An oxygen storage breathing training device for interstitial lung patients and a method of using the same

Abstract

The present application belongs to the technical field of medical breathing rehabilitation apparatuses, and particularly relates to an oxygen storage breathing training device for interstitial lung patients and a use method thereof. The training device comprises a shell, an oxygen storage device, a pressure limiting valve and a mouthpiece assembly. The shell is provided with an air inlet and an air outlet. The oxygen storage device is in communication with the shell. The input end of the pressure limiting valve is in communication with the air outlet. The mouthpiece assembly is in communication with the pressure limiting valve. The present application can temporarily store oxygen by arranging the oxygen storage device, and release oxygen during the user's inhalation stage. The pressure limiting valve is further arranged to automatically release pressure when the inhalation pressure exceeds the preset value, thereby preventing lung damage.

Description

Technical Field

[0001] This invention belongs to the technical field of medical respiratory rehabilitation devices, specifically relating to an oxygen storage breathing training device for patients with interstitial lung disease and its usage method. Background Technology

[0002] Interstitial lung disease (ILD) is a group of diffuse lung diseases characterized by pulmonary interstitial fibrosis, decreased lung compliance, and reduced diffusion capacity. Clinically, it often manifests as hypoxemia at rest or after activity, dyspnea, and a significant decrease in exercise tolerance. Long-term hypoxia can induce pulmonary hypertension, cardiopulmonary insufficiency, and hypoxic damage to multiple organs, severely impacting patients' quality of life and survival. Currently, in addition to drug therapy, respiratory rehabilitation has been proven safe and effective for ILD, significantly improving patients' exercise capacity, dyspnea symptoms, and health-related quality of life scores in the short term, and has become an important component of comprehensive ILD management.

[0003] However, existing breathing training devices have the following significant shortcomings when applied to ILD patients.

[0004] 1. The respiratory resistance is fixed and too high, lacking lung-protective design; 2. Lack of oxygen storage structure, which easily aggravates hypoxia during training; 3. Limited functionality; unable to simultaneously achieve oxygen inhalation, nebulization, sputum expectoration, and ventilation improvement. 4. No graded training model was designed for different stages of ILD rehabilitation; 5. The lack of alternating high and low resistance training programs limits rehabilitation efficiency; 6. Lack of security protection mechanisms.

[0005] In conclusion, there is an urgent need for a new technological solution to meet the pressing needs of clinical rehabilitation and home-based treatment. Summary of the Invention

[0006] This application discloses an oxygen storage breathing training device for patients with interstitial lung disease and its usage method. By setting up an oxygen storage device, oxygen can be temporarily stored and released during the user's inhalation phase. A pressure limiting valve is also set up to automatically release pressure when the inhalation pressure exceeds a preset value to prevent lung damage.

[0007] The first aspect of this application discloses an oxygen storage breathing training device for patients with interstitial lung disease. The training device includes a housing, an oxygen storage unit, a pressure limiting valve, and a mouthpiece assembly. The housing has an air inlet and an air outlet. The oxygen storage unit is connected to the housing. The input end of the pressure limiting valve is connected to the air outlet. The mouthpiece assembly is connected to the pressure limiting valve.

[0008] As an optional implementation, in the first aspect of the present application, the oxygen storage device includes a chamber and a piston, the piston being slidably connected to the inner wall of the chamber, the top of the chamber having an equalizing port, and the bottom of the chamber communicating with the shell.

[0009] As an optional implementation, in the first aspect of the present application, the pressure limiting valve includes an air guide, an air plug, and a limiting member. The air guide has a first air guide channel and an air guide hole at one end. The limiting member has a second air guide channel. A bracket is installed on the side wall of the second air guide channel. The bracket has multiple air holes. A limiting rod is installed on the bracket. A guide rod is connected to the limiting rod. A spring is sleeved on the outer side of the guide rod. The air plug has a limiting groove. One end of the spring extends into the limiting groove and abuts against the air plug to apply a force toward the air plug towards the air guide hole.

[0010] As an optional implementation, in the first aspect of the embodiments of this application, the training device further includes a first air limiting element, which is connected to the pressure limiting valve and the mouthpiece assembly.

[0011] As an optional implementation, in the first aspect of the present application, the first gas limiting member has a first channel, a limiting part is provided on the side of the first channel, and the limiting part has a first through hole.

[0012] As an optional implementation, in the first aspect of the embodiments of this application, the mouthpiece assembly includes a first pipe, a second pipe, a third pipe and a mouthpiece connector, the first pipe and the third pipe are respectively connected to the second pipe, one end of the first pipe is connected to the air outlet end of the first air limiting member, and one end of the third pipe is connected to the mouthpiece connector.

[0013] As an optional implementation, in the first aspect of the present application, the second pipeline has an exhalation outlet and a nebulized gas inlet. The exhalation outlet is provided with an exhalation one-way valve, and the input end of the exhalation one-way valve is connected to the third pipeline through the second pipeline. The nebulized gas inlet is provided with an inhalation one-way valve, and the output end of the inhalation one-way valve is connected to the third pipeline through the second pipeline. The nebulized gas inlet is covered with a cap.

[0014] As an optional implementation, in the first aspect of the present application, the exhalation outlet cover is provided with a second air limiting member, the second air limiting member has a receiving groove, one end of the second pipeline extends into the receiving groove, a limiting protrusion is provided on the side of the receiving groove, the limiting protrusion abuts against the second pipeline, and at least one air outlet hole is opened on the surface of the second air limiting member.

[0015] As an optional implementation, in the first aspect of the present application, the intake one-way valve includes a first guide member and a first diaphragm. The first guide member is disposed at the bottom of the second pipeline, and the first diaphragm is located at the outlet end of the first guide member and connected to the first guide member.

