WO2025064849A1

WO2025064849A1 - Resistive breathing circuit for use in lowering blood pressure and improving vascular health

Info

Publication number: WO2025064849A1
Application number: PCT/US2024/047735
Authority: WO
Inventors: E. Fiona BAILEY
Original assignee: Arizona Board Of Regents On Behalf Of The University Of Arizona
Priority date: 2023-09-22
Filing date: 2024-09-20
Publication date: 2025-03-27

Abstract

A real-time inspiratory resistive training (IRT) system including a computing device communicatively coupled to an IRT device, configured to accept one or more maximum inspiratory pressure (PImax) waveforms from the IRT device, and display the one or more PImax waveforms. The computing device may be further configured to establish a target training pressure based on the one or more PImax waveforms, display a target training pressure range based on the Pmax, and display one or more subsequent waveforms compared to the target training pressure.

Description

RESISTIVE BREATHING CIRCUIT FOR USE IN LOWERING BLOOD PRESSURE AND

IMPROVING VASCULAR HEALTH

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63/584,826 filed September 22, 2023, the specification of which is incorporated herein in its entirety by reference.

FIELD OF THE INVENTION

[0002] The present invention is directed to an inspiratory resistive training device with real-time feedback, that tracks training in progress and reports summary statistics for the maximal respiratory strength (PI_max), number of training sessions, and training levels achieved over weeks and months.

BACKGROUND OF THE INVENTION

[0003] Consistently elevated blood pressure has been a long-standing risk factor for cardiovascular diseases (CVDs) like atrial fibrillation, stroke, and heart failure. These diseases are the leading cause of death in the United States, accounting for 1 in every 5 deaths across the nation, despite available preventative measures. Generally, these measures focus on reducing a patient’s blood pressure and thus reducing the strain on their heart. However, people across the nation fail to engage in such activities because they are time-consuming, exhaustive, and provide a slow return. In recent years, studies have indicated a correlation between respiratory resistance training (RRT) and a significant decrease in blood pressure. This correlation has prompted further research into RRT methods and devices as a preventative measure to combat the growing prevalence of CVDs, especially in aging populations.

[0004] RRT is a novel form of exercise that has yielded surprising results including improvements in blood pressure and autonomic balance in patients suffering from elevated blood pressure, hypertension or obstructive sleep apnea (OSA). Aging has a direct effect on the heart and susceptibility to cardiovascular diseases. This risk is predominantly caused by 2 factors which are increased systolic arterial blood pressure and vascular dysfunction. This same “at-risk” population commonly does not engage in and is intolerant of, intensive physical activity which can lower blood pressure and improve vascular health. Cardiovascular diseases remain the leading cause of mortality and age is by far the strongest risk factor for CVD. Thus, 17.9 million people died from CVDs in 2019 making up 32% of total global deaths. In order to reduce the risk of patient susceptibility to CVD, decreasing blood pressure is a necessity. For many patients their lifestyles are not conducive to regular physical activity that naturally reduces BP and for those who attempt to exercise more often have low adherence to recommended lifestyle interventions or cannot devote the American Heart Association recommended guidelines of -120 mins/week of traditional aerobic exercise needed to see BP improvement. Thus, the novel RRT and associated device fills a critical need. Existing medical devices appear to address this market need but lack the necessary key requirements for effectiveness. Specifically, existing devices do not provide the user with a means of establishing the appropriate training level based on their respiratory strength. It is critical first to identify the user's maximal respiratory strength in order to establish the appropriate training level. It also is necessary to regularly reassess maximum respiratory strength to adjust training levels to ensure continued gains in respiratory strength. Existing devices also do not provide real-time visual feedback regarding breathing performance that is scaled in accordance with the individual’s target training pressure and breath duration. Further, current commercially available devices are technically complex and often come at an unnecessarily high cost to the user.

[0005] RRT offers a rapid and effective method of lowering blood pressure that requires just five minutes a day and allows users to address key cardiovascular risk factors. Currently, there are several options for RRT-type devices with digital or analog interfaces. However, these devices are not ideal for all users due to various shortcomings. The most significant limitations include; a) the inability to establish the user’s respiratory strength or maximum (inspiratory or expiratory) pressure (PI/PE_max); b) the inability to establish PI/PE_max prevents the user from establishing the appropriate training level (i.e., inspiratory pressure; c) the absence or inadequate real-time (visual) feedback regarding the target pressure, inspiratory/expiratory durations and respiratory frequency, d) restricted pressure range/sensitivity and accuracy, e) a high price point and f) ease of cleaning. Thus, there exists a critical need for an RRT device that is calibrated to the user's current respiratory capability which can only be established via assessment of their PI/PE_max. To ensure the user is performing the training correctly, there needs to be a real-time feed showing each inspiratory effort and summary statistics at the end of each training session. The device should be offered at a minimal cost, be easily cleaned/maintained, and be scalable to larger manufacturing procedures.

BRIEF SUMMARY OF THE INVENTION

[0006] It is an objective of the present invention to provide a system that allows for an\ respiratory (inspiratory or expiratory) resistive training device that first establishes the user’s maximal respiratory strength (PI/PE_max). Once PI/PE_max is determined, the training is then scaled to the individual user’s training level and capability (i.e., ranging between 45-75% of PI/PE_max). As the individual performs the training, they are provided real-time visual feedback. At the end of each session, the user is provided summary data regarding the total number of training breaths, the number of breaths that met the target pressure, training progress, and PI/PE_max, as specified in the independent claims. Given that respiratory muscle strength improves with training, the user will be prompted to reassess their PI/PE_max at the beginning of each training session. Embodiments of the invention are given in the dependent claims. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive.

