Nasal oxygen catheter device

Abstract

The application discloses a nasal oxygen supply catheter device, which comprises a gas supply pipeline, two inner branch pipes extending from the wall of the gas supply pipeline, an outer covering component, a blocking member and a flexible tube switcher. The outer covering component comprises an outer covering pipe located at the periphery of the gas supply pipeline and an outer protective pipe sleeved outside the inner branch pipes. The blocking member is attached to the end of the outer protective pipe. The flexible tube switcher is attached to the end of the inner branch pipes. The outer covering component and the gas supply pipeline define an outer flow channel, which comprises a first outer flow channel defined by the outer protective pipe, the inner branch pipes and the flexible tube switcher, and a second outer flow channel defined by the outer covering pipe and the gas supply pipeline and communicating with the first outer flow channel. The inner side of the inner branch pipes and the flexible tube switcher defines an inner flow channel.

Description

Technical Field

[0001] This invention relates to the field of oxygen supply medical device technology, and in particular to a nasal oxygen supply catheter device. Background Technology

[0002] Nasal positive pressure oxygenation (NPPOT) is a respiratory support technique that delivers oxygen or an air-gas mixture at above atmospheric pressure to the patient's airway through the nasal cavity. Compared to traditional low-flow nasal oxygenation, positive pressure oxygenation can actively open collapsed airways, increase functional residual capacity, improve oxygenation, and assist breathing to some extent. Currently, nasal positive pressure oxygenation has become an important means of treating various respiratory diseases. Its typical specific oxygenation techniques include two types: continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP).

[0003] Continuous positive airway pressure (CPAP) is characterized by applying a constant positive pressure throughout the entire respiratory cycle (i.e., during inspiration and expiration). This constant pressure acts like a "pneumatic stent," continuously maintaining the patency of the upper airway and alveoli, and has a clear therapeutic effect on diseases such as obstructive sleep apnea and cardiogenic pulmonary edema. Bilevel positive airway pressure (BiPAP) is characterized by providing two different pressures during inspiration and expiration: a higher pressure is used during inspiration to actively assist gas delivery to the lungs, while a lower pressure is switched during expiration to maintain basic airway patency and facilitate carbon dioxide expulsion. BiPAP is particularly suitable for respiratory failure with a risk of carbon dioxide retention, such as acute exacerbations of chronic obstructive pulmonary disease.

[0004] Although existing nasal positive pressure oxygen supply devices have achieved good clinical application results, their structural design still has some shortcomings, specifically in the following aspects.

[0005] 1. The problem of sharing the same gas pathway for inhalation and exhalation. Whether using a CPAP or BiPAP device, the gas pathway inside the nasal cannula or nasal mask is typically single. During inhalation, oxygen enters the patient's nasal cavity through the supply tubing and nasal cannula; during exhalation, the exhaled air also exits along the same path. Although the device often has vents at the distal end of the tubing, in cases of high expiratory flow, long tubing, or a limited number of vents, a significant portion of the exhaled air remains trapped in the shared pathway. When the patient begins their next inhalation, this air, containing a high concentration of carbon dioxide, is re-inhaled, leading to a decrease in the actual inhaled oxygen concentration and an increase in re-inhaled carbon dioxide. This problem is particularly serious for patients with a rapid respiratory rate or insufficient expiratory time, potentially inducing or worsening hypercapnia, weakening the treatment effect, and even causing adverse consequences.

[0006] 2. Insufficient expiratory resistance control during exhalation. In existing devices, the expiratory pathway is often over-open. For example, a typical CPAP device has multiple vents on the tubing or nasal plug, allowing exhaled air to escape freely. While this design makes exhalation "easier," it also makes it difficult to maintain stable end-expiratory airway pressure at the required therapeutic level. Especially in BiPAP, the expiratory phase should provide a lower positive pressure (EPAP) to prevent premature alveolar collapse. However, due to excessively low exhaust resistance, the actual pressure delivered to the patient's airway is often lower than the preset value, even dropping to near atmospheric pressure at the end of exhalation. This causes alveolar collapse at the end of exhalation, reducing functional residual capacity and gas exchange area, thus violating the core therapeutic goal of positive pressure ventilation: maintaining alveolar patency.

[0007] 3. In clinical practice, patients receiving nasal positive pressure oxygen therapy often require other nasal procedures simultaneously, such as: administration of nebulized medications, topical anesthetics, or vasoactive drugs via the nasal cavity; insertion of nasal swabs for respiratory pathogen detection; and insertion of tubular instruments such as nasopharyngeal airways or nasogastric tubes. Existing nasal oxygenation devices, whether plugs or nasal masks, are typically designed solely for oxygen supply. Their structure completely occupies both nasal cavities or forms a seal, without providing any additional channels for other tubular components to enter the nasal cavity. Therefore, when a patient needs to undergo these nasal procedures, healthcare personnel must first remove or remove the plug in use, and then re-put it on and restore oxygen supply after the procedure. This process inevitably leads to interruption of oxygen supply, which can cause serious adverse events such as a sudden drop in blood oxygen saturation and worsening respiratory distress in patients with high oxygen dependence. Summary of the Invention

[0008] In view of the above-mentioned technical problems existing in the prior art, the technical solution adopted by the present invention is as follows.

[0009] This invention provides a nasal oxygen delivery cannula device, comprising:

[0010] The gas supply pipeline has an internal airflow channel for connecting with the oxygen supply system, and two internal branch pipes are arranged at intervals extending radially outward from the pipe wall of the middle section of the gas supply pipeline.

[0011] The outer covering components are arranged at positions corresponding to the two inner branch pipes respectively; the outer covering components include an outer covering pipe located outside the gas supply pipeline and an outer protective pipe sleeved outside the inner branch pipe;

[0012] A sealing element, which is attached to the end of the outer protective tube;

[0013] A flexible tubular switch is arranged in the outer protective pipe and attached to the end of the inner branch pipe;

[0014] The outer casing and the air supply line define an outer flow channel, which includes a first outer flow channel defined by an outer protective pipe, an inner branch pipe, and a flexible tubular switch, and a second outer flow channel defined by the outer casing and the air supply line and communicating with the first outer flow channel; the inner side of the inner branch pipe and the flexible tubular switch defines an inner flow channel.