[0016] As an optional implementation, in the first aspect of the present application, the one-way exhalation valve includes a second guide member and a second diaphragm. The second guide member is disposed in the second pipeline, and the second diaphragm is located between the second guide member and the receiving groove and is connected to the second guide member.

[0017] The second aspect of this application discloses a method for using an oxygen storage breathing training device. Based on the oxygen storage breathing training device disclosed in the first aspect of this application, the method includes the following steps: S1: Set the first gas limiting component to the first training mode and maintain it for the first preset time; S2: Set the first gas limiting component to the second training mode and maintain it for the second preset time; S3: Set the first gas limiting component to the third training mode and maintain it for the third preset time; S4: Repeat steps S2 to S3, repeating 4 to 6 times.

[0018] Compared with related technologies, the embodiments of this application have the following beneficial effects: This invention discloses an oxygen storage and respiratory training device for patients with interstitial lung disease (ILD), belonging to the category of medical respiratory rehabilitation equipment. The device includes a shell, an oxygen reservoir, an inspiratory pathway, an expiratory pathway, and a nebulization interface. In daily mode, it provides lung-protective assisted ventilation and oxygen storage and supply. In training mode, it can perform progressive inspiratory muscle strength training; it supports alternating high and low resistance training methods; during exhalation, it provides positive pressure to open small airways, reduces respiratory rate, and uses vibration to assist in sputum clearance. This invention combines hypoxia correction, airway clearance, respiratory muscle training, and nebulization functions. It is safe, passive, and portable, suitable for home rehabilitation of ILD patients. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a cross-sectional view of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 2This is a schematic diagram of the structure of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 3 This is an exploded view of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 4 This is a cross-sectional view of a partial structure of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 5 This is a cross-sectional view of a pressure limiting valve of an oxygen storage breathing training device for patients with interstitial lung disease, as disclosed in an embodiment of this application. Figure 6 This is a cross-sectional view of the mouthpiece assembly and the first gas limiting element of an oxygen storage breathing training device for interstitial lung patients disclosed in an embodiment of this application; Figure 7 This is a schematic diagram of the inhalation one-way valve and the expiration one-way valve of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 8 This is a schematic diagram of the structure of the second gas limiting element of an oxygen storage breathing training device for patients with interstitial lung disease disclosed in an embodiment of this application; Figure 9 This is a schematic diagram of the first and second gas limiting components in a replaceable accessory of an oxygen storage breathing training device for interstitial lung patients disclosed in an embodiment of this application. Figure 10 This is a flowchart illustrating the method of using an oxygen storage breathing training device disclosed in an embodiment of this application.

[0021] The components are as follows: 1. Shell; 11. Air inlet; 12. Air outlet; 13. Equalizing port; 14. Third diaphragm; 15. Connecting hole; 16. Restricting groove; 17. Restricting ring; 2. Oxygen reservoir; 21. Chamber; 211. Equalizing port; 22. Piston; 23. Limiting ring; 3. Pressure limiting valve; 31. Air guide; 311. First air guide channel; 312. Air guide hole; 32. Air plug; 321. Limiting groove; 33. Limiting component; 331. Second air guide channel; 332. Support; 3321. Vent hole; 3322. Limiting rod; 3323. Guide rod; 3324. Spring; 4. Mouthpiece assembly; 41. First pipeline; 42. Second pipeline; 421. Exhalation outlet; 422. Nebulized gas inlet; 423. Exhalation check valve; 423 1. Second flow guide; 4232. Second diaphragm; 4233. Second limiting hole; 4234. Second support; 4235. Second limiting block; 4236. Second arc-shaped surface; 4237. Second flow guide hole; 424. Intake one-way valve; 4241. First flow guide; 4242. First diaphragm; 4243. First limiting hole; 4244. First support; 4245. First limiting block; 4246. First arc-shaped surface; 4247. First flow guide hole; 425. Cover; 426. Second air limiting component; 4261. Receiving groove; 4262. Limiting protrusion; 4263. Air outlet; 43. Third pipeline; 44. Biting nozzle connector; 5. First air limiting component; 51. First channel; 52. Restricting part; 521. First through hole. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] The terms “comprising” and “having”, and any variations thereof, in this application are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not necessarily limited to those steps or units that are explicitly listed, but may include other steps or units that are not explicitly listed or that are inherent to such process, method, product, or device.

[0024] In the description of the embodiments of this application, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0025] In the embodiments of this application, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0026] This invention aims to overcome the shortcomings of existing technologies and provide an oxygen storage and breathing training device for patients with interstitial lung disease (ILD). It achieves: extremely low resistance (≤5 cmH2O) assisted ventilation and lung protection in daily mode; adjustable inspiratory resistance (5–20 cmH2O) in training mode to meet muscle strength training needs; supports alternating high and low resistance training to improve rehabilitation efficiency; and simultaneously features inspiratory oxygen storage and supply, expiratory positive pressure ventilation, and nebulized therapy. It effectively corrects hypoxia, protects lung tissue, promotes airway clearance, improves ventilation efficiency, strengthens respiratory muscles, improves quality of life, and slows disease progression.

[0027] The technical solution of this application will be described in detail below with reference to specific embodiments.

[0028] Please see Figures 1 to 4 An oxygen storage breathing training device for patients with interstitial lung disease includes a housing 1, an oxygen reservoir 2, a pressure limiting valve 3, and a mouthpiece assembly 4. The pressure limiting valve 3 restricts the flow of gas from the oxygen reservoir 2 into the mouthpiece assembly 4 during the user's exhalation. During the user's inhalation, gas from the oxygen reservoir 2 flows unidirectionally into the mouthpiece assembly 4 for inhalation. The pressure limiting valve 3 can cause the gas to pulsate, which can significantly increase the contact area between the inhaled gas and lung tissue, promote efficient exchange between the inhaled gas and the gas in the lungs, and improve gas exchange efficiency. The bottom of the housing 1 is open. An air inlet 11 is provided, which is connected to the housing 1. An air outlet 12, which is connected to the housing 1, is opened on the side of the housing 1. The bottom of the oxygen storage device 2 is connected to the top of the housing 1. The input end of the pressure limiting valve 3 is connected to the air outlet 12. The input end of the mouthpiece assembly 4 is connected to the output end of the pressure limiting valve 3. A negative pressure oscillation chamber is formed inside the pressure limiting valve 3. By setting the oxygen storage device 2, oxygen can be temporarily stored and released during the user's inhalation. The pressure limiting valve 3 is also set so that it automatically releases pressure when the inhalation pressure exceeds the preset value to prevent lung damage.

