This application claims the benefit of Taiwan Patent Application No. 112134101, filed on Sep. 7, 2023, and Taiwan Patent Application No. 113119908, filed on May 29, 2024, the subject matter of which is incorporated herein by reference.
BACKGROUND OF INVENTION
1. Field of the Invention
The present invention relates to a method and device for muscle training, specifically a method and device for training respiratory muscles.
2. Description of the Prior Art
Sleep apnea is a potentially serious sleep disorder in which a person's breathing repeatedly stops and starts during sleep. People with sleep apnea not only snore loudly during sleep but also feel tired even after a full night's rest. According to statistics, the majority of sleep apnea cases are classified as obstructive sleep apnea (OSA), a condition in which the throat muscles relax and block the airflow to the lungs. The cause is that the upper respiratory tract muscles are overly relaxed thereby leading to a repeated obstruction of the upper respiratory tract during sleep.
The muscles of the throat primarily consist of the upper respiratory tract dilator muscles (UADMs), which have around twenty skeletal muscles. Due to aging or lifestyle factors, these muscles may become relaxed or atrophied, such that the necessary tension to keep the respiratory tract open during sleep cannot be maintained thereby leading to sleep apnea. Additionally, in children or adults, partial obstruction caused by allergies or respiratory infections also requires exert extra strength so as to maintain the necessary respiratory tract patency. Therefore, the medical community classifies OSA as a condition that upper respiratory tract generates resistance.
To address this issue, conventional techniques have utilized external forces to assist patients in preventing sleep apnea. For example, Taiwan Patent No. 1574654 discloses a system that combines negative pressure breathing therapy with adjusting the relative angle of a user's head, neck, and shoulders during sleep to improve upper respiratory tract patency. This system comprises an angle positioning unit, an oral interface unit, and a vacuum source. The angle positioning unit adjusts the relative angle between the user's head, neck, and upper torso to a range optimal for negative pressure breathing therapy. The vacuum source then provides negative pressure to the oral cavity through the oral interface unit such that the tongue and soft palate are pushed to move forward and upward by the negative pressure whereby the distance between the soft palate and tongue base and the back wall of the throat is increased thereby keeping the user's upper respiratory tract patency. Although the conventional technique can prevent apnea, it belongs a passive technique that requires a vacuum source to provide negative pressure which makes the equipment more complicated and constantly equipped thereby inducing problem of space occupancy and equipment cost.
Accordingly, there is a need for a solution that can assist users to autonomously train their respiratory tract muscles and to strengthen these muscles through exercise whereby the issue of sleep apnea can be fundamentally resolved.
SUMMARY OF THE INVENTION
The present invention provides a method and device for training respiratory muscles, characterized by the following features:
- 1. By using adjustable resistance to simulate respiratory tract obstruction during inhalation or exhalation and setting the initial target of inhalation volume, the effect of strengthening the dilator muscles can be gradually enhanced. In one embodiment, the load applied to train the muscle group can be based on the maximum inhalation volume during each inhalation cycle or the inhalation time, when the internal pressure of the upper respiratory tract is decreased, or even decreased to reach the negative pressure during inhalation period.
- 2. In addition, inhaling through the nasal passages optimally trains the upper respiratory tract dilator muscles. Although most current devices for respiratory training use oral inhalation, the present invention implements nasal inhalation to train the upper respiratory tract dilator muscles.
- 3. During the inhalation cycle, the negative pressure generated in the upper respiratory tract is caused by additional resistance applied to the mouth, nose, or oronasal passages such that the relaxed dilator muscles fail to maintain respiratory tract patency thereby further reducing upper respiratory tract pressure or even reducing to negative pressure and causing the diaphragm continuously contracted so as to induce soft tissue edema or even tongue obstruction thereby ultimately resulting in apnea. The diaphragm, being the largest respiratory muscle, actively participates in the process of sleep apnea, especially when respiratory tract pressure abnormally decreases or reaches a negative pressure state. Therefore, monitoring diaphragm activity is crucial, as the pressure drop caused by diaphragm contraction directly challenges the contraction tension of the upper respiratory tract dilator muscles. Thus, the present invention is pioneering in using conscious control of diaphragm contraction to apply a load or overload on the upper respiratory tract dilator muscles. By intermittently increasing training intensity, the method ultimately strengthens the muscle power and endurance of the upper respiratory tract dilators, and enhances tension of upper respiratory tract dilator muscles during sleep process so as to prevent upper respiratory tract dilator muscles from being obstructed.
In one embodiment, the present invention provides a method for training respiratory muscles, comprising the following steps of providing a mask body and placing it over the user's face at the air intake and outflow position, wherein the mask body has an airflow regulating element arranged thereon to set an inhalation resistance, simulating respiratory tract obstruction during the user's inhalation process so as to result in negative pressure within the respiratory tract, setting a training standard information, and performing a training step such that the user performs at least one inhalation or exhalation exercise under the inhalation resistance to meet the training standard information.
In one embodiment, the present invention provides a device for training respiratory muscles, comprising: a mask body, a detecting element, and a processing device. The mask body is used to cover the air intake and outflow position on user's face. The detecting element is used to detect a detecting information when the user performs an inhalation or exhalation exercise. The processing device has a training standard information set therein, which is used to determine a level information based on the detecting information. It accumulates the level information corresponding to each inhalation or exhalation exercise and determines whether the training standard information has been reached based on the accumulated level information.
In one embodiment, the present invention provides a device for training respiratory muscles, comprising a belt and a processing device. The belt is fastened around the user's waist and is equipped with a sensing element to detect the user's waist circumference information during each inhalation or exhalation exercise. The processing device has a training standard information set therein, which is used to determine a level of information based on the waist circumference information. It accumulates the level information corresponding to each inhalation or exhalation exercise and then determines whether the training standard information has been reached based on the accumulated level information.