[0007] The present invention features a real-time respiratory resistive training (RRT) system comprising a computing device communicatively coupled to an RRT device, configured to accept one or more respiratory (inspiratory/expiratory) pressure waveforms from the RRT device and display the one or more respiratory (inspiratory/expiratory) pressure waveforms. In some embodiments, the computing device may be further configured to establish the user’s target training pressure based on the one or more inspiratory/expiratory pressure waveforms, display a target inspiratory/expiratory pressure based on the target training pressure, and display one or more subsequent inspiratory/expiratory pressure waveforms compared to the target training pressure.

[0008] One of the unique and inventive technical features of the present invention is a system for RRT comprising a respiratory resistive device having a constant and near infinite resistance. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention advantageously provides for efficient respiratory resistive training with a device that requires no manipulation or adjustment for different users or users capabilities and is equally suited to inspiratory and expiratory training modalities. None of the presently known prior references or work has the unique inventive technical feature of the present invention.

[0009] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0010] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings, in which: [0011] FIG. 1A shows a schematic diagram of the inspiratory resistive training (IRT) system of the present invention.

[0012] FIG. IB shows a flow chart diagram of a process for operating the IRT system of the present invention.

[0013] FIG. 2A shows an example graph of the present invention displaying maximal respiratory pressure waveforms (P_max) from a user.

[0014] FIG. 2B shows an example graph of the user’s target training pressure waveform (a). Note that the display features both the training waveform and the target (inspiratory) pressure (b) and the target pressure range (c-d). The target pressure and range are calculated and displayed to the user based on performance of the P_max maneuvers (see Fig 2A).

[0015] FIG. 3 shows a block diagram of the inspiratory device and smartphone app interface system of the present invention. The top part references the physical device and what it consists of, and the bottom part references the functionalities found in the smartphone app. These two interfaces will communicate with each other through Bluetooth®.

[0016] FIG. 4 shows a logical flow diagram of the connection process of the IRT device to the software application of the present invention.

[0017] FIG. 5 shows a logical flow diagram of a pressure waveform generation and transmission process of the IRT device of the present invention.

[0018] FIG. 6 shows a logical flow diagram of calibrating the pressure readings from the IRT device to the specific user.

[0019] FIG. 7 shows a logical flow diagram of allowing the user to train their respiratory strength against the target training pressure through the IRT device of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The term “respiratory effort” is defined herein as an exertion of a person’s respiratory system (e.g. an inspiration, an expiration), and measured in units of pressure and representative of respiratory muscle strength.

[0021] The term “target training pressure” is defined herein as a the pressure which the user will be required to generate during daily training and which is determined as a proportion (45-75%) of the maximum respiratory pressure and based on the one or more subsequent maximum respiratory efforts against the constant and near infinite resistance on the RRT device (120).

[0022] The term “maximum respiratory pressure” (P_max) is defined herein as the maximum inspiratory or expiratory pressure (measured at the mouth) achievable by a specific person.

[0023] Referring now to FIG. 1 A, the present invention features a real-time respiratory resistive training (RRT) system (100) comprising a computing device (110) communicatively coupled to an RRT device (120) having a constant resistance. The computing device (110) may be configured to accept one or more maximum respiratory pressure (P_max) waveforms generated by the user on the RRT device (120). Upon receiving one or more maximum respiratory pressures from a user against the constant resistance, the computing device (110) may be further configured to display the one or more P_max waveforms. In some embodiments, the computing device (110) may be further configured to accept one or more subsequent P_max pressures based on the one or more subsequent respiratory efforts against the constant and near infinite resistance on the RRT (120).

[0024] In some embodiments, the RRT device (120) may comprise a mouthpiece (122) configured to accept the one or more maximum respiratory efforts from the user. The RRT device (120) may further comprise a pressure transducer (124) operatively coupled to the mouthpiece (122), configured to detect and record one or more airway pressures based on the one or more maximum respiratory efforts against a constant and near infinite resistance. The RRT device (120) may further comprise a microcontroller (126) communicatively coupled to the pressure transducer (124), configured to generate the one or more P_max waveforms based on the one or more pressure measurements. The RRT device (120) may further comprise a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more P_max waveforms to the computing device (110). In some embodiments, the RRT device (120) may further comprise a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more maximum inspiratory pressures. In some embodiments, the RRT device (120) may comprise a non-leak system with one or more maximum respiratory pressures detected by the RRT device (120).

[0025] In some embodiments, the RRT device (120) may be communicatively coupled to the computing device (110) by a Bluetooth® Low-Energy (BLE) connection. In some embodiments, the RRT device (120) may comprise an L-shape or T-shape. In some embodiments, the computing device (110) may comprise a personal computer, a smartphone, a portable computing device (110), or a combination thereof. In some embodiments, the one or more maximum respiratory pressures (P_max) may comprise inhalations, exhalations, or (inspiratory) efforts without airflow.

[0026] The present invention features a real-time respiratory resistive training (RRT) system (100). The system (100) may comprise an RRT device (120) having a constant and near infinite resistance, configured to accept one or more maximum respiratory pressures from a user and generate one or more maximum respiratory pressure (P_max) waveforms. The one or more P_max waveforms may be representative of the one or more maximum respiratory efforts against the constant and near infinite resistance. The system (100) may further comprise a computing device (110) communicatively coupled to the RRT device (120), comprising a processor (112) configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions. The computer-readable instructions may comprise accepting the one or more P_max waveforms from the RRT device (120), displaying the one or more P_max waveforms, and establishing a target training pressure based on averaging of one or more P_max waveforms.