[0015] This allows one of the inner and outer flow channels to connect with the airflow channel as an intake channel, while the other connects with the outside air as an exhaust channel. During inhalation, the flexible tube switch opens the outlet of the intake channel through the elastic deformation of its tube wall; during exhalation, the flexible tube switch closes the outlet by restoring its tube wall.

[0016] As a further improvement, multiple support protrusions are arranged in an array on the inner wall of the outer casing and on the inner walls corresponding to the outer protective tube and the inner branch tube to support the outer flow channel.

[0017] As a specific implementation, the inner flow channel is used as an air intake channel by connecting the airflow channel in the air supply pipeline to both inner branch pipes; and the outer flow channel is used as an exhaust channel by defining an annular port that communicates with the outside air between the end of the outer casing pipe and the outer circumferential surface of the air supply pipeline.

[0018] The inner side of the end of the flexible tube switch defines the outlet of the air inlet channel, and the outer side of the end and the inner wall of the outer protective tube define the inlet of the exhaust channel. The flexible tube switch is constructed with a tapered structure with a constricted end. During inhalation, positive pressure oxygen from the airflow channel enters the outer flow channel, forcing the end of the flexible tube switch wall to expand radially outward and abut against the inner wall of the outer protective tube, thereby opening the outlet of the air inlet channel and closing the inlet of the exhaust channel. During exhalation, the tube wall of the flexible tube switch returns to its original position and moves away from the inner wall of the outer protective tube, thereby closing the outlet of the air inlet channel and opening the inlet of the exhaust channel.

[0019] As a further improvement, the inner side of the tube wall of the flexible tubular switch is attached with multiple circumferentially arranged skeletons.

[0020] As a specific implementation, the end of the outer tube is sealed to the outer circumferential surface of the air supply pipeline. The middle part of the air supply pipeline has a solid section that divides the airflow channel into two. The end of each airflow channel is connected to the second outer flow channel defined by the corresponding outer tube and the air supply pipeline through a vent hole, and the outer flow channel is used as an air intake channel. The inner flow channel is used as an exhaust channel by extending the inner flow channel to the opposite side of the inner branch and penetrating the solid section and forming a far end port connected to the outside air with the outer circumferential surface of the air supply pipeline.

[0021] An exhaust component is installed at the far end of the inner flow channel. The exhaust component includes at least a one-way exhaust component, which allows gas in the inner flow channel to flow to the outside air while restricting gas in the inner flow channel from flowing to the outside air.

[0022] The end of the flexible tube switch abuts against the inner wall of the outer protective tube and defines the air outlet of the air inlet channel. The inner side of the end of the tube wall defines the air inlet of the exhaust channel. During inhalation, positive pressure oxygen from the airflow channel enters the outer flow channel through the vent, forcing the tube wall of the flexible tube switch away from the inner wall of the outer protective tube, thereby opening the air outlet of the air inlet channel. During exhalation, the tube wall of the flexible tube switch returns to its original position and closes the air outlet of the air inlet channel. The patient's exhaled air enters the inner flow channel, forcing the exhaust one-way component to open.

[0023] As a further improvement, the exhaust system also includes an intake one-way component, which allows outside air to flow into the inner channel while restricting the flow of gas in the inner channel to outside air.

[0024] The exhaust one-way component is a ring-shaped diaphragm element made of silicone material, and the intake one-way component is a duckbill-shaped element made of silicone material;

[0025] A valve plate is installed at the distal end of the inner flow channel. The valve plate has a mounting hole in the central area and multiple exhaust windows arranged circumferentially around the mounting hole. The membrane element is arranged on the outer surface of the valve plate and covers each exhaust window, and the inner side of the membrane element is fixed to the valve plate. The duckbill element extends into the inner flow channel through the mounting hole, and the tail of the duckbill element is fixed to the mounting hole. Thus, the duckbill element allows outside air to enter the inner flow channel, and the duckbill element allows tubular instruments to enter the patient's nasal cavity through the inner flow channel and the occluder.

[0026] As a further improvement, the outer circumferential surface of the air supply pipeline and the position corresponding to the outer tube of each outer covering component are provided with a plurality of circumferentially arranged and axially extended lateral exhaust grooves. The lateral exhaust grooves extend to the outer side of the end of the outer covering tube to form an exposed end, and the exposed end of the lateral exhaust groove forms a flared opening.

[0027] As a further improvement, a pressure equalization channel is provided between the two outer covering components and the first outer flow channel defined by the gas supply pipeline.

[0028] As a further improvement, a protective cover is attached to the exhaust component, and a ventilation window is provided on the side wall of the protective cover.

[0029] As a further improvement, a filter screen is detachably arranged in the mounting hole located on the front side of the tail of the duckbill element.

[0030] The beneficial effects of the nasal oxygen delivery cannula device provided by the present invention are as follows:

[0031] 1. The catheter device provided by the present invention, by configuring a double-layer flow channel structure and cooperating it with a flexible tubular switcher, achieves physical isolation of airflow during inhalation and exhalation, effectively avoiding the problem of exhaled gas being re-inhaled.

[0032] 2. An embodiment of the present invention provides a catheter device that can provide positive end-expiratory pressure support to patients.

[0033] 3. One embodiment of the present invention provides a catheter device in which the inner chamber is configured as a straight channel coaxial with the central through-hole of the occluder, and a duckbill element is arranged on the exhaust component. This allows a tubular instrument to be inserted into the nostril for additional medical treatment without removing the air supply line, and the tubular instrument does not interfere with respiratory support. The duckbill element not only prevents patient asphyxiation but also provides an insertion point for the tubular instrument. Attached Figure Description

[0034] Figure 1 This is a perspective view of the air supply pipeline of the conduit device provided in Embodiment 1 of the present invention.

[0035] Figure 2 This is a perspective view of the outer covering component of the catheter device provided in Embodiment 1 of the present invention.

[0036] Figure 3 A front view of the catheter device provided in Embodiment 1 of the present invention.

[0037] Figure 4 This is a view of the catheter device provided in Embodiment 1 of the present invention during patient inhalation.

[0038] Figure 5This is a view of the catheter device provided in Embodiment 1 of the present invention during patient exhalation.

[0039] Figure 6 A front view of the catheter device provided in Embodiment 2 of the present invention.