In one embodiment, the present invention provides a device for training respiratory muscles, comprising: a electrical sensing device and a processing device. The electrical sensing device has a plurality of electrode elements that make contact with the user's upper respiratory muscles or abdominal area to detect multiple electrical signals related to the upper respiratory muscles or the abdomen. The processing device has a training standard information set therein, which is used to determine a level of information based on these electrical signals. It accumulates the level information corresponding to each inhalation or exhalation exercise and then determines whether the training standard information has been reached based on the accumulated level information.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will now be specified with reference to its preferred embodiment illustrated in the drawings, in which:
FIG. 1 is a flowchart illustrating one embodiment of the method for training respiratory muscles of the present invention;
FIG. 2A is a schematic diagram of one embodiment of the device for training respiratory muscles of the present invention;
FIG. 2B is a schematic diagram of another embodiment of the device for training respiratory muscles of the present invention;
FIGS. 2C˜2F are respectively schematic diagrams of another embodiment of the device for training respiratory muscles of the present invention;
FIG. 3A is a schematic diagram of yet another embodiment of the device for training respiratory muscles of the present invention;
FIG. 3B is a schematic diagram of another embodiment of the device for training respiratory muscles of the present invention;
FIGS. 4A to 4C are schematic diagrams of different embodiments of the device for training respiratory muscles of the present invention;
FIG. 5 is a flowchart illustrating one embodiment of the training steps of the present invention;
FIGS. 6A and 6B are schematic diagrams illustrating diaphragm exercise in the present invention;
FIG. 6C is a schematic diagram showing the changes in inhalation and exhalation pressure of the user under resistance conditions in the present invention;
FIGS. 6D and 6E are schematic diagrams illustrating the training standard information composed of pressure and/or waist circumference information in the present invention;
FIGS. 7 and 8 are flowcharts illustrating one embodiment of the method for training respiratory muscles of the present invention;
FIG. 9 is a schematic flowchart of one embodiment of the method for training respiratory muscles according to the present invention;
FIGS. 10A and 10B are schematic diagrams of different embodiments of the respiratory muscle training evaluation device according to the present invention;
FIGS. 11 and 12 are schematic diagrams of physiological parameter curve changes according to the present invention; and
FIGS. 13A and 13B are schematic diagrams of the upper respiratory tract muscles and diaphragm activation according to the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The present disclosure is more particularly described in the following examples that are intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. Like numbers in the drawings indicate like components throughout the views. As used in the description herein and throughout the claims that follow, unless the context clearly dictates otherwise, the meaning of “a,” “an” and “the” includes plural reference, and the meaning of “in” includes “in” and “on.” Titles or subtitles can be used herein for the convenience of a reader, which shall have no influence on the scope of the present disclosure. In addition, the terms used herein generally have their ordinary meanings in the art. In the case of conflict, the present document, including any definitions given herein, will prevail. The same thing can be expressed in more than one way. Alternative language and synonyms can be used for any term(s) discussed herein, and no special significance is to be placed upon whether a term is elaborated or discussed herein. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms is illustrative only, and in no way limits the scope and meaning of the present disclosure or of any exemplified term. Likewise, the present disclosure is not limited to various embodiments given herein. Numbering terms such as “first,” “second” or “third” can be used to describe various components, signals or the like, which are for distinguishing one component/signal from another one only, and are not intended to, nor should be construed to impose any substantive limitations on the components, signals or the like.
Please refer to FIG. 1, which illustrates a flowchart of one embodiment of the method for training respiratory muscles according to the present invention. In this embodiment, the method 2 for training respiratory muscles is referred to train the respiratory tract muscle groups, which comprise the intercostal muscles, diaphragm, and/or upper respiratory tract dilator muscles (UADM). The following examples will describe training the upper respiratory tract dilator muscles; however, this is not the limitation of the present invention. Firstly, step 20 is started to provide a device for training respiratory muscle. In step 20, the training device may have various implementations but primarily achieves to simulate respiratory tract obstruction during inhalation through adjustable airflow resistance. In one embodiment, as illustrated in FIG. 2A, which shows a schematic of device for training respiratory muscle according to the present invention, wherein the device 3 comprises a mask body 30, a detecting element 31, and a processing device 32. The mask body 30 is utilized to cover the position of inhalation or exhalation exercise on face of user, wherein the position is referred to the mouth, nose, or both without specific limitations.
The detecting element 31 is arranged on the mask body 30 to detect air pressure information during the inhalation or exhalation exercise within the mask body 30, such as measuring the air pressure inside the oral cavity during inhalation or exhalation exercise. In this embodiment, the detecting element 31 is positioned on the inner surface of the mask body 30. In the present embodiment, the detecting element 31 comprises a wireless communication component 310, such as an RFID, near-field communication element, or Bluetooth device, for example, but should not be limited thereto. The wireless communication component 310 can wirelessly transmit the air pressure information detected by the detecting element 31. The processing device 32 is electrically connected or coupled to the detecting element 31 and is pre-configured with a training standard information through which the processing device 32 can determine if the training standard information is reached or not. In one embodiment, the processing device 32 may be a smart handheld device or wearable device, such as a smartphone, tablet, or smartwatch, for example. The processing device can also be a laptop or a cloud server. In the present embodiment, the processing device 32 is a smartphone equipped with a prompt unit 320 for displaying training standard information, resistance data corresponding to airflow, or pressure information detected by the detecting element 31. The prompt unit 320 can be a display unit, voice unit, or other vibration feedback device. In the present embodiment, the prompt unit 320 is a display unit, such as a display screen.
In another embodiment, as shown in FIG. 2B, the embodiment is essentially similar to the configuration in FIG. 2A, wherein the difference part is that an airflow regulating element 34 is additionally provided on the mask body 30 to regulate the amount of airflow entering the mask body 30 from the external environment. In one embodiment, the airflow adjustment component 34 can be adjustable, such as an adjustable valve, a check valve, or a flow controller that allows for the adjustment of the size of the airflow inlet and outlet, or it can be non-adjustable. The airflow amount entering the interior of the mask body 30 from the external environment can be adjusted manually or electrically. In another embodiment, the airflow adjustment component 34 has at least one opening, where the airflow intake can be controlled by adjusting the size of the opening or the covered part of the opening. The airflow entering the interior of the mask body 30 can be adjusted manually or electrically. In yet another embodiment, if the airflow adjustment component 34 is designed with holes, the objective of adjusting quantity of intake airflow can be achieved by replacing components having different open area ratios.