[0027] In some embodiments, the RRT device (120) may be further configured to accept one or more subsequent maximum respiratory pressures and generate one or more subsequent pressure waveforms based on the one or more subsequent respiratory efforts against the constant and near infinite resistance. The computer-readable instructions further comprise displaying a target training pressure that is based on a percentage of the individual’s P_max. The target training pressure may encompass a pressure range. The computer-readable instructions may further comprise accepting the one or more subsequent pressure waveforms from the RRT device (120) and displaying the one or more subsequent pressure waveforms compared to the target training pressure range. In some embodiments, the computer-readable instructions may further comprise increasing the target training pressure range if the one or more subsequent pressure waveforms are within the target training pressure range.

[0028] The present invention features a real-time inspiratory resistive training (IRT) system (100). The system (100) may comprise an L-shaped or T-shaped IRT device (120). The IRT device (120) may comprise a mouthpiece (122) configured to accept one or more initial maximum inspiratory efforts and one or more subsequent inspirations from a user. The IRT device (120) may further comprise a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more initial maximum inspiratory efforts and the one or more subsequent training inspirations. The IRT device (120) may further comprise a pressure transducer (124) having a constant and near infinite resistance, operatively coupled to the mouthpiece (122), configured to generate one or more initial pressure measurements based on the one or more initial maximum inspiratory efforts against the constant and near infinite resistance and one or more subsequent pressure measurements based on the one or more subsequent inspirations against the constant and near infinite resistance. The IRT device (120) may further comprise a pressure transducer (124) communicatively coupled to a microcontroller (126) configured to generate one or more initial maximum inspiratory pressure (PI_max) waveforms based on the one or more initial pressure measurements and one or more subsequent pressure waveforms based on the one or more subsequent pressure measurements. The IRT device (120) may further comprise a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more initial PI_max waveforms and the one or more subsequent pressure waveforms to a computing device (110).

[0029] The system (100) may further comprise the computing device (110) communicatively coupled to the IRT device (120), comprising a display component (116) configured to display data, a processor (112) operatively coupled to the display component (116), configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions. The computer-readable instructions may comprise accepting the one or more initial PI_max waveforms from the IRT device (120), displaying, by the display component (116), the one or more initial PI_max waveforms, and establishing a target training pressure based on the one or more initial PI_max waveforms. The target training pressure may comprise a range comprising the target training pressure. The computer-readable instructions may further comprise displaying, by the display component (116), a target training pressure based on initial PI_max waveforms, accepting the one or more subsequent pressure waveforms from the IRT device (120), and displaying, by the display component (116), the one or more subsequent pressure waveforms compared to the target inspiratory pressure.

[0030] In some embodiments, the mouthpiece (122) may comprise any device configured to accept a respiratory effort from the user. In some embodiments, the mouthpiece (122) may be configured to fit over the mouth of the user, the nose of the user, or a combination thereof. In some embodiments, the mouthpiece (122) may be configured to fit into the mouth of the user, the nose of the user, or a combination thereof. In some embodiments, the pressure transducer (124) may comprise any device comprising a surface and configured to measure the pressure of a gas (e.g. air) exerted on its surface and generate an electrical signal corresponding to the pressure.

[0031] In some embodiments, the microcontroller (126) may comprise a printed circuit board (PCB) device sized such that it can fit inside a handheld device. In some embodiments, the PCB device may comprise a processor configured to execute computer-readable instructions and a memory component operatively coupled to the processor, comprising a plurality of computer-readable instructions. In some embodiments, the computer-readable instructions of the memory component of the microcontroller (126) may entail receiving the electrical signal from the pressure transducer (124) and generating a P_max waveform based on the electrical signal. In some embodiments, the wireless transceiver (128) may comprise an antenna configured to transmit and receive signals wirelessly over a radiofrequency (RF) channel. In some embodiments, the antenna may comprise a monopole antenna, a dipole antenna, a Yagi antenna, a loop antenna, a bowtie antenna, or a combination thereof. In some embodiments, the display component (116) may comprise a screen or monitor configured to display digital images (e.g. real-time respiratory pressure waveforms). In some embodiments, the display component (116) may be an external component operatively and/or communicatively coupled to the computing device (110). In some embodiments, the display component (116) may be integrated into the computing device (110) (e.g. a screen on a smartphone).

[0032] The present invention features a method comprising providing a respiratory resistive training (RRT) device (120) having a constant and near infinite resistance and accepting, by the RRT, one or more maximum respiratory efforts from a user. The one or more maximum respiratory efforts may be separated by an interval. The method may further comprise generating, by the RRT, one or more initial maximum respiratory pressure (P_max) waveforms based on the one or more maximum respiratory efforts, accepting, by a computing device (110), the one or more initial P_max waveforms generated by the RRT device (120), displaying, by the computing device (110), the one or more initial P_max waveforms, and establishing, by the computing device (110), a target training pressure based on the one or more initial P_max waveforms. The target training pressure may comprise a range encompassing the target respiratory pressure. The method may further comprise displaying, by the computing device (110), a pressure based on the target training pressure, accepting, by the RRT device (120), one or more subsequent respiratory efforts from the user, generating, by the RRT, one or more subsequent pressure waveforms based on the one or more subsequent respiratory efforts, accepting, by the computing device (110), the one or more subsequent pressure waveforms from the RRT device (120), displaying, by the computing device (110), the one or more subsequent pressure waveforms compared to the target training pressure, and increasing, by the computing device (110), the target training pressure if the one or more subsequent pressure waveforms are within the target training pressure range.

