forced vital capacity (FVC), tidal volume, respiratory rate, inhale to exhale ratio, end tidal C02 (etC02), volume of C02 exhaled (VC02), arterial blood oxygen saturation (Sp02), heart rate and/or body temperature data for the patient.

37. The method of claim 35, wherein the peak expiratory flow (PEF), forced expiratory volume (FEV), forced vital capacity (FVC) , tidal volume, respiratory rate, inhale to exhale ratio, end tidal C02 (etC02), volume of C02 exhaled (VC02), arterial blood oxygen saturation (Sp02), heart rate and/or body temperature data for the patient is transmitted to a healthcare provider.

38. The method of claim 36, wherein a biofeedback is displayed during a breath exercise.

39. The method of claim 37, wherein the biofeedback has the form of a circle expanding when the user inhales and shrinks when the user exhales.

40. A handheld device comprising: a housing comprising first and second openings and at least one cavity, the first opening configured to receive exhaled air from a user; a flow chamber coupled to and situated between the first and second openings of the housing within the at least one cavity, the flow chamber having first and second ends; an orifice plate situated at the second end of the flow chamber; a pressure sensor configured to measure pressure within the flow chamber and form corresponding pressure data; a processor situated within the at least one cavity and in communication with the pressure sensor, the processor being configured to: receive, from the pressure sensor, pressure data corresponding to the pressure within the flow chamber, determine, based on the pressure data corresponding to the pressure within the flow chamber and atmospheric pressure, a pressure drop across the orifice plate, and determine, based on the pressure drop across the orifice plate, data corresponding to a flow velocity of the exhaled air in the flow chamber.

41. The handheld device of claim 39, wherein the processor is further configured to determine atmospheric pressure based upon the pressure data corresponding to the pressure within the flow chamber with a static flow environment within the flow chamber.

42. The handheld device of claim 39, wherein the processor is further configured to determine atmospheric pressure prior to receiving the exhaled air into the flow chamber.

43. The handheld device of claim 39, wherein the processor is further configured to determine atmospheric pressure based on a pressure in the flow chamber prior to receiving the exhaled air.

44. The handheld device of claim 39, wherein the pressure sensor comprises a first pressure sensor flow coupled to the flow chamber and a second pressure sensor flow coupled to a volume outside of the flow chamber.

45. The handheld device of claim 39, further comprising a carbon dioxide (CO2) sensor flow coupled to the flow chamber and configured to form data corresponding to an amount of carbon dioxide detected in the flow chamber. 46. The handheld device of claim 44, wherein the at least one processor is further configured to receive, from the carbon dioxide sensor, the data corresponding to an amount of carbon dioxide detected in the flow chamber during a period of exhalation, and determine, based on the data corresponding to the amount of carbon dioxide detected in the flow chamber during the period of exhalation, data corresponding to a volume of carbon dioxide that was exhaled by the user during the period of exhalation.

47. The handheld device of claim 39, further comprising a pulse oximeter in communication with the at least one processor, the pulse oximeter being configured to measure at least one of a heartrate and blood oxygen concentration of the user and form corresponding data.

48. The handheld device of claim 46, further comprising an activation switch on the housing and in communication with the at least one processor.

49. The handheld device of claim 47, wherein the pulse oximeter further comprises a pulse oximeter sensor for sensing the at least one of heartrate and blood oxygen concentration of the user, the pulse oximeter sensor situated on the housing at a location that is opposite the activation switch.

50. The handheld device of claim 39, further comprising a mouthpiece for receiving the exhaled air from a user and for conveying the exhaled air from the user to the flow chamber, wherein the housing further comprises a coupler for removably coupling the mouthpiece to the housing.

51. The handheld device of claim 49, wherein the mouthpiece further comprises a body having first and second openings and a mouthpiece channel situated between the first and second openings of the mouthpiece, wherein the mouthpiece is flow coupled to the flow chamber when the mouthpiece is removably coupled to the housing. 52. The handheld device of claim 49, wherein the mouthpiece has a predetermined flow rate selected from a plurality of flow rates.

53. The handheld device of claim 51, wherein the mouthpiece further comprises a unique identifier (ID) which corresponds with the flow rate of the mouthpiece.

54. The handheld device of claim 52, wherein the processor is further configured to determine the unique identifier; and determine the flow rate of the mouthpiece based on the determined unique identifier.

55. The handheld device of claim 53, wherein the flow rate of the mouthpiece is associated with a breathing exercise or pulmonary function test performed by the processor.

56. The handheld device of claim 53, wherein the processor is configured to select a breathing exercise and/or pulmonary function to run from a plurality of breathing exercises and/or pulmonary function based upon the determined unique ID of the mouthpiece.

57. The handheld device of claim 53, wherein the processor is further configured to: determine at least one of: Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV), and Forced Vital Capacity (FVC) based on the determined data corresponding to the flow velocity of the exhaled air in the flow chamber; and render at least one of the determined PEC, FEV, and FVC on a rendering device, and/or store the determined PEC, FEV, and FVC in a memory of the system.

58. The handheld device of claim 39, wherein the housing further comprises a user interface (UI) in communication with the processor and configured to render information generated by the processor related to an operating state of the pulmonary function monitoring device.

59. The handheld device of claim 39, further comprising at least one detection sensor configured to: determine an identification (ID) of a mouthpiece coupled to the housing; and communicate the ID of the connected mouthpiece to the processor. 60. The handheld device of claim 39, wherein the handheld device is provided in a form of a pulmonary function monitoring device.