In another embodiment, as shown in FIGS. 2C to 2F, which illustrate another embodiment of device for training respiratory muscle of the present invention. The embodiment is essentially similar to FIG. 2A, while the different part is that the device further comprises an air supply device 36 to provide oxygen, steam, or a combination of oxygen and steam supplied to the user via an air supply tube 360 coupled to the mask body, thereby providing the oxygen or steam, or a combination thereof, that is needed during the training process. As shown in FIG. 2C, in this embodiment, one side of the mask body 30 is connected to the air supply device 36. In this embodiment, the airflow adjustment component 34 can be positioned on the mask body 30 or on the air supply tube 360 of the air supply device 36, and is coupled with the air supply tube 360 so as to adjust the oxygen flow from the air supply device 36 to the interior of the mask body 30 during inhalation by the user, thereby simulating the effect of inhalation resistance. In another embodiment, as shown in FIG. 2D, a detection component 31, such as a pressure sensor, thermal sensor, flow sensor, or a combination of the aforementioned, is coupled to the air supply tube 360 and is located between the mask body 30 and the airflow adjustment component 34 for communicating with the mask body 30. It should be noted that the airflow adjustment component 34 and the detection component 31 can be integrated as one unit or remain as two separate components. In another embodiment, as shown in FIG. 2E, the detection component 31 further comprises a pipeline 310 coupled with the air supply tube 360, wherein the coupling position is located between the airflow adjustment component 34 and the mask body 30. In yet another embodiment, as shown in FIG. 2F, the pipeline 310 of the detection component 31 is coupled directly to the mask body 30. It should be noted that in the usage scenario of FIG. 2F, the airflow adjustment component 34 may also be arranged on the mask body 30.
In another embodiment, as shown in FIG. 3A, which is a schematic diagram of an embodiment of the device for training respiratory muscle according to the present invention. In the present embodiment, the device 4 comprises a belt 40 and a processing device 41. The belt 40 is worn around the user's waist and has a sensing element 400 to detect a waist circumference information during each inhalation or exhalation exercise. The belt 40 can be a flexible, stretchable elastic band that deforms along with the expansion and contraction of the user's abdomen during breathing. This deformation is then detected by the sensing element 400. The sensing element 400 may be mechanical, such as a spring element utilized to generate electrical signal with respect to expansion and contraction, or piezoelectric, such as a strain gauge. The technology for measuring the deformation amount of stretch and compression of the elastic band is well-known and thus is not further described hereinafter.
In this embodiment, the sensing component 400 further comprises a wireless communication element 401, such as, but not limited to, an RFID, NFC element, or Bluetooth component. The wireless communication element 401 can wirelessly transmit the waist circumference information detected by the sensing component 400. The processing device 41 is pre-configured with a training standard information, which is used to determine a level information based on the waist circumference information. The processing device 41 accumulates the corresponding level information for each inhalation or exhalation exercise, and then determine whether the accumulated level information meets the training standard information or not. In one embodiment, the computing processing device 41 may be a smart handheld device or wearable device, such as a smartphone, tablet, or wearable watch. The processing device 41 could also be a laptop or a cloud server. In this embodiment, the processing device 41 is a smartphone. The phone comprises a prompting unit 410 for indicating the training standard information and the resistance information corresponding to the amount of airflow, such as waist circumference information. The prompting unit 320 may be a display unit, a voice unit, or vibration feedback unit. In this embodiment, the prompting unit 320 is a display unit, such as a display screen.
In another embodiment, as shown in FIG. 3B, this embodiment is generally similar with the structure shown in FIG. 3A, while the different part is that the device 4 further comprises a mask body 42 having an airflow adjustment component 44 arranged thereon. The air flow adjustment component 44 regulates the amount of airflow entering the interior of mask body from the external environment. In one embodiment, the airflow adjustment component 44 may be an adjustable valve, a check valve, or a flow controller, allowing for the adjustment of the airflow in and out of the mask body. The airflow amount entering the interior of cover 42 from the external environment can be adjusted either manually or electrically. Additionally, in another embodiment shown in FIG. 3B, a pressure detecting element 43 can be added to detect the air pressure within the mouth during inhalation or exhalation. The processing device 41 can use the pressure information and the waist circumference information for performing training control.
Refer to FIG. 4A, which is a schematic diagram of another embodiment of the respiratory muscle training device of the present invention. In this embodiment, the device 5 for training respiratory muscle comprises an electrical sensing device 50 and a processing device 51. The electrical sensing device 50 has a plurality of electrode elements 500 contacting with the positions corresponding to the user's upper respiratory tract muscles or abdomen so as to detect electrical information related to the upper respiratory tract muscles or abdomen. In this embodiment, the plurality of electrode elements 500 are in contact with the abdomen. When the user breathes, the contraction and relaxation of the abdominal muscles cause the electrodes 500 attached to the abdominal to generate electrical information, such as voltage or current information from electromyography (EMG). The processing device 51 is electrically connected to the electrical sensing device 50 and has training standard information set therein. This allows the processing device 51 to determine level information based on the detected electrical information, wherein the processing device 51 further accumulates the corresponding level information for each inhalation or exhalation exercise and determines whether the training standard information has been reached according to the accumulated level information.
In one embodiment, the processing device 51 can be a smart handheld device or wearable device, such as a smartphone, tablet, or smartwatch. The processing device 51 may also be a laptop or a cloud server. In this embodiment, the processing device 51 is a smartphone. The smartphone comprises a prompt unit 510 that provides prompt information, such as electrical information, related to the training standard information and the corresponding resistance information for the airflow. The prompt unit 510 can be a display unit, a voice unit, or vibration feedback unit. In this embodiment, the prompt unit 510 is a display unit, for example, a display screen. Additionally, in this embodiment, the electrical sensing device 50 comprises a wireless communication component 502, such as RFID, near-field communication components, or Bluetooth components, but should not be limited thereto. The wireless communication component 502 can transmit the waist circumference information detected by the electrode elements 500 wirelessly. The processing device 51 is electrically connected to the wireless communication component 502 and has a training standard information set therein so as to determine whether the training standard information has been reached based on the electrical information.
In another embodiment, as shown in FIG. 4B, this embodiment is fundamentally similar to the structure shown in FIG. 4A, while the different part is that the device further comprises a mask body 52 having an airflow adjustment component 53 arranged thereon so as to regulate the amount of airflow entering the interior of mask body 52 from the external environment. In one embodiment, the airflow adjustment component 53 may be an adjustable valve, a check valve, or a flow controller wherein an flow inlet or outlet of the airflow adjustment component 53 can be adjusted. The airflow amount entering the interior of mask body 52 from the external environment can be adjusted manually or electrically. For example, in one embodiment, the airflow adjustment component 53 is electrically connected to the processing device 51 such that the size of the inlet of the airflow adjustment component 53 can be adjusted by the processing processor 51.