[0033] In some embodiments, the method is for reducing blood pressure. In some embodiments, the method is for improving nighttime breathing. In some embodiments, the method is for reducing nighttime sleep disturbance. In some embodiments, the method is for reducing respiratory fatigue. In some embodiments, the method is for reducing gastroesophageal reflux disease. In some embodiments, the method is for reducing plasma catecholamines. In some other embodiments, the method is for mobilizing immune cells into the circulation for improving immunosurveillance.

[0034] The present invention features a real-time respiratory resistive training (RRT) system (100) comprising a computing device (110) communicatively coupled to an RRT device (120) having a constant and near infinite resistance, configured to accept one or more maximum respiratory pressure (P_max) waveforms generated by the RRT device (120) upon receiving one or more maximum respiratory efforts from a user. The one or more P_max waveforms may be representative of the one or more maximum respiratory efforts against the constant and near infinite resistance. The computing device (110) may be further configured to display the one or more P_max waveforms and establish a target training pressure based on the one or more P_max waveforms. In some embodiments, the RRT device (120) may be further configured to accept one or more subsequent respiratory efforts and generate one or more subsequent pressure waveforms based on the one or more subsequent respiratory efforts against the constant and near infinite resistance. The computing device (110) may be further configured to display the target training pressure. The target training pressure may comprise a range encompassing a target respiratory pressure. The computing device (110) may be further configured to accept the one or more subsequent pressure waveforms from the RRT device (120) and display the one or more subsequent pressure waveforms compared to the target training pressure. In some embodiments, the computing device (110) may be further configured to increase the target training pressure if the one or more subsequent pressure waveforms are within the range.

[0035] The present invention features a real-time respiratory resistive training (RRT) system (100). The system (100) may comprise an RRT device (120) having a constant and near infinite resistance, configured to accept one or more maximum respiratory efforts from a user and generate one or more maximum respiratory pressure (P_max) waveforms. The one or more P_max waveforms may be representative of the one or more maximum respiratory efforts against the constant and near infinite resistance. The system (100) may further comprise a computing device (110) communicatively coupled to the RRT device (120), comprising a processor (112) configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions. The computer-readable instructions may comprise accepting the one or more P_max waveforms from the RRT device (120), displaying the one or more P_max waveforms, and establish a target training pressure based on the one or more P_max waveforms.

[0036] In some embodiments, the RRT device (120) may be further configured to accept one or more subsequent maximum respiratory pressures and generate one or more subsequent pressure waveforms based on the one or more subsequent maximum respiratory pressures against the constant and near infinite resistance. The computer-readable instructions may further comprise: displaying the target training pressure. The target training pressure may comprise a range encompassing a target respiratory pressure. The computer-readable instructions may further comprise accepting the one or more subsequent pressure waveforms from the RRT device (120) and displaying the one or more subsequent pressure waveforms compared to the target training pressure. In some embodiments, the computer-readable instructions may further comprise increasing the target training pressure if the one or more subsequent pressure waveforms are within the target pressure range.

[0037] In some embodiments, the RRT device (120) may comprise a mouthpiece (122) configured to accept the one or more maximum respiratory efforts from the user. The RRT device (120) may further comprise a pressure transducer (124) operatively coupled to the mouthpiece (122), with specifications suited to detect one or more maximum pressures associated with the one or more maximum respiratory efforts generated by the user against the constant and near infinite resistance. The RRT device (120) may further comprise a microcontroller (126) communicatively coupled to the pressure transducer (124), configured to generate one or more Pmax waveforms based on the transducer sensing the one or more maximum pressures. The RRT device (120) may further comprise a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more P_max waveforms to the computing device (110). In some embodiments, the RRT device (120) may further comprise a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more maximum respiratory efforts. In other embodiments, the RRT device (120) may comprise a non-leak system, and the one or more maximum respiratory pressures may be generated by the user against an infinite resistance.

[0038] The present invention features a real-time inspiratory resistive training (IRT) system (100). The system (100) may comprise an L-shaped or T-shaped IRT device (120). The device (120) may comprise a mouthpiece (122) configured to accept one or more initial maximum inspirations and one or more subsequent inspirations from a user. The device (120) may further comprise a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more initial maximum inspirations and the one or more subsequent inspirations. The device (120) may further comprise a pressure transducer (124) having a constant and near infinite resistance, operatively coupled to the mouthpiece (122), configured to detect one or more initial maximum inspiratory pressures based on the one or more initial maximum inspirations against the constant and near infinite resistance and one or more subsequent inspiratory pressures based on the one or more subsequent inspirations against the constant and near infinite resistance. The device (120) may further comprise a microcontroller (126) communicatively coupled to the pressure transducer (124), configured to generate one or more initial maximum inspiratory pressure (PI_max) waveforms based on detection of the one or more initial maximum inspiratory pressures and one or more subsequent inspiratory pressure waveforms based on detection of the one or more subsequent inspiration pressures by the transducer (124). The device (120) may further comprise a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more initial PI_max waveforms and the one or more subsequent inspiratory pressure waveforms to a computing device (110).

[0039] The system (100) may further comprise the computing device (110) communicatively coupled to the IRT device (120), comprising a display component (116) configured to display real time waveform data, a processor (112) operatively coupled to the display component (116), configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions. The computer-readable instructions may comprise accepting the one or more initial PI_max waveforms from the IRT device (120), displaying, by the display component (116), the one or more initial PImax waveforms, and establishing a target training pressure based on the one or more initial PI_max waveforms. The target training pressure may comprise a range that encompasses a target inspiratory pressure. The computer-readable instructions may further comprise displaying, by the display component (116), the target training pressure, accepting the one or more subsequent inspiratory pressure waveforms from the IRT device (120), and displaying, by the display component (116), the one or more subsequent inspiratory pressure waveforms compared to the target training pressure.

