TWI897450B - Method and apparatus for training and evaluating respiratory muscles - Google Patents

Abstract

The present invention provides a method for training respiratory muscles comprising steps of providing a mask covering area of user’s face utilized for breathing wherein a valve element is arranged on the mask, controlling the valve to set a inhaling resistance for simulating obstruction of respiratory tract such that when the user inhales, a negative pressure is generated in the respiratory tract, measuring physiological parameters with respect the breathing, and adjusting training modes according to the physiological parameters during the breathing process.

Description

Respiratory muscle training methods and assessment devices

The present invention relates to a method and device for muscle training, and more particularly to a method and device for evaluating the effectiveness of trained muscles, including respiratory muscle training.

Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts during sleep. Not only does sleep apnea cause loud snoring, but it can also cause fatigue even after a full night's sleep. Statistics show that the majority of sleep apnea cases are obstructive sleep apnea (OSA), a condition in which the throat muscles relax, blocking air from entering the lungs. This condition occurs when the upper airway muscles relax, causing repeated blockage during sleep.

The muscles of the throat are primarily the upper airway dilator muscles (UADMs), which comprise twenty skeletal muscles. Due to aging or lifestyle factors, these muscles become lax or atrophied, unable to maintain the tension required to maintain airway patency during sleep, leading to sleep apnea. Furthermore, partial obstruction caused by allergies or respiratory infections in children or adults also requires these muscles to exert additional strength to maintain the necessary airway patency. Therefore, the medical community considers OSA a phenomenon characterized by upper airway resistance.

To address this issue, some conventional techniques utilize external forces to assist patients and prevent sleep apnea. For example, Republic of China Patent No. I574654 discloses a system that combines negative pressure breathing therapy with adjustment of the relative angle of the user's head, neck, and shoulders during sleep to improve upper airway patency. The system includes an angle positioning unit, a mouth interface unit, and a vacuum source. The angle positioning unit adjusts the user's head, neck, and upper torso to the optimal relative angle range for negative pressure breathing therapy during sleep. The vacuum source then provides negative pressure to the oral interface unit, which is then transmitted to the oral cavity. This negative pressure then moves the tongue and soft palate toward the front and top of the oral cavity, increasing the distance between the soft palate and tongue base and the back wall of the larynx, thereby improving the patency of the user's upper airway. While this technology can prevent respiratory arrest, it utilizes an external air pressure source to generate negative pressure, resulting in complex equipment and the need for constant assembly, which in turn creates issues with space and equipment costs. Electromyography (EMG) is clinically used to assess the contraction function of the upper airway dilator muscles. However, it is difficult to perform and is invasive, so it is not widely used.

In summary, there is a need for a respiratory muscle training method and assessment device that can help users strengthen their muscles through training to fundamentally resolve the problem of sleep apnea.

The present invention provides a respiratory muscle training method and assessment device having the following features:

1. This system uses adjustable resistance to simulate respiratory obstruction, generating negative pressure during the user's inhalation process and gradually increasing the strength of the dilators. In one embodiment, the load applied to the muscle group during the inhalation cycle can be regulated by adjusting the resistance of the check valve. Each time the maximum or specified pressure drops (even to a negative pressure), the maximum or specified inhalation volume or duration is reduced.

2. Nasal inhalation, which trains the upper airway dilator muscles, achieves optimal results. While current respiratory training equipment typically uses oral inhalation, this patent utilizes nasal inhalation to train the upper airway dilator muscles.