In another embodiment, as shown in FIG. 4C, this embodiment is fundamentally similar to the structure shown in FIG. 4A, while the different part is that the electrical sensing device 50a in this embodiment further comprises a flexible band 501 with a plurality of electrode elements 500 arranged on the flexible band 501 to detect the electrical information generated by the contraction and stretching of the upper respiratory tract muscles. The upper respiratory tract muscles comprises the intercostal muscles, diaphragm, and/or upper respiratory tract dilator muscles. In this embodiment, it refers to the upper respiratory tract dilator muscles. The flexible band 501 is wrapped around the neck area, such that the electrode elements 500 contact with the skin corresponding to the upper respiratory tract dilator muscles. The electrical sensing device 50a further comprises a wireless communication component 502, such as RFID, near-field communication elements, or Bluetooth components, but should be limited thereto. The wireless communication component 502 can transmit the waist circumference information detected by the electrode elements 500 wirelessly. The processing device 51 is electrically connected to the wireless communication component 502 and has a training standard information set therein so that the processing device 501 can determine whether the training standard information is reached based on the electrical information. In another embodiment, the embodiment in FIG. 4C may also comprises the mask body 52 and airflow adjustment component 53 as shown in FIG. 4B, which function as previously described and will not be further elaborated here.
Referring back to FIG. 1, the aforementioned device represents various embodiments of the device for training respiratory muscle training in step 20 of FIG. 1. Next, a step 21 is performed to set the inhalation resistance. In one embodiment of step 21, as illustrated in FIG. 2A, 3A, 4A, or 4C, the user can increase inhalation resistance by pinching their nose and mouth. Additionally, in the embodiments shown in FIG. 2B, 3B, or 4B, with the design incorporating airflow adjustment components 34, 44, or 53, the user can manually or electrically adjust the inhalation resistance. For example, through an application running on the processing device 32, 41, or 51, the user can communicate with airflow adjustment components 34, 44, or 53 wirelessly to control the airflow entering mask body 30, 42, or 52 from the external environment. The amount of airflow represents the resistance encountered during inhalation. If the airflow entering through components 34, 44, or 53 is low, it indicates high inhalation resistance thereby making it harder for the user to inhale air. Conversely, if the airflow is high, it indicates low inhalation resistance thereby allowing the user to inhale air more easily.
After setting the inhalation resistance, step 22 is carried out to set the training standard information. In one embodiment of step 22, it can be configured through the processing device 32, 41, and 51, as shown in FIGS. 2A to 4C. For example, in one embodiment, an application runs on the processing device 32, 41, and 51, and the user can set the training standard information through the user interface displayed by the application. In one embodiment, the training standard information can, but should not be limited to, represent the number of times of inhalations that user takes after setting the resistance. For example, in another embodiment, the training standard information may also be set as the integral of pressure changes over time during breathing, representing the work W done by the upper respiratory tract muscles during breathing exercises, which can be expressed by the following equation (1):
It should be noted that the upper respiratory tract muscles comprise the intercostal muscles, diaphragm, and/or upper respiratory tract dilator muscles. Additionally, the step for determining the training standard information further comprises step 220, where at least one set of respiratory cycle patterns is input to simulate sleep-related respiratory tract resistance or obstruction. This step primarily simulates obstruction condition by setting different resistance levels. Next, step 221 is carried out to observe changes in the user's physiological state thereby estimating the contraction intensity or activity level of the respiratory muscles so as to determine the training standard information. The degree of contraction or work done by the respiratory muscles can both serve as indicators of their activity level. In this step, by setting different resistance in step 220, corresponding parameter information, such as pressure data, waist circumference data, or electrical information, can be obtained. The training standard information can then be established based on the parameter information. It should be noted that the training standard information does not necessarily be determined through steps 220 and 221. In another embodiment, the training standard information may also be self-adjusted according to the user experience.
Next, a step 23 is proceeded to perform training procedure after step 22 such that the user can perform at least one inhalation or exhalation exercise under the specified inhalation resistance to reach the training standard information. Once the resistance and training standard information are set through steps 21 and 22, the user can begin to train the upper respiratory muscles, which is the upper respiratory dilator muscles in this embodiment. In one embodiment, the training standard information is formed by at least one training cycle, each of which includes at least one inhalation exercise. The number of times is determined based on the user's training needs, and the user can make settings through the application installed in the processing device 32, 41, and 51.
For example, in one embodiment, as shown in FIG. 5, which is a schematic flowchart of the training process of the present invention. In step 23, when the user is performing the training steps, it further comprises step 230 to detect parameter information when the user performs at least one inhalation or exhalation exercise. In Step 230, the parameter information may comprises pressure information, waist circumference information, or electrical information, wherein the pressure information can be obtained by using the pressure detecting element (e.g., as shown in FIGS. 2A and 2B), the waist circumference information can be obtained by using a belt (e.g., as shown in FIGS. 3A and 3B), and electrical information is obtained by using an electrical sensing device (e.g., as shown in FIGS. 4A to 4C).
Then, a step 231 is performed to determine whether the training standard information has been reached based on the parameter information. In the step 231, the processing device 32, 41, or 51 assesses whether the training standard information has been achieved according to the parameter information. Taking pressure information as an example, the upper respiratory tract inhalation cycle will be obstructed in each inhalation exercise due to the resistance, so that the obstructive breathing interruption can be simulated. As shown in FIG. 6A, in this embodiment, user 9 uses the device illustrated in FIG. 2B. In FIG. 6A, user 9 sets the inhalation resistance through the airflow regulating element 34. When user performs inhalation exercise under resistance condition, the diaphragm 90 contracts and expands outward, causing a decrease in pressure inside the respiratory tract 91, such as creating negative pressure or a pressure lower than the atmospheric pressure in the environment, which is represented as negative pressure P0. When negative pressure P0 is generated in the respiratory tract 91, the pressure resulting from the negative pressure pulls the upper respiratory tract dilator muscle group 92 inward toward the respiratory tract, thereby obstructing respiratory tract patency. At this time point, the nervous system of the user activates to contract the upper respiratory tract dilator muscle group 92 to maintain respiratory tract patency so as to prevent the negative pressure from causing the collapse of the upper respiratory tract dilator muscle group. The functional training effect described above can also be monitored according to the variations of the breathing cycle through the processing device.