[0040] In some embodiments, the computer-readable instructions may further comprise increasing the target training pressure if the one or more subsequent inspiratory pressure waveforms fall within the range. In some embodiments, the range may encompass ±5 to ±10 mmHg compared to the target training pressure. In some embodiments, the target inspiratory pressure may be configured to increase from 55% to 65% of an average of the one or more maximum inspiratory pressures generated by the user. In some embodiments, the target inspiratory pressure may be configured to increase from 65% to 75% of an average of the one or more maximum inspiratory pressures generated by the user. In some embodiments, the one or more subsequent inspiratory pressure waveforms may be collected over 3 to 7 minute daily intervals. In some embodiments, the target inspiratory pressure may comprise 55% to 75% of an average of the one or more initial maximum inspiratory pressures generated by the user. In some embodiments, the one or more maximum respiratory efforts may comprise inhalations, exhalations, or obstructed inspiratory/expiratory efforts.

[0041] The present invention features a method comprising providing a respiratory resistive training (RRT) device (120) having a constant and near infinite resistance and accepting, by the RRT device (120), one or more maximum respiratory efforts from a user. The one or more maximum respiratory efforts may be separated by an interval. The method may further comprise generating, by the RRT device (120), one or more initial maximum respiratory pressure (P_max) waveforms based on the one or more maximum respiratory effort s generated by the user, accepting, by a computing device (110), the one or more initial P_max waveforms generated by the RRT device (120), displaying, by the computing device (110), the one or more initial P_max waveforms, and establishing, by the computing device (110), a target training pressure based on the one or more initial P_max waveforms. The target training pressure may comprise a range encompassing a target respiratory pressure. The method may further comprise displaying, by the computing device (110), the target respiratory pressure based on the maximum respiratory pressure (P_max), accepting, by the RRT device (120), one or more subsequent respiratory pressures generated by the user, generating, by the RRT, one or more subsequent pressure waveforms based on the one or more subsequent respiratory pressures, accepting, by the computing device (110), the one or more subsequent pressure waveforms from the RRT device (120), displaying, by the computing device (110), the one or more subsequent pressure waveforms compared to the target training pressure, and increasing, by the computing device (110), the target training pressure if the one or more subsequent pressure waveforms are within the range.

[0042] The IRT device outlined in this paper overcomes the shortcomings of previous devices and uses Bluetooth® Low Energy (BLE) communication to transmit data from the device to the user's smartphone. The mechanical design will be constructed with scalable manufacturing in mind, along with the capability for disassembly for sanitization. The device will resemble the same general flow as a blood alcohol content breathalyzer and may be “L” or “T”-shaped. Providing the device with a strong balance between storage capabilities and airflow passage. Electronics are intended to be placed in the long stretch of the L or T and have the pressure transducer as close to the mouthpiece as possible while the short stretch of the L or T will be hollow for exhaled/inhaled air to escape through. The present invention may account for the placement of electronics, sensors, and the creation of air-tight seals where applicable while keeping ergonomics in mind for the user.

[0043] The electronics may communicate data from the sensor in the device to a user's Android® smartphone app. This app will not only display real-time waveforms for inhalation but also handle all of the data processing and communication for relaying trial information from each unique device to clinical trial coordinators. The app has many other functionalities, that many previous devices lack, and are focused on beneficence to the user which will be discussed later. One of the most significant aspects of the app is that it will automatically calibrate and display the user’s ideal target training pressure, which is scaled according to their previously produced Plmax. Additionally, the app will track the user's progress over time and offer encouragement to the user to continue their training regime via feedback on breaths completed and success attaining the target training pressure. Making this system as accessible as possible for the target population will provide those individuals with elevated blood pressure a means of reducing it, and therefore, directly reducing their chance of developing CVD.

[0044] The present invention may comprise several separable components that would allow users to easily sterilize the device and therefore, prevent respiratory infection. The present invention may further comprise a unidirectional path for airflow which reduces the number of steps required in sterilization and potential damage to electronic components. The electrical design of the IRT device may comprise a commonly available pressure transducer connected to a BLE microcontroller for receiving, processing, and then transmitting the pressure data to an external Android® device. The product will also include an Android® application that presents and stores the data received from the BLE microcontroller and provides visual feedback to users throughout their training regimens. The app will also allow users to share their respiratory data with clinical coordinators provided a secure connection compliant with Health Insurance Portability and Accountability Act (HIPAA) regulations.

[0045] EXAMPLE

[0046] The following is a non-limiting example of the present invention. It is to be understood that said example is not intended to limit the present invention in any way. Equivalents or substitutes are within the scope of the present invention.

[0047] The application component of the IRT system was designed for Android® OS due to the easier accessibility and broader impact in communities that would benefit most from such a device. Nevertheless, the principal function of the application was the same across platforms and easily translated given appropriate resources.

[0048] The application utilizes the device’s built-in Bluetooth® Low Energy (BLE) architecture to scan for a specific device, given by its unique ID. The user must enter this ID, which is provided with the handheld device, and press a button to start the internal connection procedure. This procedure scans the room for all BLE-enabled devices and parses the list utilizing universally unique identifiers (UUIDs) which are specifically programmed onto the BLE microcontroller housed within the handheld device. Once a connection is formed, the user is notified and allowed to continue into the application. In the background of the application, a BLE Server function maintains all the information that is required to form the Bluetooth® connection so that it will be used later on in the application. During the transitions into the graphical displays for the calibration and training sequence, the application reconnects to the handheld device and resumes logging and displaying the pressure values transmitted. This localization of BLE connection to its specific use (graphical display of pressure data) was written into the software to ensure connection fidelity throughout the six or seven minute training protocol. The localization can be removed if deemed appropriate.