[0040] Figure 7 This is a view of the catheter device provided in Embodiment 2 of the present invention during patient inhalation.

[0041] Figure 8 This is a view of the catheter device provided in Embodiment 2 of the present invention during patient exhalation.

[0042] Figure 9 This is a state view of the catheter device provided in Embodiment 2 of the present invention when oxygen supply stops due to a malfunction. Detailed Implementation

[0043] The nasal oxygen delivery catheter device 100 disclosed in this invention is a medical device for positive pressure oxygen therapy. It can be used for continuous positive airway pressure (CPAP) oxygen therapy and bilevel positive airway pressure (BiPAP) oxygen therapy. The device 100, through the combination of a unique dual-layer flow channel structure (the dual-layer flow channel structure being the outer flow channel 31 and the inner flow channel 32, which will be described below) and a flexible switching valve element (the flexible switching valve element being the flexible tubular switcher 50, 50', which will be described below), achieves physical isolation of the airflow during inhalation and exhalation, effectively preventing the problem of exhaled gas being re-inhaled; at the same time, by setting an expiratory resistance element (the expiratory resistance element being the membrane element 71 in the exhaust component 70, which will be described below), a solution is provided for patients who require positive end-expiratory pressure support; the device 100, by configuring a dedicated channel for gas exhaust and also for the insertion of tubular instruments 400 through the nose (the dedicated channel being the inner flow channel 32 in Example 2, which will be described below), makes it possible to perform drug administration, sampling, and other operations without interrupting oxygen supply.

[0044] like Figure 3 and Figure 6 As shown, the device 100 mainly includes: a gas supply line 10, two inner branch pipes 12, two outer covering components 20, two sealing components 60, and two flexible tubular switches 50, 50'.

[0045] The air supply tube 10 is a hollow tube of a certain length, with an airflow channel 11 formed along its length inside. Both ends of the airflow channel 11 are open and connected to two oxygen supply tubes 200 respectively during use. The distal end of the oxygen supply tubes 200 is connected to the oxygen supply system. When in use, the air supply tube 10 spans between the patient's upper lip and the base of the nose. The shape of the air supply tube 10 is a straight or slightly curved strip to conform to the patient's facial contours. The main material of the air supply tube 10 should have appropriate flexibility so that it can be slightly bent to fit different patients' face shapes when worn, while also possessing sufficient compressive strength to prevent accidental compression and airflow obstruction during use.

[0046] In the middle section of the air supply line 10 (approximately below the two nasal cavities 300), two inner branch tubes 12 extend radially outward from the tube wall. The two inner branch tubes 12 are spaced apart by a distance that corresponds to the average distance between the left and right nasal cavities 300 of a human body. The inner branch tubes 12 and the air supply line 10 are preferably manufactured as a single piece, for example, by injection molding. This avoids the risk of air leakage at the connection and simplifies the assembly process.

[0047] Each end of the inner branch tube 12 (i.e., the end furthest from the air supply line 10) is attached with a flexible tubular switcher 50, 50' made of a highly elastic material, such as medical-grade silicone. The orifices of the flexible tubular switchers 50, 50' communicate with the orifices of the inner branch tube 12, and the internal channels of the inner branch tube 12 and the orifices of the flexible tubular switchers 50, 50' together define the inner flow channel 32. The walls of the flexible tubular switchers 50, 50' can expand or contract radially through elastic deformation under the action of the internal and external pressure difference, and can return to their original shape through their own elasticity when the pressure difference disappears or decreases significantly. This reversible elastic deformation is the basis for realizing the dynamic switching of the inspiratory and expiratory channels.

[0048] Two outer covering components 20 are respectively disposed at the locations of the two inner branch pipes 12. Each outer covering component 20 includes an outer covering pipe 22 and an outer protective pipe 21, and the outer covering pipe 22 and the outer protective pipe 21 are integrally connected and internally connected. The outer covering pipe 22 is arranged around the gas supply line 10; the outer protective pipe 21 is sleeved on the inner branch pipe 12 and the flexible tubular switchers 50, 50', and the length of the outer protective pipe 21 is set to be greater than the total length of the inner branch pipe 12 and the flexible tubular switchers 50, 50', thereby ensuring that the ends of the flexible tubular switchers 50, 50' do not protrude from the ends of the outer protective pipe 21, that is, the flexible tubular switchers 50, 50' are completely contained in the outer protective pipe 21. A sealing element 60 (or nose plug) is detachably attached to the end of each outer protective pipe 21. The occluder 60 has a central through hole and side wings around the central through hole. When the occluder 60 is inserted into the patient's nasal cavity 300, its side wings undergo compliant deformation, thereby blocking the port of the nasal cavity 300, so that gas can basically only enter and exit the nasal cavity 300 through the central through hole. In addition, the end section of the outer protective tube 21 provides a certain support for the occluder 60, which can suppress excessive swinging of the air supply line 10 during use.

[0049] The inner diameter of the section of the outer protective tube 21 of the outer covering component 20 that is opposite to the inner branch tube 12 is greater than the outer diameter of the inner branch tube 12. Thus, an annular flow channel is defined between the outer protective tube 21, the inner branch tube 12, and the flexible tubular switch 50, 50'. To distinguish it from the second outer flow channel 312 described below, this flow channel is defined as the first outer flow channel 311. The diameter of the circle containing the inner wall of the outer covering tube 22 of the outer covering component 20 is greater than the outer diameter of the section of the air supply line 10 opposite to the outer covering tube 22. Thus, a flow channel is defined between the outer covering tube 22 and the air supply line 10. To distinguish it from the first outer flow channel 311, this flow channel is defined as the second outer flow channel 312. Because the outer casing 22 is connected to the outer protective pipe 21, the first outer flow channel 311 and the second outer flow channel 312 are connected in the junction area of ​​the outer casing 22 and the outer protective pipe 21 (i.e., the junction area of ​​the gas supply line 10 and the inner branch pipe 12). The flow channel formed by connecting the first outer flow channel 311 and the second outer flow channel 312 is defined as the outer flow channel 31. The outer flow channel 31 is located inside the inner branch pipe 12 and the flexible tubular switch 50, 50', which defines the periphery of the inner flow channel 32.