3. During the inhalation cycle, the negative pressure generated in the upper respiratory tract causes additional resistance in the mouth, nose, or oropharynx. The relaxed and expanded muscles are unable to maintain the patency of the respiratory tract. Further reduction of upper respiratory tract pressure or even negative pressure, continued contraction of the diaphragm will cause soft tissue edema and even downward obstruction of the tongue, ultimately leading to respiratory arrest. The diaphragm is the largest respiratory muscle and is directly involved in the sleep apnea process. Monitoring diaphragmatic activity becomes crucial, especially when airway pressure decreases abnormally or even becomes negative. This is because the pressure drop caused by diaphragmatic contraction directly challenges the contraction of the skeletal muscles that dilate the upper airway. Therefore, this invention pioneers the use of conscious control of diaphragmatic contraction to create a load or overload on the skeletal muscles that dilate the upper airway. This intermittently increases the intensity of the training, ultimately strengthening the strength and endurance of the skeletal muscles that dilate the upper airway, thereby increasing the tension of the skeletal muscles that dilate the upper airway and preventing obstruction during sleep.

In one embodiment, the present invention provides a method for training respiratory muscles, comprising the following steps: First, a mask is provided to cover the breathing area of a user's face, the mask having a valve. Next, the valve is remotely controlled to set and adjust an inhalation resistance to simulate airway obstruction, generating negative pressure in the airway when the user inhales. During the user's breathing process, physiological parameters related to the user's respiratory movement state are measured. Finally, the training mode can be adjusted during the process based on the physiological parameters.

In one embodiment, the present invention provides a respiratory muscle training assessment device comprising a mask, a physiological parameter detection element, and a computational processing device. The mask is used to cover the breathing area of a user's face. The mask has a valve electrically connected to a control device. The valve receives input from the control device to adjust an inhalation resistance to simulate airway obstruction, generating negative pressure in the airway when the user inhales. The physiological parameter detection element measures physiological parameters related to the user's respiratory movement during breathing under the inhalation resistance. The computational processing device is electrically connected to the physiological parameter detection element and adjusts the training mode based on the physiological parameters.

In one embodiment, the present invention provides a detection carrier comprising at least one or more sensing elements that can be inserted into the oral cavity. When the exhalation or inhalation movement under the resistance mask causes the upper airway muscle group to contract, the sensing element can evaluate the contraction function of the upper airway muscle group, especially the rate and degree of muscle contraction under different resistance or flow pressure, which is the focus of observation. Sensors can be categorized as contact and non-contact. These include: (1) Contact mechanomyography (MMG), which uses piezoelectric chips to measure the frequency of muscle surface vibrations to determine muscle contraction. Ultrasound in M-mode and B-mode can also be used to directly observe muscle changes. (2) Non-contact sensors use thermal imaging to detect muscle contraction hotspots, CCD cameras to observe changes in the soft palate's appearance, such as changes in the shape and angle of the palatopharyngeal arch, or direct 3D imaging.

2: Methods

Steps 20-23:

3: Respiratory muscle training assessment device

30: Mask body

31: Valve body

310: Control Components

32: Computational processing device

320: Display unit

33: Physiological parameter detection element

9: User

90: Diaphragm

91: Respiratory tract

92: Upper airway dilator muscles

Figure 1 is a schematic diagram of the process of one embodiment of the respiratory muscle training method of the present invention.

Figures 2A and 2B are schematic diagrams of different embodiments of the respiratory muscle training assessment device of the present invention.

Figures 3 and 4 are schematic diagrams of the physiological parameter curve changes of the present invention.

Figures 5A and 5B are schematic diagrams illustrating the upper respiratory tract muscles and diaphragm muscles of the present invention.

Various exemplary embodiments will be more fully described below with reference to the accompanying drawings, some of which are shown in the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the exemplary embodiments described herein. Rather, these exemplary embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the present invention to those skilled in the art. Like numbers indicate like elements throughout. Several embodiments will be used below to illustrate the respiratory muscle training method and assessment device, and the following embodiments are not intended to limit the present invention.