[0049] The base parameters required for the connection and eventual transmission of data are as follows: 1) the handheld device must contain a microcontroller with BLE architecture, 2) the microcontroller must be able to read data from a pressure transducer, partition that data into bytes, and then transmit those bytes in an advertisement package once a connection has been established, 3) the receiving smartphone device must have Bluetooth® enabled and BLE capabilities built into the system.

[0050] Defining the individual's maximum pressure requires the calibration software component, accessible after registration with the device ID. The user can press the Calibration button to start. They’ll be taken to an instruction screen where they can review how to perform the calibration sequence. Another button will take them into the calibration procedure. A real-time graph will display the relative pressure detected by the device. Above that will be a reminder: “Sharp inhale. Exhale out all the way first. Repeat 3 times.” There is also a countdown that shows how many breaths are left in the calibration sequence. A breath is determined to be completed due to the formation of a peak, so there is no intrinsic consideration of magnitude and thus there is no prejudice against new or multiple users. However, users will need to be exposed to the “ideal” calibration waveform either by trained personnel or by watching the demonstration video included in the application prior to selecting the calibration or training sequences.

[0051] Once the user has completed three maximum inspiratory efforts (PI_max), the window closes momentarily and the user is redirected to the final stage of the calibration procedure. Here, the user will see their updated PI_max in the designated units (default: mmHg) and whether or not they have improved over their previous efforts. The value is saved to their individual app settings and will eventually be saved to their user profile to prevent the possible deletion of the recorded PI_max. However, the PI_max is also accessible via the saved calibration data on the paired Android® device or the data storage system in Firebase®, although encrypted in both locations.

[0052] Using an individual’s specific training value, a slider on the app allows the user to increase their training level in 5% increments, 45% through to 75% of their (PI_max). The user will have access to the slider display with the corresponding training value percentage. This information is saved in the recorded and encrypted .csv file, for later analysis. It is also translated through the app until the entire training sequence has been completed. After selecting the training level/difficulty from the slide bar, the program will transition into a display with a region for instructions, a breath-and-set counter, an inter-set timer, and a real-time graphical display of pressure values from the handheld device.

[0053] The instructions are much like the instructions for the calibration sequence - static. They are a supplementary reference for users who have walked through the structure of the training protocol or watched the supplementary instruction video provided in the application. The instructions remind the user to stay within the target range for 1-2 seconds during their inhale in order to trigger the feedback loop which generates a longer-lasting drop in systolic blood pressure.

[0054] The breath-and-set counter relies on the pressure data being continuously received from the handheld device, but the principal algorithm is efficient, allowing the data to be assessed without interfering with the real-time nature of the graph. If the pressure drops below 35% of PI_max, that breath is counted as an effort and will be marked off on the breath count. About 1 second after the breath count reaches zero, the real-time display will pause and clear in an effort to conserve active memory in the smartphone device. The set count will decrease by one, and the timer function will be initiated. This process repeats until the set count reaches zero, indicating the user has completely finished their training procedure. At this point, the screen is cleared again and the user is moved into the training review stage of the application. It should also be noted that the user can exit the training procedure at any time by pressing the “Finish Training” button. They will be prompted to press it again, and then the protocol will be aborted.

[0055] The inter-set timer is only dependent on the breath-and-set counter. Once the breath count reaches zero, the timer is triggered. The space assigned to the timer will be filled with text counting down from 60 seconds. When the timer reaches 5 seconds, the graph will begin displaying values again to indicate that the user should be getting ready for another set of breaths. The timer will also flash a quick message “Start/Breathe Now” for a few seconds as another reminder.

[0056] The real-time graphical display of the pressure data is the crux of this application and one of the more sensitive components. The BLE Server component must connect to the handheld device and begin receiving data. For each data packet received from the handheld device, it triggers a local function that converts the data from bytes back into a usable form (i.e., double). The first three packets of pressure data received are used to create an average and determine the atmospheric pressure so the displayed data is calibrated and only conveys the user’s relative pressure, or inspiratory pressure in this application. The pressure data is run through some checks and flags to assess whether a breath has started or finished. The pressure value and timestamp are then encrypted and written to a procedure-specific .csv file, which is uploaded after the full dataset has been processed. The data is then written for graphical display. The program plots the target pressure and two lines about 5 mmHg apart from the target line and then plots the pressure value received from the handheld device. All of these values are appended to four vectorized datasets, and then these values are updated on the graph. This entire process takes ~10 ms, with a maximum updating frequency of -100 Hz, however, due to ideal visual perception and to ensure the continued functioning of the graph, the update frequency is set to around 25 Hz. The setting is adjustable.

[0057] Once the user has finished the training procedure, the program processes all of the pressure data and determines the user’s success rate. The entire array of pressure values is transferred to the next frame of the application and processed there before results are shown. The code flags all the data values that are within the given range, so the target pressure is ± 5 mmHg, and then it counts each section as a successful breath. Even if the pressure values diverge from the target training pressure range during the breath, they are still counted as part of the same successful breath. This data is stored for future clinical analysis if necessary. A bar chart illustrates the percentage of successful breaths, with colors ranging from green to yellow to orange to red for immediate feedback. A second bar displays the average time the user spent within the designated zone of inspiratory pressure. The bar is green if the total time is anywhere between one and two seconds, yellow if the time is outside that range by about 0.2 seconds, and red if the variance is any more than that.