When the user exhales, as shown in FIG. 6B, the diaphragm 90 of user 9 relaxes and returns in the opposite direction thereby simultaneously restoring positive pressure P1 within the respiratory tract 91. Consequently, the upper respiratory tract dilator muscle group 92 is no longer pulled to stretch by negative pressure and is contracted to restore respiratory tract patency. Through repeated inhalation and exhalation exercises, the upper respiratory tract dilator muscles expand and contract, thereby achieving the effect of training the upper respiratory tract musclegroup. In one embodiment, when the number of inhalation exercises (or cycles) or the inhalation volume in each training cycle is reached, the processing device 32, 41, or 51 generates a prompt message, such as an audio or text message, for reminding the user to take a break. During the rest period, the processing device 32, 41, or 51 can automatically controls the airflow regulating element to return to a resistance-free or reduced-resistance state, or the user can manually set resistance-free or reduced-resistance state to allow normal breathing. Once the rest period ends, the processing device 32, 41, or 51 restores the original resistance setting or increase the resistance thereby enabling the user to resume inhalation training.
Thereafter, a step 232 is performed. In step 232, if the training standard information is reached, a prompt message is generated. In one embodiment of performing step 232, taking air pressure information as an example, the air pressure information detected by the pressure detecting element allows processing device 32, 41, or 52 to calculate the number of inhalation exercise or inhalation volume to determine if the training standard information has been achieved. Similarly, for waist circumference information, the processing device uses the waist circumference information to identify inhalation exercise, then calculates the number of inhalation exercises or inhalation volume to determine if the training standard information has been reached. Additionally, the analysis based on the electrical information measured by the electrical sensing device 50 or the signal patterns generated from the air pressure information measured by the pressure detecting element 31 can be utilized to monitor the relaxation level or contraction effect of the upper respiratory tract dilator muscles under simulated respiratory tract resistance. It should be noted that, although the previous example uses inhalation exercises to evaluate if the training standard information is reached, in another embodiment, the training standard information can also be assessed through parameter information detected from exhalation exercises. It is noted that the distinction between inhalation and exhalation exercises can be determined according to air pressure information or waist circumference information.
In another embodiment of step 23, the parameter information is electrical information. The method for detecting electrical information uses an electrical sensing device, which comprises a plurality of electrode elements in contact with the positions that is corresponding to upper respiratory tract muscles or abdominal area so as to detect various electrical signals related to the upper respiratory tract muscles or abdomen. In the present embodiment, taking the upper respiratory tract dilator muscles as an example, as shown in FIG. 4C, the plurality of electrode elements are attached onto the area of the upper respiratory tract dilator muscles. During inhalation or exhalation process, the upper respiratory tract dilator muscles stretch and contract, causing variation of electrical characteristic such as variations in voltage or current. Through the electrical information collected by the plurality of electrode elements, the processing device 32, 41, or 51 can calculate the number of inhalation exercises to determine whether the training standard information has been reached. Once the user adapts to the target of inhalation volume, the target of inhalation volume is progressively increased, thereby gradually raising the inhalation resistance intensity.
In another embodiment for determining whether the training standard information is reached, as shown in FIG. 6C, which illustrates the variation of pressure in inhalation and exhalation pressure under resistance for the user according to the present invention. In the present embodiment, training standard information is a reasonable inhalation volume that corresponds to the expansion of respiratory tract muscles in coordination with diaphragm contraction during each inhalation. In this embodiment, the training standard information is the work Ws for evaluating whether the guiding and monitoring actions reach the training target, such as the shaded rectangular area in FIG. 6C. The curve in FIG. 6C shows the relationship between pressure and time with respect to inhalation and exhalation exercise under resistance detected by the pressure detecting element. Please refer to FIGS. 6A through 6C, taking training of the upper respiratory tract dilator muscles as one example, during the process that the pressure drops to negative pressure due to the variation of pressure generated by inhalation, the upper respiratory tract dilator muscles 92 is stretched due to the negative pressure. At this time, the nervous system of the user activates, causing the upper respiratory tract dilator muscle group 92 to contract to keep the respiratory passage patency thereby preventing the collapse of the upper respiratory tract due to negative pressure. During this process, the upper respiratory tract dilator muscle group 92 performs work Ws, whose magnitude can be adjusted by the resistance controlled by airflow regulating element 34, the pressure of upper respiratory tract detected by detecting element 31, and/or the regulation and monitoring of contraction of the diaphragm 90 as shown in Equation (1).
In another embodiment for determining whether training standard information has been reached is shown in FIG. 6D, which illustrates a schematic of training standard information using air pressure and/or waist circumference information according to the present invention. In FIG. 6D, curve 6 represents the time-dependent pressure variation detected by a pressure sensor during the user's breathing, while curve 7 represents the variation of the user's waist over time during breathing. It should be noted that when the user engages in training, the training standard information can be set based on pressure information, waist circumference information, or a combination of both during breathing under a breathing resistance. For example, if pressure is used as the training standard information, there are three possible embodiments. In one embodiment, the standard can be defined by adjusting a specific pressure value (e.g., negative pressure), such as characteristic pressures −Ps, −Ps1, and −Ps2 illustrated in FIG. 6D. In another embodiment, the training standard information can be based on the duration after reaching a specific pressure value −Ps. Alternatively, in another embodiment, the training standard information can be a plurality of multiple specific pressure values −Ps (e.g., c1˜c4 shown in FIG. 6D) generated by a plurality of periodic breathing exercises.
In the embodiment shown in FIG. 6D, a plurality of specific pressure values −Ps are used as training standard information. In one training embodiment, as illustrated in FIG. 3B, the user can use the processing device 41, such as a smartphone, to set specific pressure values −Ps and the number of sets for each training session. In FIG. 6D, area a represents the normal breathing state, where the pressure detecting element 43 detects positive pressure information in the oral cavity, and the waist circumference information detected by the sensor element 400 on the belt 40 shows slight fluctuations of waist. In area b, this indicates that the user has used the airflow regulating element 44 to adjust the inhalation resistance to simulate respiratory tract obstruction, and the breathing training state is started. At this time point, the pressure detecting element 43 detects variation of pressure information in the oral cavity, which shows the pressure is gradually decreased from positive pressure to negative pressure.