[0029] Inhalation pathway: Oxygen passes sequentially through inlet 11, housing 1, oxygen reservoir 2, housing 1, pressure limiting valve 3, first gas limiting element 5, first pipeline 41, second pipeline 42, third pipeline 43 and nozzle interface 44; Exhalation pathway: Exhaled air passes sequentially through the mouthpiece interface 44, the third tubing 43, the second tubing 42, the one-way exhalation valve 423, and the second air-limiting element 426; Atomization path: The atomized gas passes sequentially through the second pipe 42, the third pipe 43, and the nozzle interface 44.

[0030] In some embodiments, the housing 1 is made of medical-grade PP plastic, making the housing 1 lightweight and easy to clean; the oxygen storage device 2 has a volume of 350mL and adopts a float-type or elastic airbag-type structure, storing oxygen in the non-inhalation phase and releasing oxygen (concentration ≥90%) in the inhalation phase.

[0031] In some embodiments, the air inlet 11 is connected to the output end of the oxygen concentrator, which is a household 5–10 L / min oxygen concentrator with an oxygen concentration of 93%.

[0032] In some embodiments, during nebulization, the nebulizing gas inlet 422 is connected to the output end of the nebulizer so that the nebulized gas enters the patient's body after passing through the second pipe 42, the third pipe 43 and the mouthpiece interface 44 in sequence.

[0033] In some embodiments, the tubing volume of the bite assembly 4 is ≤30mL to reduce ineffective cavities.

[0034] This invention has a daily mode and a training mode: Inhalation resistance in daily mode: ≤5 cmH2O (channel diameter ≥15mm, one-way valve opening pressure ≤2 cmH2O); The first air-limiting component 5 in the training mode is adjustable in four levels. The inhalation resistance of each level can be 5 cmH2O, 10 cmH2O, 15 cmH2O or 20 cmH2O. The level of the first air-limiting component 5 can be adjusted by adjusting the diameter of the first through hole 521 of the first air-limiting component 5. Pressure limiting valve 3: Relief pressure 25 cmH2O; Positive expiratory pressure valve: Three adjustable levels, with expiratory resistance of 5 cmH2O, 10 cmH2O or 15 cmH2O at each level. The positive expiratory pressure valve includes an expiratory one-way valve 423 and a second air-limiting element 426. The level of the positive expiratory pressure valve can be adjusted by adjusting the size of the air outlet 4263 of the second air-limiting element 426. Inhalation vibration element: including air plug 32, limit rod 3322, guide rod 3323 and spring 3324, which generates 10±30 Hz vibration when the inhalation flow rate is 10–30 L / min.

[0035] In some embodiments, the oxygen storage device 2 includes a chamber 21 and a piston 22. The piston 22 is slidably connected to the inner wall of the chamber 21. The top of the chamber 21 is provided with a pressure equalization port 211 that communicates with the interior of the chamber 21. The bottom of the chamber 21 is connected to the shell 1. When oxygen enters from the air inlet 11 of the shell 1, the oxygen will be temporarily stored in the chamber 21. When the piston 22 rises, the pressure equalization port 211 can balance the internal and external pressure of the chamber 21. The chamber 21 is a transparent structure.

[0036] In some embodiments, a pressure equalization hole 13 is provided on the side of the housing 1, and a third diaphragm 14 is provided on the inner side of the housing 1. The third diaphragm 14 covers the pressure equalization hole 13, and one end of the third diaphragm 14 is connected to the housing 1 so that the third diaphragm 14 can be movably covered on the pressure equalization hole 13. By providing the pressure equalization hole 13, the third diaphragm 14 opens under negative pressure conditions to balance the internal and external pressures of the housing 1.

[0037] In some embodiments, a connecting hole 15 is provided on the top of the housing 1, and the connecting hole 15 is connected to the compartment 21 and the housing 1 respectively.

[0038] In some embodiments, a limiting groove 16 is provided on the top edge of the housing 1, the bottom of the compartment 21 extends into the limiting groove 16, and a limiting ring 17 is provided on the top edge of the housing 1, the limiting ring 17 abutting against the outer side of the compartment 21.

[0039] In some embodiments, a limiting ring 23 is provided at the top of the chamber 21, and the limiting ring 23 is disposed opposite to the top of the piston 22 to confine the piston 22 within the chamber 21.