Please refer to FIG1 , which is a schematic flow chart of an embodiment of the method for training the respiratory muscles of the present invention. In this embodiment, step 20 is first performed to provide a mask to cover the area on the user's face for breathing. In this step, as shown in FIG2A , the mask 30 in the figure covers the area on the head of the user 9 for breathing, which can be the mouth or the nose, or both the mouth and the nose. The mask 30 of this embodiment covers the mouth and nose. The mask 30 is provided with a valve 31, which can adjust the amount of air inhaled from the external environment into the mask 30 by the user when the user inhales. In one embodiment, the mask 30 is attached to the skin of the user's face, and has an airtight effect. The mask 30 can also be buckled to the user's ears with elastic straps so that the mask can be tightly attached to the user's face. In another embodiment, the mask 30 can be placed on the user's head instead of a headband, allowing the mask 30 to fit tightly against the skin. This airtight fit ensures that air can enter the mask 30 through the valve 31 and then be inhaled into the user's upper respiratory tract.

Returning to Figure 1, after step 20, step 21 proceeds to the distal or proximal control valve to set and vary the inhalation resistance to simulate airway obstruction. This generates a negative pressure in the airway relative to the external air pressure when the user inhales. In this step, as shown in Figure 2A, valve 31 includes a control element 310 that adjusts the amount of air intake based on a control signal. The amount of air intake represents the resistance to inhalation experienced by the user. For example, a wide opening of the valve body 31 results in low inhalation resistance. Consequently, when the user inhales, a large amount of air enters the mask 30 from the external environment through the valve body 31. Conversely, a narrow opening of the valve body 31 results in greater inhalation resistance. Consequently, when the user inhales, a small amount of air enters the mask 30 from the external environment through the valve body 31. In this embodiment, the control element 310 on the valve body 31 can receive a control signal from a remote device via wired or wireless communication, such as a Bluetooth signal or wireless network signal, but this is not limiting. This control element controls the size of the valve body 31, thereby controlling the resistance experienced by the user during inhalation. The magnitude of this resistance is related to the user's upper respiratory muscle training. Therefore, properly controlling the resistance or changing it can achieve the effect of training the user's upper respiratory muscle groups.

In one embodiment of step 21, the user connects to the control element 310 of the valve body 31 through the computing device 32. In one embodiment, the computing device 32 can be a smart handheld or wearable device, such as a smart phone, a tablet computer, a wearable watch, or a device that combines the cover 30 and the valve body 31. The computing device 32 can also be a laptop or a cloud server. In this embodiment, the computing device 32 is a smart phone with a display unit 320. The computing device 32 runs an application APP, and after the user executes it, the user interface of the operation is displayed on the display unit 320. In one embodiment, the user interface includes a function option for automatically or manually connecting to the valve body 31 electrically, such as via Bluetooth, radio frequency, or wireless signals. Once connected, the user can control the valve opening of the valve body 31 through the user interface displayed on the display unit 320, setting and varying the inhalation resistance to simulate airway obstruction and generate negative pressure in the airway when the user inhales.

Next, step 22 is performed to measure physiological parameters related to the user's respiratory movement during breathing. In this step, the physiological parameters can include blood oxygen concentration, physiological potential, airway flow, airway pressure, waist circumference, chest circumference, breathing sounds (e.g., chest breathing sounds, mouth and nose breathing sounds, or laryngeal airflow sounds), or a combination of at least two of these parameters. The purpose of this step is to observe and determine the effectiveness of the user's upper airway muscle training. Since muscle training cannot be directly observed visually, the purpose of this step is to make judgments based on physiological parameters. For example, in one embodiment, as shown in FIG3 , FIG3 (a) represents the control signal sent from the computing processing device 32 to the valve body 31 from the remote end; FIG3 (b) represents the change in resistance when the user inhales; FIG3 (c) represents the change in the inspiration/expiration cycle; FIG3 (d) represents the change in the pressure curve of the upper respiratory tract; FIG3 (e) represents the change curve of the blood oxygen concentration.