[0050] With the above structure, each outer covering component 20 defines two flow channels separated by the inner branch tube 12 and the flexible tubing switch 50, 50' between itself and the air supply line 10, namely, an outer flow channel 31 and an inner flow channel 32. The ends of the flexible tubing switch 50, 50' separate the ends (proximal ends) of the inner flow channel 32 and the outer flow channel 31 near the patient's nostril and form ports. Specifically, the end of the tube wall of the flexible tubing switch 50, 50' and the inner wall of the outer protective tube 21 define the proximal port 313 of the outer flow channel 31, and the inner side of the end of the tube wall of the flexible tubing switch 50, 50' defines the proximal port 321 of the inner flow channel 32. Distal ports are constructed at positions of the inner flow channel 32 and the outer flow channel 31 away from the nasal cavity 300. The device 100 of the present invention can be designed such that the distal port of one of the outer flow channel 31 and the inner flow channel 32 is connected to the airflow channel 11 in the air supply line 10, and the distal port of the other flow channel is connected to the outside air. Thus, the flow channel connected to the airflow channel 11 is used as an intake channel 41 for supplying oxygen to perform the oxygen supply function, while the flow channel connected to the outside air is used as an exhaust channel 42 for discharging exhaled gas to perform the exhaust function. Furthermore, the flexible tubular switch 50, 50' is configured such that when inhaled, it is subjected to positive pressure oxygen and the proximal port of the flow channel 41 is opened by a closing deformation, and when exhaled, the proximal port of the flow channel 41 is closed by resetting. Thus, during inhalation, positive pressure oxygen is supplied into the nasal cavity 300 through the proximal port of the flow channel 41, which serves as the air intake channel. During exhalation, the exhaled gas is discharged into the outside air through the proximal and distal ports of the flow channel 42, which serves as the exhaust channel. Because the patient's inhalation and exhalation processes use two isolated flow channels respectively, it can effectively prevent the exhaled gas from mixing with oxygen and being re-supplied into the nasal cavity 300, thereby reducing the amount of carbon dioxide re-inhaled and improving the effect of positive pressure oxygen therapy.

[0051] Rounded corners are provided on the inner wall of the junction between the outer casing 22 and the outer protective pipe 21, and on the outer wall of the junction between the inner branch pipe 12 and the air supply pipe 10, in order to avoid the generation of airflow dead zones in the junction area between the first outer flow channel 311 and the second outer flow channel 312.

[0052] like Figure 2 , Figure 3 , Figure 6As shown, since the device 100 may be squeezed by external objects such as the patient's face, bedding, and clothing during use, in order to prevent the outer flow channel 31 from collapsing due to pressure and thus affecting normal ventilation, the present invention provides multiple support protrusions 23 on the inner wall of the outer casing 22 and on the inner walls of the outer protective tube 21 and the inner branch tube 12. These support protrusions 23 are arranged in an array (e.g., distributed in multiple rows and columns in both the axial and circumferential directions), and their shapes can be hemispherical, conical, or longitudinal short ribs, etc. The height of the support protrusions 23 is set to be slightly smaller than the radial gap of the flow channel, so that even under external pressure, when the wall of the outer casing 22 or the outer protective tube 21 undergoes elastic deformation, the support protrusions 23 will first contact the opposite wall, thereby maintaining a certain gap for gas to pass through. Sufficient gaps are left between the support protrusions 23, and a completely closed partition will not be formed along the axial direction of the flow channel, thus not generating significant resistance to the axial flow of gas.

[0053] The present invention provides two embodiments of an oxygen supply conduit device with different specific structural forms. In the two embodiments, the oxygen supply conduit device is respectively configured with an inner flow channel 32 and an outer flow channel 31 as an air intake channel 41, and with an outer flow channel 31 and an inner flow channel 32 as an exhaust channel 42.

[0054] Example 1 (Inner flow channel 32 serves as intake channel 41, and outer flow channel 31 serves as exhaust channel 42)

[0055] In this embodiment, as Figure 3 As shown, the airflow channel 11 inside the air supply pipeline 10 adopts a through structure, that is, the airflow channel 11 extends from the left end to the right end without any obstruction structure in the middle. The roots of the two inner branch pipes 12 are connected to this through airflow channel 11. The port at the junction of the inner branch pipe 12 and the airflow channel 11 is the far end port 322 of the inner flow channel 32 and becomes the air inlet of the air inlet channel 41. The near end port 321 of the inner flow channel 32 (that is, the port defined by the inner side of the pipe wall end of the flexible tubular switch 50) becomes the air outlet of the air inlet channel 41.

[0056] like Figure 2 and Figure 3As shown, the outer tube 22 of the outer covering component 20 has a circular cross-section. Before installing the outer tube 22, a through notch is machined on the tube wall of the outer tube 22. When installing the outer covering component 20, the tube wall of the outer tube 22 is unfolded so that it can be fitted outside the gas supply line 10. The inner branch tube 12 with the flexible tubular switch 50 attached is inserted into the outer protective tube 21 of the outer covering component 20. After the outer tube 22 is fitted outside the gas supply line 10, the notch is glued and sealed, thereby defining the second outer flow channel 312, which is basically annular. The edges of the adjacent ends of the two outer tubes 22 are bonded and sealed to the outer peripheral surface of the air supply line 10. The edges of the distant ends of the two outer tubes 22 are defined between the outer peripheral surface of the air supply line 10 to form an open annular port. This annular port connects the outside air to the second outer flow channel 312. This annular port serves as the distal port 314 of the outer flow channel 31, connecting the outer flow channel 31 to the outside air. The gas exhaled by the patient enters the outer flow channel 31 through the proximal port 313 of the outer flow channel 31 defined by the end of the flexible tube switch 50 and the inner wall of the outer protective tube 21, and is discharged into the outside air through the annular distal port 314. Therefore, the outer flow channel 31 is used as an exhaust channel 42. The proximal port 313 of the outer flow channel 31 becomes the air inlet of the exhaust channel 42, and the distal port 314 of the outer flow channel 31 becomes the air outlet of the exhaust channel 42.