[0058] The following is another non-limiting example of the present invention. It is to be understood that said example is not intended to limit the present invention in any way. Equivalents or substitutes are within the scope of the present invention.

[0059] Because adaptation to a training stimulus is known to occur with exercise, the application component includes capacity to vary between different training regimens. The default setting operates for the first 6 weeks, during which time the user is guided to complete 5 sets of 6 breaths (30 breath total), 5 days/week. After the user completes 6 training weeks, the app will prompt the user to select from among a range of training regimen options. Specifically, the user will be able to select between a) completing 5 sets of 6 breaths (30 breaths) once weekly; b) 3 days/week or; c) 5 days/week. At the end of 6 weeks, the app will again prompt the user to select from among once weekly, 3 times weekly or 5 times weekly training regimens.

[0060] The computer system can include a desktop computer, a workstation computer, a laptop computer, a netbook computer, a tablet, a handheld computer (including a smartphone), a server, a supercomputer, a wearable computer (including a SmartWatchTM), or the like and can include digital electronic circuitry, firmware, hardware, memory, a computer storage medium, a computer program, a processor (including a programmed processor), an imaging apparatus, wired/wireless communication components, or the like. The computing system may include a desktop computer with a screen, a tower, and components to connect the two. The tower can store digital images, numerical data, text data, or any other kind of data in binary form, hexadecimal form, octal form, or any other data format in the memory component. The data/images can also be stored in a server communicatively coupled to the computer system. The images can also be divided into a matrix of pixels, known as a bitmap that indicates a color for each pixel along the horizontal axis and the vertical axis. The pixels can include a digital value of one or more bits, defined by the bit depth. Each pixel may comprise three values, each value corresponding to a major color component (red, green, and blue). A size of each pixel in data can range from a 8 bits to 24 bits. The network or a direct connection interconnects the imaging apparatus and the computer system.

[0061] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of’ or “consisting of’, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of’ or “consisting of’ is met.

[0062] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.

Claims

WHAT IS CLAIMED IS:

1. A real-time respiratory resistive training (RRT) system (100) comprising a computing device (110) communicatively coupled to an RRT device (120) having a constant and near infinite resistance, configured to accept one or more maximum respiratory pressure (P_max) waveforms generated by the RRT device (120) upon receiving one or more maximum respiratory efforts from a user, wherein the one or more P_max waveforms are representative of the one or more maximum respiratory efforts against the constant and near infinite resistance, display the one or more P_max waveforms, and establish a target training pressure based on the one or more P_max waveforms.

2. The system (100) of claim 1, wherein the RRT device (120) is further configured to accept one or more subsequent respiratory efforts and generate one or more subsequent pressure waveforms based on the one or more subsequent respiratory efforts against the constant and near infinite resistance, wherein the computing device (110) is further configured to: a. display the target training pressure, wherein the target training pressure comprises a range encompassing a target respiratory pressure; b. accept the one or more subsequent pressure waveforms from the RRT device (120); and c. display the one or more subsequent pressure waveforms compared to the target training pressure.

3. The system (100) of claim 2, wherein the computing device (110) is further configured to increase the target training pressure if the one or more subsequent pressure waveforms are within the range.

4. A real-time respiratory resistive training (RRT) system (100) comprising: a. an RRT device (120) having a constant and near infinite resistance, configured to accept one or more maximum respiratory efforts from a user and generate one or more maximum respiratory pressure (P_max) waveforms, wherein the one or more Pmax waveforms are representative of the one or more maximum respiratory efforts against the constant and near infinite resistance; and b. a computing device (110) communicatively coupled to the RRT device (120), comprising a processor (112) configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions for: i. accepting the one or more P_max waveforms from the RRT device (120); ii. displaying the one or more P_max waveforms; and iii. establish a target training pressure based on the one or more P_max waveforms.

5. The system (100) of claim 4, wherein the RRT device (120) is further configured to accept one or more subsequent maximum respiratory pressures and generate one or more subsequent pressure waveforms based on the one or more subsequent maximum respiratory pressures against the constant and near infinite resistance, wherein the computer-readable instructions further comprise: a. displaying the target training pressure, wherein the target training pressure comprises a range encompassing a target respiratory pressure; b. accepting the one or more subsequent pressure waveforms from the RRT device (120); and c. displaying the one or more subsequent pressure waveforms compared to the target training pressure.

6. The system (100) of claim 5, wherein the computer-readable instructions further comprise increasing the target training pressure if the one or more subsequent pressure waveforms are within the target pressure range.

7. The system (100) of claim 1 or 4, wherein the RRT device (120) comprises: a. a mouthpiece (122) configured to accept the one or more maximum respiratory efforts from the user; b. a pressure transducer (124) operatively coupled to the mouthpiece (122), with specifications suited to detect one or more maximum pressures associated with the one or more maximum respiratory efforts generated by the user against the constant and near infinite resistance; c. a microcontroller (126) communicatively coupled to the pressure transducer (124), configured to generate one or more P_max waveforms based on the transducer sensing the one or more maximum pressures; and d. a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more P_max waveforms to the computing device (110).

8. The system (100) of claim 7, wherein the RRT device (120) further comprises a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more maximum respiratory efforts.

9. The system (100) of claim 7, wherein the RRT device (120) comprises a non-leak system, wherein the one or more maximum respiratory pressures are generated by the user against an infinite resistance.