[0040] In some embodiments, see Figure 4 and 5The pressure limiting valve 3 includes an air guide 31, a spring valve, and a limiting member 33. The spring valve includes an air plug 32 and a spring 3324. The air guide 31 has a first air guide channel 311, and one end of the air guide 31 is provided with an air guide hole 312. The air outlet 12 of the housing 1 communicates with the first air guide channel 311 through the air guide hole 312. One end of the limiting member 33 is sleeved on the outside of the other end of the air guide 31. The limiting member 33 has a second air guide channel 331. A bracket 332 is installed on the side wall of the second air guide channel 331. The bracket 332 has multiple air vents 3321. The first air guide channel 311 communicates with the first air guide channel 3324 through the air vents 3321. Two air passages 331 are connected. A limiting rod 3322 is installed on the bracket 332. The limiting rod 3322 is connected to a guide rod 3323. A spring 3324 is sleeved on the outside of the guide rod 3323. One end of the air plug 32 is provided with a limiting groove 321. One end of the spring 3324 extends into the limiting groove 321 and abuts against the end of the air plug 32 near the guide rod 3323 to apply a force toward the air guide hole 312 to the air plug 32, so that the air plug 32 can close the air guide hole 312. The other end of the spring 3324 abuts against the limiting rod 3322. The limiting groove 321 is used to limit and guide the spring 3324. The spring 3324 can extend and retract smoothly; one end of the guide rod 3323 extends into the limiting groove 321, and a vibration gap is provided between the outer side of the guide rod 3323 and the inner wall of the limiting groove 321. By providing a vibration gap, the air plug 32 can vibrate when it opens; the end of the guide rod 3323 extending into the limiting groove 321 and the end of the air plug 32 have an opening gap, which allows the air plug 32 to move in the direction of the guide rod 3323; the limiting rod 3322 is arranged opposite to one end of the air plug 32, and the limiting rod 3322 can limit the air plug 32 to prevent the air plug 32 from moving. Excessive displacement; the first air delivery channel 311 and the second air delivery channel 331 together form a negative pressure oscillating chamber; the patient holds the mouthpiece and actively inhales, causing the negative pressure oscillating chamber to form negative pressure; when the negative pressure reaches the trigger threshold, the spring valve opens, and oxygen in the oxygen reservoir 2 rushes into the negative pressure oscillating chamber through the spring valve to replenish the negative pressure; then the spring valve resets and closes under the elastic force of the spring 3324; as inhalation continues, the negative pressure in the negative pressure oscillating chamber accumulates to the threshold again, the spring valve opens repeatedly, and oxygen is released again; through the periodic opening and closing of the spring valve, a high-frequency oscillating airflow is finally formed, realizing the synchronous function of oxygen storage and supply and oscillating ventilation.

[0041] In some embodiments, the training device further includes a first air limiting element 5, the air inlet of the first air limiting element 5 being connected to the output end of the pressure limiting valve 3, and the air outlet of the first air limiting element 5 being connected to the input end of the mouthpiece assembly 4.

[0042] In some embodiments, the first gas limiting member 5 has a first channel 51, which is connected to the first pipeline 41. A limiting part 52 is provided on the side of the first channel 51, and the limiting part 52 has a first through hole 521. The first channel 51 is connected to the first pipeline 41 through the first through hole 521.

[0043] In some embodiments, the input end of the first air limiting member 5 is detachably connected to the output end of the pressure limiting valve 3, and the output end of the first air limiting member 5 is detachably connected to the input end of the mouthpiece assembly 4; wherein, in other embodiments, one end of the limiting member 33 is sleeved on the outside of one end of the first air limiting member 5, and the other end of the first air limiting member 5 is sleeved on the outside of one end of the first pipeline 41.

[0044] In some embodiments, the training device includes a replaceable first air limiting member 5; the first air limiting member 5 has a first channel 51, a limiting part 52 is provided on the side of the first channel 51, and a first through hole 521 is provided on the limiting part 52; wherein, in other embodiments, the training device includes at least two first air limiting members 5 of different specifications, and the first through hole 521 of the first air limiting members 5 of different specifications has different equivalent flow areas.

[0045] Commercially available inspiratory muscle trainers (IMTs) typically have adjustable inspiratory resistance within the range of 15–30 cmH2O. However, for patients with interstitial pulmonary fibrosis (ILD), due to significant differences in lung structure at different disease stages, selecting an appropriate range of expiratory resistance is crucial for treatment and rehabilitation, and must be implemented under the guidance of medical professionals. Although inspiratory muscle training has been identified as an intervention for chronic lung diseases, and existing studies have confirmed its positive effects on improving respiratory muscle function, quality of life, and exercise capacity in ILD patients, limitations in the design quality and sample size of current studies have prevented definitive clinical conclusions. Practice has shown that excessively high inspiratory resistance can significantly increase transpulmonary pressure in ILD patients, easily leading to excessive stretching of fibrotic lung tissue, and consequently causing serious complications such as cough and pneumothorax. Meanwhile, continuous high-load training can exacerbate respiratory muscle fatigue and hypoxemia, significantly reducing patients' training tolerance and rehabilitation compliance, which is detrimental to long-term rehabilitation management. Therefore, this invention provides a respiratory training program with lung-protective functions. It uses different colors for identification and configures five adjustable resistance levels, each corresponding to a different specification of the first air-limiting component 5. This design allows for precise individualized selection of resistance parameters based on the patient's specific disease stage, physiological tolerance, and medical guidance. This ensures rehabilitation effectiveness while effectively avoiding the risk of lung damage caused by high resistance, thus improving the safety and effectiveness of treatment.

[0046] Existing breathing training devices typically lack oxygen storage and supply modules. Although hypoxemia is clinically significant in ILD patients, high-quality evidence is currently lacking to guide the use of oxygen therapy in this population. Existing systematic reviews have clearly identified an evidence gap regarding the use of oxygen therapy in ILD. While hypoxia is common in ILD patients during exercise, the effectiveness of supplemental oxygen for rehabilitation training in this population lacks systematic validation. During training, patients experience increased breathing work and oxygen consumption. If air ventilation alone is insufficient without supplemental oxygen supply, hypoxemia can easily be induced or exacerbated, creating a vicious cycle of hypoxia-limited training-decreased physical performance. This invention, by incorporating an oxygen storage device 2, can provide supplemental oxygen supply.

[0047] Existing devices are mostly single-function designs: they may only provide expiratory resistance training, serve only as sputum expectoration tools (such as Flutter and Acapella), or only be used for nebulized drug delivery. Patients need to purchase multiple devices separately, which is cumbersome, costly, and makes it difficult to achieve a synergistic effect between treatment and rehabilitation. Furthermore, most existing devices are not integrated with oxygen therapy and inspiratory training, failing to achieve synergistic effects of multiple treatments. This invention, by setting up inspiratory and expiratory pathways, can integrate oxygen therapy and inspiratory training, optimizing the treatment effect.