[0057] like Figure 3 As shown, the inner wall of the proximal section of the outer sheath 21 is configured as a conical wall. In the natural state, that is, when the catheter device 100 is not providing respiratory support to the patient, the flexible tube switch 50 has a conical structure. The cone angle of the flexible tube switch 50 and the conical wall of the outer sheath 21 are in the same direction. In this state, the proximal port 321 of the inner flow channel 32, which is surrounded by the end of the tube wall of the flexible tube switch 50, is a narrowed flow section with a very small cross section. It can be considered that the proximal port 321 of the inner flow channel 32 is basically closed in this state. Therefore, it can be considered that the outlet of the air intake channel 41 is basically closed in this state. The proximal port 313 of the outer flow channel 31, which is defined by the end of the tube wall and the inner wall of the proximal section of the outer sheath 21, is open because the tube wall is away from the inner wall. Therefore, the air intake of the exhaust channel 42 is open in this state.

[0058] like Figure 4As shown, when the oxygen supply system delivers positive pressure oxygen to the airflow channel 11 (i.e., when the patient inhales), the positive pressure oxygen enters the inner flow channel 32 (i.e., the air intake channel 41) through the air supply line 10 and the inner branch pipe 12, and reaches the tube hole of the flexible tube switch 50. The positive pressure oxygen acts on the inner wall of the flexible tube switch 50, and the pressure generated forces the tube wall to expand radially outward. The expansion has two effects: first, the originally closed constriction is opened, and the proximal port 321 of the inner flow channel 32 (i.e., the outlet of the air inlet channel 41) is opened; second, the expanded end of the tube wall abuts against the conical inner wall of the outer protective tube 21, thereby closing the proximal port 313 of the outer flow channel 31 (i.e., the air inlet of the exhaust channel 42). At this time, positive pressure oxygen can only enter the patient's nasal cavity 300 through the proximal port 321 of the inner flow channel 32 and the central through hole of the sealing member 60. Since the proximal port 313 of the outer flow channel 31 is closed, positive pressure oxygen will not enter the outer flow channel 31 (i.e., the exhaust channel 42) through the proximal port 313 of the outer flow channel 31, but will be discharged into the outside air through the distal port 314 of the outer flow channel 31 (i.e., the outlet of the exhaust channel 42). Therefore, oxygen loss through the outer flow channel 31 can be avoided.

[0059] like Figure 5 As shown, when the patient exhales, the pressure inside the nasal cavity 300 increases. This pressure is transmitted to the outer end of the flexible tube switch 50 through the central through-hole of the sealing member 60. At this time, the difference between the positive oxygen pressure inside the tube wall of the flexible tube switch 50 and the expiratory pressure outside the tube wall decreases. In some cases, the pressure outside the tube may even be greater than the pressure inside the tube. The tube wall of the flexible tube switch 50 contracts inward by its own elastic restoring force and returns to its natural state. The end of the tube wall re-forms a constriction, and the proximal port 321 of the inner flow channel 32 (i.e., the outlet of the air inlet channel 41) is basically closed. At the same time, the end of the tube wall leaves the inner wall of the outer protective tube 21, and the proximal port 313 of the outer flow channel 31 (i.e., the air inlet of the exhaust channel 42) reopens. The patient's exhaled air enters the outer flow channel 31 through the proximal port 313, and then flows along the outer flow channel 31 to the outside air through the annular distal port 314 (i.e., the exhaust port of the exhaust passage 42). Since the proximal port 321 of the inner flow channel 32 is essentially closed due to the re-formation of a constriction, the patient's exhaled air does not flow into the inner flow channel 32 through the proximal port 321 and mix with the oxygen in the airflow passage 11, thereby preventing the exhaled air from being re-inhaled.

[0060] If an unexpected interruption of oxygen supply or a decrease in oxygen supply pressure occurs during treatment (e.g., due to the collapse of the oxygen supply tube 200 or a malfunction in the oxygen supply system), the positive pressure in the air supply line 10 will be lost. During the patient's subsequent inhalation, although the tube wall of the flexible tube switch 50 cannot expand outward or expands only slightly due to the lack of positive pressure oxygen acting on the inner wall, causing the proximal port 321 of the inner flow channel 32 to remain basically closed due to the narrowing, the proximal port 313 of the outer flow channel 31, defined by the end of the flexible tube switch 50 tube wall and the inner wall of the outer protective tube 21, remains open because it does not expand or expands only slightly. Therefore, the patient can directly inhale air from the outside through the outer flow channel 31, thereby avoiding insufficient oxygen intake or patient suffocation caused by interruption of oxygen supply or decrease in oxygen supply pressure.

[0061] To enhance the uniformity and reliability of the expansion of the flexible tubular switch 50 and prevent irreversible plastic deformation after repeated deformation, multiple circumferentially arranged skeletons 51 can be attached to the inner wall of the flexible tubular switch 50. The skeletons 51 can be made of polyvinyl chloride or a material with a higher elastic modulus, such as titanium alloy wire. The tube wall region between the skeletons 51 forms wavy folds. These folds provide additional deformation margin during expansion, allowing the tube wall to expand more significantly. Furthermore, the skeletons 51 ensure consistent expansion deformation of the tube wall, preventing deformation only at the ends. This ensures that the flow cross-section of the flexible tubular switch 50 is always limited by its ends. The skeletons 51 also provide additional resilience force when the tube wall returns to its original position, minimizing the size of the constricted section.

[0062] To prevent the distal port 314 of the outer flow channel 31 from being accidentally blocked by external objects (such as the patient's clothing, bedding, or face) and thus affecting the smooth expulsion of exhaled air, such as Figure 1 , Figure 3 As shown, the present invention provides multiple lateral exhaust channels 13 at positions corresponding to the outer casing 22 on the outer peripheral surface of the gas supply pipe 10. These lateral exhaust channels 13 extend axially along the gas supply pipe 10, and their length is set to extend beyond the end of the outer casing 22, thus forming an exposed end. At the exposed end, the lateral exhaust channels 13 further expand into a flared opening. When the distal port 314 of the outer flow channel 31 is blocked by an external object, gas can still be discharged into the outside air from any position of the lateral exhaust channels 13 located outside the outer casing 22. The flared opening design reduces the resistance to gas discharge and reduces airflow noise.