In Figure 3 , the processing device 32 sends control signals at three time points, T1, T2, and T3, to control the air intake of the valve body 31, representing the resistance to the user's inhalation. For example, at time T1, the resistance decreases, indicating an increase in the valve opening of the valve body 31, thus increasing the flow rate during the user's inhalation. Meanwhile, at time T2, the resistance increases, indicating a decrease in the valve opening of the valve body 31, thus decreasing the flow rate during the user's inhalation. It should be noted that, taking time T2 as an example, as shown in Figures 3(c) to 3(d), due to the increase in resistance, the user's inhalation volume per unit time decreases, thus lengthening the respiratory cycle. Simultaneously, the pressure in the upper airway decreases, becoming negative, as shown in area A of Figure 3 . At the same time, as can be seen in area B of Figure 3(e), blood oxygen levels also decrease. By guiding the user to increase their inhalation cycle, blood oxygen levels can be further increased. Therefore, by using at least one of the aforementioned physiological parameters, it is possible to correlate the changes in the user's respiratory state caused by changes in the air intake volume of valve 31. Therefore, as long as the physiological parameters are known during user training, they can be used to guide the user in training their upper airway muscles.

As shown in FIG2A , the aforementioned physiological parameters can be measured via a physiological parameter detection element 33. The physiological parameter detection element 33 varies depending on the parameter being sensed and is not limited to being located on the mask 30. For example, blood oxygen concentration can be measured by attaching a blood oxygen sensor to the user's finger. Physiological potential can be measured by attaching electrodes to the user's skin to obtain the user's ECG parameters during breathing. Airway flow or pressure can be measured by attaching an airflow characteristic sensor, such as a flow meter or pressure gauge, or a combination of both, to the mask worn by the user to measure the pressure in the user's airway and the flow rate during inhalation or exhalation. Changes in waist or chest circumference can be detected by a sensor, such as a chest strap or waist belt worn around the user's chest or waist, to detect changes in length. In another embodiment, as shown in Figure 2B , the mask 30 is connected via a conduit 330 . A physiological parameter detection element 33 , in this embodiment a pressure sensor or a flow sensor, senses pressure or flow. These various physiological parameters change as the user inhales and exhales, and the measured information can be used as a basis for subsequent training adjustments.

In another embodiment, the physiological parameter detection element 33 can further use images or sound signals to measure and observe the state of the respiratory muscles, thereby assessing the muscle's motor status (muscle strength and endurance). Physiological parameter detection elements 33 are categorized as contact and non-contact. These include: (1) Contact mechanomyography (MMG), which uses a piezoelectric chip to measure the frequency of muscle surface vibrations to determine the degree of muscle contraction; ultrasound M-mode and B-mode ultrasound can also be used to directly observe muscle changes; (2) Non-contact methods include thermal imaging to observe muscle contraction hotspots; CCD cameras to observe changes in the soft palate's appearance, such as changes in the shape and angle of the palatopharyngeal arch; or direct 3D stereoscopic imaging.

Next, proceed to step 23, where the training mode can be adjusted based on the physiological parameters. This step primarily uses the changes in the physiological parameters sensed in step 22 to determine the user's training mode and achieve the desired training effect. A training mode involves performing breathing movements based on specific frequency, depth, or pressure differential changes, or following a training cycle consisting of a specific number of inhalations and exhalations, depth, or pressure differential changes. Examples include, but are not limited to, inhalation, inhalation, exhalation, or inhalation, exhalation, exhalation. Figure 3(c) shows a curve diagram of the breathing movement.

In one embodiment, as shown in FIG4, at T1, the inhalation resistance is increased by remote control (as shown in FIG4 (a) ~ (b), under this setting condition, the user breathes at a specific frequency, depth or pressure difference, and the physiological parameter detection element 33 measures the physiological parameters of the user's breathing state, which in this embodiment are the breathing frequency (FIG4 (c)), pressure (FIG4 (d)), and blood oxygen concentration (FIG4 (e)). The obtained physiological parameters are transmitted to the user. The data is transmitted to a remote computing and processing device 32 via a transmission device. After receiving the measured physiological parameters, the computing and processing device 32 makes a judgment based on standard physiological parameters stored in a database. It then determines whether to adjust the inspiratory resistance based on these standard physiological parameters and the physiological parameters associated with specific changes in breathing frequency, depth, or pressure differential. For example, at time T2 shown in Figure 4(a), the user reduces the inspiratory resistance and increases the inspiratory flow rate.