[0048] Patients with ILD exhibit a clear stratification in terms of disease severity and rehabilitation needs: those in the acute phase or with severe hypoxia require very low-resistance assisted ventilation to protect lung tissue; patients in the stable phase require moderate resistance for muscle strengthening exercises; while patients with mild symptoms or in the later stages of rehabilitation may require higher-intensity loads. Most existing devices allow patients to arbitrarily select the resistance. Therefore, the design of this invention allows patients to select different colored resistance modules (i.e., the first air-limiting component 5) under the guidance of a physician, tailored to different stages of their condition and individual needs, for pulmonary rehabilitation exercises.

[0049] Traditional respiratory training often employs a constant load pattern. Recent studies have shown that intermittent high-low resistance alternating training may be superior to constant load training in improving respiratory muscle strength, endurance, and oxygenation efficiency. Although existing research primarily focuses on COPD patients (e.g., the randomized controlled trial by Beaumont M et al. on IMT combined with pulmonary rehabilitation showed that despite significant improvement in respiratory muscle strength, there was no significant difference in dyspnea improvement compared to the control group), the intermittent training pattern still has its physiological rationale. However, there is currently no respiratory rehabilitation device specifically designed for ILD that supports high-low resistance alternating training. Existing devices mostly function as expiratory training tools, without integrating inspiratory training, oxygen storage, and oxygen supply functions, thus limiting the overall rehabilitation effect. This invention improves the overall rehabilitation effect of the training device by integrating inspiratory training, expiratory training, and oxygen storage and supply functions.

[0050] Most breathing trainers lack pressure limiting or pressure relief protection, which can lead to excessively high airway pressure when patients are fatigued or exert excessive force, increasing the risk of lung injury. This deficiency is particularly pronounced in patients with fragile lung tissue, such as those with interstitial lung disease (ILD). This invention addresses this issue by incorporating a pressure limiting valve 3, which automatically opens to release pressure when the inspiratory pressure exceeds 25 cmH2O, thus preventing lung injury.

[0051] This invention has an inhalation pathway, including the following modes: Normal mode: Total resistance ≤ 5 cmH2O, achieved by a large-diameter channel and a one-way valve with low opening pressure (≤ 2 cmH2O); Training mode: It is equipped with an adjustable first gas limiting element 5, with an adjustment range of 5–20 cmH2O (divided into 3–5 levels), and is equipped with a daily or training mode switching valve. By replacing the first gas limiting element 5 with different specifications, the diameter of the first through hole 521 of the first gas limiting element 5 can be adjusted to switch the training mode level. Safety protection: The pressure limiting valve 3 is connected in series and automatically releases pressure when the inhalation pressure exceeds 25 cmH2O to prevent lung injury.

[0052] This invention features an expiratory pathway equipped with an adjustable positive expiratory pressure (PEP) valve, adjustable within a range of 5–15 cmH2O (divided into 2–5 levels). The pulsating airflow generated during the inhalation phase significantly increases the contact area between the inhaled gas and lung tissue, promoting efficient gas exchange and improving gas exchange efficiency. During exhalation, the gas flows out sequentially through the mouthpiece interface 44, the third tubing 43, the second tubing 42, the one-way expiratory valve 423, and the second air-limiting element 426. By adjusting the size of the outlet 4263 of the second air-limiting element 426, the user's expiratory resistance can be increased, requiring the user to exhale forcefully, thereby assisting the user in expectorating sputum. The input end of the one-way expiratory valve 423 is connected to the third tubing 43 via the second tubing 42. When the user inhales, the one-way expiratory valve 423 closes, making it easier for the user to inhale the oxygen delivered by the oxygen reservoir 2.

[0053] The cooperation between the third diaphragm 14 and the housing 1, the cooperation between the air plug 32 of the pressure limiting valve 3 and the air guide hole 312, and the cooperation between the first diaphragm 4242 and the first flow guide 4241 constitute a pneumatic one-way valve group, which can control the unidirectional flow of airflow and ensure stable oxygen storage and ventilation.

[0054] In some embodiments, a first support member 4244 is provided at one end of the first guide member 4241; a first limiting block 4245 is provided in the middle of the first support member 4244; a plurality of first guide holes 4247 are also provided on the first support member 4244, and the plurality of first guide holes 4247 are arranged around the first limiting block 4245; a first limiting hole 4243 is provided in the middle of the first diaphragm 4242; the first limiting block 4245 passes through the first limiting hole 4243; the outer side of the first limiting block 4245 has a first arc-shaped curved surface 4246, and the first arc-shaped curved surface 4246 abuts against the inner wall of the first limiting hole 4243; the first support member 4244 can support the first diaphragm 4242 to ensure its closing and opening effect, and the first guide hole 4247 can retain the ventilation effect of the first guide member 4241.

[0055] In some embodiments, see Figure 6 The mouthpiece assembly 4 includes a first pipe 41, a second pipe 42, a third pipe 43, and a mouthpiece connector 44. The first pipe 41 and the third pipe 43 are respectively connected to the second pipe 42. One end of the first pipe 41 is connected to the output end of the first air limiting element 5, and one end of the third pipe 43 is connected to the mouthpiece connector 44. One end of the first pipe 41 is connected to the side of the second pipe 42, and the other end of the third pipe 43 is connected to the second pipe 42. The first pipe 41 and the third pipe 43 are arranged opposite to each other.