[0063] Because the distal port 314 of the outer flow channel 31, which serves as the exhaust channel 42, of the catheter device 100 in Embodiment 1 is directly connected to the outside air, the exhaled gas experiences very little resistance during the process of being expelled into the outside air. Therefore, the catheter device 100 provided in Embodiment 1 is particularly suitable for providing oxygen therapy to patients without requiring positive end-expiratory pressure support.

[0064] Example 2 (Inner flow channel 32 serves as intake channel 41, and outer flow channel 31 serves as exhaust channel 42)

[0065] In this embodiment, as Figure 6 As shown, the airflow channels 11 inside the air supply pipe 10 are not continuous. Specifically, the airflow channels 11 introduced from both ends of the air supply pipe 10 only extend to a position near the outer casing 22 and are divided into two independent airflow channels 11 on the left and right by the solid section in the middle of the air supply pipe 10. The outer casing 22 of the outer casing component 20 has a semi-circular cross-section. The outer casing 22 covers the outer peripheral surface of the air supply pipe 10 facing the nose while avoiding the outer peripheral surface of the air supply pipe 10 facing the lips. The edges at both ends of the outer casing 22 are bonded and sealed to the outer peripheral surface of the air supply pipe 10, and the side of the outer casing 22 formed by the semi-circular structure is also bonded and sealed to the outer peripheral surface of the air supply pipe 10. The end of each airflow channel 11 is not directly connected to the inner branch pipe 12, but is connected to the second outer flow channel 312 through a vent. Since the first outer flow channel 311 and the second outer flow channel 312 are interconnected, the entire outer flow channel 311 is connected to the second outer flow channel 312. The channel 31 is connected to the corresponding airflow channel 11 through the vent. The positive pressure oxygen in the airflow channel 11 enters the second outer channel 312 through the vent, and then enters the first outer channel 311. It flows into the nasal cavity 300 through the proximal port 313 of the outer channel 31 defined by the end of the flexible tube switch 50' and the inner wall of the outer protective tube 21, and the central through hole of the sealing member 60. Therefore, the outer channel 31 is used as the air intake channel 41. The distal port 314 of the outer channel 31 becomes the air intake port of the air intake channel 41, and the proximal port 313 of the outer channel 31 becomes the air outlet of the air intake channel 41.

[0066] The inner flow channel 32 is no longer connected to the airflow channel 11, but extends in the opposite direction along the inner branch pipe 12, that is, it extends radially toward the solid section of the air supply pipe 10 and penetrates the solid section, and finally forms a port on the outer peripheral surface of the air supply pipe 10 that communicates with the outside air. This port becomes the distal port 322 of the inner flow channel 32. The gas exhaled by the patient enters the inner flow channel 32 through the proximal port 321 of the inner flow channel 32 defined by the wall of the flexible tubular switch 50', and is discharged into the outside air through the distal port 322 of the inner flow channel 32 that communicates with the outer peripheral surface of the air supply pipe 10. Therefore, the inner flow channel 32 is used as the exhaust channel 42, the proximal port 321 of the inner flow channel 32 becomes the air inlet of the exhaust channel 42, and the distal port 322 of the inner flow channel 32 becomes the air outlet of the exhaust channel 42. Furthermore, the distal port 322 of the inner flow channel 32 is substantially coaxial with the central through hole of the sealing member 60.

[0067] The extension section of the inner flow channel 32, which extends in the opposite direction and penetrates the solid section of the air supply pipeline 10, is enlarged so that the diameter of the extension section is larger than the diameter of the inner hole of the inner branch pipe 12. The distal port 322 of each inner flow channel 32 is machined into an attachment port, at which the exhaust component 70 is detachably attached, for example, by snap-fit ​​or threaded connection. The exhaust component 70 has the following specific structure: the exhaust component 70 includes a valve plate 73, an exhaust one-way component, and an intake one-way component. The exhaust one-way component is an annular membrane element 71 made of silicone material, and the intake one-way component is a duckbill element 72 made of silicone material. The valve plate 73 is detachably fixed to the attachment port at the far end of the inner flow channel 32. It is circular in shape and has a mounting hole in the central area. Multiple exhaust windows 731 are arranged around the mounting hole. The membrane element 71 is arranged on the outer surface of the valve plate 73 and covers all the exhaust windows 731. The inner edge of the membrane element 71 is bonded to the valve plate 73, while the outer edge is not bonded to the valve plate 73. Thus, the membrane element 71 allows the exhaled gas to be discharged into the outside air through the exhaust windows 731 by forcing the outer side of the membrane element 71 to deform. The valve plate 73 restricts the outside air from entering the inner flow channel 32 through the exhaust windows 731 by blocking the outer side of the membrane element 71 from deforming in the opposite direction. The duckbill element 72 extends into the inner flow channel 32 through the mounting hole. The edge of the tail of the duckbill element 72 is glued and fixed at the mounting hole. The duckbill element 72 allows outside air to enter the inner flow channel 32 while restricting the gas in the inner flow channel 32 from being discharged into the outside air.

[0068] In this embodiment, the inner wall of the proximal section of the outer protective tube 21 is also configured as a conical wall. In its natural state, the flexible tubular switch 50' has a cylindrical shape. Because the inner wall of the proximal section of the outer protective tube 21 is a conical wall, the end of the tube wall of the flexible tubular switch 50' abuts against the conical wall. Therefore, the proximal port 313 of the outer flow channel 31 defined by the end of the tube wall and the inner wall of the outer protective tube 21 is in a closed state. Consequently, the outlet of the air intake channel 41 is in a closed state, while the proximal port 321 of the inner flow channel 32 defined by the end of the tube wall of the flexible tubular switch 50' is in an open state. Consequently, the inlet of the exhaust channel 42 is in an open state. As a preferred structure, the thickness of the end section of the tube wall of the flexible tubular switch 50' is less than the thickness of other sections, so that the deformation and repositioning of the flexible tubular switch 50' mainly occur in the end section of the tube wall.