At the same time, the application (APP) running on the processing device 41 begins to guide the user to perform breathing training according to the pressure information during breathing. For example, during the first training period, the APP guides the user to perform four inhalations reaching the specific pressure value −Ps. In FIG. 6D, areas c1 to c4 represent these four inhalation exercises. During each breathing exercise, the breathing exercise guided by the APP causes fluctuations in waist circumference. It is noted that, for each breathing exercise, taking area c1 as an example, when the inhalation exercise reaches the specific pressure value −Ps, the APP provides a prompt message, such as a voice or sound notification, indicating that the characteristic pressure value −Ps has been reached, so that the user can begin the exhalation exercise. During exhalation exercise, since the airflow regulating element 44 provides resistance during inhalation but no resistance during exhalation exercise, the exhalation exercise is unimpeded thereby allowing air to be released smoothly. However, during inhalation exercise, it will simulate the obstruction of respiratory tract such that the airflow entering the oral cavity is reduced or blocked thereby causing a drop in oral cavity pressure and even creating negative pressure. This results in the contraction of the upper respiratory tract dilator muscle group to keep the respiratory tract patency. After four cycles, the training proceeds to the next phase. It should be noted that during the training of obstruction of breathing state in c1˜c4, abdominal waist circumference maintains a breathing state, but the airflow regulating element 44 only allows exhalation without permitting air entering the oral cavity. Consequently, the waist circumference and abdominal cavity expand such a greater negative pressure in the oral cavity (minimum pressure becomes even lower) is generated so as to further train the contraction of the upper respiratory tract dilator muscle group to keep the respiratory tract patency. Once the first training period is completed, the APP provides a prompt message to remind the user to take a short rest. After the rest period, the second training session begins.
Please refer to FIG. 6E, which illustrates another schematic of the training standard information using air pressure and/or waist circumference information in this invention. In the embodiment of variation with respect to air pressure and waist circumference, areas a, b, and c1c2 are the same as previously described. In this embodiment, areas d1 and d2 represent that when the training load is continuously increased, the insufficient strength of the respiratory tract-expanding muscles leads to relaxation, resulting in respiratory tract obstruction or partial obstruction. In this state, the negative pressure should be generated in both the abdominal cavity and the oral cavity due to the continuous expansion of abdominal cavity with the waist circumference increases; however, due to the relaxation of the upper respiratory tract-expanding muscles, the pharynx 90, as shown in FIG. 6A, becomes obstructed. At this point, the diaphragm 90 still contracts and stretches outward such that the inspiratory pressure in the abdominal cavity cannot reach the oral cavity thereby resulting in a smaller negative pressure in the oral cavity, i.e. air pressure rising, which indicates an overload training condition. The user can adjust and correct the precise training dosage based on the conditions of d1 and d2.
It should be noted that, although the air pressure is utilized to explain in the previously described embodiments, in another embodiment, waist circumference information can also be used as the training standard information. There can be three types of configurations. In one embodiment, the specific waist circumference information can serve as the training standard, such as the increase in waist circumference during inhalation. In another embodiment, the duration of maintaining waist circumference after reaching the specific waist circumference information can be used as the training standard information. Alternatively, in another embodiment, a plurality of sets of specific waist circumference information with respect to the plurality of breathing cycles can be used as the training standard information.
In this embodiment, taking FIG. 2B as an example, an application installed in the processing device 32 can receive the pressure information detected by the detecting element 31 within each unit of time. The application (APP) can calculate the integral value W with respect to the corresponding pressure P (t) over time. It then compares the integral value W with the training standard information Ws. When the integral value W equals the training standard information Ws, meaning that the work W performed by the upper respiratory tract-expanding muscles 92 during the user's inhalation exercise meets the standard, the processing device 32 will generate a warning voice or message to remind the user to rest and exhale. At the same time, the detected air pressure information and integral value information will be displayed on the prompt unit 320. The user will then repeat the next inhalation exercise for a specified number of repetitions, thereby achieving the effect of training the upper respiratory tract-expanding muscles.
Please refer to FIGS. 7-8, which illustrate the flowchart of another embodiment of the training method for respiratory muscles in this invention. In the embodiment shown in FIG. 7, it is fundamentally similar to FIG. 1, wherein the different part is that the embodiment further comprises step 24, which is the step of adjusting the training level. In step 24, once the user adapts to the target inhalation volume, the training standard information is progressively increased, that is, the inhalation resistance is gradually enhanced, allowing the user to further strengthen the upper respiratory muscles. In the embodiment illustrated in FIG. 8, the process is fundamentally similar to that of FIG. 1 wherein the different part is that the embodiment further includes step 25, in which the degree of decline in maximum inhalation volume or frequency is observed after at least one cycle of inhalation exercise, exhalation exercise, or breathing exercise. In step 25, the user is guided to inhale under the inhalation resistance conditions, allowing the upper respiratory tract to experience a decrease in pressure or negative pressure state such that diaphragm contracts to achieve the target inhalation volume. After one or several cycles, observing the degree of decline in achieving the target inhalation volume or frequency can evaluate the strength or relaxation level of the user's upper respiratory tract dilator muscles and can be used to predict the severity of respiratory sleep apnea.
In summary, through the control method and device of the present invention, the resistance during inhalation can be adjusted such that users can consciously control the contraction level of the diaphragm and the upper respiratory tract dilator muscles thereby resulting in variation of air pressure or negative pressure resistance within the respiratory tract, and allowing the upper respiratory tract dilator muscles to bear loads or overloads so as to strengthen the muscle strength and endurance of the upper respiratory tract dilator muscles and increase the tension of these muscles during actual sleep, thereby preventing obstruction whereby the respiratory sleep apnea can be prevented or treated.