[0056] In some embodiments, the second conduit 42 has an exhalation outlet 421 and a nebulized gas inlet 422. An exhalation one-way valve 423 is provided at the exhalation outlet 421. The input end of the exhalation one-way valve 423 is connected to the inner cavity of the second conduit 42, and the input end of the exhalation one-way valve 423 is connected to the third conduit 43 through the second conduit 42. An inhalation one-way valve 424 is provided at the nebulized gas inlet 422. The output end of the inhalation one-way valve 424 is connected to the inner cavity of the second conduit 42, and the output end of the inhalation one-way valve 424 is connected to the third conduit 43 through the second conduit 42. A cap 425 is provided at the nebulized gas inlet 422. The nebulized gas inlet 422 is a nebulization connection interface used to connect a nebulizer to achieve synchronous nebulization therapy. When nebulization is not required, the cap 425 is used to close the nebulized gas inlet 422.

[0057] In some embodiments, see Figure 7The intake one-way valve 424 includes a first guide member 4241 and a first diaphragm 4242. One end of the first guide member 4241 is disposed inside one end of the second pipeline 42. The first guide member 4241 is installed at one end of the second pipeline 42. The outlet end of the first guide member 4241 is connected to the inner cavity of the second pipeline 42. The outlet end of the first guide member 4241 is connected to the third pipeline 43 through the inner cavity of the second pipeline 42. The inlet end of the first guide member 4241 is connected to the atomizing gas inlet 422. The first diaphragm 4242 is covered on the outlet end of the first guide member 4241 and connected to the first guide member 4241. The first guide member 4241 has a first guide channel. The atomizing gas inlet 422 is connected to the interior of the second pipeline 42 through the first guide channel.

[0058] In some embodiments, the first guide member 4241 is disposed inside one end of the second pipe 42.

[0059] In some embodiments, see Figure 6 and 8 A second air-limiting element 426 is provided at the exhalation outlet 421. The second air-limiting element 426 has a receiving groove 4261. One end of the second pipe 42 extends into the receiving groove 4261. The output end of the exhalation one-way valve 423 is connected to the receiving groove 4261. A limiting protrusion 4262 is provided on the side of the receiving groove 4261. The limiting protrusion 4262 abuts against the second pipe 42. The limiting protrusion 4262 can limit the length of the second pipe 42 extending into the receiving groove 4261. At least one air outlet 4263 is opened on the surface of the second air-limiting element 426. The air outlet 4263 is connected to the receiving groove 4261.

[0060] In some embodiments, one end of the second gas limiting member 426 is detachably connected to one end of the second pipeline 42; specifically, in other embodiments, the second gas limiting member 426 is sleeved on the outside of one end of the second pipeline 42 through a receiving groove 4261, so that the inner wall of the receiving groove 4261 abuts against the outer wall of the second pipeline 42.

[0061] In some embodiments, the training device includes a replaceable second air limiting member 426; the second air limiting member 426 has a receiving groove 4261, one end of the second pipe 42 extends into the receiving groove 4261, and at least one air outlet 4263 is provided on the surface of the second air limiting member 426; wherein, in other embodiments, the training device includes at least two second air limiting members 426 of different specifications, and the air outlets 4263 of the second air limiting members 426 of different specifications have different equivalent flow areas.

[0062] In some embodiments, the one-way exhalation valve 423 includes a second guide member 4231 and a second diaphragm 4232. One end of the second guide member 4231 is disposed inside the other end of the second conduit 42. The second guide member 4231 is installed at the other end of the second conduit 42. The air inlet end of the second guide member 4231 communicates with the inner cavity of the second conduit 42. The air inlet end of the second guide member 4231 communicates with the third conduit 43 through the inner cavity of the second conduit 42. The air outlet end of the second guide member 4231 communicates with the container. The receiving tank 4261 is connected, and the second diaphragm 4232 is located between the second guide member 4231 and the bottom of the receiving tank 4261 and is connected to the second guide member 4231. The second diaphragm 4232 covers the air outlet end of the second guide member 4231. The second guide member 4231 has a second guide channel, and the receiving tank 4261 is connected to the interior of the second pipeline 42 through the second guide channel. It should be noted that the bottom of the receiving tank 4261 refers to the wall surface opposite to the opening of the receiving tank 4261.

[0063] In some embodiments, the second guide member 4231 is disposed inside the other end of the second conduit 42.

[0064] In some embodiments, a second support member 4234 is provided at one end of the second guide member 4231; a second limiting block 4235 is provided in the middle of the second support member 4234; a plurality of second guide holes 4237 are also provided on the second support member 4234, and the plurality of second guide holes 4237 are arranged around the second limiting block 4235; a second limiting hole 4233 is provided in the middle of the second diaphragm 4232; the second limiting block 4235 passes through the second limiting hole 4233; the outer side of the second limiting block 4235 has a second arc-shaped curved surface 4236, and the second arc-shaped curved surface 4236 abuts against the inner wall of the second limiting hole 4233; the second support member 4234 can support the second diaphragm 4232 to ensure its closing and opening effect, and the second guide holes 4237 can retain the ventilation effect of the second guide member 4231.

[0065] The working principle of the oxygen storage breathing training device for patients with interstitial lung disease according to the present invention is as follows: Normal mode: The first gas limiter 5 is in the normal position, the inspiratory resistance is ≤5 cmH2O, the patient can breathe easily, the oxygen reservoir 2 releases high concentration of oxygen, reducing the respiratory muscle load, suitable for the acute phase, resting or hypoxic state.

[0066] Training mode: The first air-limiting device 5 is in the training position and connected to the airway. The patient can adjust the resistance (5–20 cmH2O) as needed to perform respiratory muscle strength training. During exhalation, the one-way expiratory valve 423 generates a positive pressure of 5–15 cmH2O to prevent small airway collapse and prolong the expiratory time. The pressure limiting valve 3 ensures that the peak inspiratory pressure is ≤25 cmH2O to avoid lung damage.