10. A real-time inspiratory resistive training (IRT) system (100) comprising: a. an IRT device (120) comprising: i. a mouthpiece (122) configured to accept one or more initial maximum inspirations and one or more subsequent inspirations from a user; ii. a leak hole (130) fluidly coupled to the mouthpiece (122) such that suction is prevented throughout the one or more initial maximum inspirations and the one or more subsequent inspirations; iii. a pressure transducer (124) having a constant and near infinite resistance, operatively coupled to the mouthpiece (122), configured to detect one or more initial maximum inspiratory pressures based on the one or more initial maximum inspirations against the constant and near infinite resistance and one or more subsequent inspiratory pressures based on the one or more subsequent inspirations against the constant and near infinite resistance; iv. a microcontroller (126) communicatively coupled to the pressure transducer (124), configured to generate one or more initial maximum inspiratory pressure (PI_max) waveforms based on detection of the one or more initial maximum inspiratory pressures and one or more subsequent inspiratory pressure waveforms based on detection of the one or more subsequent inspiration pressures by the transducer (124); and v. a wireless transceiver (128) communicatively coupled to the microcontroller (126), configured to transmit the one or more initial PI_max waveforms and the one or more subsequent inspiratory pressure waveforms to a computing device (110); and b. the computing device (110) communicatively coupled to the IRT device (120), comprising a display component (116) configured to display real time waveform data, a processor (112) operatively coupled to the display component (116), configured to execute computer-readable instructions and a memory component (114) operatively coupled to the processor (112), comprising computer-readable instructions for: i. accepting the one or more initial PI_max waveforms from the IRT device (120); ii. displaying, by the display component (116), the one or more initial PI_max waveforms; iii. establishing a target training pressure based on the one or more initial PI_max waveforms, wherein the target training pressure comprises a range that encompasses a target inspiratory pressure; iv. displaying, by the display component (116), the target training pressure; v. accepting the one or more subsequent inspiratory pressure waveforms from the IRT device (120); and vi. displaying, by the display component (116), the one or more subsequent inspiratory pressure waveforms compared to the target training pressure.

11. The system (100) of claim 10, wherein the computer-readable instructions further comprise increasing the target training pressure if the one or more subsequent inspiratory pressure waveforms fall within the range.

12. The system (100) of claim 3, 6, or 11, wherein the range encompasses ±5 to ±10 mmHg compared to the target training pressure.

13. The system (100) of claim 3, 6, or 11, wherein the target inspiratory pressure is configured to increase from 55% to 65% of an average of the one or more maximum inspiratory pressures generated by the user.

14. The system (100) of claim 3, 6, or 11, wherein the target inspiratory pressure is configured to increase from 65% to 75% of an average of the one or more maximum inspiratory pressures generated by the user.

15. The system (100) of claim 2, 5, or 10, wherein the one or more subsequent inspiratory pressure waveforms are collected over 3 to 7 minute daily intervals.

16. The system (100) of claim 1, 4, or 10, wherein the target inspiratory pressure comprises 55% to 75% of an average of the one or more initial maximum inspiratory pressures generated by the user.

17. The system (100) of claim 1, 4, or 10, wherein the device (120) is communicatively coupled to the computing device (110) by a Bluetooth® Low-Energy (BLE) connection.

18. The system (100) of claim 1 or 4, wherein the device (120) comprises an L-shape or T-shape.

19. The system (100) of claim 1, 4, or 10 wherein the computing device (110) comprises a personal computer, a smartphone, a portable computing device, or a combination thereof.

20. The system (100) of claim 1 or 4, wherein the one or more maximum respiratory efforts comprise inhalations, exhalations, or obstructed respiratory efforts.

21. The system (100) of claim 4, wherein the computing device (110) further comprises a display component (116), configured to display data.

22. The system (100) of claim 10 or 21, wherein the display component (116) comprises a screen.

23. A method comprising: a. providing a respiratory resistive training (RRT) device (120) having a constant and near infinite resistance; b. accepting, by the RRT device (120), one or more maximum respiratory efforts from a user, wherein the one or more maximum respiratory efforts are separated by an interval; c. generating, by the RRT device (120), one or more initial maximum respiratory pressure (P_max) waveforms based on the one or more maximum respiratory effort s generated by the user; d. accepting, by a computing device (110), the one or more initial P_max waveforms generated by the RRT device (120); e. displaying, by the computing device (110), the one or more initial P_max waveforms; f. establishing, by the computing device (110), a target training pressure based on the one or more initial P_max waveforms, wherein the target training pressure comprises a range encompassing a target respiratory pressure; g. displaying, by the computing device (110), the target respiratory pressure based on the maximum respiratory pressure (P_max); h. accepting, by the RRT device (120), one or more subsequent respiratory pressures generated by the user; i. generating, by the RRT, one or more subsequent pressure waveforms based on the one or more subsequent respiratory pressures; j. accepting, by the computing device (110), the one or more subsequent pressure waveforms from the RRT device (120); k. displaying, by the computing device (110), the one or more subsequent pressure waveforms compared to the target training pressure; and

1. increasing, by the computing device (110), the target training pressure if the one or more subsequent pressure waveforms are within the range.

24. The method of claim 23, wherein the method is for reducing blood pressure.

25. The method of claim 23, wherein the method is for improving nighttime breathing.

26. The method of claim 23, wherein the method is for reducing nighttime sleep disturbance.

27. The method of claim 23, wherein the method is for reducing respiratory fatigue.

28. The method of claim 23, wherein the method is for reducing gastroesophageal reflux disease.

29. The method of claim 23, wherein the method is for reducing plasma catecholamines.

30. The method of claim 23, wherein the method is for mobilizing immune cells into the circulation for improving immunosurveillance.