Please refer to FIG. 9, which is a flowchart illustrating an embodiment of the method for training respiratory muscles according to the present invention. In this embodiment, step 20 is first performed, in which a mask body is provided to cover the area on the user's face used for breathing. In this step, as shown in FIG. 10A, the mask body 30 in the figure covers the area on the user's head used for breathing, which may be the mouth, the nose, or both. In this embodiment, the mask body 30 covers both the mouth and the nose. The mask body 30 comprises an airflow adjustment element 34 arranged thereon, which regulates the amount of air entering the mask body 30 from the external environment when the user inhales. In this embodiment, the airflow adjustment element 34 is a valve. In one embodiment, the mask body 30 fits closely against the user's facial skin, providing an airtight effect. The mask body 30 can also be secured around the user's ears with an elastic strap, allowing the mask body to fit snugly against the user's face. In another embodiment, the mask body 30 may alternatively use a headband that fits around the user's head, allowing the mask body 30 to adhere tightly and airtight to the facial skin. By creating an airtight seal against the skin, it ensures that air enters the mask body 30 through the airflow adjustment element 34 and is then inhaled by the user through the nose into the upper respiratory tract.
Returning to FIG. 9, after step 20, step 21 is performed, where the valve is controlled remotely or locally to set and adjust the inhalation resistance for simulating respiratory tract obstruction thereby creating a negative pressure in the respiratory tract relative to the external air pressure during the user's inhalation. In this step, as shown in FIG. 10A, the airflow adjustment element 34 comprises a control element 340, which adjusts the intake air volume based on control signals. The amount of the intake air volume represents the resistance during the user's inhalation. For example, when the valve opening of the airflow adjustment element 34 is large, the inhalation resistance is low, and therefore, as the user inhales, a larger intake air volume flows from the external environment into the mask body 30 via the airflow adjustment element 34. On the contrary, if the valve opening of the airflow adjustment element 34 is small, the inhalation resistance increases, resulting in a smaller intake air volume entering the mask body 30 from the external environment when the user inhales. In this embodiment, the control element 340 on the airflow adjustment element 34 can receive control signals from a remote device via wired or wireless communication, such as Bluetooth or Wi-Fi signals, without limitation, for controlling the valve size of the airflow adjustment element 34, thereby adjusting the resistance the user must overcome when inhaling. The scale of this resistance is associated with training of the upper respiratory muscles of the user. Thus, appropriate resistance control or variation can effectively train the upper respiratory muscles.
In one embodiment of Step 21, the user connects a processing device 32 to the control element 340 of the airflow adjustment element 34 via a electrical connection. In one embodiment, the processing device 32 can be a smart handheld or wearable device, such as a smartphone, tablet, or wearable smartwatch, or a device that combines the mask body 30 with the airflow adjustment element 34. The processing device 32 may also be a laptop or a cloud server. In this embodiment, the processing device 32 is a smartphone, which is equipped with a prompt unit 320 which is a display unit in this embodiment. The processing device 32 runs an application (APP), and after the user launches it, the user interface for operation is displayed on the prompt unit 320. In one embodiment, the user interface comprises a functional option that allow for automatic or manual electrical connection with the airflow adjustment element 34, such as via Bluetooth, radio frequency signals, or wireless signal connections. Once connected, the user can control the valve size of the airflow adjustment element 34 through the user interface displayed on the prompt unit 320 for setting and adjusting the inhalation resistance to simulate respiratory tract obstruction, thereby generating negative pressure in the respiratory tract during the user's inhalation.
After step 21, step 22 is performed, which is the same as previously mentioned, and it will not be described hereinafter. Then, step 22A is carried out to measure physiological parameters related to the user's breathing exercise status. In this step, the physiological parameters may comprises blood oxygen saturation, physiological potentials, respiratory tract flow, respiratory tract pressure, waist circumference, chest circumference, respiratory sounds (e.g., sounds from chest breathing, mouth and nasal breathing, or airflow sounds from the throat), or a combination of at least two of the aforementioned parameters. The purpose of this step is to observe and assess the effectiveness of the user's training of the upper respiratory muscles. Since the training of muscle groups 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 FIG. 11, wherein FIG. 11(a) represents the control signals sent from the processing device 32 to the airflow adjustment element 34 from a remote location; FIG. 11(b) represents the changes in resistance during the user's inhalation; FIG. 11(c) represents the changes in the inhalation/exhalation cycle; FIG. 11(d) represents the variations in the pressure curve of the upper respiratory tract; and FIG. 11(e) represents the changes in blood oxygen concentration.
In FIG. 11, the processing device 32 sends control signals at three time points, T1, T2, and T3, so as to adjust the intake air volume of the airflow adjustment element 34, wherein the intake air volume represents the resistance during the user's inhalation. For example, at time point T1, the resistance decreases, indicating that the valve opening of the airflow adjustment element 34 increases, resulting in an increase amount of airflow during the user's inhalation. Conversely, at time point T2, the resistance increases, indicating that the valve opening of the airflow adjustment element 34 decreases, resulting in a decrease in the amount of airflow during the user's inhalation. It should be noted that, taking time point T2 as an example, as shown in FIGS. 11(c) and 11(d), due to the increase in resistance, the user's inhalation volume per unit time decreases during the inhalation process, thereby extending the duration of the breathing cycle. At the same time, the pressure in the upper respiratory tract decreases and becomes negative pressure, as indicated in region A of FIG. 11. Meanwhile, as shown in region B of FIG. 11(e), blood oxygen levels also decrease. At this point, guiding the user to strengthen the inhalation cycle can help raise blood oxygen levels again. Therefore, through at least one of the aforementioned physiological parameters, the variation with respect to the user's breathing status caused by the alteration of the intake volume by the airflow adjustment element 34 can be correlated. Thus, as long as physiological parameters are obtained during the user's training process, the physiological parameters can be used to guide the user in training the upper respiratory muscles.
As shown in FIG. 10A, the aforementioned physiological parameters can be measured by using physiological parameter detecting elements 33, which are varied depending on the parameters being sensed and are not limited to those arranged on the mask body 30. For example, blood oxygen levels can be measured by using a blood oxygen sensor placed on the user's fingertip; physiological potentials can be obtained by attaching electrodes to the user's skin to capture ECG parameters during breathing; and respiratory tract flow or pressure can be measured by using airflow characteristic sensing elements, such as flowmeters or pressure gauges, or a combination of both, arranged on the mask body worn by the user, so as to assess the pressure in the user's respiratory tract and airflow amount during inhalation or exhalation. The variation in waist circumference or chest circumference can be detected by using sensing elements, such as a chest strap or waist belt placed around the user's chest or waist, to monitor length variations. In another embodiment, as shown in FIG. 10B, in this embodiment, a conduit 330 connects to the mask body 30, and then the physiological parameter detecting element 33, which in this case is a pressure sensor or flow sensor, is used to measure pressure or flow. The various physiological parameters previously mentioned will varied when the user inhales/exhales, so the information obtained from these measurements can serve as the basis for subsequent training adjustments.