[0067] Alternating high and low resistance training method: Step 1: Set the first gas limiting component 5 to the low setting (5–10 cmH2O) and warm it up for 2 minutes; Step 2: Adjust the first air-limiting device 5 to the high setting (15–20 cmH2O), and take 5 deep breaths (each inhalation lasts 3–4 seconds, exhalation lasts 4–6 seconds, without holding your breath); Step 3: Switch back to the low setting and take 5 relaxing breaths; Step 4: Repeat steps 2 and 3 for a total of 4–6 sets; Step 5: Finally, breathe in a low-powered manner for 2 minutes.

[0068] This alternating mode can avoid hypoxia and fatigue caused by continuous high load, while more effectively stimulating the respiratory muscles; the gear of the first air limiting component 5 can be adjusted by adjusting the diameter of the first through hole 521 of the first air limiting component 5. When in use, the first air limiting component 5 of different specifications can be replaced from the training device to achieve gear adjustment.

[0069] The structural and functional benefits of this invention are shown in the table below:

[0070] It should be noted that the low-frequency vibration function is achieved by adjusting the air resistance through the second air-limiting element 426, with an adjustment range of 5–15 cmH2O. It can generate mechanical vibrations of 10–30 Hz under the drive of expiratory airflow, helping to loosen sputum in the patient's airway. By replacing the second air-limiting element 426 with different specifications, the flow cross-sectional area of ​​the air outlet 4263 in the second air-limiting element 426 can be changed, thereby achieving air resistance adjustment through the second air-limiting element 426.

[0071] The beneficial effects of this invention are as follows: Lung protection and training are combined: the daily mode resistance is ≤5 cmH2O, and the training mode is adjustable from 5 to 20 cmH2O to adapt to different stages of the disease. Highly efficient oxygen supplementation: Stores and supplies oxygen to quickly correct hypoxia and improve training safety; Ventilation efficiency optimization: Positive expiratory pressure reduces respiratory rate, decreases dead space ventilation, and improves oxygenation; Airway clearance: Low-frequency vibration during the inspiratory phase effectively loosens sputum and reduces the risk of infection; Alternating high and low resistance training: avoids the risk of hypoxia caused by continuous high load and improves rehabilitation efficiency; Safe and reliable: Pressure limiting valve 3 prevents lung injury; passive design makes it easy to use at home. Multifunctional integration: Integrates oxygen inhalation, training, sputum clearance, and nebulization to improve treatment adherence.

[0072] The steps for using this invention are as follows: Routine use (lung protection and oxygen therapy): Move the first gas limiting component 5 to the normal position; Connect the oxygen source to the nebulizer (optional); Slow, deep breathing with the mouthpiece interface provides extremely low inhalation resistance. Each training session lasts 10–15 minutes, twice a day.

[0073] Training mode (strength training): Move the first gas limiting component 5 to the training position.

[0074] Select the initial inhalation resistance setting (it is recommended to start with 5 cmH2O); Take deep breaths, inhaling for 3–4 seconds and exhaling for 4–6 seconds each time, being careful to avoid holding your breath; After adaptation, gradually increase the resistance level, aiming for a Borg dyspnea score of 3–4. Use 1–2 times daily for 10–15 minutes each time.

[0075] Alternating high and low resistance training (advanced program): Warm up for 2 minutes in normal mode; Switch to training mode, set to low (5–10 cmH2O), and inhale 5 times. Adjust to high setting (15–20 cmH2O) and inhale 5 times; Repeat the low-high alternation for 4–6 sets; Finally, spend 2 minutes organizing the daily routine.

[0076] Safety Precautions: If SpO2 < 88% or dizziness or chest pain occurs during training, stop immediately and return to your normal routine. The training mode is contraindicated for patients in the acute exacerbation phase, pneumothorax, severe hemoptysis, or uncontrolled arrhythmia. After each use, disassemble the PEP valve and mouthpiece, and clean with warm water or use disposable parts.

[0077] Oxygen storage stage: Oxygen is introduced through the air inlet 11, pushing the piston 22 to the top of its stroke, and about 350mL of oxygen is stored in the transparent chamber 21. The completion of oxygen storage can be visually confirmed by the position of the piston 22. Inhalation and Oscillation Phase: The patient inhales actively by holding the mouthpiece connector 44 in their mouth, creating negative pressure in the chamber of the pressure limiting valve 3. When the negative pressure reaches the trigger threshold, the spring valve (air plug 32 and spring 3324) opens, and oxygen from the oxygen reservoir 2 rushes into the negative pressure chamber through the spring valve to replenish the negative pressure. Subsequently, the spring valve resets and closes under the action of elastic force. As inhalation continues, the negative pressure in the negative pressure chamber accumulates to the threshold again, and the spring valve opens repeatedly, releasing oxygen again. Through the periodic opening and closing of the spring valve, a high-frequency oscillating airflow is ultimately formed, achieving the synchronous function of oxygen storage and supply with oscillating ventilation.

[0078] Working principle of the expiratory pathway: When the patient actively exhales through the mouthpiece interface, the pressure limiting valve 3 automatically closes under the action of positive expiratory pressure, blocking the backflow of airflow to the oxygen storage / inhalation pathway on the side of the pressure limiting valve 3 near the housing 1, ensuring that the expiratory airflow can only be discharged through the one-way expiratory valve 423; the one-way expiratory valve 423 can be configured with knob end caps of different orifice diameters to adjust the expiratory flow area in stages, thereby precisely controlling the expiratory resistance and forming a stable and adjustable positive expiratory pressure (PEP) in the patient's airway, realizing the functions of lung protection, respiratory muscle training and airway clearance.