[0069] like Figure 7 As shown, when the oxygen supply system delivers positive pressure oxygen to the airflow channel 11 (i.e., when the patient inhales), the oxygen enters the outer flow channel 31 (inlet channel 41) through the airflow channel 11 and the vent. The positive pressure oxygen in the outer flow channel 31 acts on the outer wall of the flexible tubular switch 50', and the resulting pressure forces the end of the tube wall to deform radially inward (i.e., towards the center of the lumen). Due to the deformation, the end of the tube wall leaves the conical inner wall of the outer protective tube 21, thereby opening the proximal port 313 (outlet of the inlet channel 41) of the outer flow channel 31. The positive pressure oxygen enters the patient's nasal cavity 300 through this proximal port 313 and the central through-hole of the sealing member 60. At this time, since the membrane element 71 in the exhaust component 70 is designed to have a certain opening pressure (which is higher than the oxygen pressure during the oxygen supply process), the exhaust window 731 remains closed. At the same time, since the exhaust window 731 remains closed, even if the flexible tubular switch 50' with its end radially inward deformation does not close the proximal port 321 (the air inlet of the exhaust channel 42) of the inner flow channel 32, very little oxygen enters the inner flow channel 32, and there is almost no loss.

[0070] like Figure 8As shown, when the patient exhales, the pressure inside the nasal cavity 300 increases. This pressure is transmitted through the central through-hole of the sealing member 60 to the inner and outer sides of the end of the flexible tubular switch 50'. At this time, the difference between the positive pressure oxygen pressure on the outer side of the flexible tubular switch 50' and the expiratory pressure on the inner side decreases. The tubular wall returns to its original position due to its elastic restoring force, and its end rests against the conical inner wall of the outer protective tube 21, thereby closing the distal port 314 of the outer flow channel 31 (i.e., the outlet of the air inlet channel 41). The patient's exhaled air enters the inner flow channel 32 (exhaust channel 42) and flows along the inner flow channel 32 to the exhaust component 70. The pressure of the exhaled air acts on the membrane element 71, causing its outer edge to deform outward, opening the exhaust window 731, and allowing the exhaled air to be discharged into the outside air through the exhaust window 731. After the exhalation action is completed, the pressure in the inner flow channel 32 returns to normal, and the membrane element 71 resets itself by its own elastic restoring force, re-sealing the exhaust window 731 to prevent outside air from entering.

[0071] If an unexpected interruption of oxygen supply or a drop in oxygen pressure occurs during treatment, and the positive pressure is lost within 10 minutes of the gas supply line, such as... Figure 9 As shown, when the patient actively inhales, a negative pressure is generated in the nasal cavity 300. This negative pressure is transmitted through the inner flow channel 32 to the duckbill element 72 of the exhaust component 70. Because the pressure on the outside (outside air) of the duckbill element 72 is higher than the pressure on the inside (inner flow channel 32), the two lips of the duckbill element 72 open inward, and outside air is drawn into the inner flow channel 32 and enters the patient's nasal cavity 300 through the central opening of the sealing member 60. In this way, even if the oxygen supply is interrupted or the oxygen supply pressure decreases, the patient can still obtain oxygen through the outside air, thereby avoiding insufficient oxygen intake or patient suffocation caused by the interruption of oxygen supply or the decrease in oxygen supply pressure.

[0072] Because the duckbill element 72 has an openable and closable slit structure defined by two lips and the inner flow channel 32 is a straight channel coaxial with the sealing element 60, such as Figure 7 As shown, medical personnel can insert small-diameter tubular instruments 400 (such as drug delivery tubes, nebulization catheters, sampling swabs, nasogastric tubes, etc.) from the outside through the duckbill element 72 without removing the air supply line 10. In practice, the tip of the tubular instrument 400 is aligned with the opening of the duckbill element, and slight pressure is applied. The elastic lips of the duckbill element then open to the sides, allowing the tubular instrument 400 to pass through. The tubular instrument 400 can then travel along the inner flow channel 32, through the central opening of the sealing element 60, and into the patient's nasal cavity 300 to reach the target location for drug delivery, sampling, and other operations. Throughout the entire operation, although the tubular instrument 400 passes through the exhaust component 70, it does not affect the deformation of the membrane element 71 at all, and has minimal impact on the deformation of the end of the flexible tubular switcher 50'. Therefore, the insertion of the tubular instrument 400 has minimal impact on the patient's breathing.

[0073] To ensure that the oxygen supply pressure and flow rate received by the two nasal cavities 300 are basically equal, the two outer covering components 20 are integrally connected by a connecting wall. The two sides of the connecting wall are bonded and sealed to the outer peripheral surface of the solid section in the middle of the air supply pipe 10. Thus, the connecting wall and the outer peripheral surface of the air supply pipe 10 define a pressure equalization channel 33 for connecting the two outer flow channels 31. The cross-sectional area of ​​the pressure equalization channel 33 is designed to be large enough to allow the gas on both sides to flow freely, thereby automatically balancing the pressure on both sides to ensure that the oxygen supply pressure and flow rate received by the two nasal cavities 300 are basically equal.

[0074] To prevent the exhaled gas from being difficult to expel due to the front of the exhaust component 70 being blocked by external coverings, a protective cover 74 is attached to the exhaust component 70. A ventilation window 741 is provided on the side wall of the protective cover 74. The gas discharged through the exhaust window 731 of the exhaust component 70 is discharged from the side through the ventilation window 741 on the side wall of the protective cover 74.

[0075] To prevent particulate matter or microorganisms in the outside air from being inhaled into the patient's respiratory tract when oxygen supply is interrupted, a filter screen can be detachably installed on the front of the tail of the duckbill element 72. The pore size of the filter screen should be able to block common airborne suspended particles while maintaining low inhalation resistance. The filter screen can be replaced periodically to maintain its filtration efficiency.

[0076] In this embodiment, because the exhaust component 70 has a membrane element 71 designed to have a certain opening pressure, it can provide controllable flow resistance (the magnitude of which can be adjusted by selecting membranes of different thicknesses or materials of different hardness), thereby maintaining a certain positive airway pressure at the end of expiration. Therefore, the device 100 of this embodiment is particularly suitable for oxygen therapy requiring positive end-expiratory pressure support, such as bilevel positive airway pressure (BiPAP) therapy for patients with acute exacerbations of chronic obstructive pulmonary disease. In these patients, appropriate positive end-expiratory pressure support prevents premature closure of small airways at the end of expiration, improves oxygenation, and reduces the work of breathing.