Adjusting inhalation resistance can be accomplished by controlling the valve 31 on the mask body 30, either proximally or distally, to increase or decrease the airflow or resistance during inhalation. The greater the inhalation resistance, the less air from the external environment enters the user's nasal cavity through the valve 31, resulting in a decrease in upper airway pressure and a negative pressure effect. As shown in Figure 5A, user 9 sets the inhalation resistance of valve 31. Under the presence of resistance, when the user inhales, the diaphragm 90 contracts and stretches outward, causing the pressure in the airway 91 to decrease, creating a negative pressure, or pressure lower than the ambient atmospheric pressure. This is explained below using negative pressure P0. When negative pressure P0 is generated within the respiratory tract 91, the resulting pressure stretches the upper airway dilator muscles 92 inward, obstructing airway patency. At this point, the user's nervous system activates, causing the upper airway dilator muscles 92 to contract, maintaining the airway open and preventing the negative pressure from causing them to collapse. When the user exhales, as shown in Figure 5B, the user's diaphragm 90 relaxes and reverses, returning the positive pressure P1 within the respiratory tract 91. The negative pressure then releases the upper airway dilator muscles 92, which are no longer stretched. Through repeated inhalation and exhalation exercises, the upper airway dilator muscles contract and expand, thereby training the upper airway muscles. In one embodiment, the upper airway muscles 92 further include the soft palate muscles 92a.

During the inhalation/expiration cycle, the flow meter in the physiological parameter detection element 33 monitors changes in ventilation frequency (as shown in Figure 4(b)), and the blood oxygen concentration sensor in the physiological parameter detection element 33 monitors changes in oxygen concentration (as shown in Figure 4(e)). These physiological parameters are transmitted to the computational processing device 32, which then compares this information with training standard information to determine whether to adjust the resistance to air intake through the valve body 31.

In one embodiment, the computing and processing device 32 further includes a prompting device for providing prompt signals via sound, color, vibration, or touch. The prompting device can be a light-emitting diode (LED), a display, a buzzer, a speaker, or a vibrator, used to generate information regarding the progress of the training goal. In this embodiment, the prompting device is a display unit 320, such as a display screen. The prompting messages generated by the prompting device can guide the user in breathing movements to train the upper airway muscles. In another embodiment, the computing and processing device 32 and the display unit 320 can be independent devices located externally or integrated with the mask 30. This is determined based on the desired use and is not limited to specific devices.

In summary, the respiratory muscle training method and assessment device provided by the present invention does not require an external air pressure source. Instead, it uses adjustable resistance to simulate respiratory obstruction, generating negative pressure during the user's inhalation process, gradually increasing the strength of the dilator muscles. Furthermore, the present invention measures physiological parameters and correlates them with changes in upper airway muscle training. This measured physiological parameter information can be used to guide the user's breathing movements to train the respiratory muscles, thereby effectively improving the strength of the upper airway muscles.

The above merely describes the preferred embodiments or examples of the technical means employed by this invention to solve the problem, and is not intended to limit the scope of implementation of this patent. In other words, all equivalent variations and modifications that are consistent with the scope of this patent application or are made in accordance with the scope of this patent are covered by this patent.