[0079] Please see Figure 10 This application discloses a method for using an oxygen storage breathing training device, based on the above embodiments, for an oxygen storage breathing training device for patients with interstitial lung disease. The method includes: S1: Set the first gas limiting component 5 to the first training mode and maintain it for the first preset time; S2: Set the first gas limiting component 5 to the second training mode and maintain it for the second preset time; S3: Set the first gas limiting component 5 to the third training mode and maintain it for the third preset time; S4: Repeat steps S2 to S3, repeating 4 to 6 times.

[0080] It should be understood that the phrase "one embodiment" or "an embodiment" throughout the specification means that a specific feature, structure, or characteristic related to the embodiment is included in at least one embodiment of this application. Therefore, "in one embodiment" or "in an embodiment" appearing throughout the specification does not necessarily refer to the same embodiment. Furthermore, these specific features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Those skilled in the art should also recognize that the embodiments described in the specification are optional embodiments, and the actions and modules involved are not necessarily essential to this application.

[0081] In the various embodiments of this application, it should be understood that the sequence number of each process does not necessarily imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0082] The units described above as separate components may or may not be physically separate. The components shown as units may or may not be physical units; they can be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0083] Based on the disclosure and teachings of the foregoing specification, those skilled in the art can make changes and modifications to the above embodiments. Therefore, the invention is not limited to the specific embodiments described above, and any obvious improvements, substitutions, or modifications made by those skilled in the art based on this invention are within the scope of protection of this invention. Furthermore, although some specific terms are used in this specification, these terms are only for convenience of explanation and do not constitute any limitation on the invention.

Claims

1. An oxygen storage breathing training device for interstitial lung patients, characterized in that, It includes a housing (1), an oxygen reservoir (2), a pressure limiting valve (3), and a mouthpiece assembly (4). The housing (1) has an air inlet (11) and an air outlet (12). The oxygen reservoir (2) is connected to the housing (1). The input end of the pressure limiting valve (3) is connected to the air outlet (12). The mouthpiece assembly (4) is connected to the pressure limiting valve (3).

2. The oxygen storage respiratory training device for interstitial lung patients as claimed in claim 1, wherein, The oxygen storage device (2) includes a chamber (21) and a piston (22). The piston (22) is slidably connected to the inner wall of the chamber (21). The top of the chamber (21) is provided with a pressure equalization port (211). The bottom of the chamber (21) is connected to the shell (1).

3. The oxygen storage respiratory training device for interstitial lung patients as claimed in claim 1 wherein, The pressure limiting valve (3) includes an air guide (31), an air plug (32), and a limiting member (33). The air guide (31) has a first air guide channel (311), and one end of the air guide (31) is provided with an air guide hole (312). The limiting member (33) has a second air guide channel (331), and a bracket (332) is installed on the side wall of the second air guide channel (331). The bracket (332) has multiple air vents (3321). A limiting rod (3322) is installed on the frame (332), and the limiting rod (3322) is connected to a guide rod (3323). A spring (3324) is sleeved on the outside of the guide rod (3323). The air plug (32) is provided with a limiting groove (321). One end of the spring (3324) extends into the limiting groove (321) and abuts against the air plug (32) to apply a force toward the air guide hole (312) to the air plug (32).

4. The oxygen storage and breathing training device for patients with interstitial lung disease as described in claim 1, characterized in that, The training device further includes a first air limiting element (5), which is connected to the pressure limiting valve (3) and the mouthpiece assembly (4).

5. The oxygen storage and breathing training device for patients with interstitial lung disease as described in claim 4, characterized in that, The first gas limiting member (5) has a first channel (51), and a limiting part (52) is provided on the side of the first channel (51), and the limiting part (52) has a first through hole (521).

6. The oxygen storage breathing training device for patients with interstitial lung disease as described in claim 5, characterized in that, The mouthpiece assembly (4) includes a first pipe (41), a second pipe (42), a third pipe (43) and a mouthpiece connector (44). The first pipe (41) and the third pipe (43) are respectively connected to the second pipe (42). One end of the first pipe (41) is connected to the air outlet of the first air limiting member (5), and one end of the third pipe (43) is connected to the mouthpiece connector (44).

7. The oxygen storage breathing training device for patients with interstitial lung disease as described in claim 6, characterized in that, The second pipeline (42) has an exhalation outlet (421) and a nebulized gas inlet (422). The exhalation outlet (421) is equipped with an exhalation check valve (423). The input end of the exhalation check valve (423) is connected to the third pipeline (43) through the second pipeline (42). The nebulized gas inlet (422) is equipped with an inhalation check valve (424). The output end of the inhalation check valve (424) is connected to the third pipeline (43) through the second pipeline (42). The nebulized gas inlet (422) is covered with a cap (425).

8. The oxygen storage breathing training device for patients with interstitial lung disease as described in claim 7, characterized in that, The exhalation outlet (421) is covered with a second air limiting member (426), the second air limiting member (426) has a receiving groove (4261), one end of the second pipe (42) extends into the receiving groove (4261), the side of the receiving groove (4261) is provided with a limiting protrusion (4262), the limiting protrusion (4262) abuts against the second pipe (42), and at least one air outlet (4263) is opened on the surface of the second air limiting member (426).

9. The oxygen storage breathing training device for patients with interstitial lung disease as described in claim 8, characterized in that, The one-way exhalation valve (423) includes a second guide member (4231) and a second diaphragm (4232). The second guide member (4231) is disposed in the second pipeline (42), and the second diaphragm (4232) is located between the second guide member (4231) and the receiving groove (4261) and is connected to the second guide member (4231).

10. A method of using an oxygen storage breathing training device, based on the oxygen storage breathing training device as described in any one of claims 4 to 9, characterized in that, Includes the following steps: S1: Set the first gas limiting component (5) to the first training mode and maintain it for the first preset time; S2: Set the first gas limiting component (5) to the second training mode and maintain it for the second preset time; S3: Set the first gas limiting component (5) to the third training mode and maintain it for the third preset time; S4: Repeat steps S2 to S3, repeating 4 to 6 times.

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