[0077] The device 100 of this embodiment allows a tubular instrument 400 to be inserted into the nostril for additional medical treatment without removing the air supply line 10, and the tubular instrument 400 does not interfere with respiratory support, by configuring the inner chamber as a straight channel coaxial with the central through-hole of the occluder 60 and arranging a duckbill element 72 on the exhaust component 70. In this embodiment, the duckbill element 72 not only prevents patient suffocation but also provides an insertion port for the tubular instrument 400.

Claims

1. A nasal oxygen delivery cannula device, characterized in that, include: The gas supply pipeline has an internal airflow channel for connecting with the oxygen supply system, and two internal branch pipes are arranged at intervals extending radially outward from the pipe wall of the middle section of the gas supply pipeline. The outer covering components are arranged at positions corresponding to the two inner branch pipes respectively; the outer covering components include an outer covering pipe located outside the gas supply pipeline and an outer protective pipe sleeved outside the inner branch pipe; A sealing element, which is attached to the end of the outer protective tube; A flexible tubular switch is arranged in the outer protective pipe and attached to the end of the inner branch pipe; The outer casing and the air supply line define an outer flow channel, which includes a first outer flow channel defined by an outer protective pipe, an inner branch pipe, and a flexible tubular switch, and a second outer flow channel defined by the outer casing and the air supply line and communicating with the first outer flow channel; the inner side of the inner branch pipe and the flexible tubular switch defines an inner flow channel. This allows one of the inner and outer flow channels to connect with the airflow channel as an intake channel, while the other connects with the outside air as an exhaust channel. During inhalation, the flexible tube switch opens the outlet of the intake channel through the elastic deformation of its tube wall; during exhalation, the flexible tube switch closes the outlet by restoring its tube wall.

2. The nasal oxygen delivery cannula device according to claim 1, characterized in that, Multiple support protrusions are arranged in an array on the inner wall of the outer casing and on the inner walls corresponding to the outer protective pipe and the inner branch pipe to support the outer flow channel.

3. The nasal oxygen delivery cannula device according to claim 1, characterized in that, The inner flow channel is used as an air intake channel by connecting the airflow channel in the air supply pipeline to both inner branch pipes; the outer flow channel is used as an exhaust channel by defining an annular port that communicates with the outside air between the end of the outer casing and the outer circumferential surface of the air supply pipeline. The inner side of the end of the flexible tube switch defines the outlet of the air inlet channel, and the outer side of the end and the inner wall of the outer protective tube define the inlet of the exhaust channel. The flexible tube switch is constructed with a tapered structure with a constricted end. During inhalation, positive pressure oxygen from the airflow channel enters the outer flow channel, forcing the end of the flexible tube switch wall to expand radially outward and abut against the inner wall of the outer protective tube, thereby opening the outlet of the air inlet channel and closing the inlet of the exhaust channel. During exhalation, the tube wall of the flexible tube switch returns to its original position and moves away from the inner wall of the outer protective tube, thereby closing the outlet of the air inlet channel and opening the inlet of the exhaust channel.

4. The nasal oxygen delivery cannula device according to claim 3, characterized in that, The flexible tubular switch has multiple circumferentially arranged skeletons attached to the inner side of its tube wall.

5. The nasal oxygen delivery cannula device according to claim 1, characterized in that, The end of the outer tube is sealed to the outer circumferential surface of the air supply pipeline. The middle part of the air supply pipeline has a solid section that divides the airflow channel into two. The end of each airflow channel is connected to the second outer flow channel defined by the corresponding outer tube and the air supply pipeline through a vent hole, and the outer flow channel is used as an air intake channel. The inner flow channel is used as an exhaust channel by extending the inner flow channel to the opposite side of the inner branch and penetrating the solid section and forming a far end port connected to the outside air with the outer circumferential surface of the air supply pipeline. An exhaust component is installed at the far end of the inner flow channel. The exhaust component includes at least a one-way exhaust component, which allows gas in the inner flow channel to flow to the outside air while restricting gas in the inner flow channel from flowing to the outside air. The end of the flexible tube switch abuts against the inner wall of the outer protective tube and defines the air outlet of the air inlet channel. The inner side of the end of the tube wall defines the air inlet of the exhaust channel. During inhalation, positive pressure oxygen from the airflow channel enters the outer flow channel through the vent, forcing the tube wall of the flexible tube switch away from the inner wall of the outer protective tube, thereby opening the air outlet of the air inlet channel. During exhalation, the tube wall of the flexible tube switch returns to its original position and closes the air outlet of the air inlet channel. The patient's exhaled air enters the inner flow channel, forcing the exhaust one-way component to open.

6. The nasal oxygen delivery cannula device according to claim 5, characterized in that, The exhaust system also includes a one-way intake component, which allows outside air to flow into the inner channel while restricting the flow of gas in the inner channel to outside air. The exhaust one-way component is a ring-shaped diaphragm element made of silicone material, and the intake one-way component is a duckbill-shaped element made of silicone material; A valve plate is installed at the distal end of the inner flow channel. The valve plate has a mounting hole in the central area and multiple exhaust windows arranged circumferentially around the mounting hole. The membrane element is arranged on the outer surface of the valve plate and covers each exhaust window, and the inner side of the membrane element is fixed to the valve plate. The duckbill element extends into the inner flow channel through the mounting hole, and the tail of the duckbill element is fixed to the mounting hole. Thus, the duckbill element allows outside air to enter the inner flow channel, and the duckbill element allows tubular instruments to enter the patient's nasal cavity through the inner flow channel and the occluder.

7. The nasal oxygen delivery cannula device according to claim 3, characterized in that, On the outer circumferential surface of the gas supply pipeline, at the position corresponding to the outer tube of each outer covering component, there are multiple lateral exhaust grooves arranged circumferentially and extending axially. The lateral exhaust grooves extend to the outer side of the end of the outer tube to form an exposed end, and the exposed end of the lateral exhaust groove forms a flared opening.

8. The nasal oxygen delivery cannula device according to claim 5, characterized in that, A pressure equalization channel is provided between the two outer covering components and the first outer flow channel defined by the gas supply pipeline.

9. The nasal oxygen delivery cannula device according to claim 6, characterized in that, The exhaust component is fitted with a protective cover, and the side wall of the protective cover has a ventilation window.

10. The nasal oxygen delivery cannula device according to claim 6, characterized in that, A filter screen is detachably arranged in the mounting hole located on the front side of the tail of the duckbill element.

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