2: Methods

Steps 20-23:

Claims (18)

A method for training respiratory muscles includes the following steps: Providing a mask that covers the breathing area of a user's face, the mask having a valve; Controlling the valve to set and vary an inhalation resistance to simulate airway obstruction, thereby generating negative pressure in the airway when the user inhales; Measuring physiological parameters related to the user's respiratory movement during the user's breathing process, wherein the physiological parameters are measured by a physiological parameter detector. The physiological parameter detector further uses image or sound signals to measure and observe the state of the respiratory muscles, thereby assessing the muscle movement state; And The training mode can be adjusted according to the physiological parameters during the training process. The method for training respiratory muscles as described in claim 1, wherein the physiological parameter is blood oxygen concentration, physiological potential, airway flow, airway pressure, waist circumference, chest circumference, or a combination of at least two of the foregoing parameters. The method for training respiratory muscles as described in claim 1 further includes a control device in which a control program is installed for generating an operating signal and interface for proximal or remote control of the valve body. The respiratory muscle training method of claim 1 further comprises the following steps: Measuring a physiological parameter related to the user's respiratory state when the user breathes at a specific frequency; and Determining whether to adjust the inhalation resistance based on a standard physiological parameter and the physiological parameter corresponding to the breathing at the specific frequency. A method for training respiratory muscles as described in claim 1, wherein the training mode is to perform breathing movements according to a specific frequency, depth, or pressure difference, or to perform breathing movements according to a training cycle consisting of a specific number of inhalations and a specific number of exhalations, depth, or pressure difference. A respiratory muscle training and assessment device comprises: A mask for covering the breathing area of a user's face. The mask has a valve electrically connected to a control device. The valve receives an inhalation resistance from the control device to simulate airway obstruction, generating negative pressure in the airway when the user inhales; A physiological parameter detector for measuring physiological parameters related to the user's respiratory movement during breathing under the inhalation resistance; and A processing device electrically connected to the physiological parameter detector for adjusting a training mode based on the physiological parameters. The physiological parameter detector further uses image or sound signals to measure and observe the state of the respiratory muscles, thereby assessing the muscle movement status. The respiratory muscle training assessment device as described in claim 6, wherein the physiological parameter is blood oxygen concentration, physiological potential, airway flow, airway pressure, waist circumference, or a combination of at least two of the foregoing parameters. As described in claim 6, the respiratory muscle training assessment device, wherein the physiological parameter sensing element is an airflow characteristic sensing element, which is arranged on the mask or connected to the mask through the trachea to sense the flow rate or air pressure when the user breathes. The respiratory muscle training assessment device as described in claim 6, wherein the physiological parameter sensing element is a potential sensing element for detecting the electromyographic parameters of the user during breathing. A respiratory muscle training assessment device as described in claim 6, wherein the physiological parameter sensing element is a waist circumference or chest circumference sensing element, which is used to sense the waist circumference parameters of the user when breathing. A respiratory muscle training assessment device as described in claim 6, wherein the physiological parameter sensing element is a blood oxygen sensing element for sensing the blood oxygen concentration of the user when breathing. The respiratory muscle training assessment device as described in claim 6, wherein the control device is installed with an application for generating an operating interface for remotely controlling the valve body. A respiratory muscle training assessment device as described in claim 6, wherein the training mode is to perform breathing movements according to a specific frequency, or to perform breathing movements according to a training cycle consisting of a specific number of inhalations and a specific number of exhalations, depth, or pressure difference. As described in claim 6, the respiratory muscle training assessment device can independently control the inhalation resistance, and can also accept a request from a device to adjust the inhalation resistance through a wired or wireless connection. In the respiratory muscle training assessment device as described in claim 6, the physiological parameter detection element is a microphone, an accelerometer, a muscle sound sensor, an ultrasonic sensor, an image sensor, a pressure sensor, or a thermal sensor. The respiratory muscle training assessment device as described in claim 6, wherein the mask body is a mask for covering the nose or the mouth and nose. As described in claim 16, the respiratory muscle training assessment device, wherein the mask is further equipped with a prompt device for providing a prompt signal of sound, color, vibration or touch. The respiratory muscle training assessment device as described in claim 17, wherein the prompt device is a light-emitting diode light-emitting element, a buzzer or a vibrator, which is used to generate information about the training target process.