61. A pulmonary function monitoring system comprising: a first device having: a housing having first and second openings situated apart from each other and a flow chamber situated between and flow coupled to the first and second openings, the housing defining at least one cavity, the flow chamber having a proximal opening and a distal opening each of different sizes; a first coupler situated on the housing at the first opening and configured to receive a mouthpiece at the first opening; a pressure sensor coupled to at least the flow chamber and configured to measure at least one of a pressure within the flow chamber and ambient atmospheric pressure and form corresponding pressure information; a first wireless radio configured to pair to a second device using a wireless transmission method and transmit and receive information with the paired second device; and a first processor configured to: receive the pressure information from the pressure sensor, and control the first wireless radio to transmit the received pressure information to the paired second device.

62. The pulmonary function monitoring system of claim 60, further comprising the second device, the second device having a second processor and a second wireless radio configured to pair to first device using the wireless transmission method and transmit and receive information with the paired first device, wherein the second processor is configured to receive the transmitted pressure information from the first device and determine an expiration flow velocity within the flow chamber.

63. The pulmonary function monitoring system of claim 60, further comprising at least one detection sensor configured to: identify an identification (ID) of the mouthpiece coupled to the housing, and communicate the ID of the connected mouthpiece to the first processor.

64. The pulmonary function monitoring system of claim 60, further comprising at least one flow restrictor configured to restrict the airflow within the flow chamber.

65. The pulmonary function monitoring system of claim 63, wherein the at least one flow restrictor is fixed.

65. The pulmonary function monitoring system of claim 63, wherein the at least one flow restrictor is variable with a plurality of flow settings.

67. The pulmonary function monitoring system of claim 65, further comprising at least one adjuster coupled to corresponding ones of the at least one flow restrictor and configured to be grasped by a user for controlling the flow setting of the at least one flow restrictor.

68. The pulmonary function monitoring system of claim 66, further comprising: a flow setting adjuster sensor configured to: measure a flow setting of the at least one flow restrictor; form corresponding flow setting information; and communicate the flow setting information to the first processor.

69. The pulmonary function monitoring system of claim 67, wherein the second processor is further configured to determine at least one of: Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV), and Forced Vital Capacity (FVC), in accordance with the determined expiration flow velocity within the flow chamber and the flow setting information.

70. The pulmonary function monitoring system of claim 63, wherein the second processor is further configured to determine at least one of: Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV), and Forced Vital Capacity (FVC), in accordance with the determined expiration flow velocity within the flow chamber. 71. The pulmonary function monitoring system of claim 69, wherein the second processor is further configured to render at least one of the determined PEC, FEV, and FVC on a rendering device, or store the determined PEC, FEV, and FVC in a memory of the system.

72. The pulmonary function monitoring system of claim 60, further comprising an activation switch on the housing and configured to sense an activation request and communicate the activation request to first processor.

73. The pulmonary function monitoring system of claim 71, further comprising a pulse oximeter sensor situated on the housing at location that is opposite the activation switch, wherein the pulse oximeter further comprises: a pulse oximeter sensor for sensing at least one of a heartrate and a blood oxygen concentration of the user and forming corresponding heartrate and/or blood oxygen concentration sensor information; and communicating the heartrate and/or blood oxygen concentration sensor information to the first processor, the pulse oximeter sensor situated on the housing at a location that is opposite the activation switch.

74. The pulmonary function monitoring system of claim 60, further comprising a carbon dioxide (C02) sensor flow coupled to the flow chamber and configured to detect a presence of carbon dioxide in the flow chamber and form corresponding data corresponding to an amount of carbon dioxide detected in the flow chamber.

75. The pulmonary function monitoring system of claim 60, further comprising the mouthpiece, wherein the mouthpiece is configured to be removably coupled to the first coupler situated on the housing at the first opening.

76. The pulmonary function monitoring system of claim 74, further comprising a flow restrictor situated within the mouthpiece. 77. The pulmonary function monitoring system of claim 60, wherein the first device is provided in a form of a handheld device.

78. A handheld device for determining a pulse oximetry measurement, the handheld device comprising: a light transmitter configured to transmit a light into a pad of a digit which is holding the handheld device; a light receiver configured to receive reflected light from arterial blood vessels within the digit which is holding the handheld device; and a processor configured to determining the pulse oximetry measurement from the received reflected light.

79. A handheld device for inspiratory and/or expiratory muscle training and spirometry, the handheld device comprising: a housing configured to receive inspiratory and/or expiratory breaths; a user interface configured to guide the inspiratory and/or expiratory breaths; and a processor configured to determine a spirometric measurement based on the inspiratory and/or expiratory breaths.

80. A handheld device for determining a body temperature, the handheld device comprising: a housing configured to receive an expiratory breath; a temperature sensor configured to measure a temperature of the expiratory breath; and a processor configured to determine the body temperature based on the expiratory breath.

81. A handheld device for measuring a quantity of CO2 in an expiratory breath, the handheld device comprising: a housing configured to receive the expiratory breath; a CO2 sensor configured to measure the quantity of CO2 in the expiratory breath; and a processor configured to indicate the measure of CO2 in the expiratory breath. 82. The handheld device of claim 80, wherein the CO2 sensor configured to measure the quantity of CO2 in the expiratory breath as a partial pressure of CO2 in the exhaled air at the end of the expiratory breath.

83. The handheld device of claim 80, wherein the CO2 sensor configured to measure the quantity of CO2 in the expiratory breath as a volume of CO2 in the exhaled air from a beginning to an end of the expiratory breath.