In another embodiment, the physiological parameter detecting element 33 can also use image or sound signals to measure and observe the state of the respiratory muscles, thereby assessing the muscles' exercise status, e.g. strength and endurance. The physiological parameter detecting element 33 is categorized into contact and non-contact types, wherein (1) contact type comprises mechanomyography (MMG), uses piezoelectric chips to measure the surface vibration frequency of muscles to determine the degree of muscle contraction, and ultrasound techniques like M-mode and B-mode can be used to directly observe muscle changes, while (2) non-contact type comprises thermal imaging technology to observe hotspots of muscle contraction, and CCD camera can be used to observe changes in the appearance of the soft palate, such as changes in the shape and angle of the palatopharyngeal arch, or 3D imaging for direct observation.
Next, step 22B is performed, during the process of step 22B, the training mode can be adjusted based on the physiological parameters. In this step, it is mainly to determine the user's training mode through the variations in physiological parameters sensed in the previous step 22A so as to achieve the desired training effect. The breathing pattern can involve performing breathing exercise based on specific changes in frequency, changes in breathing depth, or pressure difference, or following a training cycle constituted by specific numbers of inhalations and exhalations, changes in breathing depth or pressure difference. For example, the breathing pattern can be, but should not limited to the sequences such as inhalation, inhalation, exhalation, or inhalation, exhalation, exhalation, among others. FIG. 11(c) illustrates a schematic diagram of the breathing exercise curve.
In one embodiment, as shown in FIG. 4, at T1, the inhalation resistance is increased through remote control (as illustrated in FIGS. 12(a) and 12(b)). Under these conditions, the user performs breathing exercises based on specific changes in frequency, depth, or pressure difference. The physiological parameters related to the user's breathing state are measured by the aforementioned physiological parameter detecting element 33, specifically the breathing frequency (FIG. 12(c)), pressure (FIG. 12(d)), and blood oxygen concentration (FIG. 12(e)). The obtained physiological parameters are transmitted to the remote processing device 32 via transmission means. After the processing device 32 receives the measured physiological parameters, it determines whether to adjust the inhalation resistance based on standard physiological parameters pre-stored in a database and corresponding physiological parameters during breathing based on specific changes in frequency, depth, or pressure difference. For example, at the T2 time point shown in FIG. 12(a), the user reduces resistance, thereby increasing the airflow.
The method of adjusting the inhalation resistance can be achieved by controlling the airflow adjustment element 34 on the hood 30, either remotely or locally, to increase or decrease the airflow or resistance during the user's inhalation. The greater the resistance the user experiences during inhalation, the less external air enters the user's nasal cavity through the airflow adjustment element 34, resulting in a decrease in pressure in the upper respiratory tract and creating a negative pressure effect. As shown in FIG. 13A, when the user 9 sets the airflow resistance of the airflow adjustment element 34, the user performs inhalation exercises under resistance conditions, causing the diaphragm 90 to contract and stretch outward, which decreases the pressure within the respiratory tract 91, for example, creating negative pressure or a pressure that is lower than the atmospheric pressure in the user's environment. The following will explain this using the negative pressure P0. When a negative pressure P0 is generated in the respiratory tract 91, the pressure from this negative pressure will stretch the upper respiratory tract dilator muscles 92 inward, obstructing the airflow in the respiratory tract. At this point, the user's nervous system activates, causing the upper respiratory tract dilator muscles 92 to contract in order to keep the respiratory tract open and prevent the negative pressure from collapsing them. When the user exhales, as shown in FIG. 13B, the diaphragm 90 of the user 9 relaxes and returns in the opposite direction, causing the pressure in the respiratory tract 91 to return to positive pressure P1. Consequently, the upper respiratory tract dilator muscles 92 are released from the negative pressure and are no longer stretched. Through multiple cycles of inhalation and exhalation, the upper respiratory tract dilator muscles are trained to contract and expand, thereby achieving the effect of training the upper respiratory tract muscle groups. In one embodiment, the upper respiratory tract muscle group 92 also includes the soft palate muscles 92a.
During the inhalation/exhalation cycle, the flow meter in the physiological parameter detecting element 33 can monitor changes in ventilation frequency (as shown in FIG. 12(b)), while the blood oxygen concentration sensor in the physiological parameter detecting element 33 can monitor changes in oxygen concentration during the same period (as shown in FIG. 12(e)). After these physiological parameters are transmitted to the processing device 32, it integrates the above information and compares it with training standard information to determine whether adjustments should be made to the resistance of the airflow entering through the airflow adjustment element 34.
In one embodiment, the processing device 32 is further equipped with a prompting device to provide auditory, visual, vibrational, or tactile prompt signals. The prompting device can include light-emitting diode (LED) components, displays, buzzers, speakers, or vibrators to generate information regarding the training target process. In this embodiment, the prompting device is the prompting unit 320, for example, a display screen. The prompt messages generated by the prompting device can guide the user in performing breathing actions to train the upper respiratory muscles. Additionally, in another embodiment, the processing device 32 and the display unit 320 can be set up as independent external devices or integrated with the hood 30, depending on user needs, and there are no specific limitations. After step 22B, step 23 is performed, which is the same as previously mentioned, and will not be elaborated on here.
In summary, the training method and assessment device for respiratory muscles provided by the present invention do not require an external pressure source; instead, they simulate respiratory tract obstruction through adjustable resistance, creating negative pressure during the user's inhalation process, thereby progressively increasing the strength of the dilator muscles. The invention measures physiological parameters to correlate the changes in the upper respiratory muscle groups during training, allowing the measured physiological parameter information to serve as a basis for guiding users in performing breathing actions to train the respiratory muscle groups, achieving the effect of enhancing the strength of the upper respiratory muscle groups.
The foregoing description of the exemplary embodiments of the disclosure has been presented only for the purposes of illustration and description and is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to explain the principles of the disclosure and their practical application so as to enable others skilled in the art to utilize the disclosure and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art to which the present disclosure pertains without departing from its spirit and scope.
Patent Application
20250082994
